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query-laysum | 4346 | [
{
"role": "user",
"content": "Abstract: Background\nAsparaginase has played a crucial role in the improvement of survival in children with acute lymphoblastic leukaemia (ALL), which is the commonest cancer among children. Survival rates have steadily increased over decades since the introduction of asparaginase to ALL therapy, and overall survival rates reach 90% with the best contemporary protocols. Currently, polyethylene glycolated native Escherichia coli-derived L-asparaginase (PEG-asparaginase) is the preferred first-line asparaginase preparation. Besides its clinical benefits, PEG-asparaginase is well known for severe toxicities. Agreement on the optimal dose, treatment duration, and frequency of administration has never been reached among clinicians.\nObjectives\nPrimary objective\nTo assess the effect of the number of PEG-asparaginase doses on survival and relapse in children and adolescents with ALL.\nSecondary objectives\nTo assess the association between the number of doses of PEG-asparaginase and asparaginase-associated toxicities (e.g. hypersensitivity, thromboembolism, pancreatitis and osteonecrosis).\nTo undertake a network meta-analysis at dose-level in order to generate rankings of the number of doses of PEG-asparaginase used in the treatment for ALL, according to their benefits (survival and relapse) and harms (toxicity).\nSearch methods\nWe searched CENTRAL, PubMed, Embase, Web of Science databases and three trials registers in November 2021, together with reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing different PEG-asparaginase treatment regimens in children and adolescents (< 18 years of age) with first-line ALL treated with multiagent chemotherapy including PEG-asparaginase.\nData collection and analysis\nUsing a standardised data collection form, two review authors independently screened and selected studies, extracted data, assessed risk of bias for each outcome using a standardised tool (RoB 2.0) and assessed the certainty of evidence for each outcome using the GRADE approach. Primary outcomes included overall survival, event-free survival and leukaemic relapse. Secondary outcomes included asparaginase-associated toxicities (hypersensitivity, thromboembolism, pancreatitis, sinusoidal obstruction syndrome and osteonecrosis as well as overall asparaginase-associated toxicity).\nWe conducted the review and performed the analyses in accordance with the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe included three RCTs in the review, and identified an additional four ongoing studies. We judged outcomes of two RCTs to be at low risk of bias in all the Cochrane risk of bias (RoB 2) domains. We rated the remaining study as having some concerns regarding bias. Due to concerns about imprecision, we rated all outcomes as having low- to moderate-certainty evidence.\nOne study compared intermittent PEG-asparaginase treatment (eight doses of PEG-asparaginase, 1000 IU/m2, intramuscular (IM) administration) versus continuous PEG-asparaginase treatment (15 doses of PEG-asparaginase, 1000 IU/m2, IM) in 625 participants with non-high risk ALL aged 1.0 to 17.9 years. We found that treatment with eight doses probably results in little to no difference in event-free survival compared to treatment with 15 doses (RR 1.01, 95% CI 0.97 to 1.06; moderate-certainty evidence). Compared to treatment with 15 doses, treatment with eight doses may result in either no difference or a slight reduction in hypersensitivity (RR 0.64, 95% CI 0.21 to 1.93; low-certainty evidence), thromboembolism (RR 0.55, 95% CI 0.22 to 1.36; low-certainty evidence) or osteonecrosis (RR 0.68, 95% CI 0.35 to 1.32; low-certainty evidence). Furthermore, we found that treatment with eight doses probably reduces pancreatitis (RR 0.31, 95% CI 0.12 to 0.75; moderate-certainty evidence) and asparaginase-associated toxicity (RR 0.53, 95% CI 0.35 to 0.78; moderate-certainty evidence) compared to treatment with 15 doses.\nOne study compared low-risk standard treatment with additional PEG-asparaginase (six doses, 2500 IU/m2, IM) versus low-risk standard treatment (two doses, 2500 IU/m2, IM) in 1857 participants aged one to nine years old with standard low-risk ALL. We found that, compared to treatment with two doses, treatment with six doses probably results in little to no difference in overall survival (RR 0.99, 95% CI 0.98 to 1.00; moderate-certainty evidence) and event-free survival (RR 1.01, 95% CI 0.99 to 1.04; moderate-certainty evidence), and may result in either no difference or a slight increase in osteonecrosis (RR 1.65, 95% CI 0.91 to 3.00; low-certainty evidence). Furthermore, we found that treatment with six doses probably increases hypersensitivity (RR 12.05, 95% CI 5.27 to 27.58; moderate-certainty evidence), pancreatitis (RR 4.84, 95% CI 2.15 to 10.85; moderate-certainty evidence) and asparaginase-associated toxicity (RR 4.49, 95% CI 3.05 to 6.59; moderate-certainty evidence) compared to treatment with two doses.\nOne trial compared calaspargase (11 doses, 2500 IU/m2, intravenous (IV)) versus PEG-asparaginase (16 doses, 2500 IU/m2, IV) in 239 participants aged one to 21 years with standard- and high-risk ALL and lymphoblastic lymphoma. We found that treatment with 11 doses of calaspargase probably results in little to no difference in event-free survival compared to treatment with 16 doses of PEG-asparaginase (RR 1.06, 95% CI 0.97 to 1.16; moderate-certainty evidence). However, treatment with 11 doses of calaspargase probably reduces leukaemic relapse compared to treatment with 16 doses of PEG-asparaginase (RR 0.32, 95% CI 0.12 to 0.83; moderate-certainty evidence). Furthermore, we found that treatment with 11 doses of calaspargase results in either no difference or a slight reduction in hypersensitivity (RR 1.17, 95% CI 0.64 to 2.13; low-certainty evidence), pancreatitis (RR 0.85, 95% CI 0.47 to 1.52; low-certainty evidence), thromboembolism (RR 0.83, 95% CI 0.48 to 1.42; low-certainty evidence), osteonecrosis (RR 0.63, 95% CI 0.15 to 2.56; low-certainty evidence) and asparaginase-associated toxicity (RR 1.00, 95% CI 0.71 to 1.40; low-certainty evidence) compared to treatment with 16 doses of PEG-asparaginase.\nAuthors' conclusions\nWe were not able to conduct a network meta-analysis, and could not draw clear conclusions because it was not possible to rank the interventions. Overall, we found that different numbers of doses of PEG-asparaginase probably result in little to no difference in event-free survival across all studies. In two studies, we found that a higher number of PEG-asparaginase doses probably increases pancreatitis and asparaginase-associated toxicities.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We were not able to draw any clear conclusions because we were not able to combine the results of the studies in any analyses. However, the three studies showed that there was probably little to no difference in survival estimates when different PEG-asparaginase treatments were compared. Two studies found that there was probably an increased risk of overall toxicity and pancreatitis in people given the most intensive asparaginase treatment."
}
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query-laysum | 4347 | [
{
"role": "user",
"content": "Abstract: Background\nStroke survivors are often physically inactive as well as sedentary,and may sit for long periods of time each day. This increases cardiometabolic risk and has impacts on physical and other functions. Interventions to reduce or interrupt periods of sedentary time, as well as to increase physical activity after stroke, could reduce the risk of secondary cardiovascular events and mortality during life after stroke.\nObjectives\nTo determine whether interventions designed to reduce sedentary behaviour after stroke, or interventions with the potential to do so, can reduce the risk of death or secondary vascular events, modify cardiovascular risk, and reduce sedentary behaviour.\nSearch methods\nIn December 2019, we searched the Cochrane Stroke Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, Conference Proceedings Citation Index, and PEDro. We also searched registers of ongoing trials, screened reference lists, and contacted experts in the field.\nSelection criteria\nRandomised trials comparing interventions to reduce sedentary time with usual care, no intervention, or waiting-list control, attention control, sham intervention or adjunct intervention. We also included interventions intended to fragment or interrupt periods of sedentary behaviour.\nData collection and analysis\nTwo review authors independently selected studies and performed 'Risk of bias' assessments. We analyzed data using random-effects meta-analyses and assessed the certainty of the evidence with the GRADE approach.\nMain results\nWe included 10 studies with 753 people with stroke. Five studies used physical activity interventions, four studies used a multicomponent lifestyle intervention, and one study used an intervention to reduce and interrupt sedentary behaviour. In all studies, the risk of bias was high or unclear in two or more domains. Nine studies had high risk of bias in at least one domain.\nThe interventions did not increase or reduce deaths (risk difference (RD) 0.00, 95% confidence interval (CI) -0.02 to 0.03; 10 studies, 753 participants; low-certainty evidence), the incidence of recurrent cardiovascular or cerebrovascular events (RD -0.01, 95% CI -0.04 to 0.01; 10 studies, 753 participants; low-certainty evidence), the incidence of falls (and injuries) (RD 0.00, 95% CI -0.02 to 0.02; 10 studies, 753 participants; low-certainty evidence), or incidence of other adverse events (moderate-certainty evidence).\nInterventions did not increase or reduce the amount of sedentary behaviour time (mean difference (MD) +0.13 hours/day, 95% CI -0.42 to 0.68; 7 studies, 300 participants; very low-certainty evidence). There were too few data to examine effects on patterns of sedentary behaviour.\nThe effect of interventions on cardiometabolic risk factors allowed very limited meta-analysis.\nAuthors' conclusions\nSedentary behaviour research in stroke seems important, yet the evidence is currently incomplete, and we found no evidence for beneficial effects. Current World Health Organization (WHO) guidelines recommend reducing the amount of sedentary time in people with disabilities, in general. The evidence is currently not strong enough to guide practice on how best to reduce sedentariness specifically in people with stroke.\nMore high-quality randomised trials are needed, particularly involving participants with mobility limitations. Trials should include longer-term interventions specifically targeted at reducing time spent sedentary, risk factor outcomes, objective measures of sedentary behaviour (and physical activity), and long-term follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In December 2019, after comprehensively searching the scientific literature, we identified 10 randomised controlled trials for inclusion in the review. The studies involved a total of 753 participants at all stages of care, including being in hospital or back to living at home. Most of the people who took part were able to walk and stand on their own. The interventions ranged in duration from six weeks up to 18 months and all involved some element of increased physical activity. Studies included exercise alone (one study) or in combination with education and coaching (one study); physical activity alone (one study) or in combination with a mobile phone 'app' (one study), multi-component lifestyle interventions including physical activity (four studies), and additional inpatient physiotherapy (one study). One study used an intervention specifically aimed at breaking up long periods of continuous sitting.\nBecause of problems in the ways they were conducted, and in the ways they were reported by the research teams, all studies were at high or unclear risk of bias."
}
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query-laysum | 4348 | [
{
"role": "user",
"content": "Abstract: Background\nLower respiratory tract infections (LRTIs) in young children account for 1.4 million deaths annually worldwide. Antibiotics could be beneficial in preventing LRTIs in high-risk children, and may also help prevent school absenteeism and work days missed by children and/or carers. While it is well documented that the efficacy of antibiotic prophylaxis for RTIs decreases over time, there are no reviews that describe the use of antibiotic prophylaxis to prevent LRTIs in high-risk children aged 12 years and under.\nObjectives\nTo assess the effectiveness and safety of antibiotic prophylaxis in the prevention of bacterial LRTIs in high-risk children aged 12 years and under.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 1) and the Database of Abstracts of Reviews of Effects (DARE), MEDLINE and MEDLINE In-Process (OvidSP) (1946 to 13 February 2015), EMBASE (OvidSP) (1974 to 12 February 2015), Science Citation Index Expanded (1945 to 13 February 2015) and Conference Proceedings Citation Index-Science (Web of Science Core Collection) (1990 to 13 February 2015). We searched for ongoing studies on ClinicalTrials.gov and the World Health Organization ICTRP. We handsearched the bibliographies of retrieved full texts of relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing oral or intravenous antibiotics versus placebo or no treatment to prevent infections in high-risk children aged 12 years and under. We used a combination of the Centers for Disease Control and Prevention (CDC), National Health Service (NHS), American Academy of Paediatrics (AAP) and National Institute for Health and Care Excellence (NICE) guidelines to define conditions at higher risk of complications. Our primary outcome was the incidence of bacterial lower respiratory infections. Secondary outcomes included clinical function, hospital admission, mortality, growth, use of secondary antibiotics, time off school or parental work, quality of life and adverse events.\nData collection and analysis\nWe extracted data using a customised data extraction sheet, assessed the risk of bias of included studies using the Cochrane 'Risk of bias' criteria, and used the GRADE criteria to rate the quality of the evidence. We used a random-effects model for meta-analysis. We presented the results narratively where we could not statistically combine data.\nMain results\nWe included 10 RCTs of high-risk children using antibiotics (azithromycin, ciprofloxacin, co-trimoxazole, isoniazid, oral penicillin V or vancomycin) to prevent LRTIs. Three studies included HIV-infected children (n = 1345), four cystic fibrosis (n = 429) and one each sickle cell disease (n = 219), cancer (n = 160) and low birth weight neonates with underlying respiratory disorders (n = 40). The study duration ranged from seven days to three years. The quality of the evidence from studies including children with HIV infection, cystic fibrosis or cancer was moderate. Due to inadequate data, we were unable to rate the quality of the evidence for two studies: one in children with sickle cell disease (low risk of bias), and another in low birth weight neonates with underlying respiratory disorders (high risk of bias).\nIn HIV-infected children receiving continuous isoniazid prophylaxis, there was no significant difference in the incidence of pulmonary tuberculosis (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.32 to 1.29, I2 statistic = 47%, P value = 0.21). There was no significant effect on mortality with co-trimoxazole or isoniazid prophylaxis (RR 0.82, 0.46 to 1.46, I2 statistic = 76%, P value = 0.58); however, analysis of one study that used co-trimoxazole showed a significant reduction in mortality (RR 0.67, 95% CI 0.53 to 0.85, P value = 0.001). There was a significant decrease in the rates of hospital admission per child-year of follow-up with co-trimoxazole prophylaxis in one study (P value = 0.01). There was no evidence of increased adverse events due to antibiotic prophylaxis (RR 1.10, 95% CI 0.75 to 1.64, I2 statistic = 22%, P value = 0.28); however, there was scant reporting of antibiotic resistance - the one study that did assess this found no increase.\nIn two studies of children with cystic fibrosis receiving ciprofloxacin prophylaxis, there was no significant difference in Pseudomonas infections (RR 0.76, 0.44 to 1.31, I2 statistic = 0%, P value = 0.33). In two studies assessing the benefit of azithromycin prophylaxis, there was a significant reduction in the frequency of pulmonary exacerbations (RR 0.60, 95% CI 0.48 to 0.76, I2 statistic = 0%, P value < 0.0001). The effect of antibiotic prophylaxis on growth in children with cystic fibrosis was inconsistent across the studies. There was an increased risk of emergence of pathogenic strains with either azithromycin or ciprofloxacin prophylaxis in two studies reporting this outcome. There was no significant difference in the quality of life (one study). In three studies, there was no significant increase in the frequency of adverse events with prophylaxis with azithromycin (two studies) or ciprofloxacin (one study). There was no evidence of increased antibiotic resistance in two studies.\nIn the one study of children with sickle cell disease, a significantly lesser proportion of children with pneumococcal septicaemia was reported with penicillin V prophylaxis (P value = 0.0025).\nIn the one study of children with cancer there was a significant decrease in Pneumocystis carinii pneumonia with trimethoprim-sulfamethoxazole prophylaxis (RR 0.03, 95% CI 0.00 to 0.47, P value < 0.01). There was no significant increase in the frequency of adverse events with antibiotic prophylaxis.\nIn low birth weight children with underlying respiratory disorders, there was no significant difference in the proportion of children with pulmonary infection with vancomycin prophylaxis (P value = 0.18).\nNo included studies reported time off school or carer time off work.\nAuthors' conclusions\nThere is inconclusive evidence that antibiotic prophylaxis in certain groups of high-risk children can reduce pneumonia, exacerbations, hospital admission and mortality in certain conditions. However, limitations in the evidence base mean more clinical trials assessing the effectiveness of antibiotics for preventing LRTIs in children at high risk should be conducted. Specifically, clinical trials assessing the effectiveness of antibiotics for preventing LRTIs in congenital heart disease, metabolic disease, endocrine and renal disorders, neurological disease or prematurity should be a priority.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In February 2015, we searched for studies examining the effect of antibiotics to prevent LRTI in children aged 12 years and under with an increased risk of contracting such infections.\nWe included 10 studies; three examined the effectiveness of antibiotics in 1345 children with HIV, four in 429 children with cystic fibrosis, one in 219 children with sickle cell disease, one in 160 children undergoing treatment for cancer, and one in 40 children who were underweight at birth with underlying breathing problems.\nThe study duration was between 18.9 and 24.7 months for children with HIV, between six and 36 months in children with cystic fibrosis, 15 months in one study of children with sickle cell disease, 13 to 24 months in one study of children with cancer, and seven days in low birth weight newborns with underlying respiratory problems."
}
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query-laysum | 4349 | [
{
"role": "user",
"content": "Abstract: Background\nThere is growing research and policy interest in the potential for using the natural environment to enhance human health and well-being. This resource may be underused as a health promotion tool to address the increasing burden of common health problems such as increased chronic diseases and mental health concerns. Outdoor environmental enhancement and conservation activities (EECA) (for instance unpaid litter picking, tree planting or path maintenance) offer opportunities for physical activity alongside greater connectedness with local environments, enhanced social connections within communities and improved self-esteem through activities that improve the locality which may, in turn, further improve well-being.\nObjectives\nTo assess the health and well-being impacts on adults following participation in environmental enhancement and conservation activities.\nSearch methods\nWe contacted or searched the websites of more than 250 EECA organisations to identify grey literature. Resource limitations meant the majority of the websites were from UK, USA, Canada and Australia. We searched the following databases (initially in October 2012, updated October 2014, except CAB Direct, OpenGrey, SPORTDiscus, and TRIP Database), using a search strategy developed with our project advisory groups (predominantly leaders of EECA-type activities and methodological experts): ASSIA; BIOSIS; British Education Index; British Nursing Index; CAB Abstracts; Campbell Collaboration; Cochrane Public Health Specialized Register; DOPHER; EMBASE; ERIC; Global Health; GreenFILE; HMIC; MEDLINE-in-Process; MEDLINE; OpenGrey; PsychINFO; Social Policy and Practice; SPORTDiscus; TRoPHI; Social Services Abstracts; Sociological Abstracts; The Cochrane Library; TRIP database; and Web of Science. Citation and related article chasing was used. Searches were limited to studies in English published after 1990.\nSelection criteria\nTwo review authors independently screened studies. Included studies examined the impact of EECA on adult health and well-being. Eligible interventions needed to include each of the following: intended to improve the outdoor natural or built environment at either a local or wider level; took place in urban or rural locations in any country; involved active participation; and were NOT experienced through paid employment.\nWe included quantitative and qualitative research. Includable quantitative study designs were: randomised controlled trials (RCTs), cluster RCTs, quasi-RCTs, cluster quasi-RCTs, controlled before-and-after studies, interrupted-time-series, cohort studies (prospective or retrospective), case-control studies and uncontrolled before-and-after studies (uBA). We included qualitative research if it used recognised qualitative methods of data collection and analysis.\nData collection and analysis\nOne reviewer extracted data, and another reviewer checked the data. Two review authors independently appraised study quality using the Effective Public Health Practice Project tool (for quantitative studies) or Wallace criteria (for qualitative studies). Heterogeneity of outcome measures and poor reporting of intervention specifics prevented meta-analysis so we synthesised the results narratively. We synthesised qualitative research findings using thematic analysis.\nMain results\nDatabase searches identified 21,420 records, with 21,304 excluded at title/abstract. Grey literature searches identified 211 records. We screened 327 full-text articles from which we included 21 studies (reported in 28 publications): two case-studies (which were not included in the synthesis due to inadequate robustness), one case-control, one retrospective cohort, five uBA, three mixed-method (uBA, qualitative), and nine qualitative studies. The 19 studies included in the synthesis detailed the impacts to a total of 3,603 participants: 647 from quantitative intervention studies and 2630 from a retrospective cohort study; and 326 from qualitative studies (one not reporting sample size).\nIncluded studies shared the key elements of EECA defined above, but the range of activities varied considerably. Quantitative evaluation methods were heterogeneous. The designs or reporting of quantitative studies, or both, were rated as ‘weak’ quality with high risk of bias due to one or more of the following: inadequate study design, intervention detail, participant selection, outcome reporting and blinding.\nParticipants’ characteristics were poorly reported; eight studies did not report gender or age and none reported socio-economic status. Three quantitative studies reported that participants were referred through health or social services, or due to mental ill health (five quantitative studies), however participants' engagement routes were often not clear.\nWhilst the majority of quantitative studies (n = 8) reported no effect on one or more outcomes, positive effects were reported in six quantitative studies relating to short-term physiological, mental/emotional health, and quality-of-life outcomes. Negative effects were reported in two quantitative studies; one study reported higher levels of anxiety amongst participants, another reported increased mental health stress.\nThe design or reporting, or both, of the qualitative studies was rated as good in three studies or poor in nine; mainly due to missing detail about participants, methods and interventions. Included qualitative evidence provided rich data about the experience of participation. Thematic analysis identified eight themes supported by at least one good quality study, regarding participants' positive experiences and related to personal/social identity, physical activity, developing knowledge, spirituality, benefits of place, personal achievement, psychological benefits and social contact. There was one report of negative experiences.\nAuthors' conclusions\nThere is little quantitative evidence of positive or negative health and well-being benefits from participating in EECA. However, the qualitative research showed high levels of perceived benefit among participants. Quantitative evidence resulted from study designs with high risk of bias, qualitative evidence lacked reporting detail. The majority of included studies were programme evaluations, conducted internally or funded by the provider.\nThe conceptual framework illustrates the range of interlinked mechanisms through which people believe they potentially achieve health and well-being benefits, such as opportunities for social contact. It also considers potential moderators and mediators of effect.\nOne main finding of the review is the inherent difficulty associated with generating robust evidence of effectiveness for complex interventions. We developed the conceptual framework to illustrate how people believed they benefited. Investigating such mechanisms in a subsequent theory-led review might be one way of examining evidence of effect for these activities.\nThe conceptual framework needs further refinement through linked reviews and more reliable evidence. Future research should use more robust study designs and report key intervention and participant detail.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is the report from a systematic review examining if taking part in activities that enhance the natural environment (such as maintaining paths to access the countryside) can improve people’s physical and mental health. A systematic review is a research method to identify, quality appraise and synthesise all relevant evidence about a particular topic.\nIt is thought that contact with the natural environment has a positive impact on health and well-being. For example, those living closer to green spaces have better mental health than those who don’t. Parks and countryside may also provide a place for healthy activities which can improve physical health. There is interest in understanding whether the natural environment can be a resource to improve public health."
}
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query-laysum | 4350 | [
{
"role": "user",
"content": "Abstract: Background\nHordeolum is an acute, purulent inflammation of the eyelid margin usually caused by obstructed orifices of the sebaceous glands of the eyelid. The condition, which affects sebaceous glands internally or externally, is common. When the meibomian gland in the tarsal plate is affected, internal hordeolum occurs, while when the glands of Zeis or Moll associated with eyelash follicles are affected, external hordeolum, or stye occurs. The onset of hordeolum is usually self limited, and may resolve in about a week with spontaneous drainage of the abscess. When the condition is severe, it can spread to adjacent glands and tissues. Recurrences are very common. As long as an internal hordeolum remains unresolved, it can develop into a chalazion or generalized eyelid cellulitis. Acupuncture is a traditional Chinese medical therapy aimed to treat disease by using fine needles to stimulate specific points on the body. However, it is unclear if acupuncture is an effective and safe treatment for acute hordeolum.\nObjectives\nThe objective of this review was to investigate the effectiveness and safety of acupuncture to treat acute hordeolum compared with no treatment, sham acupuncture, or other active treatment. We also compared the effectiveness and safety of acupuncture plus another treatment with that treatment alone.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, Embase, PubMed, Latin American and Caribbean Health Sciences Literature Database (LILACS), three major Chinese databases, as well as clinical trial registers all through 7 June 2016. We reviewed the reference lists from potentially eligible studies to identify additional randomised clinical trials (RCTs).\nSelection criteria\nWe included RCTs of people diagnosed with acute internal or external hordeola. We included RCTs comparing acupuncture with sham acupuncture or no treatment, other active treatments, or comparing acupuncture plus another treatment versus another treatment alone.\nData collection and analysis\nWe used standard methodological procedures used by Cochrane.\nMain results\nWe included 6 RCTs with a total of 531 participants from China. The mean age of the participants ranged from 18 to 28 years. Four RCTs included participants diagnosed with initial acute hordeolum with a duration of less than seven days; one RCT included participants diagnosed with initial acute hordeolum without specifying the duration; and one RCT included participants with recurrent acute hordeolum with a mean duration of 24 days. About 55% (291/531) of participants were women. Three RCTs included participants with either external or internal hordeolum; one RCT included participants with only external hordeolum; and two RCTs did not specify the type of hordeolum. Follow-up was no more than seven days after treatment in all included RCTs; no data were available for long-term outcomes. Overall, the certainty of the evidence for all outcomes was low to very low, and we judged all RCTs to be at high or unclear risk of bias.\nThree RCTs compared acupuncture with conventional treatments. We did not pool the data from these RCTs because the conventional treatments were not similar among trials. Two trials showed that resolution of acute hordeolum was more likely in the acupuncture group when compared with topical antibiotics (1 RCT; 32 participants; risk ratio (RR) 3.60; 95% confidence interval (CI) 1.34 to 9.70; low-certainty of evidence) or oral antibiotics plus warm compresses (1 RCT; 120 participants; RR 1.45; 95% CI 1.18 to 1.78; low-certainty of evidence). In the third trial, little or no difference in resolution of hordeolum was observed when acupuncture was compared with topical antibiotics plus warm compresses (1 RCT; 109 participants; RR 1.00; 95% CI 0.96 to 1.04; low-certainty of evidence). One RCT mentioned adverse outcomes, stating that there was no adverse event associated with acupuncture.\nThree RCTs compared acupuncture plus conventional treatments (two RCTs used topical antibiotics and warm compresses, one RCT used topical antibiotics only) versus the conventional treatments alone. One of the three RCTs, with very low-certainty evidence, did not report the resolution of acute hordeolum; however, it reported that acute hordeolum relief might be higher when acupuncture was combined with conventional treatments than with conventional treatments alone group (60 participants; RR 1.80; 95% CI 1.00 to 3.23). Pooled analysis of the remaining two RCTs, with low-certainty evidence, estimated resolution of acute hordeolum was slightly higher in the combined treatment group compared with the conventional treatment alone group at 7-day follow-up (210 participants; RR 1.12; 95% CI 1.03 to 1.23; I2 = 0%). None of the three RCTs reported adverse outcomes. Among the included RCTs, four participants, two from the acupuncture plus conventional treatments group and two from the conventional treatments alone group, withdrew due to exacerbation of symptoms.\nAuthors' conclusions\nLow-certainty evidence suggests that acupuncture with or without conventional treatments may provide short-term benefits for treating acute hordeolum when compared with conventional treatments alone. The certainty of the evidence was low to very low mainly due to small sample sizes, inadequate allocation concealment, lack of masking of the outcome assessors, inadequate or unclear randomization method, and a high or unreported number of dropouts. All RCTs were conducted in China, which may limit their generalizability to non-Chinese populations.\nBecause no RCTs included a valid sham acupuncture control, we cannot rule out a potential expectation/placebo effect associated with acupuncture. As resolution is based on clinical observation, the outcome could be influenced by the observer's knowledge of the assigned treatment. Adverse effects of acupuncture were reported sparsely in the included RCTs, and, when reported, were rare. RCTs with better methodology, longer follow-up, and which are conducted among other populations are warranted to provide more general evidence regarding the benefit of acupuncture to treat acute hordeolum.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The aim of this Cochrane review was to compare the benefits and harms of acupuncture versus conventional treatments used for treating acute hordeolum (stye)."
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query-laysum | 4351 | [
{
"role": "user",
"content": "Abstract: Background\nThere is evidence that family and friends influence children's decisions to smoke.\nObjectives\nTo assess the effectiveness of interventions to help families stop children starting smoking.\nSearch methods\nWe searched 14 electronic bibliographic databases, including the Cochrane Tobacco Addiction Group specialized register, MEDLINE, EMBASE, PsycINFO, CINAHL unpublished material, and key articles' reference lists. We performed free-text internet searches and targeted searches of appropriate websites, and hand-searched key journals not available electronically. We consulted authors and experts in the field. The most recent search was 3 April 2014. There were no date or language limitations.\nSelection criteria\nRandomised controlled trials (RCTs) of interventions with children (aged 5-12) or adolescents (aged 13-18) and families to deter tobacco use. The primary outcome was the effect of the intervention on the smoking status of children who reported no use of tobacco at baseline. Included trials had to report outcomes measured at least six months from the start of the intervention.\nData collection and analysis\nWe reviewed all potentially relevant citations and retrieved the full text to determine whether the study was an RCT and matched our inclusion criteria. Two authors independently extracted study data for each RCT and assessed them for risk of bias. We pooled risk ratios using a Mantel-Haenszel fixed effect model.\nMain results\nTwenty-seven RCTs were included. The interventions were very heterogeneous in the components of the family intervention, the other risk behaviours targeted alongside tobacco, the age of children at baseline and the length of follow-up. Two interventions were tested by two RCTs, one was tested by three RCTs and the remaining 20 distinct interventions were tested only by one RCT. Twenty-three interventions were tested in the USA, two in Europe, one in Australia and one in India.\nThe control conditions fell into two main groups: no intervention or usual care; or school-based interventions provided to all participants. These two groups of studies were considered separately.\nMost studies had a judgement of 'unclear' for at least one risk of bias criteria, so the quality of evidence was downgraded to moderate. Although there was heterogeneity between studies there was little evidence of statistical heterogeneity in the results. We were unable to extract data from all studies in a format that allowed inclusion in a meta-analysis.\nThere was moderate quality evidence family-based interventions had a positive impact on preventing smoking when compared to a no intervention control. Nine studies (4810 participants) reporting smoking uptake amongst baseline non-smokers could be pooled, but eight studies with about 5000 participants could not be pooled because of insufficient data. The pooled estimate detected a significant reduction in smoking behaviour in the intervention arms (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.68 to 0.84). Most of these studies used intensive interventions. Estimates for the medium and low intensity subgroups were similar but confidence intervals were wide. Two studies in which some of the 4487 participants already had smoking experience at baseline did not detect evidence of effect (RR 1.04, 95% CI 0.93 to 1.17).\nEight RCTs compared a combined family plus school intervention to a school intervention only. Of the three studies with data, two RCTS with outcomes for 2301 baseline never smokers detected evidence of an effect (RR 0.85, 95% CI 0.75 to 0.96) and one study with data for 1096 participants not restricted to never users at baseline also detected a benefit (RR 0.60, 95% CI 0.38 to 0.94). The other five studies with about 18,500 participants did not report data in a format allowing meta-analysis. One RCT also compared a family intervention to a school 'good behaviour' intervention and did not detect a difference between the two types of programme (RR 1.05, 95% CI 0.80 to 1.38, n = 388).\nNo studies identified any adverse effects of intervention.\nAuthors' conclusions\nThere is moderate quality evidence to suggest that family-based interventions can have a positive effect on preventing children and adolescents from starting to smoke. There were more studies of high intensity programmes compared to a control group receiving no intervention, than there were for other compairsons. The evidence is therefore strongest for high intensity programmes used independently of school interventions. Programmes typically addressed family functioning, and were introduced when children were between 11 and 14 years old. Based on this moderate quality evidence a family intervention might reduce uptake or experimentation with smoking by between 16 and 32%. However, these findings should be interpreted cautiously because effect estimates could not include data from all studies. Our interpretation is that the common feature of the effective high intensity interventions was encouraging authoritative parenting (which is usually defined as showing strong interest in and care for the adolescent, often with rule setting). This is different from authoritarian parenting (do as I say) or neglectful or unsupervised parenting.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review asks whether family interventions can influence children and adolescents not to smoke, compared to no-intervention controls or as an add-on to a school intervention. We particularly focused on children who had never smoked."
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"content": "Abstract: Background\nOut-of-hospital cardiac arrest (OHCA) is a major cause of death worldwide. Cardiac arrest can be subdivided into asphyxial and non asphyxial etiologies. An asphyxia arrest is caused by lack of oxygen in the blood and occurs in drowning and choking victims and in other circumstances. A non asphyxial arrest is usually a loss of functioning cardiac electrical activity. Cardiopulmonary resuscitation (CPR) is a well-established treatment for cardiac arrest. Conventional CPR includes both chest compressions and ‘rescue breathing’ such as mouth-to-mouth breathing. Rescue breathing is delivered between chest compressions using a fixed ratio, such as two breaths to 30 compressions or can be delivered asynchronously without interrupting chest compression. Studies show that applying continuous chest compressions is critical for survival and interrupting them for rescue breathing might increase risk of death. Continuous chest compression CPR may be performed with or without rescue breathing.\nObjectives\nTo assess the effects of continuous chest compression CPR (with or without rescue breathing) versus conventional CPR plus rescue breathing (interrupted chest compression with pauses for breaths) of non-asphyxial OHCA.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1 2017); MEDLINE (Ovid) (from 1985 to February 2017); Embase (1985 to February 2017); Web of Science (1985 to February 2017). We searched ongoing trials databases including controlledtrials.com and clinicaltrials.gov. We did not impose any language or publication restrictions.\nSelection criteria\nWe included randomized and quasi-randomized studies in adults and children suffering non-asphyxial OHCA due to any cause. Studies compared the effects of continuous chest compression CPR (with or without rescue breathing) with interrupted CPR plus rescue breathing provided by rescuers (bystanders or professional CPR providers).\nData collection and analysis\nTwo authors extracted the data and summarized the effects as risk ratios (RRs), adjusted risk differences (ARDs) or mean differences (MDs). We assessed the quality of evidence using GRADE.\nMain results\nWe included three randomized controlled trials (RCTs) and one cluster-RCT (with a total of 26,742 participants analysed). We identified one ongoing study. While predominantly adult patients, one study included children.\nUntrained bystander-administered CPR\nThree studies assessed CPR provided by untrained bystanders in urban areas of the USA, Sweden and the UK. Bystanders administered CPR under telephone instruction from emergency services. There was an unclear risk of selection bias in two trials and low risk of detection, attrition, and reporting bias in all three trials. Survival outcomes were unlikely to be affected by the unblinded design of the studies.\nWe found high-quality evidence that continuous chest compression CPR without rescue breathing improved participants’ survival to hospital discharge compared with interrupted chest compression with pauses for rescue breathing (ratio 15:2) by 2.4% (14% versus 11.6%; RR 1.21, 95% confidence interval (CI) 1.01 to 1.46; 3 studies, 3031 participants).\nOne trial reported survival to hospital admission, but the number of participants was too low to be certain about the effects of the different treatment strategies on survival to admission(RR 1.18, 95% CI 0.94 to 1.48; 1 study, 520 participants; moderate-quality evidence).\nThere were no data available for survival at one year, quality of life, return of spontaneous circulation or adverse effects.\nThere was insufficient evidence to determine the effect of the different strategies on neurological outcomes at hospital discharge (RR 1.25, 95% CI 0.94 to 1.66; 1 study, 1286 participants; moderate-quality evidence). The proportion of participants categorized as having good or moderate cerebral performance was 11% following treatment with interrupted chest compression plus rescue breathing compared with 10% to 18% for those treated with continuous chest compression CPR without rescue breathing.\nCPR administered by a trained professional\nIn one trial that assessed OHCA CPR administered by emergency medical service professionals (EMS) 23,711 participants received either continuous chest compression CPR (100/minute) with asynchronous rescue breathing (10/minute) or interrupted chest compression with pauses for rescue breathing (ratio 30:2). The study was at low risk of bias overall.\nAfter OHCA, risk of survival to hospital discharge is probably slightly lower for continuous chest compression CPR with asynchronous rescue breathing compared with interrupted chest compression plus rescue breathing (9.0% versus 9.7%) with an adjusted risk difference (ARD) of -0.7%; 95% CI (-1.5% to 0.1%); moderate-quality evidence.\nThere is high-quality evidence that survival to hospital admission is 1.3% lower with continuous chest compression CPR with asynchronous rescue breathing compared with interrupted chest compression plus rescue breathing (24.6% versus 25.9%; ARD -1.3% 95% CI (-2.4% to -0.2%)).\nSurvival at one year and quality of life were not reported.\nReturn of spontaneous circulation is likely to be slightly lower in people treated with continuous chest compression CPR plus asynchronous rescue breathing (24.2% versus 25.3%; -1.1% (95% CI -2.4 to 0.1)), high-quality evidence.\nThere is high-quality evidence of little or no difference in neurological outcome at discharge between these two interventions (7.0% versus 7.7%; ARD -0.6% (95% CI -1.4 to 0.1).\nRates of adverse events were 54.4% in those treated with continuous chest compressions plus asynchronous rescue breathing versus 55.4% in people treated with interrupted chest compression plus rescue breathing compared with the ARD being -1% (-2.3 to 0.4), moderate-quality evidence).\nAuthors' conclusions\nFollowing OHCA, we have found that bystander-administered chest compression-only CPR, supported by telephone instruction, increases the proportion of people who survive to hospital discharge compared with conventional interrupted chest compression CPR plus rescue breathing. Some uncertainty remains about how well neurological function is preserved in this population and there is no information available regarding adverse effects.\nWhen CPR was performed by EMS providers, continuous chest compressions plus asynchronous rescue breathing did not result in higher rates for survival to hospital discharge compared to interrupted chest compression plus rescue breathing. The results indicate slightly lower rates of survival to admission or discharge, favourable neurological outcome and return of spontaneous circulation observed following continuous chest compression. Adverse effects are probably slightly lower with continuous chest compression.\nIncreased availability of automated external defibrillators (AEDs), and AED use in CPR need to be examined, and also whether continuous chest compression CPR is appropriate for paediatric cardiac arrest.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "For bystander-provided CPR, the quality of the evidence was high for the outcome of survival to hospital discharge. For survival to hospital admission, one trial provided results and the evidence was of moderate-quality because of low numbers of people for whom data were available. This was also the case for neurological outcomes.\nIn the one EMS professional-provided CPR trial, the quality of the evidence was moderate for the outcome of survival to hospital discharge because the results do not exclude there being little or no difference between the two approaches, and this is also the case for adverse events. For survival to hospital admission there was high-quality evidence.\nThe main limitation of the current evidence is that only a few trials have been undertaken, and for some outcomes, not enough data have been generated."
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query-laysum | 4353 | [
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"content": "Abstract: Background\nLong chain polyunsaturated fatty acids (LCPUFA), especially docosahexaenoic acid (DHA), are the most abundant fatty acids in the brain and are necessary for growth and maturation of an infant's brain and retina. LCPUFAs are named “essential” because they cannot be synthesised efficiently by the human body and come from maternal diet. It remains controversial whether LCPUFA supplementation to breastfeeding mothers is beneficial for the development of their infants.\nObjectives\nTo assess the effectiveness and safety of supplementation with LCPUFA in breastfeeding mothers in the cognitive and physical development of their infants as well as safety for the mother and infant.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 August 2014), CENTRAL (Cochrane Library 2014, Issue 8), PubMed (1966 to August 2014), EMBASE (1974 to August 2014), LILACS (1982 to August 2014), Google Scholar (August 2014) and reference lists of published narrative and systematic reviews.\nSelection criteria\nRandomised controlled trials or cluster-randomised controlled trials evaluating the effects of LCPUFA supplementation on breastfeeding mothers (including the pregnancy period) and their infants.\nData collection and analysis\nTwo review authors independently assessed eligibility and trial quality, performed data extraction and evaluated data accuracy.\nMain results\nWe included eight randomised controlled trials involving 1567 women. All the studies were performed in high-income countries. The longest follow-up was seven years.\nWe report the results from the longest follow-up time point from included studies. Overall, there was moderate quality evidence as assessed using the GRADE approach from these studies for the following outcomes measured beyond 24 months age of children: language development and child weight. There was low-quality evidence for the outcomes: Intelligence or solving problems ability, psychomotor development, child attention, and child visual acuity.\nWe found no significant difference in children's neurodevelopment at long-term follow-up beyond 24 months: language development (standardised mean difference (SMD) -0.27, 95% confidence interval (CI) -0.56 to 0.02; two trials, 187 participants); intelligence or problem-solving ability (three trials, 238 participants; SMD 0.00, 95% CI -0.36 to 0.36); psychomotor development (SMD -0.11, 95% CI -0.48 to 0.26; one trial, 113 participants); motor development (SMD -0.23, 95% CI -0.60 to 0.14; one trial, 115 participants), or in general movements (risk ratio, RR, 1.12, 95% CI 0.58 to 2.14; one trial, 77 participants; at 12 weeks of life). However, child attention scores were better at five years of age in the group of children whose mothers had received supplementation with fatty acids (mean difference (MD) 4.70, 95% CI 1.30 to 8.10; one study, 110 participants)). In working memory and inhibitory control, we found no significant difference (MD -0.02 95% CI -0.07 to 0.03 one trial, 63 participants); the neurological optimality score did not present any difference (P value: 0.55).\nFor child visual acuity, there was no significant difference (SMD 0.33, 95% CI -0.04 to 0.71; one trial, 111 participants).\nFor growth, there were no significant differences in length (MD -0.39 cm, 95% CI -1.37 to 0.60; four trials, 441 participants), weight (MD 0.13 kg, 95% CI -0.49 to 0.74; four trials, 441 participants), and head circumference (MD 0.15 cm, 95% CI -0.27 to 0.58; three trials, 298 participants). Child fat mass and fat mass distribution did not differ between the intervention and control group (MD 2.10, 95% CI -0.48 to 4.68; one trial, 115 participants, MD -0.50, 95% CI -1.69 to 0.69; one trial, 165 participants, respectively).\nOne study (117 infants) reported a significant difference in infant allergy at short-term follow-up (risk ratio (RR) 0.13, 95% CI 0.02 to 0.95), but not at medium-term follow-up (RR 0.52, 95% CI 0.17 to 1.59).\nWe found no significant difference in two trials evaluating postpartum depression. Data were not possible to be pooled due to differences in the describing of the outcome. One study (89 women) did not find any significant difference between the LCPUFA supplementation and the control group at four weeks postpartum (MD 1.00, 95%CI -1.72 to 3.72).\nNo adverse effects were reported.\nAuthors' conclusions\nBased on the available evidence, LCPUFA supplementation did not appear to improve children's neurodevelopment, visual acuity or growth. In child attention at five years of age, weak evidence was found (one study) favouring the supplementation. Currently, there is inconclusive evidence to support or refute the practice of giving LCPUFA supplementation to breastfeeding mothers in order to improve neurodevelopment or visual acuity.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Long chain polyunsaturated fatty acids (LCPUFAs) are abundant in the brain and are necessary for growth and maturation of a young infant’s brain and the retina of the eye. These particular fatty acids include docosahexaenoic acid (DHA) and are said to be ‘essential’ because the human body is not efficient in producing them. This means that infants who are breastfeeding obtain the fatty acids from their mothers’ diet, mainly from fish oil and ocean fish. We reviewed the evidence about the effect of supplementation of LCPUFA on breastfeeding mothers on growth and neurodevelopment of their children."
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"content": "Abstract: Background\nAdjuvant aromatase inhibitors (AI) improve survival compared to tamoxifen in postmenopausal women with hormone receptor-positive stage I to III breast cancer. In approximately half of these women, AI are associated with aromatase inhibitor-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS may have significant and prolonged impact on women's quality of life. AIMSS reduces adherence to AI therapy in up to a half of women, potentially compromising breast cancer outcomes. Differing systemic therapies have been investigated for the prevention and treatment of AIMSS, but the effectiveness of these therapies remains unclear.\nObjectives\nTo assess the effects of systemic therapies on the prevention or management of AIMSS in women with stage I to III hormone receptor-positive breast cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to September 2020 and the Cochrane Breast Cancer Group (CBCG) Specialised Register to March 2021.\nSelection criteria\nWe included all randomised controlled trials that compared systemic therapies to a comparator arm. Systemic therapy interventions included all pharmacological therapies, dietary supplements, and complementary and alternative medicines (CAM). All comparator arms were allowed including placebo or standard of care (or both) with analgesia alone. Published and non-peer-reviewed studies were eligible.\nData collection and analysis\nTwo review authors independently screened studies, extracted data, and assessed risk of bias and certainty of the evidence using the GRADE approach. Outcomes assessed were pain, stiffness, grip strength, safety data, discontinuation of AI, health-related quality of life (HRQoL), breast cancer-specific quality of life (BCS-QoL), incidence of AIMSS, breast cancer-specific survival (BCSS) and overall survival (OS). For continuous outcomes, we used vote-counting by reporting how many studies reported a clinically significant benefit within the confidence intervals (CI) of the mean difference (MD) between treatment arms, as determined by the minimal clinically importance difference (MCID) for that outcome scale. For dichotomous outcomes, we reported outcomes as a risk ratio (RR) with 95% CI.\nMain results\nWe included 17 studies with 2034 randomised participants. Four studies assessed systemic therapies for the prevention of AIMSS and 13 studies investigated treatment of AIMSS. Due to the variation in systemic therapy studies, including pharmacological, and CAM, or unavailable data, meta-analysis was limited, and only two trials were combined for meta-analysis. The certainty of evidence for all outcomes was either low or very low certainty.\nPrevention studies\nThe evidence is very uncertain about the effect of systemic therapies on pain (from baseline to the end of the intervention; 2 studies, 183 women). The two studies, investigating vitamin D and omega-3 fatty acids, showed a treatment effect with 95% CIs that did not include an MCID for pain. Systemic therapies may have little to no effect on grip strength (RR 1.08, 95% CI 0.37 to 3.17; 1 study, 137 women) or on women continuing to take their AI (RR 0.16, 95% 0.01 to 2.99; 1 study, 147 women). The evidence suggests little to no effect on HRQoL and BCS-QoL from baseline to the end of intervention (the same single study; 44 women, both quality of life outcomes showed a treatment effect with 95% CIs that did include an MCID).\nThe evidence is very uncertain for outcomes assessing incidence of AIMSS (RR 0.82, 95% CI 0.63 to 1.06; 2 studies, 240 women) and the safety of systemic therapies (4 studies, 344 women; very low-certainty evidence). One study had a US Food and Drug Administration alert issued for the intervention (cyclo-oxygenase-2 inhibitor) during the study, but there were no serious adverse events in this or any study.\nThere were no data on stiffness, BCSS or OS.\nTreatment studies\nThe evidence is very uncertain about the effect of systemic therapies on pain from baseline to the end of intervention in the treatment of AIMSS (10 studies, 1099 women). Four studies showed an MCID in pain scores which fell within the 95% CI of the measured effect (vitamin D, bionic tiger bone, Yi Shen Jian Gu granules, calcitonin). Six studies showed a treatment effect with 95% CI that did not include an MCID (vitamin D, testosterone, omega-3 fatty acids, duloxetine, emu oil, cat's claw).\nThe evidence was very uncertain for the outcomes of change in stiffness (4 studies, 295 women), HRQoL (3 studies, 208 women) and BCS-QoL (2 studies, 147 women) from baseline to the end of intervention. The evidence suggests systemic therapies may have little to no effect on grip strength (1 study, 107 women). The evidence is very uncertain about the safety of systemic therapies (10 studies, 1250 women). There were no grade four/five adverse events reported in any of the studies. The study of duloxetine reported more all-grade adverse events in this treatment group than comparator group.\nThere were no data on the incidence of AIMSS, the number of women continuing to take AI, BCCS or OS from the treatment studies.\nAuthors' conclusions\nAIMSS are chronic and complex symptoms with a significant impact on women with early breast cancer taking AI. To date, evidence for safe and effective systemic therapies for prevention or treatment of AIMSS has been minimal. Although this review identified 17 studies with 2034 randomised participants, the review was challenging due to the heterogeneous systemic therapy interventions and study methodologies, and the unavailability of certain trial data. Meta-analysis was thus limited and findings of the review were inconclusive. Further research is recommended into systemic therapy for AIMSS, including high-quality adequately powered RCT, comprehensive descriptions of the intervention/placebo, and robust definitions of the condition and the outcomes being studied.\n\nGiven the provided abstract, please respond to the following query: \"What did the review study?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We looked at research studies of systemic therapies, which included medicines, vitamins, and complementary and alternative medicines, to see if these could prevent or treat the joint and muscle pains and stiffness of women taking aromatase inhibitors. We included trials of systemic therapies compared to placebo (dummy treatment), or to standard treatments. Women treated with aromatase inhibitors for early-stage hormone receptor-positive breast cancer were included. Most studies were for treatment of AIMSS.\nOutcomes that were studied included changes in pain, stiffness, hand strength (grip strength), safety and side effects of the study treatments, number of women continuing to take their aromatase inhibitors, quality of life for women, how many women developed muscle and joint aches from their aromatase inhibitors, and survival."
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"content": "Abstract: Background\nMind-body interventions are based on the holistic principle that mind, body and behaviour are all interconnected. Mind-body interventions incorporate strategies that are thought to improve psychological and physical well-being, aim to allow patients to take an active role in their treatment, and promote people's ability to cope. Mind-body interventions are widely used by people with fibromyalgia to help manage their symptoms and improve well-being. Examples of mind-body therapies include psychological therapies, biofeedback, mindfulness, movement therapies and relaxation strategies.\nObjectives\nTo review the benefits and harms of mind-body therapies in comparison to standard care and attention placebo control groups for adults with fibromyalgia, post-intervention and at three and six month follow-up.\nSearch methods\nElectronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), AMED (EBSCO) and CINAHL (Ovid) were conducted up to 30 October 2013. Searches of reference lists were conducted and authors in the field were contacted to identify additional relevant articles.\nSelection criteria\nAll relevant randomised controlled trials (RCTs) of mind-body interventions for adults with fibromyalgia were included.\nData collection and analysis\nTwo authors independently selected studies, extracted the data and assessed trials for low, unclear or high risk of bias. Any discrepancy was resolved through discussion and consensus. Continuous outcomes were analysed using mean difference (MD) where the same outcome measure and scoring method was used and standardised mean difference (SMD) where different outcome measures were used. For binary data standard estimation of the risk ratio (RR) and its 95% confidence interval (CI) was used.\nMain results\nSeventy-four papers describing 61 trials were identified, with 4234 predominantly female participants. The nature of fibromyalgia varied from mild to severe across the study populations. Twenty-six studies were classified as having a low risk of bias for all domains assessed. The findings of mind-body therapies compared with usual care were prioritised.\nThere is low quality evidence that in comparison to usual care controls psychological therapies have favourable effects on physical functioning (SMD -0.4, 95% CI -0.6 to -0.3, -7.5% absolute change, 2 point shift on a 0 to 100 scale), pain (SMD -0.3, 95% CI -0.5 to -0.2, -3.5% absolute change, 2 point shift on a 0 to 100 scale) and mood (SMD -0.5, 95% CI -0.6 to -0.3, -4.8% absolute change, 3 point shift on a 20 to 80 scale). There is very low quality evidence of more withdrawals in the psychological therapy group in comparison to usual care controls (RR 1.38, 95% CI 1.12 to 1.69, 6% absolute risk difference). There is lack of evidence of a difference between the number of adverse events in the psychological therapy and control groups (RR 0.38, 95% CI 0.06 to 2.50, 4% absolute risk difference).\nThere was very low quality evidence that biofeedback in comparison to usual care controls had an effect on physical functioning (SMD -0.1, 95% CI -0.4 to 0.3, -1.2% absolute change, 1 point shift on a 0 to 100 scale), pain (SMD -2.6, 95% CI -91.3 to 86.1, -2.6% absolute change) and mood (SMD 0.1, 95% CI -0.3 to 0.5, 1.9% absolute change, less than 1 point shift on a 0 to 90 scale) post-intervention. In view of the quality of evidence we cannot be certain that biofeedback has a little or no effect on these outcomes. There was very low quality evidence that biofeedback led to more withdrawals from the study (RR 4.08, 95% CI 1.43 to 11.62, 20% absolute risk difference). No adverse events were reported.\nThere was no advantage observed for mindfulness in comparison to usual care for physical functioning (SMD -0.3, 95% CI -0.6 to 0.1, -4.8% absolute change, 4 point shift on a scale 0 to 100), pain (SMD -0.1, CI -0.4 to 0.3, -1.3% absolute change, less than 1 point shift on a 0 to 10 scale), mood (SMD -0.2, 95% CI -0.5 to 0.0, -3.7% absolute change, 2 point shift on a 20 to 80 scale) or withdrawals (RR 1.07, 95% CI 0.67 to 1.72, 2% absolute risk difference) between the two groups post-intervention. However, the quality of the evidence was very low for pain and moderate for mood and number of withdrawals. No studies reported any adverse events.\nVery low quality evidence revealed that movement therapies in comparison to usual care controls improved pain (MD -2.3, CI -4.2 to -0.4, -23% absolute change) and mood (MD -9.8, 95% CI -18.5 to -1.2, -16.4% absolute change) post-intervention. There was no advantage for physical functioning (SMD -0.2, 95% CI -0.5 to 0.2, -3.4% absolute change, 2 point shift on a 0 to 100 scale), participant withdrawals (RR 1.95, 95% CI 1.13 to 3.38, 11% absolute difference) or adverse events (RR 4.62, 95% CI 0.23 to 93.92, 4% absolute risk difference) between the two groups, however rare adverse events may include worsening of pain.\nLow quality evidence revealed that relaxation based therapies in comparison to usual care controls showed an advantage for physical functioning (MD -8.3, 95% CI -10.1 to -6.5, -10.4% absolute change) and pain (SMD -1.0, 95% CI -1.6 to -0.5, -3.5% absolute change, 2 point shift on a 0 to 78 scale) but not for mood (SMD -4.4, CI -14.5 to 5.6, -7.4% absolute change) post-intervention. There was no difference between the groups for number of withdrawals (RR 4.40, 95% CI 0.59 to 33.07, 31% absolute risk difference) and no adverse events were reported.\nAuthors' conclusions\nPsychological interventions therapies may be effective in improving physical functioning, pain and low mood for adults with fibromyalgia in comparison to usual care controls but the quality of the evidence is low. Further research on the outcomes of therapies is needed to determine if positive effects identified post-intervention are sustained. The effectiveness of biofeedback, mindfulness, movement therapies and relaxation based therapies remains unclear as the quality of the evidence was very low or low. The small number of trials and inconsistency in the use of outcome measures across the trials restricted the analysis.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We conducted a review of the effect of mind-body therapies for adults with fibromyalgia. After searching for all relevant studies until October 2013, we found 61 studies including 4234 adults.\n- Many studies only included female participants, but some males were included in a few studies.\n- Participants had mild to severe fibromyalgia.\n- Mind-body interventions were compared to 'usual care', such as medication use. Secondary analysis also compared findings in comparison to an 'attention control therapy' which involved receiving information for the same amount of time as the mind-body therapy."
