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query-laysum | 5759 | [
{
"role": "user",
"content": "Abstract: Background\nAcute otitis media (AOM) is the most common bacterial infection among young children in the United States. There are limitations and concerns over its treatment with antibiotics and surgery and so effective preventative measures are attractive. A potential preventative measure is xylitol, a natural sugar substitute that reduces the risk of dental decay. Xylitol can reduce the adherence of Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) to nasopharyngeal cells in vitro. This is an update of a review first published in 2011.\nObjectives\nTo assess the efficacy and safety of xylitol to prevent AOM in children aged up to 12 years.\nSearch methods\nWe searched CENTRAL (to Issue 12, 2015), MEDLINE (1950 to January 2016), Embase (1974 to January 2016), CINAHL (1981 to January 2016), LILACS (1982 to January 2016), Web of Science (2011 to January 2016) and International Pharmaceutical Abstracts (2000 to January 2016).\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs of children aged 12 years or younger where xylitol supplementation was compared with placebo or no treatment to prevent AOM.\nData collection and analysis\nTwo review authors independently selected trials from search results, assessed and rated study quality and extracted relevant data for inclusion in the review. We contacted trial authors to request missing data. We noted data on any adverse events of xylitol. We extracted data on relevant outcomes and estimated the effect size by calculating risk ratio (RR), risk difference (RD) and associated 95% confidence intervals (CI).\nMain results\nWe identified five clinical trials that involved 3405 children for inclusion. For this 2016 update, we identified one new trial for inclusion. This trial was systematically reviewed but due to several sources of heterogeneity, was not included in the meta-analysis. The remaining four trials were of adequate methodological quality. In three RCTs that involved a total of 1826 healthy Finnish children attending daycare, there is moderate quality evidence that xylitol (in any form) can reduce the risk of AOM from 30% to around 22% compared with the control group (RR 0.75, 95% CI 0.65 to 0.88). Among the reasons for dropouts, there were no significant differences in abdominal discomfort and rash between the xylitol and the control groups. Xylitol was not effective in reducing AOM among healthy children during a respiratory infection (RR 1.13, 95% CI 0.83 to 1.53; moderate quality evidence) or among otitis-prone healthy children (RR 0.90, 95% CI 0.67 to 1.21; low-quality evidence).\nAuthors' conclusions\nThere is moderate quality evidence showing that the prophylactic administration of xylitol among healthy children attending daycare centres can reduce the occurrence of AOM. There is inconclusive evidence with regard to the efficacy of xylitol in preventing AOM among children with respiratory infection, or among otitis-prone children. The meta-analysis was limited because data came from a small number of studies, and most were from the same research group.\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 was moderate for healthy children and children with respiratory infections but low for otitis-prone children."
}
]
|
query-laysum | 5760 | [
{
"role": "user",
"content": "Abstract: Background\nBladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of these have moderate or severe symptoms. Stress urinary incontinence (SUI) imposes significant health and economic burdens on society and the women affected.\nObjectives\nTo determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 November 2014), and the reference lists of relevant articles.\nSelection criteria\nRandomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence.\nData collection and analysis\nAt least two authors assessed trials and extracted data independently. Two trial investigators provided additional information.\nMain results\nWe identified 10 trials, which included 375 women having six different types of needle suspension procedures and 489 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension. There was a higher subjective failure rate after the first year (91/313 (29%) failed versus 47/297 (16%) failed after open abdominal retropubic suspension). The risk ratio (RR) was 2.00 (95% confidence interval (CI) 1.47 to 2.72), although the difference in peri-operative complications was not significant (17/75 (23%) versus 12/77 (16%); RR 1.44, 95% CI 0.73 to 2.83). There were no significant differences for the other outcome measures. This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations. Needle suspensions may be as effective as anterior vaginal repair (50/156 (32%) failed after needle suspension versus 64/181 (35%) after anterior repair; RR 0.86, 95% CI 0.64 to 1.16), but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population.\nNo trials compared needle suspensions with conservative management, peri-urethral injections, or sham or laparoscopic surgery.\nAuthors' conclusions\nBladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials reviewed. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity. A Brief Economic Commentary (BEC) identified no cost-effectiveness studies comparing bladder neck needle suspension with other surgeries.\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": "More women were cured after abdominal operations such as colposuspension (84%) than after needle suspension (71%): both women who had and had not had a previous operation for incontinence. There was not enough evidence about complications, or how needle suspension compares with other operations. Needle suspension operations were not compared with conservative treatments such as pelvic floor exercises or drugs. In summary, needle suspension surgery appears to be less effective for urinary incontinence than abdominal surgery, and there is not enough evidence to compare it to other treatments."
}
]
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query-laysum | 5761 | [
{
"role": "user",
"content": "Abstract: Background\nTransurethral radiofrequency collagen denaturation is a relatively novel, minimally invasive device-based intervention used to treat individuals with urinary incontinence (UI). No systematic review of the evidence supporting its use has been published to date.\nObjectives\nTo evaluate the efficacy of transurethral radiofrequency collagen denaturation, compared with other interventions, in the treatment of women with UI.\nReview authors sought to compare the following.\n• Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment.\n• Transurethral radiofrequency collagen denaturation versus conservative physical treatment.\n• Transurethral radiofrequency collagen denaturation versus mechanical devices (pessaries for UI).\n• Transurethral radiofrequency collagen denaturation versus drug treatment.\n• Transurethral radiofrequency collagen denaturation versus injectable treatment for UI.\n• Transurethral radiofrequency collagen denaturation versus other surgery for UI.\nSearch methods\nWe conducted a systematic search of the Cochrane Incontinence Group Specialised Register (searched 19 December 2014), EMBASE and EMBASE Classic (January 1947 to 2014 Week 50), Google Scholar and three trials registries in December 2014, along with reference checking. We sought to identify unpublished studies by handsearching abstracts of major gynaecology and urology meetings, and by contacting experts in the field and the device manufacturer.\nSelection criteria\nRandomised and quasi-randomised trials of transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI in women were eligible.\nData collection and analysis\nWe screened search results and selected eligible studies for inclusion. We assessed risk of bias and analysed dichotomous variables as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous variables as mean differences (MDs) with 95% CIs. We rated the quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach.\nMain results\nWe included in the analysis one small sham-controlled randomised trial of 173 women performed in the United States. Participants enrolled in this study had been diagnosed with stress UI and were randomly assigned to transurethral radiofrequency collagen denaturation (treatment) or a sham surgery using a non-functioning catheter (no treatment). Mean age of participants in the 12-month multi-centre trial was 50 years (range 22 to 76 years).\nOf three patient-important primary outcomes selected for this systematic review, the number of women reporting UI symptoms after intervention was not reported. No serious adverse events were reported for the transurethral radiofrequency collagen denaturation arm or the sham treatment arm during the 12-month trial. Owing to high risk of bias and imprecision, we downgraded the quality of evidence for this outcome to low. The effect of transurethral radiofrequency collagen denaturation on the number of women with an incontinence quality of life (I-QOL) score improvement ≥ 10 points at 12 months was as follows: RR 1.11, 95% CI 0.77 to 1.62; participants = 142, but the confidence interval was wide. For this outcome, the quality of evidence was also low as the result of high risk of bias and imprecision.\nWe found no evidence on the number of women undergoing repeat continence surgery. The risk of other adverse events (pain/dysuria (RR 5.73, 95% CI 0.75 to 43.70; participants = 173); new detrusor overactivity (RR 1.36, 95% CI 0.63 to 2.93; participants = 173); and urinary tract infection (RR 0.95, 95% CI 0.24 to 3.86; participants = 173) could not be established reliably as the trial was small. Evidence was insufficient for assessment of whether use of transurethral radiofrequency collagen denaturation was associated with an increased rate of urinary retention, haematuria and hesitancy compared with sham treatment in 173 participants. The GRADE quality of evidence for all other adverse events with available evidence was low as the result of high risk of bias and imprecision.\nWe found no evidence to inform comparisons of transurethral radiofrequency collagen denaturation with conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI.\nAuthors' conclusions\nIt is not known whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of UI. Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment, and no evidence was found for comparison with any other method of treatment for UI.\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 studied the question of whether using low-temperature heat via the urethra is safe and helps women with involuntary urinary leakage. We looked for randomised studies comparing this treatment with no treatment or with other treatment forms."
}
]
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query-laysum | 5762 | [
{
"role": "user",
"content": "Abstract: Background\nThe long-term risk of stroke increases with age, and stroke is a common cause of disability in the community. Spasticity is considered a significantly disabling impairment that develops in people who have had a stroke. The burden of care is higher in stroke survivors who have spasticity when compared with stroke survivors without spasticity with regard to treatment costs, quality of life, and caregiver burden.\nObjectives\nTo assess if pharmacological interventions for spasticity are more effective than no intervention, normal practice, or control at improving function following stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL, 2016, Issue 5), MEDLINE (1946 to May 2016), Embase (2008 to May 2016), CINAHL (1982 to May 2016), AMED (1985 to May 2016), and eight further databases and trial registers. In an effort to identify further studies, we undertook handsearches of reference lists and contacted study authors and commercial companies.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any systemically acting or locally acting drug versus placebo, control, or comparative drug with the aim of treating spasticity.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion and extracted the data. We assessed the included studies for both quality and risk of bias. We contacted study authors to request further information when necessary.\nMain results\nWe included seven RCTs with a total 403 participants. We found a high risk of bias in all but one RCT. Two of the seven RCTs assessed a systemic drug versus placebo. We pooled data on an indirect measure of spasticity (160 participants) from these two studies but found no significant effect (odds ratio (OR) 1.66, 95% confidence interval (CI) 0.21 to 13.07; I2 = 85%). We identified a significant risk of adverse events per participant occurring in the treatment group versus placebo group (risk ratio (RR) 1.65, 95% CI 1.12 to 2.42; 160 participants; I2 = 0%). Only one of these studies used a functional outcome measure, and we found no significant difference between groups.\nOf the other five studies, two assessed a systemic drug versus another systemic drug, one assessed a systemic drug versus local drug, and the final two assessed a local drug versus another local drug.\nAuthors' conclusions\nThe lack of high-quality RCTs limited our ability to make specific conclusions. Evidence is insufficient to determine if systemic antispasmodics are effective at improving function following stroke.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence varied. We judged all but one of the studies to be at high risk of bias in at least one of the six areas considered. The sample sizes in the included studies were relatively low for drug trials; three of the seven studies had 30 or fewer participants."
}
]
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query-laysum | 5763 | [
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia (FM) syndrome is a chronic condition of unknown aetiology characterised by musculoskeletal pain that often co-exists with sleep disturbance, cognitive dysfunction and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of FM, drug therapy focuses on pain reduction and improvement of other bothersome symptoms.\nObjectives\nThe objective of this review was to assess the effectiveness and safety of monoamine oxidase inhibitors (MAOIs) in the treatment of FM syndrome.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 10), MEDLINE (1966 to November 2010), EMBASE (1980 to November 2010) and the reference lists of reviewed articles.\nSelection criteria\nWe selected all randomised, double-blind trials of MAOIs used for the treatment of FM pain in adult participants.\nData collection and analysis\nTwo authors assessed risk of bias and extracted data independently onto a specially designed pro forma and a third review author cross-checked them.\nMain results\nWe included two studies of inconsistent risk of bias with a total of 230 patients diagnosed with FM. We evaluated two MAOIs: pirlindole and moclobemide. Pirlindole showed statistically significant results compared with placebo for several outcomes (pain, tender points and overall assessment by the patient and the physician), whereas moclobemide did not show statistically significant differences between groups. Pooled results of the two studies displayed a modest effect size in pain (mean difference (MD) -1.45 (121 patients; 95% confidence interval (CI) -2.71 to -0.20; number needed to treat (NNT) 2 (95% CI 1 to 12); I2 = 59%)), implying a minimal clinically important difference (MCID) and a small effect on tender points (standardised mean difference (SMD) -0.36 (121 patients; 95% CI -0.72 to -0.00; I2 = 31%)). No effect was seen on global assessment by patient. Physical function and sleep disturbance were not measured. The most frequent adverse events were nausea and vomiting, with statistically significant differences between groups (risk ratio (RR) 7.82 (89 patients; 95% CI 1.02 to 59.97; NNT 7 (95% CI 4 to 33)).\nAuthors' conclusions\nData suggest that the effectiveness of MAOIs for the treatment of FM symptoms is limited. Although we observed a moderate effect size on pain and a small one on tender points, these results should be taken with caution as they are only based on two studies with a small number of patients and inconsistent risk of bias among them.\n\nGiven the provided abstract, please respond to the following query: \"Adverse events (nausea and vomiting)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- 16 more people out of 100 who took MAOIs (pirlindole) had nausea and vomiting.\n- 18 people out of 100 who took MAOIs (pirlindole) had nausea and vomiting.\n- 2 people out of 100 who took placebo had nausea and vomiting.\n- No information regarding people who took moclobemide is available."
}
]
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query-laysum | 5764 | [
{
"role": "user",
"content": "Abstract: Background\nPatients in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as increased patient care activities and invasive monitoring as part of their care. Sleep deprivation affects physical and psychological health, and patients perceive the quality of their sleep to be poor whilst in the ICU. Artificial lighting during night-time hours in the ICU may contribute to reduced production of melatonin in critically ill patients. Melatonin is known to have a direct effect on the circadian rhythm, and it appears to reset a natural rhythm, thus promoting sleep.\nObjectives\nTo assess whether the quantity and quality of sleep may be improved by administration of melatonin to adults in the intensive care unit. To assess whether melatonin given for sleep promotion improves both physical and psychological patient outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 8), MEDLINE (1946 to September 2017), Embase (1974 to September 2017), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to September 2017), and PsycINFO (1806 to September 2017). We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials with adult participants (over the age of 16) admitted to the ICU with any diagnoses given melatonin versus a comparator to promote overnight sleep. We included participants who were mechanically ventilated and those who were not mechanically ventilated. We planned to include studies that compared the use of melatonin, given at an appropriate clinical dose with the intention of promoting night-time sleep, against no agent; or against another agent administered specifically to promote sleep.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, assessed risk of bias, and synthesized findings. We assessed the quality of evidence with GRADE.\nMain results\nWe included four studies with 151 randomized participants. Two studies included participants who were mechanically ventilated, one study included a mix of ventilated and non-ventilated participants and in one study participants were being weaned from mechanical ventilation. Three studies reported admission diagnoses, which varied: these included sepsis, pneumonia and cardiac or cardiorespiratory arrest. All studies compared melatonin against no agent; three were placebo-controlled trials; and one compared melatonin with usual care. All studies administered melatonin in the evening.\nAll studies reported adequate methods for randomization and placebo-controlled trials were blinded at the participant and personnel level. We noted high risk of attrition bias in one study and were unclear about potential bias introduced in two studies with differences between participants at baseline.\nIt was not appropriate to combine data owing to differences in measurement tools, or methods used to report data.\nThe effects of melatonin on subjectively rated quantity and quality of sleep are uncertain (very low certainty evidence). Three studies (139 participants) reported quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments. Study authors in one study reported no difference in sleep efficiency index scores between groups for participant assessment (using Richards-Campbell Sleep Questionnaire) and nurse assessment. Two studies reported no difference in duration of sleep observed by nurses.\nThe effects of melatonin on objectively measured quantity and quality of sleep are uncertain (very low certainty evidence). Two studies (37 participants) reported quantity and quality of sleep as measured by polysomnography (PSG), actigraphy, bispectral index (BIS) or electroencephalogram (EEG). Study authors in one study reported no difference in sleep efficiency index scores between groups using BIS and actigraphy. These authors also reported longer sleep in participants given melatonin which was not statistically significant, and improved sleep (described as \"better sleep\") in participants given melatonin from analysis of area under the curve (AUC) of BIS data. One study used PSG but authors were unable to report data because of a large loss of participant data.\nOne study (82 participants) reported no evidence of a difference in anxiety scores (very low certainty evidence). Two studies (94 participants) reported data for mortality: one study reported that overall one-third of participants died; and one study reported no evidence of difference between groups in hospital mortality (very low certainty). One study (82 participants) reported no evidence of a difference in length of ICU stay (very low certainty evidence). Effects of melatonin on adverse events were reported in two studies (107 participants), and are uncertain (very low certainty evidence): one study reported headache in one participant given melatonin, and one study reported excessive sleepiness in one participant given melatonin and two events in the control group (skin reaction in one participant, and excessive sleepiness in another participant).\nThe certainty of the evidence for each outcome was limited by sparse data with few participants. We noted study limitations in some studies due to high attrition and differences between groups in baseline data; and doses of melatonin varied between studies. Methods used to measure data were not consistent for outcomes, and use of some measurement tools may not be effective for use on the ICU patient. All studies included participants in the ICU but we noted differences in ICU protocols, and one included study used a non-standard sedation protocol with participants which introduced indirectness to the evidence.\nAuthors' conclusions\nWe found insufficient evidence to determine whether administration of melatonin would improve the quality and quantity of sleep in ICU patients. We identified sparse data, and noted differences in study methodology, in ICU sedation protocols, and in methods used to measure and report sleep. We identified five ongoing studies from database and clinical trial register searches. Inclusion of data from these studies in future review updates would provide more certainty for the review outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Patients in the intensive care unit (ICU) experience poor sleep. This may be caused by constant high noise levels and 24-hour lighting in the ICU, as well as increased and intrusive patient care activities (such as measuring blood pressure, pulse, and temperature; taking blood samples; administering medications, etc.). Lack of sleep affects a person's physical and mental health. It is accepted that sleep is an essential requirement for good health. Sleep has a restorative function, and for the critically ill is thought to improve healing and survival. Patients perceive the quality of their sleep to be poor while they are in the ICU. Melatonin is a hormone produced in the body to regulate a daily cycle of sleep and wakefulness. Artificial light during night-time hours in the ICU may affect the body's natural production of melatonin, and this may affect the sleep cycle in critically ill patients."
}
]
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query-laysum | 5765 | [
{
"role": "user",
"content": "Abstract: Background\nLead exposure is a serious health hazard, especially for children. It is associated with physical, cognitive and neurobehavioural impairment in children. There are many potential sources of lead in the environment, therefore trials have tested many household interventions to prevent or reduce lead exposure. This is an update of a previously published review.\nObjectives\nTo assess the effects of household interventions intended to prevent or reduce further lead exposure in children on improvements in cognitive and neurobehavioural development, reductions in blood lead levels and reductions in household dust lead levels.\nSearch methods\nIn March 2020, we updated our searches of CENTRAL, MEDLINE, Embase, 10 other databases and ClinicalTrials.gov. We also searched Google Scholar, checked the reference lists of relevant studies and contacted experts to identify unpublished studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of household educational or environmental interventions, or combinations of interventions to prevent lead exposure in children (from birth to 18 years of age), where investigators reported at least one standardised outcome measure.\nData collection and analysis\nTwo authors independently reviewed all eligible studies for inclusion, assessed risk of bias and extracted data. We contacted trialists to obtain missing information. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 17 studies (three new to this update), involving 3282 children: 16 RCTs (involving 3204 children) and one quasi-RCT (involving 78 children). Children in all studies were under six years of age. Fifteen studies took place in urban areas of North America, one in Australia and one in China. Most studies were in areas with low socioeconomic status. Girls and boys were equally represented in those studies reporting this information. The duration of the intervention ranged from three months to 24 months in 15 studies, while two studies performed interventions on a single occasion. Follow-up periods ranged from three months to eight years. Three RCTs were at low risk of bias in all assessed domains. The other 14 studies were at unclear or high risk of bias; for example, we considered two RCTs and one quasi-RCT at high risk of selection bias and six RCTs at high risk of attrition bias. National or international research grants or governments funded 15 studies, while the other two did not report their funding sources.\nEducation interventions versus no intervention\nNone of the included studies in this comparison assessed effects on cognitive or neurobehavioural outcomes, or adverse events. All studies reported data on blood lead level outcomes.\nEducational interventions showed there was probably no evidence of a difference in reducing blood lead levels (continuous: mean difference (MD) –0.03, 95% confidence interval (CI) –0.13 to 0.07; I² = 0%; 5 studies, 815 participants; moderate-certainty evidence; log-transformed data), or in reducing floor dust levels (MD –0.07, 95% CI –0.37 to 0.24; I² = 0%; 2 studies, 318 participants; moderate-certainty evidence).\nEnvironmental interventions versus no intervention\nDust control: one study in this comparison reported data on cognitive and neurobehavioural outcomes, and on adverse events in children. The study showed numerically there may be better neurobehavioural outcomes in children of the intervention group. However, differences were small and the CI included both a beneficial and non-beneficial effect of the environmental intervention (e.g. mental development (Bayley Scales of Infant Development-II): MD 0.1, 95% CI –2.1 to 2.4; 1 study, 302 participants; low-certainty evidence). The same study did not observe any adverse events related to the intervention during the eight-year follow-up, but observed two children with adverse events in the control group (1 study, 355 participants; very low-certainty evidence).\nMeta-analysis also found no evidence of effectiveness on blood lead levels (continuous: MD –0.02, 95% CI –0.09 to 0.06; I² = 0%; 4 studies, 565 participants; moderate-certainty evidence; log-transformed data). We could not pool the data regarding floor dust levels, but studies reported that there may be no evidence of a difference between the groups (very low-certainty evidence).\nSoil abatement: the two studies assessing this environmental intervention only reported on the outcome of 'blood lead level'. One study showed a small effect on blood lead level reduction, while the other study showed no effect. Therefore, we deem the current evidence insufficient to draw conclusions about the effectiveness of soil abatement (very low-certainty evidence).\nCombination of educational and environmental interventions versus standard education\nStudies in this comparison only reported on blood lead levels and dust lead levels. We could not pool the studies in a meta-analysis due to substantial differences between the studies. Since the studies reported inconsistent results, the evidence is currently insufficient to clarify whether a combination of interventions reduces blood lead levels and floor dust levels (very low-certainty evidence).\nAuthors' conclusions\nBased on available evidence, household educational interventions and environmental interventions (namely dust control measures) show no evidence of a difference in reducing blood lead levels in children as a population health measure. The evidence of the effects of environmental interventions on cognitive and neurobehavioural outcomes and adverse events is uncertain too.\nFurther trials are required to establish the most effective intervention for reducing or even preventing further lead exposure. Key elements of these trials should include strategies to reduce multiple sources of lead exposure simultaneously using empirical dust clearance levels. It is also necessary for trials to be carried out in low- and middle-income countries and in differing socioeconomic groups in high-income countries.\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"
},
{
"role": "assistant",
"content": "- Parents and carers who want to prevent domestic lead exposure in children.\n- Health professionals and decision-makers who are interested in methods to prevent domestic lead exposure in children."
}
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query-laysum | 5766 | [
{
"role": "user",
"content": "Abstract: Background\nVenous leg ulcers (VLUs) are open skin wounds on the lower leg that occur because of poor blood flow in the veins of the leg; leg ulcers can last from weeks to years, and are both painful and costly. Prevalence in the UK is about 2.9 cases per 10,000 people. First-line treatment for VLUs is compression therapy, but around 60% of people have unhealed ulcers after 12 weeks' treatment and about 40% after 24 weeks; therefore, there is scope for further improvement. Limited evidence suggests non-healing leg ulcers may have persisting elevated levels of proteases, which is thought to deter the later stages of healing; thus, timely protease-modulating matrix (PMM) treatments may improve healing by physically removing proteases from the wound fluid.\nObjectives\nTo determine the effects of protease-modulating matrix (PMM) treatments on the healing of venous leg ulcers, in people managed in any care setting.\nSearch methods\nIn September 2016 we searched: the Cochrane Wounds Specialised Register; CENTRAL; Ovid MEDLINE; Ovid MEDLINE (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. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials (RCTs) that evaluated PMM treatments for VLUs. We defined PMM treatments as those with a purposeful intent of reducing proteases. Wound healing was the primary endpoint.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction.\nMain results\nWe included 12 studies (784 participants) in this review; sample sizes ranged from 10 to 187 participants (median 56.5). One study had three arms that were all relevant to this review and all the other studies had two arms. One study was a within-participant comparison. All studies were industry funded. Two studies provided unpublished data for healing.\nNine of the included studies compared PMM treatments with other treatments and reported results for the primary outcomes. All treatments were dressings. All studies also gave the participants compression bandaging. Seven of these studies were in participants described as having 'non-responsive' or 'hard-to-heal' ulcers. Results, reported at short, medium and long durations and as time-to-event data, are summarised for the comparison of any dressing regimen incorporating PMM versus any other dressing regimen. The majority of the evidence was of low or very low certainty, and was mainly downgraded for risk of bias and imprecision.\nIt is uncertain whether PMM dressing regimens heal VLUs quicker than non-PMM dressing regimens (low-certainty evidence from 1 trial with 100 participants) (HR 1.21, 95% CI 0.74 to 1.97).\nIn the short term (four to eight weeks) it is unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (very low-certainty evidence, 2 trials involving 207 participants).\nIn the medium term (12 weeks), it is unclear whether PMM dressing regimens increase the probability of healing compared with non-PMM dressing regimens (low-certainty evidence from 4 trials with 192 participants) (RR 1.28, 95% CI 0.95 to 1.71). Over the longer term (6 months), it is also unclear whether there is a difference between PMM dressing regimens and non-PMM dressing regimens in the probability of healing (low certainty evidence, 1 trial, 100 participants) (RR 1.06, 95% CI 0.80 to 1.41).\nIt is uncertain whether there is a difference in adverse events between PMM dressing regimens and non-PMM dressing regimens (low-certainty evidence from 5 trials, 363 participants) (RR 1.03, 95% CI 0.75 to 1.42). It is also unclear whether resource use is lower for PMM dressing regimens (low-certainty evidence, 1 trial involving 73 participants), or whether mean total costs in a German healthcare setting are different (low-certainty evidence, 1 trial in 187 participants). One cost-effectiveness analysis was not included because effectiveness was not based on complete healing.\nAuthors' conclusions\nThe evidence is generally of low certainty, particularly because of risk of bias and imprecision of effects. Within these limitations, we are unclear whether PMM dressing regimens influence venous ulcer healing relative to dressing regimens without PMM activity. It is also unclear whether there is a difference in rates of adverse events between PMM and non-PMM treatments. It is uncertain whether either resource use (products and staff time) or total costs associated with PMM dressing regimens are different from those for non-PMM dressing regimens. More research is needed to clarify the impact of PMM treatments on venous ulcer healing.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In September 2016 we searched for as many relevant studies as we could find that had a reliable design (randomised controlled trials) and had compared PMM treatments with other treatments for venous leg ulcers. We found 12 studies involving a total of 784 people. Ten studies gave results we could use and all treatments were dressings. All these studies gave all the participants compression therapy as well as the dressings. Most of the people in the trials had wounds that were not getting better or had been there a long time."
}
]
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query-laysum | 5767 | [
{
"role": "user",
"content": "Abstract: Background\nAsthma is a common long-term breathing condition that affects approximately 300 million people worldwide. People with asthma may experience short-term worsening of their asthma symptoms; these episodes are often known as ‘exacerbations’, ‘flare-ups’, ‘attacks’ or 'acute asthma'. Oral steroids, which have a potent anti-inflammatory effect, are recommended for all but the most mild asthma exacerbations; they should be initiated promptly. The most often prescribed oral steroids are prednisolone and dexamethasone, but current guidelines on dosing vary between countries, and often among different guideline producers within the same country. Despite their proven efficacy, use of steroids needs to be balanced against their potential to cause important adverse events. Evidence is somewhat limited regarding optimal dosing of oral steroids for asthma exacerbations to maximise recovery while minimising potential side effects, which is the topic of this review.\nObjectives\nTo assess the efficacy and safety of any dose or duration of oral steroids versus any other dose or duration of oral steroids for adults and children with an asthma exacerbation.\nSearch methods\nWe identified trials from the Cochrane Airways Group Specialised Register (CAGR), ClinicalTrials.gov (www.ClinicalTrials.gov), the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/) and reference lists of all primary studies and review articles. This search was up to date as of April 2016.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs), irrespective of blinding or duration, that evaluated one dose or duration of oral steroid versus any other dose or duration, for management of asthma exacerbations. We included studies involving both adults and children with asthma of any severity, in which investigators analysed adults and children separately. We allowed any other co-intervention in the management of an asthma exacerbation, provided it was not part of the randomised treatment. We included studies reported as full text, those published as abstract only and unpublished data.\nData collection and analysis\nTwo review authors independently screened the search results for included trials, extracted numerical data and assessed risk of bias; all data were cross-checked for accuracy. We resolved disagreements by discussion with the third review author or with an external advisor.\nWe analysed dichotomous data as odds ratios (ORs) or risk differences (RDs) using study participants as the unit of analysis; we analysed continuous data as mean differences (MDs). We used a random-effects model, and we carried out a fixed-effect analysis if we detected statistical heterogeneity. We rated all outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) system and presented results in 'Summary of findings' tables.\nMain results\nWe included 18 studies that randomised a total of 2438 participants - both adults and children - and performed comparisons of interest. Included studies assessed higher versus lower doses of prednisolone (n = 4); longer versus shorter courses of prednisolone (n = 3) or dexamethasone (n = 1); tapered versus non-tapered courses of prednisolone (n = 4); and prednisolone versus dexamethasone (n = 6). Follow-up duration ranged from seven days to six months. The smallest study randomised just 15 participants, and the largest 638 (median 93). The varied interventions and outcomes reported limited the number of meaningful meta-analyses that we could perform.\nFor two of our primary outcomes - hospital admission and serious adverse events - events were too infrequent to permit conclusions about the superiority of one treatment over the other, or their equivalence. Researchers in the included studies reported asthma symptoms in different ways and rarely used validated scales, again limiting our conclusions. Secondary outcome meta-analysis was similarly hampered by heterogeneity among interventions and outcome measures used. Overall, we found no convincing evidence of differences in outcomes between a higher dose or longer course and a lower dose or shorter course of prednisolone or dexamethasone, or between prednisolone and dexamethasone.\nIncluded studies were generally of reasonable methodological quality. Review authors assessed most outcomes in the review as having low or very low quality, meaning we are not confident in the effect estimates. The predominant reason for downgrading was imprecision, but indirectness and risk of bias also reduced our confidence in some estimates.\nAuthors' conclusions\nEvidence is not strong enough to reveal whether shorter or lower-dose regimens are generally less effective than longer or higher-dose regimens, or indeed that the latter are associated with more adverse events. Any changes recommended for current practice should be supported by data from larger, well-designed trials. Varied study design and outcome measures limited the number of meta-analyses that we could perform. Greater emphasis on palatability and on whether some regimens might be easier to adhere to than others could better inform clinical decisions for individual patients.\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": "Evidence presented in this review is generally considered to be of low or very low quality, which means we are not very sure whether the results are accurate, mostly because we have not been able to combine many studies. Some studies did not clearly explain how trial organisers decided which people would receive which dose of steroids, and in some studies, both participants and trial organisers knew which dose they were getting. This may have affected study results."
}
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query-laysum | 5768 | [
{
"role": "user",
"content": "Abstract: Background\nAmblyopia is defined as impaired visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing glasses.\nObjectives\nIn performing this systematic review, we aimed to synthesize the best available evidence regarding the effectiveness and safety of conventional occlusion therapy compared to atropine penalization in treating amblyopia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 8); Ovid MEDLINE; Ovid Embase; LILACS BIREME; ClinicalTrials.gov; ISRCTN; and the WHO ICTRP on 7 September 2018.\nSelection criteria\nWe included randomized/quasi-randomized controlled trials comparing conventional occlusion to atropine penalization for amblyopia.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles, abstracted data, and assessed risk of bias.\nMain results\nWe included seven trials (five randomized controlled trials and two quasi-randomized controlled trials) conducted in six countries (China, India, Iran, Ireland, Spain, and the United States) with a total of 1177 amblyopic eyes. Three of these seven trials were from the original 2009 version of the review. We assessed two trials as having a low risk of bias across all domains, and the remaining five trials as having unclear or high risk of bias for some domains.\nAs different occlusion modalities, atropine penalization regimens, and populations were used across the included trials, we did not conduct any meta-analysis due to clinical and statistical heterogeneity. Evidence from six trials (two at low risk of bias) suggests that atropine penalization is as effective as conventional occlusion in improving visual acuity. Similar improvement in visual acuity was reported at all time points at which it was assessed, ranging from five weeks (improvement of 1 line) to 10 years (improvement of greater than 3 lines). At six months, although most participants (363/522) come from a trial rated as at low risk of bias with a precise estimate (mean difference (MD) 0.03, 95% confidence interval (CI) 0.00 to 0.06), two other trials rated as at high risk of bias produced inconsistent estimates and wide confidence intervals (MD −0.02, 95% CI −0.11 to 0.07 and MD −0.14, 95% CI −0.23 to −0.05; moderate-certainty evidence). At 24 months, additional improvement was found in both groups, but there continued to be no meaningful difference between those receiving occlusion and those receiving atropine therapies (moderate-certainty evidence).\nWe did not find any difference in ocular alignment, stereo acuity, or sound eye visual acuity between occlusion and atropine penalization groups (moderate-certainty evidence). Both treatments were well tolerated. Atropine was associated with better adherence (moderate-certainty evidence) and quality of life (moderate-certainty evidence), but also a higher reported risk of adverse events in terms of mild reduction in the visual acuity of the sound eye not requiring treatment and light sensitivity (high-certainty evidence). Skin, lid, or conjunctival irritation were more common among participants receiving patching than those receiving atropine (high-certainty evidence). Atropine penalization costs less than conventional occlusion.\nAuthors' conclusions\nBoth conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the trials we analyzed.\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": "Our update of the previous version of this review included seven trials with a total of 1177 amblyopic eyes. Evidence from six trials (two of good methodological quality) suggests both patching and atropine drops produce visual acuity improvement in the short term (one to six months) and long term (24 months) in the weaker eye after starting treatment. We found no differences between the two treatments in straightening of the eyes, depth perception, or vision in the better eye. Both treatments were well tolerated. Atropine drops were taken more regularly than using the patch and associated with better quality of life, but blurry vision and sensitivity to light was more common in the atropine treated eyes. Skin, lid, or conjunctival irritation were more common among participants receiving patching than those receiving atropine."
}
]
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query-laysum | 5769 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis is a leading cause of infectious disease-related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one-third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection.\nObjectives\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high-risk groups and in the general population. Screening \"irrespective of signs or symptoms\" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough).\nTo estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high-risk groups and in the general population.\nSearch methods\nWe searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies.\nSelection criteria\nCross-sectional and cohort studies in which adults (15 years and older) in high-risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture-based drug susceptibility testing and line probe assays.\nData collection and analysis\nTwo review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS-2. We used a bivariate random-effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high-risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high-risk groups combined.\nMain results\nWe included a total of 21 studies: 18 studies (13,114 participants) evaluated Xpert MTB/RIF as a screening test for pulmonary tuberculosis and one study (571 participants) evaluated both Xpert MTB/RIF and Xpert Ultra. Three studies (159 participants) evaluated Xpert MTB/RIF for rifampicin resistance. Fifteen studies (75%) were conducted in high tuberculosis burden and 16 (80%) in high TB/HIV-burden countries. We judged most studies to have low risk of bias in all four QUADAS-2 domains and low concern for applicability.\nXpert MTB/RIF and Xpert Ultra as screening tests for pulmonary tuberculosis\nIn people living with HIV (12 studies), Xpert MTB/RIF pooled sensitivity and specificity (95% CrI) were 61.8% (53.6 to 69.9) (602 participants; moderate-certainty evidence) and 98.8% (98.0 to 99.4) (4173 participants; high-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 40 would be Xpert MTB/RIF-positive; of these, 9 (22%) would not have tuberculosis (false-positives); and 960 would be Xpert MTB/RIF-negative; of these, 19 (2%) would have tuberculosis (false-negatives).\nIn people living with HIV (1 study), Xpert Ultra sensitivity and specificity (95% CI) were 69% (57 to 80) (68 participants; very low-certainty evidence) and 98% (97 to 99) (503 participants; moderate-certainty evidence). Of 1000 people where 50 have tuberculosis on culture, 53 would be Xpert Ultra-positive; of these, 19 (36%) would not have tuberculosis (false-positives); and 947 would be Xpert Ultra-negative; of these, 16 (2%) would have tuberculosis (false-negatives).\nIn non-hospitalized people in high-risk groups (5 studies), Xpert MTB/RIF pooled sensitivity and specificity were 69.4% (47.7 to 86.2) (337 participants, low-certainty evidence) and 98.8% (97.2 to 99.5) (8619 participants, moderate-certainty evidence). Of 1000 people where 10 have tuberculosis on culture, 19 would be Xpert MTB/RIF-positive; of these, 12 (63%) would not have tuberculosis (false-positives); and 981 would be Xpert MTB/RIF-negative; of these, 3 (0%) would have tuberculosis (false-negatives).\nWe did not identify any studies using Xpert MTB/RIF or Xpert Ultra for screening in the general population.\nXpert MTB/RIF as a screening test for rifampicin resistance\nXpert MTB/RIF sensitivity was 81% and 100% (2 studies, 20 participants; very low-certainty evidence), and specificity was 94% to 100%, (3 studies, 139 participants; moderate-certainty evidence).\nAuthors' conclusions\nOf the high-risks groups evaluated, Xpert MTB/RIF applied as a screening test was accurate for tuberculosis in high tuberculosis burden settings. Sensitivity and specificity were similar in people living with HIV and non-hospitalized people in high-risk groups. In people living with HIV, Xpert Ultra sensitivity was slightly higher than that of Xpert MTB/RIF and specificity similar. As there was only one study of Xpert Ultra in this analysis, results should be interpreted with caution. There were no studies that evaluated the tests in people with diabetes mellitus and other groups considered at high-risk for tuberculosis, or in the general population.\n\nGiven the provided abstract, please respond to the following query: \"Who do the results of this review apply to?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Studies were mainly performed in high tuberculosis and high HIV burden settings. No studies evaluated the tests in people with diabetes mellitus or the general population."
}
]
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query-laysum | 5770 | [
{
"role": "user",
"content": "Abstract: Background\nNon-invasive positive pressure ventilation (NPPV) has been used to treat respiratory distress due to acute cardiogenic pulmonary oedema (ACPE). We performed a systematic review and meta-analysis update on NPPV for adults presenting with ACPE.\nObjectives\nTo evaluate the safety and effectiveness of NPPV compared to standard medical care (SMC) for adults with ACPE. The primary outcome was hospital mortality. Important secondary outcomes were endotracheal intubation, treatment intolerance, hospital and intensive care unit length of stay, rates of acute myocardial infarction, and adverse event rates.\nSearch methods\nWe searched CENTRAL (CRS Web, 20 September 2018), MEDLINE (Ovid, 1946 to 19 September 2018), Embase (Ovid, 1974 to 19 September 2018), CINAHL Plus (EBSCO, 1937 to 19 September 2018), LILACS, WHO ICTRP, and clinicaltrials.gov. We also reviewed reference lists of included studies. We applied no language restrictions.\nSelection criteria\nWe included blinded or unblinded randomised controlled trials in adults with ACPE. Participants had to be randomised to NPPV (continuous positive airway pressure (CPAP) or bilevel NPPV) plus standard medical care (SMC) compared with SMC alone.\nData collection and analysis\nTwo review authors independently screened and selected articles for inclusion. We extracted data with a standardised data collection form. We evaluated the risks of bias of each study using the Cochrane 'Risk of bias' tool. We assessed evidence quality for each outcome using the GRADE recommendations.\nMain results\nWe included 24 studies (2664 participants) of adult participants (older than 18 years of age) with respiratory distress due to ACPE, not requiring immediate mechanical ventilation. People with ACPE presented either to an Emergency Department or were inpatients. ACPE treatment was provided in an intensive care or Emergency Department setting. There was a median follow-up of 13 days for hospital mortality, one day for endotracheal intubation, and three days for acute myocardial infarction. Compared with SMC, NPPV may reduce hospital mortality (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.51 to 0.82; participants = 2484; studies = 21; I2 = 6%; low quality of evidence) with a number needed to treat for an additional beneficial outcome (NNTB) of 17 (NNTB 12 to 32). NPPV probably reduces endotracheal intubation rates (RR 0.49, 95% CI 0.38 to 0.62; participants = 2449; studies = 20; I2 = 0%; moderate quality of evidence) with a NNTB of 13 (NNTB 11 to 18). There is probably little or no difference in acute myocardial infarction (AMI) incidence with NPPV compared to SMC for ACPE (RR 1.03, 95% CI 0.91 to 1.16; participants = 1313; studies = 5; I2 = 0%; moderate quality of evidence). We are uncertain as to whether NPPV increases hospital length of stay (mean difference (MD) −0.31 days, 95% CI −1.23 to 0.61; participants = 1714; studies = 11; I2 = 55%; very low quality of evidence). Adverse events were generally similar between NPPV and SMC groups, but evidence was of low quality.\nAuthors' conclusions\nOur review provides support for continued clinical application of NPPV for ACPE, to improve outcomes such as hospital mortality and intubation rates. NPPV is a safe intervention with similar adverse event rates to SMC alone. Additional research is needed to determine if specific subgroups of people with ACPE have greater benefit of NPPV compared to SMC. Future research should explore the benefit of NPPV for ACPE patients with hypercapnia.\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": "We found 24 studies with 2664 participants comparing non-invasive ventilation to medical care alone. Non-invasive ventilation may decrease the chances of dying in hospital. The quality of results for studies reporting death in hospital was low. Studies were poorly conducted, and results were not similar across studies. In addition, non-invasive ventilation probably reduces the chances of needing a breathing tube. The quality of results for studies reporting breathing tube rates was moderate. Studies evaluating breathing tube rates were poorly conducted. Non-invasive ventilation probably has little or no effect on getting a heart attack. The quality of results for studies reporting heart attack rates was moderate, and studies had inconsistent results for this outcome. We are unsure if the length of hospital stay is improved with non-invasive ventilation. The quality of results for studies reporting hospital length of stay was very low, which was due to poor study conduct and inconsistent results. Finally, non-invasive ventilation may make little or no difference to adverse events (complications), compared to medical care. The quality of results for studies reporting adverse events was low. Studies evaluating adverse events were poorly conducted and had inconsistent results."
}
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query-laysum | 5771 | [
{
"role": "user",
"content": "Abstract: Background\nMeasles is an important cause of childhood morbidity and mortality globally, despite increasing vaccine coverage. Zinc plays a significant role in the maintenance of normal immunological functions, therefore supplements given to zinc-deficient children will increase the availability of zinc and could reduce measles-related morbidity and mortality. This is an update of a review first published in 2015.\nObjectives\nTo assess the effects of zinc supplementation in reducing morbidity and mortality in children with measles.\nSearch methods\nWe searched CENTRAL (03 February 2017, Issue 2), MEDLINE (1946 to 03 February 2017), Embase (1974 to 03 February 2017), CINAHL (1981 to 03 February 2017), LILACS (1982 to 03 February 2017), Web of Science (1985 to 03 February 2017), and BIOSIS Previews (1985 to 27 June 2014). We also searched ClinicalTrials.gov, the Australian New Zealand Clinical Trials Registry and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 03 February 2017 to identify unpublished and ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of zinc in reducing morbidity and mortality in children with measles.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion and extracted data on outcomes, details of the interventions, and other study characteristics using a standardised data extraction form. We used risk ratio (RR) and hazard ratio (HR) as measures of effect with 95% confidence intervals (CI). We included only one study, and did not conduct meta-analysis.\nMain results\nWe did not identify any new studies for inclusion in this update. One RCT met our inclusion criteria. The study was conducted in India and included 85 children diagnosed with measles and pneumonia. The trial showed no significant difference in mortality between children with measles and pneumonia who received zinc supplements and those who received placebo (RR 0.34, 95% CI 0.01 to 8.14). There was no significant difference in time to absence of fever between children who received zinc supplements and those who did not (HR 1.08, 95% CI 0.67 to 1.74). No treatment-related side effects were reported in either group. We assessed the overall quality of the evidence as very low.\nAuthors' conclusions\nWe could not draw any definitive conclusions from this review about the effects of zinc supplementation on clinical outcomes of children with measles due to the very low quality of the evidence available. There is insufficient evidence to confirm or refute the effect of zinc supplementation in children with measles.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found one small randomised trial (involving 85 children) that compared zinc supplements versus placebo administered to children with measles and pneumonia. All 85 children received supportive care and vitamin A. The study was conducted in India and funded by the Child Health Foundation USA and the Nestlé Foundation."
}
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query-laysum | 5772 | [
{
"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 do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared medicines that affect the whole body, or treatments applied to the skin (topical therapies), or rewarming techniques used to treat frostbite injuries to another treatment for frostbite, or a 'dummy' treatment (placebo), or no treatment. We looked for randomised controlled studies, in which the treatments received were decided at random, because these studies usually give the most reliable evidence about the effects of treatments.\nWe were interested in:\n- the risk of amputation;\n- serious and non-serious unwanted effects of treatment (adverse events);\n- intense pain, especially upon rewarming;\n- long-lasting pain;\n- how well people who had frostbite could perform activities of daily living;\n- the quality of life experienced by people who had frostbite;\n- the number of people who withdrew from treatment because of problems caused by the therapy;\n- the length of time people did not attend their work because of frostbite;\n- the length of time to full return to work; and\n- the number of deaths."
}
]
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query-laysum | 5773 | [
{
"role": "user",
"content": "Abstract: Background\nBronchiectasis is predominantly an acquired disease process that represents the end stage of a variety of unrelated pulmonary insults. It is defined as persistent irreversible dilatation and distortion of medium-sized bronchi. It has been suggested that with widespread use of high-resolution computed tomography, more bronchiectasis diagnoses are being made. Patients diagnosed with bronchiectasis frequently have difficulty expectorating sputum. Sputum therefore is retained in the lungs and may become infected, leading to further lung damage. Mucolytic agents target hypersecretion or changed physiochemical properties of sputum to make it easier to clear. One drug, recombinant human DNase, breaks down the DNA that is released at the site of infection by neutrophils.\nMucus clearance along with antimicrobial therapy remains an integral part of bronchiectasis management. Chest physiotherapy along with mucolytic agents is commonly used in practice without clear supportive evidence.\nObjectives\nTo determine whether ingested or inhaled mucolytics are effective in the treatment of patients with bronchiectasis.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register and reference lists of relevant articles. We contacted experts in the field and drug companies. Searches were current as of June 2013.\nSelection criteria\nRandomised trials of mucolytic treatment in people with bronchiectasis but not cystic fibrosis.\nData collection and analysis\nData extraction was performed independently by two review authors. Study authors were contacted for confirmation.\nMain results\nFour trials (with a combined total of 528 adult participants) were included, but almost none of the data from these studies could be aggregated in a meta-analysis.\nOne trial (with 88 participants) compared bromhexine versus placebo. Compared with placebo, high doses of bromhexine with antibiotics eased difficulty in expectoration (mean difference (MD) -0.53, 95% confidence interval (CI) -0.81 to -0.25 at 16 days); the quality of the evidence was rated as low. A reduction in sputum production was noted with bromhexine (MD -21.5%, 95% CI -38.9 to -4.1 at day 16); again the quality of the evidence was rated as low. No significant differences between bromhexine and placebo were observed with respect to reported adverse events (odds ratio (OR) 2.93; 95% CI 0.12 to 73.97), and again the quality of the evidence was rated as low.\nIn a single small, blinded but not placebo-controlled trial of older (> 55 years) participants with stable bronchiectasis and mucus hypersecretion, erdosteine combined with physiotherapy over a 15-day period improved spirometry and sputum purulence more effectively compared with physiotherapy alone. The spirometric improvement was small (MD 200 mL in forced expiratory volume in one second (FEV1) and 300 mL in forced vital capacity (FVC)) and was apparent only at day 15, not at earlier time points.\nThe remaining two studies (with a combined total of 410 participants) compared recombinant human DNase (RhDNase) versus placebo. These two studies were very different (one was a two-week study of 61 participants, and the other ran for 24 weeks and included 349 participants), and the opportunity for combining data from the two studies was very limited. Compared with placebo, recombinant human DNase showed no difference in FEV1 or FVC in the smaller study but showed a significant negative effect on FEV1 in the larger and longer study. For reported adverse events, no significant differences between recombinant human DNase and placebo were noted. In all of the above comparisons of recombinant human DNase versus placebo, the quality of the evidence was judged to be low.\nAuthors' conclusions\nGiven the harmful effects of recombinant human DNase in one trial and no evidence of benefit, this drug should be avoided in non–cystic fibrosis bronchiectasis, except in the context of clinical trials. Evidence is insufficient to permit evaluation of the routine use of other mucolytics for bronchiectasis. High doses of bromhexine coupled with antibiotics may help with sputum production and clearance, but long-term data and robust clinical outcomes are lacking. Similarly, erdosteine may be a useful adjunct to physiotherapy in stable patients with mucus hypersecretion, but robust longer-term trials are required.\nGenerally, clinical trials in children on the use of various mucolytic agents are lacking. As the number of agents available on the market, such as RhDNase, acetylcysteine and bromhexine, is increasing, improvement of the evidence base is needed.\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": "No strong evidence is available to support the use of these drugs in people with bronchiectasis (from causes other than cystic fibrosis); however it is not possible to draw any clear conclusions, as so few studies have been reported."
}
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query-laysum | 5774 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in The Cochrane Library 2008, Issue 3.\nUpper abdominal surgical procedures are associated with a high risk of postoperative pulmonary complications. The risk and severity of postoperative pulmonary complications can be reduced by the judicious use of therapeutic manoeuvres that increase lung volume. Our objective was to assess the effect of incentive spirometry compared to no therapy or physiotherapy, including coughing and deep breathing, on all-cause postoperative pulmonary complications and mortality in adult patients admitted to hospital for upper abdominal surgery.\nObjectives\nOur primary objective was to assess the effect of incentive spirometry (IS), compared to no such therapy or other therapy, on postoperative pulmonary complications and mortality in adults undergoing upper abdominal surgery.\nOur secondary objectives were to evaluate the effects of IS, compared to no therapy or other therapy, on other postoperative complications, adverse events, and spirometric parameters.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE, EMBASE, and LILACS (from inception to August 2013). There were no language restrictions. The date of the most recent search was 12 August 2013. The original search was performed in June 2006.\nSelection criteria\nWe included randomized controlled trials (RCTs) of IS in adult patients admitted for any type of upper abdominal surgery, including patients undergoing laparoscopic procedures.\nData collection and analysis\nTwo authors independently assessed trial quality and extracted data.\nMain results\nWe included 12 studies with a total of 1834 participants in this updated review. The methodological quality of the included studies was difficult to assess as it was poorly reported, so the predominant classification of bias was 'unclear'; the studies did not report on compliance with the prescribed therapy. We were able to include data from only 1160 patients in the meta-analysis. Four trials (152 patients) compared the effects of IS with no respiratory treatment. We found no statistically significant difference between the participants receiving IS and those who had no respiratory treatment for clinical complications (relative risk (RR) 0.59, 95% confidence interval (CI) 0.30 to 1.18). Two trials (194 patients) IS compared incentive spirometry with deep breathing exercises (DBE). We found no statistically significant differences between the participants receiving IS and those receiving DBE in the meta-analysis for respiratory failure (RR 0.67, 95% CI 0.04 to 10.50). Two trials (946 patients) compared IS with other chest physiotherapy. We found no statistically significant differences between the participants receiving IS compared to those receiving physiotherapy in the risk of developing a pulmonary condition or the type of complication. There was no evidence that IS is effective in the prevention of pulmonary complications.\nAuthors' conclusions\nThere is low quality evidence regarding the lack of effectiveness of incentive spirometry for prevention of postoperative pulmonary complications in patients after upper abdominal surgery. This review underlines the urgent need to conduct well-designed trials in this field. There is a case for large RCTs with high methodological rigour in order to define any benefit from the use of incentive spirometry regarding mortality.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence about the effect of incentive spirometry (IS), compared to no intervention or other therapy, to prevent postoperative pulmonary complications (for example, pneumonia, fever, death) in people following upper abdominal surgery."
}
]
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query-laysum | 5775 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.\nObjectives\nTo assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied.\nSelection criteria\nRandomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.\nData collection and analysis\nTwo authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD).\nMain results\nWe included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review.\nLifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I2 = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I2 = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m2) (-0.34 kg/m2, 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I2= 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I2 = 0%, low-quality evidence).\nAuthors' conclusions\nLifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.\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 on the effects of lifestyle interventions on reproductive, anthropometric (body measurement), metabolic and quality of life outcomes in women with polycystic ovary syndrome."
