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query-laysum | 4647 | [
{
"role": "user",
"content": "Abstract: Background\nHair has traditionally been removed from the surgical site before surgery; however, some studies claim that this increases surgical site infections (SSIs) and should be avoided. This is the second update of a review published in 2006 and first updated in 2011.\nObjectives\nTo determine whether routine preoperative hair removal (compared with no removal) and the method, timing, or setting of hair removal effect SSI rates.\nSearch methods\nIn November 2019, for this second update we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase; and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies, and scanned the reference lists of included studies plus reviews to identify additional studies. We applied no date or language restrictions.\nSelection criteria\nWe included randomised controlled trials or quasi-randomised trials that compared:\n· hair removal with no hair removal;\n· different methods of hair removal; and\n· hair removal at different times before surgery.\nData collection and analysis\nTwo review authors independently assessed the relevance of each study. Data were extracted independently by both review authors and cross-checked. We carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool and assessed the certainty of evidence according to GRADE. Sensitivity analyses excluding studies at high risk of bias were conducted.\nMain results\nWe included 11 new studies in this update resulting in a total of 19 randomised and 6 quasi-randomised trials (8919 participants).\nClipping compared with no hair removal\nLow certainty evidence suggests there may be little difference in risk of SSI when no hair removal is compared with hair removal using clippers (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.65 to 1.39; three studies with 1733 participants).\nShaving with a razor compared with no hair removal\nModerate certainty evidence suggests the risk of SSI is probably increased in participants who have hair removal with a razor compared with no removal (RR 1.82, 95% CI 1.05 to 3.14; seven studies with 1706 participants). In terms of absolute risk this represents 17 more SSIs per 1000 in the razor group compared with the no hair removal group (95% CI 1 more to 45 more SSI in the razor group).\nBased on low-certainty evidence, it is unclear whether there is a difference in stitch abscesses between hair removal with a razor and no hair removal (1 trial with 80 participants; RR 1.00, 95% CI 0.21 to 4.66).\nBased on narrative data from one trial with 136 participants, there may be little difference in length of hospital stay between participants having hair removed with a razor compared with those having no hair removal (low-certainty evidence).\nBased on narrative data from one trial with 278 participants, it is uncertain whether there is a difference in cost between participants having hair removed by shaving with a razor compared with no hair removal (very low certainty evidence).\nDepilatory cream compared with no hair removal\nLow certainty evidence suggests there may be little difference in SSI risk between depilatory cream or no hair removal, although there are were wide confidence intervals around the point estimate that included benefit and harm (RR 1.02, 95% CI 0.45 to 2.31; low-certainty evidence; 1 trial with 267 participants).\nBased on narrative data from one trial with 267 participants, it is uncertain whether there is a difference in cost between participants having hair removed with depilatory cream compared with no hair removal (very low certainty evidence).\nShaving with a razor compared with clipping\nModerate-certainty evidence from 7 studies with 3723 participants suggests the risk of SSI is probably increased by shaving with a razor compared with clipping (RR 1.64, 95% CI 1.16 to 2.33).\nModerate-certainty evidence suggests the risk of skin injury is probably increased in people who have hair removal with a razor rather than clipping (3 trials with 1333 participants; RR 1.74, CI 95% 1.12 to 2.71).\nShaving with a razor compared with depilatory cream\nModerate-certainty evidence from 9 studies with 1593 participants suggests there is probably more SSI risk when razors are used compared with depilatory cream (RR 2.28, 95% CI 1.12 to 4.65).\nLow-certainty evidence suggests the risk of skin injury may be increased when using a razor rather than depilatory cream for hair removal (RR 6.95, CI 95% 3.45 to 13.98; 5 trials with 937 participants).\nBased on narrative data from three trials with 402 participants, it is uncertain whether depilatory cream is more expensive than shaving (very low certainty evidence).\nHair removal on the day of surgery compared with one-day preoperatively\nLow-certainty evidence suggests that there may be a small reduction in SSI risk when hair is removed on the day of surgery compared with the day before surgery although there are were wide confidence intervals around the point estimate that included benefit and harm (one trial, 977 participants; RR 0.83, 95% CI 0.54 to 1.30).\nAuthors' conclusions\nCompared with no hair removal, there may be little difference in risk of SSI when clippers or depilatory cream are used (low-certainty evidence). However, there are probably fewer SSIs when hair is not removed compared with shaving with a razor (moderate-certainty evidence). If hair has to be removed, moderate-certainty evidence suggests using clippers or depilatory cream probably results in fewer SSIs and other complications compared with shaving using a razor. There may be a small reduction in SSIs when hair is removed on the day of, rather than the day before, surgery.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if removing hair before surgery:\n· causes or prevents infections;\n· prevents wound complications, such as cuts to the skin or the opening up of stitched wounds;\n· has an impact on how long people stay in hospital after surgery; and\n· has any cost implications.\nWe were also interested in whether some hair removal methods or times for hair removal are better than others."
}
]
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query-laysum | 4648 | [
{
"role": "user",
"content": "Abstract: Background\nAutistic spectrum disorder (ASD) is an increasingly recognised neurodevelopmental condition; that is, a neurologically-based condition which interferes with the acquisition, retention or application of specific skills. ASD is characterised by challenges with socialisation and communication, and by stereotyped and repetitive behaviours. A stereotyped behaviour is one which is repeated over and over again and which seems not to have any useful function. ASD often co-occurs with mental health disorders, including obsessive compulsive disorder (OCD). People with ASD may show certain cognitive differences (i.e. differences in ways of thinking) which influence their response to therapies. Thus, there is a need for evidence-based guidelines to treat mental health issues in this group.\nOCD, a common condition characterised by repeated obsessional thoughts and compulsive acts, occurs with greater frequency in persons with ASD than in the general population. Genetic, anatomic, neurobiological and psychological factors have been proposed to explain this co-occurrence. However, care should be taken to distinguish stereotyped and repetitive behaviours characteristic of ASD from obsessive compulsive acts in OCD.\nCognitive behavioural therapy (CBT) is the recommended treatment for OCD, but studies have suggested that this treatment may be less effective in those with OCD co-occurring with ASD. Hence, modifications to CBT treatment may be helpful when treating OCD co-occurring with ASD to optimise outcomes.\nObjectives\nTo assess the effectiveness of behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in children and adults with autism spectrum disorder (ASD).\nSearch methods\nWe searched for studies in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, five other bibliographic databases, international trial registries and other sources of grey literature (to 24 August 2020). We checked the reference lists of included studies and relevant systematic reviews to identify additional studies missed from the original electronic searches. We contacted subject experts for further information when needed.\nSelection criteria\nWe included randomised controlled trials (RCTs), cross-over, cluster- and quasi-randomised controlled trials involving both adults and children with diagnoses of OCD and ASD. We included studies of participants with co-occurring conditions (i.e. those experiencing other mental illnesses or neurodevelopmental conditions at the same time), but we did not include individuals who had a co-occurring global learning difficulty. Treatment could be in any setting or format and include behavioural therapy (BT) and cognitive behavioural therapy (CBT), which may have been adapted for those with ASD. Comparator interventions included no treatment, waiting list, attention placebo (where the control group receives non-specific aspects of therapy, but not the active ingredient) and treatment as usual (TAU, where the control group receives the usual treatment, according to accepted standards).\nData collection and analysis\nThree review authors independently screened studies for inclusion. The authors extracted relevant data from the one eligible study, assessed the risk of bias and certainty of evidence (GRADE). Outcomes of interest were changes in OCD symptoms and treatment completion (primary outcome), and severity of depressive symptoms, anxiety symptoms and behavioural difficulties, as well as degree of family accommodation (secondary outcomes). We did not conduct meta-analyses as only one study met the selection criteria.\nMain results\nWe included only one RCT of 46 participants in our analysis. This study compared CBT for OCD in persons with high-functioning ASD with a control group who received anxiety management only. There were no differences in rates of treatment completion between the CBT (87%) and anxiety management (87%) groups (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.80 to 1.25; low-certainty evidence). Behavioural difficulties were not included as an outcome measure in the study. This study showed that there may be a benefit at the end of treatment favouring CBT compared with anxiety management in OCD symptoms (mean difference (MD) -3.00, 95% CI -8.02 to 2.02), depression symptoms (MD -1.80, 95% CI -11.50 to 7.90), anxiety symptoms (MD -3.20, 95% CI -11.38 to 4.98), and quality of life (MD 5.20, 95% CI -1.41 to 11.81), but the evidence was of low certainty.\nAuthors' conclusions\nEvidence is limited regarding the efficacy of CBT for treatment of OCD in ASD. There is much scope for future study, not only examining the efficacy of CBT for OCD in ASD, but also the particular ways that OCD manifests in and affects people with ASD and the role of the family in treatment response.\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 who have been given a diagnosis of ASD tend to have certain things in common. They often understand social interactions and communication differently to other people. People with ASD may also be less flexible in their thinking than other people, which may make it more difficult for them to use psychological therapies in the way that they are usually presented. The opinions of people with ASD are valuable in helping clinicians decide which research areas related to ASD should take priority.\nSomeone who has been diagnosed with OCD has certain symptoms which, to some extent, affect how they are able to get on with their lives. Someone with OCD has persistent thoughts, although they don't want the thoughts and often think that the thoughts are unreasonable. These thoughts are often worries about themselves or someone else being harmed or about something not being perfect or just right. Sometimes the person with OCD feels as if they have to think thoughts or do actions repeatedly to 'make things right', even though they often really know that they don't need to. The repeated actions might be something like washing their hands.\nResearch has shown that people with ASD are more likely to develop OCD. People may have certain genes that make them more likely to develop both ASD and OCD, or it may be that the way people with ASD tend to think makes them more likely to have OCD.\nCognitive behavioural therapy (CBT) has been used for a long time to treat OCD. CBT is usually carried out by visiting a therapist, but it can be delivered in different ways, such as online. CBT involves talking about the repeated thoughts that occur and helping the person manage and reduce them, and also involves trying to carry out compulsive actions less often. Because people with ASD sometimes have a different way of thinking and communicating, clinicians have wondered if CBT would be as useful to treat OCD in people with ASD as it is in people who have OCD but don't have ASD. Other researchers have devised ways to change the way that CBT is delivered to people with ASD to help them to get the most out of the treatment, and this is called 'adapted CBT'. Studies have shown that adapted CBT is useful for some anxiety disorders that occur in ASD. However, not as many studies have looked at how adapted CBT might be useful for OCD in people with ASD."
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query-laysum | 4649 | [
{
"role": "user",
"content": "Abstract: Background\nHepatitis C virus infection affects around 3% of the world population or approximately 160 million people. A variable proportion (5% to 40%) of the infected people develop clinical symptoms. Hence, hepatitis C virus is a leading cause of liver-related morbidity and mortality with hepatic fibrosis, end-stage liver cirrhosis, and hepatocellular carcinoma as the dominant clinical sequelae. Combination therapy with pegylated (peg) interferon-alpha and ribavirin achieves sustained virological response (that is, undetectable hepatitis C virus RNA in serum by sensitivity testing six months after the end of treatment) in approximately 40% to 80% of treated patients, depending on viral genotype. Recently, a new class of drugs have emerged for hepatitis C infection, the direct acting antivirals, which in combination with standard therapy or alone can lead to sustained virological response in 80% or more of treated patients. Aminoadamantanes, mostly amantadine, are antiviral drugs used for the treatment of patients with chronic hepatitis C. We have previously systematically reviewed amantadine versus placebo or no intervention and found no significant effects of the amantadine on all-cause mortality or liver-related morbidity and on adverse events in patients with hepatitis C. Overall, we did not observe a significant effect of amantadine on sustained virological response. In this review, we systematically review aminoadamantanes versus other antiviral drugs.\nObjectives\nTo assess the beneficial and harmful effects of aminoadamantanes versus other antiviral drugs for patients with chronic hepatitis C virus infection by conducting a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.\nSearch methods\nThe Cochrane Hepato-Biliary Group Controlled Trials Register (1996 to December 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 11 of 12, 2013), MEDLINE (1946 to December 2013), EMBASE (1974 to December 2013), Science Citation Index EXPANDED (1900 to December 2013), the WHO International Clinical Trials Registry Platform (www.who.int/ictrp), Google Scholar, and Eudrapharm up to December 2013. Furthermore, full text searches were conducted until December 2013.\nSelection criteria\nRandomised clinical trials assessing aminoadamantanes in participants with chronic hepatitis C virus infection.\nData collection and analysis\nTwo authors independently extracted data. RevMan Analysis was used for statistical analysis of dichotomous data using risk ratio (RR) with 95% confidence intervals (CI). Methodological domains were used to assess the risk of systematic errors ('bias'). We used trial sequential analysis to assess risk of random errors ('play of chance').\nMain results\nSix randomised clinical trials with 581 participants with chronic hepatitis C were included. All trials had high risk of bias. The included trials compared amantadine versus other antiviral drugs: ribavirin, mycophenolate mofetil, interferon-alpha, or interferon-gamma. Standard antiviral therapy (interferon-alpha, interferon-alpha plus ribavirin, or peg interferon alpha) was administered equally to the intervention and the control groups in five trials, depending on when the trial was conducted. Four trials compared amantadine versus ribavirin. There were no deaths or liver-related morbidity in the two intervention groups (0/216 (0%) versus 0/211 (0%); 4 trials; very low quality of the evidence). The lower estimated risk for (serious) adverse events leading to treatment discontinuation with amantadine was imprecise (RR 0.56, 95% CI 0.27 to 1.16; based on 10/216 (5%) versus 18/211 (9%) participants in 4 trials; very low quality of the evidence). There were more participants with failure of sustained virological response in the amantadine group than in the ribavirin group (206/216 (96%) versus 176/211 (84%); RR 1.14, 95% CI 1.07 to 1.22, 4 trials; low quality of the evidence). Amantadine versus ribavirin more often failed to achieve end-of follow-up biochemical response (41/46 (89%) versus 31/46 (67%); RR 1.31, 95% CI 1.05 to 1.63; 2 trials; very low quality of the evidence). One trial compared amantadine versus mycophenolate mofetil. There were no significant differences between the two treatment groups, except that amantadine was inferior to mycophenolate mofetil regarding the outcome failure to achieve end-of treatment virological response (low quality of evidence). One trial each compared amantadine versus interferon-alpha or interferon-gamma. Both comparisons showed no significant differences in the treatment outcomes (very low quality of the evidence). The observed effects could be due to real effects, systematic errors (bias), or random errors (play of chance). This possible influence on the observed effect by play of chance is due to the fact that trial sequential analyses could not confirm our findings. We were not able to perform meta-analyses on failure of histological improvement and quality of life due to lack of valid data in all trial comparisons.\nAuthors' conclusions\nThis systematic review has identified evidence of very low quality for the key outcomes of all-cause mortality or liver-related morbidity and adverse events in people with chronic hepatitis C when treated with amantadine compared with ribavirin, mycophenolate, interferon-alpha, or interferon-gamma. The timeframe for measuring the composite outcome was insufficient in the included trials. There was low quality evidence that amantadine led to more participants who failed to achieve sustained virological response compared with ribavirin. This observation may be real or caused by systematic errors (bias), but it does not seem to be caused by random error (play of chance). Due to the low quality of the evidence, we are unable to determine definitively whether amantadine is less effective than other antivirals in patients with chronic hepatitis C. As it appears less likely that future trials assessing amantadine or potentially other aminoadamantanes for patients with chronic hepatitis C would show strong benefits, it is probably better to focus on the assessments of other direct acting antiviral drugs. We found no evidence assessing other aminoadamantanes in randomised clinical trials in order to recommend or refute their use.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All the included trials were with high risk of bias. This review did not demonstrate any benefits or harms of amantadine on all-cause mortality or liver-related morbidity and on adverse events, but data were sparse. Compared with ribavirin, amantadine seemed to lead to more participants who fail to achieve sustained virological response (that is, undetectable hepatitis C virus RNA in serum by sensitivity testing six months after the end of treatment). This may be real or due to bias (systematic errors), but it does not seem to be due to play of chance (random errors), as trial sequential analysis confirmed the result. Compared with mycophenolate mofetil, amantadine seemed less effective in achieving end-of-treatment virological response. Compared with interferon-alpha or interferon-gamma, amantadine did not seem to offer benefits. Accordingly, the evidence from this review does not support the routine clinical use of amantadine. Therefore, it is probably better to examine the effects of other direct acting antivirals in the hepatitis C field than to conduct more randomised clinical trials on amantadine. We found no randomised clinical trials assessing other aminoadamantanes, for example rimantadine."
}
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query-laysum | 4650 | [
{
"role": "user",
"content": "Abstract: Background\nGovernments use different approaches to ensure that private for-profit healthcare services meet certain quality standards. Such government guidance, referred to as public stewardship, encompasses government policies, regulatory mechanisms, and implementation strategies for ensuring accountability in the delivery of services. However, the effectiveness of these strategies in low- and middle-income countries (LMICs) have not been the subject of a systematic review.\nObjectives\nTo assess the effects of public sector regulation, training, or co-ordination of the private for-profit health sector in low- and middle-income countries.\nSearch methods\nFor related systematic reviews, we searched the Cochrane Database of Systematic Reviews (CDSR) 2015, Issue 4; Database of Abstracts of Reviews of Effectiveness (DARE) 2015, Issue 1; Health Technology Assessment Database (HTA) 2015, Issue 1; all part of The Cochrane Library, and searched 28 April 2015. For primary studies, we searched MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 16 June 2016); Science Citation Index and Social Sciences Citation Index 1987 to present, and Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 3 May 2016 for papers citing included studies); Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 3, part of The Cochrane Library (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 28 April 2015); Embase 1980 to 2015 Week 17, OvidSP (searched 28 April 2015); Global Health 1973 to 2015 Week 16, OvidSP (searched 30 April 2015); WHOLIS, WHO (searched 30 April 2015); Science Citation Index and Social Sciences Citation Index 1975 to present, ISI Web of Science (searched 30 April 2015); Health Management, ProQuest (searched 22 November 2013). In addition, in April 2016, we searched the reference lists of relevant articles, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and various electronic databases of grey literature.\nSelection criteria\nRandomised trials, non-randomised trials, interrupted time series studies, or controlled before-after studies.\nData collection and analysis\nTwo authors independently assessed study eligibility and extracted data, comparing their results and resolving discrepancies by consensus. We expressed study results as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI), where appropriate, and assessed the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). We did not conduct meta-analysis because of heterogeneity of interventions and study designs.\nMain results\nWe identified 20,177 records, 50 of them potentially eligible. We excluded 39 potentially eligible studies because they did not involve a rigorous evaluation of training, regulation, or co-ordination of private for-profit healthcare providers in LMICs; five studies identified after the review was submitted are awaiting assessment; and six studies met our inclusion criteria. Two included studies assessed training alone; one assessed regulation alone; three assessed a multifaceted intervention involving training and regulation; and none assessed co-ordination. All six included studies targeted private for-profit pharmacy workers in Africa and Asia.\nThree studies found that training probably increases sale of oral rehydration solution (one trial in Kenya, 106 pharmacies: RR 3.04, 95% CI 1.37 to 6.75; and one trial in Indonesia, 87 pharmacies: RR 1.41, 95% CI 1.03 to 1.93) and dispensing of anti-malarial drugs (one trial in Kenya, 293 pharmacies: RR 8.76, 95% CI 0.94 to 81.81); moderate-certainty evidence.\nOne study conducted in the Lao People's Democratic Republic shows that regulation of the distribution and sale of registered pharmaceutical products may improve composite pharmacy indicators (one trial, 115 pharmacies: improvements in four of six pharmacy indicators; low-certainty evidence).\nThe outcome in three multifaceted intervention studies was the quality of pharmacy practice; including the ability to ask questions, give advice, and provide appropriate treatment. The trials applied regulation, training, and peer influence in sequence; and the study design does not permit separation of the effects of the different interventions. Two trials conducted among 136 pharmacies in Vietnam found that the multifaceted intervention may improve the quality of pharmacy practice; but the third study, involving 146 pharmacies in Vietnam and Thailand, found that the intervention may have little or no effects on the quality of pharmacy practice (low-certainty evidence).\nOnly two studies (both conducted in Vietnam) reported cost data, with no rigorous assessment of the economic implications of implementing the interventions in resource-constrained settings. No study reported data on equity, mortality, morbidity, adverse effects, satisfaction, or attitudes.\nAuthors' conclusions\nTraining probably improves quality of care (i.e. adherence to recommended practice), regulation may improve quality of care, and we are uncertain about the effects of co-ordination on quality of private for-profit healthcare services in LMICs. The likelihood that further research will find the effect of training to be substantially different from the results of this review is moderate; implying that monitoring of the impact is likely to be needed if training is implemented. The low certainty of the evidence for regulation implies that the likelihood of further research finding the effect of regulation to be substantially different from the results of this review is high. Therefore, an impact evaluation is warranted if government regulation of private for-profit providers is implemented in LMICs. Rigorous evaluations of these interventions should also assess other outcomes such as impacts on equity, cost implications, mortality, morbidity, and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Co-ordination\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review did not find any eligible study that assessed the effects of co-ordination on quality of care."
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query-laysum | 4651 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in the Cochrane Library, Issue 5, 2015.\nYoga may induce relaxation and stress reduction, and influence the electroencephalogram and the autonomic nervous system, thereby controlling seizures. Yoga would be an attractive therapeutic option for epilepsy if proved effective.\nObjectives\nTo assess whether people with epilepsy treated with yoga:\n(a) have a greater probability of becoming seizure free;\n(b) have a significant reduction in the frequency or duration of seizures, or both; and\n(c) have a better quality of life.\nSearch methods\nFor this update, we searched the Cochrane Epilepsy Group Specialized Register (3 January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12) in the Cochrane Library (searched 3 January 2017), MEDLINE (Ovid, 1946 to 3 January 2017), SCOPUS (1823 to 3 January 2017), ClinicalTrials.gov (searched 3 January 2017), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (searched 3 January 2017), and also registries of the Yoga Biomedical Trust and the Research Council for Complementary Medicine. In addition, we searched the references of all the identified studies. No language restrictions were imposed.\nSelection criteria\nThe following study designs were eligible for inclusion: randomised controlled trials (RCT) of treatment of epilepsy with yoga. The studies could be double-, single- or unblinded. Eligible participants were adults with uncontrolled epilepsy comparing yoga with no treatment or different behavioural treatments.\nData collection and analysis\nTwo review authors independently assessed the trials for inclusion and extracted data. The following outcomes were assessed: (a) percentage of people rendered seizure free; (b) seizure frequency and duration; (c) quality of life. Analyses were on an intention-to-treat basis. Odds ratio (OR) with 95% confidence intervals (95% Cls) were estimated for the outcomes.\nMain results\nWe did not identify any new studies for this update, therefore the results are unchanged.\nFor the previous version of the review, the authors found two unblinded trials in people with refractory epilepsy. In total these two studies included 50 people (18 treated with yoga and 32 to control interventions). Antiepileptic drugs were continued in all the participants. Baseline phase lasted three months in both studies and treatment phase from five weeks to six months in the two trials. Randomisation was by roll of a die in one study and using a computerised randomisation table in the other one but neither study provided details of concealment of allocation and were rated as unclear risk of bias. Overall, the two studies were rated as low risk of bias (all participants were included in the analysis; all expected and pre-expected outcomes were reported; no other sources of bias).\nThe overall ORs with 95% CI were as follows: (i) seizure free for six months — for yoga versus sham yoga the OR was 14.54 (95% CI 0.67 to 316.69) and for yoga versus 'no treatment' group it was 17.31 (95% CI 0.80 to 373.45); for Acceptance and Commitment Therapy (ACT) versus yoga the OR was 1.00 (95% Cl 0.16 to 6.42); (ii) reduction in seizure frequency — the mean difference between yoga versus sham yoga group was −2.10 (95% CI −3.15 to −1.05) and for yoga versus 'no treatment' group it was −1.10 (95% CI −1.80 to −0.40); (iii) more than 50% reduction in seizure frequency — for yoga versus sham yoga group, OR was 81.00 (95% CI 4.36 to 1504.46) and for the yoga versus 'no treatment' group it was 158.33 (95% CI 5.78 to 4335.63); ACT versus yoga OR was 0.78 (95% Cl 0.04 to 14.75); (iv) more than 50% reduction in seizure duration — for yoga versus sham yoga group OR was 45.00 (95% CI 2.01 to 1006.75) and for yoga versus 'no treatment' group it was 53.57 (95% CI 2.42 to 1187.26); ACT versus yoga OR was 0.67 (95% Cl 0.10 to 4.35).\nIn addition in Panjwani 1996 the authors reported that the one-way analysis of variance revealed no statistically significant differences between the three groups. A P-Lambda test taking into account the P values between the three groups also indicated that the duration of epilepsy in the three groups was not comparable. No data were available regarding quality of life. In Lundgren 2008 the authors reported that there was no significant difference between the yoga and ACT groups in seizure-free rates, 50% or greater reduction in seizure frequency or seizure duration at one-year follow-up. The yoga group showed significant improvement in their quality of life according to the Satisfaction With Life Scale (SWLS) (P < 0.05), while the ACT group had significant improvement in the World Health Organization Quality of Life-BREF (WHOQOL-BREF) scale (P < 0.01).\nOverall, we assessed the quality of evidence as low; no reliable conclusions can be drawn at present regarding the efficacy of yoga as a treatment for epilepsy.\nAuthors' conclusions\nA study of 50 subjects with epilepsy from two trials reveals a possible beneficial effect in control of seizures. Results of the overall efficacy analysis show that yoga treatment was better when compared with no intervention or interventions other than yoga (postural exercises mimicking yoga). There was no difference between yoga and Acceptance and Commitment Therapy. However no reliable conclusions can be drawn regarding the efficacy of yoga as a treatment for uncontrolled epilepsy, in view of methodological deficiencies such as limited number of studies, limited number of participants randomised to yoga, lack of blinding and limited data on quality-of-life outcome. Physician blinding would normally be taken to be the person delivering the intervention, whereas we think the 'physician' would in fact be the outcome assessor (who could be blinded), so that would be a reduction in detection bias rather than performance bias. In addition, evidence to inform outcomes is limited and of low quality. Further high-quality research is needed to fully evaluate the efficacy of yoga for refractory epilepsy.\nSince we did not find any new studies, our conclusions remain unchanged.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For this update, we did not identify any new studies to add, and thus the conclusions remain unchanged. The review included two unblinded randomised controlled trials (RCTs) recruiting a total of 50 participants (adults) with refractory epilepsy and comparing any type of classical Indian yoga to the control groups receiving no intervention or interventions such as yoga-mimicking exercises or Acceptance and Commitment Therapy. Antiepileptic drugs were continued in all the participants. The outcomes assessed were: percentage of people rendered seizure free; seizure frequency and duration; and quality of life. Results of the overall efficacy analysis show that yoga treatment was better when compared with no intervention or interventions other than yoga, but no reliable conclusions can be drawn regarding the efficacy of yoga as a treatment for uncontrolled epilepsy. The yoga group showed significant improvement in their quality of life according to the Satisfaction With Life Scale. Blinding may reduce the observer bias. Physician blinding may be achieved with the outcomes being assessed by a physician who is not involved in the trial. Participant blinding may not be possible, since it would be easy to distinguish whether the intervention given is yoga or not. It would be ideal if the seizure records are maintained by a blinded observer. Seizure frequency outcomes should preferably be expressed as the proportion of individuals seizure free or proportion with more than 50% reduction in seizure frequency, since mean values of seizure frequency are often skewed and difficult to analyse. Seizure duration may be measured in seconds or minutes (per episode or month). Validated quality-of-life measures (disease specific) may indicate whether there is overall improvement in the quality of life as a result of the intervention, besides seizure control."
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query-laysum | 4652 | [
{
"role": "user",
"content": "Abstract: Background\nDental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the most prevalent disease worldwide and is considered the most important burden of oral health. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anaesthesia. The need for an electricity supply, expensive handpieces and highly trained dental health personnel may limit access to dental treatment, especially in underdeveloped regions.\nTo overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. ART is a minimally invasive approach which involves removal of decayed tissue using hand instruments alone, usually without use of anaesthesia and electrically driven equipment, and restoration of the dental cavity with an adhesive material (glass ionomer cement (GIC), composite resins, resin-modified glass-ionomer cement (RM-GICs) and compomers).\nObjectives\nTo assess the effects of Atraumatic Restorative Treatment (ART) compared with conventional treatment for managing dental caries lesions in the primary and permanent teeth of children and adults.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 22 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 1), MEDLINE Ovid (1946 to 22 February 2017), Embase Ovid (1980 to 22 February 2017), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 22 February 2017) and BBO BIREME Virtual Health Library (Bibliografia Brasileira de Odontologia; 1986 to 22 February 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least six months' follow-up that compared the effects of ART with a conventional restorative approach using the same or different restorative dental materials to treat caries lesions.\nData collection and analysis\nTwo review authors independently screened search results, extracted data from included studies and assessed the risk of bias in those studies. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. Where pooling was appropriate we conducted meta-analyses using the random-effects model. We assessed the quality of the evidence using GRADE criteria.\nMain results\nWe included a total of 15 eligible studies randomising 3760 participants in this review. The age of participants across the studies ranged from 3 to 101 years, with a mean of 25.42 years. 48% of participants were male. All included studies were published between 2002 and 2016. Two of the 15 studies declared that the financial support was from companies that manufacture restorative material. Five studies were individually randomised parallel-group studies; six were cluster-randomised parallel-group studies; and four were randomised studies that used a split-mouth design. Eleven studies evaluated the effects of ART on primary teeth only, and four on permanent teeth. The follow-up period of the included studies ranged from 6 months to 36 months. We judged all studies to be at high risk of bias.\nFor the main comparison of ART compared to conventional treatment using the same material: all but two studies used high-viscosity glass ionomer (H-GIC) as the restorative material; one study used a composite material; and one study used resin-modified glass ionomer cement (RM-GIC)).\nCompared to conventional treatment using H-GIC, ART may increase the risk of restoration failure in the primary dentition, over a follow-up period from 12 to 24 months (OR 1.60, 95% CI 1.13 to 2.27, five studies; 643 participants analysed; low-quality evidence). Our confidence in this effect estimate is limited due to serious concerns over risk of performance and attrition bias. For this comparison, ART may reduce pain during procedure compared with conventional treatment (MD -0.65, 95% CI -1.38 to 0.07; 40 participants analysed; low-quality evidence)\nComparisons of ART to conventional treatment using composite or RM-GIC were downgraded to very low quality due to indirectness, imprecision and high risk of performance and attrition bias. Given the very low quality of the evidence from single studies, we are uncertain about the restoration failure of ART compared with conventional treatment using composite over a 24-month follow-up period (OR 1.11, 95% CI 0.54 to 2.29; one study; 57 participants) and ART using RM-GIC in the permanent teeth of older adults with root caries lesions over a six-month follow-up period (OR 2.71, 95% CI 0.94 to 7.81; one study; 64 participants).\nNo studies reported on adverse events or costs.\nAuthors' conclusions\nLow-quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth. The effects of ART using composite and RM-GIC are uncertain due to the very low quality of the evidence and we cannot rely on the findings. Most studies evaluated the effects of ART on the primary dentition.\nWell-designed RCTs are required that report on restoration failure at clinically meaningful time points, as well as participant-reported outcomes such as pain and discomfort. Due to the potential confounding effects from the use of different dental materials, a robust body of evidence on the effects of ART compared with conventional treatment using the same restoration material is necessary. We identified four ongoing trials that could provide further insights into this area.\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": "There is low-quality evidence to suggest that primary teeth treated with the ART approach using high viscosity glass ionomer cement may be more likely than those receiving conventional treatment with the same material to result in restoration failure. In the treatment of primary teeth, ART may reduce pain experience compared with conventional treatment. The evidence available for evaluating the differences between ART and conventional treatments using other restorative materials or in permanent teeth is very low quality so we cannot draw any conclusions. None of the included studies reported on negative side effects or costs."
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{
"role": "user",
"content": "Abstract: Background\nThe prevalence of mental health problems is high, and they have a wide-ranging and deleterious effect on many sectors in society. As well as the impact on individuals and families, mental health problems in the workplace negatively affect productivity. One of the factors that may exacerbate the impact of mental health problems is a lack of 'mental health literacy' in the general population. This has been defined as 'knowledge and beliefs about mental disorders, which aid their recognition, management, or prevention'.\nMental Health First Aid (MHFA) is a brief training programme developed in Australia in 2000; its aim is to improve mental health literacy and teach mental health first aid strategies. The course has been adapted for various contexts, but essentially covers the symptoms of various mental health disorders, along with associated mental health crisis situations. The programmes also teach trainees how to provide immediate help to people experiencing mental health difficulties, as well as how to signpost to professional services. It is theorised that improved knowledge will encourage the trainees to provide support, and encourage people to actively seek help, thereby leading to improvements in mental health.\nThis review focuses on the effects of MHFA on the mental health and mental well-being of individuals and communities in which MHFA training has been provided. We also examine the impact on mental health literacy. This information is essential for decision-makers considering the role of MHFA training in their organisations.\nObjectives\nTo examine mental health and well-being, mental health service usage, and adverse effects of MHFA training on individuals in the communities in which MHFA training is delivered.\nSearch methods\nWe developed a sensitive search strategy to identify randomised controlled trials (RCTs) of MHFA training. This approach used bibliographic databases searching, using a search strategy developed for Ovid MEDLINE (1946 -), and translated across to Ovid Embase (1974 -), Ovid PsycINFO (1967 -), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Common Mental Disorders Group's Specialised Register (CCMDCTR). We also searched online clinical trial registries (ClinicalTrials.gov and WHO ICTRP), grey literature and reference lists of included studies, and contacted researchers in the field to identify additional and ongoing studies. Searches are current to 13th June 2023.\nSelection criteria\nWe included RCTs and cluster-RCTs comparing any type of MHFA-trademarked course to no intervention, active or attention control (such as first aid courses), waiting list control, or alternative mental health literacy interventions. Participants were individuals in the communities in which MHFA training is delivered and MHFA trainees. Primary outcomes included mental health and well-being of individuals, mental health service usage and adverse effects of MHFA training. Secondary outcomes related to individuals, MHFA trainees, and communities or organisations in which MHFA training has been delivered\nData collection and analysis\nWe used standard Cochrane methods. We analysed categorical outcomes as risk ratios (RRs) and odds ratios (ORs), and continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs), with 95% confidence intervals (CIs). We pooled data using a random-effects model. Two review authors independently assessed the key results using the Risk of Bias 2 tool and applied the GRADE criteria to assess the certainty of evidence\nMain results\nTwenty-one studies involving a total of 22,604 participants were included in the review. Fifteen studies compared MHFA training with no intervention/waiting list, two studies compared MHFA training with an alternative mental health literacy intervention, and four studies compared MHFA training with an active or an attention control intervention. Our primary time point was between six and 12 months.\nWhen MHFA training was compared with no intervention, it may have little to no effect on the mental health of individuals at six to 12 months, but the evidence is very uncertain (OR 0.88, 95% CI 0.61 to 1.28; 3 studies; 3939 participants). We judged all the results that contributed to this outcome as being at high risk of bias. No study measured mental health service usage at six to 12 months. We did not find published data on adverse effects.\nOnly one study with usable data compared MHFA training with an alternative mental health literacy intervention. The study did not measure outcomes in individuals in the community. It also did not measure outcomes at our primary time point of six to 12 months.\nFour studies with usable data compared MHFA training to an active or attention control. None of the studies measured outcomes at our primary time point of six to 12 months.\nAuthors' conclusions\nWe cannot draw conclusions about the effects of MHFA training on our primary outcomes due to the lack of good quality evidence. This is the case whether it is compared to no intervention, to an alternative mental health literacy intervention, or to an active control. Studies are at high risk of bias and often not sufficiently large to be able to detect differences.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Individuals considering MHFA training\nEmployees and employers\nPolicy and decision-makers"
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{
"role": "user",
"content": "Abstract: Background\nMirror therapy is used to improve motor function after stroke. During mirror therapy, a mirror is placed in the person's midsagittal plane, thus reflecting movements of the non-paretic side as if it were the affected side.\nObjectives\nTo summarise the effectiveness of mirror therapy compared with no treatment, placebo or sham therapy, or other treatments for improving motor function and motor impairment after stroke. We also aimed to assess the effects of mirror therapy on activities of daily living, pain, and visuospatial neglect.\nSearch methods\nWe searched the Cochrane Stroke Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, AMED, PsycINFO and PEDro (last searched 16 August 2017). We also handsearched relevant conference proceedings, trials and research registers, checked reference lists, and contacted trialists, researchers and experts in our field of study.\nSelection criteria\nWe included randomised controlled trials (RCTs) and randomised cross-over trials comparing mirror therapy with any control intervention for people after stroke.\nData collection and analysis\nTwo review authors independently selected trials based on the inclusion criteria, documented the methodological quality, assessed risks of bias in the included studies, and extracted data. We assessed the quality of the evidence using the GRADE approach. We analysed the results as standardised mean differences (SMDs) or mean differences (MDs) for continuous variables, and as odds ratios (ORs) for dichotomous variables.\nMain results\nWe included 62 studies with a total of 1982 participants that compared mirror therapy with other interventions. Of these, 57 were randomised controlled trials and five randomised cross-over trials. Participants had a mean age of 59 years (30 to 73 years). Mirror therapy was provided three to seven times a week, between 15 and 60 minutes for each session for two to eight weeks (on average five times a week, 30 minutes a session for four weeks).When compared with all other interventions, we found moderate-quality evidence that mirror therapy has a significant positive effect on motor function (SMD 0.47, 95% CI 0.27 to 0.67; 1173 participants; 36 studies) and motor impairment (SMD 0.49, 95% CI 0.32 to 0.66; 1292 participants; 39 studies). However, effects on motor function are influenced by the type of control intervention. Additionally, based on moderate-quality evidence, mirror therapy may improve activities of daily living (SMD 0.48, 95% CI 0.30 to 0.65; 622 participants; 19 studies). We found low-quality evidence for a significant positive effect on pain (SMD −0.89, 95% CI −1.67 to −0.11; 248 participants; 6 studies) and no clear effect for improving visuospatial neglect (SMD 1.06, 95% CI −0.10 to 2.23; 175 participants; 5 studies). No adverse effects were reported.\nAuthors' conclusions\nThe results indicate evidence for the effectiveness of mirror therapy for improving upper extremity motor function, motor impairment, activities of daily living, and pain, at least as an adjunct to conventional rehabilitation for people after stroke. Major limitations are small sample sizes and lack of reporting of methodological details, resulting in uncertain evidence quality.\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": "This review identified studies up to 16 August 2017."
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"role": "user",
"content": "Abstract: Background\nThe therapeutic management of people with metastatic colorectal cancer (CRC) who did not respond to first-line treatment represents a formidable challenge.\nObjectives\nTo determine the efficacy and toxicity of second-line systemic therapy in people with metastatic CRC.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 4), Ovid MEDLINE (1950 to May 2016), Ovid MEDLINE In-process & Other Non-Indexed Citations (1946 to May 2016) and Ovid Embase (1974 to May 2016). There were no language or date of publication restrictions.\nSelection criteria\nRandomized controlled trials (RCTs) assessing the efficacy (survival, tumour response) and toxicity (incidence of severe adverse effects (SAEs)) of second-line systemic therapy (single or combined treatment with any anticancer drug, at any dose and number of cycles) in people with metastatic CRC that progressed, recurred or did not respond to first-line systemic therapy.\nData collection and analysis\nAuthors performed a descriptive analysis of each included RCT in terms of primary (survival) and secondary (tumour response, toxicity) endpoints. In the light of the variety of drug regimens tested in the included trials, we could carry out meta-analysis considering classes of (rather than single) anticancer regimens; to this aim, we applied the random-effects model to pool the data. We used hazard ratios (HRs) and risk ratios (RRs) to describe the strength of the association for survival (overall (OS) and progression-free survival (PFS)) and dichotomous (overall response rate (ORR) and SAE rate) data, respectively, with 95% confidence intervals (CI).\nMain results\nThirty-four RCTs (enrolling 13,787 participants) fulfilled the eligibility criteria. Available evidence enabled us to address multiple clinical issues regarding the survival effects of second-line systemic therapy of people with metastatic CRC.\n1. Chemotherapy (irinotecan) was more effective than best supportive care (HR for OS: 0.58, 95% CI 0.43 to 0.80; 1 RCT; moderate-quality evidence); 2. modern chemotherapy (FOLFOX (5-fluorouracil plus leucovorin plus oxaliplatin), irinotecan) is more effective than outdated chemotherapy (5-fluorouracil) (HR for PFS: 0.59, 95% CI 0.49 to 0.73; 2 RCTs; high-quality evidence) (HR for OS: 0.69, 95% CI 0.51 to 0.94; 1 RCT; moderate-quality evidence); 3. irinotecan-based combinations were more effective than irinotecan alone (HR for PFS: 0.68, 95% CI 0.60 to 0.76; 6 RCTs; moderate-quality evidence); 4. targeted agents improved the efficacy of conventional chemotherapy both when considered together (HR for OS: 0.84, 95% CI 0.77 to 0.91; 6 RCTs; high-quality evidence) and when bevacizumab was used alone (HR for PFS: 0.67, 95% CI 0.60 to 0.75; 4 RCTs; high-quality evidence).\nWith regard to secondary endpoints, tumour response rates generally paralleled the survival results; moreover, higher anticancer efficacy was generally associated with worse treatment-related toxicity, with the important exception of bevacizumab-containing regimens, where the addition of the targeted agent to chemotherapy did not result in a significant increase in the rate of SAE. Finally, we found that oral (instead of intravenous) fluoropyrimidines significantly reduced the incidence of adverse effects (without compromising efficacy) in people treated with oxaliplatin-based regimens.\nWe could not draw any conclusions on other debated aspects in this field of oncology, such as ranking of treatments (not all possible comparisons have been tested and many comparisons were based on single trials enrolling a small number of participants) and quality of life (virtually no data available).\nAuthors' conclusions\nSystemic therapy offers a survival benefit to people with metastatic CRC who did not respond to first-line treatment, especially when targeted agents are combined with conventional chemotherapeutic drugs. Further research is needed to define the optimal regimen and to identify people who most benefit from each treatment.\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": "People with metastatic colorectal cancer (cancer that has spread to sites other than the colon) and whose disease had progressed despite one prior chemotherapy (first-line treatment) treatment, and who can be offered a second therapy (second-line treatment) with the aim of improving their poor outcome (prognosis). The treatment regimens compared were systemic (administered intravenously (through a vein))."
}
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{
"role": "user",
"content": "Abstract: Background\nChronic back pain is an important health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat people with low back pain, especially people with acute back pain. Short term NSAID use is also recommended for pain relief in people with chronic back pain. Two types of NSAIDs are available and used to treat back pain: non-selective NSAIDs and selective COX-2 NSAIDs. In 2008, a Cochrane review identified a small but significant effect from NSAIDs compared to placebo in people with chronic back pain. This is an update of the Cochrane review published in 2008 and focuses on people with chronic low back pain.\nObjectives\nTo determine if NSAIDs are more efficacious than various comparison treatments for non-specific chronic low back pain and if so, which type of NSAID is most efficacious.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PubMed and two clinical trials registry databases up to 24 June 2015 for randomized controlled trials (RCTs) published in English, German or Dutch. We also screened references cited in relevant reviews.\nSelection criteria\nWe included RCTs (double-blind and single-blind) of NSAIDs used to treat people with chronic low back pain.\nData collection and analysis\nTwo review authors independently screened trials for inclusion in this Cochrane review according to the inclusion criteria. One review author extracted the data, and a second review author checked the data. Two review authors independently evaluated the risk of bias of all included trials. If data were clinically homogeneous, we performed a meta-analysis and assessed the quality of evidence using the GRADE approach.\nMain results\nWe included 13 trials in this Cochrane review. Ten studies were at 'low' risk of bias. Six studies compared NSAIDs with placebo, and included 1354 participants in total. There is low quality evidence that NSAIDs are more effective than placebo, with a mean difference in pain intensity score from baseline of -6.97 (95% CI −10.74 to −3.19) on a 0 to 100 visual analogue scale (VAS) with a median follow-up of 56 days (interquartile range (IQR) 13 to 91 days). Four studies measured disability using the Roland Morris Disability Questionnaire. There is low quality evidence that NSAIDs are more effective than placebo on disability, with a mean difference from baseline of −0.85 (95% CI −1.30 to −0.40) on a scale from 0 to 24 with a median follow-up of 84 days (IQR 42 to 105 days). All six placebo controlled studies also reported adverse events, and suggested that adverse events are not statistically significant more frequent in participants using NSAIDs compared to placebo (RR 1.04, 95% CI 0.92 to 1.17). Due to the relatively small sample size and relatively short follow-up in most included trials, it is likely that the proportion of patients experiencing an adverse event is underestimated.\nTwo studies compared different types of non-selective NSAIDs, namely ibuprofen versus diclofenac and piroxicam versus indomethacin. The trials did not find any differences between these NSAID types, but both trials had small sample sizes. One trial reported no differences in pain intensity between treatment groups that used selective or non-selective NSAIDs. One other trial compared diflunisal with paracetamol and showed no difference in improvement from baseline on pain intensity score. One trial showed a better global improvement in favour of celecoxib versus tramadol.\nOne included trial compared NSAIDs with 'home-based exercise'. Disability improved more in participants who did exercises versus participants receiving NSAIDs, but pain scores were similar.\nAuthors' conclusions\nSix of the 13 included RCTs showed that NSAIDs are more effective than placebo regarding pain intensity. NSAIDs are slightly more effective than placebo regarding disability. However, the magnitude of the effects is small, and the level of evidence was low. When we only included RCTs at low risk of bias, differences in effect between NSAIDs and placebo were reduced. We identified no difference in efficacy between different NSAID types, including selective versus non-selective NSAIDs. Due to inclusion of RCTs only, the relatively small sample sizes and relatively short follow-up in most included trials, we cannot make firm statements about the occurrence of adverse events or whether NSAIDs are safe for long-term use.\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": "NSAIDs reduced pain and disability in people with chronic low back pain compared to placebo. However, the differences were small: 7 points on a 100-point scale for pain intensity. Regarding disability, people receiving NSAIDs scored 0.9 points better on a 0 to 24 disability scale. The number of adverse events was not significantly different between the people receiving NSAIDs and people receiving placebo, but larger studies of longer duration would be needed to identify rare or delayed adverse events, important drug interactions and adverse events occurring with prolonged use.\nDifferent types of NSAIDs did not show significantly different effects. Three of the 13 included studies compared two different types of NSAIDs and none found any differences.\nNSAIDs were also compared to other drug types: paracetamol, tramadol and pregabalin. There were no differences found between NSAIDs and paracetamol and pregabalin in either effect or adverse events. A single study comparing celecoxib with tramadol showed a better global improvement in peoples using celecoxib.\nOne trial compared NSAIDs with 'home-based exercise'. Regarding disability, people who did exercise improved more than people receiving NSAIDs, but pain scores were not statistically different."
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"role": "user",
"content": "Abstract: Background\nHepatic encephalopathy is a common complication of cirrhosis which results in poor brain functioning. The spectrum of changes associated with hepatic encephalopathy ranges from the clinically 'indiscernible' or minimal hepatic encephalopathy to the clinically 'obvious' or overt hepatic encephalopathy. Flumazenil is a synthetic benzodiazepine antagonist with high affinity for the central benzodiazepine recognition site. Flumazenil may benefit people with hepatic encephalopathy through an indirect negative allosteric modulatory effect on gamma-aminobutyric acid receptor function. The previous version of this review, which included 13 randomised clinical trials, found no effect of flumazenil on all-cause mortality, based on an analysis of 10 randomised clinical trials, but found a beneficial effect on hepatic encephalopathy, based on an analysis of eight randomised clinical trials.\nObjectives\nTo evaluate the beneficial and harmful effects of flumazenil versus placebo or no intervention for people with cirrhosis and hepatic encephalopathy.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, and LILACS; meeting and conference proceedings; and bibliographies in May 2017.\nSelection criteria\nWe included randomised clinical trials regardless of publication status, blinding, or language in the analyses of benefits and harms, and observational studies in the assessment of harms.\nData collection and analysis\nTwo review authors extracted data independently. We undertook meta-analyses and presented results using risk ratios (RR) with 95% confidence intervals (CI) and I2 values as a marker of heterogeneity. We assessed bias control using the Cochrane Hepato-Biliary Group domains; determined the quality of the evidence using GRADE; evaluated the risk of small-study effects in regression analyses; and conducted trial sequential, subgroup, and sensitivity analyses.\nMain results\nWe identified 14 eligible randomised clinical trials with 867 participants, the majority of whom had an acute episode of overt hepatic encephalopathy. In addition, we identified one ongoing randomised clinical trial. We were unable to gather outcome data from two randomised clinical trials with 25 participants. Thus, our analyses include 842 participants from 12 randomised clinical trials comparing flumazenil versus placebo. We classified one randomised clinical trial at low risk of bias in the overall assessment and the remaining randomised clinical trials at high risk of bias. The duration of follow-up ranged from a few minutes to two weeks, but it was less than one day in the majority of the trials.\nIn total, 32/433 (7.4%) participants allocated to flumazenil versus 38/409 (9.3%) participants allocated to placebo died (RR 0.75, 95% CI 0.48 to 1.16; 11 randomised clinical trials; low quality evidence). The Trial Sequential Analysis and the one randomised clinical trial assessed as low risk of bias (RR 0.76, 95% CI 0.37 to 1.53) found no beneficial or harmful effects of flumazenil on all-cause mortality. The methods used to evaluate hepatic encephalopathy included several different clinical scales, electrophysiological variables, and psychometric tests. Flumazenil was associated with a beneficial effect on hepatic encephalopathy when including all randomised clinical trials (RR 0.75, 95% CI 0.71 to 0.80; 824 participants; nine randomised clinical trials; low quality evidence), or just the trial at low risk of bias (RR 0.78, 95% CI 0.72 to 0.84; 527 participants). The Trial Sequential Analysis supported a beneficial effect of flumazenil on hepatic encephalopathy. The randomised clinical trials included little information about causes of death and little information on non-fatal serious adverse events.\nAuthors' conclusions\nWe found low quality evidence suggesting a short-term beneficial effect of flumazenil on hepatic encephalopathy in people with cirrhosis, but no evidence of an effect on all-cause mortality. Additional evidence from large, high quality randomised clinical trials is needed to evaluate the potential benefits and harms of flumazenil in people with cirrhosis and hepatic encephalopathy.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Five of the included randomised clinical trials received support from pharmaceutical companies."
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"role": "user",
"content": "Abstract: Background\nEpithelial ovarian cancer presents at an advanced stage in the majority of women. These women require a combination of surgery and chemotherapy for optimal treatment. Conventional treatment has been to perform surgery first and then give chemotherapy. However, there may be advantages to using chemotherapy before surgery.\nObjectives\nTo assess whether there is an advantage to treating women with advanced epithelial ovarian cancer with chemotherapy before debulking surgery (neoadjuvant chemotherapy (NACT)) compared with conventional treatment where chemotherapy follows debulking surgery (primary debulking surgery (PDS)).\nSearch methods\nWe searched the following databases up to 9 October 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), Embase via Ovid, MEDLINE (Silver Platter/Ovid), PDQ and MetaRegister. We also checked the reference lists of relevant papers that were identified to search for further studies. The main investigators of relevant trials were contacted for further information.\nSelection criteria\nRandomised controlled trials (RCTs) of women with advanced epithelial ovarian cancer (Federation of International Gynaecologists and Obstetricians (FIGO) stage III/IV) who were randomly allocated to treatment groups that compared platinum-based chemotherapy before cytoreductive surgery with platinum-based chemotherapy following cytoreductive surgery.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias in each included trial. We extracted data of overall (OS) and progression-free survival (PFS), adverse events, surgically-related mortality and morbidity and quality of life outcomes. We used GRADE methods to determine the certainty of evidence.\nMain results\nWe identified 2227 titles and abstracts through our searches, of which five RCTs of varying quality and size met the inclusion criteria. These studies assessed a total of 1774 women with stage IIIc/IV ovarian cancer randomised to NACT followed by interval debulking surgery (IDS) or PDS followed by chemotherapy. We pooled results of the four studies where data were available and found little or no difference with regard to overall survival (OS) (Hazard Ratio (HR) 0.96, 95% CI 0.86 to 1.08; participants = 1692; studies = 4; high-certainty evidence) or progression-free survival in four trials where we were able to pool data (Hazard Ratio 0.98, 95% CI 0.88 to 1.08; participants = 1692; studies = 4; moderate-certainty evidence).\nAdverse events, surgical morbidity and quality of life (QoL) outcomes were variably and incompletely reported across studies. There are probably clinically meaningful differences in favour of NACT compared to PDS with regard to overall postoperative serious adverse effects (SAE grade 3+): 6% in NACT group, versus 29% in PDS group, (risk ratio (RR) 0.22, 95% CI 0.13 to 0.38; participants = 435; studies = 2; heterogeneity index (I2) = 0%; moderate-certainty evidence). NACT probably results in a large reduction in the need for stoma formation: 5.9% in NACT group, versus 20.4% in PDS group, (RR 0.29, 95% CI 0.12 to 0.74; participants = 632; studies = 2; I2 = 70%; moderate-certainty evidence), and probably reduces the risk of needing bowel resection at the time of surgery: 13.0% in NACT group versus 26.6% in PDS group (RR 0.49, 95% CI 0.30 to 0.79; participants = 1565; studies = 4; I2 = 79%; moderate-certainty evidence). NACT reduces postoperative mortality: 0.6% in NACT group, versus 3.6% in PDS group, (RR 0.16, 95% CI 0.06 to 0.46; participants = 1623; studies = 5; I2 = 0%; high-certainty evidence). QoL on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale produced inconsistent and imprecise results in three studies (MD -0.29, 95% CI -2.77 to 2.20; participants = 524; studies = 3; I2 = 81%; very low-certainty evidence) but the evidence is very uncertain and should be interpreted with caution.\nAuthors' conclusions\nThe available high to moderate-certainty evidence suggests there is little or no difference in primary survival outcomes between PDS and NACT. NACT probably reduces the risk of serious adverse events, especially those around the time of surgery, and reduces the risk of postoperative mortality and the need for stoma formation. These data will inform women and clinicians (involving specialist gynaecological multidisciplinary teams) and allow treatment to be tailored to the person, taking into account surgical resectability, age, histology, stage and performance status. Data from an unpublished study and ongoing studies are awaited.\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 searched electronic databases up to October 2020 and conducted handsearches for unpublished reports of trials. We included randomised controlled trials (RCTs) of NACT and IDS versus surgery (primary debulking surgery (PDS)) followed by chemotherapy in women diagnosed with advanced stage epithelial ovarian cancer and pooled study outcome data, where appropriate."