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"content": "Abstract: Background\nPerineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.\nObjectives\nTo evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.\nSelection criteria\nPublished and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.\nMain results\nWe included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain.\nWe undertook a number of comparisons to evaluate the different treatments.\nCooling treatment (ice pack or cold gel pad) versus no treatment\nThere was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) −4.46, 95% confidence interval (CI) −5.07 to −3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of −0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance.\nCooling treatment (cold gel pad) + compression versus placebo (gel pad + compression)\nThere was limited low-certainty evidence that there may be a trivial MD of −0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI −0.73 to −0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants).\nCooling treatment (ice pack) versus placebo (water pack)\nOne study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants).\nCooling treatment (ice pack) versus cooling treatment (cold gel pad)\nThe evidence is very uncertain about the effects of using ice packs or cold gel pads on women’s self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.\nAuthors' conclusions\nThere is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Perineal tears are common during childbirth. In addition, sometimes the person attending the birth cuts the perineum to give extra room for the baby to be born (an episiotomy).\nThese tears and cuts often cause pain and the mother may have difficulty walking or sitting comfortably, or to feed and care for her baby,"
}
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query-laysum | 4357 | [
{
"role": "user",
"content": "Abstract: Background\nIncreased ultrasound surveillance of twin pregnancies has become accepted practice due to the higher risk of complications. There is no current consensus however as to the method and frequency of ultrasound monitoring that constitutes optimal care.\nObjectives\nTo systematically review the effects of different types and frequency of ultrasound surveillance for women with a twin pregnancy on neonatal, fetal and maternal outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (all searched 11 August 2017), and reference lists of retrieved studies.\nSelection criteria\nRandomised and quasi-randomised trials (including those published in abstract form) comparing the effects of described antenatal ultrasound surveillance regimens in twin pregnancies. Trials using a cluster-randomised design would have been eligible for inclusion in this review but none were identified. Trials using a cross-over design are not eligible for inclusion in this review.\nDifferent types and frequencies of ultrasound testing (for fetal surveillance and detection of specific problems) compared with each other and also compared with no testing. For example, an intervention might comprise a specific approach to ultrasound examination with dedicated components to detect twin-specific pathology. Different interventions could also include a specific type of surveillance at different intervals or different combinations at the same intervals.\nIn this review we only found one study looking at fetal growth (biometry) and Doppler ultrasounds at 25, 30 and 35 weeks' gestation versus fetal growth alone.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and quality, and extracted data. We checked data for accuracy.\nMain results\nWe included one trial of 526 women with a twin pregnancy of two viable twins, with no known morphological abnormality, in this review. The trial compared women receiving fetal growth and Doppler ultrasounds at 25, 30 and 35 weeks' gestation to fetal growth alone. We judged the included study to be at low risk of bias however the risk of performance and detection bias were unclear.\nThe primary outcome was the perinatal mortality rate (after randomisation), for which there was no evidence of a clear difference between the fetal growth + Doppler and the fetal growth alone groups (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.32 to 2.41, low-quality evidence) with similar rates in both groups (seven events in the Dopper + fetal growth group and eight in the fetal growth alone group). No clear differences were seen between the two regimens for the other outcomes in this review: stillbirth (RR 0.67, 95% CI 0.11 to 3.99), neonatal death (RR 1.01, 95% CI 0.29 to 3.46, low-quality evidence), gestational age at birth (weeks) (mean difference 0.10, 95% CI -0.39 to 0.59, moderate-quality evidence), infant requiring ventilation (RR 0.86, 95% CI 0.59 to 1.25), admission to special care or intensive care units (RR 0.96, 95% CI 0.88 to 1.05), caesarean section (any) (RR 1.00, 95% CI 0.81 to 1.23, high-quality evidence), elective caesarean section (RR 1.06, 95% CI 0.77 to 1.47), emergency caesarean section (RR 0.93, 95% CI 0.66 to 1.32), induction of labour (RR 1.10, 95% CI 0.80 to 1.50, moderate-quality evidence) or antenatal hospital admission (RR 0.96, 95% CI 0.80 to 1.15, high-quality evidence). The number of preterm births before 28 weeks' gestation was not reported in the included study. For the mortality-related outcomes, event numbers were small.\nThe included study did not report the majority of our maternal and infant secondary outcomes. Infant outcomes not reported included fetal acidosis, Apgar scores less than 7 at five minutes and preterm birth before 37 and 34 weeks' gestation. The maternal outcomes; length of antenatal hospital stay, timely diagnosis of significant complications, rate of preterm, prelabour rupture of membranes and women's level of satisfaction with their care were not reported. The study did not classify twin pregnancies according to their chorionicity. An awareness of the chorionicity may have improved applicability of this data set.\nWe downgraded outcomes assessed using GRADE for imprecision of effect estimates.\nAuthors' conclusions\nThis review is based on one small study which was underpowered for detection of rare outcomes such as perinatal mortality, stillbirth and neonatal death.\nThere is insufficient evidence from randomised controlled trials to inform best practice for fetal ultrasound surveillance regimens when caring for women with a twin pregnancy. More studies are needed to evaluate the effects of currently used ultrasound surveillance regimens in twin pregnancies. Future research could report on the important maternal and infant outcomes as listed in this review.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A multiple pregnancy is an important contributor to poor birth outcomes.\nTwin pregnancies are often more complicated than pregnancies in women where there is one baby. Infant deaths and ill health can result from growth restriction in one or both of the babies, preterm rupture of the membranes before labour begins, and increased risk of preterm birth before 37 weeks.\nWomen with twin pregnancies usually have regular, often frequent, ultrasound scans to check the health of the growing babies. Different types of scans can be performed. A regular ultrasound scan can be used to check the size and growth of the babies. The amount of fluid around each baby can also be estimated, and the blood flow through the umbilical cord and the quality of blood flow within the babies can be measured using Doppler ultrasound. We do not know the best schedule to use for women and their babies, nor whether it makes any difference in the management and outcome of the pregnancy."
}
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query-laysum | 4358 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in 2002, and previously updated in 2007. Late radiation rectal problems (proctopathy) include bleeding, pain, faecal urgency, and incontinence and may develop after pelvic radiotherapy treatment for cancer.\nObjectives\nTo assess the effectiveness and safety of non-surgical interventions for managing late radiation proctopathy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 11, 2015); MEDLINE (Ovid); EMBASE (Ovid); CANCERCD; Science Citation Index; and CINAHL from inception to November 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing non-surgical interventions for the management of late radiation proctopathy in people with cancer who have undergone pelvic radiotherapy for cancer. Primary outcomes considered were: episodes of bowel activity, bleeding, pain, tenesmus, urgency, and sphincter dysfunction.\nData collection and analysis\nStudy selection, 'Risk of bias' assessment, and data extraction were performed in duplicate, and any disagreements were resolved by involving a third review author.\nMain results\nWe identified 1221 unique references and 16 studies including 993 participants that met our inclusion criteria. One study found through the last update was moved to the 'Studies awaiting classification' section. We did not pool outcomes for a meta-analysis due to variation in study characteristics and endpoints across included studies.\nSince radiation proctopathy is a condition with various symptoms or combinations of symptoms, the studies were heterogeneous in their intended effect. Some studies investigated treatments targeted at bleeding only (group 1), some investigated treatments targeted at a combination of anorectal symptoms, but not a single treatment (group 2). The third group focused on the treatment of the collection of symptoms referred to as pelvic radiation disease. In order to enable some comparison of this heterogeneous collection of studies, we describe the effects in these three groups separately.\nNine studies assessed treatments for rectal bleeding and were unclear or at high risk of bias. The only treatments that made a significant difference on primary outcomes were argon plasma coagulation (APC) followed by oral sucralfate versus APC with placebo (endoscopic score 6 to 9 in favour of APC with placebo, risk ratio (RR) 2.26, 95% confidence interval (CI) 1.12 to 4.55; 1 study, 122 participants, low- to moderate-quality evidence); formalin dab treatment (4%) versus sucralfate steroid retention enema (symptom score after treatment graded by the Radiation Proctopathy System Assessments Scale (RPSAS) and sigmoidoscopic score in favour of formalin (P = 0.001, effect not quantified, 1 study, 102 participants, very low- to low-quality evidence), and colonic irrigation plus ciprofloxacin and metronidazole versus formalin application (4%) (bleeding (P = 0.007, effect not quantified), urgency (P = 0.0004, effect not quantified), and diarrhoea (P = 0.007, effect not quantified) in favour of colonic irrigation (1 study, 50 participants, low-quality evidence).\nThree studies, of unclear and high risk of bias, assessed treatments targeted at something very localised but not a single pathology. We identified no significant differences on our primary outcomes. We graded all studies as very low-quality evidence due to unclear risk of bias and very serious imprecision.\nFour studies, of unclear and high risk of bias, assessed treatments targeted at more than one symptom yet confined to the anorectal region. Studies that demonstrated an effect on symptoms included: gastroenterologist-led algorithm-based treatment versus usual care (detailed self help booklet) (significant difference in favour of gastroenterologist-led algorithm-based treatment on change in Inflammatory Bowel Disease Questionnaire–Bowel (IBDQ-B) score at six months, mean difference (MD) 5.47, 95% CI 1.14 to 9.81) and nurse-led algorithm-based treatment versus usual care (significant difference in favour of the nurse-led algorithm-based treatment on change in IBDQ-B score at six months, MD 4.12, 95% CI 0.04 to 8.19) (1 study, 218 participants, low-quality evidence); hyperbaric oxygen therapy (at 2.0 atmospheres absolute) versus placebo (improvement of Subjective, Objective, Management, Analytic - Late Effects of Normal Tissue (SOMA-LENT) score in favour of hyperbaric oxygen therapy (HBOT), P = 0.0019) (1 study, 150 participants, moderate-quality evidence, retinol palmitate versus placebo (improvement in RPSAS in favour of retinol palmitate, P = 0.01) (1 study, 19 participants, low-quality evidence) and integrated Chinese traditional plus Western medicine versus Western medicine (grade 0 to 1 radio-proctopathy after treatment in favour of integrated Chinese traditional medicine, RR 2.55, 95% CI 1.30 to 5.02) (1 study, 58 participants, low-quality evidence).\nThe level of evidence for the majority of outcomes was downgraded using GRADE to low or very low, mainly due to imprecision and study limitations.\nAuthors' conclusions\nAlthough some interventions for late radiation proctopathy look promising (including rectal sucralfate, metronidazole added to an anti-inflammatory regimen, and hyperbaric oxygen therapy), single small studies provide limited evidence. Furthermore, outcomes important to people with cancer, including quality of life (QoL) and long-term effects, were not well recorded. The episodic and variable nature of late radiation proctopathy requires large multi-centre placebo-controlled trials (RCTs) to establish whether treatments are effective. Future studies should address the possibility of associated injury to other gastro-intestinal, urinary, or sexual organs, known as pelvic radiation disease. The interventions, as well as the outcome parameters, should be broader and include those important to people with cancer, such as QoL evaluations.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence for the majority of outcomes was low or very low, mainly due to the small size of most studies and study limitations."
}
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query-laysum | 4359 | [
{
"role": "user",
"content": "Abstract: Background\nThe term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea (complete absence of ventilation) and hypopnoea sleep (insufficient ventilation) during sleep. Studies have demonstrated that CSA responds to some extent to pharmacological agents with distinct mechanisms, such as sleep stabilisation and respiratory stimulation. Some therapies for CSA are associated with improved quality of life, although the evidence on this association is uncertain. Moreover, treatment of CSA with non-invasive positive pressure ventilation is not always effective or safe and may result in a residual apnoea-hypopnoea index.\nObjectives\nTo evaluate the benefits and harms of pharmacological treatment compared with active or inactive controls for central sleep apnoea in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 30 August 2022.\nSelection criteria\nWe included parallel and cross-over randomised controlled trials (RCTs) that evaluated any type of pharmacological agent compared with active controls (e.g. other medications) or passive controls (e.g. placebo, no treatment or usual care) in adults with CSA as defined by the International Classification of Sleep Disorders 3rd Edition. We did not exclude studies based on the duration of intervention or follow-up. We excluded studies focusing on CSA due to periodic breathing at high altitudes.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were central apnoea-hypopnoea index (cAHI), cardiovascular mortality and serious adverse events. Our secondary outcomes were quality of sleep, quality of life, daytime sleepiness, AHI, all-cause mortality, time to life-saving cardiovascular intervention, and non-serious adverse events. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included four cross-over RCTs and one parallel RCT, involving a total of 68 participants. Mean age ranged from 66 to 71.3 years and most participants were men. Four trials recruited people with CSA associated with heart failure, and one study included people with primary CSA. Types of pharmacological agents were acetazolamide (carbonic anhydrase inhibitor), buspirone (anxiolytic), theophylline (methylxanthine derivative) and triazolam (hypnotic), which were given for between three days and one week.\nOnly the study on buspirone reported a formal evaluation of adverse events. These events were rare and mild. No studies reported serious adverse events, quality of sleep, quality of life, all-cause mortality, or time to life-saving cardiovascular intervention.\nCarbonic anhydrase inhibitors versus inactive control\nResults were from two studies of acetazolamide versus placebo (n = 12) and acetazolamide versus no acetazolamide (n = 18) for CSA associated with heart failure. One study reported short-term outcomes and the other reported intermediate-term outcomes. We are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce cAHI in the short term (mean difference (MD) −26.00 events per hour, 95% CI −43.84 to −8.16; 1 study, 12 participants; very low certainty). Similarly, we are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce AHI in the short term (MD −23.00 events per hour, 95% CI −37.70 to 8.30; 1 study, 12 participants; very low certainty) or in the intermediate term (MD −6.98 events per hour, 95% CI −10.66 to −3.30; 1 study, 18 participants; very low certainty). The effect of carbonic anhydrase inhibitors on cardiovascular mortality in the intermediate term was also uncertain (odds ratio (OR) 0.21, 95% CI 0.02 to 2.48; 1 study, 18 participants; very low certainty).\nAnxiolytics versus inactive control\nResults were based on one study of buspirone versus placebo for CSA associated with heart failure (n = 16). The median difference between groups for cAHI was −5.00 events per hour (IQR −8.00 to −0.50), the median difference for AHI was −6.00 events per hour (IQR −8.80 to −1.80), and the median difference on the Epworth Sleepiness Scale for daytime sleepiness was 0 points (IQR −1.0 to 0.00).\nMethylxanthine derivatives versus inactive control\nResults were based on one study of theophylline versus placebo for CSA associated with heart failure (n = 15). We are uncertain whether methylxanthine derivatives compared to inactive control reduce cAHI (MD −20.00 events per hour, 95% CI −32.15 to −7.85; 15 participants; very low certainty) or AHI (MD −19.00 events per hour, 95% CI −30.27 to −7.73; 15 participants; very low certainty).\nHypnotics versus inactive control\nResults were based on one trial of triazolam versus placebo for primary CSA (n = 5). Due to very serious methodological limitations and insufficient reporting of outcome measures, we were unable to draw any conclusions regarding the effects of this intervention.\nAuthors' conclusions\nThere is insufficient evidence to support the use of pharmacological therapy in the treatment of CSA. Although small studies have reported positive effects of certain agents for CSA associated with heart failure in reducing the number of respiratory events during sleep, we were unable to assess whether this reduction may impact the quality of life of people with CSA, owing to scarce reporting of important clinical outcomes such as sleep quality or subjective impression of daytime sleepiness. Furthermore, the trials mostly had short-term follow-up. There is a need for high-quality trials that evaluate longer-term effects of pharmacological interventions.\n\nGiven the provided abstract, please respond to the following query: \"What is central sleep apnoea and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "CSA is a disorder in which breathing repeatedly stops and starts during sleep because the brain does not send proper signals to the muscles that control breathing. CSA mainly affects men and people with heart disease. The condition is different from and less common than obstructive sleep apnoea, where breathing is interrupted by blocked or narrowed airways. The treatment of CSA can involve using devices to help breathing, but people with CSA do not always like using them. Treatment with medicines, such as hypnotics (used to reduce tension and induce calm) and respiratory modulators (used to stimulate breathing), may be an alternative for adults with CSA."
}
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query-laysum | 4360 | [
{
"role": "user",
"content": "Abstract: Background\nParaproteinaemic neuropathy refers to those neuropathies associated with a monoclonal gammopathy or paraprotein. The most common of these present with a chronic, predominantly sensory, symmetrical neuropathy, similar to chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) but with relatively more sensory involvement, both clinically and neurophysiologically. The optimal treatment for neuropathies associated with IgG and IgA monoclonal gammopathy of uncertain significance is not known. This is an update of a review first published in 2007.\nObjectives\nTo assess the effects of any treatment for IgG or IgA paraproteinaemic peripheral neuropathy.\nSearch methods\nOn 18 January 2014 we searched the Cochrane Neuromuscular Disease Group Trials Specialized Register, CENTRAL, MEDLINE and EMBASE. We also checked bibliographies for controlled trials of treatments for IgG or IgA paraproteinaemic peripheral neuropathy. We checked clinical trials registries for ongoing studies in November 2014.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) and quasi-RCTs using any treatment for IgG or IgA paraproteinaemic peripheral neuropathy. We excluded people with IgM paraproteins. We excluded people where the monoclonal gammopathy was considered secondary to an underlying disorder. We included participants of any age with a diagnosis of monoclonal gammopathy of uncertain significance with a paraprotein of the IgG or IgA class and a neuropathy. Included participants were not required to fulfil specific electrophysiological diagnostic criteria.\nData collection and analysis\nWe used standard Cochrane methodology to select studies, extract data and analyse results. One trial author provided additional data and clarification.\nMain results\nWe identified one RCT, with 18 participants, that fulfilled the predetermined inclusion criteria. The trial compared plasma exchange to sham plasma exchange in participants with IgG or IgA paraproteinaemic neuropathy over a three-week follow-up period. We identified four other studies but these were not RCTs or quasi-RCTs. The included RCT did not report our predefined primary outcome measure, change in disability six months after randomisation. The trial revealed a modest benefit of plasma exchange in the weakness component of the Neuropathy Disability Score (NDS, now the Neuropathy Impairment Score); the mean improvement with plasma exchange was 17 points (95% confidence interval (CI) 5.2 to 28.8 points) versus 1 point (95% CI -7.7 to 9.7 points) in the sham exchange group at three weeks' follow-up (mean difference (MD) 16.00; 95% CI 1.37 to 30.63, low quality evidence). There was no statistically significant difference in the overall NDS (MD 18.00; 95% CI -2.03 to 38.03, low quality evidence), vibration thresholds or neurophysiological indices. Adverse events were not reported. The trial was at low risk of bias overall, although limitations of trial size and duration reduce the quality of the evidence in support of its conclusions.\nAuthors' conclusions\nThe evidence from RCTs for the treatment of IgG or IgA paraproteinaemic neuropathy is currently inadequate. More RCTs of treatments are required. These should have adequate follow-up periods and contain larger numbers of participants, perhaps through multicentre collaboration, considering the relative infrequency of this condition. Observational or open trial data provide limited support for the use of treatments such as plasma exchange, cyclophosphamide combined with prednisolone, intravenous immunoglobulin, and corticosteroids. These interventions show potential therapeutic promise but the potential benefits must be weighed against adverse effects. Their optimal use and the long-term benefits need to be considered and validated with well-designed RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified only one randomised controlled trial (RCT), which compared plasma exchange with sham exchange, in 18 participants with either IgA or IgG paraproteinaemic neuropathy. The results were reported after three weeks of treatment."
}
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query-laysum | 4361 | [
{
"role": "user",
"content": "Abstract: Background\nFor people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.\nObjectives\nTo compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.\nSearch methods\nWe searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nFifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria.\nOHC interventions compared with usual care\nSeven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care.\nMulti-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS –0.66, 95% CI –1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence).\nStroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS –1.31, 95% CI –1.96 to –0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence).\nThere was no evidence of a difference in gingivitis (DMS –0.60, 95% CI –1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS –0.33, 95% CI –0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence).\nOHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence).\nOHC interventions compared with placebo\nThree trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77).\nOne OHC intervention compared with another OHC intervention\nTwelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD –0.04, 95% CI –0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Despite the inclusion of several new trials of OHC for people after stroke since our last review update there remains a lack of high-quality evidence to inform OHC in stroke care settings."
}
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query-laysum | 4362 | [
{
"role": "user",
"content": "Abstract: Background\nEach year, more than four million abdominal surgeries are performed in the US and over 250,000 in England. Acute respiratory failure, a common complication that can affect 30% to 50% of people after upper abdominal surgery, can lead to significant morbidity and mortality. Noninvasive ventilation has been associated with lower rates of tracheal intubation in adults with acute respiratory failure, thus reducing the incidence of complications and mortality. This review compared the effectiveness and safety of noninvasive positive pressure ventilation (NPPV) versus standard oxygen therapy in the treatment of acute respiratory failure after upper abdominal surgery.\nObjectives\nTo assess the effectiveness and safety of noninvasive positive pressure ventilation (NPPV), that is, continuous positive airway pressure (CPAP) or bilevel NPPV, in reducing mortality and the rate of tracheal intubation in adults with acute respiratory failure after upper abdominal surgery, compared to standard therapy (oxygen therapy), and to assess changes in arterial blood gas levels, hospital and intensive care unit (ICU) length of stay, gastric insufflation, and anastomotic leakage.\nSearch methods\nThe date of the last search was 12 May 2015. We searched the following databases: the Cochrane Handbook for Systematic Reviews of Interventions (CENTRAL) (2015, Issue 5), MEDLINE (Ovid SP, 1966 to May 2015), EMBASE (Ovid SP, 1974 to May 2015); the physiotherapy evidence database (PEDro) (1999 to May 2015); the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCOhost, 1982 to May 2015), and LILACS (BIREME, 1986 to May 2015). We reviewed reference lists of included studies and contacted experts. We also searched grey literature sources. We checked databases of ongoing trials such as www.controlled-trials.com/ and www.trialscentral.org/. We did not apply language restrictions.\nSelection criteria\nWe selected randomized or quasi-randomized controlled trials involving adults with acute respiratory failure after upper abdominal surgery who were treated with CPAP or bilevel NPPV with, or without, drug therapy as standard medical care, compared to adults treated with oxygen therapy with, or without, standard medical care.\nData collection and analysis\nTwo authors independently selected and abstracted data from eligible studies using a standardized form. We evaluated study quality by assessing allocation concealment; random sequence generation; incomplete outcome data; blinding of participants, personnel, and outcome assessors; selective reporting; and adherence to the intention-to-treat (ITT) principle.\nMain results\nWe included two trials involving 269 participants. The participants were mostly men (67%); the mean age was 65 years. The trials were conducted in China and Italy (one was a multicentre trial). Both trials included adults with acute respiratory failure after upper abdominal surgery. We judged both trials at high risk of bias. Compared to oxygen therapy, CPAP or bilevel NPPV may reduce the rate of tracheal intubation (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.08 to 0.83; low quality evidence) with a number needed to treat for an additional beneficial outcome of 11. There was very low quality evidence that the intervention may also reduce ICU length of stay (mean difference (MD) -1.84 days; 95% CI -3.53 to -0.15). We found no differences for mortality (low quality evidence) and hospital length of stay. There was insufficient evidence to be certain that CPAP or NPPV had an effect on anastomotic leakage, pneumonia-related complications, and sepsis or infections. Findings from one trial of 60 participants suggested that bilevel NPPV, compared to oxygen therapy, may improve blood gas levels and blood pH one hour after the intervention (partial pressure of arterial oxygen (PaO2): MD 22.5 mm Hg; 95% CI 17.19 to 27.81; pH: MD 0.06; 95% CI 0.01 to 0.11; partial pressure of arterial carbon dioxide (PCO2) levels (MD -9.8 mm Hg; 95% CI -14.07 to -5.53). The trials included in this systematic review did not present data on the following outcomes that we intended to assess: gastric insufflation, fistulae, pneumothorax, bleeding, skin breakdown, eye irritation, sinus congestion, oronasal drying, and patient-ventilator asynchrony.\nAuthors' conclusions\nThe findings of this review indicate that CPAP or bilevel NPPV is an effective and safe intervention for the treatment of adults with acute respiratory failure after upper abdominal surgery. However, based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, the quality of the evidence was low or very low. More good quality studies are needed to confirm these findings.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was low quality evidence for hospital mortality, low quality of evidence for rate of tracheal intubation, and very low quality of evidence for ICU length of stay."
}
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query-laysum | 4363 | [
{
"role": "user",
"content": "Abstract: Background\nDelayed recovery of urinary continence is a major adverse effect of robotic-assisted laparoscopic prostatectomy (RALP) in men undergoing prostate cancer treatment. To address this issue, a number of surgical techniques have been designed to reconstruct the posterior aspect of the rhabdosphincter, which is responsible for urinary continence after removal of the prostate; however, it is unclear how well they work.\nObjectives\nTo assess the effects of posterior musculofascial reconstruction RALP compared to no posterior reconstruction during RALP for the treatment of clinically localized prostate cancer.\nSearch methods\nWe performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to 12 March 2021. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which participants were randomized to undergo variations of posterior musculofascial reconstruction RALP versus no posterior reconstruction during RALP for clinically localized prostate cancer.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery at six and twelve months after surgery, potency recovery twelve months after surgery, positive surgical margins (PSM), and biochemical recurrence-free survival (BCRFS). We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.\nMain results\nOur search identified 13 records of eight unique RCTs, of which six were published studies and two were abstract proceedings. We included 1085 randomized participants, of whom 963 completed the trials (88.8%). All participants had either cT1c or cT2 or cT3a disease, with a mean prostate-specific antigen level of 8.15 ng/mL.\nPrimary outcomes\nPosterior reconstruction RALP (PR-RALP) may improve urinary continence one week after catheter removal compared to no posterior reconstruction during RALP (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.90 to 1.73; I2 = 42%; studies = 5, participants = 498; low CoE) although the CI also includes the possibility of no effect. Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 84 more men per 1000 (33 fewer to 244 more) reporting urinary continence recovery.\nPosterior reconstruction may have little to no effect on urinary continence three months after surgery compared to no posterior reconstruction during RALP (RR 0.98, 95% CI 0.84 to 1.14; I2 = 67%; studies = 6, participants = 842; low CoE). Assuming 701 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 14 fewer men per 1000 (112 fewer to 98 more) reporting urinary continence after three months.\nPR-RALP probably results in little to no difference in serious adverse events compared to no posterior reconstruction during RALP (RR 0.75, 95% CI 0.29 to 1.92; I2 = 0%; studies = 6, participants = 835; moderate CoE). Assuming 25 per 1000 men undergoing standard RALP experience a serious adverse event at this time point, this corresponds to six fewer men per 1000 (17 fewer to 23 more) reporting serious adverse events.\nSecondary outcomes\nPR-RALP may result in little to no difference in recovery of continence 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.98 to 1.07; I2 = 25%; studies = 3, participants = 602; low CoE). Assuming 918 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 18 more men per 1000 (18 fewer to 64 more) reporting urinary continence recovery.\nWe are very uncertain about the effects of PR-RALP on recovery of potency 12 months after surgery compared to no posterior reconstruction during RALP (RR 1.02, 95% CI 0.82 to 1.26; I2 = 3%; studies = 2, participants = 308; very low CoE). Assuming 433 per 1000 men undergoing standard RALP are potent at this time point, this corresponds to nine more men per 1000 (78 fewer to 113 more) reporting potency recovery.\nPR-RALP may result in little to no difference in positive surgical margins compared to no posterior reconstruction during RALP (RR 1.24, 95% CI 0.65 to 2.33; I2 = 50%; studies = 3, participants = 517; low CoE). Assuming 130 per 1000 men undergoing standard RALP have a positive surgical margin, this corresponds to 31 more men per 1000 (46 fewer to 173 more) reporting positive surgical margins.\nPR-RALP may result in little to no difference in biochemical recurrence compared to no posterior reconstruction during RALP (RR 1.36, 95% CI 0.74 to 2.52; I2 = 0%; studies = 2, participants = 468; low CoE). Assuming 70 per 1000 men undergoing standard RALP have experienced biochemical recurrence at this time point, this corresponds to 25 more men per 1000 (18 fewer to 107 more) reporting biochemical recurrence.\nAuthors' conclusions\nThis review found evidence that PR-RALP may improve early continence one week after catheter removal but not thereafter. Meanwhile, adverse event rates are probably not impacted and surgical margins rates are likely similar. This review was unable to determine if or how these findings may be impacted by the person's age, nerve-sparing status, or clinical stage. Study limitations, imprecision, and inconsistency lowered the certainty of evidence for the outcomes assessed.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence ranged from moderate to very low depending on the outcome, meaning that we have moderate to very little confidence in the results."
}
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query-laysum | 4364 | [
{
"role": "user",
"content": "Abstract: Background\nStandard care of adjuvant treatment for anaplastic oligodendrogliomas (AO) and anaplastic oligoastrocytomas (AOA) is not yet well defined. The benefit of adjuvant chemotherapy and radiotherapy (RT), given as single modalities or sequentially, is still unclear. Furthermore, insight into the predictive and prognostic impact of various biomarkers is surging.\nObjectives\nTo compare postoperative sequential RT and chemotherapy to RT alone in adults with newly diagnosed AO or mixed AOA. To evaluate the predictive and prognostic impact of the following biomarkers: codeletion of chromosomes 1p and 19q, O6-methylguanine-DNA methyltransferase (MGMT) promotor methylation and isocitrate dehydrogenase (IDH)-1 and -2 mutations.\nSearch methods\nWe searched the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 1, 2014), MEDLINE (2006 to March week 2, 2014) and EMBASE (2006 to week 11, 2014). We scanned reference lists from relevant studies for any additional articles.\nSelection criteria\nWe included randomized controlled trials (RCTs) of adults with AO, AOA or anaplastic astrocytoma (AA) comparing adjuvant treatment of chemotherapy, RT, or sequential chemotherapy and RT. We excluded no specific chemotherapy regimens.\nData collection and analysis\nWe critically appraised and extracted data from relevant studies. Based on the differences in participant selection with respect to the definition of AO (two versus three high-risk anaplastic features), the inclusion of AA and sequence of treatment (RT and chemotherapy), we could not consider the results from the three RCTs for meta-analysis.\nMain results\nThree RCTs, with 931 participants, tested different neoadjuvant treatments: RT alone; sequential RT and procarbazine, lomustine and vincristine (PCV) chemotherapy; PCV chemotherapy alone; and temozolomide chemotherapy alone. None of the studies blinded participants or personnel, and, therefore, are considered at high risk of performance and detection bias. The studies were otherwise at low risk of bias. One study, the European Organisation for Research and Treatment of Cancer (EORTC) trial, demonstrated a statistically significant overall survival (OS) benefit for RT plus PCV, with a median OS of 3.5 years compared with 2.6 years in the RT alone arm (P value = 0.018). This result was reported 10 years after the conclusion of the enrolment, and was not apparent in the original 2008 Cochrane review. Furthermore, with retrospective evaluation of biomarkers, codeletion of complete chromosome arms 1p and 19q and IDH-1 or -2 mutation were independent prognostic factors for OS in two of the RCTs (Radiation Therapy Oncology Group (RTOG) and EORTC), and were predictive for OS in one trial (RTOG). The third trial (NOA-04) evaluated these biomarkers prospectively and found them prognostic for progression-free survival.\nAuthors' conclusions\nEarly PCV, either before or after RT, appears to improve OS of participants with AO or AOA. Use of biomarkers including codeletion of chromosomes 1p and 19q with or without IDH-1 or -2 mutation identify a subset of people with increased sensitivity to combined PCV and RT. The important role of biomarkers was supported in all of the RCTs examined, and prospective evaluation should be undertaken in future studies. However, PCV was associated with significant grade 3 and 4 toxicities, and whether temozolomide can be substituted for this remains unclear.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the scientific literature up to March 2014 for studies of adults over 18 years of age with a diagnosis of anaplastic oligodendrogliomas, anaplastic oligoastrocytomas or anaplastic astrocytomas. After surgery, the participants had to have received radiotherapy alone, chemotherapy alone or radiotherapy plus chemotherapy. In the first review on this topic in 2009, we found two trials to include. In this update, we identified another trial for inclusion, and updates from the two previously included trials were taken into consideration."
}
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query-laysum | 4365 | [
{
"role": "user",
"content": "Abstract: Background\nThrombolytic therapy is usually reserved for people with clinically serious or massive pulmonary embolism (PE). Evidence suggests that thrombolytic agents may dissolve blood clots more rapidly than heparin and may reduce the death rate associated with PE. However, there are still concerns about the possible risk of adverse effects of thrombolytic therapy, such as major or minor haemorrhage. This is the fourth update of the Cochrane review first published in 2006.\nObjectives\nTo assess the effects of thrombolytic therapy for acute pulmonary embolism.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 17 August 2020. We undertook reference checking to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared thrombolytic therapy followed by heparin versus heparin alone, heparin plus placebo, or surgical intervention for people with acute PE (massive/submassive). We did not include trials comparing two different thrombolytic agents or different doses of the same thrombolytic drug.\nData collection and analysis\nTwo review authors (ZZ, QH) assessed the eligibility and risk of bias of trials and extracted data. We calculated effect estimates using the odds ratio (OR) with a 95% confidence interval (CI) or the mean difference (MD) with a 95% CI. The primary outcomes of interest were death, recurrence of PE and haemorrhagic events. We assessed the certainty of the evidence using GRADE criteria.\nMain results\nWe identified three new studies for inclusion in this update. We included 21 trials in the review, with a total of 2401 participants. No studies compared thrombolytics versus surgical intervention. We were not able to include one study in the meta-analysis because it provided no extractable data. Most studies carried a high or unclear risk of bias related to randomisation and blinding.\nMeta-analysis showed that, compared to control (heparin alone or heparin plus placebo), thrombolytics plus heparin probably reduce both the odds of death (OR 0.58, 95% CI 0.38 to 0.88; 19 studies, 2319 participants; low-certainty evidence), and recurrence of PE (OR 0.54, 95% CI 0.32 to 0.91; 12 studies, 2050 participants; low-certainty evidence). Effects on mortality weakened when six studies at high risk of bias were excluded from analysis (OR 0.71, 95% CI 0.45 to 1.13; 13 studies, 2046 participants) and in the analysis of submassive PE participants (OR 0.61, 95% CI 0.37 to 1.02; 1993 participants). Effects on recurrence of PE also weakened after removing one study at high risk of bias for sensitivity analysis (OR 0.60, 95% CI 0.35 to 1.04; 11 studies, 1949 participants). We downgraded the certainty of evidence to low because of 'Risk of bias' concerns.\nMajor haemorrhagic events were probably more common in the thrombolytics group than in the control group (OR 2.84, 95% CI 1.92 to 4.20; 15 studies, 2101 participants; moderate-certainty evidence), as were minor haemorrhagic events (OR 2.97, 95% CI 1.66 to 5.30; 13 studies,1757 participants; low-certainty evidence). We downgraded the certainty of the evidence to moderate or low because of 'Risk of bias' concerns and inconsistency. Haemorrhagic stroke may occur more often in the thrombolytics group than in the control group (OR 7.59, 95% CI 1.38 to 41.72; 2 studies, 1091 participants).\nLimited data indicated that thrombolytics may benefit haemodynamic outcomes, perfusion lung scanning, pulmonary angiogram assessment, echocardiograms, pulmonary hypertension, coagulation parameters, composite clinical outcomes, need for escalation and survival time to a greater extent than heparin alone. However, the heterogeneity of the studies and the small number of participants involved warrant caution when interpreting results.\nThe length of hospital stay was shorter in the thrombolytics group than in the control group (mean difference (MD) −1.40 days, 95% CI −2.69 to −0.11; 5 studies, 368 participants). Haemodynamic decompensation may occur less in the thrombolytics group than in the control group (OR 0.36, 95% CI 0.20 to 0.66; 3 studies, 1157 participants). Quality of life was similar between the two treatment groups.\nNone of the included studies provided data on post-thrombotic syndrome or on cost comparison.\nAuthors' conclusions\nLow-certainty evidence suggests that thrombolytics may reduce death following acute pulmonary embolism compared with heparin (the effectiveness was mainly driven by one trial with massive PE). Thrombolytic therapy may be helpful in reducing the recurrence of pulmonary emboli but may cause more major and minor haemorrhagic events, including haemorrhagic stroke. More studies of high methodological quality are needed to assess safety and cost effectiveness of thrombolytic therapy for people with pulmonary embolism.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The certainty of the evidence is moderate or low, because of study design limitations (risk of bias), and small sample sizes. We need more large, well-designed trials to increase our confidence in any benefits of thrombolytic therapy for pulmonary embolism."
}
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query-laysum | 4366 | [
{
"role": "user",
"content": "Abstract: Background\nPre-eclampsia is a very frequent complication of pregnancy, and anticipation of birth is often necessary. However, the best mode of giving birth remains to be established, although observational studies suggest better maternal and perinatal outcomes with vaginal birth.\nObjectives\nTo assess the effects of a policy of planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia on mortality and morbidity for mother and baby.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (6 September 2017) and reference lists of retrieved studies.\nSelection criteria\nWe planned to include all randomised trials of planned caesarean section versus planned vaginal birth for pregnant women with severe pre-eclampsia. Quasi-randomised and non-randomised studies are not eligible for inclusion in this review.\nThe focus of this review is severe pre-eclampsia; studies of planned caesarean section versus planned vaginal birth in pregnant women with eclampsia are not eligible for inclusion.\nData collection and analysis\nWe identified no studies that met the inclusion criteria. We excluded two studies.\nMain results\nThere are no included studies in this review.\nAuthors' conclusions\nThere is a lack of robust evidence from randomised controlled trials that can inform practice regarding planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia. There is a need for high-quality randomised controlled trials to assess the short- and long-term effects of caesarean section and vaginal birth for these women and their babies.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Randomised clinical trials are considered to be the best way to test different treatment options and decide which treatment is safer and better overall. We searched for studies on 6 September 2017, but did not find any randomised clinical trials comparing planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia. There is no evidence from RCTs to help decide which type of birth is better for pregnant women with serious pre-eclampsia and their babies."
}
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query-laysum | 4367 | [
{
"role": "user",
"content": "Abstract: Background\nSeveral rehabilitation programmes are available for individuals after lumbar disc surgery.\nObjectives\nTo determine whether active rehabilitation after lumbar disc surgery is more effective than no treatment, and to describe which type of active rehabilitation is most effective. This is the second update of a Cochrane Review first published in 2002.\nFirst, we clustered treatments according to the start of treatment.\n1. Active rehabilitation that starts immediately postsurgery.\n2. Active rehabilitation that starts four to six weeks postsurgery.\n3. Active rehabilitation that starts longer than 12 months postsurgery.\nFor every cluster, the following comparisons were investigated.\nA. Active rehabilitation versus no treatment, placebo or waiting list control.\nB. Active rehabilitation versus other kinds of active rehabilitation.\nC. Specific intervention in addition to active rehabilitation versus active rehabilitation alone.\nSearch methods\nWe searched CENTRAL (2013, Issue 4) and MEDLINE, EMBASE, CINAHL, PEDro and PsycINFO to May 2013.\nSelection criteria\nWe included only randomised controlled trials (RCTs).\nData collection and analysis\nPairs of review authors independently assessed studies for eligibility and risk of bias. Meta-analyses were performed if studies were clinically homogeneous. The GRADE approach was used to determine the overall quality of evidence.\nMain results\nIn this update, we identified eight new studies, thereby including a total of 22 trials (2503 participants), 10 of which had a low risk of bias. Most rehabilitation programmes were assessed in only one study. Both men and women were included, and overall mean age was 41.4 years. All participants had received standard discectomy, microdiscectomy and in one study standard laminectomy and (micro)discectomy. Mean duration of the rehabilitation intervention was 12 weeks; eight studies assessed six to eight-week exercise programmes, and eight studies assessed 12 to 13-week exercise programmes. Programmes were provided in primary and secondary care facilities and were started immediately after surgery (n = 4) or four to six weeks (n = 16) or one year after surgery (n = 2). In general, the overall quality of the evidence is low to very low. Rehabilitation programmes that started immediately after surgery were not more effective than their control interventions, which included exercise. Low- to very low-quality evidence suggests that there were no differences between specific rehabilitation programmes (multidisciplinary care, behavioural graded activity, strength and stretching) that started four to six weeks postsurgery and their comparators, which included some form of exercise. Low-quality evidence shows that physiotherapy from four to six weeks postsurgery onward led to better function than no treatment or education only, and that multidisciplinary rehabilitation co-ordinated by medical advisors led to faster return to work than usual care. Statistical pooling was performed only for three comparisons in which the rehabilitation programmes started four to six weeks postsurgery: exercise programmes versus no treatment, high- versus low-intensity exercise programmes and supervised versus home exercise programmes. Very low-quality evidence (five RCTs, N = 272) shows that exercises are more effective than no treatment for pain at short-term follow-up (standard mean difference (SMD) -0.90; 95% confidence interval (CI) -1.55 to -0.24), and low-quality evidence (four RCTs, N = 252) suggests that exercises are more effective for functional status on short-term follow-up (SMD -0.67; 95% CI -1.22 to -0.12) and that no difference in functional status was noted on long-term follow-up (three RCTs, N = 226; SMD -0.22; 95% CI -0.49 to 0.04). None of these studies reported that exercise increased the reoperation rate. Very low-quality evidence (two RCTs, N = 103) shows that high-intensity exercise programmes are more effective than low-intensity exercise programmes for pain in the short term (weighted mean difference (WMD) -10.67; 95% CI -17.04 to -4.30), and low-quality evidence (two RCTs, N = 103) shows that they are more effective for functional status in the short term (SMD -0.77; 95% CI -1.17 to -0.36). Very low-quality evidence (four RCTs, N = 154) suggests no significant differences between supervised and home exercise programmes for short-term pain relief (SMD -0.76; 95% CI -2.04 to 0.53) or functional status (four RCTs, N = 154; SMD -0.36; 95% CI -0.88 to 0.15).\nAuthors' conclusions\nConsiderable variation was noted in the content, duration and intensity of the rehabilitation programmes included in this review, and for none of them was high- or moderate-quality evidence identified. Exercise programmes starting four to six weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment, with small to medium effect sizes, and high-intensity exercise programmes seem to lead to a slightly faster decrease in pain and disability than is seen with low-intensity programmes, but the overall quality of the evidence is only low to very low. No significant differences were noted between supervised and home exercise programmes for pain relief, disability or global perceived effect. None of the trials reported an increase in reoperation rate after first-time lumbar surgery. High-quality randomised controlled trials are strongly needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A 'slipped' or 'herniated' disc is thought to be the most common cause of leg pain associated with a 'pinched' or compressed nerve in the lower back. Many patients are treated with a combination of non-surgical measures such as medication or physiotherapy. Patients with persistent symptoms may undergo surgery. Although 78% to 95% of patients will improve after surgery, some will continue to have symptoms. It is estimated that 3% to 12% of patients who have disc surgery will have recurrent symptoms, and most of these patients will have surgery again.\nRehabilitation programmes, such as exercise therapy by a physiotherapist and advice to return to normal activities like returning to work, are common approaches after surgery."
}
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query-laysum | 4368 | [
{
"role": "user",
"content": "Abstract: Background\nTetanus is an acute, often fatal, disease caused by an exotoxin produced by Clostridium tetani. It occurs in newborn infants born to mothers who do not have sufficient circulating antibodies to protect the infant passively, by transplacental transfer. Prevention may be possible by the vaccination of pregnant or non-pregnant women, or both, with tetanus toxoid, and the provision of clean delivery services. Tetanus toxoid consists of a formaldehyde-treated toxin that stimulates the production of antitoxin.\nObjectives\nTo assess the effectiveness of tetanus toxoid, administered to women of reproductive age or pregnant women, to prevent cases of, and deaths from, neonatal tetanus.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2015), CENTRAL (The Cochrane Library 2015, Issue 1), PubMed (1966 to 28 January 2015), EMBASE (1974 to 28 January 2015) and reference lists of retrieved studies.\nSelection criteria\nRandomised or quasi-randomised trials evaluating the effects of tetanus toxoid in pregnant women or women of reproductive age on numbers of neonatal tetanus cases and deaths.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nTwo effectiveness trials (9823 infants) and one safety trial (48 mothers) were included. The main outcomes were measured on infants born to a subset of those randomised women who became pregnant during the course of the studies. For our primary outcomes, there was no high-quality evidence according to GRADE assessments.\nOne study (1182 infants) assessed the effectiveness of tetanus toxoid in comparison with influenza vaccine in preventing neonatal tetanus deaths. A single dose did not provide significant protection against neonatal tetanus deaths, (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.26 to 1.24; 494 infants; GRADE: low-quality evidence). However, a two- or three-dose course did provide protection against neonatal deaths, (RR 0.02, 95% CI 0.00 to 0.30; 688 infants; GRADE: moderate-quality evidence). Administration of a two- or three-dose course resulted in significant protection when all causes of death are considered as an outcome (RR 0.31, 95% CI 0.17 to 0.55; 688 infants; GRADE: moderate-quality evidence). No effect was detected on causes of death other than tetanus. Cases of neonatal tetanus after at least one dose of tetanus toxoid were reduced in the tetanus toxoid group, (RR 0.20, 95% CI 0.10 to 0.40; 1182 infants; GRADE: moderate-quality evidence).\nAnother study, involving 8641 children, assessed the effectiveness of tetanus-diphtheria toxoid in comparison with cholera toxoid in preventing neonatal mortality after one or two doses. Neonatal mortality was reduced in the tetanus-diphtheria toxoid group (RR 0.68, 95% CI 0.56 to 0.82). In preventing deaths at four to 14 days, neonatal mortality was reduced again in the tetanus-diphtheria toxoid group (RR 0.38, 95% CI 0.27 to 0.55). The quality of evidence as assessed using GRADE was found to be low.\nThe third small trial assessed that pain at injection site was reported more frequently among pregnant women who received tetanus diphtheria acellular pertussis than placebo (RR 5.68, 95% CI 1.54 to 20.94; GRADE: moderate-quality evidence).\nAuthors' conclusions\nAvailable evidence supports the implementation of immunisation practices on women of reproductive age or pregnant women in communities with similar, or higher, levels of risk of neonatal tetanus, to the two study sites.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Tetanus in newborn babies is an infection causing rigidity, muscle spasm and often death. It is quite common in low-income countries, as a result of insufficient protection being passed from the mother to her baby during the pregnancy, together with infection entering into the baby when the umbilical cord is cut using contaminated instruments."
}
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query-laysum | 4369 | [
{
"role": "user",
"content": "Abstract: Background\nThe number of people with type 2 diabetes mellitus (T2DM) is increasing worldwide. The combination of metformin and sulphonylurea (M+S) is a widely used treatment. Whether M+S shows better or worse effects in comparison with other antidiabetic medications for people with T2DM is still controversial.\nObjectives\nTo assess the effects of metformin and sulphonylurea (second- or third-generation) combination therapy for adults with type 2 diabetes mellitus.\nSearch methods\nWe updated the search of a recent systematic review from the Agency for Healthcare Research and Quality (AHRQ). The updated search included CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP. The date of the last search was March 2018. We searched manufacturers' websites and reference lists of included trials, systematic reviews, meta-analyses and health technology assessment reports. We asked investigators of the included trials for information about additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) randomising participants 18 years old or more with T2DM to M+S compared with metformin plus another glucose-lowering intervention or metformin monotherapy with a treatment duration of 52 weeks or more.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis, and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using the GRADE instrument.\nMain results\nWe included 32 RCTs randomising 28,746 people. Treatment duration ranged between one to four years. We judged none of these trials as low risk of bias for all 'Risk of bias' domains. Most important events per person were all-cause and cardiovascular mortality, serious adverse events (SAE), non-fatal stroke (NFS), non-fatal myocardial infarction (MI) and microvascular complications. Most important comparisons were as follows:\nFive trials compared M+S (N = 1194) with metformin plus a glucagon-like peptide 1 analogue (N = 1675): all-cause mortality was 11/1057 (1%) versus 11/1537 (0.7%), risk ratio (RR) 1.15 (95% confidence interval (CI) 0.49 to 2.67); 3 trials; 2594 participants; low-certainty evidence; cardiovascular mortality 1/307 (0.3%) versus 1/302 (0.3%), low-certainty evidence; serious adverse events (SAE) 128/1057 (12.1%) versus 194/1537 (12.6%), RR 0.90 (95% CI 0.73 to 1.11); 3 trials; 2594 participants; very low-certainty evidence; non-fatal myocardial infarction (MI) 2/549 (0.4%) versus 6/1026 (0.6%), RR 0.57 (95% CI 0.12 to 2.82); 2 trials; 1575 participants; very low-certainty evidence.\nNine trials compared M+S (N = 5414) with metformin plus a dipeptidyl-peptidase 4 inhibitor (N = 6346): all-cause mortality was 33/5387 (0.6%) versus 26/6307 (0.4%), RR 1.32 (95% CI 0.76 to 2.28); 9 trials; 11,694 participants; low-certainty evidence; cardiovascular mortality 11/2989 (0.4%) versus 9/3885 (0.2%), RR 1.54 (95% CI 0.63 to 3.79); 6 trials; 6874 participants; low-certainty evidence; SAE 735/5387 (13.6%) versus 779/6307 (12.4%), RR 1.07 (95% CI 0.97 to 1.18); 9 trials; 11,694 participants; very low-certainty evidence; NFS 14/2098 (0.7%) versus 8/2995 (0.3%), RR 2.21 (95% CI 0.74 to 6.58); 4 trials; 5093 participants; very low-certainty evidence; non-fatal MI 15/2989 (0.5%) versus 13/3885 (0.3%), RR 1.45 (95% CI 0.69 to 3.07); 6 trials; 6874 participants; very low-certainty evidence; one trial in 64 participants reported no microvascular complications were observed (very low-certainty evidence).\nEleven trials compared M+S (N = 3626) with metformin plus a thiazolidinedione (N = 3685): all-cause mortality was 123/3300 (3.7%) versus 114/3354 (3.4%), RR 1.09 (95% CI 0.85 to 1.40); 6 trials; 6654 participants; low-certainty evidence; cardiovascular mortality 37/2946 (1.3%) versus 41/2994 (1.4%), RR 0.78 (95% CI 0.36 to 1.67); 4 trials; 5940 participants; low-certainty evidence; SAE 666/3300 (20.2%) versus 671/3354 (20%), RR 1.01 (95% CI 0.93 to 1.11); 6 trials; 6654 participants; very low-certainty evidence; NFS 20/1540 (1.3%) versus 16/1583 (1%), RR 1.29 (95% CI 0.67 to 2.47); P = 0.45; 2 trials; 3123 participants; very low-certainty evidence; non-fatal MI 25/1841 (1.4%) versus 21/1877 (1.1%), RR 1.21 (95% CI 0.68 to 2.14); P = 0.51; 3 trials; 3718 participants; very low-certainty evidence; three trials (3123 participants) reported no microvascular complications (very low-certainty evidence).\nThree trials compared M+S (N = 462) with metformin plus a glinide (N = 476): one person died in each intervention group (3 trials; 874 participants; low-certainty evidence); no cardiovascular mortality (2 trials; 446 participants; low-certainty evidence); SAE 34/424 (8%) versus 27/450 (6%), RR 1.68 (95% CI 0.54 to 5.21); P = 0.37; 3 trials; 874 participants; low-certainty evidence; no NFS (1 trial; 233 participants; very low-certainty evidence); non-fatal MI 2/215 (0.9%) participants in the M+S group; 2 trials; 446 participants; low-certainty evidence; no microvascular complications (1 trial; 233 participants; low-certainty evidence).\nFour trials compared M+S (N = 2109) with metformin plus a sodium-glucose co-transporter 2 inhibitor (N = 3032): all-cause mortality was 13/2107 (0.6%) versus 19/3027 (0.6%), RR 0.96 (95% CI 0.44 to 2.09); 4 trials; 5134 participants; very low-certainty evidence; cardiovascular mortality 4/1327 (0.3%) versus 6/2262 (0.3%), RR 1.22 (95% CI 0.33 to 4.41); 3 trials; 3589 participants; very low-certainty evidence; SAE 315/2107 (15.5%) versus 375/3027 (12.4%), RR 1.02 (95% CI 0.76 to 1.37); 4 trials; 5134 participants; very low-certainty evidence; NFS 3/919 (0.3%) versus 7/1856 (0.4%), RR 0.87 (95% CI 0.22 to 3.34); 2 trials; 2775 participants; very low-certainty evidence; non-fatal MI 7/890 (0.8%) versus 8/1374 (0.6%), RR 1.43 (95% CI 0.49 to 4.18; 2 trials); 2264 participants; very low-certainty evidence; amputation of lower extremity 1/437 (0.2%) versus 1/888 (0.1%); very low-certainty evidence.\nTrials reported more hypoglycaemic episodes with M+S combination compared to all other metformin-antidiabetic agent combinations. Results for M+S versus metformin monotherapy were inconclusive. There were no RCTs comparing M+S with metformin plus insulin. We identified nine ongoing trials and two trials are awaiting assessment. Together these trials will include approximately 16,631 participants.\nAuthors' conclusions\nThere is inconclusive evidence whether M+S combination therapy compared with metformin plus another glucose-lowering intervention results in benefit or harm for most patient-important outcomes (mortality, SAEs, macrovascular and microvascular complications) with the exception of hypoglycaemia (more harm for M+S combination). No RCT reported on health-related quality of life.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All included studies had deficiencies in the way they were conducted or how study authors reported the results. For individual comparisons of the antidiabetic medications the number of participants was often small, resulting in a high risk of random error (play of chance)."
}
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query-laysum | 4370 | [
{
"role": "user",
"content": "Abstract: Background\nAnderson-Fabry disease is an X-linked defect of glycosphingolipid metabolism. Progressive renal insufficiency is a major source of morbidity, additional complications result from cardio- and cerebro-vascular involvement. Survival is reduced among affected males and symptomatic female carriers.\nThis is an update of a Cochrane review first published in 2010, and previously updated in 2013.\nObjectives\nTo evaluate the effectiveness and safety of enzyme replacement therapy compared to other interventions, placebo or no interventions, for treating Anderson-Fabry disease.\nSearch methods\nWe searched the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register (date of the most recent search: 08 July 2016). We also searched 'Clinical Trials' on The Cochrane Library, MEDLINE, Embase and LILACS (date of the most recent search: 24 September 2015).\nSelection criteria\nRandomized controlled trials of agalsidase alfa or beta in participants diagnosed with Anderson-Fabry disease.\nData collection and analysis\nTwo authors selected relevant trials, assessed methodological quality and extracted data.\nMain results\nNine trials comparing either agalsidase alfa or beta in 351 participants fulfilled the selection criteria.\nBoth trials comparing agalsidase alfa to placebo reported on globotriaosylceramide concentration in plasma and tissue; aggregate results were non-significant. One trial reported pain scores measured by the Brief Pain Inventory severity, there was a statistically significant improvement for participants receiving treatment at up to three months, mean difference -2.10 (95% confidence interval -3.79 to -0.41; at up to five months, mean difference -1.90 (95% confidence interval -3.65 to -0.15); and at up to six months, mean difference -2.00 (95% confidence interval -3.66 to -0.34). There was a significant difference in the Brief Pain Inventory pain-related quality of life at over five months and up to six months, mean difference -2.10 (95% confidence interval -3.92 to -0.28) but not at other time points. Death was not an outcome in either of the trials.\nOne of the three trials comparing agalsidase beta to placebo reported on globotriaosylceramide concentration in plasma and tissue and showed significant improvement: kidney, mean difference -1.70 (95% confidence interval -2.09 to -1.31); heart, mean difference -0.90 (95% confidence interval -1.18 to -0.62); and composite results (renal, cardiac, and cerebrovascular complications and death), mean difference -4.80 (95% confidence interval -5.45 to -4.15). There was no significant difference between groups for death; no trials reported on pain.\nOnly two trials compared agalsidase alfa to agalsidase beta. One of them showed no significant difference between the groups regarding adverse events, risk ratio 0.36 (95% confidence interval 0.08 to 1.59), or any serious adverse events; risk ratio 0.30; (95% confidence interval 0.03 to 2.57).\nTwo trials compared different dosing schedules of agalsidase alfa. One of them involved three different doses (0.2 mg/kg every two weeks; 0.1 mg/kg weekly and; 0.2 mg/kg weekly), the other trial evaluated two further doses to the dosage schedules: 0.4 mg/kg every week and every other week. Both trials failed to show significant differences with various dosing schedules on globotriaosylceramide levels. No significant differences were found among the schedules for the primary efficacy outcome of self-assessed health state, or for pain scores.\nOne trial comparing agalsidase alfa to agalsidase beta showed no significant difference for any adverse events such as dyspnoea and hypertension.\nThe methodological quality of the included trials was generally unclear for the random sequence generation and allocation concealment.\nAuthors' conclusions\nTrials comparing enzyme replacement therapy to placebo show significant improvement with enzyme replacement therapy in regard to microvascular endothelial deposits of globotriaosylceramide and in pain-related quality of life. There is, however, no evidence identifying if the alfa or beta form is superior or the optimal dose or frequency of enzyme replacement therapy. With regards to safety, adverse events (i.e., rigors, fever) were more significant in the agalsidase beta as compared to placebo. The long-term influence of enzyme replacement therapy on risk of morbidity and mortality related to Anderson-Fabry disease remains to be established. This review highlights the need for continued research into the use of enzyme replacement therapy for Anderson-Fabry disease.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is current to: 08 July 2016."