}
]
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query-laysum | 5776 | [
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract, in which the pathogenesis is believed to be partly influenced by the gut microbiome. Probiotics can be used to manipulate the microbiome and have therefore been considered as a potential therapy for CD. There is some evidence that probiotics benefit other gastrointestinal conditions, such as irritable bowel syndrome and ulcerative colitis, but their efficacy in CD is unclear. This is the first update of a Cochrane Review previously published in 2008.\nObjectives\nTo assess the efficacy and safety of probiotics for the induction of remission in CD.\nSearch methods\nThe following electronic databases were searched: MEDLINE (from inception to 6 July 2020), Embase (from inception to 6 July 2020), the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane IBD Review Group Specialised Trials Register, World Health Organization (WHO) International Clinical Trials Registry, and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) that compared probiotics with placebo or any other non-probiotic intervention for the induction of remission in CD were eligible for inclusion.\nData collection and analysis\nTwo review authors independently extracted data and assessed the methodological quality of included studies. The primary outcome was clinical remission. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes.\nMain results\nThere were two studies that met criteria for inclusion. One study from Germany had 11 adult participants with mild-to-moderate CD, who were treated with a one-week course of corticosteroids and antibiotics (ciprofloxacin 500 mg twice daily and metronidazole 250 mg three times a day), followed by randomised assignment to Lactobacillus rhamnosus strain GG (two billion colony-forming units per day) or corn starch placebo. The other study from the United Kingdom (UK) had 35 adult participants with active CD (CDAI score of 150 to 450) randomised to receive a synbiotic treatment (comprised of freeze-dried Bifidobacterium longum and a commercial product) or placebo. The overall risk of bias was low in one study, whereas the other study had unclear risk of bias in relation to random sequence generation, allocation concealment, and blinding. There was no evidence of a difference between the use of probiotics and placebo for the induction of remission in CD (RR 1.06; 95% CI 0.65 to 1.71; 2 studies, 46 participants) after six months. There was no difference in adverse events between probiotics and placebo (RR 2.55; 95% CI 0.11 to 58.60; 2 studies, 46 participants). The evidence for both outcomes was of very low certainty due to risk of bias and imprecision.\nAuthors' conclusions\nThe available evidence is very uncertain about the efficacy or safety of probiotics, when compared with placebo, for induction of remission in Crohn's disease. There is a lack of well-designed RCTs in this area and further research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review found two studies that examined and showed no benefit of probiotics for the treatment of active Crohn's disease. Since the studies were very small, no definite conclusions can be made at this time. Probiotics were generally well tolerated; there was just one side effect leading to the stopping of treatment with probiotics, but details of this were not given. With the evidence presented in these studies, we are unable to make conclusions as to the effectiveness of probiotics. Better designed studies, with more participants, are needed."
}
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query-laysum | 5777 | [
{
"role": "user",
"content": "Abstract: Background\nBeta-blockers refer to a mixed group of drugs with diverse pharmacodynamic and pharmacokinetic properties. They have shown long-term beneficial effects on mortality and cardiovascular disease (CVD) when used in people with heart failure or acute myocardial infarction. Beta-blockers were thought to have similar beneficial effects when used as first-line therapy for hypertension. However, the benefit of beta-blockers as first-line therapy for hypertension without compelling indications is controversial. This review is an update of a Cochrane Review initially published in 2007 and updated in 2012.\nObjectives\nTo assess the effects of beta-blockers on morbidity and mortality endpoints in adults with hypertension.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials up to June 2016: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 6), MEDLINE (from 1946), Embase (from 1974), and ClinicalTrials.gov. We checked reference lists of relevant reviews, and reference lists of studies potentially eligible for inclusion in this review, and also searched the the World Health Organization International Clinical Trials Registry Platform on 06 July 2015.\nSelection criteria\nRandomised controlled trials (RCTs) of at least one year of duration, which assessed the effects of beta-blockers compared to placebo or other drugs, as first-line therapy for hypertension, on mortality and morbidity in adults.\nData collection and analysis\nWe selected studies and extracted data in duplicate, resolving discrepancies by consensus. We expressed study results as risk ratios (RR) with 95% confidence intervals (CI) and conducted fixed-effect or random-effects meta-analyses, as appropriate. We also used GRADE to assess the certainty of the evidence. GRADE classifies the certainty of evidence as high (if we are confident that the true effect lies close to that of the estimate of effect), moderate (if the true effect is likely to be close to the estimate of effect), low (if the true effect may be substantially different from the estimate of effect), and very low (if we are very uncertain about the estimate of effect).\nMain results\nThirteen RCTs met inclusion criteria. They compared beta-blockers to placebo (4 RCTs, 23,613 participants), diuretics (5 RCTs, 18,241 participants), calcium-channel blockers (CCBs: 4 RCTs, 44,825 participants), and renin-angiotensin system (RAS) inhibitors (3 RCTs, 10,828 participants). These RCTs were conducted between the 1970s and 2000s and most of them had a high risk of bias resulting from limitations in study design, conduct, and data analysis. There were 40,245 participants taking beta-blockers, three-quarters of them taking atenolol. We found no outcome trials involving the newer vasodilating beta-blockers (e.g. nebivolol).\nThere was no difference in all-cause mortality between beta-blockers and placebo (RR 0.99, 95% CI 0.88 to 1.11), diuretics or RAS inhibitors, but it was higher for beta-blockers compared to CCBs (RR 1.07, 95% CI 1.00 to 1.14). The evidence on mortality was of moderate-certainty for all comparisons.\nTotal CVD was lower for beta-blockers compared to placebo (RR 0.88, 95% CI 0.79 to 0.97; low-certainty evidence), a reflection of the decrease in stroke (RR 0.80, 95% CI 0.66 to 0.96; low-certainty evidence) since there was no difference in coronary heart disease (CHD: RR 0.93, 95% CI 0.81 to 1.07; moderate-certainty evidence). The effect of beta-blockers on CVD was worse than that of CCBs (RR 1.18, 95% CI 1.08 to 1.29; moderate-certainty evidence), but was not different from that of diuretics (moderate-certainty) or RAS inhibitors (low-certainty). In addition, there was an increase in stroke in beta-blockers compared to CCBs (RR 1.24, 95% CI 1.11 to 1.40; moderate-certainty evidence) and RAS inhibitors (RR 1.30, 95% CI 1.11 to 1.53; moderate-certainty evidence). However, there was little or no difference in CHD between beta-blockers and diuretics (low-certainty evidence), CCBs (moderate-certainty evidence) or RAS inhibitors (low-certainty evidence). In the single trial involving participants aged 65 years and older, atenolol was associated with an increased CHD incidence compared to diuretics (RR 1.63, 95% CI 1.15 to 2.32). Participants taking beta-blockers were more likely to discontinue treatment due to adverse events than participants taking RAS inhibitors (RR 1.41, 95% CI 1.29 to 1.54; moderate-certainty evidence), but there was little or no difference with placebo, diuretics or CCBs (low-certainty evidence).\nAuthors' conclusions\nMost outcome RCTs on beta-blockers as initial therapy for hypertension have high risk of bias. Atenolol was the beta-blocker most used. Current evidence suggests that initiating treatment of hypertension with beta-blockers leads to modest CVD reductions and little or no effects on mortality. These beta-blocker effects are inferior to those of other antihypertensive drugs. Further research should be of high quality and should explore whether there are differences between different subtypes of beta-blockers or whether beta-blockers have differential effects on younger and older people.\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 found 13 studies from high-income countries, mainly Western Europe and North America. In the studies, the people receiving beta-blockers were compared to people who received no treatment or other medicines. The studies showed the following.\nBeta-blockers probably make little or no difference in the number of deaths among people on treatment for high blood pressure. This effect appears to be similar to that of diuretics and renin-angiotensin system inhibitors, but beta-blockers are probably not as good at preventing deaths from high blood pressure as calcium-channel blockers.\nBeta-blockers may reduce the number of strokes, an effect which appears to be similar to that of diuretics. However, beta-blockers may not be as good at preventing strokes as renin-angiotensin system inhibitors or calcium-channel blockers.\nBeta-blockers may make little or no difference to the number of heart attacks among people with high blood pressure. The evidence suggests that this effect may not be different from that of diuretics, renin-angiotensin system inhibitors, or calcium-channel blockers. However, among people aged 65 years and older, the evidence suggests that beta-blockers may not be as good at reducing heart attacks as diuretics.\nPeople given beta-blockers are more likely to have side effects and stop treatment than people taking renin-angiotensin system inhibitors, but there may be little or no difference in side effects between beta-blockers and diuretics or calcium-channel blockers."
}
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query-laysum | 5778 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent guidelines recommend performance of oesophago-gastro-duodenoscopy at the time of diagnosis of hepatic cirrhosis to screen for oesophageal varices. These guidelines require people to undergo an unpleasant invasive procedure repeatedly with its attendant risks, despite the fact that half of the people do not have identifiable oesophageal varices 10 years after the initial diagnosis of cirrhosis. Video capsule endoscopy is a non-invasive test proposed as an alternative method for the diagnosis of oesophageal varices.\nObjectives\nTo determine the diagnostic accuracy of capsule endoscopy for the diagnosis of oesophageal varices in children or adults with chronic liver disease or portal vein thrombosis, irrespective of the aetiology. To investigate the accuracy of capsule endoscopy as triage or replacement of oesophago-gastro-duodenoscopy.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Diagnostic Test Accuracy Studies Register (October 2013), MEDLINE (Ovid SP) (1950 to October 2013), EMBASE (Ovid SP) (1980 to October 2013), ACP Journal Club (Ovid SP) (1991 to October 2013), Database of Abstracts of Reviews of Effects (DARE) (Ovid SP) (third quarter), Health Technology Assessment (HTA) (Ovid SP) (third quarter), NHS Economic Evaluation Database (NHSEED) (Ovid SP) (third quarter), and Science Citation Index Expanded (SCI-EXPANDED) (ISI Web of Knowledge) (1955 to October 2013). We applied no language or document type restrictions.\nSelection criteria\nStudies that evaluated the diagnostic accuracy of capsule endoscopy for the diagnosis of oesophageal varices using oesophago-gastro-duodenoscopy as the reference standard in children or adults of any age, with chronic liver disease or portal vein thrombosis.\nData collection and analysis\nWe followed the available guidelines provided in the Cochrane Handbook for Diagnostic Test of Accuracy Reviews. We calculated the pooled estimates of sensitivity and specificity using the bivariate model due to the absence of a negative correlation in the receiver operating characteristic (ROC) space and of a threshold effect.\nMain results\nThe search identified 16 eligible studies, in which only adults with cirrhosis were included. In one study, people with portal thrombosis were also included. We classified most of the studies at high risk of bias for the 'Participants selection' and the 'Flow and timing' domains. One study assessed the accuracy of capsule endoscopy for the diagnosis of large (high-risk) oesophageal varices. In the remaining15 studies that assessed the accuracy of capsule endoscopy for the diagnosis of oesophageal varices of any size in people with cirrhosis, 936 participants were included; the pooled estimate of sensitivity was 84.8% (95% confidence interval (CI) 77.3% to 90.2%) and of specificity 84.3% (95% CI 73.1% to 91.4%). Eight of these studies included people with suspected varices or people with already diagnosed or even treated varices, or both, introducing a selection bias. Seven studies including only people with suspected but unknown varices were at low risk of bias; the pooled estimate of sensitivity was 79.7% (95% CI 73.1% to 85.0%) and of specificity 86.1% (95% CI 64.5% to 95.5%). Six studies assessed the diagnostic accuracy of capsule endoscopy for the diagnosis of large oesophageal varices, associated with a higher risk of bleeding; the pooled sensitivity was 73.7% (95% CI 52.4% to 87.7%) and of specificity 90.5% (95% CI 84.1% to 94.4%). Two studies also evaluated the presence of red marks, which are another marker of high risk of bleeding; the estimates of sensitivity and specificity varied widely. Two studies obtained similar results with the use of a modified device as index test (string capsule). Due to the absence of data, we could not perform all planned subgroup analyses. Interobserver agreement in the interpretation of capsule endoscopy results and any adverse event attributable to capsule endoscopy were poorly assessed and reported. Only four studies evaluated the interobserver agreement in the interpretation of capsule endoscopy results: the concordance was moderate. The participants' preferences for capsule endoscopy or oesophago-gastro-duodenoscopy were reported differently but seemed in favour of capsule endoscopy in nine of 10 studies. In 10 studies, participants reported some minor discomfort on swallowing the capsule. Only one study identified other significant adverse events, including impaction of the capsule due to previously unidentified oesophageal strictures in two participants. No adverse events were reported as a consequence of the reference standard.\nAuthors' conclusions\nWe cannot support the use of capsule endoscopy as a triage test in adults with cirrhosis, administered before oesophago-gastro-duodenoscopy, despite the low incidence of adverse events and participant reports of being better tolerated. Thus, we cannot conclude that oesophago-gastro-duodenoscopy can be replaced by capsule endoscopy for the detection of oesophageal varices in adults with cirrhosis. We found no data assessing capsule endoscopy in children and in people with portal thrombosis.\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 16 studies assessing the ability of capsule endoscopy to diagnose the presence of varices and grade the risk of bleeding and comparing it with OGD in adults with cirrhosis. Capsule endoscopy, even if more acceptable to participants, cannot replace OGD for the detection of oesophageal varices as about 15% are left undetected and 15% are not confirmed by endoscopy. Even the accuracy in detecting large varices or red marks on varices was very lower than endoscopy. Hence, in conclusion, capsule endoscopy is not sufficiently accurate to replace OGD for the detection of oesophageal varices in cirrhotic participants."
}
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query-laysum | 5779 | [
{
"role": "user",
"content": "Abstract: Background\nTramadol is often prescribed to treat pain and associated physical disability in osteoarthritis (OA). Due to the pharmacologic mechanism of tramadol, it may lead to fewer associated adverse effects (i.e. gastrointestinal bleeding or renal problems) compared to non-steroidal anti-inflammatory drugs (NSAIDs). This is an update of a Cochrane Review originally published in 2006.\nObjectives\nTo determine the benefits and harms of oral tramadol or tramadol combined with acetaminophen or NSAIDs in people with osteoarthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases, as well as the US National Institutes of Health and World Health Organization trial registries up to February 2018. We searched the LILACS database up to August 2015.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated the effect of tramadol, or tramadol in combination with acetaminophen (paracetamol) or NSAIDs versus placebo or any comparator in people with osteoarthritis.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane.\nMain results\nWe included 22 RCTs (11 more than the previous review) of which 21 RCTs were included in meta-analyses for 3871 participants randomized to tramadol alone or tramadol in combination with another analgesic and 2625 participants randomized to placebo or active control. Seventeen studies evaluated tramadol alone and five evaluated tramadol plus acetaminophen. Thirteen studies used placebo controls and eleven studies used active controls (two trials had both placebo and active arms). The dose of tramadol ranged from 37.5 mg to 400 mg daily; all doses were pooled. Most trials were multicenter with a mean duration of two months. Participants were predominantly women with hip or knee osteoarthritis, with a mean age of 63 years and moderate to severe pain. There was a high risk of selection bias as only four trials reported both adequate sequence generation and allocation concealment. There was a low risk for performance bias as most studies blinded participants. There was a high risk of attrition bias as 10/22 trials showed incomplete outcome data. Most of the trials were funded by the pharmaceutical industry.\nModerate quality evidence (downgraded due to risk of bias) indicated that tramadol alone and in combination with acetaminophen had no important benefit on pain reduction compared to placebo control (tramadol alone: 4% absolute improvement, 95% confidence interval (CI) 3% to 5%; 8 studies, 3972 participants; tramadol in combination with acetaminophen: 4% absolute improvement, 95% CI 2% to 6%; 2 studies, 614 participants).\nFifteen out of 100 people in the tramadol group improved by 20% (which corresponded to a clinically important difference in pain) compared to 10/100 in the placebo group (5% absolute improvement). Twelve out of 100 people improved by 20% in the tramadol in combination with acetaminophen group compared to 7/100 in the placebo group (5% absolute improvement).\nModerate quality evidence (downgraded due to risk of bias) indicated that tramadol alone and in combination with acetaminophen led to no important benefit in physical function compared to placebo (tramadol alone: 4% absolute improvement, 95% CI 2% to 6%; 5 studies, 2550 participants; tramadol in combination with acetaminophen: 4% absolute improvement, 95% CI 2% to 7%; 2 studies, 614 participants).\nTwenty-one out of 100 people in the tramadol group improved by 20% (which corresponded to a clinically important difference in physical function) compared to 16/100 in the placebo group (5% absolute improvement). Fifteen out of 100 people improved by 20% in the tramadol in combination with acetaminophen group compared to 10/100 in the placebo group (5% absolute improvement).\nModerate quality evidence (downgraded due to risk of bias) indicated that, compared to placebo, there was a greater risk of developing adverse events with tramadol alone (risk ratio (RR) 1.34, 95% CI 1.24 to 1.46; 4 studies, 2039 participants) and tramadol in combination with acetaminophen compared to placebo (RR 1.91, 95% CI 1.32 to 2.76; 1 study, 308 participants). This corresponded to a 17% increase (95% CI 12% to 23%) with tramadol alone and 22% increase (95% CI 8% to 41%) with tramadol in combination with acetaminophen.\nThe three most frequent adverse events were nausea, dizziness and tiredness. Moderate quality evidence (downgraded due to risk of bias) indicated that there was a greater risk of withdrawing from the study because of adverse events with tramadol alone compared to placebo (RR 2.64, 95% CI 2.17 to 3.20; 9 studies, 4533 participants), which corresponded to a 12% increase (95% CI 9% to 16%).\nLow quality evidence (downgraded due to risk of bias and inconsistency) indicated that there was a greater risk of withdrawing from the study because of adverse events with tramadol in combination with acetaminophen compared to placebo (RR 2.78, 95% CI 1.50 to 5.16; 2 studies, 614 participants), which corresponded to a 8% absolute improvement (95% CI 2% to 19%).\nLow quality evidence (downgraded due to risk of bias and imprecision) indicated that there was a greater risk of developing serious adverse events with tramadol alone compared to placebo (110/2459 participants with tramadol compared to 22/1153 participants with placebo; RR 1.78, 95% CI 1.11 to 2.84; 7 studies, 3612 participants), which corresponded to a 1% increase (95% CI 0% to 4%). There were no serious adverse events reported in one small study (15 participants) of tramadol with acetaminophen compared to placebo.\nAuthors' conclusions\nModerate quality evidence indicates that compared to placebo, tramadol alone or in combination with acetaminophen probably has no important benefit on mean pain or function in people with osteoarthritis, although slightly more people in the tramadol group report an important improvement (defined as 20% or more). Moderate quality evidence shows that adverse events probably cause substantially more participants to stop taking tramadol. The increase in serious adverse events with tramadol is less certain, due to the small number of events.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People in the 22 included trials took various daily doses of tramadol or a placebo, an NSAID or a different pain reliever. Most of them were women, with an average age of 63 years, and with moderate to severe pain. The length of the studies ranged from one week to three months. The results below are for tramadol alone compared to placebo. There were similar results for tramadol in combination with acetaminophen."
}
]
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query-laysum | 5780 | [
{
"role": "user",
"content": "Abstract: Background\nEach year, more than four million abdominal surgeries are performed in the US and over 250,000 in England. Acute respiratory failure, a common complication that can affect 30% to 50% of people after upper abdominal surgery, can lead to significant morbidity and mortality. Noninvasive ventilation has been associated with lower rates of tracheal intubation in adults with acute respiratory failure, thus reducing the incidence of complications and mortality. This review compared the effectiveness and safety of noninvasive positive pressure ventilation (NPPV) versus standard oxygen therapy in the treatment of acute respiratory failure after upper abdominal surgery.\nObjectives\nTo assess the effectiveness and safety of noninvasive positive pressure ventilation (NPPV), that is, continuous positive airway pressure (CPAP) or bilevel NPPV, in reducing mortality and the rate of tracheal intubation in adults with acute respiratory failure after upper abdominal surgery, compared to standard therapy (oxygen therapy), and to assess changes in arterial blood gas levels, hospital and intensive care unit (ICU) length of stay, gastric insufflation, and anastomotic leakage.\nSearch methods\nThe date of the last search was 12 May 2015. We searched the following databases: the Cochrane Handbook for Systematic Reviews of Interventions (CENTRAL) (2015, Issue 5), MEDLINE (Ovid SP, 1966 to May 2015), EMBASE (Ovid SP, 1974 to May 2015); the physiotherapy evidence database (PEDro) (1999 to May 2015); the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCOhost, 1982 to May 2015), and LILACS (BIREME, 1986 to May 2015). We reviewed reference lists of included studies and contacted experts. We also searched grey literature sources. We checked databases of ongoing trials such as www.controlled-trials.com/ and www.trialscentral.org/. We did not apply language restrictions.\nSelection criteria\nWe selected randomized or quasi-randomized controlled trials involving adults with acute respiratory failure after upper abdominal surgery who were treated with CPAP or bilevel NPPV with, or without, drug therapy as standard medical care, compared to adults treated with oxygen therapy with, or without, standard medical care.\nData collection and analysis\nTwo authors independently selected and abstracted data from eligible studies using a standardized form. We evaluated study quality by assessing allocation concealment; random sequence generation; incomplete outcome data; blinding of participants, personnel, and outcome assessors; selective reporting; and adherence to the intention-to-treat (ITT) principle.\nMain results\nWe included two trials involving 269 participants. The participants were mostly men (67%); the mean age was 65 years. The trials were conducted in China and Italy (one was a multicentre trial). Both trials included adults with acute respiratory failure after upper abdominal surgery. We judged both trials at high risk of bias. Compared to oxygen therapy, CPAP or bilevel NPPV may reduce the rate of tracheal intubation (risk ratio (RR) 0.25; 95% confidence interval (CI) 0.08 to 0.83; low quality evidence) with a number needed to treat for an additional beneficial outcome of 11. There was very low quality evidence that the intervention may also reduce ICU length of stay (mean difference (MD) -1.84 days; 95% CI -3.53 to -0.15). We found no differences for mortality (low quality evidence) and hospital length of stay. There was insufficient evidence to be certain that CPAP or NPPV had an effect on anastomotic leakage, pneumonia-related complications, and sepsis or infections. Findings from one trial of 60 participants suggested that bilevel NPPV, compared to oxygen therapy, may improve blood gas levels and blood pH one hour after the intervention (partial pressure of arterial oxygen (PaO2): MD 22.5 mm Hg; 95% CI 17.19 to 27.81; pH: MD 0.06; 95% CI 0.01 to 0.11; partial pressure of arterial carbon dioxide (PCO2) levels (MD -9.8 mm Hg; 95% CI -14.07 to -5.53). The trials included in this systematic review did not present data on the following outcomes that we intended to assess: gastric insufflation, fistulae, pneumothorax, bleeding, skin breakdown, eye irritation, sinus congestion, oronasal drying, and patient-ventilator asynchrony.\nAuthors' conclusions\nThe findings of this review indicate that CPAP or bilevel NPPV is an effective and safe intervention for the treatment of adults with acute respiratory failure after upper abdominal surgery. However, based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, the quality of the evidence was low or very low. More good quality studies are needed to confirm these findings.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acute respiratory failure , where fluid builds up in the lungs stopping oxygen from crossing into the blood, is a relatively common complication after abdominal surgery and can increase the risk of dying (mortality).\nNPPV is a type of treatment that helps to improve breathing without having to insert a tube inside a person's windpipe (tracheal intubation). This intervention is effective in several illnesses."
}
]
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query-laysum | 5781 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a progressive, late-onset disorder of the macula affecting central vision. It is the leading cause of blindness in people over 65 years in industrialized countries. Recent epidemiologic, genetic, and pathological evidence has shown that AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.\nObjectives\nThe objective of this review was to examine the effectiveness of statins compared with other treatments, no treatment, or placebo in delaying the onset and progression of AMD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to March 2016), EMBASE (January 1980 to March 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to March 2016), PubMed (January 1946 to March 2016), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 5 June 2014), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 31 March 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized trials that compared statins with other treatments, no treatment, or placebo in people who were diagnosed as having the early stages of AMD.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently evaluated the search results against the selection criteria, abstracted data, and assessed risk of bias. We did not perform meta-analysis due to heterogeneity in the interventions and outcomes between the included studies.\nMain results\nTwo RCTs with a total of 144 participants met the selection criteria. Both trials compared simvastatin versus placebo in older people (older than 50 or 60 years) with high risk of developing AMD (drusen present on examination). Overall, we judged the quality of the evidence to be low, as we downgraded all outcomes due to limitations in the designs of the trials and insufficient outcome reporting. The larger trial, with 114 participants, was conducted in Australia and used a higher dose (40 mg daily) of simvastatin for three years. Participants and study personnel in this trial were adequately masked, however data were missing for 30% of participants at three years' follow-up. The smaller trial, with 30 participants, was conducted in Italy and used a lower dose (20 mg) of simvastatin for three months. This trial reported insufficient details to assess the risk of bias.\nNeither trial reported data for change in visual acuity. Low-quality evidence from the smaller trial, with 30 participants, did not show a statistically significant difference between the simvastatin and placebo groups in visual acuity values at three months of treatment (decimal visual acuity 0.21 ± 0.56 in simvastatin group and 0.19 ± 0.40 in placebo group) or 45 days after the completion of treatment (decimal visual acuity 0.20 ± 0.50 in simvastatin group and 0.19 ± 0.48 in placebo group). The lack of a difference in visual acuity was not explained by lens or retina status, which remained unchanged during and after the treatment period for both groups.\nPreliminary analyses of 42 participants who had completed 12 months' follow-up in the larger trial did not show a statistically significant difference between simvastatin and the placebo groups for visual acuity, drusen score, or visual function (effect estimates and confidence intervals were not available). Complete data for these outcomes at three years' follow-up were not reported. At three years, low-quality evidence showed an effect of simvastatin in slowing progression of AMD compared with placebo to be uncertain (odds ratio 0.51, 95% confidence interval 0.23 to 1.09).\nOne trial did not report adverse outcomes. The second trial reported no difference between groups in terms of adverse events such as death, muscle aches, and acute hepatitis.\nAuthors' conclusions\nEvidence from currently available RCTs is insufficient to conclude that statins have a role in preventing or delaying the onset or progression of AMD.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included two trials (144 total participants) in this review. Participants included men and women, most of whom were older than 50 years, who had good visual acuity. Participants were either susceptible to or had been diagnosed with an early stage of AMD. Both trials compared simvastatin with placebo. The larger trial, with 114 participants and conducted in Australia, used a higher dose of 40 mg per day and had a treatment period of three years. The smaller trial, with 30 participants and conducted in Italy, used a lower dose of 20 mg per day and had a treatment period of three months. The evidence provided in this review was up-to-date as of March 2016."
}
]
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query-laysum | 5782 | [
{
"role": "user",
"content": "Abstract: Background\nRoutine vaginal examinations are undertaken at regular time intervals during labour to assess whether labour is progressing as expected. Unusually slow progress can be due to underlying problems, described as labour dystocia, or can be a normal variation of progress. Evidence suggests that if mother and baby are well, length of labour alone should not be used to decide whether labour is progressing normally. Other methods to assess labour progress include intrapartum ultrasound and monitoring external physical and behavioural cues. Vaginal examinations can be distressing for women, and overdiagnosis of dystocia can result in iatrogenic morbidity due to unnecessary intervention. It is important to establish whether routine vaginal examinations are effective, both as an accurate measure of physiological labour progress and to distinguish true labour dystocia, or whether other methods for assessing labour progress are more effective. This Cochrane Review is an update of a review first published in 2013.\nObjectives\nTo compare the effectiveness, acceptability, and consequences of routine vaginal examinations compared with other methods, or different timings, to assess labour progress at term.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, and conference proceedings) and ClinicalTrials.gov (28 February 2021). We also searched the reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of vaginal examinations compared with other methods of assessing labour progress and studies assessing different timings of vaginal examinations. Quasi-RCTs and cluster-RCTs were eligible for inclusion. We excluded cross-over trials and conference abstracts.\nData collection and analysis\nTwo review authors independently assessed all studies identified by the search for inclusion in the review. Four review authors independently extracted data. Two review authors assessed risk of bias and certainty of the evidence using GRADE.\nMain results\nWe included four studies that randomised a total of 755 women, with data analysed for 744 women and their babies. Interventions used to assess labour progress were routine vaginal examinations, routine ultrasound assessments, routine rectal examinations, routine vaginal examinations at different frequencies, and vaginal examinations as indicated. We were unable to conduct meta-analysis as there was only one study for each comparison.\nAll studies were at high risk of performance bias due to difficulties with blinding. We assessed two studies as high risk of bias and two as low or unclear risk of bias for other domains. The overall certainty of the evidence assessed using GRADE was low or very low.\nRoutine vaginal examinations versus routine ultrasound to assess labour progress (one study, 83 women and babies)\nStudy in Turkey involving multiparous women with spontaneous onset of labour.\nRoutine vaginal examinations may result in a slight increase in pain compared to routine ultrasound (mean difference −1.29, 95% confidence interval (CI) −2.10 to −0.48; one study, 83 women, low certainty evidence) (pain measured using a visual analogue scale (VAS) in reverse: zero indicating 'worst pain', 10 indicating no pain).\nThe study did not assess our other primary outcomes: positive birth experience; augmentation of labour; spontaneous vaginal birth; chorioamnionitis; neonatal infection; admission to neonatal intensive care unit (NICU).\nRoutine vaginal examinations versus routine rectal examinations to assess labour progress (one study, 307 women and babies)\nStudy in Ireland involving women in labour at term. We assessed the certainty of the evidence as very low.\nCompared with routine rectal examinations, routine vaginal examinations may have little or no effect on: augmentation of labour (risk ratio (RR) 1.03, 95% CI 0.63 to 1.68; one study, 307 women); and spontaneous vaginal birth (RR 0.98, 95% CI 0.90 to 1.06; one study, 307 women).\nWe found insufficient data to fully assess: neonatal infections (RR 0.33, 95% CI 0.01 to 8.07; one study, 307 babies); and admission to NICU (RR 1.32, 95% CI 0.47 to 3.73; one study, 307 babies).\nThe study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; maternal pain.\nRoutine four-hourly vaginal examinations versus routine two-hourly examinations (one study, 150 women and babies)\nUK study involving primiparous women in labour at term. We assessed the certainty of the evidence as very low.\nCompared with routine two-hourly vaginal examinations, routine four-hourly vaginal examinations may have little or no effect, with data compatible with both benefit and harm, on: augmentation of labour (RR 0.97, 95% CI 0.60 to 1.57; one study, 109 women); and spontaneous vaginal birth (RR 1.02, 95% CI 0.83 to 1.26; one study, 150 women).\nThe study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; neonatal infection; admission to NICU; maternal pain.\nRoutine vaginal examinations versus vaginal examinations as indicated (one study, 204 women and babies)\nStudy in Malaysia involving primiparous women being induced at term. We assessed the certainty of the evidence as low.\nCompared with vaginal examinations as indicated, routine four-hourly vaginal examinations may result in more women having their labour augmented (RR 2.55, 95% CI 1.03 to 6.31; one study, 204 women).\nThere may be little or no effect on:\n• spontaneous vaginal birth (RR 1.08, 95% CI 0.73 to 1.59; one study, 204 women);\n• chorioamnionitis (RR 3.06, 95% CI 0.13 to 74.21; one study, 204 women);\n• neonatal infection (RR 4.08, 95% CI 0.46 to 35.87; one study, 204 babies);\n• admission to NICU (RR 2.04, 95% CI 0.63 to 6.56; one study, 204 babies).\nThe study did not assess our other primary outcomes of positive birth experience or maternal pain.\nAuthors' conclusions\nBased on these findings, we cannot be certain which method is most effective or acceptable for assessing labour progress. Further large-scale RCT trials are required. These should include essential clinical and experiential outcomes. This may be facilitated through the development of a tool to measure positive birth experiences. Data from qualitative studies are also needed to fully assess whether methods to evaluate labour progress meet women's needs for a safe and positive labour and birth, and if not, to develop an approach that does.\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": "The aim of this Cochrane Review was to find out if routine vaginal examinations for assessing labour progress are effective and acceptable to women, and to compare the use of these examinations to other methods of assessing labour progress."
}
]
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query-laysum | 5783 | [
{
"role": "user",
"content": "Abstract: Background\nMany women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined evidence about the use of acupuncture and acupressure for pain management in labour. This is an update of a review last published in 2011.\nObjectives\nTo examine the effects of acupuncture and acupressure for pain management in labour.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, (25 February 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library 2019, Issue 1), MEDLINE (1966 to February 2019), CINAHL (1980 to February 2019), ClinicalTrials.gov (February 2019), the WHO International Clinical Trials Registry Platfory (ICTRP) (February 2019) and reference lists of included studies.\nSelection criteria\nPublished and unpublished randomised controlled trials (RCTs) comparing acupuncture or acupressure with placebo, no treatment or other non-pharmacological forms of pain management in labour. We included all women whether nulliparous or multiparous, and in spontaneous or induced labour.\nWe included studies reported in abstract form if there was sufficient information to permit assessment of risk of bias. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 28 trials with data reporting on 3960 women. Thirteen trials reported on acupuncture and 15 trials reported on acupressure. No study was at a low risk of bias on all domains. Pain intensity was generally measured on a visual analogue scale (VAS) of 0 to 10 or 0 to 100 with low scores indicating less pain.\nAcupuncture versus sham acupuncture\nAcupuncture may make little or no difference to the intensity of pain felt by women when compared with sham acupuncture (mean difference (MD) -4.42, 95% confidence interval (CI) -12.94 to 4.09, 2 trials, 325 women, low-certainty evidence). Acupuncture may increase satisfaction with pain relief compared to sham acupuncture (risk ratio (RR) 2.38, 95% CI 1.78 to 3.19, 1 trial, 150 women, moderate-certainty evidence), and probably reduces the use of pharmacological analgesia (RR 0.75, 95% CI 0.63 to 0.89, 2 trials, 261 women, moderate-certainty evidence). Acupuncture may have no effect on assisted vaginal birth (very low-certainty evidence), and probably little to no effect on caesarean section (low-certainty evidence).\nAcupuncture compared to usual care\nWe are uncertain if acupuncture reduces pain intensity compared to usual care because the evidence was found to be very low certainty (standardised mean difference (SMD) -1.31, 95% CI -2.14 to -0.49, 4 trials, 495 women, I2 = 93%). Acupuncture may have little to no effect on satisfaction with pain relief (low-certainty evidence). We are uncertain if acupuncture reduces the use of pharmacological analgesia because the evidence was found to be very low certainty (average RR 0.72, 95% CI 0.60 to 0.85, 6 trials, 1059 women, I2 = 70%). Acupuncture probably has little to no effect on assisted vaginal birth (low-certainty evidence) or caesarean section (low-certainty evidence).\nAcupuncture compared to no treatment\nOne trial compared acupuncture to no treatment. We are uncertain if acupuncture reduces pain intensity (MD -1.16, 95% CI -1.51 to -0.81, 163 women, very low-certainty evidence), assisted vaginal birth or caesarean section because the evidence was found to be very low certainty.\nAcupuncture compared to sterile water injection\nWe are uncertain if acupuncture has any effect on use of pharmacological analgesia, assisted vaginal birth or caesarean section because the evidence was found to be very low certainty.\nAcupressure compared to a sham control\nWe are uncertain if acupressure reduces pain intensity in labour (MD -1.93, 95% CI -3.31 to -0.55, 6 trials, 472 women) or assisted vaginal birth because the evidence was found to be very low certainty. Acupressure may have little to no effect on use of pharmacological analgesia (low-certainty evidence). Acupressure probably reduces the caesarean section rate (RR 0.44, 95% CI 0.27 to 0.71, 4 trials, 313 women, moderate-certainty evidence).\nAcupressure compared to usual care\nWe are uncertain if acupressure reduces pain intensity in labour (SMD -1.07, 95% CI -1.45 to -0.69, 8 trials, 620 women) or increases satisfaction with pain relief (MD 1.05, 95% CI 0.75 to 1.35, 1 trial, 105 women) because the evidence was found to be very low certainty. Acupressure may have little to no effect on caesarean section (low-certainty evidence).\nAcupressure compared to a combined control\nAcupressure probably slightly reduces the intensity of pain during labour compared with the combined control (measured on a scale of 0 to 10 with low scores indicating less pain) (SMD -0.42, 95% CI -0.65 to -0.18, 2 trials, 322 women, moderate-certainty evidence). We are uncertain if acupressure has any effect on the use of pharmacological analgesia (RR 0.94, 95% CI 0.71 to 1.25, 1 trial, 212 women), satisfaction with childbirth, assisted vaginal birth or caesarean section because the certainty of the evidence was all very low.\nNo studies were found that reported on sense of control in labour and only one reported on satisfaction with the childbirth experience.\nAuthors' conclusions\nAcupuncture in comparison to sham acupuncture may increase satisfaction with pain management and reduce use of pharmacological analgesia. Acupressure in comparison to a combined control and usual care may reduce pain intensity. However, for other comparisons of acupuncture and acupressure, we are uncertain about the effects on pain intensity and satisfaction with pain relief due to very low-certainty evidence. Acupuncture may have little to no effect on the rates of caesarean or assisted vaginal birth. Acupressure probably reduces the need for caesarean section in comparison to a sham control. There is a need for further high-quality research that include sham controls and comparisons to usual care and report on the outcomes of sense of control in labour, satisfaction with the childbirth experience or satisfaction with pain relief.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Acupuncture has a long history of use in Asia, including China, Korea and Japan. Technical needling skills are needed to apply the needles at the correct points. Acupressure also has its origins in early China. To apply acupressure, the therapist uses their hands and fingers to activate the same points as in acupuncture. Sometimes only a few points are needed to alleviate pain or bring about a feeling of relaxation. Other times a combination of points may be required for greater effect. Some forms of acupressure are applied by trained health professionals, while others can be applied by the individual as a form of self-massage."
}
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query-laysum | 5784 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is a major cause of chronic, neurological disability, with a significant long-term disability burden, often requiring comprehensive rehabilitation.\nObjectives\nTo systematically evaluate evidence from published Cochrane Reviews of clinical trials to summarise the evidence regarding the effectiveness and safety of rehabilitation interventions for people with MS (pwMS), to improve patient outcomes, and to highlight current gaps in knowledge.\nMethods\nWe searched the Cochrane Database of Systematic Reviews up to December 2017, to identify Cochrane Reviews that assessed the effectiveness of organised rehabilitation interventions for pwMS. Two reviewers independently assessed the quality of included reviews, using the Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) tool, and the quality of the evidence for reported outcomes, using the GRADE framework.\nMain results\nOverall, we included 15 reviews published in the Cochrane Library, comprising 164 randomised controlled trials (RCTs) and four controlled clinical trials, with a total of 10,396 participants. The included reviews evaluated a wide range of rehabilitation interventions, including: physical activity and exercise therapy, hyperbaric oxygen therapy (HBOT), whole-body vibration, occupational therapy, cognitive and psychological interventions, nutritional and dietary supplements, vocational rehabilitation, information provision, telerehabilitation, and interventions for the management of spasticity. We assessed all reviews to be of high to moderate methodological quality, based on R-AMSTAR criteria.\nModerate-quality evidence suggested that physical therapeutic modalities (exercise and physical activities) improved functional outcomes (mobility, muscular strength), reduced impairment (fatigue), and improved participation (quality of life). Moderate-quality evidence suggested that inpatient or outpatient multidisciplinary rehabilitation programmes led to longer-term gains at the levels of activity and participation, and interventions that provided information improved patient knowledge. Low-qualitty evidence suggested that neuropsychological interventions, symptom-management programmes (spasticity), whole body vibration, and telerehabilitation improved some patient outcomes. Evidence for other rehabilitation modalities was inconclusive, due to lack of robust studies.\nAuthors' conclusions\nThe evidence suggests that regular specialist evaluation and follow-up to assess the needs of patients with all types of MS for appropriate rehabilitation interventions may be of benefit, although the certainty of evidence varies across the different types of interventions evaluated by the reviews. Structured, multidisciplinary rehabilitation programmes and physical therapy (exercise or physical activities) can improve functional outcomes (mobility, muscle strength, aerobic capacity), and quality of life. Overall, the evidence for many rehabilitation interventions should be interpreted cautiously, as the majority of included reviews did not include data from current studies. More studies, with appropriate design, which report the type and intensity of modalities and their cost-effectiveness are needed to address the current gaps in knowledge.\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": "MS is a complex condition, which requires comprehensive, long-term management. Rehabilitation programmes aim to improve function, well-being, and quality of life for people with MS. Currently, a wide variety of rehabilitation therapies are used to treat MS. Published literature, including Cochrane Reviews, that evaluates these interventions, has grown. To guide clinicians, this review assessed current Cochrane Reviews, and provides an overview of the effectiveness of rehabilitation therapies used to treat people with MS."
}
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query-laysum | 5785 | [
{
"role": "user",
"content": "Abstract: Background\nPsychosis is an illness characterised by the presence of hallucinations and delusions that can cause distress or a marked change in an individual's behaviour (e.g. social withdrawal, flat or blunted affect). A first episode of psychosis (FEP) is the first time someone experiences these symptoms that can occur at any age, but the condition is most common in late adolescence and early adulthood. This review is concerned with FEP and the early stages of a psychosis, referred to throughout this review as 'recent-onset psychosis.'\nSpecialised early intervention (SEI) teams are community mental health teams that specifically treat people who are experiencing, or have experienced, a recent-onset psychosis. SEI teams provide a range of treatments including medication, psychotherapy, psychoeducation, educational and employment support, augmented by assertive contact with the service user and small caseloads. Treatment is time limited, usually offered for two to three years, after which service users are either discharged to primary care or transferred to a standard adult community mental health team. Evidence suggests that once SEI treatment ends, improvements may not be sustained, bringing uncertainty about the optimal duration of SEI to ensure the best long-term outcomes. Extending SEI has been proposed as a way of providing continued intensive treatment and continuity of care, of usually up to five years, in order to a) sustain the positive initial outcomes of SEI; and b) improve the long-term trajectory of the illness.\nObjectives\nTo compare extended SEI teams with treatment as usual (TAU) for people with recent-onset psychosis.\nTo compare extended SEI teams with standard SEI teams followed by TAU (standard SEI + TAU) for people with recent-onset psychosis.\nSearch methods\nOn 3 October 2018 and 22 October 2019, we searched Cochrane Schizophrenia's study-based register of trials, including registries of clinical trials.\nSelection criteria\nWe selected all randomised controlled trials (RCTs) comparing extended SEI with TAU for people with recent-onset psychosis and all RCTs comparing extended SEI with standard SEI + TAU for people with recent-onset psychosis. We entered trials meeting these criteria and reporting usable data as included studies.\nData collection and analysis\nWe independently inspected citations, selected studies, extracted data and appraised study quality. For binary outcomes we calculated the risk ratios (RRs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean difference (MD) and their 95% CIs, or if assessment measures differed for the same construct, we calculated the standardised mean difference (SMD) with 95% CIs. We assessed risk of bias for included studies and created a 'Summary of findings' table using the GRADE approach.\nMain results\nWe included three RCTs, with a total 780 participants, aged 16 to 35 years. All participants met the criteria for schizophrenia spectrum disorders or affective psychoses. No trials compared extended SEI with TAU. All three trials randomly allocated people approximately two years into standard SEI to either extended SEI or standard SEI + TAU.\nThe certainty of evidence for outcomes varied from low to very low. Our primary outcomes were recovery and disengagement from mental health services. No trials reported on recovery, and we used remission as a proxy.\nThree trials reported on remission, with the point estimate suggesting a 13% increase in remission in favour of extended SEI, but this included wide confidence intervals (CIs) and a very uncertain estimate of no benefit (RR 1.13, 95% CI 0.97 to 1.31; 3 trials, 780 participants; very low-certainty evidence).\nTwo trials provided data on disengagement from services with evidence that extended SEI care may result in fewer disengagements from mental health treatment (15%) in comparison to standard SEI + TAU (34%) (RR 0.45, 95% CI 0.27 to 0.75; 2 trials, 380 participants; low-certainty evidence).\nThere may be no evidence of a difference in rates of psychiatric hospital admission (RR 1.55, 95% CI 0.68 to 3.52; 1 trial, 160 participants; low-certainty evidence), or the number of days spent in a psychiatric hospital (MD -2.70, 95% CI -8.30 to 2.90; 1 trial, 400 participants; low-certainty evidence).\nOne trial found uncertain evidence regarding lower global psychotic symptoms in extended SEI in comparison to standard SEI + TAU (MD -1.90, 95% CI -3.28 to -0.52; 1 trial, 156 participants; very low-certainty evidence).\nIt was uncertain whether the use of extended SEI over standard SEI + TAU resulted in fewer deaths due to all-cause mortality, as so few deaths were recorded in trials (RR 0.38, 95% CI 0.09 to 1.64; 3 trials, 780 participants; low-certainty evidence).\nVery uncertain evidence suggests that using extended SEI instead of standard SEI + TAU may not improve global functioning (SMD 0.23, 95% CI -0.29 to 0.76; 2 trials, 560 participants; very low-certainty evidence).\nThere was low risk of bias in all three trials for random sequence generation, allocation concealment and other biases. All three trials had high risk of bias for blinding of participants and personnel due to the nature of the intervention. For the risk of bias for blinding of outcome assessments and incomplete outcome data there was at least one trial with high or unclear risk of bias.\nAuthors' conclusions\nThere may be preliminary evidence of benefit from extending SEI team care for treating people experiencing psychosis, with fewer people disengaging from mental health services. Evidence regarding other outcomes was uncertain. The certainty of evidence for the measured outcomes was low or very low.\nFurther, suitably powered studies that use a consistent approach to outcome selection are needed, but with only one further ongoing trial, there is unlikely to be any definitive conclusion for the effectiveness of extended SEI for at least the next few years.\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 looked at the use of longer treatment of recent-onset psychosis by specialist early intervention teams.\nWe looked for randomised controlled studies, in which the treatments people received were decided at random. This type of study usually gives the most reliable evidence about the effects of a treatment.\nWe wanted to find out, at the end of the treatment:\n- how many people recovered;\n- how many people stopped their treatment too soon;\n- how many people were admitted to a psychiatric hospital, and for how long;\n- people's psychotic symptoms and functioning (how well they cope with daily life); and\n- how many people died."
}
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query-laysum | 5786 | [
{
"role": "user",
"content": "Abstract: Background\nSubfertility due to anovulation is a common problem in women. First-line oral treatment is with antioestrogens such as clomiphene citrate, but resistance may be apparent with clomiphene. Alternative and adjunctive treatments have been used including tamoxifen, dexamethasone, and bromocriptine. The effectiveness of these is to be determined.\nObjectives\nTo determine the relative effectiveness of antioestrogen agents including clomiphene alone or in combination with other medical therapies in women with subfertility associated with anovulation, possibly caused by polycystic ovarian syndrome.\nSearch methods\nWe conducted a search of the Cochrane Gynaecology and Fertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, and CINAHL (all from inception to August 2016) to identify relevant randomised controlled trials (RCTs). We searched the United Kingdom National Institute for Clinical Excellence (NICE) guidelines and the references of relevant reviews and RCTs. We also searched the clinical trial registries for ongoing trials (inception until August 2016).\nSelection criteria\nWe considered RCTs comparing oral antioestrogen agents for ovulation induction (alone or in conjunction with medical therapies) in anovulatory subfertility. We excluded insulin-sensitising agents, aromatase inhibitors, and hyperprolactinaemic infertility.\nData collection and analysis\nTwo review authors independently performed data extraction and quality assessment. The primary outcome was live birth; secondary outcomes were pregnancy, ovulation, miscarriage, multiple pregnancy, ovarian hyperstimulation syndrome, and adverse effects.\nMain results\nThis is a substantive update of a previous review. We identified an additional 13 studies in the 2016 update. The review now includes 28 RCTs (3377 women) and five RCTs awaiting classification. Five of the 28 included trials reported live birth/ongoing pregnancy. Secondary outcomes were poorly reported.\nThe quality of the evidence ranged from low to very low. The primary reasons for downgrading the evidence were imprecision and risk of bias associated with poor reporting.\nAntioestrogen versus placebo\nLive birth rate, miscarriage rate, multiple pregnancy rate, and ovarian hyperstimulation syndrome (OHSS)\nNo data were reported for these outcomes.\nClinical pregnancy rate\nClomiphene citrate was associated with an increased chance of a clinical pregnancy compared with placebo, though the size of the benefit was very uncertain (odds ratio (OR) 5.91, 95% confidence interval (CI) 1.77 to 19.68; 3 studies; 133 women; low-quality evidence). If the chance of a clinical pregnancy was 5% in the placebo group, then between 8% and 50% of women would have a clinical pregnancy in the clomiphene group.\nClomiphene citrate versus tamoxifen\nLive birth rate\nThere was no clear evidence of a difference in the chance of a live birth between the clomiphene citrate and tamoxifen groups (OR 1.24, 95% CI 0.59 to 2.62; 2 studies; 195 women; low-quality evidence). If 20% of women in the tamoxifen group had a live birth, then between 13% and 40% of women in the clomiphene citrate group would have a live birth.\nMiscarriage rate\nThere was no clear evidence of a difference in the chance of a miscarriage between the clomiphene citrate and tamoxifen groups (OR 1.81, 95% CI 0.80 to 4.12; 4 studies; 653 women; low-quality evidence). If 3% of women in the tamoxifen group had a miscarriage, then between 2% and 10% in the clomiphene citrate group would have a miscarriage.\nClinical pregnancy rate\nThere was no clear evidence of a difference in the chance of a clinical pregnancy between the clomiphene citrate and tamoxifen groups (OR 1.30, 95% CI 0.92 to 1.85; 5 studies; 757 women; I2 = 69%; low-quality evidence). If 22% of women in the tamoxifen group had a clinical pregnancy, then between 21% and 35% in the clomiphene citrate group would have a clinical pregnancy.\nMultiple pregnancy rate\nThere was insufficient evidence of a difference in the chance of a multiple pregnancy between the clomiphene citrate group (OR 2.34, 95% CI 0.34 to 16.04; 3 studies; 567 women; very low-quality evidence). If 0% of women in the tamoxifen group had a multiple pregnancy, then between 0% and 0.5% of women in the clomiphene group would have a multiple pregnancy.\nOHSS\nThere were no instances of OHSS in either the clomiphene citrate or the tamoxifen group reported from three studies.\nClomiphene citrate with tamoxifen versus tamoxifen alone\nClinical pregnancy rate\nThere was insufficient evidence to determine whether there was a difference between groups (OR 3.32, 95% CI 0.12 to 91.60; 1 study; 20 women; very low-quality evidence). No data were reported for the other outcomes.\nOther comparisons of interest\nLimited evidence suggested that compared with a gonadotropin, clomiphene citrate was associated with a reduced chance of a pregnancy, ongoing pregnancy, or live birth, with no clear evidence of a difference in multiple pregnancy rates.\nThe comparison of clomiphene citrate plus medical adjunct versus clomiphene alone was limited by the number of trials reporting the comparison and poor reporting of clinical outcomes relevant to this systematic review and by the number of adjuncts reported (ketoconazole, bromocriptine, dexamethasone, combined oral contraceptive, human chorionic gonadotropin, hormone supplementation). The addition of dexamethasone or combined oral contraceptive suggested a possible benefit in pregnancy outcomes, but findings were very uncertain and further research is required to confirm this.\nThere was limited evidence suggesting that a 10-day regimen of clomiphene citrate improves pregnancy outcomes compared with a 5-day regimen. Data for early versus late regimens of clomiphene citrate were insufficient to be able to make a judgement on differences for pregnancy outcomes.\nAuthors' conclusions\nWe found evidence suggesting that clomiphene citrate improves the chance of a clinical pregnancy compared with placebo, but may reduce the chance of live birth or ongoing pregnancy when compared with a gonadotropin. Due to low event rates, we advise caution interpreting these data.\nThe comparison of clomiphene citrate plus medical adjunctive versus clomiphene alone was limited by the number of trials reporting the comparison. The evidence was very low quality and no firm conclusions could be drawn, but very limited evidence suggested a benefit from adjunctive dexamethasone or combined oral contraceptives. Low-quality evidence suggested that a 10-day regimen of clomiphene citrate improves pregnancy rates compared with a 5-day regimen, but further research is required.\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 ranged from low to very low. The primary reasons for downgrading evidence were imprecision and risk of bias."