}
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query-laysum | 4659 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a global leading cause of morbidity and mortality, characterised by acute deterioration in symptoms. During these exacerbations, people are prone to developing alveolar hypoventilation, which may be partly caused by the administration of high inspired oxygen concentrations.\nObjectives\nTo determine the effect of different inspired oxygen concentrations (\"high flow\" compared to \"controlled\") in the pre-hospital setting (prior to casualty/emergency department) on outcomes for people with acute exacerbations of COPD (AECOPD).\nSearch methods\nThe Cochrane Airways Group Specialised Register, reference lists of articles and online clinical trial databases were searched. Authors of identified randomised controlled trials (RCTs) were also contacted for details of other relevant published and unpublished studies. The most recent search was conducted on 16 September 2019.\nSelection criteria\nWe included RCTs comparing oxygen therapy at different concentrations or oxygen therapy versus placebo in the pre-hospital setting for treatment of AECOPD.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. The primary outcome was all-cause and respiratory-related mortality.\nMain results\nThe search identified a total of 824 citations; one study was identified for inclusion and two studies are awaiting classification. The 214 participants involved in the included study were adults with AECOPD, receiving treatment by paramedics en route to hospital. The mean age of participants was 68 years.\nA reduction in pre/in-hospital mortality was observed in favour of the titrated oxygen group (two deaths in the titrated oxygen group compared to 11 deaths in the high-flow control arm; risk ratio (RR) 0.22, 95% confidence interval (CI) 0.05 to 0.97; 214 participants). This translates to an absolute effect of 94 per 1000 (high-flow oxygen) compared to 21 per 1000 (titrated oxygen), and a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 12 to 355) with titrated oxygen therapy. Other than mortality, no other adverse events were reported in the included study.\nWide confidence intervals were observed between groups for arterial blood gas (though this may be confounded by protocol infidelity in the included study for this outcome measure), treatment failure requiring invasive or non-invasive ventilation or hospital utilisation. No data were reported for quality of life, lung function or dyspnoea. Risk of bias within the included study was largely unclear, though there was high risk of bias in domains relating to performance and attrition bias. We judged the evidence to be of low certainty, according to GRADE criteria.\nAuthors' conclusions\nThe one included study found a reduction in pre/in-hospital mortality for the titrated oxygen arm compared to the high-flow control arm. However, the paucity of evidence somewhat limits the reliability of these findings and generalisability to other settings. There is a need for robust, well-designed RCTs to further investigate the effect of oxygen therapies in the pre-hospital setting for people with AECOPD.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to inclusion of only one study, and the small number of deaths that occurred, our confidence in the size of the difference between the two treatments is limited. We judged the evidence to be of low certainty."
}
]
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query-laysum | 4660 | [
{
"role": "user",
"content": "Abstract: Background\nPsychological problems are common complications following stroke that can cause stroke survivors to lack the motivation to take part in activities of daily living. Motivational interviewing provides a specific way for enhancing intrinsic motivation, which may help to improve activities of daily living for stroke survivors.\nObjectives\nTo investigate the effect of motivational interviewing for improving activities of daily living after stroke.\nSearch methods\nWe searched the Cochrane Stroke Group's Trials Register (November 2014), the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 1), MEDLINE (1948 to March 2015), EMBASE (1980 to March 2015), CINAHL (1982 to March 2015), AMED (1985 to March 2015), PsycINFO (1806 to March 2015), PsycBITE (March 2015) and four Chinese databases. In an effort to identify further published, unpublished and ongoing trials, we searched ongoing trials registers and conference proceedings, checked reference lists, and contacted authors of relevant studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing motivational interviewing with no intervention, sham motivational interviewing or other psychological therapy for people with stroke were eligible.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted eligible data and assessed risk of bias. Outcome measures included activities of daily living, mood and death.\nMain results\nOne study involving a total of 411 participants, which compared motivational interviewing with usual care, met our inclusion criteria. The results of this review did not show significant differences between groups receiving motivational interviewing or usual stroke care for participants who were not dependent on others for activities of daily living, nor on the death rate after three-month and 12-month follow-up, but participants receiving motivational interviewing were more likely to have a normal mood than those who received usual care at three-months and 12-months follow-up.\nAuthors' conclusions\nThere is insufficient evidence to support the use of motivational interviewing for improving activities of daily living after stroke. Further well designed RCTs are needed.\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": "The evidence is current to March 2015. Only one study met our criteria: it involved a total of 411 stroke patients aged 18 years and over who had received either motivational interviewing or usual care between five and 28 days after stroke; the follow-up period was 12 months. Motivational interviewing consisted of one session per week for four individual sessions, with each session lasting for 30 to 60 minutes."
}
]
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query-laysum | 4661 | [
{
"role": "user",
"content": "Abstract: Background\nAcute gout flares cause significant pain and disability and it is important to provide quick and effective pain relief. Traditional options for managing acute flares include colchicine, non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids.\nObjectives\nTo assess the benefits and harms of interleukin-1 inhibitors (anakinra, canakinumab, rilonacept) in acute gout.\nSearch methods\nWe searched The Cochrane Library, MEDLINE and EMBASE on 19 June 2013. We applied no date or language restrictions. We performed a handsearch of the abstracts from the European League Against Rheumatism (EULAR) (2009 to 2012) and American College of Rheumatology (ACR) (2009 to 2011) conferences and of the references of all included trials. We also screened the Clinical Trials Registry Platform of the World Health Organization and Clinical Trials Registry Platform of the US National Institutes of Health.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised clinical trials (controlled clinical trials (CCTs)) assessing an interleukin-1 inhibitor (anakinra, canakinumab or rilonacept) against placebo or another active treatment (colchicine, paracetamol, NSAIDs, glucocorticoids (systemic or intra-articular), adrenocorticotropin hormone, a different interleukin-1 blocking agent or a combination of any of the above) in adults with acute gout.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, assessed the risk of bias and extracted the data. If appropriate, we pooled data in a meta-analysis. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included four studies (806 participants) in the review. The studies had an unclear risk of selection bias and low risk of performance and attrition biases. One study each had an unclear risk of detection and selection bias.\nThree studies (654 participants) compared subcutaneous canakinumab compared with intramuscular triamcinolone acetonide 40 mg in the treatment of acute gout flares of no more than five days' duration. Doses of canakinumab were varied (10 to 150 mg), but most people (255/368) were treated with canakinumab 150 mg. None of the studies provided data on participant-reported pain relief of 30% or greater. Moderate-quality evidence indicated that canakinumab 150 mg was probably superior to triamcinolone acetonide 40 mg in terms of pain relief, resolution of joint swelling and in achieving a good treatment response at 72 hours following treatment, but was probably associated with an increased risk of adverse events.\nMean pain (0- to 100-mm visual analogue scale (VAS), where 0 mm was no pain) was 36 mm after triamcinolone acetonide treatment; pain was further reduced by a mean of 11 mm with canakinumab treatment (mean difference (MD) -10.6 mm, 95% confidence interval (CI) -15.2 to -5.9). Forty-four per cent of participants treated with canakinumab had resolution of joint swelling at 72 hours compared with 32% of participants treated with triamcinolone (risk ratio (RR) 1.39, 95% CI 1.11 to 1.74, number needed to treat for an addition beneficial outcome (NNTB) 9); 65% of participants treated with canakinumab assessed their response to treatment as good or excellent compare with 47% of participants treated with triamcinolone acetonide (RR 1.37, 95% CI 1.16 to 1.61, NNTB 6). Function or health-related quality of life were not measured. In both groups, 0.7% of participants withdrew from treatment (RR 1.1, 95% CI 0.2 to 7.2); there was one death and one alteration of laboratory results in each of the treatment groups. Adverse events were more frequent in participants receiving canakinumab (61%) compared with triamcinolone acetonide (51%; RR 1.2, 95% CI 1.1 to 1.4, number needed to treat for an addition harmful outcome (NNTH) 10).\nLow-quality evidence from one study (152 participants with an acute gout flare of no more than 48 hours' duration and affecting fewer than four joints) comparing rilonacept 320 mg with indomethacin (50 mg three times a day for three days followed by 25 mg three times a day for up to nine days) indicated that indomethacin may improve pain more than rilonacept at 24 to 72 hours, and there may be no evidence of a difference in withdrawal rates or adverse events. The mean change (improvement) in pain from baseline with indomethacin was 4.3 points (measured on a 0 to 10 numerical rating scale, where 0 was no pain); pain was improved by a mean of only 2.5 points with rilonacept (MD 2.52, 95% CI 0.29 to 4.75, 25% less improvement in absolute pain with rilonacept). Inflammation, function health-related quality of life and participant global assessment of treatment success were not measured. Rates of study withdrawals due to adverse events were low in both groups: 1/75 (1%) participants in the rilonacept group compared with 2/76 (3%) participants in the indomethacin group (RR 0.5, 95% CI 0.05 to 5.5). Adverse events were reported in 27/75 (36%) participants in the rilonacept group and 23/76 (30%) in the indomethacin group (RR 1.2, 95% CI 0.8 to 1.9).\nAuthors' conclusions\nModerate-quality evidence indicated that compared with a single suboptimal 40-mg dose of intramuscular injection of triamcinolone acetonide, a single subcutaneous dose of 150 mg of canakinumab probably results in better pain relief, joint swelling and participant-assessed global assessment of treatment response in people with an acute gout flare but is probably associated with an increased risk of adverse events. The cost of canakinumab is over 5000 times higher than triamcinolone acetonide; however, there are no data on the cost-effectiveness of this approach. We found no studies comparing canakinumab with more commonly used first-line therapies for acute gout flares such as NSAIDs or colchicine. Low-quality evidence indicated that compared with maximum doses of indomethacin (50 mg three times a day), 320 mg of rilonacept may provide less pain relief with a similar rate of adverse events.\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": "We found moderate-quality evidence that, compared with a single intramuscular injection of the steroid, triamcinolone acetonide, canakinumab injection probably improves pain, swelling and the number of good or excellent treatment responses, but probably results in more side effects. Possible side effects included back pain, headache, high blood pressure, joint pain and a rise in the liver enzyme gamma-glutamyl transpeptidase. Function or quality of life were not measured. Further research may change the estimates.\nThere was low-quality evidence from one study that rilonacept injection may improve pain less than indomethacin and may not be associated with an increase in side effects. Inflammation, disability, quality of life and participant assessment of treatment success were not measured. Further research is likely to change these estimates.\nWe found no studies comparing canakinumab with more commonly used therapies for acute gout flares such as NSAIDs or colchicine."
}
]
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query-laysum | 4662 | [
{
"role": "user",
"content": "Abstract: Background\nAirway infection leads to progressive damage of the lungs in cystic fibrosis (CF) and oxidative stress has been implicated in the etiology. Supplementation of antioxidant micronutrients (vitamin E, vitamin C, beta-carotene and selenium) or N-acetylcysteine (NAC) as a source of glutathione, may therefore potentially help maintain an oxidant-antioxidant balance. Glutathione or NAC can also be inhaled and if administered in this way can also have a mucolytic effect besides the antioxidant effect. Current literature suggests a relationship between oxidative status and lung function. This is an update of a previously published review.\nObjectives\nTo synthesise existing knowledge on the effect of antioxidants such as vitamin C, vitamin E, beta-carotene, selenium and glutathione (or NAC as precursor of glutathione) on lung function through inflammatory and oxidative stress markers in people with CF.\nSearch methods\nThe Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register and PubMed were searched using detailed search strategies. We contacted authors of included studies and checked reference lists of these studies for additional, potentially relevant studies. We also searched online trials registries.\nLast search of Cystic Fibrosis Trials Register: 08 January 2019.\nSelection criteria\nRandomised and quasi-randomised controlled studies comparing antioxidants as listed above (individually or in combination) in more than a single administration to placebo or standard care in people with CF.\nData collection and analysis\nTwo authors independently selected studies, extracted data and assessed the risk of bias in the included studies. We contacted study investigators to obtain missing information. If meta-analysed, studies were subgrouped according to supplement, method of administration and the duration of supplementation. We assessed the quality of the evidence using GRADE.\nMain results\nOne quasi-randomised and 19 randomised controlled studies (924 children and adults) were included; 16 studies (n = 639) analysed oral antioxidant supplementation and four analysed inhaled supplements (n = 285). Only one of the 20 included studies was judged to be free of bias.\nOral supplements versus control\nThe change from baseline in forced expiratory volume in one second (FEV1) % predicted at three months and six months was only reported for the comparison of NAC to control. Four studies (125 participants) reported at three months; we are uncertain whether NAC improved FEV1 % predicted as the quality of the evidence was very low, mean difference (MD) 2.83% (95% confidence interval (CI) -2.16 to 7.83). However, at six months two studies (109 participants) showed that NAC probably increased FEV1 % predicted from baseline (moderate-quality evidence), MD 4.38% (95% CI 0.89 to 7.87). A study of a combined vitamin and selenium supplement (46 participants) reported a greater change from baseline in FEV1 % predicted in the control group at two months, MD -4.30% (95% CI -5.64 to -2.96). One study (61 participants) found that NAC probably makes little or no difference in the change from baseline in quality of life (QoL) at six months (moderate-quality evidence), standardised mean difference (SMD) -0.03 (95% CI -0.53 to 0.47), but the two-month combined vitamin and selenium study reported a small difference in QoL in favour of the control group, SMD -0.66 (95% CI -1.26 to -0.07). The NAC study reported on the change from baseline in body mass index (BMI) (62 participants) and similarly found that NAC probably made no difference between groups (moderate-quality evidence). One study (69 participants) found that a mixed vitamin and mineral supplement may lead to a slightly lower risk of pulmonary exacerbation at six months than a multivitamin supplement (low-quality evidence). Nine studies (366 participants) provided information on adverse events, but did not find any clear and consistent evidence of differences between treatment or control groups with the quality of the evidence ranging from low to moderate. Studies of β-carotene and vitamin E consistently reported greater plasma levels of the respective antioxidants.\nInhaled supplements versus control\nTwo studies (258 participants) showed inhaled glutathione probably improves FEV1 % predicted at three months, MD 3.50% (95% CI 1.38 to 5.62), but not at six months compared to placebo, MD 2.30% (95% CI -0.12 to 4.71) (moderate-quality evidence). The same studies additionally reported an improvement in FEV1 L in the treated group compared to placebo at both three and six months. One study (153 participants) reported inhaled glutathione probably made little or no difference to the change in QoL from baseline, MD 0.80 (95% CI -1.63 to 3.23) (moderate-quality evidence). No study reported on the change from baseline in BMI at six months, but one study (16 participants) reported at two months and a further study (105 participants) at 12 months; neither study found any difference at either time point. One study (153 participants) reported no difference in the time to the first pulmonary exacerbation at six months. Two studies (223 participants) reported treatment may make little or no difference in adverse events (low-quality evidence), a further study (153 participants) reported that the number of serious adverse events were similar across groups.\nAuthors' conclusions\nWith regards to micronutrients, there does not appear to be a positive treatment effect of antioxidant micronutrients on clinical end-points; however, oral supplementation with glutathione showed some benefit to lung function and nutritional status. Based on the available evidence, inhaled and oral glutathione appear to improve lung function, while oral administration decreases oxidative stress; however, due to the very intensive antibiotic treatment and other concurrent treatments that people with CF take, the beneficial effect of antioxidants remains difficult to assess in those with chronic infection without a very large population sample and a long-term study period. Further studies, especially in very young children, using outcome measures such as lung clearance index and the bronchiectasis scores derived from chest scans, with improved focus on study design variables (such as dose levels and timing), and elucidating clear biological pathways by which oxidative stress is involved in CF, are necessary before a firm conclusion regarding effects of antioxidants supplementation can be drawn. The benefit of antioxidants in people with CF who receive CFTR modulators therapies should also be assessed in the future.\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": "Last search for this updated review: 08 January 2019."
}
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query-laysum | 4663 | [
{
"role": "user",
"content": "Abstract: Background\nIt is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is the second update of the review first published in 2008.\nObjectives\nThe aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis compared to single modalities in preventing VTE.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 January 2021. We searched the reference lists of relevant articles for additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE compared to either intervention individually.\nData collection and analysis\nWe independently selected studies, applied Cochrane's risk of bias tool, and extracted data. We resolved disagreements by discussion. We performed fixed-effect model meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs). We used a random-effects model when there was heterogeneity. We assessed the certainty of the evidence using GRADE. The outcomes of interest were PE, DVT, bleeding and major bleeding.\nMain results\nWe included a total of 34 studies involving 14,931 participants, mainly undergoing surgery or admitted with trauma. Twenty-five studies were RCTs (12,672 participants) and nine were CCTs (2259 participants). Overall, the risk of bias was mostly unclear or high. We used GRADE to assess the certainty of the evidence and this was downgraded due to the risk of bias, imprecision or indirectness.\nThe addition of pharmacological prophylaxis to IPC compared with IPC alone reduced the incidence of symptomatic PE from 1.34% (34/2530) in the IPC group to 0.65% (19/2932) in the combined group (OR 0.51, 95% CI 0.29 to 0.91; 19 studies, 5462 participants, low-certainty evidence). The incidence of DVT was 3.81% in the IPC group and 2.03% in the combined group showing a reduced incidence of DVT in favour of the combined group (OR 0.51, 95% CI 0.36 to 0.72; 18 studies, 5394 participants, low-certainty evidence). The addition of pharmacological prophylaxis to IPC, however, increased the risk of any bleeding compared to IPC alone: 0.95% (22/2304) in the IPC group and 5.88% (137/2330) in the combined group (OR 6.02, 95% CI 3.88 to 9.35; 13 studies, 4634 participants, very low-certainty evidence). Major bleeding followed a similar pattern: 0.34% (7/2054) in the IPC group compared to 2.21% (46/2079) in the combined group (OR 5.77, 95% CI 2.81 to 11.83; 12 studies, 4133 participants, very low-certainty evidence).\nTests for subgroup differences between orthopaedic and non-orthopaedic surgery participants were not possible for PE incidence as no PE events were reported in the orthopaedic subgroup. No difference was detected between orthopaedic and non-orthopaedic surgery participants for DVT incidence (test for subgroup difference P = 0.19).\nThe use of combined IPC and pharmacological prophylaxis modalities compared with pharmacological prophylaxis alone reduced the incidence of PE from 1.84% (61/3318) in the pharmacological prophylaxis group to 0.91% (31/3419) in the combined group (OR 0.46, 95% CI 0.30 to 0.71; 15 studies, 6737 participants, low-certainty evidence). The incidence of DVT was 9.28% (288/3105) in the pharmacological prophylaxis group and 5.48% (167/3046) in the combined group (OR 0.38, 95% CI 0.21 to 0.70; 17 studies; 6151 participants, high-certainty evidence). Increased bleeding side effects were not observed for IPC when it was added to anticoagulation (any bleeding: OR 0.87, 95% CI 0.56 to 1.35, 6 studies, 1314 participants, very low-certainty evidence; major bleeding: OR 1.21, 95% CI 0.35 to 4.18, 5 studies, 908 participants, very low-certainty evidence).\nNo difference was detected between the orthopaedic and non-orthopaedic surgery participants for PE incidence (test for subgroup difference P = 0.82) or for DVT incidence (test for subgroup difference P = 0.69).\nAuthors' conclusions\nEvidence suggests that combining IPC with pharmacological prophylaxis, compared to IPC alone reduces the incidence of both PE and DVT (low-certainty evidence). Combining IPC with pharmacological prophylaxis, compared to pharmacological prophylaxis alone, reduces the incidence of both PE (low-certainty evidence) and DVT (high-certainty evidence). We downgraded due to risk of bias in study methodology and imprecision. Very low-certainty evidence suggests that the addition of pharmacological prophylaxis to IPC increased the risk of bleeding compared to IPC alone, a side effect not observed when IPC is added to pharmacological prophylaxis (very low-certainty evidence), as expected for a physical method of thromboprophylaxis. The certainty of the evidence for bleeding was downgraded to very low due to risk of bias in study methodology, imprecision and indirectness. The results of this update agree with current guideline recommendations, which support the use of combined modalities in hospitalised people (limited to those with trauma or undergoing surgery) at risk of developing VTE. More studies on the role of combined modalities in VTE prevention are needed to provide evidence for specific patient groups and to increase our certainty in the evidence.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Deep vein thrombosis (DVT) and pulmonary embolism are collectively known as venous thromboembolism, and occur when a blood clot develops inside the leg veins and travels to the lungs. They are possible complications of staying in hospital after surgery, trauma or other risk factors. These complications extend hospital stay and are associated with long-term disability and death. Patients undergoing total hip or knee replacement (orthopaedic) surgery or surgery for colorectal cancer are at high risk of venous thromboembolism. Sluggish blood flow, increased blood clotting and blood vessel wall injury are factors that make it more likely that people will experience a blood clot. Treating more than one of these factors may improve prevention. Mechanical intermittent pneumatic leg compression involves wrapping the legs with inflatable sleeves or using foot pumps. These put gentle pressure on the legs and its veins, reducing sluggish blood flow, while medications such as aspirin and anticoagulants reduce blood clotting. These medications are known as pharmacological prophylaxis (drugs used to prevent blood clots). However, these medications can also increase the risk of bleeding. We wanted to find out if combining compression and medication to stop blood clots was more effective than either compression or medication alone."
}
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query-laysum | 4664 | [
{
"role": "user",
"content": "Abstract: Background\nRadial head fracture is the most common fracture of the elbow. It usually results from a fall onto an outstretched arm. In 1954, Mason classified these fractures into type 1 (undisplaced), type 2 (simple displaced), and type 3 (comminuted fractures). Aspiration of the elbow joint aims to relieve pressure in the elbow joint and has been used as an initial treatment option for radial head fractures. However, it is an invasive technique with the potential for complications such as infection and injury to nerves and vessels.\nObjectives\nTo assess the effects (benefits and harms) of elbow joint aspiration for treating radial head fracture in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (14 April 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (14 April 2014), MEDLINE (1946 to April Week 1 2014) and EMBASE (1980 to 2014 Week 15), trial registries, bibliographies and conference proceedings.\nSelection criteria\nRandomised and quasi-randomised controlled clinical trials comparing aspiration versus no aspiration for treating radial head fractures in adults.\nData collection and analysis\nTwo review authors independently selected articles, assessed risk of bias and extracted data. Disagreements were resolved by discussion. Where appropriate, we pooled results of comparable studies using fixed-effect meta-analysis.\nMain results\nWe included two trials that involved 126 participants but provided results for only 108 participants. Most participants were adults, typically over 30 years of age. Both trials were at high risk of selection, performance, detection and reporting bias. Reflecting this high risk of bias, we downgraded the quality of evidence two levels for study limitations and a further level for imprecision. Thus we judged the evidence for all outcomes to be 'very low' quality, meaning that we are very uncertain about these estimates.\nOne trial included participants with Mason type 1, 2 or 3 radial head fractures and also a few cases of traumatic elbow hemarthrosis without fracture. The other trial included participants with Mason type 1 and 2 fractures. All participants were managed non-surgically.\nNeither trial reported functional outcome based on validated patient-reported outcome measures of function or pain using validated measures such as a visual analogue scale. Very low quality evidence (108 participants, two trials) indicates little difference between aspiration and no aspiration in impaired function (unable to carry heavy loads; discomfort when carrying loads) at 12 months (9/51 in aspiration group versus 7/57 in the no aspiration group; risk ratio 1.43 favouring no aspiration, 95% confidence interval (CI) 0.57 to 3.58). Very low quality evidence (two trials) suggests a beneficial effect of aspiration on pain relief immediately after aspiration. Very low quality evidence (one trial, 28 participants) shows less pain after aspiration at three weeks, but it is unclear whether this applies subsequently. Neither trial reported on adverse events (for example, nerve and vascular injuries; deep or superficial infection) from the procedure, but aspiration was reported as being unsuccessful in three participants (7.9%) in one trial. Very low quality evidence indicates little difference in range of motion (based on elbow extension) between the two groups at six weeks (28 participants, one trial) or 12 months (108 participants, two trials). The report of adverse events was incomplete, but one trial (80 participants) reported the absence of three specific complications: myositis ossificans, joint instability or late displacement of the fracture.\nAuthors' conclusions\nThere is insufficient evidence to determine the effectiveness of joint aspiration for the initial treatment of radial head fracture in terms of function, pain and range of motion or to determine the safety of the procedure. An examination of current aspiration use, the prospective collection of adverse events and consultation with patients as to their preferences and values would be helpful in guiding decisions about the future design of a multicentre randomised trial aiming to obtain definitive evidence on the use of aspiration for treating radial head fractures.\n\nGiven the provided abstract, please respond to the following query: \"What is aspiration?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One treatment for radial head fracture is aspiration. This is a procedure where a sterile needle and syringe are used to drain excess fluid and blood from the elbow joint to relieve pressure and thus, in theory, relieve pain and improve clinical outcome. However, aspiration is an invasive procedure that puts the patient at further risk of complications, such as infection and injury to nerves and vessels. The procedure is typically done in the first few days after injury."
}
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query-laysum | 4665 | [
{
"role": "user",
"content": "Abstract: Background\nCannabis and cannabinoids are often promoted as treatment for many illnesses and are widely used among patients with ulcerative colitis (UC). Few studies have evaluated the use of these agents in UC. Further, cannabis has potential for adverse events and the long-term consequences of cannabis and cannabinoid use in UC are unknown.\nObjectives\nTo assess the efficacy and safety of cannabis and cannabinoids for the treatment of patients with UC.\nSearch methods\nWe searched MEDLINE, Embase, WHO ICTRP, AMED, PsychINFO, the Cochrane IBD Group Specialized Register, CENTRAL, ClinicalTrials.Gov and the European Clinical Trials Register from inception to 2 January 2018. Conference abstracts and references were searched to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs) comparing any form or dose of cannabis or its cannabinoid derivatives (natural or synthetic) to placebo or an active therapy for adults (> 18 years) with UC were included.\nData collection and analysis\nTwo authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. The primary outcomes were clinical remission and relapse (as defined by the primary studies). Secondary outcomes included clinical response, endoscopic remission, endoscopic response, histological response, quality of life, C-reactive protein (CRP) and fecal calprotectin measurements, symptom improvement, adverse events, serious adverse events, withdrawal due to adverse events, psychotropic adverse events, and cannabis dependence and withdrawal effects. We calculated the risk ratio (RR) and corresponding 95% confidence interval for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) and corresponding 95% CI. Data were pooled for analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). Data were analyzed on an intention-to-treat basis. GRADE was used to evaluate the overall certainty of evidence.\nMain results\nTwo RCTs (92 participants) met the inclusion criteria. One study (N = 60) compared 10 weeks of cannabidiol capsules with up to 4.7% D9-tetrahydrocannabinol (THC) with placebo capsules in participants with mild to moderate UC. The starting dose of cannabidiol was 50 mg twice daily increasing to 250 mg twice daily if tolerated. Another study (N = 32) compared 8 weeks of therapy with two cannabis cigarettes per day containing 0.5 g of cannabis, corresponding to 23 mg THC/day to placebo cigarettes in participants with UC who did not respond to conventional medical treatment. No studies were identified that assessed cannabis therapy in quiescent UC. The first study was rated as low risk of bias and the second study (published as an abstract) was rated as high risk of bias for blinding of participants and personnel. The studies were not pooled due to differences in the interventional drug.\nThe effect of cannabidiol capsules (100 mg to 500 mg daily) compared to placebo on clinical remission and response is uncertain. Clinical remission at 10 weeks was achieved by 24% (7/29) of the cannabidiol group compared to 26% (8/31) in the placebo group (RR 0.94, 95% CI 0.39 to 2.25; low certainty evidence). Clinical response at 10 weeks was achieved in 31% (9/29) of cannabidiol participants compared to 22% (7/31) of placebo patients (RR 1.37, 95% CI 0.59 to 3.21; low certainty evidence). Serum CRP levels were similar in both groups after 10 weeks of therapy. The mean CRP in the cannabidiol group was 9.428 mg/L compared to 7.638 mg/L in the placebo group (MD 1.79, 95% CI -5.67 to 9.25; moderate certainty evidence). There may be a clinically meaningful improvement in quality of life at 10 weeks, measured with the IBDQ scale (MD 17.4, 95% CI -3.45 to 38.25; moderate certainty evidence). Adverse events were more frequent in cannabidiol participants compared to placebo. One hundred per cent (29/29) of cannabidiol participants had an adverse event, compared to 77% (24/31) of placebo participants (RR 1.28, 95% CI 1.05 to1.56; moderate certainty evidence). However, these adverse events were considered to be mild or moderate in severity. Common adverse events included dizziness, disturbance in attention, headache, nausea and fatigue. None (0/29) of the cannabidiol participants had a serious adverse event compared to 10% (3/31) of placebo participants (RR 0.15, 95% CI 0.01 to 2.83; low certainty evidence). Serious adverse events in the placebo group included worsening of UC and one complicated pregnancy. These serious adverse events were thought to be unrelated to the study drug. More participants in the cannabidiol group withdrew due to an adverse event than placebo participants. Thirty-four per cent (10/29) of cannabidiol participants withdrew due to an adverse event compared to 16% (5/31) of placebo participants (RR 2.14, 95% CI 0.83 to 5.51; low certainty evidence). Withdrawls in the cannabidiol group were mostly due to dizziness. Withdrawals in the placebo group were due to worsening UC.\nThe effect of cannabis cigarettes (23 mg THC/day) compared to placebo on mean disease activity, CRP levels and mean fecal calprotectin levels is uncertain. After 8 weeks, the mean disease activity index score in cannabis participants was 4 compared with 8 in placebo participants (MD -4.00, 95% CI -5.98 to -2.02). After 8 weeks, the mean change in CRP levels was similar in both groups (MD -0.30, 95% CI -1.35 to 0.75; low certainty evidence). The mean fecal calprotectin level in cannabis participants was 115 mg/dl compared to 229 mg/dl in placebo participants (MD -114.00, 95% CI -246.01 to 18.01). No serious adverse events were observed. This study did not report on clinical remission, clinical response, quality of life, adverse events or withdrawal due to adverse events.\nAuthors' conclusions\nThe effects of cannabis and cannabidiol on UC are uncertain, thus no firm conclusions regarding the efficacy and safety of cannabis or cannabidiol in adults with active UC can be drawn.There is no evidence for cannabis or cannabinoid use for maintenance of remission in UC. Further studies with a larger number of patients are required to assess the effects of cannabis in UC patients with active and quiescent disease. Different doses of cannabis and routes of administration should be investigated. Lastly, follow-up is needed to assess the long term safety outcomes of frequent cannabis use.\n\nGiven the provided abstract, please respond to the following query: \"What is ulcerative colitis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Ulcerative colitis is a chronic, long-term illness that causes inflammation of the colon and rectum. Symptoms may include diarrhea, rectal bleeding, passage of mucus, and abdominal pain. It is characterized by periods of acute flares when people experience symptoms as well as periods of remission when symptoms stop."
}
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query-laysum | 4666 | [
{
"role": "user",
"content": "Abstract: Background\nBurning mouth syndrome (BMS) is a term used for oral mucosal pain (burning pain or discomfort in the tongue, lips or entire oral cavity) without identifiable cause. General population prevalence varies from 0.1% to 3.9%. Many BMS patients indicate anxiety, depression, personality disorders and impaired quality of life (QoL). This review updates the previous versions published in 2000 and 2005.\nObjectives\nTo determine the effectiveness and safety of any intervention versus placebo for symptom relief and changes in QoL, taste, and feeling of dryness in people with BMS.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 31 December 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 11) in the Cochrane Library (searched 31 December 2015), MEDLINE Ovid (1946 to 31 December 2015), and Embase Ovid (1980 to 31 December 2015). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching the electronic databases\nSelection criteria\nRandomised controlled trials (RCTs) comparing any treatment against placebo in people with BMS. The primary outcomes were symptom relief (pain/burning) and change in QoL. Secondary outcomes included change in taste, feeling of dryness, and adverse effects.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Outcome data were analysed as short-term (up to three months) or long-term (three to six months).\nMain results\nWe included 23 RCTs (1121 analysed participants; 83% female). Interventions were categorised as: antidepressants and antipsychotics, anticonvulsants, benzodiazepines, cholinergics, dietary supplements, electromagnetic radiation, physical barriers, psychological therapies, and topical treatments.\nOnly one RCT was assessed at low risk of bias overall, four RCTs' risk of bias was unclear, and 18 studies were at high risk of bias. Overall quality of the evidence for effectiveness was very low for all interventions and all outcomes.\nTwenty-one RCTs assessed short-term symptom relief. There is very low-quality evidence of benefit from electromagnetic radiation (one RCT, 58 participants), topical benzodiazepines (two RCTs, 111 participants), physical barriers (one RCT, 50 participants), and anticonvulsants (one RCT, 100 participants). We found insufficient/contradictory evidence regarding the effectiveness of antidepressants, cholinergics, systemic benzodiazepines, dietary supplements or topical treatments. No RCT assessing psychological therapies evaluated short-term symptom relief.\nFour studies assessed long-term symptom relief. There is very low-quality evidence of a benefit from psychological therapies (one RCT, 30 participants), capsaicin oral rinse (topical treatment) (one RCT, 18 participants), and topical benzodiazepines (one RCT, 66 participants). We found no evidence of a difference for dietary supplements or lactoperoxidase oral rinse. No studies assessing antidepressants, anticonvulsants, cholinergics, electromagnetic radiation or physical barriers evaluated long-term symptom relief.\nShort-term change in QoL was assessed by seven studies (none long-term).The quality of evidence was very low. A benefit was found for electromagnetic radiation (one RCT, 58 participants), however findings were inconclusive for antidepressants, benzodiazepines, dietary supplements and physical barriers.\nSecondary outcomes (change in taste and feeling of dryness) were only assessed short-term, and the findings for both were also inconclusive.\nWith regard to adverse effects, there is very low-quality evidence that antidepressants increase dizziness and drowsiness (one RCT, 37 participants), and that alpha lipoic acid increased headache (two RCTs, 118 participants) and gastrointestinal complaints (3 RCTs, 138 participants). We found insufficient/contradictory evidence regarding adverse events for anticonvulsants or benzodiazepines. Adverse events were poorly reported or unreported for cholinergics, electromagnetic radiation, and psychological therapies. No adverse events occurred from physical barriers or topical therapy use.\nAuthors' conclusions\nGiven BMS' potentially disabling nature, the need to identify effective modes of treatment for sufferers is vital. Due to the limited number of clinical trials at low risk of bias, there is insufficient evidence to support or refute the use of any interventions in managing BMS. Further clinical trials, with improved methodology and standardised outcome sets are required in order to establish which treatments are effective. Future studies are encouraged to assess the role of treatments used in other neuropathic pain conditions and psychological therapies in the treatment of BMS.\n\nGiven the provided abstract, please respond to the following query: \"Change in QoL\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There was evidence of short-term improvement in QoL for directed energy waves (one study, 58 patients), although no difference was found for antidepressants, tranquillisers, dietary supplements and physical barriers. No study assessed long-term QoL changes."
}
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query-laysum | 4667 | [
{
"role": "user",
"content": "Abstract: Background\nBreast cancer is the cancer most frequently diagnosed in women worldwide. Even though survival rates are continually increasing, breast cancer is often associated with long-term psychological distress, chronic pain, fatigue and impaired quality of life. Yoga comprises advice for an ethical lifestyle, spiritual practice, physical activity, breathing exercises and meditation. It is a complementary therapy that is commonly recommended for breast cancer-related impairments and has been shown to improve physical and mental health in people with different cancer types.\nObjectives\nTo assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment.\nSearch methods\nWe searched the Cochrane Breast Cancer Specialised Register, MEDLINE (via PubMed), Embase, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), Indexing of Indian Medical Journals (IndMED), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal and Clinicaltrials.gov on 29 January 2016. We also searched reference lists of identified relevant trials or reviews, as well as conference proceedings of the International Congress on Complementary Medicine Research (ICCMR), the European Congress for Integrative Medicine (ECIM) and the American Society of Clinical Oncology (ASCO). We applied no language restrictions.\nSelection criteria\nRandomised controlled trials were eligible when they (1) compared yoga interventions versus no therapy or versus any other active therapy in women with a diagnosis of non-metastatic or metastatic breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances.\nData collection and analysis\nTwo review authors independently collected data on methods and results. We expressed outcomes as standardised mean differences (SMDs) with 95% confidence intervals (CIs) and conducted random-effects model meta-analyses. We assessed potential risk of publication bias through visual analysis of funnel plot symmetry and heterogeneity between studies by using the Chi2 test and the I2 statistic. We conducted subgroup analyses for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention.\nMain results\nWe included 24 studies with a total of 2166 participants, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias.\nSeventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life (pooled SMD 0.22, 95% CI 0.04 to 0.40; 10 studies, 675 participants), reduced fatigue (pooled SMD -0.48, 95% CI -0.75 to -0.20; 11 studies, 883 participants) and reduced sleep disturbances in the short term (pooled SMD -0.25, 95% CI -0.40 to -0.09; six studies, 657 participants). The funnel plot for health-related quality of life was asymmetrical, favouring no therapy, and the funnel plot for fatigue was roughly symmetrical. This hints at overall low risk of publication bias. Yoga did not appear to reduce depression (pooled SMD -0.13, 95% CI -0.31 to 0.05; seven studies, 496 participants; low-quality evidence) or anxiety (pooled SMD -0.53, 95% CI -1.10 to 0.04; six studies, 346 participants; very low-quality evidence) in the short term and had no medium-term effects on health-related quality of life (pooled SMD 0.10, 95% CI -0.23 to 0.42; two studies, 146 participants; low-quality evidence) or fatigue (pooled SMD -0.04, 95% CI -0.36 to 0.29; two studies, 146 participants; low-quality evidence). Investigators reported no serious adverse events.\nFour studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression (pooled SMD -2.29, 95% CI -3.97 to -0.61; four studies, 226 participants), anxiety (pooled SMD -2.21, 95% CI -3.90 to -0.52; three studies, 195 participants) and fatigue (pooled SMD -0.90, 95% CI -1.31 to -0.50; two studies, 106 participants) in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life (pooled SMD 0.81, 95% CI -0.50 to 2.12; two studies, 153 participants) or sleep disturbances (pooled SMD -0.21, 95% CI -0.76 to 0.34; two studies, 119 participants). No trial adequately reported safety-related data.\nThree studies that compared yoga versus exercise presented very low-quality evidence showing no short-term effects on health-related quality of life (pooled SMD -0.04, 95% CI -0.30 to 0.23; three studies, 233 participants) or fatigue (pooled SMD -0.21, 95% CI -0.66 to 0.25; three studies, 233 participants); no trial provided safety-related data.\nAuthors' conclusions\nModerate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.\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": "Breast cancer is the most common cancer among women worldwide. Although the number of women who survive breast cancer is increasing, those women often suffer from psychological or physical problems. We wanted to find out whether yoga can improve quality of life, mental health and symptoms related to cancer in women with a diagnosis of breast cancer. We included all forms of yoga but excluded multi-modal interventions such as mindfulness-based stress reduction."
}
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query-laysum | 4668 | [
{
"role": "user",
"content": "Abstract: Background\nIndividual counselling from a smoking cessation specialist may help smokers to make a successful attempt to stop smoking.\nObjectives\nThe review addresses the following hypotheses:\n1. Individual counselling is more effective than no treatment or brief advice in promoting smoking cessation.\n2. Individual counselling is more effective than self-help materials in promoting smoking cessation.\n3. A more intensive counselling intervention is more effective than a less intensive intervention.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register for studies with counsel* in any field in May 2016.\nSelection criteria\nRandomized or quasi-randomized trials with at least one treatment arm consisting of face-to-face individual counselling from a healthcare worker not involved in routine clinical care. The outcome was smoking cessation at follow-up at least six months after the start of counselling.\nData collection and analysis\nBoth authors extracted data in duplicate. We recorded characteristics of the intervention and the target population, method of randomization and completeness of follow-up. We used the most rigorous definition of abstinence in each trial, and biochemically-validated rates where available. In analysis, we assumed that participants lost to follow-up continued to smoke. We expressed effects as a risk ratio (RR) for cessation. Where possible, we performed meta-analysis using a fixed-effect (Mantel-Haenszel) model. We assessed the quality of evidence within each study using the Cochrane 'Risk of bias' tool and the GRADE approach.\nMain results\nWe identified 49 trials with around 19,000 participants. Thirty-three trials compared individual counselling to a minimal behavioural intervention. There was high-quality evidence that individual counselling was more effective than a minimal contact control (brief advice, usual care, or provision of self-help materials) when pharmacotherapy was not offered to any participants (RR 1.57, 95% confidence interval (CI) 1.40 to 1.77; 27 studies, 11,100 participants; I2 = 50%). There was moderate-quality evidence (downgraded due to imprecision) of a benefit of counselling when all participants received pharmacotherapy (nicotine replacement therapy) (RR 1.24, 95% CI 1.01 to 1.51; 6 studies, 2662 participants; I2 = 0%). There was moderate-quality evidence (downgraded due to imprecision) for a small benefit of more intensive counselling compared to brief counselling (RR 1.29, 95% CI 1.09 to 1.53; 11 studies, 2920 participants; I2 = 48%). None of the five other trials that compared different counselling models of similar intensity detected significant differences.\nAuthors' conclusions\nThere is high-quality evidence that individually-delivered smoking cessation counselling can assist smokers to quit. There is moderate-quality evidence of a smaller relative benefit when counselling is used in addition to pharmacotherapy, and of more intensive counselling compared to a brief counselling intervention.\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 searched for trials in May 2016 and identified 49 trials Inlcuding around 19,000 participants. All the trials involved one or more face-to-face counselling sessions lasting at least 10 minutes, but most were much longer. Many also included further telephone contact for additional support. Thirty-three of the trials compared individual counselling to a control group that only had minimal support, which could be usual care, brief advice about stopping smoking, or written materials. Of these, 27 did not offer any medication such as nicotine replacement therapy (NRT), which also helps people stop. Six of the 33 provided NRT or other medication to everyone in the trial. Twelve studies compared more intensive to less intensive counselling, and five compared different types of counselling."
}
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query-laysum | 4669 | [
{
"role": "user",
"content": "Abstract: Background\nPain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain.\nObjectives\nTo assess the effects of CAM for post-caesarean pain.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain.\nData collection and analysis\nTwo review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE.\nMain results\nWe included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge.\nPrimary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect\nAcupuncture or acupressure\nWe are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 2 studies; 130 women; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence).\nIt is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low.\nAromatherapy\nAromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia.\nElectromagnetic therapy\nElectromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence).\nMassage\nWe identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty.\nMusic\nMusic plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; 2 studies; 115 women; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low.\nReiki\nWe are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women).\nRelaxation\nRelaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).\nTranscutaneous electrical nerve stimulation\nTENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 1 study; 108 women; low-certainty evidence).\nTENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence).\nWe are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).\nAuthors' conclusions\nSome CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain.\nSince pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.\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 may be some benefit of acupuncture or acupressure, aromatherapy, electromagnetic therapy, massage, music therapy, relaxation, and TENS in the management of pain in women undergoing CS. From these trials, the evidence on harmful effects of CAM are lacking or are very uncertain.\nSince pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Future trials also need to have be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales."
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query-laysum | 4670 | [
{
"role": "user",
"content": "Abstract: Background\nSoft tissue sarcomas (STS) are a highly heterogeneous group of rare malignant solid tumors. Nonrhabdomyosarcoma soft tissue sarcomas (NRSTS) comprise all STS except rhabdomyosarcoma. In people with advanced local or metastatic disease, autologous hematopoietic stem cell transplantation (HSCT) applied after high-dose chemotherapy (HDCT) is a planned rescue therapy for HDCT-related severe hematologic toxicity. The rationale for this update is to determine whether any randomized controlled trials (RCTs) have been conducted and to clarify whether HDCT followed by autologous HSCT has a survival advantage.\nObjectives\nTo assess the efficacy and safety of high-dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation (HSCT) for all stages of nonrhabdomyosarcoma soft tissue sarcomas (NRSTS) in children and adults.\nSearch methods\nFor this update, we revised the search strategy to improve the precision and reduce the number of irrelevant hits. We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8), PubMed from 2012 to 6 September 2016, and Embase from 2012 to 26 September 2016. We searched online trial registries and congress proceedings from 2012 to 26 September 2016.\nSelection criteria\nTerms representing STS and autologous HSCT were required in the title or abstract. We restricted the study design to RCTs. We included studies if at least 80% of participants had a diagnosis listed in any version of the World Health Organization (WHO) classification and classified as malignant. The search included children and adults with no age limits.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane. The primary outcomes were overall survival and treatment-related mortality.\nMain results\nWe identified 1549 records; 85 items from electronic databases, 45 from study registries, and 1419 from congress proceedings. The revised search strategy did not identify any additional RCTs. In the previous version of the review, we identified one RCT comparing HDCT followed by autologous HSCT versus standard-dose chemotherapy (SDCT). The trial randomized 87 participants who were considerably heterogeneous with respect to 19 different tumor entities. The data from 83 participants were available for analysis.\nIn the single included trial, overall survival at three years was 32.7% in the HDCT arm versus 49.4% in the SDCT arm and there was no difference between the treatment groups (hazard ratio (HR) 1.26, 95% confidence interval (CI) 0.70 to 2.29, P = 0.44; 1 study, 83 participants; high quality evidence). In a subgroup of participants who had a complete response before HDCT, overall survival was higher in both treatment groups and overall survival at three years was 42.8% in the HDCT arm versus 83.9% in the SDCT arm and favored the SDCT group (HR 2.92, 95% CI 1.1 to 7.6, P = 0.028; 1 study, 39 participants).\nIn the single included trial, the authors reported one treatment-related leukemia death two years after HDCT. They also evaluated severe adverse events WHO grade 3 to 4 in 22 participants in the HDCT arm and in 51 participants in the SDCT arm. The authors reported 11 events concerning digestive-, infection-, pain-, or asthenia-related toxicity in the HDCT arm and one event in the SDCT arm (moderate quality evidence). The development of secondary neoplasia was not addressed. We judged the study to have an overall unclear risk of bias as three of seven items had unclear and four items had low risk of bias. For GRADE, we judged three items as high quality and three items were not reported.\nAuthors' conclusions\nThe limited data of a single RCT with an unclear risk of bias and moderate to high quality evidence showed no survival advantage for HDCT. If this treatment is offered it should only be given after careful consideration on an individual person basis and possibly only as part of a well-designed RCT.\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": "We reviewed the evidence about the effect of high-dose chemotherapy (medicines to kill the cancer) followed by autologous hematopoietic stem cell transplantation compared to standard-dose chemotherapy on overall survival (time from cancer diagnosis, or treatment, to death from any cause) in people with nonrhabdomyosarcoma soft tissue sarcomas. We found one randomized controlled trial (RCT; a clinical study where people are randomly put into one of two or more treatment groups) comparing both treatments."
}
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query-laysum | 4671 | [
{
"role": "user",
"content": "Abstract: Background\nCollaborative writing applications (CWAs), such as wikis and Google Documents, hold the potential to improve the use of evidence in both public health and healthcare. Although a growing body of literature indicates that CWAs could have positive effects on healthcare, such as improved collaboration, behavioural change, learning, knowledge management, and adaptation of knowledge to local context, this has never been assessed systematically. Moreover, several questions regarding safety, reliability, and legal aspects exist.\nObjectives\nThe objectives of this review were to (1) assess the effects of the use of CWAs on process (including the behaviour of healthcare professionals) and patient outcomes, (2) critically appraise and summarise current evidence on the use of resources, costs, and cost-effectiveness associated with CWAs to improve professional practices and patient outcomes, and (3) explore the effects of different CWA features (e.g. open versus closed) and different implementation factors (e.g. the presence of a moderator) on process and patient outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and 11 other electronic databases. We searched the grey literature, two trial registries, CWA websites, individual journals, and conference proceedings. We also contacted authors and experts in the field. We did not apply date or language limits. We searched for published literature to August 2016, and grey literature to September 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-and-after (CBA) studies, interrupted time series (ITS) studies, and repeated measures studies (RMS), in which CWAs were used as an intervention to improve the process of care, patient outcomes, or healthcare costs.\nData collection and analysis\nTeams of two review authors independently assessed the eligibility of studies. Disagreements were resolved by discussion, and when consensus was not reached, a third review author was consulted.\nMain results\nWe screened 11,993 studies identified from the electronic database searches and 346 studies from grey literature sources. We analysed the full text of 99 studies. None of the studies met the eligibility criteria; two potentially relevant studies are ongoing.\nAuthors' conclusions\nWhile there is a high number of published studies about CWAs, indicating that this is an active field of research, additional studies using rigorous experimental designs are needed to assess their impact and cost-effectiveness on process and patient outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched 14 scientific bibliographic databases, two trial registries, and grey literature sources. We also contacted 106 authors and experts in the field to ask for relevant papers. No studies met our eligibility criteria; two potentially relevant studies are ongoing."
}
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query-laysum | 4672 | [
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory joint diseases (IJDs) affect 1% to 2% of the population in developed countries. IJDs include rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and other forms of spondyloarthritis (SpA). Tobacco smoking is considered a significant environmental risk factor for developing IJDs. There are indications that smoking exacerbates the symptoms and worsens disease outcomes.\nObjectives\nThe objective of this review was to investigate the evidence for effects of smoking cessation interventions on smoking cessation and disease activity in smokers with IJD.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library; PubMed/MEDLINE; Embase; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and three trials registers to October 2018.\nSelection criteria\nWe included randomised controlled trials testing any form of smoking cessation intervention for adult daily smokers with a diagnosis of IJD, and measuring smoking cessation at least six months after baseline.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included two studies with 57 smokers with a diagnosis of rheumatoid arthritis (RA). We identified no studies including other IJDs. One pilot study compared a smoking cessation intervention specifically for people with RA with a less intensive, generic smoking cessation intervention. People included in the study had a mean age of 56.5 years and a disease duration of 7.7 years (mean). The second study tested effects of an eight-week cognitive-behavioural patient education intervention on cardiovascular disease (CVD) risk for people with RA and compared this with information on CVD risk only. The intervention encouraged participants to address multiple behaviours impacting CVD risk, including smoking cessation, but did not target smoking cessation alone. People included in the study had a mean age of 62.2 years (intervention group) and 60.8 years (control group), and disease duration of 11.6 years (intervention group) and 14.1 years (control group). It was not appropriate to perform a meta-analysis of abstinence data from the two studies due to clinical heterogeneity between interventions. Neither of the studies individually provided evidence to show benefit of the interventions tested. Only one study reported on adverse effects. These effects were non-serious, and numbers were comparable between trial arms. Neither of the studies assessed or reported disease activity or any of the predefined secondary outcomes. We assessed the overall certainty of evidence as very low due to indirectness, imprecision, and high risk of detection bias based on GRADE.\nAuthors' conclusions\nWe found very little research investigating the efficacy of smoking cessation intervention specifically in people with IJD. Included studies are limited by imprecision, risk of bias, and indirectness. Neither of the included studies investigated whether smoking cessation intervention reduced disease activity among people with IJD. High-quality, adequately powered studies are warranted. In particular, researchers should ensure that they measure disease markers and quality of life, in addition to long-term smoking cessation.\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": "Tobacco smoking increases the risk of developing inflammatory joint diseases (IJDs) such as rheumatoid arthritis, where the joints are progressively damaged by the body's own immune system. Smoking may also worsen symptoms of these diseases. This review looked at whether supportive programmes to help smokers with IJDs quit smoking actually lead to quitting and reduced inflammation in the joints and elsewhere. Inflammation from these diseases can lead to heart attack and stroke, for which people with IJD are at higher risk."