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query-laysum | 4371 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis is a leading cause of infectious disease-related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one-third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection.\nObjectives\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high-risk groups and in the general population. Screening \"irrespective of signs or symptoms\" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough).\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high-risk groups and in the general population.\nSearch methods\nWe searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies.\nSelection criteria\nCross-sectional and cohort studies in which adults (15 years and older) in high-risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture-based drug susceptibility testing and line probe assays.\nData collection and analysis\nTwo review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS-2. We used a bivariate random-effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high-risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high-risk groups combined.\nMain results\nWe included a total of 21 studies: 18 studies (13,114 participants) evaluated Xpert MTB/RIF as a screening test for pulmonary tuberculosis and one study (571 participants) evaluated both Xpert MTB/RIF and Xpert Ultra. Three studies (159 participants) evaluated Xpert MTB/RIF for rifampicin resistance. Fifteen studies (75%) were conducted in high tuberculosis burden and 16 (80%) in high TB/HIV-burden countries. We judged most studies to have low risk of bias in all four QUADAS-2 domains and low concern for applicability.\nXpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis\nIn people living with HIV (12 studies), Xpert MTB/RIF pooled sensitivity and specificity (95% CrI) were 61.8% (53.6 to 69.9) (602 participants; moderate-certainty evidence) and 98.8% (98.0 to 99.4) (4173 participants; high-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 40 would be Xpert MTB/RIF-positive; of these, 9 (22%) would not have tuberculosis (false-positives); and 960 would be Xpert MTB/RIF-negative; of these, 19 (2%) would have tuberculosis (false-negatives).\nIn people living with HIV (1 study), Xpert Ultra sensitivity and specificity (95% CI) were 69% (57 to 80) (68 participants; very low-certainty evidence) and 98% (97 to 99) (503 participants; moderate-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 53 would be Xpert Ultra-positive; of these, 19 (36%) would not have tuberculosis (false-positives); and 947 would be Xpert Ultra-negative; of these, 16 (2%) would have tuberculosis (false-negatives).\nIn non-hospitalized people in high-risk groups (5 studies), Xpert MTB/RIF pooled sensitivity and specificity were 69.4% (47.7 to 86.2) (337 participants, low-certainty evidence) and 98.8% (97.2 to 99.5) (8619 participants, moderate-certainty evidence). Of 1000 people where 10 have tuberculosis on culture, 19 would be Xpert MTB/RIF-positive; of these, 12 (63%) would not have tuberculosis (false-positives); and 981 would be Xpert MTB/RIF-negative; of these, 3 (0%) would have tuberculosis (false-negatives).\nWe did not identify any studies using Xpert MTB/RIF or Xpert Ultra for screening in the general population.\nXpert MTB/RIF as a screening test for rifampicin resistance\nXpert MTB/RIF sensitivity was 81% and 100% (2 studies, 20 participants; very low-certainty evidence), and specificity was 94% to 100%, (3 studies, 139 participants; moderate-certainty evidence).\nAuthors' conclusions\nOf the high-risks groups evaluated, Xpert MTB/RIF applied as a screening test was accurate for tuberculosis in high tuberculosis burden settings. Sensitivity and specificity were similar in people living with HIV and non-hospitalized people in high-risk groups. In people living with HIV, Xpert Ultra sensitivity was slightly higher than that of Xpert MTB/RIF and specificity similar. As there was only one study of Xpert Ultra in this analysis, results should be interpreted with caution. There were no studies that evaluated the tests in people with diabetes mellitus and other groups considered at high-risk for tuberculosis, or in the general population.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In the included studies, the reference standards for diagnosing pulmonary tuberculosis (culture) and rifampicin resistance (drug susceptibility testing) are likely to have been reliable methods for deciding whether patients really had the conditions. We were fairly confident in the results for Xpert MTB/RIF in PLHIV, and less so for other high-risk groups. Not enough people have been studied to be confident about the results for Xpert Ultra or for detection of rifampicin resistance."
}
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query-laysum | 4372 | [
{
"role": "user",
"content": "Abstract: Background\nOrganised inpatient (stroke unit) care is provided by multi-disciplinary teams that manage stroke patients. This can been provided in a ward dedicated to stroke patients (stroke ward), with a peripatetic stroke team (mobile stroke team), or within a generic disability service (mixed rehabilitation ward). Team members aim to provide co-ordinated multi-disciplinary care using standard approaches to manage common post-stroke problems.\nObjectives\n• To assess the effects of organised inpatient (stroke unit) care compared with an alternative service.\n• To use a network meta-analysis (NMA) approach to assess different types of organised inpatient (stroke unit) care for people admitted to hospital after a stroke (the standard comparator was care in a general ward).\nOriginally, we conducted this systematic review to clarify:\n• The characteristic features of organised inpatient (stroke unit) care?\n• Whether organised inpatient (stroke unit) care provide better patient outcomes than alternative forms of care?\n• If benefits are apparent across a range of patient groups and across different approaches to delivering organised stroke unit care?\nWithin the current version, we wished to establish whether previous conclusions were altered by the inclusion of new outcome data from recent trials and further analysis via NMA.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (2 April 2019); the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 4), in the Cochrane Library (searched 2 April 2019); MEDLINE Ovid (1946 to 1 April 2019); Embase Ovid (1974 to 1 April 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 April 2019). In an effort to identify further published, unpublished, and ongoing trials, we searched seven trial registries (2 April 2019). We also performed citation tracking of included studies, checked reference lists of relevant articles, and contacted trialists.\nSelection criteria\nRandomised controlled clinical trials comparing organised inpatient stroke unit care with an alternative service (typically contemporary conventional care), including comparing different types of organised inpatient (stroke unit) care for people with stroke who are admitted to hospital.\nData collection and analysis\nTwo review authors assessed eligibility and trial quality. We checked descriptive details and trial data with co-ordinators of the original trials, assessed risk of bias, and applied GRADE. The primary outcome was poor outcome (death or dependency (Rankin score 3 to 5) or requiring institutional care) at the end of scheduled follow-up. Secondary outcomes included death, institutional care, dependency, subjective health status, satisfaction, and length of stay. We used direct (pairwise) comparisons to compare organised inpatient (stroke unit) care with an alternative service. We used an NMA to confirm the relative effects of different approaches.\nMain results\nWe included 29 trials (5902 participants) that compared organised inpatient (stroke unit) care with an alternative service: 20 trials (4127 participants) compared organised (stroke unit) care with a general ward, six trials (982 participants) compared different forms of organised (stroke unit) care, and three trials (793 participants) incorporated more than one comparison.\nCompared with the alternative service, organised inpatient (stroke unit) care was associated with improved outcomes at the end of scheduled follow-up (median one year): poor outcome (odds ratio (OR) 0.77, 95% confidence interval (CI) 0.69 to 0.87; moderate-quality evidence), death (OR 0.76, 95% CI 0.66 to 0.88; moderate-quality evidence), death or institutional care (OR 0.76, 95% CI 0.67 to 0.85; moderate-quality evidence), and death or dependency (OR 0.75, 95% CI 0.66 to 0.85; moderate-quality evidence). Evidence was of very low quality for subjective health status and was not available for patient satisfaction. Analysis of length of stay was complicated by variations in definition and measurement plus substantial statistical heterogeneity (I² = 85%). There was no indication that organised stroke unit care resulted in a longer hospital stay. Sensitivity analyses indicated that observed benefits remained when the analysis was restricted to securely randomised trials that used unequivocally blinded outcome assessment with a fixed period of follow-up. Outcomes appeared to be independent of patient age, sex, initial stroke severity, stroke type, and duration of follow-up. When calculated as the absolute risk difference for every 100 participants receiving stroke unit care, this equates to two extra survivors, six more living at home, and six more living independently.\nThe analysis of different types of organised (stroke unit) care used both direct pairwise comparisons and NMA.\nDirect comparison of stroke ward versus general ward: 15 trials (3523 participants) compared care in a stroke ward with care in general wards. Stroke ward care showed a reduction in the odds of a poor outcome at the end of follow-up (OR 0.78, 95% CI 0.68 to 0.91; moderate-quality evidence).\nDirect comparison of mobile stroke team versus general ward: two trials (438 participants) compared care from a mobile stroke team with care in general wards. Stroke team care may result in little difference in the odds of a poor outcome at the end of follow-up (OR 0.80, 95% CI 0.52 to 1.22; low-quality evidence).\nDirect comparison of mixed rehabilitation ward versus general ward: six trials (630 participants) compared care in a mixed rehabilitation ward with care in general wards. Mixed rehabilitation ward care showed a reduction in the odds of a poor outcome at the end of follow-up (OR 0.65, 95% CI 0.47 to 0.90; moderate-quality evidence).\nIn a NMA using care in a general ward as the comparator, the odds of a poor outcome were as follows: stroke ward - OR 0.74, 95% CI 0.62 to 0.89, moderate-quality evidence; mobile stroke team - OR 0.88, 95% CI 0.58 to 1.34, low-quality evidence; mixed rehabilitation ward - OR 0.70, 95% CI 0.52 to 0.95, low-quality evidence.\nAuthors' conclusions\nWe found moderate-quality evidence that stroke patients who receive organised inpatient (stroke unit) care are more likely to be alive, independent, and living at home one year after the stroke. The apparent benefits were independent of patient age, sex, initial stroke severity, or stroke type, and were most obvious in units based in a discrete stroke ward. We observed no systematic increase in the length of inpatient stay, but these findings had considerable uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Organised inpatient (stroke unit) care is a form of care provided in hospital by nurses, doctors, and therapists who specialise in looking after people with stroke. They aim to work as a co-ordinated team to provide the most appropriate care tailored to the needs of individual people with stroke."
}
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query-laysum | 4373 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) recommends artemisinin-based combination therapy (ACT) for treating people with Plasmodium falciparum malaria. Five combinations are currently recommended, all administered over three days. Artemisinin-naphthoquine is a new combination developed in China, which is being marketed as a one-day treatment. Although shorter treatment courses may improve adherence, the WHO recommends at least three days of the short-acting artemisinin component to eliminate 90% P. falciparum parasites in the bloodstream, before leaving the longer-acting partner drug to clear the remaining parasites.\nObjectives\nTo evaluate the efficacy and safety of the artemisinin-naphthoquine combination for treating adults and children with uncomplicated P. falciparum malaria.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL) published in The Cochrane Library; MEDLINE; EMBASE; and LILACS up to January 2015. We also searched the metaRegister of Controlled Trials (mRCT) using 'malaria' and 'arte* OR dihydroarte*' as search terms.\nSelection criteria\nRandomized controlled trials comparing artemisinin-naphthoquine combinations with established WHO-recommended ACTs for the treatment of adults and children with uncomplicated malaria due to P. falciparum.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and risk of bias, and extracted data. We analysed primary outcomes in line with the WHO 'Protocol for assessing and monitoring antimalarial drug efficacy’ and compared drugs using risk ratios (RR) and 95% confidence intervals (CI). Secondary outcomes were effects on gametocytes, haemoglobin, and adverse events. We assessed the quality of evidence using the GRADE approach.\nMain results\nFour trials, enrolling 740 adults and children, met the inclusion criteria. Artemisinin-naphthoquine was administered as a single dose (two trials), as two doses given eight hours apart (one trial), and once daily for three days (one trial), and compared to three-day regimens of established ACTs. Three additional small pharmaceutical company trials have been carried out. We have requested the data but have not received a response from the company.\nArtemisinin-naphthoquine versus artemether-lumefantrine\nIn three small trials from Benin, Côte d'Ivoire, and Papua New Guinea, both combinations had a very low incidence of treatment failure at Day 28, and there were no differences demonstrated in PCR-unadjusted, or PCR-adjusted treatment failure (three trials, 487 participants, low quality evidence). Only the single study from Papua New Guinea followed participants up to Day 42, and the number of treatment failures remained very low with both combinations (one trial, 186 participants, very low quality evidence).\nArtemisinin-naphthoquine versus dihydroartemisinin-piperaquine\nIn a single small trial from Indonesia, treatment failure at Day 28 and Day 42 was very low in both groups with no differences demonstrated (one trial, 144 participants, very low quality evidence).\nAuthors' conclusions\nThe results of these few trials of artemisinin-naphthoquine are promising, but further trials from multiple settings are required to reliably demonstrate the relative efficacy and safety compared to established ACTs. Future trials should be adequately powered to demonstrate non-inferiority, and regimens incorporating three days of the artemisinin component are probably preferable to the one-day regimens.\n\nGiven the provided abstract, please respond to the following query: \"What the research says\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Artemisinin-naphthoquine versus artemether-lumefantrine\nIn three small trials from Benin, Côte d'Ivoire, and Papua New Guinea, both artemisinin-naphthoquine and AL had a very low incidence of treatment failure at Day 28 (low quality evidence), and in the trial from Papua New Guinea it remained low in both groups at Day 42 (very low quality evidence).\nArtemisinin-naphthoquine versus dihydroartemisinin-piperaquine\nIn a single small study from Indonesia, treatment failure at Day 28 and Day 42 was very low with both artemisinin-naphthoquine and DHA-P (very low quality evidence)."
}
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query-laysum | 4374 | [
{
"role": "user",
"content": "Abstract: Background\nConvalescent plasma may reduce mortality in patients with viral respiratory diseases, and is being investigated as a potential therapy for coronavirus disease 2019 (COVID-19). A thorough understanding of the current body of evidence regarding benefits and risks of this intervention is required.\nObjectives\nTo assess the effectiveness and safety of convalescent plasma transfusion in the treatment of people with COVID-19; and to maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nTo identify completed and ongoing studies, we searched the World Health Organization (WHO) COVID-19 Global literature on coronavirus disease Research Database, MEDLINE, Embase, Cochrane COVID-19 Study Register, and the Epistemonikos COVID-19 L*OVE Platform. We searched monthly until 03 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating convalescent plasma for COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies that included populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)), as well as studies evaluating standard immunoglobulin.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies we used RoB 2. We used the GRADE approach to rate the certainty of evidence for the following outcomes: all-cause mortality at up to day 28, worsening and improvement of clinical status (for individuals with moderate to severe disease), hospital admission or death, COVID-19 symptoms resolution (for individuals with mild disease), quality of life, grade 3 or 4 adverse events, and serious adverse events.\nMain results\nIn this fourth review update version, we included 33 RCTs with 24,861 participants, of whom 11,432 received convalescent plasma. Of these, nine studies are single-centre studies and 24 are multi-centre studies. Fourteen studies took place in America, eight in Europe, three in South-East Asia, two in Africa, two in western Pacific and three in eastern Mediterranean regions and one in multiple regions. We identified a further 49 ongoing studies evaluating convalescent plasma, and 33 studies reporting as being completed.\nIndividuals with a confirmed diagnosis of COVID-19 and moderate to severe disease\n29 RCTs investigated the use of convalescent plasma for 22,728 participants with moderate to severe disease. 23 RCTs with 22,020 participants compared convalescent plasma to placebo or standard care alone, five compared to standard plasma and one compared to human immunoglobulin. We evaluate subgroups on detection of antibodies detection, symptom onset, country income groups and several co-morbidities in the full text.\nConvalescent plasma versus placebo or standard care alone\nConvalescent plasma does not reduce all-cause mortality at up to day 28 (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.92 to 1.03; 220 per 1000; 21 RCTs, 19,021 participants; high-certainty evidence). It has little to no impact on need for invasive mechanical ventilation, or death (RR 1.03, 95% CI 0.97 to 1.11; 296 per 1000; 6 RCTs, 14,477 participants; high-certainty evidence) and has no impact on whether participants are discharged from hospital (RR 1.00, 95% CI 0.97 to 1.02; 665 per 1000; 6 RCTs, 12,721 participants; high-certainty evidence). Convalescent plasma may have little to no impact on quality of life (MD 1.00, 95% CI −2.14 to 4.14; 1 RCT, 483 participants; low-certainty evidence). Convalescent plasma may have little to no impact on the risk of grades 3 and 4 adverse events (RR 1.17, 95% CI 0.96 to 1.42; 212 per 1000; 6 RCTs, 2392 participants; low-certainty evidence). It has probably little to no effect on the risk of serious adverse events (RR 1.14, 95% CI 0.91 to 1.44; 135 per 1000; 6 RCTs, 3901 participants; moderate-certainty evidence).\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces or increases all-cause mortality at up to day 28 (RR 0.73, 95% CI 0.45 to 1.19; 129 per 1000; 4 RCTs, 484 participants; very low-certainty evidence). We are uncertain whether convalescent plasma reduces or increases the need for invasive mechanical ventilation, or death (RR 5.59, 95% CI 0.29 to 108.38; 311 per 1000; 1 study, 34 participants; very low-certainty evidence) and whether it reduces or increases the risk of serious adverse events (RR 0.80, 95% CI 0.55 to 1.15; 236 per 1000; 3 RCTs, 327 participants; very low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus human immunoglobulin\nConvalescent plasma may have little to no effect on all-cause mortality at up to day 28 (RR 1.07, 95% CI 0.76 to 1.50; 464 per 1000; 1 study, 190 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nIndividuals with a confirmed diagnosis of SARS-CoV-2 infection and mild disease\nWe identified two RCTs reporting on 536 participants, comparing convalescent plasma to placebo or standard care alone, and two RCTs reporting on 1597 participants with mild disease, comparing convalescent plasma to standard plasma.\nConvalescent plasma versus placebo or standard care alone\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (odds ratio (OR) 0.36, 95% CI 0.09 to 1.46; 8 per 1000; 2 RCTs, 536 participants; very low-certainty evidence). It may have little to no effect on admission to hospital or death within 28 days (RR 1.05, 95% CI 0.60 to 1.84; 117 per 1000; 1 RCT, 376 participants; low-certainty evidence), on time to COVID-19 symptom resolution (hazard ratio (HR) 1.05, 95% CI 0.85 to 1.30; 483 per 1000; 1 RCT, 376 participants; low-certainty evidence), on the risk of grades 3 and 4 adverse events (RR 1.29, 95% CI 0.75 to 2.19; 144 per 1000; 1 RCT, 376 participants; low-certainty evidence) and the risk of serious adverse events (RR 1.14, 95% CI 0.66 to 1.94; 133 per 1000; 1 RCT, 376 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nConvalescent plasma versus standard plasma\nWe are uncertain whether convalescent plasma reduces all-cause mortality at up to day 28 (OR 0.30, 95% CI 0.05 to 1.75; 2 per 1000; 2 RCTs, 1597 participants; very low-certainty evidence). It probably reduces admission to hospital or death within 28 days (RR 0.49, 95% CI 0.31 to 0.75; 36 per 1000; 2 RCTs, 1595 participants; moderate-certainty evidence). Convalescent plasma may have little to no effect on initial symptom resolution at up to day 28 (RR 1.12, 95% CI 0.98 to 1.27; 1 RCT, 416 participants; low-certainty evidence). We did not identify any study reporting other key outcomes.\nThis is a living systematic review. We search monthly for new evidence and update the review when we identify relevant new evidence.\nAuthors' conclusions\nFor the comparison of convalescent plasma versus placebo or standard care alone, our certainty in the evidence that convalescent plasma for individuals with moderate to severe disease does not reduce mortality and has little to no impact on clinical improvement or worsening is high. It probably has little to no effect on SAEs. For individuals with mild disease, we have very-low to low certainty evidence for most primary outcomes and moderate certainty for hospital admission or death. There are 49 ongoing studies, and 33 studies reported as complete in a trials registry. Publication of ongoing studies might resolve some of the uncertainties around convalescent plasma therapy for people with asymptomatic or mild disease.\n\nGiven the provided abstract, please respond to the following query: \"time until COVID-19 symptoms resolved\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "time until COVID-19 symptoms resolved(1 study, 376 people)."
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query-laysum | 4375 | [
{
"role": "user",
"content": "Abstract: Background\nHereditary ataxia syndromes can result in significant speech impairment, a symptom thought to be responsive to treatment. The type of speech impairment most commonly reported in hereditary ataxias is dysarthria. Dysarthria is a collective term referring to a group of movement disorders affecting the muscular control of speech. Dysarthria affects the ability of individuals to communicate and to participate in society. This in turn reduces quality of life. Given the harmful impact of speech disorder on a person's functioning, treatment of speech impairment in these conditions is important and evidence-based interventions are needed.\nObjectives\nTo assess the effects of interventions for speech disorder in adults and children with Friedreich ataxia and other hereditary ataxias.\nSearch methods\nOn 14 October 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE, EMBASE, CINAHL Plus, PsycINFO, Education Resources Information Center (ERIC), Linguistics and Language Behavior Abstracts (LLBA), Dissertation Abstracts and trials registries. We checked all references in the identified trials to identify any additional published data.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) or quasi-RCTs that compared treatments for hereditary ataxias with no treatment, placebo or another treatment or combination of treatments, where investigators measured speech production.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed the risk of bias of included studies using the standard methodological procedures expected by The Cochrane Collaboration. The review authors collected information on adverse effects from included studies. We did not conduct a meta-analysis as no two studies utilised the same assessment procedures within the same treatment.\nMain results\nFourteen clinical trials, involving 721 participants, met the criteria for inclusion in the review. Thirteen studies compared a pharmaceutical treatment with placebo (or a low dose of the intervention), in heterogenous groups of degenerative cerebellar ataxias. Three compounds were studied in two trials each: a levorotatory form of 5-hydroxytryptophan (L-5HT), idebenone and thyrotropin-releasing hormone tartrate (TRH-T); each of the other compounds (riluzole, varenicline, buspirone, betamethasone, coenzyme Q10 with vitamin E, α-tocopheryl quinone and erythropoietin) were studied in one trial. The 14th trial, involving a mixed group of participants with spinocerebellar ataxia, compared the effectiveness of nonspecific physiotherapy and occupational therapy within an inpatient hospital setting to no treatment. No studies utilised traditional speech therapies. We defined the primary outcome measure in this review as the percentage change (improvement) in overall speech production immediately following completion of the intervention or later, measured by any validated speech assessment tool. None of the trials included speech as a primary outcome or examined speech using any validated speech assessment tool. Eleven studies reported speech outcomes derived from a subscale embedded within disease rating scales. The remaining three studies used alternative assessments to measure speech, including mean time to produce a standard sentence, a subjective rating of speech on a 14-point analogue scale, patient-reported assessment of the impact of dysarthria on activities of daily living and acoustic measures of syllable length. One study measured speech both subjectively as part of a disease rating scale and with further measures of speech timing. Three studies utilised the Short Form-36 Health Survey (SF-36) and one used the Child Health Questionnaire as measures of general quality of life. A further study utilised the Functional Independence Measure to assess functional health.\nFive studies reported statistically significant improvement on an overall disease rating scale in which a speech subscale was included. Only three of those studies provided specific data on speech performance; all were comparisons with placebo. Improvements in overall disease severity were observed with α-tocopheryl quinone; however, no significant changes were found on the speech subscale in a group of individuals with Friedreich ataxia. A statistically significant improvement in speech according to a speech disorders subscale was observed with betamethasone. Riluzole was found to have a statistically significant effect on speech in a group of participants with mixed hereditary, sporadic and unknown origin ataxias. No significant differences were observed between treatment and placebo in any other pharmaceutical study. A statistically significant improvement in functional independence occurred at the end of the treatment period in the rehabilitation study compared to the delayed treatment group but these effects were not present 12 to 24 weeks after treatment. Of the four studies that assessed quality of life, none found a significant effect. A variety of minor adverse events were reported for the 13 pharmaceutical therapies, including gastrointestinal side effects and nausea. Serious adverse effects were reported in two participants in one of the L-5HT trials (participants discontinued due to gastrointestinal effects), and in four participants (three taking idebenone, one taking placebo) in the idebenone studies. Serious adverse events with idebenone were gastrointestinal side effects and, in people with a previous history of these events, chest pain and idiopathic thrombocytopenic purpura. The rehabilitation study did not report any adverse events.\nWe considered six studies to be at high risk of bias in some respect. We suspected inadequate blinding of participants or assessors in four studies and poor randomisation in a further two studies. There was a high risk of reporting bias in two studies and attrition bias in four studies. Only one study had a low risk of bias across all criteria. Taken together with other limitations of the studies relating to the validity of the measurement scales used, we downgraded the quality of the evidence for many of the outcomes to low or very low.\nAuthors' conclusions\nThere is insufficient and low or very low quality evidence from either RCTs or observational studies to determine the effectiveness of any treatment for speech disorder in any of the hereditary ataxia syndromes.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "When planning the review, we decided to use the percentage change in speech production after treatment as our primary measure of whether treatments were effective. None of the studies measured speech in a way that allowed us to report this. Five studies reported improvement in overall disease severity but only two studies, of riluzole in various ataxias and betamethasone in ataxia telangiectasia, demonstrated improvement of speech production. It is difficult to say whether these improvements in speech might make a meaningful difference to patients.\nA variety of minor adverse events occurred with the medicines, including effects on the stomach and intestines, such as feeling sick. This kind of effect caused two people taking L-5HT to stop treatment. Another person experienced this effect while taking idebenone. Two more people taking idebenone experienced heart or autoimmune problems; however, they each had experienced those problems earlier in their life. None of the other studies found differences in speech performance on active treatment. All trials had some problems in conduct or design that could potentially affect the findings."
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query-laysum | 4376 | [
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"role": "user",
"content": "Abstract: Background\nGlaucoma is the leading cause of global irreversible blindness, often associated with raised intraocular pressure (IOP). Where medical or laser treatment has failed or is not tolerated, surgery is often required. Minimally-invasive surgical approaches have been developed in recent years to reduce IOP with lower surgical risks. Supraciliary microstent surgery for the treatment of open-angle glaucoma (OAG) is one such approach.\nObjectives\nTo evaluate the efficacy and safety of supraciliary microstent surgery for the treatment of OAG, and to compare with standard medical, laser or surgical treatments.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2020, Issue 8); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 27 August 2020.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) of supraciliary microstent surgery, alone or with cataract surgery, compared to other surgical treatments (cataract surgery alone, other minimally invasive glaucoma device techniques, trabeculectomy), laser treatment or medical treatment.\nData collection and analysis\nTwo review authors independently screened titles and abstracts from the database search to identify studies that met the selection criteria. Data extraction, analysis, and evaluation of risk of bias from selected studies was performed independently and according to standard Cochrane methodology.\nMain results\nOne study met the inclusion criteria of this review, evaluating the efficacy and safety of the Cypass supraciliary microstent surgery for the treatment of OAG, comparing phacoemulsification + supraciliary microstent surgery with phacoemulsification alone over 24 months. This study comprised 505 eyes of 505 participants with both OAG and cataract, 374 randomised to the phacoemulsification + microstent group.\nIn this study, the perceived risk of bias from random sequence generation, allocation concealment and selective reporting was low. However, we considered the study to be at high risk of performance bias as surgeons/investigators were unmasked. Attrition bias was unclear, with 448/505 participants contributing to per protocol analysis.\nInsertion of a Cypass supraciliary microstent combined with phacoemulsification probably increases the proportion of participants who are medication-free (not using eye-drops) at 24 months compared with phacoemulsification alone (85% versus 59%, risk ratio (RR) 1.27, 95% confidence interval (CI) 1.09 to 1.49, moderate-certainty evidence).\nThere is high-certainty evidence that a greater improvement in mean IOP occurs in the phacoemulsification + microstent group - mean (SD) change in IOP from baseline of -5.4 (3.9) mmHg in the phacoemulsification group, compared to -7.4 (4.4) mmHg in the phacoemulsification + microstent group at 24 months (mean difference -2.0 mmHg, 95% CI -2.85 to -1.15).\nThere is moderate-certainty evidence that insertion of a microstent is probably associated with a greater reduction in use of IOP-lowering drops (mean reduction of 0.7 medications in the phacoemulsification group, compared to a mean reduction of 1.2 medications in the phacoemulsification + microstent group).\nInsertion of a microstent during phacoemulsification may reduce the requirement for further glaucoma intervention to control IOP at a later stage compared to phacoemulsification alone (RR 0.26, 95% CI 0.07 to 1.04, low-certainty evidence).\nThere is no evidence relating to the rate of visual field progression, or proportion of participants whose visual field loss progressed in this study.\nThere is moderate-certainty evidence showing little or no difference in the proportion of participants experiencing postoperative complications over 24 months between participants in the microstent group compared to those who received phacoemulsification alone (RR 1.1, 95% CI 0.8 to 1.4).\nFive year post-approval data regarding the safety of the Cypass supraciliary microstent showed increased endothelial cell loss, associated with the position of the microstent in the anterior chamber.\nThere were no reported health-related quality of life (HRQoL) outcomes in the included study.\nAuthors' conclusions\nData from this single RCT show superiority of supraciliary microstent surgery when combined with phacoemulsification compared to phacoemulsification alone in achieving medication-free control of OAG. However, there are long-term safety concerns with the device used in this trial, relating to the observed significant loss of corneal endothelial cells at five years following device implantation. At the time of this review, this device has been withdrawn from the market.\nThis review has found that few high-quality studies exist comparing supraciliary microstent surgery to standard medical, laser or surgical glaucoma treatments. This should be addressed by further appropriately designed RCTs with sufficient long-term follow-up to ensure robust safety data are obtained. Consideration of health-related quality of life outcomes should also feature in trial design.\n\nGiven the provided abstract, please respond to the following query: \"Treatments for glaucoma\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Treatment cannot reverse any loss of sight that happened before glaucoma was diagnosed but can slow or stop loss of sight. All treatments for glaucoma aim to reduce the pressure in the eye. These include:\n- medicines, given as eye-drops;\n- laser treatment to reduce the production of fluid and open up blocked drainage channels; or\n- surgery to drain fluid from the eye.\nOne treatment involves placing a tiny tube (called a microstent) under the surface of the eye to create a drainage channel for excess fluid. Microstents can often be placed during surgery to treat cataracts: cloudy patches that develop on the lens inside the eye and make sight misty and blurred."
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query-laysum | 4377 | [
{
"role": "user",
"content": "Abstract: Background\nPatellar (knee cap) dislocation occurs when the patella disengages completely from the trochlear (femoral) groove. It affects up to 42/100,000 people, and is most prevalent in those aged 20 to 30 years old. It is uncertain whether surgical or non-surgical treatment is the best approach. This is important as recurrent dislocation occurs in up to 40% of people who experience a first time (primary) dislocation. This can reduce quality of life and as a result people have to modify their lifestyle. This review is needed to determine whether surgical or non-surgical treatment should be offered to people after patellar dislocation.\nObjectives\nTo assess the effects (benefits and harms) of surgical versus non-surgical interventions for treating people with primary or recurrent patellar dislocation.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, AMED, CINAHL, Physiotherapy Evidence Database and trial registries in December 2021. We contacted corresponding authors to identify additional studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled clinical trials evaluating surgical versus non-surgical interventions for treating primary or recurrent lateral patellar dislocation in adults or children.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent patellar dislocation, and patient-rated knee and physical function scores. Our secondary outcomes were health-related quality of life, return to former activities, knee pain during activity or at rest, adverse events, patient-reported satisfaction, patient-reported knee instability symptoms and subsequent requirement for knee surgery. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included 10 studies (eight randomised controlled trials (RCTs) and two quasi-RCTs) of 519 participants with patellar dislocation. The mean ages in the individual studies ranged from 13.0 to 27.2 years. Four studies included children, mainly adolescents, as well as adults; two only recruited children. Study follow-up ranged from one to 14 years.\nWe are unsure of the evidence for all outcomes in this review because we judged the certainty of the evidence to be very low. We downgraded each outcome by three levels. Reasons included imprecision (when fewer than 100 events were reported or the confidence interval (CI) indicated appreciable benefits as well as harms), risk of bias (when studies were at high risk of performance, detection and attrition bias), and inconsistency (in the event that pooled analysis included high levels of statistical heterogeneity).\nWe are uncertain whether surgery lowers the risk of recurrent dislocation following primary patellar dislocation compared with non-surgical management at two to nine year follow-up. Based on an illustrative risk of recurrent dislocation in 348 people per 1000 in the non-surgical group, we found that 157 fewer people per 1000 (95% CI 209 fewer to 87 fewer) had recurrent dislocation between two and nine years after surgery (8 studies, 438 participants).\nWe are uncertain whether surgery improves patient-rated knee and function scores. Studies measured this outcome using different scales (the Tegner activity scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm, Kujala Patellofemoral Disorders score and Hughston visual analogue scale). The most frequently reported score was the Kujala Patellofemoral Disorders score. This indicated people in the surgical group had a mean score of 5.73 points higher at two to nine year follow-up (95% CI 2.91 lower to 14.37 higher; 7 studies, 401 participants). On this 100-point scale, higher scores indicate better function, and a change score of 10 points is considered to be clinically meaningful; therefore, this CI includes a possible meaningful improvement.\nWe are uncertain whether surgery increases the risk of adverse events. Based on an assumed risk of overall incidence of complications during the first two years in 277 people out of 1000 in the non-surgical group, 335 more people per 1000 (95% CI 75 fewer to 723 more) had an adverse event in the surgery group (2 studies, 144 participants).\nThree studies (176 participants) assessed participant satisfaction at two to nine year follow-up, reporting little difference between groups. Based on an assumed risk of 763 per 1000 non-surgical participants reporting excellent or good outcomes, seven more participants per 1000 (95% CI 199 fewer to 237 more) reported excellent or good satisfaction.\nFour studies (256 participants) assessed recurrent patellar subluxation at two to nine year follow-up. Based on an assumed risk of patellar subluxation in 292 out of 1000 in the non-surgical group, 73 fewer people per 1000 (95% CI 146 fewer to 35 more) had patellar subluxation as a result of surgery.\nSlightly more people had subsequent surgery in the non-surgical group. Pooled two to nine year follow-up data from three trials (195 participants) indicated that, based on an assumed risk of subsequent surgery in 215 people per 1000 in the non-surgical group, 118 fewer people per 1000 (95% CI 200 fewer to 372 more) had subsequent surgery after primary surgery.\nAuthors' conclusions\nWe are uncertain whether surgery improves outcome compared to non-surgical management as the certainty of the evidence was very low. No sufficiently powered trial has examined people with recurrent patellar dislocation. Adequately powered, multicentre, randomised trials are needed. To inform the design and conduct of these trials, expert consensus should be achieved on the minimal description of both surgical and non-surgical interventions, and the pathological variations that may be relevant to both choice of these interventions.\n\nGiven the provided abstract, please respond to the following query: \"How is a dislocated knee cap treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "When the knee cap dislocates, the soft tissues around the knee are injured. People need to have treatment to help restore the knee back to full health. This may include treatments such as holding the knee in place (by wearing a kind of brace or bandage), exercises, manual therapy (such as physiotherapy) and taping the area around the knee. However, some doctors suggest that people may have a better outcome if surgery is performed. Surgery may be used to: repair or reconstruct the injured ligaments and muscles that hold the knee cap in the groove, reshape the groove, or change where the knee cap attaches to the shin-bone to stop it from dislocating again."
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query-laysum | 4378 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants are susceptible to hyperglycaemia and hypoglycaemia, which may lead to adverse neurodevelopment. The use of continuous glucose monitoring (CGM) devices might help in keeping glucose levels in the normal range, and reduce the need for blood sampling. However, the use of CGM might be associated with harms in the preterm infant.\nObjectives\nTo assess the benefits and harms of CGM versus intermittent modalities to measure glycaemia in preterm infants 1. at risk of hypoglycaemia or hyperglycaemia; 2. with proven hypoglycaemia; or 3. with proven hyperglycaemia.\nSearch methods\nWe searched CENTRAL (2021, Issue 4); PubMed; Embase; and CINAHL in April 2021. We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs comparing the use of CGM versus intermittent modalities to measure glycaemia in preterm infants at risk of hypoglycaemia or hyperglycaemia; with proven hypoglycaemia; or with proven hyperglycaemia.\nData collection and analysis\nWe assessed the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) with 95% confidence intervals (CI) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included four trials enrolling 300 infants in our updated review. We included one new study and excluded another previously included study (because the inclusion criteria of the review have been narrowed). We compared the use of CGM to intermittent modalities in preterm infants at risk of hypoglycaemia or hyperglycaemia; however, one of these trials was analyzed separately because CGM was used as a standalone device, without being coupled to a control algorithm as in the other trials. We identified no studies in preterm infants with proven hypoglycaemia or hyperglycaemia.\nNone of the four included trials reported the neurodevelopmental outcome (i.e. the primary outcome of this review), or seizures. The effect of the use of CGM on mortality during hospitalization is uncertain (RR 0.59, 95% CI 0.16 to 2.13; RD −0.02, 95% CI −0.07 to 0.03; 230 participants; 2 studies; very low-certainty evidence). The certainty of the evidence was very low for all outcomes because of limitations in study design, and imprecision of estimates. One study is ongoing (estimated sample size 60 infants) and planned to be completed in 2022.\nAuthors' conclusions\nThere is insufficient evidence to determine if CGM affects preterm infant mortality or morbidities. We are very uncertain of the safety of CGM and the available management algorithms, and many morbidities remain unreported. Preterm infants at risk of hypoglycaemia or hyperglycaemia were enrolled in all four included studies. No studies have been conducted in preterm infants with proven hypoglycaemia or hyperglycaemia. Long-term outcomes were not reported. Events of necrotizing enterocolitis, reported in the study published in 2021, were lower in the CGM group. However, the effect of CGM on this outcome remains very uncertain. Clinical trials are required to determine the most effective CGM and glycaemic management regimens in preterm infants before larger studies can be performed to assess the efficacy of CGM for reducing mortality, morbidity, and long-term neurodevelopmental impairments.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "None of the four included studies reported on the long-term neurodevelopmental outcome of preterm infants. The studies were too small to determine if CGM has an effect on survival. One study is ongoing. Although one study published in 2021 reported the incidence of serious intestinal injury (necrotizing enterocolitis, a serious inflammation of the intestines that can be life threatening) was lower in the CGM group, this finding is very uncertain because the results were very imprecise. Further research is needed."
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query-laysum | 4379 | [
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"role": "user",
"content": "Abstract: Background\nEarly discharge hospital at home is a service that provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care. This is an update of a Cochrane review.\nObjectives\nTo determine the effectiveness and cost of managing patients with early discharge hospital at home compared with inpatient hospital care.\nSearch methods\nWe searched the following databases to 9 January 2017: the Cochrane Effective Practice and Organisation of Care Group (EPOC) register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and EconLit. We searched clinical trials registries.\nSelection criteria\nRandomised trials comparing early discharge hospital at home with acute hospital inpatient care for adults. We excluded obstetric, paediatric and mental health hospital at home schemes.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the body of evidence for the most important outcomes.\nMain results\nWe included 32 trials (N = 4746), six of them new for this update, mainly conducted in high-income countries. We judged most of the studies to have a low or unclear risk of bias. The intervention was delivered by hospital outreach services (17 trials), community-based services (11 trials), and was co-ordinated by a hospital-based stroke team or physician in conjunction with community-based services in four trials.\nStudies recruiting people recovering from stroke\nEarly discharge hospital at home probably makes little or no difference to mortality at three to six months (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.57 to 1.48, N = 1114, 11 trials, moderate-certainty evidence) and may make little or no difference to the risk of hospital readmission (RR 1.09, 95% CI 0.71 to 1.66, N = 345, 5 trials, low-certainty evidence). Hospital at home may lower the risk of living in institutional setting at six months (RR 0.63, 96% CI 0.40 to 0.98; N = 574, 4 trials, low-certainty evidence) and might slightly improve patient satisfaction (N = 795, low-certainty evidence). Hospital at home probably reduces hospital length of stay, as moderate-certainty evidence found that people assigned to hospital at home are discharged from the intervention about seven days earlier than people receiving inpatient care (95% CI 10.19 to 3.17 days earlier, N = 528, 4 trials). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nStudies recruiting people with a mix of medical conditions\nEarly discharge hospital at home probably makes little or no difference to mortality (RR 1.07, 95% CI 0.76 to 1.49; N = 1247, 8 trials, moderate-certainty evidence). In people with chronic obstructive pulmonary disease (COPD) there was insufficient information to determine the effect of these two approaches on mortality (RR 0.53, 95% CI 0.25 to 1.12, N = 496, 5 trials, low-certainty evidence). The intervention probably increases the risk of hospital readmission in a mix of medical conditions, although the results are also compatible with no difference and a relatively large increase in the risk of readmission (RR 1.25, 95% CI 0.98 to 1.58, N = 1276, 9 trials, moderate-certainty evidence). Early discharge hospital at home may decrease the risk of readmission for people with COPD (RR 0.86, 95% CI 0.66 to 1.13, N = 496, 5 trials low-certainty evidence). Hospital at home may lower the risk of living in an institutional setting (RR 0.69, 0.48 to 0.99; N = 484, 3 trials, low-certainty evidence). The intervention might slightly improve patient satisfaction (N = 900, low-certainty evidence). The effect of early discharge hospital at home on hospital length of stay for older patients with a mix of conditions ranged from a reduction of 20 days to a reduction of less than half a day (moderate-certainty evidence, N = 767). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nStudies recruiting people undergoing elective surgery\nThree studies did not report higher rates of mortality with hospital at home compared with inpatient care (data not pooled, N = 856, low-certainty evidence; mainly orthopaedic surgery). Hospital at home may lead to little or no difference in readmission to hospital for people who were mainly recovering from orthopaedic surgery (N = 1229, low-certainty evidence). We could not establish the effects of hospital at home on the risk of living in institutional care, due to a lack of data. The intervention might slightly improve patient satisfaction (N = 1229, low-certainty evidence). People recovering from orthopaedic surgery allocated to early discharge hospital at home were discharged from the intervention on average four days earlier than people allocated to usual inpatient care (4.44 days earlier, 95% CI 6.37 to 2.51 days earlier, , N = 411, 4 trials, moderate-certainty evidence). It is uncertain whether hospital at home has an effect on cost (very low-certainty evidence).\nAuthors' conclusions\nDespite increasing interest in the potential of early discharge hospital at home services as a less expensive alternative to inpatient care, this review provides insufficient evidence of economic benefit (through a reduction in hospital length of stay) or improved health outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors found 32 studies, six of which are new for this update. In total, 4746 people from twelve countries participated in those studies. The intervention was mainly delivered by hospital outreach services and community-based services. Most of the studies were well designed and conducted. The studies looked at the effect of these services in patients with different types of conditions: patients who had a stroke, older patients with different types of medical conditions and patients who had surgery. These studies show that, when compared to in-hospital care, early discharge hospital at home services probably make little or no difference to patient health outcomes or being readmitted to hospital, yet probably decreases hospital length of stay. Patients who receive care at home might be more satisfied and less likely to be admitted to institutional care. There is little evidence of cost savings to the healthcare system of discharging patients home early to hospital at home care."
}
]
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query-laysum | 4380 | [
{
"role": "user",
"content": "Abstract: Background\nTreadmill training, with or without body weight support using a harness, is used in rehabilitation and might help to improve walking after stroke. This is an update of the Cochrane review first published in 2003 and updated in 2005 and 2014.\nObjectives\nTo determine if treadmill training and body weight support, individually or in combination, improve walking ability, quality of life, activities of daily living, dependency or death, and institutionalisation or death, compared with other physiotherapy gait-training interventions after stroke. The secondary objective was to determine the safety and acceptability of this method of gait training.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched 14 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Reviews of Effects (DARE) (the Cochrane Library 2017, Issue 2), MEDLINE (1966 to 14 February 2017), Embase (1980 to 14 February 2017), CINAHL (1982 to 14 February 2017), AMED (1985 to 14 February 2017) and SPORTDiscus (1949 to 14 February 2017). We also handsearched relevant conference proceedings and ongoing trials and research registers, screened reference lists, and contacted trialists to identify further trials.\nSelection criteria\nRandomised or quasi-randomised controlled and cross-over trials of treadmill training and body weight support, individually or in combination, for the treatment of walking after stroke.\nData collection and analysis\nTwo review authors independently selected trials, extracted data, and assessed risk of bias and methodological quality. The primary outcomes investigated were walking speed, endurance, and dependency.\nMain results\nWe included 56 trials with 3105 participants in this updated review. The average age of the participants was 60 years, and the studies were carried out in both inpatient and outpatient settings. All participants had at least some walking difficulties and many could not walk without assistance. Overall, the use of treadmill training did not increase the chances of walking independently compared with other physiotherapy interventions (risk difference (RD) -0.00, 95% confidence interval (CI) -0.02 to 0.02; 18 trials, 1210 participants; P = 0.94; I² = 0%; low-quality evidence). Overall, the use of treadmill training in walking rehabilitation for people after stroke increased the walking velocity and walking endurance significantly. The pooled mean difference (MD) (random-effects model) for walking velocity was 0.06 m/s (95% CI 0.03 to 0.09; 47 trials, 2323 participants; P < 0.0001; I² = 44%; moderate-quality evidence) and the pooled MD for walking endurance was 14.19 metres (95% CI 2.92 to 25.46; 28 trials, 1680 participants; P = 0.01; I² = 27%; moderate-quality evidence). Overall, the use of treadmill training with body weight support in walking rehabilitation for people after stroke did not increase the walking velocity and walking endurance at the end of scheduled follow-up. The pooled MD (random-effects model) for walking velocity was 0.03 m/s (95% CI -0.05 to 0.10; 12 trials, 954 participants; P = 0.50; I² = 55%; low-quality evidence) and the pooled MD for walking endurance was 21.64 metres (95% CI -4.70 to 47.98; 10 trials, 882 participants; P = 0.11; I² = 47%; low-quality evidence). In 38 studies with a total of 1571 participants who were independent in walking at study onset, the use of treadmill training increased the walking velocity significantly. The pooled MD (random-effects model) for walking velocity was 0.08 m/s (95% CI 0.05 to 0.12; P < 0.00001; I2 = 49%). There were insufficient data to comment on any effects on quality of life or activities of daily living. Adverse events and dropouts did not occur more frequently in people receiving treadmill training and these were not judged to be clinically serious events.\nAuthors' conclusions\nOverall, people after stroke who receive treadmill training, with or without body weight support, are not more likely to improve their ability to walk independently compared with people after stroke not receiving treadmill training, but walking speed and walking endurance may improve slightly in the short term. Specifically, people with stroke who are able to walk (but not people who are dependent in walking at start of treatment) appear to benefit most from this type of intervention with regard to walking speed and walking endurance. This review did not find, however, that improvements in walking speed and endurance may have persisting beneficial effects. Further research should specifically investigate the effects of different frequencies, durations, or intensities (in terms of speed increments and inclination) of treadmill training, as well as the use of handrails, in ambulatory participants, but not in dependent walkers.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 56 relevant trials, involving 3105 participants, up to March 2017. Twenty-six studies (1410 participants) compared treadmill training with body weight support to another physiotherapy treatment; 20 studies (889 participants) compared treadmill training without body weight support to other physiotherapy treatment, no treatment, or sham treatment; two studies (100 participants) compared treadmill training with body weight support to treadmill training without body weight support; and four studies (147 participants) did not state whether they used body weight support or not. The average age of the participants was 60 years, and the studies were carried out in both inpatient and outpatient settings."
}
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query-laysum | 4381 | [
{
"role": "user",
"content": "Abstract: Background\nPlasma volume expanders are used in connection to paracentesis in people with cirrhosis to prevent reduction of effective plasma volume, which may trigger deleterious effect on haemodynamic balance, and increase morbidity and mortality. Albumin is considered the standard product against which no plasma expansion or other plasma expanders, e.g. other colloids (polygeline , dextrans, hydroxyethyl starch solutions, fresh frozen plasma), intravenous infusion of ascitic fluid, crystalloids, or mannitol have been compared. However, the benefits and harms of these plasma expanders are not fully clear.\nObjectives\nTo assess the benefits and harms of any plasma volume expanders such as albumin, other colloids (polygeline, dextrans, hydroxyethyl starch solutions, fresh frozen plasma), intravenous infusion of ascitic fluid, crystalloids, or mannitol versus no plasma volume expander or versus another plasma volume expander for paracentesis in people with cirrhosis and large ascites.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, CNKI, VIP, Wanfang, Science Citation Index Expanded, and Conference Proceedings Citation Index until January 2019. Furthermore, we searched FDA, EMA, WHO (last search January 2019), www.clinicaltrials.gov/, and www.controlled-trials.com/ for ongoing trials.\nSelection criteria\nRandomised clinical trials, no matter their design or year of publication, publication status, and language, assessing the use of any type of plasma expander versus placebo, no intervention, or a different plasma expander in connection with paracentesis for ascites in people with cirrhosis. We considered quasi-randomised, retrieved with the searches for randomised clinical trials only, for reports on harms.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We calculated the risk ratio (RR) or mean difference (MD) using the fixed-effect model and the random-effects model meta-analyses, based on the intention-to-treat principle, whenever possible. If the fixed-effect and random-effects models showed different results, then we made our conclusions based on the analysis with the highest P value (the more conservative result). We assessed risks of bias of the individual trials using predefined bias risk domains. We assessed the certainty of the evidence at an outcome level, using GRADE, and constructed 'Summary of Findings' tables for seven of our review outcomes.\nMain results\nWe identified 27 randomised clinical trials for inclusion in this review (24 published as full-text articles and 3 as abstracts). Five of the trials, with 271 participants, assessed plasma expanders (albumin in four trials and ascitic fluid in one trial) versus no plasma expander. The remaining 22 trials, with 1321 participants, assessed one type of plasma expander, i.e. dextran, hydroxyethyl starch, polygeline, intravenous infusion of ascitic fluid, crystalloids, or mannitol versus another type of plasma expander, i.e. albumin in 20 of these trials and polygeline in one trial. Twenty-five trials provided data for quantitative meta-analysis. According to the Child-Pugh classification, most participants were at an intermediate to advanced stage of liver disease in the absence of hepatocellular carcinoma, recent gastrointestinal bleeding, infections, and hepatic encephalopathy. All trials were assessed as at overall high risk of bias. Ten trials seemed not to have been funded by industry; twelve trials were considered unclear about funding; and five trials were considered funded by industry or a for-profit institution.\nWe found no evidence of a difference in effect between plasma expansion versus no plasma expansion on mortality (RR 0.52, 95% CI 0.06 to 4.83; 248 participants; 4 trials; very low certainty); renal impairment (RR 0.32, 95% CI 0.02 to 5.88; 181 participants; 4 trials; very low certainty); other liver-related complications (RR 1.61, 95% CI 0.79 to 3.27; 248 participants; 4 trials; very low certainty); and non-serious adverse events (RR 1.04, 95% CI 0.32 to 3.40; 158 participants; 3 trials; very low certainty). Two of the trials stated that no serious adverse events occurred while the remaining trials did not report on this outcome. No trial reported data on health-related quality of life.\nWe found no evidence of a difference in effect between experimental plasma expanders versus albumin on mortality (RR 1.03, 95% CI 0.82 to 1.30; 1014 participants; 14 trials; very low certainty); serious adverse events (RR 0.89, 95% CI 0.10 to 8.30; 118 participants; 2 trials; very low certainty); renal impairment (RR 1.17, 95% CI 0.71 to 1.91; 1107 participants; 17 trials; very low certainty); other liver-related complications (RR 1.10, 95% CI 0.82 to 1.48; 1083 participants; 16 trials; very low certainty); and non-serious adverse events (RR 1.37, 95% CI 0.66 to 2.85; 977 participants; 14 trials; very low certainty). We found no data on heath-related quality of life and refractory ascites.\nAuthors' conclusions\nOur systematic review and meta-analysis did not find any benefits or harms of plasma expanders versus no plasma expander or of one plasma expander such as polygeline, dextrans, hydroxyethyl starch, intravenous infusion of ascitic fluid, crystalloids, or mannitol versus albumin on primary or secondary outcomes. The data originated from few, small, mostly short-term trials at high risks of systematic errors (bias) and high risks of random errors (play of chance). GRADE assessments concluded that the evidence was of very low certainty. Therefore, we can neither demonstrate or discard any benefit of plasma expansion versus no plasma expansion, and differences between one plasma expander versus another plasma expander.\nLarger trials at low risks of bias are needed to assess the role of plasma expanders in connection with paracentesis. Such trials should be conducted according to the SPIRIT guidelines and reported according to the CONSORT guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our systematic review could not show any benefit or harm of plasma expansion versus no plasma expansion or of one plasma expander like dextran, polygeline, hydroxyethyl starch, intravenous infusion of ascitic fluid, crystalloids, or mannitol versus albumin on primary or secondary outcomes."
}
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query-laysum | 4382 | [
{
"role": "user",
"content": "Abstract: Background\nApnoea is a breathing disorder marked by the absence of airflow at the nose or mouth. In children, risk factors include adenotonsillar hypertrophy, obesity, neuromuscular disorders and craniofacial anomalies. The most common treatment for obstructive sleep apnoea syndrome (OSAS) in childhood is adeno-tonsillectomy. This approach is limited by its surgical risks, mostly in children with comorbidities and, in some patients, by recurrence that can be associated with craniofacial problems. Oral appliances and functional orthopaedic appliances have been used for patients who have OSAS and craniofacial anomalies because they hold the lower jaw (mandible) forwards which potentially enlarges the upper airway and increases the upper airspace, improving the respiratory function.\nObjectives\nTo assess the effects of oral appliances or functional orthopaedic appliances for obstructive sleep apnoea in children.\nSearch methods\nWe searched the following electronic databases: Cochrane Oral Health's Trials Register (to 7 April 2016); Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3) in the Cochrane Library (searched 7 April 2016); MEDLINE Ovid (1946 to 7 April 2016); Embase Ovid (1980 to 7 April 2016); LILACS BIREME (from 1982 to 7 April 2016); BBO BIREME (from 1986 to 7 April 2016) and SciELO Web of Science (from 1997 to 7 April 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials on 7 April 2016. We placed no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nAll randomised or quasi-randomised controlled trials comparing all types of oral and functional orthopaedic appliances with placebo or no treatment, in children 15 years old or younger. Primary outcome: reduction of apnoea to less than one episode per hour. Secondary outcomes: dental and skeletal relationship, sleep parameters improvement, cognitive and phonoaudiological function, behavioural problems, quality of life, side effects (tolerability) and economic evaluation.\nData collection and analysis\nTwo review authors screened studies and extracted data independently. Authors were contacted for additional information. We calculated risk ratios with 95% confidence intervals for all important dichotomous outcomes. We assessed the quality of the evidence of included studies using GRADEpro software.\nMain results\nThe initial search identified 686 trials. Only one trial, reporting the results from a total of 23 children and comparing an oral appliance to no treatment, was suitable for inclusion in the review. The trial assessed apnoea-hypopnoea, daytime symptoms (sleepiness, irritability, tiredness, school problems, morning headache, thirstiness in the morning, oral breathing and nasal stuffiness) and night-time symptoms (habitual snoring, restless sleep and nightmares measured by questionnaire). Results were inconsistent across outcomes measures and time points. The evidence was considered very low quality.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the effectiveness of oral appliances and functional orthopaedic appliances for the treatment of obstructive sleep apnoea in children. Oral appliances or functional orthopaedic appliances may be considered in specified cases as an auxiliary in the treatment of children who have craniofacial anomalies which are risk factors for apnoea.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Treatment of obstructive sleep apnoea syndrome in children appears to be possible with oral appliances or functional orthopaedic appliances. However, this is only based on data from one small study."
}
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query-laysum | 4383 | [
{
"role": "user",
"content": "Abstract: Background\nHumour-based interventions are defined as any intervention that promotes health and wellness by stimulating a playful discovery, expression, or appreciation of the absurdity or incongruity of life's situations. Humour-based interventions can be implemented in different settings, including hospitals, nursing homes and day care centres. They have been posed as an adjunct to usual care for people with schizophrenia, but a summary of the evidence is lacking.\nObjectives\nTo examine the effects of humour-based interventions as an add-on intervention to standard care for people with schizophrenia.\nSearch methods\nOn 31 July 2019 and 10 February 2021 we searched the Cochrane Schizophrenia Group's study-based register of trials, which is based on CENTRAL, CINAHL, ClinicalTrials.Gov, Embase, ISRCTN, MEDLINE, PsycINFO, PubMed, and WHO ICTRP.\nSelection criteria\nWe included all randomised controlled trials comparing humour-based interventions with active controls, other psychological interventions, or standard care for people with schizophrenia. We excluded studies fulfilling our prespecified selection criteria but without useable data from further quantitative synthesis.\nData collection and analysis\nTwo review authors independently inspected citations, selected studies, extracted data and appraised study quality, following the guidance from the Cochrane Handbook for Systematic Reviews of Interventions. For binary outcomes we calculated risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean differences (MDs) and their 95% CIs. We assessed risks of bias for included studies and created summary of findings tables using the GRADE approach.\nMain results\nWe included three studies in this review for qualitative synthesis, although one study did not report any relevant outcomes. We therefore include two studies (n = 96) in our quantitative synthesis. No data were available on the following prespecified primary outcomes: clinically-important change in general mental state, clinically-important change in negative symptoms, clinically-important change in overall quality of life, and adverse effects. As compared with active control, humour-based interventions may not improve the average endpoint score of a general mental state scale (Positive and Negative Syndrome Scale (PANSS) total score: MD −1.70, 95% CI −17.01 to 13.61; 1 study, 30 participants; very low certainty of evidence); positive symptoms (PANSS positive symptom score: MD 0.00, 95% CI −2.58 to 2.58; 1 study, 30 participants; low certainty of evidence), negative symptoms (PANSS negative symptom score: MD −0.70, 95% CI −4.22 to 2.82; 1 study, 30 participants; very low certainty of evidence) and anxiety (State-Trait Anxiety Inventory (STAI): MD −2.60, 95% CI −5.76 to 0.56; 1 study, 30 participants; low certainty of evidence). Due to the small sample size, we remain uncertain about the effect of humour-based interventions on leaving the study early as compared with active control (no event, 1 study, 30 participants; very low certainty of evidence). On the other hand, humour-based interventions may reduce depressive symptoms (Beck Depression Inventory (BDI): MD −6.20, 95% CI −12.08 to −0.32; 1 study, 30 participants; low certainty of evidence). Compared with standard care, humour-based interventions may not improve depressive symptoms (BDI second edition: MD 0.80, 95% CI −2.64 to 4.24; 1 study, 59 participants; low certainty of evidence). We are uncertain about the effect of humour-based interventions on leaving the study early for any reason compared with standard care (risk ratio 0.38, 95% CI 0.08 to 1.80; 1 study, 66 participants; very low certainty of evidence).\nAuthors' conclusions\nWe are currently uncertain whether the evidence supports the use of humour-based interventions in people with schizophrenia. Future research with rigorous and transparent methodology investigating clinically important outcomes is warranted.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Schizophrenia is a serious mental illness. It is a disorder of thought, namely firm fixed false beliefs despite there being evidence to the contrary, loss of reality ties, and altered perception. These symptoms are further classified as (i) positive symptoms, such as speech without order, illusions or mistaken and persistent ideas; and (ii) negative symptoms, a lack of emotion or restricted quantity of speech; and decline in cognitive function, including attention, memory, and behavior control. The standard treatment for schizophrenia is antipsychotic medications. Treatment with humour-based interventions, such as watching humorous movies, funny videos, or comedies, has been proposed as an add-on treatment that promotes health and wellness by stimulating a playful discovery, expression, or appreciation of the irrationality or inconsistency of life's situations."