}
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query-laysum | 5787 | [
{
"role": "user",
"content": "Abstract: Background\nProton pump inhibitors (PPIs) are a class of medications that reduce acid secretion and are used for treating many conditions such as gastroesophageal reflux disease (GERD), dyspepsia, reflux esophagitis, peptic ulcer disease, and hypersecretory conditions (e.g. Zollinger-Ellison syndrome), and as part of the eradication therapy for Helicobacter pylori bacteria. However, approximately 25% to 70% of people are prescribed a PPI inappropriately. Chronic PPI use without reassessment contributes to polypharmacy and puts people at risk of experiencing drug interactions and adverse events (e.g. Clostridium difficile infection, pneumonia, hypomagnesaemia, and fractures).\nObjectives\nTo determine the effects (benefits and harms) associated with deprescribing long-term PPI therapy in adults, compared to chronic daily use (28 days or greater).\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 10), MEDLINE, Embase, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP). The last date of search was November 2016. We handsearched the reference lists of relevant studies. We screened 2357 articles (2317 identified through search strategy, 40 through other resources). Of these articles, we assessed 89 for eligibility.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized trials comparing at least one deprescribing modality (e.g. stopping PPI or reducing PPI) with a control consisting of no change in continuous daily PPI use in adult chronic users. Outcomes of interest were: change in gastrointestinal (GI) symptoms, drug burden/PPI use, cost/resource use, negative and positive drug withdrawal events, and participant satisfaction.\nData collection and analysis\nTwo review authors independently reviewed and extracted data and completed the risk of bias assessment. A third review author independently confirmed risk of bias assessment. We used Review Manager 5 software for data analysis. We contacted study authors if there was missing information.\nMain results\nThe review included six trials (n = 1758). Trial participants were aged 48 to 57 years, except for one trial that had a mean age of 73 years. All participants were from the outpatient setting and had either nonerosive reflux disease or milder grades of esophagitis (LA grade A or B). Five trials investigated on-demand deprescribing and one trial examined abrupt discontinuation. There was low quality evidence that on-demand use of PPI may increase risk of 'lack of symptom control' compared with continuous PPI use (risk ratio (RR) 1.71, 95% confidence interval (CI) 1.31 to 2.21), thereby favoring continuous PPI use (five trials, n = 1653). There was a clinically significant reduction in 'drug burden', measured as PPI pill use per week with on-demand therapy (mean difference (MD) -3.79, 95% CI -4.73 to -2.84), favoring deprescribing based on moderate quality evidence (four trials, n = 1152). There was also low quality evidence that on-demand PPI use may be associated with reduced participant satisfaction compared with continuous PPI use. None of the included studies reported cost/resource use or positive drug withdrawal effects.\nAuthors' conclusions\nIn people with mild GERD, on-demand deprescribing may lead to an increase in GI symptoms (e.g. dyspepsia, regurgitation) and probably a reduction in pill burden. There was a decline in participant satisfaction, although heterogeneity was high. There were insufficient data to make a conclusion regarding long-term benefits and harms of PPI discontinuation, although two trials (one on-demand trial and one abrupt discontinuation trial) reported endoscopic findings in their intervention groups at study end.\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 that deprescribing methods led to worse symptoms control while considerably reducing pill use. Deprescribing PPIs may lead to side effects such as inflammation of the esophagus. Very few data were available to make a conclusion regarding long-term benefits and harms of PPI reduction or discontinuation."
}
]
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query-laysum | 5788 | [
{
"role": "user",
"content": "Abstract: Background\nSurgery is the preferred treatment for resectable oesophageal cancers, and can be performed in different ways. Transhiatal oesophagectomy (oesophagectomy without thoracotomy, with a cervical anastomosis) is one way to resect oesophageal cancers. It can be performed laparoscopically or by open method. With other organs, laparoscopic surgery has been shown to reduce complications and length of hospital stay compared to open surgery. However, concerns remain about the safety of laparoscopic transhiatal oesophagectomy in terms of post-operative complications and oncological clearance compared with open transhiatal oesophagectomy.\nObjectives\nTo assess the benefits and harms of laparoscopic versus open oesophagectomy for people with oesophageal cancer undergoing transhiatal oesophagectomy.\nSearch methods\nWe electronically searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and trials registers until August 2015. We also searched the references of included trials to identify further trials.\nSelection criteria\nWe considered randomised controlled trials and non-randomised studies comparing laparoscopic with open transhiatal oesophagectomy in patients with resectable oesophageal cancer, regardless of language, blinding, or publication status for the review.\nData collection and analysis\nThree review authors independently identified trials, assessed risk of bias and extracted data. We calculated the risk ratio (RR) or hazard ratio (HR) with 95% confidence intervals (CI), using both fixed-effect and random-effects models, with RevMan 5, based on intention-to-treat analyses.\nMain results\nWe found no randomised controlled trials on this topic. We included six non-randomised studies (five retrospective) that compared laparoscopic versus open transhiatal oesophagectomy (334 patients: laparoscopic = 154 patients; open = 180 patients); five studies (326 patients: laparoscopic = 151 patients; open = 175 patients) provided information for one or more outcomes. Most studies included a mixture of adenocarcinoma and squamous cell carcinoma and different stages of oesophageal cancer, without metastases. All the studies were at unclear or high risk of bias; the overall quality of evidence was very low for all the outcomes.\nThe differences between laparoscopic and open transhiatal oesophagectomy were imprecise for short-term mortality (laparoscopic = 0/151 (adjusted proportion based on meta-analysis estimate: 0.5%) versus open = 2/175 (1.1%); RR 0.44; 95% CI 0.05 to 4.09; participants = 326; studies = 5; I² = 0%); long-term mortality (HR 0.97; 95% CI 0.81 to 1.16; participants = 193; studies = 2; I² = 0%); anastomotic stenosis (laparoscopic = 4/36 (11.1%) versus open = 3/37 (8.1%); RR 1.37; 95% CI 0.33 to 5.70; participants = 73; studies = 1); short-term recurrence (laparoscopic = 1/16 (6.3%) versus open = 0/4 (0%); RR 0.88; 95% CI 0.04 to 18.47; participants = 20; studies = 1); long-term recurrence (HR 1.00; 95% CI 0.84 to 1.18; participants = 173; studies = 2); proportion of people who required blood transfusion (laparoscopic = 0/36 (0%) versus open = 6/37 (16.2%); RR 0.08; 95% CI 0.00 to 1.35; participants = 73; studies = 1); proportion of people with positive resection margins (laparoscopic = 15/102 (15.8%) versus open = 27/111 (24.3%); RR 0.65; 95% CI 0.37 to 1.12; participants = 213; studies = 3; I² = 0%); and the number of lymph nodes harvested during surgery (median difference between the groups varied from 12 less to 3 more lymph nodes in the laparoscopic compared to the open group; participants = 326; studies = 5).\nThe proportion of patients with serious adverse events was lower in the laparoscopic group (10/99, (10.3%) compared to the open group = 24/114 (21.1%); RR 0.49; 95% CI 0.24 to 0.99; participants = 213; studies = 3; I² = 0%); as it was for adverse events in the laparoscopic group = 37/99 (39.9%) versus the open group = 71/114 (62.3%); RR 0.64; 95% CI 0.48 to 0.86; participants = 213; studies = 3; I² = 0%); and the median lengths of hospital stay were significantly less in the laparoscopic group than the open group (three days less in all three studies that reported this outcome; number of participants = 266). There was lack of clarity as to whether the median difference in the quantity of blood transfused was statistically significant favouring laparoscopic oesophagectomy in the only study that reported this information. None of the studies reported post-operative dysphagia, health-related quality of life, time-to-return to normal activity (return to pre-operative mobility without caregiver support), or time-to-return to work.\nAuthors' conclusions\nThere are currently no randomised controlled trials comparing laparoscopic with open transhiatal oesophagectomy for patients with oesophageal cancers. In observational studies, laparoscopic transhiatal oesophagectomy is associated with fewer overall complications and shorter hospital stays than open transhiatal oesophagectomy. However, this association is unlikely to be causal. There is currently no information to determine a causal association in the differences between the two surgical approaches. Randomised controlled trials comparing laparoscopic transhiatal oesophagectomy with other methods of oesophagectomy are required to determine the optimal method of oesophagectomy.\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": "The oesophagus (food pipe) is located mainly in the chest; it enters the abdomen (tummy) through an opening in the diaphragm (muscle that separates the chest from the abdomen). Removing tumours by surgery (oesophagectomy) is one of the recommended treatments for cancers that are limited to the oesophagus. The tumour can be removed through an abdominal opening, a chest opening, or a combination. When the tumour is removed through an abdominal opening, it is called transhiatal oesophagectomy (as the oesophagus is separated from its surrounding structures through the opening in the diaphragm). The abdominal surgery can be performed through either a key-hole or a standard cut. Key-hole surgery to remove oesophageal cancer (laparoscopic transhiatal oesophagectomy) is a relatively new procedure compared to the well-established standard cut surgery (open transhiatal oesophagectomy). In operations on other parts of the body, laparoscopic surgery has been shown to reduce complications and length of hospital stays compared to open surgery.\nHowever, concerns remain about the safety of laparoscopic surgery. How do complications after operation (post-operative complications) compare between the two procedures? Does laparoscopic surgery remove the same amount of cancer and healthy border tissue as open surgery? Do people recovery more quickly after laparoscopic or open surgery? We sought to resolve these issues by searching the medical literature for studies on this topic."
}
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query-laysum | 5789 | [
{
"role": "user",
"content": "Abstract: Background\nSymptoms of autism spectrum disorder (ASD) have been associated, in part, with the dysfunction of N-methyl-D-aspartate (NMDA) glutamate receptors at excitatory synapses and glutamate abnormalities. Medications related to glutamatergic neurotransmission, such as D-cycloserine - which is a partial agonist of the NMDA glutamate receptor - are potential treatment options for the core features of ASD. However, the potential effect of D-cycloserine on the social and communication skills deficits of individuals with ASD has not been thoroughly explored and no systematic reviews of the evidence have been conducted.\nObjectives\nTo assess the efficacy and adverse effects of D-cycloserine compared with placebo for social and communication skills in individuals with ASD.\nSearch methods\nIn November 2020, we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers. We also searched the reference lists of relevant publications and contacted the authors of the included study, Minshawi 2016, to identify any additional studies. In addition, we contacted pharmaceutical companies, searched manufacturers' websites and sources of reports of adverse events.\nSelection criteria\nAll randomised controlled trials (RCTs) of any duration and dose of D-cycloserine, with or without adjunct treatment, compared to placebo in individuals with ASD.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted relevant data, assessed the risk of bias, graded the certainty of the evidence using the GRADE approach, and analysed and evaluated the data. We provide a narrative report of the findings as only one study is included in this review.\nMain results\nWe included a single RCT (Minshawi 2016) funded by the United States Department of Defense. It was conducted at two sites in the USA: Indiana University School of Medicine and Cincinnati Children's Hospital Medical Centre. In the included study, 67 children with ASD aged between 5 and 11 years were randomised to receive either 10 weeks (10 doses) of (50 mg) D-cycloserine plus social skills training, or placebo plus social skills training. Randomisation was carried out 1:1 between D-cycloserine and placebo arms, and outcome measures were recorded at one-week post-treatment. The 'risk of bias' assessment for the included study was low for five domains and unclear for two domains.\nThe study (67 participants) reported low certainty evidence of little to no difference between the two groups for all outcomes measured at one week post-treatment: social interaction impairment (mean difference (MD) 3.61 (assessed with the Social Responsiveness Scale), 95% confidence interval (CI) -5.60 to 12.82); social communication impairment (MD -1.08 (measured using the inappropriate speech subscale of the Aberrant Behavior Checklist (ABC)), 95% CI -2.34 to 0.18); restricted, repetitive, stereotyped patterns of behaviour (MD 0.12 (measured by the ABC stereotypy subscale), 95% CI -1.71 to 1.95); serious adverse events (risk ratio (RR) 1.11, 95% CI 0.94 to 1.31); non-core symptoms of ASD (RR 0.97 (measured by the Clinical Global Impression-Improvement scale), 95% CI 0.49 to 1.93); and tolerability of D-cycloserine (RR 0.32 (assessed by the number of dropouts), 95% CI 0.01 to 7.68).\nAuthors' conclusions\nWe are unable to conclude with certainty whether D-cycloserine is effective for individuals with ASD. This review included low certainty data from only one study with methodological issues and imprecision. The added value of this review compared to the included study is we assessed the risk of bias and evaluated the certainty of evidence using the GRADE approach. Moreover, if we find new trials in future updates of this review, we could potentially pool the data, which may either strengthen or decrease the evidence for our findings.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched databases of scientific studies and found one relevant study to include in this review. The study took place in the USA and did not have industry funding. A total of 67 children aged 5 to 11 years were included in the study. One group took a medicine called D-cycloserine once a week plus social skills training, and the other group took a placebo pill (dummy pill which does not include medicine) plus social skills training. The treatment lasted for 10 weeks."
}
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query-laysum | 5790 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is a life-limiting inherited condition which affects one in 2500 newborns in the UK and 70,000 children and adults worldwide. The condition is multifaceted and affects many systems in the body. The respiratory system is particularly affected due to a build up of thickened secretions and a predisposition to infection. Inhaled bronchodilators are prescribed for 80% of people with cystic fibrosis in order to widen the airways and alleviate symptoms. Both short- and long-acting inhaled bronchodilators are used to improve respiratory symptoms. Short-acting inhaled bronchodilators take effect in minutes and typically last for four to eight hours (muscarinic antagonists). Long-acting inhaled bronchodilators also take effect within minutes but typically last for around 12 hours and sometimes longer. This review is one of two which are replacing a previously published review of both long- and short-acting inhaled bronchodilators. However, due to the lack of research in this area, we do not envisage undertaking any further updates of this long-acting inhaled bronchodilators review.\nObjectives\nThis review aims to evaluate long-acting inhaled bronchodilators in children and adults with cystic fibrosis in terms of clinical outcomes and safety. If possible, we aimed to assess the optimal drug and dosage regimen.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books.\nDate of last search: 10 October 2017.\nWe also carried out a separate search of Embase and the reference lists of included trials. We searched clinical trials registries for any ongoing trials and made contact with pharmaceutical companies for any further trials.\nDate of Embase search: 11 October 2017.\nSelection criteria\nRandomised or quasi-randomised parallel trials comparing long-acting inhaled bronchodilators (beta-2 agonists and muscarinic antagonists) with placebo, no treatment or a different long-acting inhaled bronchodilator in adults and children with cystic fibrosis.\nData collection and analysis\nBoth authors independently assessed trials for inclusion (based on title, abstract and full text). The authors independently assessed the included trials for quality and risk of bias and extracted data. Discrepancies were resolved by a third party.\nMain results\nThe searches identified 195 unique references, of which 155 were excluded on title and abstract. We assessed the full texts of the remaining references, excluded 16 trials (28 references) and included four trials (12 references) in the review with 1082 participants.\nOne trial (n = 16) measuring the effect of beta-2 agonists reported an improvement in forced expiratory volume at one second (FEV1) after treatment (at one month), but the trial was small with an unclear risk of bias so we judged the evidence to be very low quality. The trial did not report on participant-reported outcomes, quality of life or adverse events.\nThree trials (n = 1066) looked at the effects of the muscarinic antagonist tiotropium at doses of 2.5 µg and 5.0 µg in both the short term (up to 28 days) and the longer term (up to three months). Only one of the trials reported the change in FEV1 (L) after 28 days treatment and showed no significant difference between groups; with 2.5 µg tiotropium, mean difference (MD) -0.02 (95% confidence interval (CI) -0.13 to 0.09), or 5.0 µg tiotropium, MD 0.00 (95% CI -0.10 to 0.10) (moderate-quality evidence). All three trials of muscarinic antagonists provided data on adverse events which were found to differ little from placebo at doses of 2.5 µg, risk ratio (RR) 1.01 (95% CI 0.92 to 1.11) or 5.0 µg, RR 0.98 (95% CI 0.90 to 1.06). Very little participant-reported outcome data or quality of life data were available for analysis. Two of the trials were at low risk of bias overall whilst the remaining trial was at an unclear risk overall.\nAuthors' conclusions\nNeither long-acting beta-2 agonists nor long-acting muscarinic antagonist bronchodilators demonstrate improvement in our primary outcome of FEV1. No difference was observed between intervention and placebo in terms of quality of life or adverse events. The quality of evidence for the use of beta-2 agonists was very low. The use of a long-acting inhaled bronchodilator may help to reduce the burden of treatment for people with cystic fibrosis as it is taken less often than a short-acting inhaled bronchodilator, but future trials would benefit from looking at the effects on our primary outcomes (spirometric changes from baseline, quality of life and adverse effects) in the longer term.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 10 October 2017."
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query-laysum | 5791 | [
{
"role": "user",
"content": "Abstract: Background\nThe leading causes of mortality globally in children younger than five years of age (under-fives), and particularly in the regions of sub-Saharan Africa (SSA) and Southern Asia, in 2018 were infectious diseases, including pneumonia (15%), diarrhoea (8%), malaria (5%) and newborn sepsis (7%) (UNICEF 2019). Nutrition-related factors contributed to 45% of under-five deaths (UNICEF 2019).\nWorld Health Organization (WHO) and United Nations Children's Fund (UNICEF), in collaboration with other development partners, have developed an approach – now known as integrated community case management (iCCM) – to bring treatment services for children 'closer to home'. The iCCM approach provides integrated case management services for two or more illnesses – including diarrhoea, pneumonia, malaria, severe acute malnutrition or neonatal sepsis – among under-fives at community level (i.e. outside of healthcare facilities) by lay health workers where there is limited access to health facility-based case management services (WHO/UNICEF 2012).\nObjectives\nTo assess the effects of the integrated community case management (iCCM) strategy on coverage of appropriate treatment for childhood illness by an appropriate provider, quality of care, case load or severity of illness at health facilities, mortality, adverse events and coverage of careseeking for children younger than five years of age in low- and middle-income countries.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL on 7 November 2019, Virtual Health Library on 8 November 2019, and Popline on 5 December 2018, three other databases on 22 March 2019 and two trial registers on 8 November 2019. We performed reference checking, and citation searching, and contacted study authors to identify additional studies.\nSelection criteria\nRandomized controlled trials (RCTs), cluster-RCTs, controlled before-after studies (CBAs), interrupted time series (ITS) studies and repeated measures studies comparing generic WHO/UNICEF iCCM (or local adaptation thereof) for at least two iCCM diseases with usual facility services (facility treatment services) with or without single disease community case management (CCM). We included studies reporting on coverage of appropriate treatment for childhood illness by an appropriate provider, quality of care, case load or severity of illness at health facilities, mortality, adverse events and coverage of careseeking for under-fives in low- and middle-income countries.\nData collection and analysis\nAt least two review authors independently screened abstracts, screened full texts and extracted data using a standardised data collection form adapted from the EPOC Good Practice Data Collection Form. We resolved any disagreements through discussion or, if required, we consulted a third review author not involved in the original screening. We contacted study authors for clarification or additional details when necessary. We reported risk ratios (RR) for dichotomous outcomes and hazard ratios (HR) for time to event outcomes, with 95% confidence intervals (CI), adjusted for clustering, where possible. We used estimates of effect from the primary analysis reported by the investigators, where possible. We analysed the effects of randomized trials and other study types separately. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included seven studies, of which three were cluster RCTs and four were CBAs. Six of the seven studies were in SSA and one study was in Southern Asia.\nThe iCCM components and inputs were fairly consistent across the seven studies with notable variation for the training and deployment component (e.g. on payment of iCCM providers) and the system component (e.g. on improving information systems).\nWhen compared to usual facility services, we are uncertain of the effect of iCCM on coverage of appropriate treatment from an appropriate provider for any iCCM illness (RR 0.96, 95% CI 0.77 to 1.19; 2 CBA studies, 5898 children; very low-certainty evidence). iCCM may have little to no effect on neonatal mortality (HR 1.01, 95% 0.73 to 1.28; 2 trials, 65,209 children; low-certainty evidence). We are uncertain of the effect of iCCM on infant mortality (HR 1.02, 95% CI 0.83 to 1.26; 2 trials, 60,480 children; very low-certainty evidence) and under-five mortality (HR 1.18, 95% CI 1.01 to 1.37; 1 trial, 4729 children; very low-certainty evidence). iCCM probably increases coverage of careseeking to an appropriate provider for any iCCM illness by 68% (RR 1.68, 95% CI 1.24 to 2.27; 2 trials, 9853 children; moderate-certainty evidence). None of the studies reported quality of care, severity of illness or adverse events for this comparison.\nWhen compared to usual facility services plus CCM for malaria, we are uncertain of the effect of iCCM on coverage of appropriate treatment from an appropriate provider for any iCCM illness (very low-certainty evidence) and iCCM may have little or no effect on careseeking to an appropriate provider for any iCCM illness (RR 1.06, 95% CI 0.97 to 1.17; 1 trial, 811 children; low-certainty evidence). None of the studies reported quality of care, case load or severity of illness at health facilities, mortality or adverse events for this comparison.\nAuthors' conclusions\niCCM probably increases coverage of careseeking to an appropriate provider for any iCCM illness. However, the evidence presented here underscores the importance of moving beyond training and deployment to valuing iCCM providers, strengthening health systems and engaging community systems.\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": "The review authors searched for studies that had been published up to 7 November 2019."
}
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query-laysum | 5792 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a common skin condition. Although topical corticosteroids have been a first-line treatment for eczema for decades, there are uncertainties over their optimal use.\nObjectives\nTo establish the effectiveness and safety of different ways of using topical corticosteroids for treating eczema.\nSearch methods\nWe searched databases to January 2021 (Cochrane Skin Specialised Register; CENTRAL; MEDLINE; Embase; GREAT) and five clinical trials registers. We checked bibliographies from included trials to identify further trials.\nSelection criteria\nRandomised controlled trials in adults and children with eczema that compared at least two strategies of topical corticosteroid use. We excluded placebo comparisons, other than for trials that evaluated proactive versus reactive treatment.\nData collection and analysis\nWe used standard Cochrane methods, with GRADE certainty of evidence for key findings. Primary outcomes were changes in clinician-reported signs and relevant local adverse events. Secondary outcomes were patient-reported symptoms and relevant systemic adverse events. For local adverse events, we prioritised abnormal skin thinning as a key area of concern for healthcare professionals and patients.\nMain results\nWe included 104 trials (8443 participants). Most trials were conducted in high-income countries (81/104), most likely in outpatient or other hospital settings. We judged only one trial to be low risk of bias across all domains. Fifty-five trials had high risk of bias in at least one domain, mostly due to lack of blinding or missing outcome data.\nStronger-potency versus weaker-potency topical corticosteroids\nSixty-three trials compared different potencies of topical corticosteroids: 12 moderate versus mild, 22 potent versus mild, 25 potent versus moderate, and 6 very potent versus potent. Trials were usually in children with moderate or severe eczema, where specified, lasting one to five weeks. The most reported outcome was Investigator Global Assessment (IGA) of clinician-reported signs of eczema.\nWe pooled four trials that compared moderate- versus mild-potency topical corticosteroids (420 participants). Moderate-potency topical corticosteroids probably result in more participants achieving treatment success, defined as cleared or marked improvement on IGA (52% versus 34%; odds ratio (OR) 2.07, 95% confidence interval (CI) 1.41 to 3.04; moderate-certainty evidence). We pooled nine trials that compared potent versus mild-potency topical corticosteroids (392 participants). Potent topical corticosteroids probably result in a large increase in number achieving treatment success (70% versus 39%; OR 3.71, 95% CI 2.04 to 6.72; moderate-certainty evidence). We pooled 15 trials that compared potent versus moderate-potency topical corticosteroids (1053 participants). There was insufficient evidence of a benefit of potent topical corticosteroids compared to moderate topical corticosteroids (OR 1.33, 95% CI 0.93 to 1.89; moderate-certainty evidence). We pooled three trials that compared very potent versus potent topical corticosteroids (216 participants). The evidence is uncertain with a wide confidence interval (OR 0.53, 95% CI 0.13 to 2.09; low-certainty evidence).\nTwice daily or more versus once daily application\nWe pooled 15 of 25 trials in this comparison (1821 participants, all reported IGA). The trials usually assessed adults and children with moderate or severe eczema, where specified, using potent topical corticosteroids, lasting two to six weeks.\nApplying potent topical corticosteroids only once a day probably does not decrease the number achieving treatment success compared to twice daily application (OR 0.97, 95% CI 0.68 to 1.38; 15 trials, 1821 participants; moderate-certainty evidence).\nLocal adverse events\nWithin the trials that tested 'treating eczema flare-up' strategies, we identified only 26 cases of abnormal skin thinning from 2266 participants (1% across 22 trials). Most cases were from the use of higher-potency topical corticosteroids (16 with very potent, 6 with potent, 2 with moderate and 2 with mild). We assessed this evidence as low certainty, except for very potent versus potent topical corticosteroids, which was very low-certainty evidence.\nLonger versus shorter-term duration of application for induction of remission\nNo trials were identified.\nTwice weekly application (weekend, or ‘proactive therapy') to prevent relapse (flare-ups) versus no topical corticosteroids/reactive application\nNine trials assessed this comparison, generally lasting 16 to 20 weeks. We pooled seven trials that compared weekend (proactive) topical corticosteroids therapy versus no topical corticosteroids (1179 participants, children and adults with a range of eczema severities, though mainly moderate or severe).\nWeekend (proactive) therapy probably results in a large decrease in likelihood of a relapse from 58% to 25% (risk ratio (RR) 0.43, 95% CI 0.32 to 0.57; 7 trials, 1149 participants; moderate-certainty evidence).\nLocal adverse events\nWe did not identify any cases of abnormal skin thinning in seven trials that assessed skin thinning (1050 participants) at the end of treatment. We assessed this evidence as low certainty.\nOther comparisons\nOther comparisons included newer versus older preparations of topical corticosteroids (15 trials), cream versus ointment (7 trials), topical corticosteroids with wet wrap versus no wet wrap (6 trials), number of days per week applied (4 trials), different concentrations of the same topical corticosteroids (2 trials), time of day applied (2 trials), topical corticosteroids alternating with topical calcineurin inhibitors versus topical corticosteroids alone (1 trial), application to wet versus dry skin (1 trial) and application before versus after emollient (1 trial). No trials compared branded versus generic topical corticosteroids and time between application of emollient and topical corticosteroids.\nAuthors' conclusions\nPotent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids, primarily in moderate or severe eczema; however, there is uncertain evidence to support any advantage of very potent over potent topical corticosteroids. Effectiveness is similar between once daily and twice daily (or more) frequent use of potent topical corticosteroids to treat eczema flare-ups, and topical corticosteroids weekend (proactive) therapy is probably better than no topical corticosteroids/reactive use to prevent eczema relapse (flare-ups). Adverse events were not well reported and came largely from low- or very low-certainty, short-term trials. In trials that reported abnormal skin thinning, frequency was low overall and increased with increasing potency. We found no trials on the optimum duration of treatment of a flare, branded versus generic topical corticosteroids, and time to leave between application of topical corticosteroids and emollient. There is a need for longer-term trials, in people with mild eczema.\n\nGiven the provided abstract, please respond to the following query: \"What is eczema and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eczema is a common, long-lasting condition that results in inflamed, dry, itchy patches of skin and its severity varies; it is incurable currently, so treatment aims to control symptoms (inflammation and itching). The first choice of treatment is emollients (moisturisers) combined with treatment to reduce inflammation, often steroid cream."
}
]
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query-laysum | 5793 | [
{
"role": "user",
"content": "Abstract: Background\nDespite considerable improvement in outcomes for preterm infants, rates of bronchopulmonary dysplasia (BPD) remain high, affecting an estimated 33% of very low birthweight infants, with corresponding long-term respiratory and neurosensory issues. Systemic corticosteroids can address the inflammation underlying BPD, but the optimal regimen for prevention of this disease, balancing of the benefits with the potentially meaningful risks of systemic corticosteroids, continues to be a medical quandary.\nNumerous studies have shown that systemic corticosteroids, particularly dexamethasone and hydrocortisone, effectively treat or prevent BPD. However, concerning short and long-term side effects have been reported and the optimal approach to corticosteroid treatment remains unclear.\nObjectives\nTo determine whether differences in efficacy and safety exist between high-dose dexamethasone, moderate-dose dexamethasone, low-dose dexamethasone, hydrocortisone, and placebo in the prevention of BPD, death, the composite outcome of death or BPD, and other relevant morbidities, in preterm infants through a network meta-analysis, generating both pairwise comparisons between all treatments and rankings of the treatments.\nSearch methods\nWe searched the Cochrane Library for all systematic reviews of systemic corticosteroids for the prevention of BPD and searched for completed and ongoing studies in the following databases in January 2023: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and clinical trial databases.\nSelection criteria\nWe included randomized controlled trials (RCTs) in preterm infants (< 37 weeks’ gestation) at risk for BPD that evaluated systemic corticosteroids (high-dose [≥ 4 mg/kg cumulative dose] dexamethasone, moderate-dose [≥ 2 to < 4 mg/kg] dexamethasone, low-dose [< 2 mg/kg] dexamethasone, or hydrocortisone) versus control or another systemic corticosteroid.\nData collection and analysis\nOur main information sources were the systematic reviews, with reference to the original manuscript only for data not included in these reviews. Teams of two paired review authors independently performed data extraction, with disagreements resolved by discussion. Data were entered into Review Manager 5 and exported to R software for network meta-analysis (NMA). NMA was performed using a frequentist model with random-effects. Two separate networks were constructed, one for early (< seven days) initiation of treatment and one for late (≥ seven days) treatment initiation, to reflect the different patient populations evaluated. We assessed the certainty of evidence derived from the NMA for our primary outcomes using principles of the GRADE framework modified for application to NMA.\nMain results\nWe included 59 studies, involving 6441 infants, in our analyses.\nOnly six of the included studies provided direct comparisons between any of the treatment (dexamethasone or hydrocortisone) groups, forcing network comparisons between treatments to rely heavily on indirect evidence through comparisons with placebo/no treatment groups. Thirty-one studies evaluated early corticosteroid treatment, 27 evaluated late corticosteroid treatment, and one study evaluated both early and late corticosteroid treatments.\nEarly treatment (prior to seven days after birth):\nBenefits:NMA for early treatment showed only moderate-dose dexamethasone to decrease the risk of BPD at 36 weeks' postmenstrual age (PMA) compared with control (RR 0.56, 95% CI 0.39 to 0.80; moderate-certainty evidence), although the other dexamethasone dosing regimens may have similar effects compared with control (high-dose dexamethasone, RR 0.71, 95% CI 0.50 to 1.01; low-certainty evidence; low-dose dexamethasone, RR 0.83, 95% CI 0.67 to 1.03; low-certainty evidence). Other early treatment regimens may have little or no effect on the risk of death at 36 weeks' PMA. Only moderate-dose dexamethasone decreased the composite outcome of death or BPD at 36 weeks' PMA compared with control (RR 0.77, 95% CI 0.60 to 0.98; moderate-certainty evidence).\nHarms: Low-dose dexamethasone increased the risk for cerebral palsy (RR 1.92, 95% CI 1.12 to 3.28; moderate-certainty evidence) compared with control. Hydrocortisone may decrease the risk of major neurosensory disability versus low-dose dexamethasone (RR 0.65, 95% CI 0.41 to 1.01; low-certainty evidence).\nLate treatment (at seven days or later after birth):\nBenefits: NMA for late treatment showed high-dose dexamethasone to decrease the risk of BPD both versus hydrocortisone (RR 0.66, 95% CI 0.51 to 0.85; low-certainty evidence) and versus control (RR 0.72, CI 0.59 to 0.87; moderate-certainty evidence). The late treatment regimens evaluated may have little or no effect on the risk of death at 36 weeks' PMA. High-dose dexamethasone decreased risk for the composite outcome of death or BPD compared with all other treatments (control, RR 0.69, 95% CI 0.59 to 0.80, high-certainty evidence; hydrocortisone, RR 0.69, 95% CI 0.58 to 0.84, low-certainty evidence; low-dose dexamethasone, RR 0.73, 95% CI 0.60 to 0.88, low-certainty evidence; moderate-dose dexamethasone, RR 0.76, 95% CI 0.62 to 0.93, low-certainty evidence).\nHarms: No effect was observed for the outcomes of major neurosensory disability or cerebral palsy.\nThe evidence for the primary outcomes was of overall low certainty, with notable deductions for imprecision and heterogeneity across the networks.\nAuthors' conclusions\nWhile early treatment with moderate-dose dexamethasone or late treatment with high-dose dexamethasone may lead to the best effects for survival without BPD, the certainty of the evidence is low. There is insufficient evidence to guide this therapy with regard to plausible adverse long-term outcomes. Further RCTs with direct comparisons between systemic corticosteroid treatments are needed to determine the optimal treatment approach, and these studies should be adequately powered to evaluate survival without major neurosensory disability.\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": "Our certainty in the evidence was generally low."
}
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query-laysum | 5794 | [
{
"role": "user",
"content": "Abstract: Background\n18F-flutemetamol uptake by brain tissue, measured by positron emission tomography (PET), is accepted by regulatory agencies like the Food and Drug Administration (FDA) and the European Medicine Agencies (EMA) for assessing amyloid load in people with dementia. Its added value is mainly demonstrated by excluding Alzheimer's pathology in an established dementia diagnosis. However, the National Institute on Aging and Alzheimer's Association (NIA-AA) revised the diagnostic criteria for Alzheimer's disease and the confidence in the diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease may be increased when using some amyloid biomarkers tests like 18F-flutemetamol. These tests, added to the MCI core clinical criteria, might increase the diagnostic test accuracy (DTA) of a testing strategy. However, the DTA of 18F-flutemetamol to predict the progression from MCI to Alzheimer’s disease dementia (ADD) or other dementias has not yet been systematically evaluated.\nObjectives\nTo determine the DTA of the 18F-flutemetamol PET scan for detecting people with MCI at time of performing the test who will clinically progress to ADD, other forms of dementia (non-ADD) or any form of dementia at follow-up.\nSearch methods\nThe most recent search for this review was performed in May 2017. We searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), BIOSIS Citation Index (Thomson Reuters Web of Science), Web of Science Core Collection, including the Science Citation Index (Thomson Reuters Web of Science) and the Conference Proceedings Citation Index (Thomson Reuters Web of Science), LILACS (BIREME), CINAHL (EBSCOhost), ClinicalTrials.gov (https://clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (http://www.who.int/ictrp/search/en/). We also searched ALOIS, the Cochrane Dementia & Cognitive Improvement Group’s specialised register of dementia studies (http://www.medicine.ox.ac.uk/alois/). We checked the reference lists of any relevant studies and systematic reviews, and performed citation tracking using the Science Citation Index to identify any additional relevant studies. No language or date restrictions were applied to the electronic searches.\nSelection criteria\nWe included studies that had prospectively defined cohorts with any accepted definition of MCI at time of performing the test and the use of 18F-flutemetamol scan to evaluate the DTA of the progression from MCI to ADD or other forms of dementia. In addition, we only selected studies that applied a reference standard for Alzheimer’s dementia diagnosis, for example, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) or Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria.\nData collection and analysis\nWe screened all titles and abstracts identified in electronic-database searches. Two review authors independently selected studies for inclusion and extracted data to create two-by-two tables, showing the binary test results cross-classified with the binary reference standard. We used these data to calculate sensitivities, specificities, and their 95% confidence intervals. Two independent assessors performed quality assessment using the QUADAS-2 tool plus some additional items to assess the methodological quality of the included studies.\nMain results\nProgression from MCI to ADD was evaluated in 243 participants from two studies. The studies reported data on 19 participants with two years of follow-up and on 224 participants with three years of follow-up. Nine (47.4%) participants converted at two years follow-up and 81 (36.2%) converted at three years of follow-up.\nThere were concerns about participant selection and sampling in both studies. The index test domain in one study was considered unclear and in the second study it was considered at low risk of bias. For the reference standard domain, one study was considered at low risk and the second study was considered to have an unclear risk of bias. Regarding the domains of flow and timing, both studies were considered at high risk of bias.\nMCI to ADD;\nProgression from MCI to ADD at two years of follow-up had a sensitivity of 89% (95% CI 52 to 100) and a specificity of 80% (95% CI 44 to 97) by quantitative assessment by SUVR (n = 19, 1 study).\nProgression from MCI to ADD at three years of follow-up had a sensitivity of 64% (95% CI 53 to 75) and a specificity of 69% (95% CI 60 to 76) by visual assessment (n = 224, 1 study).\nThere was no information regarding the other two objectives in this systematic review (SR): progression from MCI to other forms of dementia and progression to any form of dementia at follow-up.\nAuthors' conclusions\nDue to the varying sensitivity and specificity for predicting the progression from MCI to ADD and the limited data available, we cannot recommend routine use of 18F-flutemetamol in clinical practice. 18F-flutemetamol has high financial costs; therefore, clearly demonstrating its DTA and standardising the process of the 18F-flutemetamol modality is important prior to its wider use.\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 main limitation of this review was that our findings were based on only two studies, with not enough details on how the people were selected, how the interpretation of the PET scan was made in one study, how the clinical diagnosis of dementia was established in the other study. The studies were considered to be at high risk of bias due to potential conflicts of interest detected."
}
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query-laysum | 5795 | [
{
"role": "user",
"content": "Abstract: Background\nGastro-oesophageal reflux (GOR) is characterised by the regurgitation of gastric contents into the oesophagus. GOR is a common presentation in infancy, both in primary and secondary care, affecting approximately 50% of infants under three months old. The natural history of GOR in infancy is generally of a self-limiting condition that improves with age, but older children and children with co-existing medical conditions can have more protracted symptoms. The distinction between gastro-oesophageal reflux disease (GORD) and GOR is debated. Current National Institute of Health and Care Excellence (NICE) guidelines define GORD as GOR causing symptoms severe enough to merit treatment. This is an update of a review first published in 2014.\nObjectives\nTo assess the effects of pharmacological treatments for GOR in infants and children.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, Embase, and Web of Science up to 17 September 2022. We also searched for ongoing trials in clinical trials registries, contacted experts in the field, and searched the reference lists of trials and reviews for any additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any currently-available pharmacological treatment for GOR in children with placebo or another medication. We excluded studies assessing dietary management of GORD and studies of thickened feeds. We included studies in infants and children up to 16 years old.\nData collection and analysis\nWe used standard methodology expected by Cochrane.\nMain results\nWe included 36 RCTs involving 2251 children and infants. We were able to extract summary data from 14 RCTs; the remaining trials had insufficient data for extraction. We were unable to pool results in a meta-analysis due to methodological differences in the included studies (including heterogeneous outcomes, study populations, and study design).\nWe present the results in two groups by age: infants up to 12 months old, and children aged 12 months to 16 years old.\nInfants\nOmeprazole versus placebo: there is no clear effect on symptoms from omeprazole. One study (30 infants; very low-certainty evidence) showed cry/fuss time in infants aged three to 12 months had altered from 246 ± 105 minutes/day at baseline (mean +/- standard deviation (SD)) to 191 ± 120 minutes/day in the omeprazole group and from 287 ± 132 minutes/day to 201 ± 100 minutes/day in the placebo group (mean difference (MD) 10 minutes/day lower (95% confidence interval (CI) -89.1 to 69.1)). The reflux index changed in the omeprazole group from 9.9 ± 5.8% in 24 hours to 1.0 ± 1.3% and in the placebo group from 7.2 ± 6.0% to 5.3 ± 4.9% in 24 hours (MD 7% lower, 95% CI -4.7 to -9.3).\nOmeprazole versus ranitidine: one study (76 infants; very low-certainty evidence) showed omeprazole may or may not provide symptomatic benefit equivalent to ranitidine. Symptom scores in the omeprazole group changed from 51.9 ± 5.4 to 2.4 ± 1.2, and in the ranitidine group from 47 ± 5.6 to 2.5 ± 0.6 after two weeks: MD -4.97 (95% CI -7.33 to -2.61).\nEsomeprazole versus placebo: esomeprazole appeared to show no additional reduction in the number of GORD symptoms compared to placebo (1 study, 52 neonates; very low-certainty evidence): both the esomeprazole group (184.7 ± 78.5 to 156.7 ± 75.1) and placebo group (183.1 ± 77.5 to 158.3 ± 75.9) improved: MD -3.2 (95% CI -4.6 to -1.8).\nChildren\nProton pump inhibitors (PPIs) at different doses may provide little to no symptomatic and endoscopic benefit.\nRabeprazole given at different doses (0.5 mg/kg and 1 mg/kg) may provide similar symptom improvement (127 children in total; very low-certainty evidence). In the lower-dose group (0.5 mg/kg), symptom scores improved in both a low-weight group of children (< 15 kg) (mean -10.6 ± SD 11.13) and a high-weight group of children (> 15 kg) (mean -13.6 ± 13.1). In the higher-dose groups (1 mg/kg), scores improved in the low-weight (-9 ± 11.2) and higher-weight groups (-8.3 ± 9.2). For the higher-weight group, symptom score mean difference between the two different dosing regimens was 2.3 (95% CI -2 to 6.6), and for the lower-weight group, symptom score MD was 4.6 (95% CI -2.9 to 12).\nPantoprazole: pantoprazole may or may not improve symptom scores at 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg pantoprazole in children aged one to five years by week eight, with no difference between 0.3 mg/kg and 1.2 mg/kg dosing (0.3 mg/kg mean −2.4 ± 1.7; 1.2 mg/kg −1.7 ± 1.2: MD 0.7 (95% CI -0.4 to 1.8)) (one study, 60 children; very low-certainty evidence).\nThere were insufficient summary data to assess other medications.\nAuthors' conclusions\nThere is very low-certainty evidence about symptom improvements and changes in pH indices for infants. There are no summary data for endoscopic changes. Medications may or may not provide a benefit (based on very low-certainty evidence) for infants whose symptoms remain bothersome, despite nonmedical interventions or parental reassurance. If a medication is required, there is no clear evidence based on summary data for omeprazole, esomeprazole (in neonates), H₂antagonists, and alginates for symptom improvements (very low-certainty evidence). Further studies with longer follow-up are needed.\nIn older children with GORD, in studies with summary data extracted, there is very low-certainty evidence that PPIs (rabeprazole and pantoprazole) may or may not improve GORD outcomes. No robust data exist for other medications.\nFurther RCT evidence is required in all areas, including subgroups (preterm babies and children with neurodisabilities).\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": "- the evidence for medications for babies with gastro-oesophageal reflux/reflux disease is very uncertain;\n- for children with gastro-oesophageal reflux disease, the evidence is very uncertain regarding the effects of proton pump inhibitors. There was no adequate evidence to draw conclusions regarding other medications."
}
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query-laysum | 5796 | [
{
"role": "user",
"content": "Abstract: Background\nEndometriosis is associated with pain and infertility. Surgical interventions aim to remove visible areas of endometriosis and restore the anatomy.\nObjectives\nTo assess the effectiveness and safety of laparoscopic surgery in the treatment of pain and infertility associated with endometriosis.\nSearch methods\nThis review has drawn on the search strategy developed by the Cochrane Gynaecology and Fertility Group including searching the Cochrane Gynaecology and Fertility Group's specialised register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, reference lists for relevant trials, and trial registries from inception to April 2020.\nSelection criteria\nWe selected randomised controlled trials (RCTs) that compared the effectiveness and safety of laparoscopic surgery with any other laparoscopic or robotic intervention, holistic or medical treatment, or diagnostic laparoscopy only.\nData collection and analysis\nTwo review authors independently performed selection of studies, assessment of trial quality and extraction of relevant data with disagreements resolved by a third review author. We collected data for the core outcome set for endometriosis. Primary outcomes included overall pain and live birth. We evaluated the quality of evidence using GRADE methods.\nMain results\nWe included 14 RCTs. The studies randomised 1563 women with endometriosis. Four RCTs compared laparoscopic ablation or excision with diagnostic laparoscopy only. Two RCTs compared laparoscopic excision with diagnostic laparoscopy only. One RCT compared laparoscopic ablation or excision with laparoscopic ablation or excision and uterine suspension. Two RCTs compared laparoscopic ablation and uterine nerve transection with diagnostic laparoscopy only. One RCT compared laparoscopic ablation with diagnostic laparoscopy and gonadotropin-releasing hormone (GnRH) analogues. Two RCTs compared laparoscopic ablation with laparoscopic excision. One RCT compared laparoscopic ablation or excision with helium thermal coagulator with laparoscopic ablation or excision with electrodiathermy. One RCT compared conservative laparoscopic surgery with laparoscopic colorectal resection of deep endometriosis infiltrating the rectum. Common limitations in the primary studies included lack of clearly described blinding, failure to fully describe methods of randomisation and allocation concealment, and poor reporting of outcome data.\nLaparoscopic treatment versus diagnostic laparoscopy\nWe are uncertain of the effect of laparoscopic treatment on overall pain scores compared to diagnostic laparoscopy only at six months (mean difference (MD) 0.90, 95% confidence interval (CI) 0.31 to 1.49; 1 RCT, 16 participants; very low quality evidence) and at 12 months (MD 1.65, 95% CI 1.11 to 2.19; 1 RCT, 16 participants; very low quality evidence), where a positive value means pain relief (the higher the score, the more pain relief) and a negative value reflects pain increase (the lower the score, the worse the increase in pain). No studies looked at live birth.\nWe are uncertain of the effect of laparoscopic treatment on quality of life compared to diagnostic laparoscopy only: EuroQol-5D index summary at six months (MD 0.03, 95% CI –0.12 to 0.18; 1 RCT, 39 participants; low quality evidence), 12-item Short Form (SF-12) mental health component (MD 2.30, 95% CI –4.50 to 9.10; 1 RCT, 39 participants; low quality evidence) and SF-12 physical health component (MD 2.70, 95% CI –2.90 to 8.30; 1 RCT, 39 participants; low quality evidence). Laparoscopic treatment probably improves viable intrauterine pregnancy rate compared to diagnostic laparoscopy only (odds ratio (OR) 1.89, 95% CI 1.25 to 2.86; 3 RCTs, 528 participants; I2 = 0%; moderate quality evidence). We are uncertain of the effect of laparoscopic treatment compared to diagnostic laparoscopy only on ectopic pregnancy (MD 1.18, 95% CI 0.10 to 13.48; 1 RCT, 100 participants; low quality evidence) and miscarriage (MD 0.94, 95% CI 0.35 to 2.54; 2 RCTs, 112 participants; low quality evidence). There was limited reporting of adverse events. No conversions to laparotomy were reported in both groups (1 RCT, 341 participants).\nLaparoscopic ablation and uterine nerve transection versus diagnostic laparoscopy\nWe are uncertain of the effect of laparoscopic ablation and uterine nerve transection on adverse events (more specifically vascular injury) compared to diagnostic laparoscopy only (OR 0.33, 95% CI 0.01 to 8.32; 1 RCT, 141 participants; low quality evidence). No studies looked at overall pain scores (at six and 12 months), live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage.\nLaparoscopic ablation versus laparoscopic excision\nThere was insufficient evidence to determine whether there was a difference in overall pain, measured at 12 months, for laparoscopic ablation compared with laparoscopic excision (MD 0.00, 95% CI –1.22 to 1.22; 1 RCT, 103 participants; very low quality evidence). No studies looked at overall pain scores at six months, live birth, quality of life, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy, miscarriage and adverse events.\nHelium thermal coagulator versus electrodiathermy\nWe are uncertain whether helium thermal coagulator compared to electrodiathermy improves quality of life using the 30-item Endometriosis Health Profile (EHP-30) at nine months, when considering the components: pain (MD 6.68, 95% CI –3.07 to 16.43; 1 RCT, 119 participants; very low quality evidence), control and powerlessness (MD 4.79, 95% CI –6.92 to 16.50; 1 RCT, 119 participants; very low quality evidence), emotional well-being (MD 6.17, 95% CI –3.95 to 16.29; 1 RCT, 119 participants; very low quality evidence) and social support (MD 5.62, 95% CI –6.21 to 17.45; 1 RCT, 119 participants; very low quality evidence). Adverse events were not estimable. No studies looked at overall pain scores (at six and 12 months), live birth, viable intrauterine pregnancy confirmed by ultrasound, ectopic pregnancy and miscarriage.\nAuthors' conclusions\nCompared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. No data were reported on live birth. There is moderate quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only. No studies were found that looked at live birth for any of the comparisons. Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions. There was insufficient evidence on adverse events to allow any conclusions to be drawn regarding safety.\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 that it is uncertain whether laparoscopic surgery improves overall pain compared to diagnostic laparoscopy only. Unfortunately, there were no data on live birth; however, we found that laparoscopic surgery may increase intrauterine (within the womb) pregnancy rates compared to diagnostic laparoscopy only. We are uncertain whether laparoscopic excision is more effective than ablation in relieving pain, although this result came from a single study. There was insufficient evidence on side effects to allow any conclusions to be drawn regarding safety."
}
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query-laysum | 5797 | [
{
"role": "user",
"content": "Abstract: Background\nMany women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined evidence about the use of acupuncture and acupressure for pain management in labour. This is an update of a review last published in 2011.\nObjectives\nTo examine the effects of acupuncture and acupressure for pain management in labour.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, (25 February 2019), the Cochrane Central Register of Controlled Trials (the Cochrane Library 2019, Issue 1), MEDLINE (1966 to February 2019), CINAHL (1980 to February 2019), ClinicalTrials.gov (February 2019), the WHO International Clinical Trials Registry Platfory (ICTRP) (February 2019) and reference lists of included studies.\nSelection criteria\nPublished and unpublished randomised controlled trials (RCTs) comparing acupuncture or acupressure with placebo, no treatment or other non-pharmacological forms of pain management in labour. We included all women whether nulliparous or multiparous, and in spontaneous or induced labour.\nWe included studies reported in abstract form if there was sufficient information to permit assessment of risk of bias. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 28 trials with data reporting on 3960 women. Thirteen trials reported on acupuncture and 15 trials reported on acupressure. No study was at a low risk of bias on all domains. Pain intensity was generally measured on a visual analogue scale (VAS) of 0 to 10 or 0 to 100 with low scores indicating less pain.\nAcupuncture versus sham acupuncture\nAcupuncture may make little or no difference to the intensity of pain felt by women when compared with sham acupuncture (mean difference (MD) -4.42, 95% confidence interval (CI) -12.94 to 4.09, 2 trials, 325 women, low-certainty evidence). Acupuncture may increase satisfaction with pain relief compared to sham acupuncture (risk ratio (RR) 2.38, 95% CI 1.78 to 3.19, 1 trial, 150 women, moderate-certainty evidence), and probably reduces the use of pharmacological analgesia (RR 0.75, 95% CI 0.63 to 0.89, 2 trials, 261 women, moderate-certainty evidence). Acupuncture may have no effect on assisted vaginal birth (very low-certainty evidence), and probably little to no effect on caesarean section (low-certainty evidence).\nAcupuncture compared to usual care\nWe are uncertain if acupuncture reduces pain intensity compared to usual care because the evidence was found to be very low certainty (standardised mean difference (SMD) -1.31, 95% CI -2.14 to -0.49, 4 trials, 495 women, I2 = 93%). Acupuncture may have little to no effect on satisfaction with pain relief (low-certainty evidence). We are uncertain if acupuncture reduces the use of pharmacological analgesia because the evidence was found to be very low certainty (average RR 0.72, 95% CI 0.60 to 0.85, 6 trials, 1059 women, I2 = 70%). Acupuncture probably has little to no effect on assisted vaginal birth (low-certainty evidence) or caesarean section (low-certainty evidence).\nAcupuncture compared to no treatment\nOne trial compared acupuncture to no treatment. We are uncertain if acupuncture reduces pain intensity (MD -1.16, 95% CI -1.51 to -0.81, 163 women, very low-certainty evidence), assisted vaginal birth or caesarean section because the evidence was found to be very low certainty.\nAcupuncture compared to sterile water injection\nWe are uncertain if acupuncture has any effect on use of pharmacological analgesia, assisted vaginal birth or caesarean section because the evidence was found to be very low certainty.\nAcupressure compared to a sham control\nWe are uncertain if acupressure reduces pain intensity in labour (MD -1.93, 95% CI -3.31 to -0.55, 6 trials, 472 women) or assisted vaginal birth because the evidence was found to be very low certainty. Acupressure may have little to no effect on use of pharmacological analgesia (low-certainty evidence). Acupressure probably reduces the caesarean section rate (RR 0.44, 95% CI 0.27 to 0.71, 4 trials, 313 women, moderate-certainty evidence).\nAcupressure compared to usual care\nWe are uncertain if acupressure reduces pain intensity in labour (SMD -1.07, 95% CI -1.45 to -0.69, 8 trials, 620 women) or increases satisfaction with pain relief (MD 1.05, 95% CI 0.75 to 1.35, 1 trial, 105 women) because the evidence was found to be very low certainty. Acupressure may have little to no effect on caesarean section (low-certainty evidence).\nAcupressure compared to a combined control\nAcupressure probably slightly reduces the intensity of pain during labour compared with the combined control (measured on a scale of 0 to 10 with low scores indicating less pain) (SMD -0.42, 95% CI -0.65 to -0.18, 2 trials, 322 women, moderate-certainty evidence). We are uncertain if acupressure has any effect on the use of pharmacological analgesia (RR 0.94, 95% CI 0.71 to 1.25, 1 trial, 212 women), satisfaction with childbirth, assisted vaginal birth or caesarean section because the certainty of the evidence was all very low.\nNo studies were found that reported on sense of control in labour and only one reported on satisfaction with the childbirth experience.\nAuthors' conclusions\nAcupuncture in comparison to sham acupuncture may increase satisfaction with pain management and reduce use of pharmacological analgesia. Acupressure in comparison to a combined control and usual care may reduce pain intensity. However, for other comparisons of acupuncture and acupressure, we are uncertain about the effects on pain intensity and satisfaction with pain relief due to very low-certainty evidence. Acupuncture may have little to no effect on the rates of caesarean or assisted vaginal birth. Acupressure probably reduces the need for caesarean section in comparison to a sham control. There is a need for further high-quality research that include sham controls and comparisons to usual care and report on the outcomes of sense of control in labour, satisfaction with the childbirth experience or satisfaction with pain relief.\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": "Our updated search in February 2019 identified 17 new trials.\nThis review now includes 28 trials reporting on 3960 women, with 27 trials contributing results. The trials compared acupuncture or acupressure with sham treatment as placebo, no treatment or usual care for pain management during labour. Thirteen trials reported on acupuncture and 15 trials reported on acupressure. For 18 of the 27 trials women were in spontaneous labour. In other studies labour may have been induced.\nEight studies applied individualised traditional Chinese medicine while set acupuncture points were used in the majority of studies. We noted wide variation in how stimulation was applied (manually or with electro-stimulation), duration of needling, number of points used, and depth of needling. It is unclear how representative the trial treatments were of acupuncture in practice.\nMost comparisons suggest a small beneficial effect from acupuncture, though the supporting evidence was limited. We are uncertain if acupuncture reduces the intensity of pain when compared with sham acupuncture (2 trials, 325 women), usual care (4 trials, 495 women) and no treatment (1 trial, 163 women). The certainty of the evidence was low or very low. Acupuncture may increase satisfaction with pain relief compared to sham acupuncture (one trial, moderate-certainty evidence). It slightly reduced the use of pharmacological analgesia compared to sham acupuncture (2 trials, 261 women, moderate-certainty evidence). Use of acupressure was associated with a reduction in pain intensity in labour when compared to a combined control (2 trials, 322 women, moderate-certainty evidence). Acupuncture did not appear to have any effect on the need for assisted vaginal births or caesarean births, but acupressure reduced the rate of caesarean section when compared to sham acupressure."
