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query-laysum | 3238 | [
{
"role": "user",
"content": "Abstract: Background\nThe number of people living with dementia is increasing rapidly. Clinical dementia does not develop suddenly, but rather is preceded by a period of cognitive decline beyond normal age-related change. People at this intermediate stage between normal cognitive function and clinical dementia are often described as having mild cognitive impairment (MCI). Considerable research and clinical efforts have been directed toward finding disease-modifying interventions that may prevent or delay progression from MCI to clinical dementia.\nObjectives\nTo evaluate the effects of at least 12 weeks of computerised cognitive training (CCT) on maintaining or improving cognitive function and preventing dementia in people with mild cognitive impairment.\nSearch methods\nWe searched to 31 May 2018 in ALOIS (www.medicine.ox.ac.uk/alois) and ran additional searches in MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, and the WHO portal/ICTRP (www.apps.who.int/trialsearch) to identify published, unpublished, and ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in which cognitive training via interactive computerised technology was compared with an active or inactive control intervention. Experimental computerised cognitive training (CCT) interventions had to adhere to the following criteria: minimum intervention duration of 12 weeks; any form of interactive computerised cognitive training, including computer exercises, computer games, mobile devices, gaming console, and virtual reality. Participants were adults with a diagnosis of mild cognitive impairment (MCI) or mild neurocognitive disorder (MND), or otherwise at high risk of cognitive decline.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias of the included RCTs. We expressed treatment effects as mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes and as risk ratios (RRs) for dichotomous outcomes. We used the GRADE approach to describe the overall quality of evidence for each outcome.\nMain results\nEight RCTs with a total of 660 participants met review inclusion criteria. Duration of the included trials varied from 12 weeks to 18 months. Only one trial used an inactive control. Most studies were at unclear or high risk of bias in several domains. Overall, our ability to draw conclusions was hampered by very low-quality evidence. Almost all results were very imprecise; there were also problems related to risk of bias, inconsistency between trials, and indirectness of the evidence.\nNo trial provided data on incident dementia. For comparisons of CCT with both active and inactive controls, the quality of evidence on our other primary outcome of global cognitive function immediately after the intervention period was very low. Therefore, we were unable to draw any conclusions about this outcome.\nDue to very low quality of evidence, we were also unable to determine whether there was any effect of CCT compared to active control on our secondary outcomes of episodic memory, working memory, executive function, depression, functional performance, and mortality. We found low-quality evidence suggesting that there is probably no effect on speed of processing (SMD 0.20, 95% confidence interval (CI) -0.16 to 0.56; 2 studies; 119 participants), verbal fluency (SMD -0.16, 95% CI -0.76 to 0.44; 3 studies; 150 participants), or quality of life (mean difference (MD) 0.40, 95% CI -1.85 to 2.65; 1 study; 19 participants).\nWhen CCT was compared with inactive control, we obtained data on five secondary outcomes, including episodic memory, executive function, verbal fluency, depression, and functional performance. We found very low-quality evidence; therefore, we were unable to draw any conclusions about these outcomes.\nAuthors' conclusions\nCurrently available evidence does not allow us to determine whether or not computerised cognitive training will prevent clinical dementia or improve or maintain cognitive function in those who already have evidence of cognitive impairment. Small numbers of trials, small samples, risk of bias, inconsistency between trials, and highly imprecise results mean that it is not possible to derive any implications for clinical practice, despite some observed large effect sizes from individual studies. Direct adverse events are unlikely to occur, although the time and sometimes the money involved in computerised cognitive training programmes may represent significant burdens. Further research is necessary and should concentrate on improving methodological rigour, selecting suitable outcomes measures, and assessing generalisability and persistence of any effects. Trials with long-term follow-up are needed to determine the potential of this intervention to reduce the risk of dementia.\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 eight trials with 660 participants to include in the review. Seven of the trials (623 participants) compared CCT to an alternative activity. None of the included trials examined development of dementia, so this review presents no evidence on whether taking part in computerised cognitive training will help to prevent dementia. Our main finding in relation to all of the other outcomes in which we were interested was that the overall quality of the evidence was very low. This very low quality was mainly due to small sample sizes, problems with study methods, and differences between trials. Therefore, although we found some evidence for a few benefits of CCT for cognition, we were highly uncertain about study results and consider it likely that future research might lead to different results."
}
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query-laysum | 3239 | [
{
"role": "user",
"content": "Abstract: Background\nRemote cognitive assessments are increasingly needed to assist in the detection of cognitive disorders, but the diagnostic accuracy of telephone- and video-based cognitive screening remains unclear.\nObjectives\nTo assess the test accuracy of any multidomain cognitive test delivered remotely for the diagnosis of any form of dementia.\nTo assess for potential differences in cognitive test scoring when using a remote platform, and where a remote screener was compared to the equivalent face-to-face test.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, LILACS, and ClinicalTrials.gov (www.clinicaltrials.gov/) databases on 2 June 2021. We performed forward and backward searching of included citations.\nSelection criteria\nWe included cross-sectional studies, where a remote, multidomain assessment was administered alongside a clinical diagnosis of dementia or equivalent face-to-face test.\nData collection and analysis\nTwo review authors independently assessed risk of bias and extracted data; a third review author moderated disagreements. Our primary analysis was the accuracy of remote assessments against a clinical diagnosis of dementia. Where data were available, we reported test accuracy as sensitivity and specificity. We did not perform quantitative meta-analysis as there were too few studies at individual test level.\nFor those studies comparing remote versus in-person use of an equivalent screening test, if data allowed, we described correlations, reliability, differences in scores and the proportion classified as having cognitive impairment for each test.\nMain results\nThe review contains 31 studies (19 differing tests, 3075 participants), of which seven studies (six telephone, one video call, 756 participants) were relevant to our primary objective of describing test accuracy against a clinical diagnosis of dementia. All studies were at unclear or high risk of bias in at least one domain, but were low risk in applicability to the review question. Overall, sensitivity of remote tools varied with values between 26% and 100%, and specificity between 65% and 100%, with no clearly superior test.\nAcross the 24 papers comparing equivalent remote and in-person tests (14 telephone, 10 video call), agreement between tests was good, but rarely perfect (correlation coefficient range: 0.48 to 0.98).\nAuthors' conclusions\nDespite the common and increasing use of remote cognitive assessment, supporting evidence on test accuracy is limited. Available data do not allow us to suggest a preferred test. Remote testing is complex, and this is reflected in the heterogeneity seen in tests used, their application, and their analysis. More research is needed to describe accuracy of contemporary approaches to remote cognitive assessment. While data comparing remote and in-person use of a test were reassuring, thresholds and scoring rules derived from in-person testing may not be applicable when the equivalent test is adapted for remote use.\n\nGiven the provided abstract, please respond to the following query: \"Who do the results of this study apply to?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most studies investigated older adults (over 65 years). The findings may not be representative of all older adults with dementia, as some studies only examined specific groups of people, for example, after stroke. The studies were usually performed in specialist centres by experts. So, we do not know how well these tests identify dementia in routine community practice."
}
]
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query-laysum | 3240 | [
{
"role": "user",
"content": "Abstract: Background\nThe pure soybean oil based lipid emulsions (S-LE) conventionally used for parenteral nutrition (PN) in preterm infants have high polyunsaturated fatty acid (PUFA) content. The newer lipid emulsions (LE) from alternative lipid sources with reduced PUFA content may improve clinical outcomes in preterm infants.\nObjectives\nTo determine the safety and efficacy of the newer alternative LE compared with the conventional S-LE for PN in preterm infants.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG) to search the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 7), MEDLINE (1946 to 31 July 2015), EMBASE (1947 to 31 July 2015), CINAHL (1982 to 31 July 2015), Web of Science (31 July 2015), conference proceedings, trial registries (clinicaltrials.gov, controlled-trials.com, WHO's ICTRP), and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled trials in preterm infants (< 37 weeks), comparing newer alternative LE with S-LE.\nData collection and analysis\nData collection and analysis conformed to the methods of the CNRG. We assessed the quality of evidence for important outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, in addition to reporting the conventional statistical significance of results.\nMain results\nFifteen studies (N = 979 infants) are included in this review. Alternative LE including medium chain triglycerides/long chain triglycerides (MCT/LCT) LE (3 studies; n = 108), MCT-olive-fish-soy oil-LE (MOFS-LE; 7 studies; n = 469), MCT-fish-soy oil-LE (MFS-LE; 1 study; n = 60), olive-soy oil-LE (OS-LE; 7 studies; n = 406), and borage-soy oil-LE (BS-LE; 1 study; n = 34) were compared with S-LE. The different LE were also considered together to compare ‘all fish oil containing-LE’ versus S-LE (7 studies; n = 499) and ‘all alternative LE’ versus S-LE (15 studies; n = 979). Some studies had multiple intervention arms and were included in more than one comparison. No study compared pure fish oil-LE or structured-LE to S-LE.\nThe GRADE quality of evidence (GRADE QoE) ranged from ‘low’ to ‘very low.’ Evidence came mostly from small single centre studies, many focusing on biochemical aspects as their primary outcomes, with optimal information size not achieved for the important clinical outcomes in any comparison.\nIn the primary outcomes of the review there was a pooled effect towards decreased bronchopulmonary dysplasia (BPD) in OS-LE vs S-LE (4 studies, n = 261) not reaching statistical significance (typical risk ratio (RR) 0.69, 95% confidence interval (CI) 0.46 to 1.04, I² = 32%; typical risk difference (RD) -0.08, 95% CI -0.17 to 0.00, I² = 76%; GRADE QoE: ‘very low’). No difference in BPD was observed in any other comparison. There were no statistically significant differences in the primary outcomes of death, growth rate (g/kg/day) or days to regain birth weight in any comparison.\nRetinopathy of prematurity (ROP) stage 1-2 was reported to be statistically significantly lower in one single centre study (n = 80) in the MOFS-LE group compared with the S-LE group (1/40 vs 12/40, respectively; RR 0.08, 95% CI 0.01 to 0.61; RD -0.27, 95% CI -0.43 to -0.12; number needed to benefit (NNTB) 4, 95% CI 2 to 8). However there were no statistically significant differences in the secondary outcome of ROP ≥ stage 3 in any of the individual studies or in any comparison (GRADE QoE: ‘low’ to ‘very low’). No other study reported on ROP stages 1 and 2 separately.\nThere were no statistically significant differences in the secondary outcomes of sepsis, PN associated liver disease (PNALD)/cholestasis, ventilation duration, necrotising enterocolitis (NEC) ≥ stage 2, jaundice requiring treatment, intraventricular haemorrhage grade III-IV, periventricular leukomalacia (PVL), patent ductus arteriosus (PDA), hypertriglyceridaemia, and hyperglycaemia in any comparison.\nNo study reported on neurodevelopmental outcomes or essential fatty acid deficiency.\nAuthors' conclusions\nAll lipid emulsions in this review appeared to be safe and were well tolerated in preterm infants. Compared with the pure soy oil based LE, use of MOFS-LE was associated with a decrease in the early stages (1-2) of ROP in one study. However there were no statistically significant differences in clinically important outcomes including death, growth, BPD, sepsis, ROP ≥ stage 3, and PNALD with the use of newer alternative LE versus the conventional pure soy oil based LE (GRADE QoE ranged from ‘low’ to ‘very low’). Currently there is insufficient evidence to recommend any alternative LE over S-LE or vice versa in preterm infants.\nLarger randomised studies focusing on important clinical outcomes, targeting specific ‘at risk’ population subgroups (e.g. extreme prematurity, long term PN, etc), and exploring the effect of different proportions of lipid constituents are required to evaluate the effectiveness of newer lipid emulsions compared with the conventional pure soy based LE in preterm infants.\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": "Preterm infants who need nutrition through intravenous lines have been conventionally given pure soy oil based fat emulsions. High polyunsaturated fatty acid (PUFA) content in pure soy oil based emulsions can, however, be harmful to preterm infants. The newer lipid emulsions (LE) from alternative lipid sources with reduced PUFA content may improve clinical outcomes in preterm infants."