}
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query-laysum | 4384 | [
{
"role": "user",
"content": "Abstract: Background\nChronic plaque psoriasis is an immune-mediated, chronic, inflammatory skin disease, which can impair quality of life and social interaction. Disease severity can be classified by the psoriasis area and severity index (PASI) score ranging from 0 to 72 points. Indoor artificial salt bath with or without artificial ultraviolet B (UVB) light is used to treat psoriasis, simulating sea bathing and sunlight exposure; however, the evidence base needs clear evaluation.\nObjectives\nTo assess the effects of indoor (artificial) salt water baths followed by exposure to artificial UVB for treating chronic plaque psoriasis in adults.\nSearch methods\nWe searched the following databases up to June 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registers, and checked the reference lists of included studies, recent reviews, and relevant papers for further references to relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) of salt bath indoors followed by exposure to artificial UVB in adults who have been diagnosed with chronic plaque type psoriasis. We included studies reporting between-participant data and within-participant data. We evaluated two different comparisons: 1) salt bath + UVB versus other treatment without UVB; eligible comparators were exposure to psoralen bath, psoralen bath + artificial ultraviolet A UVA) light, topical treatment, systemic treatment, or placebo, and 2) salt bath + UVB versus other treatment + UVB or UVB only; eligible comparators were exposure to bath containing other compositions or concentrations + UVB or UVB only.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence.\nThe primary efficacy outcome was PASI-75, to detect people with a 75% or more reduction in PASI score from baseline. The primary adverse outcome was treatment-related adverse events requiring withdrawal. For the dichotomous variables PASI-75 and treatment-related adverse events requiring withdrawal, we estimated the proportion of events among the assessed participants.\nThe secondary outcomes were health-related quality of life using the Dermatology Life Quality Index, (DLQI) pruritus severity measured using a visual analogue scale, time to relapse, and secondary malignancies.\nMain results\nWe included eight RCTs: six reported between-participant data (2035 participants; 1908 analysed), and two reported within-participant data (70 participants, 68 analysed; 140 limbs; 136 analysed). One study reported data for the comparison salt bath with UVB versus other treatment without UVB; and eight studies reported data for salt bath with UVB versus other treatment with UVB or UVB only. Of these eight studies, only five reported any of our pre-specified outcomes and assessed the comparison of salt bath with UVB versus UVB only. The one included trial that assessed salt bath plus UVB versus other treatment without UVB (psoralen bath + UVA) did not report any of our primary outcomes. The mean age of the participants ranged from 41 to 50 years of age in 75% of the studies. None of the included studies reported on the predefined secondary outcomes of this review. We judged seven of the eight studies as at high risk of bias in at least one domain, most commonly performance bias. Total trial duration ranged between at least two months and up to 13 months.\nIn five studies, the median participant PASI score at baseline ranged from 15 to 18 and was balanced between treatment arms. Three studies did not report PASI score. Most studies were conducted in Germany; all were set in Europe. Half of the studies were multi-centred (set in spa centres or outpatient clinics); half were set in a single centre in either an unspecified settings, a psoriasis daycare centre, or a spa centre. Commercial spa or salt companies sponsored three of eight studies, health insurance companies funded another, the association of dermatologists funded another, and three did not report on funding.\nWhen comparing salt bath plus UVB versus UVB only, two between-participant studies found that salt bath plus UVB may improve psoriasis when measured using PASI 75 (achieving a 75% or more reduction in PASI score from baseline) (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.24 to 2.35; 278 participants; low-certainty evidence). Assessment was conducted at the end of treatment, which was equivalent to six to eight weeks after start of treatment. The two trials which contributed data for the primary efficacy outcome were conducted by the same group, and did not blind outcome assessors. The German Spas Association funded one of the trials and the funding source was not stated for the other trial.\nTwo other between-participant studies found salt bath plus UVB may make little to no difference to outcome treatment-related adverse events requiring withdrawal compared with UVB only (RR 0.96, 95% CI 0.35 to 2.64; 404 participants; low-certainty evidence). One of the studies reported adverse events, but did not specify the type of events; the other study reported skin irritation. One within-participant study found similar results, with one participant reporting severe itch immediately after Dead Sea salt soak in the salt bath and UVB group and two instances of inadequate response to phototherapy and conversion to psoralen bath + UVA reported in the UVB only group (low-certainty evidence).\nAuthors' conclusions\nSalt bath with artificial ultraviolet B (UVB) light may improve psoriasis in people with chronic plaque psoriasis compared with UVB light treatment alone, and there may be no difference in the occurrence of treatment-related adverse events requiring withdrawal. Both results are based on data from a limited number of studies, which provided low-certainty evidence, so we cannot draw any clear conclusions.\nThe reporting of our pre-specified outcomes was either non-existent or limited, with a maximum of two studies reporting a given outcome.\nThe same group conducted the two trials which contributed data for the primary efficacy outcome, and the German Spas Association funded one of these trials. We recommend further RCTs that assess PASI-75, with detailed reporting of the outcome and time point, as well as treatment-related adverse events. Risk of bias was an issue; future studies should ensure blinding of outcome assessors and full reporting.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the evidence for ‘PASI-75’ and ‘treatment-related adverse events requiring withdrawal’ as low certainty. Our confidence was affected by limitations, such as risk of bias (examples being inadequate blinding and high probability of publication bias). The reporting of our outcomes was non-existent or limited."
}
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query-laysum | 4385 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical removal of the tonsils, with or without adenoidectomy (adeno-/tonsillectomy), is a common ENT operation, but the indications for surgery are controversial. This is an update of a Cochrane review first published in The Cochrane Library in Issue 3, 1999 and previously updated in 2009.\nObjectives\nTo assess the effectiveness of tonsillectomy (with and without adenoidectomy) in children and adults with chronic/recurrent acute tonsillitis in reducing the number and severity of episodes of tonsillitis or sore throat.\nSearch methods\nWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 30 June 2014.\nSelection criteria\nRandomised controlled trials comparing tonsillectomy (with or without adenoidectomy) with non-surgical treatment in adults and children with chronic/recurrent acute tonsillitis.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nThis review includes seven trials with low to moderate risk of bias: five undertaken in children (987 participants) and two in adults (156 participants). An eighth trial in adults (40 participants) was at high risk of bias and did not provide any data for analysis. Good information about the effectiveness of adeno-/tonsillectomy is only available for the first year following surgery in children and for a shorter period (five to six months) in adults.\nWe combined data from five trials in children; these trials included children who were 'severely affected' (based on the specific 'Paradise' criteria) and less severely affected. Children who had an adeno-/tonsillectomy had an average of three episodes of sore throats (of any severity) in the first postoperative year, compared to 3.6 episodes in the control group; a difference of 0.6 episodes (95% confidence interval (CI) -1 to -0.1; moderate quality evidence). One of the three episodes in the surgical group was the 'predictable' one that occurred in the immediate postoperative period.\nWhen we analysed only episodes of moderate/severe sore throat, children who had been more severely affected and had adeno-/tonsillectomy had on average 1.1 episodes of sore throat in the first postoperative year, compared with 1.2 episodes in the control group (low quality evidence). This is not a significant difference but one episode in the surgical group was that occurring immediately after surgery.\nLess severely affected children had more episodes of moderate/severe sore throat after surgery (1.2 episodes) than in the control group (0.4 episodes: difference 0.8, 95% CI 0.7 to 0.9), but again one episode was the predictable postoperative episode (moderate quality evidence).\nData on the number of sore throat days is only available for moderately affected children and is consistent with the data on episodes. In the first year after surgery children undergoing surgery had an average of 18 days of sore throat (of which some - between five and seven on average - will be in the immediate postoperative period), compared with 23 days in the control group (difference 5.1 days, 95% CI 2.2 to 8.1; moderate quality evidence).\nWhen we pooled the data from two studies in adults (156 participants), there were 3.6 fewer episodes (95% CI 7.9 fewer to 0.70 more; low quality evidence) in the group receiving surgery within six months post-surgery. However, statistical heterogeneity was significant. The pooled mean difference for number of days with sore throat in a follow-up period of about six months was 10.6 days fewer in favour of the group receiving surgery (95% CI 5.8 fewer to 15.8 fewer; low quality evidence). However, there was also significant statistical heterogeneity in this analysis and the number of days with postoperative pain (which appeared to be on average 13 to 17 days in the two trials) was not included. Given the short duration of follow-up and the differences between studies, we considered the evidence for adults to be of low quality.\nTwo studies in children reported that there was \"no statistically significant difference\" in quality of life outcomes, but the data could not be pooled. One study reported no difference in analgesics consumption. We found no evidence for prescription of antibiotics.\nLimited data are available from the included studies to quantify the important risks of primary and secondary haemorrhage.\nAuthors' conclusions\nAdeno-/tonsillectomy leads to a reduction in the number of episodes of sore throat and days with sore throat in children in the first year after surgery compared to (initial) non-surgical treatment. Children who were more severely affected were more likely to benefit as they had a small reduction in moderate/severe sore throat episodes. The size of the effect is very modest, but there may be a benefit to knowing the precise timing of one episode of pain lasting several days - it occurs immediately after surgery as a direct consequence of the procedure. It is clear that some children get better without any surgery, and that whilst removing the tonsils will always prevent 'tonsillitis', the impact of the procedure on 'sore throats' due to pharyngitis is much less predictable.\nInsufficient information is available on the effectiveness of adeno-/tonsillectomy versus non-surgical treatment in adults to draw a firm conclusion.\nThe impact of surgery, as demonstrated in the included studies, is modest. Many participants in the non-surgical group improve spontaneously (although some people randomised to this group do in fact undergo surgery). The potential 'benefit' of surgery must be weighed against the risks of the procedure as adeno-/tonsillectomy is associated with a small but significant degree of morbidity in the form of primary and secondary haemorrhage and, even with good analgesia, is particularly uncomfortable for adults.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We judged the quality of the evidence to be moderate for the data on children (this means that further research is likely to have an important impact on how confident we are in the results and may change those results). Quality is affected by a large number of children who are 'lost to follow-up' after the first year of the study. In addition, some children who are assigned to the 'no surgery' group end up having surgery.\nThe quality of evidence for tonsillectomy in adults in adults is low.\nAs always, any potential benefits of surgery should be carefully weighed against the possible harms as the procedure is associated with a small but significant degree of morbidity in the form of bleeding (either during or after the surgery). In addition, even with good pain relief medication, the surgery is particularly uncomfortable for adults."
}
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query-laysum | 4386 | [
{
"role": "user",
"content": "Abstract: Background\nEmotional and behavioural problems in children are common. Research suggests that parenting has an important role to play in helping children to become well-adjusted, and that the first few months and years are especially important. Parenting programmes may have a role to play in improving the emotional and behavioural adjustment of infants and toddlers, and this review examined their effectiveness with parents and carers of young children.\nObjectives\n1. To establish whether group-based parenting programmes are effective in improving the emotional and behavioural adjustment of young children (maximum mean age of three years and 11 months); and\n2. To assess whether parenting programmes are effective in the primary prevention of emotional and behavioural problems.\nSearch methods\nIn July 2015 we searched CENTRAL (the Cochrane Library), Ovid MEDLINE, Embase (Ovid), and 10 other databases. We also searched two trial registers and handsearched reference lists of included studies and relevant systematic reviews.\nSelection criteria\nTwo reviewers independently assessed the records retrieved by the search. We included randomised controlled trials (RCTs) and quasi-RCTs of group-based parenting programmes that had used at least one standardised instrument to measure emotional and behavioural adjustment in children.\nData collection and analysis\nOne reviewer extracted data and a second reviewer checked the extracted data. We presented the results for each outcome in each study as standardised mean differences (SMDs) with 95% confidence intervals (CIs). Where appropriate, we combined the results in a meta-analysis using a random-effects model. We used the GRADE (Grades of Recommendations, Assessment, Development, and Evaluation) approach to assess the overall quality of the body of evidence for each outcome.\nMain results\nWe identified 22 RCTs and two quasi-RCTs evaluating the effectiveness of group-based parenting programmes in improving the emotional and behavioural adjustment of children aged up to three years and 11 months (maximum mean age three years 11 months).\nThe total number of participants in the studies were 3161 parents and their young children. Eight studies were conducted in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the included studies were of behavioural, cognitive-behavioural or videotape modelling parenting programmes.\nWe judged 50% (or more) of the included studies to be at low risk for selection bias, detection bias (observer-reported outcomes), attrition bias, selective reporting bias, and other bias. As it is not possible to blind participants and personnel to the type of intervention in these trials, we judged all studies to have high risk of performance bias. Also, there was a high risk of detection bias in the 20 studies that included parent-reported outcomes.\nThe results provide evidence that group-based parenting programmes reduce overall emotional and behavioural problems (SMD -0.81, 95% CI -1.37 to -0.25; 5 studies, 280 participants, low quality evidence) based on total parent-reported data assessed at postintervention. This result was not, however, maintained when two quasi-RCTs were removed as part of a sensitivity analysis (SMD -0.67, 95% CI -1.43 to 0.09; 3 studies, 221 participants). The results of data from subscales show evidence of reduced total externalising problems (SMD -0.23, 95% CI -0.46 to -0.01; 8 studies, 989 participants, moderate quality evidence). Single study results show very low quality evidence of reductions in externalising problems hyperactivity-inattention subscale (SMD -1.34; 95% CI -2.37 to -0.31; 19 participants), low quality evidence of no effect on total internalising problems (SMD 0.34; 95% CI -0.12 to 0.81; 73 participants), and very low quality evidence of an increase in social skills (SMD 3.59; 95% CI 2.42 to 4.76; 32 participants), based on parent-reported data assessed at postintervention. Results for secondary outcomes, which were also measured using subscales, show an impact on parent-child interaction in terms of reduced negative behaviour (SMD -0.22, 95% CI -0.39 to -0.06; 7 studies, 941 participants, moderate quality evidence), and improved positive behaviour (SMD 0.48, 95% CI 0.17 to 0.79; 4 studies, 173 participants, moderate quality evidence) as rated by independent observers postintervention. No further meta-analyses were possible. Results of subgroup analyses show no evidence for treatment duration (seven weeks or less versus more than eight weeks) and inconclusive evidence for prevention versus treatment interventions.\nAuthors' conclusions\nThe findings of this review, which relate to the broad group of universal and at-risk (targeted) children and parents, provide tentative support for the use of group-based parenting programmes to improve the overall emotional and behavioural adjustment of children with a maximum mean age of three years and 11 months, in the short-term. There is, however, a need for more research regarding the role that these programmes might play in the primary prevention of both emotional and behavioural problems, and their long-term effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Some of the studies we found included people chosen specially because they were ‘at risk’ of behavioural problems, while others included parents and children without any specific risks. When we put all of the studies together, overall, we found that group-based parenting programmes can improve the emotional and behavioural development of young children, although the quality of the evidence was, on the whole, low. Furthermore, our findings were not convincing when we removed two studies that used quasi-randomised methods.\nOur findings also showed evidence of an improvement in externalising problems (these might include negative behaviours in children or young people that are directed towards the external environment such as anger, aggression or conflict with the law). However, the evidence for this, once again, came from studies that we rated as being of only moderate quality, and was only found for some parts of the outcome measure (known as a subscale).\nResults from single studies that could not be combined with other studies and that were of poor quality, on the whole, showed no impact on children’s internalising problems (e.g. depression and anxiety). However, there was some improvement on one subscale of a measure that focused on children’s hyperactivity-inattention and another subscale that focused on social skills.\nThere was moderate-quality evidence that group-based parenting programmes also improve the way in which parents and children interact, as measured by fewer negative behaviours.\nOur reasons for rating the quality of the evidence as low or moderate included: inconsistency in the findings from different studies (different studies yielded different results); unclear risk of bias (where it was not possible for us to assess the ways in which the included studies might be biased due to inadequate information); and small numbers of parents in the included studies.\nWe believe more research is needed to be able to reach a firm conclusion about whether the effects we have found are short term only or whether they continue over time and therefore may be able to prevent future behavioural problems."
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query-laysum | 4387 | [
{
"role": "user",
"content": "Abstract: Background\nTo reduce the morbidity and mortality associated with preterm birth, home uterine activity monitoring aims for early detection of increased contraction frequency, and early intervention with tocolytic drugs to inhibit labour and prolong pregnancy. However, the effectiveness of such monitoring is disputed.\nObjectives\nTo determine whether home uterine activity monitoring is effective in improving the outcomes for women and their infants considered to be at high risk of preterm birth, when compared with care that does not include home uterine activity monitoring.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 June 2016), CENTRAL (Cochrane Library 2016, Issue 5), MEDLINE (1966 to 28 June 2016), Embase (1974 to 28 June 2016), CINAHL (1982 to 28 June 2016), and scanned reference lists of retrieved studies.\nSelection criteria\nRandomised control trials of home uterine activity monitoring, with or without patient education programmes, for women at risk of preterm birth, compared with care that does not include home uterine activity monitoring.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We did not attempt to contact authors to resolve queries. We assessed the evidence using the GRADE approach.\nMain results\nThere were 15 included studies (6008 enrolled participants); 13 studies contributed data. Women using home uterine monitoring were less likely to experience preterm birth at less than 34 weeks (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.62 to 0.99; three studies, 1596 women; fixed-effect analysis) (GRADE high). This difference was not evident when we carried out a sensitivity analysis, restricting the analysis to studies at low risk of bias based on study quality (RR 0.75, 95% CI 0.57 to 1.00; one study, 1292 women). There was no difference in the rate of perinatal mortality (RR 1.22, 95% CI 0.86 to 1.72; two studies, 2589 babies) (GRADE low).\nThere was no difference in the number of preterm births at less than 37 weeks (average RR 0.85, CI 0.72 to 1.01; eight studies, 4834 women; random-effects, Tau2 = 0.03, I2 = 68%) (GRADE very low). Infants born to women using home uterine monitoring were less likely to be admitted to neonatal intensive care unit (average RR 0.77, 95% CI 0.62 to 0.96; five studies, 2367 babies; random-effects, Tau2 = 0.02, I2 = 32%) (GRADE moderate). This difference was not maintained when we restricted the analysis to studies at low risk of bias (RR 0.86, 95% CI 0.74 to 1.01; one study, 1292 babies). Women using home uterine monitoring made more unscheduled antenatal visits (mean difference (MD) 0.48, 95% CI 0.31 to 0.64; two studies, 1994 women) (GRADE moderate). Women using home uterine monitoring were also more likely to have prophylactic tocolytic drug therapy (average RR 1.21, 95% CI 1.01 to 1.45; seven studies, 4316 women; random-effects, Tau2 = 0.03, I2 = 62%), but this difference was no longer evident when we restricted the analysis to studies at low risk of bias (average RR 1.22, 95% CI 0.90 to 1.65; three studies, 3749 women; random-effects, Tau2 = 0.05, I2 = 76%) (GRADE low). The number of antenatal hospital admissions did not differ between home groups (RR 0.91, 95% CI 0.74 to 1.11; three studies, 1494 women (GRADE low)). We found no data on maternal anxiety or acceptability.\nAuthors' conclusions\nHome uterine monitoring may result in fewer admissions to a neonatal intensive care unit but in more unscheduled antenatal visits and tocolytic treatment; the level of evidence is generally low to moderate. Important group differences were not evident when we undertook sensitivity analysis using only trials at low risk of bias. There is no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Babies who are born too early are more likely to become ill or die. If preterm labour is detected, treatment can start to slow down or stop labour. This also gives time for treatment to improve the baby’s breathing at birth. Increased contractions can be a sign of labour starting early."
}
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query-laysum | 4388 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy is one of the major causes of blindness and the number of cases has risen in recent years. Herbal medicine has been used to treat diabetes and its complications including diabetic retinopathy for thousands of years around the world. However, common practice is not always evidence-based. Evidence is needed to help people with diabetic retinopathy or doctors to make judicious judgements about using herbal medicine as treatment.\nObjectives\nTo evaluate the effectiveness and harm of single herbal medicine for diabetic retinopathy.\nSearch methods\nWe searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register, MEDLINE, Embase, OpenGrey, the ISRCTN registry, ClinicalTrials.gov and the ICTRP. The date of the search was 12 June 2018. We also searched the following Chinese databases in June 2013: Chinese BioMedical Literature Database (CBM), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), Wanfang China Dissertation Database (CDDB), Wanfang China Conference Paper Database (CCPD) and the Index to Chinese Periodical Literature.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of any single herb (or extracts from a single herb) as a treatment for people with diabetic retinopathy. We considered the following comparators: placebo, no treatment, non-herbal (conventional) medicine or surgical treatment.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias in the studies. Our prespecified outcomes were: progression of diabetic retinopathy, visual acuity, microaneurysms and haemorrhages in the retina, blood glycated haemoglobin A1c (HbA1c) (%) and adverse effects. We performed meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 10 studies involving 754 participants, of which nine were conducted in China and one in Poland. In all studies, participants in both groups received conventional treatment for diabetic retinopathy which included maintaining blood glucose and lipids using medicines and keeping a stable diabetic diet. In three studies, the comparator group also received an additional potentially active comparator in the form of a vasoprotective drug. The single herbs or extracts included Ruscus extract tablet, Sanqi Tongshu capsule, tetramethylpyrazine injection, Xueshuantong injection, Puerarin injection and Xuesaitong injection. The Sanqi Tongshu capsule, Xueshuantong injection and Xuesaitong injection were all made from the extract of Radix Notoginseng (San qi) and the main ingredient was sanchinoside. The risk of bias was high in all included studies mainly due to lack of masking (blinding). None of the studies reported the primary outcome of this review, progression of retinopathy.\nCombined analysis of herbal interventions suggested that people who took these herbs in combination with conventional treatment may have been more likely to gain 2 or more lines of visual acuity compared to people who did not take these herbs when compared to conventional intervention alone at the end of treatment (RR 1.26, 95% CI 1.08 to 1.48; 5 trials, 541 participants; low-certainty evidence). Subgroup analyses based on the different single herbs found no evidence for different effects of different herbs, but the power of this analysis was low. One study reported Sanqi Tongshu capsule might be associated with a greater reduction in microaneurysms and haemorrhages in the retina (very low-certainty evidence). The pooled analysis of two studies on tetramethylpyrazine or Xueshuantong injection showed such herbs may have had little effect on lowering HbA1c (MD 0.00, 95% CI -0.58 to 0.58; 215 participants; low-certainty evidence).\nThere was very low-certainty evidence on adverse events. Two studies reported minor adverse events such as uncomfortable stomach, urticaria, dizziness and headache. There was no report of observation on adverse events in the other studies.\nAuthors' conclusions\nNo conclusions could be drawn about the effect of any single herb or herbal extract on diabetic retinopathy from the current available evidence. It was difficult to exclude the placebo effect as a possible explanation for observed differences due to the lack of placebo control in the included studies. Further adequately designed trials are needed to establish the evidence.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The Cochrane researchers found 10 relevant studies involving 754 participants; nine studies were from China and one was from Poland.\nThese studies compared herbal medicine combined with conventional treatment with conventional treatment alone for people with diabetic retinopathy. None of the studies reported where the funding for the study came from. The findings were as follows.\n• None of the studies reported on the progression of diabetic retinopathy.\n• The studies provided low-certainty evidence that herbal extracts may have increased the chances of visual improvement (being able to read 2 or more additional lines on an Eye chart, which is used to measure visual acuity).\n• The Cochrane researchers judged the evidence on some of the signs of diabetic retinopathy (such as reduction in blood vessels bleeding at the back of the eye) as being very low-certainty.\n• Similarly, there was low-certainty evidence as to the effect of herbal extracts on blood sugar levels but the available evidence suggested little effect.\n• Most of the studies did not report on side effects. Two studies reported minor side effects such as uncomfortable stomach, itching, dizziness and headache."
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query-laysum | 4389 | [
{
"role": "user",
"content": "Abstract: Background\nEvidence that antihyperglycaemic therapy is beneficial for people with type 2 diabetes mellitus is conflicting. While the United Kingdom Prospective Diabetes Study (UKPDS) found tighter glycaemic control to be positive, other studies, such as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, found the effects of an intensive therapy to lower blood glucose to near normal levels to be more harmful than beneficial. Study results also showed different effects for different antihyperglycaemic drugs, regardless of the achieved blood glucose levels. In consequence, firm conclusions on the effect of interventions on patient-relevant outcomes cannot be drawn from the effect of these interventions on blood glucose concentration alone. In theory, the use of newer insulin analogues may result in fewer macrovascular and microvascular events.\nObjectives\nTo compare the effects of long-term treatment with (ultra-)long-acting insulin analogues (insulin glargine U100 and U300, insulin detemir and insulin degludec) with NPH (neutral protamine Hagedorn) insulin (human isophane insulin) in adults with type 2 diabetes mellitus.\nSearch methods\nFor this Cochrane Review update, we searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was 5 November 2019, except Embase which was last searched 26 January 2017. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing the effects of treatment with (ultra-)long-acting insulin analogues to NPH in adults with type 2 diabetes mellitus.\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, extracted data and evaluated the overall certainty of the evidence using GRADE. Trials were pooled using random-effects meta-analyses.\nMain results\nWe identified 24 RCTs. Of these, 16 trials compared insulin glargine to NPH insulin and eight trials compared insulin detemir to NPH insulin. In these trials, 3419 people with type 2 diabetes mellitus were randomised to insulin glargine and 1321 people to insulin detemir. The duration of the included trials ranged from 24 weeks to five years. For studies, comparing insulin glargine to NPH insulin, target values ranged from 4.0 mmol/L to 7.8 mmol/L (72 mg/dL to 140 mg/dL) for fasting blood glucose (FBG), from 4.4 mmol/L to 6.6 mmol/L (80 mg/dL to 120 mg/dL) for nocturnal blood glucose and less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, when applicable. Blood glucose and glycosylated haemoglobin A1c (HbA1c) target values for studies comparing insulin detemir to NPH insulin ranged from 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for FBG, less than 6.7 mmol/L (120 mg/dL) to less than 10 mmol/L (180 mg/dL) for postprandial blood glucose, 4.0 mmol/L to 7.0 mmol/L (72 mg/dL to 126 mg/dL) for nocturnal blood glucose and 5.8% to less than 6.4% HbA1c, when applicable.\nAll trials had an unclear or high risk of bias for several risk of bias domains.\nOverall, insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Changes in HbA1c were comparable for long-acting insulin analogues and NPH insulin.\nInsulin glargine compared to NPH insulin had a risk ratio (RR) for severe hypoglycaemia of 0.68 (95% confidence interval (CI) 0.46 to 1.01; P = 0.06; absolute risk reduction (ARR) –1.2%, 95% CI –2.0 to 0; 14 trials, 6164 participants; very low-certainty evidence). The RR for serious hypoglycaemia was 0.75 (95% CI 0.52 to 1.09; P = 0.13; ARR –0.7%, 95% CI –1.3 to 0.2; 10 trials, 4685 participants; low-certainty evidence). Treatment with insulin glargine reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia.\nTreatment with insulin detemir compared to NPH insulin found an RR for severe hypoglycaemia of 0.45 (95% CI 0.17 to 1.20; P = 0.11; ARR –0.9%, 95% CI –1.4 to 0.4; 5 trials, 1804 participants; very low-certainty evidence). The Peto odds ratio for serious hypoglycaemia was 0.16, 95% CI 0.04 to 0.61; P = 0.007; ARR –0.9%, 95% CI –1.1 to –0.4; 5 trials, 1777 participants; low-certainty evidence). Treatment with detemir also reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia.\nInformation on patient-relevant outcomes such as death from any cause, diabetes-related complications, health-related quality of life and socioeconomic effects was insufficient or lacking in almost all included trials. For those outcomes for which some data were available, there were no meaningful differences between treatment with glargine or detemir and treatment with NPH. There was no clear difference between insulin-analogues and NPH insulin in terms of weight gain.\nThe incidence of adverse events was comparable for people treated with glargine or detemir, and people treated with NPH.\nWe found no trials comparing ultra-long-acting insulin glargine U300 or insulin degludec with NPH insulin.\nAuthors' conclusions\nWhile the effects on HbA1c were comparable, treatment with insulin glargine and insulin detemir resulted in fewer participants experiencing hypoglycaemia when compared with NPH insulin. Treatment with insulin detemir also reduced the incidence of serious hypoglycaemia. However, serious hypoglycaemic events were rare and the absolute risk reducing effect was low. Approximately one in 100 people treated with insulin detemir instead of NPH insulin benefited.\nIn the studies, low blood glucose and HbA1c targets, corresponding to near normal or even non-diabetic blood glucose levels, were set. Therefore, results from the studies are only applicable to people in whom such low blood glucose concentrations are targeted. However, current guidelines recommend less-intensive blood glucose lowering for most people with type 2 diabetes in daily practice (e.g. people with cardiovascular diseases, a long history of type 2 diabetes, who are susceptible to hypoglycaemia or older people). Additionally, low-certainty evidence and trial designs that did not conform with current clinical practice meant it remains unclear if the same effects will be observed in daily clinical practice. Most trials did not report patient-relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "It is unclear if or to what extent (ultra-)long-acting insulin analogues show more benefit or less harm compared to NPH insulin."
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query-laysum | 4390 | [
{
"role": "user",
"content": "Abstract: Background\nFluid excess may place people undergoing surgery at risk for various complications. Hypertonic salt solution (HS) maintains intravascular volume with less intravenous fluid than isotonic salt (IS) solutions, but may increase serum sodium. This review was published in 2010 and updated in 2016.\nObjectives\nTo determine the benefits and harms of HS versus IS solutions administered for fluid resuscitation to people undergoing surgery.\nSearch methods\nIn this updated review we have searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2016); MEDLINE (January 1966 to April 2016); EMBASE (January 1980 to April 2016); LILACS (January 1982 to April 2016) and CINAHL (January 1982 to April 2016) without language restrictions. We conducted the original search on April 30th, 2007, and reran it on April 8th, 2016.\nSelection criteria\nWe have included randomized clinical trials (RCTs) comparing HS to IS in people undergoing surgery, irrespective of blinding, language, and publication status.\nData collection and analysis\nTwo independent review authors read studies that met our selection criteria. We collected study information and data using a data collection sheet with predefined parameters. We have assessed the impact of HS administration on mortality, organ failure, fluid balance, serum sodium, serum osmolarity, diuresis and physiologic measures of cardiovascular function. We have pooled the data using the mean difference (MD) for continuous outcomes. We evaluated heterogeneity between studies by I² percentage. We consider studies with an I² of 0% to 30% to have no or little heterogeneity, 30% to 60% as having moderate heterogeneity, and more than 60% as having high heterogeneity. In studies with low heterogeneity we have used a fixed-effect model, and a random-effects model for studies with moderate to high heterogeneity.\nMain results\nWe have included 18 studies with 1087 participants of whom 545 received HS compared to 542 who received IS. All participants were over 18 years of age and all trials excluded high-risk patients (ASA IV). All trials assessed haematological parameters peri-operatively and up to three days post-operatively.\nThere were three (< 1%) deaths reported in the IS group and four (< 1%) in the HS group, as assessed at 90 days in one study. There were no reports of serious adverse events. Most participants were in a positive fluid balance postoperatively (4.4 L IS and 2.5 L HS), with the excess significantly less in HS participants (MD -1.92 L, 95% confidence interval (CI) -2.61 to -1.22 L; P < 0.00001). IS participants received a mean volume of 2.4 L and HS participants received 1.49 L, significantly less fluid than IS-treated participants (MD -0.91 L, 95% CI -1.24 to -0.59 L; P < 0.00001). The maximum average serum sodium ranged between 138.5 and 159 in HS groups compared to between 136 and 143 meq/L in the IS groups. The maximum serum sodium was significantly higher in HS participants (MD 7.73, 95% CI 5.84 to 9.62; P < 0.00001), although the level remained within normal limits (136 to 146 meq/L).\nA high degree of heterogeneity appeared to be related to considerable differences in the dose of HS between studies. The quality of the evidence for the outcomes reported ranged from high to very low. The risk of bias for many of the studies could not be determined for performance and detection bias, criteria that we assess as likely to impact the study outcomes.\nAuthors' conclusions\nHS reduces the volume of intravenous fluid required to maintain people undergoing surgery but transiently increases serum sodium. It is not known if HS affects survival and morbidity, but this should be examined in randomized controlled trials that are designed and powered to test these outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 18 trials that compared HS to IS in people undergoing surgery. The trials included 1087 participants. Five hundred and forty-five (545) participants received HS and 542 received IS during their operations. The participants were randomly assigned to their groups. The studies took place in 11 countries. Study participants were over the age of 18. All studies excluded people with serious health risks from participating. All studies monitored fluid levels during the operation and up to three days after."
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query-laysum | 4391 | [
{
"role": "user",
"content": "Abstract: Background\nOutcome after acute spontaneous (non-traumatic) intracerebral haemorrhage (ICH) is influenced by haematoma volume. ICH expansion occurs in about 20% of people with acute ICH. Early haemostatic therapy might improve outcome by limiting ICH expansion. This is an update of a Cochrane Review first published in 2006, and last updated in 2018.\nObjectives\nTo examine 1. the effects of individual classes of haemostatic therapies, compared with placebo or open control, in adults with acute spontaneous ICH, and 2. the effects of each class of haemostatic therapy according to the use and type of antithrombotic drug before ICH onset.\nSearch methods\nWe searched the Cochrane Stroke Trials Register, CENTRAL (2022, Issue 8), MEDLINE Ovid, and Embase Ovid on 12 September 2022. To identify further published, ongoing, and unpublished randomised controlled trials (RCTs), we scanned bibliographies of relevant articles and searched international registers of RCTs in September 2022.\nSelection criteria\nWe included RCTs of any haemostatic intervention (i.e. procoagulant treatments such as clotting factor concentrates, antifibrinolytic drugs, platelet transfusion, or agents to reverse the action of antithrombotic drugs) for acute spontaneous ICH, compared with placebo, open control, or an active comparator.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was death/dependence (modified Rankin Scale (mRS) 4 to 6) by day 90. Secondary outcomes were ICH expansion on brain imaging after 24 hours, all serious adverse events, thromboembolic adverse events, death from any cause, quality of life, mood, cognitive function, Barthel Index score, and death or dependence measured on the Extended Glasgow Outcome Scale by day 90.\nMain results\nWe included 20 RCTs involving 4652 participants: nine RCTs of recombinant activated factor VII (rFVIIa) versus placebo/open control (1549 participants), eight RCTs of antifibrinolytic drugs versus placebo/open control (2866 participants), one RCT of platelet transfusion versus open control (190 participants), and two RCTs of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) (47 participants). Four (20%) RCTs were at low risk of bias in all criteria.\nFor rFVIIa versus placebo/open control for spontaneous ICH with or without surgery there was little to no difference in death/dependence by day 90 (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.05; 7 RCTs, 1454 participants; low-certainty evidence). We found little to no difference in ICH expansion between groups (RR 0.81, 95% CI 0.56 to 1.16; 4 RCTs, 220 participants; low-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 0.81, 95% CI 0.30 to 2.22; 2 RCTs, 87 participants; very low-certainty evidence; death from any cause: RR 0.78, 95% CI 0.56 to 1.08; 8 RCTs, 1544 participants; moderate-certainty evidence).\nFor antifibrinolytic drugs versus placebo/open control for spontaneous ICH, there was no difference in death/dependence by day 90 (RR 1.00, 95% CI 0.93 to 1.07; 5 RCTs, 2683 participants; high-certainty evidence). We found a slight reduction in ICH expansion with antifibrinolytic drugs for spontaneous ICH compared to placebo/open control (RR 0.86, 95% CI 0.76 to 0.96; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.02, 95% CI 0.75 to 1.39; 4 RCTs, 2599 participants; high-certainty evidence; death from any cause: RR 1.02, 95% CI 0.89 to 1.18; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in quality of life, mood, or cognitive function (quality of life: mean difference (MD) 0, 95% CI -0.03 to 0.03; 2 RCTs, 2349 participants; mood: MD 0.30, 95% CI -1.98 to 2.57; 2 RCTs, 2349 participants; cognitive function: MD -0.37, 95% CI -1.40 to 0.66; 1 RCTs, 2325 participants; all high-certainty evidence).\nPlatelet transfusion likely increases death/dependence by day 90 compared to open control for antiplatelet-associated ICH (RR 1.29, 95% CI 1.04 to 1.61; 1 RCT, 190 participants; moderate-certainty evidence). We found little to no difference in ICH expansion between groups (RR 1.32, 95% CI 0.91 to 1.92; 1 RCT, 153 participants; moderate-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.46, 95% CI 0.98 to 2.16; 1 RCT, 190 participants; death from any cause: RR 1.42, 95% CI 0.88 to 2.28; 1 RCT, 190 participants; both moderate-certainty evidence).\nFor PCC versus FFP for anticoagulant-associated ICH, the evidence was very uncertain about the effect on death/dependence by day 90, ICH expansion, all serious adverse events, and death from any cause between groups (death/dependence by day 90: RR 1.21, 95% CI 0.76 to 1.90; 1 RCT, 37 participants; ICH expansion: RR 0.54, 95% CI 0.23 to 1.22; 1 RCT, 36 participants; all serious adverse events: RR 0.27, 95% CI 0.02 to 3.74; 1 RCT, 5 participants; death from any cause: RR 0.49, 95% CI 0.16 to 1.56; 2 RCTs, 42 participants; all very low-certainty evidence).\nAuthors' conclusions\nIn this updated Cochrane Review including 20 RCTs involving 4652 participants, rFVIIa likely results in little to no difference in reducing death or dependence after spontaneous ICH with or without surgery; antifibrinolytic drugs result in little to no difference in reducing death or dependence after spontaneous ICH, but result in a slight reduction in ICH expansion within 24 hours; platelet transfusion likely increases death or dependence after antiplatelet-associated ICH; and the evidence is very uncertain about the effect of PCC compared to FFP on death or dependence after anticoagulant-associated ICH. Thirteen RCTs are ongoing and are likely to increase the certainty of the estimates of treatment effect.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review updates our previous review in 2018. The evidence is up to date to September 2022."
}
]
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query-laysum | 4392 | [
{
"role": "user",
"content": "Abstract: Background\nDespite conflicting evidence, chest physiotherapy has been widely used as an adjunctive treatment for adults with pneumonia. This is an update of a review first published in 2010 and updated in 2013.\nObjectives\nTo assess the effectiveness and safety of chest physiotherapy for pneumonia in adults.\nSearch methods\nWe updated our searches in the following databases to May 2022: the Cochrane Central Register of Controlled Trials (CENTRAL) via OvidSP, MEDLINE via OvidSP (from 1966), Embase via embase.com (from 1974), Physiotherapy Evidence Database (PEDro) (from 1929), CINAHL via EBSCO (from 2009), and the Chinese Biomedical Literature Database (CBM) (from 1978).\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs assessing the efficacy of chest physiotherapy for treating pneumonia in adults.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included two new trials in this update (540 participants), for a total of eight RCTs (974 participants). Four RCTs were conducted in the United States, two in Sweden, one in China, and one in the United Kingdom. The studies looked at five types of chest physiotherapy: conventional chest physiotherapy; osteopathic manipulative treatment (OMT, which includes paraspinal inhibition, rib raising, and myofascial release); active cycle of breathing techniques (which includes active breathing control, thoracic expansion exercises, and forced expiration techniques); positive expiratory pressure; and high-frequency chest wall oscillation.\nWe assessed four trials as at unclear risk of bias and four trials as at high risk of bias.\nConventional chest physiotherapy (versus no physiotherapy) may have little to no effect on improving mortality, but the certainty of evidence is very low (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.15 to 7.13; 2 trials, 225 participants; I² = 0%). OMT (versus placebo) may have little to no effect on improving mortality, but the certainty of evidence is very low (RR 0.43, 95% CI 0.12 to 1.50; 3 trials, 327 participants; I² = 0%). Similarly, high-frequency chest wall oscillation (versus no physiotherapy) may also have little to no effect on improving mortality, but the certainty of evidence is very low (RR 0.75, 95% CI 0.17 to 3.29; 1 trial, 286 participants).\nConventional chest physiotherapy (versus no physiotherapy) may have little to no effect on improving cure rate, but the certainty of evidence is very low (RR 0.93, 95% CI 0.56 to 1.55; 2 trials, 225 participants; I² = 85%). Active cycle of breathing techniques (versus no physiotherapy) may have little to no effect on improving cure rate, but the certainty of evidence is very low (RR 0.60, 95% CI 0.29 to 1.23; 1 trial, 32 participants). OMT (versus placebo) may improve cure rate, but the certainty of evidence is very low (RR 1.59, 95% CI 1.01 to 2.51; 2 trials, 79 participants; I² = 0%).\nOMT (versus placebo) may have little to no effect on mean duration of hospital stay, but the certainty of evidence is very low (mean difference (MD) −1.08 days, 95% CI −2.39 to 0.23; 3 trials, 333 participants; I² = 50%). Conventional chest physiotherapy (versus no physiotherapy, MD 0.7 days, 95% CI −1.39 to 2.79; 1 trial, 54 participants) and active cycle of breathing techniques (versus no physiotherapy, MD 1.4 days, 95% CI −0.69 to 3.49; 1 trial, 32 participants) may also have little to no effect on duration of hospital stay, but the certainty of evidence is very low. Positive expiratory pressure (versus no physiotherapy) may reduce the mean duration of hospital stay by 1.4 days, but the certainty of evidence is very low (MD −1.4 days, 95% CI −2.77 to −0.03; 1 trial, 98 participants).\nPositive expiratory pressure (versus no physiotherapy) may reduce the duration of fever by 0.7 days, but the certainty of evidence is very low (MD −0.7 days, 95% CI −1.36 to −0.04; 1 trial, 98 participants). Conventional chest physiotherapy (versus no physiotherapy, MD 0.4 days, 95% CI −1.01 to 1.81; 1 trial, 54 participants) and OMT (versus placebo, MD 0.6 days, 95% CI −1.60 to 2.80; 1 trial, 21 participants) may have little to no effect on duration of fever, but the certainty of evidence is very low.\nOMT (versus placebo) may have little to no effect on the mean duration of total antibiotic therapy, but the certainty of evidence is very low (MD −1.07 days, 95% CI −2.37 to 0.23; 3 trials, 333 participants; I² = 61%). Active cycle of breathing techniques (versus no physiotherapy) may have little to no effect on duration of total antibiotic therapy, but the certainty of evidence is very low (MD 0.2 days, 95% CI −4.39 to 4.69; 1 trial, 32 participants).\nHigh-frequency chest wall oscillation plus fibrobronchoscope alveolar lavage (versus fibrobronchoscope alveolar lavage alone) may reduce the MD of intensive care unit (ICU) stay by 3.8 days (MD −3.8 days, 95% CI −5.00 to −2.60; 1 trial, 286 participants) and the MD of mechanical ventilation by three days (MD −3 days, 95% CI −3.68 to −2.32; 1 trial, 286 participants), but the certainty of evidence is very low.\nOne trial reported transient muscle tenderness emerging after OMT in two participants. In another trial, three serious adverse events led to early withdrawal after OMT. One trial reported no adverse events after positive expiratory pressure treatment.\nLimitations of this review were the small sample size and unclear or high risk of bias of the included trials.\nAuthors' conclusions\nThe inclusion of two new trials in this update did not change the main conclusions of the original review. The current evidence is very uncertain about the effect of chest physiotherapy on improving mortality and cure rate in adults with pneumonia. Some physiotherapies may slightly shorten hospital stays, fever duration, and ICU stays, as well as mechanical ventilation. However, all of these findings are based on very low certainty evidence and need to be further validated.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "1. Death\nConventional chest physiotherapy, OMT, and high-frequency chest wall oscillation (versus no physiotherapy or placebo therapy) may have little to no effect on reducing death, but the certainty of evidence is very low.\n2. Cure rate\nOMT (versus placebo therapy) may improve cure rate as defined by the study authors, but the certainty of evidence is very low. Conventional chest physiotherapy (versus no physiotherapy) and active cycle of breathing techniques may have little to no effect on improving cure rate, but the certainty of evidence is very low.\n3. Duration of hospital stay\nPositive expiratory pressure (versus no physiotherapy) may reduce the duration of hospital stay by 1.4 days, but the certainty of evidence is very low. OMT, conventional chest physiotherapy, and active cycle of breathing techniques (versus placebo therapy or no physiotherapy) may have little to no effect on duration of hospital stay, but the certainty of evidence is very low.\n4. Duration of fever\nPositive expiratory pressure (versus no physiotherapy) may reduce the duration of fever by 0.7 days, but the certainty of evidence is very low. Conventional chest physiotherapy (versus no physiotherapy) or OMT (versus placebo therapy) may have little to no effect on duration of fever, but the certainty of evidence is very low.\n5. Duration of antibiotic use\nOMT (versus placebo therapy) and active cycle of breathing techniques (versus no physiotherapy) may have little to no effect on the duration of antibiotic use, but the certainty of evidence is very low.\n6. Duration of intensive care unit (ICU) stay\nHigh-frequency chest wall oscillation (versus no physiotherapy) may reduce the duration of ICU stay by 3.8 days in people with severe pneumonia who received mechanical ventilation (use of a machine to help people breathe), but the certainty of evidence is very low.\n7. Duration of mechanical ventilation\nHigh-frequency chest wall oscillation (versus no physiotherapy) may reduce the duration of mechanism ventilation by three days in people with severe pneumonia who received mechanical ventilation, but the certainty of evidence is very low.\n8. Adverse events (unwanted events that cause harm to the patient)\nOne study reported three serious adverse events (not specified) that caused early withdrawal of participants after OMT. One study reported adverse events as short-term muscle tenderness after treatment in two participants. Another study reported no adverse events."
}
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query-laysum | 4393 | [
{
"role": "user",
"content": "Abstract: Background\nPilonidal sinus disease is a common condition that mainly affects young adults. This condition can cause significant pain and impairment of normal activities. No consensus currently exists on the optimum treatment for pilonidal sinus and current therapies have various advantages and disadvantages. Fibrin glue has emerged as a potential treatment as both monotherapy and an adjunct to surgery.\nObjectives\nTo assess the effects of fibrin glue alone or in combination with surgery compared with surgery alone in the treatment of pilonidal sinus disease.\nSearch methods\nIn December 2016 we searched: the Cochrane Wounds Specialised Register; CENTRAL; MEDLINE; Embase and CINAHL Plus. We also searched clinical trials registries and conference proceedings for ongoing and unpublished studies and scanned reference lists to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) only. We included studies involving participants of all ages and studies conducted in any setting. We considered studies involving people with both new and recurrent pilonidal sinus. We included studies which evaluated fibrin glue monotherapy or as an adjunct to surgery.\nData collection and analysis\nTwo study authors independently extracted data and assessed risk of bias. We used standard methods expected by Cochrane.\nMain results\nWe included four RCTs with 253 participants, all were at risk of bias. One unpublished study evaluated fibrin glue monotherapy compared with Bascom's procedure, two studies evaluated fibrin glue as an adjunct to Limberg flap and one study evaluated fibrin glue as an adjunct to Karydakis flap.\nFor fibrin glue monotherapy compared with Bascom's procedure, there were no data available for the primary outcomes of time to healing and adverse events. There was low-quality evidence of less pain on day one after the procedure with fibrin glue monotherapy compared with Bascom's procedure (mean difference (MD) -2.50, 95% confidence interval (CI) -4.03 to -0.97) (evidence downgraded twice for risk of performance and detection bias). Fibrin glue may reduce the time taken to return to normal activities compared with Bascom's procedure (mean time 42 days with surgery and 7 days with glue, MD -34.80 days, 95% CI -66.82 days to -2.78 days) (very low-quality evidence, downgraded as above and for imprecision).\nFibrin glue as an adjunct to the Limberg flap may reduce the healing time from 22 to 8 days compared with the Limberg flap alone (MD -13.95 days, 95% CI -16.76 days to -11.14 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). It is uncertain whether use of fibrin glue affects the incidence of postoperative seroma (an adverse event) (risk ratio (RR) 0.27, 95% CI 0.05 to 1.61; very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). There was low-quality evidence that fibrin glue, as an adjunct to Limberg flap, may reduce postoperative pain (median 2 versus 4; P < 0.001) and time to return to normal activities (median 8 days versus 17 days; P < 0.001). The addition of fibrin glue to the Limberg flap may reduce the length of hospital stay (MD -1.69 days, 95% CI -2.08 days to -1.29 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for unexplained heterogeneity).\nA single RCT evaluating fibrin glue as an adjunct to the Karydakis flap did not report data for the primary outcome of time to healing. It is uncertain whether fibrin glue with the Karydakis flap affects the incidence of postoperative seroma (adverse event) (RR 3.00, 95% CI 0.67 to 13.46) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for imprecision). Fibrin glue as an adjunct to Karydakis flap may reduce length of stay but this is highly uncertain (mean 2 days versus 3.7 days; P < 0.001, low-quality evidence downgraded twice for risk of selection, performance and detection bias).\nAuthors' conclusions\nCurrent evidence is uncertain regarding any benefits associated with fibrin glue either as monotherapy or as an adjunct to surgery for people with pilonidal sinus disease. We identified only four RCTs and each was small and at risk of bias resulting in very low-quality evidence for the primary outcomes of time to healing and adverse events. Future studies should enrol many more participants, ensure adequate randomisation and blinding, whilst measuring clinically relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is not known whether fibrin glue on its own affects time to healing and adverse events compared with a type of surgery (Bascom's procedure). Fibrin glue may result in less pain on the first day after the procedure compared with Bascom's procedure.\nWhen fibrin glue is used alongside a type of surgery called the Limberg flap it may reduce the healing time by approximately 14 days compared with the surgery on its own, however this finding is highly uncertain as the evidence is very low-quality. It is uncertain whether using the fibrin glue alongside the Limberg flap affects the incidence of a complication called seroma (a collection of fluid) but it may reduce postoperative pain (this evidence is low-quality and therefore quite uncertain) and may reduce time to return to normal activities (low-quality evidence) and length of hospital stay (this was very low-quality evidence and therefore very uncertain).\nOne study evaluated the effect of adding fibrin glue to a type of surgery called the Karydakis flap. It is not clear from this study whether using the glue affects time to healing or the incidence of seroma. Using the fibrin glue with the Karydakis flap may reduce length of hospital stay compared with surgery alone but again this is low-quality evidence."
}
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query-laysum | 4394 | [
{
"role": "user",
"content": "Abstract: Background\nGroup A streptococcus (GAS) accounts for 20% to 40% of cases of pharyngitis in children; the remaining cases are caused by viruses. Compared with throat culture, rapid antigen detection tests (RADTs) offer diagnosis at the point of care (within five to 10 minutes).\nObjectives\nTo determine the diagnostic accuracy of RADTs for diagnosing GAS in children with pharyngitis. To assess the relative diagnostic accuracy of the two major types of RADTs (enzyme immunoassays (EIA) and optical immunoassays (OIA)) by indirect and direct comparison.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, Web of Science, CDSR, DARE, MEDION and TRIP (January 1980 to July 2015). We also conducted related citations tracking via PubMed, handsearched reference lists of included studies and relevant review articles, and screened all articles citing included studies via Google Scholar.\nSelection criteria\nWe included studies that compared RADT for GAS pharyngitis with throat culture on a blood agar plate in a microbiology laboratory in children seen in ambulatory care.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance, assessed full texts for inclusion, and carried out data extraction and quality assessment using the QUADAS-2 tool. We used bivariate meta-analysis to estimate summary sensitivity and specificity, and to investigate heterogeneity across studies. We compared the accuracy of EIA and OIA tests using indirect and direct evidence.\nMain results\nWe included 98 unique studies in the review (116 test evaluations; 101,121 participants). The overall methodological quality of included studies was poor, mainly because many studies were at high risk of bias regarding patient selection and the reference standard used (in 73% and 43% of test evaluations, respectively). In studies in which all participants underwent both RADT and throat culture (105 test evaluations; 58,244 participants; median prevalence of participants with GAS was 29.5%), RADT had a summary sensitivity of 85.6%; 95% confidence interval (CI) 83.3 to 87.6 and a summary specificity of 95.4%; 95% CI 94.5 to 96.2. There was substantial heterogeneity in sensitivity across studies; specificity was more stable. There was no evidence of a trade-off between sensitivity and specificity. Heterogeneity in accuracy was not explained by study-level characteristics such as whether an enrichment broth was used before plating, mean age and clinical severity of participants, and GAS prevalence. The sensitivity of EIA and OIA tests was comparable (summary sensitivity 85.4% versus 86.2%). Sensitivity analyses showed that summary estimates of sensitivity and specificity were stable in low risk of bias studies.\nAuthors' conclusions\nIn a population of 1000 children with a GAS prevalence of 30%, 43 patients with GAS will be missed. Whether or not RADT can be used as a stand-alone test to rule out GAS will depend mainly on the epidemiological context. The sensitivity of EIA and OIA tests seems comparable. RADT specificity is sufficiently high to ensure against unnecessary use of antibiotics. Based on these results, we would expect that amongst 100 children with strep throat, 86 would be correctly detected with the rapid test while 14 would be missed and not receive antibiotic treatment.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Important study design features were frequently not reported. The overall methodological quality of included studies was poor. For most studies, we had concerns about the ways in which participants were selected."