}
]
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query-laysum | 4673 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 50% of patients with newly diagnosed non-small cell lung cancer (NSCLC) are over 70 years of age at diagnosis. Despite this fact, these patients are underrepresented in randomized controlled trials (RCTs). As a consequence, the most appropriate regimens for these patients are controversial, and the role of single-agent or combination therapy is unclear. In this setting, a critical systematic review of RCTs in this group of patients is warranted.\nObjectives\nTo assess the effectiveness and safety of different cytotoxic chemotherapy regimens for previously untreated elderly patients with advanced (stage IIIB and IV) NSCLC. To also assess the impact of cytotoxic chemotherapy on quality of life.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to 31 October 2014), EMBASE (1974 to 31 October 2014), and Latin American Caribbean Health Sciences Literature (LILACS) (1982 to 31 October 2014). In addition, we handsearched the proceedings of major conferences, reference lists from relevant resources, and the ClinicalTrial.gov database.\nSelection criteria\nWe included only RCTs that compared non-platinum single-agent therapy versus non-platinum combination therapy, or non-platinum therapy versus platinum combination therapy in patients over 70 years of age with advanced NSCLC. We allowed inclusion of RCTs specifically designed for the elderly population and those designed for elderly subgroup analyses.\nData collection and analysis\nTwo review authors independently assessed search results, and a third review author resolved disagreements. We analyzed the following endpoints: overall survival (OS), one-year survival rate (1yOS), progression-free survival (PFS), objective response rate (ORR), major adverse events, and quality of life (QoL).\nMain results\nWe included 51 trials in the review: non-platinum single-agent therapy versus non-platinum combination therapy (seven trials) and non-platinum combination therapy versus platinum combination therapy (44 trials).\nNon-platinum single-agent versus non-platinum combination therapy\nLow-quality evidence suggests that these treatments have similar effects on overall survival (hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.72 to 1.17; participants = 1062; five RCTs), 1yOS (risk ratio (RR) 0.88, 95% CI 0.73 to 1.07; participants = 992; four RCTs), and PFS (HR 0.94, 95% CI 0.83 to 1.07; participants = 942; four RCTs). Non-platinum combination therapy may better improve ORR compared with non-platinum single-agent therapy (RR 1.79, 95% CI 1.41 to 2.26; participants = 1014; five RCTs; low-quality evidence).\nDifferences in effects on major adverse events between treatment groups were as follows: anemia: RR 1.10, 95% 0.53 to 2.31; participants = 983; four RCTs; very low-quality evidence; neutropenia: RR 1.26, 95% CI 0.96 to 1.65; participants = 983; four RCTs; low-quality evidence; and thrombocytopenia: RR 1.45, 95% CI 0.73 to 2.89; participants = 914; three RCTs; very low-quality evidence. Only two RCTs assessed quality of life; however, we were unable to perform a meta-analysis because of the paucity of available data.\nNon-platinum therapy versus platinum combination therapy\nPlatinum combination therapy probably improves OS (HR 0.76, 95% CI 0.69 to 0.85; participants = 1705; 13 RCTs; moderate-quality evidence), 1yOS (RR 0.89, 95% CI 0.82 to 0.96; participants = 813; 13 RCTs; moderate-quality evidence), and ORR (RR 1.57, 95% CI 1.32 to 1.85; participants = 1432; 11 RCTs; moderate-quality evidence) compared with non-platinum therapies. Platinum combination therapy may also improve PFS, although our confidence in this finding is limited because the quality of evidence was low (HR 0.76, 95% CI 0.61 to 0.93; participants = 1273; nine RCTs).\nEffects on major adverse events between treatment groups were as follows: anemia: RR 2.53, 95% CI 1.70 to 3.76; participants = 1437; 11 RCTs; low-quality evidence; thrombocytopenia: RR 3.59, 95% CI 2.22 to 5.82; participants = 1260; nine RCTs; low-quality evidence; fatigue: RR 1.56, 95% CI 1.02 to 2.38; participants = 1150; seven RCTs; emesis: RR 3.64, 95% CI 1.82 to 7.29; participants = 1193; eight RCTs; and peripheral neuropathy: RR 7.02, 95% CI 2.42 to 20.41; participants = 776; five RCTs; low-quality evidence. Only five RCTs assessed QoL; however, we were unable to perform a meta-analysis because of the paucity of available data.\nAuthors' conclusions\nIn people over the age of 70 with advanced NSCLC who do not have significant co-morbidities, increased survival with platinum combination therapy needs to be balanced against higher risk of major adverse events when compared with non-platinum therapy. For people who are not suitable candidates for platinum treatment, we have found low-quality evidence suggesting that non-platinum combination and single-agent therapy regimens have similar effects on survival. We are uncertain as to the comparability of their adverse event profiles. Additional evidence on quality of life gathered from additional studies is needed to help inform decision making.\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": "Non-platinum single-agent versus non-platinum combination therapy\nWe downgraded to low the quality of evidence on survival because different results were reported across studies, and because three included trials were stopped early, which also influenced the quality of evidence for chance of decreasing tumor size and low hemoglobin, platelet, and white cell counts. For theses outcomes, issues with study design were also a matter of concern, leading to low quality of evidence.\nNon-platinum combination versus platinum combination therapy\nWe downgraded to moderate the quality of evidence on the benefit of platinum combination therapy for survival based on inclusion of nine trials that were not specifically designed for older patients. Other issues with study design influenced the quality of evidence on interval to tumor growth after start of treatment, rate of tumor shrinkage, and toxicity. Regarding low hemoglobin and platelet levels, we further reduced the quality of evidence to low because of imprecision of reported results. We recognize that other limitations such as age alone might not be adequate criteria for selection of the best treatment. Older people can be very different from one another in terms of other health conditions associated with aging. Older patients included in randomized trials were selected through strict eligibility criteria that excluded most patients with other health problems. Therefore, we believe that these results must be interpreted with clinical judgement applied regarding selection of an appropriate treatment regimen."
}
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query-laysum | 4674 | [
{
"role": "user",
"content": "Abstract: Background\nHeart failure is a condition in which the heart does not pump enough blood to meet all the needs of the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention. Outcomes for patients with heart failure are highly variable; however on average, these patients have a poor prognosis. Prognosis can be improved with early diagnosis and appropriate use of medical treatment, use of devices and transplantation. Patients with heart failure are high users of healthcare resources, not only due to drug and device treatments, but due to high costs of hospitalisation care. B-type natriuretic peptide levels are already used as biomarkers for diagnosis and prognosis of heart failure, but could offer to clinicians a possible tool to guide drug treatment. This could optimise drug management in heart failure patients whilst allaying concerns over potential side effects due to drug intolerance.\nObjectives\nTo assess whether treatment guided by serial BNP or NT-proBNP (collectively referred to as NP) monitoring improves outcomes compared with treatment guided by clinical assessment alone.\nSearch methods\nSearches were conducted up to 15 March 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (OVID), Embase (OVID), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database in the Cochrane Library. Searches were also conducted in the Science Citation Index Expanded, the Conference Proceedings Citation Index on Web of Science (Thomson Reuters), World Health Organization International Clinical Trials Registry and ClinicalTrials.gov. We applied no date or language restrictions.\nSelection criteria\nWe included randomised controlled trials of NP-guided treatment of heart failure versus treatment guided by clinical assessment alone with no restriction on follow-up. Adults treated for heart failure, in both in-hospital and out-of-hospital settings, and trials reporting a clinical outcome were included.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data and evaluated risk of bias. Risk ratios (RR) were calculated for dichotomous data, and pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated for continuous data. We contacted trial authors to obtain missing data. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table.\nMain results\nWe included 18 randomised controlled trials with 3660 participants (range of mean age: 57 to 80 years) comparing NP-guided treatment with clinical assessment alone. The evidence for all-cause mortality using NP-guided treatment showed uncertainty (RR 0.87, 95% CI 0.76 to 1.01; patients = 3169; studies = 15; low quality of the evidence), and for heart failure mortality (RR 0.84, 95% CI 0.54 to 1.30; patients = 853; studies = 6; low quality of evidence).\nThe evidence suggested heart failure admission was reduced by NP-guided treatment (38% versus 26%, RR 0.70, 95% CI 0.61 to 0.80; patients = 1928; studies = 10; low quality of evidence), but the evidence showed uncertainty for all-cause admission (57% versus 53%, RR 0.93, 95% CI 0.84 to 1.03; patients = 1142; studies = 6; low quality of evidence).\nSix studies reported on adverse events, however the results could not be pooled (patients = 1144; low quality of evidence). Only four studies provided cost of treatment results, three of these studies reported a lower cost for NP-guided treatment, whilst one reported a higher cost (results were not pooled; patients = 931, low quality of evidence). The evidence showed uncertainty for quality of life data (MD -0.03, 95% CI -1.18 to 1.13; patients = 1812; studies = 8; very low quality of evidence).\nWe completed a 'Risk of bias' assessment for all studies. The impact of risk of bias from lack of blinding of outcome assessment and high attrition levels was examined by restricting analyses to only low 'Risk of bias' studies.\nAuthors' conclusions\nIn patients with heart failure low-quality evidence showed a reduction in heart failure admission with NP-guided treatment while low-quality evidence showed uncertainty in the effect of NP-guided treatment for all-cause mortality, heart failure mortality, and all-cause admission. Uncertainty in the effect was further shown by very low-quality evidence for patient's quality of life. The evidence for adverse events and cost of treatment was low quality and we were unable to pool results.\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 aimed to discover whether using B-type natriuretic-guided treatment or a health plan alone is more effective for managing patients with heart failure."
}
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query-laysum | 4675 | [
{
"role": "user",
"content": "Abstract: Background\nMedical abortion became an alternative method of pregnancy termination following the development of prostaglandins and antiprogesterone in the 1970s and 1980s. Recently, synthesis inhibitors of oestrogen (such as letrozole) have also been used to enhance efficacy. The most widely researched drugs are prostaglandins (such as misoprostol, which has a strong uterotonic effect), mifepristone, mifepristone with prostaglandins, and letrozole with prostaglandins. More evidence is needed to identify the best dosage, regimen, and route of administration to optimise patient outcomes. This is an update of a review last published in 2011.\nObjectives\nTo compare the effectiveness and side effects of different medical methods for first trimester abortion.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Global Health, and LILACs on 28 February 2021. We also searched Clinicaltrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform, and reference lists of retrieved papers.\nSelection criteria\nWe considered randomised controlled trials (RCTs) that compared different medical methods for abortion before the 12th week of gestation. The primary outcome is failure to achieve complete abortion. Secondary outcomes are mortality, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the method.\nData collection and analysis\nTwo review authors independently selected and evaluated studies for inclusion, and assessed the risk of bias. We processed data using Review Manager 5 software. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 99 studies in the review (58 from the original review and 41 new studies).\n1. Combined regimen mifepristone/prostaglandin\nMifepristone dose: high-dose (600 mg) compared to low-dose (200 mg) mifepristone probably has similar effectiveness in achieving complete abortion (RR 1.07, 95% CI 0.87 to 1.33; I2 = 0%; 4 RCTs, 3494 women; moderate-certainty evidence).\nProstaglandin dose: 800 µg misoprostol probably reduces abortion failure compared to 400 µg (RR 0.63, 95% CI 0.51 to 0.78; I2= 0%; 3 RCTs, 4424 women; moderate-certainty evidence).\nProstaglandin timing: misoprostol administered on day one probably achieves more success on complete abortion than on day three (RR 1.94, 95% CI 1.05 to 3.58; 1489 women; 1 RCT; moderate-certainty evidence).\nAdministration strategy: there may be no difference in failure of complete abortion with self-administration at home compared with hospital administration (RR 1.63, 95% CI 0.68 to 3.94; I2 = 84%; 2263 women; 4 RCTs; low-certainty evidence), but failure may be higher when administered by nurses in hospital compared to by doctors in hospital (RR 2.69, 95% CI 1.39 to 5.22; I2 = 66%; 3 RCTs, 3056 women; low-certainty evidence).\nAdministration route: oral misoprostol probably leads to more failures than the vaginal route (RR 2.38, 95% CI 1.46 to 3.87; I2 = 39%; 3 RCTs, 1704 women; moderate-certainty evidence) and may be associated with more frequent side effects such as nausea (RR 1.14, 95% CI 1.03 to 1.26; I2 = 0%; 2 RCTs, 1380 women; low-certainty evidence) and diarrhoea (RR 1.80 95% CI 1.49 to 2.17; I2 = 0%; 2 RCTs, 1379 women). Compared with the vaginal route, complete abortion failure is probably lower with sublingual (RR 0.68, 95% CI 0.22 to 2.11; I2 = 59%; 2 RCTs, 3229 women; moderate-certainty evidence) and may be lower with buccal administration (RR 0.71, 95% CI 0.34 to 1.46; I2 = 0%; 2 RCTs, 479 women; low-certainty evidence), but sublingual or buccal routes may lead to more side effects. Women may experience more vomiting with sublingual compared to buccal administration (RR 1.33, 95% CI 1.01 to 1.77; low-certainty evidence).\n2. Mifepristone alone versus combined regimen\nThe efficacy of mifepristone alone in achieving complete abortion compared to combined mifepristone/prostaglandin up to 12 weeks is unclear (RR of failure 3.25, 95% CI 0.81 to 13.09; I2 = 83%; 3 RCTs, 273 women; very low-certainty evidence).\n3. Prostaglandin alone versus combined regimen\nNineteen studies compared prostaglandin alone to a combined regimen (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate). Compared to any of the combination regimens, misoprostol alone may increase the risk for failure to achieve complete abortion (RR of failure 2.39, 95% CI 1.89 to 3.02; I2 = 64%; 18 RCTs, 3471 women; low-certainty evidence), and with more diarrhoea.\n4. Prostaglandin alone (route of administration)\nOral misoprostol alone may lead to more failures in complete abortion than the vaginal route (RR 3.68, 95% CI 1.56 to 8.71, 2 RCTs, 216 women; low-certainty evidence). Failure to achieve complete abortion may be slightly reduced with sublingual compared with vaginal (RR 0.69, 95% CI 0.37 to 1.28; I2 = 87%; 5 RCTs, 2705 women; low-certainty evidence) and oral administration (RR 0.58, 95% CI 0.11 to 2.99; I2 = 66%; 2 RCTs, 173 women). Failure to achieve complete abortion may be similar or slightly higher with sublingual administration compared to buccal administration (RR 1.11, 95% CI 0.71 to 1.74; 1 study, 401 women).\nAuthors' conclusions\nSafe and effective medical abortion methods are available. Combined regimens (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate) may be more effective than single agents (prostaglandin alone or mifepristone alone). In the combined regimen, the dose of mifepristone can probably be lowered to 200 mg without significantly decreasing effectiveness. Vaginal misoprostol is probably more effective than oral administration, and may have fewer side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all studies were conducted in settings with good access to emergency services, which may limit the generalisability of these results.\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": ""
}
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query-laysum | 4676 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. Colic appears to be more frequent in the first six weeks of life (prevalence range of 17% to 25%), depending on the specific location reported and definitions used, and usually resolves by three months. The aetiopathogenesis of infantile colic is unclear but most likely multifactorial. A number of psychological, behavioural and biological components (food hypersensitivity, allergy or both; gut microflora and dysmotility) are thought to contribute to it. The role of diet as a component in infantile colic remains controversial.\nObjectives\nTo assess the effects of dietary modifications for reducing colic in infants less than four months of age.\nSearch methods\nIn July 2018 we searched CENTRAL, MEDLINE, Embase, 17 other databases and 2 trials registers. We also searched Google, checked references and contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of dietary modifications, alone or in combination, for colicky infants younger than four months of age versus another intervention or placebo. We used specific definitions for colic, age of onset and the methods for performing the intervention. We defined 'modified diet' as any diet altered to include or exclude certain components.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcome was duration of crying, and secondary outcomes were response to intervention, frequency of crying episodes, parental/family quality of life, infant sleep duration, parental satisfaction and adverse effects.\nMain results\nWe included 15 RCTs involving 1121 infants aged 2 to 16 weeks. All studies were small and at high risk of bias across multiple design factors (e.g. selection, attrition). The studies covered a wide range of dietary interventions, and there was no scope for meta-analysis. Using GRADE, we assessed the quality of the evidence as very low.\nNo study reported on parental or family quality of life, infant sleep duration per 24 h, or parental satisfaction.\nLow-allergen maternal diet versus a diet containing potential allergens: one study (90 infants) found that 35/47 (74%) of infants responded (reduction in cry/fuss duration of 25%) to a low-allergen maternal diet, compared with 16/43 (37%) of infants with a maternal diet containing potential allergens (37% difference; 95% confidence interval (CI) 18 to 56; P < 0.001).\nLow-allergen diet or soy milk formula versus standard diet or cow's milk formula and dicyclomine hydrochloride: one study (120 infants) found that 10/15 (66.6%) breastfed babies responded to dicyclomine hydrochloride and a normal diet, compared with 10/16 (62.5%) on a low-allergen diet, while 24/45 (53.3%) standard formula-fed babies taking dicyclomine hydrochloride improved compared with 29/44 (65.9%) on soy milk formula. Response was defined as a reduction of crying to less than one hour per day after 48 hours of treatment, with remission persisting for one month.\nHydrolysed formula versus standard formula: one study (43 infants) reported that the number of infants who responded to the intervention (cried for less than 3 hours per day on at least 3 days a week) was 8/23 in the whey hydrolysate group versus 5/20 in the standard formula group (χ2 using yate's correction = 0.20, P = 0.65).\nThe same study (43 infants) reported a greater reduction in crying time postintervention with hydrolysed formula (104 min/d, 95% CI 55 to 155) than with standard formula (3 min/d, 95% CI −63 to 67); difference = 101 min/d, 95% CI 25 to 179; P = 0.02).\nThe author confirmed there were no adverse effects.\nHydrolysed formula or dairy- and soy-free maternal diet versus standard diet/formula and parental education or counselling: one study (21 infants) found that crying time decreased to 2.03 h/d (SD 1.03) in the hydrolysed or dairy- and soy-free maternal diet group compared with 1.08 h/d (SD 0.7) in the parent education or counselling group, nine days postintervention.\nPartially hydrolysed, lower lactose, whey-based formulae containing oligosaccharide versus standard formula with simethicone: one study (267 infants) found both groups experienced decreased colic episodes after seven days (partially hydrolysed formula: from 5.99 episodes (SD 1.84) to 2.47 episodes (SD 1.94); standard formula: from 5.41 episodes (SD 1.88) to 3.72 episodes (SD 1.98)); 95% CI 95% −0.7 to −1.8; P < 0.001). This difference was significant after two weeks (partially hydrolysed: 1.76 episodes (SD 1.60); standard formula: 3.32 episodes (SD 2.06); P < 0.001). The study author confirmed there were no adverse effects.\nLactase enzyme supplementation versus placebo: three studies (138 infants) assessed this comparison, but they are cross-over trials that did not report data from before washout. There were no adverse effects in any of the studies.\nExtract of Foeniculum vulgare, Matricariae recutita, and Melissa officinalis versus placebo: one study (93 infants) found that average daily crying time was lower for infants given the extract (76.9 min/d (SD 23.5), than infants given placebo (169.9 min/d (SD 23.1) at the end of the one-week study (95% CI −102.89 to −83.11; P < 0.01). There were no adverse effects.\nSoy protein-based formula versus standard cows' milk protein-based formula: one study (19 infants) reported a mean crying time of 12.7 h/week (SD 16.4) in the soy formula group versus 17.3 h/week (SD 6.9) in the standard cows' milk group, and that 5/10 (50%) responded in the soy formula group versus 0/9 (0%) in the standard cows' milk group.\nSoy protein formula with polysaccharide versus standard soy protein formula: one cross-over study (27 infants) assessed this comparison but did not provide disaggregated data for the pre-wash-out data.\nAuthors' conclusions\nCurrently, evidence of the effectiveness of dietary modifications for the treatment of infantile colic is sparse and at significant risk of bias. The few available studies had small sample sizes, and most had serious limitations. There were insufficient studies, making the use of meta-analysis unfeasable. Benefits reported for hydrolysed formulas were inconsistent.\nBased on available evidence, we are unable to recommend any intervention. Future studies of single interventions, using clinically significant outcome measures, and appropriate design and power are needed.\n\nGiven the provided abstract, please respond to the following query: \"Hydrolysed formula milk\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study (43 infants) found no clear difference in resolving symptoms of colic between the hydrolysed (hypoallergenic) and standard cow's milk groups. They also reported a greater reduction in crying time at study end in infants who were given hydrolysed, and reported no adverse effects.\nA third study (21 infants) reported that infants whose parents were given information and support experienced a more rapid reduction in crying time than infants who were given a hydrolysed formula or dairy- and soy-free diet (within nine days).\nA fourth study (267 infants) found that both partially hydrolysed formula with oligosaccharides (carbohydrates) and a standard formula with simethicone (a drug for treating symptoms of gas) reduced colic episodes after seven days, but effects were greater in the hydrolysed plus oligosaccharides group after two weeks. The study author confirmed there were no adverse effects."
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query-laysum | 4677 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis (OA) is the most common form of arthritis and is caused by degeneration of the joint cartilage and growth of new bone, cartilage and connective tissue. It is often associated with major disability and impaired quality of life. There is currently no consensus on the best treatment to improve OA symptoms. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID).\nObjectives\nTo assess the clinical benefits (pain, function, quality of life) and safety (withdrawals due to adverse effects, serious adverse effects, overall discontinuation rates) of celecoxib in osteoarthritis (OA).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers up to April 11, 2017, as well as reference and citation lists of included studies. Pharmaceutical companies and authors of published articles were contacted.\nSelection criteria\nWe included published studies (full reports in a peer reviewed journal) of prospective randomized controlled trials (RCTs) that compared oral celecoxib versus no intervention, placebo or another traditional NSAID (tNSAID) in participants with clinically- or radiologically-confirmed primary OA of the knee or hip, or both knee and hip.\nData collection and analysis\nTwo authors independently performed data extraction, quality assessment, and compared results. Main analyses for patient-reported outcomes of pain and physical function were conducted on studies with low risk of bias for sequence generation, allocation concealment and blinding of participants and personnel.\nMain results\nWe included 36 trials that provided data for 17,206 adults: 9402 participants received celecoxib 200 mg/day, and 7804 were assigned to receive either tNSAIDs (N = 1869) or placebo (N = 5935). Celecoxib was compared with placebo (32 trials), naproxen (6 trials) and diclofenac (3 trials). Studies were published between 1999 and 2014. Studies included participants with knee, hip or both knee and hip OA; mean OA duration was 7.9 years. Most studies included predominantly white participants whose mean age was 62 (± 10) years; most participants were women. There were no concerns about risk of bias for performance and detection bias, but selection bias was poorly reported in most trials. Most trials had high attrition bias, and there was evidence of selective reporting in a third of the studies.\nCelecoxib versus placebo\nCompared with placebo celecoxib slightly reduced pain on a 500-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale, accounting for 3% absolute improvement (95% CI 2% to 5% improvement) or 12% relative improvement (95% CI 7% to 18% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence).\nCompared with placebo celecoxib slightly improved physical function on a 1700-point WOMAC scale, accounting for 4% absolute improvement (95% CI 2% to 6% improvement), 12% relative improvement (95% CI 5% to 19% improvement) (4 studies, 1622 participants). This improvement may not be clinically significant (high quality evidence).\nThere was no evidence of an important difference for withdrawals due to adverse events (Peto OR 0.99, 95% CI 0.85 to 1.15) (moderate quality evidence due to study limitations).\nResults were inconclusive for numbers of participants experiencing any serious AEs (SAEs) (Peto OR 0.95, 95% CI 0.66 to 1.36), gastro-intestinal events (Peto OR 1.91, 95% CI 0.24 to 14.90) and cardiovascular events (Peto OR 3.40, 95% CI 0.73 to 15.88) (very low quality evidence due to serious imprecision and study limitations). However, regulatory agencies have warned of increased cardiovascular events for celecoxib.\nCelecoxib versus tNSAIDs\nThere were inconclusive results regarding the effect on pain between celecoxib and tNSAIDs on a 100-point visual analogue scale (VAS), showing 5% absolute improvement (95% CI 11% improvement to 2% worse), 11% relative improvement (95% CI 26% improvement to 4% worse) (2 studies, 1180 participants, moderate quality evidence due to publication bias).\nCompared to a tNSAID celecoxib slightly improved physical function on a 100-point WOMAC scale, showing 6% absolute improvement (95% CI 6% to 11% improvement) and 16% relative improvement (95% CI 2% to 30% improvement). This improvement may not be clinically significant (low quality evidence due to missing data and few participants) (1 study, 264 participants).\nBased on low or very low quality evidence (downgraded due to missing data, high risk of bias, few events and wide confidence intervals) results were inconclusive for withdrawals due to AEs (Peto OR 0.97, 95% CI 0.74 to 1.27), number of participants experiencing SAEs (Peto OR 0.92, 95% CI 0.66 to 1.28), gastro-intestinal events (Peto OR 0.61, 0.15 to 2.43) and cardiovascular events (Peto OR 0.47, 95% CI 0.17 to 1.25).\nIn comparisons of celecoxib and placebo there were no differences in pooled analyses between our main analysis with low risk of bias and all eligible studies. In comparisons of celecoxib and tNSAIDs, only one outcome showed a difference between studies at low risk of bias and all eligible studies: physical function (6% absolute improvement in low risk of bias, no difference in all eligible studies).\nNo studies included in the main comparisons measured quality of life. Of 36 studies, 34 reported funding by drug manufacturers and in 34 studies one or more study authors were employees of the sponsor.\nAuthors' conclusions\nWe are highly reserved about results due to pharmaceutical industry involvement and limited data. We were unable to obtain data from three studies, which included 15,539 participants, and classified as awaiting assessment. Current evidence indicates that celecoxib is slightly better than placebo and some tNSAIDs in reducing pain and improving physical function. We are uncertain if harms differ among celecoxib and placebo or tNSAIDs due to risk of bias, low quality evidence for many outcomes, and that some study authors and Pfizer declined to provide data from completed studies with large numbers of participants. To fill the evidence gap, we need to access existing data and new, independent clinical trials to investigate benefits and harms of celecoxib versus tNSAIDs for people with osteoarthritis, with longer follow-up and more direct head-to-head comparisons with other tNSAIDs.\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": "Evidence quality was poor and results should be interpreted cautiously. Because it is known that sponsorship by the manufacturing drug company may lead to more favorable results and conclusions than sponsorship from other sources, we are highly reserved about results due to significant drug industry involvement and few data.\nWe were unable to obtain data from three trials which included 15,539 participants (awaiting assessment); Pfizer declined to provide data for two reports that involved 14,042 participants.\nWe need access to all trials results to better understand the benefits and harms of celecoxib and other treatments. New trials researching benefits and harms of celecoxib versus tNSAIDs for people with osteoarthritis, that have longer follow-up periods, more direct comparisons with other tNSAIDs, and funded by non-commercial sources, are needed."
}
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query-laysum | 4678 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pain following mesh-based inguinal hernia repair is frequently reported, and has a significant impact on quality of life. Whether mesh fixation with glue can reduce chronic pain without increasing the recurrence rate is still controversial.\nObjectives\nTo determine whether tissue adhesives can reduce postoperative complications, especially chronic pain, with no increase in recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair.\nSearch methods\nWe searched the following electronic databases with no language restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL; issue 4, 2016) in the Cochrane Library (searched 11 May 2016), MEDLINE Ovid (1986 to 11 May 2016), Embase Ovid (1986 to 11 May 2016), Science Citation Index (Web of Science) (1986 to 11 May 2016), CBM (Chinese Biomedical Database), CNKI (China National Knowledge Infrastructure), VIP (a full-text database in China), Wanfang databases. We also checked reference lists of identified papers (included studies and relevant reviews).\nSelection criteria\nWe included all randomised and quasi-randomised controlled trials comparing glue versus sutures for mesh fixation in Lichtenstein hernia repair. Cluster-RCTs were also eligible.\nData collection and analysis\nTwo review authors extracted data and assessed the risk of bias independently. Dichotomous outcomes were expressed as odds ratio (OR) with 95% confidence intervals (CI). Continuous outcomes were expressed as mean differences (MD) with 95% CIs.\nMain results\nTwelve trials with a total of 1932 participants were included in this review. The overall postoperative chronic pain in the glue group was reduced by 37% (OR 0.63, 95% CI 0.44 to 0.91; 10 studies, 1418 participants, low-quality evidence) compared with the suture group. However, the results changed when we conducted subgroup analysis with regard to the type of mesh. Subgroup analysis of included studies using lightweight mesh showed the reduction of chronic pain was less profound and insignificant (OR 0.77, 95% CI 0.50 to 1.17). Subgroup analysis of included studies using heavyweight mesh resulted in a significant benefit from the fixation with glue (OR 0.38, 95% CI 0.17 to 0.82).\nHernia recurrence was similar between the two groups (OR 1.44, 95% CI 0.63 to 3.28; 12 studies, 1932 participants, low-quality evidence). Fixation with glue was superior to suture regarding duration of the operation (MD −3.13, 95% CI −4.48 to −1.78; 9 studies, 1790 participants, low-quality evidence); haematoma (OR 0.52, 95% CI 0.31 to 0.86; 10 studies, 1384 participants, moderate-quality evidence); and recovery time to daily activities (MD −1.26, 95% CI −1.89 to −0.63; 3 studies, 403 participants, low-quality evidence).\nWe also investigated adverse events. There were no significant differences between the two groups. For superficial wound infection pooled analyses showed OR 1.23, 95% CI 0.37 to 4.11; 7 studies, 763 participants (low-quality evidence); for mesh/deep infection OR 0.67, 95% CI 0.16 to 2.83; 8 studies, 1393 participants (low-quality evidence). Furthermore, we investigated seroma (a postoperative swelling caused by fluid) (OR 0.83, 95% CI 0.51 to 1.33); and persisting numbness (OR 0.81, 95% CI 0.57 to 1.14).\nFinally, six trials involving 1009 participants reported postoperative length of stay, resulting in non-significant difference between the two groups (MD −0.12, 95% CI: −0.35 to 0.10)\nDue to the lack of data, it was impossible to draw any distinction between synthetic glue and biological glue.\nEight out of 12 trials showed high risk of bias in at least one of the investigated domains. Two studies were quasi-randomised controlled trials and the allocation sequence of one trial was not concealed. Nearly half of the included trials either did not provide adequate information or had high risk of bias regarding blinding processes. The risk of bias for incomplete outcome data of all the included studies varied from low to high risk of bias. Two trials did not report on some important outcomes. One study was funded by the manufacturer producing the fibrin sealant. Therefore, according to the 'Summary of findings' tables, the quality of the evidence (GRADE) for the outcomes is moderate to low.\nAuthors' conclusions\nBased on the short-term results, glue may reduce postoperative chronic pain and not simultaneously increase the recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair. Glue may therefore be a sensible alternative to suture for mesh fixation in Lichtenstein repair. Larger trials with longer follow-up and high quality are warranted. The difference between synthetic glue and biological glue should also be assessed in the future.\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 hernia is a weakness of the abdominal wall and allows escape of soft tissue or internal organs. It usually appears as a reducible lump and might cause discomfort and pain, limit daily activities, and affect quality of life. It can be life threatening if the bowel is ischemic or necrotic. Lichtenstein inguinal hernioplasty, which employs a synthetic mesh prosthesis to bridge the defect, is the standard open tension-free repair of inguinal hernia. The recurrence rate of the Lichtenstein technique is acceptable. However, postoperative chronic pain is common and difficult to deal with. Suture is the traditional method for fixation of the mesh, but it may cause irritation or nerve compression which in turn leads to postoperative neuropathic pain. Therefore glue, as a non-traumatic method for mesh fixation, is thought to reduce chronic pain. However, glue fixation might have an effect on the postoperative hernia recurrence rate."
}
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query-laysum | 4679 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is common in young people. It has a marked negative impact and is associated with self-harm and suicide. Preventing its onset would be an important advance in public health. This is an update of a Cochrane review that was last updated in 2011.\nObjectives\nTo determine whether evidence-based psychological interventions (including cognitive behavioural therapy (CBT), interpersonal therapy (IPT) and third wave CBT)) are effective in preventing the onset of depressive disorder in children and adolescents.\nSearch methods\nWe searched the specialised register of the Cochrane Common Mental Disorders Group (CCMDCTR to 11 September 2015), which includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We searched conference abstracts and reference lists of included trials and reviews, and contacted experts in the field.\nSelection criteria\nWe included randomised controlled trials of an evidence-based psychological prevention programme compared with any comparison control for young people aged 5 to 19 years, who did not currently meet diagnostic criteria for depression.\nData collection and analysis\nTwo authors independently assessed trials for inclusion and rated their risk of bias. We adjusted sample sizes to take account of cluster designs and multiple comparisons. We contacted trial authors for additional information where needed. We assessed the quality of evidence for the primary outcomes using GRADE.\nMain results\nWe included 83 trials in this review. The majority of trials (67) were carried out in school settings with eight in colleges or universities, four in clinical settings, three in the community and four in mixed settings. Twenty-nine trials were carried out in unselected populations and 53 in targeted populations.\nFor the primary outcome of depression diagnosis at medium-term follow-up (up to 12 months), there were 32 trials with 5965 participants and the risk of having a diagnosis of depression was reduced for participants receiving an intervention compared to those receiving no intervention (risk difference (RD) -0.03, 95% confidence interval (CI) -0.05 to -0.01; P value = 0.01). We rated this evidence as moderate quality according to the GRADE criteria. There were 70 trials (73 trial arms) with 13,829 participants that contributed to the analysis for the primary outcome of depression symptoms (self-rated) at the post-intervention time point, with results showing a small but statistically significant effect (standardised mean difference (SMD) -0.21, 95% CI -0.27 to -0.15; P value < 0.0001). This effect persisted to the short-term assessment point (up to three months) (SMD -0.31, 95% CI -0.45 to -0.17; P value < 0.0001; 16 studies; 1558 participants) and medium-term (4 to 12 months) assessment point (SMD -0.12, 95% CI -0.18 to -0.05; P value = 0.0002; 53 studies; 11,913 participants); however, the effect was no longer evident at the long-term follow-up. We rated this evidence as low to moderate quality according to the GRADE criteria.\nThe evidence from this review is unclear with regard to whether the type of population modified the overall effects; there was statistically significant moderation of the overall effect for depression symptoms (P value = 0.0002), but not for depressive disorder (P value = 0.08). For trials implemented in universal populations there was no effect for depression diagnosis (RD -0.01, 95% CI -0.03 to 0.01) and a small effect for depression symptoms (SMD -0.11, 95% CI -0.17 to -0.05). For trials implemented in targeted populations there was a statistically significantly beneficial effect of intervention (depression diagnosis RD -0.04, 95% CI -0.07 to -0.01; depression symptoms SMD -0.32, 95% CI -0.42 to -0.23). Of note were the lack of attention placebo-controlled trials in targeted populations (none for depression diagnosis and four for depression symptoms). Among trials implemented in universal populations a number used an attention placebo comparison in which the intervention consistently showed no effect.\nAuthors' conclusions\nOverall the results show small positive benefits of depression prevention, for both the primary outcomes of self-rated depressive symptoms post-intervention and depression diagnosis up to 12 months (but not beyond). Estimates of numbers needed to treat to benefit (NNTB = 11) compare well with other public health interventions. However, the evidence was of moderate to low quality using the GRADE framework and the results were heterogeneous. Prevention programmes delivered to universal populations showed a sobering lack of effect when compared with an attention placebo control. Interventions delivered to targeted populations, particularly those selected on the basis of depression symptoms, had larger effect sizes, but these seldom used an attention placebo comparison and there are practical difficulties inherent in the implementation of targeted programmes. We conclude that there is still not enough evidence to support the implementation of depression prevention programmes.\nFuture research should focus on current gaps in our knowledge. Given the relative lack of evidence for universal interventions compared with attention placebo controls and the poor results from well-conducted effectiveness trials of universal interventions, in our opinion any future such trials should test a depression prevention programme in an indicated targeted population using a credible attention placebo comparison group. Depressive disorder as the primary outcome should be measured over the longer term, as well as clinician-rated depression. Such a trial should consider scalability as well as the potential for the intervention to do harm.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Depressive disorder is common. It is associated with a negative impact on the functioning of young people and is expensive to society at large. Finding a way to prevent the onset of depressive disorder has the potential to make an important impact on the burden of depression in young people."
}
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query-laysum | 4680 | [
{
"role": "user",
"content": "Abstract: Background\nEndophthalmitis is a sight-threatening emergency that requires prompt diagnosis and treatment. The condition is characterised by purulent inflammation of the intraocular fluids caused by an infective agent. In exogenous endophthalmitis, the infective agent is foreign and typically introduced into the eye through intraocular surgery or open globe trauma.\nObjectives\nTo assess the potential role of combined pars plana vitrectomy and intravitreal antibiotics in the acute management of exogenous endophthalmitis, versus the standard of care, defined as vitreous tap and intravitreal antibiotics.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 5); Ovid MEDLINE; Ovid Embase; the International Standard Randomised Controlled Trial Number registry; ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. There were no restrictions to language or year of publication. The date of the search was 5 May 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared pars plana vitrectomy and intravitreal injection of antibiotics versus intravitreal injection of antibiotics alone, for the immediate management of exogenous endophthalmitis.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors independently screened search results and extracted data. We considered the following outcomes: visual acuity improvement and change in visual acuity at three and six months; additional surgical procedures, including vitrectomy and cataract surgery, at any time during follow-up; quality of life and adverse effects. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe identified a single RCT that met our inclusion criteria. The included RCT enrolled a total of 420 participants with clinical evidence of endophthalmitis, within six weeks of cataract surgery or secondary intraocular lens implantation. Participants were randomly assigned according to a 2 x 2 factorial design to either treatment with vitrectomy (VIT) or vitreous tap biopsy (TAP) and to treatment with or without systemic antibiotics. Twenty-four participants did not have a final follow-up: 12 died, five withdrew consent to be followed up, and seven were not willing to return for the visit.\nThe study did not report visual acuity according to the review's predefined outcomes. At three months, 41% of all participants achieved 20/40 or better visual acuity and 69% had 20/100 or better acuity. The study authors reported that there was no statistically significant difference in visual acuity between treatment groups (very low-certainty evidence). There was low-certainty evidence of a similar requirement for additional surgical procedures (risk ratio RR 0.90, 95% confidence interval 0.66 to 1.21). Adverse effects included: VIT group: dislocated intraocular lens (n = 2), macular infarction (n = 1). TAP group: expulsive haemorrhage (n = 1). Quality of life and mean change in visual acuity were not reported.\nAuthors' conclusions\nWe identified a single RCT (published 27 years ago) for the role of early vitrectomy in exogenous endophthalmitis, which suggests that there may be no difference between groups (VIT vs TAP) for visual acuity at three or nine months' follow-up.\nWe are of the opinion that there is a clear need for more randomised studies comparing the role of primary vitrectomy in exogenous endophthalmitis. Moreover, since the original RCT study, there have been incremental changes in the surgical techniques with which vitrectomy is performed. Such advances are likely to influence the outcome of early vitrectomy in exogenous endophthalmitis.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified one randomised control trial (RCT) that studied vitrectomy compared to antibiotic eye injections in endophthalmitis after cataract surgery. The single RCT suggested that vitrectomy had no advantage over standard treatment of intravitreal antibiotics alone."
}
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query-laysum | 4681 | [
{
"role": "user",
"content": "Abstract: Background\nShared decision-making is important in child and adolescent healthcare because there is growing international recognition of children and young people's rights to be included in decisions that affect them. In order for young people to participate effectively in shared decision-making they need to develop the skills of engagement with healthcare professionals and confidence in interacting with them. They also need to learn how to manage their condition and treatments on their own when they move into adulthood. Children and young people who participate in shared decision-making in healthcare are likely to be more informed, feel more prepared, and experience less anxiety about the unknown. Significant improvements in cystic fibrosis (CF) survival over recent decades, due to improved therapies and better management of care, means that young people with CF are routinely transitioning to adult healthcare where increasing emphasis on self-management brings greater complexity in decision-making. We need to know what interventions are effective in promoting shared decision-making for young people with CF.\nObjectives\nTo assess the effectiveness of interventions that promote participation in shared decision-making for children and adolescents (aged between four and 18 years) with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearches of journals and conference abstract books. We also searched the reference lists of articles and reviews addressing shared decision-making.\nDate of most recent search: 12 March 2019.\nWe searched PubMed, CINAHL (EBSCO), Embase (Elsevier), PsycINFO (EBSCO), WHO ICTRP, ASSIA (ProQuest), ERIC (ProQuest), ProQuest Dissertations and Theses, and ClinicalTrials.gov. We contacted study authors with published relevant research in shared decision-making for adults to ask if they were aware of any published or ongoing studies on the promotion of the intervention for children or adolescents (or both) with CF.\nDate of most recent search: 19 March 2019.\nSelection criteria\nWe planned to include randomised controlled trials (RCTs) (but not cross-over RCTs) of interventions promoting shared decision-making for children and adolescents with CF aged between four and 18 years, such as information provision, booklets, two-way interaction, checking understanding (by the participant), preparation to participate in a healthcare decision, decision-aids, and training interventions or educational programs. We planned to include interventions aimed at children or adolescents (or both), parents or healthcare professionals or any combination of these groups provided that the focus was aimed at promoting shared decision-making for children and adolescents with CF.\nData collection and analysis\nTwo authors independently reviewed papers identified in the searches.\nMain results\nNo eligible RCTs were identified for inclusion in this systematic review.\nAuthors' conclusions\nWe were unable to identify RCTs with evidence which would support healthcare policy-making and practice related to implementation of shared decision-making for children and adolescents (aged between four and 18 years) with CF). We hope that having identified this gap in research, awareness will increase amongst researchers of the need to design high-quality shared decision-making interventions for young people with CF, perhaps adapted from existing models for adults, and to test these interventions and children's preferences in RCTs. It is also important to target health professionals with evidence-based education programmes on shared decision-making and a need for international consensus on addressing the variability in education programmes.\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": "We did not find any studies that were eligible to include in the review. We think future research should aim to test models of shared decision-making for young people with cystic fibrosis, which could be developed from existing models for adults; and also work out which methods young people prefer. It is also important to train health professionals in using shared decision-making and make sure that training is consistent across all countries."
}
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query-laysum | 4682 | [
{
"role": "user",
"content": "Abstract: Background\nMinistries of health, donors, and other decision-makers are exploring how they can use mobile technologies to acquire accurate and timely statistics on births and deaths. These stakeholders have called for evidence-based guidance on this topic. This review was carried out to support World Health Organization (WHO) recommendations on digital interventions for health system strengthening.\nObjectives\nPrimary objective: To assess the effects of birth notification and death notification via a mobile device, compared to standard practice.\nSecondary objectives: To describe the range of strategies used to implement birth and death notification via mobile devices and identify factors influencing the implementation of birth and death notification via mobile devices.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, the Global Health Library, and POPLINE (August 2, 2019). We searched two trial registries (August 2, 2019). We also searched Epistemonikos for related systematic reviews and potentially eligible primary studies (August 27, 2019). We conducted a grey literature search using mHealthevidence.org (August 15, 2017) and issued a call for papers through popular digital health communities of practice. Finally, we conducted citation searches of included studies in Web of Science and Google Scholar (May 15, 2020). We searched for studies published after 2000 in any language.\nSelection criteria\nFor the primary objective, we included individual and cluster-randomised trials; cross-over and stepped-wedge study designs; controlled before-after studies, provided they have at least two intervention sites and two control sites; and interrupted time series studies. For the secondary objectives, we included any study design, either quantitative, qualitative, or descriptive, that aimed to describe current strategies for birth and death notification via mobile devices; or to explore factors that influence the implementation of these strategies, including studies of acceptability or feasibility.\nFor the primary objective, we included studies that compared birth and death notification via mobile devices with standard practice. For the secondary objectives, we included studies of birth and death notification via mobile device as long as we could extract data relevant to our secondary objectives.\nWe included studies of all cadres of healthcare providers, including lay health workers; administrative, managerial, and supervisory staff; focal individuals at the village or community level; children whose births were being notified and their parents/caregivers; and individuals whose deaths were being notified and their relatives/caregivers.\nData collection and analysis\nFor the primary objective, two authors independently screened all records, extracted data from the included studies and assessed risk of bias. For the analyses of the primary objective, we reported means and proportions, where appropriate. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence and we prepared a 'Summary of Findings' table.\nFor the secondary objectives, two authors screened all records, one author extracted data from the included studies and assessed methodological limitations using the WEIRD tool and a second author checked the data and assessments. We carried out a framework analysis using the Supporting the Use of Research Evidence (SURE) framework to identify themes in the data. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in the evidence and we prepared a 'Summary of Qualitative Findings' table.\nMain results\nFor the primary objective, we included one study, which used a controlled before-after study design. The study was conducted in Lao People’s Democratic Republic and assessed the effect of using mobile devices for birth notification on outcomes related to coverage and timeliness of Hepatitis B vaccination. However, we are uncertain of the effect of this approach on these outcomes because the certainty of this evidence was assessed as very low. The included study did not assess resource use or unintended consequences. For the primary objective, we did not identify any studies using mobile devices for death notification.\nFor the secondary objective, we included 21 studies. All studies were conducted in low- or middle-income settings. They focussed on identification of births and deaths in rural, remote, or marginalised populations who are typically under-represented in civil registration processes or traditionally seen as having poor access to health services.\nThe review identified several factors that could influence the implementation of birth-death notification via mobile device. These factors were tied to the health system, the person responsible for notifying, the community and families; and include:\n- Geographic barriers that could prevent people’s access to birth-death notification and post-notification services\n- Access to health workers and other notifiers with enough training, supervision, support, and incentives\n- Monitoring systems that ensure the quality and timeliness of the birth and death data\n- Legal frameworks that allow births and deaths to be notified by mobile device and by different types of notifiers\n- Community awareness of the need to register births and deaths\n- Socio-cultural norms around birth and death\n- Government commitment\n- Cost to the system, to health workers and to families\n- Access to electricity and network connectivity, and compatibility with existing systems\n- Systems that protect data confidentiality\nWe have low to moderate confidence in these findings. This was mainly because of concerns about methodological limitations and data adequacy.\nAuthors' conclusions\nWe need more, well-designed studies of the effect of birth and death notification via mobile devices and on factors that may influence its implementation.\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 August 2, 2019."
}
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query-laysum | 4683 | [
{
"role": "user",
"content": "Abstract: Background\nOperations on structures in the chest (usually the lungs) involve cutting between the ribs (thoracotomy). Severe post-thoracotomy pain can result from pleural (lung lining) and muscular damage, costovertebral joint (ribcage) disruption and intercostal nerve (nerves that run along the ribs) damage during surgery. Poor pain relief after surgery can impede recovery and increase the risks of developing complications such as lung collapse, chest infections and blood clots due to ineffective breathing and clearing of secretions. Effective management of acute pain following thoracotomy may prevent these complications and reduce the likelihood of developing chronic pain. A multi-modal approach to analgesia is widely employed by thoracic anaesthetists using a combination of regional anaesthetic blockade and systemic analgesia, with both non-opioid and opioid medications and local anaesthesia blockade.\nThere is some evidence that blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may be associated with a lower risk of major complications in thoracic surgery but the majority of thoracic anaesthetists still prefer to use a thoracic epidural blockade (TEB) as analgesia for their patients undergoing thoracotomy. In order to bring about a change in practice, anaesthetists need a review that evaluates the risk of all major complications associated with thoracic epidural and paravertebral block in thoracotomy.\nObjectives\nTo compare the two regional techniques of TEB and PVB in adults undergoing elective thoracotomy with respect to:\n1. analgesic efficacy;\n2. the incidence of major complications (including mortality);\n3. the incidence of minor complications;\n4. length of hospital stay;\n5. cost effectiveness.\nSearch methods\nWe searched for studies in the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 9); MEDLINE via Ovid (1966 to 16 October 2013); EMBASE via Ovid (1980 to 16 October 2013); CINAHL via EBSCO host (1982 to 16 October 2013); and reference lists of retrieved studies. We handsearched the Journal of Cardiothoracic Surgery and Journal of Cardiothoracic and Vascular Anesthesia (16 October 2013). We reran the search on 31st January 2015. We found one additional study which is awaiting classification and will be addressed when we update the review.\nSelection criteria\nWe included all randomized controlled trials (RCTs) comparing PVB with TEB in thoracotomy, including upper gastrointestinal surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors (JY and SG) independently assessed the studies for inclusion and then extracted data as eligible for inclusion in qualitative and quantitative synthesis (meta-analysis).\nMain results\nWe included 14 studies with a total of 698 participants undergoing thoracotomy. There are two studies awaiting classification. The studies demonstrated high heterogeneity in insertion and use of both regional techniques, reflecting real-world differences in the anaesthesia techniques. Overall, the included studies have a moderate to high potential for bias, lacking details of randomization, group allocation concealment or arrangements to blind participants or outcome assessors. There was low to very low-quality evidence that showed no significant difference in 30-day mortality (2 studies, 125 participants. risk ratio (RR) 1.28, 95% confidence interval (CI) 0.39 to 4.23, P value = 0.68) and major complications (cardiovascular: 2 studies, 114 participants. Hypotension RR 0.30, 95% CI 0.01 to 6.62, P value = 0.45; arrhythmias RR 0.36, 95% CI 0.04 to 3.29, P value = 0.36, myocardial infarction RR 3.19, 95% CI 0.13, 76.42, P value = 0.47); respiratory: 5 studies, 280 participants. RR 0.62, 95% CI 0.26 to 1.52, P value = 0.30). There was moderate-quality evidence that showed comparable analgesic efficacy across all time points both at rest and after coughing or physiotherapy (14 studies, 698 participants). There was moderate-quality evidence that showed PVB had a better minor complication profile than TEB including hypotension (8 studies, 445 participants. RR 0.16, 95% CI 0.07 to 0.38, P value < 0.0001), nausea and vomiting (6 studies, 345 participants. RR 0.48, 95% CI 0.30 to 0.75, P value = 0.001), pruritis (5 studies, 249 participants. RR 0.29, 95% CI 0.14 to 0.59, P value = 0.0005) and urinary retention (5 studies, 258 participants. RR 0.22, 95% CI 0.11 to 0.46, P value < 0.0001). There was insufficient data in chronic pain (six or 12 months). There was no difference found in and length of hospital stay (3 studies, 124 participants). We found no studies that reported costs.\nAuthors' conclusions\nParavertebral blockade reduced the risks of developing minor complications compared to thoracic epidural blockade. Paravertebral blockade was as effective as thoracic epidural blockade in controlling acute pain. There was a lack of evidence in other outcomes. There was no difference in 30-day mortality, major complications, or length of hospital stay. There was insufficient data on chronic pain and costs. Results from this review should be interpreted with caution due to the heterogeneity of the included studies and the lack of reliable evidence. Future studies in this area need well-conducted, adequately-powered RCTs that focus not only on acute pain but also on major complications, chronic pain, length of stay and costs.\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": "We found no difference between PVB and TEB in terms of death at 30 days and major complications. PVB appeared to be as effective as TEB in pain control post-surgery. TEB was associated with minor complications such as low blood pressure, nausea and vomiting, itching and urinary retention when compared to PVB. We did not find any difference in length of hospital stay between PVB and TEB. There was insufficient information to assess chronic pain and health costs."
}
]
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query-laysum | 4684 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin A deficiency is a significant public health problem in low- and middle-income countries. Vitamin A supplementation provided to infants less than six months of age is one of the strategies to improve the nutrition of infants at high risk of vitamin A deficiency and thus potentially reduce their mortality and morbidity.\nObjectives\nTo evaluate the effect of synthetic vitamin A supplementation in infants one to six months of age in low- and middle-income countries, irrespective of maternal antenatal or postnatal vitamin A supplementation status, on mortality, morbidity and adverse effects.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 2), MEDLINE via PubMed (1966 to 5 March 2016), Embase (1980 to 5 March 2016) and CINAHL (1982 to 5 March 2016). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised, individually or cluster randomised trials involving synthetic vitamin A supplementation compared to placebo or no intervention provided to infants one to six months of age were eligible.\nData collection and analysis\nTwo review authors assessed the studies for eligibility and assessed their risk of bias and collected data on outcomes.\nMain results\nThe review included 12 studies (reported in 22 publications). The included studies assigned 24,846 participants aged one to six months to vitamin A supplementation or control group. There was no effect of vitamin A supplementation for the primary outcome of all-cause mortality based on seven studies that included 21,339 (85%) participants (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.89 to 1.25; I2 = 0%; test for heterogeneity: P = 0.79; quality of evidence: moderate). Also, there was no effect of vitamin A supplementation on mortality or morbidity due to diarrhoea and respiratory tract infection. There was an increased risk of bulging fontanelle within 24 to 72 hours of supplementation in the vitamin A group compared to control (RR 3.10, 95% CI 1.89 to 5.09; I2 = 9%, test for heterogeneity: P = 0.36; quality of evidence: high). There was no reported subsequent increased risk of death, convulsions or irritability in infants who developed bulging fontanelle after vitamin A supplementation, and it resolved in most cases within 72 hours. There was no increased risk of other adverse effects such as vomiting, irritability, diarrhoea, fever and convulsions in the vitamin A supplementation group compared to control. Vitamin A supplementation did not have any statistically significant effect on vitamin A deficiency (RR 0.86, 95% CI 0.70 to 1.06; I2 = 27%; test for heterogeneity: P = 0.25; quality of evidence: moderate).\nAuthors' conclusions\nThere is no convincing evidence that vitamin A supplementation for infants one to six months of age results in a reduction in infant mortality or morbidity in low- and middle-income countries. There is an increased risk of bulging fontanelle with vitamin A supplementation in this age group; however, there were no reported subsequent complications because of this adverse effect.\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": "Vitamin A deficiency is a significant public health problem in low- and middle-income countries. Vitamin A supplementation given to children between the ages of six months and five years reduces deaths in these settings. This review focused on babies one to six months of age."