}
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query-laysum | 3241 | [
{
"role": "user",
"content": "Abstract: Background\nGastric cancer is the fifth most common cancer diagnosed worldwide. Due to improved early detection rates of gastric cancer and technological advances in treatments, a significant improvement in survival rates has been achieved in people with cancer undergoing gastrectomy. Subsequently, there has been increasing emphasis on postgastrectomy syndrome (e.g. fullness, delayed emptying, and cold sweat, amongst others) and quality of life postsurgery. However, it is uncertain which types of reconstruction result in better outcomes postsurgery.\nObjectives\nTo assess the evidence on health-related quality of life and safety outcomes of Roux-en-Y and Billroth-I reconstructions after distal gastrectomy for people with gastric cancer.\nSearch methods\nWe searched the Cochrane Library and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 4 May 2021. We checked the reference lists of the included studies and contacted manufacturers and professionals in the field. There were no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) allocating participants to Roux-en-Y reconstruction or Billroth-I reconstruction after distal gastrectomy for gastric cancer.\nData collection and analysis\nTwo review authors independently screened studies identified by the search for eligibility and extracted data. The primary outcomes were health-related quality of life after surgery and incidence of anastomotic leakage. The secondary outcomes included body weight loss, incidence of bile reflux, length of hospital stay, and overall morbidity. We used a random-effects model to conduct meta-analyses. We assessed risk of bias of the included studies in accordance with the Cochrane Handbook for Systematic Reviews of Interventions, and the certainty of the evidence using the GRADE approach.\nMain results\nWe included eight RCTs (942 participants) in the review. One study included both cancer patients and benign disease patients such as stomach ulcers. Two studies compared Roux-en-Y, Billroth-I, and Billroth-II reconstructions, whilst the other studies compared Roux-en-Y and Billroth-I directly.\nFor the primary outcomes, the evidence suggests that there may be little to no difference in health-related quality of life between Roux-en-Y and Billroth-I reconstruction (standardised mean difference 0.04, 95% confidence interval (CI) −0.11 to 0.18; I² = 0%; 6 studies; 695 participants; low-certainty evidence due to study limitations and imprecision). The evidence for the effect of Roux-en-Y versus Billroth-I reconstruction on the incidence of anastomotic leakage is very uncertain (risk ratio (RR) 0.63, 95% CI 0.16 to 2.53; I² = 0%; 5 studies; 711 participants; very low-certainty evidence). The incidence of anastomotic leakage was 0.6% and 1.4% in the Roux-en-Y and Billroth-I groups, respectively.\nFor the secondary outcomes, the evidence suggests that Billroth-I reconstruction may result in little to no difference in loss of body weight compared to Roux-en-Y reconstruction (mean difference (MD) 0.41, 95% CI −0.77 to 1.59; I² = 0%; 4 studies; 541 participants; low-certainty evidence). Roux-en-Y reconstruction probably reduces the incidence of bile reflux compared to Billroth-I reconstruction (RR 0.40, 95% CI 0.25 to 0.63; I² = 22%; 4 studies; 399 participants; moderate-certainty evidence). Billroth-I reconstruction may shorten postoperative hospital stay, but the evidence for this outcome is very uncertain (MD 0.96, 95% CI 0.16 to 1.76; I² = 56%; 7 studies; 894 participants; very low-certainty evidence). Billroth-I reconstruction may reduce postoperative overall morbidity compared to Roux-en-Y reconstruction (RR 1.47, 95% CI 1.02 to 2.11; I² = 0%; 7 studies; 891 participants; low-certainty evidence).\nAuthors' conclusions\nThe evidence suggests that there is little to no difference between Roux-en-Y and Billroth-I reconstruction for the outcome health-related quality of life. The evidence for the effect of Roux-en-Y versus Billroth-I reconstruction on the incidence of anastomotic leakage is very uncertain as the incidence of this outcome was low. Although the certainty of evidence was low, we found some possibly clinically meaningful differences between Roux-en-Y and Billroth-I reconstruction for short-term outcomes. Roux-en-Y reconstruction probably reduces the incidence of bile reflux into the remnant stomach compared to Billroth-I reconstruction. Billroth-I reconstruction may shorten postoperative hospital stay compared to Roux-en-Y reconstruction, but the evidence is very uncertain. Billroth-I reconstruction may reduce postoperative overall morbidity compared to Roux-en-Y reconstruction. Future trials should include long-term follow-up of health-related quality of life and body weight loss.\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 for the effect of Roux-en-Y compared to Billroth-I reconstruction after surgery for gastric cancer. We found eight studies."
}
]
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query-laysum | 3242 | [
{
"role": "user",
"content": "Abstract: Background\nRadiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness.\nObjectives\nThe objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results.\nSelection criteria\nWe included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions.\nData collection and analysis\nPairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.\nMain results\nIn total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur.\nAuthors' conclusions\nThe review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.\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": "Low back pain is a widespread problem that has major social and economic consequences. In all, 85% to 90% of low back pain cases are classified as 'non-specific'. Most patients with low back pain are treated successfully in primary care, but approximately 10% to 15% develop chronic symptoms (lasting longer than three months). Chronic low back pain can come from any part of the back that has a nerve supply capable of transmitting pain signals. These sources include discs, vertebrae, sacroiliac joints, facet joints, muscles, ligaments and other structures. Pain specialists try to identify the source of low back pain by using nerve blocks. They numb individual spinal nerves with anaesthetic injections to see if this leads to improvement in back symptoms. With substantial pain relief, they attempt to eliminate pain for a longer time by heating the spinal nerves with radiofrequency waves to ensure that the pain stimulus cannot be passed. This invasive procedure is called radiofrequency denervation. At this time, the effectiveness of this approach has not been proven."
}
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query-laysum | 3243 | [
{
"role": "user",
"content": "Abstract: Background\nOlder patients with multiple health problems (multi-morbidity) value being involved in decision-making about their health care. However, they are less frequently involved than younger patients. To maximise quality of life, day-to-day function, and patient safety, older patients require support to identify unmet healthcare needs and to prioritise treatment options.\nObjectives\nTo assess the effects of interventions for older patients with multi-morbidity aiming to involve them in decision-making about their health care during primary care consultations.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; all years to August 2018), in the Cochrane Library; MEDLINE (OvidSP) (1966 to August 2018); Embase (OvidSP) (1988 to August 2018); PsycINFO (OvidSP) (1806 to August 2018); the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (Ovid) (1982 to September 2008), then in Ebsco (2009 to August 2018); Centre for Reviews and Dissemination Databases (Database of Abstracts and Reviews of Effects (DARE)) (all years to August 2018); the Health Technology Assessment (HTA) Database (all years to August 2018); the Ongoing Reviews Database (all years to August 2018); and Dissertation Abstracts International (1861 to August 2018).\nSelection criteria\nWe sought randomised controlled trials (RCTs), cluster-RCTs, and quasi-RCTs of interventions to involve patients in decision-making about their health care versus usual care/control/another intervention, for patients aged 65 years and older with multi-morbidity in primary care.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Meta-analysis was not possible; therefore we prepared a narrative synthesis.\nMain results\nWe included three studies involving 1879 participants: two RCTs and one cluster-RCT. Interventions consisted of:\n· patient workshop and individual coaching using behaviour change techniques;\n· individual patient coaching utilising cognitive-behavioural therapy and motivational interviewing; and\n· holistic patient review, multi-disciplinary practitioner training, and organisational change.\nNo studies reported the primary outcome ‘patient involvement in decision-making’ or the primary adverse outcome ‘less patient involvement as a result of the intervention’.\nComparing interventions (patient workshop and individual coaching, holistic patient review plus practitioner training, and organisational change) to usual care: we are uncertain whether interventions had any effect on patient reports of high self-rated health (risk ratio (RR) 1.40, 95% confidence interval (CI) 0.36 to 5.49; very low-certainty evidence) or on patient enablement (mean difference (MD) 0.60, 95% CI -9.23 to 10.43; very low-certainty evidence) compared with usual care. Interventions probably had no effect on health-related quality of life (adjusted difference in means 0.00, 95% CI -0.02 to 0.02; moderate-certainty evidence) or on medication adherence (MD 0.06, 95% CI -0.05 to 0.17; moderate-certainty evidence) but probably improved the number of patients discussing their priorities (adjusted odds ratio 1.85, 95% CI 1.44 to 2.38; moderate-certainty evidence) and probably increased the number of nurse consultations (incident rate ratio from adjusted multi-level Poisson model 1.37, 95% CI 1.17 to 1.61; moderate-certainty evidence) compared with usual care. Practitioner outcomes were not measured. Interventions were not reported to adversely affect rates of participant death or anxiety, emergency department attendance, or hospital admission compared with usual care.\nComparing interventions (patient workshop and coaching, individual patient coaching) to attention-control conditions: we are uncertain whether interventions affect patient-reported high self-rated health (RR 0.38, 95% CI 0.15 to 1.00, favouring attention control, with very low-certainty evidence; RR 2.17, 95% CI 0.85 to 5.52, favouring the intervention, with very low-certainty evidence). We are uncertain whether interventions affect patient enablement and engagement by increasing either patient activation (MD 1.20, 95% CI -8.21 to 10.61; very low-certainty evidence) or self-efficacy (MD 0.29, 95% CI -0.21 to 0.79; very low-certainty evidence); or whether interventions affect the number of general practice visits (MD 0.51, 95% CI -0.34 to 1.36; very low-certainty evidence), compared to attention-control conditions. The intervention may however lead to more patient-reported changes in management of their health conditions (RR 1.82, 95% CI 1.35 to 2.44; low-certainty evidence). Practitioner outcomes were not measured. Interventions were not reported to adversely affect emergency department attendance nor hospital admission when compared with attention control.\nComparing one form of intervention with another: not measured.\nThere was 'unclear' risk across studies for performance bias, detection bias, and reporting bias; however, no aspects were 'high' risk. Evidence was downgraded via GRADE, most often because of 'small sample size' and 'evidence from a single study'.\nAuthors' conclusions\nLimited available evidence does not allow a robust conclusion regarding the objectives of this review. Whilst patient involvement in decision-making is seen as a key mechanism for improving care, it is rarely examined as an intervention and was not measured by included studies. Consistency in design, analysis, and evaluation of interventions would enable a greater likelihood of robust conclusions in future reviews.\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 research published up until August 2018. We found three relevant studies involving 1879 participants. These studies were reported from three countries. Participants were over 65 years of age with three or more long-term health problems on average. Interventions investigated included:\n· patient workshops and individual patient coaching;\n· patient coaching including cognitive-behavioural therapy; and\n· whole-person patient review, practitioner training, and organisational changes.\nAll studies were funded by national research bodies."