}
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query-laysum | 4395 | [
{
"role": "user",
"content": "Abstract: Background\nGeneral anaesthesia is usually associated with unconsciousness. 'Awareness' is when patients have postoperative recall of events or experiences during surgery. 'Wakefulness' is when patients become conscious during surgery, but have no postoperative recollection of the period of consciousness.\nObjectives\nTo evaluate the efficacy of two types of anaesthetic interventions in reducing clinically significant awareness:\n- anaesthetic drug regimens; and\n- intraoperative anaesthetic depth monitors.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, ISSUE 4 2016); PubMed from 1950 to April 2016; MEDLINE from 1950 to April 2016; and Embase from 1980 to April 2016. We contacted experts to identify additional studies. We performed a handsearch of the citations in the review. We did not search trial registries.\nSelection criteria\nWe included randomized controlled trials (RCTs) of either anaesthetic regimens or anaesthetic depth monitors. We excluded volunteer studies, studies of patients prior to skin incision, intensive care unit studies, and studies that only randomized different word presentations for memory tests (not anaesthetic interventions).\nAnaesthetic drug regimens included studies of induction or maintenance, or both. Anaesthetic depth monitors included the Bispectral Index monitor, M-Entropy, Narcotrend monitor, cerebral function monitor, cerebral state monitor, patient state index, and lower oesophageal contractility monitor. The use of anaesthetic depth monitors allows the titration of anaesthetic drugs to maintain unconsciousness.\nData collection and analysis\nAt least two authors independently scanned abstracts, extracted data from the studies, and evaluated studies for risk of bias. We made attempts to contact all authors for additional clarification. We performed meta-analysis statistics in packages of the R language.\nMain results\nWe included 160 studies with 54,109 enrolled participants; 53,713 participants started the studies and 50,034 completed the studies or data analysis (or both). We could not use 115 RCTs in meta-analytic comparisons because they had zero awareness events. We did not merge 27 of the remaining 45 studies because they had excessive clinical and methodological heterogeneity. We pooled the remaining 18 eligible RCTs in meta-analysis. There are 10 studies awaiting classification which we will process when we update the review.\nThe meta-analyses included 18 trials with 36,034 participants. In the analysis of anaesthetic depth monitoring (either Bispectral Index or M-entropy) versus standard clinical and electronic monitoring, there were nine trials with 34,744 participants. The overall event rate was 0.5%. The effect favoured neither anaesthetic depth monitoring nor standard clinical and electronic monitoring, with little precision in the odds ratio (OR) estimate (OR 0.98, 95% confidence interval (CI) 0.59 to 1.62).\nIn a five-study subset of Bispectral Index monitoring versus standard clinical and electronic monitoring, with 34,181 participants, 503 participants gave awareness reports to a blinded, expert panel who adjudicated or judged the outcome for each patient after reviewing the questionnaires: no awareness, possible awareness, or definite awareness. Experts judged 351 patient awareness reports to have no awareness, 87 to have possible awareness, and 65 to have definite awareness. The effect size favoured neither Bispectral Index monitoring nor standard clinical and electronic monitoring, with little precision in the OR estimate for the combination of definite and possible awareness (OR 0.96, 95% CI 0.35 to 2.65). The effect size favoured Bispectral Index monitoring for definite awareness, but with little precision in the OR estimate (OR 0.60, 95% CI 0.13 to 2.75).\nWe performed three smaller meta-analyses of anaesthetic drugs. There were nine studies with 1290 participants. Wakefulness was reduced by ketamine and etomidate compared to thiopental. Wakefulness was more frequent than awareness. Benzodiazepines reduces awareness compared to thiopental, ketamine, and placebo., Also, higher doses of inhaled anaesthetics versus lower doses reduced the risk of awareness.\nWe graded the quality of the evidence as low or very low in the 'Summary of findings' tables for the five comparisons.\nMost of the secondary outcomes in this review were not reported in the included RCTs.\nAuthors' conclusions\nAnaesthetic depth monitors may have similar effects to standard clinical and electrical monitoring on the risk of awareness during surgery. In older studies comparing anaesthetics in a smaller portion of the patient sample, wakefulness occurred more frequently than awareness. Use of etomidate and ketamine lowered the risk of wakefulness compared to thiopental. Benzodiazepines compared to thiopental and ketamine, or higher doses of inhaled anaesthetics versus lower doses, reduced the risk of awareness.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to April 2016."
}
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query-laysum | 4396 | [
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory infections (ARIs) last for less than 30 days and are the most common acute diseases affecting people. Exercise has been shown to improve health generally, but it is uncertain whether exercise may be effective in reducing the occurrence, severity, and duration of ARIs. This is an update of our review published in 2015.\nObjectives\nTo evaluate the effectiveness of exercise for altering the occurrence, severity, or duration of acute respiratory infections.\nSearch methods\nWe searched CENTRAL (2020, Issue 2), MEDLINE (1948 to March week 1, 2020), Embase (1974 to 05 March 2020), CINAHL (1981 to 05 March 2020), LILACS (1982 to 05 March 2020), SPORTDiscus (1985 to 05 March 2020), PEDro (searched 05 March 2020), OTseeker (searched 05 March 2020), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (searched 05 March 2020).\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs (method of allocation that is not truly random, e.g. based on date of birth, medical record number) of exercise for ARIs in the general population.\nData collection and analysis\nTwo review authors independently extracted data from the included trials using a standard form. One review author entered data, which a second review author checked. We contacted trial authors to request missing data. There were sufficient differences in the populations trialed and in the nature of the interventions to use the random-effects model (which makes fewer assumptions than the fixed-effect model) in the analysis.\nMain results\nWe included three new trials for this update (473 participants) for a total of 14 trials involving 1377 adults, published between 1990 and 2018. Nine trials were conducted in the USA, and one each in Brazil, Canada, Portugal, Spain, and Turkey.\nSample sizes ranged from 16 to 419 participants, aged from 18 to 85 years. The proportion of female participants ranged from 52% to 100%. Follow-up duration ranged from 1 to 36 weeks (median = 12 weeks).\nModerate-intensity aerobic exercise (walking, bicycling, treadmill, or a combination) was evaluated in 11 trials, and was most commonly prescribed at least three times a week for 30 to 45 minutes.\nThere was no difference between exercise and no exercise in the number of ARI episodes per person per year (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.77 to 1.30; 4 trials; 514 participants; low-certainty evidence); proportion of participants who experienced at least one ARI over the study period (RR 0.88, 95% CI 0.72 to 1.08; 5 trials; 520 participants; low-certainty evidence); and the number of symptom days per episode of illness (mean difference (MD) −0.44 day, 95% CI −2.33 to 1.46; 6 trials; 557 participants; low-certainty evidence). Exercise reduced the severity of ARI symptoms measured on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) (MD −103.57, 95% CI −198.28 to −8.87; 2 trials; 373 participants; moderate-certainty evidence) and the number of symptom days during follow-up period (MD −2.24 days, 95% CI −3.50 to −0.98; 4 trials; 483 participants; low-certainty evidence).\nExcercise did not have a significant effect on laboratory parameters (blood lymphocytes, salivary secretory immunoglobulin, and neutrophils), quality of life outcomes, cost-effectiveness, and exercise-related injuries. There was no difference in participant dropout between the intervention and control groups.\nOverall, the certainty of the evidence was low, downgraded mainly due to limitations in study design and implementation, imprecision, and inconsistency.\nSeven trials were funded by public agencies; five trials did not report funding; and two trials were funded by private companies.\nAuthors' conclusions\nExercise did not reduce the number of ARI episodes, proportion of participants experiencing at least one ARI during the study, or the number of symptom days per episode of illness. However, exercise reduced the severity of ARI symptoms (two studies) and the number of symptom days during the study follow-up period (four studies). Small study size, risk of bias, and heterogeneity in the populations studied contributed to the uncertainty of the findings. Larger trials that are designed to avoid risk of bias associated with participant selection, blinding of outcomes assessors, and with adequate reporting of all outcomes proposed for measurement in trials, would help to provide more robust evidence.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is unclear whether exercise changed the number of acute respiratory infections a person experiences each year; the number of people who experienced at least one acute respiratory infection during the study period; or the number of days with symptoms during each episode of illness. Exercise reduced symptom severity and the number of days symptoms lasted whilst participants were enrolled in the trial. We are uncertain whether exercise has an important effect on other outcomes, such as effects measured by laboratory tests (blood and salivary samples), quality of life, cost-effectiveness, or injuries related to exercise."
}
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query-laysum | 4397 | [
{
"role": "user",
"content": "Abstract: Background\nLung cancer is the most common cause of cancer-related death in the world, however lung cancer screening has not been implemented in most countries at a population level. A previous Cochrane Review found limited evidence for the effectiveness of lung cancer screening with chest radiography (CXR) or sputum cytology in reducing lung cancer-related mortality, however there has been increasing evidence supporting screening with low-dose computed tomography (LDCT).\nObjectives\nTo determine whether screening for lung cancer using LDCT of the chest reduces lung cancer-related mortality and to evaluate the possible harms of LDCT screening.\nSearch methods\nWe performed the search in collaboration with the Information Specialist of the Cochrane Lung Cancer Group and included the Cochrane Lung Cancer Group Trial Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library, current issue), MEDLINE (accessed via PubMed) and Embase in our search. We also searched the clinical trial registries to identify unpublished and ongoing trials. We did not impose any restriction on language of publication. The search was performed up to 31 July 2021.\nSelection criteria\nRandomised controlled trials (RCTs) of lung cancer screening using LDCT and reporting mortality or harm outcomes.\nData collection and analysis\nTwo review authors were involved in independently assessing trials for eligibility, extraction of trial data and characteristics, and assessing risk of bias of the included trials using the Cochrane RoB 1 tool. We assessed the certainty of evidence using GRADE. Primary outcomes were lung cancer-related mortality and harms of screening. We performed a meta-analysis, where appropriate, for all outcomes using a random-effects model. We only included trials in the analysis of mortality outcomes if they had at least 5 years of follow-up. We reported risk ratios (RRs) and hazard ratios (HRs), with 95% confidence intervals (CIs) and used the I2 statistic to investigate heterogeneity.\nMain results\nWe included 11 trials in this review with a total of 94,445 participants. Trials were conducted in Europe and the USA in people aged 40 years or older, with most trials having an entry requirement of ≥ 20 pack-year smoking history (e.g. 1 pack of cigarettes/day for 20 years or 2 packs/day for 10 years etc.). One trial included male participants only. Eight trials were phase three RCTs, with two feasibility RCTs and one pilot RCT. Seven of the included trials had no screening as a comparison, and four trials had CXR screening as a comparator. Screening frequency included annual, biennial and incrementing intervals. The duration of screening ranged from 1 year to 10 years. Mortality follow-up was from 5 years to approximately 12 years.\nNone of the included trials were at low risk of bias across all domains. The certainty of evidence was moderate to low across different outcomes, as assessed by GRADE.\nIn the meta-analysis of trials assessing lung cancer-related mortality, we included eight trials (91,122 participants), and there was a reduction in mortality of 21% with LDCT screening compared to control groups of no screening or CXR screening (RR 0.79, 95% CI 0.72 to 0.87; 8 trials, 91,122 participants; moderate-certainty evidence). There were probably no differences in subgroups for analyses by control type, sex, geographical region, and nodule management algorithm. Females appeared to have a larger lung cancer-related mortality benefit compared to males with LDCT screening. There was also a reduction in all-cause mortality (including lung cancer-related) of 5% (RR 0.95, 95% CI 0.91 to 0.99; 8 trials, 91,107 participants; moderate-certainty evidence).\nInvasive tests occurred more frequently in the LDCT group (RR 2.60, 95% CI 2.41 to 2.80; 3 trials, 60,003 participants; moderate-certainty evidence). However, analysis of 60-day postoperative mortality was not significant between groups (RR 0.68, 95% CI 0.24 to 1.94; 2 trials, 409 participants; moderate-certainty evidence).\nFalse-positive results and recall rates were higher with LDCT screening compared to screening with CXR, however there was low-certainty evidence in the meta-analyses due to heterogeneity and risk of bias concerns. Estimated overdiagnosis with LDCT screening was 18%, however the 95% CI was 0 to 36% (risk difference (RD) 0.18, 95% CI -0.00 to 0.36; 5 trials, 28,656 participants; low-certainty evidence).\nFour trials compared different aspects of health-related quality of life (HRQoL) using various measures. Anxiety was pooled from three trials, with participants in LDCT screening reporting lower anxiety scores than in the control group (standardised mean difference (SMD) -0.43, 95% CI -0.59 to -0.27; 3 trials, 8153 participants; low-certainty evidence).\nThere were insufficient data to comment on the impact of LDCT screening on smoking behaviour.\nAuthors' conclusions\nThe current evidence supports a reduction in lung cancer-related mortality with the use of LDCT for lung cancer screening in high-risk populations (those over the age of 40 with a significant smoking exposure). However, there are limited data on harms and further trials are required to determine participant selection and optimal frequency and duration of screening, with potential for significant overdiagnosis of lung cancer. Trials are ongoing for lung cancer screening in non-smokers.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eight of the trials (91,122 participants) were included in the main outcome analysis of lung cancer-related mortality. In people over 40 years with significant smoking exposure, CT screening reduced deaths from lung cancer by 21%, with 226 people needing to undergo screening to prevent one death from lung cancer. We also found that deaths from any cause (including lung cancer) were less with CT screening. However, the effect was much lower (only 5% reduction in risk). Lung cancer was detected more frequently in the group of people who had CT screening compared with no screening. However, CT scans can induce false-positive scans (a test that is positive or indeterminate for lung cancer, when the person does not actually have lung cancer). We found that false-positive results were more common among people who were screened with CT than chest x-ray. Because of that, those that underwent CT screening had more tests to investigate both cancer and non-cancer-related diseases. Screening also implies a risk of detecting lung cancers that may have never progressed to cause harm to the person (this is referred to as overdiagnosis). The risk of lung cancer overdiagnosis with CT screening was estimated to be 18%.\nThe trials were too different or did not provide enough information to look at the impact of screening on stopping smoking or quality of life. There was some evidence to suggest there were no long-term psychological harms from screening, with some people in the CT screening group feeling less anxious compared to the control groups who were not offered screening."
}
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query-laysum | 4398 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review, published in 2016, Issue 7.\nSudden Unexpected Death in Epilepsy (SUDEP) is defined as sudden, unexpected, witnessed or unwitnessed, non-traumatic or non-drowning death of people with epilepsy, with or without evidence of a seizure, excluding documented status epilepticus and in whom postmortem examination does not reveal a structural or toxicological cause for death. SUDEP has a reported incidence of 1 to 2 per 1000 patient-years and represents the most common epilepsy-related cause of death. The presence and frequency of generalised tonic-clonic seizures (GTCS), male sex, early age of seizure onset, duration of epilepsy, and polytherapy are all predictors of risk of SUDEP. The exact pathophysiology of SUDEP is currently unknown, although GTCS-induced cardiac, respiratory, and brainstem dysfunction appears likely. Appropriately chosen antiepileptic drug treatment can render around 70% of patients free of all seizures. However, around one-third will remain drug-resistant despite polytherapy. Continuing seizures place patients at risk of SUDEP, depression, and reduced quality of life. Preventative strategies for SUDEP include reducing the occurrence of GTCS by timely referral for presurgical evaluation in people with lesional epilepsy and advice on lifestyle measures; detecting cardiorespiratory distress through clinical observation and seizure, respiratory, and heart rate monitoring devices; preventing airway obstruction through nocturnal supervision and safety pillows; reducing central hypoventilation through physical stimulation and enhancing serotonergic mechanisms of respiratory regulation using selective serotonin reuptake inhibitors (SSRIs); and reducing adenosine and endogenous opioid-induced brain and brainstem depression.\nObjectives\nTo assess the effectiveness of interventions in preventing SUDEP in people with epilepsy by synthesising evidence from randomised controlled trials of interventions and cohort and case-control non-randomised studies.\nSearch methods\nFor the latest update we searched the following databases without language restrictions: Cochrane Register of Studies (CRS Web, 4 February 2019); MEDLINE (Ovid, 1946 to 1 February 2019); SCOPUS (1823 to 4 February 2019); PsycINFO (EBSCOhost, 1887 to 4 January 2019); CINAHL Plus (EBSCOhost, 1937 to 4 February 2019); ClinicalTrials.gov (5 February 2019); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP, 5 February 2019). We checked the reference lists of retrieved studies for additional reports of relevant studies and contacted lead study authors for any relevant unpublished material. We identified any grey literature studies published in the last five years by searching: Zetoc database; ISI Proceedings; International Bureau for Epilepsy (IBE) congress proceedings database; International League Against Epilepsy (ILAE) congress proceedings database; abstract books of symposia and congresses, meeting abstracts, and research reports.\nSelection criteria\nWe aimed to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs; prospective non-randomised cohort controlled and uncontrolled studies; and case-control studies of adults and children with epilepsy receiving an intervention for the prevention of SUDEP. Types of interventions included: early versus delayed pre-surgical evaluation for lesional epilepsy; educational programmes; seizure-monitoring devices; safety pillows; nocturnal supervision; selective serotonin reuptake inhibitors (SSRIs); opiate antagonists; and adenosine antagonists.\nData collection and analysis\nWe aimed to collect data on study design factors and participant demographics for included studies. The primary outcome of interest was the number of deaths from SUDEP. Secondary outcomes included: number of other deaths (unrelated to SUDEP); change in mean depression and anxiety scores (as defined within the study); clinically important change in quality of life, that is any change in quality of life score (average and endpoint) according to validated quality of life scales; and number of hospital attendances for seizures.\nMain results\nWe identified 1277 records from the databases and search strategies. We found 10 further records by searching other resources (handsearching). We removed 469 duplicate records and screened 818 records (title and abstract) for inclusion in the review. We excluded 785 records based on the title and abstract and assessed 33 full-text articles. We excluded 29 studies: eight studies did not assess interventions to prevent SUDEP; eight studies were review articles, not clinical studies; five studies measured sensitivity of devices to detect GTCS but did not directly measure SUDEP; six studies assessed risk factors for SUDEP but not interventions for preventing SUDEP; and two studies did not have a control group.\nWe included one cohort study and three case-control studies of serious to critical risk of bias. The 6-month prospective cohort study observed no significant effect of providing patients with SUDEP information on drug compliance and quality of life, anxiety and depression levels. The study was too short and with no deaths observed in either group to determine a protective effect. Two case control studies reported a protective effect for nocturnal supervision against SUDEP. However due to significant heterogeneity, the results could not be combined in meta-analysis. One study of 154 SUDEP cases and 616 controls reported an unadjusted odds ratio (OR) of 0.34 (95% CI 0.22 to 0.53; P < 0.0001). The same study demonstrated the protective effect was independent of seizure control, suggesting that nocturnal supervision is not just a surrogate marker of seizure control. The second case-control study of 48 SUDEP cases and 220 controls reported an unadjusted OR of 0.08 (95% CI 0.02 to 0.27; P < 0.0001). The third case-control study of residential care centre patients who were already receiving physical checks more than 15 minutes apart throughout the night did not report any protective effect for additional nocturnal supervision (physical checks < 15 minutes apart; use of listening devices; dormitory setting; and use of bed sensors). However the same study did ascertain a difference between centres: the residential centre with the lowest level of supervision had the highest incidence of SUDEP. The case-control studies did not report on quality of life or depression and anxiety scores.\nAuthors' conclusions\nWe found limited, very low-certainty evidence that supervision at night reduces the incidence of SUDEP. Further research is required to identify the effectiveness of other current interventions — for example seizure detection devices, safety pillows, SSRIs, early surgical evaluation, educational programmes, and opiate and adenosine antagonists — in preventing SUDEP in people with epilepsy.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To examine the effectiveness of treatments designed to prevent SUDEP."
}
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query-laysum | 4399 | [
{
"role": "user",
"content": "Abstract: Background\nFor people with cystic fibrosis and advanced pulmonary damage, lung transplantation is an available and viable option. However, graft rejection is an important potential consequence after lung transplantation. Immunosuppressive therapy is needed to prevent episodes of graft rejection and thus subsequently reduce morbidity and mortality in this population. There are a number of classes of immunosuppressive drugs which act on different components of the immune system. There is considerable variability in the use of immunosuppressive agents after lung transplantation in cystic fibrosis. While much of the research in immunosuppressive drug therapy has focused on the general population of lung transplant recipients, little is known about the comparative effectiveness and safety of these agents in people with cystic fibrosis. This is the final update of a previously published review; no longer being updated due to a lack of research in the area.\nObjectives\nTo assess the effects of individual drugs or combinations of drugs compared to placebo or other individual drugs or combinations of drugs in preventing rejection following lung transplantation in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register and scanned references of the potentially eligible study. We also searched the www.clinicaltrials.gov registry and the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) to obtain information on unpublished and ongoing studies.\nDate of latest search: 29 May 2018.\nSelection criteria\nRandomised and quasi-randomised studies.\nData collection and analysis\nWe independently assessed the studies identified from our searches for inclusion in the review. If we had found eligible studies to include in the review, we planned to independently extract data and assess the risk of bias. We planned to use GRADE to summarize our results through a summary of findings table for each comparison we could present in the review.\nMain results\nWhile five studies addressed the interventions of interest, we did not include them in the review because the investigators of the studies did not report any information specific to people with cystic fibrosis. Our attempts to obtain this information have not yet been successful.\nAuthors' conclusions\nThe lack of currently available evidence makes it impossible to draw conclusions about the comparative efficacy and safety of the various immunosuppressive drugs among people with cystic fibrosis after lung transplantation. A 2013 Cochrane Review comparing tacrolimus with cyclosporine in all lung transplant recipients (not restricted to those with cystic fibrosis) reported no significant difference in mortality and risk of acute rejection. However, tacrolimus use was associated with lower risk of broncholitis obliterans syndrome and arterial hypertension and higher risk of diabetes mellitus. It should be noted that this wider review contained only a small number of included studies (n = 3) with a high risk of bias. Additional randomised studies are required to provide evidence for the benefit and safety of the use of immunosuppressive therapy among people with cystic fibrosis after lung transplantation.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed evidence to find out the effects of individual drugs or combinations of drugs when they are given to prevent donor lungs being rejected following transplantation in people with cystic fibrosis. We only considered randomised studies (where it is decided at random which drug volunteers are given) comparing individual drugs or combinations of drugs to a placebo (dummy treatment with no active medicine) or to each other."
}
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query-laysum | 4400 | [
{
"role": "user",
"content": "Abstract: Background\nScrub typhus, an important cause of acute fever in Asia, is caused by Orientia tsutsugamushi, an obligate intracellular bacterium. Antibiotics currently used to treat scrub typhus include tetracyclines, chloramphenicol, macrolides, and rifampicin.\nObjectives\nTo assess and compare the effects of different antibiotic regimens for treatment of scrub typhus.\nSearch methods\nWe searched the following databases up to 8 January 2018: the Cochrane Infectious Diseases Group specialized trials register; CENTRAL, in the Cochrane Library (2018, Issue 1); MEDLINE; Embase; LILACS; and the metaRegister of Controlled Trials (mRCT). We checked references and contacted study authors for additional data. We applied no language or date restrictions.\nSelection criteria\nRandomized controlled trials (RCTs) or quasi-RCTs comparing antibiotic regimens in people with the diagnosis of scrub typhus based on clinical symptoms and compatible laboratory tests (excluding the Weil-Felix test).\nData collection and analysis\nFor this update, two review authors re-extracted all data and assessed the certainty of evidence. We meta-analysed data to calculate risk ratios (RRs) for dichotomous outcomes when appropriate, and elsewhere tabulated data to facilitate narrative analysis.\nMain results\nWe included six RCTs and one quasi-RCT with 548 participants; they took place in the Asia-Pacific region: Korea (three trials), Malaysia (one trial), and Thailand (three trials). Only one trial included children younger than 15 years (N = 57). We judged five trials to be at high risk of performance and detection bias owing to inadequate blinding. Trials were heterogenous in terms of dosing of interventions and outcome measures. Across trials, treatment failure rates were low.\nTwo trials compared doxycycline to tetracycline. For treatment failure, the difference between doxycycline and tetracycline is uncertain (very low-certainty evidence). Doxycycline compared to tetracycline may make little or no difference in resolution of fever within 48 hours (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.90 to 1.44, 55 participants; one trial; low-certainty evidence) and in time to defervescence (116 participants; one trial; low-certainty evidence). We were unable to extract data for other outcomes.\nThree trials compared doxycycline versus macrolides. For most outcomes, including treatment failure, resolution of fever within 48 hours, time to defervescence, and serious adverse events, we are uncertain whether study results show a difference between doxycycline and macrolides (very low-certainty evidence). Macrolides compared to doxycycline may make little or no difference in the proportion of patients with resolution of fever within five days (RR 1.05, 95% CI 0.99 to 1.10; 185 participants; two trials; low-certainty evidence). Another trial compared azithromycin versus doxycycline or chloramphenicol in children, but we were not able to disaggregate date for the doxycycline/chloramphenicol group.\nOne trial compared doxycycline versus rifampicin. For all outcomes, we are uncertain whether study results show a difference between doxycycline and rifampicin (very low-certainty evidence). Of note, this trial deviated from the protocol after three out of eight patients who had received doxycycline and rifampicin combination therapy experienced treatment failure.\nAcross trials, mild gastrointestinal side effects appeared to be more common with doxycycline than with comparator drugs.\nAuthors' conclusions\nTetracycline, doxycycline, azithromycin, and rifampicin are effective treatment options for scrub typhus and have resulted in few treatment failures. Chloramphenicol also remains a treatment option, but we could not include this among direct comparisons in this review.\nMost available evidence is of low or very low certainty. For specific outcomes, some low-certainty evidence suggests there may be little or no difference between tetracycline, doxycycline, and azithromycin as treatment options. Given very low-certainty evidence for rifampicin and the risk of inducing resistance in undiagnosed tuberculosis, clinicians should not regard this as a first-line treatment option. Clinicians could consider rifampicin as a second-line treatment option after exclusion of active tuberculosis.\nFurther research should consist of additional adequately powered trials of doxycycline versus azithromycin or other macrolides, trials of other candidate antibiotics including rifampicin, and trials of treatments for severe scrub typhus. Researchers should standardize diagnostic techniques and reporting of clinical outcomes to allow robust comparisons.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that had been published up to 8 January 2018."
}
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query-laysum | 4401 | [
{
"role": "user",
"content": "Abstract: Background\nGlobally, about 6% of children are born with a serious birth defect of genetic or partially genetic origin. Carrier screening or testing is one way to identify couples at increased risk of having a child with an autosomal recessive condition. The most common autosomal recessive conditions are thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease, with higher carrier rates in high-risk populations of specific ancestral backgrounds. Identifying and counselling couples at genetic risk of the conditions before pregnancy enables them to make fully informed reproductive decisions, with some of these choices not being available if testing is only offered in an antenatal setting. This is an update of a previously published review.\nObjectives\nTo assess the effectiveness of systematic preconception genetic risk assessment to enable autonomous reproductive choice and to improve reproductive outcomes in women and their partners who are both identified as carriers of thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease in healthcare settings when compared to usual care.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Registers. Date of latest search of the registers: 04 August 2021.\nIn addition, we searched for all relevant trials from 1970 (or the date at which the database was first available if after 1970) to date using electronic databases (MEDLINE, Embase, CINAHL, PsycINFO), clinical trial databases (National Institutes of Health, Clinical Trials Search portal of the World Health Organization, metaRegister of controlled clinical trials), and hand searching of key journals and conference abstract books from 1998 to date (European Journal of Human Genetics, Genetics in Medicine, Journal of Community Genetics). We also searched the reference lists of relevant articles, reviews and guidelines and also contacted subject experts in the field to request any unpublished or other published trials. Date of latest search of all these sources: 25 June 2021.\nSelection criteria\nAny randomised controlled trials (RCTs) or quasi-RCTs (published or unpublished) comparing reproductive outcomes of systematic preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease when compared to usual care.\nData collection and analysis\nWe identified 37 papers, describing 22 unique trials which were potentially eligible for inclusion in the review. However, after assessment, we found no RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease.\nMain results\nNo RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease are included. A trial identified earlier has published its results and has subsequently been listed as excluded in this review.\nAuthors' conclusions\nAs there are no RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis, or Tay-Sachs disease included in either the earlier or current versions of this review, we recommend considering potential non-RCTs studies (for example prospective cohorts or before-and-after studies) for future reviews. While RCTs are desirable to inform evidence-based practice and robust recommendations, the ethical, legal and social implications associated with using this trial design to evaluate the implementation of preconception genetic risk assessment involving carrier testing and reproductive autonomy must also be considered. In addition, rather than focusing on single gene-by-gene carrier testing for specific autosomal-recessive conditions as the intervention being evaluated, preconception expanded genetic screening should also be included in future searches as this has received much attention in recent years as a more pragmatic strategy.\nThe research evidence for current international policy recommendations is limited to non-randomised studies.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Although no trials were identified in which people taking part would have equal chances of being in either group, there are several studies which are not so strictly designed which support current policy recommendations for genetic risk assessment prior to pregnancy in routine clinical practice. We recommend considering potential observational studies in future reviews as well as looking at ‘expanded carrier screening’ before pregnancy and not just screening for one condition. Any future trials need to consider legal, ethical and cultural barriers to implementing genetic risk assessment before pregnancy."
}
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query-laysum | 4402 | [
{
"role": "user",
"content": "Abstract: Background\nGarlic is alleged to have antimicrobial and antiviral properties that relieve the common cold, among other beneficial effects. There is widespread usage of garlic supplements. The common cold is associated with significant morbidity and economic consequences. On average, children have six to eight colds per year and adults have two to four.\nObjectives\nTo determine whether garlic (Allium sativum) is effective for the prevention or treatment of the common cold, when compared to placebo, no treatment or other treatments.\nSearch methods\nWe searched CENTRAL (2014, Issue 7), OLDMEDLINE (1950 to 1965), MEDLINE (January 1966 to July week 5, 2014), EMBASE (1974 to August 2014) and AMED (1985 to August 2014).\nSelection criteria\nRandomised controlled trials of common cold prevention and treatment comparing garlic with placebo, no treatment or standard treatment.\nData collection and analysis\nTwo review authors independently reviewed and selected trials from searches, assessed and rated study quality and extracted relevant data.\nMain results\nIn this updated review, we identified eight trials as potentially relevant from our searches. Again, only one trial met the inclusion criteria. This trial randomly assigned 146 participants to either an allicin-containing garlic capsule (dose unspecified) or a placebo (once daily) for 12 weeks. The trial reported 24 occurrences of the common cold in the garlic intervention group compared with 65 in the placebo group (P < 0.001), resulting in fewer days of illness in the garlic group compared with the placebo group (111 versus 366). The number of days to recovery from an occurrence of the common cold was similar in both groups (4.63 versus 5.63). Only one trial met the inclusion criteria, therefore limited conclusions can be drawn. The trial relied on self reported episodes of the common cold but was of reasonable quality in terms of randomisation and allocation concealment. Adverse effects included rash and odour.\nAuthors' conclusions\nThere is insufficient clinical trial evidence regarding the effects of garlic in preventing or treating the common cold. A single trial suggested that garlic may prevent occurrences of the common cold but more studies are needed to validate this finding. Claims of effectiveness appear to rely largely on poor-quality evidence.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Garlic is popularly believed to be useful for the common cold. This belief is based on traditional use and some laboratory evidence that garlic has antibacterial and antiviral properties. On average, adults have two to four common colds per year."
}
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query-laysum | 4403 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with chronic kidney disease (CKD) requiring dialysis are at a particularly high risk of cardiovascular death and morbidity. Several clinical studies suggested that aldosterone antagonists would be a promising treatment option for people undergoing dialysis. However, the clinical efficacy and potential harm of aldosterone antagonists for people with CKD on dialysis has yet to be determined.\nObjectives\nThis review aimed to evaluate the benefits and harms of aldosterone antagonists, both non-selective (spironolactone) and selective (eplerenone), in comparison to control (placebo or standard care) in people with CKD requiring haemodialysis (HD) or peritoneal dialysis (PD).\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 5 August 2020 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs), cross-over RCTs, and quasi-RCTs (where group allocation is by a method that is not truly random, such as alternation, assignment based on alternate medical records, date of birth, case record number, or other predictable methods) that compared aldosterone antagonists with placebo or standard care in people with CKD requiring dialysis.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias for included studies. We used a random-effects model meta-analysis to perform a quantitative synthesis of the data. We used the I² statistic to measure heterogeneity among the studies in each analysis. We indicated summary estimates as a risk ratio (RR) for dichotomous outcomes, mean difference (MD) for continuous outcomes, or standardised mean differences (SMD) if different scales were used, with their 95% confidence interval (CI). We assessed the certainty of the evidence for each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach.\nMain results\nWe included 16 studies (14 parallel RCTs and two cross-over RCTs) involving a total of 1446 participants. Thirteen studies compared spironolactone to placebo or standard care and one study compared eplerenone to a placebo. Most included studies had an unclear or high risk of bias. Compared to control, aldosterone antagonists probably reduced the risk of death (any cause) for people with CKD requiring dialysis (9 studies, 1119 participants: RR 0.45, 95% CI 0.30 to 0.67; I² = 0%; moderate certainty of evidence). Aldosterone antagonist probably decreased the risk of death due to cardiovascular disease (6 studies, 908 participants: RR 0.37, 95% CI 0.22 to 0.64; I² = 0%; moderate certainty of evidence) and cardiovascular and cerebrovascular morbidity (3 studies, 328 participants: RR 0.38, 95% CI 0.18 to 0.76; I² = 0%; moderate certainty of evidence). While aldosterone antagonists probably increased risk of gynaecomastia compared with control (4 studies, 768 participants: RR 5.95, 95% CI 1.93 to 18.3; I² = 0%; moderate certainty of evidence), aldosterone antagonists may make little or no difference to the risk of hyperkalaemia (9 studies, 981 participants: RR 1.41, 95% CI 0.72 to 2.78; I² = 47%; low certainty of evidence). Aldosterone antagonists had a marginal effect on left ventricular mass among participants undergoing dialysis (8 studies, 633 participants: SMD -0.42, 95% CI -0.78 to 0.05; I² = 77%).\nIn people with CKD requiring dialysis received aldosterone antagonists compared to control, there were 72 fewer deaths from all causes per 1000 participants (95% CI 47 to 98) with a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 10 to 21) and for gynaecomastia were 26 events per 1000 participants (95% CI 15 to 39) with a number need to treat for an additional harmful outcome (NNTH) of 38 (95% CI 26 to 68).\nAuthors' conclusions\nBased on moderate certainty of the evidence, aldosterone antagonists probably reduces the risk of all-cause and cardiovascular death and probably reduces morbidity due to cardiovascular and cerebrovascular disease in people with CKD requiring dialysis. For the adverse effect of gynaecomastia, the risk was increased compared to control. For this outcome, the absolute risk was lower than the absolute risk of death. It is hoped the three large ongoing studies will provide better certainty of evidence.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with chronic kidney disease (CKD) requiring dialysis are at an increased risk of death and other illnesses. One particular cause of this is an increased risk of heart disease. Aldosterone antagonists (e.g. spironolactone or eplerenone) are one kind of drug for treating high blood pressure that may be a promising treatment option for these people, but which can be associated with adverse effects such as high potassium concentration in the blood (also called hyperkalaemia). This high potassium concentration in the blood may be potentially harmful in people undergoing dialysis."
}
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query-laysum | 4404 | [
{
"role": "user",
"content": "Abstract: Background\nCataract surgery is one of the most common surgical procedures performed worldwide. Achieving appropriate intraoperative mydriasis is one of the critical factors associated with the safety and performance of the surgery. Inadequate pupillary dilation or constriction of the pupil during cataract surgery can impair the surgeon’s field of view and make it difficult to maneuver instruments.\nObjectives\nTo evaluate the relative effectiveness of achieving pupillary dilation during phacoemulsification for cataract extraction using three methods of pupillary dilation: topical mydriatics, intracameral mydriatics, or depot delivery systems. We also planned to document and compare the risk of intraoperative and postoperative complications following phacoemulsification for cataract extraction, as well as the cost-effectiveness of these methods for pupillary dilation.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register) (2021, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 22 January 2021.\nSelection criteria\nWe included only randomized controlled trial (RCTs) in which participants underwent phacoemulsification for cataract extraction.\nData collection and analysis\nWe followed standard Cochrane methodology.\nMain results\nWe included a total of 14 RCTs (1670 eyes of 1652 participants) in this review. Of the 14 trials, 7 compared topical versus intracameral mydriatics, 6 compared topical mydriatics versus depot delivery systems, and 1 compared all three methods.\nWe were unable to calculate overall estimates of comparative effectiveness for most outcomes due to statistical heterogeneity among the estimates from individual studies or because outcome data were available from only a single study. Furthermore, the certainty of evidence for most outcomes was low or very low, due primarily to imprecision and risk of bias.\nComparison 1: topical mydriatics versus intracameral mydriatics\nFour RCTs (739 participants, 757 eyes) of the 8 RCTs that had compared these two methods reported mean pupillary diameters at the time surgeons had performed capsulorhexis; all favored topical mydriatics, but heterogeneity was high (I2 = 95%). After omitting 1 RCT that used a paired-eyes design, evidence from three RCTs (721 participants and eyes) suggests that mean pupil diameter at the time of capsulorhexis may be greater with topical mydriatics than with intracameral mydriatics, but the evidence is of low certainty (mean difference 1.06 mm, 95% confidence interval (CI) 0.81 mm to 1.31 mm; I2 = 49%).\nFour RCTs (224 participants, 242 eyes) reported mean pupillary diameter at the beginning of cataract surgery; the effect estimates from all trials favored topical mydriatics, with very low-certainty evidence.\nFive RCTs (799 participants, 817 eyes) reported mean pupillary diameter at the end of cataract surgery. Data for this outcome from the largest RCT (549 participants and eyes) provided evidence of a small difference in favor of intracameral mydriasis. On the other hand, 2 small RCTs (78 participants, 96 eyes) favored topical mydriatics, and the remaining 2 RCTs (172 participants) found no meaningful difference between the two methods, with very low-certainty evidence.\nFive RCTs (799 participants, 817 eyes) reported total intraoperative surgical time. The largest RCT (549 participants and eyes) reported decreased total intraoperative time with intracameral mydriatics, whereas 1 RCT (18 participants, 36 eyes) favored topical mydriatics, and the remaining 3 RCTs (232 participants) found no difference between the two methods, with very low-certainty evidence.\nComparison 2: topical mydriatics versus depot delivery systems\nOf the 7 RCTs that compared these two methods, none reported mean pupillary diameter at the time surgeons performed capsulorhexis.\nSix RCTs (434 participants) reported mean pupillary diameter at the beginning of cataract surgery. After omitting 1 RCT suspected to be responsible for high heterogeneity (I2 = 80%), meta-analysis of the other 5 RCTs (324 participants and eyes) found no evidence of a meaningful difference between the two methods, with very low-certainty evidence.\nThree RCTs (210 participants) reported mean pupillary diameter at the end of cataract surgery, with high heterogeneity among effect estimates for this outcome. Estimates of mean differences and confidence intervals from these three RCTs were consistent with no difference between the two methods. A fourth RCT reported only means for this outcome, with low-certainty evidence.\nTwo small RCTs (118 participants) reported total intraoperative time. Surgical times were lower when depot delivery was used, but the confidence interval estimated from one trial was consistent with no difference, and only mean times were reported from the other trial, with very low-certainty evidence.\nComparison 3: Intracameral mydriatics versus depot delivery systems\nOnly one RCT (60 participants) compared intracameral mydriatics versus depot delivery system. Mean pupillary diameter at the time the surgeon performed capsulorhexis, phacoemulsification time, and cost outcomes were not reported. Mean pupil diameter at the beginning and end of cataract surgery favored the depot delivery system, with very low-certainty evidence.\nAdverse events\nEvidence from one RCT (555 participants and eyes) comparing topical mydriatics versus intracameral mydriatics suggests that ocular discomfort may be greater with topical mydriatics than with intracameral mydriatics at one week (risk ratio (RR) 10.57, 95% CI 1.37 to 81.34) and one month (RR 2.51, 95% CI 1.36 to 4.65) after cataract surgery, with moderate-certainty evidence at both time points. Another RCT (30 participants) reported iris-related complications in 11 participants in the intracameral mydriatics group versus no complications in the depot delivery system group, with very low-certainty evidence. Cardiovascular related adverse events were rarely mentioned.\nAuthors' conclusions\nData from 14 completed RCTs were inadequate to establish the superiority of any of three methods to achieve mydriasis for cataract surgery, based on pupillary dilation at different times during the surgery or on time required for surgery. Only one trial had a \nsample size adequate to yield a robust effect estimate. Larger, well-designed trials are needed to provide robust estimates for the comparison of mydriasis approaches for beneficial and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of the 14 studies comparing eye drops against injections or depot devices did not show sufficiently clear differences between different methods. Not all studies reported results for the measures we were interested in.\nWe do not know whether one method worked better than either of the others to:\n· widen the pupil (measured during surgery, and at the beginning and end of surgery);\n· reduce how much time the surgery lasted; or\n· reduce how much time it took to replace the lens during surgery.\nNot all studies reported on unwanted effects. One study showed that eye discomfort was probably greater with eye drops than with an injection, when measured at one week (555 people) and one month (543 people) after surgery. Another study reported problems with the iris (the colored disc that surrounds the pupil) in 11 people who had an injection, compared with none in the group who had a depot device, although our confidence in these results is limited.\nNo studies reported on cost-effectiveness of any of the delivery methods."
}
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query-laysum | 4405 | [
{
"role": "user",
"content": "Abstract: Background\nPoor diet and insufficient physical activity are major risk factors for non-communicable diseases. Developing healthy diet and physical activity behaviors early in life is important as these behaviors track between childhood and adulthood. Parents and other adult caregivers have important influences on children's health behaviors, but whether their involvement in children's nutrition and physical activity interventions contributes to intervention effectiveness is not known.\nObjectives\n• To assess effects of caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors, including those intended to prevent overweight and obesity\n• To describe intervention content and behavior change techniques employed, drawing from a behavior change technique taxonomy developed and advanced by Abraham, Michie, and colleagues (Abraham 2008; Michie 2011; Michie 2013; Michie 2015)\n• To identify content and techniques related to reported outcomes when such information was reported in included studies\nSearch methods\nIn January 2019, we searched CENTRAL, MEDLINE, Embase, 11 other databases, and three trials registers. We also searched the references lists of relevant reports and systematic reviews.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of interventions to improve children's dietary intake or physical activity behavior, or both, with children aged 2 to 18 years as active participants and at least one component involving caregivers versus the same interventions but without the caregiver component(s). We excluded interventions meant as treatment or targeting children with pre-existing conditions, as well as caregiver-child units residing in orphanages and school hostel environments.\nData collection and analysis\nWe used standard methodological procedures outlined by Cochrane.\nMain results\nWe included 23 trials with approximately 12,192 children in eligible intervention arms. With the exception of two studies, all were conducted in high-income countries, with more than half performed in North America. Most studies were school-based and involved the addition of healthy eating or physical education classes, or both, sometimes in tandem with other changes to the school environment. The specific intervention strategies used were not always reported completely. However, based on available reports, the behavior change techniques used most commonly in the child-only arm were \"shaping knowledge,\" \"comparison of behavior,\" \"feedback and monitoring,\" and \"repetition and substitution.\" In the child + caregiver arm, the strategies used most commonly included additional \"shaping knowledge\" or \"feedback and monitoring\" techniques, as well as \"social support\" and \"natural consequences.\"\nWe considered all trials to be at high risk of bias for at least one design factor. Seven trials did not contribute any data to analyses. The quality of reporting of intervention content varied between studies, and there was limited scope for meta-analysis. Both validated and non-validated instruments were used to measure outcomes of interest. Outcomes measured and reported differed between studies, with 16 studies contributing data to the meta-analyses. About three-quarters of studies reported their funding sources; no studies reported industry funding. We assessed the quality of evidence to be low or very low.\nDietary behavior change interventions with a caregiver component versus interventions without a caregiver component\nSeven studies compared dietary behavior change interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (mean difference [MD] −0.42%, 95% confidence interval [CI] −1.25 to 0.41, 1 study, n = 207; low-quality evidence) or from sodium intake (MD −0.12 g/d, 95% CI −0.36 to 0.12, 1 study, n = 207; low-quality evidence). No trial in this comparison reported data for children's combined fruit and vegetable intake, sugar-sweetened beverage (SSB) intake, or physical activity levels, nor for adverse effects of interventions.\nPhysical activity interventions with a caregiver component versus interventions without a caregiver component\nSix studies compared physical activity interventions with and without a caregiver component. At the end of the intervention, we did not detect a difference between intervention arms in children's total physical activity (MD 0.20 min/h, 95% CI −1.19 to 1.59, 1 study, n = 54; low-quality evidence) or moderate to vigorous physical activity (MVPA) (standard mean difference [SMD] 0.04, 95% CI −0.41 to 0.49, 2 studies, n = 80; moderate-quality evidence). No trial in this comparison reported data for percentage of children's total energy intake from saturated fat, sodium intake, fruit and vegetable intake, or SSB intake, nor for adverse effects of interventions.\nCombined dietary and physical activity interventions with a caregiver component versus interventions without a caregiver component\nTen studies compared dietary and physical activity interventions with and without a caregiver component. At the end of the intervention, we detected a small positive impact of a caregiver component on children's SSB intake (SMD −0.28, 95% CI −0.44 to −0.12, 3 studies, n = 651; moderate-quality evidence). We did not detect a difference between intervention arms in children's percentage of total energy intake from saturated fat (MD 0.06%, 95% CI −0.67 to 0.80, 2 studies, n = 216; very low-quality evidence), sodium intake (MD 35.94 mg/d, 95% CI −322.60 to 394.47, 2 studies, n = 315; very low-quality evidence), fruit and vegetable intake (MD 0.38 servings/d, 95% CI −0.51 to 1.27, 1 study, n = 134; very low-quality evidence), total physical activity (MD 1.81 min/d, 95% CI −15.18 to 18.80, 2 studies, n = 573; low-quality evidence), or MVPA (MD −0.05 min/d, 95% CI −18.57 to 18.47, 1 study, n = 622; very low-quality evidence). One trial indicated that no adverse events were reported by study participants but did not provide data.\nAuthors' conclusions\nCurrent evidence is insufficient to support the inclusion of caregiver involvement in interventions to improve children's dietary intake or physical activity behavior, or both. For most outcomes, the quality of the evidence is adversely impacted by the small number of studies with available data, limited effective sample sizes, risk of bias, and imprecision. To establish the value of caregiver involvement, additional studies measuring clinically important outcomes using valid and reliable measures, employing appropriate design and power, and following established reporting guidelines are needed, as is evidence on how such interventions might contribute to health equity.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diet and physical activity behaviors are important determinants of health. Parents and other adult caregivers have an essential role in shaping children's health habits by controlling availability of and access to healthy foods and opportunities to be active; supporting, encouraging, and role-modeling healthy behaviors; and adopting supportive feeding styles and practices. For these reasons, it often is argued that parent and caregiver involvement in children's diet and physical activity interventions is important; however, it remains unclear if involvement of parents and caregivers actually provides benefit."
}
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query-laysum | 4406 | [
{
"role": "user",
"content": "Abstract: Background\nVenous leg ulcers are a common and recurring type of complex wound. They can be painful, malodorous, prone to infection and slow to heal. Standard treatment includes compression therapy and a dressing. The use of protease-modulating treatments for venous leg ulcers is increasing. These treatments are based on some evidence that a proportion of slow to heal ulcers have elevated protease activity in the wound. Point-of-care tests which aim to detect elevated protease activity are now available. A 'test and treat' strategy involves testing for elevated proteases and then using protease-modulating treatments in ulcers which show elevated protease levels.\nObjectives\nTo determine the effects on venous leg ulcer healing of a 'test and treat' strategy involving detection of high levels of wound protease activity and treatment with protease-modulating therapies, compared with alternative treatment strategies such as using the same treatment for all participants or using a different method of treatment selection.\nSearch methods\nWe searched the following electronic databases to identify reports of relevant randomised clinical trials: The Cochrane Wounds Group Specialised Register (January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) Issue 12, 2015); Ovid MEDLINE (1946 to January 2016); Ovid MEDLINE (In-Process & Other Non-Indexed Citations January 2016); Ovid EMBASE (1974 to January 2016); EBSCO CINAHL (1937 to January 2016). We also searched three clinical trials registers, reference lists and the websites of regulatory agencies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished or unpublished RCTs which assessed a test and treat strategy for elevated protease activity in venous leg ulcers in adults compared with an alternative treatment strategy. The test and treat strategy needed to be the only systematic difference between the groups.\nData collection and analysis\nTwo review authors independently performed study selection; we planned that two authors would also assess risk of bias and extract data.\nMain results\nWe did not identify any studies which met the inclusion criteria for this review. We identified one ongoing study; it was unclear whether this would be eligible for inclusion.\nAuthors' conclusions\nCurrently there is no randomised evidence on the impact of a test and treat policy for protease levels on outcomes in people with venous leg ulcers.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In January 2016 we searched for as many relevant studies as possible that were randomised controlled trials, and which compared a 'test and treat' strategy with another treatment in people with venous leg ulcers. We did not find any eligible randomised studies. We found one ongoing study which might be relevant but could not obtain any more information on this. Research is still needed to find out if it is helpful to test venous leg ulcers for high levels of protease activity and then treat high levels using protease-modulating treatments. This review is part of a set of reviews investigating different aspects of using protease-modulating treatments in people with venous leg ulcers."
}
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query-laysum | 4407 | [
{
"role": "user",
"content": "Abstract: Background\nPatients with longstanding ulcerative colitis and colonic Crohn's disease have an increased risk of colorectal cancer (CRC) compared with the general population. This review assessed the evidence that endoscopic surveillance may prolong life by allowing earlier detection of CRC or its pre-cursor lesion, dysplasia, in patients with inflammatory bowel disease (IBD).\nObjectives\nTo assess the effectiveness of cancer surveillance programs for diagnosis of IBD-associated colorectal cancer and in reducing the mortality rate from colorectal cancer in patients with IBD.\nSearch methods\nWe searched MEDLINE, EMBASE, CENTRAL and clinical clinicaltrials.gov from inception to 19 September 2016. We also searched conference abstracts and reference lists to identify additional studies.\nSelection criteria\nPotentially relevant articles were reviewed independently and unblinded by two authors to determine eligibility. Randomised controlled trials (RCTs) or observational studies (cohort or case control) assessing any form of endoscopic surveillance aimed at early detection of CRC were considered for inclusion. Studies had to have a no surveillance comparison group to be eligible for inclusion.\nData collection and analysis\nEligible studies were reviewed in duplicate and the results of the primary research trials were independently extracted by two authors. The primary outcome was detection of CRC. Secondary outcomes included death from CRC, time to cancer detection, time to death and adverse events. Deaths from CRC were derived from life tables, survival curves or where possible, by calculating life tables from the data provided. The presence of significant heterogeneity among studies was tested by the chi-square test. Because this is a relatively insensitive test, a P value of less than 0.1 was considered statistically significant. Provided statistical heterogeneity was not present, the fixed effects model was used for the pooling of data. The 2x2 tables were combined into a summary test statistic using the pooled odds ratio (OR) and 95% confidence intervals as described by Cochrane and Mantel and Haenszel. The methodological quality of the included studies was assessed using the Newcastle-Ottawa scale for non-randomised studies The overall quality of the evidence supporting the primary and selected secondary outcomes was assessed using the GRADE criteria.\nMain results\nNo RCTs were identified. Five observational studies (N = 7199) met the inclusion criteria. The studies scored well on the Newcastle-Ottawa scale, but due to the nature of observational studies, a high risk of bias was assigned to all the studies. Three studies were pooled to assess the rate of cancer detected in the surveillance group compared to the non-surveillance group. The studies found a significantly higher rate of cancer detection in the non surveillance group compared to the surveillance group. CRC was detected in 1.83% (53/2895) of patients in the surveillance group compared to 3.17% (135/4256) of patients in the non-surveillance group (OR 0.58, 95% CI 0.42 to 0.80; P = 0.0009). Four studies were pooled to assess the death rate associated with CRC in patients who underwent surveillance compared to patients who did not undergo surveillance. There was a significantly lower death rate associated with CRC in the surveillance group compared to the non-surveillance group. Eight per cent (15/176) of patients in the surveillance group died from CRC compared to 22% (79/354) of patients in the non-surveillance group (OR 0.36, 95% CI 0.19 to 0.69, P=0.002). Data were pooled from two studies to examine the rate of early stage versus late stage colorectal cancer (Duke stages A & B compared to Duke stages C & D) in patients who underwent surveillance compared to patients who do not undergo surveillance. A significantly higher rate of early stage CRC (Duke A & B) was detected in the surveillance group compared to the non-surveillance group. Sixteen per cent (17/110) of patients in the surveillance group had early stage CRC compared to 8% (9/117) of patients in the non-surveillance group (OR 5.40, 95% CI 1.51 to 19.30; P = 0.009). A higher rate of late stage CRC (Duke C & D) was observed in the non-surveillance group compared to the surveillance group. Nine per cent (10/110) of patients in the surveillance group had late stage CRC compared to 16% (19/117) of patients in the non-surveillance group (OR 0.46, 95% CI 0.08 to 2.51; P = 0.37). A GRADE analysis indicated that the quality of the data was very low for all of these outcomes. The included studies did not report on the other pre-specified outcomes including time to cancer detection, time to death and adverse events.\nAuthors' conclusions\nThe current data suggest that colonoscopic surveillance in IBD may reduce the development of both CRC and the rate of CRC-associated death through early detection, although the quality of the evidence is very low. The detection of earlier stage CRC in the surveillance group may explain some of the survival benefit observed. RCTs assessing the efficacy of endoscopic surveillance in people with IBD are unlikely to be undertaken due to ethical considerations.\n\nGiven the provided abstract, please respond to the following query: \"What is endoscopic surveillance?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "An endoscopy is a non-surgical procedure used to view the digestive tract using a camera. The doctor who performs the endoscopy can take tissue samples of suspicious lesions or growths during the procedure. Endoscopic surveillance is used to identify pre-cancerous growths (called dysplasia) or colon cancer in patients with IBD. Endoscopy may help to identify colon cancer at an earlier stage and help prolong survival and lower the death rate due to colon cancer"
}
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query-laysum | 4408 | [
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring. The prevalence of SAD ranges from 1.5% to 9%, depending on latitude. The predictable seasonal aspect of SAD provides a promising opportunity for prevention. This is one of four reviews on the efficacy and safety of interventions to prevent SAD; we focus on psychological therapies as preventive interventions.\nObjectives\nTo assess the efficacy and safety of psychological therapies (in comparison with no treatment, other types of psychological therapy, second-generation antidepressants, light therapy, melatonin or agomelatine or lifestyle interventions) in preventing SAD and improving person-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nTo examine efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. To examine adverse events, we intended to include non-randomised studies. We planned to include studies that compared psychological therapy versus no treatment, or any other type of psychological therapy, light therapy, second-generation antidepressants, melatonin, agomelatine or lifestyle changes. We also planned to compare psychological therapy in combination with any of the comparator interventions listed above versus no treatment or the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors screened abstracts and full-text publications against the inclusion criteria, independently extracted data, assessed risk of bias, and graded the certainty of evidence.\nMain results\nWe identified 3745 citations through electronic searches and reviews of reference lists after deduplication of search results. We excluded 3619 records during title and abstract review and assessed 126 articles at full-text review for eligibility. We included one controlled study enrolling 46 participants. We rated this RCT at high risk for performance and detection bias due to a lack of blinding.\nThe included RCT compared preventive use of mindfulness-based cognitive therapy (MBCT) with treatment as usual (TAU) in participants with a history of SAD. MBCT was administered in spring in eight weekly individual 45- to 60-minute sessions. In the TAU group participants did not receive any preventive treatment but were invited to start light therapy as first depressive symptoms occurred. Both groups were assessed weekly for occurrence of a new depressive episode measured with the Inventory of Depressive Syptomatology-Self-Report (IDS-SR, range 0-90) from September 2011 to mid-April 2012. The incidence of a new depressive episode in the upcoming winter was similar in both groups. In the MBCT group 65% of 23 participants developed depression (IDS-SR ≥ 20), compared to 74% of 23 people in the TAU group (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.30; 46 participants; very low quality-evidence).\nFor participants with depressive episodes, severity of depression was comparable between groups. Participants in the MBCT group had a mean score of 26.5 (SD 7.0) on the IDS-SR, and TAU participants a mean score of 25.3 (SD 6.3) (mean difference (MD) 1.20, 95% CI -3.44 to 5.84; 32 participants; very low quality-evidence).\nThe overall discontinuation rate was similar too, with 17% discontinuing in the MBCT group and 13% in the TAU group (RR 1.33, 95% CI 0.34 to 5.30; 46 participants; very low quality-evidence).\nReasons for downgrading the quality of evidence included high risk of bias of the included study and imprecision.\nInvestigators provided no information on adverse events. We could not find any studies that compared psychological therapy with other interventions of interest such as second-generation antidepressants, light therapy, melatonin or agomelatine.\nAuthors' conclusions\nThe evidence on psychological therapies to prevent the onset of a new depressive episode in people with a history of SAD is inconclusive. We identified only one study including 46 participants focusing on one type of psychological therapy. Methodological limitations and the small sample size preclude us from drawing a conclusion on benefits and harms of MBCT as a preventive intervention for SAD. Given that there is no comparative evidence for psychological therapy versus other preventive options, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences and other preventive interventions that are supported by evidence.\n\nGiven the provided abstract, please respond to the following query: \"Who might be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Anyone who has experienced SAD or who has relatives and friends who have experienced SAD, as well as researchers working in this field might be interested in this review."