}
]
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query-laysum | 4685 | [
{
"role": "user",
"content": "Abstract: Background\nAcute ischemic stroke (AIS) is the abrupt reduction of blood flow to a certain area of the brain which causes neurologic dysfunction. Different types of percutaneous arterial endovascular interventions have been developed, but as yet there is no consensus on the optimal therapy for people with AIS.\nObjectives\nTo compare the safety and efficacy of different types of percutaneous arterial endovascular interventions for treating people with AIS.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4 of 12, 2022), MEDLINE Ovid (1946 to 13 May 2022), Embase (1947 to 15 May 2022), Science Citation Index Web of Science (1900 to 15 May 2022), Scopus (1960 to 15 May 2022), and China Biological Medicine Database (CBM; 1978 to 16 May 2022). We also searched the ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 16 May 2022.\nSelection criteria\nRandomized controlled trials (RCTs) comparing one percutaneous arterial endovascular intervention with another in treating adult patients who have a clinical diagnosis of AIS due to large vessel occlusion and confirmed by imaging evidence, including thrombo-aspiration, stent-retrieval thrombectomy, aspiration-retriever combined technique, and thrombus mechanical fragmentation.\nData collection and analysis\nTwo review authors independently performed the literature searches, identified eligible trials, and extracted data. A third review author participated in discussions to reach consensus decisions when any disputes occurred. We assessed risk of bias and applied the GRADE approach to evaluate the quality of the evidence. The primary outcome was rate of modified Rankin Scale (mRS) of 0 to 2 at three months. Secondary outcomes included the rate of modified Thrombolysis In Cerebral Infarction (mTICI) of 2b to 3 postprocedure, all-cause mortality within three months, rate of intracranial hemorrhage on imaging at 24 hours, rate of symptomatic intracranial hemorrhage at 24 hours, and rate of procedure-related adverse events within three months.\nMain results\nFour RCTs were eligible. The current meta-analysis included two trials with 651 participants comparing thrombo-aspiration with stent-retrieval thrombectomy. We judged the quality of evidence to be high in both trials according to Cochrane's risk of bias tool RoB 2.\nThere were no significant differences between thrombo-aspiration and stent-retrieval thrombectomy in rate of mRS of 0 to 2 at three months (risk ratio [RR] 0.97, 95% confidence interval [CI] 0.82 to 1.13; P = 0.68; 633 participants; 2 RCTs); rate of mTICI of 2b to 3 postprocedure (RR 1.01, 95% CI 0.95 to 1.07; P = 0.77; 650 participants; 2 RCTs); all-cause mortality within three months (RR 1.01, 95% CI 0.74 to 1.37; P = 0.95; 633 participants; 2 RCTs); rate of intracranial hemorrhage on imaging at 24 hours (RR 1.03, 95% CI 0.86 to 1.24; P = 0.73; 645 participants; 2 RCTs); rate of symptomatic intracranial hemorrhage at 24 hours (RR 0.90, 95% CI 0.49 to 1.68; P = 0.75; 645 participants; 2 RCTs); and rate of procedure-related adverse events within three months (RR 0.98, 95% CI 0.68 to 1.41; P = 0.90; 651 participants; 2 RCTs).\nAnother two included studies reported no differences for the comparisons of combined therapy versus stent-retrieval thrombectomy or thrombo-aspiration. One RCT is ongoing.\nAuthors' conclusions\nThis review did not establish any difference in safety and effectiveness between the thrombo-aspiration approach and stent-retrieval thrombectomy for treating people with AIS. Furthermore, the combined group did not show any obvious advantage over either intervention applied alone.\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 evidence in the review was high, although the doctors and participants knew which treatment was being given, which could have led to bias."
}
]
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query-laysum | 4686 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom in people with cancer; 30% to 50% of people with cancer will experience moderate-to-severe pain. This can have a major negative impact on their quality of life. Opioid (morphine-like) medications are commonly used to treat moderate or severe cancer pain, and are recommended for this purpose in the World Health Organization (WHO) pain treatment ladder. Pain is not sufficiently relieved by opioid medications in 10% to 15% of people with cancer. In people with insufficient relief of cancer pain, new analgesics are needed to effectively and safely supplement or replace opioids.\nObjectives\nTo evaluate the benefits and harms of cannabis-based medicines, including medical cannabis, for treating pain and other symptoms in adults with cancer compared to placebo or any other established analgesic for cancer pain.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 26 January 2023.\nSelection criteria\nWe selected double-blind randomised, controlled trials (RCT) of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment for cancer pain in adults, with any treatment duration and at least 10 participants per treatment arm.\nData collection and analysis\nWe used standard Cochrane methods. The primary outcomes were 1. proportions of participants reporting no worse than mild pain; 2. Patient Global Impression of Change (PGIC) of much improved or very much improved and 3. withdrawals due to adverse events. Secondary outcomes were 4. number of participants who reported pain relief of 30% or greater and overall opioid use reduced or stable; 5. number of participants who reported pain relief of 30% or greater, or 50% or greater; 6. pain intensity; 7. sleep problems; 8. depression and anxiety; 9. daily maintenance and breakthrough opioid dosage; 10. dropouts due to lack of efficacy; 11. all central nervous system adverse events. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified 14 studies involving 1823 participants. No study assessed the proportions of participants reporting no worse than mild pain on treatment by 14 days after start of treatment.\nWe found five RCTs assessing oromucosal nabiximols (tetrahydrocannabinol (THC) and cannabidiol (CBD)) or THC alone involving 1539 participants with moderate or severe pain despite opioid therapy. The double-blind periods of the RCTs ranged between two and five weeks. Four studies with a parallel design and 1333 participants were available for meta-analysis.\nThere was moderate-certainty evidence that there was no clinically relevant benefit for proportions of PGIC much or very much improved (risk difference (RD) 0.06, 95% confidence interval (CI) 0.01 to 0.12; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 8 to 100). There was moderate-certainty evidence for no clinically relevant difference in the proportion of withdrawals due to adverse events (RD 0.04, 95% CI 0 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 16 to endless). There was moderate-certainty evidence for no difference between nabiximols or THC and placebo in the frequency of serious adverse events (RD 0.02, 95% CI −0.03 to 0.07). There was moderate-certainty evidence that nabiximols and THC used as add-on treatment for opioid-refractory cancer pain did not differ from placebo in reducing mean pain intensity (standardised mean difference (SMD) −0.19, 95% CI −0.40 to 0.02).\nThere was low-certainty evidence that a synthetic THC analogue (nabilone) delivered over eight weeks was not superior to placebo in reducing pain associated with chemotherapy or radiochemotherapy in people with head and neck cancer and non-small cell lung cancer (2 studies, 89 participants, qualitative analysis). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that synthetic THC analogues were superior to placebo (SMD −0.98, 95% CI −1.36 to −0.60), but not superior to low-dose codeine (SMD 0.03, 95% CI −0.25 to 0.32; 5 single-dose trials; 126 participants) in reducing moderate-to-severe cancer pain after cessation of previous analgesic treatment for three to four and a half hours (2 single-dose trials; 66 participants). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that CBD oil did not add value to specialist palliative care alone in the reduction of pain intensity in people with advanced cancer. There was no difference in the number of dropouts due to adverse events and serious adverse events (1 study, 144 participants, qualitative analysis).\nWe found no studies using herbal cannabis.\nAuthors' conclusions\nThere is moderate-certainty evidence that oromucosal nabiximols and THC are ineffective in relieving moderate-to-severe opioid-refractory cancer pain. There is low-certainty evidence that nabilone is ineffective in reducing pain associated with (radio-) chemotherapy in people with head and neck cancer and non-small cell lung cancer. There is low-certainty evidence that a single dose of synthetic THC analogues is not superior to a single low-dose morphine equivalent in reducing moderate-to-severe cancer pain. There is low-certainty evidence that CBD does not add value to specialist palliative care alone in the reduction of pain in people with advanced cancer.\n\nGiven the provided abstract, please respond to the following query: \"Pain in cancer and its treatment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One person in two or three who gets cancer will have pain that becomes moderate or severe in intensity. The pain tends to get worse as the cancer progresses.\nThe WHO recommends taking morphine-like medicines for moderate-to-severe pain from cancer, but 1 in 6 to 10 people with cancer pain do not experience sufficient pain relief from morphine-like medicines. Several products based on the cannabis plant have been suggested as treatment for cancer pain. These products include inhaled or orally ingested herbal cannabis, and various oils, sprays or tablets containing active cannabis ingredients obtained from the plant, or made synthetically. Some people with cancer pain have reported that CbMs are effective for them, and that is often highlighted in the media."
}
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query-laysum | 4687 | [
{
"role": "user",
"content": "Abstract: Background\nThere is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment).\nObjectives\nTo evaluate the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two trials registers up to 15 August 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review included five RCTs with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events.\nMcKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention - main comparison)\nThere is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.30, 95% CI -12.04 to -2.56; 2 trials, 328 participants) but not in the intermediate term (MD -5.00, 95% CI -14.29 to 4.29; 1 trial, 180 participants).\nThere is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.74, 95% CI -7.52 to 2.04; 2 trials, 328 participants) nor in the intermediate term (MD -0.87, 95% CI -7.31 to 5.57; 1 trial, 180 participants).\nMcKenzie method versus manual therapy\nThere is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.67, 95% CI -27.37 to 10.02; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.00, 95% CI 0.70 to 13.30; 1 trial, 235 participants).\nThere is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -4.98, 95% CI -15.00 to 5.04; 3 trials, 298 participants) nor in the intermediate term (MD 4.30, 95% CI -0.72 to 9.32; 1 trial, 235 participants).\nMcKenzie method versus other interventions (massage and advice)\nThere is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.00, 95% CI -15.44 to 23.44; 1 trial, 30 participants) nor in the intermediate term (MD 10.00, 95% CI -8.95 to 28.95; 1 trial, 25 participants).\nAuthors' conclusions\nBased on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.\n\nGiven the provided abstract, please respond to the following query: \"What is the McKenzie method?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The McKenzie method is a treatment applied by trained healthcare providers (typically physiotherapists) for the care of people with NSLBP. It comprises an individualized program of exercises based on clinical clues (changes in pain location or restricted movement), observed during the assessment. It also includes the teaching of postures and home exercises to encourage people to control their symptoms by themselves."
}
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query-laysum | 4688 | [
{
"role": "user",
"content": "Abstract: Background\nDietary supplements are frequently used for the treatment of several medical conditions, both prescribed by physicians or self administered. However, evidence of benefit and safety of these supplements is usually limited or absent.\nObjectives\nTo assess the efficacy and safety of dietary supplementation for people with chronic gout.\nSearch methods\nWe updated the original search by searching CENTRAL, MEDLINE, Embase, CINAHL, and four trials registers (August 2020). We applied no date or language restrictions. We also handsearched the abstracts from the 2010 to 2019 American College of Rheumatology and European League against Rheumatism conferences, and checked the references of all included studies.\nSelection criteria\nWe considered all published randomised controlled trials (RCTs) or quasi-RCTs that compared dietary supplements with no supplements, placebo, another supplement, or pharmacological agents for adults with chronic gout for inclusion. Dietary supplements included, but were not limited to, amino acids, antioxidants, essential minerals, polyunsaturated fatty acids, prebiotic agents, probiotic agents, and vitamins. The major outcomes were acute gout flares, study withdrawal due to adverse events (AEs), serum uric acid (sUA) reduction, joint pain reduction, participant global assessment, total number of AEs, and tophus regression.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nTwo previously included RCTs (160 participants) met our inclusion criteria; we did not identify any new trials for this update. As these two trials evaluated different diet supplements (enriched skim milk powder (SMP) and vitamin C) with different outcomes (gout flare prevention for enriched SMP, and sUA reduction for vitamin C), we reported the results separately.\nOne trial (120 participants), at unclear risk of selection and detection bias, compared SMP enriched with glycomacropeptides (GMP) with un-enriched SMP, and with lactose, over three months. Participants were predominantly men, aged in their 50s, who had severe gout. The results for all major outcomes were imprecise, except for pain. None of the results were clinically significant.\nThe frequency of acute gout attacks, measured as the number of flares per month, decreased in all three groups over the three-month study period. The effects of enriched SMP (SMP/GMP/G600) compared with the combined control groups (SMP and lactose powder) at three months in terms of mean number of gout flares per month were not clinically significant (mean (standard deviation (SD)) flares per month: 0.49 (1.52) in SMP/GMP/G600 group versus 0.70 (1.28) in the control groups; absolute risk difference: mean difference (MD) -0.21 flares per month, 95% confidence interval (CI) -0.76 to 0.34; low-quality evidence).\nThe number of withdrawals due to adverse effects was similar between groups (7/40 in SMP/GMP/G600 group versus 11/80 in control groups; (risk ratio (RR) 1.27, 95% CI 0.53 to 3.03); there were 4% more withdrawals in the SMP/lactose groups (10% fewer to 18% more; low-quality evidence).\nSerum uric acid reduction was similar across groups (mean (SD) -0.025 (0.067) mmol/L in SMP/GMP/G600 group versus -0.010 (0.069) in control groups; MD -0.01, 95% CI -0.04 to 0.01; low-quality evidence).\nPain from self-reported gout flares (measured on a 10-point Likert scale) improved slightly more in the GMP/G600 SMP group compared with controls (mean (SD) -1.97 (2.28) in SMP/GMP/G600 group versus -0.94 (2.25) in control groups; MD -1.03, 95% CI -1.89 to -0.17). This was an absolute reduction of 10% (95% CI 20% to 1% reduction; low-quality evidence), which may not be of clinical relevance.\nThe risk of adverse events was similar between groups (19/40 in SMP/GMP/G600 group versus 39/80 in control groups; RR 0.97, 95% CI 0.66 to 1.45); the absolute risk difference was 1% fewer adverse events (1% fewer to 2% more), low-quality evidence). Gastrointestinal events such as nausea, flatulence and diarrhoea were the most commonly reported adverse effects.\nData for participant global assessment were not available for analysis; the study did not report tophus regression.\nOne trial (40 participants), at high risk of selection, performance, and detection bias, compared vitamin C alone with allopurinol, and with allopurinol plus vitamin C, in a three-arm study. We only included data from the vitamin C versus allopurinol comparison in this review. Participants were predominantly middle-aged men, and their severity of gout was representative of gout in general.\nAllopurinol reduced sUA levels more than vitamin C (MD 0.10 mmol/L, 95% CI 0.06 to 0.15), low-quality evidence. The study reported no adverse events; none of the participants withdrew due to adverse events.\nThe study did not assess the rate of gout attacks, joint pain reduction, participant global assessment, or tophus regression.\nAuthors' conclusions\nWhile dietary supplements may be widely used for gout, this review found no high-quality that supported or refuted the use of glycomacropeptide-enriched skim milk powder or vitamin C for adults with chronic gout.\n\nGiven the provided abstract, please respond to the following query: \"Key results – what happens to people with gout who take vitamin C?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Serum uric acid levels\n- People who took vitamin C showed a reduction in serum uric acid levels of 0.014 mmol/L after eight weeks (or 2.8% reduction)\n- People who took allopurinol showed a reduction in serum uric acid levels of 0.118 mmol/L after eight weeks (or 23.6% reduction).\nThere were no reports of side effects or withdrawals due to side effects in either treatment group.\nEffects of vitamin C on gout attacks, pain reduction, overall assessment by participants, and tophus disappearance were not measured."
}
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query-laysum | 4689 | [
{
"role": "user",
"content": "Abstract: Background\nPulmonary embolism (PE) is a potentially life-threatening condition in which a clot can migrate from the deep veins, most commonly in the leg, to the lungs. Conventional treatment of PE used unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux, and vitamin K antagonists (VKAs). Recently, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors. DOACs have characteristics that may be favourable to conventional treatment, including oral administration, a predictable effect, no need for frequent monitoring or re-dosing, and few known drug interactions. This review reports the efficacy and safety of these drugs in the long-term treatment of PE (minimum duration of three months). This is an update of a Cochrane Review first published in 2015.\nObjectives\nTo assess the efficacy and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of PE.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 2 March 2022. We checked the reference lists of relevant articles for additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which people with a PE confirmed by standard imaging techniques were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with a conventional anticoagulant or compared with each other for the long-term treatment of PE (minimum duration three months).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent PE, recurrent venous thromboembolism (VTE), and deep vein thrombosis (DVT). Secondary outcomes were all-cause mortality, major bleeding, and health-related quality of life. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified five additional RCTs with 1484 participants for this update. Together with the previously included trials, we have included ten RCTs with a total of 13,073 participants. Two studies investigated an oral DTI (dabigatran) and eight studies investigated oral factor Xa inhibitors (three rivaroxaban, three apixaban, and two edoxaban). The studies were of good methodological quality overall.\nMeta-analysis showed no clear difference in the efficacy and safety of oral DTI compared with conventional anticoagulation in preventing recurrent PE (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.50 to 2.04; 2 studies, 1602 participants; moderate-certainty evidence), recurrent VTE (OR 0.93, 95% CI 0.52 to 1.66; 2 studies, 1602 participants; moderate-certainty evidence), DVT (OR 0.79, 95% CI 0.29 to 2.13; 2 studies, 1602 participants; moderate-certainty evidence), and major bleeding (OR 0.50, 95% CI 0.15 to 1.68; 2 studies, 1527 participants; moderate-certainty evidence). We downgraded the certainty of evidence by one level for imprecision due to the low number of events.\nThere was also no clear difference between the oral factor Xa inhibitors and conventional anticoagulation in the prevention of recurrent PE (OR 0.92, 95% CI 0.66 to 1.29; 3 studies, 8186 participants; moderate-certainty evidence), recurrent VTE (OR 0.83, 95% CI 0.66 to 1.03; 8 studies, 11,416 participants; moderate-certainty evidence), DVT (OR 0.77, 95% CI 0.48 to 1.25; 2 studies, 8151 participants; moderate-certainty evidence), all-cause mortality (OR 1.16, 95% CI 0.79 to 1.70; 1 study, 4817 participants; moderate-certainty evidence) and major bleeding (OR 0.71, 95% CI 0.36 to 1.41; 8 studies, 11,447 participants; low-certainty evidence); the heterogeneity for major bleeding was significant (I2 = 79%). We downgraded the certainty of the evidence to moderate and low because of imprecision due to the low number of events and inconsistency due to clinical heterogeneity. None of the included studies measured health-related quality of life.\nAuthors' conclusions\nAvailable evidence shows there is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent PE, recurrent VTE, DVT, all-cause mortality, and major bleeding. The certainty of evidence was moderate or low. Future large clinical trials are required to identify if individual drugs differ in effectiveness and bleeding risk, and to explore effect differences in subgroups, including people with cancer and obesity.\n\nGiven the provided abstract, please respond to the following query: \"What is a pulmonary embolism?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A pulmonary embolism occurs when a piece of blood clot breaks off from a clot somewhere else in the body and travels in the blood to the lungs. This can be life-threatening and occurs in approximately 4 to 12 per 10,000 people. The chances of getting a pulmonary embolism can increase with risk factors, including previous clots, prolonged periods of immobility (such as travelling on aeroplanes or taking bed rest), cancer, exposure to oestrogens (pregnancy, oral contraceptives, or hormone replacement therapy), blood disorders (thrombophilia), and trauma."
}
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query-laysum | 4690 | [
{
"role": "user",
"content": "Abstract: Background\nThis review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 6, 2015).\nFailure to respond to antiepileptic drugs in patients with uncontrolled seizure activity such as refractory status epilepticus (RSE) has led to the use of anaesthetic drugs. Coma is induced with anaesthetic drugs to achieve complete control of seizure activity. Thiopental sodium and propofol are popularly used for this purpose. Both agents have been found to be effective. However, there is a substantial lack of evidence as to which of the two drugs is better in terms of clinical outcomes.\nObjectives\nTo compare the efficacy, adverse effects, and short- and long-term outcomes of refractory status epilepticus (RSE) treated with one of the two anaesthetic agents, thiopental sodium or propofol.\nSearch methods\nWe searched the Cochrane Epilepsy Group Specialized Register (16 August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 16 August 2016), MEDLINE (Ovid, 1946 to 16 August 2016), ClinicalTrials.gov (16 August 2016), and the South Asian Database of Controlled Clinical Trials (16 August 2016). Previously we searched IndMED, but this was not accessible at the time of the latest update.\nSelection criteria\nAll randomised controlled trials (RCTs) or quasi-RCTs (regardless of blinding) assessing the control of RSE using either thiopental sodium or propofol in patients of any age and gender.\nData collection and analysis\nTwo review authors screened the search results and reviewed the abstracts of relevant and eligible trials before retrieving the full-text publications.\nMain results\nOne study with a total of 24 participants was available for review. This study was a small, single-blind, multicentre trial studying adults with RSE receiving either propofol or thiopental sodium for the control of seizure activity. This study was terminated early due to recruitment problems. For our primary outcome of total control of seizures after the first course of study drug, there were 6/14 patients versus 2/7 patients in the propofol and thiopental sodium groups, respectively (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.40 to 5.61, low quality evidence). Mortality was seen in 3/14 patients versus 1/7 patients in the propofol and thiopental sodium groups, respectively (RR 1.50, 95% CI 0.19 to 11.93, low quality evidence). Our third primary outcome of length of ICU stay was not reported. For our secondary outcomes of adverse events, infection was seen in 7/14 patients versus 5/7 patients in the propofol and thiopental sodium groups, respectively (RR 0.70; 95% CI 0.35 to 1.41). Hypotension during administration of study drugs and requiring use of vasopressors was seen in 7/14 patients versus 4/7 patients in the propofol and thiopental sodium groups, respectively (RR 0.87; 95% CI 0.38 to 2.00). The other severe complication noted was non-fatal propofol infusion syndrome in one patient. Patients receiving thiopental sodium required more days of mechanical ventilation when compared with patients receiving propofol: (median (range) 17 days (5 to 70 days) with thiopental sodium versus four days (2 to 28 days) with propofol). At three months there was no evidence of a difference between the drugs with respect to outcome measures such as control of seizure activity and functional outcome.\nAuthors' conclusions\nSince the last version of this review we have found no new studies.\nThere is a lack of robust, randomised, controlled evidence to clarify the efficacy of propofol and thiopental sodium compared to each other in the treatment of RSE. There is a need for large RCTs for this serious condition.\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 this review we evaluated the evidence for the use of these anaesthetic drugs in controlling seizure activity in patients with RSE."
}
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query-laysum | 4691 | [
{
"role": "user",
"content": "Abstract: Background\nLeg ulcers are chronic wounds of the lower leg, caused by poor blood flow, that can take a long time to heal. The pooling of blood in the veins can damage the skin and surrounding tissues, causing an ulcer to form. Venous leg ulcers are associated with impaired quality of life, reduced mobility, pain, stress and loss of dignity. The standard treatment for venous leg ulcers is compression bandages or stockings. Shock wave therapy may aid the healing of these wounds through the promotion of angiogenesis (the formation and development of blood vessels) and reduction of inflammation, though this process is poorly understood at present.\nObjectives\nTo assess the effects of extracorporeal shock wave therapy on the healing and management of venous leg ulceration.\nSearch methods\nIn April 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. We applied no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe considered all published and unpublished randomised controlled trials (RCTs) assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration.\nData collection and analysis\nTwo review authors independently performed study selection. We planned that two review authors would also assess the risk of bias of included studies, extract study data and rate the certainty of the evidence using GRADE.\nMain results\nWe found no RCTs that met the inclusion criteria for this review.\nAuthors' conclusions\nWe found no RCTs assessing the effectiveness of extracorporeal shock wave therapy in the healing and management of venous leg ulceration. The lack of high-quality evidence in this area highlights a gap in research and may serve to justify the need for further research and evidence to provide guidance concerning the use of this treatment option for this condition. Future trials should be of clear design and include concomitant use of the current best practice treatment, multilayer compression therapy. Recruitment should aspire to best represent patients seen in clinical practice and patient-related outcome measures should be included in study design.\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 April 2018."
}
]
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query-laysum | 4692 | [
{
"role": "user",
"content": "Abstract: Background\nIllicit drug use in pregnancy is a complex social and public health problem. The consequences of drug use in pregnancy are high for both the woman and her child. Therefore, it is important to develop and evaluate effective treatments. There is evidence for the effectiveness of psychosocial interventions in drug treatment but it is unclear whether they are effective in pregnant women. This is an update of a Cochrane review originally published in 2007.\nObjectives\nTo evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in illicit drug treatment programmes on birth and neonatal outcomes, on attendance and retention in treatment, as well as on maternal and neonatal drug abstinence. In short, do psychosocial interventions translate into less illicit drug use, greater abstinence, better birth outcomes, or greater clinic attendance?\nSearch methods\nWe conducted the original literature search in May 2006 and performed the search update up to January 2015. For both review stages (original and update), we searched the Cochrane Drugs and Alcohol Group Trial's register (May 2006 and January 2015); the Cochrane Central Register of Trials (CENTRAL; the Cochrane Library 2015, Issue 1); PubMed (1996 to January 2015); EMBASE (1996 to January 2015); and CINAHL (1982 to January 2015).\nSelection criteria\nWe included randomized controlled trials comparing any psychosocial intervention vs. a control intervention that could include pharmacological treatment, such as methadone maintenance, a different psychosocial intervention, counselling, prenatal care, STD counselling and testing, transportation, or childcare.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane Collaboration. We performed analyses based on three comparisons: any psychosocial intervention vs. control, contingency management (CM) interventions vs. control, and motivational interviewing based (MIB) interventions vs. control.\nMain results\nIn total, we included 14 studies with 1298 participants: nine studies (704 participants) compared CM vs. control, and five studies (594 participants) compared MIB interventions vs. control. We did not find any studies that assessed other types of psychosocial interventions. For the most part, it was unclear if included studies adequately controlled for biases within their studies as such information was not often reported. We assessed risk of bias in the included studies relating to participant selection, allocation concealment, personnel and outcome assessor blinding, and attrition.\nThe included trials rarely captured maternal and neonatal outcomes. For studies that did measure such outcomes, no difference was observed in pre-term birth rates (RR 0.71, 95% confidence interval (CI) 0.34 to 1.51; three trials, 264 participants, moderate quality evidence), maternal toxicity at delivery (RR 1.18, 95% CI 0.52 to 2.65; two trials, 217 participants, moderate quality evidence), or low birth weight (RR 0.72, 95% CI 0.36 to 1.43; one trial, 160 participants, moderate quality evidence). However, the results did show that neonates remained in hospital for fewer days after delivery in CM intervention groups (RR -1.27, 95% CI -2.52 to -0.03; two trials, 103 participants, moderate quality evidence). There were no differences observed at the end of studies in retention or abstinence (as assessed by positive drug test at the end of treatment) in any psychosocial intervention group compared to control (Retention: RR 0.99, 95% CI 0.93 to 1.06, nine trials, 743 participants, low quality evidence; and Abstinence: RR 1.14, 95% CI 0.75 to 1.73, three trials, 367 participants, low quality evidence). These results held for both CM and MIB combined. Overall, the quality of the evidence was low to moderate.\nAuthors' conclusions\nThe present evidence suggests that there is no difference in treatment outcomes to address drug use in pregnant women with use of psychosocial interventions, when taken in the presence of other comprehensive care options. However, few studies evaluated obstetrical or neonatal outcomes and rarely did so in a systematic way, making it difficult to assess the effect of psychosocial interventions on these clinically important outcomes. It is important to develop a better evidence base to evaluate psychosocial modalities of treatment in this important population.\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": "There were no differences in retention or abstinence between CM or MIB techniques and usual care. There were also no differences in birth outcomes between the groups.\nOverall, there is low to moderate quality of evidence from the included studies. Allocation methods were often described in very limited manner. Furthermore, many studies lacked attrition information which could have impacted results. While further information related to these methods could be helpful, future randomized trials using psychosocial interventions are unlikely to show a benefit. In addition, there was significant heterogeneity in terms of methods for measuring outcomes."
}
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query-laysum | 4693 | [
{
"role": "user",
"content": "Abstract: Background\nNeck pain is common, disabling and costly. Exercise is one treatment approach.\nObjectives\nTo assess the effectiveness of exercises to improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain.\nSearch methods\nWe searched MEDLINE, MANTIS, ClinicalTrials.gov and three other computerized databases up to between January and May 2014 plus additional sources (reference checking, citation searching, contact with authors).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing single therapeutic exercise with a control for adults suffering from neck pain with or without cervicogenic headache or radiculopathy.\nData collection and analysis\nTwo review authors independently conducted trial selection, data extraction, 'Risk of bias' assessment and clinical relevance. The quality of the evidence was assessed using GRADE. Meta-analyses were performed for relative risk and standardized mean differences (SMD) with 95% confidence intervals (CIs) after judging clinical and statistical heterogeneity.\nMain results\nTwenty-seven trials (2485 analyzed /3005 randomized participants) met our inclusion criteria.\nFor acute neck pain only, no evidence was found.\nFor chronic neck pain, moderate quality evidence supports 1) cervico-scapulothoracic and upper extremity strength training to improve pain of a moderate to large amount immediately post treatment [pooled SMD (SMDp) -0.71 (95% CI: -1.33 to -0.10)] and at short-term follow-up; 2) scapulothoracic and upper extremity endurance training for slight beneficial effect on pain at immediate post treatment and short-term follow-up; 3) combined cervical, shoulder and scapulothoracic strengthening and stretching exercises varied from a small to large magnitude of beneficial effect on pain at immediate post treatment [SMDp -0.33 (95% CI: -0.55 to -0.10)] and up to long-term follow-up and a medium magnitude of effect improving function at both immediate post treatment and at short-term follow-up [SMDp -0.45 (95%CI: -0.72 to -0.18)]; 4) cervico-scapulothoracic strengthening/stabilization exercises to improve pain and function at intermediate term [SMDp -14.90 (95% CI:-22.40 to -7.39)]; 5) Mindfulness exercises (Qigong) minimally improved function but not global perceived effect at short term. Low evidence suggests 1) breathing exercises; 2) general fitness training; 3) stretching alone; and 4) feedback exercises combined with pattern synchronization may not change pain or function at immediate post treatment to short-term follow-up. Very low evidence suggests neuromuscular eye-neck co-ordination/proprioceptive exercises may improve pain and function at short-term follow-up.\nFor chronic cervicogenic headache, moderate quality evidence supports static-dynamic cervico-scapulothoracic strengthening/endurance exercises including pressure biofeedback immediate post treatment and probably improves pain, function and global perceived effect at long-term follow-up. Low grade evidence supports sustained natural apophyseal glides (SNAG) exercises.\nFor acute radiculopathy, low quality evidence suggests a small benefit for pain reduction at immediate post treatment with cervical stretch/strengthening/stabilization exercises.\nAuthors' conclusions\nNo high quality evidence was found, indicating that there is still uncertainty about the effectiveness of exercise for neck pain. Using specific strengthening exercises as a part of routine practice for chronic neck pain, cervicogenic headache and radiculopathy may be beneficial. Research showed the use of strengthening and endurance exercises for the cervico-scapulothoracic and shoulder may be beneficial in reducing pain and improving function. However, when only stretching exercises were used no beneficial effects may be expected. Future research should explore optimal dosage.\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": "The evidence is current to May 2014. We found 27 trials (with a total of 2485 participants) examining whether exercise can help reduce neck pain and disability; improve function, global perceived effect, patient satisfaction and/or quality of life. In these trials, exercise was compared to either a placebo treatment, or no treatment (waiting list), or exercise combined with another intervention was compared with that same intervention (which could include manipulation, education/advice, acupuncture, massage, heat or medications). Twenty-four of 27 trials evaluating neck pain reported on the duration of the disorder: 1 acute; 1 acute to chronic; 1 subacute; 4 subacute/chronic; and 16 chronic. One study reported on neck disorder with acute radiculopathy; two trials investigated subacute to chronic cervicogenic headache."
}
]
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query-laysum | 4694 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is a chronic lung condition characterised by persistent respiratory symptoms and limited lung airflow, dyspnoea and recurrent exacerbations. Suboptimal therapy or non-adherence may result in limited effectiveness of pharmacological treatments and subsequently poor health outcomes.\nObjectives\nTo determine the efficacy and safety of interventions intended to improve adherence to single or combined pharmacological treatments compared with usual care or interventions that are not intended to improve adherence in people with COPD.\nSearch methods\nWe identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register, CENTRAL, MEDLINE and Embase (search date 1 May 2020). We also searched web-based clinical trial registers.\nSelection criteria\nRCTs included adults with COPD diagnosed by established criteria (e.g. Global Initiative for Obstructive Lung Disease). Interventions included change to pharmacological treatment regimens, adherence aids, education, behavioural or psychological interventions (e.g. cognitive behavioural therapy), communication or follow-up by a health professional (e.g. telephone, text message or face-to-face), multi-component interventions, and interventions to improve inhaler technique.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Working in pairs, four review authors independently selected trials for inclusion, extracted data and assessed risk of bias. We assessed confidence in the evidence for each primary outcome using GRADE. Primary outcomes were adherence, quality of life and hospital service utilisation. Adherence measures included the Adherence among Patients with Chronic Disease questionnaire (APCD). Quality of life measures included the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and Clinical COPD Questionnaire (CCQ).\nMain results\nWe included 14 trials (2191 participants) in the analysis with follow-up ranging from six to 52 weeks. Age ranged from 54 to 75 years, and COPD severity ranged from mild to very severe. Trials were conducted in the USA, Spain, Germany, Japan, Jordan, Northern Ireland, Iran, South Korea, China and Belgium. Risk of bias was high due to lack of blinding. Evidence certainty was downgraded due to imprecision and small participant numbers.\nSingle component interventions\nSix studies (55 to 212 participants) reported single component interventions including changes to pharmacological treatment (different roflumilast doses or different inhaler types), adherence aids (Bluetooth inhaler reminder device), educational (comprehensive verbal instruction), behavioural or psychological (motivational interview).\nChange in dose of roflumilast may result in little to no difference in adherence (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.22 to 1.99; studies = 1, participants = 55; low certainty). A Bluetooth inhaler reminder device did not improve adherence, but comprehensive verbal instruction from a health professional did improve mean adherence (prescription refills) (mean difference (MD) 1.00, 95% CI 0.46 to 1.54). Motivational interview improved mean adherence scores on the APCD scale (MD 22.22, 95% CI 8.42 to 36.02).\nUse of a single inhaler compared to two separate inhalers may have little to no impact on quality of life (SGRQ; MD 0.80, 95% CI –3.12 to 4.72; very low certainty). A Bluetooth inhaler monitoring device may provide a small improvement in quality of life on the CCQ (MD 0.40, 95% CI 0.07 to 0.73; very low certainty).\nSingle inhaler use may have little to no impact on the number of people admitted to hospital compared to two separate inhalers (OR 1.47, 95% CI 0.75 to 2.90; very low certainty). Single component interventions may have little to no impact on the number of people expereincing adverse events (very low certainty evidence from studies of a change in pharmacotherapy or use of adherence aids). A change in pharmacotherapy may have little to no impact on exacerbations or deaths (very low certainty).\nMulti-component interventions\nEight studies (30 to 734 participants) reported multi-component interventions including tailored care package that included adherence support as a key component or included inhaler technique as a component.\nA multi-component intervention may result in more people adhering to pharmacotherapy compared to control at 40.5 weeks (risk ratio (RR) 1.37, 95% CI 1.18 to 1.59; studies = 4, participants = 446; I2 = 0%; low certainty).\nThere may be little to no impact on quality of life (SGRQ, Chronic Respiratory Disease Questionnaire, CAT) (studies = 3; low to very low certainty).\nMulti-component interventions may help to reduce the number of people admitted to hospital for any cause (OR 0.37, 95% CI 0.22 to 0.63; studies = 2, participants = 877; low certainty), or COPD-related hospitalisations (OR 0.15, 95% CI 0.07 to 0.34; studies = 2, participants = 220; moderate certainty). There may be a small benefit on people experiencing severe exacerbations.\nThere may be little to no effect on adverse events, serious adverse events or deaths, but events were infrequently reported and were rare (low to very low certainty).\nAuthors' conclusions\nSingle component interventions (e.g. education or motivational interviewing provided by a health professional) can help to improve adherence to pharmacotherapy (low to very low certainty). There were slight improvements in quality of life with a Bluetooth inhaler device, but evidence is from one study and very low certainty. Change to pharmacotherapy (e.g. single inhaler instead of two, or different doses of roflumilast) has little impact on hospitalisations or exacerbations (very low certainty). There is no difference in people experiencing adverse events (all-cause or COPD-related), or deaths (very low certainty).\nMulti-component interventions may improve adherence with education, motivational or behavioural components delivered by health professionals (low certainty). There is little to no impact on quality of life (low to very low certainty). They may help reduce the number of people admitted to hospital overall (specifically pharmacist-led approaches) (low certainty), and fewer people may have COPD-related hospital admissions (moderately certainty). There may be a small reduction in people experiencing severe exacerbations, but evidence is from one study (low certainty). Limited evidence found no difference in people experiencing adverse events, serious adverse events or deaths (low to very low certainty).\nThe evidence presented should be interpreted with caution. Larger studies with more intervention types, especially single interventions, are needed. It is unclear which specific COPD subgroups would benefit, therefore discussions between health professionals and patients may help to determine whether they will help to improve health outcomes.\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": "Which approaches help people maintain taking prescribed medication(s), improve quality of life and reduce hospital admissions in people with chronic obstructive pulmonary disease (COPD)?"
}
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query-laysum | 4695 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Lifestyle or dietary modifications (including reducing the amount of salt or caffeine in the diet) are sometimes suggested to be of benefit for this condition. The underlying cause of Ménière's disease is unknown, as is the way in which these interventions may work. The efficacy of these different interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of lifestyle and dietary interventions versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with Ménière's disease comparing any lifestyle or dietary intervention with either placebo or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two RCTs, one related to diet, and the other related to fluid intake and sleep. In a Swedish study, 51 participants were randomised to receive 'specially processed cereals' or standard cereals. The specially processed cereals are thought to stimulate the production of anti-secretory factor - a protein that reduces inflammation and fluid secretion. Participants received the cereals for three months. The only outcome reported by this study was disease-specific health-related quality of life.\nThe second study was conducted in Japan. The participants (223) were randomised to receive abundant water intake (35 mL/kg/day), or to sleep in darkness (in an unlit room for six to seven hours per night), or to receive no intervention. The duration of follow-up was two years. The outcomes assessed were 'improvement in vertigo' and hearing.\nAs these studies considered different interventions we were unable to carry out any meta-analysis, and for almost all outcomes the certainty of the evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nThe evidence for lifestyle or dietary interventions for Ménière's disease is very uncertain. We did not identify any placebo-controlled RCTs for interventions that are frequently recommended for those with Ménière's disease, such as salt restriction or caffeine restriction. We identified only two RCTs that compared a lifestyle or dietary intervention to placebo or no treatment, and the evidence that is currently available from these studies is of low or very low certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\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": "Due to a lack of robust evidence, it is not clear whether any lifestyle or dietary changes used to treat Ménière's disease work to improve people's symptoms, despite their routine use in clinical practice. We also do not know if there are any risks associated with these interventions.\nLarger, well-conducted studies are needed in order to identify whether any lifestyle or dietary changes may be effective, and assess whether they have any harmful effects.\nFurther work also needs to be done to find out how best to measure the symptoms of people with Ménière's disease, in order to assess whether treatments are beneficial or not. This should include the development of a 'core outcome set' - a list of things that should be measured in all studies on Ménière's disease."
}
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query-laysum | 4696 | [
{
"role": "user",
"content": "Abstract: Background\nIncreasingly, cancer is recognised as a chronic condition with a growing population of informal caregivers providing care for cancer patients. Informal caregiving can negatively affect the health and well-being of caregivers. We need a synthesised account of best evidence to aid decision-making about effective ways to support caregivers for individuals 'living with cancer'.\nObjectives\nTo assess the effectiveness of psychosocial interventions designed to improve the quality of life (QoL), physical health and well-being of informal caregivers of people living with cancer compared with usual care.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, ProQuest, Open SIGLE, Web of Science from inception up to January 2018, trial registries and citation lists of included studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials comparing psychosocial interventions delivered to adult informal caregivers of adults affected by cancer on a group or individual basis with usual care. Psychosocial interventions included non-pharmacological interventions that involved an interpersonal relationship between caregivers and healthcare professionals. We included interventions delivered also to caregiver-patient dyads. Interventions delivered to caregivers of individuals receiving palliative or inpatient care were excluded. Our primary outcome was caregiver QoL. Secondary outcomes included patient QoL, caregiver and patient depression, anxiety, psychological distress, physical health status and intervention satisfaction and adverse effects.\nData collection and analysis\nPairs of review authors independently screened studies for eligibility, extracted data and conducted 'Risk of bias' assessments. We synthesised findings using meta-analysis, where possible, and reported remaining results in a narrative synthesis.\nMain results\nNineteen trials (3725 participants) were included in the review. All trials were reported in English and were undertaken in high-income countries. Trials targeted caregivers of patients affected by a number of cancers spanning newly diagnosed patients, patients awaiting treatment, patients who were being treated currently and individuals post-treatment. Most trials delivered interventions to caregiver-patient dyads (predominantly spousal dyads) and there was variation in intervention delivery to groups or individual participants. There was much heterogeneity across interventions though the majority were defined as psycho-educational. All trials were rated as being at 'high risk of bias'.\nCompared to usual care, psychosocial interventions may improve slightly caregiver QoL immediately post intervention (standardised mean difference (SMD) 0.29, 95% confidence interval (CI) 0.04 to 0.53; two studies, 265 participants) and may have little to no effect on caregiver QoL at 12 months (SMD 0.14, 95% CI - 0.11 to 0.40; two studies, 239 participants) post-intervention (both low-quality evidence).\nPsychosocial interventions probably have little to no effect on caregiver depression immediately to one-month post-intervention (SMD 0.01, 95% CI -0.14 to 0.15; nine studies, 702 participants) (moderate-quality evidence). Psychosocial interventions may have little to no effect on caregiver anxiety immediately post-intervention (SMD -0.12, 95 % CI -0.33 to 0.10; five studies, 329 participants), depression three-to-six months (SMD 0.03, 95% CI -0.33 to 0.38; five studies, 379 participants) post-intervention and patient QoL six to 12 months (SMD -0.05, 95% CI -0.37 to 0.26; three studies, 294 participants) post-intervention (all low-quality evidence). There was uncertainty whether psychosocial interventions improve patient QoL immediately (SMD -0.03, 95 %CI -0.50 to 0.44; two studies, 292 participants) or caregiver anxiety three-to-six months (SMD-0.25, 95% CI -0.64 to 0.13; four studies, 272 participants) post-intervention (both very low-quality evidence). Two studies which could not be pooled in a meta-analysis for caregiver physical health status found little to no effect immediately post-intervention and a small intervention effect 12 months post-intervention. Caregiver or patient satisfaction or cost-effectiveness of interventions were not assessed in any studies. Interventions demonstrated good feasibility and acceptability.\nPsychosocial interventions probably have little to no effect on patient physical health status immediately post-intervention (SMD 0.17, 95 % CI -0.07 to 0.41; four studies, 461 participants) and patient depression three to six months post-intervention (SMD-0.11, 95% CI -0.33 to 0.12; six studies, 534 participants) (both moderate-quality evidence).\nPsychosocial interventions may have little to no effect on caregiver psychological distress immediately to one-month (SMD -0.08, 95% CI -0.42 to 0.26; three studies, 134 participants), and seven to 12 months (SMD 0.08, 95% CI -0.42 to 0.58; two studies, 62 participants) post-intervention; patient depression immediately (SMD -0.12, 95% CI -0.31 to 0.07; nine studies, 852 participants); anxiety immediately (SMD -0.13, 95% CI -0.41 to 0.15; four studies, 422 participants), and three to six months (SMD -0.22, 95% CI -0.45 to 0.02; four studies, 370 participants); psychological distress immediately (SMD -0.02, 95% CI -0.47 to 0.44; two studies, 74 participants) and seven to 12 months (SMD -0.27, 95% CI -0.78 to 0.24; two studies, 61 participants); and physical health status six to 12 months (SMD 0.06, 95% CI -0.18 to 0.30; two studies, 275 participants) post-intervention (all low-quality evidence).\nThree trials reported adverse effects associated with the interventions, compared with usual care, including higher distress, sexual function-related distress and lower relationship satisfaction levels for caregivers, higher distress levels for patients, and that some content was perceived as insensitive to some participants.\nTrials not able to be pooled in a meta-analysis did not tend to report effect size and it was difficult to discern intervention effectiveness. Variable intervention effects were reported for patient and caregiver outcomes.\nAuthors' conclusions\nHeterogeneity across studies makes it difficult to draw firm conclusions regarding the effectiveness of psychosocial interventions for this population. There is an immediate need for rigorous trials with process evaluations and clearer, detailed intervention descriptions. Cost-effectiveness studies should be conducted alongside future trials.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found19 trials that compared psychosocial interventions with usual care, in studies that included almost four thousand participants. Studies included caregivers of people affected by different cancers across all stages of the disease. There were differences in intervention make-up. Intervention examples include providing information and/or teaching caregivers (or caregiver-patient pairs) coping, communication or problem-solving skills to manage symptoms or improve relationships. Interventions were delivered by nurses, psychologists or other professionals on an outpatient basis or at home via telephone.\nThere may be a minimal benefit for caregiver quality-of-life immediately after the intervention, but this may not last. Psychosocial interventions may have little to no effect on quality of life for patients six to 12 months post-intervention, but we are uncertain whether or not interventions improve quality of life for patients immediately post-intervention.\nPsychosocial interventions may have little to no effect on caregiver depression, anxiety, distress and physical health and patient anxiety and distress at any time after the intervention, or on patient depression immediately and patient physical health six to 12 months post-intervention. Psychosocial interventions probably have little to no effect on patient physical health immediately post-intervention or patient depression three to six months post-intervention.\nThree studies reported adverse effects including increased distress and sexual function-related distress and lower relationship satisfaction levels for carers, increased distress levels for patients, and intervention content that was seen as inappropriate for some participants. No studies looked at cost-effectiveness or intervention satisfaction for caregivers or patients. Because the quality of evidence was low generally, findings must be treated with caution."
}
]
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query-laysum | 4697 | [
{
"role": "user",
"content": "Abstract: Background\nPrimary healthcare (PHC) integration has been promoted globally as a tool for health sector reform and universal health coverage (UHC), especially in low-resource settings. However, for a range of reasons, implementation and impact remain variable. PHC integration, at its simplest, can be considered a way of delivering PHC services together that sometimes have been delivered as a series of separate or 'vertical' health programmes. Healthcare workers are known to shape the success of implementing reform interventions. Understanding healthcare worker perceptions and experiences of PHC integration can therefore provide insights into the role healthcare workers play in shaping implementation efforts and the impact of PHC integration. However, the heterogeneity of the evidence base complicates our understanding of their role in shaping the implementation, delivery, and impact of PHC integration, and the role of contextual factors influencing their responses.\nObjectives\nTo map the qualitative literature on healthcare workers' perceptions and experiences of PHC integration to characterise the evidence base, with a view to better inform future syntheses on the topic.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 28 July 2020. We did not search for grey literature due to the many published records identified.\nSelection criteria\nWe included studies with qualitative and mixed methods designs that reported on healthcare worker perceptions and experiences of PHC integration from any country. We excluded settings other than PHC and community-based health care, participants other than healthcare workers, and interventions broader than healthcare services. We used translation support from colleagues and Google Translate software to screen non-English records. Where translation was not feasible we categorised these records as studies awaiting classification.\nData collection and analysis\nFor data extraction, we used a customised data extraction form containing items developed using inductive and deductive approaches. We performed independent extraction in duplicate for a sample on 10% of studies allowed for sufficient agreement to be reached between review authors. We analysed extracted data quantitatively by counting the number of studies per indicator and converting these into proportions with additional qualitative descriptive information. Indicators included descriptions of study methods, country setting, intervention type, scope and strategies, implementing healthcare workers, and client target population.\nMain results\nThe review included 184 studies for analysis based on 191 included papers. Most studies were published in the last 12 years, with a sharp increase in the last five years. Studies mostly employed methods with cross-sectional qualitative design (mainly interviews and focus group discussions), and few used longitudinal or ethnographic (or both) designs. Studies covered 37 countries, with close to an even split in the proportions of high-income countries (HICs) and low- and middle-income countries (LMICs). There were gaps in the geographical spread for both HICs and LMICs and some countries were more dominant, such as the USA for HICs, South Africa for middle-income countries, and Uganda for low-income countries. Methods were mainly cross-sectional observational studies with few longitudinal studies. A minority of studies used an analytical conceptual model to guide the design, implementation, and evaluation of the integration study.\nThe main finding was the various levels of diversity found in the evidence base on PHC integration studies that examined healthcare workers' perceptions and experiences. The review identified six different configurations of health service streams that were being integrated and these were categorised as: mental and behavioural health; HIV, tuberculosis (TB) and sexual reproductive health; maternal, women, and child health; non-communicable diseases; and two broader categories, namely general PHC services, and allied and specialised services. Within the health streams, the review mapped the scope of the interventions as full or partial integration. The review mapped the use of three different integration strategies and categorised these as horizontal integration, service expansion, and service linkage strategies. The wide range of healthcare workers who participated in the implementation of integration interventions was mapped and these included policymakers, senior managers, middle and frontline managers, clinicians, allied healthcare professionals, lay healthcare workers, and health system support staff. We mapped the range of client target populations.\nAuthors' conclusions\nThis scoping review provides a systematic, descriptive overview of the heterogeneity in qualitative literature on healthcare workers' perceptions and experience of PHC integration, pointing to diversity with regard to country settings; study types; client populations; healthcare worker populations; and intervention focus, scope, and strategies. It would be important for researchers and decision-makers to understand how the diversity in PHC integration intervention design, implementation, and context may influence how healthcare workers shape PHC integration impact. The classification of studies on the various dimensions (e.g. integration focus, scope, strategy, and type of healthcare workers and client populations) can help researchers to navigate the way the literature varies and for specifying potential questions for future qualitative evidence syntheses.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 184 studies. The studies were from 37 countries. About half the studies took place in high-income countries and half in low- and middle-income countries.\nThe studies we found in our review covered a variety of settings, participants, and types of primary healthcare integration. There were different configurations for which healthcare service programmes were being combined for integrated service delivery. These were categorised into the following six configurations: mental health; HIV, tuberculosis, and sexual reproductive health; maternal, woman, and child health; non-communicable diseases (for example, heart disease, diabetes); general primary health integration, and allied and specialised services. We also explored whether integrated service delivery was fully or partially integrated, and the different integration strategies used to link and co-ordinate services.\nThe people participating in the implementation of integration interventions included policymakers, senior managers, middle and frontline managers, clinicians, allied healthcare professionals, lay health workers, and health system support staff. A wide range of clients were recipients of the integrated services."