}
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query-laysum | 3244 | [
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic disease of the gut. About 75% of people with CD undergo surgery at least once in their lifetime to induce remission. However, as there is no known cure for the disease, patients usually experience a recurrence even after surgery. Different interventions are routinely used in maintaining postsurgical remission. There is currently no consensus on which treatment is the most effective.\nObjectives\nTo assess the effects and harms of interventions for the maintenance of surgically induced remission in Crohn's disease and rank the treatments in order of effectiveness.\nSearch methods\nWe searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, and Embase from inception to 15 January 2019. We also searched reference lists of relevant articles, abstracts from major gastroenterology meetings, ClinicalTrials.gov, and the WHO ICTRP. There was no restriction on language, date, or publication status.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) that compared different interventions used for maintaining surgically induced remission in people with CD who were in postsurgical remission. Participants had to have received maintenance treatment for at least three months. We excluded studies assessing enteral diet, diet manipulation, herbal medicine, and nutritional supplementation.\nData collection and analysis\nTwo review authors independently selected relevant studies, extracted data, and assessed the risk of bias. Any disagreements were resolved by discussion or by arbitration of a third review author when necessary. We conducted a network meta-analysis (NMA) using a Bayesian approach through Markov Chain Monte Carlo (MCMC) simulation. For the pairwise comparisons carried out in Review Manager 5, we calculated risk ratios (RR) with their corresponding 95% confidence intervals (95% CI). For the NMA, we presented hazard ratios (HR) with corresponding 95% credible intervals (95% CrI) and reported ranking probabilities for each intervention. For the NMA, we focused on three main outcomes: clinical relapse, endoscopic relapse, and withdrawals due to adverse events. Data were insufficient to assess time to relapse and histologic relapse. Adverse events and serious adverse events were not sufficiently or objectively reported to permit an NMA. We used CINeMA (Confidence in Network Meta-Analysis) methods to evaluate our confidence in the findings within networks, and GRADE for entire networks.\nMain results\nWe included 35 RCTs (3249 participants) in the review. The average age of study participants ranged between 33.6 and 38.8 years. Risk of bias was high in 18 studies, low in four studies, and unclear in 13 studies. Of the 35 included RCTs, 26 studies (2581 participants; 9 interventions) were considered eligible for inclusion in the NMA. The interventions studied included 5-aminosalicylic acid (5-ASA), adalimumab, antibiotics, budesonide, infliximab, probiotics, purine analogues, sulfasalazine, and a combination of sulfasalazine and prednisolone. This resulted in 30 direct contrasts, which informed 102 mixed-treatment contrasts.\nThe evidence for the clinical relapse network (21 studies; 2245 participants) and endoscopic relapse (12 studies; 1128 participants) were of low certainty while the evidence for withdrawal due to adverse events (15 studies; 1498 participants) was of very low certainty. This assessment was due to high risk of bias in most of the studies, inconsistency, and imprecision across networks. We mainly judged individual contrasts as of low or very low certainty, except 5-ASA versus placebo, the evidence for which was judged as of moderate certainty.\nWe ranked the treatments based on effectiveness and the certainty of the evidence. For clinical relapse, the five most highly ranked treatments were adalimumab, infliximab, budesonide, 5-ASA, and purine analogues. We found some evidence that adalimumab (HR 0.11, 95% Crl 0.02 to 0.33; low-certainty evidence) and 5-ASA may reduce the probability of clinical relapse compared to placebo (HR 0.69, 95% Crl 0.53 to 0.87; moderate-certainty evidence). However, budesonide may not be effective in preventing clinical relapse (HR 0.66, 95% CrI 0.27 to 1.34; low-certainty evidence). We are less confident about the effectiveness of infliximab (HR 0.36, 95% CrI 0.02 to 1.74; very low-certainty evidence) and purine analogues (HR 0.75, 95% CrI 0.55 to 1.00; low-certainty evidence). It was unclear whether the other interventions reduced the probability of a clinical relapse, as the certainty of the evidence was very low.\nDue to high risk of bias and limited data across the network, we are uncertain about the effectiveness of interventions for preventing endoscopic relapse. Whilst there might be some evidence of prevention of endoscopic relapse with adalimumab (HR 0.10, 95% CrI 0.01 to 0.32; low-certainty evidence), no other intervention studied appeared to be effective.\nDue to high risk of bias and limited data across the network, we are uncertain about the effectiveness of interventions for preventing withdrawal due to adverse events. Withdrawal due to adverse events appeared to be least likely with sulfasalazine (HR 1.96, 95% Crl 0.00 to 8.90; very low-certainty evidence) and most likely with antibiotics (HR 53.92, 95% Crl 0.43 to 259.80; very low-certainty evidence). When considering the network as a whole, two adverse events leading to study withdrawal (i.e. pancreatitis and leukopenia) occurred in more than 1% of participants treated with an intervention. Pancreatitis occurred in 2.8% (11/399) of purine analogue participants compared to 0.17% (2/1210) of all other groups studied. Leukopenia occurred in 2.5% (10/399) of purine analogue participants compared to 0.08% (1/1210) of all other groups studied.\nAuthors' conclusions\nDue to low-certainty evidence in the networks, we are unable to draw conclusions on which treatment is most effective for preventing clinical relapse and endoscopic relapse. Evidence on the safety of the interventions was inconclusive, however cases of pancreatitis and leukopenia from purine analogues were evident in the studies. Larger trials are needed to further understand the effect of the interventions on endoscopic relapse.\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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"content": "Crohn's disease is a chronic disease of the gut. It is known to change from periods when people experience a flare-up of the disease (relapse) to periods of good health (remission). Symptoms include abdominal pain, diarrhoea and weight loss. People with Crohn's disease may undergo surgery to remove diseased parts of their gut and achieve remission. However, their symptoms return after a while. Different drugs can be given to ensure that people with Crohn's disease remain in remission for as long as possible. These drugs include mesalazine, antibiotics, corticosteroids, and adalimumab, amongst others. Whilst these drugs have been known to reduce inflammation (pain and swelling) in the gut, side effects can occur with their use. We attempted to find out which treatments are the safest and most effective for maintaining remission in people with Crohn's disease after surgery."
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"role": "user",
"content": "Abstract: Background\nEmotional and behavioural problems in children are common. Research suggests that parenting has an important role to play in helping children to become well-adjusted, and that the first few months and years are especially important. Parenting programmes may have a role to play in improving the emotional and behavioural adjustment of infants and toddlers, and this review examined their effectiveness with parents and carers of young children.\nObjectives\n1. To establish whether group-based parenting programmes are effective in improving the emotional and behavioural adjustment of young children (maximum mean age of three years and 11 months); and\n2. To assess whether parenting programmes are effective in the primary prevention of emotional and behavioural problems.\nSearch methods\nIn July 2015 we searched CENTRAL (the Cochrane Library), Ovid MEDLINE, Embase (Ovid), and 10 other databases. We also searched two trial registers and handsearched reference lists of included studies and relevant systematic reviews.\nSelection criteria\nTwo reviewers independently assessed the records retrieved by the search. We included randomised controlled trials (RCTs) and quasi-RCTs of group-based parenting programmes that had used at least one standardised instrument to measure emotional and behavioural adjustment in children.\nData collection and analysis\nOne reviewer extracted data and a second reviewer checked the extracted data. We presented the results for each outcome in each study as standardised mean differences (SMDs) with 95% confidence intervals (CIs). Where appropriate, we combined the results in a meta-analysis using a random-effects model. We used the GRADE (Grades of Recommendations, Assessment, Development, and Evaluation) approach to assess the overall quality of the body of evidence for each outcome.\nMain results\nWe identified 22 RCTs and two quasi-RCTs evaluating the effectiveness of group-based parenting programmes in improving the emotional and behavioural adjustment of children aged up to three years and 11 months (maximum mean age three years 11 months).\nThe total number of participants in the studies were 3161 parents and their young children. Eight studies were conducted in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the included studies were of behavioural, cognitive-behavioural or videotape modelling parenting programmes.\nWe judged 50% (or more) of the included studies to be at low risk for selection bias, detection bias (observer-reported outcomes), attrition bias, selective reporting bias, and other bias. As it is not possible to blind participants and personnel to the type of intervention in these trials, we judged all studies to have high risk of performance bias. Also, there was a high risk of detection bias in the 20 studies that included parent-reported outcomes.\nThe results provide evidence that group-based parenting programmes reduce overall emotional and behavioural problems (SMD -0.81, 95% CI -1.37 to -0.25; 5 studies, 280 participants, low quality evidence) based on total parent-reported data assessed at postintervention. This result was not, however, maintained when two quasi-RCTs were removed as part of a sensitivity analysis (SMD -0.67, 95% CI -1.43 to 0.09; 3 studies, 221 participants). The results of data from subscales show evidence of reduced total externalising problems (SMD -0.23, 95% CI -0.46 to -0.01; 8 studies, 989 participants, moderate quality evidence). Single study results show very low quality evidence of reductions in externalising problems hyperactivity-inattention subscale (SMD -1.34; 95% CI -2.37 to -0.31; 19 participants), low quality evidence of no effect on total internalising problems (SMD 0.34; 95% CI -0.12 to 0.81; 73 participants), and very low quality evidence of an increase in social skills (SMD 3.59; 95% CI 2.42 to 4.76; 32 participants), based on parent-reported data assessed at postintervention. Results for secondary outcomes, which were also measured using subscales, show an impact on parent-child interaction in terms of reduced negative behaviour (SMD -0.22, 95% CI -0.39 to -0.06; 7 studies, 941 participants, moderate quality evidence), and improved positive behaviour (SMD 0.48, 95% CI 0.17 to 0.79; 4 studies, 173 participants, moderate quality evidence) as rated by independent observers postintervention. No further meta-analyses were possible. Results of subgroup analyses show no evidence for treatment duration (seven weeks or less versus more than eight weeks) and inconclusive evidence for prevention versus treatment interventions.\nAuthors' conclusions\nThe findings of this review, which relate to the broad group of universal and at-risk (targeted) children and parents, provide tentative support for the use of group-based parenting programmes to improve the overall emotional and behavioural adjustment of children with a maximum mean age of three years and 11 months, in the short-term. There is, however, a need for more research regarding the role that these programmes might play in the primary prevention of both emotional and behavioural problems, and their long-term effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Emotional and behavioural problems are common among infants and toddlers and, for many children, these problems continue into their early school and teenage years as well. Parenting practices play an important role in how emotional and behavioural problems in children develop. Parent training programmes aimed at parents of infants and toddlers might help to prevent such problems before they start, as well as treat them after they are established."
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"role": "user",
"content": "Abstract: Background\nPine bark (Pinus spp.) extract is rich in bioflavonoids, predominantly proanthocyanidins, which are antioxidants. Commercially-available extract supplements are marketed for preventing or treating various chronic conditions associated with oxidative stress. This is an update of a previously published review.\nObjectives\nTo assess the efficacy and safety of pine bark extract supplements for treating chronic disorders.\nSearch methods\nWe searched three databases and three trial registries; latest search: 30 September 2019.\nWe contacted the manufacturers of pine bark extracts to identify additional studies and hand-searched bibliographies of included studies.\nSelection criteria\nRandomised controlled trials (RCTs) evaluating pine bark extract supplements in adults or children with any chronic disorder.\nData collection and analysis\nTwo authors independently assessed trial eligibility, extracted data and assessed risk of bias. Where possible, we pooled data in meta-analyses. We used GRADE to evaluate the certainty of evidence.\nPrimary outcomes were participant- and investigator-reported clinical outcomes directly related to each disorder and all-cause mortality. We also assessed adverse events and biomarkers of oxidative stress.\nMain results\nThis review included 27 RCTs (22 parallel and five cross-over designs; 1641 participants) evaluating pine bark extract supplements across 10 chronic disorders: asthma (two studies; 86 participants); attention deficit hyperactivity disorder (ADHD) (one study; 61 participants), cardiovascular disease (CVD) and risk factors (seven studies; 338 participants), chronic venous insufficiency (CVI) (two studies; 60 participants), diabetes mellitus (DM) (six studies; 339 participants), erectile dysfunction (three studies; 277 participants), female sexual dysfunction (one study; 83 participants), osteoarthritis (three studies; 293 participants), osteopenia (one study; 44 participants) and traumatic brain injury (one study; 60 participants).\nTwo studies exclusively recruited children; the remainder recruited adults. Trials lasted between four weeks and six months. Placebo was the control in 24 studies. Overall risk of bias was low for four, high for one and unclear for 22 studies.\nIn adults with asthma, we do not know whether pine bark extract increases change in forced expiratory volume in one second (FEV1) % predicted/forced vital capacity (FVC) (mean difference (MD) 7.70, 95% confidence interval (CI) 3.19 to 12.21; one study; 44 participants; very low-certainty evidence), increases change in FEV1 % predicted (MD 7.00, 95% CI 0.10 to 13.90; one study; 44 participants; very low-certainty evidence), improves asthma symptoms (risk ratio (RR) 1.85, 95% CI 1.32 to 2.58; one study; 60 participants; very low-certainty evidence) or increases the number of people able to stop using albuterol inhalers (RR 6.00, 95% CI 1.97 to 18.25; one study; 60 participants; very low-certainty evidence).\nIn children with ADHD, we do not know whether pine bark extract decreases inattention and hyperactivity assessed by parent- and teacher-rating scales (narrative synthesis; one study; 57 participants; very low-certainty evidence) or increases the change in visual-motoric coordination and concentration (MD 3.37, 95% CI 2.41 to 4.33; one study; 57 participants; very low-certainty evidence).\nIn participants with CVD, we do not know whether pine bark extract decreases diastolic blood pressure (MD -3.00 mm Hg, 95% CI -4.51 to -1.49; one study; 61 participants; very low-certainty evidence); increases HDL cholesterol (MD 0.05 mmol/L, 95% CI -0.01 to 0.11; one study; 61 participants; very low-certainty evidence) or decreases LDL cholesterol (MD -0.03 mmol/L, 95% CI -0.05 to 0.00; one study; 61 participants; very low-certainty evidence).\nIn participants with CVI, we do not know whether pine bark extract decreases pain scores (MD -0.59, 95% CI -1.02 to -0.16; one study; 40 participants; very low-certainty evidence), increases the disappearance of pain (RR 25.0, 95% CI 1.58 to 395.48; one study; 40 participants; very low-certainty evidence) or increases physician-judged treatment efficacy (RR 4.75, 95% CI 1.97 to 11.48; 1 study; 40 participants; very low-certainty evidence).\nIn type 2 DM, we do not know whether pine bark extract leads to a greater reduction in fasting blood glucose (MD 1.0 mmol/L, 95% CI 0.91 to 1.09; one study; 48 participants;very low-certainty evidence) or decreases HbA1c (MD -0.90 %, 95% CI -1.78 to -0.02; 1 study; 48 participants; very low-certainty evidence). In a mixed group of participants with type 1 and type 2 DM we do not know whether pine bark extract decreases HbA1c (MD -0.20 %, 95% CI -1.83 to 1.43; one study; 67 participants; very low-certainty evidence).\nIn men with erectile dysfunction, we do not know whether pine bark extract supplements increase International Index of Erectile Function-5 scores (not pooled; two studies; 147 participants; very low-certainty evidence). In women with sexual dysfunction, we do not know whether pine bark extract increases satisfaction as measured by the Female Sexual Function Index (MD 5.10, 95% CI 3.49 to 6.71; one study; 75 participants; very low-certainty evidence) or leads to a greater reduction of pain scores (MD 4.30, 95% CI 2.69 to 5.91; one study; 75 participants; very low-certainty evidence).\nIn adults with osteoarthritis of the knee, we do not know whether pine bark extract decreases composite Western Ontario and McMaster Universities Osteoarthritis Index scores (MD -730.00, 95% CI -1011.95 to -448.05; one study; 37 participants; very low-certainty evidence) or the use of non-steroidal anti-inflammatory medication (MD -18.30, 95% CI -25.14 to -11.46; one study; 35 participants; very low-certainty evidence). We do not know whether pine bark extract increases bone alkaline phosphatase in post-menopausal women with osteopenia (MD 1.16 ug/L, 95% CI -2.37 to 4.69; one study; 40 participants; very low-certainty evidence).\nIn individuals with traumatic brain injury, we do not know whether pine bark extract decreases cognitive failure scores (MD -2.24, 95% CI -11.17 to 6.69; one study; 56 participants; very low-certainty evidence) or post-concussion symptoms (MD -0.76, 95% CI -5.39 to 3.87; one study; 56 participants; very low-certainty evidence).\nFor most comparisons, studies did not report outcomes of hospital admissions or serious adverse events.\nAuthors' conclusions\nSmall sample sizes, limited numbers of RCTs per condition, variation in outcome measures, and poor reporting of the included RCTs mean no definitive conclusions regarding the efficacy or safety of pine bark extract supplements are possible.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 27 studies (1641 participants) across 10 chronic diseases. These included: asthma (two studies; 86 participants), attention deficit hyperactivity disorder (ADHD) (one study; 61 participants), heart disease and risk factors (seven studies; 332 participants), chronic venous insufficiency (leg veins not working effectively; two studies; 60 participants), diabetes (six studies; 336 participants), erectile dysfunction (three studies; 227 participants), female sexual dysfunction (one study; 75 participants), osteoarthritis (cartilage damage in joints; three studies; 293 participants), osteopenia (beginning of bone mass loss; one study; 44 participants) and traumatic brain injury (one study; 56 participants). Two of the studies were conducted exclusively in children; the others were in adults. Studies compared pine bark supplements with placebo (i.e. a dummy supplement) or non-antioxidant interventions and participants were randomly selected for one treatment or the other. The duration of treatment ranged from four weeks to six months."