}
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query-laysum | 4409 | [
{
"role": "user",
"content": "Abstract: Background\nPrimary malignant brain tumours can have an unpredictable course, but high-grade gliomas typically have a relentlessly progressive disease trajectory. They can cause profound symptom burden, affecting physical, neurocognitive, and social functioning from an early stage in the illness. This can significantly impact on role function and on the experiences and needs of informal caregivers. Access to specialist palliative and supportive care early in the disease trajectory, for those with high-grade tumours in particular, has the potential to improve patients' and caregivers' quality of life. However, provision of palliative and supportive care for people with primary brain tumours - and their informal caregivers - is historically ill-defined and ad hoc, and the benefits of early palliative interventions have not been confirmed. It is therefore important to define the role and effectiveness of early referral to specialist palliative care services and/or the effectiveness of other interventions focused on palliating disease impact on people and their informal caregivers. This would help guide improvement to service provision, by defining those interventions which are effective across a range of domains, and developing an evidence-based model of integrated supportive and palliative care for this population.\nObjectives\nTo assess the evidence base for early palliative care interventions, including referral to specialist palliative care services compared to usual care, for improving outcomes in adults diagnosed with a primary brain tumour and their carers.\nSearch methods\nWe conducted searches of electronic databases, CENTRAL, MEDLINE, CINAHL, Web of Science, and PsycINFO (last searched 16 November 2021). We conducted searches to incorporate both qualitative and quantitative search terms. In addition to this, we searched for any currently recruiting trials in ClinicalTrials.gov and in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal, and undertook citation tracking via Scopus. We also handsearched reference lists of potentially eligible systematic review articles to identify any other relevant studies, contacted experts in the field and searched key authors via Web of Science and searched SIGLE (System of Information on Grey Literature in Europe).\nSelection criteria\nWe included studies looking at early referral to specialist palliative care services - or early targeted palliative interventions by other healthcare professionals - for improving quality of life, symptom control, psychological outcomes, or overall survival as a primary or secondary outcome measure. Studies included randomised controlled trials (RCTs), non-randomised studies (NRS), as well as qualitative and mixed-methods studies where both qualitative and quantitative data were included. Participants were adults with a confirmed radiological and/or histological diagnosis of a primary malignant brain tumour, and/or informal adult carers (either at individual or family level) of people with a primary malignant brain tumour.\nData collection and analysis\nWe followed standard Cochrane methodological procedures for data extraction, management, and analysis. We used GRADE to assess the certainty of the evidence for symptom control, i.e. cognitive function.\nMain results\nWe identified 9748 references from the searches, with 8337 remaining after duplicates were removed. After full-text review, we included one trial. There were no studies of early specialist palliative care interventions or of early, co-ordinated generalist palliative care approaches.\nThe included randomised trial addressed a single symptom area, focusing on early cognitive rehabilitation, administered within two weeks of surgery in a mixed brain tumour population, of whom approximately half had a high-grade glioma. The intervention was administered individually as therapist-led computerised exercises over 16 one-hour sessions, four times/week for four weeks. Sessions addressed several cognitive domains including time orientation, spatial orientation, visual attention, logical reasoning, memory, and executive function.\nThere were no between-group differences in outcome for tests of logical-executive function, but differences were observed in the domains of visual attention and verbal memory. Risk of bias was assessed and stated as high for performance bias and attrition bias but for selective reporting it was unclear whether all outcomes were reported. We considered the certainty of the evidence, as assessed by GRADE, to be very low.\nAuthors' conclusions\nCurrently there is a lack of research focusing on the introduction of early palliative interventions specifically for people with primary brain tumours, either as co-ordinated specialist palliative care approaches or interventions focusing on a specific aspect of palliation. Future research should address the methodological shortcomings described in early palliative intervention studies in other cancers and chronic conditions. In particular, the specific population under investigation, the timing and the setting of the intervention should be clearly described and the standardised palliative care-specific components of the intervention should be defined in detail.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to assess studies that included early palliative care interventions, including referral to specialist palliative care services compared to usual care, for improving outcomes in adults diagnosed with a primary brain tumour and their carers."
}
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query-laysum | 4410 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original review published in the Cochrane Database of Systematic Reviews Issue 10, 2015.\nInvasive aspergillosis (IA) is the most common life-threatening opportunistic invasive mould infection in immunocompromised people. Early diagnosis of IA and prompt administration of appropriate antifungal treatment are critical to the survival of people with IA. Antifungal drugs can be given as prophylaxis or empirical therapy, instigated on the basis of a diagnostic strategy (the pre-emptive approach) or for treating established disease. Consequently, there is an urgent need for research into both new diagnostic tools and drug treatment strategies. Increasingly, newer methods such as polymerase chain reaction (PCR) to detect fungal nucleic acids are being investigated.\nObjectives\nTo provide an overall summary of the diagnostic accuracy of PCR-based tests on blood specimens for the diagnosis of IA in immunocompromised people.\nSearch methods\nWe searched MEDLINE (1946 to June 2015) and Embase (1980 to June 2015). We also searched LILACS, DARE, Health Technology Assessment, Web of Science and Scopus to June 2015. We checked the reference lists of all the studies identified by the above methods and contacted relevant authors and researchers in the field. For this review update we updated electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid (June 2015 to March week 2 2018); and Embase via Ovid (June 2015 to 2018 week 12).\nSelection criteria\nWe included studies that: i) compared the results of blood PCR tests with the reference standard published by the European Organisation for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG); ii) reported data on false-positive, true-positive, false-negative and true-negative results of the diagnostic tests under investigation separately; and iii) evaluated the test(s) prospectively in cohorts of people from a relevant clinical population, defined as a group of individuals at high risk for invasive aspergillosis. Case-control and retrospective studies were excluded from the analysis.\nData collection and analysis\nAuthors independently assessed quality and extracted data. For PCR assays, we evaluated the requirement for either one or two consecutive samples to be positive for diagnostic accuracy. We investigated heterogeneity by subgroup analyses. We plotted estimates of sensitivity and specificity from each study in receiver operating characteristics (ROC) space and constructed forest plots for visual examination of variation in test accuracy. We performed meta-analyses using the bivariate model to produce summary estimates of sensitivity and specificity.\nMain results\nWe included 29 primary studies (18 from the original review and 11 from this update), corresponding to 34 data sets, published between 2000 and 2018 in the meta-analyses, with a mean prevalence of proven or probable IA of 16.3 (median prevalence 11.1% , range 2.5% to 57.1%). Most patients had received chemotherapy for haematological malignancy or had undergone hematopoietic stem cell transplantation. Several PCR techniques were used among the included studies. The sensitivity and specificity of PCR for the diagnosis of IA varied according to the interpretative criteria used to define a test as positive. The summary estimates of sensitivity and specificity were 79.2% (95% confidence interval (CI) 71.0 to 85.5) and 79.6% (95% CI 69.9 to 86.6) for a single positive test result, and 59.6% (95% CI 40.7 to 76.0) and 95.1% (95% CI 87.0 to 98.2) for two consecutive positive test results.\nAuthors' conclusions\nPCR shows moderate diagnostic accuracy when used as screening tests for IA in high-risk patient groups. Importantly the sensitivity of the test confers a high negative predictive value (NPV) such that a negative test allows the diagnosis to be excluded. Consecutive positives show good specificity in diagnosis of IA and could be used to trigger radiological and other investigations or for pre-emptive therapy in the absence of specific radiological signs when the clinical suspicion of infection is high. When a single PCR positive test is used as the diagnostic criterion for IA in a population of 100 people with a disease prevalence of 16.3% (overall mean prevalence), three people with IA would be missed (sensitivity 79.2%, 20.8% false negatives), and 17 people would be unnecessarily treated or referred for further tests (specificity of 79.6%, 21.4% false positives). If we use the two positive test requirement in a population with the same disease prevalence, it would mean that nine IA people would be missed (sensitivity 59.6%, 40.4% false negatives) and four people would be unnecessarily treated or referred for further tests (specificity of 95.1%, 4.9% false positives). Like galactomannan, PCR has good NPV for excluding disease, but the low prevalence of disease limits the ability to rule in a diagnosis. As these biomarkers detect different markers of disease, combining them is likely to prove more useful.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the accuracy of polymerase chain reaction (PCR) tests for diagnosing invasive aspergillosis (IA) among people with defective immune systems from medical treatment such as chemotherapy or following organ or bone marrow transplant."
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query-laysum | 4411 | [
{
"role": "user",
"content": "Abstract: Background\nPsychosis is an illness characterised by the presence of hallucinations and delusions that can cause distress or a marked change in an individual's behaviour (e.g. social withdrawal, flat or blunted affect). A first episode of psychosis (FEP) is the first time someone experiences these symptoms that can occur at any age, but the condition is most common in late adolescence and early adulthood. This review is concerned with first episode psychosis (FEP) and the early stages of a psychosis, referred to throughout this review as 'recent-onset psychosis.'\nSpecialised early intervention (SEI) teams are community mental health teams that specifically treat people who are experiencing, or have experienced a recent-onset psychosis. The purpose of SEI teams is to intensively treat people with psychosis early in the course of the illness with the goal of increasing the likelihood of recovery and reducing the need for longer-term mental health treatment. SEI teams provide a range of treatments including medication, psychotherapy, psychoeducation, and occupational, educational and employment support, augmented by assertive contact with the service user and small caseloads. Treatment is time limited, usually offered for two to three years, after which service users are either discharged to primary care or transferred to a standard adult community mental health team. A previous Cochrane Review of SEI found preliminary evidence that SEI may be superior to standard community mental health care (described as 'treatment as usual (TAU)' in this review) but these recommendations were based on data from only one trial. This review updates the evidence for the use of SEI services.\nObjectives\nTo compare specialised early intervention (SEI) teams to treatment as usual (TAU) for people with recent-onset psychosis.\nSearch methods\nOn 3 October 2018 and 22 October 2019, we searched Cochrane Schizophrenia's study-based register of trials, including registries of clinical trials.\nSelection criteria\nWe selected all randomised controlled trials (RCTs) comparing SEI with TAU for people with recent-onset psychosis. We entered trials meeting these criteria and reporting useable data as included studies.\nData collection and analysis\nWe independently inspected citations, selected studies, extracted data and appraised study quality. For binary outcomes we calculated the risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean difference (MD) and their 95% CIs, or if assessment measures differed for the same construct, we calculated the standardised mean difference (SMD) with 95% CIs. We assessed risk of bias for included studies and created a 'Summary of findings' table using the GRADE approach.\nMain results\nWe included three RCTs and one cluster-RCT with a total of 1145 participants. The mean age in the trials was between 23.1 years (RAISE) and 26.6 years (OPUS). The included participants were 405 females (35.4%) and 740 males (64.6%). All trials took place in community mental healthcare settings.\nTwo trials reported on recovery from psychosis at the end of treatment, with evidence that SEI team care may result in more participants in recovery than TAU at the end of treatment (73% versus 52%; RR 1.41, 95% CI 1.01 to 1.97; 2 studies, 194 participants; low-certainty evidence).\nThree trials provided data on disengagement from services at the end of treatment, with fewer participants probably being disengaged from mental health services in SEI (8%) in comparison to TAU (15%) (RR 0.50, 95% CI 0.31 to 0.79; 3 studies, 630 participants; moderate-certainty evidence).\nThere was low-certainty evidence that SEI may result in fewer admissions to psychiatric hospital than TAU at the end of treatment (52% versus 57%; RR 0.91, 95% CI 0.82 to 1.00; 4 studies, 1145 participants) and low-certainty evidence that SEI may result in fewer psychiatric hospital days (MD -27.00 days, 95% CI -53.68 to -0.32; 1 study, 547 participants).\nTwo trials reported on general psychotic symptoms at the end of treatment, with no evidence of a difference between SEI and TAU, although this evidence is very uncertain (SMD -0.41, 95% CI -4.58 to 3.75; 2 studies, 304 participants; very low-certainty evidence). A different pattern was observed in assessment of general functioning with an end of trial difference that may favour SEI (SMD 0.37, 95% CI 0.07 to 0.66; 2 studies, 467 participants; low-certainty evidence).\nIt was uncertain whether the use of SEI resulted in fewer deaths due to all-cause mortality at end of treatment (RR 0.21, 95% CI 0.04 to 1.20; 3 studies, 741 participants; low-certainty evidence).\nThere was low risk of bias for random sequence generation and allocation concealment in three of the four included trials; the remaining trial had unclear risk of bias. Due to the nature of the intervention, we considered all trials at high risk of bias for blinding of participants and personnel. Two trials had low risk of bias and two trials had high risk of bias for blinding of outcomes assessments. Three trials had low risk of bias for incomplete outcome data, while one trial had high risk of bias. Two trials had low risk of bias, one trial had high risk of bias, and one had unclear risk of bias for selective reporting.\nAuthors' conclusions\nThere is evidence that SEI may provide benefits to service users during treatment compared to TAU. These benefits probably include fewer disengagements from mental health services (moderate-certainty evidence), and may include small reductions in psychiatric hospitalisation (low-certainty evidence), and a small increase in global functioning (low-certainty evidence) and increased service satisfaction (moderate-certainty evidence). The evidence regarding the effect of SEI over TAU after treatment has ended is uncertain. Further evidence investigating the longer-term outcomes of SEI is needed. Furthermore, all the eligible trials included in this review were conducted in high-income countries, and it is unclear whether these findings would translate to low- and middle-income countries, where both the intervention and the comparison conditions may be different.\n\nGiven the provided abstract, please respond to the following query: \"Psychosis is treatable\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Many people recover from a first episode and never experience another psychotic episode.\nMental health professionals assess a person before recommending a specific treatment. Depending on the services available, they may send people for treatment to:\n- a community mental health team: mental health professionals who support people with complex mental health conditions;\n- a crisis resolution team: mental health professionals who treat people who would otherwise need treatment in hospital; or\n- an early intervention team: mental health professionals who work with people who are currently or have recently experienced their first episode of psychosis.\nEarly intervention teams specialise in treating recent-onset psychosis, and aim to treat it as quickly and intensively as possible."
}
]
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query-laysum | 4412 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and has a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.\nObjectives\nTo assess the effects of moisturisers for eczema.\nSearch methods\nWe searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, and GREAT. We searched five trials registers and checked references of included and excluded studies for further relevant trials.\nSelection criteria\nRandomised controlled trials in people with eczema.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 77 studies (mean duration: 6.7 weeks; 6603 participants, mean age: 18.6 years). Thirty-six studies were at high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome of participant-assessed disease severity, 13 assessed satisfaction, and 41 assessed adverse events. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).\nSix studies evaluated moisturiser versus no moisturiser. Participant-assessed disease severity and satisfaction were not assessed. Moisturiser use yielded lower SCORing Atopic Dermatitis (SCORAD) scores than no moisturiser (3 studies, 276 participants; mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) was unmet. Moisturiser use resulted in fewer flares (2 studies, 87 participants; RR 0.40, 95% CI 0.23 to 0.70), prolonged time to flare (median: 180 versus 30 days), and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30 g, 95% CI -15.3 to -3.27). There was no clear difference in adverse events (1 study, 173 participants; risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.\nWith Atopiclair, 174/232 participants reported improvement in disease severity versus 27/158 using vehicle (3 studies; RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (4 studies, 396 participants; MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (2 studies, 248 participants; RR 2.14, 95% CI 1.58 to 2.89), fewer flares (3 studies, 397 participants; RR 0.18, 95% CI 0.11 to 0.31), and lower Eczema Area and Severity Index (EASI) scores (4 studies, 426 participants; MD -4.0, 95% CI -5.42 to -2.57), but the MID was unmet. The number of participants reporting adverse events was not statistically different (4 studies, 430 participants; RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.\nParticipants reported skin improvement more frequently with urea-containing cream than placebo (1 study, 129 participants; RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (1 study, 38 participants; low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) (1 study, 128 participants; RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence), and produced fewer flares (1 study, 44 participants; RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but caused more adverse events (1 study, 129 participants; RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).\nThree studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (1 study, 134 participants; RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), which also included improved investigator-assessed SCORAD scores (1 study, 249 participants; MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but the MID was unmet. Participant satisfaction was not addressed. The number of adverse events reported was not statistically significant (2 studies, 385 participants; RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).\nFour studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (1 study, 50 participants; RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (1 study, 50 participants; RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), or investigator-assessed disease severity (3 studies, 272 participants; standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (1 study, 43 participants; RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and reduced use of topical corticosteroids (2 studies, 222 participants; MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events (1 study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).\nWe compared all moisturisers to placebo, vehicle, or no moisturiser. Participants considered moisturisers to be more effective for reducing eczema (5 studies, 572 participants; RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (7 studies, 749 participants; SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (3 studies, 296 participants; RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity scores (12 studies, 1281 participants; SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (6 studies, 607 participants; RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), without a difference in adverse events (10 studies, 1275 participants; RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).\nTopical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity scores (3 studies, 192 participants; SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (1 study, 105 participants; RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no clear difference in number of adverse events (1 study, 125 participants; RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.\nAuthors' conclusions\nMost moisturisers showed some beneficial effects; prolonging time to flare, reducing the number of flares and the amount of topical corticosteroids needed to achieve similar reductions in eczema severity. Moisturisers combined with active treatment gave better results than active treatment alone. We did not find reliable evidence that one moisturiser is better than another.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do emollients and moisturisers help control eczema?"
}
]
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query-laysum | 4413 | [
{
"role": "user",
"content": "Abstract: Background\nAllergic bronchopulmonary aspergillosis (ABPA) is an allergic reaction to colonisation of the lungs with the fungus Aspergillus fumigatus, and affects around 10% of people with cystic fibrosis. ABPA is associated with an accelerated decline in lung function. High doses of corticosteroids are the main treatment for ABPA; although the long-term benefits are not clear, and their many side effects are well-documented. A group of compounds, the azoles, have activity against A fumigatus, and have been proposed as an alternative treatment for ABPA. Of this group, itraconazole is the most active. A separate antifungal compound, amphotericin B, has been used in aerosolised form to treat invasive infection with A fumigatus, and may have potential for the treatment of ABPA. Antifungal therapy for ABPA in cystic fibrosis needs to be evaluated. This is an update of a previously published review.\nObjectives\nThe review aimed to test the hypotheses that antifungal interventions for the treatment of ABPA in cystic fibrosis:\n1. improve clinical status compared to placebo or standard therapy (no placebo); and\n2. do not have unacceptable adverse effects.\nIf benefit was demonstrated, we planned to assess the optimal type, duration, and dose of antifungal therapy.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals, and abstract books of conference proceedings. Date of the most recent search of the Group's Trials Register was 28 September 2021.\nWe searched ongoing trials registries, most recently on 11 March 2022.\nEarlier, we also approached pharmaceutical companies regarding possible unpublished trials.\nSelection criteria\nPublished or unpublished randomised controlled trials, in which antifungal treatments were compared to either placebo or no treatment, or where different doses of the same treatment were used in the treatment of ABPA in people with cystic fibrosis.\nData collection and analysis\nThe searches identified six trials; none of which met the inclusion criteria for the review.\nMain results\nWe included no completed randomised controlled trials. There is currently one ongoing trial, which we may find eligible for a future update.\nAuthors' conclusions\nAt present, there are no randomised controlled trials that evaluate the use of antifungal therapies for the treatment of ABPA in people with cystic fibrosis, although one trial is currently ongoing.\nTrials with clear outcome measures are needed to properly evaluate the use of corticosteroids in people with ABPA and cystic fibrosis.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to 28 September 2021."
}
]
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query-laysum | 4414 | [
{
"role": "user",
"content": "Abstract: Background\nHereditary ataxia syndromes can result in significant speech impairment, a symptom thought to be responsive to treatment. The type of speech impairment most commonly reported in hereditary ataxias is dysarthria. Dysarthria is a collective term referring to a group of movement disorders affecting the muscular control of speech. Dysarthria affects the ability of individuals to communicate and to participate in society. This in turn reduces quality of life. Given the harmful impact of speech disorder on a person's functioning, treatment of speech impairment in these conditions is important and evidence-based interventions are needed.\nObjectives\nTo assess the effects of interventions for speech disorder in adults and children with Friedreich ataxia and other hereditary ataxias.\nSearch methods\nOn 14 October 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE, EMBASE, CINAHL Plus, PsycINFO, Education Resources Information Center (ERIC), Linguistics and Language Behavior Abstracts (LLBA), Dissertation Abstracts and trials registries. We checked all references in the identified trials to identify any additional published data.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) or quasi-RCTs that compared treatments for hereditary ataxias with no treatment, placebo or another treatment or combination of treatments, where investigators measured speech production.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed the risk of bias of included studies using the standard methodological procedures expected by The Cochrane Collaboration. The review authors collected information on adverse effects from included studies. We did not conduct a meta-analysis as no two studies utilised the same assessment procedures within the same treatment.\nMain results\nFourteen clinical trials, involving 721 participants, met the criteria for inclusion in the review. Thirteen studies compared a pharmaceutical treatment with placebo (or a low dose of the intervention), in heterogenous groups of degenerative cerebellar ataxias. Three compounds were studied in two trials each: a levorotatory form of 5-hydroxytryptophan (L-5HT), idebenone and thyrotropin-releasing hormone tartrate (TRH-T); each of the other compounds (riluzole, varenicline, buspirone, betamethasone, coenzyme Q10 with vitamin E, α-tocopheryl quinone and erythropoietin) were studied in one trial. The 14th trial, involving a mixed group of participants with spinocerebellar ataxia, compared the effectiveness of nonspecific physiotherapy and occupational therapy within an inpatient hospital setting to no treatment. No studies utilised traditional speech therapies. We defined the primary outcome measure in this review as the percentage change (improvement) in overall speech production immediately following completion of the intervention or later, measured by any validated speech assessment tool. None of the trials included speech as a primary outcome or examined speech using any validated speech assessment tool. Eleven studies reported speech outcomes derived from a subscale embedded within disease rating scales. The remaining three studies used alternative assessments to measure speech, including mean time to produce a standard sentence, a subjective rating of speech on a 14-point analogue scale, patient-reported assessment of the impact of dysarthria on activities of daily living and acoustic measures of syllable length. One study measured speech both subjectively as part of a disease rating scale and with further measures of speech timing. Three studies utilised the Short Form-36 Health Survey (SF-36) and one used the Child Health Questionnaire as measures of general quality of life. A further study utilised the Functional Independence Measure to assess functional health.\nFive studies reported statistically significant improvement on an overall disease rating scale in which a speech subscale was included. Only three of those studies provided specific data on speech performance; all were comparisons with placebo. Improvements in overall disease severity were observed with α-tocopheryl quinone; however, no significant changes were found on the speech subscale in a group of individuals with Friedreich ataxia. A statistically significant improvement in speech according to a speech disorders subscale was observed with betamethasone. Riluzole was found to have a statistically significant effect on speech in a group of participants with mixed hereditary, sporadic and unknown origin ataxias. No significant differences were observed between treatment and placebo in any other pharmaceutical study. A statistically significant improvement in functional independence occurred at the end of the treatment period in the rehabilitation study compared to the delayed treatment group but these effects were not present 12 to 24 weeks after treatment. Of the four studies that assessed quality of life, none found a significant effect. A variety of minor adverse events were reported for the 13 pharmaceutical therapies, including gastrointestinal side effects and nausea. Serious adverse effects were reported in two participants in one of the L-5HT trials (participants discontinued due to gastrointestinal effects), and in four participants (three taking idebenone, one taking placebo) in the idebenone studies. Serious adverse events with idebenone were gastrointestinal side effects and, in people with a previous history of these events, chest pain and idiopathic thrombocytopenic purpura. The rehabilitation study did not report any adverse events.\nWe considered six studies to be at high risk of bias in some respect. We suspected inadequate blinding of participants or assessors in four studies and poor randomisation in a further two studies. There was a high risk of reporting bias in two studies and attrition bias in four studies. Only one study had a low risk of bias across all criteria. Taken together with other limitations of the studies relating to the validity of the measurement scales used, we downgraded the quality of the evidence for many of the outcomes to low or very low.\nAuthors' conclusions\nThere is insufficient and low or very low quality evidence from either RCTs or observational studies to determine the effectiveness of any treatment for speech disorder in any of the hereditary ataxia syndromes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with hereditary ataxia develop problems with co-ordinating movement, which becomes worse over time. There are a range of other symptoms but this is the main feature of this group of diseases. Symptom onset is dependent on disease type and can begin in childhood or adulthood. Some types of hereditary ataxia appear later in life, even in middle age or older. Friedreich ataxia (FRDA) is the most common of the young onset hereditary ataxias.\nSpeech difficulties are a major feature of many of these disorders. People with ataxia often seek medical help because of slower speech, slurred speech or because the voice sounds harsh, or more nasal. Such difficulties can affect how well a person is able to communicate with friends, family and workmates."
}
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query-laysum | 4415 | [
{
"role": "user",
"content": "Abstract: Background\nThe optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the third update of a review first published in 2007.\nObjectives\nTo assess the efficacy and safety of topical, medical, and surgical treatments for ST of the leg in improving local symptoms and decreasing thromboembolic complications.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (March 2017), CENTRAL (2017, Issue 2), and trials registries (March 2017). We handsearched the reference lists of relevant papers and conference proceedings.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the legs that included people with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in a superficial vein.\nData collection and analysis\nTwo authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe identified three additional trials (613 participants), therefore this update considered 33 studies involving 7296 people with ST of the legs. Treatment included fondaparinux; rivaroxaban; low molecular weight heparin (LMWH); unfractionated heparin (UFH); non-steroidal anti-inflammatory drugs (NSAIDs); compression stockings; and topical, intramuscular, or intravenous treatment to surgical interventions such as thrombectomy or ligation. Only a minority of trials compared treatment with placebo rather than an alternative treatment and many studies were small and of poor quality. Pooling of the data was possible for few outcomes, and none were part of a placebo-controlled trial. In one large, placebo-controlled RCT of 3002 participants, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.04 to 0.50; moderate-quality evidence), ST extension (RR 0.08, 95% CI 0.03 to 0.22; moderate-quality evidence), and ST recurrence (RR 0.21, 95% CI 0.08 to 0.54; moderate-quality evidence) relative to placebo. Major bleeding was infrequent in both groups with very wide CIs around risk estimate (RR 0.99, 95% CI 0.06 to 15.86; moderate-quality evidence). In one RCT on 472 high-risk participants with ST, fondaparinux was associated with a non-significant reduction of symptomatic VTE compared to rivaroxaban 10 mg (RR 0.33, 95% CI 0.03 to 3.18; low-quality evidence). There were no major bleeding events in either group (low-quality evidence). In another placebo-controlled trial, both prophylactic and therapeutic doses of LMWH (prophylactic: RR 0.44, 95% CI 0.26 to 0.74; therapeutic: RR 0.46, 95% CI 0.27 to 0.77) and NSAIDs (RR 0.46, 95% CI 0.27 to 0.78) reduced the extension (low-quality evidence) and recurrence of ST (low-quality evidence) in comparison to placebo, with no significant effects on symptomatic VTE (low-quality evidence) or major bleeding (low-quality evidence). Overall, topical treatments improved local symptoms compared with placebo, but no data were provided on the effects on VTE and ST extension. Surgical treatment combined with elastic stockings was associated with a lower VTE rate and ST progression compared with elastic stockings alone. However, the majority of studies that compared different oral treatments, topical treatments, or surgery did not report VTE, ST progression, adverse events, or treatment adverse effects.\nAuthors' conclusions\nProphylactic dose fondaparinux given for 45 days appears to be a valid therapeutic option for ST of the legs for most people. The evidence on topical treatment or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE. Further research is needed to assess the role of rivaroxaban and other direct oral factor-X or thrombin inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment in people at various risk of recurrence; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, the quality of evidence was very low for most treatments due to poor study design, imprecision of results, lack of a placebo (non-treated) group and only one study in some comparison. The quality of evidence was low to moderate for comparisons in two placebo-controlled trials.\nIn conclusion, fondaparinux appears to be an adequate treatment for most people with ST. The optimal dose and duration of treatment need to be established in people at high risk as well as people at low risk for recurrent thrombotic events. Further research is needed to assess the role of rivaroxaban and other such medicines, or thrombin, low molecular weight heparin or NSAIDs and to demonstrate the effectiveness, if any, of topical treatment, or surgery in terms of VTE."
}
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query-laysum | 4416 | [
{
"role": "user",
"content": "Abstract: Background\nManagement of rotator cuff disease may include use of electrotherapy modalities (also known as electrophysical agents), which aim to reduce pain and improve function via an increase in energy (electrical, sound, light, or thermal) into the body. Examples include therapeutic ultrasound, low-level laser therapy (LLLT), transcutaneous electrical nerve stimulation (TENS), and pulsed electromagnetic field therapy (PEMF). These modalities are usually delivered as components of a physical therapy intervention. This review is one of a series of reviews that form an update of the Cochrane review, 'Physiotherapy interventions for shoulder pain'.\nObjectives\nTo synthesise available evidence regarding the benefits and harms of electrotherapy modalities for the treatment of people with rotator cuff disease.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), Ovid MEDLINE (January 1966 to March 2015), Ovid EMBASE (January 1980 to March 2015), CINAHL Plus (EBSCOhost, January 1937 to March 2015), ClinicalTrials.gov and the WHO ICTRP clinical trials registries up to March 2015, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials, to identify potentially relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised trials, including adults with rotator cuff disease (e.g. subacromial impingement syndrome, rotator cuff tendinitis, calcific tendinitis), and comparing any electrotherapy modality with placebo, no intervention, a different electrotherapy modality or any other intervention (e.g. glucocorticoid injection). Trials investigating whether electrotherapy modalities were more effective than placebo or no treatment, or were an effective addition to another physical therapy intervention (e.g. manual therapy or exercise) were the main comparisons of interest. Main outcomes of interest were overall pain, function, pain on motion, patient-reported global assessment of treatment success, quality of life and the number of participants experiencing adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment and assessed the quality of the body of evidence for the main outcomes using the GRADE approach.\nMain results\nWe included 47 trials (2388 participants). Most trials (n = 43) included participants with rotator cuff disease without calcification (four trials included people with calcific tendinitis). Sixteen (34%) trials investigated the effect of an electrotherapy modality delivered in isolation. Only 23% were rated at low risk of allocation bias, and 49% were rated at low risk of both performance and detection bias (for self-reported outcomes). The trials were heterogeneous in terms of population, intervention and comparator, so none of the data could be combined in a meta-analysis.\nIn one trial (61 participants; low quality evidence), pulsed therapeutic ultrasound (three to five times a week for six weeks) was compared with placebo (inactive ultrasound therapy) for calcific tendinitis. At six weeks, the mean reduction in overall pain with placebo was -6.3 points on a 52-point scale, and -14.9 points with ultrasound (MD -8.60 points, 95% CI -13.48 to -3.72 points; absolute risk difference 17%, 7% to 26% more). Mean improvement in function with placebo was 3.7 points on a 100-point scale, and 17.8 points with ultrasound (mean difference (MD) 14.10 points, 95% confidence interval (CI) 5.39 to 22.81 points; absolute risk difference 14%, 5% to 23% more). Ninety-one per cent (29/32) of participants reported treatment success with ultrasound compared with 52% (15/29) of participants receiving placebo (risk ratio (RR) 1.75, 95% CI 1.21 to 2.53; absolute risk difference 39%, 18% to 60% more). Mean improvement in quality of life with placebo was 0.40 points on a 10-point scale, and 2.60 points with ultrasound (MD 2.20 points, 95% CI 0.91 points to 3.49 points; absolute risk difference 22%, 9% to 35% more). Between-group differences were not important at nine months. No participant reported adverse events.\nTherapeutic ultrasound produced no clinically important additional benefits when combined with other physical therapy interventions (eight clinically heterogeneous trials, low quality evidence). We are uncertain whether there are differences in patient-important outcomes between ultrasound and other active interventions (manual therapy, acupuncture, glucocorticoid injection, glucocorticoid injection plus oral tolmetin sodium, or exercise) because the quality of evidence is very low. Two placebo-controlled trials reported results favouring LLLT up to three weeks (low quality evidence), however combining LLLT with other physical therapy interventions produced few additional benefits (10 clinically heterogeneous trials, low quality evidence). We are uncertain whether transcutaneous electrical nerve stimulation (TENS) is more or less effective than glucocorticoid injection with respect to pain, function, global treatment success and active range of motion because of the very low quality evidence from a single trial. In other single, small trials, no clinically important benefits of pulsed electromagnetic field therapy (PEMF), microcurrent electrical stimulation (MENS), acetic acid iontophoresis and microwave diathermy were observed (low or very low quality evidence).\nNo adverse events of therapeutic ultrasound, LLLT, TENS or microwave diathermy were reported by any participants. Adverse events were not measured in any trials investigating the effects of PEMF, MENS or acetic acid iontophoresis.\nAuthors' conclusions\nBased on low quality evidence, therapeutic ultrasound may have short-term benefits over placebo in people with calcific tendinitis, and LLLT may have short-term benefits over placebo in people with rotator cuff disease. Further high quality placebo-controlled trials are needed to confirm these results. In contrast, based on low quality evidence, PEMF may not provide clinically relevant benefits over placebo, and therapeutic ultrasound, LLLT and PEMF may not provide additional benefits when combined with other physical therapy interventions. We are uncertain whether TENS is superior to placebo, and whether any electrotherapy modality provides benefits over other active interventions (e.g. glucocorticoid injection) because of the very low quality of the evidence. Practitioners should communicate the uncertainty of these effects and consider other approaches or combinations of treatment. Further trials of electrotherapy modalities for rotator cuff disease should be based upon a strong rationale and consideration of whether or not they would alter the conclusions of this review.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This summary of an updated Cochrane review presents what we know from research about the benefits and harms of electrotherapy modalities in people with rotator cuff disease. After searching for all relevant studies published up to March 2015, we included 47 trials (2388 participants). Among the included participants, 67% were women, the average age was 53 years, and the average duration of the condition was eight months. Electrotherapy was delivered for three weeks on average."
}
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query-laysum | 4417 | [
{
"role": "user",
"content": "Abstract: Background\nPrimary liver tumours and liver metastases from colorectal carcinoma are two of the most common malignant tumours to affect the liver. The liver is second only to the lymph nodes as the most common site for metastatic disease. More than half of the people with metastatic liver disease will die from metastatic complications. Electrocoagulation by diathermy is a method used to destroy tumour tissue, using a high-frequency electric current generating high temperatures, applied locally with an electrode (needle, blade, or ball). The objective of this method is to destroy the tumour completely, if possible, in a single session. With the time, electrocoagulation by diathermy has been replaced by other techniques, but the evidence is unclear.\nObjectives\nTo assess the beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus no intervention, other ablation methods, or systemic treatments in people with liver metastases.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index – Science, CINAHL, ClinicalTrials.gov, ICTRP, and FDA to October 2020.\nSelection criteria\nWe considered all randomised trials that assessed beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus comparators, in people with liver metastases, regardless of the location of the primary tumour.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We assessed risk of bias of the included trial using predefined risk of bias domains, and presented the review results incorporating the certainty of the evidence using GRADE.\nMain results\nWe included one randomised clinical trial with 306 participants (175 males; 131 females) who had undergone resection of the sigmoid colon, and who had five or more visible and palpable hepatic metastases. The diagnosis was confirmed by histological assessment (biopsy) and by carcinoembryonic antigen (CEA) level. The trial was conducted in Iraq. The age of participants ranged between 38 and 79 years. The participants were randomised to four different study groups. The liver metastases were biopsied and treated (only once) in three of the groups: 75 received electrocoagulation by diathermy alone, 76 received electrocoagulation plus allopurinol, 78 received electrocoagulation plus dimethyl sulphoxide. In the fourth intervention group, 77 participants functioning as controls received a vehicle solution of allopurinol 5 mL 4 x a day by mouth; the metastases were left untouched. The status of the liver and lungs was followed by ultrasound investigations, without the use of a contrast agent. Participants were followed for five years.\nThe analyses are based on per-protocol data only analysing 223 participants. We judged the trial to be at high risk of bias. After excluding 'nonevaluable patients', the groups seemed comparable for baseline characteristics.\nMortality due to disease spread at five-year follow-up was 98% in the electrocoagulation group (57/58 evaluable people); 87% in the electrocoagulation plus allopurinol group (46/53 evaluable people); 86% in the electrocoagulation plus dimethyl sulphoxide group (49/57 evaluable people); and 100% in the control group (55/55 evaluable people). We observed no difference in mortality between the electrocoagulation alone group versus the control group (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.94 to 1.03; 113 participants; very low-certainty evidence). We observed lower mortality in the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus the control group (RR 0.87, 95% CI 0.80 to 0.95; 165 participants; low-certainty evidence). We are very uncertain regarding post-operative deaths between the electrocoagulation alone group versus the control group (RR 1.03, 95% CI 0.07 to 16.12; 152 participants; very low-certainty evidence) and between the electrocoagulation combined with allopurinol or dimethyl sulphoxide groups versus the control group (RR 1.00, 95% CI 0.09 to 10.86; 231 participants; very low-certainty evidence).\nThe trial authors did not report data on number of participants with other adverse events and complications, recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life. Data on failure to clear liver metastases were not provided for the control group.\nThere was no information on funding or conflict of interest.\nWe identified no ongoing trials.\nAuthors' conclusions\nThe evidence on the beneficial and harmful effects of electrocoagulation alone or in combination with allopurinol or dimethyl sulphoxide in people with liver metastases is insufficient, as it is based on one randomised clinical trial at low to very low certainty.\nIt is very uncertain if there is a difference in all-cause mortality and post-operative mortality between electrocoagulation alone versus control. It is also uncertain if electrocoagulation in combination with allopurinol or dimethyl sulphoxide may result in a slight reduction of all-cause mortality in comparison with a vehicle solution of allopurinol (control). It is very uncertain if there is a difference in post-operative mortality between the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus control. Data on other adverse events and complications, failure to clear liver metastases or recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life were most lacking or insufficiently reported for analysis.\nElectrocoagulation by diathermy is no longer used in the described way, and this may explain the lack of further trials.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the evidence to be of low to very low certainty because the trial was not properly performed, putting it at high risk of bias regarding the reliability of the obtained data. The trial included a relatively small number of participants and it described overall few events. The reported results were insufficient as only few outcomes of interest to people with liver metastases and their doctors were reported.\nElectrocoagulation by diathermy is no longer used in the way it is described in the trial as it has been replaced by other techniques. This could be a reason for the lack of further trials."
}
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query-laysum | 4418 | [
{
"role": "user",
"content": "Abstract: Background\nAmong subfertile women undergoing assisted reproductive technology (ART), hormone pills given before ovarian stimulation may improve outcomes.\nObjectives\nTo determine whether pretreatment with the combined oral contraceptive pill (COCP) or with a progestogen or oestrogen alone in ovarian stimulation protocols affects outcomes in subfertile couples undergoing ART.\nSearch methods\nWe searched the following databases from inception to January 2017: Cochrane Gynaecology and Fertility Group Specialised Register, The Cochrane Central Register Studies Online, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the reference lists of relevant articles and registers of ongoing trials.\nSelection criteria\nRandomised controlled trials (RCTs) of hormonal pretreatment in women undergoing ART.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were live birth or ongoing pregnancy and pregnancy loss.\nMain results\nWe included 29 RCTs (4701 women) of pretreatment with COCPs, progestogens or oestrogens versus no pretreatment or alternative pretreatments, in gonadotrophin-releasing hormone (GnRH) agonist or antagonist cycles. Overall, evidence quality ranged from very low to moderate. The main limitations were risk of bias and imprecision. Most studies did not describe their methods in adequate detail.\nCombined oral contraceptive pill versus no pretreatment\nWith antagonist cycles in both groups the rate of live birth or ongoing pregnancy was lower in the pretreatment group (OR 0.74, 95% CI 0.58 to 0.95; 6 RCTs; 1335 women; I2 = 0%; moderate quality evidence). There was insufficient evidence to determine whether the groups differed in rates of pregnancy loss (OR 1.36, 95% CI 0.82 to 2.26; 5 RCTs; 868 women; I2 = 0%; moderate quality evidence), multiple pregnancy (OR 2.21, 95% CI 0.53 to 9.26; 2 RCTs; 125 women; I2 = 0%; low quality evidence), ovarian hyperstimulation syndrome (OHSS; OR 0.98, 95% CI 0.28 to 3.40; 2 RCTs; 642 women; I2 = 0%, low quality evidence), or ovarian cyst formation (OR 0.47, 95% CI 0.08 to 2.75; 1 RCT; 64 women; very low quality evidence).\nIn COCP plus antagonist cycles versus no pretreatment in agonist cycles, there was insufficient evidence to determine whether the groups differed in rates of live birth or ongoing pregnancy (OR 0.89, 95% CI 0.64 to 1.25; 4 RCTs; 724 women; I2 = 0%; moderate quality evidence), multiple pregnancy (OR 1.36, 95% CI 0.85 to 2.19; 4 RCTs; 546 women; I2 = 0%; moderate quality evidence), or OHSS (OR 0.63, 95% CI 0.20 to 1.96; 2 RCTs; 290 women, I2 = 0%), but there were fewer pregnancy losses in the pretreatment group (OR 0.40, 95% CI 0.22 to 0.72; 5 RCTs; 780 women; I2 = 0%; moderate quality evidence). There were no data suitable for analysis on ovarian cyst formation.\nOne small study comparing COCP versus no pretreatment in agonist cycles showed no clear difference between the groups for any of the reported outcomes.\nProgestogen versus no pretreatment\nAll studies used the same protocol (antagonist, agonist or gonadotrophins) in both groups. There was insufficient evidence to determine any differences in rates of live birth or ongoing pregnancy (agonist: OR 1.35, 95% CI 0.69 to 2.65; 2 RCTs; 222 women; I2 = 24%; low quality evidence; antagonist: OR 0.67, 95% CI 0.18 to 2.54; 1 RCT; 47 women; low quality evidence; gonadotrophins: OR 0.63, 95% CI 0.09 to 4.23; 1 RCT; 42 women; very low quality evidence), pregnancy loss (agonist: OR 2.26, 95% CI 0.67 to 7.55; 2 RCTs; 222 women; I2 = 0%; low quality evidence; antagonist: OR 0.36, 95% CI 0.06 to 2.09; 1 RCT; 47 women; low quality evidence; gonadotrophins: OR 1.00, 95% CI 0.06 to 17.12; 1 RCT; 42 women; very low quality evidence) or multiple pregnancy (agonist: no data available; antagonist: OR 1.05, 95% CI 0.06 to 17.76; 1 RCT; 47 women; low quality evidence; gonadotrophins: no data available). Three studies, all using agonist cycles, reported ovarian cyst formation: rates were lower in the pretreatment group (OR 0.16, 95% CI 0.08 to 0.32; 374 women; I2 = 1%; moderate quality evidence). There were no data on OHSS.\nOestrogen versus no pretreatment\nIn antagonist or agonist cycles, there was insufficient evidence to determine whether the groups differed in rates of live birth or ongoing pregnancy (antagonist versus antagonist: OR 0.79, 95% CI 0.53 to 1.17; 2 RCTs; 502 women; I2 = 0%; low quality evidence; antagonist versus agonist: OR 0.88, 95% CI 0.51 to 1.50; 2 RCTs; 242 women; I2 = 0%; very low quality evidence), pregnancy loss (antagonist versus antagonist: OR 0.16, 95% CI 0.02 to 1.47; 1 RCT; 49 women; very low quality evidence; antagonist versus agonist: OR 1.59, 95% CI 0.62 to 4.06; 1 RCT; 220 women; very low quality evidence), multiple pregnancy (antagonist versus antagonist: no data available; antagonist versus agonist: OR 2.24, 95% CI 0.09 to 53.59; 1 RCT; 22 women; very low quality evidence) or OHSS (antagonist versus antagonist: no data available; antagonist versus agonist: OR 1.54, 95% CI 0.25 to 9.42; 1 RCT; 220 women). Ovarian cyst formation was not reported.\nHead-to-head comparisons\nCOCP was compared with progestogen (1 RCT, 44 women), and with oestrogen (2 RCTs, 146 women), and progestogen was compared with oestrogen (1 RCT, 48 women), with an antagonist cycle in both groups. COCP in an agonist cycle was compared with oestrogen in an antagonist cycle (1 RCT, 25 women). Data were scant but there was no clear evidence that any of the groups differed in rates of live birth or ongoing pregnancy, pregnancy loss or other adverse events.\nAuthors' conclusions\nAmong women undergoing ovarian stimulation in antagonist protocols, COCP pretreatment was associated with a lower rate of live birth or ongoing pregnancy than no pretreatment. There was insufficient evidence to determine whether rates of live birth or ongoing pregnancy were influenced by pretreatment with progestogens or oestrogens, or by COCP pretreatment using other stimulation protocols. Findings on adverse events were inconclusive, except that progesterone pretreatment may reduce the risk of ovarian cysts in agonist cycles, and COCP in antagonist cycles may reduce the risk of pregnancy loss compared with no pretreatment in agonist cycles.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ".\nOverall evidence quality ranged from very low to moderate. The main problems were risk of bias and imprecision. Most studies did not describe their methods in adequate detail."
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query-laysum | 4419 | [
{
"role": "user",
"content": "Abstract: Background\nTriple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with shorter survival and a higher likelihood of the cancer returning. In early TNBC, platinum-based chemotherapy has been shown to improve pathological complete response (pCR); however, its effect on long-term survival outcomes has not been fully elucidated and recommendations to include platinum chemotherapy are not consistent in international guidelines.\nObjectives\nTo evaluate the benefits and harms of platinum-based chemotherapy as adjuvant and neoadjuvant treatment in people with early triple-negative breast cancer.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 4 April 2022.\nSelection criteria\nWe included randomised controlled trials examining neoadjuvant or adjuvant platinum chemotherapy for early TNBC.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were disease-free survival (DFS) and overall survival (OS). Our secondary outcomes were pCR, treatment adherence, grade III or IV toxicity related to chemotherapy, and quality of life. Prespecified subgroups included BRCA mutation status, homologous recombination deficiency (HRD) status, frequency of chemotherapy, type of platinum agent used, and the presence or absence of anthracycline chemotherapy. We assessed risk of bias using Cochrane's RoB 1 tool and certainty of evidence using the GRADE approach.\nMain results\nFrom 3972 records, we included 20 published studies involving 21 treatment comparisons, and 25 ongoing studies. For most domains, risk of bias was low across studies. There were 16 neoadjuvant chemotherapy studies (one of which combined neoadjuvant and adjuvant therapy) and four adjuvant chemotherapy trials. Most studies used carboplatin (17 studies) followed by cisplatin (two), and lobaplatin (one). Eight studies had an anthracycline-free intervention arm, five of which had a carboplatin-taxane intervention compared to an anthracycline-taxane control.\nAll studies reporting DFS and OS used carboplatin. Inclusion of platinum chemotherapy improved DFS in neoadjuvant and adjuvant settings (neoadjuvant: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.53 to 0.75; 7 studies, 8 treatment comparisons, 1966 participants; high-certainty evidence; adjuvant: HR 0.69, 95% CI 0.54 to 0.88; 4 studies, 1256 participants; high-certainty evidence). Platinum chemotherapy in the regimen improved OS (neoadjuvant: HR 0.69, 95% CI 0.55 to 0.86; 7 studies, 8 treatment comparisons, 1973 participants; high-certainty evidence; adjuvant: 0.70, 95% CI 0.50 to 0.96; 4 studies, 1256 participants; high-certainty evidence). Median follow-up for survival outcomes ranged from 36 to 97.6 months.\nOur analysis confirmed platinum chemotherapy increased pCR rates (risk ratio (RR) 1.44, 95% CI 1.31 to 1.59; 15 studies, 16 treatment comparisons, 3083 participants; high-certainty evidence). Subgroup analyses showed no evidence of differences in DFS according to BRCA mutation status, HRD status, lymph node status, or whether the intervention arm contained anthracycline chemotherapy or not.\nPlatinum chemotherapy was associated with reduced dose intensity, with participants more likely to require chemotherapy delays (RR 2.23, 95% CI 1.70 to 2.94; 4 studies, 5 treatment comparisons, 1053 participants; moderate-certainty evidence), dose reductions (RR 1.77, 95% CI 1.56 to 2.02; 7 studies, 8 treatment comparisons, 2055 participants; moderate-certainty evidence) and early cessation of treatment (RR 1.20, 95% CI 1.04 to 1.38; 16 studies, 17 treatment comparisons, 4178 participants; moderate-certainty evidence). Increased haematological toxicity occurred in the platinum group who were more likely to experience grade III/IV neutropenia (RR 1.53, 95% CI 1.43 to 1.63; 19 studies, 20 treatment comparisons, 4849 participants; moderate-certainty evidence), anaemia (RR 8.20, 95% CI 5.66 to 11.89; 18 studies, 19 treatment comparisons, 4757 participants; moderate-certainty evidence) and thrombocytopenia (RR 7.59, 95% CI 5.10 to 11.29; 18 studies, 19 treatment comparisons, 4731 participants; moderate-certainty evidence). There was no evidence of a difference between chemotherapy groups in febrile neutropenia (RR 1.16, 95% CI 0.89 to 1.49; 11 studies, 3771 participants; moderate-certainty evidence). Renal impairment was very rare (0.4%, 2 events in 463 participants; note 3 studies reported 0 events in both arms; 4 studies; high-certainty evidence). Treatment-related death was very rare (0.2%, 7 events in 3176 participants and similar across treatment groups; RR 0.58, 95% 0.14 to 2.33; 10 studies, 11 treatment comparisons; note 8 studies reported treatment-related deaths but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 3 studies rather than 11; 3176 participants; high-certainty evidence). Five studies collected quality of life data but did not report them.\nAuthors' conclusions\nPlatinum-based chemotherapy using carboplatin in the adjuvant or neoadjuvant setting improves long-term outcomes of DFS and OS in early TNBC, with no evidence of differences by subgroup. This was at the cost of more frequent chemotherapy delays and dose reductions, and greater haematological toxicity, though serious adverse events including neuropathy, febrile neutropenia or treatment-related death were not increased.\nThese findings support the use of platinum-based chemotherapy for people with early TNBC. The optimal dose and regimen are not defined by this analysis, but there is a suggestion that similar relative benefits result from the addition of carboplatin to either anthracycline-free regimens or those containing anthracycline agents.\n\nGiven the provided abstract, please respond to the following query: \"How is early triple-negative breast cancer treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Treatments for early triple-negative breast cancer include:\n– surgery to remove the cancer from the breast and lymph nodes;\n– radiotherapy to the breast and lymph nodes, used to prevent the cancer from coming back in these areas;\n– chemotherapy, used to prevent the cancer from coming back anywhere in the body. This can be given before surgery (called 'neoadjuvant') or after surgery (called 'adjuvant')."
}
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query-laysum | 4420 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in older people. Opioids may be a viable treatment option if people have severe pain or if other analgesics are contraindicated. However, the evidence about their effectiveness and safety is contradictory. This is an update of a Cochrane review first published in 2009.\nObjectives\nTo determine the effects on pain, function, safety, and addiction of oral or transdermal opioids compared with placebo or no intervention in people with knee or hip osteoarthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and CINAHL (up to 28 July 2008, with an update performed on 15 August 2012), checked conference proceedings, reference lists, and contacted authors.\nSelection criteria\nWe included randomised or quasi-randomised controlled trials that compared oral or transdermal opioids with placebo or no treatment in people with knee or hip osteoarthritis. We excluded studies of tramadol. We applied no language restrictions.\nData collection and analysis\nWe extracted data in duplicate. We calculated standardised mean differences (SMDs) and 95% confidence intervals (CI) for pain and function, and risk ratios for safety outcomes. We combined trials using an inverse-variance random-effects meta-analysis.\nMain results\nWe identified 12 additional trials and included 22 trials with 8275 participants in this update. Oral oxycodone was studied in 10 trials, transdermal buprenorphine and oral tapentadol in four, oral codeine in three, oral morphine and oral oxymorphone in two, and transdermal fentanyl and oral hydromorphone in one trial each. All trials were described as double-blind, but the risk of bias for other domains was unclear in several trials due to incomplete reporting. Opioids were more beneficial in pain reduction than control interventions (SMD -0.28, 95% CI -0.35 to -0.20), which corresponds to a difference in pain scores of 0.7 cm on a 10-cm visual analogue scale (VAS) between opioids and placebo. This corresponds to a difference in improvement of 12% (95% CI 9% to 15%) between opioids (41% mean improvement from baseline) and placebo (29% mean improvement from baseline), which translates into a number needed to treat (NNTB) to cause one additional treatment response on pain of 10 (95% CI 8 to 14). Improvement of function was larger in opioid-treated participants compared with control groups (SMD -0.26, 95% CI -0.35 to -0.17), which corresponds to a difference in function scores of 0.6 units between opioids and placebo on a standardised Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability scale ranging from 0 to 10. This corresponds to a difference in improvement of 11% (95% CI 7% to 14%) between opioids (32% mean improvement from baseline) and placebo (21% mean improvement from baseline), which translates into an NNTB to cause one additional treatment response on function of 11 (95% CI 7 to 14). We did not find substantial differences in effects according to type of opioid, analgesic potency, route of administration, daily dose, methodological quality of trials, and type of funding. Trials with treatment durations of four weeks or less showed larger pain relief than trials with longer treatment duration (P value for interaction = 0.001) and there was evidence for funnel plot asymmetry (P value = 0.054 for pain and P value = 0.011 for function). Adverse events were more frequent in participants receiving opioids compared with control. The pooled risk ratio was 1.49 (95% CI 1.35 to 1.63) for any adverse event (9 trials; 22% of participants in opioid and 15% of participants in control treatment experienced side effects), 3.76 (95% CI 2.93 to 4.82) for drop-outs due to adverse events (19 trials; 6.4% of participants in opioid and 1.7% of participants in control treatment dropped out due to adverse events), and 3.35 (95% CI 0.83 to 13.56) for serious adverse events (2 trials; 1.3% of participants in opioid and 0.4% of participants in control treatment experienced serious adverse events). Withdrawal symptoms occurred more often in opioid compared with control treatment (odds ratio (OR) 2.76, 95% CI 2.02 to 3.77; 3 trials; 2.4% of participants in opioid and 0.9% of participants control treatment experienced withdrawal symptoms).\nAuthors' conclusions\nThe small mean benefit of non-tramadol opioids are contrasted by significant increases in the risk of adverse events. For the pain outcome in particular, observed effects were of questionable clinical relevance since the 95% CI did not include the minimal clinically important difference of 0.37 SMDs, which corresponds to 0.9 cm on a 10-cm VAS.\n\nGiven the provided abstract, please respond to the following query: \"The review shows that in people with osteoarthritis\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Opioids have a small effect on pain or physical function.\n- Opioids probably cause side effects. However, we do not have precise information about rare but serious side effects."