}
]
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query-laysum | 4699 | [
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is a major public health issue with rates increasing globally. Gestational diabetes, glucose intolerance first recognised during pregnancy, usually resolves after birth and is associated with short- and long-term complications for the mother and her infant. Treatment options can include oral anti-diabetic pharmacological therapies.\nObjectives\nTo evaluate the effects of oral anti-diabetic pharmacological therapies for treating women with GDM.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (14 May 2016), ClinicalTrials.gov, WHO ICTRP (14 May 2016) and reference lists of retrieved studies.\nSelection criteria\nWe included published and unpublished randomised controlled trials assessing the effects of oral anti-diabetic pharmacological therapies for treating pregnant women with GDM. We included studies comparing oral anti-diabetic pharmacological therapies with 1) placebo/standard care, 2) another oral anti-diabetic pharmacological therapy, 3) combined oral anti-diabetic pharmacological therapies. Trials using insulin as the comparator were excluded as they are the subject of a separate Cochrane systematic review.\nWomen with pre-existing type 1 or type 2 diabetes were excluded.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted data and data were checked for accuracy.\nMain results\nWe included 11 studies (19 publications) (1487 women and their babies). Eight studies had data that could be included in meta-analyses. Studies were conducted in Brazil, India, Israel, UK, South Africa and USA. The studies varied in diagnostic criteria and treatment targets for glycaemic control for GDM. The overall risk of bias was 'unclear' due to inadequate reporting of methodology. Using GRADE the quality of the evidence ranged from moderate to very low quality. Evidence was downgraded for risk of bias (reporting bias, lack of blinding), inconsistency, indirectness, imprecision and for oral anti-diabetic therapy versus placebo for generalisability.\nOral anti-diabetic pharmacological therapies versus placebo/standard care\nThere was no evidence of a difference between glibenclamide and placebo groups for hypertensive disorders of pregnancy (risk ratio (RR) 1.24, 95% confidence interval (CI) 0.81 to 1.90; one study, 375 women, very low-quality evidence), birth by caesarean section (RR 1.03, 95% CI 0.79 to 1.34; one study, 375 women, very low-quality evidence), perineal trauma (RR 0.98, 95% CI 0.06 to 15.62; one study, 375 women, very low-quality evidence) or induction of labour (RR 1.18, 95% CI 0.79 to 1.76; one study, 375 women; very low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant, there was no evidence of a difference in the risk of being born large-for-gestational age (LGA) between infants whose mothers had been treated with glibenclamide and those in the placebo group (RR 0.89, 95% CI 0.51 to 1.58; one study, 375, low-quality evidence). No data were reported for other infant primary or GRADE outcomes (perinatal mortality, death or serious morbidity composite, neurosensory disability in later childhood, neonatal hypoglycaemia, adiposity, diabetes).\nMetformin versus glibenclamide\nThere was no evidence of a difference between metformin- and glibenclamide-treated groups for the risk of hypertensive disorders of pregnancy (RR 0.70, 95% CI 0.38 to 1.30; three studies, 508 women, moderate-quality evidence), birth by caesarean section (average RR 1.20, 95% CI 1.20; 95% CI 0.83 to 1.72, four studies, 554 women, I2 = 61%, Tau2 = 0.07 low-quality evidence), induction of labour (0.81, 95% CI 0.61 to 1.07; one study, 159 women; low-quality evidence) or perineal trauma (RR 1.67, 95% CI 0.22 to 12.52; two studies, 158 women; low-quality evidence). No data were reported for development of type 2 diabetes or other pre-specified GRADE maternal outcomes (return to pre-pregnancy weight, postnatal depression). For the infant there was no evidence of a difference between the metformin- and glibenclamide-exposed groups for the risk of being born LGA (average RR 0.67, 95% CI 0.24 to 1.83; two studies, 246 infants, I2 = 54%, Tau2 = 0.30 low-quality evidence). Metformin was associated with a decrease in a death or serious morbidity composite (RR 0.54, 95% CI 0.31 to 0.94; one study, 159 infants, low-quality evidence). There was no clear difference between groups for neonatal hypoglycaemia (RR 0.86, 95% CI 0.42 to 1.77; four studies, 554 infants, low-quality evidence) or perinatal mortality (RR 0.92, 95% CI 0.06 to 14.55, two studies, 359 infants). No data were reported for neurosensory disability in later childhood or for adiposity or diabetes.\nGlibenclamide versus acarbose\nThere was no evidence of a difference between glibenclamide and acarbose from one study (43 women) for any of their maternal or infant primary outcomes (caesarean section, RR 0.95, 95% CI 0.53 to 1.70; low-quality evidence; perinatal mortality - no events; low-quality evidence; LGA , RR 2.38, 95% CI 0.54 to 10.46; low-quality evidence). There was no evidence of a difference between glibenclamide and acarbose for neonatal hypoglycaemia (RR 6.33, 95% CI 0.87 to 46.32; low-quality evidence). There were no data reported for other pre-specified GRADE or primary maternal outcomes (hypertensive disorders of pregnancy, development of type 2 diabetes, perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour) or neonatal outcomes (death or serious morbidity composite, adiposity or diabetes).\nAuthors' conclusions\nThere were insufficient data comparing oral anti-diabetic pharmacological therapies with placebo/standard care (lifestyle advice) to inform clinical practice. There was insufficient high-quality evidence to be able to draw any meaningful conclusions as to the benefits of one oral anti-diabetic pharmacological therapy over another due to limited reporting of data for the primary and secondary outcomes in this review. Short- and long-term clinical outcomes for this review were inadequately reported or not reported. Current choice of oral anti-diabetic pharmacological therapy appears to be based on clinical preference, availability and national clinical practice guidelines.\nThe benefits and potential harms of one oral anti-diabetic pharmacological therapy compared with another, or compared with placebo/standard care remains unclear and requires further research. Future trials should attempt to report on the core outcomes suggested in this review, in particular long-term outcomes for the woman and the infant that have been poorly reported to date, women's experiences and cost benefit.\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": "Globally the number of women being diagnosed with gestational diabetes mellitus (GDM) is increasing. GDM is an intolerance to glucose leading to high blood sugars, first recognised during pregnancy and usually resolving after birth. Standard care involves lifestyle advice on diet and exercise. Treatment for some women includes oral anti-diabetic medications, such as metformin and glibenclamide, which are an alternative to, or can be used alongside, insulin to control the blood sugar. This review aimed to investigate benefits of taking oral medication to treat GDM in pregnant women. Another Cochrane Review compares the effects of insulin with oral anti-diabetic pharmacological therapies (Brown 2016)."
}
]
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query-laysum | 4700 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is caused by a defective gene encoding a protein called the cystic fibrosis transmembrane conductance regulator (CFTR), and is characterised by chronic lung infection resulting in inflammation and progressive lung damage that results in a reduced life expectancy.\nObjectives\nTo determine whether topical CFTR gene replacement therapy to the lungs in people with cystic fibrosis is associated with improvements in clinical outcomes, and to assess any adverse effects.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearching relevant journals and abstract books of conference proceedings.\nDate of most recent search: 05 May 2016.\nAn additional search of the National Institutes for Health (NIH) Genetic Modification Clinical Research Information System (GeMCRIS) was also performed for the years 1992 to 2015.\nDate of most recent search: 20 April 2016.\nSelection criteria\nRandomised controlled studies comparing topical CFTR gene delivery to the lung, using either viral or non-viral delivery systems, with placebo or an alternative delivery system in people with confirmed cystic fibrosis.\nData collection and analysis\nThe authors independently extracted data and assessed study quality. Authors of included studies were contacted and asked for any available additional data. Meta-analysis was limited due to differing study designs.\nMain results\nFour randomised controlled studies met the inclusion criteria for this review, involving a total of 302 participants lasting from 29 days to 13 months; 14 studies were excluded. The included studies differed in terms of CFTR gene replacement agent and study design, which limited the meta-analysis. One study only enrolled adult males, the remaining studies included both males and females aged 12 years and over.\nRisk of bias in the studies was moderate. Random sequence generation and allocation concealment was only described in the more recent study; the remaining three studies were judged to have an unclear risk of bias. All four studies documented double-blinding to the intervention, but there is some uncertainty with regards to participant blinding in one study. Some outcome data were missing from all four studies.\nThere were no differences in either the number of respiratory exacerbations or the number of participants with an exacerbation between replacement therapy or placebo groups at any time point. Meta-analysis of most respiratory function tests showed no difference between treatment and placebo groups, but the smallest study (n = 16) reported forced vital capacity (litres) increased more in the placebo group at up to 24 hours. A further study reported a significant improvement in forced expiratory volume at one second (litres) at 30 days after participants had received their first dose of favouring the gene therapy agent, but this finding was not confirmed when combined with at second study in the meta-analysis. The more recent study (n = 140) demonstrated a small improvement in forced vital capacity (per cent predicted) at two and three months and again at 11 and 12 months for participants receiving CFTR gene replacement therapy compared to those receiving placebo. The same study reported a significant difference in the relative change in forced expiratory volume at one second (per cent predicted) at two months, three months and 12 months.\nOne small study reported significant concerns with \"influenza-like\" symptoms in participants treated with CFTR gene replacement therapy; this was not reported on repeated use of the same agent in a larger recent study.\nThere was no other evidence of positive impact on outcomes, in particular improved quality of life or reduced treatment burden.\nTwo studies measured ion transport in the lower airways; one (n = 16) demonstrated significant changes toward normal values in the participants who received gene transfer agents (P < 0.0001), mean difference 6.86 (95% confidence interval 3.77 to 9.95). The second study (n = 140) also reported significant changes toward normal values (P = 0.032); however, aggregate data were not available for analysis. In the most recent study, there was also evidence of increased salt transport in cells obtained by brushing the lower airway. These outcomes, whilst important, are not of direct clinical relevance.\nAuthors' conclusions\nOne study of liposome-based CFTR gene transfer therapy demonstrated some improvements in respiratory function in people with CF, but this limited evidence of efficacy does not support this treatment as a routine therapy at present. There was no evidence of efficacy for viral-mediated gene delivery.\nFuture studies need to investigate clinically important outcome measures.\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 effect of delivering the correct copy of the cystic fibrosis transmembrane conductance regulator (CFTR) gene directly to the lungs of people with cystic fibrosis in order to treat progressive lung disease."
}
]
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query-laysum | 4701 | [
{
"role": "user",
"content": "Abstract: Background\nMalaria is transmitted through the bite of Plasmodium-infected adult female Anopheles mosquitoes. Ivermectin, an anti-parasitic drug, acts by killing mosquitoes that are exposed to the drug while feeding on the blood of people (known as blood feeds) who have ingested the drug. This effect on mosquitoes has been demonstrated by individual randomized trials. This effect has generated interest in using ivermectin as a tool for malaria control.\nObjectives\nTo assess the effect of community administration of ivermectin on malaria transmission.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation index - expanded, the World Health Organization (WHO) International Clinical Trials Registry Platform, ClinicalTrials.gov, and the National Institutes of Health (NIH) RePORTER database to 14 January 2021.\nWe checked the reference lists of included studies for other potentially relevant studies, and contacted researchers working in the field for unpublished and ongoing trials.\nSelection criteria\nWe included cluster-randomized controlled trials (cRCTs) that compared ivermectin, as single or multiple doses, with a control treatment or placebo given to populations living in malaria-endemic areas, in the context of mass drug administration. Primary outcomes were prevalence of malaria parasite infection and incidence of clinical malaria in the community.\nData collection and analysis\nTwo review authors independently extracted data on the number of events and the number of participants in each trial arm at the time of assessment. For rate data, we noted the total time at risk in each trial arm. To assess risk of bias, we used Cochrane's RoB 2 tool for cRCTs. We documented the method of data analysis, any adjustments for clustering or other covariates, and recorded the estimate of the intra-cluster correlation (ICC) coefficient.\nWe re-analysed the trial data provided by the trial authors to adjust for cluster effects. We used a Poisson mixed-effect model with small sample size correction, and a cluster-level analysis using the linear weighted model to adequately adjust for clustering.\nMain results\nWe included one cRCT and identified six ongoing trials.\nThe included cRCT examined the incidence of malaria in eight villages in Burkina Faso, randomized to two arms. Both trial arms received a single dose of ivermectin 150 µg/kg to 200 µg/kg, together with a dose of albendazole. The villages in the intervention arm received an additional five doses of ivermectin, once every three weeks. Children were enrolled into an active cohort, in which they were repeatedly screened for malaria infection.\nThe primary outcome was the cumulative incidence of uncomplicated malaria in a cohort of children aged five years and younger, over the 18-week study. We judged the study to be at high risk of bias, as the analysis did not account for clustering or correlation between participants in the same village.\nThe study did not demonstrate an effect of Ivermectin on the cumulative incidence of uncomplicated malaria in the cohort of children over the 18-week study (risk ratio 0.86, 95% confidence interval (CI) 0.62 to 1.17; P = 0.2607; very low-certainty evidence).\nAuthors' conclusions\nWe are uncertain whether community administration of ivermectin has an effect on malaria transmission, based on one trial published to date.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study met the inclusion criteria. This study included eight villages in Burkina Faso, which were randomly assigned to receive ivermectin or a control. All villages received ivermectin, as part of the scheduled control of lymphatic filariasis. In addition, the treatment villages received five more doses of ivermectin, once every three weeks. The effect of ivermectin on malaria was measured in children younger than five years of age. In these children, the treatment did not show a notable difference in the presence of malaria between the treatment and control groups (very low-certainty evidence).\nTherefore, it is not possible to say at this point if the treatment of entire communities with ivermectin has an effect on reducing malaria. Several studies are currently ongoing; we anticipate they will provide more answers in the future."
}
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query-laysum | 4702 | [
{
"role": "user",
"content": "Abstract: Background\nUlcerative colitis (UC) is a chronic inflammatory bowel disease. Corticosteroids and 5-aminosalicylates are the most commonly used therapies. However, many patients require immunosuppressive therapy for steroid-refractory and steroid-dependent disease. Methotrexate is a medication that is effective for treating a variety of inflammatory diseases, including Crohn's disease. This review was performed to determine the effectiveness of methotrexate treatment in UC patients. This review is an update of a previously published Cochrane review.\nObjectives\nTo assess the efficacy and safety of methotrexate for induction of remission in patients with UC.\nSearch methods\nMEDLINE, EMBASE, CENTRAL and the Cochrane IBD/FBD group specialized trials register were searched from from inception to June 26, 2014. Study references and review papers were also searched for additional trials. Abstracts from major gastroenterological meetings were searched to identify research published in abstract form only.\nSelection criteria\nRandomized controlled trials comparing methotrexate with placebo or an active comparator in patients with active ulcerative colitis were considered for inclusion.\nData collection and analysis\nTwo authors independently reviewed studies for eligibility, extracted data and assessed study quality using the Cochrane risk of bias tool. The primary outcome measure was the proportion of patients who achieved clinical remission and withdrawal from steroids as defined by the studies and expressed as a percentage of the total number of patients randomized (intention-to-treat analysis). We calculated the risk ratio (RR) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The overall quality of the evidence supporting the primary outcome was assessed using the GRADE criteria.\nMain results\nTwo studies (n = 101 patients) were included in the review. One study (n = 67) compared oral methotrexate 12.5 mg/week) to placebo. The other study (n = 34) compared oral methotrexate (15 mg/week) to 6-mercaptopurine (1.5 mg/kg/day) and 5-aminosalicylic acid (3 g/day). The placebo-controlled study was judged to be at low risk of bias. The other study was judged to be at high risk of bias due to an open-label design. There was no statistically significant difference in clinical remission rates between methotrexate and placebo patients. Forty-seven per cent (14/30) of methotrexate patients achieved clinical remission and complete withdrawal from steroids during the study period compared to 49% (18/37) of placebo patients (RR 0.96, 95% CI 0.58 to 1.59. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was low due to very sparse data (32 events). There were no statistically significant differences in the proportion of patients who achieved clinical remission and withdrawal from steroids in the study comparing oral methotrexate to 6-mercaptopurine and 5-aminosalicylic acid. At 30 weeks, 58% (7/12) of methotrexate patients achieved clinical remission and withdrawal from steroids compared to 79% (11/14) of 6-mercaptopurine patients (RR 0.74, 95% CI 0.43 to 1.29) and 25% of 5-aminosalicylic acid patients (RR 2.33, 95% CI 0.64 to 8.49). GRADE analyses indicated that the overall quality of the evidence was very low due to very sparse data (18 and 9 events respectively) and and high risk of bias. In the placebo-controlled trial two patients (7%) were withdrawn from the methotrexate group due to adverse events (leucopenia, migraine) compared to one patient (3%) who had a rash in the placebo group (RR 2.47, 95% CI 0.23 to 25.91). Adverse events experienced by methotrexate patients in the active comparator study included nausea and dyspepsia, mild alopecia, mild increase in aspartate aminotransferase levels, peritoneal abscess, hypoalbuminemia, severe rash and atypical pneumonia.\nAuthors' conclusions\nAlthough methotrexate was well-tolerated, the studies showed no benefit for methotrexate over placebo or active comparators. The results for efficacy outcomes between methotrexate and placebo, methotrexate and 6-mercaptopurine and methotrexate and 5-aminosalicylic acid were uncertain. Whether a higher dose or parenteral administration would be effective for induction therapy is unknown. At present there is no evidence supporting the use of methotrexate for induction of remission in active ulcerative colitis. A trial in which larger numbers of patients receive a higher dose of oral methotrexate should be considered. Currently there are two large ongoing placebo-controlled trials (METEOR and MERIT-UC) assessing the efficacy and safety of intramuscular or subcutaneous methotrexate in patients with active UC which may help resolve the evidence supporting the use of methotrexate as therapy for active of ulcerative colitis.\n\nGiven the provided abstract, please respond to the following query: \"What is ulcerative colitis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Ulcerative colitis is a long-term (chronic) inflammatory bowel disease characterized by pains (abdominal cramping), a need to rush to the toilet to pass feces (fecal urgency) and bloody diarrhea."
}
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query-laysum | 4703 | [
{
"role": "user",
"content": "Abstract: Background\nRoot canal therapy is a sequence of treatments involving root canal cleaning, shaping, decontamination, and obturation. It is conventionally performed through a hole drilled into the crown of the affected tooth, namely orthograde root canal therapy. When it fails, retrograde filling, which seals the root canal from the root apex, is a good alternative. Many materials are used for retrograde filling. Since none meets all the criteria an ideal material should possess, selecting the most efficacious material is of utmost importance. This is an update of a Cochrane Review first published in 2016.\nObjectives\nTo determine the effects of different materials used for retrograde filling in children and adults for whom retrograde filling is necessary in order to save the tooth.\nSearch methods\nAn Information Specialist searched five bibliographic databases up to 21 April 2021 and used additional search methods to identify published, unpublished, and ongoing studies. We also searched four databases in the Chinese language.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that compared different retrograde filling materials, with the reported success rate that was assessed by clinical or radiological methods for which the follow-up period was at least 12 months.\nData collection and analysis\nRecords were screened in duplicate by independent screeners. Two review authors extracted data independently and in duplicate. Original trial authors were contacted for any missing information. Two review authors independently assessed the risk of bias of the included studies. We followed Cochrane's statistical guidelines and assessed the certainty of the evidence using GRADE.\nMain results\nWe included eight studies, all at high risk of bias, involving 1399 participants with 1471 teeth, published between 1995 and 2019, and six comparisons of retrograde filling materials.\n- Mineral trioxide aggregate (MTA) versus intermediate restorative material (IRM): there may be little to no effect of MTA compared to IRM on success rate at one year, but the evidence is very uncertain (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.97 to 1.22; I2 = 0%; 2 studies; 222 teeth; very low-certainty evidence).\n- MTA versus super ethoxybenzoic acid (Super-EBA): there may be little to no effect of MTA compared to Super-EBA on success rate at one year, but the evidence is very uncertain (RR 1.03, 95% CI 0.96 to 1.10; 1 study; 192 teeth; very low-certainty evidence).\n- Super-EBA versus IRM: the evidence is very uncertain about the effect of Super-EBA compared with IRM on success rate at 1 year, with results indicating Super-EBA may reduce or have no effect on success rate (RR 0.90, 95% CI 0.80 to 1.01; 1 study; 194 teeth; very low-certainty evidence).\n- Dentine-bonded resin composite versus glass ionomer cement: compared to glass ionomer cement, dentine-bonded resin composite may increase the success rate of the treatment at 1 year, but the evidence is very uncertain (RR 2.39, 95% CI 1.60 to 3.59; 1 study; 122 teeth; very low-certainty evidence). Same result was obtained when considering the root as unit of analysis at one year (RR 1.59, 95% CI 1.20 to 2.09; 1 study; 127 roots; very low-certainty evidence).\n- Glass ionomer cement versus amalgam: the evidence is very uncertain about the effect of glass ionomer cement compared with amalgam on success rate at one year, with results indicating glass ionomer cement may reduce or have no effect on success rate (RR 0.98, 95% CI 0.86 to 1.12; 1 study; 105 teeth; very low-certainty evidence).\n- MTA versus root repair material (RRM): there may be little to no effect of MTA compared to RRM on success rate at one year, but the evidence is very uncertain (RR 1.00, 95% CI 0.94 to 1.07; I2 = 0%; 2 studies; 278 teeth; very low-certainty evidence).\nAdverse events were not assessed by any of the included studies.\nAuthors' conclusions\nBased on the present limited evidence, there is insufficient evidence to draw any conclusion as to the benefits of any one material over another for retrograde filling in root canal therapy. We conclude that more high-quality RCTs are required.\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 for studies that compared different materials used for retrograde filling in root canal therapy. We 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 | 4704 | [
{
"role": "user",
"content": "Abstract: Background\nWith the increased demand for whiter teeth, home-based bleaching products, either dentist-prescribed or over-the-counter products have been exponentially increasing in the past few decades. This is an update of a Cochrane Review first published in 2006.\nObjectives\nTo evaluate the effects of home-based tooth whitening products with chemical bleaching action, dispensed by a dentist or over-the-counter.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 12 June 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 6) in the Cochrane Library (searched 12 June 2018), MEDLINE Ovid (1946 to 12 June 2018), and Embase Ovid (1980 to 12 June 2018). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (12 June 2018) and the World Health Organization International Clinical Trials Registry Platform (12 June 2018) were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included in our review randomised controlled trials (RCTs) which involved adults who were 18 years and above, and compared dentist-dispensed or over-the-counter tooth whitening (bleaching) products with placebo or other comparable products.\nQuasi-randomised trials, combination of in-office and home-based treatments, and home-based products having physical removal of stains were excluded.\nData collection and analysis\nTwo review authors independently selected trials. Two pairs of review authors independently extracted data and assessed risk of bias. We estimated risk ratios (RRs) for dichotomous data, and mean differences (MDs) or standardised mean difference (SMD) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 71 trials in the review with 26 studies (1398 participants) comparing a bleaching agent to placebo and 51 studies (2382 participants) comparing a bleaching agent to another bleaching agent. Two studies were at low overall risk of bias; two at high overall risk of bias; and the remaining 67 at unclear overall risk of bias.\nThe bleaching agents (carbamide peroxide (CP) gel in tray, hydrogen peroxide (HP) gel in tray, HP strips, CP paint-on gel, HP paint-on gel, sodium hexametaphosphate (SHMP) chewing gum, sodium tripolyphosphate (STPP) chewing gum, and HP mouthwash) at different concentrations with varying application times whitened teeth compared to placebo over a short time period (from 2 weeks to 6 months), however the certainty of the evidence is low to very low.\nIn trials comparing one bleaching agent to another, concentrations, application method and application times, and duration of use varied widely. Most of the comparisons were reported in single trials with small sample sizes and event rates and certainty of the evidence was assessed as low to very low. Therefore the evidence currently available is insufficient to draw reliable conclusions regarding the superiority of home-based bleaching compositions or any particular method of application or concentration or application time or duration of use.\nTooth sensitivity and oral irritation were the most common side effects which were more prevalent with higher concentrations of active agents though the effects were mild and transient. Tooth whitening did not have any effect on oral health-related quality of life.\nAuthors' conclusions\nWe found low to very low-certainty evidence over short time periods to support the effectiveness of home-based chemically-induced bleaching methods compared to placebo for all the outcomes tested.\nWe were unable to draw any conclusions regarding the superiority of home-based bleaching compositions or any particular method of application or concentration or application time or duration of use, as the overall evidence generated was of very low certainty. Well-planned RCTs need to be conducted by standardising methods of application, concentrations, application times, and duration of treatment.\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": "There has been an increasing demand for whiter teeth. Home-based whitening products with a bleaching action have become popular and are prescribed to people by the dentist or purchased over-the-counter. A variety of whitening products are available which include hydrogen peroxide, carbamide peroxide, sodium percarbonate, sodium hexametaphosphate, sodium tripolyphosphate, and calcium peroxide. These agents are supplied in different concentrations and are used with different methods of application (gel in tray, strips, paint-on gel, chewing gum, and mouthwash), which have varying application times and duration of treatment."
}
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query-laysum | 4706 | [
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy, or psychotherapy.\nObjectives\nTo assess the efficacy and safety of second-generation antidepressants (SGAs) for the treatment of seasonal affective disorder (SAD) in adults in comparison with placebo, light therapy, other SGAs, or psychotherapy.\nSearch methods\nThis is an update of an earlier review first published in 2011. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 1) in the Cochrane Library (all years), Ovid MEDLINE, Embase, and PsycINFO (2011 to January 2020), together with the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) (all available years), for reports of randomised controlled trials (RCTs). We hand searched the reference lists of all included studies and other systematic reviews. We searched ClinicalTrials.gov for unpublished/ongoing trials. We ran a separate update search for reports of adverse events in the Ovid databases.\nSelection criteria\nFor efficacy we included RCTs of SGAs compared with other SGAs, placebo, light therapy, or psychotherapy in adult participants with SAD. For adverse events we also included non-randomised studies.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text publications against the inclusion criteria. Data extraction and 'Risk of bias' assessment were conducted individually. We pooled data for meta-analysis where the participant groups were similar, and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment.\nMain results\nIn this update we identified no new RCT on the effectiveness of SGAs in SAD patients. We included 2 additional single-arm observational studies that reported on adverse events of SGAs.\nFor efficacy we included three RCTs of between five and eight weeks' duration with a total of 204 participants. For adverse events we included two RCTs and five observational (non-randomised) studies of five to eight weeks' duration with a total of 249 participants. All participants met the DSM (Diagnostic and Statistical Manual of Mental Disorders) criteria for SAD. The average age ranged from 34 to 42 years, and the majority of participants were female (66% to 100%).\nResults from one trial with 68 participants showed that fluoxetine (20/36) was numerically superior to placebo (11/32) in achieving clinical response; however, the confidence interval (CI) included both a potential benefit as well as no benefit of fluoxetine (risk ratio (RR) 1.62, 95% CI 0.92 to 2.83, very low-certainty evidence). The number of adverse events was similar in both groups (very low-certainty evidence).\nTwo trials involving a total of 136 participants compared fluoxetine versus light therapy. Meta-analysis showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24, low-certainty evidence), RR of remission 0.81 (95% CI 0.39 to 1.71, very low-certainty evidence). The number of adverse events was similar in both groups (low-certainty evidence).\nWe did not identify any eligible study comparing SGA with another SGA or with psychotherapy.\nTwo RCTs and five non-randomised studies reported adverse event data on a total of 249 participants who received bupropion, fluoxetine, escitalopram, duloxetine, nefazodone, reboxetine, light therapy, or placebo. We were only able to obtain crude rates of adverse events, therefore caution is advised regarding interpretation of this information. Between 0% and 100% of participants who received an SGA suffered an adverse event, and between 0% and 25% of participants withdrew from the study due to adverse events.\nAuthors' conclusions\nEvidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo showing a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy suggesting equivalence between the two interventions. The lack of available evidence precluded us from drawing any overall conclusions on the use of SGAs for SAD. Further, larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs.\nData on adverse events were sparse, and a comparative analysis was not possible. The data we obtained on adverse events is therefore not robust, and our confidence in the data is limited. Overall, up to 25% of participants treated with SGAs for SAD withdrew from the study early due to adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three trials with a total of 204 participants that looked at one SGA (fluoxetine) compared with placebo (dummy pill) or light therapy. One trial (68 participants) compared fluoxetine with placebo, although participants receiving fluoxetine were more likely to respond to treatment, there wasn't enough data to be sure of any differences with placebo. Approximately the same number of participants in both groups experienced a side effect.\nWe found two trials with a total of 136 participants that compared fluoxetine with light therapy. When we combined the results of these two trials, we found that the two treatments were similar in their effects: approximately 66 out of 100 people improved in both the fluoxetine and light therapy groups. The number of participants with side effects was also about the same in the fluoxetine and light therapy groups.\nWe found five additional studies that provided information on the safety of SGAs for the treatment of winter depression. They reported side effects of the SGAs bupropion, fluoxetine, escitalopram, duloxetine, nefazodone, and reboxetine. We were unable to compare the drugs directly, but we can report that about 0% to 25% of people left the study early due to side effects, and the most common side effects were nausea, diarrhoea, disturbed sleep, decreased sex drive, dry mouth, and agitation. We could not compare the rates of side effects in people taking SGAs compared with placebo, which means that our confidence in the information on side effects is limited."
}
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query-laysum | 4707 | [
{
"role": "user",
"content": "Abstract: Background\nInjuries to the recurrent inferior laryngeal nerve (RILN) remain one of the major post-operative complications after thyroid and parathyroid surgery. Damage to this nerve can result in a temporary or permanent palsy, which is associated with vocal cord paresis or paralysis. Visual identification of the RILN is a common procedure to prevent nerve injury during thyroid and parathyroid surgery. Recently, intraoperative neuromonitoring (IONM) has been introduced in order to facilitate the localisation of the nerves and to prevent their injury during surgery. IONM permits nerve identification using an electrode, where, in order to measure the nerve response, the electric field is converted to an acoustic signal.\nObjectives\nTo assess the effects of IONM versus visual nerve identification for the prevention of RILN injury in adults undergoing thyroid surgery.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 21 August 2018. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing IONM nerve identification plus visual nerve identification versus visual nerve identification alone for prevention of RILN injury in adults undergoing thyroid surgery\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance. One review author carried out screening for inclusion, data extraction and 'Risk of bias' assessment and a second review author checked them. For dichotomous outcomes, we calculated risk ratios (RRs) with 95% confidence intervals (CIs). For continuous outcomes, we calculated mean differences (MDs) with 95% CIs. We assessed trials for certainty of the evidence using the GRADE instrument.\nMain results\nFive RCTs with 1558 participants (781 participants were randomly assigned to IONM and 777 to visual nerve identification only) met the inclusion criteria; two trials were performed in Poland and one trial each was performed in China, Korea and Turkey. Inclusion and exclusion criteria differed among trials: previous thyroid or parathyroid surgery was an exclusion criterion in three trials. In contrast, this was a specific inclusion criterion in another trial. Three trials had central neck compartment dissection or lateral neck dissection and Graves’ disease as exclusion criteria. The mean duration of follow-up ranged from 6 to 12 months. The mean age of participants ranged between 41.7 years and 51.9 years.\nThere was no firm evidence of an advantage or disadvantage comparing IONM with visual nerve identification only for permanent RILN palsy (RR 0.77, 95% CI 0.33 to 1.77; P = 0.54; 4 trials; 2895 nerves at risk; very low-certainty evidence) or transient RILN palsy (RR 0.62, 95% CI 0.35 to 1.08; P = 0.09; 4 trials; 2895 nerves at risk; very low-certainty evidence). None of the trials reported health-related quality of life. Transient hypoparathyroidism as an adverse event was not substantially different between intervention and comparator groups (RR 1.25; 95% CI 0.45 to 3.47; P = 0.66; 2 trials; 286 participants; very low-certainty evidence). Operative time was comparable between IONM and visual nerve monitoring alone (MD 5.5 minutes, 95% CI −0.7 to 11.8; P = 0.08; 3 trials; 1251 participants; very low-certainty evidence). Three of five included trials provided data on all-cause mortality: no deaths were reported. None of the trials reported socioeconomic effects. The evidence reported in this review was mostly of very low certainty, particularly because of risk of bias, a high degree of imprecision due to wide confidence intervals and substantial between-study heterogeneity.\nAuthors' conclusions\nResults from this systematic review and meta-analysis indicate that there is currently no conclusive evidence for the superiority or inferiority of IONM over visual nerve identification only on any of the outcomes measured. Well-designed, executed, analysed and reported RCTs with a larger number of participants and longer follow-up, employing the latest IONM technology and applying new surgical techniques are 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": "Thyroidectomy is an operation that removes a part or all of the thyroid gland to cure benign disorders (for example multinodular goitre), or cancer. The recurrent laryngeal nerves are responsible for the movement of the vocal cords and they can easily be injured during thyroid surgery, resulting in one-sided or two-sided vocal cord paralysis leading to difficulty in speaking (dysphonia), breathing problems, or both. This, in turn may result in decreased health-related quality of life and may lead to permanent disability. Visual identification of recurrent laryngeal nerves during surgery has long been a standard procedure to prevent their injury. Recently, intraoperative neuromonitoring, which identifies nerves using an electrode, has been introduced to help the surgeon find and protect the recurrent laryngeal nerves."
}
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query-laysum | 4708 | [
{
"role": "user",
"content": "Abstract: Background\nDepression is a debilitating condition affecting more than 350 million people worldwide (WHO 2012) with a limited number of evidence-based treatments. Drug treatments may be inappropriate due to side effects and cost, and not everyone can use talking therapies.There is a need for evidence-based treatments that can be applied across cultures and with people who find it difficult to verbally articulate thoughts and feelings. Dance movement therapy (DMT) is used with people from a range of cultural and intellectual backgrounds, but effectiveness remains unclear.\nObjectives\nTo examine the effects of DMT for depression with or without standard care, compared to no treatment or standard care alone, psychological therapies, drug treatment, or other physical interventions. Also, to compare the effectiveness of different DMT approaches.\nSearch methods\nThe Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR-Studies and CCDANCTR-References) and CINAHL were searched (to 2 Oct 2014) together with the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The review authors also searched the Allied and Complementary Medicine Database (AMED), the Education Resources Information Center (ERIC) and Dissertation Abstracts (to August 2013), handsearched bibliographies, contacted professional associations, educational programmes and dance therapy experts worldwide.\nSelection criteria\nInclusion criteria were: randomised controlled trials (RCTs) studying outcomes for people of any age with depression as defined by the trialist, with at least one group being DMT. DMT was defined as: participatory dance movement with clear psychotherapeutic intent, facilitated by an individual with a level of training that could be reasonably expected within the country in which the trial was conducted. For example, in the USA this would either be a trainee, or qualified and credentialed by the American Dance Therapy Association (ADTA). In the UK, the therapist would either be in training with, or accredited by, the Association for Dance Movement Psychotherapy (ADMP, UK). Similar professional bodies exist in Europe, but in some countries (e.g. China) where the profession is in development, a lower level of qualification would mirror the situation some decades previously in the USA or UK. Hence, the review authors accepted a relevant professional qualification (e.g. nursing or psychodynamic therapies) plus a clear description of the treatment that would indicate its adherence to published guidelines including Levy 1992, ADMP UK 2015, Meekums 2002, and Karkou 2006.\nData collection and analysis\nStudy methodological quality was evaluated and data were extracted independently by the first two review authors using a data extraction form, the third author acting as an arbitrator.\nMain results\nThree studies totalling 147 participants (107 adults and 40 adolescents) met the inclusion criteria. Seventy-four participants took part in DMT treatment, while 73 comprised the control groups. Two studies included male and female adults with depression. One of these studies included outpatient participants; the other study was conducted with inpatients at an urban hospital. The third study reported findings with female adolescents in a middle-school setting. All included studies collected continuous data using two different depression measures: the clinician-completed Hamilton Depression Rating Scale (HAM-D); and the Symptom Checklist-90-R (SCL-90-R) (self-rating scale).\nStatistical heterogeneity was identified between the three studies. There was no reliable effect of DMT on depression (SMD -0.67 95% CI -1.40 to 0.05; very low quality evidence). A planned subgroup analysis indicated a positive effect in adults, across two studies, 107 participants, but this failed to meet clinical significance (SMD -7.33 95% CI -9.92 to -4.73).\nOne adult study reported drop-out rates, found to be non-significant with an odds ratio of 1.82 [95% CI 0.35 to 9.45]; low quality evidence. One study measured social functioning, demonstrating a large positive effect (MD -6.80 95 % CI -11.44 to -2.16; very low quality evidence), but this result was imprecise. One study showed no effect in either direction for quality of life (0.30 95% CI -0.60 to 1.20; low quality evidence) or self esteem (1.70 95% CI -2.36 to 5.76; low quality evidence).\nAuthors' conclusions\nThe low-quality evidence from three small trials with 147 participants does not allow any firm conclusions to be drawn regarding the effectiveness of DMT for depression. Larger trials of high methodological quality are needed to assess DMT for depression, with economic analyses and acceptability measures and for all age groups.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to the low number of studies and low quality of evidence, it was not possible to draw firm conclusions about the effectiveness of DMT for depression. It was not possible to compare DMT with medication, talking therapies, physical treatments or to compare types of DMT due to lack of available evidence. Key findings were:\nOverall, there is no evidence for or against DMT as a treatment for depression. There is some evidence to suggest DMT is more effective than standard care for adults, but this was not clinically significant. DMT is no more effective than standard care for young people.\nEvidence from just one study of low methodological quality suggested that drop-out rates from the DMT group were not significant, and there is no reliable effect in either direction for quality of life or self esteem. A large positive effect was observed for social functioning, but since this was from one study of low methodological quality the result is imprecise."
}
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query-laysum | 4709 | [
{
"role": "user",
"content": "Abstract: Background\nRespiratory tract infections with Pseudomonas aeruginosa occur in most people with cystic fibrosis (CF). Established chronic P aeruginosa infection is virtually impossible to eradicate and is associated with increased mortality and morbidity. Early infection may be easier to eradicate.\nThis is an updated review.\nObjectives\nDoes giving antibiotics for P aeruginosa infection in people with CF at the time of new isolation improve clinical outcomes (e.g. mortality, quality of life and morbidity), eradicate P aeruginosa infection, and delay the onset of chronic infection, but without adverse effects, compared to usual treatment or an alternative antibiotic regimen? We also assessed cost-effectiveness.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and conference proceedings. Latest search: 24 March 2022.\nWe searched ongoing trials registries. Latest search: 6 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of people with CF, in whom P aeruginosa had recently been isolated from respiratory secretions. We compared combinations of inhaled, oral or intravenous (IV) antibiotics with placebo, usual treatment or other antibiotic combinations. We excluded non-randomised trials and cross-over trials.\nData collection and analysis\nTwo authors independently selected trials, assessed risk of bias and extracted data. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 11 trials (1449 participants) lasting between 28 days and 27 months; some had few participants and most had relatively short follow-up periods. Antibiotics in this review are: oral – ciprofloxacin and azithromycin; inhaled – tobramycin nebuliser solution for inhalation (TNS), aztreonam lysine (AZLI) and colistin; IV – ceftazidime and tobramycin. There was generally a low risk of bias from missing data. In most trials it was difficult to blind participants and clinicians to treatment. Two trials were supported by the manufacturers of the antibiotic used.\nTNS versus placebo\nTNS may improve eradication; fewer participants were still positive for P aeruginosa at one month (odds ratio (OR) 0.06, 95% confidence interval (CI) 0.02 to 0.18; 3 trials, 89 participants; low-certainty evidence) and two months (OR 0.15, 95% CI 0.03 to 0.65; 2 trials, 38 participants). We are uncertain whether the odds of a positive culture decrease at 12 months (OR 0.02, 95% CI 0.00 to 0.67; 1 trial, 12 participants).\nTNS (28 days) versus TNS (56 days)\nOne trial (88 participants) comparing 28 days to 56 days TNS treatment found duration of treatment may make little or no difference in time to next isolation (hazard ratio (HR) 0.81, 95% CI 0.37 to 1.76; low-certainty evidence).\nCycled TNS versus culture-based TNS\nOne trial (304 children, one to 12 years old) compared cycled TNS to culture-based therapy and also ciprofloxacin to placebo. We found moderate-certainty evidence of an effect favouring cycled TNS therapy (OR 0.51, 95% CI 0.31 to 0.82), although the trial publication reported age-adjusted OR and no difference between groups.\nCiprofloxacin versus placebo added to cycled and culture-based TNS therapy\nOne trial (296 participants) examined the effect of adding ciprofloxacin versus placebo to cycled and culture-based TNS therapy. There is probably no difference between ciprofloxacin and placebo in eradicating P aeruginosa (OR 0.89, 95% CI 0.55 to 1.44; moderate-certainty evidence).\nCiprofloxacin and colistin versus TNS\nWe are uncertain whether there is any difference between groups in eradication of P aeruginosa at up to six months (OR 0.43, 95% CI 0.15 to 1.23; 1 trial, 58 participants) or up to 24 months (OR 0.76, 95% CI 0.24 to 2.42; 1 trial, 47 participants); there was a low rate of short-term eradication in both groups.\nCiprofloxacin plus colistin versus ciprofloxacin plus TNS\nOne trial (223 participants) found there may be no difference in positive respiratory cultures at 16 months between ciprofloxacin with colistin versus TNS with ciprofloxacin (OR 1.28, 95% CI 0.72 to 2.29; low-certainty evidence).\nTNS plus azithromycin compared to TNS plus oral placebo\nAdding azithromycin may make no difference to the number of participants eradicating P aeruginosa after a three-month treatment phase (risk ratio (RR) 1.01, 95% CI 0.75 to 1.35; 1 trial, 91 participants; low-certainty evidence); there was also no evidence of any difference in the time to recurrence.\nCiprofloxacin and colistin versus no treatment\nA single trial only reported one of our planned outcomes; there were no adverse effects in either group.\nAZLI for 14 days plus placebo for 14 days compared to AZLI for 28 days\nWe are uncertain whether giving 14 or 28 days of AZLI makes any difference to the proportion of participants having a negative respiratory culture at 28 days (mean difference (MD) -7.50, 95% CI -24.80 to 9.80; 1 trial, 139 participants; very low-certainty evidence).\nCeftazidime with IV tobramycin compared with ciprofloxacin (both regimens in conjunction with three months colistin)\nIV ceftazidime with tobramycin compared with ciprofloxacin may make little or no difference to eradication of P aeruginosa at three months, sustained to 15 months, provided that inhaled antibiotics are also used (RR 0.84, 95 % CI 0.65 to 1.09; P = 0.18; 1 trial, 255 participants; high-certainty evidence). The results do not support using IV antibiotics over oral therapy to eradicate P aeruginosa, based on both eradication rate and financial cost.\nAuthors' conclusions\nWe found that nebulised antibiotics, alone or with oral antibiotics, were better than no treatment for early infection with P aeruginosa. Eradication may be sustained in the short term. There is insufficient evidence to determine whether these antibiotic strategies decrease mortality or morbidity, improve quality of life, or are associated with adverse effects compared to placebo or standard treatment. Four trials comparing two active treatments have failed to show differences in rates of eradication of P aeruginosa. One large trial showed that intravenous ceftazidime with tobramycin is not superior to oral ciprofloxacin when inhaled antibiotics are also used. There is still insufficient evidence to state which antibiotic strategy should be used for the eradication of early P aeruginosa infection in CF, but there is now evidence that intravenous therapy is not superior to oral antibiotics.\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": "Three small studies (of 89 people) treating early infection showed that after one month, inhaled antibiotics were better than no treatment and cleared P aeruginosa in most people, but our confidence in the evidence is low.\nThere is likely to be little difference in the other treatments regarding how well they clear P aeruginosa from the lungs, although we found that inhaled antibiotics, alone or with oral antibiotics, were better than no treatment for early infection with Pseudomonas aeruginosa. A study of IV ceftazidime with tobramycin in comparison with oral ciprofloxacin also showed neither group was better at getting rid of P aeruginosa, but we are more certain of the results and this means that it may be just as effective to treat with oral antibiotics."
}
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query-laysum | 4710 | [
{
"role": "user",
"content": "Abstract: Background\nSelf-management interventions help people with chronic obstructive pulmonary disease (COPD) to acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable them to control their disease. Since the 2014 update of this review, several studies have been published.\nObjectives\nPrimary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of health-related quality of life (HRQoL) and respiratory-related hospital admissions.\nTo evaluate the safety of COPD self-management interventions compared to usual care in terms of respiratory-related mortality and all-cause mortality.\nSecondary objectives\nTo evaluate the effectiveness of COPD self-management interventions compared to usual care in terms of other health outcomes and healthcare utilisation.\nTo evaluate effective characteristics of COPD self-management interventions.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, EMBASE, trials registries and the reference lists of included studies up until January 2020.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-randomised trials (CRTs) published since 1995. To be eligible for inclusion, self-management interventions had to include at least two intervention components and include an iterative process between participant and healthcare provider(s) in which goals were formulated and feedback was given on self-management actions by the participant.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. We contacted study authors to obtain additional information and missing outcome data where possible. Primary outcomes were health-related quality of life (HRQoL), number of respiratory-related hospital admissions, respiratory-related mortality, and all-cause mortality. When appropriate, we pooled study results using random-effects modelling meta-analyses.\nMain results\nWe included 27 studies involving 6008 participants with COPD. The follow-up time ranged from two-and-a-half to 24 months and the content of the interventions was diverse. Participants' mean age ranged from 57 to 74 years, and the proportion of male participants ranged from 33% to 98%. The post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of participants ranged from 33.6% to 57.0%. The FEV1/FVC ratio is a measure used to diagnose COPD and to determine the severity of the disease. Studies were conducted on four different continents (Europe (n = 15), North America (n = 8), Asia (n = 1), and Oceania (n = 4); with one study conducted in both Europe and Oceania).\nSelf-management interventions likely improve HRQoL, as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score (lower score represents better HRQoL) with a mean difference (MD) from usual care of -2.86 points (95% confidence interval (CI) -4.87 to -0.85; 14 studies, 2778 participants; low-quality evidence). The pooled MD of -2.86 did not reach the SGRQ minimal clinically important difference (MCID) of four points. Self-management intervention participants were also at a slightly lower risk for at least one respiratory-related hospital admission (odds ratio (OR) 0.75, 95% CI 0.57 to 0.98; 15 studies, 3263 participants; very low-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over a mean of 9.75 months' follow-up was 15 (95% CI 8 to 399) for participants with high baseline risk and 26 (95% CI 15 to 677) for participants with low baseline risk. No differences were observed in respiratory-related mortality (risk difference (RD) 0.01, 95% CI -0.02 to 0.04; 8 studies, 1572 participants ; low-quality evidence) and all-cause mortality (RD -0.01, 95% CI -0.03 to 0.01; 24 studies, 5719 participants; low-quality evidence).\nWe graded the evidence to be of ‘moderate’ to ‘very low’ quality according to GRADE. All studies had a substantial risk of bias, because of lack of blinding of participants and personnel to the interventions, which is inherently impossible in a self-management intervention. In addition, risk of bias was noticeably increased because of insufficient information regarding a) non-protocol interventions, and b) analyses to estimate the effect of adhering to interventions. Consequently, the highest GRADE evidence score that could be obtained by studies was ‘moderate’.\nAuthors' conclusions\nSelf-management interventions for people with COPD are associated with improvements in HRQoL, as measured with the SGRQ, and a lower probability of respiratory-related hospital admissions. No excess respiratory-related and all-cause mortality risks were observed, which strengthens the view that COPD self-management interventions are unlikely to cause harm. By using stricter inclusion criteria, we decreased heterogeneity in studies, but also reduced the number of included studies and therefore our capacity to conduct subgroup analyses. Data were therefore still insufficient to reach clear conclusions about effective (intervention) characteristics of COPD self-management interventions. As tailoring of COPD self-management interventions to individuals is desirable, heterogeneity is and will likely remain present in self-management interventions.\nFor future studies, we would urge using only COPD self-management interventions that include iterative interactions between participants and healthcare professionals who are competent using behavioural change techniques (BCTs) to elicit participants' motivation, confidence and competence to positively adapt their health behaviour(s) and develop skills to better manage their disease. In addition, to inform further subgroup and meta-regression analyses and to provide stronger conclusions regarding effective COPD self-management interventions, there is a need for more homogeneity in outcome measures. More attention should be paid to behavioural outcome measures and to providing more detailed, uniform and transparently reported data on self-management intervention components and BCTs. Assessment of outcomes over the long term is also recommended to capture changes in people's behaviour. Finally, information regarding non-protocol interventions as well as analyses to estimate the effect of adhering to interventions should be included to increase the quality of evidence.\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": "Our confidence in the evidence for the main findings in this review ranged from ‘very low’ to ‘moderate’, due to the nature of the COPD self-management intervention – none of the studies prevented participants and personnel from knowing what treatment the participants were getting. Additionally, none of the studies provided detailed information about the extent to which participants adhere to the self-management intervention or whether any further treatments were given during the course of the study. Consequently, study evidence could not be graded higher than ‘moderate’ in any of the studies."
}
]
|
query-laysum | 4711 | [
{
"role": "user",
"content": "Abstract: Background\nChemotherapy is the treatment of choice in patients with advanced or metastatic colorectal cancer (CRC) where surgical resection of metastases is not an option. Both irinotecan (IRI) and fluoropyrimidines are often included in first- or second- line chemotherapy treatment regimens in such patients. However, it is not clear whether combining these agents is superior to irinotecan alone.\nObjectives\nTo compare the efficacy and safety of two chemotherapeutic regimens, irinotecan monotherapy or irinotecan in combination with fluoropyrimidines, for patients with advanced CRC when administered in the first or second-line settings.\nSearch methods\nWe searched the following electronic databases to identify randomized controlled trials: Cochrane Colorectal Cancer Group Specialised Register (January 13, 2016), Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library Issue 12, 2016), Ovid MEDLINE (1950 to January 13, 2016), Ovid EMBASE (1974 to January 13, 2016), registers of controlled trials in progress, references cited in relevant publications and conference proceedings in related fields (BioMed Central and Medscape's Conference). The key authors or investigators of all eligible studies, and professionals in the field were contacted when necessary. The search from January 2016 identified one eligible study, an ongoing trial currently presented as an abstract, to be considered in an update of this review.\nSelection criteria\nRandomized controlled trials (RCTs) investigating the efficacy and safety of IRI chemotherapy combined with fluoropyrimidine compared with IRI alone for the treatment of patients with advanced CRC, regardless of treatment line settings.\nData collection and analysis\nStudy eligibility and methodological quality were assessed independently by the two authors, and any disagreement was solved by a third author. The data collected from the studies were reviewed qualitatively and quantitatively using the Cochrane Collaboration statistical software RevMan 5.3.\nMain results\nFive studies were included in this review with a total of 1,726 patients. The top-up search resulted in an additional ongoing trial, the results of which have not been incorporated in this review. Among five included studies, no reduction in all-cause mortality was observed in the combination arm, with a summary hazard ratio (HR) of 0.91 (95% CI: 0.81-1.02). Longer progression-free survival was observed in those treated with the combination chemotherapy (HR: 0.68, 95% CI: 0.53-0.87), however, this result may have been driven by findings from the single first-line treatment setting study.\nThe quality of evidence for overall survival was low and for progression-free survival was moderate, mainly due to study limitation from the lack of information on randomisation methods and allocation concealment.\nThere were higher risks of toxicity outcomes grade 3 or 4 diarrhoea and grade 1 or 2 alopecia, and a lower risk of grade 3 or 4 neutropenia in controls compared to the invervention group. Evidence for toxicity has been assessed to be low to moderate quality.\nAuthors' conclusions\nThere was no overall survival benefit of the irinotecan and fluoropyrimidine treatment over irinotecan alone, thus both regimens remain reasonable options in treating patients with advanced or metastatic CRC. Given the low and moderate quality of the evidence, future studies with sufficient numbers of patients in each treatment arms are needed to clarify the benefit observed in progression-free survival with combination irinotecan and fluoropyrimidines.\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": "Patients with inoperable colorectal cancer (CRC) are likely to receive chemotherapy drugs as their primary treatment. Irinotecan (IRI) and fluoropyrimidines are two such drugs widely used in this setting, either alone or as part of multi-drug chemotherapy treatments."
}
]
|
query-laysum | 4712 | [
{
"role": "user",
"content": "Abstract: Background\nAcute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome.\nAPE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE is systemic anticoagulation.\nHigh-risk (massive) APE accounts for less than 10% of APE cases and is a life-threatening medical emergency, requiring immediate reperfusion treatment to prevent death. Systemic thrombolysis is the recommended treatment for high-risk (massive) APE. However, only a minority of the people affected receive systemic thrombolysis, due to comorbidities or the 10% risk of major haemorrhagic side effects. Of those who do receive systemic thrombolysis, 8% do not respond in a timely manner. Surgical pulmonary embolectomy is an alternative reperfusion treatment, but is not widely available.\nIntermediate-risk (submassive) APE represents 45% to 65% of APE cases, with a short-term mortality rate of around 3%. Systemic thrombolysis is not recommended for this group, as major haemorrhagic complications outweigh the benefit. However, the people at higher risk within this group have a short-term mortality of around 12%, suggesting that anticoagulation alone is not an adequate treatment. Identification and more aggressive treatment of people at intermediate to high risk, who have a more favourable risk profile for reperfusion treatments, could reduce short-term mortality and potentially reduce post-PE syndrome.\nCatheter-directed treatments (catheter-directed thrombolysis and catheter embolectomy) are minimally invasive reperfusion treatments for high- and intermediate-risk APE. Catheter-directed treatments can be used either as the primary treatment or as salvage treatment after failure of systemic thrombolysis. Catheter-directed thrombolysis administers 10% to 20% of the systemic thrombolysis dose directly into the thrombus in the lungs, potentially reducing the risks of haemorrhagic side effects. Catheter embolectomy mechanically removes the thrombus without the need for thrombolysis, and may be useful for people with contraindications for thrombolysis.\nCurrently, the benefits of catheter-based APE treatments compared with existing medical and surgical treatment are unclear despite increasing adoption of catheter treatments by PE response teams. This review examines the evidence for the use of catheter-directed treatments in high- and intermediate-risk APE. This evidence could help guide the optimal treatment strategy for people affected by this common and life-threatening condition.\nObjectives\nTo assess the effects of catheter-directed therapies versus alternative treatments for high-risk (massive) and intermediate-risk (submassive) APE.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 15 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) of catheter-directed therapies for the treatment of high-risk (massive) and intermediate-risk (submassive) APE. We excluded catheter-directed treatments for non-PE. We applied no restrictions on participant age or on the date, language or publication status of RCTs.\nData collection and analysis\nWe used standard Cochrane methods. The main outcomes were all-cause mortality, treatment-associated major and minor haemorrhage rates based on two established clinical definitions, recurrent APE requiring retreatment or change to a different APE treatment, length of hospital stay, and quality of life. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified one RCT (59 participants) of (ultrasound-augmented) catheter-directed thrombolysis for intermediate-risk (submassive) APE.\nWe found no trials of any catheter-directed treatments (thrombectomy or thrombolysis) in people with high-risk (massive) APE or of catheter-based embolectomy in people with intermediate-risk (submassive) APE.\nThe included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone. In the treatment group, each participant received an infusion of alteplase 10 mg or 20 mg over 15 hours. We identified a high risk of selection and performance bias, low risk of detection and reporting bias, and unclear risk of attrition and other bias. Certainty of evidence was very low because of risk of bias and imprecision.\nBy 90 days, there was no clear difference in all-cause mortality between the treatment group and control group. A single death occurred in the control group at 20 days after randomisation, but it was unrelated to the treatment or to APE (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.01 to 7.96; 59 participants).\nBy 90 days, there were no episodes of treatment-associated major haemorrhage in either the treatment or control group. There was no clear difference in treatment-associated minor haemorrhage between the treatment and control group by 90 days (OR 3.11, 95% CI 0.30 to 31.79; 59 participants).\nBy 90 days, there were no episodes of recurrent APE requiring retreatment or change to a different APE treatment in the treatment or control group.\nThere was no clear difference in the length of mean total hospital stay between the treatment and control groups. Mean stay was 8.9 (standard deviation (SD) 3.4) days in the treatment group versus 8.6 (SD 3.9) days in the control group (mean difference 0.30, 95% CI −1.57 to 2.17; 59 participants).\nThe included trial did not investigate quality of life measures.\nAuthors' conclusions\nThere is a lack of evidence to support widespread adoption of catheter-based interventional therapies for APE. We identified one small trial showing no clear differences between ultrasound-augmented catheter-directed thrombolysis with alteplase plus systemic heparinisation versus systemic heparinisation alone in all-cause mortality, major and minor haemorrhage rates, recurrent APE and length of hospital stay. Quality of life was not assessed.\nMultiple small retrospective case series, prospective patient registries and single-arm studies suggest potential benefits of catheter-based treatments, but they provide insufficient evidence to recommend this approach over other evidence-based treatments.\nResearchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have very little confidence in the evidence because the trial staff and participants were aware of which treatment the participants received, and the trial involved a small number of participants."