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"role": "user",
"content": "Abstract: Background\nTransthoracic defibrillation is a potentially life-saving treatment for people with ventricular fibrillation (VF) and haemodynamically unstable ventricular tachycardia (VT). In recent years, biphasic waveforms have become more commonly used for defibrillation than monophasic waveforms. Clinical trials of internal defibrillation and transthoracic defibrillation of short-duration arrhythmias of up to 30 seconds have demonstrated the superiority of biphasic waveforms over monophasic waveforms. However, out-of-hospital cardiac arrest (OHCA) involves a duration of VF/VT of several minutes before defibrillation is attempted.\nObjectives\nTo determine the efficacy and safety of biphasic defibrillation waveforms, compared to monophasic, for resuscitation of people experiencing out-of-hospital cardiac arrest.\nSearch methods\nWe searched the following electronic databases for potentially relevant studies up to 10 September 2014: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Also we checked the bibliographies of relevant studies and review articles, contacted authors of published reviews and reviewed webpages (including those of device manufacturers) relevant to the review topic. We handsearched the abstracts of conference proceedings for the American Heart Association, American College of Cardiology, European Society of Cardiology, European Resuscitation Council, Society of Critical Care Medicine and European Society of Intensive Care Medicine. Regarding language restrictions, we did not apply any.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared biphasic and monophasic waveform defibrillation in adults with OHCA. Two review authors independently screened the literature search results.\nData collection and analysis\nTwo review authors independently extracted data from the included trials and performed 'Risk of bias' assessments. We resolved any disagreements by discussion and consensus. The primary outcome was the risk of failure to achieve return of spontaneous circulation (ROSC). Secondary outcomes included risk of failure to revert VF to an organised rhythm following the first shock or up to three shocks, survival to hospital admission and survival to discharge.\nMain results\nWe included four trials (552 participants) that compared biphasic and monophasic waveform defibrillation in people with OHCA. Based on the assessment of five quality domains, we identified two trials that were at high risk of bias, one trial at unclear risk of bias and one trial at low risk of bias. The risk ratio (RR) for failure to achieve ROSC after biphasic compared to monophasic waveform defibrillation was 0.86 (95% CI 0.62 to 1.20; four trials, 552 participants). The RR for failure to defibrillate on the first shock following biphasic defibrillation compared to monophasic was 0.84 (95% CI 0.70 to 1.01; three trials, 450 participants); and 0.81 (95% CI 0.61 to 1.09; two trials, 317 participants) for one to three stacked shocks. The RR for failure to achieve ROSC after the first shock was 0.92 (95% CI 0.81 to 1.04; two trials, 285 participants). Biphasic waveforms did not reduce the risk of death before hospital admission (RR 1.05, 95% CI 0.90 to 1.23; three trials, 383 participants) or before hospital discharge (RR 1.05, 95% CI 0.78 to 1.42; four trials, 550 participants). There was no statistically significant heterogeneity in any of the pooled analyses. None of the included trials reported adverse events.\nAuthors' conclusions\nIt is uncertain whether biphasic defibrillators have an important effect on defibrillation success in people with OHCA. Further large studies are needed to provide adequate statistical power.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the literature up to 10 September 2014 and tried to find all available research (published and unpublished) that compared these two types of defibrillators. We only included trials with a high-quality study design to avoid the possibility of inaccurate results."
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"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in The Cochrane Library in Issue 4, 2007 and previously updated in 2011.\nUnilateral peripheral vestibular dysfunction (UPVD) can occur as a result of disease, trauma or postoperatively. The dysfunction is characterised by complaints of dizziness, visual or gaze disturbances and balance impairment. Current management includes medication, physical manoeuvres and exercise regimes, the latter known collectively as vestibular rehabilitation.\nObjectives\nTo assess the effectiveness of vestibular rehabilitation in the adult, community-dwelling population of people with symptomatic unilateral peripheral vestibular dysfunction.\nSearch methods\nWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The most recent search was 18 January 2014.\nSelection criteria\nRandomised controlled trials of adults living in the community, diagnosed with symptomatic unilateral peripheral vestibular dysfunction. We sought comparisons of vestibular rehabilitation versus control (e.g. placebo), other treatment (non-vestibular rehabilitation, e.g. pharmacological) or another form of vestibular rehabilitation. Our primary outcome measure was change in the specified symptomatology (for example, proportion with dizziness resolved, frequency or severity of dizziness). Secondary outcomes were measures of function, quality of life and/or measure(s) of physiological status, where reproducibility has been confirmed and shown to be relevant or related to health status (for example, posturography), and adverse effects\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included 39 studies involving 2441 participants with unilateral peripheral vestibular disorders in the review. Trials addressed the effectiveness of vestibular rehabilitation against control/sham interventions, medical interventions or other forms of vestibular rehabilitation. Non-blinding of outcome assessors and selective reporting were threats that may have biased the results in 25% of studies, but otherwise there was a low risk of selection or attrition bias.\nIndividual and pooled analyses of the primary outcome, frequency of dizziness, showed a statistically significant effect in favour of vestibular rehabilitation over control or no intervention (odds ratio (OR) 2.67, 95% confidence interval (CI) 1.85 to 3.86; four studies, 565 participants). Secondary outcomes measures related to levels of activity or participation measured, for example, with the Dizziness Handicap Inventory, which also showed a strong trend towards significant differences between the groups (standardised mean difference (SMD) -0.83, 95% CI -1.02 to -0.64). The exception to this was when movement-based vestibular rehabilitation was compared to physical manoeuvres for benign paroxysmal positional vertigo (BPPV), where the latter was shown to be superior in cure rate in the short term (OR 0.19, 95% CI 0.07 to 0.49). There were no reported adverse effects.\nAuthors' conclusions\nThere is moderate to strong evidence that vestibular rehabilitation is a safe, effective management for unilateral peripheral vestibular dysfunction, based on a number of high-quality randomised controlled trials. There is moderate evidence that vestibular rehabilitation resolves symptoms and improves functioning in the medium term. However, there is evidence that for the specific diagnostic group of BPPV, physical (repositioning) manoeuvres are more effective in the short term than exercise-based vestibular rehabilitation; although a combination of the two is effective for longer-term functional recovery. There is insufficient evidence to discriminate between differing forms of vestibular rehabilitation.\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": "Due to the variation between studies, only limited pooling (combining) of data was possible. The results of four studies could be combined, which demonstrated that vestibular rehabilitation was more effective than control or sham interventions in improving subjective reports of dizziness, and in improving participation in life roles. Two studies gave a combined result in favour of vestibular rehabilitation for improving walking. Other single studies all found in favour of vestibular rehabilitation for improvements in areas such as balance, vision and activities of daily living. The exception to these findings was for the specific group of people with BPPV, where comparisons of vestibular rehabilitation with specific physical repositioning manoeuvres showed that these manoeuvres were more effective in dizziness symptom reduction, particularly in the short term. However, other studies demonstrated that combining the manoeuvres with vestibular rehabilitation was effective in improving functional recovery in the longer term. There were no reports of adverse effects following any vestibular rehabilitation. In the studies with a follow-up assessment (3 to 12 months) positive effects were maintained. There was no evidence that one form of vestibular rehabilitation is superior to another. There is a growing and consistent body of evidence to support the use of vestibular rehabilitation for people with dizziness and functional loss as a result of UPVD."
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"role": "user",
"content": "Abstract: Background\nNecrotizing enterocolitis (NEC) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period. There have been published reports that suggest that oral immunoglobulins (Ig)A and IgG produce an immunoprotective effect in the gastrointestinal mucosa.\nObjectives\nTo determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm or low birth weight (or both) neonates.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Group. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2016, Issue 1), PubMed (1966 to January 2016), CINAHL (1982 to January 2016) and EMBASE (1980 to January 2016) and conference proceedings.\nSelection criteria\nAll randomized or quasi-randomised controlled trials where oral immunoglobulins were used as prophylaxis against NEC in preterm (less than 37 weeks' gestation) or low birth weight (less than 2500 gram), or both, neonates.\nData collection and analysis\nWe performed data collection and analysis in accordance with the standard methods of the Cochrane Neonatal Review Group.\nMain results\nThe search identified five studies on oral immunoglobulin for the prevention of NEC of which three met the inclusion criteria. In this review of the three eligible trials (including 2095 neonates), the oral administration of IgG or an IgG/IgA combination did not result in a significant reduction in the incidence of definite NEC (typical risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.25; typical risk difference (RD) -0.01, 95% CI -0.03 to 0.01; 3 studies, 1840 infants), suspected NEC (RR 0.84, 95% CI 0.49 to 1.46; RD -0.01, 95% CI -0.02 to 0.01; 1 study, 1529 infants), need for surgery (typical RR 0.21, 95% CI 0.02 to 1.75; typical RD -0.03, 95% CI -0.06 to 0.00; 2 studies, 311 infants) or death from NEC (typical RR 1.10, 95% CI 0.47 to 2.59; typical RD 0.00, 95% CI -0.01 to 0.01; 3 studies, 1840 infants).\nAuthors' conclusions\nBased on the available trials, the evidence does not support the administration of oral immunoglobulin for the prevention of NEC. There are no randomized controlled trials of oral IgA alone for the prevention of NEC.\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": "Immunoglobulin given orally for preventing emergency intestinal problems (necrotizing enterocolitis) in premature and low birth weight newborn infants. Destructive inflammation of the intestine (called necrotizing enterocolitis, NEC) is caused by gas-producing bacteria that ferment milk. It is a potential problem for newborn preterm (born before their due date) and low birth weight (born at less than 2500 grams) infants. Even after leaving hospital, affected infants may need frequent and prolonged hospitalisation because of continuing nutritional problems. This makes it difficult for parents both emotionally and financially. Immunoglobulins are proteins found in the blood that give the body immunity to disease. Immunoglobulins (types IgA and IgG) taken by mouth (orally) may protect susceptible infants from developing NEC."