}
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query-laysum | 5798 | [
{
"role": "user",
"content": "Abstract: Background\nDischarge planning is a routine feature of health systems in many countries that aims to reduce delayed discharge from hospital, and improve the co-ordination of services following discharge from hospital and reduce the risk of hospital readmission. This is the fifth update of the original review.\nObjectives\nTo assess the effectiveness of planning the discharge of individual patients moving from hospital.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two trials registers on 20 April 2021. We searched two other databases up to 31 March 2020. We also conducted reference checking, citation searching and contact with study authors to identify additional studies.\nSelection criteria\nRandomised trials that compared an individualised discharge plan with routine discharge that was not tailored to individual participants. Participants were hospital inpatients.\nData collection and analysis\nTwo review authors independently undertook data analysis and quality assessment using a pre-designed data extraction sheet. We grouped studies by older people with a medical condition, people recovering from surgery, and studies that recruited participants with a mix of conditions. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous data using fixed-effect meta-analysis. When combining outcome data it was not possible because of differences in the reporting of outcomes, we summarised the reported results for each trial in the text.\nMain results\nWe included 33 trials (12,242 participants), four new trials included in this update. The majority of trials (N = 30) recruited participants with a medical diagnosis, average age range 60 to 84 years; four of these trials also recruited participants who were in hospital for a surgical procedure. Participants allocated to discharge planning and who were in hospital for a medical condition had a small reduction in the initial hospital length of stay (MD − 0.73, 95% confidence interval (CI) − 1.33 to − 0.12; 11 trials, 2113 participants; moderate-certainty evidence), and a relative reduction in readmission to hospital over an average of three months follow-up (RR 0.89, 95% CI 0.81 to 0.97; 17 trials, 5126 participants; moderate-certainty evidence). There was little or no difference in participant's health status (mortality at three- to nine-month follow-up: RR 1.05, 95% CI 0.85 to 1.29; 8 trials, 2721 participants; moderate certainty) functional status and psychological health measured by a range of measures, 12 studies, 2927 participants; low certainty evidence). There was some evidence that satisfaction might be increased for patients (7 trials), caregivers (1 trial) or healthcare professionals (2 trials) (very low certainty evidence). The cost of a structured discharge plan compared with routine discharge is uncertain (7 trials recruiting 7873 participants with a medical condition; very low certainty evidence).\nAuthors' conclusions\nA structured discharge plan that is tailored to the individual patient probably brings about a small reduction in the initial hospital length of stay and readmissions to hospital for older people with a medical condition, may slightly increase patient satisfaction with healthcare received. The impact on patient health status and healthcare resource use or cost to the health service is uncertain.\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": "When people leave hospital with a personalised discharge plan there is probably a small reduction in length of stay, they are probably slightly less likely to be admitted to hospital after their discharge from hospital. There is little evidence on the impact on patient health status, patient satisfaction with the care received. The cost of discharge planning is uncertain."
}
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query-laysum | 5799 | [
{
"role": "user",
"content": "Abstract: Background\nBreast cancer-related lymphoedema can be a debilitating long-term sequela of breast cancer treatment. Several studies have investigated the effectiveness of different treatment strategies to reduce the risk of breast cancer-related lymphoedema.\nObjectives\nTo assess the effects of conservative (non-surgical and non-pharmacological) interventions for preventing clinically-detectable upper-limb lymphoedema after breast cancer treatment.\nSearch methods\nWe searched the Cochrane Breast Cancer Group's (CBCG) Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL, PEDro, PsycINFO, and the World Health Organization (WHO) International Clinical Trials Registry Platform in May 2013. Reference lists of included trials and other systematic reviews were searched.\nSelection criteria\nRandomised controlled trials that reported lymphoedema as the primary outcome and compared any conservative intervention to either no intervention or to another conservative intervention.\nData collection and analysis\nThree authors independently assessed the risk of bias and extracted data. Outcome measures included lymphoedema, infection, range of motion of the shoulder, pain, psychosocial morbidity, level of functioning in activities of daily life (ADL), and health-related quality of life (HRQoL). Where possible, meta-analyses were performed. Risk ratio (RRs) or hazard ratio (HRs) were reported for dichotomous outcomes or lymphoedema incidence, and mean differences (MDs) for range of motion and patient-reported outcomes.\nMain results\nTen trials involving 1205 participants were included. The duration of patient follow-up ranged from 2 days to 2 years after the intervention. Overall, the quality of the evidence generated by these trials was low, due to risk of bias in the included trials and inconsistency in the results.\nManual lymph drainage\nIn total, four studies used manual lymph drainage (MLD) in combination with usual care or other interventions. In one study, lymphoedema incidence was lower in patients receiving MLD and usual care (consisting of standard education or exercise, or both) compared to usual care alone. A second study reported no difference in lymphoedema incidence when MLD was combined with physiotherapy and education compared to physiotherapy alone. Two other studies combining MLD with compression and scar massage or exercise observed a reduction in lymphoedema incidence compared to education only, although this was not significant in one of the studies. Two out of the four studies reported on shoulder mobility where MLD combined with exercise gave better shoulder mobility for lateral arm movement (shoulder abduction) and forward flexion in the first weeks after breast cancer surgery, compared to education only (mean difference for abduction 22°; 95% confidence interval (CI) 14 to 30; mean difference for forward flexion 14°; 95% CI 7 to 22). Two of the studies on MLD reported on pain, with inconsistent results. Results on HRQoL in two studies on MLD were also contradictory.\nExercise: early versus delayed start of shoulder mobilising exercises\nThree studies examined early versus late start of postoperative shoulder exercises. The pooled relative risk of lymphoedema after an early start of exercises was 1.69 (95% CI 0.94 to 3.01, 3 studies, 378 participants). Shoulder forward flexion was better at one and six months follow-up for participants who started early with mobilisation exercises compared to a delayed start (two studies), but no meta-analysis could be performed due to statistical heterogeneity. There was no difference in shoulder mobility or self-reported shoulder disability at 12 months follow-up (one study). One study evaluated HRQoL and reported difference at one year follow-up (mean difference 1.6 points, 95% CI -2.14 to 5.34, on the Trial Outcome Index of the FACT-B). Two studies collected data on wound drainage volumes and only one study reported higher wound drainage volumes in the early exercise group.\nExercise: resistance training\nTwo studies compared progressive resistance training to restricted activity. Resistance training after breast cancer treatment did not increase the risk of developing lymphoedema (RR 0.58; 95% CI 0.30 to 1.13, two studies, 358 participants) provided that symptoms are monitored and treated immediately if they occur. One out of the two studies measured pain where participants in the resistance training group reported pain more often at three months and six months compared to the control group. One study reported HRQoL and found no significant difference between the groups.\nPatient education, monitoring and early intervention\nOne study investigated the effects of a comprehensive outpatient follow-up programme, consisting of patient education, exercise, monitoring of lymphoedema symptoms and early intervention for lymphoedema, compared to education alone. Lymphoedema incidence was lower in the comprehensive outpatient follow-up programme (at any time point) compared to education alone (65 people). Participants in the outpatient follow-up programme had a significantly faster recovery of shoulder abduction compared to the education alone group.\nAuthors' conclusions\nBased on the current available evidence, we cannot draw firm conclusions about the effectiveness of interventions containing MLD. The evidence does not indicate a higher risk of lymphoedema when starting shoulder-mobilising exercises early after surgery compared to a delayed start (i.e. seven days after surgery). Shoulder mobility (that is, lateral arm movements and forward flexion) is better in the short term when starting shoulder exercises earlier compared to later. The evidence suggests that progressive resistance exercise therapy does not increase the risk of developing lymphoedema, provided that symptoms are closely monitored and adequately treated if they occur.\nGiven the degree of heterogeneity encountered, limited precision, and the risk of bias across the included studies, the results of this review should be interpreted with caution.\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": "No firm conclusion can be drawn about the effect of manual lymph drainage in addition to exercise and education on preventing the incidence of lymphoedema. This is because the two included studies found contradicting results. In addition, no firm conclusion can be drawn about manual lymph drainage in combination with other interventions, because only two studies were found that each tested different combinations. One of these studies found that manual lymph drainage combined with exercise lowered the risk of lymphoedema. The other study combined manual lymph drainage with compression, but this study was too small to draw conclusions.\nArm mobility (i.e. reaching upwards over the head) was better after manual lymph drainage than without it, but this improvement lasted only for the first few weeks after breast cancer surgery.\nWhen assessing whether early or late shoulder exercises reduced the likelihood of developing lymphoedema, the studies did not provide a clear result. The likely incidence of lymphoedema ranged from 5% to 27% (early start) compared to 4% to 20% (for delayed start) during the first 6 to 12 months after surgery. Starting shoulder exercises immediately after surgery may improve shoulder mobility in the first month, compared to starting after the first week but no firm conclusions can be drawn and mobility is comparable later on.\nProgressive resistance training did not increase the risk of developing lymphoedema compared to restricted activity, on the basis that symptoms were monitored and treated immediately if they occurred.\nFor all investigated interventions, no firm conclusion can be drawn about their effectiveness in reducing pain or improving quality of life."
}
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query-laysum | 5800 | [
{
"role": "user",
"content": "Abstract: Background\nCocaine misuse is a disorder for which no pharmacological treatment of proven efficacy exists. Advances in neurobiology could guide future medication development.\nObjectives\nTo investigate the efficacy and acceptability of dopamine agonists alone or in combination with any psychosocial intervention for the treatment of of people who misuse cocaine.\nSearch methods\nWe run the search on 12 January 2015. We searched the Cochrane Drugs and Alcohol Group (CDAG) Specialized Register, PubMed, EMBASE, CINAHL, PsycINFO, ICTRP, clinicaltrials.gov and screened reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing dopamine agonists alone or associated with psychosocial intervention with placebo, no treatment or other pharmacological interventions.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nTwenty four studies, including 2147 participants, met the inclusion criteria. Comparing any dopamine agonist versus placebo, we found no differences for any of the outcomes considered: dropout (moderate quality of evidence), abstinence (low quality of evidence), severity of dependence (low quality of evidence), adverse events (moderate quality of evidence). This was also observed when single dopamine agonists were compared against placebo. Comparing amantadine versus antidepressants, we found low quality of evidence that antidepressants performed better for abstinence (RR 0.25, 95% CI 0.12 to 0.53) based on two studies with 44 participants. No differences were found for dropout or adverse events, for both moderate quality of evidence.\nThe major flaws of the included studies concerned selection bias because most studies did not report information about sequence generation (80%) and allocation concealment methods (86%): half of the included studies were judged at unclear risk of performance bias and 62.5% at unclear risk of detection bias for what concerns subjective outcomes.\nAuthors' conclusions\nCurrent evidence from RCTs does not support the use of dopamine agonists for treating cocaine misuse. This absence of evidence may leave to clinicians the alternative of balancing the possible benefits against the potential adverse effects of the treatment. Even the potential benefit of combining a dopamine agonist with a more potent psychosocial intervention, which was suggested by the previous Cochrane Review (Soares 2003), is not supported by the results of this Cochrane Review update.\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 pharmacological agent with proven efficacy does not exist for treatment of cocaine misuse. Cocaine is an alkaloid derived from the erythroxylon coca leaf that is used as powder for intranasal or intravenous use or as crack, a free-base form which is smoked. Cocaine misuse is a major public health problem because its use can be associated with medical and psychosocial complications including the spread of infectious diseases (such as AIDS, hepatitis and tuberculosis), crime, violence and neonatal drug exposure. In this Cochrane Review we looked at the evidence on the efficacy and acceptability of dopamine agonists as a treatment, used either alone or in combination with any psychosocial intervention, for people addicted to cocaine."
}
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query-laysum | 5801 | [
{
"role": "user",
"content": "Abstract: Background\nProgrammes that introduce rapid molecular tests for tuberculosis and tuberculosis drug resistance aim to bring tests closer to the community, and thereby cut delay in diagnosis, ensure early treatment, and improve health outcomes, as well as overcome problems with poor laboratory infrastructure and inadequately trained personnel. Yet, diagnostic technologies only have an impact if they are put to use in a correct and timely manner. Views of the intended beneficiaries are important in uptake of diagnostics, and their effective use also depends on those implementing testing programmes, including providers, laboratory professionals, and staff in health ministries. Otherwise, there is a risk these technologies will not fit their intended use and setting, cannot be made to work and scale up, and are not used by, or not accessible to, those in need.\nObjectives\nTo synthesize end-user and professional user perspectives and experiences with low-complexity nucleic acid amplification tests (NAATs) for detection of tuberculosis and tuberculosis drug resistance; and to identify implications for effective implementation and health equity.\nSearch methods\nWe searched MEDLINE, Embase, CINAHL, PsycInfo and Science Citation Index Expanded databases for eligible studies from 1 January 2007 up to 20 October 2021. We limited all searches to 2007 onward because the development of Xpert MTB/RIF, the first rapid molecular test in this review, was completed in 2009.\nSelection criteria\nWe included studies that used qualitative methods for data collection and analysis, and were focused on perspectives and experiences of users and potential users of low-complexity NAATs to diagnose tuberculosis and drug-resistant tuberculosis. NAATs included Xpert MTB/RIF, Xpert MTB/RIF Ultra, Xpert MTB/XDR, and the Truenat assays. Users were people with presumptive or confirmed tuberculosis and drug-resistant tuberculosis (including multidrug-resistant (MDR-TB)) and their caregivers, healthcare providers, laboratory technicians and managers, and programme officers and staff; and were from any type of health facility and setting globally. MDR-TB is tuberculosis caused by resistance to at least rifampicin and isoniazid, the two most effective first-line drugs used to treat tuberculosis.\nData collection and analysis\nWe used a thematic analysis approach for data extraction and synthesis, and assessed confidence in the findings using GRADE CERQual approach. We developed a conceptual framework to illustrate how the findings relate.\nMain results\nWe found 32 studies. All studies were conducted in low- and middle-income countries. Twenty-seven studies were conducted in high-tuberculosis burden countries and 21 studies in high-MDR-TB burden countries. Only one study was from an Eastern European country. While the studies covered a diverse use of low-complexity NAATs, in only a minority of studies was it used as the initial diagnostic test for all people with presumptive tuberculosis.\nWe identified 18 review findings and grouped them into three overarching categories.\nCritical aspects users value\nPeople with tuberculosis valued reaching diagnostic closure with an accurate diagnosis, avoiding diagnostic delays, and keeping diagnostic-associated cost low. Similarly, healthcare providers valued aspects of accuracy and the resulting confidence in low-complexity NAAT results, rapid turnaround times, and keeping cost to people seeking a diagnosis low. In addition, providers valued diversity of sample types (for example, gastric aspirate specimens and stool in children) and drug resistance information. Laboratory professionals appreciated the improved ease of use, ergonomics, and biosafety of low-complexity NAATs compared to sputum microscopy, and increased staff satisfaction.\nChallenges reported to realizing those values\nPeople with tuberculosis and healthcare workers were reluctant to test for tuberculosis (including MDR-TB) due to fears, stigma, or cost concerns. Thus, low-complexity NAAT testing is not implemented with sufficient support or discretion to overcome barriers that are common to other approaches to testing for tuberculosis. Delays were reported at many steps of the diagnostic pathway owing to poor sample quality; difficulties with transporting specimens; lack of sufficient resources; maintenance of low-complexity NAATs; increased workload; inefficient work and patient flows; over-reliance on low-complexity NAAT results in lieu of clinical judgement; and lack of data-driven and inclusive implementation processes. These challenges were reported to lead to underutilization.\nConcerns for access and equity\nThe reported concerns included sustainable funding and maintenance and equitable use of resources to access low-complexity NAATs, as well as conflicts of interest between donors and people implementing the tests. Also, lengthy diagnostic delays, underutilization of low-complexity NAATs, lack of tuberculosis diagnostic facilities in the community, and too many eligibility restrictions hampered access to prompt and accurate testing and treatment. This was particularly the case for vulnerable groups, such as children, people with MDR-TB, or people with limited ability to pay.\nWe had high confidence in most of our findings.\nAuthors' conclusions\nLow-complexity diagnostics have been presented as a solution to overcome deficiencies in laboratory infrastructure and lack of skilled professionals. This review indicates this is misleading. The lack of infrastructure and human resources undermine the added value new diagnostics of low complexity have for recipients and providers. We had high confidence in the evidence contributing to these review findings.\nImplementation of new diagnostic technologies, like those considered in this review, will need to tackle the challenges identified in this review including weak infrastructure and systems, and insufficient data on ground level realities prior and during implementation, as well as problems of conflicts of interest in order to ensure equitable use of resources.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to understand the experiences and opinions of people using rapid automated tests that identify tuberculosis and resistance to tuberculosis drugs (molecular diagnostic tests). Users include people who might have tuberculosis and their families or caregivers, doctors, nurses, laboratory staff, and managers of services or programmes."
}
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query-laysum | 5802 | [
{
"role": "user",
"content": "Abstract: Background\nThe mean age of women undergoing local treatment for pre-invasive cervical disease (cervical intra-epithelial neoplasia; CIN) or early cervical cancer (stage IA1) is around their 30s and similar to the age of women having their first child. Local cervical treatment has been correlated to adverse reproductive morbidity in a subsequent pregnancy, however, published studies and meta-analyses have reached contradictory conclusions.\nObjectives\nTo assess the effect of local cervical treatment for CIN and early cervical cancer on obstetric outcomes (after 24 weeks of gestation) and to correlate these to the cone depth and comparison group used.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, 2017, Issue 5), MEDLINE (up to June week 4, 2017) and Embase (up to week 26, 2017). In an attempt to identify articles missed by the search or unpublished data, we contacted experts in the field and we handsearched the references of the retrieved articles and conference proceedings.\nSelection criteria\nWe included all studies reporting on obstetric outcomes (more than 24 weeks of gestation) in women with or without a previous local cervical treatment for any grade of CIN or early cervical cancer (stage IA1). Treatment included both excisional and ablative methods. We excluded studies that had no untreated reference population, reported outcomes in women who had undergone treatment during pregnancy or had a high-risk treated or comparison group, or both\nData collection and analysis\nWe classified studies according to the type of treatment and the obstetric endpoint. Studies were classified according to method and obstetric endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CIs) were calculated using a random-effects model and inverse variance. Inter-study heterogeneity was assessed with I2 statistics. We assessed maternal outcomes that included preterm birth (PTB) (spontaneous and threatened), preterm premature rupture of the membranes (pPROM), chorioamnionitis, mode of delivery, length of labour, induction of delivery, oxytocin use, haemorrhage, analgesia, cervical cerclage and cervical stenosis. The neonatal outcomes included low birth weight (LBW), neonatal intensive care unit (NICU) admission, stillbirth, perinatal mortality and Apgar scores.\nMain results\nWe included 69 studies (6,357,823 pregnancies: 65,098 pregnancies of treated and 6,292,725 pregnancies of untreated women). Many of the studies included only small numbers of women, were of heterogenous design and in their majority retrospective and therefore at high risk of bias. Many outcomes were assessed to be of low or very low quality (GRADE assessment) and therefore results should be interpreted with caution. Women who had treatment were at increased overall risk of preterm birth (PTB) (less than 37 weeks) (10.7% versus 5.4%, RR 1.75, 95% CI 1.57 to 1.96, 59 studies, 5,242,917 participants, very low quality), severe (less than 32 to 34 weeks) (3.5% versus 1.4%, RR 2.25, 95% CI 1.79 to 2.82), 24 studies, 3,793,874 participants, very low quality), and extreme prematurity (less than 28 to 30 weeks) (1.0% versus 0.3%, (RR 2.23, 95% CI 1.55 to 3.22, 8 studies, 3,910,629 participants, very low quality), as compared to women who had no treatment.\nThe risk of overall prematurity was higher for excisional (excision versus no treatment: 11.2% versus 5.5%, RR 1.87, 95% CI 1.64 to 2.12, 53 studies, 4,599,416 participants) than ablative (ablation versus no treatment: 7.7% versus 4.6%, RR 1.35, 95% CI 1.20 to 1.52, 14 studies, 602,370 participants) treatments and the effect was higher for more radical excisional techniques (less than 37 weeks: cold knife conisation (CKC) (RR 2.70, 95% CI 2.14 to 3.40, 12 studies, 39,102 participants), laser conisation (LC) (RR 2.11, 95% CI 1.26 to 3.54, 9 studies, 1509 participants), large loop excision of the transformation zone (LLETZ) (RR 1.58, 95% CI 1.37 to 1.81, 25 studies, 1,445,104 participants). Repeat treatment multiplied the risk of overall prematurity (repeat versus no treatment: 13.2% versus 4.1%, RR 3.78, 95% CI 2.65 to 5.39, 11 studies, 1,317,284 participants, very low quality). The risk of overall prematurity increased with increasing cone depth (less than 10 mm to 12 mm versus no treatment: 7.1% versus 3.4%, RR 1.54, 95% CI 1.09 to 2.18, 8 studies, 550,929 participants, very low quality; more than 10 mm to 12 mm versus no treatment: 9.8% versus 3.4%, RR 1.93, 95% CI 1.62 to 2.31, 8 studies, 552,711 participants, low quality; more than 15 mm to 17 mm versus no treatment: 10.1 versus 3.4%, RR 2.77, 95% CI 1.95 to 3.93, 4 studies, 544,986 participants, very low quality; 20 mm or more versus no treatment: 10.2% versus 3.4%, RR 4.91, 95% CI 2.06 to 11.68, 3 studies, 543,750 participants, very low quality). The comparison group affected the magnitude of effect that was higher for external, followed by internal comparators and ultimately women with disease, but no treatment. Untreated women with disease and the pre-treatment pregnancies of the women who were treated subsequently had higher risk of overall prematurity than the general population (5.9% versus 5.6%, RR 1.24, 95% CI 1.14 to 1.34, 15 studies, 4,357,998 participants, very low quality).\npPROM (6.1% versus 3.4%, RR 2.36, 95% CI 1.76 to 3.17, 21 studies, 477,011 participants, very low quality), low birth weight (7.9% versus 3.7%, RR 1.81, 95% CI 1.58 to 2.07, 30 studies, 1,348,206 participants, very low quality), NICU admission rate (12.6% versus 8.9%, RR 1.45, 95% CI 1.16 to 1.81, 8 studies, 2557 participants, low quality) and perinatal mortality (0.9% versus 0.7%, RR 1.51, 95% CI 1.13 to 2.03, 23 studies, 1,659,433 participants, low quality) were also increased after treatment.\nAuthors' conclusions\nWomen with CIN have a higher baseline risk for prematurity. Excisional and ablative treatment appears to further increases that risk. The frequency and severity of adverse sequelae increases with increasing cone depth and is higher for excision than it is for ablation. However, the results should be interpreted with caution as they were based on low or very low quality (GRADE assessment) observational studies, most of which were retrospective.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to assess whether the local conservative treatment techniques for cervical precancer (CIN) and early cervical cancer increased the risk of complications for mother and baby during pregnancy occurring after treatment, and especially whether treatment is associated with an increase in the risk of PTB. We also studied whether the risk of PTB increases with increasing amount of cervical tissue removed."
}
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query-laysum | 5803 | [
{
"role": "user",
"content": "Abstract: Background\nThe role of vitamin D supplementation as a treatment for COVID-19 has been a subject of considerable discussion. A thorough understanding of the current evidence regarding the effectiveness and safety of vitamin D supplementation for COVID-19 based on randomised controlled trials is required.\nObjectives\nTo assess whether vitamin D supplementation is effective and safe for the treatment of COVID-19 in comparison to an active comparator, placebo, or standard of care alone, and to maintain the currency of the evidence, using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register, Web of Science and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 11 March 2021.\nSelection criteria\nWe followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating vitamin D supplementation for people with COVID-19, irrespective of disease severity, age, gender or ethnicity.\nWe excluded studies investigating preventive effects, or studies including populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)).\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies, we used the Cochrane risk of bias tool (ROB 2) for RCTs. We rated the certainty of evidence using the GRADE approach for the following prioritised outcome categories: individuals with moderate or severe COVID-19: all-cause mortality, clinical status, quality of life, adverse events, serious adverse events, and for individuals with asymptomatic or mild disease: all-cause mortality, development of severe clinical COVID-19 symptoms, quality of life, adverse events, serious adverse events.\nMain results\nWe identified three RCTs with 356 participants, of whom 183 received vitamin D. In accordance with the World Health Organization (WHO) clinical progression scale, two studies investigated participants with moderate or severe disease, and one study individuals with mild or asymptomatic disease. The control groups consisted of placebo treatment or standard of care alone.\nEffectiveness of vitamin D supplementation for people with COVID-19 and moderate to severe disease\nWe included two studies with 313 participants. Due to substantial clinical and methodological diversity of both studies, we were not able to pool data. Vitamin D status was unknown in one study, whereas the other study reported data for vitamin D deficient participants. One study administered multiple doses of oral calcifediol at days 1, 3 and 7, whereas the other study gave a single high dose of oral cholecalciferol at baseline. We assessed one study with low risk of bias for effectiveness outcomes, and the other with some concerns about randomisation and selective reporting.\nAll-cause mortality at hospital discharge (313 participants)\nWe found two studies reporting data for this outcome. One study reported no deaths when treated with vitamin D out of 50 participants, compared to two deaths out of 26 participants in the control group (Risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.13). The other study reported nine deaths out of 119 individuals in the vitamin D group, whereas six participants out of 118 died in the placebo group (RR 1.49, 95% CI 0.55 to 4.04]. We are very uncertain whether vitamin D has an effect on all-cause mortality at hospital discharge (very low-certainty evidence).\nClinical status assessed by the need for invasive mechanical ventilation (237 participants)\nWe found one study reporting data for this outcome. Nine out of 119 participants needed invasive mechanical ventilation when treated with vitamin D, compared to 17 out of 118 participants in the placebo group (RR 0.52, 95% CI 0.24 to 1.13). Vitamin D supplementation may decrease need for invasive mechanical ventilation, but the evidence is uncertain (low-certainty evidence).\nQuality of life\nWe did not find data for quality of life.\nSafety of vitamin D supplementation for people with COVID-19 and moderate to severe disease\nWe did not include data from one study, because assessment of serious adverse events was not described and we are concerned that data might have been inconsistently measured. This study reported vomiting in one out of 119 participants immediately after vitamin D intake (RR 2.98, 95% CI 0.12 to 72.30). We are very uncertain whether vitamin D supplementation is associated with higher risk for adverse events (very low-certainty).\nEffectiveness and safety of vitamin D supplementation for people with COVID-19 and asymptomatic or mild disease\nWe found one study including 40 individuals, which did not report our prioritised outcomes, but instead data for viral clearance, inflammatory markers, and vitamin D serum levels. The authors reported no events of hypercalcaemia, but recording and assessment of further adverse events remains unclear. Authors administered oral cholecalciferol in daily doses for at least 14 days, and continued with weekly doses if vitamin D blood levels were > 50 ng/mL.\nAuthors' conclusions\nThere is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19. The evidence for the effectiveness of vitamin D supplementation for the treatment of COVID-19 is very uncertain. Moreover, we found only limited safety information, and were concerned about consistency in measurement and recording of these outcomes.\nThere was substantial clinical and methodological heterogeneity of included studies, mainly because of different supplementation strategies, formulations, vitamin D status of participants, and reported outcomes.\nThere is an urgent need for well-designed and adequately powered randomised controlled trials (RCTs) with an appropriate randomisation procedure, comparability of study arms and preferably double-blinding. We identified 21 ongoing and three completed studies without published results, which indicates that these needs will be addressed and that our findings are subject to change in the future. Due to the living approach of this work, we will update the review periodically.\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 assessed the use of vitamin D as a treatment for adults with confirmed COVID-19 compared with a placebo (sham treatment) or another treatment. Vitamin D could be given in any form and in any dose.\nWe compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 5804 | [
{
"role": "user",
"content": "Abstract: Background\nInsomnia disorder is a subjective condition of unsatisfactory sleep (e.g. sleep onset, maintenance, early waking, impairment of daytime functioning). Insomnia disorder impairs quality of life and is associated with an increased risk of physical and mental health problems including anxiety, depression, drug and alcohol abuse, and increased health service use. hypnotic medications (e.g. benzodiazepines and 'Z' drugs) are licensed for sleep promotion, but can induce tolerance and dependence, although many people remain on long-term treatment. Antidepressant use for insomnia is widespread, but none is licensed for insomnia and the evidence for their efficacy is unclear. This use of unlicensed medications may be driven by concern over longer-term use of hypnotics and the limited availability of psychological treatments.\nObjectives\nTo assess the effectiveness, safety and tolerability of antidepressants for insomnia in adults.\nSearch methods\nThis review incorporated the results of searches to July 2015 conducted on electronic bibliographic databases: the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 6), MEDLINE (1950 to 2015), Embase (1980 to 2015) and PsycINFO (1806 to 2015). We updated the searches to December 2017, but these results have not yet been incorporated into the review.\nSelection criteria\nRandomised controlled trials (RCTs) of adults (aged 18 years or older) with a primary diagnosis of insomnia and all participant types including people with comorbidities. Any antidepressant as monotherapy at any dose whether compared with placebo, other medications for insomnia (e.g. benzodiazepines and 'Z' drugs), a different antidepressant, waiting list control or treatment as usual.\nData collection and analysis\nTwo review authors independently assessed trials for eligibility and extracted data using a data extraction form. A third review author resolved disagreements on inclusion or data extraction.\nMain results\nThe search identified 23 RCTs (2806 participants).\nSelective serotonin reuptake inhibitors (SSRIs) compared with placebo: three studies (135 participants) compared SSRIs with placebo. Combining results was not possible. Two paroxetine studies showed significant improvements in subjective sleep measures at six (60 participants, P = 0.03) and 12 weeks (27 participants, P < 0.001). There was no difference in the fluoxetine study (low quality evidence).\nThere were either no adverse events or they were not reported (very low quality evidence).\nTricyclic antidepressants (TCA) compared with placebo: six studies (812 participants) compared TCA with placebo; five used doxepin and one used trimipramine. We found no studies of amitriptyline. Four studies (518 participants) could be pooled, showing a moderate improvement in subjective sleep quality over placebo (standardised mean difference (SMD) -0.39, 95% confidence interval (CI) -0.56 to -0.21) (moderate quality evidence). Moderate quality evidence suggested that TCAs possibly improved sleep efficiency (mean difference (MD) 6.29 percentage points, 95% CI 3.17 to 9.41; 4 studies; 510 participants) and increased sleep time (MD 22.88 minutes, 95% CI 13.17 to 32.59; 4 studies; 510 participants). There may have been little or no impact on sleep latency (MD -4.27 minutes, 95% CI -9.01 to 0.48; 4 studies; 510 participants).\nThere may have been little or no difference in adverse events between TCAs and placebo (risk ratio (RR) 1.02, 95% CI 0.86 to 1.21; 6 studies; 812 participants) (low quality evidence).\n'Other' antidepressants with placebo: eight studies compared other antidepressants with placebo (one used mianserin and seven used trazodone). Three studies (370 participants) of trazodone could be pooled, indicating a moderate improvement in subjective sleep outcomes over placebo (SMD -0.34, 95% CI -0.66 to -0.02). Two studies of trazodone measured polysomnography and found little or no difference in sleep efficiency (MD 1.38 percentage points, 95% CI -2.87 to 5.63; 169 participants) (low quality evidence).\nThere was low quality evidence from two studies of more adverse effects with trazodone than placebo (i.e. morning grogginess, increased dry mouth and thirst).\nAuthors' conclusions\nWe identified relatively few, mostly small studies with short-term follow-up and design limitations. The effects of SSRIs compared with placebo are uncertain with too few studies to draw clear conclusions. There may be a small improvement in sleep quality with short-term use of low-dose doxepin and trazodone compared with placebo. The tolerability and safety of antidepressants for insomnia is uncertain due to limited reporting of adverse events. There was no evidence for amitriptyline (despite common use in clinical practice) or for long-term antidepressant use for insomnia. High-quality trials of antidepressants for insomnia are needed.\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": "People with sleep problems and their doctors will be interested in this review to better understand the research evidence and enable informed decision-making regarding using antidepressants for insomnia."
}
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query-laysum | 5805 | [
{
"role": "user",
"content": "Abstract: Background\nNeuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months.\nObjectives\nTo assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use.\nSearch methods\nWe searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018. We identified additional studies from the reference lists of the retrieved papers. We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies.\nSelection criteria\nWe included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more.\nWe applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant.\nWe excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30%, or 50%, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table.\nMain results\nWe included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies.\nTwo herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2%, nutmeg oil 14%, methyl salicylate 6%, menthol 6%, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 μg total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia.\nBoth reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50% or greater or PGIC (moderate and substantial) outcomes.\nWhen looking at participant-reported pain relief of 30% or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95% confidence interval (CI) 0.69 to 1.85; 48.6% vs 43.2%). We downgraded the evidence for this outcome to very low quality.\nWe observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John’s wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale.\nThere was a total of five withdrawals out of 91 participants (5%) in the treatment groups compared to six of 91 (6.5%) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups.\nWe judged neither study as having a low risk of bias. We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate.\nAuthors' conclusions\nThere was insufficient evidence to determine whether nutmeg or St John's wort has any meaningful efficacy in neuropathic pain conditions.\nThe quality of the current evidence raises serious uncertainties about the estimates of effect observed, therefore, we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of 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"
},
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"role": "assistant",
"content": "Neuropathic pain is a complex and often disabling condition and many people suffer moderate or severe pain for many years, affecting quality of life. This condition is difficult to treat and typically only 40% to 60% of people with this condition achieve partial relief.\nNeuropathic pain is pain coming from damaged nerves. It is different from pain messages that are carried along healthy nerves from damaged tissue (for example, a fall or cut, or arthritic knee). Neuropathic pain is often treated by different medicines to those used for pain from damaged tissue. Medicines that are sometimes used to treat neuropathic pain can have damaging side effects and therefore people are now trying herbal products to help relieve pain instead.\nWe conducted a search for relevant clinical trials in March 2018. We looked for studies in adults suffering from moderate neuropathic pain who took some form of herbal product, either by consuming it in their diet, in tablet form, or by applying it to the skin to relieve pain. We also collected information on side effects these herbal products might have."
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query-laysum | 5806 | [
{
"role": "user",
"content": "Abstract: Background\nLong-term physical conditions affect 10% to 12% of children and adolescents worldwide; these individuals are at greater risk of developing psychological problems, particularly anxiety and depression. Access to face-to-face treatment for such problems is often limited, and available interventions usually have not been tested with this population. As technology improves, e-health interventions (delivered via digital means, such as computers and smart phones and ranging from simple text-based programmes through to multimedia and interactive programmes, serious games, virtual reality and biofeedback programmes) offer a potential solution to address the psychological needs of this group of young people.\nObjectives\nTo assess the effectiveness of e-health interventions in comparison with attention placebos, psychological placebos, treatment as usual, waiting-list controls, or non-psychological treatments for treating anxiety and depression in children and adolescents with long-term physical conditions.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group's Controlled Trials Register (CCMDTR to May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2017), Web of Science (1900 - 18 August 2016, updated 31 August 2017) and Ovid MEDLINE, Embase, PsycINFO (cross-search 2016 to 18 Aug 2017). We hand-searched relevant conference proceedings, reference lists of included articles, and the grey literature to May 2016. We also searched international trial registries to identify unpublished or ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-randomised trials, and cross-over trials of e-health interventions for treating any type of long-term physical condition in children and adolescents (aged 0 to 18 years), and that measured changes in symptoms or diagnoses of anxiety, depression, or subthreshold depression. We defined long-term physical conditions as those that were more than three-months' duration. We assessed symptoms of anxiety and depression using patient- or clinician-administered validated rating scales based on DSM III, IV or 5 (American Psychological Association 2013), or ICD 9 or 10 criteria (World Health Organization 1992). Formal depressive and anxiety disorders were diagnosed using structured clinical interviews. Attention placebo, treatment as usual, waiting list, psychological placebo, and other non-psychological therapies were eligible comparators.\nData collection and analysis\nTwo review authors independently reviewed titles, abstracts, and full-text articles; discrepancies were resolved through discussion or addressed by a third author. When available, we used odds ratio (OR) to compare dichotomous data and standardised mean differences (SMD) to analyse continuous data, both with 95% confidence intervals (CI). We undertook meta-analysis when treatments, participants, and the underlying clinical question were adequately similar. Otherwise, we undertook a narrative analysis.\nMain results\nWe included five trials of three interventions (Breathe Easier Online, Web-MAP, and multimodal cognitive behavioural therapy (CBT)), which included 463 participants aged 10 to 18 years. Each trial contributed to at least one meta-analysis. Trials involved children and adolescents with long-term physical conditions, such as chronic headache (migraine, tension headache, and others), chronic pain conditions (abdominal, musculoskeletal, and others), chronic respiratory illness (asthma, cystic fibrosis, and others), and symptoms of anxiety or depression. Participants were recruited from community settings and hospital clinics in high income countries.\nFor the primary outcome of change in depression symptoms versus any control, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.06, 95% CI -0.35 to 0.23; five RCTs, 441 participants). For the primary outcome of change in anxiety symptoms versus any comparator, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.07, 95% CI -0.29 to 0.14; two RCTs, 324 participants). For the primary outcome of treatment acceptability, there was very low-quality evidence that e-health interventions were less acceptable than any comparator (SMD 0.46, 95% CI 0.23 to 0.69; two RCTs, 304 participants).\nFor the secondary outcome of quality of life, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.83, 95% CI -1.53 to -0.12; one RCT, 34 participants). For the secondary outcome of functioning, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD -0.08, 95% CI -0.33 to 0.18; three RCTs, 368 participants). For the secondary outcome of status of long-term physical condition, there was very low-quality evidence meaning that it could not be determined whether e-health interventions were clearly better than any comparator (SMD 0.06, 95% CI -0.12 to 0.24; five RCTs, 463 participants).\nThe risk of selection bias was considered low in most trials. However, the risk of bias due to inadequate blinding of participants or outcome assessors was considered unclear or high in all trials. Only one study had a published protocol; two trials had incomplete outcome data. All trials were conducted by the intervention developers, introducing another possible bias. No adverse effects were reported by any authors.\nAuthors' conclusions\nAt present, the field of e-health interventions for the treatment of anxiety or depression in children and adolescents with long-term physical conditions is limited to five low quality trials. The very low-quality of the evidence means the effects of e-health interventions are uncertain at this time, especially in children aged under 10 years.\nAlthough it is too early to recommend e-health interventions for this clinical population, given their growing number, and the global improvement in access to technology, there appears to be room for the development and evaluation of acceptable and effective technologically-based treatments to suit children and adolescents with long-term physical conditions.\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": "We included five trials of three e-health interventions (Breathe Easier Online, Web-MAP, and multimodal cognitive behavioural therapy (CBT)), undertaken with children aged 10 to 18 years old. Although some of these interventions were acceptable to users, none of them were clearly any better than a selected range of other therapies or waiting list at reducing symptoms of anxiety or depression.The very low quality of the evidence means the effects of e-health interventions are uncertain at this time, especially in children aged under 10 years. The review authors rated the overall risk of bias in the trials as high or uncertain."
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query-laysum | 5807 | [
{
"role": "user",
"content": "Abstract: Background\nDementia assessment often involves initial screening, using a brief tool, followed by more detailed assessment where required. The AD-8 is a short questionnaire, completed by a suitable 'informant' who knows the person well. AD-8 is designed to assess change in functional performance secondary to cognitive change.\nObjectives\nTo determine the diagnostic accuracy of the informant-based AD-8 questionnaire, in detection of all-cause (undifferentiated) dementia in adults. Where data were available, we described the following: the diagnostic accuracy of the AD-8 at various predefined threshold scores; the diagnostic accuracy of the AD-8 for each healthcare setting and the effects of heterogeneity on the reported diagnostic accuracy of the AD-8.\nSearch methods\nWe searched the following sources on 27 May 2014, with an update to 7 June 2018: ALOIS (Cochrane Dementia and Cognitive Improvement Group), MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), BIOSIS Previews (Thomson Reuters Web of Science), Web of Science Core Collection (includes Conference Proceedings Citation Index) (Thomson Reuters Web of Science), CINAHL (EBSCOhost) and LILACS (BIREME). We checked reference lists of relevant studies and reviews, used searches of known relevant studies in PubMed to track related articles, and contacted research groups conducting work on the AD-8 to try to find additional studies. We developed a sensitive search strategy and used standardised database subject headings as appropriate. Foreign language publications were translated.\nSelection criteria\nWe selected those studies which included the AD-8 to assess for the presence of dementia and where dementia diagnosis was confirmed with clinical assessment. We only included those studies where the AD-8 was used as an informant assessment. We made no exclusions in relation to healthcare setting, language of AD-8 or the AD-8 score used to define a 'test positive' case.\nData collection and analysis\nWe screened all titles generated by electronic database searches, and reviewed abstracts of potentially relevant studies. Two independent assessors checked full papers for eligibility and extracted data. We extracted data into two-by-two tables to allow calculation of accuracy metrics for individual studies. We then created summary estimates of sensitivity, specificity and likelihood ratios using the bivariate approach and plotting results in receiver operating characteristic (ROC) space. We determined quality assessment (risk of bias and applicability) using the QUADAS-2 tool.\nMain results\nFrom 36 papers describing AD-8 test accuracy, we included 10 papers. We utilised data from nine papers with 4045 individuals, 1107 of whom (27%) had a clinical diagnosis of dementia. Pooled analysis of seven studies, using an AD-8 informant cut-off score of two, indicated that sensitivity was 0.92 (95% confidence interval (CI) 0.86 to 0.96); specificity was 0.64 (95% CI 0.39 to 0.82); the positive likelihood ratio was 2.53 (95% CI 1.38 to 4.64); and the negative likelihood ratio was 0.12 (95% CI 0.07 to 0.21). Pooled analysis of five studies, using an AD-8 informant cut-off score of three, indicated that sensitivity was 0.91 (95% CI 0.80 to 0.96); specificity was 0.76 (95% CI 0.57 to 0.89); the positive likelihood ratio was 3.86 (95% CI 2.03 to 7.34); and the negative likelihood ratio was 0.12 (95% CI 0.06 to 0.24).\nFour studies were conducted in community settings; four were in secondary care (one in the acute hospital); and one study was in primary care. The AD-8 has a higher relative sensitivity (1.11, 95% CI 1.02 to 1.21), but lower relative specificity (0.51, 95% CI 0.23 to 1.09) in secondary care compared to community care settings.\nThere was heterogeneity across the included studies. Dementia prevalence rate varied from 12% to 90% of included participants. The tool was also used in various different languages. Among all the included studies there was evidence of risk of bias. Issues included the selection of participants, conduct of index test, and flow of assessment procedures.\nAuthors' conclusions\nThe high sensitivity of the AD-8 suggests it can be used to identify adults who may benefit from further specialist assessment and diagnosis, but is not a diagnostic test in itself. This pattern of high sensitivity and lower specificity is often suited to a screening test. Test accuracy varies by setting, however data in primary care and acute hospital settings are limited. This review identified significant heterogeneity and risk of bias, which may affect the validity of its summary findings.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The AD-8 questionnaire includes eight ‘yes or no’ questions, to be answered by someone who knows the person under investigation; for example, a relative, carer or close friend (sometimes described as an informant). The questions ask about whether the informant has noticed a change in the individual’s memory and thinking abilities over the past years. A point is given for every item where they think the person’s abilities have changed. Higher scores occur when more changes are noted by the informant. The AD-8 would not usually be used to make a final diagnosis of dementia, but it may help identify those who require further assessment."
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query-laysum | 5808 | [
{
"role": "user",
"content": "Abstract: Background\nObservational studies have shown differences in process and outcome between the consultations of primary care physicians whose average consultation lengths differ. These differences may be due to self selection. This is the first update of the original review.\nObjectives\nTo assess the effects of interventions to alter the length of primary care physicians' consultations.\nSearch methods\nWe searched the following electronic databases until 4 January 2016: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP).\nSelection criteria\nRandomised controlled trials and non-randomised controlled trials of interventions to alter the length of primary care physicians' consultations.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of included studies using agreed criteria and resolved disagreements by discussion. We attempted to contact authors of primary studies with missing data. Given the heterogeneity of studies, we did not conduct a meta-analysis. We assessed the certainty of the evidence for the most important outcomes using the GRADE approach and have presented the results in a narrative summary.\nMain results\nFive studies met the inclusion criteria. All were conducted in the UK, and tested short-term changes in the consultation time allocated to each patient. Overall, our confidence in the results was very low; most studies had a high risk of bias, particularly due to non-random allocation of participants and the absence of data on participants' characteristics and small sample sizes. We are uncertain whether altering appointment length increases primary care consultation length, number of referrals and investigations, prescriptions, or patient satisfaction based on very low-certainty evidence. None of the studies reported on the effects of altering the length of consultation on resources used.\nAuthors' conclusions\nWe did not find sufficient evidence to support or refute a policy of altering the lengths of primary care physicians' consultations. It is possible that these findings may change if high-quality trials are reported in the future. Further trials are needed that focus on health outcomes and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "All studies tested short-term changes in the consultation time allocated to each patient. Our confidence in the results of these studies is very low. Consequently, we are not certain whether changing appointment slots leads to an actual increase of the length of the consultation, number of referrals and investigations requested by the doctor, and number of medications prescribed. Likewise, it is unclear whether patients are more satisfied with the health care they receive when appointments are longer. None of the studies reported on the resources associated with lengthening appointments."
}
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query-laysum | 5809 | [
{
"role": "user",
"content": "Abstract: Background\nNon-small cell lung cancer (NSCLC) is the most common lung cancer, accounting for approximately 80% to 85% of all cases. For people with localised NSCLC (stages I to III), it has been speculated that immunotherapy may be helpful for reducing postoperative recurrence rates, or improving the clinical outcomes of current treatment for unresectable tumours. This is an update of a Cochrane Review first published in 2017 and it includes two new randomised controlled trials (RCTs).\nObjectives\nTo assess the effectiveness and safety of immunotherapy (excluding checkpoint inhibitors) among people with localised NSCLC of stages I to III who received curative intent of radiotherapy or surgery.\nSearch methods\nWe searched the following databases (from inception to 19 May 2021): CENTRAL, MEDLINE, Embase, CINAHL, and five trial registers. We also searched conference proceedings and reference lists of included trials.\nSelection criteria\nWe included RCTs conducted in adults (≥ 18 years) diagnosed with NSCLC stage I to III after surgical resection, and those with unresectable locally advanced stage III NSCLC receiving radiotherapy with curative intent. We included participants who underwent primary surgical treatment, postoperative radiotherapy or chemoradiotherapy if the same strategy was provided for both intervention and control groups.\nData collection and analysis\nTwo review authors independently selected eligible trials, assessed risk of bias, and extracted data. We used survival analysis to pool time-to-event data, using hazard ratios (HRs). We used risk ratios (RRs) for dichotomous data, and mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). Due to clinical heterogeneity (immunotherapeutic agents with different underlying mechanisms), we combined data by applying random-effects models.\nMain results\nWe included 11 RCTs involving 5128 participants (this included 2 new trials with 188 participants since the last search dated 20 January 2017). Participants who underwent surgical resection or received curative radiotherapy were randomised to either an immunotherapy group or a control group. The immunological interventions were active immunotherapy Bacillus Calmette-Guérin (BCG) adoptive cell transfer (i.e. transfer factor (TF), tumour-infiltrating lymphocytes (TIL), dendritic cell/cytokine-induced killer (DC/CIK), antigen-specific cancer vaccines (melanoma-associated antigen 3 (MAGE-A3) and L-BLP25), and targeted natural killer (NK) cells. Seven trials were at high risk of bias for at least one of the risk of bias domains. Three trials were at low risk of bias across all domains and one small trial was at unclear risk of bias as it provided insufficient information. We included data from nine of the 11 trials in the meta-analyses involving 4863 participants.\nThere was no evidence of a difference between the immunotherapy agents and the controls on any of the following outcomes: overall survival (HR 0.94, 95% CI 0.84 to 1.05; P = 0.27; 4 trials, 3848 participants; high-quality evidence), progression-free survival (HR 0.94, 95% CI 0.86 to 1.03; P = 0.19; moderate-quality evidence), adverse events (RR 1.12, 95% CI 0.97 to 1.28; P = 0.11; 4 trials, 4126 evaluated participants; low-quality evidence), and severe adverse events (RR 1.14, 95% CI 0.92 to 1.40; 6 trials, 4546 evaluated participants; low-quality evidence).\nSurvival rates at different time points showed no evidence of a difference between immunotherapy agents and the controls. Survival rate at 1-year follow-up (RR 1.02, 95% CI 0.96 to 1.08; I2 = 57%; 7 trials, 4420 participants; low-quality evidence), 2-year follow-up (RR 1.02, 95% CI 0.93 to 1.12; 7 trials, 4420 participants; moderate-quality evidence), 3-year follow-up (RR 0.99, 95% CI 0.90 to 1.09; 7 trials, 4420 participants; I2 = 22%; moderate-quality evidence) and at 5-year follow-up (RR 0.98, 95% CI 0.86 to 1.12; I2 = 0%; 7 trials, 4389 participants; moderate-quality evidence).\nOnly one trial reported overall response rates. Two trials provided health-related quality of life results with contradicting results.\nAuthors' conclusions\nBased on this updated review, the current literature does not provide evidence that suggests a survival benefit from adding immunotherapy (excluding checkpoint inhibitors) to conventional curative surgery or radiotherapy, for people with localised NSCLC (stages I to III). Several ongoing trials with immune checkpoints inhibitors (PD-1/PD-L1) might bring new insights into the role of immunotherapy for people with stages I to III NSCLC.\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 treatments that help the body's immune system fight cancer cells (immunotherapy) make people with non-small cell lung cancer (NSCLC) who have had surgery or radiotherapy aimed at a cure, live longer?"