}
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query-laysum | 4713 | [
{
"role": "user",
"content": "Abstract: Background\nNon-adherence to immunosuppressant therapy is a significant concern following a solid organ transplant, given its association with graft failure. Adherence to immunosuppressant therapy is a modifiable patient behaviour, and different approaches to increasing adherence have emerged, including multi-component interventions. There has been limited exploration of the effectiveness of interventions to increase adherence to immunosuppressant therapy.\nObjectives\nThis review aimed to look at the benefits and harms of using interventions for increasing adherence to immunosuppressant therapies in solid organ transplant recipients, including adults and children with a heart, lung, kidney, liver and pancreas transplant.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 14 October 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs examining interventions to increase immunosuppressant adherence following a solid organ transplant (heart, lung, kidney, liver, pancreas) were included. There were no restrictions on language or publication type.\nData collection and analysis\nTwo authors independently screened titles and abstracts of identified records, evaluated study quality and assessed the quality of the evidence using the GRADE approach. The risk of bias was assessed using the Cochrane tool. The ABC taxonomy for measuring medication adherence provided the analysis framework, and the primary outcomes were immunosuppressant medication initiation, implementation (taking adherence, dosing adherence, timing adherence, drug holidays) and persistence. Secondary outcomes were surrogate markers of adherence, including self-reported adherence, trough concentration levels of immunosuppressant medication, acute graft rejection, graft loss, death, hospital readmission and health-related quality of life (HRQoL). Meta-analysis was conducted where possible, and narrative synthesis was carried out for the remainder of the results.\nMain results\nForty studies involving 3896 randomised participants (3718 adults and 178 adolescents) were included. Studies were heterogeneous in terms of the type of intervention and outcomes assessed. The majority of studies (80%) were conducted in kidney transplant recipients. Two studies examined paediatric solid organ transplant recipients. The risk of bias was generally high or unclear, leading to lower certainty in the results. Initiation of immunosuppression was not measured by the included studies.\nThere is uncertain evidence of an association between immunosuppressant medication adherence interventions and the proportion of participants classified as adherent to taking immunosuppressant medication (4 studies, 445 participants: RR 1.09, 95% CI 0.95 to 1.20; I² = 78%). There was very marked heterogeneity in treatment effects between the four studies evaluating taking adherence, which may have been due to the different types of interventions used. There was evidence of increasing dosing adherence in the intervention group (8 studies, 713 participants: RR 1.14, 95% CI 1.03 to 1.26, I² = 61%). There was very marked heterogeneity in treatment effects between the eight studies evaluating dosing adherence, which may have been due to the different types of interventions used. It was uncertain if an intervention to increase immunosuppressant adherence had an effect on timing adherence or drug holidays. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on persistence.\nThere was limited evidence that an intervention to increase immunosuppressant adherence had an effect on secondary outcomes. For self-reported adherence, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants classified as medically adherent to immunosuppressant therapy (9 studies, 755 participants: RR 1.21, 95% CI 0.99 to 1.49; I² = 74%; very low certainty evidence). Similarly, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the mean adherence score on self-reported adherence measures (5 studies, 471 participants: SMD 0.65, 95% CI -0.31 to 1.60; I² = 96%; very low certainty evidence). For immunosuppressant trough concentration levels, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants who reach target immunosuppressant trough concentration levels (4 studies, 348 participants: RR 0.98, 95% CI 0.68 to 1.40; I² = 40%; very low certainty evidence). It is uncertain whether an intervention to increase adherence to immunosuppressant medication may reduce hospitalisations (5 studies, 460 participants: RR 0.67, 95% CI 0.44 to 1.02; I² = 64%; low certainty evidence). There were limited, low certainty effects on patient-reported health outcomes such as HRQoL. There was no clear evidence to determine the effect of interventions on secondary outcomes, including acute graft rejection, graft loss and death. No harms from intervention participation were reported.\nAuthors' conclusions\nInterventions to increase taking and dosing adherence to immunosuppressant therapy may be effective; however, our findings suggest that current evidence in support of interventions to increase adherence to immunosuppressant therapy is overall of low methodological quality, attributable to small sample sizes, and heterogeneity identified for the types of interventions. Twenty-four studies are currently ongoing or awaiting assessment (3248 proposed participants); therefore, it is possible that findings may change with the inclusion of these large ongoing studies in future updates.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 40 studies that involved 3718 adults and 178 adolescents. The majority of studies included participants with a kidney transplant. We found that the types of interventions varied across the studies, and 27 studies included more than one approach to increase immunosuppressant medication adherence. We found some evidence to support the effectiveness of interventions to increase taking the correct dosage of medication. It was unclear whether using an intervention increased adherence to immunosuppressant medication following a solid organ transplant. It was also unclear if interventions affected concentrations of immunosuppressant medication in the blood, rates of transplant rejection, death, the need for hospital admission and health-related quality of life. There was low confidence in the information about the effects of interventions as some studies were small, the types of interventions varied, and studies defined and measured medication adherence in different ways. We didn't find enough information to assess whether certain types of interventions were more effective than other types."
}
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query-laysum | 4714 | [
{
"role": "user",
"content": "Abstract: Background\nIn in vitro fertilisation (IVF) with or without intracytoplasmic sperm injection (ICSI), selection of the most competent embryo(s) for transfer is based on morphological criteria. However, many women do not achieve a pregnancy even after 'good quality' embryo transfer. One of the presumed causes is that such morphologically normal embryos have an abnormal number of chromosomes (aneuploidies). Preimplantation genetic testing for aneuploidies (PGT-A), formerly known as preimplantation genetic screening (PGS), was therefore developed as an alternative method to select embryos for transfer in IVF. In PGT-A, the polar body or one or a few cells of the embryo are obtained by biopsy and tested. Only polar bodies and embryos that show a normal number of chromosomes are transferred.\nThe first generation of PGT-A, using cleavage-stage biopsy and fluorescence in situ hybridisation (FISH) for the genetic analysis, was demonstrated to be ineffective in improving live birth rates. Since then, new PGT-A methodologies have been developed that perform the biopsy procedure at other stages of development and use different methods for genetic analysis.\nWhether or not PGT-A improves IVF outcomes and is beneficial to patients has remained controversial.\nObjectives\nTo evaluate the effectiveness and safety of PGT-A in women undergoing an IVF treatment.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in September 2019 and checked the references of appropriate papers.\nSelection criteria\nAll randomised controlled trials (RCTs) reporting data on clinical outcomes in participants undergoing IVF with PGT-A versus IVF without PGT-A were eligible for inclusion.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed risk of bias, and extracted study data. The primary outcome was the cumulative live birth rate (cLBR). Secondary outcomes were live birth rate (LBR) after the first embryo transfer, miscarriage rate, ongoing pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, proportion of women reaching an embryo transfer, and mean number of embryos per transfer.\nMain results\nWe included 13 trials involving 2794 women. The quality of the evidence ranged from low to moderate. The main limitations were imprecision, inconsistency, and risk of publication bias.\nIVF with PGT-A versus IVF without PGT-A with the use of genome-wide analyses\nPolar body biopsy\nOne trial used polar body biopsy with array comparative genomic hybridisation (aCGH). It is uncertain whether the addition of PGT-A by polar body biopsy increases the cLBR compared to IVF without PGT-A (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.66 to 1.66, 1 RCT, N = 396, low-quality evidence). The evidence suggests that for the observed cLBR of 24% in the control group, the chance of live birth following the results of one IVF cycle with PGT-A is between 17% and 34%. It is uncertain whether the LBR after the first embryo transfer improves with PGT-A by polar body biopsy (OR 1.10, 95% CI 0.68 to 1.79, 1 RCT, N = 396, low-quality evidence). PGT-A with polar body biopsy may reduce miscarriage rate (OR 0.45, 95% CI 0.23 to 0.88, 1 RCT, N = 396, low-quality evidence). No data on ongoing pregnancy rate were available. The effect of PGT-A by polar body biopsy on improving clinical pregnancy rate is uncertain (OR 0.77, 95% CI 0.50 to 1.16, 1 RCT, N = 396, low-quality evidence).\nBlastocyst stage biopsy\nOne trial used blastocyst stage biopsy with next-generation sequencing. It is uncertain whether IVF with the addition of PGT-A by blastocyst stage biopsy increases cLBR compared to IVF without PGT-A, since no data were available. It is uncertain if LBR after the first embryo transfer improves with PGT-A with blastocyst stage biopsy (OR 0.93, 95% CI 0.69 to 1.27, 1 RCT, N = 661, low-quality evidence). It is uncertain whether PGT-A with blastocyst stage biopsy reduces miscarriage rate (OR 0.89, 95% CI 0.52 to 1.54, 1 RCT, N = 661, low-quality evidence). No data on ongoing pregnancy rate or clinical pregnancy rate were available.\nIVF with PGT-A versus IVF without PGT-A with the use of FISH for the genetic analysis\nEleven trials were included in this comparison. It is uncertain whether IVF with addition of PGT-A increases cLBR (OR 0.59, 95% CI 0.35 to 1.01, 1 RCT, N = 408, low-quality evidence). The evidence suggests that for the observed average cLBR of 29% in the control group, the chance of live birth following the results of one IVF cycle with PGT-A is between 12% and 29%. PGT-A performed with FISH probably reduces live births after the first transfer compared to the control group (OR 0.62, 95% CI 0.43 to 0.91, 10 RCTs, N = 1680, I² = 54%, moderate-quality evidence). The evidence suggests that for the observed average LBR per first transfer of 31% in the control group, the chance of live birth after the first embryo transfer with PGT-A is between 16% and 29%. There is probably little or no difference in miscarriage rate between PGT-A and the control group (OR 1.03, 95%, CI 0.75 to 1.41; 10 RCTs, N = 1680, I² = 16%; moderate-quality evidence). The addition of PGT-A may reduce ongoing pregnancy rate (OR 0.68, 95% CI 0.51 to 0.90, 5 RCTs, N = 1121, I² = 60%, low-quality evidence) and probably reduces clinical pregnancies (OR 0.60, 95% CI 0.45 to 0.81, 5 RCTs, N = 1131; I² = 0%, moderate-quality evidence).\nAuthors' conclusions\nThere is insufficient good-quality evidence of a difference in cumulative live birth rate, live birth rate after the first embryo transfer, or miscarriage rate between IVF with and IVF without PGT-A as currently performed. No data were available on ongoing pregnancy rates. The effect of PGT-A on clinical pregnancy rate is uncertain.\nWomen need to be aware that it is uncertain whether PGT-A with the use of genome-wide analyses is an effective addition to IVF, especially in view of the invasiveness and costs involved in PGT-A. PGT-A using FISH for the genetic analysis is probably harmful.\nThe currently available evidence is insufficient to support PGT-A in routine clinical practice.\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": "In in vitro fertilisation (IVF) with or without intracytoplasmic sperm injection (ICSI), the selection of the best embryo(s) for transfer is mainly based on morphological assessment of the embryos, which includes the number of cells, the regularity of cells, and the presence of cell fragments. Unfortunately, almost two-thirds of couples do not get pregnant even after transfer of ‘good quality’ embryos. One of the presumed causes is that such embryos have an abnormal number of chromosomes (aneuploidy). Preimplantation genetic testing for aneuploidy (PGT-A) is a technique used to analyse the number of chromosomes present in IVF embryos. In PGT-A, a polar body (a waste product of maternal meiosis),or one or a few cells of the embryo are obtained by biopsy and tested. Only polar bodies or embryos with a normal number of chromosomes in each cell, so-called 'euploid embryos', are transferred into the uterus. The idea is that this will increase the live birth rate per started IVF cycle. Previous studies on PGT-A that used a genetic analysis technique called fluorescence in situ hybridisation (FISH) found PGT-A to be ineffective in improving live birth rates. Since then, new methodologies and techniques in PGT-A have been developed that perform the procedure on polar bodies or other stages of embryo development and use different methods of genetic analysis (array comparative genomic hybridisation (aCGH) or next-generation sequencing (NGS)).\nWe compared the benefits and risks of IVF with and without PGT-A, performed with different techniques at different stages: polar body or other stage of embryo development."
}
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query-laysum | 4715 | [
{
"role": "user",
"content": "Abstract: Background\nWhen treating elevated blood pressure (BP), doctors often want to know what blood pressure target they should try to achieve. The standard blood pressure target in clinical practice for some time has been less than 140 - 160/90 - 100 mmHg for the general population of people with elevated blood pressure. Several clinical guidelines published in recent years have recommended lower targets (less than 130/80 mmHg) for people with diabetes mellitus. It is not known whether attempting to achieve targets lower than the standard target reduces mortality and morbidity in those with elevated blood pressure and diabetes.\nObjectives\nTo determine if 'lower' BP targets (any target less than 130/85 mmHg) are associated with reduction in mortality and morbidity compared with 'standard' BP targets (less than 140 - 160/90 - 100 mmHg) in people with diabetes.\nSearch methods\nWe searched the Database of Abstracts of Reviews of Effectiveness (DARE) and the Cochrane Database of Systematic Reviews for related reviews. We conducted electronic searches of the Hypertension Group Specialised Register (January 1946 - October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 9), MEDLINE (January 1946 - October 2013), EMBASE (January 1974 - October 2013) and ClinicalTrials.gov. The most recent search was performed on October 4, 2013.\nOther search sources were the International Clinical Trials Registry Platform (WHO ICTRP), and reference lists of all papers and relevant reviews.\nSelection criteria\nRandomized controlled trials comparing people with diabetes randomized to lower or to standard BP targets as previously defined, and providing data on any of the primary outcomes below.\nData collection and analysis\nTwo review authors independently assessed and established the included trials and data entry. Primary outcomes were total mortality; total serious adverse events; myocardial infarction, stroke, congestive heart failure and end-stage renal disease. Secondary outcomes were achieved mean systolic and diastolic BP, and withdrawals due to adverse effects.\nMain results\nWe found five randomized trials, recruiting a total of 7314 participants and with a mean follow-up of 4.5 years. Only one trial (ACCORD) compared outcomes associated with 'lower' (< 120 mmHg) or 'standard' (< 140 mmHg) systolic blood pressure targets in 4734 participants. Despite achieving a significantly lower BP (119.3/64.4 mmHg vs 133.5/70.5 mmHg, P < 0.0001), and using more antihypertensive medications, the only significant benefit in the group assigned to 'lower' systolic blood pressure (SBP) was a reduction in the incidence of stroke: risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.88, P = 0.009, absolute risk reduction 1.1%. The effect of SBP targets on mortality was compatible with both a reduction and increase in risk: RR 1.05 CI 0.84 to 1.30, low quality evidence. Trying to achieve the 'lower' SBP target was associated with a significant increase in the number of other serious adverse events: RR 2.58, 95% CI 1.70 to 3.91, P < 0.00001, absolute risk increase 2.0%.\nFour trials (ABCD-H, ABCD-N, ABCD-2V, and a subgroup of HOT) specifically compared clinical outcomes associated with 'lower' versus 'standard' targets for diastolic blood pressure (DBP) in people with diabetes. The total number of participants included in the DBP target analysis was 2580. Participants assigned to 'lower' DBP had a significantly lower achieved BP: 128/76 mmHg vs 135/83 mmHg, P < 0.0001. There was a trend towards reduction in total mortality in the group assigned to the 'lower' DBP target (RR 0.73, 95% CI 0.53 to 1.01), mainly due to a trend to lower non-cardiovascular mortality. There was no difference in stroke (RR 0.67, 95% CI 0.42 to 1.05), in myocardial infarction (RR 0.95, 95% CI 0.64 to 1.40) or in congestive heart failure (RR 1.06, 95% CI 0.58 to 1.92), low quality evidence. End-stage renal failure and total serious adverse events were not reported in any of the trials. A sensitivity analysis of trials comparing DBP targets < 80 mmHg (as suggested in clinical guidelines) versus < 90 mmHg showed similar results. There was a high risk of selection bias for every outcome analyzed in favor of the 'lower' target in the trials included for the analysis of DBP targets.\nAuthors' conclusions\nAt the present time, evidence from randomized trials does not support blood pressure targets lower than the standard targets in people with elevated blood pressure and diabetes. More randomized controlled trials are needed, with future trials reporting total mortality, total serious adverse events as well as cardiovascular and renal events.\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": "The evidence is current to October 2013. We found and analyzed five randomized trials including 7134 adult participants with type 2 diabetes and high blood pressure, 40-80 years old, who received treatment aimed to lower blood pressure to a standard compared to a lower blood pressure target and followed for 2 to 5 years to detect differences in mortality and adverse events. Four out of five studies were funded by the drug manufacturer, which had a potential of impacting the results. One study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI) from the United States."
}
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query-laysum | 4716 | [
{
"role": "user",
"content": "Abstract: Background\nAccidental awareness during general anaesthesia (AAGA) is when a patient unintentionally becomes conscious during a procedure performed with general anaesthesia and subsequently has explicit recall of this event. Incidence estimates for AAGA vary, with the most common estimate being one to two cases per 1000 general anaesthetics. Evidence linking nitrous oxide use and an increased risk of AAGA has come from observational studies data but the literature is contradictory, with some studies finding a protective effect of nitrous oxide.\nObjectives\nTo assess the effect of general anaesthesia including nitrous oxide on the risk of AAGA in patients aged five years and over.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and trial registers ((www.clinicaltrials.gov), the WHO International Clinical Trials Registry Platform (www.who.int/ictrp/network/en/) and Current Controlled Trials (www.isrctn.com/)) for eligible studies on December 9 2015. In addition, we conducted forward and backward citation searching using key identified papers.\nSelection criteria\nWe considered all randomized controlled trials (RCTs), including quasi-randomized studies and cluster-randomized studies, of participants aged five years or older receiving general anaesthesia for any type of surgery.\nWe included trials in which participants receiving general anaesthesia that included nitrous oxide for maintenance at a concentration of at least 30% were compared with participants receiving no nitrous oxide during general anaesthesia. The intervention group must have received nitrous oxide in conjunction with an additional anaesthetic. We excluded studies where the depth of anaesthesia differed between the study arms. For inclusion in the review, studies needed to state in their methods that they planned to assess AAGA. We defined this as when a patient becomes conscious during a procedure performed with general anaesthesia and subsequently has explicit recall of this event.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane to identify studies. We extracted data and conducted 'Risk of bias' assessment using the Covidence database.\nMain results\nWe included 15 studies. The total number of participants included in the analyses was 3520. Most studies were small with fewer than 120 participants, although two larger studies with 2012 and 671 participants were included. There was considerable variation in many of the study characteristics, including the anaesthetics used. The concentrations of nitrous oxide varied between 50% and 70%, and half of the studies used clinical signs and haemodynamic changes to monitor depth of anaesthesia.\nAs it was not possible to blind the anaesthetist to the anaesthetic used, we rated all studies at high risk of performance bias and we therefore downgraded the quality of evidence by one level for risk of bias using the GRADE approach. Other types of bias were generally low, or were rated unclear due to missing information.\nNo studies were designed to measure AAGA as the primary outcome, and were therefore statistically underpowered to answer this review question. Despite the inclusion of 3520 participants, only three awareness events were reported by two studies. In one study the event was due to technical failure. Due to the rarity of the events, we did not consider it appropriate to pool the data, and we therefore downgraded the quality of evidence by a further level for imprecision using GRADE.\nAuthors' conclusions\nIt is not possible to draw any conclusions from this review. The included studies were mainly small (fewer than 120 participants) and there were limited estimates of effect, with only two studies reporting any events. We cannot therefore determine whether the use of nitrous oxide in general anaesthesia increases, decreases or has no effect on the risk of accidental 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": "We searched for studies in December 2015."
}
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query-laysum | 4717 | [
{
"role": "user",
"content": "Abstract: Background\nEnd-stage kidney disease (ESKD) is a chronic, debilitative and progressive illness that may need interventions such as dialysis, transplantation, dietary and fluid restrictions. Most patients with ESKD will require renal replacement therapy, such as kidney transplantation or maintenance dialysis. Advance care planning traditionally encompass instructions via living wills, and concern patient preferences about interventions such as cardiopulmonary resuscitation and feeding tubes, or circumstances around assigning surrogate decision makers. Most people undergoing haemodialysis are not aware of advance care planning and few patients formalise their wishes as advance directives and of those who do, many do not discuss their decisions with a physician. Advance care planning involves planning for future healthcare decisions and preferences of the patient in advance while comprehension is intact. It is an essential part of good palliative care that likely improves the lives and deaths of haemodialysis patients.\nObjectives\nThe objective of this review was to determine whether advance care planning in haemodialysis patients, compared with no or less structured forms of advance care planning, can result in fewer hospital admissions or less use of treatments with life-prolonging or curative intent, and if patient's wishes were followed at end-of-life.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register to 27 June 2016 through contact with the Information Specialist using search terms relevant to this review. We also searched the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and Social Work Abstracts (OvidSP).\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods) looking at advance care planning versus no form of advance care planning in haemodialysis patients was considered for inclusion without language restriction.\nData collection and analysis\nData extraction was carried out independently by two authors using standard data extraction forms. Studies reported in non-English language journals were translated before assessment. Where more than one publication of one study exists, reports were grouped together and the publication with the most complete data was used in the analyses. Where relevant outcomes are only published in earlier versions these data were used. Any discrepancies between published versions were highlighted. Non-randomised controlled studies were excluded.\nMain results\nWe included two studies (three reports) that involved 337 participants which investigated advance care planning for people with ESKD. Neither of the included studies reported outcomes relevant to this review. Study quality was assessed as suboptimal.\nAuthors' conclusions\nWe found sparse data that were assessed at suboptimal quality and therefore we were unable to formulate conclusions about whether advance care planning can influence numbers of hospital admissions and treatment required by people with ESKD, or if patients' advance care directives were followed at end-of-life. Further well designed and adequately powered RCTs are needed to better inform patient and clinical decision-making about advance care planning and advance directives among people with ESKD who are undergoing dialysis.\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 chronic kidney disease and end-stage kidney disease (ESKD) have irreversible kidney damage and require renal replacement therapy. In developed countries, haemodialysis has become the most common treatment for people with ESKD. Despite its life-saving potential, haemodialysis can be a significant physical and psychological burden to patients. Advance care planning is the process of planning for a person’s future health and personal care decisions in terms of level of healthcare and quality of life the person would want, should for any reason, the person becomes unable to participate in decision-making. Advance care goals can change over time and advance care planning assists in addressing these changes and readdress care goals over time. This helps to ensure that individual choices are respected in future medical treatment in an event where the person cannot communicate or make decisions.\nWe wanted to find out if advance care planning can improve health outcomes among people with ESKD in terms of use of resuscitation measures such as cardiopulmonary resuscitation, and withdrawal from dialysis. Additionally, we wanted to find out whether patient wishes were followed in the end of life period."
}
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query-laysum | 4718 | [
{
"role": "user",
"content": "Abstract: Background\nHodgkin lymphoma (HL) is one of the most common haematological malignancies in young adults and, with cure rates of 90%, has become curable for the majority of individuals. Positron emission tomography (PET) is an imaging tool used to monitor a tumour’s metabolic activity, stage and progression. Interim PET during chemotherapy has been posited as a prognostic factor in individuals with HL to distinguish between those with a poor prognosis and those with a better prognosis. This distinction is important to inform decision-making on the clinical pathway of individuals with HL.\nObjectives\nTo determine whether in previously untreated adults with HL receiving first-line therapy, interim PET scan results can distinguish between those with a poor prognosis and those with a better prognosis, and thereby predict survival outcomes in each group.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL and conference proceedings up until April 2019. We also searched one trial registry (ClinicalTrials.gov).\nSelection criteria\nWe included retrospective and prospective studies evaluating interim PET scans in a minimum of 10 individuals with HL (all stages) undergoing first-line therapy. Interim PET was defined as conducted during therapy (after one, two, three or four treatment cycles). The minimum follow-up period was at least 12 months. We excluded studies if the trial design allowed treatment modification based on the interim PET scan results.\nData collection and analysis\nWe developed a data extraction form according to the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS). Two teams of two review authors independently screened the studies, extracted data on overall survival (OS), progression-free survival (PFS) and PET-associated adverse events (AEs), assessed risk of bias (per outcome) according to the Quality in Prognosis Studies (QUIPS) tool, and assessed the certainty of the evidence (GRADE). We contacted investigators to obtain missing information and data.\nMain results\nOur literature search yielded 11,277 results. In total, we included 23 studies (99 references) with 7335 newly-diagnosed individuals with classic HL (all stages).\nParticipants in 16 studies underwent (interim) PET combined with computed tomography (PET-CT), compared to PET only in the remaining seven studies. The standard chemotherapy regimen included ABVD (16) studies, compared to BEACOPP or other regimens (seven studies). Most studies (N = 21) conducted interim PET scans after two cycles (PET2) of chemotherapy, although PET1, PET3 and PET4 were also reported in some studies. In the meta-analyses, we used PET2 data if available as we wanted to ensure homogeneity between studies. In most studies interim PET scan results were evaluated according to the Deauville 5-point scale (N = 12).\nEight studies were not included in meta-analyses due to missing information and/or data; results were reported narratively. For the remaining studies, we pooled the unadjusted hazard ratio (HR). The timing of the outcome measurement was after two or three years (the median follow-up time ranged from 22 to 65 months) in the pooled studies.\nEight studies explored the independent prognostic ability of interim PET by adjusting for other established prognostic factors (e.g. disease stage, B symptoms). We did not pool the results because the multivariable analyses adjusted for a different set of factors in each study.\nOverall survival\nTwelve (out of 23) studies reported OS. Six of these were assessed as low risk of bias in all of the first four domains of QUIPS (study participation, study attrition, prognostic factor measurement and outcome measurement). The other six studies were assessed as unclear, moderate or high risk of bias in at least one of these four domains. Four studies were assessed as low risk, and eight studies as high risk of bias for the domain other prognostic factors (covariates). Nine studies were assessed as low risk, and three studies as high risk of bias for the domain 'statistical analysis and reporting'.\nWe pooled nine studies with 1802 participants. Participants with HL who have a negative interim PET scan result probably have a large advantage in OS compared to those with a positive interim PET scan result (unadjusted HR 5.09, 95% confidence interval (CI) 2.64 to 9.81, I² = 44%, moderate-certainty evidence). In absolute values, this means that 900 out of 1000 participants with a negative interim PET scan result will probably survive longer than three years compared to 585 (95% CI 356 to 757) out of 1000 participants with a positive result.\nAdjusted results from two studies also indicate an independent prognostic value of interim PET scan results (moderate-certainty evidence).\nProgression-free survival\nTwenty-one studies reported PFS. Eleven out of 21 were assessed as low risk of bias in the first four domains. The remaining were assessed as unclear, moderate or high risk of bias in at least one of the four domains. Eleven studies were assessed as low risk, and ten studies as high risk of bias for the domain other prognostic factors (covariates). Eight studies were assessed as high risk, thirteen as low risk of bias for statistical analysis and reporting.\nWe pooled 14 studies with 2079 participants. Participants who have a negative interim PET scan result may have an advantage in PFS compared to those with a positive interim PET scan result, but the evidence is very uncertain (unadjusted HR 4.90, 95% CI 3.47 to 6.90, I² = 45%, very low-certainty evidence). This means that 850 out of 1000 participants with a negative interim PET scan result may be progression-free longer than three years compared to 451 (95% CI 326 to 569) out of 1000 participants with a positive result.\nAdjusted results (not pooled) from eight studies also indicate that there may be an independent prognostic value of interim PET scan results (low-certainty evidence).\nPET-associated adverse events\nNo study measured PET-associated AEs.\nAuthors' conclusions\nThis review provides moderate-certainty evidence that interim PET scan results predict OS, and very low-certainty evidence that interim PET scan results predict progression-free survival in treated individuals with HL. This evidence is primarily based on unadjusted data. More studies are needed to test the adjusted prognostic ability of interim PET against established prognostic factors.\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 Cochrane Review aimed to find out whether the results of a positron emission tomography (PET) during therapy in people with Hodgkin lymphoma (HL) can help to distinguish between those with a poor prognosis and those with a better prognosis, and predict survival outcomes in each group."
}
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query-laysum | 4719 | [
{
"role": "user",
"content": "Abstract: Background\nAnaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiological needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations.\nObjectives\nTo determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, 21 other databases and two trials registers up to 21 July 2020, together with contacting key organisations to identify additional studies.\nSelection criteria\nWe included cluster- or individually-randomised controlled trials (RCTs) carried out among the general population from any country, aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. We included trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat\nData collection and analysis\nTwo review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risks of bias. We followed Cochrane methods in this review.\nMain results\nOur search identified 3538 records, after removing duplicates. We included 10 trials, involving 3319 participants, carried out in Bangladesh, Brazil, India, Kuwait, Philippines, South Africa and Sri Lanka. We identified two ongoing studies and one study is awaiting classification. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias.\nThree trials used 41 mg to 60 mg iron/kg flour, three trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial used various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate.\nAll included studies contributed data for the meta-analyses.\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added\nIron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added may reduce by 27% the risk of anaemia in populations (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.55 to 0.97; 5 studies, 2315 participants; low-certainty evidence).\nIt is uncertain whether iron-fortified wheat flour with or without other micronutrients reduces iron deficiency (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 748 participants; very low-certainty evidence) or increases haemoglobin concentrations (in g/L) (mean difference MD 2.75, 95% CI 0.71 to 4.80; 8 studies, 2831 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to the risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (mean difference (MD) 0.04, 95% CI −0.02 to 0.11; 2 studies, 558 participants; moderate-certainty evidence).\nIron-fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added)\nIt is unclear whether wheat flour fortified with iron, in combination with other micronutrients decreases anaemia (RR 0.77, 95% CI 0.41 to 1.46; 2 studies, 317 participants; very low-certainty evidence). The intervention probably reduces the risk of iron deficiency (RR 0.73, 95% CI 0.54 to 0.99; 3 studies, 382 participants; moderate-certainty evidence) and it is unclear whether it increases average haemoglobin concentrations (MD 2.53, 95% CI −0.39 to 5.45; 4 studies, 532 participants; very low-certainty evidence).\nNo trials reported data on adverse effects in children.\nNine out of 10 trials reported sources of funding, with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials.\nAuthors' conclusions\nFortification of wheat flour with iron (in comparison to unfortified flour, or where both groups received the same other micronutrients) may reduce anaemia in the general population above two years of age, but its effects on other outcomes are uncertain.\nIron-fortified wheat flour in combination with other micronutrients, in comparison with unfortified flour, probably reduces iron deficiency, but its effects on other outcomes are uncertain.\nNone of the included trials reported data on adverse side effects except for risk of infection or inflammation at the individual level. The effects of this intervention on other health outcomes are unclear. Future studies at low risk of bias should aim to measure all important outcomes, and to further investigate which variants of fortification, including the role of other micronutrients as well as types of iron fortification, are more effective, and for whom.\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": "we included evidence published up to 21 July 2020."
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query-laysum | 4720 | [
{
"role": "user",
"content": "Abstract: Background\nEndotracheal intubation is a commonly performed procedure in neonates, the risks of which are well-described. Some endotracheal tubes (ETT) are equipped with a cuff that can be inflated after insertion of the ETT in the airway to limit leak or aspiration. Cuffed ETTs have been shown in larger children and adults to reduce gas leak around the ETT, ETT exchange, accidental extubation, and exposure of healthcare workers to anesthetic gas during surgery. With improved understanding of neonatal airway anatomy and the widespread use of cuffed ETTs by anesthesiologists, the use of cuffed tubes is increasing in neonates.\nObjectives\nTo assess the benefits and harms of cuffed ETTs (inflated or non-inflated) compared to uncuffed ETTs for respiratory support in neonates.\nSearch methods\nWe searched CENTRAL, PubMed, and CINAHL on 20 August 2021; we also searched trial registers and checked reference lists to identify additional studies.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, and cluster-randomized trials comparing cuffed (inflated and non-inflated) versus uncuffed ETTs in newborns. We sought to compare 1. inflated, cuffed versus uncuffed ETT; 2. non-inflated, cuffed versus uncuffed ETT; and 3. inflated, cuffed versus non-inflated, cuffed ETT.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. Two review authors independently assessed studies identified by the search strategy for inclusion, extracted data, and assessed risk of bias. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe identified one eligible RCT for inclusion that compared the use of cuffed (inflated if ETT leak greater than 20% with cuff pressure 20 cm H2O or less) versus uncuffed ETT. The author provided a spreadsheet with individual data. Among 76 infants in the original manuscript, 69 met the inclusion and exclusion criteria for this Cochrane Review. We found possible bias due to lack of blinding and other bias.\nWe are very uncertain about frequency of postextubation stridor, because the confidence intervals (CI) of the risk ratio (RR) were very wide (RR 1.36, 95% CI 0.35 to 5.25; risk difference (RD) 0.03, −0.11 to 0.18; 1 study, 69 participants; very low-certainty evidence).\nNo neonate was diagnosed with postextubation subglottic stenosis; however, endoscopy was not available to confirm the clinical diagnosis.\nWe are very uncertain about reintubation for stridor or subglottic stenosis because the CIs of the RR were very wide (RR 0.27, 95% CI 0.01 to 6.49; RD −0.03, 95% CI −0.11 to 0.05; 1 study, 69 participants; very low-certainty evidence).\nNo neonate had surgical intervention (e.g. endoscopic balloon dilation, cricoid split, tracheostomy) for stridor or subglottic stenosis (1 study, 69 participants).\nNeonates randomized to cuffed ETT may be less likely to have a reintubation for any reason (RR 0.06, 95% CI 0.01 to 0.45; RD −0.39, 95% CI −0.57 to −0.21; number needed to treat for an additional beneficial outcome 3, 95% CI 2 to 5; 1 study, 69 participants; very low-certainty evidence).\nWe are very uncertain about accidental extubation because the CIs of the RR were wide (RR 0.82, 95% CI 0.12 to 5.46; RD −0.01, 95% CI −0.12 to 0.10; 1 study, 69 participants; very low-certainty evidence).\nWe are very uncertain about all-cause mortality during initial hospitalization because the CIs of the RR were extremely wide (RR 2.46, 95% CI 0.10 to 58.39; RD 0.03, 95% CI −0.05 to 0.10; 1 study, 69 participants; very low-certainty evidence).\nThere is one ongoing trial. We classified two studies as awaiting classification because outcome data were not reported separately for newborns and older infants.\nAuthors' conclusions\nEvidence for comparing cuffed versus uncuffed ETTs in neonates is limited by a small number of babies in a single RCT with possible bias. There is very low certainty evidence for all outcomes of this review. CIs of the estimate for postextubation stridor were wide. No neonate had clinical evidence for subglottic stenosis; however, endoscopy results were not available to assess the anatomy.\nAdditional RCTs are necessary to evaluate the benefits and harms of cuffed ETTs (inflated and non-inflated) in the neonatal population. These studies must include neonates and be conducted both for short-term use (in the setting of the operating room) and chronic use (in the setting of chronic lung disease) of cuffed ETTs.\n\nGiven the provided abstract, please respond to the following query: \"Reliability of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we judged the reliability of the evidence to be very low. This is because only a few babies were in a single trial and there was possible bias. There is one ongoing trial. We classified two studies as awaiting classification because outcome data were not reported separately for newborns and older infants."
}
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query-laysum | 4721 | [
{
"role": "user",
"content": "Abstract: Background\nPeriodontitis is a bacterially-induced, chronic inflammatory disease that destroys the connective tissues and bone that support teeth. Active periodontal treatment aims to reduce the inflammatory response, primarily through eradication of bacterial deposits. Following completion of treatment and arrest of inflammation, supportive periodontal therapy (SPT) is employed to reduce the probability of re-infection and progression of the disease; to maintain teeth without pain, excessive mobility or persistent infection in the long term, and to prevent related oral diseases.\nAccording to the American Academy of Periodontology, SPT should include all components of a typical dental recall examination, and importantly should also include periodontal re-evaluation and risk assessment, supragingival and subgingival removal of bacterial plaque and calculus, and re-treatment of any sites showing recurrent or persistent disease. While the first four points might be expected to form part of the routine examination appointment for periodontally healthy patients, the inclusion of thorough periodontal evaluation, risk assessment and subsequent treatment - normally including mechanical debridement of any plaque or calculus deposits - differentiates SPT from routine care.\nSuccess of SPT has been reported in a number of long-term, retrospective studies. This review aimed to assess the evidence available from randomised controlled trials (RCTs).\nObjectives\nTo determine the effects of supportive periodontal therapy (SPT) in the maintenance of the dentition of adults treated for periodontitis.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 8 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 5), MEDLINE Ovid (1946 to 8 May 2017), and Embase Ovid (1980 to 8 May 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating SPT versus monitoring only or alternative approaches to mechanical debridement; SPT alone versus SPT with adjunctive interventions; different approaches to or providers of SPT; and different time intervals for SPT delivery.\nWe excluded split-mouth studies where we considered there could be a risk of contamination.\nParticipants must have completed active periodontal therapy at least six months prior to randomisation and be enrolled in an SPT programme. Trials must have had a minimum follow-up period of 12 months.\nData collection and analysis\nTwo review authors independently screened search results to identify studies for inclusion, assessed the risk of bias in included studies and extracted study data. When possible, we calculated mean differences (MDs) and 95% confidence intervals (CIs) for continuous variables. Two review authors assessed the quality of evidence for each comparison and outcome using GRADE criteria.\nMain results\nWe included four trials involving 307 participants aged 31 to 85 years, who had been previously treated for moderate to severe chronic periodontitis. Three studies compared adjuncts to mechanical debridement in SPT versus debridement only. The adjuncts were local antibiotics in two studies (one at high risk of bias and one at low risk) and photodynamic therapy in one study (at unclear risk of bias). One study at high risk of bias compared provision of SPT by a specialist versus general practitioner. We did not identify any RCTs evaluating the effects of SPT versus monitoring only, or of providing SPT at different time intervals, or that compared the effects of mechanical debridement using different approaches or technologies.\nNo included trials measured our primary outcome 'tooth loss'; however, studies evaluated signs of inflammation and potential periodontal disease progression, including bleeding on probing (BoP), clinical attachment level (CAL) and probing pocket depth (PPD).\nThere was no evidence of a difference between SPT delivered by a specialist versus a general practitioner for BoP or PPD at 12 months (very low-quality evidence). This study did not measure CAL or adverse events.\nDue to heterogeneous outcome reporting, it was not possible to combine data from the two studies comparing mechanical debridement with or without the use of adjunctive local antibiotics. Both studies found no evidence of a difference between groups at 12 months (low to very low-quality evidence). There were no adverse events in either study.\nThe use of adjunctive photodynamic therapy did not demonstrate evidence of benefit compared to mechanical debridement only (very low-quality evidence). Adverse events were not measured.\nThe quality of the evidence is low to very low for these comparisons. Future research is likely to change the findings, therefore the results should be interpreted with caution.\nAuthors' conclusions\nOverall, there is insufficient evidence to determine the superiority of different protocols or adjunctive strategies to improve tooth maintenance during SPT. No trials evaluated SPT versus monitoring only. The evidence available for the comparisons evaluated is of low to very low quality, and hampered by dissimilarities in outcome reporting. More trials using uniform definitions and outcomes are required to address the objectives of this review.\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": "Periodontitis (gum disease) is a chronic condition caused by bacteria, which stimulate inflammation and destruction of the bone and gum tissue supporting teeth. People treated for periodontitis can reduce the probability of re-infection and disease progression through regular supportive periodontal therapy (SPT). SPT starts once periodontitis has been treated satisfactorily, meaning that inflammation has been controlled and destruction of tissues supporting the tooth (bone and gums) has been arrested. SPT aims to maintain teeth in function, without pain, excessive mobility or persistent infection over the long term. SPT treatment typically includes ensuring excellent oral hygiene, frequent monitoring for progression or recurrence of disease, and removal of microbial deposits by dental professionals. Although success of SPT has been suggested through a number of long-term, retrospective studies, it is important to consider evidence available from randomised controlled trials (RCTs)."
}
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query-laysum | 4722 | [
{
"role": "user",
"content": "Abstract: Background\nAlemtuzumab is a humanised monoclonal antibody that alters the circulating lymphocyte pool, causing prolonged lymphopenia, thus remoulding the immune repertoire that accompanies homeostatic lymphocyte reconstitution. It has been proved more effective than interferon (IFN) 1a for the treatment of relapsing-remitting multiple sclerosis (RRMS).\nObjectives\nTo compare the efficacy, tolerability and safety of alemtuzumab versus interferon beta 1a in the treatment of people with RRMS to prevent disease activity.\nSearch methods\nWe searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group Trials Register (1 February 2017) which, among other sources, contains records from CENTRAL, MEDLINE, Embase, CINAHL, LILACS, PEDRO and the trial registry databases Clinical Trials.gov and WHO International Clinical Trials Registry Platform for all prospectively registered and ongoing trials.\nSelection criteria\nAll double-blind, randomised, controlled trials comparing intravenous alemtuzumab (12 mg per day or 24 mg per day on five consecutive days during the first month and on three consecutive days at months 12, 24, 36) versus subcutaneous IFN beta 1a (Rebif), 22 μg or 44 μg three times per week, or IFN beta 1a (Avonex) by intramuscular injection 30 μg once a week, in people of any gender and age with RRMS.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included three trials involving 1694 participants. All trials compared alemtuzumab 12 mg per day or 24 mg per day versus IFN beta 1a for treating RRMS. In CAMMS223, participants received either subcutaneous IFN beta 1a 44 μg three times per week or annual intravenous cycles of alemtuzumab (at a dose of 12 mg per day or 24 mg per day) for 36 months. In CARE-MS I and CARE-MS II, participants received subcutaneous IFN beta 1a 44 μg three times per week or annual intravenous cycles of alemtuzumab 12 mg per day for 24 months. All three studies were at risk of performance bias and attrition bias, one study was 'unclear' risk in selection bias.\nCompared with interferon beta 1a, alemtuzumab given at a dose of 12 mg per day probably reduces the risk of relapse (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.52 to 0.70, moderate quality evidence), may reduce the risk of worsening disability (RR 0.60, 95% CI 0.45 to 0.79, low quality evidence) and the risk of developing new T2 lesions on magnetic resonance imaging (RR 0.75, 95% CI 0.61 to 0.93, low quality evidence) after 24 and 36 months' follow-up. Mean Expanded Disability Status Scale (EDSS) scores may be similar between the treatment regimens (mean difference (MD) -0.35, 95% CI -0.73 to 0.03, low quality evidence).\nAt a dose of 24 mg per day alemtuzumab may reduce relapse (RR 0.38, 95% CI 0.23 to 0.62, low quality evidence), worsening disability (RR 0.42, 95% CI 0.21 to 0.84, low quality evidence). The effects on EDSS scores when compared with interferon beta 1a at three years are uncertain due to the very low quality of evidence (MD -0.83, 95% CI -1.17 to -0.49).\nAll three trials reported adverse events and serious adverse events. The risk of experiencing an adverse event in either alemtuzumab 12 mg or interferon groups may be similar (RR 1.03, 95% CI 0.98 to 1.08, low quality evidence). The risk of serious adverse events is probably similar between treatments (RR 1.03, 95% CI 0.82 to 1.29, moderate quality evidence). The risk of any adverse event may be similar between alemtuzumab 24 mg and interferon (RR 1.02, 95% CI 0.96 to 1.08, low quality evidence). The risk of serious adverse events is probably similar between treatments (RR 0.95, 95% CI 0.70 to 1.31, moderate quality evidence).\nAuthors' conclusions\nAnnual intravenous cycles of alemtuzumab at a dose of 12 mg per day probably reduces the proportion of participants who experience relapse, may reduce the proportion of participants who experience disability worsening and development of new T2 lesions on MRI over 2 to 3 years in comparison with subcutaneous IFN beta-1a 44 μg three times per week. Annual intravenous cycles of alemtuzumab at a dose of 24 mg per day may reduce the proportion of participants who experience relapse and disability worsening over 3 years in comparison with subcutaneous IFN beta-1a 44 μg three times per week. An average reduction of 0.8 EDSS units with alemtuzumab compared with interferon beta-1a was observed at a dose of 24 mg per day in one study.\nThe rates of adverse events were similarly high for both treatments. The most frequently reported adverse events for both treatments were infusion-associated reactions, infections and autoimmune events. The use of alemtuzumab requires careful monitoring so that potentially serious adverse events can be treated early and effectively.\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": "Multiple sclerosis is a progressive disease of the central nervous system where the person's own body destroys the coating that protects nerves. The disease may go into remission (where the symptoms reduce or stop) and then relapse (where the symptoms return). This is called relapsing-remitting multiple sclerosis (RRMS). Medicines called monoclonal antibodies (such as alemtuzumab) could be a possible alternative immunotherapy (treatment to stimulate the immune system) to interferon beta treatment (one of the usual treatments) in people with RRMS. In this review, we aimed to compare the benefits, side effects and safety of alemtuzumab versus interferon beta 1a in the treatment of people with RRMS."
}
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query-laysum | 4723 | [
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma occurs mostly in people with chronic liver disease and ranks sixth in terms of global incidence of cancer, and fourth in terms of cancer deaths. In clinical practice, computed tomography (CT) is used as a second-line diagnostic imaging modality to confirm the presence of focal liver lesions suspected as hepatocellular carcinoma on prior diagnostic test such as abdominal ultrasound or alpha-foetoprotein, or both, either in surveillance programmes or in clinical settings. According to current guidelines, a single contrast-enhanced imaging study CT or magnetic resonance imaging (MRI) showing typical hallmarks of hepatocellular carcinoma in people with cirrhosis is valid to diagnose hepatocellular carcinoma. However, a significant number of hepatocellular carcinomas do not show typical hallmarks on imaging modalities, and hepatocellular carcinoma is, therefore, missed. There is no clear evidence of the benefit of surveillance programmes in terms of overall survival: the conflicting results can be a consequence of inaccurate detection, ineffective treatment, or both. Assessing the diagnostic accuracy of CT may clarify whether the absence of benefit could be related to underdiagnosis. Furthermore, an assessment of the accuracy of CT in people with chronic liver disease, who are not included in surveillance programmes is needed for either ruling out or diagnosing hepatocellular carcinoma.\nObjectives\nPrimary: to assess the diagnostic accuracy of multidetector, multiphasic contrast-enhanced CT for the diagnosis of hepatocellular carcinoma of any size and at any stage in adults with chronic liver disease, either in a surveillance programme or in a clinical setting.\nSecondary: to assess the diagnostic accuracy of CT for the diagnosis of resectable hepatocellular carcinoma in adults with chronic liver disease.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Trials Register, Cochrane Hepato-Biliary Diagnostic-Test-Accuracy Studies Register, the Cochrane Library, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index – Science until 4 May 2021. We applied no language or document-type restrictions.\nSelection criteria\nStudies assessing the diagnostic accuracy of CT for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, with cross-sectional designs, using one of the acceptable reference standards, such as pathology of the explanted liver and histology of resected or biopsied focal liver lesion with at least a six-month follow-up.\nData collection and analysis\nAt least two review authors independently screened studies, extracted data, and assessed the risk of bias and applicability concerns, using the QUADAS-2 checklist. We presented the results of sensitivity and specificity, using paired forest plots, and tabulated the results. We used a hierarchical meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). We double-checked all data extractions and analyses.\nMain results\nWe included 21 studies, with a total of 3101 participants. We judged all studies to be at high risk of bias in at least one domain because most studies used different reference standards, often inappropriate to exclude the presence of the target condition, and the time-interval between the index test and the reference standard was rarely defined. Regarding applicability in the patient selection domain, we judged 14% (3/21) of studies to be at low concern and 86% (18/21) of studies to be at high concern owing to characteristics of the participants who were on waiting lists for orthotopic liver transplantation.\nCT for hepatocellular carcinoma of any size and stage: sensitivity 77.5% (95% CI 70.9% to 82.9%) and specificity 91.3% (95% CI 86.5% to 94.5%) (21 studies, 3101 participants; low-certainty evidence).\nCT for resectable hepatocellular carcinoma: sensitivity 71.4% (95% CI 60.3% to 80.4%) and specificity 92.0% (95% CI 86.3% to 95.5%) (10 studies, 1854 participants; low-certainty evidence).\nIn the three studies at low concern for applicability (861 participants), we found sensitivity 76.9% (95% CI 50.8% to 91.5%) and specificity 89.2% (95% CI 57.0% to 98.1%).\nThe observed heterogeneity in the results remains mostly unexplained. The sensitivity analyses, which included only studies with clearly prespecified positivity criteria and only studies in which the reference standard results were interpreted without knowledge of the results of the index test, showed no variation in the results.\nAuthors' conclusions\nIn the clinical pathway for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, CT has roles as a confirmatory test for hepatocellular carcinoma lesions, and for staging assessment. We found that using CT in detecting hepatocellular carcinoma of any size and stage, 22.5% of people with hepatocellular carcinoma would be missed, and 8.7% of people without hepatocellular carcinoma would be unnecessarily treated. For resectable hepatocellular carcinoma, we found that 28.6% of people with resectable hepatocellular carcinoma would improperly not be resected, while 8% of people without hepatocellular carcinoma would undergo inappropriate surgery. The uncertainty resulting from the high risk of bias in the included studies and concerns regarding their applicability limit our ability to confidently draw conclusions based on our results.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if CT is accurate enough to diagnose liver cancer in adults with chronic liver disease. We were interested firstly, in liver cancers of any size and stage and secondly, in liver cancers that were suitable for resection."
}
]
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query-laysum | 4724 | [
{
"role": "user",
"content": "Abstract: Background\nDemodex blepharitis is a chronic condition commonly associated with recalcitrant dry eye symptoms though many people with Demodex mites are asymptomatic. The primary cause of this condition in humans is two types of Demodex mites: Demodex folliculorum and Demodex brevis. There are varying reports of the prevalence of Demodex blepharitis among adults, and it affects both men and women equally. While Demodex mites are commonly treated with tea tree oil, the effectiveness of tea tree oil for treating Demodex blepharitis is not well documented.\nObjectives\nTo evaluate the effects of tea tree oil on ocular Demodex infestation in people with Demodex blepharitis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 6); Ovid MEDLINE; Embase.com; PubMed; LILACS; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions in the electronic search for trials. We last searched the databases on 18 June 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared treatment with tea tree oil (or its components) versus another treatment or no treatment for people with Demodex blepharitis.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts and then full text of records to determine their eligibility. The review authors independently extracted data and assessed risk of bias using Covidence. A third review author resolved any conflicts at all stages.\nMain results\nWe included six RCTs (1124 eyes of 562 participants; 17 to 281 participants per study) from the US, Korea, China, Australia, Ireland, and Turkey. The RCTs compared some formulation of tea tree oil to another treatment or no treatment. Included participants were both men and women, ranging from 39 to 55 years of age. All RCTs were assessed at unclear or high risk of bias in one or more domains. We also identified two RCTs that are ongoing or awaiting publications.\nData from three RCTs that reported a short-term mean change in the number of Demodex mites per eight eyelashes contributed to a meta-analysis. We are uncertain about the mean reduction for the groups that received the tea tree oil intervention (mean difference [MD] 0.70, 95% confidence interval [CI] 0.24 to 1.16) at four to six weeks as compared to other interventions. Only one RCT reported data for long-term changes, which found that the group that received intense pulse light as the treatment had complete eradication of Demodex mites at three months. We graded the certainty of the evidence for this outcome as very low.\nThree RCTs reported no evidence of a difference for participant reported symptoms measured on the Ocular Surface Disease Index (OSDI) between the tea tree oil group and the group receiving other forms of intervention. Mean differences in these studies ranged from -10.54 (95% CI – 24.19, 3.11) to 3.40 (95% CI -0.70 7.50). We did not conduct a meta-analysis for this outcome given substantial statistical heterogeneity and graded the certainty of the evidence as low.\nOne RCT provided information concerning visual acuity but did not provide sufficient data for between-group comparisons. The authors noted that mean habitual LogMAR visual acuity for all study participants improved post-treatment (mean LogMAR 1.16, standard deviation 0.26 at 4 weeks). We graded the certainty of evidence for this outcome as low. No RCTs provided data on mean change in number of cylindrical dandruff or the proportion of participants experiencing conjunctival injection or experiencing meibomian gland dysfunction.\nThree RCTs provided information on adverse events. One reported no adverse events. The other two described a total of six participants randomized to treatment with tea tree oil who experienced ocular irritation or discomfort that resolved with re-educating the patient on application techniques and continuing use of the tea tree oil. We graded the certainty of the evidence for this outcome as very low.\nAuthors' conclusions\nThe current review suggests that there is uncertainty related to the effectiveness of 5% to 50% tea tree oil for the short-term treatment of Demodex blepharitis; however, if used, lower concentrations may be preferable in the eye care arena to avoid induced ocular irritation. Future studies should be better controlled, assess outcomes at long term (e.g. 10 to 12 weeks or beyond), account for patient compliance, and study the effects of different tea tree oil concentrations.\n\nGiven the provided abstract, please respond to the following query: \"What did we study in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Blepharitis causes symptoms such as eye itching, burning, dryness, irritation, watering, or blurry vision, which lead people to seek medical attention. This study aimed to understand the ability of tea tree oil to improve symptoms or to treat Demodex blepharitis (or both) in comparison to no treatment or other forms of treatment containing no tea tree oil."