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"content": "Abstract: Background\nWith potential antiviral and anti-inflammatory properties, Janus kinase (JAK) inhibitors represent a potential treatment for symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. They may modulate the exuberant immune response to SARS-CoV-2 infection. Furthermore, a direct antiviral effect has been described. An understanding of the current evidence regarding the efficacy and safety of JAK inhibitors as a treatment for coronavirus disease 2019 (COVID-19) is required.\nObjectives\nTo assess the effects of systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo) on clinical outcomes in individuals (outpatient or in-hospital) with any severity of COVID-19, and to maintain the currency of the evidence using a living systematic review approach.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (comprising MEDLINE, Embase, ClinicalTrials.gov, World Health Organization (WHO) International Clinical Trials Registry Platform, medRxiv, and Cochrane Central Register of Controlled Trials), Web of Science, WHO COVID-19 Global literature on coronavirus disease, and the US Department of Veterans Affairs Evidence Synthesis Program (VA ESP) Covid-19 Evidence Reviews to identify studies up to February 2022. We monitor newly published randomised controlled trials (RCTs) weekly using the Cochrane COVID-19 Study Register, and have incorporated all new trials from this source until the first week of April 2022.\nSelection criteria\nWe included RCTs that compared systemic JAK inhibitors plus standard of care to standard of care alone (plus/minus placebo) for the treatment of individuals with COVID-19. We used the WHO definitions of illness severity for COVID-19.\nData collection and analysis\nWe assessed risk of bias of primary outcomes using Cochrane's Risk of Bias 2 (RoB 2) tool. We used GRADE to rate the certainty of evidence for the following primary outcomes: all-cause mortality (up to day 28), all-cause mortality (up to day 60), improvement in clinical status: alive and without need for in-hospital medical care (up to day 28), worsening of clinical status: new need for invasive mechanical ventilation or death (up to day 28), adverse events (any grade), serious adverse events, secondary infections.\nMain results\nWe included six RCTs with 11,145 participants investigating systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo). Standard of care followed local protocols and included the application of glucocorticoids (five studies reported their use in a range of 70% to 95% of their participants; one study restricted glucocorticoid use to non-COVID-19 specific indications), antibiotic agents, anticoagulants, and antiviral agents, as well as non-pharmaceutical procedures. At study entry, about 65% of participants required low-flow oxygen, about 23% required high-flow oxygen or non-invasive ventilation, about 8% did not need any respiratory support, and only about 4% were intubated. We also identified 13 ongoing studies, and 9 studies that are completed or terminated and where classification is pending.\nIndividuals with moderate to severe disease\nFour studies investigated the single agent baricitinib (10,815 participants), one tofacitinib (289 participants), and one ruxolitinib (41 participants).\nSystemic JAK inhibitors probably decrease all-cause mortality at up to day 28 (95 of 1000 participants in the intervention group versus 131 of 1000 participants in the control group; risk ratio (RR) 0.72, 95% confidence interval (CI) 0.57 to 0.91; 6 studies, 11,145 participants; moderate-certainty evidence), and decrease all-cause mortality at up to day 60 (125 of 1000 participants in the intervention group versus 181 of 1000 participants in the control group; RR 0.69, 95% CI 0.56 to 0.86; 2 studies, 1626 participants; high-certainty evidence).\nSystemic JAK inhibitors probably make little or no difference in improvement in clinical status (discharged alive or hospitalised, but no longer requiring ongoing medical care) (801 of 1000 participants in the intervention group versus 778 of 1000 participants in the control group; RR 1.03, 95% CI 1.00 to 1.06; 4 studies, 10,802 participants; moderate-certainty evidence). They probably decrease the risk of worsening of clinical status (new need for invasive mechanical ventilation or death at day 28) (154 of 1000 participants in the intervention group versus 172 of 1000 participants in the control group; RR 0.90, 95% CI 0.82 to 0.98; 2 studies, 9417 participants; moderate-certainty evidence).\nSystemic JAK inhibitors probably make little or no difference in the rate of adverse events (any grade) (427 of 1000 participants in the intervention group versus 441 of 1000 participants in the control group; RR 0.97, 95% CI 0.88 to 1.08; 3 studies, 1885 participants; moderate-certainty evidence), and probably decrease the occurrence of serious adverse events (160 of 1000 participants in the intervention group versus 202 of 1000 participants in the control group; RR 0.79, 95% CI 0.68 to 0.92; 4 studies, 2901 participants; moderate-certainty evidence). JAK inhibitors may make little or no difference to the rate of secondary infection (111 of 1000 participants in the intervention group versus 113 of 1000 participants in the control group; RR 0.98, 95% CI 0.89 to 1.09; 4 studies, 10,041 participants; low-certainty evidence). Subgroup analysis by severity of COVID-19 disease or type of JAK inhibitor did not identify specific subgroups which benefit more or less from systemic JAK inhibitors.\nIndividuals with asymptomatic or mild disease\nWe did not identify any trial for this population.\nAuthors' conclusions\nIn hospitalised individuals with moderate to severe COVID-19, moderate-certainty evidence shows that systemic JAK inhibitors probably decrease all-cause mortality. Baricitinib was the most often evaluated JAK inhibitor. Moderate-certainty evidence suggests that they probably make little or no difference in improvement in clinical status. Moderate-certainty evidence indicates that systemic JAK inhibitors probably decrease the risk of worsening of clinical status and make little or no difference in the rate of adverse events of any grade, whilst they probably decrease the occurrence of serious adverse events. Based on low-certainty evidence, JAK inhibitors may make little or no difference in the rate of secondary infection. Subgroup analysis by severity of COVID-19 or type of agent failed to identify specific subgroups which benefit more or less from systemic JAK inhibitors.\nCurrently, there is no evidence on the efficacy and safety of systemic JAK inhibitors for individuals with asymptomatic or mild disease (non-hospitalised individuals).\n\nGiven the provided abstract, please respond to the following query: \"How might JAK inhibitors treat COVID-19?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In COVID-19, the immune system sometimes overreacts, which can lead to a severe course of disease. JAK inhibitors can block parts of the immune system and counteract any clinical deteriorations."
}
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query-laysum | 3251 | [
{
"role": "user",
"content": "Abstract: Background\nFunctional endoscopic sinus surgery (FESS) has become a well-established approach for treating patients with chronic rhinosinusitis (CRS) refractory to medical management. However, the surgical outcome may be compromised by postoperative inflammation, polyposis and adhesions, which often require subsequent intervention. Bioabsorbable, steroid-eluting sinus stents are inserted into the nose, sinuses or both following surgery to prevent stenosis of the sinus openings during the postoperative healing period. The slow release of corticosteroid aims to decrease mucosal oedema and expedite wound healing. Whether a steroid-eluting stent offers any beneficial effects in terms of improving sinonasal symptoms has not been systematically reviewed.\nObjectives\nTo assess the safety and efficacy of steroid-eluting sinus stent placement in CRS patients after FESS.\nSearch methods\nThe Cochrane Ear, Nose and Throat Disorders Group (CENTDG) Trials Search Co-ordinator searched the CENTDG Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 4); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 May 2015.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing steroid-eluting sinus stents with non-steroid-eluting sinus stents, nasal packing or no treatment in adult CRS patients undergoing FESS.\nData collection and analysis\nWe used the standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe identified no RCTs that met our inclusion criteria. Among the 159 records retrieved using our search strategy, 21 trials had the potential to be included given that they had tested sinus stents, spacers and packing materials for patients with CRS undergoing FESS. However, we excluded these trials from the review because they met some but not all of the inclusion criteria.\nAuthors' conclusions\nWe are unable to provide evidence to establish whether steroid-eluting sinus stents have potential advantages and disadvantages for patients with CRS undergoing FESS. Future, high-quality RCTs are needed to assess whether or not steroid-eluting sinus stents confer any beneficial effects, over those of surgery alone, when compared to non-steroid sinus stents.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are unable to conclude whether or not steroid-eluting sinus stents offer more beneficial effects, over those of surgery alone, than non-steroid-eluting sinus stents, nasal packing or no treatment in patients with CRS undergoing FESS. High-quality RCTs are needed to answer this question. This review is current to May 2015."
}
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query-laysum | 3252 | [
{
"role": "user",
"content": "Abstract: Background\nHistorically, whole brain radiation therapy (WBRT) has been the main treatment for brain metastases. Stereotactic radiosurgery (SRS) delivers high-dose focused radiation and is being increasingly utilized to treat brain metastases. The benefit of adding SRS to WBRT is unclear. This is an updated version of the original Cochrane Review published in Issue 9, 2012.\nObjectives\nTo assess the efficacy of WBRT plus SRS versus WBRT alone in the treatment of adults with brain metastases.\nSearch methods\nFor the original review, in 2009 we searched the following electronic databases: CENTRAL, MEDLINE, Embase, and CancerLit in order to identify trials for inclusion in this review. For the first update the searches were updated in May 2012.\nFor this update, in May 2017 we searched CENTRAL, MEDLINE, and Embase in order to identify trials for inclusion in the review.\nSelection criteria\nWe restricted the review to randomized controlled trials (RCTs) that compared use of WBRT plus SRS versus WBRT alone for upfront treatment of adults with newly diagnosed metastases (single or multiple) in the brain resulting from any primary, extracranial cancer.\nData collection and analysis\nWe used the generic inverse variance method, random-effects model in Review Manager 5 for the meta-analysis.\nMain results\nWe identified three studies and one abstract for inclusion but we could only include two studies, with a total of 358 participants in a meta-analysis. This found no difference in overall survival (OS) between the WBRT plus SRS and WBRT alone groups (hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.65 to 1.02; 2 studies, 358 participants; moderate-quality evidence). For participants with one brain metastasis median survival was significantly longer in the WBRT plus SRS group (6.5 months) versus WBRT group (4.9 months; P = 0.04). Participants in the WBRT plus SRS group had decreased local failure compared to participants who received WBRT alone (HR 0.27, 95% CI 0.14 to 0.52; 2 studies, 129 participants; moderate-quality evidence). Furthermore, we observed an improvement in performance status scores and decrease in steroid use in the WBRT plus SRS group (risk ratio (RR) 0.64 CI 0.42 to 0.97; 1 study, 118 participants; low-quality evidence). Unchanged or improved Karnofsky Performance Scale (KPS) at six months was seen in 43% of participants in the combined therapy group versus only 28% in the WBRT-alone group (RR 0.78 CI 0.61 to 1.00; P value = 0.05; 1 study, 118 participants; low-quality evidence). Overall, risk of bias in the included studies was unclear.\nAuthors' conclusions\nSince the last version of this review we have identified one new study that met the inclusion criteria. However, due to a lack of data from this study we were not able to include it in a meta-analysis. Given the unclear risk of bias in the included studies, the results of this analysis have to be interpreted with caution. In our analysis of all included participants, SRS plus WBRT did not show a survival benefit over WBRT alone. However, performance status and local control were significantly better in the SRS plus WBRT group. Furthermore, significantly longer OS was reported in the combined treatment group for recursive partitioning analysis (RPA) Class I patients as well as patients with single metastasis. Most of our outcomes of interest were graded as moderate-quality evidence according to the GRADE criteria and the risk of bias in the majority of included studies was mostly unclear.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The overall quality of the evidence was moderate based on the GRADE assessments for our outcomes of interest, and the overall risk of bias was unclear."