}
]
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query-laysum | 5810 | [
{
"role": "user",
"content": "Abstract: Background\nApnoea is a breathing disorder marked by the absence of airflow at the nose or mouth. In children, risk factors include adenotonsillar hypertrophy, obesity, neuromuscular disorders and craniofacial anomalies. The most common treatment for obstructive sleep apnoea syndrome (OSAS) in childhood is adeno-tonsillectomy. This approach is limited by its surgical risks, mostly in children with comorbidities and, in some patients, by recurrence that can be associated with craniofacial problems. Oral appliances and functional orthopaedic appliances have been used for patients who have OSAS and craniofacial anomalies because they hold the lower jaw (mandible) forwards which potentially enlarges the upper airway and increases the upper airspace, improving the respiratory function.\nObjectives\nTo assess the effects of oral appliances or functional orthopaedic appliances for obstructive sleep apnoea in children.\nSearch methods\nWe searched the following electronic databases: Cochrane Oral Health's Trials Register (to 7 April 2016); Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3) in the Cochrane Library (searched 7 April 2016); MEDLINE Ovid (1946 to 7 April 2016); Embase Ovid (1980 to 7 April 2016); LILACS BIREME (from 1982 to 7 April 2016); BBO BIREME (from 1986 to 7 April 2016) and SciELO Web of Science (from 1997 to 7 April 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials on 7 April 2016. We placed no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nAll randomised or quasi-randomised controlled trials comparing all types of oral and functional orthopaedic appliances with placebo or no treatment, in children 15 years old or younger. Primary outcome: reduction of apnoea to less than one episode per hour. Secondary outcomes: dental and skeletal relationship, sleep parameters improvement, cognitive and phonoaudiological function, behavioural problems, quality of life, side effects (tolerability) and economic evaluation.\nData collection and analysis\nTwo review authors screened studies and extracted data independently. Authors were contacted for additional information. We calculated risk ratios with 95% confidence intervals for all important dichotomous outcomes. We assessed the quality of the evidence of included studies using GRADEpro software.\nMain results\nThe initial search identified 686 trials. Only one trial, reporting the results from a total of 23 children and comparing an oral appliance to no treatment, was suitable for inclusion in the review. The trial assessed apnoea-hypopnoea, daytime symptoms (sleepiness, irritability, tiredness, school problems, morning headache, thirstiness in the morning, oral breathing and nasal stuffiness) and night-time symptoms (habitual snoring, restless sleep and nightmares measured by questionnaire). Results were inconsistent across outcomes measures and time points. The evidence was considered very low quality.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the effectiveness of oral appliances and functional orthopaedic appliances for the treatment of obstructive sleep apnoea in children. Oral appliances or functional orthopaedic appliances may be considered in specified cases as an auxiliary in the treatment of children who have craniofacial anomalies which are risk factors for apnoea.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Obstructive sleep apnoea in children is a breathing disorder characterized by episodes of partial or complete upper airway obstruction that occur during sleep. There are various risk factors and is associated with daytime and night-time symptoms including among others sleepiness, irritability, tiredness, morning headaches, nasal stuffiness, habitual snoring, nightmares, etc. The common treatment for obstructive sleep apnoea in childhood is adeno-tonsillectomy, the removal of the adenoids and tonsils. This approach is limited by recurrence that can be associated with craniofacial problems. Oral/functional orthopaedic appliances have been used for patients who have obstructive sleep apnoea and craniofacial anomalies because they hold the lower jaw (mandible) forwards which potentially enlarges the upper airway and increases the upper airspace, improving the respiratory function."
}
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query-laysum | 5811 | [
{
"role": "user",
"content": "Abstract: Background\nVestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. The unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used, or proposed to be used, at the time of a vestibular migraine attack to help reduce the severity or resolve the symptoms. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar.\nObjectives\nTo assess the benefits and harms of pharmacological interventions used to relieve acute attacks of vestibular migraine.\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 23 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing triptans, ergot alkaloids, dopamine antagonists, antihistamines, 5-HT3 receptor antagonists, gepants (CGRP receptor antagonists), magnesium, paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) with either placebo or no treatment.\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) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 2 hours, 2 to 12 hours, > 12 to 72 hours. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two RCTs with a total of 133 participants, both of which compared the use of triptans to placebo for an acute attack of vestibular migraine. One study was a parallel-group RCT (of 114 participants, 75% female). This compared the use of 10 mg rizatriptan to placebo. The second study was a smaller, cross-over RCT (of 19 participants, 70% female). This compared the use of 2.5 mg zolmitriptan to placebo.\nTriptans may result in little or no difference in the proportion of people whose vertigo improves at up to two hours after taking the medication. However, the evidence was very uncertain (risk ratio 0.84, 95% confidence interval 0.66 to 1.07; 2 studies; based on 262 attacks of vestibular migraine treated in 124 participants; very low-certainty evidence). We did not identify any evidence on the change in vertigo using a continuous scale. Only one of the studies assessed serious adverse events. No events were noted in either group, but as the sample size was small we cannot be sure if there are risks associated with taking triptans for this condition (0/75 receiving triptans, 0/39 receiving placebo; 1 study; 114 participants; very low-certainty evidence).\nAuthors' conclusions\nThe evidence for interventions used to treat acute attacks of vestibular migraine is very sparse. We identified only two studies, both of which assessed the use of triptans. We rated all the evidence as very low-certainty, meaning that we have little confidence in the effect estimates and cannot be sure if triptans have any effect on the symptoms of vestibular migraine. Although we identified sparse information on potential harms of treatment in this review, the use of triptans for other conditions (such as headache migraine) is known to be associated with some adverse effects.\nWe did not identify any placebo-controlled randomised trials for other interventions that may be used for this condition. Further research is needed to identify whether any interventions help to improve the symptoms of vestibular migraine attacks and to determine if there are side effects associated with their use.\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 in adults that compared different medications to either no treatment or placebo (dummy) treatment. We used standard methods to assess the quality of the evidence. We rated our confidence in the evidence, based on factors such as study methods, the number of participants in them and the consistency of findings across studies."
}
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query-laysum | 5812 | [
{
"role": "user",
"content": "Abstract: Background\nLithium salts, particularly lithium carbonate, are frequently used to treat bipolar disorder and mania. Lithium poisoning, which can occur as a result of reduced renal elimination, prescribing error, drug-drug interactions, or deliberate overdosage, produces neurologic injury that can be permanent. Hemodialysis is often recommended to treat lithium poisoning. Although hemodialysis clearly enhances the elimination of lithium, it is unclear whether this translates into improved patient outcomes. Evidence from observational studies, generally of low methodological quality, shows similar outcomes in patients managed with or without the use of hemodialysis.\nObjectives\nTo determine whether hemodialysis, applied in addition to standard therapy, reduces the likelihood, severity, or duration of neurological sequelae following lithium poisoning.\nSearch methods\nWe ran the search on 15 May 2015. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE (OvidSP), Embase Classic+Embase (OvidSP), CINAHL Plus, clinical trials registers and four other databases. We screened the reference lists of relevant studies, textbook chapters, and review articles, and performed a Google search to identify grey literature.\nSelection criteria\nIn the context of this review, hemodialysis was defined as any extracorporeal technique to filter and extract toxicants from the serum, including all forms of hemodialysis, hemofiltration, and continuous renal replacement techniques, but not peritoneal dialysis. We included any clinical trials in which patients were randomly allocated to receive, or not receive, hemodialysis in addition to standard care for lithium poisoning.\nData collection and analysis\nTwo authors reviewed the abstracts of all identified articles. If either author identified an article as potentially meeting the inclusion criteria, both authors reviewed the full text of the article.\nMain results\nNo randomized controlled trials of hemodialysis therapy for lithium poisoning were identified.\nAuthors' conclusions\nAlthough the use of hemodialysis to enhance the elimination of lithium in patients with lithium poisoning appears logical, there is no evidence from randomized controlled trials to support nor refute the use of hemodialysis in the management of patients with lithium poisoning.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The information in this review is up to date to 15 May 2015."
}
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query-laysum | 5813 | [
{
"role": "user",
"content": "Abstract: Background\nAnti-neutrophilic cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) are a group of rare auto-inflammatory diseases that affects mainly small vessels. AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Anti-cytokine targeted therapy uses biological agents capable of specifically targeting and neutralising cytokine mediators of the inflammatory response.\nObjectives\nTo assess the benefits and harms of anti-cytokine targeted therapy for adults with AAV.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (2019, Issue 7), MEDLINE and Embase up to 16 August 2019. We also examined reference lists of articles, clinical trial registries, websites of regulatory agencies and contacted manufacturers.\nSelection criteria\nRandomised controlled trials (RCTs) or controlled clinical trials of targeted anti-cytokine therapy in adults (18 years or older) with AAV compared with placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included four RCTs with a total of 440 participants (mean age 48 to 56 years). We analysed the studies in three groups: 1) mepolizumab (300 mg; three separate injections every four weeks for 52 weeks) versus placebo in participants with relapsing or refractory EGPA; 2) belimumab (10 mg/kg on days 0, 14, 28 and every 28 days thereafter until 12 months after the last participant was randomised) or etanercept (25 mg twice a week) with standard therapy (median 25 months) versus placebo with standard therapy (median 19 months) in participants with GPA/MPA; and 3) infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42) versus rituximab (0.375g/m2 on days 1, 8, 15 and 22) in participants with refractory GPA for up to 12 months. None of the studies were assessed as low risk of bias in all domains: one study did not report randomisation or blinding methods clearly. Three studies were at high risk and one study was at unclear risk of bias for selective outcome reporting.\nOne trial with 136 participants with relapsing or refractory EGPA compared mepolizumab with placebo during 52 weeks of follow-up and observed one death in the mepolizumab group (1/68, 1.5%) and none in the placebo group (0/68, 0%) (Peto odds ratio (OR) 7.39, 95% confidence interval (CI) 0.15 to 372.38; low-certainty evidence). Low-certainty evidence suggests that more participants in the mepolizumab group had ≥ 24 weeks of accrued remission over 52 weeks compared to placebo (27.9% versus 2.9%; risk ratio (RR) 9.5, 95% CI 2.30 to 39.21), and durable remission within the first 24 weeks sustained until week 52 (19.1% mepolizumab versus 1.5% placebo; RR 13.0, 95% CI 1.75 to 96.63; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% Cl 4 to 13). Mepolizumab probably decreases risk of relapse (55.8% versus 82.4%; RR 0.68, 95% CI 0.53 to 0.86; NNTB 4, 95% CI 3 to 9; moderate-certainty evidence). There was low-certainty evidence regarding similar frequency of adverse events (AEs): total AEs (96.9% versus 94.1%; RR 1.03, 95% CI 0.96 to 1.11), serious AEs (17.7% versus 26.5%; RR 0.67, 95% CI 0.35 to 1.28) and withdrawals due to AEs (2.9% versus 1.5%; RR 2.00, 95% CI 0.19 to 21.54). Disease flares were not measured.\nBased on two trials with different follow-up periods (mean of 27 months for etanercept study; up to four years for belimumab study) including people with GPA (n = 263) and a small group of participants with MPA (n = 22) analysed together, we found low-certainty evidence suggesting that adding an active drug (etanercept or belimumab) to standard therapy does not increase or reduce mortality (3.4% versus 1.4%; Peto OR 2.45, 95% CI 0.55 to 10.97). Etanercept may have little or no effect on remission (92.3% versus 89.5%; RR 0.97, 95% CI 0.89 to 1.07), durable remission (70% versus 75.3%; RR 0.93, 95% CI 0.77 to 1.11; low-certainty evidence) and disease flares (56% versus 57.1%; RR 0.98, 95% CI 0.76 to 1.27; moderate-certainty evidence). Low-certainty evidence suggests that belimumab does not increase or reduce major relapse (1.9% versus 0%; RR 2.94, 95% CI 0.12 to 70.67) or any AE (92.5% versus 82.7%; RR 1.12, 95% CI 0.97 to 1.29). Low-certainty evidence suggests a similar frequency of serious or severe AEs (47.6% versus 47.6%; RR 1.00, 95% CI 0.80 to 1.27), but more frequent withdrawals due to AEs in the active drug group (11.2%) compared to the placebo group (4.2%), RR 2.66, 95% CI 1.07 to 6.59).\nOne trial involving 17 participants with refractory GPA compared infliximab versus rituximab added to steroids and cytotoxic agents for 12 months. One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%). We have very low-certainty evidence for remission (22% versus 50%, RR 0.44, 95% Cl 0.11 to 1.81) and durable remission (11% versus 50%, RR 0.22, 95% CI 0.03 to 1.60), any severe AE (22.3% versus 12.5%; RR 1.78, 95% CI 0.2 to 16.1) and withdrawals due to AEs (0% versus 0%; RR 2.70, 95% CI 0.13 to 58.24). Disease flare/relapse and the frequency of any AE were not reported.\nAuthors' conclusions\nWe found four studies but concerns about risk of bias and small sample sizes preclude firm conclusions.\nWe found moderate-certainty evidence that in patients with relapsing or refractory EGPA, mepolizumab compared to placebo probably decreases disease relapse and low-certainty evidence that mepolizumab may increase the probability of accruing at least 24 weeks of disease remission. There were similar frequencies of total and serious AEs in both groups, but the study was too small to reliably assess these outcomes. Mepolizumab may result in little to no difference in mortality. However, there were very few events.\nIn participants with GPA (and a small subgroup of participants with MPA), etanercept or belimumab may increase the probability of withdrawal due to AEs and may have little to no impact on serious AEs. Etanercept may have little or no impact on durable remission and probably does not reduce disease flare.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found four studies on a total of 440 adults from the USA and Europe. The average age of people ranged between 48 and 56 years. They received treatment for between 2 and 25 months, and were then followed for between 8 weeks and four years. Three studies compared anti-cytokine medicines (mepolizumab, belimumab and etanercept) to a placebo (fake medicine) and one study compared two different anti-cytokine medicines (rituximab versus infliximab). Three studies received at least partial funding from pharmaceutical companies.\nMepolizumab versus placebo in people with EGPA that returned after, or did not respond to, initial treatment\nModerate-certainty evidence indicates that mepolizumab probably reduces the likelihood of the disease returning within a year of treatment.\nLow-certainty evidence suggests that mepolizumab:\n- may make little or no difference to mortality;\n- may increase the likelihood of the disease partially or fully disappearing for at least 24 weeks, and may increase the chances of this disappearance lasting for another six months at least;\n- may make little or no difference to unwanted events, serious unwanted events or withdrawal from studies due to unwanted events.\nThe impact of mepolizumab on disease flare (worsening) is unknown, as this was not measured.\nEtanercept or belimumab versus placebo in GPA and MPA\nModerate-certainty evidence indicates that etanercept probably makes little or no difference to disease flare.\nLow-certainty evidence suggests that etanercept or belimumab may make little or no difference to:\n- mortality;\n- the disease fully disappearing for at least 24 weeks, or disappearance lasting at least another six months after that;\n- the disease returning strongly;\n- unwanted events or severe/serious unwanted events\nEvidence of low certainty suggests that etanercept or belimumab may slightly increase chances of people withdrawing from studies due to unwanted events.\nInfliximab versus rituximab, plus steroids and cytotoxic agents (substances that kill cells), in people with GPA that did not respond to other treatments\nThe one study we found was too small to assess the differences between treatments (very low-certainty evidence)."
}
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query-laysum | 5814 | [
{
"role": "user",
"content": "Abstract: Background\nAntiviral therapy for recurrent hepatitis C infection after liver transplantation is controversial due to unresolved balance between benefits and harms.\nObjectives\nTo compare the therapeutic benefits and harms of different antiviral regimens in patients with hepatitis C re-infected grafts after liver transplantation.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to February 2013.\nSelection criteria\nWe considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing various antiviral therapies (alone or in combination) in the treatment of hepatitis C virus recurrence in liver transplantation for the review.\nData collection and analysis\nTwo authors collected the data independently. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) using the fixed-effect and the random-effects models based on available case-analysis. In the presence of only trials for a dichotomous outcome, we performed the Fisher's exact test.\nMain results\nOverall, 17 trials with 736 patients met the inclusion criteria for this review. All trials had high risk of bias. Five hundred and one patients randomised in 11 trials provided information for various comparisons in this systematic review after excluding post-randomisation drop-outs and patients from trials that did not report any of the outcomes of interest for this review. The comparisons for which outcomes were available included pegylated (peg) interferon versus control; peg interferon plus ribavirin versus control; ribavirin plus peg interferon versus peg interferon; peg interferon (1.5 μg/kg/week) plus ribavirin versus peg interferon (0.5 μg/kg/week) plus ribavirin; amantadine plus peg interferon plus ribavirin versus peg interferon plus ribavirin; interferon versus control; interferon plus ribavirin versus control; ribavirin versus interferon; and ribavirin versus placebo. Long-term follow-up was not available in these trials. There were no significant differences in mortality, retransplantation, graft rejections requiring retransplantation or medical treatment, or fibrosis worsening between the groups in any of the comparisons in which these outcomes were reported. Quality of life and liver decompensation were not reported in any of the trials. There was a significantly higher proportion of participants who developed serious adverse events in the ribavirin plus peg interferon combination therapy group than in the peg interferon monotherapy group (1 trial; 56 participants; 17/28 (60.7%) in the intervention group versus 5/28 (17.9%) in the control group; RR 3.40; 95% CI 1.46 to 7.94). There was no significant difference in proportion of participants who developed serious adverse events or in the number of serious adverse events between the intervention and control groups in the other comparisons that reported serious adverse events.\nAuthors' conclusions\nConsidering the lack of clinical benefit, there is currently no evidence to recommend or refute antiviral treatment for recurrent liver graft infection with hepatitis C virus. Further randomised clinical trials with low risk of bias and low risk of random errors with adequate duration of follow-up are necessary.\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": "Eleven trials including 501 liver transplant recipients provided data for this review. The patients were randomised to receive different treatments including no treatment in these 11 trials. Long-term follow-up was not available in these trials."
}
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query-laysum | 5815 | [
{
"role": "user",
"content": "Abstract: Background\nDysfunctional breathing/hyperventilation syndrome (DB/HVS) is a respiratory disorder, psychologically or physiologically based, involving breathing too deeply and/or too rapidly (hyperventilation) or erratic breathing interspersed with breath-holding or sighing (DB). DB/HVS can result in significant patient morbidity and an array of symptoms including breathlessness, chest tightness, dizziness, tremor and paraesthesia. DB/HVS has an estimated prevalence of 9.5% in the general adult population, however, there is little consensus regarding the most effective management of this patient group.\nObjectives\n1) To determine whether breathing exercises in patients with DB/HVS have beneficial effects as measured by quality of life indices\n2) To determine whether there are any adverse effects of breathing exercises in patients with DB/HVS\nSearch methods\nWe identified trials for consideration using both electronic and manual search strategies. We searched CENTRAL, MEDLINE, EMBASE, and four other databases. The latest search was in February 2013.\nSelection criteria\nWe planned to include randomised, quasi-randomised or cluster randomised controlled trials (RCTs) in which breathing exercises, or a combined intervention including breathing exercises as a key component, were compared with either no treatment or another therapy that did not include breathing exercises in patients with DB/HVS. Observational studies, case studies and studies utilising a cross-over design were not eligible for inclusion.\nWe considered any type of breathing exercise for inclusion in this review, such as breathing control, diaphragmatic breathing, yoga breathing, Buteyko breathing, biofeedback-guided breathing modification, yawn/sigh suppression. Programs where exercises were either supervised or unsupervised were eligible as were relaxation techniques and acute-episode management, as long as it was clear that breathing exercises were a key component of the intervention.\nWe excluded any intervention without breathing exercises or where breathing exercises were not key to the intervention.\nData collection and analysis\nTwo review authors independently checked search results for eligible studies, assessed all studies that appeared to meet the selection criteria and extracted data. We used standard procedures recommended by The Cochrane Collaboration.\nMain results\nWe included a single RCT assessed at unclear risk of bias, which compared relaxation therapy (n = 15) versus relaxation therapy and breathing exercises (n = 15) and a no therapy control group (n = 15).\nQuality of life was not an outcome measure in this RCT, and no numerical data or statistical analysis were presented in this paper. A significant reduction in the frequency and severity of hyperventilation attacks in the breathing exercise group compared with the control group was reported. In addition, a significant difference in frequency and severity of hyperventilation attacks between the breathing and relaxation group was reported. However, no information could be extracted from the paper regarding the size of the treatment effects.\nAuthors' conclusions\nThe results of this systematic review are unable to inform clinical practice, based on the inclusion of only one small, poorly reported RCT. There is no credible evidence regarding the effectiveness of breathing exercises for the clinical symptoms of DB/HVS. It is currently unknown whether these interventions offer any added value in this patient group or whether specific types of breathing exercise demonstrate superiority over others. Given that breathing exercises are frequently used to treat DB/HVS, there is an urgent need for further well designed clinical trials in this area. Future trials should conform to the CONSORT statement for standards of reporting and use appropriate, validated outcome measures. Trial reports should also ensure full disclosure of data for all important clinical outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Dysfunctional breathing/hyperventilation syndrome (DB/HVS) is a breathing problem that involves breathing too deeply and/or too rapidly (hyperventilation). There are many possible causes of DB/HVS and if left untreated it can lead to a variety of unpleasant symptoms such as breathlessness, dizziness, pins and needles and chest pain."
}
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query-laysum | 5816 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a degenerative condition of the back of the eye that occurs in people over the age of 50 years. Antioxidants may prevent cellular damage in the retina by reacting with free radicals that are produced in the process of light absorption. Higher dietary levels of antioxidant vitamins and minerals may reduce the risk of progression of AMD. This is the third update of the review.\nObjectives\nTo assess the effects of antioxidant vitamin and mineral supplements on the progression of AMD in people with AMD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, one other database, and three trials registers, most recently on 29 November 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared antioxidant vitamin or mineral supplementation to placebo or no intervention, in people with AMD.\nData collection and analysis\nWe used standard methods expected by Cochrane.\nMain results\nWe included 26 studies conducted in the USA, Europe, China, and Australia. These studies enroled 11,952 people aged 65 to 75 years and included slightly more women (on average 56% women). We judged the studies that contributed data to the review to be at low or unclear risk of bias.\nThirteen studies compared multivitamins with control in people with early and intermediate AMD. Most evidence came from the Age-Related Eye Disease Study (AREDS) in the USA. People taking antioxidant vitamins were less likely to progress to late AMD (odds ratio (OR) 0.72, 95% confidence interval (CI) 0.58 to 0.90; 3 studies, 2445 participants; moderate-certainty evidence). In people with early AMD, who are at low risk of progression, this means there would be approximately four fewer cases of progression to late AMD for every 1000 people taking vitamins (one fewer to six fewer cases). In people with intermediate AMD at higher risk of progression, this corresponds to approximately 78 fewer cases of progression for every 1000 people taking vitamins (26 fewer to 126 fewer). AREDS also provided evidence of a lower risk of progression for both neovascular AMD (OR 0.62, 95% CI 0.47 to 0.82; moderate-certainty evidence) and geographic atrophy (OR 0.75, 95% CI 0.51 to 1.10; moderate-certainty evidence), and a lower risk of losing 3 or more lines of visual acuity (OR 0.77, 95% CI 0.62 to 0.96; moderate-certainty evidence). Low-certainty evidence from one study of 110 people suggested higher quality of life scores (measured with the Visual Function Questionnaire) in treated compared with non-treated people after 24 months (mean difference (MD) 12.30, 95% CI 4.24 to 20.36). In exploratory subgroup analyses in the follow-on study to AREDS (AREDS2), replacing beta-carotene with lutein/zeaxanthin gave hazard ratios (HR) of 0.82 (95% CI 0.69 to 0.96), 0.78 (95% CI 0.64 to 0.94), 0.94 (95% CI 0.70 to 1.26), and 0.88 (95% CI 0.75 to 1.03) for progression to late AMD, neovascular AMD, geographic atrophy, and vision loss, respectively.\nSix studies compared lutein (with or without zeaxanthin) with placebo and one study compared a multivitamin including lutein/zeaxanthin with multivitamin alone. The duration of supplementation and follow-up ranged from six months to five years. Most evidence came from the AREDS2 study in the USA; almost all participants in AREDS2 also took the original AREDS supplementation formula. People taking lutein/zeaxanthin may have similar or slightly reduced risk of progression to late AMD (RR 0.94, 95% CI 0.87 to 1.01), neovascular AMD (RR 0.92, 95% CI 0.84 to 1.02), and geographic atrophy (RR 0.92, 95% CI 0.80 to 1.05) compared with control (1 study, 4176 participants, 6891 eyes; low-certainty evidence). A similar risk of progression to visual loss of 15 or more letters was seen in the lutein/zeaxanthin and control groups (RR 0.98, 95% CI 0.91 to 1.05; 6656 eyes; low-certainty evidence). Quality of life (Visual Function Questionnaire) was similar between groups (MD 1.21, 95% CI -2.59 to 5.01; 2 studies, 308 participants; moderate-certainty evidence).\nOne study in Australia randomised 1204 people to vitamin E or placebo with four years of follow-up; 19% of participants had AMD. The number of late AMD events was low (N = 7) and the estimate of effect was uncertain (RR 1.36, 95% CI 0.31 to 6.05; very low-certainty evidence). There was no evidence of any effect of treatment on visual loss (RR 1.04, 95% CI 0.74 to 1.47; low-certainty evidence). There were no data on neovascular AMD, geographic atrophy, or quality of life.\nFive studies compared zinc with placebo. Evidence largely drawn from the largest study (AREDS) found a lower progression to late AMD over six years (OR 0.83, 95% CI 0.70 to 0.98; 3 studies, 3790 participants; moderate-certainty evidence), neovascular AMD (OR 0.76, 95% CI 0.62 to 0.93; moderate-certainty evidence), geographic atrophy (OR 0.84, 95% CI 0.64 to 1.10; moderate-certainty evidence), or visual loss (OR 0.87, 95% CI 0.75 to 1.00; 2 studies, 3791 participants; moderate-certainty evidence). There were no data on quality of life. Gastrointestinal symptoms were the main reported adverse effect. In AREDS, zinc was associated with a higher risk of genitourinary problems in men, but no difference was seen between high- and low-dose zinc groups in AREDS2.\nMost studies were too small to detect rare adverse effects. Data from larger studies (AREDS/AREDS2) suggested there may be little or no effect on mortality with multivitamin (HR 0.87, 95% CI 0.60 to 1.25; low-certainty evidence) or lutein/zeaxanthin supplementation (HR 1.06, 95% CI 0.87 to 1.31; very low-certainty evidence), but confirmed the increased risk of lung cancer with beta-carotene, mostly in former smokers.\nAuthors' conclusions\nModerate-certainty evidence suggests that antioxidant vitamin and mineral supplementation (AREDS: vitamin C, E, beta-carotene, and zinc) probably slows down progression to late AMD. People with intermediate AMD have a higher chance of benefiting from antioxidant supplements because their risk of progression is higher than people with early AMD. Although low-certainty evidence suggested little effect with lutein/zeaxanthin alone compared with placebo, exploratory subgroup analyses from one large American study support the view that lutein/zeaxanthin may be a suitable replacement for the beta-carotene used in the original AREDS formula.\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 whether antioxidant vitamin and mineral supplements slow down the progression of age-related macular degeneration (AMD) and prevent visual loss."
}
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query-laysum | 5817 | [
{
"role": "user",
"content": "Abstract: Background\nFrequent consumption of excess amounts of sugar-sweetened beverages (SSB) is a risk factor for obesity, type 2 diabetes, cardiovascular disease and dental caries. Environmental interventions, i.e. interventions that alter the physical or social environment in which individuals make beverage choices, have been advocated as a means to reduce the consumption of SSB.\nObjectives\nTo assess the effects of environmental interventions (excluding taxation) on the consumption of sugar-sweetened beverages and sugar-sweetened milk, diet-related anthropometric measures and health outcomes, and on any reported unintended consequences or adverse outcomes.\nSearch methods\nWe searched 11 general, specialist and regional databases from inception to 24 January 2018. We also searched trial registers, reference lists and citations, scanned websites of relevant organisations, and contacted study authors.\nSelection criteria\nWe included studies on interventions implemented at an environmental level, reporting effects on direct or indirect measures of SSB intake, diet-related anthropometric measures and health outcomes, or any reported adverse outcome. We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) and interrupted-time-series (ITS) studies, implemented in real-world settings with a combined length of intervention and follow-up of at least 12 weeks and at least 20 individuals in each of the intervention and control groups. We excluded studies in which participants were administered SSB as part of clinical trials, and multicomponent interventions which did not report SSB-specific outcome data. We excluded studies on the taxation of SSB, as these are the subject of a separate Cochrane Review.\nData collection and analysis\nTwo review authors independently screened studies for inclusion, extracted data and assessed the risks of bias of included studies. We classified interventions according to the NOURISHING framework, and synthesised results narratively and conducted meta-analyses for two outcomes relating to two intervention types. We assessed our confidence in the certainty of effect estimates with the GRADE framework as very low, low, moderate or high, and presented ‘Summary of findings’ tables.\nMain results\nWe identified 14,488 unique records, and assessed 1030 in full text for eligibility. We found 58 studies meeting our inclusion criteria, including 22 RCTs, 3 NRCTs, 14 CBA studies, and 19 ITS studies, with a total of 1,180,096 participants. The median length of follow-up was 10 months. The studies included children, teenagers and adults, and were implemented in a variety of settings, including schools, retailing and food service establishments. We judged most studies to be at high or unclear risk of bias in at least one domain, and most studies used non-randomised designs. The studies examine a broad range of interventions, and we present results for these separately.\nLabelling interventions (8 studies): We found moderate-certainty evidence that traffic-light labelling is associated with decreasing sales of SSBs, and low-certainty evidence that nutritional rating score labelling is associated with decreasing sales of SSBs. For menu-board calorie labelling reported effects on SSB sales varied.\nNutrition standards in public institutions (16 studies): We found low-certainty evidence that reduced availability of SSBs in schools is associated with decreased SSB consumption. We found very low-certainty evidence that improved availability of drinking water in schools and school fruit programmes are associated with decreased SSB consumption. Reported associations between improved availability of drinking water in schools and student body weight varied.\nEconomic tools (7 studies): We found moderate-certainty evidence that price increases on SSBs are associated with decreasing SSB sales. For price discounts on low-calorie beverages reported effects on SSB sales varied.\nWhole food supply interventions (3 studies): Reported associations between voluntary industry initiatives to improve the whole food supply and SSB sales varied.\nRetail and food service interventions (7 studies): We found low-certainty evidence that healthier default beverages in children’s menus in chain restaurants are associated with decreasing SSB sales, and moderate-certainty evidence that in-store promotion of healthier beverages in supermarkets is associated with decreasing SSB sales. We found very low-certainty evidence that urban planning restrictions on new fast-food restaurants and restrictions on the number of stores selling SSBs in remote communities are associated with decreasing SSB sales. Reported associations between promotion of healthier beverages in vending machines and SSB intake or sales varied.\nIntersectoral approaches (8 studies): We found moderate-certainty evidence that government food benefit programmes with restrictions on purchasing SSBs are associated with decreased SSB intake. For unrestricted food benefit programmes reported effects varied. We found moderate-certainty evidence that multicomponent community campaigns focused on SSBs are associated with decreasing SSB sales. Reported associations between trade and investment liberalisation and SSB sales varied.\nHome-based interventions (7 studies): We found moderate-certainty evidence that improved availability of low-calorie beverages in the home environment is associated with decreased SSB intake, and high-certainty evidence that it is associated with decreased body weight among adolescents with overweight or obesity and a high baseline consumption of SSBs.\nAdverse outcomes reported by studies, which may occur in some circumstances, included negative effects on revenue, compensatory SSB consumption outside school when the availability of SSBs in schools is reduced, reduced milk intake, stakeholder discontent, and increased total energy content of grocery purchases with price discounts on low-calorie beverages, among others. The certainty of evidence on adverse outcomes was low to very low for most outcomes.\nWe analysed interventions targeting sugar-sweetened milk separately, and found low- to moderate-certainty evidence that emoticon labelling and small prizes for the selection of healthier beverages in elementary school cafeterias are associated with decreased consumption of sugar-sweetened milk. We found low-certainty evidence that improved placement of plain milk in school cafeterias is not associated with decreasing sugar-sweetened milk consumption.\nAuthors' conclusions\nThe evidence included in this review indicates that effective, scalable interventions addressing SSB consumption at a population level exist. Implementation should be accompanied by high-quality evaluations using appropriate study designs, with a particular focus on the long-term effects of approaches suitable for large-scale implementation.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean in practice?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our review shows that measures which change the environment in which people make beverage choices can help people drink less SSB. Based on our findings we suggest that such measures may be used more widely. Government officials, business people and health professionals implementing such measures should work together with researchers to find out more about their effects in the short and long term."
}
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query-laysum | 5818 | [
{
"role": "user",
"content": "Abstract: Background\nSeasonal affective disorder (SAD) is a seasonal pattern of recurrent major depressive episodes that most commonly occurs during autumn or winter and remits in spring. The prevalence of SAD ranges from 1.5% to 9%, depending on latitude. The predictable seasonal aspect of SAD provides a promising opportunity for prevention. This is one of four reviews on the efficacy and safety of interventions to prevent SAD; we focus on psychological therapies as preventive interventions.\nObjectives\nTo assess the efficacy and safety of psychological therapies (in comparison with no treatment, other types of psychological therapy, second-generation antidepressants, light therapy, melatonin or agomelatine or lifestyle interventions) in preventing SAD and improving person-centred outcomes among adults with a history of SAD.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 19 June 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to 11 August 2015). Furthermore, we searched the Cumulative Index to Nursing and Allied Health Literature, Web of Science, the Cochrane Library, the Allied and Complementary Medicine Database and international trial registers (to 19 June 2018). We also conducted a grey literature search and handsearched the reference lists of included studies and pertinent review articles.\nSelection criteria\nTo examine efficacy, we included randomised controlled trials (RCTs) on adults with a history of winter-type SAD who were free of symptoms at the beginning of the study. To examine adverse events, we intended to include non-randomised studies. We planned to include studies that compared psychological therapy versus no treatment, or any other type of psychological therapy, light therapy, second-generation antidepressants, melatonin, agomelatine or lifestyle changes. We also planned to compare psychological therapy in combination with any of the comparator interventions listed above versus no treatment or the same comparator intervention as monotherapy.\nData collection and analysis\nTwo review authors screened abstracts and full-text publications against the inclusion criteria, independently extracted data, assessed risk of bias, and graded the certainty of evidence.\nMain results\nWe identified 3745 citations through electronic searches and reviews of reference lists after deduplication of search results. We excluded 3619 records during title and abstract review and assessed 126 articles at full-text review for eligibility. We included one controlled study enrolling 46 participants. We rated this RCT at high risk for performance and detection bias due to a lack of blinding.\nThe included RCT compared preventive use of mindfulness-based cognitive therapy (MBCT) with treatment as usual (TAU) in participants with a history of SAD. MBCT was administered in spring in eight weekly individual 45- to 60-minute sessions. In the TAU group participants did not receive any preventive treatment but were invited to start light therapy as first depressive symptoms occurred. Both groups were assessed weekly for occurrence of a new depressive episode measured with the Inventory of Depressive Syptomatology-Self-Report (IDS-SR, range 0-90) from September 2011 to mid-April 2012. The incidence of a new depressive episode in the upcoming winter was similar in both groups. In the MBCT group 65% of 23 participants developed depression (IDS-SR ≥ 20), compared to 74% of 23 people in the TAU group (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.30; 46 participants; very low quality-evidence).\nFor participants with depressive episodes, severity of depression was comparable between groups. Participants in the MBCT group had a mean score of 26.5 (SD 7.0) on the IDS-SR, and TAU participants a mean score of 25.3 (SD 6.3) (mean difference (MD) 1.20, 95% CI -3.44 to 5.84; 32 participants; very low quality-evidence).\nThe overall discontinuation rate was similar too, with 17% discontinuing in the MBCT group and 13% in the TAU group (RR 1.33, 95% CI 0.34 to 5.30; 46 participants; very low quality-evidence).\nReasons for downgrading the quality of evidence included high risk of bias of the included study and imprecision.\nInvestigators provided no information on adverse events. We could not find any studies that compared psychological therapy with other interventions of interest such as second-generation antidepressants, light therapy, melatonin or agomelatine.\nAuthors' conclusions\nThe evidence on psychological therapies to prevent the onset of a new depressive episode in people with a history of SAD is inconclusive. We identified only one study including 46 participants focusing on one type of psychological therapy. Methodological limitations and the small sample size preclude us from drawing a conclusion on benefits and harms of MBCT as a preventive intervention for SAD. Given that there is no comparative evidence for psychological therapy versus other preventive options, the decision for or against initiating preventive treatment of SAD and the treatment selected should be strongly based on patient preferences and other preventive interventions that are supported by evidence.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched databases up to 19 June 2018 for studies on psychological therapies to prevent SAD. Among 3745 records, we found one randomised controlled study including 46 people who received a form of psychological therapy - the so called mindfulness-based cognitive therapy (MBCT) or treatment as usual. Treatment as usual meant that participants did not receive any preventive treatment but were invited to start light therapy as first depressive symptoms occurred. All individuals in these studies had a history of winter depression and were free of depressive symptoms when the study started."
}
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query-laysum | 5819 | [
{
"role": "user",
"content": "Abstract: Background\nChildren and adolescents who have experienced trauma are at high risk of developing post-traumatic stress disorder (PTSD) and other negative emotional, behavioural and mental health outcomes, all of which are associated with high personal and health costs. A wide range of psychological treatments are used to prevent negative outcomes associated with trauma in children and adolescents.\nObjectives\nTo assess the effects of psychological therapies in preventing PTSD and associated negative emotional, behavioural and mental health outcomes in children and adolescents who have undergone a traumatic event.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Group's Specialised Register to 29 May 2015. This register contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We also checked reference lists of relevant studies and reviews. We did not restrict the searches by date, language or publication status.\nSelection criteria\nAll randomised controlled trials of psychological therapies compared with a control such as treatment as usual, waiting list or no treatment, pharmacological therapy or other treatments in children or adolescents who had undergone a traumatic event.\nData collection and analysis\nTwo members of the review group independently extracted data. We calculated odds ratios for binary outcomes and standardised mean differences for continuous outcomes using a random-effects model. We analysed data as short-term (up to and including one month after therapy), medium-term (one month to one year after therapy) and long-term (one year or longer).\nMain results\nInvestigators included 6201 participants in the 51 included trials. Twenty studies included only children, two included only preschool children and ten only adolescents; all others included both children and adolescents. Participants were exposed to sexual abuse in 12 trials, to war or community violence in ten, to physical trauma and natural disaster in six each and to interpersonal violence in three; participants had suffered a life-threatening illness and had been physically abused or maltreated in one trial each. Participants in remaining trials were exposed to a range of traumas.\nMost trials compared a psychological therapy with a control such as treatment as usual, wait list or no treatment. Seventeen trials used cognitive-behavioural therapy (CBT); four used family therapy; three required debriefing; two trials each used eye movement desensitisation and reprocessing (EMDR), narrative therapy, psychoeducation and supportive therapy; and one trial each provided exposure and CBT plus narrative therapy. Eight trials compared CBT with supportive therapy, two compared CBT with EMDR and one trial each compared CBT with psychodynamic therapy, exposure plus supportive therapy with supportive therapy alone and narrative therapy plus CBT versus CBT alone. Four trials compared individual delivery of psychological therapy to a group model of the same therapy, and one compared CBT for children versus CBT for both mothers and children.\nThe likelihood of being diagnosed with PTSD in children and adolescents who received a psychological therapy was significantly reduced compared to those who received no treatment, treatment as usual or were on a waiting list for up to a month following treatment (odds ratio (OR) 0.51, 95% confidence interval (CI) 0.34 to 0.77; number needed to treat for an additional beneficial outcome (NNTB) 6.25, 95% CI 3.70 to 16.67; five studies; 874 participants). However the overall quality of evidence for the diagnosis of PTSD was rated as very low. PTSD symptoms were also significantly reduced for a month after therapy (standardised mean difference (SMD) -0.42, 95% CI -0.61 to -0.24; 15 studies; 2051 participants) and the quality of evidence was rated as low. These effects of psychological therapies were not apparent over the longer term.\nCBT was found to be no more or less effective than EMDR and supportive therapy in reducing diagnosis of PTSD in the short term (OR 0.74, 95% CI 0.29 to 1.91; 2 studies; 160 participants), however this was considered very low quality evidence. For reduction of PTSD symptoms in the short term, there was a small effect favouring CBT over EMDR, play therapy and supportive therapies (SMD -0.24, 95% CI -0.42 to -0.05; 7 studies; 466 participants). The quality of evidence for this outcome was rated as moderate.\nWe did not identify any studies that compared pharmacological therapies with psychological therapies.\nAuthors' conclusions\nThe meta-analyses in this review provide some evidence for the effectiveness of psychological therapies in prevention of PTSD and reduction of symptoms in children and adolescents exposed to trauma for up to a month. However, our confidence in these findings is limited by the quality of the included studies and by substantial heterogeneity between studies. Much more evidence is needed to demonstrate the relative effectiveness of different psychological therapies for children exposed to trauma, particularly over the longer term. High-quality studies should be conducted to compare these therapies.\n\nGiven the provided abstract, please respond to the following query: \"What does evidence presented in the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Children and adolescents receiving psychological therapies were less likely to be diagnosed with PTSD and had fewer symptoms of PTSD up to a month after treatment compared with those who received no treatment, treatment as usual or were on a waiting list. Our confidence in these findings is limited as the overall quality of evidence was very low to low. There was no evidence for the effectiveness of psychological therapies beyond one month. There was moderate quality evidence that cognitive-behavioural therapy (CBT) might be more effective in reducing symptoms of PTSD compared to other psychological therapies for up to a month. Adverse effects were not reported. There were no studies which compared psychological therapies to drug treatments."
}
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query-laysum | 5820 | [
{
"role": "user",
"content": "Abstract: Background\nBrain arteriovenous malformations (AVMs) are the single most common cause of intracerebral haemorrhage in young adults. Brain AVMs also cause seizure(s) and focal neurological deficits (in the absence of haemorrhage, migraine or an epileptic seizure); approximately one-fifth are incidental discoveries. Various interventions are used in an attempt to eradicate brain AVMs: neurosurgical excision, stereotactic radiosurgery, endovascular embolization, and staged combinations of these interventions. This is an update of a Cochrane Review first published in 2006, and last updated in 2009.\nObjectives\nTo determine the effectiveness and safety of the different interventions, alone or in combination, for treating brain AVMs in adults compared against either each other, or conservative management, in randomized controlled trials (RCTs).\nSearch methods\nThe Cochrane Stroke Group Information Specialist searched the Cochrane Stroke Group Trials Register (last searched 7 January 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1) in the Cochrane Library, MEDLINE Ovid (1980 to 14 January 2019), and Embase OVID (1980 to 14 January 2019). We searched international registers of clinical trials, the contents pages of relevant journals, and bibliographies of relevant articles (November 2009). We also contacted manufacturers of interventional treatments for brain AVMs (March 2005).\nSelection criteria\nWe sought RCTs of any intervention for brain AVMs (used alone or in combination), compared against each other or against conservative management, with relevant clinical outcome measures.\nData collection and analysis\nOne author screened the results of the updated searches for potentially eligible RCTs for this updated review. Both authors independently read the potentially eligible RCTs in full and confirmed their inclusion according to the inclusion criteria. We resolved disagreement by discussion. We assessed the risk of bias in included studies and applied GRADE.\nMain results\nWe included one trial with 226 participants: A Randomized trial of Unruptured Brain Arteriovenous Malformations (ARUBA), comparing intervention versus conservative management for unruptured brain AVMs (that had never bled). The quality of evidence was moderate because we found just one trial that was at low risk of bias other than a high risk of performance bias due to participants and treating physicians not being blinded to allocated treatment. Data on functional outcome and death at a follow-up of 12 months were provided for 218 (96%) of the participants in ARUBA. In this randomized controlled trial (RCT), intervention compared to conservative management increased death or dependency (modified Rankin Scale score ≥ 2, risk ratio (RR) 2.53, 95% confidence interval (CI) 1.28 to 4.98; 1 trial, 226 participants; moderate-quality evidence) and the proportion of participants with symptomatic intracranial haemorrhage (RR 6.75, 95% CI 2.07 to 21.96; 1 trial, 226 participants; moderate-quality evidence), but there was no difference in the frequency of epileptic seizures (RR 1.14, 95% CI 0.63 to 2.06; 1 trial, 226 participants; moderate-quality evidence). Three RCTs are ongoing.\nAuthors' conclusions\nWe found moderate-quality evidence from one RCT including adults with unruptured brain AVMs that conservative management was superior to intervention with respect to functional outcome and symptomatic intracranial haemorrhage over one year after randomization. More RCTs will help to confirm or refute these findings.\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": "We found moderate-quality evidence of harm (stroke due to bleeding in the brain, and death or dependency) over one year of follow-up from interventional treatments compared to conservative management for adults who had a brain AVM that had never bled. The long-term risks are unknown."
}
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query-laysum | 5821 | [
{
"role": "user",
"content": "Abstract: Background\nPressure ulcers, which are a localised injury to the skin, or underlying tissue, or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful, expensive to manage and have a negative impact on quality of life. While individual patient safety and quality care stem largely from direct healthcare practitioner-patient interactions, each practitioner-patient wound-care contact may be constrained or enhanced by healthcare organisation of services. Research is needed to demonstrate clearly the effect of different provider-orientated approaches to pressure ulcer prevention and treatment.\nObjectives\nTo assess the effects of different provider-orientated interventions targeted at the organisation of health services, on the prevention and treatment of pressure ulcers.\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 three 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. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-RCTs, non-RCTs, controlled before-and-after studies and interrupted time series, which enrolled people at risk of, or people with existing pressure ulcers, were eligible for inclusion in the review.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence.\nMain results\nThe search yielded a total of 3172 citations and, following screening and application of the inclusion and exclusion criteria, we deemed four studies eligible for inclusion. These studies reported the primary outcome of pressure ulcer incidence or pressure ulcer healing, or both.\nOne controlled before-and-after study explored the impact of transmural care (a care model that provided activities to support patients and their family/partners and activities to promote continuity of care), among 62 participants with spinal cord injury. It is unclear whether transmural care leads to a difference in pressure ulcer incidence compared with usual care (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.53 to 1.64; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).\nOne RCT explored the impact of hospital-in-the-home care, among 100 older adults. It is unclear whether hospital-in-the-home care leads to a difference in pressure ulcer incidence risk compared with hospital admission (RR 0.32, 95% CI 0.03 to 2.98; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).\nA third study (cluster-randomised stepped-wedge trial), explored the impact of being cared for by enhanced multidisciplinary teams (EMDT), among 161 long-term-care residents. The analyses of the primary outcome used measurements of 201 pressure ulcers from 119 residents. It is unclear if EMDT reduces the pressure ulcer incidence rate compared with usual care (hazard ratio (HR) 1.12, 95% CI 0.74 to 1.68; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the number of wounds healed (RR 1.69, 95% CI 1.00 to 2.87; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the reduction in surface area, with and without EMDT, (healing rate 1.006; 95% CI 0.99 to 1.03; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if EMDT leads to a difference in time to complete healing (HR 1.48, 95% CI 0.79 to 2.78, very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).\nThe final study (quasi-experimental cluster trial), explored the impact of multidisciplinary wound care among 176 nursing home residents. It is unclear whether there is a difference in the number of pressure ulcers healed between multidisciplinary care, or usual care (RR 1.18, 95% CI 0.98 to 1.42; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if this type of care leads to a difference in time to complete healing compared with usual care (HR 1.73, 95% CI 1.20 to 2.50; very low-certainty evidence; downgraded twice for very serious study limitations and twice for very serious imprecision).\nIn all studies the certainty of the evidence is very low due to high risk of bias and imprecision. We downgraded the evidence due to study limitations, which included selection and attrition bias, and sample size. Secondary outcomes, such as adverse events were not reported in all studies. Where they were reported it was unclear if there was a difference as the certainty of evidence was very low.\nAuthors' conclusions\nEvidence for the impact of organisation of health services for preventing and treating pressure ulcers remains unclear. Overall, GRADE assessments of the evidence resulted in judgements of very low-certainty evidence. The studies were at high risk of bias, and outcome measures were imprecise due to wide confidence intervals and small sample sizes, meaning that additional research is required to confirm these results. The secondary outcomes reported varied across the studies and some were not reported. We judged the evidence from those that were reported (including adverse events), to be of very low certainty.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Pressure ulcers, sometimes known as bedsores or pressure sores, are injuries that develop as a result of continued pressure on bony parts of the body such as the hips, heels or lower back. It is thought that the way health services are organised can influence the development of pressure ulcers among people at risk, and may also influence the healing of these wounds.\nCare can be delivered to people with pressure ulcers in various ways. We wanted to find out whether different types of care delivery affected the number of people developing pressure ulcers and how fast existing ulcers healed."
}
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query-laysum | 5822 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a highly prevalent condition in an ever-increasing elderly population. Although insidious in the early stages, advanced AMD (neovascular and atrophic forms) can cause significant visual disability and economic burden on health systems worldwide. The most common form, geographic atrophy, has no effective treatment to date, whereas neovascular AMD can be treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections. Geographic atrophy has a slow disease progression and patients tend to have preserved central vision until the final stages. This tendency, coupled with the use of modern imaging modalities, provides a large window of opportunity to intervene with validated methods to assess treatment efficacy. As geographic atrophy is an increasingly common condition with no effective intervention, many treatments are under investigation, one of which is visual cycle modulators. These medications have been shown to reduce lipofuscin accumulation in pre-clinical studies that have led to several clinical trials, reviewed herein.\nObjectives\nTo assess the efficacy and safety of visual cycle modulators for the prevention and treatment of geographic atrophy secondary to AMD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 1); MEDLINE Ovid; Embase Ovid; Web of Science Core Collection; Scopus; Association for Research in Vision and Ophthalmology (ARVO) website; ClinicalTrials.gov and the WHO ICTRP to 11 January 2020 with no language restrictions. We also searched using the reference lists of reviews and existing studies and the Cited Reference Search function in Web of Science to identify further relevant studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised clinical studies (if available) that compared visual cycle modulators to placebo or no treatment (observation) in people diagnosed with AMD (early, intermediate or geographic atrophy).\nData collection and analysis\nTwo authors independently assessed risk of bias in the included studies and extracted data. Both authors entered data into RevMan 5. We resolved discrepancies through discussion. We graded the certainty of the evidence using the GRADE approach.\nMain results\nWe included three RCTs from the USA; one of these had clinical sites in Germany. Two studies compared emixustat to placebo while the other compared fenretinide to placebo. All assigned one study eye per participant and, combined, have a total of 821 participants with a majority white ethnicity (97.6%). All participants were diagnosed with geographic atrophy due to AMD based on validated imaging modalities. All three studies have high risk of attrition bias mainly due to ocular adverse effects of emixustat and fenretinide. We considered only one study to be adequately conducted and reported with high risk of bias in only one domain (attrition bias). We considered the other two studies to be poorly reported and to have high risk of attrition bias and reporting bias.\nPeople with geographic atrophy treated with emixustat may not experience a clinically important change in best-corrected visual acuity (BCVA) between baseline and 24 months compared to people treated with placebo (mean difference (MD) 1.9 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, 95% confidence interval (CI) -2.34 to 6.14, low-certainty evidence). Emixustat may also result in little or no difference in loss of 15 ETDRS letters or more of BCVA compared with placebo at 24 months (16.4% versus 18%) (risk ratio (RR) 0.91, 95% CI 0.59 to 1.4, low-certainty evidence). In terms of disease progression, emixustat may result in little or no difference in the annual growth rate of geographic atrophy compared with placebo (mean difference MD 0.09 mm2/year (95% CI -0.26 to 0.44, low-certainty evidence).\nAll three studies reported adverse events of both drugs (emixustat: moderate-certainty evidence; fenretinide: low-certainty evidence). The main adverse events were ocular in nature and associated with the mechanism of action of the drugs. Delayed dark adaptation (emixustat: 54.5%; fenretinide: 39.3%) and chromatopsia (emixustat: 22.6%; fenretinide: 25.2%) were the most common adverse events reported, and were the most prevalent reasons for study dropout in emixustat trials. These effects were dose-dependent and resolved after drug cessation. No specific systemic adverse events were considered related to emixustat; only pruritus and rash were considered to be due to fenretinide. One emixustat study reported six deaths, none deemed related to the drug.\nNone of the included RCTs reported the other pre-specified outcomes, including proportion of participants losing 10 letters or more, and mean change in macular sensitivity. We planned to investigate progression to advanced AMD (geographic atrophy or neovascular AMD) in prevention studies, including participants with early or intermediate AMD, but we identified no such studies.\nTwo of the included studies reported an additional outcome - incidence of choroidal neovascularisation (CNV) - that was not in our published protocol. CNV onset may be reduced in those treated with emixustat but the evidence was uncertain (risk ratio (RR) 0.67, 95% CI 0.27 to 1.65, low-certainty evidence), or fenretinide (RR 0.5, 95% CI 0.26 to 0.98, low-certainty evidence) compared to placebo. A dose-dependent relationship was observed with emixustat.\nAuthors' conclusions\nThere is limited evidence to support the use of visual cycle modulators (emixustat and fenretinide) for the treatment of established geographic atrophy due to AMD. The possible reduction in the incidence of CNV observed with fenretinide, and to a lesser extent, emixustat, requires formal assessment in focused studies.\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"
},
{
"role": "assistant",
"content": "Our review of the evidence suggests that, in people with advanced AMD, visual cycle modulators may make little or no difference to:\n• the progression of geographic atrophy; and\n• vision loss.\nOur confidence in these findings is low. The results of our review are likely to change if more evidence becomes available."