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query-laysum | 4421 | [
{
"role": "user",
"content": "Abstract: Background\nHepatitis B virus (HBV) infection is a liver disease caused by hepatitis B virus, which may lead to serious complications such as cirrhosis and hepatocellular carcinoma. People with HBV infection may also have coinfections including HIV and other hepatitis viruses (hepatitis C or D), and coinfections may increase the risk of all-cause mortality. Chronic HBV infection increases morbidity, psychological stress, and it is an economic burden on people with chronic hepatitis B and their families. Radix Sophorae flavescentis, a herbal medicine, is administered mostly in combination with other drugs or herbs. It is believed that it decreases discomfort and prevents the replication of the virus in people with chronic hepatitis B. However, the benefits and harms of Radix Sophorae flavescentis on patient-centred outcomes are unknown, and its wide usage has never been established with rigorous review methodology.\nObjectives\nTo assess the benefits and harms of Radix Sophorae flavescentis versus other drugs or herbs in people with chronic hepatitis B.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and seven other databases to December 2018. We also searched the World Health Organization International Clinical Trials Registry Platform (www.who.int/ictrp), ClinicalTrials.gov (www.clinicaltrials.gov/), and the Chinese Clinical Trial Registry for ongoing or unpublished trials to December 2018.\nSelection criteria\nWe included randomised clinical trials, irrespective of publication status, language, or blinding, comparing Radix Sophorae flavescentis versus other drugs or herbs for people with chronic hepatitis B. In addition to chronic hepatitis B, participants could also have had cirrhosis, hepatocellular carcinoma, or any other concomitant disease. We excluded polyherbal blends containing Radix Sophorae flavescentis. We allowed cointerventions when the cointerventions were administered equally to all intervention groups.\nData collection and analysis\nReview authors in pairs individually retrieved data from published reports and after correspondence with investigators. Our primary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. Our secondary outcomes were hepatitis B-related mortality, hepatitis B-related morbidity, and adverse events considered 'not to be serious'. We presented the meta-analysed results as risk ratios (RR) with 95% confidence intervals (CI). We assessed the risk of bias using domains with predefined definitions. We conducted Trial Sequential Analyses to control the risks of random errors. We used GRADE methodology to evaluate our certainty in the evidence (i.e. \"the extent of our confidence that the estimates of the effect are correct or are adequate to support a particular decision or recommendation\").\nMain results\nWe included 10 randomised clinical trials with 898 participants. We judged all trials at high risk of bias. The trials covered oral capsules, intravenous infusion, intramuscular injection, and acupoint (a specifically chosen site of acupuncture) injection of Radix Sophorae flavescentis with a follow-up period from 1 to 12 months. The drugs being used as a comparator were lamivudine, adefovir, interferon, tiopronin, thymosin, or other Chinese herbs. Two trials included children up to 14 years old. Participants in one trial had cirrhosis in chronic hepatitis B. None of the trials reported all-cause mortality, health-related quality of life, serious adverse events, hepatitis B-related mortality, or morbidity. We are uncertain as to whether Radix Sophorae flavescentis has a beneficial or harmful effect on adverse events considered 'not to be serious' (RR 0.86, 95% CI 0.42 to 1.75; I2 = 0%; 2 trials, 163 participants; very low-certainty evidence), as well as if it decreases or increases the proportion of participants with detectable HBV-DNA (RR 1.14, 95% CI 0.81 to 1.63; I2 = 92%; 8 trials, 719 participants; very low-certainty evidence). Radix Sophorae flavescentis showed a reduction in the proportion of participants with detectable hepatitis B virus e-antigen (HBeAg) (RR 0.86, 95% CI 0.75 to 0.98; I2 = 43%; 7 trials, 588 participants; very low-certainty evidence).\nTwo of the 10 trials were not funded, and one received academic funding. The remaining seven trials provided no information on funding.\nThe randomisation process in another 109 trials was insufficiently reported to ensure the inclusion of any of these studies in our review.\nAuthors' conclusions\nThe included trials lacked data on all-cause mortality, health-related quality of life, serious adverse events, hepatitis-B related mortality, and hepatitis-B related morbidity. The evidence on the effect of Radix Sophorae flavescentis on the proportion of participants with adverse events considered 'not to be serious' and on the proportion of participants with detectable HBV-DNA is still unclear. We advise caution regarding the results of Radix Sophorae flavescentis showing a reduction in the proportion of people with detectable HBeAg because the trials were at high risk of bias, because it is a non-validated surrogate outcome, and because of the very low certainty in the evidence. As we were unable to obtain information on a large number of studies regarding their trial design, we were deterred from including them in our review. Undisclosed funding may have influence on trial results and lead to poor design of the trial. In view of the wide usage of Radix Sophorae flavescentis, we need large, unbiased, high-quality placebo-controlled randomised trials assessing patient-centred outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 10 randomised clinical trials (clinical studies where people are randomly put into one of two or more treatment groups) with 898 participants. All the trials were at high risk of bias. The trials covered oral capsules, intravenous (into a vein) infusion, intramuscular (into a muscle) injection, and acupoint (a specifically chosen site of acupuncture) injection of Radix Sophorae flavescentis with treatment duration from 1 month to 12 months. Radix Sophorae flavescentis was compared with lamivudine, adefovir, interferon, tiopronin, thymosin, and other Chinese herbs. Two trials included children up to 14 years old. Participants in one trial had cirrhosis (late stage of scarring of the liver) in chronic hepatitis B."
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query-laysum | 4422 | [
{
"role": "user",
"content": "Abstract: Background\nPharmacological interventions are the most used treatment for low back pain (LBP). Use of evidence from systematic reviews of the effects of pharmacological interventions for LBP published in the Cochrane Library, is limited by lack of a comprehensive overview.\nObjectives\nTo summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non-specific LBP.\nMethods\nThe Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non-specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.\nMain results\nSeven Cochrane Reviews that included 103 studies (22,238 participants) were included. There is high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub-acute LBP and five reviews included participants with chronic LBP.\nAcute LBP\nParacetamol\nThere was high-certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI -0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).\nNSAIDs\nThere was moderate-certainty evidence for a small between-group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD -7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -10.98 to -3.61), high-certainty evidence for a small between-group difference for reducing disability (MD -2.02 on a 0-24 scale (higher scores indicate worse disability), 95% CI -2.89 to -1.15), and very low-certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).\nMuscle relaxants and benzodiazepines\nThere was moderate-certainty evidence for a small between-group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).\nOpioids\nNone of the included Cochrane Reviews aimed to identify evidence for acute LBP.\nAntidepressants\nNo evidence was identified by the included reviews for acute LBP.\nChronic LBP\nParacetamol\nNo evidence was identified by the included reviews for chronic LBP.\nNSAIDs\nThere was low-certainty evidence for a small between-group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD -6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -10.74 to -3.19), reducing disability (MD -0.85 on a 0-24 scale (higher scores indicate worse disability), 95% CI -1.30 to -0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI -0.92 to 1.17), all at intermediate-term follow-up (> 3 months and ≤ 12 months postintervention).\nMuscle relaxants and benzodiazepines\nThere was low-certainty evidence for a small between-group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low-certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).\nOpioids\nThere was high-certainty evidence for a small between-group difference favouring tapentadol compared to placebo at reducing pain intensity (MD -8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -1.22 to -0.38), moderate-certainty evidence for a small between-group difference favouring strong opioids for reducing pain intensity (SMD -0.43, 95% CI -0.52 to -0.33), low-certainty evidence for a medium between-group difference favouring tramadol for reducing pain intensity (SMD -0.55, 95% CI -0.66 to -0.44) and very low-certainty evidence for a small between-group difference favouring buprenorphine for reducing pain intensity (SMD -0.41, 95% CI -0.57 to -0.26).\nThere was moderate-certainty evidence for a small between-group difference favouring strong opioids compared to placebo for reducing disability (SMD -0.26, 95% CI -0.37 to -0.15), moderate-certainty evidence for a small between-group difference favouring tramadol for reducing disability (SMD -0.18, 95% CI -0.29 to -0.07), and low-certainty evidence for a small between-group difference favouring buprenorphine for reducing disability (SMD -0.14, 95% CI -0.53 to -0.25).\nThere was low-certainty evidence for a small between-group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).\nAntidepressants\nThere was low-certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD -0.04, 95% CI -0.25 to 0.17) and reducing disability (SMD -0.06, 95% CI -0.40 to 0.29).\nAuthors' conclusions\nWe found no high- or moderate-certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate-certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high-certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low- and high-certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate-certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low-certainty evidence that NSAIDs and very low- to high-certainty evidence that opioids may provide a small effect on pain. For safety, we found low-certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low-certainty evidence that opioids may increase the risk of adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What is low back pain and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "Low back pain (LBP) is a common and debilitating health condition. In most cases, the cause or causes of low back pain cannot be reliably identified and is described as ‘non-specific’ LBP. Physicians commonly prescribe medicines to treat LBP. There are many types of medicines and medicine classes available, for example, opioid analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), and paracetamol. With so many options available, there is a need to determine which medicines are best and safest."
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query-laysum | 4423 | [
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"role": "user",
"content": "Abstract: Background\nUterine tachysystole (more than 5 contractions per 10 minutes in 2 consecutive intervals) is common during labour, particularly with use of labour-stimulating agents. Tachysystole may reduce fetal oxygenation by interrupting maternal blood flow to the placenta during contractions. Reducing uterine contractions may improve placental blood flow, improving fetal oxygenation. This review aimed to evaluate the use of tocolytics to reduce or stop uterine contractions for improvement of the condition of the fetus in utero. This new review supersedes an earlier Cochrane Review on the same topic.\nObjectives\nTo assess the effects of the use of acute tocolysis during labour for uterine tachysystole or suspected fetal distress, or both, on fetal, maternal and neonatal outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (2 February 2018), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating acute tocolysis for uterine tachysystole, intrapartum fetal distress, or both.\nData collection and analysis\nWe used standard methods expected by Cochrane.\nMain results\nWe included eight studies (734 women), conducted in hospital settings, predominantly in high-income countries (USA, Austria, Uruguay). Two trials were conducted in upper and lower middle-income countries (South Africa, Sri Lanka). The hospital facilities all had the capacity to perform caesarean section. Overall, the studies had a low risk of bias, except for methods to maintain blinding. All of the trials used a selective beta2 (ß2)-adrenergic agonist in one arm, however the drug used varied, as did the comparator. Limited information was available on maternal outcomes.\nSelective ß2-adrenergic agonist versus no tocolytic agent, whilst awaiting emergency delivery\nThere were two stillbirths, both in the no tocolytic control group (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.01 to 4.55; 2 studies, 57 women; low-quality evidence). One had gross hydrocephalus and the second occurred with vaginal delivery after waiting 55 minutes for caesarean section. The decision for caesarean section delivery was an inclusion criterion in both studies so we could not assess this as an outcome under this comparison. Abnormal fetal heart trace is probably lower with tocolytic treatment (RR 0.28, 95% CI 0.08 to 0.95; 2 studies, 43 women; moderate-quality evidence). The effects on the number of babies with Apgar score below seven were uncertain (low-quality evidence).\nIntravenous (IV) atosiban versus IV hexoprenaline (1 study, 26 women)\nOne infant in the hexoprenaline group required > 24 hours in the neonatal intensive care unit (NICU) following a forceps delivery (RR 0.33, 95% CI 0.01 to 7.50; low-quality evidence). There were no fetal or neonatal mortalities and no Apgar scores below seven. There was one caesarean delivery in the IV hexoprenaline group (RR 0.33, 95% CI 0.01 to 7.50; low-quality evidence), and one case of abnormal fetal heart score in the atosiban group (RR 3.00, 95% CI 0.13 to 67.51; very low-quality evidence).\nIV fenoterol bromhydrate versus emergency delivery (1 study, 390 women)\nNo data were reported for perinatal death, severe morbidity or fetal or neonatal mortality. IV fenoterol probably increases the risk of caesarean delivery (RR 1.12, 95% CI 1.04 to 1.22; moderate-quality evidence). Fenoterol may have little or no effect on the risk of Apgar scores below seven (RR 1.28, 95% CI 0.35 to 4.68; low-quality evidence).\nIV hexoprenaline versus no tocolytic agent, whilst awaiting emergency delivery (1 study, 37 women)\nNo data were reported for perinatal death or severe morbidity. There were two fetal deaths in the no tocolytic control group (RR 0.23, 95% CI 0.01 to 4.55; low-quality evidence). The rate of caesarean delivery was not reported. There were two babies with Apgar scores below seven in the control group and none in the hexoprenaline group (RR 0.24, 95% CI 0.01 to 4.57; 35 women; low-quality evidence).\nSubcutaneous terbutaline versus IV magnesium sulphate (1 study, 46 women)\nNo data were reported for perinatal death, severe morbidity or fetal or neonatal mortality. The decision for caesarean section was an inclusion criterion, so we could not assess this. The effects on abnormal fetal heart trace are uncertain (very low-quality evidence).\nSubcutaneous terbutaline with continuation of oxytocic infusion versus cessation of oxytocic infusion without tocolytic agent (1 study, 28 women)\nNo data were reported for perinatal death, severe morbidity or fetal or neonatal mortality. There may be little or no difference in the rates of caesarean delivery in the subcutaneous terbutaline (8/15) and control groups (4/13) (RR 1.73, 95% CI 0.68 to 4.45; low-quality evidence). There were no cases of Apgar scores below seven or abnormal fetal heart trace.\nSubcutaneous terbutaline versus no tocolytic agent, whilst awaiting emergency delivery (1 study, 20 women)\nNo data were reported for perinatal death or severe morbidity. There were no fetal or neonatal mortalities. The decision for caesarean section was an inclusion criterion, so we could not assess this. There were two babies with Apgar scores below seven in the control group and none in the terbutaline group (RR 0.17, 95% CI 0.01 to 3.08; low-quality evidence).\nIV terbutaline versus IV nitroglycerin (1 study, 110 women)\nNo data were reported for perinatal death or severe morbidity or fetal or neonatal mortality. There may be little or no difference in the rates of caesarean delivery between the IV terbutaline (30/57) and control groups (29/53) (RR 0.96, 95% CI 0.68 to 1.36; low-quality evidence). There were no cases of Apgar scores below seven.\nAuthors' conclusions\nThere is insufficient evidence to determine the effects of tocolytics for uterine tachysystole or suspected fetal distress during labour. The clinical significance for some of the improvements in measures of fetal well-being with tocolytics is unclear. The sample sizes were too small to detect effects on neonatal morbidity, mortality or serious adverse effects. The majority of studies are from high-income countries in facilities with access to caesarean section, which may limit the generalisability of the results to lower-resource settings, or settings where caesarean section is not available.\nFurther well-designed and adequately powered RCTs are required to evaluate clinically relevant indicators of maternal and neonatal morbidity and mortality.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There is not enough evidence from randomised controlled trials to determine the effects of tocolysis for women with fetal distress or excessive uterine contractions, nor to identify whether one type of tocolytic drug is safer or more effective than another.\nThe clinical significance for some of improvements in measures of fetal well-being with tocolytics is unclear. Generally, sample sizes were too small to detect effects on maternal or infant well-being or serious adverse effects. The majority of studies were from high-income countries in healthcare facilities with access to caesarean section, which may limit the applicability of these results to lower-resource settings, or settings where caesarean section is not available.\nFurther high-quality studies, involving large numbers of women, are needed. Such studies could focus on measuring clinically relevant outcomes for the mother and her baby such as death of the mother, her baby, and other measures of well-being and safety."
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query-laysum | 4424 | [
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"role": "user",
"content": "Abstract: Background\nLength of postnatal hospital stay has declined dramatically in the past 50 years. There is ongoing controversy about whether staying less time in hospital is harmful or beneficial. This is an update of a Cochrane Review first published in 2002, and previously updated in 2009.\nObjectives\nTo assess the effects of a policy of early postnatal discharge from hospital for healthy mothers and term infants in terms of important maternal, infant and paternal health and related outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (21 May 2021) and the reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials comparing early discharge from hospital of healthy mothers and term infants (at least 37 weeks' gestation and greater than or equal to 2500 g), with the standard care in the respective settings in which trials were conducted. Trials using allocation methods that were not truly random (e.g. based on patient number or day of the week), trials with a cluster-randomisation design and trials published only in abstract form were also eligible for inclusion.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted and checked data for accuracy, and assessed the certainty of evidence using the GRADE approach. We contacted authors of ongoing trials for additional information.\nMain results\nWe identified 17 trials (involving 9409 women) that met our inclusion criteria. We did not identify any trials from low-income countries. There was substantial variation in the definition of 'early discharge', ranging from six hours to four to five days. The extent of antenatal preparation and midwifery home care offered to women following discharge in intervention and control groups also varied considerably among trials. Nine trials recruited and randomised women in pregnancy, seven trials randomised women following childbirth and one did not report whether randomisation took place before or after childbirth.\nRisk of bias was generally unclear in most domains due to insufficient reporting of trial methods. The certainty of evidence is moderate to low and the reasons for downgrading were high or unclear risk of bias, imprecision (low numbers of events or wide 95% confidence intervals (CI)), and inconsistency (heterogeneity in direction and size of effect).\nInfant outcomes\nEarly discharge probably slightly increases the number of infants readmitted within 28 days for neonatal morbidity (including jaundice, dehydration, infections) (risk ratio (RR) 1.59, 95% CI 1.27 to 1.98; 6918 infants; 10 studies; moderate-certainty evidence). In the early discharge group, the risk of infant readmission was 69 per 1000 infants compared to 43 per 1000 infants in the standard care group. It is uncertain whether early discharge has any effect on the risk of infant mortality within 28 days (RR 0.39, 95% CI 0.04 to 3.74; 4882 infants; two studies; low-certainty evidence). Early postnatal discharge probably makes little to no difference in the number of infants having at least one unscheduled medical consultation or contact with health professionals within the first four weeks after birth (RR 0.88, 95% CI 0.67 to 1.16; 639 infants; four studies; moderate-certainty evidence).\nMaternal outcomes\nEarly discharge probably results in little to no difference in women readmitted within six weeks postpartum for complications related to childbirth (RR 1.12, 95% CI 0.82 to 1.54; 6992 women; 11 studies; moderate-certainty evidence) but the wide 95% CI indicates the possibility that the true effect is either an increase or a reduction in risk. Similarly, early discharge may result in little to no difference in the risk of depression within six months postpartum (RR 0.80, 95% CI 0.46 to 1.42; 4333 women; five studies; low-certainty evidence) but the wide 95% CI suggests the possibility that the true effect is either an increase or a reduction in risk.\nEarly discharge probably results in little to no difference in women breastfeeding at six weeks postpartum (RR 1.04, 95% CI 0.96 to 1.13; 7156 women; 10 studies; moderate-certainty evidence) or in the number of women having at least one unscheduled medical consultation or contact with health professionals (RR 0.72, 95% CI 0.43 to 1.20; 464 women; two studies; moderate-certainty evidence).\nMaternal mortality within six weeks postpartum was not reported in any of the studies.\nCosts\nEarly discharge may slightly reduce the costs of hospital care in the period immediately following the birth up to the time of discharge (low-certainty evidence; data not pooled) but it may result in little to no difference in costs of postnatal care following discharge from hospital, in the period up to six weeks after the birth (low-certainty evidence; data not pooled).\nAuthors' conclusions\nThe definition of 'early discharge' varied considerably among trials, which made interpretation of results challenging. Early discharge probably leads to a higher risk of infant readmission within 28 days of birth, but probably makes little to no difference to the risk of maternal readmission within six weeks postpartum. We are uncertain if early discharge has any effect on the risk of infant or maternal mortality. With regard to maternal depression, breastfeeding, the number of contacts with health professionals, and costs of care, there may be little to no difference between early discharge and standard discharge but further trials measuring these outcomes are needed in order to enhance the level of certainty of the evidence. Large well-designed trials of early discharge policies, incorporating process evaluation and using standardized approaches to outcome assessment, are needed to assess the uptake of co-interventions. Since none of the evidence presented here comes from low-income countries, where infant and maternal mortality may be higher, it is important to conduct future trials in low-income settings.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "We searched for evidence in May 2021 and identified 17 trials involving 9409 women. The evidence is of low to moderate certainty because of limitations in the ways the studies were conducted. There was considerable variation in how early discharge was defined, ranging from six hours to four to five days. In most of the trials included in this review, early discharge was accompanied by some level of nursing or midwifery support. None of the trials took place in low-income countries.\nEarly discharge probably slightly increases the number of babies readmitted to hospital within 28 days of being born (10 studies, 6918 babies, moderate-certainty evidence). It is uncertain whether early discharge has any effect on the risk of babies dying within 28 days (two studies, 4882 babies). Early postnatal discharge probably makes little to no difference to the number of babies having at least one unscheduled medical consultation or contact with health professionals within the first four weeks after birth (four studies, 639 babies, moderate-certainty evidence).\nEarly discharge probably results in little to no difference in the number of women readmitted to hospital within six weeks of giving birth for complications related to childbirth (11 studies, 6992 women, moderate-certainty evidence). No deaths were reported. The number of women having at least one unscheduled medical consultation or contact with health professionals was not clearly different (two studies, 464 women, moderate-certainty evidence). Similarly, early discharge may result in little to no difference in the risk of depression within six months after giving birth (five studies, 4333 women, low-certainty evidence).\nEarly discharge probably results in little to no difference in the number of women breastfeeding at six weeks after giving birth or in the number of women having at least one unscheduled medical consultation or contact with health professionals.\nEarly discharge may slightly reduce the costs of hospital care with little to no difference in the cost of care from discharge to six weeks after the birth."
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query-laysum | 4425 | [
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"role": "user",
"content": "Abstract: Background\nSystemic corticosteroids are used to treat people with COVID-19 because they counter hyper-inflammation. Existing evidence syntheses suggest a slight benefit on mortality. Nonetheless, size of effect, optimal therapy regimen, and selection of patients who are likely to benefit most are factors that remain to be evaluated.\nObjectives\nTo assess whether and at which doses systemic corticosteroids are effective and safe in the treatment of people with COVID-19, to explore equity-related aspects in subgroup analyses, and to keep up to date with the evolving evidence base using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which includes PubMed, Embase, CENTRAL, ClinicalTrials.gov, WHO ICTRP, and medRxiv), Web of Science (Science Citation Index, Emerging Citation Index), and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies to 6 January 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated systemic corticosteroids for people with COVID-19.\nWe included any type or dose of systemic corticosteroids and the following comparisons: systemic corticosteroids plus standard care versus standard care, different types, doses and timings (early versus late) of corticosteroids.\nWe excluded corticosteroids in combination with other active substances versus standard care, topical or inhaled corticosteroids, and corticosteroids for long-COVID treatment.\nData collection and analysis\nWe followed standard Cochrane methodology. To assess the risk of bias in included studies, we used the Cochrane 'Risk of bias' 2 tool for RCTs. We rated the certainty of the evidence using the GRADE approach for the following outcomes: all-cause mortality up to 30 and 120 days, discharged alive (clinical improvement), new need for invasive mechanical ventilation or death (clinical worsening), serious adverse events, adverse events, hospital-acquired infections, and invasive fungal infections.\nMain results\nWe included 16 RCTs in 9549 participants, of whom 8271 (87%) originated from high-income countries. A total of 4532 participants were randomised to corticosteroid arms and the majority received dexamethasone (n = 3766). These studies included participants mostly older than 50 years and male. We also identified 42 ongoing and 23 completed studies lacking published results or relevant information on the study design.\nHospitalised individuals with a confirmed or suspected diagnosis of symptomatic COVID-19\nSystemic corticosteroids plus standard care versus standard care plus/minus placebo\nWe included 11 RCTs (8019 participants), one of which did not report any of our pre-specified outcomes and thus our analyses included outcome data from 10 studies.\nSystemic corticosteroids plus standard care compared to standard care probably reduce all-cause mortality (up to 30 days) slightly (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.97; 7898 participants; estimated absolute effect: 274 deaths per 1000 people not receiving systemic corticosteroids compared to 246 deaths per 1000 people receiving the intervention (95% CI 230 to 265 per 1000 people); moderate-certainty evidence).\nThe evidence is very uncertain about the effect on all-cause mortality (up to 120 days) (RR 0.74, 95% CI 0.23 to 2.34; 485 participants). The chance of clinical improvement (discharged alive at day 28) may slightly increase (RR 1.07, 95% CI 1.03 to 1.11; 6786 participants; low-certainty evidence) while the risk of clinical worsening (new need for invasive mechanical ventilation or death) may slightly decrease (RR 0.92, 95% CI 0.84 to 1.01; 5586 participants; low-certainty evidence).\nFor serious adverse events (two RCTs, 678 participants), adverse events (three RCTs, 447 participants), hospital-acquired infections (four RCTs, 598 participants), and invasive fungal infections (one study, 64 participants), we did not perform any analyses beyond the presentation of descriptive statistics due to very low-certainty evidence (high risk of bias, heterogeneous definitions, and underreporting).\nDifferent types, dosages or timing of systemic corticosteroids\nWe identified one RCT (86 participants) comparing methylprednisolone to dexamethasone, thus the evidence is very uncertain about the effect of methylprednisolone on all-cause mortality (up to 30 days) (RR 0.51, 95% CI 0.24 to 1.07; 86 participants). None of the other outcomes of interest were reported in this study.\nWe included four RCTs (1383 participants) comparing high-dose dexamethasone (12 mg or higher) to low-dose dexamethasone (6 mg to 8 mg).\nHigh-dose dexamethasone compared to low-dose dexamethasone may reduce all-cause mortality (up to 30 days) (RR 0.87, 95% CI 0.73 to 1.04; 1269 participants; low-certainty evidence), but the evidence is very uncertain about the effect of high-dose dexamethasone on all-cause mortality (up to 120 days) (RR 0.93, 95% CI 0.79 to 1.08; 1383 participants) and it may have little or no impact on clinical improvement (discharged alive at 28 days) (RR 0.98, 95% CI 0.89 to 1.09; 200 participants; low-certainty evidence). Studies did not report data on clinical worsening (new need for invasive mechanical ventilation or death).\nFor serious adverse events, adverse events, hospital-acquired infections, and invasive fungal infections, we did not perform analyses beyond the presentation of descriptive statistics due to very low-certainty evidence.\nWe could not identify studies for comparisons of different timing and systemic corticosteroids versus other active substances.\nEquity-related subgroup analyses\nWe conducted the following subgroup analyses to explore equity-related factors: sex, age (< 70 years; ≥ 70 years), ethnicity (Black, Asian or other versus White versus unknown) and place of residence (high-income versus low- and middle-income countries). Except for age and ethnicity, no evidence for differences could be identified. For all-cause mortality up to 30 days, participants younger than 70 years seemed to benefit from systemic corticosteroids in comparison to those aged 70 years and older. The few participants from a Black, Asian, or other minority ethnic group showed a larger estimated effect than the many White participants.\nOutpatients with asymptomatic or mild disease\nThere are no studies published in populations with asymptomatic infection or mild disease.\nAuthors' conclusions\nSystemic corticosteroids probably slightly reduce all-cause mortality up to 30 days in people hospitalised because of symptomatic COVID-19, while the evidence is very uncertain about the effect on all-cause mortality up to 120 days. For younger people (under 70 years of age) there was a potential advantage, as well as for Black, Asian, or people of a minority ethnic group; further subgroup analyses showed no relevant effects. Evidence related to the most effective type, dose, or timing of systemic corticosteroids remains immature. Currently, there is no evidence on asymptomatic or mild disease (non-hospitalised participants). Due to the low to very low certainty of the current evidence, we cannot assess safety adequately to rule out harmful effects of the treatment, therefore there is an urgent need for good-quality safety data. Findings of equity-related subgroup analyses should be interpreted with caution because of their explorative nature, low precision, and missing data.\nWe identified 42 ongoing and 23 completed studies lacking published results or relevant information on the study design, suggesting there may be possible changes of the effect estimates and certainty of the evidence in the future.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We looked for studies that investigated systemic corticosteroids for people with COVID-19. People could be of any age, sex, or ethnicity.\nStudies could compare corticosteroids:\n• plus usual care versus usual care with or without placebo (sham medicine);\n• versus another type of corticosteroid;\n• versus a different medicine;\n• in different doses;\n• given as early versus late treatment.\nWe compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
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query-laysum | 4426 | [
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"role": "user",
"content": "Abstract: Background\nPostoperative nausea and vomiting (PONV) is a common adverse effect of anaesthesia and surgery. Up to 80% of patients may be affected. These outcomes are a major cause of patient dissatisfaction and may lead to prolonged hospital stay and higher costs of care along with more severe complications. Many antiemetic drugs are available for prophylaxis. They have various mechanisms of action and side effects, but there is still uncertainty about which drugs are most effective with the fewest side effects.\nObjectives\n• To compare the efficacy and safety of different prophylactic pharmacologic interventions (antiemetic drugs) against no treatment, against placebo, or against each other (as monotherapy or combination prophylaxis) for prevention of postoperative nausea and vomiting in adults undergoing any type of surgery under general anaesthesia\n• To generate a clinically useful ranking of antiemetic drugs (monotherapy and combination prophylaxis) based on efficacy and safety\n• To identify the best dose or dose range of antiemetic drugs in terms of efficacy and safety\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, and reference lists of relevant systematic reviews. The first search was performed in November 2017 and was updated in April 2020. In the update of the search, 39 eligible studies were found that were not included in the analysis (listed as awaiting classification).\nSelection criteria\nRandomized controlled trials (RCTs) comparing effectiveness or side effects of single antiemetic drugs in any dose or combination against each other or against an inactive control in adults undergoing any type of surgery under general anaesthesia. All antiemetic drugs belonged to one of the following substance classes: 5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, corticosteroids, antihistamines, and anticholinergics. No language restrictions were applied. Abstract publications were excluded.\nData collection and analysis\nA review team of 11 authors independently assessed trials for inclusion and risk of bias and subsequently extracted data. We performed pair-wise meta-analyses for drugs of direct interest (amisulpride, aprepitant, casopitant, dexamethasone, dimenhydrinate, dolasetron, droperidol, fosaprepitant, granisetron, haloperidol, meclizine, methylprednisolone, metoclopramide, ondansetron, palonosetron, perphenazine, promethazine, ramosetron, rolapitant, scopolamine, and tropisetron) compared to placebo (inactive control). We performed network meta-analyses (NMAs) to estimate the relative effects and ranking (with placebo as reference) of all available single drugs and combinations. Primary outcomes were vomiting within 24 hours postoperatively, serious adverse events (SAEs), and any adverse event (AE). Secondary outcomes were drug class-specific side effects (e.g. headache), mortality, early and late vomiting, nausea, and complete response. We performed subgroup network meta-analysis with dose of drugs as a moderator variable using dose ranges based on previous consensus recommendations. We assessed certainty of evidence of NMA treatment effects for all primary outcomes and drug class-specific side effects according to GRADE (CINeMA, Confidence in Network Meta-Analysis). We restricted GRADE assessment to single drugs of direct interest compared to placebo.\nMain results\nWe included 585 studies (97,516 randomized participants). Most of these studies were small (median sample size of 100); they were published between 1965 and 2017 and were primarily conducted in Asia (51%), Europe (25%), and North America (16%). Mean age of the overall population was 42 years. Most participants were women (83%), had American Society of Anesthesiologists (ASA) physical status I and II (70%), received perioperative opioids (88%), and underwent gynaecologic (32%) or gastrointestinal surgery (19%) under general anaesthesia using volatile anaesthetics (88%).\nIn this review, 44 single drugs and 51 drug combinations were compared. Most studies investigated only single drugs (72%) and included an inactive control arm (66%). The three most investigated single drugs in this review were ondansetron (246 studies), dexamethasone (120 studies), and droperidol (97 studies).\nAlmost all studies (89%) reported at least one efficacy outcome relevant for this review. However, only 56% reported at least one relevant safety outcome.\nAltogether, 157 studies (27%) were assessed as having overall low risk of bias, 101 studies (17%) overall high risk of bias, and 327 studies (56%) overall unclear risk of bias.\nVomiting within 24 hours postoperatively\nRelative effects from NMA for vomiting within 24 hours (282 RCTs, 50,812 participants, 28 single drugs, and 36 drug combinations) suggest that 29 out of 36 drug combinations and 10 out of 28 single drugs showed a clinically important benefit (defined as the upper end of the 95% confidence interval (CI) below a risk ratio (RR) of 0.8) compared to placebo. Combinations of drugs were generally more effective than single drugs in preventing vomiting. However, single NK₁ receptor antagonists showed treatment effects similar to most of the drug combinations. High-certainty evidence suggests that the following single drugs reduce vomiting (ordered by decreasing efficacy): aprepitant (RR 0.26, 95% CI 0.18 to 0.38, high certainty, rank 3/28 of single drugs); ramosetron (RR 0.44, 95% CI 0.32 to 0.59, high certainty, rank 5/28); granisetron (RR 0.45, 95% CI 0.38 to 0.54, high certainty, rank 6/28); dexamethasone (RR 0.51, 95% CI 0.44 to 0.57, high certainty, rank 8/28); and ondansetron (RR 0.55, 95% CI 0.51 to 0.60, high certainty, rank 13/28). Moderate-certainty evidence suggests that the following single drugs probably reduce vomiting: fosaprepitant (RR 0.06, 95% CI 0.02 to 0.21, moderate certainty, rank 1/28) and droperidol (RR 0.61, 95% CI 0.54 to 0.69, moderate certainty, rank 20/28).\nRecommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol showed clinically important benefit, but low doses showed no clinically important benefit. Aprepitant was used mainly at high doses, ramosetron at recommended doses, and fosaprepitant at doses of 150 mg (with no dose recommendation available).\nFrequency of SAEs\nTwenty-eight RCTs were included in the NMA for SAEs (10,766 participants, 13 single drugs, and eight drug combinations). The certainty of evidence for SAEs when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to low. Droperidol (RR 0.88, 95% CI 0.08 to 9.71, low certainty, rank 6/13) may reduce SAEs. We are uncertain about the effects of aprepitant (RR 1.39, 95% CI 0.26 to 7.36, very low certainty, rank 11/13), ramosetron (RR 0.89, 95% CI 0.05 to 15.74, very low certainty, rank 7/13), granisetron (RR 1.21, 95% CI 0.11 to 13.15, very low certainty, rank 10/13), dexamethasone (RR 1.16, 95% CI 0.28 to 4.85, very low certainty, rank 9/13), and ondansetron (RR 1.62, 95% CI 0.32 to 8.10, very low certainty, rank 12/13). No studies reporting SAEs were available for fosaprepitant.\nFrequency of any AE\nSixty-one RCTs were included in the NMA for any AE (19,423 participants, 15 single drugs, and 11 drug combinations). The certainty of evidence for any AE when using one of the best and most reliable anti-vomiting drugs (aprepitant, ramosetron, granisetron, dexamethasone, ondansetron, and droperidol compared to placebo) ranged from very low to moderate. Granisetron (RR 0.92, 95% CI 0.80 to 1.05, moderate certainty, rank 7/15) probably has no or little effect on any AE. Dexamethasone (RR 0.77, 95% CI 0.55 to 1.08, low certainty, rank 2/15) and droperidol (RR 0.89, 95% CI 0.81 to 0.98, low certainty, rank 6/15) may reduce any AE. Ondansetron (RR 0.95, 95% CI 0.88 to 1.01, low certainty, rank 9/15) may have little or no effect on any AE. We are uncertain about the effects of aprepitant (RR 0.87, 95% CI 0.78 to 0.97, very low certainty, rank 3/15) and ramosetron (RR 1.00, 95% CI 0.65 to 1.54, very low certainty, rank 11/15) on any AE. No studies reporting any AE were available for fosaprepitant.\nClass-specific side effects\nFor class-specific side effects (headache, constipation, wound infection, extrapyramidal symptoms, sedation, arrhythmia, and QT prolongation) of relevant substances, the certainty of evidence for the best and most reliable anti-vomiting drugs mostly ranged from very low to low. Exceptions were that ondansetron probably increases headache (RR 1.16, 95% CI 1.06 to 1.28, moderate certainty, rank 18/23) and probably reduces sedation (RR 0.87, 95% CI 0.79 to 0.96, moderate certainty, rank 5/24) compared to placebo. The latter effect is limited to recommended and high doses of ondansetron. Droperidol probably reduces headache (RR 0.76, 95% CI 0.67 to 0.86, moderate certainty, rank 5/23) compared to placebo. We have high-certainty evidence that dexamethasone (RR 1.00, 95% CI 0.91 to 1.09, high certainty, rank 16/24) has no effect on sedation compared to placebo. No studies assessed substance class-specific side effects for fosaprepitant.\nDirection and magnitude of network effect estimates together with level of evidence certainty are graphically summarized for all pre-defined GRADE-relevant outcomes and all drugs of direct interest compared to placebo in http://doi.org/10.5281/zenodo.4066353.\nAuthors' conclusions\nWe found high-certainty evidence that five single drugs (aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron) reduce vomiting, and moderate-certainty evidence that two other single drugs (fosaprepitant and droperidol) probably reduce vomiting, compared to placebo. Four of the six substance classes (5-HT₃ receptor antagonists, D₂ receptor antagonists, NK₁ receptor antagonists, and corticosteroids) were thus represented by at least one drug with important benefit for prevention of vomiting. Combinations of drugs were generally more effective than the corresponding single drugs in preventing vomiting. NK₁ receptor antagonists were the most effective drug class and had comparable efficacy to most of the drug combinations. 5-HT₃ receptor antagonists were the best studied substance class. For most of the single drugs of direct interest, we found only very low to low certainty evidence for safety outcomes such as occurrence of SAEs, any AE, and substance class-specific side effects.\nRecommended and high doses of granisetron, dexamethasone, ondansetron, and droperidol were more effective than low doses for prevention of vomiting. Dose dependency of side effects was rarely found due to the limited number of studies, except for the less sedating effect of recommended and high doses of ondansetron.\nThe results of the review are transferable mainly to patients at higher risk of nausea and vomiting (i.e. healthy women undergoing inhalational anaesthesia and receiving perioperative opioids). Overall study quality was limited, but certainty assessments of effect estimates consider this limitation. No further efficacy studies are needed as there is evidence of moderate to high certainty for seven single drugs with relevant benefit for prevention of vomiting. However, additional studies are needed to investigate potential side effects of these drugs and to examine higher-risk patient populations (e.g. individuals with diabetes and heart disease).\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "For people at higher risk, we found that some antiemetic medicines work well to prevent them from being sick after general anaesthesia. The best antiemetic medicines with reliable evidence were aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron, followed by fosaprepitant and droperidol.\nHowever, we did not find enough reliable evidence about potential unwanted effects to rank these medicines reliably according to how well they are tolerated."
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query-laysum | 4427 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple analgesic strategies for pain relief during labour are available. Recently remifentanil, a short-acting opioid, has recently been used as an alternative analgesic due to its unique pharmacological properties.\nObjectives\nTo systematically assess the effectiveness of remifentanil intravenous patient-controlled analgesia (PCA) for labour pain, along with any potential harms to the mother and the newborn.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (9 December 2015), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), handsearched congress abstracts (November 2015), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-randomised trials comparing remifentanil (PCA) with another opioid (intravenous (IV)/intramuscular (IM)), or with another opioid (PCA), or with epidural analgesia, or with remifentanil (continuous IV), or with remifentanil (PCA, different regimen), or with inhalational analgesia, or with placebo/no treatment in all women in labour including high-risk groups with planned vaginal delivery.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data, and appraised study quality.\nWe contacted study authors for additional information other than incomplete outcome data. We performed random-effects meta-analysis.\nTo reduce the risk of random error in meta-analysis we performed trial sequential analysis. We included total zero event trials and used a constant continuity correction of 0.01 (ccc 0.01) for meta-analysis. We applied the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nTwenty RCTs with 3569 women were included. Of those, 10 trials (2983 participants) compared remifentanil (PCA) to an epidural, four trials (216 participants) to another opioid (IV/IM), three trials (215 participants) to another opioid (PCA), two trials (135 participants) to remifentanil (continuous IV), and one trial (20 participants) to remifentanil (PCA, different regimen). No trials were identified for the remaining comparisons.\nMethodological quality of studies was moderate to poor. We assessed risk of bias as high for blinding issues and incomplete outcome data in 65% and 45% of the included studies, respectively.\nThere is evidence of effect that women in the remifentanil (PCA) group were more satisfied with pain relief than women in the other opioids (IV/IM) group (standardised mean difference (SMD) 2.11, 95% confidence interval (CI) 0.72 to 3.49, four trials, very low-quality evidence), and that women were less satisfied compared to women in the epidural group (SMD -0.22, 95% CI -0.40 to -0.04, seven trials, very low-quality evidence).\nThere is evidence of effect that remifentanil (PCA) provided stronger pain relief at one hour than other opioids administered IV/IM (SMD -1.58, 95% CI -2.69 to -0.48, three trials, very low-quality evidence) or via PCA (SMD -0.51, 95% CI -1.01 to -0.00, three trials, very low-quality evidence). Pain intensity was higher in the remifentanil (PCA) group compared to the epidural group (SMD 0.57, 95% CI 0.31 to 0.84, six trials, low-quality evidence).\nData were limited on safety aspects for both the women and the newborns. Only one study analysed maternal apnoea in a comparison of remifentanil (PCA) versus epidural and reported that half of the women in the remifentanil and none in the epidural group had an apnoea (very low-quality evidence). There is no evidence of effect that remifentanil (PCA) was associated with an increased risk for maternal respiratory depression when compared to epidural analgesia (RR 0.91, 95% CI 0.51 to 1.62, ccc 0.01, three trials, low-quality evidence) and no reliable conclusion might be reached compared to remifentanil (continuous IV) (all study arms included zero events, two trials, low-quality evidence). In one trial of remifentanil (PCA) versus another opioid (IM) three out of 18 women in the remifentanil and none out of 18 in the control group had a respiratory depression (very low-quality evidence).\nThere is no evidence of effect that remifentanil (PCA) was associated with an increased risk for newborns with Apgar scores less than seven at five minutes compared to epidural analgesia (RR 1.26, 95% CI 0.62 to 2.57, ccc 0.01, five trials, low-quality evidence) and no reliable conclusion might be reached compared to another opioid (IV) and compared to remifentanil (PCA, different regimen) both with zero events in all study arms (one trial, very-low quality evidence). In one trial of remifentanil (PCA) versus another opioid (PCA) none out of nine newborns in the remifentanil and three out of eight in the opioid (PCA) group had Apgar scores less than seven (very-low quality evidence).\nThere is evidence that remifentanil (PCA) was associated with a lower risk for the requirement of additional analgesia when compared to other opioids (IV/IM) (RR 0.57, 95% CI 0.40 to 0.81, three trials, moderate-quality evidence) and that it was associated with a higher risk compared to epidural analgesia (RR 9.27, 95% CI 3.73 to 23.03, ccc 0.01, six trials, moderate-quality evidence). There is no evidence of effect that remifentanil (PCA) reduced the requirement for additional analgesia compared to other opioids (PCA) (RR 0.76, 95% CI 0.45 to 1.28, three trials, low-quality evidence).\nThere is evidence that there was no difference in the risk for caesarean delivery between remifentanil (PCA) and other opioids (IV/IM) (RR 0.63, 95% CI 0.30 to 1.32, ccc 0.01, four trials, low-quality evidence) and epidural analgesia (RR 1.0, 95% CI 0.82 to 1.22, ccc 0.01, nine trials, moderate-quality evidence), respectively. Pooled meta-analysis revealed an increased risk for caesarean section under remifentanil (PCA) compared to other opioids (PCA) (RR 2.78, 95% CI 0.99 to 7.82, two trials, very low-quality evidence). However, a wide range of clinically relevant and non-relevant treatment effects is compatible with this result.\nAuthors' conclusions\nBased on the current systematic review, there is mostly low-quality evidence to inform practice and future research may significantly alter the current situation. The quality of evidence is mainly limited by poor quality of the studies, inconsistency, and imprecision. More research is needed on maternal and neonatal safety outcomes (maternal apnoea and respiratory depression, Apgar score) and on the optimal mode and regimen of remifentanil administration to provide highest efficacy with reasonable adverse effects for mothers and their newborns.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "Labour pain may be associated with adverse effects for the mother and her baby and can result in prolonged labour.\nThis review aimed to compare remifentanil given via a patient-controlled analgesia (PCA) device with other opioids given via the same way or via an intramuscular or intravenous injection, with epidural analgesia, with different regimens of remifentanil (PCA) or with remifentanil as a continuous intravenous infusion, with inhalational analgesia, or with no treatment for women during normal vaginal birth. Our main outcomes of interest were satisfaction with pain relief, pain scores, side effects for the women and their babies, need for additional analgesia and the risk for a caesarean section."
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query-laysum | 4428 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough lifestyle interventions are often recommended in the management of chronic gout, the evidence from trial data of the benefits and safety of using lifestyle interventions for treating acute gout attacks have not previously been examined in a systematic review.\nObjectives\nThe objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with acute gout.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE for studies (up to 5 April 2013). We also searched the 2010 to 2011 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) abstracts and performed a handsearch of the reference lists of included articles.\nSelection criteria\nStudies were included if they were randomised or quasi-randomised controlled trials which compared lifestyle interventions to another therapy (active or placebo) in patients with acute gout. Outcomes of interest were the change in participant-reported pain in the target joint(s), target joint inflammation and function, health-related quality of life (HRQoL), patient global assessment, study participant withdrawals due to adverse events (AEs) and serious adverse events (SAEs).\nData collection and analysis\nTwo review authors independently applied methods recommended by The Cochrane Collaboration for the selection, appraisal, data collection and synthesis of studies. We assessed the quality of the body of evidence for each outcome using the GRADE approach.\nMain results\nOnly one study (19 participants) at high risk of bias was included in the review. Patients were randomised to receive oral prednisolone and colchicine with or without concomitant topical ice therapy. Topical ice therapy provided significant additional benefit over oral prednisolone and colchicine alone with respect to pain, but did not significantly reduce swelling during acute gout episodes. Mean pain reduction with standard medical treatment was 4.4 cm on a 0 to 10 cm visual analogue scale (VAS) after one week; the addition of topical ice reduced pain by an additional 3.33 cm (95% CI 5.84 to 0.82), or an absolute reduction of 33% (8% to 58% reduction). Joint swelling was reduced by a mean of 3.8 cm in the standard medical treatment group; the addition of topical ice therapy did not reduce swelling significantly (mean difference (MD) 2.07 cm, 95% CI -1.56 to 5.70). Target joint function, HRQoL, patient global assessment, study participant withdrawals due to AEs and SEAs were not reported in this study.\nAuthors' conclusions\nThere is low quality evidence, from a single trial at high risk of bias, that the addition of topical ice therapy to oral prednisolone and colchicine for oligoarticular attacks of acute gout results in significantly greater pain reduction at one week.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with acute gout using topical ice in addition to medications\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "Joint pain (lower score means less pain)\nPeople who used topical ice (for half-an-hour, four times per day for one week) in addition to medical treatment (oral prednisolone and colchicine) rated their pain 3.33 points lower on a 0 to 10 point pain scale (33% absolute improvement).\n- People who used topical ice in addition to medical treatment (prednisolone and colchicine) rated their pain to be 2.25 points on a scale of 0 to 10.\n- People who used medical treatment alone rated their pain to be 5.58 points on a scale of 0 to 10.\n- Three people would need to be treated with topical ice for one person to benefit from pain relief.\nAdverse events\nSide effects or complications of using topical ice in addition to medical therapy were not reported in the study."
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query-laysum | 4429 | [
{
"role": "user",
"content": "Abstract: Background\nUnemployment is associated with decreased health which may be a reason or a consequence of becoming unemployed. Decreased health can inhibit re-employment.\nObjectives\nTo assess the effectiveness of health-improving interventions for obtaining employment in unemployed job seekers.\nSearch methods\nWe searched (3 May 2018, updated 13 August 2019) the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, PsycINFO, CINAHL, SocINDEX, OSH Update, ClinicalTrials.gov, the WHO trials portal, and also reference lists of included studies and selected reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the effectiveness of health-improving interventions for obtaining employment in unemployed job seekers. The primary outcome was re-employment reported as the number or percentage of participants who obtained employment. Our secondary outcomes were health and work ability.\nData collection and analysis\nTwo authors independently screened studies, extracted outcome data, and assessed risk of bias. We pooled study results with random-effect models and reported risk ratios (RRs) with 95% confidence intervals (CIs) and assessed the overall quality of the evidence for each comparison using the GRADE approach.\nMain results\nWe included 15 randomised controlled trials (16 interventions) with a total of 6397 unemployed participants. Eight studies evaluated therapeutic interventions such as cognitive behavioural therapy, physical exercise, and health-related advice and counselling and, in seven studies, interventions were combined using therapeutic methods and job-search training.\nTherapeutic interventions\nTherapeutic interventions compared to no intervention may increase employment at an average of 11 months follow-up but the evidence is very uncertain (RR = 1.41, 95% CI 1.07 to 1.87, n = 1142, 8 studies with 9 interventions, I² = 52%, very low-quality evidence). There is probably no difference in the effects of therapeutic interventions compared to no intervention on mental health (SMD 0.12, 95% CI -0.06 to 0.29, n = 530, 2 studies, low-quality evidence) and on general health (SMD 0.19, 95% CI -0.04 to 0.41, n = 318, 1 study, moderate-quality evidence).\nCombined interventions\nCombined interventions probably increase employment slightly compared to no intervention at an average of 10 months follow-up (RR 1.12, 95% CI 1.06 to 1.20, n = 4101, 6 studies, I² = 7%).\nThere were no studies that measured work-ability, adverse events, or cost-effectiveness.\nAuthors' conclusions\nInterventions combining therapeutic methods and job-search training probably have a small beneficial effect in increasing employment. Therapeutic interventions may have an effect on re-employment, but we are very uncertain. Therapeutic interventions may not improve health in unemployed job seekers. Large high-quality RCTs targeting short-term or long-term unemployed people are needed to increase the quality of the evidence. A cost-effectiveness assessment is needed of the small beneficial effects.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for studies that had been published up to August 2019."
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query-laysum | 4430 | [
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"role": "user",
"content": "Abstract: Background\nChinese herbal medicines have been used for a long time to treat osteoporosis. The evidence of their benefits and harms needs to be systematically reviewed.\nObjectives\nTo assess the beneficial and harmful effects of Chinese herbal medicines as a general experimental intervention for treating primary osteoporosis by comparing herbal treatments with placebo, no intervention and conventional medicine.\nSearch methods\nWe searched the following electronic databases to January 2013: the Specialised Register of the Cochrane Complementary Medicine Field, CENTRAL, MEDLINE, EMBASE, LILACS, JICST-E, AMED, Chinese Biomedical Database and CINAHL.\nSelection criteria\nRandomised controlled trials of Chinese herbal medicines compared with placebo, no intervention or conventional medicine were included.\nData collection and analysis\nTwo authors extracted data and assessed risk of bias independently. Disagreement was resolved by discussion.\nMain results\nOne hundred and eight randomised trials involving 10,655 participants were included. Ninety-nine different Chinese herbal medicines were tested and compared with placebo (three trials), no intervention (five trials) or conventional medicine (61 trials), or Chinese herbal medicines plus western medicine were compared with western medicine (47 trials). The risk of bias across all studies was unclear for most domains primarily due to inadequate reporting of study design. Although we rated the risk of selective reporting for all studies as unclear, only a few studies contributed numerical data to the key outcomes.\nSeven trials reported fracture incidence, but they were small in sample size, suffered from various biases and tested different Chinese herbal medicines. These trials compared Kanggusong capsules versus placebo, Kanggusong granule versus Caltrate or ipriflavone plus Caltrate, Yigu capsule plus calcium versus placebo plus calcium, Xianlinggubao capsule plus Caltrate versus placebo plus Caltrate, Bushen Zhuanggu granules plus Caltrate versus placebo granules plus Caltrate, Kanggusong soup plus Caltrate versus Caltrate, Zhuangguqiangjin tablets and Shujinbogu tablets plus calcitonin ampoule versus calcitonin ampoule. The results were inconsistent.\nOne trial showed that Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol had a better effect on quality of life score (scale 0 to 100, higher is better) than calcium carbonate tablets and alfacalcidol (mean difference (MD) 5.30; 95% confidence interval (CI) 3.67 to 6.93).\nCompared with placebo in three separate trials, Chinese herbal medicines (Migu decoction, Bushen Yigu soft extract, Kanggusong capsules) showed a statistically significant increase in bone mineral density (BMD) (e.g. Kanggusong capsules, MD 0.06 g/cm3; 95% CI 0.02 to 0.10). Compared with no intervention in five trials, only two showed that Chinese herbal medicines had a statistically significant effect on increase in BMD (e.g. Shigu yin, MD 0.08 g/cm3; 95% CI 0.03 to 0.13). Compared with conventional medicine in 61 trials, 23 showed that Chinese herbal medicines had a statistically significant effect on increase in BMD. In 48 trials evaluating Chinese herbal medicines plus western medication against western medication, 26 showed better effects of the combination therapy on increase in BMD.\nNo trial reported death or serious adverse events of Chinese herbal medicines, while some trials reported minor adverse effects such as nausea, diarrhoea, etc.\nAuthors' conclusions\nCurrent findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Serious side effects or deaths\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "No serious side effects or deaths occurred in the trials.\nWe often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Possible side effects may include a mild stomach ache or diarrhoea."
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query-laysum | 4431 | [
{
"role": "user",
"content": "Abstract: Background\nProximal femoral fracture (PFF) is a common orthopaedic emergency that affects mainly elderly people at high risk of complications. Advanced methods for managing fluid therapy during treatment for PFF are available, but their role in reducing risk is unclear.\nObjectives\nTo compare the safety and effectiveness of the following methods of perioperative fluid optimization in adult participants undergoing surgical repair of hip fracture: advanced invasive haemodynamic monitoring, such as transoesophageal Doppler and pulse contour analysis; a protocol using standard measures, such as blood pressure, urine output and central venous pressure; and usual care.\nComparisons of fluid types (e.g. crystalloid vs colloid) and other methods of optimizing oxygen delivery, such as blood product therapies and pharmacological treatment with inotropes and vasoactive drugs, are considered in other reviews.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 9); MEDLINE (October 2012 to September 2015); and EMBASE (October 2012 to September 2015) without language restrictions. We ran forward and backward citation searches on identified trials. We searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for unpublished trials. This is an updated version of a review published originally in 2004 and updated first in 2013 and again in 2015. Original searches were performed in October 2003 and October 2012.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adult participants undergoing surgical treatment for PFF that compared any two of advanced haemodynamic monitoring, protocols using standard measures or usual care, irrespective of blinding, language or publication status.\nData collection and analysis\nTwo review authors assessed the impact of fluid optimization interventions on outcomes of mortality, length of hospital stay, time to medical fitness, whether participants were able to return to pre-fracture accommodation at six months, participant mobility at six months and adverse events in-hospital. We pooled data using risk ratio (RR) or mean difference (MD) for dichotomous or continuous data, respectively, on the basis of random-effects models.\nMain results\nWe included in this updated review five RCTs with a total of 403 participants, and we added two new trials identified during the 2015 search. One of the included studies was found to have a high risk of bias; no trial featured all pre-specified outcomes. We found two trials for which data are awaited for classification and one ongoing trial.\nThree studies compared advanced haemodynamic monitoring with a protocol using standard measures; three compared advanced haemodynamic monitoring with usual care; and one compared a protocol using standard measures with usual care. Meta-analyses for the two advanced haemodynamic monitoring comparisons are consistent with both increased and decreased risk of mortality (RR Mantel-Haenszel (M-H) random-effects 0.41, 95% confidence interval (CI) 0.14 to 1.20; 280 participants; RR M-H random-effects 0.45, 95% CI 0.07 to 2.95; 213 participants, respectively). The study comparing a protocol with usual care found no difference between groups for this outcome.\nThree studies comparing advanced haemodynamic monitoring with usual care reported data for length of stay and time to medical fitness. There was no statistically significant difference between groups for these outcomes in the two studies that we were able to combine (MD IV fixed 0.63, 95% CI -1.70 to 2.96); MD IV fixed 0.01, 95% CI -1.74 to 1.71, respectively) and no statistically significant difference in the third study. One study reported reduced time to medical fitness when comparing advanced haemodynamic monitoring with a protocol, and when comparing protocol monitoring with usual care.\nThe number of participants with one or more complications showed no statistically significant differences in each of the two advanced haemodynamic monitoring comparisons (RR M-H random-effects 0.83, 95% CI 0.59 to 1.17; 280 participants; RR M-H random-effects 0.72, 95% CI 0.40 to 1.31; 173 participants, respectively), nor any differences in the protocol and usual care comparison.\nOnly one study reported the number of participants able to return to normal accommodation after discharge with no statistically significant difference between groups.\nThere were few studies with a small number of participants, and by using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) approach, we judged the quality of the outcome evidence as low. We had included one study with a high risk of bias, but upon applying GRADE, we downgraded the quality of this outcome evidence to very low.\nAuthors' conclusions\nFive studies including a total of 403 participants provided no evidence that fluid optimization strategies improve outcomes for participants undergoing surgery for PFF. Further research powered to test some of these outcomes is ongoing.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hip fractures are common among elderly people, who often have medical conditions that put them at risk of developing other problems whilst their fracture is treated. Treatment usually involves an operation to fix the break in the bone, and giving too much or too little fluid to a patient around this time may increase the risk of additional problems. Healthcare staff use many approaches to determine how much fluid a patient needs in this situation, but it is not clear whether some methods are better than others. For this Cochrane review, we looked at research on the effects of different methods of finding maximum effective fluid levels for adult men and women who undergo surgery for any type of hip fracture."