}
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query-laysum | 3253 | [
{
"role": "user",
"content": "Abstract: Background\nIn a review and meta-analysis conducted in 1993, psychological preparation was found to be beneficial for a range of outcome variables including pain, behavioural recovery, length of stay and negative affect. Since this review, more detailed bibliographic searching has become possible, additional studies testing psychological preparation for surgery have been completed and hospital procedures have changed. The present review examines whether psychological preparation (procedural information, sensory information, cognitive intervention, relaxation, hypnosis and emotion-focused intervention) has impact on the outcomes of postoperative pain, behavioural recovery, length of stay and negative affect.\nObjectives\nTo review the effects of psychological preparation on postoperative outcomes in adults undergoing elective surgery under general anaesthetic.\nSearch methods\nWe searched the Cochrane Register of Controlled Trials (CENTRAL 2014, Issue 5), MEDLINE (OVID SP) (1950 to May 2014), EMBASE (OVID SP) (1982 to May 2014), PsycINFO (OVID SP) (1982 to May 2014), CINAHL (EBESCOhost) (1980 to May 2014), Dissertation Abstracts (to May 2014) and Web of Science (1946 to May 2014). We searched reference lists of relevant studies and contacted authors to identify unpublished studies. We reran the searches in July 2015 and placed the 38 studies of interest in the `awaiting classification' section of this review.\nSelection criteria\nWe included randomized controlled trials of adult participants (aged 16 or older) undergoing elective surgery under general anaesthesia. We excluded studies focusing on patient groups with clinically diagnosed psychological morbidity. We did not limit the search by language or publication status. We included studies testing a preoperative psychological intervention that included at least one of these seven techniques: procedural information; sensory information; behavioural instruction; cognitive intervention; relaxation techniques; hypnosis; emotion-focused intervention. We included studies that examined any one of our postoperative outcome measures (pain, behavioural recovery, length of stay, negative affect) within one month post-surgery.\nData collection and analysis\nOne author checked titles and abstracts to exclude obviously irrelevant studies. We obtained full reports of apparently relevant studies; two authors fully screened these. Two authors independently extracted data and resolved discrepancies by discussion.\nWhere possible we used random-effects meta-analyses to combine the results from individual studies. For length of stay we pooled mean differences. For pain and negative affect we used a standardized effect size (the standardized mean difference (SMD), or Hedges' g) to combine data from different outcome measures. If data were not available in a form suitable for meta-analysis we performed a narrative review.\nMain results\nSearches identified 5116 unique papers; we retrieved 827 for full screening. In this review, we included 105 studies from 115 papers, in which 10,302 participants were randomized. Mainly as a result of updating the search in July 2015, 38 papers are awaiting classification. Sixty-one of the 105 studies measured the outcome pain, 14 behavioural recovery, 58 length of stay and 49 negative affect. Participants underwent a wide range of surgical procedures, and a range of psychological components were used in interventions, frequently in combination. In the 105 studies, appropriate data were provided for the meta-analysis of 38 studies measuring the outcome postoperative pain (2713 participants), 36 for length of stay (3313 participants) and 31 for negative affect (2496 participants). We narratively reviewed the remaining studies (including the 14 studies with 1441 participants addressing behavioural recovery). When pooling the results for all types of intervention there was low quality evidence that psychological preparation techniques were associated with lower postoperative pain (SMD -0.20, 95% confidence interval (CI) -0.35 to -0.06), length of stay (mean difference -0.52 days, 95% CI -0.82 to -0.22) and negative affect (SMD -0.35, 95% CI -0.54 to -0.16) compared with controls. Results tended to be similar for all categories of intervention, although there was no evidence that behavioural instruction reduced the outcome pain. However, caution must be exercised when interpreting the results because of heterogeneity in the types of surgery, interventions and outcomes. Narratively reviewed evidence for the outcome behavioural recovery provided very low quality evidence that psychological preparation, in particular behavioural instruction, may have potential to improve behavioural recovery outcomes, but no clear conclusions could be reached.\nGenerally, the evidence suffered from poor reporting, meaning that few studies could be classified as having low risk of bias. Overall,we rated the quality of evidence for each outcome as ‘low’ because of the high level of heterogeneity in meta-analysed studies and the unclear risk of bias. In addition, for the outcome behavioural recovery, too few studies used robust measures and reported suitable data for meta-analysis, so we rated the quality of evidence as `very low'.\nAuthors' conclusions\nThe evidence suggested that psychological preparation may be beneficial for the outcomes postoperative pain, behavioural recovery, negative affect and length of stay, and is unlikely to be harmful. However, at present, the strength of evidence is insufficient to reach firm conclusions on the role of psychological preparation for surgery. Further analyses are needed to explore the heterogeneity in the data, to identify more specifically when intervention techniques are of benefit. As the current evidence quality is low or very low, there is a need for well-conducted and clearly reported research.\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": "In this review we included 105 studies, which were reported in 115 papers. A total of 10,302 participants were randomized in these studies. For pain, length of stay and negative emotion we combined numerical findings from the studies. We found that psychological preparation before surgery seemed to reduce pain and negative emotion after the operation and may reduce the time spent in hospital by around half a day but the quality of the evidence was low. Also, the studies used many different psychological preparation techniques (often in different combinations) so it was not possible to discover which techniques were better. We could not statistically combine numerical findings for behavioural recovery because few studies provided sufficient details and studies used different ways of measuring how quickly people returned to usual activities. In reviewing the studies, we found that psychological preparation, in particular behavioural instruction, may have the potential to improve behavioural recovery. However, the quality of this evidence was very low. We looked at the effect of psychological preparation on pain, behavioural recovery, length of stay and negative emotion in this review and did not find evidence to suggest that psychological preparation might lead to harm in these outcomes. However, as we did not look at other outcomes it is possible that we did not identify potential harm."
}
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query-laysum | 3254 | [
{
"role": "user",
"content": "Abstract: Background\nNeonatal hypoglycaemia is a common condition that can be associated with brain injury. Current practice usually includes early identification of at-risk infants (e.g. infants of diabetic mothers; preterm, small- or large-for-gestational-age infants), and prophylactic measures are advised. However, these measures usually involve use of formula milk or admission to the neonatal unit. Dextrose gel is non-invasive, inexpensive and effective for treatment of neonatal hypoglycaemia. Prophylactic dextrose gel can reduce the incidence of neonatal hypoglycaemia, thus potentially reducing separation of mother and baby and supporting breastfeeding, as well as preventing brain injury.\nThis is an update of a previous Cochrane Review published in 2017.\nObjectives\nTo assess the effectiveness and safety of oral dextrose gel given to newborn infants at risk of hypoglycaemia in preventing hypoglycaemia and reducing long-term neurodevelopmental impairment.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 10) in the Cochrane Library; and Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) on 19 October 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no intervention, or other therapies for the prevention of neonatal hypoglycaemia.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias. We contacted investigators to obtain additional information. We used fixed-effect meta-analyses. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included two studies conducted in high-income countries comparing oral dextrose gel versus placebo in 2548 infants at risk of neonatal hypoglycaemia. Of these, one study was included in the previous version of this review. We judged these two studies to be at low risk of bias, and that the evidence for most outcomes was of moderate certainty.\nMeta-analysis of the two studies showed that oral dextrose gel reduces the risk of hypoglycaemia (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.79 to 0.95; risk difference (RD) -0.06, 95% CI -0.10 to -0.02; 2548 infants; high certainty evidence). One study reported that oral dextrose gel probably reduces the risk of major neurological disability at two years' corrected age (RR 0.21, 95% CI 0.05 to 0.78; RD -0.05, 95% CI -0.09 to 0.00; 360 infants; moderate certainty evidence).\nMeta-analysis of the two studies showed that oral dextrose gel probably reduces the risk of receipt of treatment for hypoglycaemia during initial hospital stay (RR 0.89, 95% CI 0.79 to 1.00; 2548 infants; moderate certainty evidence) but makes little or no difference to the risk of receipt of intravenous treatment for hypoglycaemia (RR 1.01, 0.68 to 1.49; 2548 infants; moderate certainty evidence). Oral dextrose gel may have little or no effect on the risk of separation from the mother for treatment of hypoglycaemia (RR 1.12, 95% CI 0.81 to 1.55; two studies, 2548 infants; low certainty evidence).\nThere is probably little or no difference in the risk of adverse events in infants who receive oral dextrose gel compared to placebo gel (RR 1.22, 95% CI 0.64 to 2.33; two studies, 2510 infants; moderate certainty evidence), but there are no studies comparing oral dextrose with other comparators such as no treatment, standard care or other therapies.\nNo data were available on exclusive breastfeeding after discharge.\nAuthors' conclusions\nOral dextrose gel reduces the risk of neonatal hypoglycaemia in at-risk infants and probably reduces the risk of major neurological disability at two years of age or greater without increasing the risk of adverse events compared to placebo gel. Additional large follow-up studies at two years of age or older are required. Future research should also be undertaken in low- and middle-income countries, preterm infants, using other dextrose gel preparations, and using comparators other than placebo gel. There are three studies awaiting classification and one ongoing study which may alter the conclusions of the review when published.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Is oral dextrose gel effective and safe in preventing low blood glucose levels and reducing long-term disability in newborn babies at risk of low blood glucose levels?"
}
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query-laysum | 3255 | [
{
"role": "user",
"content": "Abstract: Background\nPancreatic cancer (PC) is a highly lethal disease with few effective treatment options. Over the past few decades, many anti-cancer therapies have been tested in the locally advanced and metastatic setting, with mixed results. This review attempts to synthesise all the randomised data available to help better inform patient and clinician decision-making when dealing with this difficult disease.\nObjectives\nTo assess the effect of chemotherapy, radiotherapy or both for first-line treatment of advanced pancreatic cancer. Our primary outcome was overall survival, while secondary outcomes include progression-free survival, grade 3/4 adverse events, therapy response and quality of life.\nSearch methods\nWe searched for published and unpublished studies in CENTRAL (searched 14 June 2017), Embase (1980 to 14 June 2017), MEDLINE (1946 to 14 June 2017) and CANCERLIT (1999 to 2002) databases. We also handsearched all relevant conference abstracts published up until 14 June 2017.\nSelection criteria\nAll randomised studies assessing overall survival outcomes in patients with advanced pancreatic ductal adenocarcinoma. Chemotherapy and radiotherapy, alone or in combination, were the eligible treatments.\nData collection and analysis\nTwo review authors independently analysed studies, and a third settled any disputes. We extracted data on overall survival (OS), progression-free survival (PFS), response rates, adverse events (AEs) and quality of life (QoL), and we assessed risk of bias for each study.\nMain results\nWe included 42 studies addressing chemotherapy in 9463 patients with advanced pancreatic cancer. We did not identify any eligible studies on radiotherapy.\nWe did not find any benefit for chemotherapy over best supportive care. However, two identified studies did not have sufficient data to be included in the analysis, and many of the chemotherapy regimens studied were outdated.\nCompared to gemcitabine alone, participants receiving 5FU had worse OS (HR 1.69, 95% CI 1.26 to 2.27, moderate-quality evidence), PFS (HR 1.47, 95% CI 1.12 to 1.92) and QoL. On the other hand, two studies showed FOLFIRINOX was better than gemcitabine for OS (HR 0.51 95% CI 0.43 to 0.60, moderate-quality evidence), PFS (HR 0.46, 95% CI 0.38 to 0.57) and response rates (RR 3.38, 95% CI 2.01 to 5.65), but it increased the rate of side effects. The studies evaluating CO-101, ZD9331 and exatecan did not show benefit or harm when compared with gemcitabine alone.\nGiving gemcitabine at a fixed dose rate improved OS (HR 0.79, 95% CI 0.66 to 0.94, high-quality evidence) but increased the rate of side effects when compared with bolus dosing.\nWhen comparing gemcitabine combinations to gemcitabine alone, gemcitabine plus platinum improved PFS (HR 0.80, 95% CI 0.68 to 0.95) and response rates (RR 1.48, 95% CI 1.11 to 1.98) but not OS (HR 0.94, 95% CI 0.81 to 1.08, low-quality evidence). The rate of side effects increased. Gemcitabine plus fluoropyrimidine improved OS (HR 0.88, 95% CI 0.81 to 0.95), PFS (HR 0.79, 95% CI 0.72 to 0.87) and response rates (RR 1.78, 95% CI 1.29 to 2.47, high-quality evidence), but it also increased side effects. Gemcitabine plus topoisomerase inhibitor did not improve survival outcomes but did increase toxicity. One study demonstrated that gemcitabine plus nab-paclitaxel improved OS (HR 0.72, 95% CI 0.62 to 0.84, high-quality evidence), PFS (HR 0.69, 95% CI 0.58 to 0.82) and response rates (RR 3.29, 95% CI 2.24 to 4.84) but increased side effects. Gemcitabine-containing multi-drug combinations (GEMOXEL or cisplatin/epirubicin/5FU/gemcitabine) improved OS (HR 0.55, 95% CI 0.39 to 0.79, low-quality evidence), PFS (HR 0.43, 95% CI 0.30 to 0.62) and QOL.\nWe did not find any survival advantages when comparing 5FU combinations to 5FU alone.\nAuthors' conclusions\nCombination chemotherapy has recently overtaken the long-standing gemcitabine as the standard of care. FOLFIRINOX and gemcitabine plus nab-paclitaxel are highly efficacious, but our analysis shows that other combination regimens also offer a benefit. Selection of the most appropriate chemotherapy for individual patients still remains difficult, with clinicopathological stratification remaining elusive. Biomarker development is essential to help rationalise treatment selection for patients.\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": "This review has shown that in advanced disease, combination chemotherapy with FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin combination); GEMOXEL (gemcitabine, oxaliplatin and capecitabine); cisplatin/epirubicin/5FU/gemcitabine; gemcitabine plus nab-paclitaxel; and gemcitabine plus a fluoropyrimidine agent, provide a survival advantage over gemcitabine alone. These combinations do increase side effects. Gemcitabine given slowly using a fixed rate of infusion may be more effective than giving it in the standard way, which is quickly over 30 minutes."