}
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query-laysum | 5823 | [
{
"role": "user",
"content": "Abstract: Background\nMeningitis is inflammation of the meninges, the layers that protect the brain and spinal cord. Acute meningitis is an emergent disease that develops over the course of hours to several days. Delay in treatment can lead to serious outcomes.\nInflammation of the meninges is assessed by analysing cerebrospinal fluid. Identifying the pathogen in cerebrospinal fluid is another way to diagnose meningitis. Cerebrospinal fluid is collected by doing a lumbar puncture, which is an invasive test, and can be avoided if a physical examination excludes the diagnosis of meningitis. However, most physical examinations, such as nuchal rigidity, Kernig's test, and Brudzinski's test, are not sufficiently sensitive to exclude meningitis completely.\nJolt accentuation of headache is a new and less well-recognised physical examination, which assesses meningeal irritation. It is judged as positive if the headache is exacerbated by rotating the head horizontally two or three times per second. A 1991 observational study initially reported high sensitivity of this examination to predict pleocytosis. Pleocytosis, an abnormally high cerebrospinal fluid sample white cell count, is an accepted indicator of nervous system infection or inflammation. Jolt accentuation of headache may therefore accurately rule out meningitis without the use of lumbar puncture. However, more recent cross-sectional studies have reported variable diagnostic accuracy.\nObjectives\nTo estimate the diagnostic accuracy of jolt accentuation of headache for detecting acute meningitis in emergency settings. Secondary objectives: to investigate the sources of heterogeneity, including study population, patient condition, and types of meningitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), and Embase (Elsevier) to 27 April 2020. We searched ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and Ichushi-Web Version 5.0 to 28 April 2020.\nSelection criteria\nWe included cross-sectional studies that assessed the diagnostic accuracy of jolt accentuation of headache for people with suspected meningitis in emergency settings. We included participants of any age and any severity of illness. Meningitis should be diagnosed with any reference standard, such as cerebrospinal fluid pleocytosis, proof of causative agents, or autopsy.\nData collection and analysis\nTwo review authors independently collated study data. We assessed methodological quality of studies using QUADAS-2 criteria. We used a bivariate random-effects model to determine summary estimates of sensitivity and specificity where meta-analysis was possible. We performed sensitivity analyses to validate the robustness of outcomes. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included nine studies (1161 participants). Five studies included only adults. Four studies included both adults and children; however, the proportion was not reported in three of these studies. The youngest child reported in the studies was aged 13 years. There was no study including only children.\nThe reference standard was pleocytosis in eight studies, and the combination of pleocytosis and increased protein in the cerebrospinal fluid in one study. Two studies also used smear or positive culture of cerebrospinal fluid.\nRisk of bias and concern about applicability was high in the participant selection domain for all included studies and the consciousness subgroup.\nOverall, pooled sensitivity was 65.3% (95% confidence interval (CI) 37.3 to 85.6), and pooled specificity was 70.4% (95% CI 47.7 to 86.1) (very low-certainty evidence). We established the possibility of heterogeneity from visual inspection of forest plots. However, we were unable to conduct further analysis for study population, types of meningitis, and participants' condition, other than disturbance of consciousness (a secondary outcome).\nAmongst participants whose consciousness was undisturbed (8 studies, 921 participants), pooled sensitivity and specificity were 75.2% (95% CI 54.3 to 88.6) and 60.8% (95% CI 43.4 to 75.9), respectively (very low-certainty evidence).\nAuthors' conclusions\nJolt accentuation for headache may exclude diagnoses of meningitis in emergency settings, but high-quality evidence to support use of this test is lacking. Even where jolt accentuation of headache is negative, there is still the possibility of acute meningitis. This review identified the possibility of heterogeneity. However, factors that contribute to heterogeneity are incompletely understood, and should be considered in future research.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included nine studies involving 1161 participants who presented with potential acute meningitis. Five studies included only adults, and four studies included both adults and children. Due to lack of data, we could not perform separate analyses for adults and children."
}
]
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query-laysum | 5824 | [
{
"role": "user",
"content": "Abstract: Background\nWe performed a systematic review, a standard meta-analysis and network meta-analysis (NMA), which updates the 2009 Cochrane Overview, 'Biologics for rheumatoid arthritis (RA)'. This review is focused on biologic monotherapy in people with RA in whom treatment with traditional disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) had failed (MTX/other DMARD-experienced).\nObjectives\nTo assess the benefits and harms of biologic monotherapy (includes anti-tumor necrosis factor (TNF) (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) or non-TNF (abatacept, anakinra, rituximab, tocilizumab)) or tofacitinib monotherapy (oral small molecule) versus comparator (placebo or MTX/other DMARDs) in adults with RA who were MTX/other DMARD-experienced.\nMethods\nWe searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2015, Issue 6, June), MEDLINE (via OVID 1946 to June 2015), and Embase (via OVID 1947 to June 2015). Article selection, data extraction and risk of bias and GRADE assessments were done in duplicate. We calculated direct estimates with 95% confidence intervals (CI) using standard meta-analysis. We used a Bayesian mixed treatment comparisons (MTC) approach for NMA estimates with 95% credible intervals (CrI). We converted odds ratios (OR) to risk ratios (RR) for ease of understanding. We calculated absolute measures as risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB).\nMain results\nThis update includes 40 new RCTs for a total of 46 RCTs, of which 41 studies with 14,049 participants provided data. The comparator was placebo in 16 RCTs (4,532 patients), MTX or other DMARD in 13 RCTs (5,602 patients), and another biologic in 12 RCTs (3,915 patients).\nMonotherapy versus placebo\nBased on moderate-quality direct evidence, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in American College of Rheumatology score (ACR50) and physical function, as measured by the Health Assessment Questionnaire (HAQ) versus placebo. RR was 4.68 for ACR50 (95% CI, 2.93 to 7.48); absolute benefit RD 23% (95% CI, 18% to 29%); and NNTB = 5 (95% CI, 3 to 8). The mean difference (MD) was -0.32 for HAQ (95% CI, -0.42 to -0.23; a negative sign represents greater HAQ improvement); absolute benefit of -10.7% (95% CI, -14% to -7.7%); and NNTB = 4 (95% CI, 3 to 5). Direct and NMA estimates for TNF biologic, non-TNF biologic or tofacitinib monotherapy showed similar results for ACR50 , downgraded to moderate-quality evidence. Direct and NMA estimates for TNF biologic, anakinra or tofacitinib monotherapy showed a similar results for HAQ versus placebo with mostly moderate quality evidence.\nBased on moderate-quality direct evidence, biologic monotherapy was associated with a clinically meaningful and statistically significant greater proportion of disease remission versus placebo with RR 1.12 (95% CI 1.03 to 1.22); absolute benefit 10% (95% CI, 3% to 17%; NNTB = 10 (95% CI, 8 to 21)).\nBased on low-quality direct evidence, results for biologic monotherapy for withdrawals due to adverse events and serious adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase. The direct estimate for TNF monotherapy for withdrawals due to adverse events showed a clinically meaningful and statistically significant result with RR 2.02 (95% CI, 1.08 to 3.78), absolute benefit RD 3% (95% CI,1% to 4%), based on moderate-quality evidence. The NMA estimates for TNF biologic, non-TNF biologic, anakinra, or tofacitinib monotherapy for withdrawals due to adverse events and for serious adverse events were all inconclusive and downgraded to low-quality evidence.\nMonotherapy versus active comparator (MTX/other DMARDs)\nBased on direct evidence of moderate quality, biologic monotherapy (without concurrent MTX/other DMARDs) was associated with a clinically meaningful and statistically significant improvement in ACR50 and HAQ scores versus MTX/other DMARDs with a RR of 1.54 (95% CI, 1.14 to 2.08); absolute benefit 13% (95% CI, 2% to 23%), NNTB = 7 (95% CI, 4 to 26) and a mean difference in HAQ of -0.27 (95% CI, -0.40 to -0.14); absolute benefit of -9% (95% CI, -13.3% to -4.7%), NNTB = 2 (95% CI, 2 to 4). Direct and NMA estimates for TNF monotherapy and NMA estimate for non-TNF biologic monotherapy for ACR50 showed similar results, based on moderate-quality evidence. Direct and NMA estimates for non-TNF biologic monotherapy, but not TNF monotherapy, showed similar HAQ improvements , based on mostly moderate-quality evidence.\nThere were no statistically significant or clinically meaningful differences for direct estimates of biologic monotherapy versus active comparator for RA disease remission. NMA estimates showed a statistically significant and clinically meaningful difference versus active comparator for TNF monotherapy (absolute improvement 7% (95% CI, 2% to 14%)) and non-TNF monotherapy (absolute improvement 19% (95% CrI, 7% to 36%)), both downgraded to moderate quality.\nBased on moderate-quality direct evidence from a single study, radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologic monotherapy versus active comparator, MD -4.34 (95% CI, -7.56 to -1.12), though the absolute reduction was small, -0.97% (95% CI, -1.69% to -0.25%). We are not sure of the clinical relevance of this reduction.\nDirect and NMA evidence (downgraded to low quality), showed inconclusive results for withdrawals due to adverse events, serious adverse events and cancer, with wide confidence intervals encompassing the null effect and evidence of an important increase.\nAuthors' conclusions\nBased mostly on RCTs of six to 12-month duration in people with RA who had previously experienced and failed treatment with MTX/other DMARDs, biologic monotherapy improved ACR50, function and RA remission rates compared to placebo or MTX/other DMARDs.\nRadiographic progression was reduced versus active comparator, although the clinical significance was unclear.\nResults were inconclusive for whether biologic monotherapy was associated with an increased risk of withdrawals due to adverse events, serious adverse events or cancer, versus placebo (no data on cancer) or MTX/other DMARDs.\n\nGiven the provided abstract, please respond to the following query: \"RA Symptoms\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
]
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query-laysum | 5825 | [
{
"role": "user",
"content": "Abstract: Background\nRecurrent high-grade glioma (HGG) carries an extremely poor prognosis. There is no current standard of care or guideline-based recommendations. Nitrosourea-based multidrug chemotherapy or PCV — procarbazine, lomustine (CCNU) and vincristine — is one of the treatment options at recurrence. There has been no meta-analysis which looks at the benefits and harms of PCV chemotherapy in adults with recurrent HGG.\nObjectives\nTo assess the effectiveness and safety of procarbazine, lomustine, and vincristine (PCV) chemotherapy with other interventions in adults with recurrent high-grade glioma. To investigate whether predefined subgroups of people benefit more or less from chemotherapy.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, 2017), MEDLINE (1946 to 22 May 2017), and Embase (1980 to 22 May 2017). We searched trial registries including the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP; apps.who.int/trialsearch) and the National Institutes of Health (NIH; ClinicalTrials.gov). We searched the reference lists of all identified studies; the electronic table of contents of the Journal of Neuro-Oncology (1983 to 2016) and Neuro-Oncology (1999 to 2016); and conference abstracts from the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO 2004 to 2016). We also searched unpublished grey literature and other regional databases. There were no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs), quasi-randomised trials (QRCTs), or controlled clinical trials (CCTs) where PCV was used to treat adults with recurrent HGG. Comparison arm included no chemotherapy, other second line chemotherapy or best supportive care.\nData collection and analysis\nTwo review authors extracted the data and undertook a 'Risk of bias' assessment and critical appraisal of the studies.\nMain results\nWe identified two RCTs meeting our inclusion criteria. The two trials tested different comparisons.\nOne RCT included 35 participants and compared PCV with 'eight drugs in one day' multidrug chemotherapy, which is a combination of drugs with different mechanisms of action. Median survival was 6 months for the PCV group and 6.5 months for the 'eight drugs in one day' group. Adverse event outcomes were not graded or quantified. Progression-free survival (PFS) and quality of life (QoL) were not described in the methods and were not an outcome of interest. The sample size in this study was small, which lead to insufficient statistical power to detect clinical differences. According to the GRADE approach we judged the quality of evidence to be low for survival outcome and very low for chemotherapy toxicity\nThe second multi-institutional RCT included 447 participants and compared PCV with Temozolomide (TMZ). Participants were randomised into three arms to receive PCV, and two different regimens of TMZ in a 2:1:1 ratio at first recurrence. The trial reported a median overall survival of 6.7 months and 7.2 months for the PCV and TMZ group respectively. It reported a PFS of 3.6 months for the PCV group and 4.7 months for the TMZ group. There was no observed difference of effect on overall survival (hazard ratio (HR) 0.91, 95% CI 0.74 to 1.11; P = 0.35) or PFS (HR 0.89, 95% CI 0.73 to 1.08; P = 0.23) in participants receiving PCV or TMZ chemotherapy. The proportion of people with at least one grade 3 or 4 adverse event was not clinically important at 9.2% versus 12.2% in PCV and TMZ arms respectively. Mean QoL scores calculated at baseline, 12 weeks and 24 weeks was 51.9 versus 59.8 favouring TMZ (P = 0.04) which is statistically but not clinically significant and was less than the pre-defined 10 point change for moderate improvement. We judged the GRADE quality of evidence to be moderate for overall survival, PFS, and chemotherapy toxicity and low for QoL.\nAuthors' conclusions\nEvidence is based on a single large trial analysis as the other trial was small, with inadequate power to detect survival difference. Chemotherapy-naive patients with HGG at first recurrence when treated with PCV or TMZ have similar survival and time-to-progression outcomes. Adverse events are similar and QoL scores are statistically but not clinically significant between TMZ and PCV. Further RCTs should be conducted with adequate power following CONSORT guidelines with emphasis on QoL outcomes.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Recurrent high-grade glioma carries a very poor prognosis. Treatment options are limited at recurrence. PCV is a nitrosourea-based multi-drug chemotherapy which can be used at recurrence. A multidrug regimen kills the cancer cells in more than one way and is therefore assumed to be more effective. There is lack of knowledge about the efficacy and adverse effects of PCV when used for treating recurrent HGG."
}
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query-laysum | 5826 | [
{
"role": "user",
"content": "Abstract: Background\nInhaled nitric oxide (iNO) is effective in term infants with hypoxic respiratory failure. The pathophysiology of respiratory failure and the potential risks of iNO differ substantially in preterm infants, necessitating specific study in this population.\nObjectives\nTo determine effects of treatment with inhaled nitric oxide (iNO) on death, bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH) or other serious brain injury and on adverse long-term neurodevelopmental outcomes in preterm newborn infants with hypoxic respiratory failure.\nOwing to substantial variation in study eligibility criteria, which decreases the utility of an overall analysis, we divided participants post hoc into three groups: (1) infants treated over the first three days of life because of defects in oxygenation, (2) preterm infants with evidence of pulmonary disease treated routinely with iNO and (3) infants treated later (after three days of age) because of elevated risk of BPD.\nSearch methods\nWe used standard methods of the Cochrane Neonatal Review Group. We searched MEDLINE, Embase, Healthstar and the Cochrane Central Register of Controlled Trials in the Cochrane Library through January 2016. We also searched the abstracts of the Pediatric Academic Societies.\nSelection criteria\nEligible for inclusion were randomised and quasi-randomised studies in preterm infants with respiratory disease that compared effects of iNO gas versus control, with or without placebo.\nData collection and analysis\nWe used standard methods of the Cochrane Neonatal Review Group and applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence.\nMain results\nWe found 17 randomised controlled trials of iNO therapy in preterm infants. We grouped these trials post hoc into three categories on the basis of entry criteria: treatment during the first three days of life for impaired oxygenation, routine use in preterm babies along with respiratory support and later treatment for infants at increased risk for bronchopulmonary dysplasia (BPD). We performed no overall analyses.\nEight trials providing early rescue treatment for infants on the basis of oxygenation criteria demonstrated no significant effect of iNO on mortality or BPD (typical risk ratio (RR) 0.94, 95% confidence interval (CI) 0.87 to 1.01; 958 infants). Four studies examining routine use of iNO in infants with pulmonary disease reported no significant reduction in death or BPD (typical RR 0.94, 95% CI 0.87 to 1.02; 1924 infants), although this small effect approached significance. Later treatment with iNO based on risk of BPD (three trials) revealed no significant benefit for this outcome in analyses of summary data (typical RR 0.92, 95% CI 0.85 to 1.01; 1075 infants).\nInvestigators found no clear effect of iNO on the frequency of all grades of IVH nor severe IVH. Early rescue treatment was associated with a non-significant 20% increase in severe IVH.\nWe found no effect on the incidence of neurodevelopmental impairment.\nAuthors' conclusions\niNO does not appear to be effective as rescue therapy for the very ill preterm infant. Early routine use of iNO in preterm infants with respiratory disease does not prevent serious brain injury or improve survival without BPD. Later use of iNO to prevent BPD could be effective, but current 95% confidence intervals include no effect; the effect size is likely small (RR 0.92) and requires further study.\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": "In none of the three groups of trials did iNO improve survival, and no consistent evidence suggests that iNO decreases lung injury. Studies in group 1 (early rescue treatment) reported a 20% increase in severe bleeding into the brain. This finding was close to statistically significant. The quality of the evidence was moderate to high.\nThis review of studies found that inhaled nitric oxide therapy does not appear to improve the chances of improved outcomes for preterm infants with pulmonary disease. When given to babies who were very ill, iNO did not seem to help and may have contributed to increased risk of intracranial haemorrhage."
}
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query-laysum | 5827 | [
{
"role": "user",
"content": "Abstract: Background\nPegylated interferon (peginterferon) plus ribavirin is the recommended treatment for patients with chronic hepatitis C, but systematic assessment of the effect of this treatment compared with interferon plus ribavirin is needed.\nObjectives\nTo systematically evaluate the benefits and harms of peginterferon plus ribavirin versus interferon plus ribavirin for patients with chronic hepatitis C.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index-Expanded, and LILACS. We also searched conference abstracts, journals, and grey literature. The last searches were conducted in September 2013.\nSelection criteria\nWe included randomised clinical trials comparing peginterferon plus ribavirin versus interferon plus ribavirin with or without co-intervention(s) (e.g., other antiviral drugs) for chronic hepatitis C. Quasi-randomised and observational studies retrieved through the searches for randomised clinical trials were also considered for reports of harms. Our primary outcomes were liver-related morbidity, all-cause mortality, serious adverse events, adverse events leading to treatment discontinuation, other adverse events, and quality of life. Our secondary outcome was sustained virological response in serum, that is, undetectable hepatitis C virus RNA in serum by sensitive tests six months after the end of treatment.\nData collection and analysis\nTwo review authors independently used a standardised data collection form. We meta-analysed data with both fixed-effect and random-effects models. For each outcome, we calculated the odds ratio (OR) (for liver-related morbidity or all-cause mortality) or the risk ratio (RR) along with 95% confidence interval (CI) based on intention-to-treat analysis. We used domains of the trials to assess the risk of systematic errors (bias) and trial sequential analyses to assess the risk of random errors (play of chance).\nFor each outcome, we calculated the RR with 95% CI based on intention-to-treat analysis. Effects of interventions on outcomes were assessed according to GRADE.\nMain results\nWe included 27 randomised trials with 5938 participants. All trials had high risk of bias. We considered that the risk of bias did not impact on the quality of evidence for liver-related mortality and adverse event outcomes, but it did for virological response. All trials compared peginterferon alpha-2a or peginterferon alpha-2b plus ribavirin versus interferon plus ribavirin for participants with chronic hepatitis C. Three trials administered co-interventions (amantadine hydrochloride 200 mg daily to both intervention groups), and 24 trials were conducted without co-interventions. The effect observed between the two intervention groups regarding liver-related morbidity plus all-cause mortality (5/907 (0.55%) versus 4/882 (0.45%) was imprecise: OR 1.14 ( 95% CI 0.38 to 3.42; five trials; low quality of evidence), as was the risk of adverse events leading to treatment discontinuation (332/2692 (12.3%) versus 409/2176 (18.8%); RR 0.86, 95% CI 0.68 to 1.09; 15 trials; low quality of evidence) or regarding adverse events leading to treatment discontinuation (332/2692 (12.3%) versus 409/2176 (18.8%); RR 0.86, 95% CI 0.66 to 1.12; 17 trials; low quality of evidence). However, peginterferon plus ribavirin versus interferon plus ribavirin significantly increased the risk of neutropenia (332/2202 (15.1%) versus 117/1653 (7.1%); RR 2.15, 95% CI 1.76 to 2.61; 13 trials), thrombocytopenia (65/1113 (5.8%) versus 23/1082 (2.1%); RR 2.63, 95% CI 1.68 to 4.11; 10 trials), arthralgia (517/1740 (29.7%) versus 282/1194 (23.6%); RR 1.19, 95% CI 1.05 to 1.35; four trials), injection site reaction (627/1168 (53.7%) versus 186/649 (28.7%); RR 1.71, 95% CI 1.50 to 1.93; four trials), and nausea (606/1784 (34.0%) versus 354/1239 (28.6%); RR 1.13, 95% CI 1.01 to 1.26; four trials). The most frequent adverse event was fatigue, which occurred in 57% of participants (2024/3608). No significant difference was noted between peginterferon plus ribavirin versus interferon plus ribavirin in terms of fatigue (1177/2062 (57.1%) versus 847/1546 (54.8%); RR 1.01, 95% CI 0.96 to 1.07; 12 trials). No significant differences were reported between the two treatment groups regarding anaemia, headache, rigours, myalgia, pyrexia, weight loss, asthenia, depression, insomnia, irritability, alopecia, pruritus, skin rash, thyroid malfunction, decreased appetite, or diarrhoea. We were unable to identify any data on quality of life. Peginterferon plus ribavirin versus interferon plus ribavirin seemed to significantly increase the number of participants achieving sustained virological response (1673/3300 participants (50.7%) versus 1081/2804 patients (36.7%); RR 1.39, 95% CI 1.25 to 1.56; I2 = 64%; 27 trials; very low quality of evidence). However, the risk of bias in the 13/27 (48.1%) trials reporting on this outcome was high and was considered only 'lower' in the remainder. Because the conventional meta-analysis did not reach its required information size (n = 14,486 participants), we used trial sequential analysis to control for risks of random errors. Again, in this analysis, the estimated effect was statistically significant in favour of peginterferon. Subgroup analyses according to risk of bias, viral genotype, baseline viral load, past treatment history, and type of intervention yielded similarly significant results favouring peginterferon over interferon on the outcome of sustained virological response.\nAuthors' conclusions\nPeginterferon plus ribavirin versus interferon plus ribavirin seems to significantly increase the proportion of patients with sustained virological response, as well as the risk of certain adverse events. However, we have insufficient evidence to recommend or reject peginterferon plus ribavirin for liver-related morbidity plus all-cause mortality compared with interferon plus ribavirin. The clinical consequences of achieved sustained virological response are unknown, as sustained virological response is still an unvalidated surrogate outcome. We found no evidence of the potential benefits on quality of life in patients with achieved sustained virological response. Further high-quality research is likely to have an important impact on our confidence in the estimate of patient-relevant outcomes and is likely to change our estimates.There is very low quality evidence that peginterferon plus ribavirin increases the proportion of patients with sustained virological response in comparison with interferon plus ribavirin. There is evidence that it also increases the risk of certain adverse events.\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": "This effect on virological response seems robust to analysis controlling for the risk of random errors ('play of chance'), but it may be due to the fact that all trials were considered at high risk of bias. Furthermore, we still need to have proof that sustained virological response induced by antiviral treatment has any association with patient-relevant and clinically relevant outcomes."
}
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query-laysum | 5828 | [
{
"role": "user",
"content": "Abstract: Background\nUrgent-start peritoneal dialysis (PD), defined as initiation of PD within two weeks of catheter insertion, has been emerging as an alternative mode of dialysis initiation for patients with chronic kidney disease (CKD) requiring urgent dialysis without established permanent dialysis access. Recently, several small studies have reported comparable patient outcomes between urgent-start and conventional-start PD.\nObjectives\nTo examine the benefits and harms of urgent-start PD compared with conventional-start PD in adults and children with CKD requiring long-term kidney replacement therapy.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 25 May 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nFor non-randomised controlled trials, MEDLINE (OVID) (1946 to 27 June 2019), EMBASE (OVID) (1980 to 27 June 2019), Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov (up to 27 June 2019) were searched.\nSelection criteria\nAll randomised controlled trials (RCTs) and non-RCTs comparing the outcomes of urgent-start PD (within 2 weeks of catheter insertion) and conventional-start PD ( ≥ 2 weeks of catheter insertion) treatment in children and adults CKD patients requiring long-term dialysis were included. Studies without a control group were excluded.\nData collection and analysis\nData were extracted and quality of studies were examined by two independent authors. The authors contacted investigators for additional information. Summary estimates of effect were examined using random-effects model and results were presented as risk ratios (RR) with 95% confidence intervals (CI) as appropriate for the data. The certainty of evidence for individual outcome was assessed using the GRADE approach.\nMain results\nA total of 16 studies (2953 participants) were included in this review, which included one multicentre RCT (122 participants) and 15 non-RCTs (2831 participants): 13 cohort studies (2671 participants) and 2 case-control studies (160 participants). The review included unadjusted data for analyses due to paucity of studies reporting adjusted data.\nIn low certainty evidence, urgent-start PD may increase dialysate leak (1 RCT, 122 participants: RR 3.90, 95% CI 1.56 to 9.78) compared with conventional-start PD which translated into an absolute number of 210 more leaks per 1000 (95% CI 40 to 635).\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases catheter blockage (4 cohort studies, 1214 participants: RR 1.33, 95% CI 0.40 to 4.43; 2 case-control studies, 160 participants: RR 1.89, 95% CI 0.58 to 6.13), catheter malposition (6 cohort studies, 1353 participants: RR 1.63, 95% CI 0.80 to 3.32; 1 case-control study, 104 participants: RR 3.00, 95% CI 0.64 to 13.96), and PD dialysate flow problems (3 cohort studies, 937 participants: RR 1.44, 95% CI 0.34 to 6.14) compared to conventional-start PD.\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases exit-site infection (2 cohort studies, 337 participants: RR 1.43, 95% CI 0.24 to 8.61; 1 case-control study, 104 participants RR 1.20, 95% CI 0.41 to 3.50), exit-site bleeding (1 RCT, 122 participants: RR 0.70, 95% CI 0.03 to 16.81; 1 cohort study, 27 participants: RR 1.58, 95% CI 0.07 to 35.32), peritonitis (7 cohort studies, 1497 participants: RR 1.00, 95% CI 0.68 to 1.46; 2 case-control studies, 160 participants: RR 1.09, 95% CI 0.12 to 9.51), catheter readjustment (2 cohort studies, 739 participants: RR 1.27, 95% CI 0.40 to 4.02), or reduces technique survival (1 RCT, 122 participants: RR 1.09, 95% CI 1.00 to 1.20; 8 cohort studies, 1668 participants: RR 0.90, 95% CI 0.76 to 1.07; 2 case-control studies, 160 participants: RR 0.92, 95% CI 0.79 to 1.06).\nIn very low certainty evidence, it is uncertain whether urgent-start PD compared with conventional-start PD increased death (any cause) (1 RCT, 122 participants: RR 1.49, 95% CI 0.87 to 2.53; 7 cohort studies, 1509 participants: RR 1.89, 95% CI 1.07 to 3.3; 1 case-control study, 104 participants: RR 0.90, 95% CI 0.27 to 3.02; very low certainty evidence). None of the included studies reported on tunnel tract infection.\nAuthors' conclusions\nIn patients with CKD who require dialysis urgently without ready-to-use dialysis access in place, urgent-start PD may increase the risk of dialysate leak and has uncertain effects on catheter blockage, malposition or readjustment, PD dialysate flow problems, infectious complications, exit-site bleeding, technique survival, and patient survival compared with conventional-start PD.\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 16 studies (2953 participants) examining the outcomes of urgent versus conventional start peritoneal dialysis. When we compared results from patients who initiated dialysis two weeks after catheter insertion, patients who initiated dialysis urgently were more likely to have leakage of dialysis fluid outside the abdominal cavity into the skin near the exit site of peritoneal dialysis catheter. The differences in infection of the lining of the abdomen (peritonitis), infection at the exit point of the peritoneal dialysis catheter (exit-site infection), mechanical complications of peritoneal dialysis (including catheter blockage, catheter malposition and catheter readjustment), patients remaining on peritoneal dialysis (technique survival), and death between patients who started dialysis urgently and those who waited for two weeks after catheter insertion remain unclear."
}
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query-laysum | 5829 | [
{
"role": "user",
"content": "Abstract: Background\nCorticosteroids are medications with anti-inflammatory and immunosuppressant properties. Systemic corticosteroids administered through the oral, intravenous, or intramuscular routes have been used to treat various types of low back pain, including radicular back pain (not due to spinal stenosis), non-radicular back pain, and spinal stenosis. However, there is uncertainty about the benefits and harms of systemic corticosteroids for low back pain.\nObjectives\nTo evaluate the benefits and harms of systemic corticosteroids versus placebo or no corticosteroid for radicular low back pain, non-radicular low back pain, and symptomatic spinal stenosis in adults.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was September 2021.\nSelection criteria\nWe included randomized and quasi-randomized trials in adults of systematic corticosteroids versus placebo or no corticosteroid.\nData collection and analysis\nWe used standard Cochrane methods. The major outcomes were pain, function, need for surgery, serious adverse effect, and presence of hyperglycemia. The minor outcomes were quality of life, successful outcomes, non-serious adverse events, and withdrawal due to adverse events. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nThirteen trials (1047 participants) met the inclusion criteria. Nine trials included participants with radicular low back pain, two trial with low back pain, and two trials with spinal stenosis. All trials blinded participants to receipt of systemic corticosteroids. Seven trials were at low risk of bias, five at unclear risk, and one at high risk of selection bias. Two trials were at high risk of attrition bias. Doses and duration of systemic corticosteroid therapy varied.\nRadicular low back pain\nFor radicular low back pain, moderate-certainty evidence indicated that systemic corticosteroids probably slightly decrease pain versus placebo at short-term follow-up (mean difference (MD) 0.56 points better, 95% confidence interval (CI) 1.08 to 0.04 on a 0 to 10 scale) and may slightly increase the likelihood of experiencing improvement in pain at short-term follow-up (risk ratio (RR) 1.21, 95% CI 0.88 to 1.66; absolute effect 5% better (95% CI 5% worse to 15% better).\nSystemic corticosteroids may not improve function at short-term follow-up (standardized mean difference (SMD) 0.14 better; range 0.49 better to 0.21 worse) and probably increase the likelihood of improvement in function at short-term follow-up (RR 1.52, 95% CI 1.22 to 1.91; absolute effect 19% better, 95% CI 8% better to 30% better). Systemic corticosteroids were associated with greater improvement in function versus placebo at long-term follow-up (MD −7.40, 95% CI −12.55 to −2.25 on the 0 to 100 Oswestry Disability Index) and greater likelihood of functional improvement (RR 1.29, 95% CI 1.06 to 1.56), based on a single trial. There was no difference in likelihood of surgery (RR 1.00, 95% CI 0.68 to 1.47).\nEvidence indicated that systemic corticosteroids (administered as a single dose or as a short course of therapy) are not associated with increased risk of any adverse event, serious adverse events, withdrawal due to adverse events, or hyperglycemia, but estimates were imprecise as some trials did not report harms, and harms reporting was suboptimal in trials that did provide data. Limitations included variability across trials in interventions (e.g. corticosteroid used, dose and duration of treatment), clinical settings, and participants (e.g. duration of symptoms, methods for diagnosis); limited utility of subgroup analyses due to small numbers of trials; methodologic limitations or suboptimal reporting of methods by some trials; and too few trials to formally assess for publication bias using graphical or statistical tests for small sample effects.\nNon-radicular low back pain\nEvidence on systemic corticosteroids versus placebo for non-radicular pain was limited and suggested that systemic corticosteroids may be associated with slightly worse short-term pain but slightly better function.\nSpinal stenosis\nFor spinal stenosis, limited evidence indicated that systemic corticosteroids are probably no more effective than placebo for short-term pain or function.\nAuthors' conclusions\nSystemic corticosteroids appear to be slightly effective at improving short-term pain and function in people with radicular low back pain not due to spinal stenosis, and might slightly improve long-term function. The effects of systemic corticosteroids in people with non-radicular low back pain are unclear and systemic corticosteroids are probably ineffective for spinal stenosis. A single dose or short course of systemic corticosteroids for low back pain does not appear to cause serious harms, but evidence is limited.\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 medical databases for clinical trials comparing corticosteroids versus placebo (dummy treatment) or no corticosteroids in adults with low back pain. We compared and summarized their results, and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 5830 | [
{
"role": "user",
"content": "Abstract: Background\nDespite the widespread use of antenatal corticosteroids to prevent respiratory distress syndrome (RDS) in preterm infants, there is currently no consensus as to the type of corticosteroid to use, dose, frequency, timing of use or the route of administration.\nObjectives\nTo assess the effects on fetal and neonatal morbidity and mortality, on maternal morbidity and mortality, and on the child and adult in later life, of administering different types of corticosteroids (dexamethasone or betamethasone), or different corticosteroid dose regimens, including timing, frequency and mode of administration.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 May 2022) and reference lists of retrieved studies.\nSelection criteria\nWe included all identified published and unpublished randomised controlled trials or quasi-randomised controlled trials comparing any two corticosteroids (dexamethasone or betamethasone or any other corticosteroid that can cross the placenta), comparing different dose regimens (including frequency and timing of administration) in women at risk of preterm birth. We planned to exclude cross-over trials and cluster-randomised trials. We planned to include studies published as abstracts only along with studies published as full-text manuscripts.\nData collection and analysis\nAt least two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. We assessed the certainty of the evidence using GRADE.\nMain results\nWe included 11 trials (2494 women and 2762 infants) in this update, all of which recruited women who were at increased risk of preterm birth or had a medical indication for preterm birth. All trials were conducted in high-income countries.\nDexamethasone versus betamethasone\nNine trials (2096 women and 2319 infants) compared dexamethasone versus betamethasone. All trials administered both drugs intramuscularly, and the total dose in the course was consistent (22.8 mg or 24 mg), but the regimen varied. We assessed one new study to have no serious risk of bias concerns for most outcomes, but other studies were at moderate (six trials) or high (two trials) risk of bias due to selection, detection and attrition bias. Our GRADE assessments ranged between high- and low-certainty, with downgrades due to risk of bias and imprecision.\nMaternal outcomes\nThe only maternal primary outcome reported was chorioamnionitis (death and puerperal sepsis were not reported). Although the rate of chorioamnionitis was lower with dexamethasone, we did not find conclusive evidence of a difference between the two drugs (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.48 to 1.06; 1 trial, 1346 women; moderate-certainty evidence). The proportion of women experiencing maternal adverse effects of therapy was lower with dexamethasone; however, there was not conclusive evidence of a difference between interventions (RR 0.63, 95% CI 0.35 to 1.13; 2 trials, 1705 women; moderate-certainty evidence).\nInfant outcomes\nWe are unsure whether the choice of drug makes a difference to the risk of any known death after randomisation, because the 95% CI was compatible with both appreciable benefit and harm with dexamethasone (RR 1.03, 95% CI 0.66 to 1.63; 5 trials, 2105 infants; moderate-certainty evidence). The choice of drug may make little or no difference to the risk of RDS (RR 1.06, 95% CI 0.91 to 1.22; 5 trials, 2105 infants; high-certainty evidence). While there may be little or no difference in the risk of intraventricular haemorrhage (IVH), there was substantial unexplained statistical heterogeneity in this result (average (a) RR 0.71, 95% CI 0.28 to 1.81; 4 trials, 1902 infants; I² = 62%; low-certainty evidence). We found no evidence of a difference between the two drugs for chronic lung disease (RR 0.92, 95% CI 0.64 to 1.34; 1 trial, 1509 infants; moderate-certainty evidence), and we are unsure of the effects on necrotising enterocolitis, because there were few events in the studies reporting this outcome (RR 5.08, 95% CI 0.25 to 105.15; 2 studies, 441 infants; low-certainty evidence).\nLonger-term child outcomes\nOnly one trial consistently followed up children longer term, reporting at two years' adjusted age. There is probably little or no difference between dexamethasone and betamethasone in the risk of neurodevelopmental disability at follow-up (RR 1.02, 95% CI 0.85 to 1.22; 2 trials, 1151 infants; moderate-certainty evidence). It is unclear whether the choice of drug makes a difference to the risk of visual impairment (RR 0.33, 95% CI 0.01 to 8.15; 1 trial, 1227 children; low-certainty evidence). There may be little or no difference between the drugs for hearing impairment (RR 1.16, 95% CI 0.63 to 2.16; 1 trial, 1227 children; moderate-certainty evidence), motor developmental delay (RR 0.89, 95% CI 0.66 to 1.20; 1 trial, 1166 children; moderate-certainty evidence) or intellectual impairment (RR 0.97, 95% CI 0.79 to 1.20; 1 trial, 1161 children; moderate-certainty evidence). However, the effect estimate for cerebral palsy is compatible with both an important increase in risk with dexamethasone, and no difference between interventions (RR 2.50, 95% CI 0.97 to 6.39; 1 trial, 1223 children; low-certainty evidence).\nNo trials followed the children beyond early childhood.\nComparisons of different preparations and regimens of corticosteroids\nWe found three studies that included a comparison of a different regimen or preparation of either dexamethasone or betamethasone (oral dexamethasone 32 mg versus intramuscular dexamethasone 24 mg; betamethasone acetate plus phosphate versus betamethasone phosphate; 12-hourly betamethasone versus 24-hourly betamethasone). The certainty of the evidence for the main outcomes from all three studies was very low, due to small sample size and risk of bias. Therefore, we were limited in our ability to draw conclusions from any of these studies.\nAuthors' conclusions\nOverall, it remains unclear whether there are important differences between dexamethasone and betamethasone, or between one regimen and another.\nMost trials compared dexamethasone versus betamethasone. While for most infant and early childhood outcomes there may be no difference between these drugs, for several important outcomes for the mother, infant and child the evidence was inconclusive and did not rule out significant benefits or harms.\nThe evidence on different antenatal corticosteroid regimens was sparse, and does not support the use of one particular corticosteroid regimen over another.\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 9 May 2022, and identified 18 trials. We checked all trials for trustworthiness and did not include trials where we had doubts. We included 11 trials (2494 women and 2762 babies). One of these trials included over 1500 babies, finished in 2013 and was at low risk of bias. The other trials were smaller, older and at moderate or high risk of bias.\nNine trials compared the two corticosteroids most commonly used before early birth, dexamethasone and betamethasone. For the mother, while there may be no difference between these medicines, we could not rule out the possibility that the risk of both infection and side effects were lower with dexamethasone (moderate-quality evidence). For the baby, we are unsure whether the choice of medicine make a difference to the risk of any death after the start of the trial (moderate-quality evidence). The choice of medicine probably makes little or no difference to the risk of respiratory distress syndrome (high-quality evidence) and chronic lung disease (moderate-quality evidence). We found that there may be little or no difference between dexamethasone and betamethasone in the risk of intraventricular haemorrhage (low-quality evidence). We are uncertain whether the choice of medicine makes a difference to the risk of necrotising enterocolitis (inflammation of the small and large intestines), because this happened so rarely in the trials (low-quality evidence).\nOne large trial attempted to monitor all children longer term, reporting results when children were two years of age. This trial found that overall there is probably little or no difference in the risk of neurodevelopmental disability (illnesses that affect how the brain functions) at two years of age (moderate-quality evidence). The choice of medicine may make little or no difference to specific developmental outcomes including hearing impairment (moderate-quality evidence), developmental delay (moderate-quality evidence) or learning difficulties (moderate-quality evidence). It is unclear whether the choice of medicine makes a difference to sight impairment (low-quality evidence). We are also unsure whether dexamethasone increases the risk of cerebral palsy (a group of disorders that affect the ability to move and maintain balance and posture) because there were few events in the one study looking at this. We need information from more children to accurately assess the differences between these medicines for this outcome (low-quality evidence).\nThree trials compared different ways of giving corticosteroids. One trial compared two ways of giving dexamethasone (by mouth or injection into the muscle), another trial compared different preparations of betamethasone and a third trial compared two ways of giving betamethasone (different time intervals between doses). Because these trials were small and at moderate risk of bias, we do not know whether their findings give a good indication of how best to give these medicines."
}
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query-laysum | 5831 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is clinically defined as two or more unprovoked epileptic seizures more than 24 hours apart. Given that, a diagnosis of epilepsy can be associated with significant morbidity and mortality, it is imperative that clinicians (and people with seizures and their relatives) have access to accurate and reliable prognostic estimates, to guide clinical practice on the risks of developing further unprovoked seizures (and by definition, a diagnosis of epilepsy) following single unprovoked epileptic seizure.\nObjectives\n1. To provide an accurate estimate of the proportion of individuals going on to have further unprovoked seizures at subsequent time points following a single unprovoked epileptic seizure (or cluster of epileptic seizures within a 24-hour period, or a first episode of status epilepticus), of any seizure type (overall prognosis).\n2. To evaluate the mortality rate following a first unprovoked epileptic seizure.\nSearch methods\nWe searched the following databases on 19 September 2019 and again on 30 March 2021, with no language restrictions.\nThe Cochrane Register of Studies (CRS Web), MEDLINE Ovid (1946 to March 29, 2021), SCOPUS (1823 onwards), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). CRS Web includes randomized or quasi-randomized, controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialized Registers of Cochrane Review Groups including Epilepsy. In MEDLINE (Ovid) the coverage end date always lags a few days behind the search date.\nSelection criteria\nWe included studies, both retrospective and prospective, of all age groups (except those in the neonatal period (< 1 month of age)), of people with a single unprovoked seizure, followed up for a minimum of six months, with no upper limit of follow-up, with the study end point being seizure recurrence, death, or loss to follow-up. To be included, studies must have included at least 30 participants.\nWe excluded studies that involved people with seizures that occur as a result of an acute precipitant or provoking factor, or in close temporal proximity to an acute neurological insult, since these are not considered epileptic in aetiology (acute symptomatic seizures). We also excluded people with situational seizures, such as febrile convulsions.\nData collection and analysis\nTwo review authors conducted the initial screening of titles and abstracts identified through the electronic searches, and removed non-relevant articles. We obtained the full-text articles of all remaining potentially relevant studies, or those whose relevance could not be determined from the abstract alone and two authors independently assessed for eligibility. All disagreements were resolved through discussion with no need to defer to a third review author.\nWe extracted data from included studies using a data extraction form based on the checklist for critical appraisal and data extraction for systematicreviews of prediction modelling studies (CHARMS).\nTwo review authors then appraised the included studies, using a standardised approach based on the quality in prognostic studies (QUIPS) tool, which was adapted for overall prognosis (seizure recurrence).\nWe conducted a meta-analysis using Review Manager 2014, with a random-effects generic inverse variance meta-analysis model, which accounted for any between-study heterogeneity in the prognostic effect. We then summarised the meta-analysis by the pooled estimate (the average prognostic factor effect), its 95% confidence interval (CI), the estimates of I² and Tau² (heterogeneity), and a 95% prediction interval for the prognostic effect in a single population at three various time points, 6 months, 12 months and 24 months. Subgroup analysis was performed according to the ages of the cohorts included; studies involving all ages, studies that recruited adult only and those that were purely paediatric.\nMain results\nFifty-eight studies (involving 54 cohorts), with a total of 12,160 participants (median 147, range 31 to 1443), met the inclusion criteria for the review. Of the 58 studies, 26 studies were paediatric studies, 16 were adult and the remaining 16 studies were a combination of paediatric and adult populations.\nMost included studies had a cohort study design with two case-control studies and one nested case-control study. Thirty-two studies (29 cohorts) reported a prospective longitudinal design whilst 15 studies had a retrospective design whilst the remaining studies were randomised controlled trials.\nNine of the studies included presented mortality data following a first unprovoked seizure. For a mortality study to be included, a proportional mortality ratio (PMR) or a standardised mortality ratio (SMR) had to be given at a specific time point following a first unprovoked seizure.\nTo be included in the meta-analysis a study had to present clear seizure recurrence data at 6 months, 12 months or 24 months. Forty-six studies were included in the meta-analysis, of which 23 were paediatric, 13 were adult, and 10 were a combination of paediatric and adult populations.\nA meta-analysis was performed at three time points; six months, one year and two years for all ages combined, paediatric and adult studies, respectively. We found an estimated overall seizure recurrence of all included studies at six months of 27% (95% CI 24% to 31%), 36% (95% CI 33% to 40%) at one year and 43% (95% CI 37% to 44%) at two years, with slightly lower estimates for adult subgroup analysis and slightly higher estimates for paediatric subgroup analysis. It was not possible to provide a summary estimate of the risk of seizure recurrence beyond these time points as most of the included studies were of short follow-up and too few studies presented recurrence rates at a single time point beyond two years. The evidence presented was found to be of moderate certainty.\nAuthors' conclusions\nDespite the limitations of the data (moderate-certainty of evidence), mainly relating to clinical and methodological heterogeneity we have provided summary estimates for the likely risk of seizure recurrence at six months, one year and two years for both children and adults. This provides information that is likely to be useful for the clinician counselling patients (or their parents) on the probable risk of further seizures in the short-term whilst acknowledging the paucity of long-term recurrence data, particularly beyond 10 years.\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": "Despite some quite big differences in the design of the studies included in this review, we were able to provide information on the risk of having another seizure at 6 months, 12 months and 24 months."
}
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query-laysum | 5832 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections are important causes of morbidity and mortality among critically ill patients. Early institution of antifungal therapy is pivotal for mortality reduction. Starting a targeted antifungal therapy after culture positivity and fungi identification requires a long time. Therefore, alternative strategies (globally defined as 'untargeted antifungal treatments') for antifungal therapy institution in patients without proven microbiological evidence of fungal infections have been discussed by international guidelines. This review was originally published in 2006 and updated in 2016. This updated review provides additional evidence for the clinician dealing with suspicion of fungal infection in critically ill, non-neutropenic patients, taking into account recent findings in this field.\nObjectives\nTo assess the effects of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) compared to placebo or no antifungal or any other antifungal drug (either systemic or nonabsorbable) in non-neutropenic, critically ill adults and children. We assessed effectiveness in terms of total (all-cause) mortality and incidence of proven invasive fungal infections as primary outcomes.\nSearch methods\nWe searched the following databases to February 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), and EMBASE (OVID). We also searched reference lists of identified studies and major reviews, abstracts of conference proceedings, scientific meetings and clinical trials registries. We contacted experts in the field, study authors and pharmaceutical companies as part of the search strategy.\nSelection criteria\nWe included randomized controlled trials (RCTs) (irrespective of language or publication status) comparing the use of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) to placebo, no antifungal, or another antifungal agent in non-neutropenic critically ill participants.\nData collection and analysis\nThree authors independently applied selection criteria, extracted data and assessed the risk of bias. We resolved any discrepancies by discussion. We synthesized data using the random-effects model and expressed the results as risk ratios (RR) with 95% confidence intervals. We assessed overall evidence quality using the GRADE approach.\nMain results\nWe included 22 studies (total of 2761 participants). Of those 22 studies, 12 were included in the original published review and 10 were newly identified. Eleven trials compared the use of fluconazole to placebo or no antifungal treatment. Three trials compared ketoconazole versus placebo. One trial compared anidulafungin with placebo. One trial compared caspofungin to placebo. Two trials compared micafungin to placebo. One trial compared amphotericin B to placebo. Two trials compared nystatin to placebo and one trial compared the effect of clotrimazole, ketoconazole, nystatin and no treatment. We found two new ongoing studies and four new studies awaiting classification. The RCTs included participants of both genders with wide age range, severity of critical illness and clinical characteristics. Funding sources from pharmaceutical companies were reported in 11 trials and one trial reported funding from a government agency. Most of the studies had an overall unclear risk of bias for key domains of this review (random sequence generation, allocation concealment, incomplete outcome data). Two studies had a high risk of bias for key domains. Regarding the other domains (blinding of participants and personnel, outcome assessment, selective reporting, other bias), most of the studies had a low or unclear risk but four studies had a high risk of bias.\nThere was moderate grade evidence that untargeted antifungal treatment did not significantly reduce or increase total (all-cause) mortality (RR 0.93, 95% CI 0.79 to 1.09, P value = 0.36; participants = 2374; studies = 19). With regard to the outcome of proven invasive fungal infection, there was low grade evidence that untargeted antifungal treatment significantly reduced the risk (RR 0.57, 95% CI 0.39 to 0.83, P value = 0.0001; participants = 2024; studies = 17). The risk of fungal colonization was significantly reduced (RR 0.71, 95% CI 0.52 to 0.97, P value = 0.03; participants = 1030; studies = 12) but the quality of evidence was low. There was no difference in the risk of developing superficial fungal infection (RR 0.69, 95% CI 0.37 to 1.29, P value = 0.24; participants = 662; studies = 5; low grade of evidence) or in adverse events requiring cessation of treatment between the untargeted treatment group and the other group (RR 0.89, 95% CI 0.62 to 1.27, P value = 0.51; participants = 1691; studies = 11; low quality of evidence). The quality of evidence for the outcome of total (all-cause) mortality was moderate due to limitations in study design. The quality of evidence for the outcome of invasive fungal infection, superficial fungal infection, fungal colonization and adverse events requiring cessation of therapy was low due to limitations in study design, non-optimal total population size, risk of publication bias, and heterogeneity across studies.\nAuthors' conclusions\nThere is moderate quality evidence that the use of untargeted antifungal treatment is not associated with a significant reduction in total (all-cause) mortality among critically ill, non-neutropenic adults and children compared to no antifungal treatment or placebo. The untargeted antifungal treatment may be associated with a reduction of invasive fungal infections but the quality of evidence is low, and both the heterogeneity and risk of publication bias is high.\nFurther high-quality RCTs are needed to improve the strength of the evidence, especially for more recent and less studied drugs (e.g. echinocandins). Future trials should adopt standardized definitions for microbiological outcomes (e.g. invasive fungal infection, colonization) to reduce heterogeneity. Emergence of resistance to antifungal drugs should be considered as outcome in studies investigating the effects of untargeted antifungal treatment to balance risks and benefit.\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": "Critically ill adults and children may suffer from invasive fungal infections, such as those affecting the bloodstream and other organs. Once established, such infections are difficult to treat and frequently result in death. Antifungal medications are sometimes given to critically ill adults and children most prone to developing fungal infections and to those with signs of infections when it is still unclear if a fungus is the cause."