}
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query-laysum | 4725 | [
{
"role": "user",
"content": "Abstract: Background\nMissed hospital outpatient appointments is a commonly reported problem in healthcare services around the world; for example, they cost the National Health Service (NHS) in the UK millions of pounds every year and can cause operation and scheduling difficulties worldwide. In 2002, the World Health Organization (WHO) published a report highlighting the need for a model of care that more readily meets the needs of people with chronic conditions. Patient-initiated appointment systems may be able to meet this need at the same time as improving the efficiency of hospital appointments.\nObjectives\nTo assess the effects of patient-initiated appointment systems compared with consultant-led appointment systems for people with chronic or recurrent conditions managed in secondary care.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and six other databases. We contacted authors of identified studies and conducted backwards and forwards citation searching. We searched for current/ongoing research in two trial registers. Searches were run on 13 March 2019.\nSelection criteria\nWe included randomised trials, published and unpublished in any language that compared the use of patient-initiated appointment systems to consultant-led appointment systems for adults with chronic or recurrent conditions managed in secondary care if they reported one or more of the following outcomes: physical measures of health status or disease activity (including harms), quality of life, service utilisation or cost, adverse effects, patient or clinician satisfaction, or failures of the 'system'.\nData collection and analysis\nTwo review authors independently screened all references at title/abstract stage and full-text stage using prespecified inclusion criteria. We resolved disagreements though discussion. Two review authors independently completed data extraction for all included studies. We discussed and resolved discrepancies with a third review author. Where needed, we contacted authors of included papers to provide more information. Two review authors independently assessed the risk of bias using the Cochrane Effective Practice and Organisation of Care 'Risk of bias' tool, resolving any discrepancies with a third review author. Two review authors independently assessed the certainty of the evidence using GRADE.\nMain results\nThe 17 included randomised trials (3854 participants; mean age 41 to 76 years; follow-up 12 to 72 months) covered six broad health conditions: cancer, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, psoriasis and inflammatory bowel disease. The certainty of the evidence using GRADE ratings was mainly low to very low. The results suggest that patient-initiated clinics may make little or no difference to anxiety (odds ratio (OR) 0.87, 95% confidence interval (CI) 0.68 to 1.12; 5 studies, 1019 participants; low-certainty evidence) or depression (OR 0.79 95% CI 0.51 to 1.23; 6 studies, 1835 participants; low-certainty evidence) compared to the consultant-led appointment system. The results also suggest that patient-initiated clinics may make little or no difference to quality of life (standardised mean difference (SMD) 0.12, 95% CI 0.00 to 0.25; 7 studies, 1486 participants; low-certainty evidence) compared to the consultant-led appointment system. Results for service utilisation (contacts) suggest there may be little or no difference in service utilisation in terms of contacts between the patient-initiated and consultant-led appointment groups; however, the effect is not certain as the rate ratio ranged from 0.68 to 3.83 across the studies (median rate ratio 1.11, interquartile (IQR) 0.93 to 1.37; 15 studies, 3348 participants; low-certainty evidence). It is uncertain if service utilisation (costs) are reduced in the patient-initiated compared to the consultant-led appointment groups (8 studies, 2235 participants; very low-certainty evidence). The results suggest that adverse events such as relapses in some conditions (inflammatory bowel disease and cancer) may have little or no reduction in the patient-initiated appointment group in comparison with the consultant-led appointment group (MD –0.20, 95% CI –0.54 to 0.14; 3 studies, 888 participants; low-certainty evidence). The results are unclear about any differences the intervention may make to patient satisfaction (SMD 0.05, 95% CI –0.41 to 0.52; 2 studies, 375 participants) because the certainty of the evidence is low, as each study used different questions to collect their data at different time points and across different health conditions. Some areas of risk of bias across all the included studies was consistently high (i.e. for blinding of participants and personnel and blinding of outcome assessment, other areas were largely of low risk of bias or were affected by poor reporting making the assessment unclear).\nAuthors' conclusions\nPatient-initiated appointment systems may have little or no effect on patient anxiety, depression and quality of life compared to consultant-led appointment systems. Other aspects of disease status and experience also appear to show little or no difference between patient-initiated and consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on service utilisation in terms of service contact and there is uncertainty about costs compared to consultant-led appointment systems. Patient-initiated appointment systems may have little or no effect on adverse events such as relapse or patient satisfaction compared to consultant-led appointment systems.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review identified 17 studies. The studies covered six health conditions cancer (seven studies), rheumatoid arthritis (four), digestive conditions (three), asthma (one), psoriasis (one) and coronary obstructive pulmonary disease (one). Most studies were based in the UK (nine) but Sweden (three), Denmark (three), Finland (one) and the Netherlands (one) were also represented. The mean age of the 3854 patients ranged from 41 to 76 years and most were female. The results suggest patient-initiated appointment systems may make little or no difference to patient anxiety, depression and quality of life compared to the consultant-led appointment system (low-quality evidence due to high risk of bias and variation in results). Other aspects of disease status and experience also appear to show little or no difference between patient-initiated and consultant-led appointment systems. Results for service utilisation (contact with health services and staff) suggest there may be little or no difference in service contacts between the patient-initiated and consultant-led services (low-quality evidence due to different levels of contact reported across studies making it difficult to assess). We do not know if service utilisation (costs of services or staff) are reduced in the patient-initiated compared to the consultant-led appointment groups as the quality of this evidence is very low (due to the risk of bias and the variability of currencies and levels of costs reported across studies). The results suggest that there may be little or no impact on adverse events such as relapses in some conditions (cancer or inflammatory bowel disease) in the patient-initiated appointment group in comparison with the consultant-led appointment group (low-quality evidence due to the inconsistency and precision across studies in reporting and measuring relapse). The results suggest there may be little or no impact on patient satisfaction (low-quality evidence as each study used different questions to collect their data at different time points and across different illnesses). Not all studies reported their funding sources, but of those that were reported, most were funded by not-for-profit organisations. One study (on asthma) was funded by a pharmaceutical company."
}
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query-laysum | 4726 | [
{
"role": "user",
"content": "Abstract: Background\nNeonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures.\nOptions for pain management include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported.\nObjectives\nTo evaluate the benefits and harms of opioids in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was December 2021.\nSelection criteria\nWe included randomized controlled trials conducted in preterm and term infants of a postmenstrual age (PMA) up to 46 weeks and 0 days exposed to procedural pain where opioids were compared to 1) placebo or no drug; 2) non-pharmacological intervention; 3) other analgesics or sedatives; 4) other opioids; or 5) the same opioid administered by a different route.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods and any harms. We used a fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, and their confidence intervals (CI). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 13 independent studies (enrolling 823 newborn infants): seven studies compared opioids to no treatment or placebo (the main comparison in this review), two studies to oral sweet solution or non-pharmacological intervention, and five studies (of which two were part of the same study) to other analgesics and sedatives. All studies were performed in a hospital setting.\nOpioids compared to placebo or no drug\nCompared to placebo, opioids probably reduce pain score assessed with the Premature Infant Pain Profile (PIPP)/PIPP-Revised (PIPP-R) scale during the procedure (MD −2.58, 95% CI −3.12 to −2.03; 199 participants, 3 studies; moderate-certainty evidence); may reduce Neonatal Infant Pain Scale (NIPS) during the procedure (MD −1.97, 95% CI −2.46 to −1.48; 102 participants, 2 studies; low-certainty evidence); and may result in little to no difference in pain score assessed with the Douleur Aiguë du Nouveau-né (DAN) scale one to two hours after the procedure (MD −0.20, 95% CI −2.21 to 1.81; 42 participants, 1 study; low-certainty evidence). The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R scale up to 30 minutes after the procedure (MD 0.14, 95% CI −0.17 to 0.45; 123 participants, 2 studies; very low-certainty evidence) or one to two hours after the procedure (MD −0.83, 95% CI −2.42 to 0.75; 54 participants, 2 studies; very low-certainty evidence). The evidence is very uncertain about the effect of opioids on episodes of bradycardia (RR 3.19, 95% CI 0.14 to 72.69; 172 participants, 3 studies; very low-certainty evidence). Opioids may result in an increase in episodes of apnea compared to placebo (RR 3.15, 95% CI 1.08 to 9.16; 199 participants, 3 studies; low-certainty evidence): with one study reporting a concerning increase in severe apnea (RR 7.44, 95% CI 0.42 to 132.95; 31 participants, 1 study; very low-certainty). The evidence is very uncertain about the effect of opioids on episodes of hypotension (RR not estimable, risk difference 0.00, 95% CI −0.06 to 0.06; 88 participants, 2 studies; very low-certainty evidence). No studies reported parent satisfaction with care provided in the neonatal intensive care unit (NICU).\nOpioids compared to non-pharmacological intervention\nThe evidence is very uncertain about the effect of opioids on pain score assessed with the Crying Requires oxygen Increased vital signs Expression Sleep (CRIES) scale during the procedure when compared to facilitated tucking (MD −4.62, 95% CI −6.38 to −2.86; 100 participants, 1 study; very low-certainty evidence) or sensorial stimulation (MD 0.32, 95% CI −1.13 to 1.77; 100 participants, 1 study; very low-certainty evidence). The other main outcomes were not reported.\nOpioids compared to other analgesics or sedatives\nThe evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R during the procedure (MD −0.29, 95% CI −1.58 to 1.01; 124 participants, 2 studies; very low-certainty evidence); up to 30 minutes after the procedure (MD −1.10, 95% CI −2.82 to 0.62; 12 participants, 1 study; very low-certainty evidence); and one to two hours after the procedure (MD −0.17, 95% CI −2.22 to 1.88; 12 participants, 1 study; very low-certainty evidence). No studies reported any harms. The evidence is very uncertain about the effect of opioids on episodes of apnea during (RR 3.27, 95% CI 0.85 to 12.58; 124 participants, 2 studies; very low-certainty evidence) and after the procedure (RR 2.71, 95% CI 0.11 to 64.96; 124 participants, 2 studies; very low-certainty evidence) and on hypotension (RR 1.34, 95% CI 0.32 to 5.59; 204 participants, 3 studies; very low-certainty evidence). The other main outcomes were not reported.\nWe identified no studies comparing different opioids (e.g. morphine versus fentanyl) or different routes for administration of the same opioid (e.g. morphine enterally versus morphine intravenously).\nAuthors' conclusions\nCompared to placebo, opioids probably reduce pain score assessed with PIPP/PIPP-R scale during the procedure; may reduce NIPS during the procedure; and may result in little to no difference in DAN one to two hours after the procedure. The evidence is very uncertain about the effect of opioids on pain assessed with other pain scores or at different time points. The evidence is very uncertain about the effect of opioids on episodes of bradycardia, hypotension or severe apnea. Opioids may result in an increase in episodes of apnea. No studies reported parent satisfaction with care provided in the NICU. The evidence is very uncertain about the effect of opioids on any outcome when compared to non-pharmacological interventions or to other analgesics. We identified no studies comparing opioids to other opioids or comparing different routes of administration of the same opioid.\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": "• Due to a lack of strong evidence, the benefits and risks of opioids for managing pain in babies exposed to painful procedures are unclear.\n• Compared to placebo (a 'dummy' treatment, or sham treatment, that does not contain any medicine but looks identical to the medicine being tested), opioids may reduce pain assessed with certain scales during the procedure, but may not make a difference with other scales one to two hours after the procedure.\n• The evidence is very uncertain about the effect of opioids on: pain assessed with other pain scores or at different time points, episodes of bradycardia (slow heart rate), or hypotension (low blood pressure). Opioids may increase episodes of breathing stops."
}
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query-laysum | 4727 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative pancreatic fistula is a common and serious complication following pancreaticoduodenectomy. Duct-to-mucosa pancreaticojejunostomy has been used in many centers to reconstruct pancreatic digestive continuity following pancreatoduodenectomy, however, its efficacy and safety are uncertain.\nObjectives\nTo assess the benefits and harms of duct-to-mucosa pancreaticojejunostomy versus other types of pancreaticojejunostomy for the reconstruction of pancreatic digestive continuity in participants undergoing pancreaticoduodenectomy, and to compare the effects of different duct-to-mucosa pancreaticojejunostomy techniques.\nSearch methods\nWe searched the Cochrane Library (2021, Issue 1), MEDLINE (1966 to 9 January 2021), Embase (1988 to 9 January 2021), and Science Citation Index Expanded (1982 to 9 January 2021).\nSelection criteria\nWe included all randomized controlled trials (RCTs) that compared duct-to-mucosa pancreaticojejunostomy with other types of pancreaticojejunostomy (e.g. invagination pancreaticojejunostomy, binding pancreaticojejunostomy) in participants undergoing pancreaticoduodenectomy. We also included RCTs that compared different types of duct-to-mucosa pancreaticojejunostomy in participants undergoing pancreaticoduodenectomy.\nData collection and analysis\nTwo review authors independently identified the studies for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CIs). For all analyses, we used the random-effects model. We used the Cochrane RoB 1 tool to assess the risk of bias. We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nWe included 11 RCTs involving a total of 1696 participants in the review. One RCT was a dual-center study; the other 10 RCTs were single-center studies conducted in: China (4 studies); Japan (2 studies); USA (1 study); Egypt (1 study); Germany (1 study); India (1 study); and Italy (1 study). The mean age of participants ranged from 54 to 68 years. All RCTs were at high risk of bias.\nDuct-to-mucosa versus any other type of pancreaticojejunostomy\nWe included 10 RCTs involving 1472 participants comparing duct-to-mucosa pancreaticojejunostomy with invagination pancreaticojejunostomy: 732 participants were randomized to the duct-to-mucosa group, and 740 participants were randomized to the invagination group after pancreaticoduodenectomy. Comparing the two techniques, the evidence is very uncertain for the rate of postoperative pancreatic fistula (grade B or C; RR 1.45, 95% CI 0.64 to 3.26; 7 studies, 1122 participants; very low-certainty evidence), postoperative mortality (RR 0.77, 95% CI 0.39 to 1.49; 10 studies, 1472 participants; very low-certainty evidence), rate of surgical reintervention (RR 1.12, 95% CI 0.65 to 1.95; 10 studies, 1472 participants; very low-certainty evidence), rate of postoperative bleeding (RR 0.85, 95% CI 0.51 to 1.42; 9 studies, 1275 participants; very low-certainty evidence), overall rate of surgical complications (RR 1.12, 95% CI 0.92 to 1.36; 5 studies, 750 participants; very low-certainty evidence), and length of hospital stay (MD -0.41 days, 95% CI -1.87 to 1.04; 4 studies, 658 participants; very low-certainty evidence). The studies did not report adverse events or quality of life outcomes.\nOne type of duct-to-mucosa pancreaticojejunostomy versus a different type of duct-to-mucosa pancreaticojejunostomy\nWe included one RCT involving 224 participants comparing duct-to-mucosa pancreaticojejunostomy using the modified Blumgart technique with duct-to-mucosa pancreaticojejunostomy using the traditional interrupted technique: 112 participants were randomized to the modified Blumgart group, and 112 participants were randomized to the traditional interrupted group after pancreaticoduodenectomy. Comparing the two techniques, the evidence is very uncertain for the rate of postoperative pancreatic fistula (grade B or C; RR 1.51, 95% CI 0.61 to 3.75; 1 study, 210 participants; very low-certainty evidence), postoperative mortality (there were no deaths in either group; 1 study, 210 participants; very low-certainty evidence), rate of surgical reintervention (RR 1.93, 95% CI 0.18 to 20.91; 1 study, 210 participants; very low-certainty evidence), rate of postoperative bleeding (RR 2.89, 95% CI 0.12 to 70.11; 1 study, 210 participants; very low-certainty evidence), overall rate of surgical complications (RR 1.10, 95% CI 0.80 to 1.51; 1 study, 210 participants; very low-certainty evidence), and length of hospital stay (15 days versus 15 days; 1 study, 210 participants; very low-certainty evidence). The study did not report adverse events or quality of life outcomes.\nAuthors' conclusions\nThe evidence is very uncertain about the effects of duct-to-mucosa pancreaticojejunostomy compared to invagination pancreaticojejunostomy on any of the outcomes, including rate of postoperative pancreatic fistula (grade B or C), postoperative mortality, rate of surgical reintervention, rate of postoperative bleeding, overall rate of surgical complications, and length of hospital stay. The evidence is also very uncertain whether duct-to-mucosa pancreaticojejunostomy using the modified Blumgart technique is superior, equivalent or inferior to duct-to-mucosa pancreaticojejunostomy using the traditional interrupted technique. None of the studies reported adverse events or quality of life outcomes.\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": "- We do not know whether duct-to-mucosa pancreaticojejunostomy (attachment of the excretory duct of the pancreas to the second part of the small intestine) reduces postoperative pancreatic fistula (leakage of juice from the pancreas to the abdominal tissues) compared to invagination pancreaticojejunostomy (insertion of the pancreas within the second part of the small intestine).\n- We do not know whether modified duct-to-mucosa pancreaticojejunostomy is superior, equivalent or inferior to traditional duct-to-mucosa pancreaticojejunostomy.\n- Future studies should use adequate methods to improve our confidence in the evidence."
}
]
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query-laysum | 4728 | [
{
"role": "user",
"content": "Abstract: Background\nTotal thyroidectomy (TT) and subtotal thyroidectomy (ST) are worldwide treatment options for multinodular non-toxic goitre in adults. Near TT, defined as a postoperative thyroid remnant less than 1 mL, is supposed to be a similarly effective but safer option than TT. ST has been shown to be marginally safer than TT, but it may leave an undetected thyroid cancer in place.\nObjectives\nThe objective was to assess the effects of total or near-total thyroidectomy compared to subtotal thyroidectomy for multinodular non-toxic goitre.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, PubMed, EMBASE, as well as the ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was 18 June 2015 for all databases. No language restrictions were applied.\nSelection criteria\nTwo review authors independently scanned the abstract, title or both sections of every record retrieved to identify randomised controlled trials (RCTs) on thyroidectomy for multinodular non-toxic goitre for further assessment.\nData collection and analysis\nTwo review authors independently extracted data, assessed studies for risk of bias and evaluated overall study quality utilising the GRADE instrument. We calculated the odds ratio (OR) and corresponding 95% confidence interval (CI) for dichotomous outcomes. A random-effects model was used for pooling data.\nMain results\nWe examined 1430 records, scrutinized 14 full-text publications and included four RCTs. Altogether 1305 participants entered the four trials, 543 participants were randomised to TT and 762 participants to ST. A total of 98% and 97% of participants finished the trials in the TT and ST groups, respectively. Two trials had a duration of follow-up between 12 and 39 months and two trials a follow-up of 5 and 10 years, respectively. Risk of bias across studies was mainly unknown for selection, performance and detection bias. Attrition bias was generally low and reporting bias high for some outcomes. In the short-term postoperative period no deaths were reported for both TT and ST groups. However, longer-term data on all-cause mortality were not reported (1284 participants; 4 trials; moderate quality evidence). Goiter recurrence was lower in the TT group compared to ST. Goiters recurred in 0.2% (1/425) of the TT group compared to 8.4% (53/632) of the ST group (OR 0.05 (95% CI 0.01 to 0.21); P < 0.0001; 1057 participants; 3 trials; moderate quality evidence). Re-intervention due to goitre recurrence was lower in the TT group compared to ST. Re-intervention was necessary in 0.5% (1/191) of TT patients compared to 0.8% (3/379)of ST patients (OR 0.66 (95% CI 0.07 to 6.38); P = 0.72; 570 participants; 1 trial; low quality evidence). The incidence of permanent recurrent laryngeal nerve palsy was lower for ST compared with TT. Permanent recurrent laryngeal nerve palsy occurred in 0.8% (6/741) of ST patients compared to 0.7% (4/543) of TT patients (OR 1.28, (95% CI 0.38 to 4.36); P = 0.69; 1275 participants; 4 trials; low quality evidence). The incidence of permanent hypoparathyroidism was lower for ST compared with TT. Permanent hypoparathyroidism occurred in 0.1% (1/741) of ST patients compared to 0.6% (3/543) of TT patients (OR 3.09 (95% CI 0.45 to 21.36); P = 0.25; 1275 participants: 4 trials; low quality evidence). The incidence of thyroid cancer was lower for ST compared with TT. Thyroid cancer occurred in 6.1% (41/669) of ST patients compared to 7.3% (34/465)of TT patients (OR 1.32 (95% CI 0.81 to 2.15); P = 0.27; 1134 participants; 3 trials; low quality evidence). No data on health-related quality of life or socioeconomic effects were reported in the included studies.\nAuthors' conclusions\nThe body of evidence on TT compared with ST is limited. Goiter recurrence is reduced following TT. The effects on other key outcomes such as re-interventions due to goitre recurrence, adverse events and thyroid cancer incidence are uncertain. New long-term RCTs with additional data such as surgeons level of experience, treatment volume of surgical centres and details on techniques used are 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": "Multinodular goitre refers to a generalised enlarged thyroid gland with recognisable nodules within it. The thyroid gland consists of two connected lobes. People affected by goitre often present with a non-symmetrical enlargement of the thyroid gland with a visible swelling in the anterior aspect of the neck. One or more nodules can be recognised. The most frequent cause of multinodular goitre is iodine deficiency. Non-toxic goitre means that the nodules do not secret thyroid hormones in an uncontrolled way. Total thyroidectomy is an operation that involves the surgical removal of the whole thyroid gland. Near-total thyroidectomy is an operation that involves the surgical removal of both thyroid lobes except for a small amount of thyroid tissue (on one or both sides less than 1.0 mL). Subtotal thyroidectomy leaves 3 g to 5 g on the less affected side of the thyroid gland.\nAfter thyroidectomy one of the most important complications is recurrent nerve palsy because this nerve might be traumatised during the surgery. A wide spectrum of complications to the voice, swallowing mechanisms, or both, can occur. A temporary or permanent voice change can result. If the goitre reappears (goitre recurrence) some time after thyroidectomy, another surgical intervention might be necessary. This surgery is more complicated than the initial surgery because of scar tissue making it difficult to identify nerves and other important tissues. There is also the possibility that subtotal thyroidectomy, which is thought to be somewhat safer than total thyroidectomy, may leave an undetected thyroid cancer in place."
}
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query-laysum | 4729 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoradionecrosis (ORN) of the jaws is among the most serious oral complications of head and neck cancer radiotherapy, arising from radiation-induced fibro-atrophic tissue injury, manifested by necrosis of osseous tissues and failure to heal, often secondary to operative interventions in the oral cavity. It is associated with considerable morbidity and has important quality of life ramifications. Since ORN is very difficult to treat effectively, preventive measures to limit the onset of this disease are needed; however, the effects of various preventive interventions has not been adequately quantified.\nObjectives\nTo assess the effects of interventions for preventing ORN of the jaws in adult patients with head and neck cancer undergoing curative or adjuvant (i.e. non-palliative) radiotherapy.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 5 November 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 10) in the Cochrane Library (searched 5 November 2019), MEDLINE Ovid (1946 to 5 November 2019), Embase Ovid (1980 to 5 November 2019), Allied and Complementary Medicine (AMED) Ovid (1985 to 5 November 2019), Scopus (1966 to 5 November 2019), Proquest Dissertations and Theses International (1861 to 5 November 2019) and Web of Science Conference Proceedings (1990 to 5 November 2019). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe selected randomised controlled trials (RCTs) or quasi-RCTs of adult patients 18 years or older with head and neck cancer who had undergone curative or adjuvant radiotherapy to the head and neck, who had received an intervention to prevent the onset of ORN. Eligible patients were those subjected to pre- or post-irradiation dental evaluation. Management of these patients was to be with interventions independent of their cancer therapy, including but not limited to local, systemic, or behavioural interventions.\nData collection and analysis\nTwo review authors independently selected trials from search results, assessed risk of bias, and extracted relevant data for inclusion in the review. Authors of included studies were contacted to request missing data. We used standard methodological procedures expected by Cochrane.\nMain results\nFour studies were identified that met pre-determined eligibility criteria, evaluating a total of 342 adults. From the four studies, all assessed as at high risk of bias, three broad interventions were identified that may potentially reduce the risk of ORN development: one study showed no reduction in ORN when using platelet-rich plasma placed in the extraction sockets of prophylactically removed healthy mandibular molar teeth prior to radiotherapy (odds ratio (OR) 3.32, 95% confidence interval (CI) 0.58 to 19.09; one trial, 44 participants; very low-certainty evidence). Another study involved comparing fluoride gel and high-content fluoride toothpaste (1350 parts per million (ppm)) in prevention of post-radiation caries, and found no difference between their use as no cases of ORN were reported (one trial, 220 participants; very low-certainty evidence). The other two studies involved the use of perioperative hyperbaric oxygen (HBO) therapy and antibiotics. One study showed that treatment with HBO caused a reduction in the development of ORN in comparison to patients treated with antibiotics following dental extractions (risk ratio (RR) 0.18, 95% CI 0.43 to 0.76; one trial, 74 participants; very low-certainty evidence). Another study found no difference between combined HBO and antibiotics compared to antibiotics alone prior to dental implant placement (RR 3.00, 95% CI 0.14 to 65.16; one trial, 26 participants; very low-certainty evidence).\nAdverse effects of the different interventions were not reported clearly or were not important.\nAuthors' conclusions\nGiven the suboptimal reporting and inadequate sample sizes of the included studies, evidence regarding the interventions evaluated by the trials included in this review is uncertain. More well-designed RCTs with larger samples are required to make conclusive statements regarding the efficacy of these interventions.\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": "With this Cochrane Review we tried to find out the best way to prevent the death and exposure of bone in the jaws of people who have had radiotherapy for head and neck cancer. This is a condition called osteoradionecrosis (ORN)."
}
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query-laysum | 4730 | [
{
"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 evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence on 28 June 2016 and found 15 randomised studies, involving 6008 women. Thirteen of these studies provided data we could use. The quality of results ranged from very low to high (GRADE). Most studies had design limitations, which in some were serious. Most studies compared women taught how to check for signs of premature labour with women who were also given a home uterine activity monitor. In some studies both groups used a monitor but one group had a ‘sham’ monitor that did not actually send the data to the women’s healthcare providers.Using a monitor at home made very little difference to many of the outcomes for mother or baby, although not all studies measured all outcomes. Women using monitors were no less likely to experience preterm birth at less than 37 or 32 weeks of pregnancy (GRADE very low). Women using monitors were less likely to experience preterm birth at less than 34 weeks, but when we analysed only high-quality studies, no clear difference remained (GRADE high). Babies born to women using the monitor were less likely to be admitted to neonatal intensive care (GRADE moderate) but there were no fewer deaths (GRADE low). Women using the monitor were more likely to make an unscheduled antenatal visit (GRADE moderate), but the number of antenatal hospital admissions did not differ (GRADE low). Women using monitors appeared to be more likely to receive tocolysis (treatment to stop labour) (GRADE low), but when we looked only at high-quality studies there was no clear difference. We found no data to assess women's views, although one large trial reported low compliance with monitor use. In some studies, women with monitors had more contact with midwives or maternity nurses, but it is unclear what effect this had."
}
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query-laysum | 4731 | [
{
"role": "user",
"content": "Abstract: Background\nTension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache day per month), frequent episodic TTH (2 to 14 headache days per month), and chronic TTH (15 headache days a month or more). Ketoprofen is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.\nObjectives\nTo assess the efficacy and safety of ketoprofen for treatment of episodic TTH in adults compared with placebo or any active comparator.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Oxford Pain Relief Database up to May 2016, and also reference lists of relevant published studies and reviews. We sought unpublished studies by asking personal contacts and searching online clinical trial registers and manufacturers' websites.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled studies (parallel-group or cross-over) using oral ketoprofen for symptomatic relief of an acute episode of TTH. Studies had to be prospective, with participants aged 18 years or over, and include at least 10 participants per treatment arm.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and extracted data. We used the numbers of participants achieving each outcome to calculate the risk ratio (RR) and number needed to treat for one additional beneficial outcome (NNT) or one additional harmful outcome (NNH) for oral ketoprofen compared to placebo or an active intervention for a range of outcomes, predominantly those recommended by the International Headache Society (IHS).\nWe assessed the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included four studies, all of which enrolled adults with frequent episodic TTH. They all specified using the IHS diagnostic criteria and reported mean baseline pain of at least moderate intensity. While 1253 people with TTH participated in these studies, the numbers available for any analysis were lower than this because outcomes were inconsistently reported and because many participants received active comparators.\nNone of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged one study to be at high risk of bias due to small size.\nUseful information was available only for ketoprofen 25 mg. For the IHS preferred outcome of being pain-free at two hours the NNT for ketoprofen 25 mg compared with placebo was 9.0 (95% confidence interval (CI) 4.8 to 72) in two studies (272 participants; low quality evidence). The NNT was 3.7 (95% CI 2.6 to 6.3) for pain-free or mild pain at two hours in two studies (272 participants; moderate quality evidence). Fewer people needed rescue medication with ketoprofen 25 mg than with placebo, with a number needed to treat to prevent one event (NNTp) of 6.2 (95% CI 4.3 to 11) in three studies (605 participants; moderate quality evidence). The number of participants reporting any adverse event was higher with ketoprofen 25 mg than placebo (NNH 15, (95% CI 8.7 to 45)) in three studies (651 participants with 66 events; low quality evidence). Most events were of mild to moderate intensity.\nKetoprofen 25 mg was not different from paracetamol 1000 mg in two studies with 276 participants for any efficacy outcomes (low to moderate quality evidence); the RR for pain-free at two hours was 1.3 (95% CI 0.9 to 2.0). The number of participants reporting any adverse event was higher with ketoprofen 25 mg than with paracetamol (NNH 17, 95% CI 8.9 to 130)) in two studies (582 participants, 68 events; low quality evidence).\nStudies reported no serious adverse events.\nWe judged the quality of the evidence comparing ketoprofen 25 mg with placebo or paracetamol 1000 mg as moderate to very low. Where evidence was downgraded it was because of the small number of studies and events.\nAuthors' conclusions\nKetoprofen 25 mg provided a small benefit compared with placebo in terms of being pain-free at two hours or having mild or no pain at two hours for people with frequent episodic TTH who have an acute headache of moderate or severe intensity. Its use was associated with more people experiencing adverse events. Ketoprofen 25 mg was not superior to paracetamol 1000 mg for any efficacy outcome.\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 being pain-free at two hours was low quality, and for having mild pain at two hours was moderate quality. Moderate quality evidence means that we are reasonably confident about the results. Low quality evidence means that we are not very certain about the results and they could change with more information."
}
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query-laysum | 4732 | [
{
"role": "user",
"content": "Abstract: Background\nInhaled corticosteroids (ICS) are the mainstay treatment for persistent asthma. Escalating treatment is required when asthma is not controlled with ICS therapy alone, which would include, but is not limited to, adding a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA) or doubling the dose of ICS.\nObjectives\nTo assess the efficacy and safety of adding a LABA or LAMA to ICS therapy versus doubling the dose of ICS in adolescents and adults whose asthma is not well controlled on medium-dose (MD)-ICS using a network meta-analysis (NMA), and to provide a ranking of these treatments according to their efficacy and safety.\nSearch methods\nWe searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, Global Health, ClinicalTrials.gov, and the World Health Organization ICTRP for pre-registered randomised controlled trials (RCTs) from January 2008 to 19 December 2022.\nSelection criteria\nWe searched for studies including adolescents and adults with uncontrolled asthma who had been treated with or were eligible for MD-ICS, comparing it to high-dose (HD)-ICS, ICS/LAMA, or ICS/LABA. We excluded cluster- and cross-over RCTs. Studies were of at least 12 weeks duration.\nData collection and analysis\nWe conducted a systematic review and network meta-analysis according to a previously published protocol. We used Cochrane’s Screen4ME workflow to assess search results. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of evidence. The primary outcome is asthma exacerbations (moderate and severe).\nMain results\nWe included 38,276 participants from 35 studies (median duration 24 weeks (range 12 to 78); mean age 44.1; 38% male; 69% white; mean forced expiratory volume in one second 2.1 litres and 68% of predicted).\nMD- and HD-ICS/LABA likely reduce and MD-ICS/LAMA possibly reduces moderate to severe asthma exacerbations compared to MD-ICS (hazard ratio (HR) 0.70, 95% credible interval (CrI) 0.59 to 0.82; moderate certainty; HR 0.59, 95% CrI 0.46 to 0.76; moderate certainty; and HR 0.56, 95% CrI 0.38 to 0.82; low certainty, respectively), whereas HD-ICS probably does not (HR 0.94, 95% CrI 0.70 to 1.24; moderate certainty). There is no clear evidence to suggest that any combination therapy or HD-ICS reduces severe asthma exacerbations compared to MD-ICS (low to moderate certainty).\nThis study suggests no clinically meaningful differences in the symptom or quality of life score between dual combinations and monotherapy (low to high certainty).\nMD- and HD-ICS/LABA increase or likely increase the odds of Asthma Control Questionnaire (ACQ) responders at 6 and 12 months compared to MD-ICS (odds ratio (OR) 1.47, 95% CrI 1.23 to 1.76; high certainty; and OR 1.59, 95% CrI 1.31 to 1.94; high certainty at 6 months; and OR 1.61, 95% CrI 1.22 to 2.13; moderate certainty and OR 1.55, 95% CrI 1.20 to 2.00; high certainty at 12 months, respectively).\nMD-ICS/LAMA probably increases the odds of ACQ responders at 6 months (OR 1.32, 95% CrI 1.11 to 1.57; moderate certainty). No data were available at 12 months. There is no clear evidence to suggest that HD-ICS increases the odds of ACQ responders or improves the symptom or qualify of life score compared to MD-ICS (very low to high certainty).\nThere is no evidence to suggest that ICS/LABA or ICS/LAMA reduces asthma-related or all-cause serious adverse events (SAEs) compared to MD-ICS (very low to high certainty). HD-ICS results in or likely results in little or no difference in the included safety outcomes compared to MD-ICS as well as HD-ICS/LABA compared to MD-ICS/LABA.\nThe pairwise meta-analysis shows that MD-ICS/LAMA likely reduces all-cause adverse events (AEs) and results in a slight reduction in treatment discontinuation due to AEs compared to MD-ICS (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.77 to 0.96; 4 studies, 2238 participants; moderate certainty; and RR 0.51, 95% CI 0.26 to 0.99; 4 studies, 2239 participants; absolute risk reduction 10 fewer per 1000 participants; moderate certainty, respectively). The NMA evidence is in agreement with the pairwise evidence on treatment discontinuation due to AEs, but very uncertain on all-cause AEs, due to imprecision and heterogeneity.\nAuthors' conclusions\nThe review findings suggest that MD- or HD-ICS/LABA and MD-ICS/LAMA reduce moderate to severe asthma exacerbations and increase the odds of ACQ responders compared to MD-ICS whereas HD-ICS probably does not. The evidence is generally stronger for MD- and HD-ICS/LABA than for MD-ICS/LAMA primarily due to a larger evidence base. There is no evidence to suggest that ICS/LABA, ICS/LAMA, or HD-ICS/LABA reduces severe asthma exacerbations or SAEs compared to MD-ICS. MD-ICS/LAMA likely reduces all-cause AEs and results in a slight reduction in treatment discontinuation due to AEs compared to MD-ICS.\nThe above findings may assist in deciding on a treatment option during the stepwise approach of asthma management. Longer-term safety of higher than medium-dose ICS needs to be addressed in phase 4 or observational studies given that the median duration of included studies was six months.\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": "• Adding a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA) to medium-dose inhaled corticosteroids (ICS) likely reduces asthma attacks requiring treatment with oral steroids and increases the odds of satisfactory symptom control compared to ICS alone, whereas doubling the dose of ICS probably does not. The amount of data we found was much larger for LABAs than for LAMAs.\n• We need to learn more about the long-term side effects of high-dose ICS because the average duration of the included studies was only six months. Using the lowest effective ICS doses is encouraged to minimise corticosteroid-associated side effects."
}
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query-laysum | 4733 | [
{
"role": "user",
"content": "Abstract: Background\nFrostbite is a thermal injury caused when tissue is exposed to sub-zero temperatures (in degrees Celsius) long enough for ice crystals to form in the affected tissue. Depending on the degree of tissue damage, thrombosis, ischaemia, necrosis (tissue death), gangrene and ultimately amputation may occur. Several interventions for frostbite injuries have been proposed, such as hyperbaric oxygen therapy, sympathectomy (nerve block), thrombolytic (blood-thinning) therapy and vasodilating agents such as iloprost, reserpine, pentoxifylline and buflomedil, but the benefits and harms of these interventions are unclear.\nObjectives\nTo assess the benefits and harms of the different management options for frostbite injuries.\nSearch methods\nOn 25 February 2020, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase (OvidSP), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), Conference Proceedings Citation Index-Science (CPCI-S), as well as trials registers. Shortly before publication, we searched Clinicaltrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform, OpenGrey and GreyLit (9 November 2020) again. We investigated references from relevant articles, and corresponded with a trial author.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any medical intervention, e.g. pharmacological therapy, topical treatments or rewarming techniques, for frostbite injuries to another treatment, placebo or no treatment.\nData collection and analysis\nTwo authors independently extracted data. We used Review Manager 5 for statistical analysis of dichotomous data with risk ratio (RR) with 95% confidence intervals (CIs). We used the Cochrane 'Risk of bias' tool to assess bias in the included trial. We assessed incidence of amputations, rates of serious and non-serious adverse events, acute pain, chronic pain, ability to perform activities of daily living, quality of life, withdrawal rate from medical therapy due to adverse events, occupational effects and mortality. We used GRADE to assess the quality of the evidence.\nMain results\nWe included one, open-label randomised trial involving 47 participants with severe frostbite injuries. We judged this trial to be at high risk of bias for performance bias, and uncertain risk for attrition bias; all other risk of bias domains we judged as low.\nAll participants underwent rapid rewarming, received 250 mg of aspirin and 400 mg intravascular (IV) buflomedil (since withdrawn from practice), and were then randomised to one of three treatment groups for the following eight days. Group 1 received additional IV buflomedil 400 mg for one hour per day. Group 2 received the prostacyclin, iloprost, 0.5 ng to 2 ng/kg/min IV for six hours per day. Group 3 received IV iloprost 2 ng/kg/min for six hours per day plus fibrinolysis with 100 mg recombinant tissue plasminogen activator (rtPA) for the first day only.\nThe results suggest that iloprost and iloprost plus rtPA may reduce the rate of amputations in people with severe frostbite compared to buflomedil alone, RR 0.05 (95% CI 0.00 to 0.78; P = 0.03; very low-quality evidence) and RR 0.31 (95% CI 0.10 to 0.94; P = 0.04; very low-quality evidence), respectively. Iloprost may be as effective as iloprost plus rtPA at reducing the amputation rate, RR 0.14 (95% CI 0.01 to 2.56; P = 0.19; very low-quality evidence). There were no reported deaths or withdrawals due to adverse events in any of the groups; we assessed evidence for both outcomes as being of very low quality. Adverse events (including flushing, nausea, palpitations and vomiting) were common, but not reported separately by comparator arm (very low-quality evidence). The included study did not measure the outcomes of acute pain, chronic pain, ability to perform activities of daily living, quality of life or occupational effects.\nAuthors' conclusions\nThere is a paucity of evidence regarding interventions for frostbite injuries. Very low-quality evidence from a single small trial indicates that iloprost, and iloprost plus rtPA, in combination with buflomedil may reduce the need for amputation in people with severe frostbite compared to buflomedil alone. However, buflomedil has been withdrawn from use. High quality randomised trials are needed to establish firm evidence for the treatment of frostbite injuries.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found one randomised controlled trial (RCT) involving 47 people who were rescued by mountain rescue teams in the French Alps. Everybody was treated with a dose of two medicines, aspirin and buflomedil, then allocated to one of three groups for further treatment.\nGroup 1 received additional buflomedil (since this RCT took place, buflomedil was withdrawn from use because of reports of severe adverse events associated with its use);\nGroup 2 received another medicine called iloprost;\nGroup 3 received iloprost and a substance involved naturally in the breakdown of blood clots (recombinant tissue plasminogen activator (rtPA))."
}
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query-laysum | 4734 | [
{
"role": "user",
"content": "Abstract: Background\nFalls and fall-related injuries are common, particularly in those aged over 65, with around one-third of older people living in the community falling at least once a year. Falls prevention interventions may comprise single component interventions (e.g. exercise), or involve combinations of two or more different types of intervention (e.g. exercise and medication review). Their delivery can broadly be divided into two main groups: 1) multifactorial interventions where component interventions differ based on individual assessment of risk; or 2) multiple component interventions where the same component interventions are provided to all people.\nObjectives\nTo assess the effects (benefits and harms) of multifactorial interventions and multiple component interventions for preventing falls in older people living in the community.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature, trial registers and reference lists. Date of search: 12 June 2017.\nSelection criteria\nRandomised controlled trials, individual or cluster, that evaluated the effects of multifactorial and multiple component interventions on falls in older people living in the community, compared with control (i.e. usual care (no change in usual activities) or attention control (social visits)) or exercise as a single intervention.\nData collection and analysis\nTwo review authors independently selected studies, assessed risks of bias and extracted data. We calculated the rate ratio (RaR) with 95% confidence intervals (CIs) for rate of falls. For dichotomous outcomes we used risk ratios (RRs) and 95% CIs. For continuous outcomes, we used the standardised mean difference (SMD) with 95% CIs. We pooled data using the random-effects model. We used the GRADE approach to assess the quality of the evidence.\nMain results\nWe included 62 trials involving 19,935 older people living in the community. The median trial size was 248 participants. Most trials included more women than men. The mean ages in trials ranged from 62 to 85 years (median 77 years). Most trials (43 trials) reported follow-up of 12 months or over. We assessed most trials at unclear or high risk of bias in one or more domains.\nForty-four trials assessed multifactorial interventions and 18 assessed multiple component interventions. (I2 not reported if = 0%).\nMultifactorial interventions versus usual care or attention control\nThis comparison was made in 43 trials. Commonly-applied or recommended interventions after assessment of each participant's risk profile were exercise, environment or assistive technologies, medication review and psychological interventions. Multifactorial interventions may reduce the rate of falls compared with control: rate ratio (RaR) 0.77, 95% CI 0.67 to 0.87; 19 trials; 5853 participants; I2 = 88%; low-quality evidence. Thus if 1000 people were followed over one year, the number of falls may be 1784 (95% CI 1553 to 2016) after multifactorial intervention versus 2317 after usual care or attention control. There was low-quality evidence of little or no difference in the risks of: falling (i.e. people sustaining one or more fall) (RR 0.96, 95% CI 0.90 to 1.03; 29 trials; 9637 participants; I2 = 60%); recurrent falls (RR 0.87, 95% CI 0.74 to 1.03; 12 trials; 3368 participants; I2 = 53%); fall-related hospital admission (RR 1.00, 95% CI 0.92 to 1.07; 15 trials; 5227 participants); requiring medical attention (RR 0.91, 95% CI 0.75 to 1.10; 8 trials; 3078 participants). There is low-quality evidence that multifactorial interventions may reduce the risk of fall-related fractures (RR 0.73, 95% CI 0.53 to 1.01; 9 trials; 2850 participants) and may slightly improve health-related quality of life but not noticeably (SMD 0.19, 95% CI 0.03 to 0.35; 9 trials; 2373 participants; I2 = 70%). Of three trials reporting on adverse events, one found none, and two reported 12 participants with self-limiting musculoskeletal symptoms in total.\nMultifactorial interventions versus exercise\nVery low-quality evidence from one small trial of 51 recently-discharged orthopaedic patients means that we are uncertain of the effects on rate of falls or risk of falling of multifactorial interventions versus exercise alone. Other fall-related outcomes were not assessed.\nMultiple component interventions versus usual care or attention control\nThe 17 trials that make this comparison usually included exercise and another component, commonly education or home-hazard assessment. There is moderate-quality evidence that multiple interventions probably reduce the rate of falls (RaR 0.74, 95% CI 0.60 to 0.91; 6 trials; 1085 participants; I2 = 45%) and risk of falls (RR 0.82, 95% CI 0.74 to 0.90; 11 trials; 1980 participants). There is low-quality evidence that multiple interventions may reduce the risk of recurrent falls, although a small increase cannot be ruled out (RR 0.81, 95% CI 0.63 to 1.05; 4 trials; 662 participants). Very low-quality evidence means that we are uncertain of the effects of multiple component interventions on the risk of fall-related fractures (2 trials) or fall-related hospital admission (1 trial). There is low-quality evidence that multiple interventions may have little or no effect on the risk of requiring medical attention (RR 0.95, 95% CI 0.67 to 1.35; 1 trial; 291 participants); conversely they may slightly improve health-related quality of life (SMD 0.77, 95% CI 0.16 to 1.39; 4 trials; 391 participants; I2 = 88%). Of seven trials reporting on adverse events, five found none, and six minor adverse events were reported in two.\nMultiple component interventions versus exercise\nThis comparison was tested in five trials. There is low-quality evidence of little or no difference between the two interventions in rate of falls (1 trial) and risk of falling (RR 0.93, 95% CI 0.78 to 1.10; 3 trials; 863 participants) and very low-quality evidence, meaning we are uncertain of the effects on hospital admission (1 trial). One trial reported two cases of minor joint pain. Other falls outcomes were not reported.\nAuthors' conclusions\nMultifactorial interventions may reduce the rate of falls compared with usual care or attention control. However, there may be little or no effect on other fall-related outcomes. Multiple component interventions, usually including exercise, may reduce the rate of falls and risk of falling compared with usual care or attention control.\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": "To assess whether fall-prevention strategies which target two or more risk factors for falls (multifactorial interventions) or fixed combinations of interventions (multiple component interventions) are effective in preventing falls in older people living in the community."
}
]
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query-laysum | 4735 | [
{
"role": "user",
"content": "Abstract: Background\nDental sealants were introduced in the 1960s to help prevent dental caries, mainly in the pits and fissures of occlusal tooth surfaces. Sealants act to prevent bacteria growth that can lead to dental decay. Evidence suggests that fissure sealants are effective in preventing caries in children and adolescents compared to no sealants. Effectiveness may, however, be related to caries incidence level of the population. This is an update of a review published in 2004, 2008 and 2013.\nObjectives\nTo compare the effects of different types of fissure sealants in preventing caries in occlusal surfaces of permanent teeth in children and adolescents.\nSearch methods\nCochrane Oral Health’s Information Specialist searched: Cochrane Oral Health’s Trials Register (to 3 August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 7), MEDLINE Ovid (1946 to 3 August 2016), and Embase Ovid (1980 to 3 August 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 3 August 2016. No restrictions were placed on language or date of publication.\nSelection criteria\nRandomised controlled trials (RCTs) comparing sealants with no sealant or a different type of sealant material for preventing caries of occlusal surfaces of premolar or molar teeth in children and adolescents aged up to 20 years. Studies required at least 12 months follow-up. We excluded studies that compared compomers to resins/composites.\nData collection and analysis\nTwo review authors independently screened search results, extracted data and assessed risk of bias of included studies. We presented outcomes for caries or no caries on occlusal surfaces of permanent molar teeth as odds ratio (OR) or risk ratio (RR). We used mean difference (MD) for mean caries increment. All measures were presented with 95% confidence intervals (CI). We conducted meta-analyses using a random-effects model for comparisons where there were more than three trials; otherwise we used the fixed-effect model. We used GRADE methods to assess evidence quality.\nMain results\nWe included 38 trials that involved a total of 7924 children; seven trials were new for this update (1693 participants). Fifteen trials evaluated the effects of resin-based sealant versus no sealant (3620 participants in 14 studies plus 575 tooth pairs in one study); three trials with evaluated glass ionomer sealant versus no sealant (905 participants); and 24 trials evaluated one type of sealant versus another (4146 participants). Children were aged from 5 to 16 years. Trials rarely reported background exposure to fluoride of trial participants or baseline caries prevalence.\nResin-based sealant versus no sealant: second-, third- and fourth-generation resin-based sealants prevented caries in first permanent molars in children aged 5 to 10 years (at 24 months follow-up: OR 0.12, 95% CI 0.08 to 0.19, 7 trials (5 published in the 1970s; 2 in the 2010s), 1548 children randomised, 1322 children evaluated; moderate-quality evidence). If we were to assume that 16% of the control tooth surfaces were decayed during 24 months of follow-up (160 carious teeth per 1000), then applying a resin-based sealant would reduce the proportion of carious surfaces to 5.2% (95% CI 3.13% to 7.37%). Similarly, assuming that 40% of control tooth surfaces were decayed (400 carious teeth per 1000), then applying a resin-based sealant would reduce the proportion of carious surfaces to 6.25% (95% CI 3.84% to 9.63%). If 70% of control tooth surfaces were decayed, there would be 19% decayed surfaces in the sealant group (95% CI 12.3% to 27.2%). This caries-preventive effect was maintained at longer follow-up but evidence quality and quantity was reduced (e.g. at 48 to 54 months of follow-up: OR 0.21, 95% CI 0.16 to 0.28, 4 trials, 482 children evaluated; RR 0.24, 95% CI 0.12 to 0.45, 203 children evaluated). Although studies were generally well conducted, we assessed blinding of outcome assessment for caries at high risk of bias for all trials (blinding of outcome assessment is not possible in sealant studies because outcome assessors can see and identify sealant).\nGlass ionomer sealant versus no sealant: was evaluated by three studies. Results at 24 months were inconclusive (very low-quality evidence).\nOne sealant versus another sealant: the relative effectiveness of different types of sealants is unknown (very low-quality evidence). We included 24 trials that directly compared two different sealant materials. Comparisons varied in terms of types of sealant assessed, outcome measures chosen and duration of follow-up.\nAdverse events: only four trials assessed adverse events. No adverse events were reported.\nAuthors' conclusions\nResin-based sealants applied on occlusal surfaces of permanent molars are effective for preventing caries in children and adolescents. Our review found moderate-quality evidence that resin-based sealants reduced caries by between 11% and 51% compared to no sealant, when measured at 24 months. Similar benefit was seen at timepoints up to 48 months; after longer follow-up, the quantity and quality of evidence was reduced. There was insufficient evidence to judge the effectiveness of glass ionomer sealant or the relative effectiveness of different types of sealants. Information on adverse effects was limited but none occurred where this was reported. Further research with long follow-up is needed.\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": "We found moderate-quality evidence that resin-based sealant is more effective than no sealant for preventing tooth decay, reducing it by between 11% and 51% more than in children without sealant (measured two years after application). 'Moderate quality' means we are reasonably certain of this finding, although it is possible that future research could change it. Most of the studies included in this analysis were carried out in the 1970s. We are not able to draw conclusions about the other comparisons included in our review as the available evidence is very low quality. More studies with long follow-up times are needed."