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query-laysum | 3256 | [
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"role": "user",
"content": "Abstract: Background\nEstablishment of a secure airway is a critical part of neonatal resuscitation in the delivery room and the neonatal intensive care unit. Videolaryngoscopy has the potential to facilitate successful endotracheal intubation, and decrease adverse consequences of a delay in airway stabilization. Videolaryngoscopy may enhance visualization of the glottis and intubation success in neonates. This is an update of a review first published in 2015, and updated in 2018.\nObjectives\nTo determine the effectiveness and safety of videolaryngoscopy compared to direct laryngoscopy in decreasing the time and attempts required for endotracheal intubation and increasing the success rate on first intubation attempt in neonates (0 to 28 days of age).\nSearch methods\nIn November 2022, we updated the search for trials evaluating videolaryngoscopy for neonatal endotracheal intubation in CENTRAL, MEDLINE, Embase, CINAHL, and BIOSIS. We also searched abstracts of the Pediatric Academic Societies, clinical trials registries (www.clinicaltrials.gov; www.controlled-trials.com), and reference lists of relevant studies.\nSelection criteria\nRandomized controlled trials (RCTs), quasi-RCTs, cluster-RCTs, or cross-over trials, in neonates (0 to 28 days of age), evaluating videolaryngoscopy with any device used for endotracheal intubation compared with direct laryngoscopy.\nData collection and analysis\nThree review authors performed data collection and analysis, as recommended by Cochrane Neonatal. Two review authors independently assessed studies identified by the search strategy for inclusion.\nWe used the GRADE approach to assess the certainty of the evidence.\nMain results\nThe updated search yielded 7786 references, from which we identified five additional RCTs for inclusion, seven ongoing trials, and five studies awaiting classification. Three studies were included in the previous version of the review. For this update, we included eight studies, which provided data on 759 intubation attempts in neonates. We included neonates of either sex, who were undergoing endotracheal intubation in international hospitals. Different videolaryngoscopy devices (including C-MAC, Airtraq, and Glidescope) were used in the studies.\nFor the primary outcomes; videolaryngoscopy may not reduce the time required for successful intubation when compared with direct laryngoscopy (mean difference [MD] 0.74, 95% confidence interval [CI] -0.19 to 1.67; 5 studies; 505 intubations; low-certainty evidence). Videolaryngoscopy may result in fewer intubation attempts (MD -0.08, 95% CI -0.15 to 0.00; 6 studies; 659 intubations; low-certainty evidence). Videolaryngoscopy may increase the success of intubation at the first attempt (risk ratio [RR] 1.24, 95% CI 1.13 to 1.37; risk difference [RD] 0.14, 95% CI 0.08 to 0.20; number needed to treat for an additional beneficial outcome [NNTB] 7, 95% CI 5 to 13; 8 studies; 759 intubation attempts; low-certainty evidence).\nFor the secondary outcomes; the evidence is very uncertain about the effect of videolaryngoscopy on desaturation or bradycardia episodes, or both, during intubation (RR 0.94, 95% CI 0.38 to 2.30; 3 studies; 343 intubations; very-low certainty evidence). Videolaryngoscopy may result in little to no difference in the lowest oxygen saturations during intubation compared with direct laryngoscopy (MD -0.76, 95% CI -5.74 to 4.23; 2 studies; 359 intubations; low-certainty evidence). Videolaryngoscopy likely results in a slight reduction in the incidence of airway trauma during intubation attempts compared with direct laryngoscopy (RR 0.21, 95% CI 0.05 to 0.79; RD -0.04, 95% CI -0.07 to -0.01; NNTB 25, 95% CI 14 to 100; 5 studies; 467 intubations; moderate-certainty evidence).\nThere were no data available on other adverse effects of videolaryngoscopy. We found a high risk of bias in areas of allocation concealment and performance bias in the included studies.\nAuthors' conclusions\nVideolaryngoscopy may increase the success of intubation on the first attempt and may result in fewer intubation attempts, but may not reduce the time required for successful intubation (low-certainty evidence). Videolaryngoscopy likely results in a reduced incidence of airway-related adverse effects (moderate-certainty evidence).\nThese results suggest that videolaryngoscopy may be more effective and potentially reduce harm when compared to direct laryngoscopy for endotracheal intubation in neonates.\nWell-designed, adequately powered RCTS are necessary to confirm the efficacy and safety of videolaryngoscopy in neonatal intubation.\n\nGiven the provided abstract, please respond to the following query: \"What is the problem?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "One in 100 newborn babies may need a breathing tube placed in their mouth or nose to keep them alive when they have difficulty breathing. Placing a breathing tube using direct laryngoscopy (without video assistance) may be challenging in newborns because their mouths and airways are small, and not all care providers are experienced."
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query-laysum | 3257 | [
{
"role": "user",
"content": "Abstract: Background\nChronic infection with Pseudomonas aeruginosa (PA) in cystic fibrosis (CF) is a source of much morbidity and mortality. Eradication of early PA infection is possible, but can recur in many individuals. We sought to examine strategies to delay the time to PA recurrence in people with CF.\nObjectives\nTo establish whether secondary prevention strategies, using antibiotics or other therapies, increase the chances of people with CF remaining free from PA infection following successful eradication therapy.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched ongoing trials registries and the reference lists of relevant articles and reviews.\nDate of last search: 21 August 2019.\nSelection criteria\nRandomised controlled trials (and quasi-randomised trials where the risk of bias was low) comparing any treatment modality aimed at preventing recurrence of PA infection with placebo, standard therapy or any other treatment modality in people with CF who have undergone successful eradication of PA.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias. Quality of the evidence was assessed using GRADE. Conflicts were resolved by discussion and the opinion of a third review author was sought where necessary. Only a subset of participants in the included trial were eligible, therefore individual participant data were requested and obtained from the trial investigators.\nMain results\nWe included one trial (n = 306) in the review; however, only 253 participants had undergone successful eradication of PA, so fulfilling the inclusion criteria for our review. Information presented relates only to the included subset of participants. The trial recruited children aged one to 12 years (mean (standard deviation (SD)) age of 5.8 (3.5) years), 129 participants (51.0%) were female and the median follow-up was 494 days. We compared cycled therapy with tobramycin inhalation solution (TIS), in which participants underwent 28 days of TIS every three months, with culture-based therapy, in which participants were only prescribed medication when a quarterly sputum sample was positive for PA. Reasons for downgrading the quality of the evidence included applicability (only included children), incomplete outcome data and a small number of participants.\nThe time to next isolation of PA was probably shorter with cycled TIS therapy than with culture-based therapy, hazard ratio (HR) 2.04 days (95% confidence interval (CI) 1.28 to 3.26) (moderate-quality evidence). This is in contrast to the main publication of the only included trial, which examined rate of PA positivity rather than time to PA infection and included participants not eligible for inclusion in this review. At the end of the trial, there was no difference between the cycled and culture-based groups in the change from baseline in forced expiratory volume in one second (FEV1) L, mean difference (MD) 0.0 L (95% CI -0.09 to 0.09) or in FEV1 % predicted, MD 0.70% (95% CI -4.33 to 5.73) (both very low-quality evidence). There was no difference in the change from baseline for FVC between the groups. There was also no difference in the frequency of pulmonary exacerbations between groups, MD -0.18 (95% CI -0.51 to 0.14) (moderate-quality evidence). Similarly, there was no difference between groups in the risk of participants developing novel resistant bacteria, RR 1.00 (95% CI 0.67 to 1.5) (moderate-quality evidence). There were more severe adverse events in the cycled group, but the type of treatment probably makes little or no difference to the results, RR 0.65 (95% CI 0.39 to 1.11) (moderate-quality evidence).\nThere was no difference between groups in the change in weight or height from baseline or in rates of adherence to tobramycin or all trial medicines. The included trial did not assess changes in quality of life, the time to chronic infection with PA or the cost-effectiveness of treatment.\nAuthors' conclusions\nCycled TIS therapy may be beneficial in prolonging the time to recurrence of PA after successful eradication, but further trials are required, specifically addressing this question and in both adults and children.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "People with CF experience frequent, severe chest infections. These infections may be caused by bacteria that do not cause disease in healthy people, such as PA. PA is an important infection in CF since if it is not treated early it cannot be cleared from the lungs (termed chronic PA). When it cannot be cleared from the lungs, it causes ongoing damage to the lung tissue as well as worse chest infections. People with CF who have chronic PA may be more unwell than those without it.\nEarly treatment can remove PA from the lungs of people with CF, but infection can happen again and is difficult to prevent. We want to know if giving extra treatment after the PA has been successfully treated, can prolong the time to the next infection. The treatment could be antibiotics or another treatment, for example something that helps the person's immune system fight the PA."
}
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query-laysum | 3258 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2018.\nEpilepsy is a common neurological disorder characterised by recurrent seizures. Most people with epilepsy have a good prognosis and their seizures are well controlled by a single antiepileptic drug, but up to 30% develop drug-resistant epilepsy, especially people with focal seizures. In this review, we summarised the evidence from randomised controlled trials (RCTs) of gabapentin, when used as an add-on treatment for drug-resistant focal epilepsy.\nObjectives\nTo evaluate the efficacy and tolerability of gabapentin when used as an add-on treatment for people with drug-resistant focal epilepsy.\nSearch methods\nFor the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) on 11 August 2020. CRS Web includes randomised or quasi-randomised, 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 Specialised Registers of Cochrane Review Groups including Epilepsy. We imposed no language restrictions.\nSelection criteria\nRandomised, placebo-controlled, double-blind, add-on trials of gabapentin in people with drug-resistant focal epilepsy. We also included trials using an active drug control group or comparing different doses of gabapentin.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: seizure frequency, seizure freedom, treatment withdrawal (any reason) and adverse effects. Primary analyses were intention-to-treat. We also undertook sensitivity best-case and worst-case analyses. We estimated summary risk ratios (RR) for each outcome and evaluated dose-response in regression models.\nMain results\nWe identified no new studies for this update, therefore, the results and conclusions are unchanged.\nIn the previous update of this review, we combined data from six trials in meta-analyses of 1206 randomised participants. The overall risk ratio (RR) for reduction in seizure frequency of 50% or more compared to placebo was 1.89 (95% confidence interval (CI) 1.40 to 2.55; 6 studies, 1206 participants; moderate-certainty evidence). Dose regression analysis (for trials in adults) showed increasing efficacy with increasing dose, with 25.3% (95% CI 19.3 to 32.3) of people responding to gabapentin 1800 mg compared to 9.7% on placebo, a 15.5% increase in response rate (95% CI 8.5 to 22.5). The RR for treatment withdrawal compared to placebo was 1.05 (95% CI 0.74 to 1.49; 6 trials, 1206 participants; moderate-certainty evidence). Adverse effects were significantly associated with gabapentin compared to placebo. RRs were as follows: ataxia 2.01 (99% CI 0.98 to 4.11; 3 studies, 787 participants; low-certainty evidence), dizziness 2.43 (99% CI 1.44 to 4.12; 6 studies, 1206 participants; moderate-certainty evidence), fatigue 1.95 (99% CI 0.99 to 3.82; 5 studies, 1161 participants; low-certainty evidence) and somnolence 1.93 (99% CI 1.22 to 3.06; 6 studies, 1206 participants; moderate-certainty evidence). There was no evidence of a difference for the adverse effects of headache (RR 0.79, 99% CI 0.46 to 1.35; 6 studies, 1206 participants; moderate-certainty evidence) or nausea (RR 0.95, 99% CI 0.52 to 1.73; 4 trials, 1034 participants; moderate-certainty evidence). Overall, the studies were at low to unclear risk of bias due to information on each risk of bias domain not being available. We judged the overall certainty of the evidence (using the GRADE approach) as low to moderate due to potential attrition bias resulting from missing outcome data and imprecise results with wide CIs.\nAuthors' conclusions\nGabapentin has efficacy as an add-on treatment in people with drug-resistant focal epilepsy, and seems to be fairly well-tolerated. However, the trials reviewed were of relatively short duration and provide no evidence for the long-term efficacy of gabapentin beyond a three-month period. The results cannot be extrapolated to monotherapy or to people with other epilepsy types. Further trials are needed to assess the long-term effects of gabapentin, and to compare gabapentin with other add-on drugs.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Overall, the quality of evidence was low to moderate as information was not reported for all participants in some of the trials and some of the results were imprecise. Research is needed into the effects of the long-term use of gabapentin, and to compare gabapentin with other add-on medicines.\nThe evidence is current to 11 August 2020."