}
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query-laysum | 5833 | [
{
"role": "user",
"content": "Abstract: Background\nMedications licensed for the treatment of dementia have limited efficacy against cognitive impairment or against the distressed behaviours (behavioural and psychological symptoms, or behaviour that challenges) which are also often the most distressing aspect of the disorder for caregivers. Complementary therapies, including aromatherapy, are attractive to patients, practitioners and families, because they are perceived as being unlikely to cause adverse effects. Therefore there is interest in whether aromatherapy might offer a safe means of alleviating distressed behaviours in dementia.\nObjectives\nTo assess the efficacy and safety of aromatherapy for people with dementia.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 5 May 2020 using the terms: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils. In addition, we searched MEDLINE, Embase, PsycINFO (all via Ovid SP), Web of Science Core Collection (via Thompson Web of Science), LILACS (via BIREME), CENTRAL (via the Cochrane Library), ClinicalTrials.gov and the World Health Organization (WHO) trials portal (ICTRP) on 5 May 2020.\nSelection criteria\nWe included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.\nData collection and analysis\nTwo reviewers independently selected studies for inclusion, extracted data and assessed risk of bias in included studies, involving other authors to reach consensus decisions where necessary. We did not perform any meta-analyses because of heterogeneity between studies, but presented a narrative synthesis of results from the included trials. Because of the heterogeneity of analysis methods and inadequate or absent reporting of data from some trials, we used statistical significance (P ≤ or > 0.5) as a summary metric when synthesising results across studies. As far as possible, we used GRADE methods to assess our confidence in the results of the trials, downgrading for risk of bias and imprecision.\nMain results\nWe included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were lavender (eight studies); lemon balm (four studies); lavender and lemon balm, lavender and orange, and cedar extracts (one study each). For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66), reducing our confidence in the results. Our primary outcomes were agitation, overall behavioural and psychological symptoms, and adverse effects. Ten trials assessed agitation using various scales. Among the five trials for which our confidence in the results was moderate or low, four trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other five trials either reported no useable data or our confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and we had moderate or low confidence in the results of five of them. Of these, four reported significant benefit from aromatherapy and one reported no significant effect. Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. We did not find evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. Our confidence in the results of these studies was low.\nAuthors' conclusions\nWe have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.\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": "We have found no convincing evidence that aromatherapy is beneficial for people with dementia although there are many limitations to the data reported by the studies so conclusions cannot be drawn with confidence. In order to determine whether aromatherapy is safe and effective at relieving symptoms of dementia, larger, well-designed studies with clearer reporting are needed."
}
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query-laysum | 5835 | [
{
"role": "user",
"content": "Abstract: Background\nNormal aging is associated with changes in cognitive function that are non-pathological and are not necessarily indicative of future neurocognitive disease. Low cognitive and brain reserve and limited cognitive stimulation are associated with increased risk of dementia. Emerging evidence now suggests that subtle cognitive changes, detectable years before criteria for mild cognitive impairment are met, may be predictive of future dementia. Important for intervention and reduction in disease risk, research also suggests that engaging in stimulating mental activity throughout adulthood builds cognitive and brain reserve and reduces dementia risk. Therefore, midlife (defined here as 40 to 65 years) may be a suitable time to introduce cognitive interventions for maintaining cognitive function and, in the longer term, possibly preventing or delaying the onset of clinical dementia.\nObjectives\nTo evaluate the effects of computerised cognitive training interventions lasting at least 12 weeks for maintaining or improving cognitive function in cognitively healthy people in midlife.\nSearch methods\nWe searched up to 31 March 2018 in ALOIS (www.medicine.ox.ac.uk/alois), the specialised register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG). We ran additional searches in MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, and the WHO Portal/ICTRP at www.apps.who.int/trialsearch, to ensure that the search was as comprehensive and as up-to-date as possible, to identify published, unpublished, and ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs, published or unpublished, reported in any language. Participants were cognitively healthy people between 40 and 65 years of age (80% of study population within this age range). Experimental interventions adhered to the following criteria: intervention was any form of interactive computerised cognitive intervention - including computer exercises, computer games, mobile devices, gaming console, and virtual reality - that involved repeated practice on standardised exercises of specified cognitive domain(s) for the purpose of enhancing cognitive function; duration of the intervention was at least 12 weeks; cognitive outcomes were measured; and cognitive training interventions were compared with active or inactive control interventions.\nData collection and analysis\nFor preliminary screening of search results, we used a 'crowd' method to identify RCTs. At least two review authors working independently screened remaining citations against inclusion criteria; independently extracted data; and assessed the quality of the included trial, using the Cochrane risk of bias assessment tool. We used GRADE to describe the overall quality of the evidence.\nMain results\nWe identified one eligible study that examined the effect of computerised cognitive training (CCT) in 6742 participants over 50 years of age, with training and follow-up duration of six months. We considered the study to be at high risk of attrition bias and the overall quality of the evidence to be low.\nResearchers provided no data on our primary outcome. Results indicate that there may be a small advantage for the CCT group for executive function (mean difference (MD) -1.57, 95% confidence interval (CI) -1.85 to -1.29; participants = 3994; low-quality evidence) and a very small advantage for the control group for working memory (MD 0.09, 95% CI 0.03 to 0.15; participants = 5831; low-quality evidence). The intervention may have had little or no effect on episodic memory (MD -0.03, 95% CI -0.10 to 0.04; participants = 3090; low-quality evidence).\nAuthors' conclusions\nWe found low-quality evidence from only one study. We are unable to determine whether computerised cognitive training is effective in maintaining global cognitive function among healthy adults in midlife. We strongly recommend that high-quality studies be undertaken to investigate the effectiveness and acceptability of cognitive training in midlife, using interventions that last long enough that they may have enduring effects on cognitive and brain reserve, and with investigators following up long enough to assess effects on clinically important outcomes in later life.\n\nGiven the provided abstract, please respond to the following query: \"What we did\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the medical literature up to 15 March 2018 for trials that compared the cognitive function of people 40 to 65 years of age who had taken part in computerised cognitive training lasting at least three months versus a control group that had not done so. For the comparison to be as fair as possible, it should have been decided randomly whether participants were assigned to the cognitive training group or the control group. We were primarily interested in overall measures of cognition. The choice of three months of intervention was somewhat arbitrary, but we thought it unlikely that shorter periods of training could have long-lasting effects."
}
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query-laysum | 5836 | [
{
"role": "user",
"content": "Abstract: Background\nRecruitment manoeuvres involve transient elevations in airway pressure applied during mechanical ventilation to open (‘recruit’) collapsed lung units and increase the number of alveoli participating in tidal ventilation. Recruitment manoeuvres are often used to treat patients in intensive care who have acute respiratory distress syndrome (ARDS), but the effect of this treatment on clinical outcomes has not been well established. This systematic review is an update of a Cochrane review originally published in 2009.\nObjectives\nOur primary objective was to determine the effects of recruitment manoeuvres on mortality in adults with acute respiratory distress syndrome.\nOur secondary objective was to determine, in the same population, the effects of recruitment manoeuvres on oxygenation and adverse events (e.g. rate of barotrauma).\nSearch methods\nFor this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCO), Latin American and Caribbean Health Sciences (LILACS) and the International Standard Randomized Controlled Trial Number (ISRCTN) registry from inception to August 2016.\nSelection criteria\nWe included randomized controlled trials (RCTs) of adults who were mechanically ventilated that compared recruitment manoeuvres versus standard care for patients given a diagnosis of ARDS.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors for additional information.\nMain results\nTen trials met the inclusion criteria for this review (n = 1658 participants). We found five trials to be at low risk of bias and five to be at moderate risk of bias. Six of the trials included recruitment manoeuvres as part of an open lung ventilation strategy that was different from control ventilation in aspects other than the recruitment manoeuvre (such as mode of ventilation, higher positive end-expiratory pressure (PEEP) titration and lower tidal volume or plateau pressure). Six studies reported mortality outcomes. Pooled data from five trials (1370 participants) showed a reduction in intensive care unit (ICU) mortality (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.72 to 0.97, P = 0.02, low-quality evidence), pooled data from five trials (1450 participants) showed no difference in 28-day mortality (RR 0.86, 95% CI 0.74 to 1.01, P = 0.06, low-quality evidence) and pooled data from four trials (1313 participants) showed no difference in in-hospital mortality (RR 0.88, 95% CI 0.77 to 1.01, P = 0.07, low-quality evidence). Data revealed no differences in risk of barotrauma (RR 1.09, 95% CI 0.78 to 1.53, P = 0.60, seven studies, 1508 participants, moderate-quality evidence).\nAuthors' conclusions\nWe identified significant clinical heterogeneity in the 10 included trials. Results are based upon the findings of several (five) trials that included an \"open lung ventilation strategy\", whereby the intervention group differed from the control group in aspects other than the recruitment manoeuvre (including co-interventions such as higher PEEP, different modes of ventilation and higher plateau pressure), making interpretation of the results difficult. A ventilation strategy that included recruitment manoeuvres in participants with ARDS reduced intensive care unit mortality without increasing the risk of barotrauma but had no effect on 28-day and hospital mortality. We downgraded the quality of the evidence to low, as most of the included trials provided co-interventions as part of an open lung ventilation strategy, and this might have influenced results of the outcome.\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": "Evidence is current to August 2016."
}
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query-laysum | 5837 | [
{
"role": "user",
"content": "Abstract: Background\nIndividuals with pulmonary hypertension (PH) have reduced exercise capacity and quality of life. Despite initial concerns that exercise training may worsen symptoms in this group, several studies have reported improvements in functional capacity and well-being following exercise-based rehabilitation.\nObjectives\nTo evaluate the benefits and harms of exercise-based rehabilitation for people with PH compared with usual care or no exercise-based rehabilitation.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 28 June 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) in people with PH comparing supervised exercise-based rehabilitation programmes with usual care or no exercise-based rehabilitation.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. exercise capacity, 2. serious adverse events during the intervention period and 3. health-related quality of life (HRQoL). Our secondary outcomes were 4. cardiopulmonary haemodynamics, 5. Functional Class, 6. clinical worsening during follow-up, 7. mortality and 8. changes in B-type natriuretic peptide. We used GRADE to assess certainty of evidence.\nMain results\nWe included eight new studies in the current review, which now includes 14 RCTs. We extracted data from 11 studies. The studies had low- to moderate-certainty evidence with evidence downgraded due to inconsistencies in the data and performance bias. The total number of participants in meta-analyses comparing exercise-based rehabilitation to control groups was 462. The mean age of the participants in the 14 RCTs ranged from 35 to 68 years. Most participants were women and classified as Group I pulmonary arterial hypertension (PAH). Study durations ranged from 3 to 25 weeks. Exercise-based programmes included both inpatient- and outpatient-based rehabilitation that incorporated both upper and lower limb exercise.\nThe mean six-minute walk distance following exercise-based rehabilitation was 48.52 metres higher than control (95% confidence interval (CI) 33.42 to 63.62; I² = 72%; 11 studies, 418 participants; low-certainty evidence), the mean peak oxygen uptake was 2.07 mL/kg/min higher than control (95% CI 1.57 to 2.57; I² = 67%; 7 studies, 314 participants; low-certainty evidence) and the mean peak power was 9.69 W higher than control (95% CI 5.52 to 13.85; I² = 71%; 5 studies, 226 participants; low-certainty evidence). Three studies reported five serious adverse events; however, exercise-based rehabilitation was not associated with an increased risk of serious adverse event (risk difference 0, 95% CI −0.03 to 0.03; I² = 0%; 11 studies, 439 participants; moderate-certainty evidence). The mean change in HRQoL for the 36-item Short Form (SF-36) Physical Component Score was 3.98 points higher (95% CI 1.89 to 6.07; I² = 38%; 5 studies, 187 participants; moderate-certainty evidence) and for the SF-36 Mental Component Score was 3.60 points higher (95% CI 1.21 to 5.98 points; I² = 0%; 5 RCTs, 186 participants; moderate-certainty evidence). There were similar effects in the subgroup analyses for participants with Group 1 PH versus studies of groups with mixed PH. Two studies reported mean reduction in mean pulmonary arterial pressure following exercise-based rehabilitation (mean reduction: 9.29 mmHg, 95% CI −12.96 to −5.61; I² = 0%; 2 studies, 133 participants; low-certainty evidence).\nAuthors' conclusions\nIn people with PH, supervised exercise-based rehabilitation may result in a large increase in exercise capacity. Changes in exercise capacity remain heterogeneous and cannot be explained by subgroup analysis. It is likely that exercise-based rehabilitation increases HRQoL and is probably not associated with an increased risk of a serious adverse events. Exercise training may result in a large reduction in mean pulmonary arterial pressure. Overall, we assessed the certainty of the evidence to be low for exercise capacity and mean pulmonary arterial pressure, and moderate for HRQoL and adverse events. Future RCTs are needed to inform the application of exercise-based rehabilitation across the spectrum of people with PH, including those with chronic thromboembolic PH, PH with left-sided heart disease and those with more severe disease.\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": "The studies reported that exercise-based rehabilitation may result in large increases in exercise capacity as evaluated by how far people could walk in six minutes and maximal oxygen consumption using a specialised exercise test; however, there was marked variability in this response. Health-related quality of life was also most likely to be improved and exercise-based rehabilitation may also result in a large reduction in the pressure in the pulmonary circulation. Serious side effects were rare and exercise-based rehabilitation was unlikely to increase the risk of them."
}
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query-laysum | 5838 | [
{
"role": "user",
"content": "Abstract: Background\nThis is a updated version of our Cochrane Review published in Issue 6, 2012. Sexually-transmitted infections (STIs) continue to rise worldwide, imposing an enormous morbidity and mortality burden. Effective prevention strategies, including microbicides, are needed to achieve the goals of the World Heath Organization (WHO) global strategy for the prevention and control of these infections.\nObjectives\nTo determine the effectiveness and safety of topical microbicides for preventing acquisition of STIs, including HIV.\nSearch methods\nWe undertook a comprehensive search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, CLIB, Web of Science, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and reference lists of relevant articles up to August 2020. In addition, we contacted relevant organisations and experts.\nSelection criteria\nWe included randomised controlled trials of vaginal microbicides compared to placebo (except for nonoxynol-9 because it is covered in related Cochrane Reviews). Eligible participants were sexually-active non-pregnant, WSM and MSM, who had no laboratory confirmed STIs.\nData collection and analysis\nTwo review authors independently screened and selected studies, extracted data, and assessed risks of bias in duplicate, resolving differences by consensus. We conducted a fixed-effect meta-analysis, stratified by type of microbicide, and assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included eight trials from the earlier version of the review and four new trials, i.e. a total of 12 trials with 32,464 participants (all WSM). We did not find any eligible study that enrolled MSM or reported fungal STI as an outcome. We have no study awaiting assessment.\nAll 12 trials were conducted in sub-Saharan Africa, with one having a study site in the USA, and another having a site in India. Vaginal microbicides tested were BufferGel and PRO 2000 (1 trial, 3101 women), Carraguard (1 trial, 6202 women), cellulose sulphate (2 trials, 3069 women), dapivirine (2 trials, 4588 women), PRO 2000 (1 trial, 9385 women), C31G (SAVVY) (2 trials, 4295 women), and tenofovir (3 trials, 4958 women). All microbicides were compared to placebo and all trials had low risk of bias.\nDapivirine probably reduces the risk of acquiring HIV infection: risk ratio (RR) 0.71, (95% confidence interval (CI) 0.57 to 0.89, I2 = 0%, 2 trials, 4588 women; moderate-certainty evidence). The other microbicides may result in little to no difference in the risk of acquiring HIV (low-certainty evidence); including tenofovir (RR 0.83, 95% CI 0.68 to 1.02, cellulose sulphate (RR 1.20, 95% CI 0.74 to 1.95, BufferGel (RR 1.05, 95% CI 0.73 to 1.52), Carraguard (RR 0.89, 95% CI 0.71 to 1.11), PRO 2000 (RR 0.93, 95% CI 0.77 to 1.14), and SAVVY (RR 1.38, 95% CI 0.79 to 2.41).\nExisting evidence suggests that cellulose sulphate (RR 0.99, 95% CI 0.37 to 2.62, 1 trial, 1425 women), and PRO 2000 (RR 0.95, 95% CI 0.73 to 1.23) may result in little to no difference in the risk of getting herpes simplex virus type 2 infection (low-certainty evidence). Two studies reported data on tenofovir's effect on this virus. One suggested that tenofovir may reduce the risk (RR 0.55, 95% CI 0.36 to 0.82; 224 participants) while the other did not find evidence of an effect (RR 0.94, 95% CI 0.85 to 1.03; 1003 participants). We have not reported the pooled result because of substantial heterogeneity of effect between the two studies (l2 = 85%).\nThe evidence also suggests that dapivirine (RR 1.70, 95% CI 0.63 to 4.59), tenofovir (RR 1.27, 95% CI 0.58 to 2.78), cellulose sulphate (RR 0.69, 95% CI 0.26 to 1.81), and (Carraguard (RR 1.07, 95% CI 0.75 to 1.52) may have little or no effect on the risk of acquiring syphilis (low-certainty evidence).\nIn addition, dapivirine (RR 0.97, 95% CI 0.89 to 1.07), tenofovir (RR 0.90, 95% CI 0.71 to 1.13), cellulose sulphate (RR 0.70, 95% CI 0.49 to 0.99), BufferGel (RR 0.97, 95% CI 0.65 to 1.45), Carraguard (RR 0.96, 95% CI 0.83 to 1.12), and PRO 2000 (RR 1.01, 95% CI 0.84 to 1.22) may result in little to no difference in the risk of acquiring chlamydia infection (low-certainty evidence).\nThe evidence also suggests that current topical microbicides may not have an effect on the risk of acquiring gonorrhoea, condyloma acuminatum, trichomoniasis, or human papillomavirus infection (low-certainty evidence). Microbicide use in the 12 trials, compared to placebo, did not lead to any difference in adverse event rates.\nNo study reported on acceptability of the intervention.\nAuthors' conclusions\nCurrent evidence shows that vaginal dapivirine microbicide probably reduces HIV acquisition in women who have sex with men. Other types of vaginal microbicides have not shown evidence of an effect on acquisition of STIs, including HIV. Further research should continue on the development and testing of new microbicides.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This is an updated version of our Cochrane Review published in 2012. Both curable and incurable STIs continue to rise, despite the prevention strategies implemented to date. Women often have the highest rates of STIs and account for a disproportionate number of new infections. STIs are often without symptoms. Despite their greater vulnerability, current options to reduce the spread of STI remain limited for women. There is thus a clear need for new and effective strategies to prevent people from getting STIs, including HIV."
}
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query-laysum | 5839 | [
{
"role": "user",
"content": "Abstract: Background\nTraumatic dental injuries are common. One of the most severe injuries is when a permanent tooth is knocked completely out of the mouth (avulsed). In most circumstances the tooth should be replanted as quickly as possible. There is uncertainty on which interventions will maximise the survival and repair of the replanted tooth. This is an update of a Cochrane Review first published in 2010.\nObjectives\nTo compare the effects of a range of interventions for managing traumatised permanent front teeth with avulsion injuries.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 8 March 2018), Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 2) in the Cochrane Library (searched 8 March 2018), MEDLINE Ovid (1946 to 8 March 2018), and Embase Ovid (1980 to 8 March 2018). The US National Institutes of Health Ongoing 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 considered randomised and quasi-randomised controlled trials that included a minimum follow-up period of 12 months, for interventions for avulsed and replanted permanent front teeth.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed the risk of bias. Authors were contacted where further information about their study was required.\nMain results\nFour studies, involving a total of 183 participants and 257 teeth were identified. Each of the interventions aimed to reduce infection or alter the inflammatory response or both at the time of or shortly after the tooth or teeth were replanted. Each study assessed a different intervention and therefore it was not appropriate or possible to numerically synthesise the data. All evidence was rated as being of very low quality due to problems with risk of bias and imprecision of results. This means that we are very uncertain about all of the results presented in this review.\nOne study at high risk of bias with 69 participants (138 teeth) compared a 20-minute soak with gentamycin sulphate for both groups prior to replantation with the experimental group receiving daily hyperbaric oxygen for 80 minutes for the first 10 days. There was some evidence of a benefit for the hyperbaric oxygen group in respect of periodontal healing, tooth survival, and pulpal healing.\nOne study at unclear risk of bias with 22 participants (27 teeth) compared the use of two root canal medicaments, Ledermix and Ultracal. There was insufficient evidence of a difference for periodontal healing or tooth survival. This was the only study to formally report adverse events with none identified. Study authors reported that Ledermix caused a greater level of patient dissatisfaction with the colour of avulsed and replanted teeth.\nA third study at high risk of bias with 19 participants compared extra- or intra-oral endodontics for avulsed teeth which were stored dry for longer than 60 minutes before replantation. There was insufficient evidence of a difference in periodontal healing.\nThe fourth study at high risk of bias with 73 participants compared a 10-minute soak in either thymosin alpha 1 or saline before replantation followed by daily gingival injections with these same medicaments for the first 7 days. There was some evidence of a benefit for thymosin alpha 1 with respect to periodontal healing and tooth survival.\nAuthors' conclusions\nBased on the results of the included studies, there is insufficient evidence to support or refute the effectiveness of different interventions for avulsed and replanted permanent front teeth. The overall quality of existing evidence was very low, and therefore great caution should be exercised when generalising the results of the included trials. There is urgent need for further well-designed randomised controlled trials.\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 evidence currently available is insufficient to draw reliable conclusions regarding the superiority of different interventions for knocked out and replanted permanent front teeth. There is urgent need for further well-designed randomised controlled trials."
}
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query-laysum | 5840 | [
{
"role": "user",
"content": "Abstract: Background\nRates of injury and death caused by car crashes with teenage drivers remain high in most high-income countries. In addition to injury and death, car use includes other non-traffic risks; these may be health-related, such as physical inactivity or respiratory disease caused by air pollution, or have global significance, such as the environmental impact of car use. Research demonstrates that reducing the amount of time driving reduces the risk of injury, and it is expected that it would also reduce other risks that are unrelated to traffic. Mobility management interventions aim to increase mobility awareness and encourage a shift from private car use to active (walking, cycling, skateboarding), and public (bus, tram, train), transportation. 'Soft' mobility management interventions include the application of strategies and policies to reduce travel demand and may be instigated locally or more widely, to target a specific or a non-specific population group; 'hard' mobility management interventions include changes to the built environment or transport infrastructure and are not the focus of this review.\nBetween the ages of 15 to 19 years, young people enter a development stage known as the 'transition teens' in which they are likely to make long-lasting lifestyle changes. It is possible that using this specific time point to introduce mobility management interventions may influence a person's long-term mobility behaviour.\nObjectives\nTo assess whether 'soft' mobility management interventions prevent, reduce, or delay car driving in teenagers aged 15 to 19 years, and to assess whether these mobility management interventions also reduce crashes caused by teenage drivers.\nSearch methods\nWe searched the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE, Embase, Web of Science, and Social Policy and Practice on 16 August 2019. We searched clinical trials registers, relevant conference proceedings, and online media sources of transport organisations, and conducted backward- and forward-citation searching of relevant articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) or controlled before-after studies (CBAs) evaluating mobility management interventions in teenagers aged 15 to 19 years. We included informational, educational, or behavioural interventions that aimed to prevent, reduce, or delay car driving in this age group, and we compared these interventions with no intervention or with standard practice. We excluded studies that evaluated graduated drivers licensing (GDL) programmes, separate components of GDL, or interventions that act in conjunction with, or as an extension of, GDL. Such programmes aim to increase driving experience and skills through stages of supervised and unsupervised exposure, but assume that all participants will drive; they do not attempt to encourage people to drive less in the long term or promote alternatives to driving. We also excluded studies which evaluated school-based safe-driving initiatives.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We assessed the certainty of evidence with GRADE.\nMain results\nWe included one RCT with 178 participants and one CBA with 860 participants. The RCT allocated university students, with a mean age of 18 years, who had not yet acquired a driving licence, to one of four interventions that provided educational information about negative aspects of car use, or to a fifth group in which no information was given. Types of educational information about car use related to cost, risk, or stress, or all three types of educational information combined.\nIn the CBA, 860 school students, aged 17 to 18 years taking a driving theory course, had an additional interactive lesson about active transport (walking or cycling), and some were invited to join a relevant Facebook group with posts targeting awareness and habit.\nWe did not conduct meta-analyses because we had insufficient studies.\nWe could not be certain whether educational interventions versus no information affected people's decision to obtain a driving licence 18 months after receiving the intervention (risk ratio 0.62, 95% confidence interval 0.45 to 0.85; very low-certainty evidence). We noted that fewer participants who were given information obtained a driving licence (42.6%) compared to those who did not receive information (69%), but we had very little confidence in the effect estimate; the study had high or unclear risks of bias and the evidence was from one small study and was therefore imprecise.\nWe could not be certain whether interventions about active transport, given during a driving theory course, could influence behavioural predictors of car use. Study authors noted:\n- an increased intention to use active transport after obtaining a driving licence between postintervention and an eight-week follow-up in students who were given an active transport lesson and a Facebook invitation compared to those given only the active transport lesson; and\n- a decrease in intention between pre- and postintervention in those given an active transport lesson and Facebook invitation compared to those given the active transport lesson only.\nThere were high risks of bias in this CBA study design, a large amount of missing data (very few participants accepted the Facebook invitation), and data came from a single study only, so we judged the evidence to be of very low certainty.\nThese studies did not measure our primary outcome (driving frequency), or other secondary outcomes (driving distance, driving hours, use of alternative modes of transport, or car crashes).\nAuthors' conclusions\nWe found only two small studies, and could not determine whether mobility management interventions were effective to prevent, reduce, or delay car driving in teenagers. The lack of evidence in this review raises two points. First, more foundational research is needed to discover how and why young people make decisions surrounding their personal transport, in order to find out what might encourage them to delay licensing and driving. Second, we need longitudinal studies with a robust study design – such as RCTs – and with large sample sizes that incorporate different socioeconomic groups in order to evaluate the feasibility and effectiveness of relevant interventions. Ideally, evaluations will include an assessment of how attitudes and beliefs evolve in teenagers during these transition years, and the potential effect of these on the design of a mobility management intervention for this age group.\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": "We found only two small studies that investigated ways to present mobility management information to teenagers. We could not be sure of their effect on obtaining a driving licence, or intention to use active transport (walking or cycling) after obtaining a driving licence, because the quality of the evidence was very low. Risks from driving are a public health concern, and, because we did not find enough evidence, large studies with a long follow-up (monitoring) period are needed to find out whether teenagers can be encouraged to reduce or delay driving."
}
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query-laysum | 5841 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic retinopathy (DR) is characterised by neurovascular degeneration as a result of chronic hyperglycaemia. Proliferative diabetic retinopathy (PDR) is the most serious complication of DR and can lead to total (central and peripheral) visual loss. PDR is characterised by the presence of abnormal new blood vessels, so-called “new vessels,” at the optic disc (NVD) or elsewhere in the retina (NVE). PDR can progress to high-risk characteristics (HRC) PDR (HRC-PDR), which is defined by the presence of NVD more than one-fourth to one-third disc area in size plus vitreous haemorrhage or pre-retinal haemorrhage, or vitreous haemorrhage or pre-retinal haemorrhage obscuring more than one disc area. In severe cases, fibrovascular membranes grow over the retinal surface and tractional retinal detachment with sight loss can occur, despite treatment. Although most, if not all, individuals with diabetes will develop DR if they live long enough, only some progress to the sight-threatening PDR stage.\nObjectives\nTo determine risk factors for the development of PDR and HRC-PDR in people with diabetes and DR.\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, and Ovid Embase. The date of the search was 27 May 2022. Additionally, the search was supplemented by screening reference lists of eligible articles. There were no restrictions to language or year of publication.\nSelection criteria\nWe included prospective or retrospective cohort studies and case-control longitudinal studies evaluating prognostic factors for the development and progression of PDR, in people who have not had previous treatment for DR. The target population consisted of adults (≥18 years of age) of any gender, sexual orientation, ethnicity, socioeconomic status, and geographical location, with non-proliferative diabetic retinopathy (NPDR) or PDR with less than HRC-PDR, diagnosed as per standard clinical practice. Two review authors independently screened titles and abstracts, and full-text articles, to determine eligibility; discrepancies were resolved through discussion. We considered prognostic factors measured at baseline and any other time points during the study and in any clinical setting. Outcomes were evaluated at three and eight years (± two years) or lifelong.\nData collection and analysis\nTwo review authors independently extracted data from included studies using a data extraction form that we developed and piloted prior to the data collection stage. We resolved any discrepancies through discussion. We used the Quality in Prognosis Studies (QUIPS) tool to assess risk of bias. We conducted meta-analyses in clinically relevant groups using a random-effects approach. We reported hazard ratios (HR), odds ratios (OR), and risk ratios (RR) separately for each available prognostic factor and outcome, stratified by different time points. Where possible, we meta-analysed adjusted prognostic factors. We evaluated the certainty of the evidence with an adapted version of the GRADE framework.\nMain results\nWe screened 6391 records. From these, we identified 59 studies (87 articles) as eligible for inclusion. Thirty-five were prospective cohort studies, 22 were retrospective studies, 18 of which were cohort and six were based on data from electronic registers, and two were retrospective case-control studies. Twenty-three studies evaluated participants with type 1 diabetes (T1D), 19 with type 2 diabetes (T2D), and 17 included mixed populations (T1D and T2D). Studies on T1D included between 39 and 3250 participants at baseline, followed up for one to 45 years. Studies on T2D included between 100 and 71,817 participants at baseline, followed up for one to 20 years. The studies on mixed populations of T1D and T2D ranged from 76 to 32,553 participants at baseline, followed up for four to 25 years.\nWe found evidence indicating that higher glycated haemoglobin (haemoglobin A1c (HbA1c)) levels (adjusted OR ranged from 1.11 (95% confidence interval (CI) 0.93 to 1.32) to 2.10 (95% CI 1.64 to 2.69) and more advanced stages of retinopathy (adjusted OR ranged from 1.38 (95% CI 1.29 to 1.48) to 12.40 (95% CI 5.31 to 28.98) are independent risk factors for the development of PDR in people with T1D and T2D. We rated the evidence for these factors as of moderate certainty because of moderate to high risk of bias in the studies.\nThere was also some evidence suggesting several markers for renal disease (for example, nephropathy (adjusted OR ranged from 1.58 (95% CI not reported) to 2.68 (2.09 to 3.42), and creatinine (adjusted meta-analysis HR 1.61 (95% CI 0.77 to 3.36)), and, in people with T1D, age at diagnosis of diabetes (< 12 years of age) (standardised regression estimate 1.62, 95% CI 1.06 to 2.48), increased triglyceride levels (adjusted RR 1.55, 95% CI 1.06 to 1.95), and larger retinal venular diameters (RR 4.28, 95% CI 1.50 to 12.19) may increase the risk of progression to PDR. The certainty of evidence for these factors, however, was low to very low, due to risk of bias in the included studies, inconsistency (lack of studies preventing the grading of consistency or variable outcomes), and imprecision (wide CIs). There was no substantial and consistent evidence to support duration of diabetes, systolic or diastolic blood pressure, total cholesterol, low- (LDL) and high- (HDL) density lipoproteins, gender, ethnicity, body mass index (BMI), socioeconomic status, or tobacco and alcohol consumption as being associated with incidence of PDR. There was insufficient evidence to evaluate prognostic factors associated with progression of PDR to HRC-PDR.\nAuthors' conclusions\nIncreased HbA1c is likely to be associated with progression to PDR; therefore, maintaining adequate glucose control throughout life, irrespective of stage of DR severity, may help to prevent progression to PDR and risk of its sight-threatening complications. Renal impairment in people with T1D or T2D, as well as younger age at diagnosis of diabetes mellitus (DM), increased triglyceride levels, and increased retinal venular diameters in people with T1D may also be associated with increased risk of progression to PDR. Given that more advanced DR severity is associated with higher risk of progression to PDR, the earlier the disease is identified, and the above systemic risk factors are controlled, the greater the chance of reducing the risk of PDR and saving sight.\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": "Of the 6391 articles we found, 59 studies (87 articles) were eligible, and we included them in our review. We found that higher blood sugar (which means poorer diabetes control) and more advanced diabetic retinopathy (more changes from diabetes in the retina) put people at higher risk of having PDR. People with kidney disease seemed also to be at higher risk of progressing to PDR. It is also possible that people with type 1 diabetes who were diagnosed at a young age, and those with higher triglyceride levels (triglycerides are a type of fat in the blood, like cholesterol) or who have retinal veins with larger diameters, are more at risk of developing PDR. Other risk factors studied - for example, duration of diabetes, blood pressure, and cholesterol - did not seem to be risk factors for PDR. There was not enough information from the included studies for us to analyse risk factors for HRC-PDR."
}
]
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query-laysum | 5842 | [
{
"role": "user",
"content": "Abstract: Background\nPanic disorder (PD) is a common type of anxiety disorder, characterized by unexpected and repeated panic attacks or fear of future panic attacks, or both. Individuals with PD are often resistant to pharmacological or psychological treatments and this can lead to the disorder becoming a chronic and disabling illness. Repetitive transcranial magnetic stimulation (rTMS) can deliver sustained and spatially selective current to suppress or induce cortical excitability, and its therapeutic effect on pathological neuronal activity in people with PD has already been examined in case studies and clinical trials. However, a systematic review is necessary to assess the efficacy and safety of rTMS for PD.\nObjectives\nTo assess the effects of repetitive transcranial magnetic stimulation (rTMS) for panic disorder (PD) in adults aged 18 to 65 years, either as a monotherapy or as an augmentation strategy.\nSearch methods\nAn electronic search of the Cochrane Depression, Anxiety and Neurosis Review Group Controlled Trials Register (CCDANCTR) was conducted to 19 February 2014. The CCDANCTR includes reports of relevant randomised controlled trials (RCTs) from MEDLINE (1950 to date), EMBASE (1974 to date), PsycINFO (1967 to date) and the Cochrane Central Register of Controlled Trials (CENTRAL) (all years). Additional searches were conducted in Psyndex and the main Chinese medical databases.\nSelection criteria\nRCTs or quasi-randomised trials evaluating rTMS for PD in people aged between 18 and 65 years, either as a monotherapy or as an augmentation strategy.\nData collection and analysis\nTwo review authors independently selected studies and extracted data and verified the data by cross-checking. Disagreements were resolved by discussion. For binary data, we calculated fixed-effect model risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we calculated fixed-effect model standardized mean difference (SMD) and its 95% CI.\nMain results\nTwo RCTs (n = 40) were included in this review. The included trials compared rTMS with sham rTMS; no trials comparing rTMS with active treatments (electroconvulsive therapy (ECT), pharmacotherapy, psychotherapy) met our inclusion criteria. Both included studies used 1 Hz rTMS over the right dorso-lateral prefrontal cortex (DLPFC) for two or four weeks as an augmentation treatment for PD. However, in both studies the data for the primary outcome, panic symptoms as measured by the Panic Disorder Severity Scale (PDSS), were skewed and could not be pooled for a quantitative analysis. For this primary outcome one trial with 25 participants reported a superior effect of rTMS in reducing panic symptoms compared with sham rTMS (t = 3.04, df = 16.57, P = 0.007), but this trial had a 16% dropout rate and so was deemed as having a high risk of attrition bias. The other trial found that all 15 participants exhibited a reduction in panic symptoms but there was no significant difference between rTMS and sham rTMS (Mann Whitney U test, P > 0.05). Regarding the acceptability of rTMS, no significant difference was found between rTMS and sham rTMS in dropout rates or in reports of side effects. The quality of evidence contributing to this review was assessed as very low. Assessments of the risk of bias for the two studies were hampered by the lack of information provided in the reports, especially on methods of sequence generation and whether allocation concealment had been applied. Of the remaining sources of bias, we considered one of the studies to have been at risk of attrition bias.\nAuthors' conclusions\nOnly two RCTs of rTMS were available and their sample sizes were small. The available data were insufficient for us to draw any conclusions about the efficacy of rTMS for PD. Further trials with large sample sizes and adequate methodology are needed to confirm the effectiveness of rTMS for PD.\n\nGiven the provided abstract, please respond to the following query: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is rTMS effective in treating adults with panic disorder, either on its own or in combination with other treatments?"
}
]
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query-laysum | 5844 | [
{
"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: \"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 found no randomised controlled trials evaluating the use of ESWT for venous leg ulcers. This highlights a gap in medical evidence which may justify further research into this area."
}
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query-laysum | 5845 | [
{
"role": "user",
"content": "Abstract: Background\nInfantile hypertrophic pyloric stenosis (IHPS) is a disorder of young children (aged one year or less) and can be treated by laparoscopic (LP) or open (OP) longitudinal myotomy of the pylorus. Since the first description in 1990, LP is being performed more often worldwide.\nObjectives\nTo compare the efficacy and safety of open versus laparoscopic pyloromyotomy for IHPS.\nSearch methods\nWe conducted a literature search on 04 February 2021 to identify all randomised controlled trials (RCTs), without any language restrictions. We searched the following electronic databases: MEDLINE (1990 to February 2021), Embase (1990 to February 2021), and the Cochrane Central Register of Controlled Trials (CENTRAL). We also searched the Internet using the Google Search engine (www.google.com) and Google Scholar (scholar.google.com) to identify grey literature not indexed in databases.\nSelection criteria\nWe included RCTs and quasi-randomised trials comparing LP with OP for hypertrophic pyloric stenosis.\nData collection and analysis\nTwo review authors independently screened references and extracted data from trial reports. Where outcomes or study details were not reported, we requested missing data from the corresponding authors of the primary RCTs. We used a random-effects model to calculate risk ratios (RRs) for binary outcomes, and mean differences (MDs) for continuous outcomes. Two review authors independently assessed risks of bias. We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nThe electronic database search resulted in a total of 434 records. After de-duplication, we screened 410 independent publications, and ultimately included seven RCTs (reported in 8 reports) in quantitative analysis. The seven included RCTs enrolled 720 participants (357 with open pyloromyotomy and 363 with laparoscopic pyloromyotomy). One study was a multi-country trial, three were carried out in the USA, and one study each was carried out in France, Japan, and Bangladesh.\nThe evidence suggests that LP may result in a small increase in mucosal perforation compared with OP (RR 1.60, 95% CI 0.49 to 5.26; 7 studies, 720 participants; low-certainty evidence). LP may result in up to 5 extra instances of mucosal perforation per 1,000 participants; however, the confidence interval ranges from 4 fewer to 44 more per 1,000 participants.\nFour RCTs with 502 participants reported on incomplete pyloromyotomy. They indicate that LP may increase the risk of incomplete pyloromyotomy compared with OP, but the confidence interval crosses the line of no effect (RR 7.37, 95% CI 0.92 to 59.11; 4 studies, 502 participants; low-certainty evidence). In the LP groups, 6 cases of incomplete pyloromyotomy were reported in 247 participants while no cases of incomplete pyloromyotomy were reported in the OP groups (from 255 participants).\nAll included studies (720 participants) reported on postoperative wound infections or abscess formations. The evidence is very uncertain about the effect of LP on postoperative wound infection or abscess formation compared with OP (RR 0.59, 95% CI 0.24 to 1.45; 7 studies, 720 participants; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on postoperative incisional hernia compared with OP (RR 1.01, 95% CI 0.11 to 9.53; 4 studies, 382 participants; very low-certainty evidence).\nLength of hospital stay was assessed by five RCTs, including 562 participants. The evidence is very uncertain about the effect of LP compared to OP (mean difference −3.01 hours, 95% CI −8.39 to 2.37 hours; very low-certainty evidence). Time to full feeds was assessed by six studies, including 622 participants. The evidence is very uncertain about the effect of LP on time to full feeds compared with OP (mean difference −5.86 hours, 95% CI −15.95 to 4.24 hours; very low-certainty evidence). The evidence is also very uncertain about the effect of LP on operating time compared with OP (mean difference 0.53 minutes, 95% CI −3.53 to 4.59 minutes; 6 studies, 622 participants; very low-certainty evidence).\nAuthors' conclusions\nLaparoscopic pyloromyotomy may result in a small increase in mucosal perforation when compared with open pyloromyotomy for IHPS. There may be an increased risk of incomplete pyloromyotomy following LP compared with OP, but the effect estimate is imprecise and includes the possibility of no difference. We do not know about the effect of LP compared with OP on the need for re-operation, postoperative wound infections or abscess formation, postoperative haematoma or seroma formation, incisional hernia occurrence, length of postoperative stay, time to full feeds, or operating time because the certainty of the evidence was very low for these outcomes. We downgraded the certainty of the evidence for most outcomes due to limitations in the study design (most outcomes were susceptible to detection bias) and imprecision. There is limited evidence available comparing LP with OP for IHPS. The included studies did not provide sufficient information to determine the effect of training, experience, or surgeon preferences on the outcomes assessed.\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 open versus laparoscopic pyloromyotomy in infants with a diagnosis of infantile hypertrophic pyloric stenosis. We found 7 studies (reported in 8 reports)."
}
]
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query-laysum | 5846 | [
{
"role": "user",
"content": "Abstract: Background\nUrinary incontinence in women is associated with poor quality of life and difficulties in social, psychological and sexual functioning. The condition may affect up to 15% of middle-aged or older women in the general population. Conservative treatments such as lifestyle interventions, bladder training and pelvic floor muscle training (used either alone or in combination with other interventions) are the initial approaches to the management of urinary incontinence. Many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India.\nObjectives\nTo assess the effects of yoga for treating urinary incontinence in women.\nSearch methods\nWe searched the Cochrane Incontinence and Cochrane Complementary Medicine Specialised Registers. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov to identify any ongoing or unpublished studies. We handsearched Proceedings of the International Congress on Complementary Medicine Research and the European Congress for Integrative Medicine. We searched the NHS Economic Evaluation Database for economic studies, and supplemented this search with searches for economics studies in MEDLINE and Embase from 2015 onwards. Database searches are up-to-date as of 21 June 2018.\nSelection criteria\nRandomised controlled trials in women diagnosed with urinary incontinence in which one group was allocated to treatment with yoga.\nData collection and analysis\nTwo review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias and evaluated the certainty of the evidence for each reported outcome. Any disagreements were resolved by consensus. We planned to combine clinically comparable studies in Review Manager 5 using random-effects meta-analysis and to carry out sensitivity and subgroup analyses. We planned to create a table listing economic studies on yoga for incontinence but not carry out any analyses on these studies.\nMain results\nWe included two studies (involving a total of 49 women). Each study compared yoga to a different comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment.\nOne included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a difference between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean difference (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a difference in the number of women who experienced at least one adverse event (risk difference 0%, 95% CI -38% to 38%; no difference from 222 per 1000, 95% CI 380 fewer to 380 more).\nThe second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the effect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse effects.\nAuthors' conclusions\nWe identified few trials on yoga for incontinence, and the existing trials were small and at high risk of bias. In addition, we did not find any studies of economic outcomes related to yoga for urinary incontinence. Due to the lack of evidence to answer the review question, we are uncertain whether yoga is useful for women with urinary incontinence. Additional, well-conducted trials with larger sample sizes are needed.\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": "The evidence is current to 21 June 2018."
}
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query-laysum | 5847 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review, published in 2009, Issue 2.\nKleine-Levin syndrome (KLS) is a rare disorder that mainly affects adolescent men. It is characterised by recurrent episodes of hypersomnia, usually accompanied by hyperphagia, cognitive and mood disturbances, abnormal behaviour, such as hypersexuality, and signs of dysautonomia.\nIn 1990, the diagnostic criteria for Kleine-Levin syndrome were modified in the International Classification of Sleep Disorders, where KLS was defined as a syndrome comprised of recurring episodes of undue sleepiness lasting some days, which may or may not be associated with hyperphagia and abnormal behaviour. According to the International Classification of Sleepiness Disorders, 3rd version (ICSD-3), revised in 2014, the Kleine-Levin syndrome is a disorder characterized by recurrent episodes of hypersomnia that last from two days to four weeks, with at least annual recurrence, and hyperphagia (rapid consumption of a large amount of food), usually with onset in early adolescence in males but occasionally in later life and in women. A monosymptomatic form of the disorder with hypersomnia only can occur without binge eating or hypersexuality.\nThe cause of Kleine-Levin syndrome remains unknown, and several treatment strategies have been used. Some medications have been reported to provide benefit in the treatment of patients with KLS, but because of the rarity of the condition, no long-term follow-up therapies have yet been described.\nObjectives\nThis review aimed to evaluate:\n1. whether pharmacological treatment for Kleine Levin syndrome was effective and safe.\n2. which drug or category of drugs was effective and safe.\nSearch methods\nFor the latest update, we searched the following sources: the Cochrane Epilepsy Group Specialized Register (7 April 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online CRSO (7 April 2016); MEDLINE (1946 to April 2016); LILACS (7 April 2016); ClinicalTrials.gov (7 April 2016); WHO International Clinical Trials Registry Platform ICTRP (7 April 2016); reference lists of sleep medicine textbooks; review articles and reference lists of articles identified by the search strategies.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-randomised controlled trials looking at pharmacological interventions for Kleine-Levin syndrome were eligible. We had planned to include both parallel-group and cross-over studies.\nData collection and analysis\nTwo review authors (MMO and CC) had planned to extract the data reported in the original articles.\nMain results\nNo studies met the inclusion criteria for this systematic review.\nAuthors' conclusions\nTherapeutic trials of pharmacological treatment for Kleine-Levin syndrome with a double-blind, placebo-controlled design are needed.\n\nGiven the provided abstract, please respond to the following query: \"Objectives\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The authors of this review aimed to identify and evaluate randomised controlled trials (RCTs) studying the effectiveness of pharmacological treatment for Kleine-Levin syndrome."
}
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query-laysum | 5848 | [
{
"role": "user",
"content": "Abstract: Background\nUlcerative colitis (UC) is a chronic inflammation of the colon characterised by periods of relapse and remission. It starts in the rectum and can extend throughout the colon. UC and Crohn’s disease (CD) are the most common inflammatory bowel diseases (IBDs). However, UC tends to be more common than CD. It has no known cure but can be managed with medication and surgery. However, studies have shown that abdominal pain persists in up to one-third of people with UC in remission. Abdominal pain could be a symptom of relapse of the disease due to adverse effects of medication, surgical complications and strictures or adhesions secondary to UC.\nObjectives\nTo assess the efficacy and safety of interventions for managing abdominal pain in people with ulcerative colitis.\nSearch methods\nWe searched CENTRAL, MEDLINE and five other databases and clinical trials registries on 28 April 2021. We contacted authors of relevant studies and ongoing or unpublished trials that may be relevant to the review. We also searched references of trials and systematic reviews for any additional trials.\nSelection criteria\nAll published, unpublished and ongoing randomised trials that compared interventions for the management of abdominal pain with other active interventions or standard therapy, placebo or no therapy were included. People with both active and inactive disease were included. We excluded studies that did not report on any abdominal pain outcomes.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessments. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs), respectively, with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nWe included five studies (360 randomised participants). Studies considered mainly participants in an inactive state of the disease.\nNo conclusions could be drawn about the efficacy of any of the interventions on pain frequency, pain intensity, and treatment success. The certainty of the evidence was very low for all comparisons because of imprecision due to sparse data, and risk of bias.\nOne study compared a low FODMAPs diet (n=13) to a sham diet (n=13). The evidence is very uncertain about the effect of this treatment on pain frequency (MD -4.00, 95% CI -20.61 to 12.61) and intensity (MD -9.00, 95% CI -20.07 to 2.07). Treatment success was not reported.\nOne study compared relaxation training (n=20) to wait-list (n=20). The evidence is very uncertain about the effect of this treatment on pain frequency at end of intervention (MD 2.60, 95% CI 1.14 to 4.06) and 6-month follow-up (MD 3.30, 95% CI 1.64 to 4.96). Similarly, the evidence is very uncertain about the effect of this treatment on pain intensity at end of intervention (MD -1.70, 95% CI -2.92 to -0.48) and 6-month follow-up (MD -2.30, 95% CI -3.70 to -0.90). Treatment success was not reported.\nOne study compared yoga (n=30) to no intervention (n=30). The study defined treatment success as the presence or absence of pain; however, the data they provided was unclear. Pain frequency and intensity were not reported.\nOne study compared a kefir diet (Lactobacillus bacteria, n=15) to no intervention (n=15). The evidence is very uncertain about the effect of this treatment on pain intensity (MD -0.17, 95% CI -0.91 to 0.57). Pain frequency and treatment success were not reported.\nOne study compared a stellate ganglion block treatment (n=90) to sulfasalazine treatment (n=30). The study defined treatment success as \"stomachache\"; however, the data they provided was unclear. Pain frequency and intensity were not reported.\nTwo studies reported withdrawals due to adverse events. One study reported withdrawals due to adverse events as zero. Two studies did not report this outcome. We cannot draw any conclusions about the effects of any of the interventions on withdrawals due to adverse events because of the very limited evidence.\nThe reporting of secondary outcomes was inconsistent.\nAdverse events tended to be very low or zero. However, we can make no clear judgements about adverse events for any of the interventions, due to the low number of events.\nAnxiety was measured and reported at end of intervention in only one study (yoga versus no intervention), and depression was not measured in any of the studies. We can therefore draw no meaningful conclusions about these outcomes.\nAuthors' conclusions\nWe found very low-certainty evidence on the efficacy and safety of interventions for the management of abdominal pain in ulcerative colitis. Pervasive issues with very serious imprecision from small samples size and high risk of bias have led to very low-certainty outcomes, precluding conclusions.\nWhile few adverse events and no serious adverse events were reported, the certainty of these findings was again very low for all comparisons, so no conclusions can be drawn.\nThere is a need for further research. We have identified eight ongoing studies in this review, so an update will be warranted. It is key that future research addresses the issues leading to reduced certainty of outcomes, specifically sample size and reporting that leads to high risk of bias. It is also important that if researchers are considering pain as a critical outcome, they should report clearly if participants were pain-free at baseline; in that case, data would be best presented as separate subgroups throughout their research.\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 for randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) comparing any treatment with another or with a dummy/placebo treatment. We found five RCTs looking at 360 participants.\n1) Authors reported improvement in pain for a relaxation training compared to no relaxation training, but we cannot draw conclusions about whether this is really the case because of the very low certainty of the evidence.\n2) It is unclear whether there is any difference between any of the other therapies studied for the management of pain.\n3) It is unclear whether any therapy leads to a difference in adverse events (minor or serious) when compared to any other therapy."
}
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query-laysum | 5849 | [
{
"role": "user",
"content": "Abstract: Background\nThe most frequent indications for tooth extractions, generally performed by general dental practitioners, are dental caries and periodontal infections. Systemic antibiotics may be prescribed to patients undergoing extractions to prevent complications due to infection. This is an update of a review first published in 2012.\nObjectives\nTo determine the effect of systemic antibiotic prophylaxis on the prevention of infectious complications following tooth extractions.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health Trials Register (to 16 April 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 3), MEDLINE Ovid (1946 to 16 April 2020), Embase Ovid (1980 to 16 April 2020), and LILACS (1982 to 16 April 2020). 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, double-blind, placebo-controlled trials of systemic antibiotic prophylaxis in patients undergoing tooth extraction(s) for any indication.\nData collection and analysis\nAt least two review authors independently performed data extraction and 'Risk of bias' assessment for the included studies. We contacted trial authors for further details where these were unclear. For dichotomous outcomes, we calculated risk ratios (RR) and 95% confidence intervals (CI) using random-effects models. For continuous outcomes, we used mean differences (MD) with 95% CI using random-effects models. We examined potential sources of heterogeneity. We assessed the certainty of the body of evidence for key outcomes as high, moderate, low, or very low, using the GRADE approach.\nMain results\nWe included 23 trials that randomised approximately 3206 participants (2583 analysed) to prophylactic antibiotics or placebo. Although general dentists perform dental extractions because of severe dental caries or periodontal infection, only one of the trials evaluated the role of antibiotic prophylaxis in groups of patients affected by those clinical conditions.\nWe assessed 16 trials as being at high risk of bias, three at low risk, and four as unclear.\nCompared to placebo, antibiotics may reduce the risk of postsurgical infectious complications in patients undergoing third molar extractions by approximately 66% (RR 0.34, 95% CI 0.19 to 0.64; 1728 participants; 12 studies; low-certainty evidence), which means that 19 people (95% CI 15 to 34) need to be treated with antibiotics to prevent one infection following extraction of impacted wisdom teeth. Antibiotics may also reduce the risk of dry socket by 34% (RR 0.66, 95% CI 0.45 to 0.97; 1882 participants; 13 studies; low-certainty evidence), which means that 46 people (95% CI 29 to 62) need to take antibiotics to prevent one case of dry socket following extraction of impacted wisdom teeth.\nThe evidence for our other outcomes is uncertain: pain, whether measured dichotomously as presence or absence (RR 0.59, 95% CI 0.31 to 1.12; 675 participants; 3 studies) or continuously using a visual analogue scale (0-to-10-centimetre scale, where 0 is no pain) (MD −0.26, 95% CI −0.59 to 0.07; 422 participants; 4 studies); fever (RR 0.66, 95% CI 0.24 to 1.79; 475 participants; 4 studies); and adverse effects, which were mild and transient (RR 1.46, 95% CI 0.81 to 2.64; 1277 participants; 8 studies) (very low-certainty evidence).\nWe found no clear evidence that the timing of antibiotic administration (preoperative, postoperative, or both) was important.\nThe included studies enrolled a subset of patients undergoing dental extractions, that is healthy people who had surgical extraction of third molars. Consequently, the results of this review may not be generalisable to all people undergoing tooth extractions.\nAuthors' conclusions\nThe vast majority (21 out of 23) of the trials included in this review included only healthy patients undergoing extraction of impacted third molars, often performed by oral surgeons. None of the studies evaluated tooth extraction in immunocompromised patients. We found low-certainty evidence that prophylactic antibiotics may reduce the risk of infection and dry socket following third molar extraction when compared to placebo, and very low-certainty evidence of no increase in the risk of adverse effects. On average, treating 19 healthy patients with prophylactic antibiotics may stop one person from getting an infection. It is unclear whether the evidence in this review is generalisable to patients with concomitant illnesses or patients at a higher risk of infection. Due to the increasing prevalence of bacteria that are resistant to antibiotic treatment, clinicians should evaluate if and when to prescribe prophylactic antibiotic therapy before a dental extraction for each patient on the basis of the patient's clinical conditions (healthy or affected by systemic pathology) and level of risk from infective complications. Immunocompromised patients, in particular, need an individualised approach in consultation with their treating medical specialist.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our confidence in the results is limited because we had concerns about aspects of the design and reporting of all of the included studies."