}
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query-laysum | 4432 | [
{
"role": "user",
"content": "Abstract: Background\nDepressive disorders are the most common psychiatric comorbidity in people with epilepsy, affecting around one-third, with a significant negative impact on quality of life. There is concern that people may not be receiving appropriate treatment for their depression because of uncertainty regarding which antidepressant or class works best, and the perceived risk of exacerbating seizures. This review aimed to address these issues, and inform clinical practice and future research.\nThis is an updated version of the original Cochrane Review published in Issue 12, 2014.\nObjectives\nTo evaluate the efficacy and safety of antidepressants in treating depressive symptoms and the effect on seizure recurrence, in people with epilepsy and depression.\nSearch methods\nFor this update, we searched CRS Web, MEDLINE, SCOPUS, PsycINFO, and ClinicalTrials.gov (February 2021). We searched the World Health Organization Clinical Trials Registry in October 2019, but were unable to update it because it was inaccessible. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) and prospective non-randomised studies of interventions (NRSIs), investigating children or adults with epilepsy, who were treated with an antidepressant and compared to placebo, comparative antidepressant, psychotherapy, or no treatment for depressive symptoms.\nData collection and analysis\nThe primary outcomes were changes in depression scores (proportion with a greater than 50% improvement, mean difference, and proportion who achieved complete remission) and change in seizure frequency (mean difference, proportion with a seizure recurrence, or episode of status epilepticus). Secondary outcomes included the number of participants who withdrew from the study and reasons for withdrawal, quality of life, cognitive functioning, and adverse events.\nTwo review authors independently extracted data for each included study. We then cross-checked the data extraction. We assessed risk of bias using the Cochrane tool for RCTs, and the ROBINS-I for NRSIs. We presented binary outcomes as risk ratios (RRs) with 95% confidence intervals (CIs) or 99% CIs for specific adverse events. We presented continuous outcomes as standardised mean differences (SMDs) with 95% CIs, and mean differences (MDs) with 95% CIs.\nMain results\nWe included 10 studies in the review (four RCTs and six NRSIs), with 626 participants with epilepsy and depression, examining the effects of antidepressants. One RCT was a multi-centre study comparing an antidepressant with cognitive behavioural therapy (CBT). The other three RCTs were single-centre studies comparing an antidepressant with an active control, placebo, or no treatment. The NRSIs reported on outcomes mainly in participants with focal epilepsy before and after treatment for depression with a selective serotonin reuptake inhibitor (SSRI); one NRSI compared SSRIs to CBT.\nWe rated one RCT at low risk of bias, three RCTs at unclear risk of bias, and all six NRSIs at serious risk of bias. We were unable to conduct any meta-analysis of RCT data due to heterogeneity of treatment comparisons. We judged the certainty of evidence to be moderate to very low across comparisons, because single studies contributed limited outcome data, and because of risk of bias, particularly for NRSIs, which did not adjust for confounding variables.\nMore than 50% improvement in depressive symptoms ranged from 43% to 82% in RCTs, and from 24% to 97% in NRSIs, depending on the antidepressant given. Venlafaxine improved depressive symptoms by more than 50% compared to no treatment (mean difference (MD) -7.59 (95% confidence interval (CI) -11.52 to -3.66; 1 study, 64 participants; low-certainty evidence); the results between other comparisons were inconclusive. Two studies comparing SSRIs to CBT reported inconclusive results for the proportion of participants who achieved complete remission of depressive symptoms.\nSeizure frequency data did not suggest an increased risk of seizures with antidepressants compared to control treatments or baseline. Two studies measured quality of life; antidepressants did not appear to improve quality of life over control. No studies reported on cognitive functioning.\nTwo RCTs and one NRSI reported comparative data on adverse events; antidepressants did not appear to increase the severity or number of adverse events compared to controls. The NSRIs reported higher rates of withdrawals due to adverse events than lack of efficacy. Reported adverse events for antidepressants included nausea, dizziness, sedation, headache, gastrointestinal disturbance, insomnia, and sexual dysfunction.\nAuthors' conclusions\nExisting evidence on the effectiveness of antidepressants in treating depressive symptoms associated with epilepsy is still very limited. Rates of response to antidepressants were highly variable. There is low certainty evidence from one small RCT (64 participants) that venlafaxine may improve depressive symptoms more than no treatment; this evidence is limited to treatment between 8 and 16 weeks, and does not inform longer-term effects. Moderate to low evidence suggests neither an increase nor exacerbation of seizures with SSRIs.\nThere are no available comparative data to inform the choice of antidepressant drug or classes of drug for efficacy or safety for treating people with epilepsy and depression.\nRCTs of antidepressants utilising interventions from other treatment classes besides SSRIs, in large samples of patients with epilepsy and depression, are needed to better inform treatment policy. Future studies should assess interventions across a longer treatment duration to account for delayed onset of action, sustainability of treatment responses, and to provide a better understanding of the impact on seizure control.\n\nGiven the provided abstract, please respond to the following query: \"Characteristics of studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found ten studies that included 626 patients with epilepsy and depression treated with an antidepressant. Four were randomised controlled trials, and six were non-randomised prospective cohort studies. The studies observed the effect of different antidepressants, mainly a class of antidepressant called a selective serotonin reuptake inhibitor (SSRI). One randomised controlled trial and one prospective study also observed the effect of cognitive behavioural therapy on depression."
}
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query-laysum | 4433 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of non-alcohol-related fatty liver disease (NAFLD) varies between 19% and 33% in different populations. NAFLD decreases life expectancy and increases risks of liver cirrhosis, hepatocellular carcinoma, and the requirement for liver transplantation. Uncertainty surrounds relative benefits and harms of various nutritional supplements in NAFLD. Currently no nutritional supplement is recommended for people with NAFLD.\nObjectives\n• To assess the benefits and harms of different nutritional supplements for treatment of NAFLD through a network meta-analysis\n• To generate rankings of different nutritional supplements according to their safety and efficacy\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, the World Health Organization International Clinical Trials Registry Platform, and trials registers until February 2021 to identify randomised clinical trials in people with NAFLD.\nSelection criteria\nWe included only randomised clinical trials (irrespective of language, blinding, or status) for people with NAFLD, irrespective of method of diagnosis, age and diabetic status of participants, or presence of non-alcoholic steatohepatitis (NASH). We excluded randomised clinical trials in which participants had previously undergone liver transplantation.\nData collection and analysis\nWe performed a network meta-analysis with OpenBUGS using Bayesian methods whenever possible and calculated differences in treatments using hazard ratios (HRs), odds ratios (ORs), and rate ratios with 95% credible intervals (CrIs) based on an available-case analysis, according to National Institute of Health and Care Excellence Decision Support Unit guidance.\nMain results\nWe included in the review a total of 202 randomised clinical trials (14,200 participants). Nineteen trials were at low risk of bias. A total of 32 different interventions were compared in these trials. A total of 115 trials (7732 participants) were included in one or more comparisons. The remaining trials did not report any of the outcomes of interest for this review.\nFollow-up ranged from 1 month to 28 months. The follow-up period in trials that reported clinical outcomes was 2 months to 28 months. During this follow-up period, clinical events related to NAFLD such as mortality, liver cirrhosis, liver decompensation, liver transplantation, hepatocellular carcinoma, and liver-related mortality were sparse.\nWe did not calculate effect estimates for mortality because of sparse data (zero events for at least one of the groups in the trial). None of the trials reported that they measured overall health-related quality of life using a validated scale. The evidence is very uncertain about effects of interventions on serious adverse events (number of people or number of events).\nWe are very uncertain about effects on adverse events of most of the supplements that we investigated, as the evidence is of very low certainty. However, people taking PUFA (polyunsaturated fatty acid) may be more likely to experience an adverse event than those not receiving an active intervention (network meta-analysis results: OR 4.44, 95% CrI 2.40 to 8.48; low-certainty evidence; 4 trials, 203 participants; direct evidence: OR 4.43, 95% CrI 2.43 to 8.42). People who take other supplements (a category that includes nutritional supplements other than vitamins, fatty acids, phospholipids, and antioxidants) had higher numbers of adverse events than those not receiving an active intervention (network meta-analysis: rate ratio 1.73, 95% CrI 1.26 to 2.41; 6 trials, 291 participants; direct evidence: rate ratio 1.72, 95% CrI 1.25 to 2.40; low-certainty evidence).\nData were sparse (zero events in all groups in the trial) for liver transplantation, liver decompensation, and hepatocellular carcinoma. So, we did not perform formal analysis for these outcomes. The evidence is very uncertain about effects of other antioxidants (antioxidants other than vitamins) compared to no active intervention on liver cirrhosis (HR 1.68, 95% CrI 0.23 to 15.10; 1 trial, 99 participants; very low-certainty evidence).\nThe evidence is very uncertain about effects of interventions in any of the remaining comparisons, or data were sparse (with zero events in at least one of the groups), precluding formal calculations of effect estimates.\nData were probably because of the very short follow-up period (2 months to 28 months). It takes follow-up of 8 to 28 years to detect differences in mortality between people with NAFLD and the general population. Therefore, it is unlikely that differences in clinical outcomes are noted in trials providing less than 5 to 10 years of follow-up.\nAuthors' conclusions\nThe evidence indicates considerable uncertainty about effects of nutritional supplementation compared to no additional intervention on all clinical outcomes for people with non-alcohol-related fatty liver disease.\nAccordingly, high-quality randomised comparative clinical trials with adequate follow-up are needed. We propose registry-based randomised clinical trials or cohort multiple randomised clinical trials (study design in which multiple interventions are trialed within large longitudinal cohorts of patients to gain efficiencies and align trials more closely to standard clinical practice) comparing interventions such as vitamin E, prebiotics/probiotics/synbiotics, PUFAs, and no nutritional supplementation. The reason for the choice of interventions is the impact of these interventions on indirect outcomes, which may translate to clinical benefit. Outcomes in such trials should be mortality, health-related quality of life, decompensated liver cirrhosis, liver transplantation, and resource utilisation measures including costs of intervention and decreased healthcare utilisation after minimum follow-up of 8 years (to find meaningful differences in clinically important outcomes).\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the Review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Review looked at people of any sex, age, and ethnic origin, with non-alcohol-related liver disease. Review authors excluded studies of people with previous liver transplantation. The average age of participants, when reported, ranged from 7 to 61 years. Participants were given different treatments including various vitamins and other nutritional supplements. Review authors wanted to gather and analyse data on death, quality of life, serious and non-serious adverse events, severe liver damage, complications resulting from severe liver damage, liver cancer, and death due to liver damage ('clinical outcomes').What were the main results of the Review?The 202 studies included 14,200 participants. Study data were sparse. In all, 115 studies with 7732 participants provided data for analyses. Follow-up of trial participants ranged from 1 month to 28 months (2 months to 28 months for trials that reported clinical outcomes). The Review shows the following.- The evidence indicates considerable uncertainty about effects of interventions on all clinical outcomes.- Well-designed trials that collect data over longer follow-up times are needed in the future to find out the best nutritional supplementation (if any) for people with NAFLD."
}
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query-laysum | 4434 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of a previously published review in the Cochrane Database of Systematic Reviews (2009, Issue 3).Tea is one of the most commonly consumed beverages worldwide. Teas from the plant Camellia sinensis can be grouped into green, black and oolong tea, and drinking habits vary cross-culturally. C sinensis contains polyphenols, one subgroup being catechins. Catechins are powerful antioxidants, and laboratory studies have suggested that these compounds may inhibit cancer cell proliferation. Some experimental and nonexperimental epidemiological studies have suggested that green tea may have cancer-preventative effects.\nObjectives\nTo assess possible associations between green tea consumption and the risk of cancer incidence and mortality as primary outcomes, and safety data and quality of life as secondary outcomes.\nSearch methods\nWe searched eligible studies up to January 2019 in CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and reference lists of previous reviews and included studies.\nSelection criteria\nWe included all epidemiological studies, experimental (i.e. randomised controlled trials (RCTs)) and nonexperimental (non-randomised studies, i.e. observational studies with both cohort and case-control design) that investigated the association of green tea consumption with cancer risk or quality of life, or both.\nData collection and analysis\nTwo or more review authors independently applied the study criteria, extracted data and assessed methodological quality of studies. We summarised the results according to diagnosis of cancer type.\nMain results\nIn this review update, we included in total 142 completed studies (11 experimental and 131 nonexperimental) and two ongoing studies. This is an additional 10 experimental and 85 nonexperimental studies from those included in the previous version of the review.\nEleven experimental studies allocated a total of 1795 participants to either green tea extract or placebo, all demonstrating an overall high methodological quality based on 'Risk of bias' assessment. For incident prostate cancer, the summary risk ratio (RR) in the green tea-supplemented participants was 0.50 (95% confidence interval (CI) 0.18 to 1.36), based on three studies and involving 201 participants (low-certainty evidence). The summary RR for gynaecological cancer was 1.50 (95% CI 0.41 to 5.48; 2 studies, 1157 participants; low-certainty evidence). No evidence of effect of non-melanoma skin cancer emerged (summary RR 1.00, 95% CI 0.06 to 15.92; 1 study, 1075 participants; low-certainty evidence). In addition, adverse effects of green tea extract intake were reported, including gastrointestinal disorders, elevation of liver enzymes, and, more rarely, insomnia, raised blood pressure and skin/subcutaneous reactions. Consumption of green tea extracts induced a slight improvement in quality of life, compared with placebo, based on three experimental studies.\nIn nonexperimental studies, we included over 1,100,000 participants from 46 cohort studies and 85 case-control studies, which were on average of intermediate to high methodological quality based on Newcastle-Ottawa Scale 'Risk of bias' assessment. When comparing the highest intake of green tea with the lowest, we found a lower overall cancer incidence (summary RR 0.83, 95% CI 0.65 to 1.07), based on three studies, involving 52,479 participants (low-certainty evidence). Conversely, we found no association between green tea consumption and cancer-related mortality (summary RR 0.99, 95% CI 0.91 to 1.07), based on eight studies and 504,366 participants (low-certainty evidence).\nFor most of the site-specific cancers we observed a decreased RR in the highest category of green tea consumption compared with the lowest one. After stratifying the analysis according to study design, we found strongly conflicting results for some cancer sites: oesophageal, prostate and urinary tract cancer, and leukaemia showed an increased RR in cohort studies and a decreased RR or no difference in case-control studies.\nAuthors' conclusions\nOverall, findings from experimental and nonexperimental epidemiological studies yielded inconsistent results, thus providing limited evidence for the beneficial effect of green tea consumption on the overall risk of cancer or on specific cancer sites.\nSome evidence of a beneficial effect of green tea at some cancer sites emerged from the RCTs and from case-control studies, but their methodological limitations, such as the low number and size of the studies, and the inconsistencies with the results of cohort studies, limit the interpretability of the RR estimates. The studies also indicated the occurrence of several side effects associated with high intakes of green tea. In addition, the majority of included studies were carried out in Asian populations characterised by a high intake of green tea, thus limiting the generalisability of the findings to other populations. Well conducted and adequately powered RCTs would be needed to draw conclusions on the possible beneficial effects of green tea consumption on cancer risk.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed the association between green tea consumption and the risk of developing cancer in epidemiologic studies."
}
]
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query-laysum | 4435 | [
{
"role": "user",
"content": "Abstract: Background\nTopical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known about their safety in pregnancy.\nObjectives\nTo assess the effects of topical corticosteroids on pregnancy outcomes in pregnant women.\nSearch methods\nThis is an update of a review previously published in 2009. We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, the Cochrane Pregnancy and Childbirth Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE, EMBASE, and LILACS. We also searched five trials registers and checked the reference lists of included studies, published reviews, articles that had cited the included studies, and one author's literature collection, for further references to relevant RCTs.\nSelection criteria\nRandomised controlled trials and cohort studies of topical corticosteroids in pregnant women, as well as case-control studies comparing maternal exposure to topical corticosteroids between cases and controls when studies reported pre-specified outcomes. The primary outcomes included mode of delivery, major congenital abnormality, birth weight, and preterm delivery (delivery before 37 completed weeks gestation); the secondary outcomes included foetal death, minor congenital abnormality, and low Apgar score (less than seven at 5 min).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two authors independently applied selection criteria, extracted data, and assessed the quality of the included studies. A third author was available for resolving differences of opinion. A further author independently extracted data from included studies that were conducted by authors of this systematic review.\nMain results\nWe included 7 new observational studies in this update, bringing the total number to 14, including 5 cohort and 9 case-control studies, with 1,601,515 study subjects.\nMost studies found no causal associations between maternal exposure to topical corticosteroids of any potency and pregnancy outcomes when compared with no exposure. These outcomes included: mode of delivery (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.15, 1 cohort study, n = 9904, low quality evidence); congenital abnormalities, including orofacial cleft or cleft palate and hypospadias (where the urethral opening is on the underside of the penis) (RR 0.82, 95% CI 0.34 to 1.96, 2 cohort studies, n = 9512, low quality evidence; and odds ratio (OR) 1.07, 95% CI 0.71 to 1.60, 1 case-control study, n = 56,557); low birth weight (RR 1.08, 95% CI 0.86 to 1.36; n = 59,419, 4 cohort studies; very low quality evidence); preterm delivery (RR 0.93, 95% CI 0.81 to 1.08, 4 cohort studies, n = 59,419, low quality evidence); foetal death (RR 1.02, 95% CI 0.60 to 1.73, 4 cohort studies, n = 63,885, very low quality evidence); and low Apgar score (RR 0.84, 95% CI 0.54 to 1.31, 1 cohort study, n = 9220, low quality evidence).\nWe conducted stratified analyses of mild or moderate potency, and potent or very potent topical corticosteroids, but we found no causal associations between maternal exposure to topical corticosteroid of any potency and congenital abnormality, orofacial clefts, preterm delivery, or low Apgar score. For low birth weight, although the meta-analysis based on study-level data was not significant for either mild to moderate corticosteroids (pooled RR 0.90, 95% CI 0.74 to 1.09, 3 cohort studies, n > 55,713) or potent to very potent corticosteroids (pooled RR 1.58, 95% CI 0.96 to 2.58, 4 cohort studies, n > 47,651), there were significant differences between the two subgroups (P = 0.04). The results from three of the individual studies in the meta-analysis indicated an increased risk of low birth weight in women who received potent to very potent topical corticosteroids. Maternal use of mild to moderate potency topical steroids was associated with a decreased risk of foetal death (pooled RR 0.70, 95% CI 0.64 to 0.77, 2 studies, n = 48,749; low quality evidence), but we did not observe this effect when potent to very potent topical corticosteroids were given during pregnancy (pooled RR 1.14, 95% CI 0.69 to 1.88, 3 studies, n = 37,086, low quality evidence).\nWe used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group approach to rate the overall quality of the evidence. Data from observational studies started at low quality. We further downgraded the evidence because of imprecision in low birth weight and inconsistency in foetal death. Lower quality evidence resulted in lower confidence in the estimate of effect for those outcomes.\nAuthors' conclusions\nThis update adds more evidence showing no causal associations between maternal exposure to topical corticosteroids of all potencies and pregnancy outcomes including mode of delivery, congenital abnormalities, preterm delivery, foetal death, and low Apgar score, which is consistent with the previous version of this review. This update provides stratified analyses based on steroid potency; we found no association between maternal use of topical corticosteroids of any potency and an increase in adverse pregnancy outcomes, including mode of delivery, congenital abnormality, preterm delivery, foetal death, and low Apgar score. Similar to the previous version of the review, this update identified a probable association between low birth weight and maternal use of potent to very potent topical corticosteroids, especially when the cumulative dosage of topical corticosteroids throughout the pregnancy is very large, which warrants further investigation. The finding of a possible protective effect of mild to moderate topical corticosteroids on foetal death could also be examined.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Topical steroids are the most commonly used medicines for skin conditions. Pregnant women may need topical steroids to treat skin conditions, but it is unclear if they are safe or harmful during pregnancy. We aimed to examine the safety of topical steroids in pregnancy."
}
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query-laysum | 4436 | [
{
"role": "user",
"content": "Abstract: Background\nFractures of the distal femur (the far end of the thigh bone just above the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains unknown.\nObjectives\nTo evaluate the benefits and harms of interventions for treating fractures of the distal femur in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was October 2021.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials in adults comparing interventions for treating fractures of the distal femur. Interventions included surgical implants (retrograde intramedullary nail (RIMN), fixed-angle devices, non-locking plate fixation, locking plate, internal fixation, distal femoral replacement, mono-axial plates, poly-axial plates and condylar buttress plates) and non-surgical management.\nData collection and analysis\nWe used standard Cochrane methods. Our critical outcomes were validated patient-reported outcome measures (PROMs), direct adverse events, participant-reported quality of life (QoL) and pain scores. Our other important outcomes were adverse events indirectly related to intervention, symptomatic non-union, malunion and resource use. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included 14 studies with 753 participants: 13 studies compared different surgical interventions, and one study compared surgical with non-surgical management. Here, we report the effects for RIMN compared with locking plates. Three studies (221 participants) reported this comparison; it included the largest study population and these are the two most commonly used devices in contemporary orthopaedic trauma practice.\nStudies used three different tools to assess PROMs. We found very-low certainty evidence for lower Disability Rating Index scores after RIMN at short-term follow-up favouring RIMN (mean difference (MD) −21.90, 95% confidence interval (CI) −38.16 to −5.64; 1 study, 12 participants) and low-certainty evidence of little or no difference at long-term follow-up (standardised mean difference (SMD) −0.22, 95% CI −0.50 to 0.06; 2 studies, 198 participants). Re-expressing the SMD of the long-term follow-up data to Knee Society Score (KSS) used by one study found no clinical benefit of RIMN, based on a minimal clinically important difference of 9 points (MD 2.47, 95% CI −6.18 to 0.74). The effect on QoL was very uncertain at four months (MD 0.01, 95% CI −0.42 to 0.44; 1 study, 14 participants) and one year (MD 0.10, 95% CI −0.01 to 0.21; 1 study, 156 participants); this evidence was very low certainty.\nFor direct adverse events, studies reported reoperation, loss of fixation, superficial and deep infection, haematoma formation and implant loosening. Effects for all events were imprecise with the possibility of benefit or harm for both treatments. We considered reoperation the most clinically relevant. There was very low-certainty evidence of little or no difference in reoperation between the two implants (risk ratio (RR) 1.48, 95% CI 0.55 to 4.00; 1 study, 104 participants).\nNo studies reported pain.\nFor other important outcomes, we noted that people treated with RIMN may be more likely to have varus/valgus deformity (RR 2.18, 95% CI 1.09 to 4.37; 1 study, 33 participants; low-certainty evidence). However, we found no evidence of any important differences between treatments in terms of bony union, indirect adverse events, or resource use.\nOther comparisons of surgical interventions included in the review were: RIMN versus single fixed-angle device (3 studies, 175 participants); RIMN versus non-locking plate fixation (1 study, 18 participants); locking plate versus single fixed-angle device (2 studies, 130 participants); internal fixation versus distal femoral replacement (1 study, 23 participants); mono-axial plates versus poly-axial plates (2 studies, 67 participants); mono-axial plate versus condylar buttress plate (1 study, 78 participants). The certainty of the evidence for outcomes in these comparisons was low to very low, and most effect estimates were imprecise.\nAuthors' conclusions\nThis review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform clinical practice. Priority should be given to randomised controlled trials comparing contemporary treatments for people with fractures of the distal femur. At a minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years, with an agreed core outcome set. All trials should be reported in full using the CONSORT guidelines.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the scientific literature for randomised controlled trials (RCTs) (studies where patients are randomly assigned a treatment group) and quasi-RCTs (where patients are assigned a treatment group with no randomisation), published up to October 2021.\nWe summarised each study's results, assessing our confidence in the evidence based upon the study's methods and size."
}
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query-laysum | 4437 | [
{
"role": "user",
"content": "Abstract: Background\nThe keratocystic odontogenic tumours (KCOTs) account for between about 2% and 11% of all jaw cysts and can occur at any age. They are more common in males than females with a male:female ratio of approximately 2:1. Although they are benign, KCOTs are locally very aggressive and have a tendency to recur after treatment. Reported recurrence rates range from 3% to 60%. The traditional method for the treatment of most KCOTs is surgical enucleation. However, due to the lining of the cyst being delicate and the fact that they frequently recur, this method alone is not sufficient. Adjunctive surgical treatment has been proposed in addition to the surgical enucleation, such as removal of the peripheral bone (ostectomy) or resection of the cyst with surrounding bone (en-bloc) resection. Other adjunctive treatments proposed are: cryotherapy (freezing) with liquid nitrogen and the use of the fixative Carnoy's solution placed in the cyst cavity after enucleation; both of which attempt to address residual tissue to prevent recurrence.\nObjectives\nTo assess the available evidence comparing the effectiveness of interventions for the treatment of KCOTs.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 17 March 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2015, Issue 2), MEDLINE via Ovid (1946 to 17 March 2015) and EMBASE via Ovid (1980 to 17 March 2015). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials comparing one modality of intervention with another with or without adjunctive treatment for the treatment of KCOTs. Adults, over the age of 18 with a validated diagnosis of solitary KCOTs arising in the jaw bones of the maxilla or mandible. Patients with known Gorlin syndrome were to be excluded.\nData collection and analysis\nReview authors screened trials for inclusion. Full papers were obtained for relevant and potentially relevant trials. If data had been extracted, it would have been synthesised using the fixed-effect model, if substantial clinical diversity were identified between studies we planned to use the random-effects model with studies grouped by action provided there were four or more studies included in the meta-analysis, and we would have explored the heterogeneity between the included studies.\nMain results\nNo randomised controlled trials that met the inclusion criteria were identified.\nAuthors' conclusions\nThere are no published randomised controlled trials relevant to this review question, therefore no conclusions could be reached about the effectiveness or otherwise of the interventions considered in this review. There is a need for well designed and conducted randomised controlled trials to evaluate treatments for KCOTs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review has been conducted to assess the effects of different interventions for the treatment of a particular type of cyst that occurs mainly in the lower jawbone, called a keratocystic odontogenic tumour (KCOT)."
}
]
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query-laysum | 4438 | [
{
"role": "user",
"content": "Abstract: Background\nObservational studies have shown differences in process and outcome between the consultations of primary care physicians whose average consultation lengths differ. These differences may be due to self selection. This is the first update of the original review.\nObjectives\nTo assess the effects of interventions to alter the length of primary care physicians' consultations.\nSearch methods\nWe searched the following electronic databases until 4 January 2016: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP).\nSelection criteria\nRandomised controlled trials and non-randomised controlled trials of interventions to alter the length of primary care physicians' consultations.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of included studies using agreed criteria and resolved disagreements by discussion. We attempted to contact authors of primary studies with missing data. Given the heterogeneity of studies, we did not conduct a meta-analysis. We assessed the certainty of the evidence for the most important outcomes using the GRADE approach and have presented the results in a narrative summary.\nMain results\nFive studies met the inclusion criteria. All were conducted in the UK, and tested short-term changes in the consultation time allocated to each patient. Overall, our confidence in the results was very low; most studies had a high risk of bias, particularly due to non-random allocation of participants and the absence of data on participants' characteristics and small sample sizes. We are uncertain whether altering appointment length increases primary care consultation length, number of referrals and investigations, prescriptions, or patient satisfaction based on very low-certainty evidence. None of the studies reported on the effects of altering the length of consultation on resources used.\nAuthors' conclusions\nWe did not find sufficient evidence to support or refute a policy of altering the lengths of primary care physicians' consultations. It is possible that these findings may change if high-quality trials are reported in the future. Further trials are needed that focus on health outcomes and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Doctors not having enough time with patients during consultations has been a matter of concern. It has been suggested that if doctors and patients had more time to talk, then patients might be more satisfied with care and their problems better dealt with, or doctors might prescribe less and talk more about how to make lifestyle changes."
}
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query-laysum | 4439 | [
{
"role": "user",
"content": "Abstract: Background\nGrade I or low-grade chondrosarcoma (LGCS) is a primary bone tumour with low malignant potential. Historically, it was treated by wide resection, since accurate pre-operative exclusion of more aggressive cancers can be challenging and under-treatment of a more aggressive cancer could negatively influence oncological outcomes. Intralesional surgery for LGCS has been advocated more often in the literature over the past few years. The potential advantages of less aggressive treatment are better functional outcome and lower complication rates although these need to be weighed against the potential for compromising survival outcomes.\nObjectives\nTo assess the benefits and harms of intralesional treatment by curettage compared to wide resection for central low-grade chondrosarcoma (LGCS) of the long bones.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE and Embase up to April 2018. We extended the search to include trials registries, reference lists of relevant articles and review articles. We also searched 'related articles' of included studies suggested by PubMed.\nSelection criteria\nIn the absence of prospective randomised controlled trials (RCTs), we included retrospective comparative studies and case series that evaluated outcome of treatment of central LGCS of the long bones. The primary outcome was recurrence-free survival after a minimal follow-up of 24 months. Secondary outcomes were upgrading of tumour; functional outcome, as assessed by the Musculoskeletal Tumor Society (MSTS) score; and occurrence of complications.\nData collection and analysis\nWe used standard methodological procedures recognised by Cochrane. We conducted a systematic literature search using several databases and contacted corresponding authors, appraised the evidence using the ROBINS-I risk of bias tool and GRADE, and performed a meta-analysis. If data extraction was not possible, we included studies in a narrative summary.\nMain results\nWe included 18 studies, although we were only able to extract participant data from 14 studies that included a total of 511 participants; 419 participants were managed by intralesional treatment and 92 underwent a wide resection. We were not able to extract participant data from four studies, including 270 participants, and so we included them as a narrative summary only. The evidence was at high risk of performance, detection and reporting bias.\nMeta-analysis of data from 238 participants across seven studies demonstrated little or no difference in recurrence-free survival after intralesional treatment versus wide resection for central LGCS in the long bones (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.92 to 1.04; very low-certainty evidence). MSTS scores were probably better after intralesional surgery (mean score 93%) versus resection (mean score 78%) with a mean difference of 12.69 (95% CI 2.82 to 22.55; P value < 0.001; 3 studies; 72 participants; low-certainty evidence). Major complications across six studies (203 participants) were lower in cases treated by intralesional treatment (5/125 cases) compared to those treated by wide resection (18/78 cases), with RR 0.23 (95% CI 0.10 to 0.55; low-certainty evidence). In four people (0.5% of total participants) a high-grade (grade 2 or dedifferentiated) tumour was found after a local recurrence. Two participants were treated with second surgery with no evidence of disease at their final follow-up and two participants (0.26% of total participants) died due to disease. Kaplan-Meier analysis of data from 115 individual participants across four studies demonstrated 96% recurrence-free survival after a maximum follow-up of 300 months after resection versus 94% recurrence-free survival after a maximum follow-up of 251 months after intralesional treatment (P value = 0.58; very low-certainty evidence). Local recurrence or metastases were not reported after 41 months in either treatment group.\nAuthors' conclusions\nOnly evidence of low- and very low-certainty was available for this review according to the GRADE system. Included studies were all retrospective in nature and at high risk of selection and attrition bias. Therefore, we could not determine whether wide resection is superior to intralesional treatment in terms of event-free survival and recurrence rates. However, functional outcome and complication rates are probably better after intralesional surgery compared to wide resection, although this is low-certainty evidence, considering the large effect size. Nevertheless, recurrence-free survival was excellent in both groups and a prospective RCT comparing intralesional treatment versus wide resection may be challenging for both practical and ethical reasons. Future research could instead focus on less invasive treatment strategies for these tumours by identifying predictors that help to stratify participants for surgical intervention or close observation.\n\nGiven the provided abstract, please respond to the following query: \"Background and review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chondrosarcomas are one of the most common types of bone cancer, with varying degrees of severity. These tumours grow from cartilage forming cells, within the bone, or on the surface of the bone. Low-grade chondrosarcomas (LGCS) are tumours that grow slowly over time and do not generally metastasize and people do not usually die from this disease. In the late 20th century, the condition was treated by cutting out large portions of bone surrounding the tumour (wide resection). However, surgeons today more commonly treat these tumours by scraping the tumour out of the bone (intralesional treatment). In this way, the bone structure is preserved and more extensive surgery can be avoided. Therefore, people are potentially less disabled and complications can be reduced. This is only appropriate if the survival outcome of the cancer treatment is not compromised compared to wide resection. We reviewed the evidence for the harms and benefits of both types of surgery on outcomes in people with LGCS, including tumour recurrence after surgery (local recurrence), level of physical functioning and complications after surgery."
}
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query-laysum | 4440 | [
{
"role": "user",
"content": "Abstract: Background\nPostpolio syndrome (PPS) may affect survivors of paralytic poliomyelitis and is characterised by a complex of neuromuscular symptoms leading to a decline in physical functioning. The effectiveness of pharmacological treatment and rehabilitation management in PPS is not yet established. This is an update of a review first published in 2011.\nObjectives\nTo systematically review the evidence from randomised and quasi-randomised controlled trials for the effect of any pharmacological or non-pharmacological treatment for PPS compared to placebo, usual care or no treatment.\nSearch methods\nWe searched the following databases on 21 July 2014: Cochrane Neuromuscular Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and CINAHL Plus. We also checked reference lists of all relevant articles, searched the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment (HTA) Database and trial registers and contacted investigators known to be involved in research in this area.\nSelection criteria\nRandomised and quasi-randomised trials of any form of pharmacological or non-pharmacological treatment for people with PPS. The primary outcome was self perceived activity limitations and secondary outcomes were muscle strength, muscle endurance, fatigue, pain and adverse events.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included 10 pharmacological (modafinil, intravenous immunoglobulin (IVIg), pyridostigmine, lamotrigine, amantadine, prednisone) and three non-pharmacological (muscle strengthening, rehabilitation in a warm climate (that is temperature ± 25°C, dry and sunny) and a cold climate (that is temperature ± 0°C, rainy or snowy), static magnetic fields) studies with a total of 675 participants with PPS in this review. None of the included studies were completely free from any risk of bias, the most prevalent risk of bias being lack of blinding.\nThere was moderate- and low-quality evidence that IVIg has no beneficial effect on activity limitations in the short term and long term, respectively, and inconsistency in the evidence for effectiveness on muscle strength. IVIg caused minor adverse events in a substantial proportion of the participants. Results of one trial provided very low-quality evidence that lamotrigine might be effective in reducing pain and fatigue, resulting in fewer activity limitations without generating adverse events. Data from two single trials suggested that muscle strengthening of thumb muscles (very low-quality evidence) and static magnetic fields (moderate-quality evidence) are safe and beneficial for improving muscle strength and pain, respectively, with unknown effects on activity limitations. Finally, there was evidence varying from very low quality to high quality that modafinil, pyridostigmine, amantadine, prednisone and rehabilitation in a warm or cold climate are not beneficial in PPS.\nAuthors' conclusions\nDue to insufficient good-quality data and lack of randomised studies, it was impossible to draw definite conclusions about the effectiveness of interventions for PPS. Results indicated that IVIg, lamotrigine, muscle strengthening exercises and static magnetic fields may be beneficial but need further investigation to clarify whether any real and meaningful effect exists.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "IVIg is a treatment in which antibodies that have been purified from donated blood are given as an infusion into a vein over a period of time. There was moderate- and low-quality evidence that IVIg has no beneficial effect on activity limitations in the short term and long term, respectively. Evidence for effectiveness on muscle strength was inconsistent, as results differed across studies. IVIg caused minor side effects in a substantial proportion of the participants.\nLamotrigine is a drug used to help control certain kinds of epilepsy and to treat bipolar psychiatric disorder. Results of one trial provided very low-quality evidence that lamotrigine might be effective in reducing pain and fatigue, resulting in fewer activity limitations, and in this study it was well-tolerated. We based these conclusions on results of only one small trial with important limitations in study design.\nThere was very low-quality evidence that muscle strengthening of thumb muscles is safe and beneficial for improving muscle strength. Again, we based these conclusions on results of only one small trial with important limitations in study design, and they are applicable only to thumb muscles.\nStatic magnetic fields is a therapy in which electrical currents are applied to the skin with the intention of reducing pain. There was moderate-quality evidence that static magnetic fields are safe and beneficial for reducing pain directly after treatment, although functional effects on activity limitations and long-term effects are unknown.\nFinally, there was evidence varying from very low quality to high quality that modafinil, pyridostigmine, amantadine, prednisone and rehabilitation in a warm or cold climate are not beneficial in PPS."
}
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query-laysum | 4441 | [
{
"role": "user",
"content": "Abstract: Background\nWhile cigarette smoking has declined globally, waterpipe smoking is rising, especially among youth. The impact of this rise is amplified by mounting evidence of its addictive and harmful nature. Waterpipe smoking is influenced by multiple factors, including appealing flavors, marketing, use in social settings, and misperceptions that waterpipe is less harmful or addictive than cigarettes. People who use waterpipes are interested in quitting, but are often unsuccessful at doing so on their own. Therefore, developing and testing waterpipe cessation interventions to help people quit was identified as a priority for global tobacco control efforts.\nObjectives\nTo evaluate the effectiveness of tobacco cessation interventions for people who smoke waterpipes.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Review Group Specialized Register from database inception to 29 July 2022, using variant terms and spellings ('waterpipe' or 'narghile' or 'arghile' or 'shisha' or 'goza' or 'narkeela' or 'hookah' or 'hubble bubble'). We searched for trials, published or unpublished, in any language.\nSelection criteria\nWe sought randomized controlled trials (RCTs), quasi-RCTs, or cluster-RCTs of any smoking cessation interventions for people who use waterpipes, of any age or gender. In order to be included, studies had to measure waterpipe abstinence at a three-month follow-up or longer.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was abstinence from waterpipe use at least three months after baseline. We also collected data on adverse events. Individual study effects and pooled effects were summarized as risk ratios (RR) and 95% confidence intervals (95% CI), using Mantel-Haenszel random-effects models to combine studies, where appropriate. We assessed statistical heterogeneity with the I2 statistic. We summarized secondary outcomes narratively. We used the five GRADE considerations (risk of bias, inconsistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of the body of evidence for our primary outcome in four categories high, moderate, low, or very low.\nMain results\nThis review included nine studies, involving 2841 participants. All studies were conducted in adults, and were carried out in Iran, Vietnam, Syria, Lebanon, Egypt, Pakistan, and the USA. Studies were conducted in several settings, including colleges/universities, community healthcare centers, tuberculosis hospitals, and cancer treatment centers, while two studies tested e-health interventions (online web-based educational intervention, text message intervention). Overall, we judged three studies to be at low risk of bias, and six studies at high risk of bias.\nWe pooled data from five studies (1030 participants) that tested intensive face-to-face behavioral interventions compared with brief behavioral intervention (e.g. one behavioral counseling session), usual care (e.g. self-help materials), or no intervention. In our meta-analysis, we included people who used waterpipe exclusively, or with another form of tobacco. Overall, we found low-certainty evidence of a benefit of behavioral support for waterpipe abstinence (RR 3.19 95% CI 2.17 to 4.69; I2 = 41%; 5 studies, N = 1030). We downgraded the evidence because of imprecision and risk of bias.\nWe pooled data from two studies (N = 662 participants) that tested varenicline combined with behavioral intervention compared with placebo combined with behavioral intervention. Although the point estimate favored varenicline, 95% CIs were imprecise, and incorporated the potential for no difference and lower quit rates in the varenicline groups, as well as a benefit as large as that found in cigarette smoking cessation (RR 1.24, 95% CI 0.69 to 2.24; I2 = 0%; 2 studies, N = 662; low-certainty evidence). We downgraded the evidence because of imprecision. We found no clear evidence of a difference in the number of participants experiencing adverse events (RR 0.98, 95% CI 0.67 to 1.44; I2 = 31%; 2 studies, N = 662). The studies did not report serious adverse events.\nOne study tested the efficacy of seven weeks of bupropion therapy combined with behavioral intervention. There was no clear evidence of benefit for waterpipe cessation when compared with behavioral support alone (RR 0.77, 95% CI 0.42 to 1.41; 1 study, N = 121; very low-certainty evidence), or with self-help (RR 1.94, 95% CI 0.94 to 4.00; 1 study, N = 86; very low-certainty evidence).\nTwo studies tested e-health interventions. One study reported higher waterpipe quit rates among participants randomized to either a tailored mobile phone or untailored mobile phone intervention compared with those randomized to no intervention (RR 1.48, 95% CI 1.07 to 2.05; 2 studies, N = 319; very low-certainty evidence). Another study reported higher waterpipe abstinence rates following an intensive online educational intervention compared with a brief online educational intervention (RR 1.86, 95% CI 1.08 to 3.21; 1 study, N = 70; very low-certainty evidence).\nAuthors' conclusions\nWe found low-certainty evidence that behavioral waterpipe cessation interventions can increase waterpipe quit rates among waterpipe smokers. We found insufficient evidence to assess whether varenicline or bupropion increased waterpipe abstinence; available evidence is compatible with effect sizes similar to those seen for cigarette smoking cessation.\nGiven e-health interventions' potential reach and effectiveness for waterpipe cessation, trials with large samples and long follow-up periods are needed. Future studies should use biochemical validation of abstinence to prevent the risk of detection bias. Finally, there has been limited attention given to high-risk groups for waterpipe smoking, such as youth, young adults, pregnant women, and dual or poly tobacco users. These groups would benefit from targeted studies.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "• Limited evidence showed that behavioral support might be helpful for quitting waterpipe use. \n• There was not enough evidence to evaluate the effect of varenicline, bupropion, or e-health interventions for quitting waterpipe use.\n• In all cases, further studies may change our conclusions. Further large and well-designed trials on behavioral and pharmacological waterpipe cessation interventions are needed. \n• Given the potential reach and effectiveness of e-health interventions to help quit waterpipe smoking, trials with large samples and long follow-up periods are needed. \n• Reporting more details about the behavioral strategies used in study interventions would help identify vital components in waterpipe interventions."
}
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query-laysum | 4442 | [
{
"role": "user",
"content": "Abstract: Background\nCentral venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce catheter-related blood stream infection (CRBSI) by decreasing colonisation. However, there may be concerns on the local and systemic adverse effects of these dressings in neonates.\nObjectives\nWe assessed the effectiveness and safety of antimicrobial (antiseptic or antibiotic) dressings in reducing CVC-related infections in newborn infants. Had there been relevant data, we would have evaluated the effects of antimicrobial dressings in different subgroups, including infants who received different types of CVCs, infants who required CVC for different durations, infants with CVCs with and without other antimicrobial modifications, and infants who received an antimicrobial dressing with and without a clearly defined co-intervention.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 9), MEDLINE (PubMed), EMBASE (EBCHOST), CINAHL and references cited in our short-listed articles using keywords and MeSH headings, up to September 2015.\nSelection criteria\nWe included randomised controlled trials that compared an antimicrobial CVC dressing against no dressing or another dressing in newborn infants.\nData collection and analysis\nWe extracted data using the standard methods of the CNRG. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using risk difference (RD) and risk ratio (RR) with 95% confidence intervals (CIs).\nMain results\nOut of 173 articles screened, three studies were included. There were two comparisons: chlorhexidine dressing following alcohol cleansing versus polyurethane dressing following povidone-iodine cleansing (one study); and silver-alginate patch versus control (two studies). A total of 855 infants from level III neonatal intensive care units (NICUs) were evaluated, 705 of whom were from a single study. All studies were at high risk of bias for blinding of care personnel or unclear risk of bias for blinding of outcome assessors. There was moderate-quality evidence for all major outcomes.\nThe single study comparing chlorhexidine dressing/alcohol cleansing against polyurethane dressing/povidone-iodine cleansing showed no significant difference in the risk of CRBSI (RR 1.18, 95% CI 0.53 to 2.65; RD 0.01, 95% CI −0.02 to 0.03; 655 infants, moderate-quality evidence) and sepsis without a source (RR 1.06, 95% CI 0.75 to 1.52; RD 0.01, 95% CI −0.04 to 0.06; 705 infants, moderate-quality evidence). There was a significant reduction in the risk of catheter colonisation favouring chlorhexidine dressing/alcohol cleansing group (RR 0.62, 95% CI 0.45 to 0.86; RD −0.09, 95% CI −0.15 to −0.03; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 33; 655 infants, moderate-quality evidence). However, infants in the chlorhexidine dressing/alcohol cleansing group were significantly more likely to develop contact dermatitis, with 19 infants in the chlorhexidine dressing/alcohol cleansing group having developed contact dermatitis compared to none in the polyurethane dressing/povidone-iodine cleansing group (RR 43.06, 95% CI 2.61 to 710.44; RD 0.06, 95% CI 0.03 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 13 to 33; 705 infants, moderate-quality evidence). The roles of chlorhexidine dressing in the outcomes reported were unclear, as the two assigned groups received different co-interventions in the form of different skin cleansing agents prior to catheter insertion and during each dressing change.\nIn the other comparison, silver-alginate patch versus control, the data for CRBSI were analysed separately in two subgroups as the two included studies reported the outcome using different denominators: one using infants and another using catheters. There were no significant differences between infants who received silver-alginate patch against infants who received standard line dressing in CRBSI, whether expressed as the number of infants (RR 0.50, 95% CI 0.14 to 1.78; RD −0.12, 95% CI −0.33 to 0.09; 1 study, 50 participants, moderate-quality evidence) or as the number of catheters (RR 0.72, 95% CI 0.27 to 1.89; RD −0.05, 95% CI −0.20 to 0.10; 1 study, 118 participants, moderate-quality evidence). There was also no significant difference between the two groups in mortality (RR 0.55, 95% CI 0.15 to 2.05; RD −0.04, 95% CI −0.13 to 0.05; two studies, 150 infants, I² = 0%, moderate-quality evidence). No adverse skin reaction was recorded in either group.\nAuthors' conclusions\nBased on moderate-quality evidence, chlorhexidine dressing/alcohol skin cleansing reduced catheter colonisation, but made no significant difference in major outcomes like sepsis and CRBSI compared to polyurethane dressing/povidone-iodine cleansing. Chlorhexidine dressing/alcohol cleansing posed a substantial risk of contact dermatitis in preterm infants, although it was unclear whether this was contributed mainly by the dressing material or the cleansing agent. While silver-alginate patch appeared safe, evidence is still insufficient for a recommendation in practice. Future research that evaluates antimicrobial dressing should ensure blinding of caregivers and outcome assessors and ensure that all participants receive the same co-interventions, such as the skin cleansing agent. Major outcomes like sepsis, CRBSI and mortality should be assessed in infants of different gestation and birth weight.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In newborn infants who require a central venous catheter, does the use of antiseptic or antibiotic catheter dressing, compared to no dressing, reduce catheter-related infections?"
}
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query-laysum | 4443 | [
{
"role": "user",
"content": "Abstract: Background\nVisual problems in older people are common and frequently under-reported. The effects of poor vision in older people are wide reaching and include falls, confusion and reduced quality of life. Much of the visual impairment in older ages can be treated (e.g. cataract surgery, correction of refractive error). Vision screening may therefore reduce the number of older people living with sight loss.\nObjectives\nThe objective of this review was to assess the effects on vision of community vision screening of older people for visual impairment.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 23 November 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared vision screening alone or as part of a multi-component screening package as compared to no vision screening or standard care, on the vision of people aged 65 years or over in a community setting. We included trials that used self-reported visual problems or visual acuity testing as the screening tool.\nData collection and analysis\nWe used standard methods expected by Cochrane. We graded the certainty of the evidence using GRADE.\nMain results\nVisual outcome data were available for 10,608 people in 10 trials. Four trials took place in the UK, two in Australia, two in the United States and two in the Netherlands. Length of follow-up ranged from one to five years. Three of these studies were cluster-randomised trials whereby general practitioners or family physicians were randomly allocated to undertake vision screening or no vision screening. All studies were funded by government agencies. Overall we judged the studies to be at low risk of bias and only downgraded the certainty of the evidence (GRADE) for imprecision.\nSeven trials compared vision screening as part of a multi-component screening versus no screening. Six of these studies used self-reported vision as both screening tool and outcome measure, but did not directly measure vision. One study used a combination of self-reported vision and visual acuity measurement: participants reporting vision problems at screening were treated by the attending doctor, referred to an eye care specialist or given information about resources that were available to assist with poor vision. There was a similar risk of \"not seeing well\" at follow-up in people screened compared with people not screened in meta-analysis of six studies (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.97 to 1.14, 4522 participants high-certainty evidence). One trial reported \"improvement in vision\" and this occurred slightly less frequently in the screened group (RR 0.85, 95% CI 0.52 to 1.40, 230 participants, moderate-certainty evidence).\nTwo trials compared vision screening (visual acuity testing) alone with no vision screening. In one study, distance visual acuity was similar in the two groups at follow-up (mean difference (MD) 0.02 logMAR, 95% CI −0.02 to 0.05, 532 participants, high-certainty evidence). There was also little difference in near acuity (MD 0.02 logMAR, 95% CI −0.03 to 0.07, 532 participants, high-certainty evidence). There was no evidence of any important difference in quality of life (MD −0.06 National Eye Institute 25-item visual function questionnaire (VFQ-25) score adjusted for baseline VFQ-25 score, 95% CI −2.3 to 1.1, 532 participants, high-certainty evidence). The other study could not be included in the data analysis as the number of participants in each of the arms at follow-up could not be determined. However the authors stated that there was no significant difference in mean visual acuity in participants who had visual acuity assessed at baseline (39 letters) as compared to those who did not have their visual acuity assessed (35 letters, P = 0.25, 121 participants).\nOne trial compared a detailed health assessment including measurement of visual acuity (intervention) with a brief health assessment including one question about vision (standard care). People given the detailed health assessment had a similar risk of visual impairment (visual acuity worse than 6/18 in either eye) at follow-up compared with people given the brief assessment (RR 1.07, 95% CI 0.84 to 1.36, 1807 participants, moderate-certainty evidence). The mean composite score of the VFQ-25 was 86.0 in the group that underwent visual acuity screening compared with 85.6 in the standard care group, a difference of 0.40 (95% CI −1.70 to 2.50, 1807 participants, high-certainty evidence).\nAuthors' conclusions\nThe evidence from RCTs undertaken to date does not support vision screening for older people living independently in a community setting, whether in isolation or as part of a multi-component screening package. This is true for screening programmes involving questions about visual problems, or direct measurements of visual acuity.\nThe most likely reason for this negative review is that the populations within the trials often did not take up the offered intervention as a result of the vision screening and large proportions of those who did not have vision screening appeared to seek their own intervention. Also, trials that use questions about vision have a lower sensitivity and specificity than formal visual acuity testing. Given the importance of visual impairment among older people, further research into strategies to improve vision of older people is needed. The effectiveness of an optimised primary care-based screening intervention that overcomes possible factors contributing to the observed lack of benefit in trials to date warrants assessment; trials should consider including more dependent participants, rather than those living independently in the community.\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to find out if community screening for visual impairment (sight loss) in older people results in improvements in vision. Cochrane Review authors collected and analysed all relevant studies to answer this question and found 10 studies."
}
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query-laysum | 4444 | [
{
"role": "user",
"content": "Abstract: Background\nWorkplace aggression constitutes a serious issue for healthcare workers and organizations. Aggression is tied to physical and mental health issues at an individual level, as well as to absenteeism, decreased productivity or quality of work, and high employee turnover rates at an organizational level. To counteract these negative impacts, organizations have used a variety of interventions, including education and training, to provide workers with the knowledge and skills needed to prevent aggression.\nObjectives\nTo assess the effectiveness of education and training interventions that aim to prevent and minimize workplace aggression directed toward healthcare workers by patients and patient advocates.\nSearch methods\nCENTRAL, MEDLINE, Embase, six other databases and five trial registers were searched from their inception to June 2020 together with reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs), cluster-randomized controlled trials (CRCTs), and controlled before and after studies (CBAs) that investigated the effectiveness of education and training interventions targeting aggression prevention for healthcare workers.\nData collection and analysis\nFour review authors evaluated and selected the studies resulting from the search. We used standard methodological procedures expected by Cochrane. We assessed the certainty of evidence using the GRADE approach.\nMain results\nWe included nine studies—four CRCTs, three RCTs, and two CBAs—with a total of 1688 participants. Five studies reported episodes of aggression, and six studies reported secondary outcomes. Seven studies were conducted among nurses or nurse aides, and two studies among healthcare workers in general. Three studies took place in long-term care, two in the psychiatric ward, and four in hospitals or health centers. Studies were reported from the United States, Switzerland, the United Kingdom, Taiwan, and Sweden.\nAll included studies reported on education combined with training interventions. Four studies evaluated online programs, and five evaluated face-to-face programs. Five studies were of long duration (up to 52 weeks), and four studies were of short duration. Eight studies had short-term follow-up (< 3 months), and one study long-term follow-up (> 1 year). Seven studies were rated as being at \"high\" risk of bias in multiple domains, and all had \"unclear\" risk of bias in a single domain or in multiple domains.\nEffects on aggression\nShort-term follow-up\nThe evidence is very uncertain about effects of education and training on aggression at short-term follow-up compared to no intervention (standardized mean difference [SMD] -0.33, 95% confidence interval [CI] -1.27 to 0.61, 2 CRCTs; risk ratio [RR] 2.30, 95% CI 0.97 to 5.42, 1 CBA; SMD -1.24, 95% CI -2.16 to -0.33, 1 CBA; very low-certainty evidence).\nLong-term follow-up\nEducation may not reduce aggression compared to no intervention in the long term (RR 1.14, 95% CI 0.95 to 1.37, 1 CRCT; low-certainty evidence).\nEffects on knowledge, attitudes, skills, and adverse outcomes\nEducation may increase personal knowledge about workplace aggression at short-term follow-up (SMD 0.86, 95% CI 0.34 to 1.38, 1 RCT; low-certainty evidence). The evidence is very uncertain about effects of education on personal knowledge in the long term (RR 1.26, 95% CI 0.90 to 1.75, 1 RCT; very low-certainty evidence). Education may improve attitudes among healthcare workers at short-term follow-up, but the evidence is very uncertain (SMD 0.59, 95% CI 0.24 to 0.94, 2 CRCTs and 3 RCTs; very low-certainty evidence). The type and duration of interventions resulted in different sizes of effects. Education may not have an effect on skills related to workplace aggression (SMD 0.21, 95% CI -0.07 to 0.49, 1 RCT and 1 CRCT; very low-certainty evidence) nor on adverse personal outcomes, but the evidence is very uncertain (SMD -0.31, 95% CI -1.02 to 0.40, 1 RCT; very low-certainty evidence).\nMeasurements of these concepts showed high heterogeneity.\nAuthors' conclusions\nEducation combined with training may not have an effect on workplace aggression directed toward healthcare workers, even though education and training may increase personal knowledge and positive attitudes. Better quality studies that focus on specific settings of healthcare work where exposure to patient aggression is high are needed. Moreover, as most studies have assessed episodes of aggression toward nurses, future studies should include other types of healthcare workers who are also victims of aggression in the same settings, such as orderlies (healthcare assistants). Studies should especially use reports of aggression at an institutional level and should rely on multi-source data while relying on validated measures. Studies should also include days lost to sick leave and employee turnover and should measure outcomes at one-year follow-up. Studies should specify the duration and type of delivery of education and should use an active comparison to prevent raising awareness and reporting in the intervention group only.\n\nGiven the provided abstract, please respond to the following query: \"What is aggressive behavior?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The International Labour Organization uses the term \"workplace violence\" defined as \"any action, incident or behaviour that departures from reasonable conduct in which a person is threatened, harmed, injured in the course of, or as a direct result of, his or her work\". Experiencing aggressive behavior at work can affect people's ability to do their job well, can cause physical and mental health problems, and can also affect home life. Aggressive behavior may lead to absences from work; some people might leave their job if they experience aggressive behavior."
}
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query-laysum | 4445 | [
{
"role": "user",
"content": "Abstract: Background\nElevation of pulmonary pressure is no longer a rare disease, given its multifactorial etiology. However data on the actual incidence of this condition are still limited, and controversies regarding its management are ongoing. Use of anticoagulation in the management of pulmonary hypertension is based on the presence of in situ thrombosis in the patient with pulmonary arterial hypertension (PAH) and on retrospective evidence of clinical benefit. Current practice is dependent mostly on expert opinion and individualised experience. The real benefit of its use in different types of pulmonary hypertension is still debatable, and the therapeutic target of the international normalised ratio (INR) among treated patients remains inconclusive. Adverse outcomes associated with anticoagulants are significant and can include fatal haemorrhage. Justification for the use of this intervention requires critical evaluation of randomised controlled trials.\nObjectives\n1. To evaluate the effectiveness of, and potential adverse events associated with, anticoagulation in the management of pulmonary hypertension (PH).\n2. To evaluate the effective therapeutic INR in pulmonary hypertensive patients receiving anticoagulants (North American centres 1.5 to 2.5, European centres 2.0 to 3.0).\nSearch methods\nWe identified trials through searches of the following databases.\nCochrane Airways Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library; MEDLINE (Ovid); EMBASE (Ovid); CINAHL (EBSCOhost); Clinical trials.gov and the World Health Organization (WHO) trials portal. The trial search date was 28 March 2014.\nSelection criteria\nWe planned to include only randomised controlled trials. Participants with PH with co-morbidities including medical conditions requiring long-term anticoagulation were to be included. We also planned to include trials comparing any anticoagulant with placebo.\nData collection and analysis\nReview authors (IE and HE) independently appraised all identified citations to establish their relevance for inclusion in the review. IE and HE independently screened the titles and abstracts of all identified potential studies for inclusion.\nMain results\nNo eligible trials were identified for inclusion in this review.\nAuthors' conclusions\nNo eligible studies were identified for inclusion in this review. Although our review of available non-randomised studies shows beneficial effect, this finding should be interpreted with caution since there are likely to be biases associated with their design and our methods were not designed to identify, appraise and summarise evidence from them. So that better decisions can be made regarding the effectiveness of this intervention, well-designed randomised controlled trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No randomised evidence is available. We decided to look at the results of other studies (non-randomised control trials). They provide only poor quality evidence of effectiveness of this intervention, and the results should be interpreted with caution. We are uncertain as to how far the results of studies with this design can be believed, and our own approach was not designed to properly look for them and incorporate them in our systematic review. This review therefore highlights the need for appropriately designed randomised controlled trials."
}
]
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