}
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query-laysum | 4736 | [
{
"role": "user",
"content": "Abstract: Background\nExtensive evidence exists showing analgesic effects of sweet solutions for newborns and infants. It is less certain if the same analgesic effects exist for children one year to 16 years of age. This is an updated version of the original Cochrane review published in Issue 10, 2011 (Harrison 2011) titled Sweet tasting solutions for reduction of needle-related procedural pain in children aged one to 16 years.\nObjectives\nTo determine the efficacy of sweet tasting solutions or substances for reducing needle-related procedural pain in children beyond one year of age.\nSearch methods\nSearches were run to the end of June 2014. We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Cochrane Methodology Register, Health Technology Assessment, the NHS Economic Evaluation Database, MEDLINE, EMBASE, PsycINFO, and ACP Journal Club (all via OvidSP), and CINAH (via EBSCOhost). We applied no language restrictions.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCT) in which children aged one year to 16 years, received a sweet tasting solution or substance for needle-related procedural pain. Control conditions included water, non-sweet tasting substances, pacifier, distraction, positioning/containment, breastfeeding, or no treatment.\nData collection and analysis\nOutcome measures included crying duration, composite pain scores, physiological or behavioral pain indicators, self-report of pain or parental or healthcare professional-report of the child's pain. We reported mean differences (MD), weighted mean difference (WMD), or standardized mean difference (SMD) with 95% confidence intervals (CI) using fixed-effect or random-effects models as appropriate for continuous outcome measures. We reported risk ratio (RR), risk difference (RD), and the number needed to treat to benefit (NNTB) for dichotomous outcomes. We used the I2 statistic to assess between-study heterogeneity.\nMain results\nWe included one unpublished and seven published studies (total of 808 participants); four more studies and 478 more participants than the 2011 review. Six trials included young children aged one to four years receiving sucrose or candy lollypops for immunisation pain compared with water or no treatment. Usual care included topical anaesthetics, upright parental holding, and distraction. All studies were well designed blinded RCTs, however, five of the six studies had a high risk of bias based on small sample sizes.\nTwo studies included school-aged children receiving sweet or unsweetened chewing gum before, or before and during, immunisation and blood collection. Both studies, conducted by the same author, had a high risk of bias based on small sample sizes.\nResults for the toddlers/pre-school children were conflicting. Duration of cry, using a random-effects model, was not significantly reduced by sweet taste (six trials, 520 children, WMD -15 seconds, 95% CI -54 to 24, I2 = 94%).\nComposite pain score at time of first needle was reported in four studies (n = 121 children). The scores were not significantly different between the sucrose and control group (SMD -0.26, 95% CI -1.27 to 0.75, I2 = 86%).\nA Children's Hospital of Eastern Ontario Pain Scale score > 4 was significantly less common in the sucrose group compared to the control group in one study (n = 472, RR 0.55, 95% CI 0.45 to 0.67; RD -0.29, 95% CI -0.37 to -0.20; NNTB 3, 95% CI 3 to 5; tests for heterogeneity not applicable.\nFor school-aged children, chewing sweet gum before needle-related painful procedures (two studies, n = 111 children) or during the procedures (two studies, n = 103 children) did not significantly reduce pain scores. A comparison of the Faces Pain Scale scores in children chewing sweet gum before the procedures compared with scores of children chewing unsweetened gum revealed a WMD of -0.15 (95% CI -0.61 to 0.30). Similar results were found when comparing the chewing of sweet gum with unsweetened gum during the procedure (WMD 0.23, 95% CI -0.28 to 0.74). The Colored Analogue Scale for children chewing sweet gum compared to unsweetened gum before the procedure was not significantly different (WMD 0.24 (-0.69 to 1.18)) nor was it different when children chewed the gum during the procedure (WMD 0.86 (95% CI -0.12 to 1.83)). There was no heterogeneity for any of these analyses in school-aged children (I2 = 0%).\nAuthors' conclusions\nBased on the eight studies included in this systematic review update, two of which were subgroups of small numbers of eligible toddlers from larger studies, and three of which were pilot RCTs with small numbers of participants, there is insufficient evidence of the analgesic effects of sweet tasting solutions or substances during acutely painful procedures in young children between one and four years of age. Further rigorously conducted, adequately powered RCTs are warranted in this population. Based on the two studies by the same author, there was no evidence of analgesic effects of sweet taste in school-aged children. As there are other effective evidence-based strategies available to use in this age group, further trials are not warranted.\nDespite the addition of four studies in this review, conclusions have not changed since the last version of the review.\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 sweet tasting solutions reduce pain during needles in children aged from one to 16 years, compared to no treatment, water, other non-sweet solutions, or other interventions such as non-nutritive sucking (babies) or sweet foods or chewing gum (children), topical anaesthetics, music, and distraction?"
}
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query-laysum | 4737 | [
{
"role": "user",
"content": "Abstract: Background\nFoot ulcers are a disabling complication of diabetes that affect 15% to 25% of people with diabetes at some time in their lives. Phototherapy is a relatively new, non-invasive, and pain-free treatment method, which promotes the ulcer repair process through multiple mechanisms such as increased cell growth and vascular activity. Phototherapy may be used as an alternative approach for the treatment of foot ulcers in people with diabetes, but the evidence for its effect compared with placebo or other treatments has not yet been established.\nObjectives\nTo assess the effects of phototherapy for the treatment of foot ulcers in people with diabetes.\nSearch methods\nWe searched the Cochrane Wounds Specialised Register (11 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 10), Ovid MEDLINE (11 October 2016), Ovid MEDLINE (In-Process & Other Non-Indexed Citations) (11 October 2016), Ovid Embase (11 October 2016), EBSCO CINAHL Plus (11 October 2016), and China National Knowledge Infrastructure (24 June 2017). We also searched clinical trials registries for ongoing and unpublished studies on 24 June 2017, and screened reference lists to identify additional studies. We used no restrictions with respect to language, date of publication, or study setting.\nSelection criteria\nRandomised controlled trials or cluster randomised controlled trials that 1) compared phototherapy with sham phototherapy, no phototherapy, or other physical therapy modalities, 2) compared different forms of phototherapy, or 3) compared phototherapy of different output power, wavelength, power density, or dose range, in adults with diabetes and an open foot ulcer of any severity, in any setting.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction, and 'Risk of bias' assessment. We combined the study outcomes when appropriate.\nMain results\nEight trials with 316 participants met the inclusion criteria. Most of the included studies were single-centre studies that were carried out in clinics or hospitals with a sample size ranging from 14 to 84. We generally considered the included studies to be at unclear or high risk of bias, as they had one domain at high risk of bias, or three or more domains at unclear risk of bias.\nWe did not identify any studies that reported valid data for time to complete wound healing. Meta-analysis of four studies including 116 participants indicated that participants receiving phototherapy may experience a greater proportion of wounds completely healed during follow-up compared with those receiving no phototherapy/placebo (64.5% for the phototherapy group versus 37.0% for the no phototherapy/placebo group; risk ratio 1.57, 95% confidence interval 1.08 to 2.28; low-quality evidence, downgraded for study limitations and imprecision). Two studies mentioned adverse events in the results; one study with 16 participants suggested that there were no device-related adverse events, and the other study with 14 participants suggested that there was no clear difference between phototherapy and placebo group.\nFour studies reported change in ulcer size, but primarily due to high heterogeneity, they were not combined. Results from individual trials (including 16 participants to 84 participants) generally suggested that after two to four weeks of treatment phototherapy may result in a greater reduction in ulcer size but the quality of the evidence was low due to unclear risk of bias in the original trial and small sample size. We based the analyses for quality of life and amputations on only one study each (28 participants and 23 participants respectively); both outcomes showed no clear difference between the phototherapy group and the no phototherapy/placebo group.\nAuthors' conclusions\nThis systematic review of randomised trials suggested that phototherapy, when compared to no phototherapy/placebo, may increase the proportion of wounds completely healed during follow-up and may reduce wound size in people with diabetes, but there was no evidence that phototherapy improves quality of life. Due to the small sample size and methodological flaws in the original trials, the quality of the evidence was low, which reduces our confidence in these results. Large, well-designed randomised controlled trials are needed to confirm whether phototherapy could be an effective option for the treatment of foot ulcers in people with diabetes.\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": "The results suggested that phototherapy, when compared to no phototherapy or a placebo, may increase the proportion of wounds completely healed during follow-up and reduce wound size. However, as the included studies involved small numbers of participants and had drawbacks in study methods, our confidence in these results is limited. We did not find sufficient evidence that the potential harms or incidence of amputations differed between the phototherapy group and the no phototherapy/placebo group."
}
]
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query-laysum | 4738 | [
{
"role": "user",
"content": "Abstract: Background\nDental sealants were introduced in the 1960s to help prevent dental caries, mainly in the pits and fissures of occlusal tooth surfaces. Sealants act to prevent bacteria growth that can lead to dental decay. Evidence suggests that fissure sealants are effective in preventing caries in children and adolescents compared to no sealants. Effectiveness may, however, be related to caries incidence level of the population. This is an update of a review published in 2004, 2008 and 2013.\nObjectives\nTo compare the effects of different types of fissure sealants in preventing caries in occlusal surfaces of permanent teeth in children and adolescents.\nSearch methods\nCochrane Oral Health’s Information Specialist searched: Cochrane Oral Health’s Trials Register (to 3 August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 7), MEDLINE Ovid (1946 to 3 August 2016), and Embase Ovid (1980 to 3 August 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 3 August 2016. No restrictions were placed on language or date of publication.\nSelection criteria\nRandomised controlled trials (RCTs) comparing sealants with no sealant or a different type of sealant material for preventing caries of occlusal surfaces of premolar or molar teeth in children and adolescents aged up to 20 years. Studies required at least 12 months follow-up. We excluded studies that compared compomers to resins/composites.\nData collection and analysis\nTwo review authors independently screened search results, extracted data and assessed risk of bias of included studies. We presented outcomes for caries or no caries on occlusal surfaces of permanent molar teeth as odds ratio (OR) or risk ratio (RR). We used mean difference (MD) for mean caries increment. All measures were presented with 95% confidence intervals (CI). We conducted meta-analyses using a random-effects model for comparisons where there were more than three trials; otherwise we used the fixed-effect model. We used GRADE methods to assess evidence quality.\nMain results\nWe included 38 trials that involved a total of 7924 children; seven trials were new for this update (1693 participants). Fifteen trials evaluated the effects of resin-based sealant versus no sealant (3620 participants in 14 studies plus 575 tooth pairs in one study); three trials with evaluated glass ionomer sealant versus no sealant (905 participants); and 24 trials evaluated one type of sealant versus another (4146 participants). Children were aged from 5 to 16 years. Trials rarely reported background exposure to fluoride of trial participants or baseline caries prevalence.\nResin-based sealant versus no sealant: second-, third- and fourth-generation resin-based sealants prevented caries in first permanent molars in children aged 5 to 10 years (at 24 months follow-up: OR 0.12, 95% CI 0.08 to 0.19, 7 trials (5 published in the 1970s; 2 in the 2010s), 1548 children randomised, 1322 children evaluated; moderate-quality evidence). If we were to assume that 16% of the control tooth surfaces were decayed during 24 months of follow-up (160 carious teeth per 1000), then applying a resin-based sealant would reduce the proportion of carious surfaces to 5.2% (95% CI 3.13% to 7.37%). Similarly, assuming that 40% of control tooth surfaces were decayed (400 carious teeth per 1000), then applying a resin-based sealant would reduce the proportion of carious surfaces to 6.25% (95% CI 3.84% to 9.63%). If 70% of control tooth surfaces were decayed, there would be 19% decayed surfaces in the sealant group (95% CI 12.3% to 27.2%). This caries-preventive effect was maintained at longer follow-up but evidence quality and quantity was reduced (e.g. at 48 to 54 months of follow-up: OR 0.21, 95% CI 0.16 to 0.28, 4 trials, 482 children evaluated; RR 0.24, 95% CI 0.12 to 0.45, 203 children evaluated). Although studies were generally well conducted, we assessed blinding of outcome assessment for caries at high risk of bias for all trials (blinding of outcome assessment is not possible in sealant studies because outcome assessors can see and identify sealant).\nGlass ionomer sealant versus no sealant: was evaluated by three studies. Results at 24 months were inconclusive (very low-quality evidence).\nOne sealant versus another sealant: the relative effectiveness of different types of sealants is unknown (very low-quality evidence). We included 24 trials that directly compared two different sealant materials. Comparisons varied in terms of types of sealant assessed, outcome measures chosen and duration of follow-up.\nAdverse events: only four trials assessed adverse events. No adverse events were reported.\nAuthors' conclusions\nResin-based sealants applied on occlusal surfaces of permanent molars are effective for preventing caries in children and adolescents. Our review found moderate-quality evidence that resin-based sealants reduced caries by between 11% and 51% compared to no sealant, when measured at 24 months. Similar benefit was seen at timepoints up to 48 months; after longer follow-up, the quantity and quality of evidence was reduced. There was insufficient evidence to judge the effectiveness of glass ionomer sealant or the relative effectiveness of different types of sealants. Information on adverse effects was limited but none occurred where this was reported. Further research with long follow-up is needed.\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": "Can sealants prevent tooth decay in permanent teeth and what are the effects of different types of sealants?"
}
]
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query-laysum | 4739 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 2006 (McGuinness 2006), and previously updated in 2009 (McGuinness 2009). Hypertension is a risk factor for dementia. Observational studies suggest antihypertensive treatment is associated with lower incidences of cognitive impairment and dementia. There is already clear evidence to support the treatment of hypertension after stroke.\nObjectives\nTo assess whether pharmacological treatment of hypertension can prevent cognitive impairment or dementia in people who have no history of cerebrovascular disease.\nSearch methods\nWe searched the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group, CENTRAL, MEDLINE, Embase, three other databases, as well as many trials registries and grey literature sources, most recently on 7 July 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which pharmacological interventions to treat hypertension were given for at least 12 months. We excluded trials of pharmacological interventions to lower blood pressure in non-hypertensive participants. We also excluded trials conducted solely in people with stroke.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We collected information regarding incidence of dementia, cognitive decline, change in blood pressure, adverse effects and quality of life. We assessed the certainty of evidence using GRADE.\nMain results\nWe included 12 studies, totaling 30,412 participants, in this review. Eight studies compared active treatment with placebo. Of the four non-placebo-controlled studies, two compared intensive versus standard blood pressure reduction. The two final included studies compared different classes of antihypertensive drug. Study durations varied from one to five years.\nThe combined result of four placebo-controlled trials that reported incident dementia indicated no evidence of a difference in the risk of dementia between the antihypertensive treatment group and the placebo group (236/7767 versus 259/7660, odds ratio (OR) 0.89, 95% confidence interval (CI) 0.72 to 1.09; very low certainty evidence, downgraded due to study limitations and indirectness).\nThe combined results from five placebo-controlled trials that reported change in Mini-Mental State Examination (MMSE) may indicate a modest benefit from antihypertensive treatment (mean difference (MD) 0.20, 95% CI 0.10 to 0.29; very low certainty evidence, downgraded due to study limitations, indirectness and imprecision).\nThe certainty of evidence for both cognitive outcomes was downgraded on the basis of study limitations and indirectness. Study durations were too short, overall, to expect a significant difference in dementia rates between groups. Dementia and cognitive decline were secondary outcomes for most studies. Additional sources of bias include: the use of antihypertensive medication by the placebo group in the placebo-controlled trials; failure to reach recruitment targets; and early termination of studies on safety grounds.\nMeta-analysis of the placebo-controlled trials reporting results found a mean change in systolic blood pressure of -9.25 mmHg (95% CI -9.73, -8.78) between treatment (n = 8973) and placebo (n = 8820) groups, and a mean change in diastolic blood pressure of -2.47 mmHg (95% CI -2.70, -2.24) between treatment (n = 7700) and placebo (n = 7509) groups (both low certainty evidence downgraded on the basis of study limitations and inconsistency).\nThree trials - SHEP 1991, LOMIR MCT IL 1996 and MRC 1996 - reported more withdrawals due to adverse events in active treatment groups than placebo groups. Participants on active treatment in Syst Eur 1998 were less likely to discontinue treatment due to side effects, and participants on active treatment in HYVET 2008 reported fewer 'serious adverse events' than in the placebo group. There was no evidence of a difference in withdrawals rates between groups in SCOPE 2003, and results were unclear for Perez Stable 2000 and Zhang 2018. Heterogeneity precluded meta-analysis.\nFive of the placebo-controlled trials provided quality of life (QOL) data. Heterogeneity again precluded meta-analysis. SHEP 1991, Syst Eur 1998 and HYVET 2008 reported no evidence of a difference in QOL measures between active treatment and placebo groups over time. The SCOPE 2003 sub-study (Degl'Innocenti 2004) showed a smaller drop in QOL measures in the active treatment compared to the placebo group. LOMIR MCT IL 1996 reported an improvement in a QOL measure at twelve months in one active treatment group and deterioration in another.\nAuthors' conclusions\nHigh certainty randomised controlled trial evidence regarding the effect of hypertension treatment on dementia and cognitive decline does not yet exist.\nThe studies included in this review provide low certainty evidence (downgraded primarily due to study limitations and indirectness) that pharmacological treatment of hypertension, in people without prior cerebrovascular disease, leads to less cognitive decline compared to controls. This difference is below the level considered clinically significant. The studies included in this review also provide very low certainty evidence that pharmacological treatment of hypertension, in people without prior cerebrovascular disease, prevents dementia.\n\nGiven the provided abstract, please respond to the following query: \"Limitations of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We were unable to find evidence to confirm that treating high blood pressure with medicines will prevent future dementia or problems with memory and thinking. Based on the evidence available, all we can say is that the methods used in the studies we looked at were not sufficient to answer our study question. In practice, we want to know if treating high blood pressure in mid-life reduces dementia and problems with memory and thinking in later life. These studies were too short in duration to answer this question. They tended to be designed to investigate heart attack and stroke as outcome measures, with memory and thinking tests added on, which means they were less likely to include the numbers of people with problems with memory and thinking necessary to reliably answer the question. In the studies comparing active medicines and placebo (inactive medicine), many people in the placebo groups ultimately did receive active medicine which further complicated the results.\nAntihypertensive treatment may prevent new problems with memory and thinking, or dementia, or both, despite the findings of this review. To be more confident in our conclusions, we would need studies that have more distinct treatment and placebo groups, and that treat participants starting at a younger age and with a longer follow-up."
}
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query-laysum | 4740 | [
{
"role": "user",
"content": "Abstract: Background\nInfants born preterm are at increased risk of developing cognitive and motor impairment compared with infants born at term. Early developmental interventions have been provided in the clinical setting with the aim of improving overall functional outcomes for these infants. Long-term benefits of these programmes remain unclear.\nObjectives\nPrimary objective \nTo compare the effectiveness of early developmental intervention programmes provided post hospital discharge to prevent motor or cognitive impairment in preterm (< 37 weeks) infants versus standard medical follow-up of preterm infants at infancy (zero to < three years), preschool age (three to < five years), school age (five to < 18 years) and adulthood (≥ 18 years).\nSecondary objectives\nTo perform subgroup analyses to determine the following.\n• Effects of gestational age, birth weight and brain injury (periventricular leukomalacia (PVL)/intraventricular haemorrhage (IVH)) on cognitive and motor outcomes when early intervention is compared with standard follow-up.\n∘ Gestational age: < 28 weeks, 28 to < 32 weeks, 32 to < 37 weeks.\n∘ Birth weight: < 1000 grams, 1000 to < 1500 grams, 1500 to < 2500 grams.\n∘ Brain injury: absence or presence of grade III or grade IV IVH or cystic PVL (or both) or an abnormal ultrasound/magnetic resonance image (MRI) before initiation of the intervention.\n• Effects of interventions started during inpatient stay with a post-discharge component versus standard follow-up care.\n• Effects of interventions focused on the parent-infant relationship, infant development or both compared with standard follow-up care.\nTo perform sensitivity analysis to identify the following.\n• Effects on motor and cognitive impairment when early developmental interventions are provided within high-quality randomised trials with low risk of bias for sequence generation, allocation concealment, blinding of outcome measures and selective reporting bias.\nSearch methods\nThe search strategy of the Cochrane Neonatal Review Group was used to identify randomised and quasi-randomised controlled trials of early developmental interventions provided post hospital discharge. Two review authors independently searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Advanced, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and EMBASE (1966 to August 2015).\nSelection criteria\nStudies included had to be randomised or quasi-randomised controlled trials of early developmental intervention programmes that began within the first 12 months of life for infants born before 37 weeks' gestational age. Interventions could commence on an inpatient basis but had to include a post-discharge component for inclusion in this review. Outcome measures were not prespecified, other than that they had to assess cognitive outcomes, motor outcomes or both. Rates of cerebral palsy were documented.\nData collection and analysis\nTwo independent review authors extracted and entered data. Cognitive and motor outcomes were pooled by four age groups: infancy (zero to < three years), preschool age (three to < five years), school age (five to < 18 years) and adulthood (≥ 18 years). Meta-analysis using RevMan 5.1 was carried out to determine the effects of early developmental interventions at each age range. Subgroup analyses focused on gestational age, birth weight, brain injury, commencement of the intervention, focus of the intervention and study quality.\nMain results\nTwenty-five studies met the inclusion criteria (3615 randomly assigned participants). Only 12 of these studies were randomised controlled trials with appropriate allocation concealment. Variability was evident with regard to focus and intensity of the intervention, participant characteristics and length of follow-up. Meta-analysis led to the conclusion that intervention improved cognitive outcomes at infancy (developmental quotient (DQ): standardised mean difference (SMD) 0.32 standard deviations (SDs), 95% confidence interval (CI) 0.16 to 0.47; P value < 0.001; 16 studies; 2372 participants) and at preschool age (intelligence quotient (IQ); SMD 0.43 SDs, 95% CI 0.32 to 0.54; P value < 0.001; eight studies; 1436 participants). However, this effect was not sustained at school age (IQ: SMD 0.18 SDs, 95% CI -0.08 to 0.43; P value = 0.17; five studies; 1372 participants). Heterogeneity between studies for cognitive outcomes at infancy and at school age was significant. With regards to motor outcomes, meta-analysis of 12 studies showed a significant effect in favour of early developmental interventions at infancy only; however, this effect was small (motor scale DQ: SMD 0.10 SDs, 95% CI 0.01 to 0.19; P value = 0.03; 12 studies; 1895 participants). No effect was noted on the rate of cerebral palsy among survivors (risk ratio (RR) 0.82, 95% CI 0.52 to 1.27; seven studies; 985 participants). Little evidence showed a positive effect on motor outcomes in the long term, but only five included studies reported outcomes at preschool age (n = 3) or at school age (n = 2).\nAuthors' conclusions\nEarly intervention programmes for preterm infants have a positive influence on cognitive and motor outcomes during infancy, with cognitive benefits persisting into preschool age. A great deal of heterogeneity between studies was due to the variety of early developmental intervention programmes tested and to gestational ages of included preterm infants; thus, comparisons of intervention programmes were limited. Further research is needed to determine which early developmental interventions are most effective in improving cognitive and motor outcomes, and to discern the longer-term effects of these programmes.\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": "Twenty-five studies met the inclusion criteria (3615 randomly assigned participants). Only 12 of these studies were randomised controlled trials with appropriate allocation concealment. Variability was noted with regard to focus and intensity of the intervention, participant characteristics and length of follow-up."
}
]
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query-laysum | 4741 | [
{
"role": "user",
"content": "Abstract: Background\nChildren and adolescents diagnosed with cancer are at high risk of experiencing severe side effects from cancer treatment, many of which are amenable to physical therapy. These side effects can negatively impact a child's quality of life and ability to participate in daily activities (e.g. play and attendance at school). Researchers have evaluated physical therapy interventions in children with cancer and childhood cancer survivors. However, factors such as small sample sizes, varying intervention protocols and differences in cancer types among trials make it difficult to draw conclusions about efficacy.\nObjectives\nThe primary aim of this review was to evaluate the efficacy of physical therapy interventions - with a specific focus on symptom relief and compensation of therapy-related side effects - on the quality of life of children and adolescents diagnosed with cancer. Participants must be between the ages of 0 and 19 years at the time of the physical therapy intervention study. The intervention may occur prior to, during or following cancer treatment. The intervention must be compared to a control group of children receiving standard care, no physical therapy intervention or a comparison intervention. We have excluded general physical exercise studies where the primary aim was to improve physical fitness through aerobic, anaerobic, resistance exercise or combined physical exercise training regimens (i.e. combined aerobic and resistance exercise regimens). We have also intended to record the occurrence of any adverse effects resulting from physical therapy interventions.\nThe secondary aims were to evaluate the efficacy of physical therapy on impairments of pain, peripheral neuropathy, balance, gait, functional abilities and mobility, motor function and performance, range of motion, strength and fatigue.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, PEDro, ongoing trial registries, conference proceedings and the reference lists of relevant studies and reviews in March 2020. We also contacted oncology rehabilitation researchers working in paediatrics in March 2020 to identify additional studies.\nSelection criteria\nThe review included randomised controlled trials (RCTs), cross-over trials, and controlled clinical trials (CCTs) that compared the effects of physical therapy interventions to a control group, and involved children and adolescents diagnosed with cancer between the ages of 0 and 19 years at the time of the intervention. We excluded studies examining general physical exercise interventions where the primary aim was to improve physical fitness through aerobic exercise, resistance exercise or combined physical exercise training regimens (i.e. combined aerobic and resistance exercise regimens).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe found no RCTs, cross-over trials or CCTs comparing the effects of physical therapy interventions with a focus on symptom relief and compensation of therapy-related side effects for children and adolescents between the ages of 0 and 19 years.\nAuthors' conclusions\nResults demonstrate that the evidence to date is inadequate to inform clinical practice. Recommendations for future research include the need for large-scale, high-quality designs that examine: (1) paediatric populations with same cancer types; (2) similar intervention protocols; (3) long-term outcomes; (4) physical therapy interventions (e.g. electrophysical modalities and sensory interventions); and (5) outcomes commonly impaired in children with cancer (e.g. peripheral neuropathy and gait deficits).\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": "The evidence is current to March 2020. We did not identify any eligible studies."
}
]
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query-laysum | 4742 | [
{
"role": "user",
"content": "Abstract: Background\nVenous access is an essential part of caring for the sick neonate. However, problems such as contamination of fluids with bacteria, endotoxins and particulates have been associated with intravenous infusion therapy. Intravenous in-line filters claim to be an effective strategy for the removal of bacteria, endotoxins and particulates associated with intravenous therapy in adults and are increasingly being recommended for use in neonates.\nObjectives\nTo determine the effect of intravenous in-line filters on morbidity and mortality in neonates.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group. We searched the electronic databases MEDLINE (from 1966 to May, 2015), EMBASE (from 1980 to May, 2015), CINAHL (from 1982 to May 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5). We did not impose any language restrictions. Further searching included cross references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that compared the use of intravenous in-line filters with placebo or nothing in neonates.\nData collection and analysis\nWe followed the procedures of the Cochrane Neonatal Review Group throughout. We checked titles and abstracts identified from the search. We obtained the full text of all studies of possible relevance. We independently assessed the trials for their methodological quality and subsequent inclusion in the review. We contacted authors for further information as needed. Statistical analysis followed the procedures of the Cochrane Neonatal Review Group.\nMain results\nThere were four eligible studies that recruited a total of 704 neonates. This review of low to very low quality evidence found that the use of in-line filters compared with unfiltered fluids for intravenous infusion had no statistically significant difference in effectiveness on overall mortality (typical RR 0.87, 95% CI 0.52 to 1.47; typical RD -0.01, 95% CI -0.06 to 0.04; two studies, 530 infants), proven and suspect septicaemia (typical RR 0.86, 95% CI 0.59 to 1.27; typical RD -0.02, 95% CI -0.09 to 0.04; two studies, 530 infants), or other secondary outcomes (including local phlebitis and thrombus, necrotising enterocolitis, duration of cannula patency, length of stay in hospital, number of catheters inserted and financial costs).\nAuthors' conclusions\nThere is insufficient evidence to recommend the use of intravenous in-line filters to prevent morbidity and mortality in neonates.\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"
},
{
"role": "assistant",
"content": "There is insufficient evidence to recommend the use of intravenous in-line filters to prevent morbidity and mortality in newborn infants."
}
]
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query-laysum | 4743 | [
{
"role": "user",
"content": "Abstract: Background\nDentistry is a profession with a high prevalence of work-related musculoskeletal disorders (WMSD) among practitioners, with symptoms often starting as early in the career as the student phase. Ergonomic interventions in physical, cognitive, and organisational domains have been suggested to prevent their occurrence, but evidence of their effects remains unclear.\nObjectives\nTo assess the effect of ergonomic interventions for the prevention of work-related musculoskeletal disorders among dental care practitioners.\nSearch methods\nWe searched CENTRAL, MEDLINE PubMed, Embase, PsycINFO ProQuest, NIOSHTIC, NIOSHTIC-2, HSELINE, CISDOC (OSH-UPDATE), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP) Search Portal to August 2018, without language or date restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs, in which participants were adults, aged 18 and older, who were engaged in the practice of dentistry. At least 75% of them had to be free from musculoskeletal pain at baseline. We only included studies that measured at least one of our primary outcomes; i.e. physician diagnosed WMSD, self-reported pain, or work functioning.\nData collection and analysis\nThree authors independently screened and selected 20 potentially eligible references from 946 relevant references identified from the search results. Based on the full-text screening, we included two studies, excluded 16 studies, and two are awaiting classification. Four review authors independently extracted data, and two authors assessed the risk of bias. We calculated the mean difference (MD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% confidence intervals for dichotomous outcomes. We assessed the quality of the evidence for each outcome using the GRADE approach.\nMain results\nWe included two RCTs (212 participants), one of which was a cluster-randomised trial. Adjusting for the design effect from clustering, reduced the total sample size to 210. Both studies were carried out in dental clinics and assessed ergonomic interventions in the physical domain, one by evaluating a multi-faceted ergonomic intervention, which consisted of imparting knowledge and training about ergonomics, work station modification, training and surveying ergonomics at the work station, and a regular exercise program; the other by studying the effectiveness of two different types of instrument used for scaling in preventing WMSDs. We were unable to combine the results from the two studies because of the diversity of interventions and outcomes.\nPhysical ergonomic interventions. Based on one study, there is very low-quality evidence that a multi-faceted intervention has no clear effect on dentists' risk of WMSD in the thighs (RR 0.57, 95% CI 0.23 to 1.42; 102 participants), or feet (RR 0.64, 95% CI 0.29 to 1.41; 102 participants) when compared to no intervention over a six-month period. Based on one study, there is low-quality evidence of no clear difference in elbow pain (MD −0.14, 95% CI −0.39 to 0.11; 110 participants), or shoulder pain (MD −0.32, 95% CI −0.75 to 0.11; 110 participants) in participants who used light weight curettes with wider handles or heavier curettes with narrow handles for scaling over a 16-week period.\nCognitive ergonomic interventions. We found no studies evaluating the effectiveness of cognitive ergonomic interventions.\nOrganisational ergonomic interventions. We found no studies evaluating the effectiveness of organisational ergonomic interventions.\nAuthors' conclusions\nThere is very low-quality evidence from one study showing that a multi-faceted intervention has no clear effect on dentists' risk of WMSD in the thighs or feet when compared to no intervention over a six-month period. This was a poorly conducted study with several shortcomings and errors in statistical analysis of data. There is low-quality evidence from one study showing no clear difference in elbow pain or shoulder pain in participants using light weight, wider handled curettes or heavier and narrow handled curettes for scaling over a 16-week period.\nWe did not find any studies evaluating the effectiveness of cognitive ergonomic interventions or organisational ergonomic interventions.\nOur ability to draw definitive conclusions is restricted by the paucity of suitable studies available to us, and the high risk of bias of the studies that are available. This review highlights the need for well-designed, conducted, and reported RCTs, with long-term follow-up that assess prevention strategies for WMSDs among dental care practitioners.\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": "There is very low-quality evidence from one study, that a comprehensive ergonomics intervention, consisting of training, work station modification, and a regular exercise program has no effect on dentists' risk of WMSDs in the thighs or feet, over a period of six months. There is low-quality evidence from one study that changing the tools used for scraping off dental plaque has no clear effect on dentists' elbow pain or shoulder pain over a four-month period. Both included studies have several shortcomings, and did not follow-up with participants for a sufficiently long period of time. We found no studies that evaluated the effectiveness of cognitive or organisational ergonomics interventions. We need better studies to evaluate the effectiveness of ergonomic interventions in dental care practitioners. It is very likely that including the results of new studies will change the conclusions of this review."
}
]
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query-laysum | 4744 | [
{
"role": "user",
"content": "Abstract: Background\nRebleeding is an important cause of death and disability in people with aneurysmal subarachnoid haemorrhage. Rebleeding is probably related to the dissolution of the blood clot at the site of the aneurysm rupture by natural fibrinolytic activity. This review is an update of previously published Cochrane Reviews.\nObjectives\nTo assess the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2022), CENTRAL (in the Cochrane Library 2021, Issue 1), MEDLINE (December 2012 to May 2022), and Embase (December 2012 to May 2022). In an effort to identify further published, unpublished, and ongoing studies, we searched reference lists and trial registers, performed forward tracking of relevant references, and contacted drug companies (the latter in previous versions of this review).\nSelection criteria\nRandomised trials comparing oral or intravenous antifibrinolytic drugs (tranexamic acid, epsilon amino-caproic acid, or an equivalent) with control in people with subarachnoid haemorrhage of suspected or proven aneurysmal cause.\nData collection and analysis\nTwo review authors (MRG & WJD) independently selected trials for inclusion, and extracted the data for the current update. In total, three review authors (MIB & MRG in the previous update; MRG & WJD in the current update) assessed risk of bias. For the primary outcome, we dichotomised the outcome scales into good and poor outcome, with poor outcome defined as death, vegetative state, or (moderate) severe disability, assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale. We assessed death from any cause, rates of rebleeding, delayed cerebral ischaemia, and hydrocephalus per treatment group. We expressed effects as risk ratios (RR) with 95% confidence intervals (CI). We used random-effects models for all analyses. We assessed the quality of the evidence with GRADE.\nMain results\nWe included one new trial in this update, for a total of 11 included trials involving 2717 participants. The risk of bias was low in six studies. Five studies were open label, and we rated them at high risk of performance bias. We also rated one of these studies at high risk for attrition and reporting bias.\nFive trials reported on poor outcome (death, vegetative state, or (moderate) severe disability), with a pooled risk ratio (RR) of 1.03 (95% confidence interval (CI) 0.94 to 1.13; P = 0.53; 5 trials, 2359 participants; high-quality evidence), which showed no difference between groups. All trials reported on death from all causes, which showed no difference between groups, with a pooled RR of 1.02 (95% CI 0.90 to 1.16; P = 0.77; 11 trials, 2717 participants; high-quality evidence). In trials that combined short-term antifibrinolytic treatment (< 72 hours) with preventative measures for delayed cerebral ischaemia, the RR for poor outcome was 0.98 (95% CI 0.81 to 1.18; P = 0.83; 2 trials, 1318 participants; high-quality evidence).\nAntifibrinolytic treatment reduced the risk of rebleeding, reported at the end of follow-up (RR 0.65, 95% CI 0.47 to 0.91; P = 0.01; 11 trials, 2717 participants; absolute risk reduction 7%, 95% CI 3 to 12%; moderate-quality evidence), but there was heterogeneity (I² = 59%) between the trials. The pooled RR for delayed cerebral ischaemia was 1.27 (95% CI 1.00 to 1.62; P = 0.05; 7 trials, 2484 participants; moderate-quality evidence). However, this effect was less extreme after the implementation of ischaemia preventative measures and < 72 hours of treatment (RR 1.10, 95% CI 0.83 to 1.46; P = 0.49; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment showed no effect on the reported rate of hydrocephalus (RR 1.09, 95% CI 0.99 to 1.20; P = 0.09; 6 trials, 1992 participants; high-quality evidence).\nAuthors' conclusions\nThe current evidence does not support the routine use of antifibrinolytic drugs in the treatment of people with aneurysmal subarachnoid haemorrhage. More specifically, early administration with concomitant treatment strategies to prevent delayed cerebral ischaemia does not improve clinical outcome. There is sufficient evidence from multiple randomised controlled trials to incorporate this conclusion in treatment guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Research question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "What are the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage?"
}
]
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query-laysum | 4745 | [
{
"role": "user",
"content": "Abstract: Background\nIntra-uterine insemination (IUI) is a widely-used fertility treatment for couples with unexplained subfertility. Although IUI is less invasive and less expensive than in vitro fertilisation (IVF), the safety of IUI in combination with ovarian hyperstimulation (OH) is debated. The main concern about IUI treatment with OH is the increase in multiple pregnancy rates.\nObjectives\nTo determine whether, for couples with unexplained subfertility, the live birth rate is improved following IUI treatment with or without OH compared to timed intercourse (TI) or expectant management with or without OH, or following IUI treatment with OH compared to IUI in a natural cycle.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers up to 17 October 2019, together with reference checking and contact with study authors for missing or unpublished data.\nSelection criteria\nRandomised controlled trials (RCTs) comparing IUI with TI or expectant management, both in stimulated or natural cycles, or IUI in stimulated cycles with IUI in natural cycles in couples with unexplained subfertility.\nData collection and analysis\nTwo review authors independently performed study selection, quality assessment and data extraction. Primary review outcomes were live birth rate and multiple pregnancy rate.\nMain results\nWe include 15 trials with 2068 women. The evidence was of very low to moderate quality. The main limitation was very serious imprecision.\nIUI in a natural cycle versus timed intercourse or expectant management in a natural cycle\nIt is uncertain whether treatment with IUI in a natural cycle improves live birth rate compared to treatment with expectant management in a natural cycle (odds ratio (OR) 1.60, 95% confidence interval (CI) 0.92 to 2.78; 1 RCT, 334 women; low-quality evidence). If we assume the chance of a live birth with expectant management in a natural cycle to be 16%, that of IUI in a natural cycle would be between 15% and 34%. It is uncertain whether treatment with IUI in a natural cycle reduces multiple pregnancy rates compared to control (OR 0.50, 95% CI 0.04 to 5.53; 1 RCT, 334 women; low-quality evidence).\nIUI in a stimulated cycle versus timed intercourse or expectant management in a stimulated cycle\nIt is uncertain whether treatment with IUI in a stimulated cycle improves live birth rates compared to treatment with TI in a stimulated cycle (OR 1.59, 95% CI 0.88 to 2.88; 2 RCTs, 208 women; I2 = 72%; low-quality evidence). If we assume the chance of achieving a live birth with TI in a stimulated cycle was 26%, the chance with IUI in a stimulated cycle would be between 23% and 50%. It is uncertain whether treatment with IUI in a stimulated cycle reduces multiple pregnancy rates compared to control (OR 1.46, 95% CI 0.55 to 3.87; 4 RCTs, 316 women; I2 = 0%; low-quality evidence).\nIUI in a stimulated cycle versus timed intercourse or expectant management in a natural cycle\nIn couples with a low prediction score of natural conception, treatment with IUI combined with clomiphene citrate or letrozole probably results in a higher live birth rate compared to treatment with expectant management in a natural cycle (OR 4.48, 95% CI 2.00 to 10.01; 1 RCT; 201 women; moderate-quality evidence). If we assume the chance of a live birth with expectant management in a natural cycle was 9%, the chance of a live birth with IUI in a stimulated cycle would be between 17% and 50%. It is uncertain whether treatment with IUI in a stimulated cycle results in a lower multiple pregnancy rate compared to control (OR 3.01, 95% CI 0.47 to 19.28; 2 RCTs, 454 women; I2 = 0%; low-quality evidence).\nIUI in a natural cycle versus timed intercourse or expectant management in a stimulated cycle\nTreatment with IUI in a natural cycle probably results in a higher cumulative live birth rate compared to treatment with expectant management in a stimulated cycle (OR 1.95, 95% CI 1.10 to 3.44; 1 RCT, 342 women: moderate-quality evidence). If we assume the chance of a live birth with expectant management in a stimulated cycle was 13%, the chance of a live birth with IUI in a natural cycle would be between 14% and 34%. It is uncertain whether treatment with IUI in a natural cycle results in a lower multiple pregnancy rate compared to control (OR 1.05, 95% CI 0.07 to 16.90; 1 RCT, 342 women; low-quality evidence).\nIUI in a stimulated cycle versus IUI in a natural cycle\nTreatment with IUI in a stimulated cycle may result in a higher cumulative live birth rate compared to treatment with IUI in a natural cycle (OR 2.07, 95% CI 1.22 to 3.50; 4 RCTs, 396 women; I2 = 0%; low-quality evidence). If we assume the chance of a live birth with IUI in a natural cycle was 14%, the chance of a live birth with IUI in a stimulated cycle would be between 17% and 36%. It is uncertain whether treatment with IUI in a stimulated cycle results in a higher multiple pregnancy rate compared to control (OR 3.00, 95% CI 0.11 to 78.27; 2 RCTs, 65 women; low-quality evidence).\nAuthors' conclusions\nDue to insufficient data, it is uncertain whether treatment with IUI with or without OH compared to timed intercourse or expectant management with or without OH improves cumulative live birth rates with acceptable multiple pregnancy rates in couples with unexplained subfertility. However, treatment with IUI with OH probably results in a higher cumulative live birth rate compared to expectant management without OH in couples with a low prediction score of natural conception. Similarly, treatment with IUI in a natural cycle probably results in a higher cumulative live birth rate compared to treatment with timed intercourse with OH. Treatment with IUI in a stimulated cycle may result in a higher cumulative live birth rate compared to treatment with IUI in a natural cycle.\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": "IUI is a treatment often used for couples with unexplained subfertility. In an IUI cycle, the male partner's sperm is prepared and placed directly in the womb around the time of ovulation. IUI cycles can be used in combination with fertility drugs to increase the number of available eggs. However, these drugs can have side effects, and also increase the risk of multiple pregnancies. Expectant management and timed intercourse have also been shown to increase pregnancy rates, resulting in live births. With this review, we would like to enhance decision-making for couples starting treatment for unexplained subfertility."
}
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query-laysum | 4746 | [
{
"role": "user",
"content": "Abstract: Background\nAcute necrotising pancreatitis carries significant mortality, morbidity, and resource use. There is considerable uncertainty as to how people with necrotising pancreatitis should be treated.\nObjectives\nTo assess the benefits and harms of different interventions in people with acute necrotising pancreatitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 4), MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers to April 2015 to identify randomised controlled trials (RCT). We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered only RCTs performed in people with necrotising pancreatitis, irrespective of aetiology, presence of infection, language, blinding, or publication status for inclusion in the review.\nData collection and analysis\nTwo review authors independently identified trials and extracted data. We calculated the odds ratio (OR) and mean difference with 95% confidence intervals (CI) using Review Manager 5 based on an available-case analysis using fixed-effect and random-effects models. We planned a network meta-analysis using Bayesian methods, but due to sparse data and uncertainty about the transitivity assumption, performed only indirect comparisons and used Frequentist methods.\nMain results\nWe included eight RCTs with 311 participants in this review. After exclusion of five participants, we included 306 participants in one or more outcomes. Five trials (240 participants) investigated the three main treatments: open necrosectomy (121 participants), minimally invasive step-up approach (80 participants), and peritoneal lavage (39 participants) and were included in the network meta-analysis. Three trials (66 participants) investigated the variations in the main treatments: early open necrosectomy (25 participants), delayed open necrosectomy (11 participants), video-assisted minimally invasive step-up approach (12 participants), endoscopic minimally invasive step-up approach (10 participants), minimally invasive step-up approach (planned surgery) (four participants), and minimally invasive step-up approach (continued percutaneous drainage) (four participants). The trials included infected or sterile necrotising pancreatitis of varied aetiology.\nAll the trials were at unclear or high risk of bias and the overall quality of evidence was low or very low for all the outcomes. Overall, short-term mortality was 30% and serious adverse events rate was 139 serious adverse events per 100 participants. The differences in short-term mortality and proportion of people with serious adverse events were imprecise in all the comparisons. The number of serious adverse events and adverse events were fewer in the minimally invasive step-up approach compared to open necrosectomy (serious adverse events: rate ratio 0.41, 95% CI 0.25 to 0.68; 88 participants; 1 study; adverse events: rate ratio 0.41, 95% CI 0.25 to 0.68; 88 participants; 1 study). The proportion of people with organ failure and the mean costs were lower in the minimally invasive step-up approach compared to open necrosectomy (organ failure: OR 0.20, 95% CI 0.07 to 0.60; 88 participants; 1 study; mean difference in costs: USD -11,922; P value < 0.05; 88 participants; 1 studies). There were more adverse events with video-assisted minimally invasive step-up approach group compared to endoscopic-assisted minimally invasive step-up approach group (rate ratio 11.70, 95% CI 1.52 to 89.87; 22 participants; 1 study), but the number of interventions per participant was less with video-assisted minimally invasive step-up approach group compared to endoscopic minimally invasive step-up approach group (difference in medians: 2 procedures; P value < 0.05; 20 participants; 1 study). The differences in any of the other comparisons for number of serious adverse events, proportion of people with organ failure, number of adverse events, length of hospital stay, and intensive therapy unit stay were either imprecise or were not consistent. None of the trials reported long-term mortality, infected pancreatic necrosis (trials that included participants with sterile necrosis), health-related quality of life at any time frame, proportion of people with adverse events, requirement for additional invasive intervention, time to return to normal activity, and time to return to work.\nAuthors' conclusions\nLow to very low quality evidence suggested that the minimally invasive step-up approach resulted in fewer adverse events, serious adverse events, less organ failure, and lower costs compared to open necrosectomy. Very low quality evidence suggested that the endoscopic minimally invasive step-up approach resulted in fewer adverse events than the video-assisted minimally invasive step-up approach but increased the number of procedures required for treatment. There is currently no evidence to suggest that early open necrosectomy is superior or inferior to peritoneal lavage or delayed open necrosectomy. However, the CIs were wide and significant benefits or harms of different treatments cannot be ruled out. The TENSION trial currently underway in Netherlands is assessing the optimal way to perform the minimally invasive step-up approach (endoscopic drainage followed by endoscopic necrosectomy if necessary versus percutaneous drainage followed by video-assisted necrosectomy if necessary) and is assessing important clinical outcomes of interest for this review. Implications for further research on this topic will be determined after the results of this RCT are available.\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": "Eight trials including 311 participants met the inclusion criteria for the review, of whom 306 participants were included in various comparisons. The treatments compared in five trials included necrosectomy, peritoneal lavage, and the step-up approach. Three other trials compared variations in timing of necrosectomy and methods of step-up approach. The participants in the trials had infected or sterile pancreatic necrosis resulting from varying causes."
}
]
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query-laysum | 4747 | [
{
"role": "user",
"content": "Abstract: Background\nIn endemic malarial areas, young children have high levels of malaria morbidity and mortality. The World Health Organization recommends oral artemisinin-based combination therapy (ACT) for treating uncomplicated malaria. Paediatric formulations of ACT have been developed to make it easier to treat children.\nObjectives\nTo evaluate evidence from trials on the efficacy, safety, tolerability, and acceptability of paediatric ACT formulations compared to tablet ACT formulations for uncomplicated P falciparum malaria in children up to 14 years old.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; the Latin American and Caribbean Health Science Information database (LILACS); ISI Web of Science; Google Scholar; Scopus; and the metaRegister of Controlled Trials (mRCT) to 11 December 2019.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) of paediatric versus non-paediatric formulated ACT in children aged 14 years or younger with acute uncomplicated malaria.\nData collection and analysis\nTwo authors independently assessed eligibility and risk of bias, and carried out data extraction. We analyzed the primary outcomes of efficacy, safety and tolerability of paediatric versus non-paediatric ACT using risk ratios (RR) and 95% confidence intervals (CI). Secondary outcomes were: treatment failure on the last day of observation (day 42), fever clearance time, parasite clearance time, pharmacokinetics, and acceptability.\nMain results\nThree trials met the inclusion criteria. Two compared a paediatric dispersible tablet formulation against crushed tablets of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DHA-PQ), and one trial assessed artemether-lumefantrine formulated as powder for suspension compared with crushed tablets. The trials were carried out between 2006 and 2015 in sub-Saharan Africa (Benin, Mali, Mozambique, Tanzania, Kenya, Democratic Republic of the Congo, Burkina Faso, and The Gambia).\nIn all three trials, the paediatric and control ACT achieved polymerase chain reaction (PCR)-adjusted treatment failure rates of < 10% on day 28 in the per-protocol (PP) population.\nFor the comparison of dispersible versus crushed tablets, the two trials did not detect a difference for treatment failure by day 28 (PCR-adjusted PP population: RR 1.35, 95% CI 0.49 to 3.72; 1061 participants, 2 studies, low-certainty evidence). Similarly, for the comparison of suspension versus crushed tablet ACT, we did not detect any difference in treatment failure at day 28 (PCR-adjusted PP population: RR 1.64, 95% CI 0.55 to 4.87; 245 participants, 1 study).\nWe did not detect any difference in serious adverse events for the comparison of dispersible versus crushed tablets (RR 1.05, 95% CI 0.38 to 2.88; 1197 participants, 2 studies, low-certainty evidence), or for the comparison of suspension versus crushed tablet ACT (RR 0.74, 95% CI 0.17 to 3.26; 267 participants, 1 study).\nIn the dispersible ACT arms, drug-related adverse events occurred in 9% of children in the AL study and 34% of children in the DHA-PQ study. In the control arms, drug-related adverse events occurred in 12% of children in the AL study and in 42% of children in the DHA-PQ study. Drug-related adverse events were lower in the dispersible ACT arms (RR 0.78, 95% CI 0.62 to 0.99; 1197 participants, 2 studies, moderate-certainty evidence).\nThere was no detected difference in the rate of drug-related adverse events for suspension ACT versus crushed tablet ACT (RR 0.66, 95% CI 0.33 to 1.32; 267 participants, 1 study).\nDrug-related vomiting appeared to be less common in the dispersible ACT arms (RR 0.75, 95% CI 0.56 to 1.01; 1197 participants, 2 studies, low-certainty evidence) and in the suspension ACT arm (RR 0.66, 95% CI 0.33 to 1.32; 267 participants, 1 study), but both analyses were underpowered.\nNo study assessed acceptability.\nAuthors' conclusions\nTrials did not demonstrate a difference in efficacy between paediatric dispersible or suspension ACT when compared with the respective crushed tablet ACT for treating uncomplicated P falciparum malaria in children. However, the evidence is of low to moderate certainty due to limited power. There appeared to be fewer drug-related adverse events with dispersible ACT compared to crushed tablet ACT. None of the included studies assessed acceptability of paediatric ACT formulation.\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 11 December 2019."
}
]
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query-laysum | 4748 | [
{
"role": "user",
"content": "Abstract: Background\nVentilator-associated pneumonia (VAP) is common in intensive care units (ICUs). Some evidence indicates that probiotics may reduce the incidence of VAP. Several additional published studies have demonstrated that probiotics are safe and efficacious in preventing VAP in ICUs. We aimed to systematically summarise the results of all available data to generate the best evidence for the prevention of VAP.\nObjectives\nTo evaluate the effectiveness and safety of probiotics for preventing VAP.\nSearch methods\nWe searched CENTRAL (2014, Issue 8), MEDLINE (1948 to September week 1, 2014) and EMBASE (2010 to September 2014).\nSelection criteria\nRandomised controlled trials (RCTs) comparing probiotics with placebo or another control (excluding RCTs that use probiotics in both study groups) to prevent VAP.\nData collection and analysis\nTwo review authors independently assessed eligibility and the quality of trials, and extracted data.\nMain results\nWe included eight RCTs, with 1083 participants. All studies compared a form of probiotic (Lactobacillus casei rhamnosus; Lactobacillus plantarum; Synbiotic 2000FORTE; Ergyphilus; combination Bifidobacterium longum + Lactobacillus bulgaricus + Streptococcus thermophilus) versus a control group (placebo; glutamine; fermentable fibre; peptide; chlorhexidine). The analysis of all RCTs showed that the use of probiotics decreased the incidence of VAP (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.52 to 0.95, low quality evidence). However, the aggregated results were uncertain for ICU mortality (OR 0.84, 95% CI 0.58 to 1.22 very low quality evidence), in-hospital mortality (OR 0.78, 95% CI 0.54 to 1.14, very low quality evidence), incidence of diarrhoea (OR 0.72, 95% CI 0.47 to 1.09, very low quality evidence), length of ICU stay (mean difference (MD) -1.60, 95% CI -6.53 to 3.33, very low quality evidence), duration of mechanical ventilation (MD -6.15, 95% CI -18.77 to 6.47, very low quality evidence) and antibiotic use (OR 1.23, 95% CI 0.51 to 2.96, low quality evidence). Antibiotics for VAP were used for a shorter duration (in days) when participants received probiotics in one small study (MD -3.00, 95% CI -6.04 to 0.04). However, the CI of the estimated effect was too wide to exclude no difference with probiotics. There were no reported events of nosocomial probiotic infections in any included study.\nThe overall methodological quality of the included studies, based on our 'Risk of bias' assessments, was moderate with half of the included studies rated as a 'low' risk of bias; however, we rated four included studies as a 'high' risk of bias across one or more of the domains. The study limitations, differences in probiotics administered and participants, and small sample sizes across the included studies mean that the power to detect a trend of overall effect may be limited and chance findings cannot be excluded.\nTo explore the influence of some potential confounding factors in the studies, we conducted an intention-to-treat (ITT) analysis, which did not change the inference of per-protocol analysis. However, our sensitivity analysis did not indicate a significant difference between groups for instances of VAP.\nAuthors' conclusions\nEvidence suggests that use of probiotics is associated with a reduction in the incidence of VAP. However, the quality of the evidence is low and the exclusion of the one study that did not provide a robust definition of VAP increased the uncertainty in this finding. The available evidence is not clear regarding a decrease in ICU or hospital mortality with probiotic use. Three trials reported on the incidence of diarrhoea and the pooled results indicate no clear evidence of a difference. The results of this meta-analysis do not provide sufficient evidence to draw conclusions on the efficacy and safety of probiotics for the prevention of VAP in ICU patients.\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": "The results from these trials show that probiotics are associated with a reduction in instances of VAP. However, the quality of the evidence is low and the exclusion of the one study that did not provide a robust definition of VAP increased the uncertainty in this finding. Results for all remaining reported outcomes (including mortality, incidence of diarrhoea, length of ICU stay, duration of mechanical ventilation and general antibiotic use) were uncertain between groups receiving either probiotics or placebo or standard treatment. Incidence of diarrhoea was reported in half of the included studies, which demonstrated no clear evidence of a difference between probiotics over standard care or placebo. The quality of the evidence was generally low to very low between studies. Due to the contradictions in the results from previously published systematic reviews and the uncertainty of these results, there is need for larger, well-designed and robustly reported studies."
}
]
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