}
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query-laysum | 5850 | [
{
"role": "user",
"content": "Abstract: Background\nImmune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis have changed the first-line treatment of people with advanced non-small cell lung cancer (NSCLC). Single-agent pembrolizumab (a PD-1 inhibitor) is currently the standard of care as monotherapy in patients with PD-L1 expression ≥ 50%, either alone or in combination with chemotherapy when PD-L1 expression is less than 50%. Atezolizumab (PD-L1 inhibitor) has also been approved in combination with chemotherapy and bevacizumab (an anti-angiogenic antibody) in first-line NSCLC regardless of PD-L1 expression. The combination of first-line PD-1/PD-L1 inhibitors with anti-CTLA-4 antibodies has also been shown to improve survival compared to platinum-based chemotherapy in advanced NSCLC, particularly in people with high tumour mutational burden (TMB). The association of ipilimumab (an anti CTLA4) and nivolumab (PD-1 inhibitor) has been approved by the US Food and Drug Administration (FDA) in all patients with PD-L1 expression ≥1%. Although these antibodies are currently used in clinical practice, some questions remain unanswered, such as the best-treatment strategy, the role of different biomarkers for treatment selection and the effectiveness of immunotherapy according to specific clinical characteristics.\nObjectives\nTo determine the effectiveness and safety of first-line immune checkpoint inhibitors (ICIs), as monotherapy or in combination, compared to platinum-based chemotherapy, with or without bevacizumab for people with advanced NSCLC, according to the level of PD-L1 expression.\nSearch methods\nWe performed an electronic search of the main databases (Cochrane Central Register of Controlled Trials, MEDLINE, Embase) from inception until 31 December 2020 and conferences meetings from 2015 onwards.\nSelection criteria\nWe included randomised controlled trials (RCTs) reporting on the efficacy or safety of first-line ICI treatment for adults with advanced NSCLC who had not previously received any anticancer treatment. We included trials comparing single- or double-ICI treatment to standard first-line therapy (platinum-based chemotherapy +/- bevacizumab). All data come from ‘international multicentre studies involving adults, age 18 or over, with histologically-confirmed stage IV NSCLC.\nData collection and analysis\nThree review authors independently assessed the search results and a fourth review author resolved any disagreements. Primary outcomes were overall survival (OS) and progression-free survival (PFS); secondary outcomes were overall objective response rate (ORR) by RECIST v 1.1, grade 3 to 5 treatment-related adverse events (AEs) (CTCAE v 5.0) and health-related quality of life (HRQoL). We performed meta-analyses where appropriate using the random-effects model for hazard ratios (HRs) or risk ratios (RRs), with 95% confidence intervals (95% CIs), and used the I² statistic to investigate heterogeneity.\nMain results\nMain results\nWe identified 15 trials for inclusion, seven completed and eight ongoing trials. We obtained data for 5893 participants from seven trials comparing first-line single- (six trials) or double- (two trials) agent ICI with platinum-based chemotherapy, one trial comparing both first-line single- and double-agent ICsI with platinum-based chemotherapy. All trials were at low risk of selection and detection bias, some were classified at high risk of performance, attrition or other source of bias. The overall certainty of evidence according to GRADE ranged from moderate-to-low because of risk of bias, inconsistency, or imprecision. The majority of the included trials reported their outcomes by PD-L1 expressions, with PD-L1 ≥ 50 being considered the most clinically useful cut-off level for decision makers. Also, iIn order to avoid overlaps between various PDL-1 expressions we prioritised the review outcomes according to PD-L1 ≥ 50.\nSingle-agent ICI\nIn the PD-L1 expression ≥ 50% group single-agent ICI probably improved OS compared to platinum-based chemotherapy (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.60 to 0.76, 6 RCTs, 2111 participants, moderate-certainty evidence). In this group, single-agent ICI also may improve PFS (HR: 0.68, 95% CI 0.52 to 0.88, 5 RCTs, 1886 participants, low-certainty evidence) and ORR (risk ratio (RR):1.40, 95% CI 1.12 to 1.75, 4 RCTs, 1672 participants, low-certainty evidence). HRQoL data were available for only one study including only people with PD-L1 expression ≥ 50%, which suggested that single-agent ICI may improve HRQoL at 15 weeks compared to platinum-based chemotherapy (RR: 1.51, 95% CI 1.08 to 2.10, 1 RCT, 297 participants, low-certainty evidence).\nIn the included studies, treatment-related AEs were not reported according to PD-L1 expression levels. Grade 3-4 AEs may be less frequent with single-agent ICI compared to platinum-based chemotherapy (RR: 0.41, 95% CI 0.33 to 0.50, I² = 62%, 5 RCTs, 3346 participants, low-certainty evidence).\nMore information about efficacy of single-agent ICI compared to platinum-based chemotherapy according to the level of PD-L1 expression and to TMB status or specific clinical characteristics is available in the full text.\nDouble-agent ICI \nDouble-ICI treatment probably prolonged OS compared to platinum-based chemotherapy in people with PD-L1 expression ≥50% (HR: 0.72, 95% CI 0.59 to 0.89 2 RCTs, 612 participants, moderate-certainty evidence).\nTrials did not report data on HRQoL, PFS and ORR according to PD-L1 groups.\nTreatment related AEs were not reported according to PD-L1 expression levels. The frequency of grade 3-4 AEs may not differ between double-ICI treatment and platinum-based chemotherapy (RR: 0.78, 95% CI 0.55 to 1.09, I² = 81%, 2 RCTs, 1869 participants, low-certainty evidence).\nMore information about efficacy of double-agent ICI according to the level of PD-L1 expression and to TMB status is available in the full text.\nAuthors' conclusions\nAuthors' conclusions\nThe evidence in this review suggests that single-agent ICI in people with NSCLC and PD-L1 ≥50% probably leads to a higher overall survival rate and may lead to a higher progression-free survival and overall response rate when compared to platinum-based chemotherapy and may also lead to a lower rate of adverse events and higher HRQoL. Combined ICI in people with NSCLC and PD-L1 ≥50% also probably leads to a higher overall survival rate when compared to platinum-based chemotherapy, but its effect on progression-free survival, overall response rate and HRQoL is unknown due to a lack of data. The rate of adverse events may not differ between groups.\nThis review used to be a living review. It is transitioned out of living mode because current research is exploring ICI in association with chemotherapy or other immunotherapeutic drugs versus ICI as single agent rather than platinum based chemotherapy.\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": "Is immunotherapy more effective and less toxic than chemotherapy for people diagnosed with non-small cell lung cancer (a subtype of lung cancer) who have not previously been treated and who are not suitable for curative treatment?"
}
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query-laysum | 5851 | [
{
"role": "user",
"content": "Abstract: Background\nMaintaining adequate nutrition is critical for people with amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND). Enteral tube feeding is offered to people experiencing difficulty swallowing (dysphagia) to prevent weight loss and aspiration pneumonia. Among the types of enteral tube feeding, percutaneous endoscopic gastrostomy (PEG) is the typical procedure offered to people with ALS and will be mainly discussed here.\nObjectives\nTo examine the effectiveness of percutaneous endoscopic gastrostomy or other enteral tube feeding in people with ALS, compared to oral feeds without enteral tube feeding on:\n1. survival;\n2. nutritional status;\n3. quality of life.\nTo examine the incidence of minor and major complications of percutaneous endoscopic gastrostomy (PEG) and other enteral tube feeding procedures in people with ALS.\nSearch methods\nOn 3 January 2020 and 6 February 2021, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE. Embase, ClinicalTrials.gov and WHO ICTRP. We screened the results to identify randomized controlled studies on enteral tube feeding in ALS. We reviewed all references from the search in published articles to identify any additional references.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, and cross-over trials evaluating the effectiveness and complications of PEG or other enteral tube feeding placement in ALS.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe found no RCTs or quasi-RCTs comparing the effectiveness of enteral tube feeding versus oral feeds without enteral tube feeding.\nAuthors' conclusions\nThere are no RCTs or quasi-RCTs to indicate whether enteral tube feeding is effective compared to continuation of oral feeding for any of the outcome measures. Such RCTs are very unlikely to be performed for ethical reasons. RCTs evaluating the effect of different enteral tube insertion techniques and timings of tube placement on survival and quality of life of people with ALS dysphagia are feasible and warranted.\n\nGiven the provided abstract, please respond to the following query: \"What is ALS?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "ALS is a condition where the nerves that control movement cease to work. ALS causes weakness that worsens over time until the person becomes paralyzed. It is almost always fatal.\nMost people with ALS develop swallowing difficulties. These can cause serious weight loss and people affected are at risk of inhaling food or drink, since effective swallowing normally protects the airway from foods and liquids. If food or drink enters the lower airways or lung, these may become inflamed or infected (a condition called aspiration pneumonia)."
}
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query-laysum | 5852 | [
{
"role": "user",
"content": "Abstract: Background\nTo evaluate the effects of administering chemotherapy following surgery, or following surgery plus radiotherapy (known as adjuvant chemotherapy) in patients with early stage non-small cell lung cancer (NSCLC),we performed two systematic reviews and meta-analyses of all randomised controlled trials using individual participant data. Results were first published in The Lancet in 2010.\nObjectives\nTo compare, in terms of overall survival, time to locoregional recurrence, time to distant recurrence and recurrence-free survival:\nA. Surgery versus surgery plus adjuvant chemotherapy\nB. Surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy\nin patients with histologically diagnosed early stage NSCLC.\n(2)To investigate whether or not predefined patient subgroups benefit more or less from cisplatin-based chemotherapy in terms of survival.\nSearch methods\nWe supplemented MEDLINE and CANCERLIT searches (1995 to December 2013) with information from trial registers, handsearching relevant meeting proceedings and by discussion with trialists and organisations.\nSelection criteria\nWe included trials of a) surgery versus surgery plus adjuvant chemotherapy; and b) surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy, provided that they randomised NSCLC patients using a method which precluded prior knowledge of treatment assignment.\nData collection and analysis\nWe carried out a quantitative meta-analysis using updated information from individual participants from all randomised trials. Data from all patients were sought from those responsible for the trial. We obtained updated individual participant data (IPD) on survival, and date of last follow-up, as well as details of treatment allocated, date of randomisation, age, sex, histological cell type, stage, and performance status. To avoid potential bias, we requested information for all randomised patients, including those excluded from the investigators' original analyses. We conducted all analyses on intention-to-treat on the endpoint of survival. For trials using cisplatin-based regimens, we carried out subgroup analyses by age, sex, histological cell type, tumour stage, and performance status.\nMain results\nWe identified 35 trials evaluating surgery plus adjuvant chemotherapy versus surgery alone. IPD were available for 26 of these trials and our analyses are based on 8447 participants (3323 deaths) in 34 trial comparisons. There was clear evidence of a benefit of adding chemotherapy after surgery (hazard ratio (HR)= 0.86, 95% confidence interval (CI)= 0.81 to 0.92, p< 0.0001), with an absolute increase in survival of 4% at five years.\nWe identified 15 trials evaluating surgery plus radiotherapy plus chemotherapy versus surgery plus radiotherapy alone. IPD were available for 12 of these trials and our analyses are based on 2660 participants (1909 deaths) in 13 trial comparisons. There was also evidence of a benefit of adding chemotherapy to surgery plus radiotherapy (HR= 0.88, 95% CI= 0.81 to 0.97, p= 0.009). This represents an absolute improvement in survival of 4% at five years.\nFor both meta-analyses, we found similar benefits for recurrence outcomes and there was little variation in effect according to the type of chemotherapy, other trial characteristics or patient subgroup.\nWe did not undertake analysis of the effects of adjuvant chemotherapy on quality of life and adverse events. Quality of life information was not routinely collected during the trials, but where toxicity was assessed and mentioned in the publications, it was thought to be manageable. We considered the risk of bias in the included trials to be low.\nAuthors' conclusions\nResults from 47 trial comparisons and 11,107 patients demonstrate the clear benefit of adjuvant chemotherapy for these patients, irrespective of whether chemotherapy was given in addition to surgery or surgery plus radiotherapy. This is the most up-to-date and complete systematic review and individual participant data (IPD) meta-analysis that has been carried out.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for relevant trials up to December 2013. The studies brought together trial data from all over the world with 26 trials (34 trial comparisons) and 8447 patients in the first meta-analysis (surgery versus surgery plus adjuvant chemotherapy); and 12 trials (13 trial comparisons) and 2660 patients in the second meta-analysis (surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy). Trials were carried out between 1979 and 2003."
}
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query-laysum | 5853 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2018.\nThe incidence of seizures following supratentorial craniotomy for non-traumatic pathology has been estimated to be between 15% to 20%; however, the risk of experiencing a seizure appears to vary from 3% to 92% over a five-year period. Postoperative seizures can precipitate the development of epilepsy; seizures are most likely to occur within the first month of cranial surgery. The use of antiepileptic drugs (AEDs) administered pre- or postoperatively to prevent seizures following cranial surgery has been investigated in a number of randomised controlled trials (RCTs).\nObjectives\nTo determine the efficacy and safety of AEDs when used prophylactically in people undergoing craniotomy and to examine which AEDs are most effective.\nSearch methods\nFor the latest update we searched the following databases on 29 September 2019: Cochrane Epilepsy Group Specialized Register, CENTRAL, MEDLINE, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP). We did not apply any language restrictions.\nSelection criteria\nWe included RCTs of people with no history of epilepsy who were undergoing craniotomy for either therapeutic or diagnostic reasons. We included trials with adequate randomisation methods and concealment; these could either be blinded or unblinded parallel trials. We did not stipulate a minimum treatment period, and we included trials using active drugs or placebo as a control group.\nData collection and analysis\nThree review authors (JW, JG, YD) independently selected trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through discussion. Outcomes investigated included the number of participants experiencing seizures (early (occurring within first week following craniotomy), and late (occurring after first week following craniotomy)), the number of deaths and the number of people experiencing disability and adverse effects. Due to the heterogeneous nature of the trials, we did not combine data from the included trials in a meta-analysis; we presented the findings of the review in narrative format. Visual comparisons of outcomes are presented in forest plots.\nMain results\nWe included 10 RCTs (N = 1815), which were published between 1983 and 2015. Three trials compared a single AED (phenytoin) with placebo or no treatment. One, three-armed trial compared two AEDs (phenytoin, carbamazepine) with no treatment. A second three-armed trial compared phenytoin, phenobarbital with no treatment. Of these five trials comparing AEDs with placebo or no treatment, two trials reported a statistically significant advantage for AED treatment compared to controls for early seizure occurrence; all other comparisons showed no clear or statistically significant differences between AEDs and control treatment. None of the trials that were head-to-head comparisons of AEDs (phenytoin versus sodium valproate, phenytoin versus phenobarbital, levetiracetam versus phenytoin, zonisamide versus phenobarbital) reported any statistically significant differences between treatments for either early or late seizure occurrence.\nOnly five trials reported incidences of death. One trial reported statistically significantly fewer deaths in the carbamazepine and no-treatment groups compared with the phenytoin group after 24 months of treatment, but not after six months of treatment. Incidences of adverse effects of treatment were poorly reported; however, three trials did show that significantly more adverse events occurred on phenytoin compared to valproate, placebo, or no treatment. No trials reported any results relating to functional outcomes such as disability.\nWe considered the evidence to be of low certainty for all reported outcomes due to methodological issues and variability of comparisons made in the trials.\nAuthors' conclusions\nThere is limited, low-certainly evidence to suggest that AED treatment administered prophylactically is either effective or not effective in the prevention of postcraniotomy (early or late) seizures. The current evidence base is limited due to the different methodologies employed in the trials and inconsistencies in the reporting of outcomes including deaths and adverse events. Further evidence from good-quality, contemporary trials is required in order to assess the clinical effectiveness of prophylactic AED treatment compared to placebo or no treatment, or other AEDs in preventing postcraniotomy seizures in this select group of patients.\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 examines the evidence for the effectiveness and safety of antiepileptic drugs (AEDs) when they are given to people who do not have epilepsy to prevent them experiencing seizures after craniotomy surgery (a type of brain surgery commonly used to remove brain tumours). We also planned to assess whether any particular AED is more effective in preventing seizures after craniotomy surgery."
}
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query-laysum | 5854 | [
{
"role": "user",
"content": "Abstract: Background\nVisual problems in older people are common and frequently under-reported. The effects of poor vision in older people are wide reaching and include falls, confusion and reduced quality of life. Much of the visual impairment in older ages can be treated (e.g. cataract surgery, correction of refractive error). Vision screening may therefore reduce the number of older people living with sight loss.\nObjectives\nThe objective of this review was to assess the effects on vision of community vision screening of older people for visual impairment.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 10); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 23 November 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared vision screening alone or as part of a multi-component screening package as compared to no vision screening or standard care, on the vision of people aged 65 years or over in a community setting. We included trials that used self-reported visual problems or visual acuity testing as the screening tool.\nData collection and analysis\nWe used standard methods expected by Cochrane. We graded the certainty of the evidence using GRADE.\nMain results\nVisual outcome data were available for 10,608 people in 10 trials. Four trials took place in the UK, two in Australia, two in the United States and two in the Netherlands. Length of follow-up ranged from one to five years. Three of these studies were cluster-randomised trials whereby general practitioners or family physicians were randomly allocated to undertake vision screening or no vision screening. All studies were funded by government agencies. Overall we judged the studies to be at low risk of bias and only downgraded the certainty of the evidence (GRADE) for imprecision.\nSeven trials compared vision screening as part of a multi-component screening versus no screening. Six of these studies used self-reported vision as both screening tool and outcome measure, but did not directly measure vision. One study used a combination of self-reported vision and visual acuity measurement: participants reporting vision problems at screening were treated by the attending doctor, referred to an eye care specialist or given information about resources that were available to assist with poor vision. There was a similar risk of \"not seeing well\" at follow-up in people screened compared with people not screened in meta-analysis of six studies (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.97 to 1.14, 4522 participants high-certainty evidence). One trial reported \"improvement in vision\" and this occurred slightly less frequently in the screened group (RR 0.85, 95% CI 0.52 to 1.40, 230 participants, moderate-certainty evidence).\nTwo trials compared vision screening (visual acuity testing) alone with no vision screening. In one study, distance visual acuity was similar in the two groups at follow-up (mean difference (MD) 0.02 logMAR, 95% CI −0.02 to 0.05, 532 participants, high-certainty evidence). There was also little difference in near acuity (MD 0.02 logMAR, 95% CI −0.03 to 0.07, 532 participants, high-certainty evidence). There was no evidence of any important difference in quality of life (MD −0.06 National Eye Institute 25-item visual function questionnaire (VFQ-25) score adjusted for baseline VFQ-25 score, 95% CI −2.3 to 1.1, 532 participants, high-certainty evidence). The other study could not be included in the data analysis as the number of participants in each of the arms at follow-up could not be determined. However the authors stated that there was no significant difference in mean visual acuity in participants who had visual acuity assessed at baseline (39 letters) as compared to those who did not have their visual acuity assessed (35 letters, P = 0.25, 121 participants).\nOne trial compared a detailed health assessment including measurement of visual acuity (intervention) with a brief health assessment including one question about vision (standard care). People given the detailed health assessment had a similar risk of visual impairment (visual acuity worse than 6/18 in either eye) at follow-up compared with people given the brief assessment (RR 1.07, 95% CI 0.84 to 1.36, 1807 participants, moderate-certainty evidence). The mean composite score of the VFQ-25 was 86.0 in the group that underwent visual acuity screening compared with 85.6 in the standard care group, a difference of 0.40 (95% CI −1.70 to 2.50, 1807 participants, high-certainty evidence).\nAuthors' conclusions\nThe evidence from RCTs undertaken to date does not support vision screening for older people living independently in a community setting, whether in isolation or as part of a multi-component screening package. This is true for screening programmes involving questions about visual problems, or direct measurements of visual acuity.\nThe most likely reason for this negative review is that the populations within the trials often did not take up the offered intervention as a result of the vision screening and large proportions of those who did not have vision screening appeared to seek their own intervention. Also, trials that use questions about vision have a lower sensitivity and specificity than formal visual acuity testing. Given the importance of visual impairment among older people, further research into strategies to improve vision of older people is needed. The effectiveness of an optimised primary care-based screening intervention that overcomes possible factors contributing to the observed lack of benefit in trials to date warrants assessment; trials should consider including more dependent participants, rather than those living independently in the community.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Vision problems are common in older people and are associated with an increased chance of falls and lower quality of life. Many older people have undiagnosed vision problems and therefore do not receive appropriate treatment. Community vision screening of older people could lead to improvements in vision by helping to find people with vision problems and putting them in contact with appropriate health care services that can provide treatment for the vision problem. The screening may consist of simple questions about vision (self-reported vision problems) or an eye test involving reading letters on a chart.\nCochrane Review authors wanted to find out if vision screening results in an improvement in vision in people over 65 years old."
}
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query-laysum | 5855 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a previous Cochrane Review, last updated in 2014. Ovarian cancer is the eighth most common cancer and seventh most common cause of death due to cancer in women worldwide. Traditionally, most women who have been treated for cancer undergo long-term follow-up in secondary care. However, it has been suggested that the use of routine review may not be effective in improving survival, or health-related quality of life (HRQOL), or relieving anxiety. In addition, traditional follow-up may not be cost-effective.\nObjectives\nTo compare the potential effects of different strategies of follow-up in women with epithelial ovarian cancer, following completion of primary treatment.\nSearch methods\nFor this update, we searched the Cochrane Gynaecological Cancer Group Trials Register, CENTRAL 2022, Issue 11, MEDLINE, and Embase from August 2013 to November 2022. We also searched review articles and contacted experts in the field.\nSelection criteria\nAll randomised controlled trials (RCTs) that evaluated follow-up strategies for women with epithelial ovarian cancer following completion of primary treatment.\nData collection and analysis\nWe followed standard Cochrane methodology. Two review authors independently selected potentially relevant trials, extracted data, and assessed risk of bias. They compared results, and resolved disagreements by discussion. We assessed the certainty of evidence, using the GRADE approach, for the outcomes of interest: overall survival (OS), health-related quality of life (HRQOL), psychological effects, and cost analysis.\nMain results\nFor this update, we included one new RCT, including 112 women with ovarian, fallopian tube, or peritoneal cancer, who had completed primary treatment by surgery, with or without chemotherapy. This study reported the effect of individualised, i.e. individually tailored, nurse-led follow-up versus conventional medical follow-up on HRQOL, psychological outcomes, and cost-analysis.\nIndividualised follow-up improved HRQOL in one of the two scales, with a decrease in mean difference (MD) in the QLQ-C30 discomfort scale following 12 months of individualised treatment compared to 12 months of conventional treatment (MD -5.76 points, 95% confidence interval (CI) -10.92 to -0.60; 1 study, 112 participants; low-certainty evidence; minimal important difference 4 to 10 points). There may be little or no difference in the other HRQOL scale (QLQ-Ov28, MD -0.97 points, 95% CI -2.57 to 0.63; 1 study, 112 participants: low-certainty evidence); psychological outcome, measured with the hospital anxiety and depression scale (HADS; MD 0.10 point, 95% CI -0.81 to 1.02; 1 study, 112 participants: low-certainty evidence), or cost analysis (MD -GBP 695.00, 95% CI -1467.23 to 77.23; 1 study, 112 participants: moderate-certainty evidence).\nOur previous review included one RCT, with 529 women in a confirmed remission, with normal CA125 concentration and no radiological evidence of disease, after surgery and first-line chemotherapy for ovarian cancer. This study evaluated immediate treatment of ovarian cancer relapse following a rise of serum CA125 levels versus delaying treatment until symptoms developed for OS, and HRQOL.\nThere was little or no difference in OS between the immediate and delayed arms after a median follow-up of 56.9 months (unadjusted hazard ratio (HR) 0.98, 95% CI 0.80 to 1.20; 1 study, 529 participants; moderate-certainty evidence). Time from randomisation to first deterioration in global health score or death was shorter in the immediate treatment group than in the delayed treatment group (HR 0.71, 95% CI 0.58 to 0.88).\nAuthors' conclusions\nLimited evidence from one trial suggests that routine surveillance with CA125 in asymptomatic women and treatment at CA125-defined relapse does not seem to offer survival advantage when compared to treatment at symptomatic relapse. However, this study pre-dates the use of PARPi maintenance treatment and the increased use of secondary cytoreductive surgery, so the results may be limited in their applicability to current practice.\nLimited evidence from one trial suggests that individualised nurse-led follow-up may improve HRQOL in women with ovarian cancer following completion of primary treatment.\nLarge RCTs are needed to compare different types of follow-up, looking at survival, HRQOL, psychological effects, and cost as outcomes.\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 two randomised studies, in which women who had completed their treatment for ovarian cancer were randomly assigned to one of two follow-up groups. Each study examined two different types of follow-up, so we had to examine each study separately, rather than pooling their results.\nLimited evidence from one study suggests that regardless of whether women receive chemotherapy immediately after discovering their cancer has recurred (identified by the increase of a tumour marker in the blood, called CA125), or delay treatment until they develop symptoms, there is no real difference in how long they survive. Early treatment of recurrence with chemotherapy may reduce overall quality of life.\nLimited evidence from one study suggests that women who receive individualised nurse-led follow-up report better health-related quality of life outcomes compared to those who receive conventional medical follow-up. Psychological effects (anxiety and depression) and costs were similar in both groups of women."
}
]
|
query-laysum | 5856 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a bone marrow-based hematological malignancy accounting for approximately two per cent of cancers. First-line treatment for transplant-ineligible individuals consists of multiple drug combinations of bortezomib (V), lenalidomide (R), or thalidomide (T). However, access to these medicines is restricted in many countries worldwide.\nObjectives\nTo assess and compare the effectiveness and safety of multiple drug combinations of V, R, and T for adults with newly diagnosed transplant-ineligible multiple myeloma and to inform an application for the inclusion of these medicines into the World Health Organization's (WHO) list of essential medicines.\nSearch methods\nWe searched CENTRAL and MEDLINE, conference proceedings and study registries on 14 February 2019 for randomised controlled trials (RCTs) comparing multiple drug combinations of V, R and T for adults with newly diagnosed transplant-ineligible multiple myeloma.\nSelection criteria\nWe included RCTs comparing combination therapies of V, R, and T, plus melphalan and prednisone (MP) or dexamethasone (D) for first-line treatment of adults with transplant-ineligible multiple myeloma. We excluded trials including adults with relapsed or refractory disease, trials comparing drug therapies to other types of therapy and trials including second-generation novel agents.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias of included trials. As effect measures we used hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) and risk ratios (RRs) for adverse events. An HR or RR < 1 indicates an advantage for the intervention compared to the main comparator MP. Where available, we extracted quality of life (QoL) data (scores of standardised questionnaires). Results quoted are from network meta-analysis (NMA) unless stated.\nMain results\nWe included 25 studies (148 references) comprising 11,403 participants and 21 treatment regimens. Treatments were differentiated between restricted treatment duration (treatment with a pre-specified amount of cycles) and continuous therapy (treatment administered until disease progression, the person becomes intolerant to the drug, or treatment given for a prolonged period). Continuous therapies are indicated with a \"c\". Risk of bias was generally high across studies due to the open-label study design.\nOverall survival (OS)\nEvidence suggests that treatment with RD (HR 0.63 (95% confidence interval (CI) 0.40 to 0.99), median OS 55.2 months (35.2 to 87.0)); TMP (HR 0.75 (95% CI 0.58 to 0.97), median OS: 46.4 months (35.9 to 60.0)); and VRDc (HR 0.49 (95% CI 0.26 to 0.92), median OS 71.0 months (37.8 to 133.8)) probably increases survival compared to median reported OS of 34.8 months with MP (moderate certainty). Treatment with VMP may result in a large increase in OS, compared to MP (HR 0.70 (95% CI 0.45 to 1.07), median OS 49.7 months (32.5 to 77.3)), low certainty).\nProgression-free survival (PFS)\nTreatment withRD (HR 0.65 (95% CI0.44 to 0.96), median PFS: 24.9 months (16.9 to 36.8)); TMP (HR 0.63 (95% CI 0.50 to 0.78), median PFS:25.7 months (20.8 to 32.4)); VMP (HR 0.56 (95% CI 0.35 to 0.90), median PFS: 28.9 months (18.0 to 46.3)); and VRDc (HR 0.34 (95% CI 0.20 to 0.58), median PFS: 47.6 months (27.9 to 81.0)) may result in a large increase in PFS (low certainty) compared to MP (median reported PFS: 16.2 months).\nAdverse events\nThe risk of polyneuropathies may be lower with RD compared to treatment with MP (RR 0.57 (95% CI 0.16 to 1.99), risk for RD: 0.5% (0.1 to 1.8), mean reported risk for MP: 0.9% (10 of 1074 patients affected), low certainty). However, the CIs are also compatible with no difference or an increase in neuropathies. Treatment with TMP (RR 4.44 (95% CI1.77 to 11.11), risk: 4.0% (1.6 to 10.0)) and VMP (RR 88.22 (95% CI 5.36 to 1451.11), risk: 79.4% (4.8 to 1306.0)) probably results in a large increase in polyneuropathies compared to MP (moderate certainty). No study reported the amount of participants with grade ≥ 3 polyneuropathies for treatment with VRDc.\nVMP probably increases the proportion of participants with serious adverse events (SAEs) compared to MP (RR 1.28 (95% CI 1.06 to 1.54), risk for VMP: 46.2% (38.3 to 55.6), mean risk for MP: 36.1% (177 of 490 patients affected), moderate certainty). RD, TMP, and VRDc were not connected to MP in the network and the risk of SAEs could not be compared.\nTreatment with RD (RR 4.18 (95% CI 2.13 to 8.20), NMA-risk: 38.5% (19.6 to 75.4)); and TMP (RR 4.10 (95% CI 2.40 to 7.01), risk: 37.7% (22.1 to 64.5)) results in a large increase of withdrawals from the trial due to adverse events (high certainty) compared to MP (mean reported risk: 9.2% (77 of 837 patients withdrew)). The risk is probably slightly increased with VMP (RR 1.06 (95% CI 0.63 to 1.81), risk: 9.75% (5.8 to 16.7), moderate certainty), while it is much increased with VRDc (RR 8.92 (95% CI 3.82 to 20.84), risk: 82.1% (35.1 to 191.7), high certainty) compared to MP.\nQuality of life\nQoL was reported in four studies for seven different treatment regimens (MP, MPc, RD, RMP, RMPc, TMP, TMPc) and was measured with four different tools. Assessment and reporting differed between studies and could not be meta-analysed. However, all studies reported an improvement of QoL after initiation of anti-myeloma treatment for all assessed treatment regimens.\nAuthors' conclusions\nBased on our four pre-selected comparisons of interest, continuous treatment with VRD had the largest survival benefit compared with MP, while RD and TMP also probably considerably increase survival. However, treatment combinations of V, R, and T also substantially increase the incidence of AEs, and lead to a higher risk of treatment discontinuation. Their effectiveness and safety profiles may best be analysed in further randomised head-to-head trials. Further trials should focus on consistent reporting of safety outcomes and should use a standardised instrument to evaluate QoL to ensure comparability of treatment-combinations.\n\nGiven the provided abstract, please respond to the following query: \"RD\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "RDdecreases the risk of developing a polyneuropathy, compared to MP. The estimated risk of polyneuropathies withRDwas 0.5%. Treatment withTMPandVMPprobably increases the risk of experiencing polyneuropathies compared to MP (moderate certainty). The estimated risk withTMPwas 4.0%, and withVMP79.4%. NoVRDctreatment study reported the number of participants with severe polyneuropathies."
}
]
|
query-laysum | 5857 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm infants and neonates with respiratory conditions commonly require intubation and conventional mechanical ventilation (CMV) to maintain airway patency and support their respiration. Whilst this therapy is often lifesaving, it simultaneously carries the risk of lung injury. The use of lung recruitment manoeuvres (LRMs) has been found to reduce the incidence of lung injury, and improve oxygenation and lung compliance in ventilated adults. However, evidence pertaining to their use in neonates is limited, and there is no consensus of opinion as to whether LRMs are appropriate or effective in this population.\nObjectives\nTo determine the effects of LRMs on mortality and respiratory outcomes in mechanically ventilated neonates, when compared to no recruitment (routine care).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to 13 April 2020), and CINAHL via EBSCOhost (1989 to 13 April 2020). We also handsearched the reference lists of retrieved studies to source additional articles.\nSelection criteria\nWe included randomised controlled trials (RCTs), quasi-RCTs and randomised cross-over studies that compared the effect of LRMs to no recruitment (routine care) in mechanically ventilated neonates.\nData collection and analysis\nTwo review authors independently assessed trial eligibility, extracted data and evaluated risk of bias in the included studies. When studies were sufficiently similar, we performed a meta-analysis using mean difference (MD) for continuous data and risk ratio (RR) for dichotomous data, with their respective 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of the evidence for key (clinically important) outcomes.\nMain results\nWe included four studies (152 participants in total) in this review. Three of these studies, enrolling 56 participants, contributed data to our prespecified outcomes.\nTwo studies enrolling 44 participants on CMV for respiratory distress syndrome compared a stepwise LRM with positive end-expiratory pressure (PEEP) to routine care. Meta-analysis demonstrated no evidence of a difference between the LRM and routine care on mortality by hospital discharge (RR 1.00, 95% CI 0.17 to 5.77; low-certainty evidence), incidence of bronchopulmonary dysplasia (RR 0.25, 95% CI 0.03 to 2.07; low-certainty evidence), duration of supplemental oxygen (MD -7.52 days, 95% CI -20.83 to 5.78; very low-certainty evidence), and duration of ventilatory support (MD -3.59 days, 95% CI -12.97 to 5.79; very low-certainty evidence). The certainty of the evidence for these outcomes was downgraded due to risk of bias, imprecision, and inconsistency. Whilst these studies contributed data to four of our primary outcomes, we were unable to identify any studies that reported our other primary outcomes: duration of continuous positive airway pressure therapy, duration of neonatal intensive care unit stay, and duration of hospital stay.\nThe third study that contributed data to the review enrolled 12 participants on CMV for respiratory and non-respiratory causes, and compared two different LRMs applied after endotracheal tube suctioning to routine care. It was determined that both LRMs may slightly improve end-expiratory lung volume at 120 minutes' post-suctioning, when compared to routine care (incremental PEEP LRM versus routine care: MD -0.21, 95% CI -0.37 to -0.06; double PEEP LRM versus routine care: MD -0.18, 95% CI -0.35 to -0.02). It was also demonstrated that a double PEEP LRM may slightly reduce mean arterial pressure at 30 minutes' post-suctioning, when compared with routine care (MD -16.00, 95% CI -29.35 to -2.65).\nAuthors' conclusions\nThere is insufficient evidence to guide the use of LRMs in mechanically ventilated neonates. Well-designed randomised trials with larger sample sizes are needed to further evaluate the potential benefits and risks of LRM application in this population.\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 mechanically ventilated neonates, do lung recruitment manoeuvres (LRMs) help to reduce mortality and respiratory morbidity, compared to no recruitment?"
}
]
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query-laysum | 5858 | [
{
"role": "user",
"content": "Abstract: Background\nChoroidal neovascularisation (CNV) is a common complication of pathological myopia. Once developed, most eyes with myopic CNV (mCNV) experience a progression to macular atrophy, which leads to irreversible vision loss. Anti-vascular endothelial growth factor (anti-VEGF) therapy is used to treat diseases characterised by neovascularisation and is increasingly used to treat mCNV.\nObjectives\nTo assess the effects of anti-vascular endothelial growth factor (anti-VEGF) therapy for choroidal neovascularisation (CNV), compared with other treatments, sham treatment or no treatment, in people with pathological myopia.\nSearch methods\nWe searched a number of electronic databases including CENTRAL and Ovid MEDLINE, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform ICTRP). We did not use any date or language restrictions in the electronic searches for trials. Electronic databases were last searched on 16 June 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing anti-VEGF therapy with another treatment (e.g. photodynamic therapy (PDT) with verteporfin, laser photocoagulation, macular surgery, another anti-VEGF), sham treatment or no treatment in participants with mCNV.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two authors independently screened records, extracted data, and assessed risk of bias. We contacted trial authors for additional data. We analysed outcomes as risk ratios (RRs) or mean differences (MDs). We graded the certainty of the evidence using GRADE.\nMain results\nThe present review included six studies which provided data on the comparison between anti-VEGF with PDT, laser, sham treatment and another anti-VEGF treatment, with 594 participants with mCNV. Three trials compared bevacizumab or ranibizumab with PDT, one trial compared bevacizumab with laser, one trial compared aflibercept with sham treatment, and two trials compared bevacizumab with ranibizumab. Pharmaceutical companies conducted two trials. The trials were conducted at multiple clinical centres across three continents (Europe, Asia and North America). In all these six trials, one eye for each participant was included in the study.\nWhen compared with PDT, people treated with anti-VEGF agents (ranibizumab (one RCT), bevacizumab (two RCTs)), were more likely to regain vision. At one year of follow-up, the mean visual acuity (VA) in participants treated with anti-VEGFs was -0.14 logMAR better, equivalent of seven Early Treatment Diabetic Retinopathy Study (ETDRS) letters, compared with people treated with PDT (95% confidence interval (CI) -0.20 to -0.08, 3 RCTs, 263 people, low-certainty evidence). The RR for proportion of participants gaining 3+ lines of VA was 1.86 (95% CI 1.27 to 2.73, 2 RCTs, 226 people, moderate-certainty evidence). At two years, the mean VA in people treated with anti-VEGFs was -0.26 logMAR better, equivalent of 13 ETDRS letters, compared with people treated with PDT (95% CI -0.38 to -0.14, 2 RCTs, 92 people, low-certainty evidence). The RR for proportion of people gaining 3+ lines of VA at two years was 3.43 (95% CI 1.37 to 8.56, 2 RCTs, 92 people, low-certainty evidence). People treated with anti-VEGFs showed no obvious reduction (improvement) in central retinal thickness at one year compared with people treated with PDT (MD -17.84 μm, 95% CI -41.98 to 6.30, 2 RCTs, 226 people, moderate-certainty evidence). There was low-certainty evidence that people treated with anti-VEGF were more likely to have CNV angiographic closure at 1 year (RR 1.24, 95% CI 0.99 to 1.54, 2 RCTs, 208 people). One study allowed ranibizumab treatment as of month 3 in participants randomised to PDT, which may have led to an underestimate of the benefits of anti-VEGF treatment.\nWhen compared with laser photocoagulation, there was more improvement in VA among bevacizumab-treated people than among laser-treated people after one year (MD -0.22 logMAR, equivalent of 11 ETDRS letters, 95% CI -0.43 to -0.01, 1 RCT, 36 people, low-certainty evidence) and after two years (MD -0.29 logMAR, equivalent of 14 ETDRS letters, 95% CI -0.50 to -0.08, 1 RCT, 36 people, low-certainty evidence).\nWhen compared with sham treatment, people treated with aflibercept had better vision at one year (MD -0.19 logMAR, equivalent of 9 ETDRS letters, 95% CI -0.27 to -0.12, 1 RCT, 121 people, moderate-certainty evidence). The fact that this study allowed for aflibercept treatment at 6 months in the control group might cause an underestimation of the benefit with anti-VEGF.\nPeople treated with ranibizumab had similar improvement in VA recovery compared with people treated with bevacizumab after one year (MD -0.02 logMAR, equivalent of 1 ETDRS letter, 95% CI -0.11 to 0.06, 2 RCTs, 80 people, moderate-certainty evidence).\nOf the included six studies, two studies reported no adverse events in either group and two industry-sponsored studies reported both systemic and ocular adverse events. In the control group, there were no systemic or ocular adverse events reported in 149 participants. Fifteen people reported systemic serious adverse events among 359 people treated with anti-VEGF agents (15/359, 4.2%). Five people reported ocular adverse events among 359 people treated with anti-VEGF agents (5/359, 1.4%). The number of adverse events was low, and the estimate of RR was uncertain regarding systemic serious adverse events (4 RCTs, 15 events in 508 people, RR 4.50, 95% CI 0.60 to 33.99, very low-certainty evidence) and serious ocular adverse events (4 RCTs, 5 events in 508 people, RR 1.82, 95% CI 0.23 to 14.71, very low-certainty evidence). There were no reports of mortality or cases of endophthalmitis or retinal detachment.\nThere was sparse reporting of data for vision-related quality of life (in favour of anti-VEGF) in only one trial at one year of follow-up. The studies did not report data for other outcomes, such as percentage of participants with newly developed chorioretinal atrophy.\nAuthors' conclusions\nThere is low to moderate-certainty evidence from RCTs for the efficacy of anti-VEGF agents to treat mCNV at one year and two years. Moderate-certainty evidence suggests ranibizumab and bevacizumab are equivalent in terms of efficacy. Adverse effects occurred rarely and the trials included here were underpowered to assess these. Future research should be focused on the efficacy and safety of different drugs and treatment regimens, the efficacy on different location of mCNV, as well as the effects on practice in the real world.\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 Cochrane researchers found six relevant studies. These studies took place in multiple clinical centres across three continents (Europe, Asia and North America), Three studies compared anti-VEGF treatment with photodynamic therapy (PDT; a treatment with a light-sensitive medicine and a light source that destroys abnormal cells); one study compared anti-VEGF with laser treatment; one study compared anti-VEGF with no treatment; and two studies compared different types of anti-VEGF to each other. In some of the studies, the comparison group received anti-VEGF after a short period which may mean that the results underestimate the beneficial effect of anti-VEGF.\nThe results of the review show that:\n• People with severe myopia who have anti-VEGF treatment probably achieve better vision than people receiving PDT, laser or no treatment (moderate- and low-certainty evidence).\n• Two different types of anti-VEGF - ranibizumab and bevacizumab - probably have similar effects on vision (moderate-certainty evidence).\n• Side effects (harms) occur rarely."
}
]
|
query-laysum | 5859 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal abstinence syndrome (NAS) due to opioid withdrawal may result in disruption of the mother–infant relationship, sleep–wake abnormalities, feeding difficulties, weight loss, seizures and neurodevelopmental problems.\nObjectives\nTo assess the effectiveness and safety of using a sedative versus control (placebo, usual treatment or non-pharmacological treatment) for NAS due to withdrawal from opioids and determine which type of sedative is most effective and safe for NAS due to withdrawal from opioids.\nSearch methods\nWe ran an updated search on 17 September 2020 in CENTRAL via CRS Web and MEDLINE via Ovid. We searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included trials enrolling infants with NAS born to mothers with an opioid dependence with more than 80% follow-up and using randomised, quasi-randomised and cluster-randomised allocation to sedative or control.\nData collection and analysis\nThree review authors assessed trial eligibility and risk of bias, and independently extracted data. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 10 trials (581 infants) with NAS secondary to maternal opioid use in pregnancy. There were multiple comparisons of different sedatives and regimens. There were limited data available for use in sensitivity analysis of studies at low risk of bias.\nPhenobarbital versus supportive care: one study reported there may be little or no difference in treatment failure with phenobarbital and supportive care versus supportive care alone (risk ratio (RR) 2.73, 95% confidence interval (CI) 0.94 to 7.94; 62 participants; very low-certainty evidence). No infant had a clinical seizure. The study did not report mortality, neurodevelopmental disability and adverse events. There may be an increase in days' hospitalisation and treatment from use of phenobarbital (hospitalisation: mean difference (MD) 20.80, 95% CI 13.64 to 27.96; treatment: MD 17.90, 95% CI 11.98 to 23.82; both 62 participants; very low-certainty evidence).\nPhenobarbital versus diazepam: there may be a reduction in treatment failure with phenobarbital versus diazepam (RR 0.39, 95% CI 0.24 to 0.62; 139 participants; 2 studies; low-certainty evidence). The studies did not report mortality, neurodevelopmental disability and adverse events. One study reported there may be little or no difference in days' hospitalisation and treatment (hospitalisation: MD 3.89, 95% CI –1.20 to 8.98; 32 participants; treatment: MD 4.30, 95% CI –0.73 to 9.33; 31 participants; both low-certainty evidence).\nPhenobarbital versus chlorpromazine: there may be a reduction in treatment failure with phenobarbital versus chlorpromazine (RR 0.55, 95% CI 0.33 to 0.92; 138 participants; 2 studies; very low-certainty evidence), and no infant had a seizure. The studies did not report mortality and neurodevelopmental disability. One study reported there may be little or no difference in days' hospitalisation (MD 7.00, 95% CI –3.51 to 17.51; 87 participants; low-certainty evidence) and 0/100 infants had an adverse event.\nPhenobarbital and opioid versus opioid alone: one study reported no infants with treatment failure and no clinical seizures in either group (low-certainty evidence). The study did not report mortality, neurodevelopmental disability and adverse events. One study reported there may be a reduction in days' hospitalisation for infants treated with phenobarbital and opioid (MD –43.50, 95% CI –59.18 to –27.82; 20 participants; low-certainty evidence).\nClonidine and opioid versus opioid alone: one study reported there may be little or no difference in treatment failure with clonidine and dilute tincture of opium (DTO) versus DTO alone (RR 0.09, 95% CI 0.01 to 1.59; 80 participants; very low-certainty evidence). All five infants with treatment failure were in the DTO group. There may be little or no difference in seizures (RR 0.14, 95% CI 0.01 to 2.68; 80 participants; very low-certainty evidence). All three infants with seizures were in the DTO group. There may be little or no difference in mortality after discharge (RR 7.00, 95% CI 0.37 to 131.28; 80 participants; very low-certainty evidence). All three deaths were in the clonidine and DTO group. The study did not report neurodevelopmental disability. There may be little or no difference in days' treatment (MD –4.00, 95% CI –8.33 to 0.33; 80 participants; very low-certainty evidence). One adverse event occurred in the clonidine and DTO group. There may be little or no difference in rebound NAS after stopping treatment, although all seven cases were in the clonidine and DTO group.\nClonidine and opioid versus phenobarbital and opioid: there may be little or no difference in treatment failure (RR 2.27, 95% CI 0.98 to 5.25; 2 studies, 93 participants; very low-certainty evidence). One study reported one infant in the clonidine and morphine group had a seizure, and there were no infant mortalities. The studies did not report neurodevelopmental disability. There may be an increase in days' hospitalisation and days' treatment with clonidine and opioid versus phenobarbital and opioid(hospitalisation: MD 7.13, 95% CI 6.38 to 7.88; treatment: MD 7.57, 95% CI 3.97 to 11.17; both 2 studies, 91 participants; low-certainty evidence). There may be little or no difference in adverse events (RR 1.55, 95% CI 0.44 to 5.40; 2 studies, 93 participants; very low-certainty evidence). However, there was oversedation only in the phenobarbital and morphine group; and hypotension, rebound hypertension and rebound NAS only in the clonidine and morphine group.\nAuthors' conclusions\nThere is very low-certainty evidence that phenobarbital increases duration of hospitalisation and treatment, but reduces days to regain birthweight and duration of supportive care each day compared to supportive care alone. There is low-certainty evidence that phenobarbital reduces treatment failure compared to diazepam and very low-certainty evidence that phenobarbital reduces treatment failure compared to chlorpromazine. There is low-certainty evidence of an increase in days' hospitalisation and days' treatment with clonidine and opioid compared to phenobarbital and opioid. There are insufficient data to determine the safety and incidence of adverse events for infants treated with combinations of opioids and sedatives including phenobarbital and clonidine.\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 search was up-to-date to September 2020."
}
]
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query-laysum | 5860 | [
{
"role": "user",
"content": "Abstract: Background\nEpiretinal membrane is an abnormal sheet of avascular fibrocellular tissue that develops on the inner surface of the retina. Epiretinal membrane can cause impairment of sight as a consequence of progressive distortion of retinal architecture.\nObjectives\nTo determine the effects of surgery compared to no intervention for epiretinal membrane.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, ISRCTN registry, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). There were no restrictions to language or year of publication. The databases were last searched on 20 May 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) assessing surgical removal of idiopathic epiretinal membrane compared to placebo, no treatment or sham treatment. Paired or within-person studies were included, as well as those where both eyes of a single participant were treated.\nData collection and analysis\nWe used standard methods expected by Cochrane, and assessed certainty using the GRADE system. We considered the following five outcome measures: mean change in best corrected visual acuity (BCVA) in the study eye between baseline (before randomisation), 6 months and 12 months later; proportion of people with a gain of 0.3 logMAR or more of visual acuity in the study eye as measured by a logMAR chart at a starting distance of 4 m at 6 months and 12 months after randomisation; proportion of people with a loss of 0.3 logMAR or more of visual acuity in the study eye as measured by a logMAR chart at a starting distance of 4 m at 6 months and 12 months after randomisation; mean quality of life score at 6 months and 12 months following surgery, measured using a validated questionnaire; and any harm identified during follow-up.\nMain results\nWe included one study in the review. This was a RCT including 53 eyes of 53 participants with mild symptomatic epiretinal membrane and BCVA of 65 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Participants were randomly allocated to immediate surgery or to watchful waiting with deferred surgery if indicated by evidence of disease progression. The study was limited by imprecision owing to the small number of participants and was at some risk of bias owing to inconsistencies in the time points for outcome assessment and in the management of lens opacity.\nAt 12 months, the visual acuity in the immediate surgery group was higher by a mean of 2.1 (95% confidence interval (CI) -2.0 to 6.2 ETDRS letters; 53 participants; low-certainty evidence) than the watchful waiting/deferred surgery group.\nThe evidence of the effect of immediate surgery on gains of 0.3 logMAR or more of visual acuity is very uncertain (risk ratio (RR) 0.55, 95% CI 0.06 to 4.93; 53 participants; very low-certainty evidence).\nAt 12 months, no participant in either group sustained a loss of 0.3 logMAR or more of visual acuity (53 participants; low-certainty evidence).\nThe included study did not measure quality of life.\nAt 12 months, no serious adverse event was identified in any participant. One participant developed chronic minimal cystoid macular oedema following immediate surgery (53 participants; low-certainty evidence).\nAuthors' conclusions\nWe found no RCT that directly investigated the effect of surgery compared to no intervention. For severe disabling epiretinal membrane, the lack of a RCT comparing surgery to no intervention may reflect evidence from non-randomised studies in favour of surgery; a RCT may be considered unnecessary and ethically unacceptable because a superior effect of surgery is widely accepted. For mild symptomatic epiretinal membrane, however, the value of surgery is uncertain. Low-certainty evidence from this review suggests that watchful waiting or deferred surgery may offer outcomes as favourable as immediate surgery. However, this finding needs to be confirmed in further RCTs with appropriate statistical power, masking of treatment allocation, consistent management of cataract, and measurement of outcomes including patient-reported quality of life over a more extended time frame.\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": "An epiretinal membrane is an abnormal layer of tissue that develops at the back of the eye. It affects around one in five people aged 75 years and older. In most people, the development of an epiretinal membrane is linked to the normal ageing processes in the eye and is described as 'idiopathic'. In other instances, epiretinal membrane is caused by a pre-existing condition affecting the retina, such as inflammation or poor circluation. Epiretinal membrane can also develop after eye surgery.\nEpiretinal membrane typically forms over the part of the eye responsible for seeing fine detail (the macula). In some people, this does not affect vision. In others, it causes distorted or blurred vision, which can affect people’s quality of life. For example, an epiretinal membrane may impair people’s ability to read or drive.\nIf an epiretinal membrane affects vision, it is commonly removed by surgery. A local anaesthetic (medication) is used to numb the eye area. As with any procedure, this surgery carries risks of harm from side effects. These include potential problems such as cataract, detached retina, infection and bleeding in the eye.\nTo understand when the benefits of surgery outweigh its risks, we reviewed the research evidence."
}
]
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