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query-laysum | 3259 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding without an organic lesion is mainly due to an imbalance of the various hormones which have a regulatory effect on the menstrual cycle. Another cause of heavy menstrual bleeding with no pelvic pathology, is the presence of an acquired or inherited bleeding disorder. The haemostatic system has a central role in controlling the amount and the duration of menstrual bleeding, thus abnormally prolonged or profuse bleeding does occur in most women affected by bleeding disorders. Whereas irregular, pre-menarchal or post-menopausal uterine bleeding is unusual in inherited or acquired haemorrhagic disorders, severe acute bleeding and heavy menstrual bleeding at menarche and chronic heavy menstrual bleeding during the entire reproductive life are common. This is an update of a previously published Cochrane Review.\nObjectives\nTo determine the efficacy and safety of non-surgical interventions versus each other, placebo or no treatment for reducing menstrual blood loss in women with bleeding disorders.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Haemoglobinopathies Trials Register (25 August 2016), Embase (May 2013), LILACS (February 2013) and the WHO International Clinical Trial registry (February 2013).\nSelection criteria\nRandomised controlled studies of non-surgical interventions for treating heavy menstrual bleeding (menorrhagia) in women of reproductive age suffering from a congenital or acquired bleeding disorder.\nData collection and analysis\nTwo authors independently assessed studies for inclusion, extracted data and assessed the risk of bias.\nMain results\nThree cross-over studies, with 175 women were included in the review. All three studies had an unclear risk of bias with regards to trial design and overall, the quality of evidence generated was judged to be poor.\nTwo of the studies (n = 59) compared desmopressin (1-deamino-8-D-arginine vasopressin) with placebo. Menstrual blood loss was the primary outcome for both of these studies. Neither study found clear evidence of a difference between groups. The first of these reported a mean difference in menstrual blood loss in the desmopressin versus placebo group of 21.20 mL (95% confidence interval -19.00 to 61.50)\nThe second study reported that even though there was an improvement of pictorial bleeding assessment chart scores with desmopressin and placebo when compared to pretreatment assessment, there was no clear evidence of difference in these scores when the two were compared to each other (results presented graphically, P = 0.51). The data from these studies could not be combined.\nThe third study (n = 116) compared desmopressin with tranexamic acid (n = 116). This study found a decrease in pictorial bleeding assessment chart scores after both treatments as compared to baseline. The decrease in these scores was greater for tranexamic acid than for desmopressin, with a mean difference of 41.6 mL (95% confidence interval 19.6 to 63) (P < 0.0002).\nIn relation to adverse events, across two studies, there was no clear evidence of a difference when placebo was compared to desmopressin, risk ratio 1.17 (95% confidence interval 0.41 to 3.34) . The same was also true when desmopressin was compared to tranexamic acid, risk ratio 1.17 (95% confidence interval 0.41 to 3.34).\nOnly the study that compared desmopressin to tranexamic acid assessed quality of life. However, we are unable to present any data from this study, since no differences in this outcome between the two intervention groups were reported.\nAuthors' conclusions\nEvidence from randomised controlled studies on the effect of desmopressin when compared to placebo in reducing menstrual blood loss is very limited and inconclusive. Two studies, each with a very limited number of participants, have shown uncertain effects in menstrual blood loss and adverse effects. A non-randomised comparison in one of the studies points to the value of combining desmopressin and tranexamic acid, which needs to be tested in a formal randomised controlled study comparison.\nWhen tranexamic acid was compared to desmopressin, a single study showed a reduction in menstrual blood loss with tranexamic acid use compared to desmopressin.\nThere is a need to evaluate non-surgical methods for treating of menorrhagia in women with bleeding disorders through randomised controlled studies. Such methods would be more acceptable than surgery for women wishing to retain their fertility. Given that women may need to use these treatments throughout their entire reproductive life, long-term side-effects should be evaluated.\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 and safety of non-surgical treatments versus each other, placebo or no treatment for reducing menstrual blood loss in women with bleeding disorders. This is an update of a previously published Cochrane Review."
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query-laysum | 3260 | [
{
"role": "user",
"content": "Abstract: Background\nShortening the duration of radiation therapy would benefit women with early breast cancer treated with breast conserving surgery. It may also improve access to radiation therapy by improving efficiency in radiation oncology departments globally. This can only happen if the shorter treatment is as effective and safe as conventional radiation therapy. This is an update of a Cochrane Review first published in 2008 and updated in 2009.\nObjectives\nTo assess the effect of altered radiation fraction size for women with early breast cancer who have had breast conserving surgery.\nSearch methods\nWe searched the Cochrane Breast Cancer Specialised Register (23 May 2015), CENTRAL (The Cochrane Library 2015, Issue 4), MEDLINE (Jan 1996 to May 2015), EMBASE (Jan 1980 to May 2015), the WHO International Clinical Trials Registry Platform (ICTRP) search portal (June 2010 to May 2015) and ClinicalTrials.gov (16 April 2015), reference lists of articles and relevant conference proceedings. No language or publication constraints were applied.\nSelection criteria\nRandomised controlled trials of altered fraction size versus conventional fractionation for radiation therapy in women with early breast cancer who had undergone breast conserving surgery.\nData collection and analysis\nTwo authors performed data extraction independently, with disagreements resolved by discussion. We sought missing data from trial authors.\nMain results\nWe studied 8228 women in nine studies. Eight out of nine studies were at low or unclear risk of bias. Altered fraction size (delivering radiation therapy in larger amounts each day but over fewer days than with conventional fractionation) did not have a clinically meaningful effect on: local recurrence-free survival (Hazard Ratio (HR) 0.94, 95% CI 0.77 to 1.15, 7095 women, four studies, high-quality evidence), cosmetic outcome (Risk ratio (RR) 0.90, 95% CI 0.81 to 1.01, 2103 women, four studies, high-quality evidence) or overall survival (HR 0.91, 95% CI 0.80 to 1.03, 5685 women, three studies, high-quality evidence). Acute radiation skin toxicity (RR 0.32, 95% CI 0.22 to 0.45, 357 women, two studies) was reduced with altered fraction size. Late radiation subcutaneous toxicity did not differ with altered fraction size (RR 0.93, 95% CI 0.83 to 1.05, 5130 women, four studies, high-quality evidence). Breast cancer-specific survival (HR 0.91, 95% CI 0.78 to 1.06, 5685 women, three studies, high quality evidence) and relapse-free survival (HR 0.93, 95% CI 0.82 to 1.05, 5685 women, three studies, moderate-quality evidence) did not differ with altered fraction size. We found no data for mastectomy rate. Altered fraction size was associated with less patient-reported (P < 0.001) and physician-reported (P = 0.009) fatigue at six months (287 women, one study). We found no difference in the issue of altered fractionation for patient-reported outcomes of: physical well-being (P = 0.46), functional well-being (P = 0.38), emotional well-being (P = 0.58), social well-being (P = 0.32), breast cancer concerns (P = 0.94; 287 women, one study). We found no data with respect to costs.\nAuthors' conclusions\nWe found that using altered fraction size regimens (greater than 2 Gy per fraction) does not have a clinically meaningful effect on local recurrence, is associated with decreased acute toxicity and does not seem to affect breast appearance, late toxicity or patient-reported quality-of-life measures for selected women treated with breast conserving therapy. These are mostly women with node negative tumours smaller than 3 cm and negative pathological margins.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found high quality evidence for the following outcomes: local recurrence-free survival, breast appearance, toxicity, overall survival and breast cancer-specific survival. We found moderate quality evidence for relapse-free survival, and no data for mastectomy rate (mastectomy may be required because of local recurrence or unacceptable treatment-related toxicity) or costs."
}
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query-laysum | 3261 | [
{
"role": "user",
"content": "Abstract: Background\nVarious techniques have been employed for the early detection of perioperative cerebral ischaemia and hypoxia. Cerebral near-infrared spectroscopy (NIRS) is increasingly used in this clinical scenario to monitor brain oxygenation. However, it is unknown whether perioperative cerebral NIRS monitoring and the subsequent treatment strategies are of benefit to patients.\nObjectives\nTo assess the effects of perioperative cerebral NIRS monitoring and corresponding treatment strategies in adults and children, compared with blinded or no cerebral oxygenation monitoring, or cerebral oxygenation monitoring based on non-NIRS technologies, on the detection of cerebral oxygen desaturation events (CDEs), neurological outcomes, non-neurological outcomes and socioeconomic impact (including cost of hospitalization and length of hospital stay).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 12), Embase (1974 to 20 December 2016) and MEDLINE (PubMed) (1975 to 20 December 2016). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing studies on 20 December 2016. We updated this search in November 2017, but these results have not yet been incorporated in the review. We imposed no language restriction.\nSelection criteria\nWe included all relevant randomized controlled trials (RCTs) dealing with the use of cerebral NIRS in the perioperative setting (during the operation and within 72 hours after the operation), including the operating room, the postanaesthesia care unit and the intensive care unit.\nData collection and analysis\nTwo authors independently selected studies, assessed risk of bias and extracted data. For binary outcomes, we calculated the risk ratio (RR) and its 95% confidence interval (CI). For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. As we expected clinical and methodological heterogeneity between studies, we employed a random-effects model for analyses and we examined the data for heterogeneity (I2 statistic). We created a 'Summary of findings' table using GRADEpro.\nMain results\nWe included 15 studies in the review, comprising a total of 1822 adult participants. There are 12 studies awaiting classification, and eight ongoing studies.\nNone of the 15 included studies considered the paediatric population. Four studies were conducted in the abdominal and orthopaedic surgery setting (lumbar spine, or knee and hip replacement), one study in the carotid endarterectomy setting, and the remaining 10 studies in the aortic or cardiac surgery setting. The main sources of bias in the included studies related to potential conflict of interest from industry sponsorship, unclear blinding status or missing participant data.\nTwo studies with 312 participants considered postoperative neurological injury, however no pooled effect estimate could be calculated due to discordant direction of effect between studies (low-quality evidence). One study (N = 126) in participants undergoing major abdominal surgery reported that 4/66 participants experienced neurological injury with blinded monitoring versus 0/56 in the active monitoring group. A second study (N = 195) in participants having coronary artery bypass surgery reported that 1/96 participants experienced neurological injury in the blinded monitoring group compared with 4/94 participants in the active monitoring group.\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on the risk of postoperative stroke because of the low number of events and wide confidence interval (RR 0.25, 95% CI 0.03 to 2.20; 2 studies, 240 participants; low-quality evidence).\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on postoperative delirium because of the wide confidence interval (RR 0.63, 95% CI 0.27 to 1.45; 1 study, 190 participants; low-quality evidence).\nTwo studies with 126 participants showed that active cerebral NIRS monitoring may reduce the incidence of mild postoperative cognitive dysfunction (POCD) as defined by the original studies at one week after surgery (RR 0.53, 95% CI 0.30 to 0.95, I2 = 49%, low-quality evidence).\nBased on six studies with 962 participants, there was moderate-quality evidence that active cerebral oxygenation monitoring probably does not decrease the occurrence of POCD (decline in cognitive function) at one week after surgery (RR 0.62, 95% CI 0.37 to 1.04, I2 = 80%). The different type of monitoring equipment in one study could potentially be the cause of the heterogeneity.\nWe are uncertain whether active cerebral NIRS monitoring has an important effect on intraoperative mortality or postoperative mortality because of the low number of events and wide confidence interval (RR 0.63, 95% CI 0.08 to 5.03, I2= 0%; 3 studies, 390 participants; low-quality evidence). There was no evidence to determine whether routine use of NIRS-based cerebral oxygenation monitoring causes adverse effects.\nAuthors' conclusions\nThe effects of perioperative active cerebral NIRS monitoring of brain oxygenation in adults for reducing the occurrence of short-term, mild POCD are uncertain due to the low quality of the evidence. There is uncertainty as to whether active cerebral NIRS monitoring has an important effect on postoperative stroke, delirium or death because of the low number of events and wide confidence intervals. The conclusions of this review may change when the eight ongoing studies are published and the 12 studies awaiting assessment are classified. More RCTs performed in the paediatric population and high-risk patients undergoing non-cardiac surgery (e.g. neurosurgery, carotid endarterectomy and other surgery) are needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Overall, it is uncertain whether active NIRS monitoring has a crucial effect on postoperative stroke, delirium or death because of the imprecision of the results (low-quality evidence). Therefore, the effects of active cerebral NIRS monitoring on postoperative nervous system injury, delirium, decline in cognitive function and death are uncertain. For some outcomes, such as postoperative stroke or other neurological injury, the evidence was based on few studies with limited numbers of participants. Reporting of outcomes was often incomplete for all study participants, as was reporting of the study design, such as blinding. Some studies had potential conflicts of interest from industry sponsorship."
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query-laysum | 3262 | [
{
"role": "user",
"content": "Abstract: Background\nThe morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a person's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture by stimulating osteoblasts and other bone-forming proteins. This is an update of a review previously published in February 2014.\nObjectives\nTo assess the effects of low-intensity ultrasound (LIPUS), high-intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase (1980 to March 2022), Orthopaedic Proceedings, trial registers and reference lists of articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs including participants over 18 years of age with acute fractures (complete or stress fractures) treated with either LIPUS, HIFUS or ECSW versus a control or placebo-control.\nData collection and analysis\nWe used standard methodology expected by Cochrane. We collected data for the following critical outcomes: participant-reported quality of life, quantitative functional improvement, time to return to normal activities, time to fracture union, pain, delayed or non-union of fracture. We also collected data for treatment-related adverse events. We collected data in the short term (up to three months after surgery) and in the medium term (later than three months after surgery).\nMain results\nWe included 21 studies, involving 1543 fractures in 1517 participants; two studies were quasi-RCTs. Twenty studies tested LIPUS and one trial tested ECSW; no studies tested HIFUS. Four studies did not report any of the critical outcomes.\nAll studies had unclear or high risk of bias in at least one domain. The certainty of the evidence was downgraded for imprecision, risk of bias and inconsistency.\nLIPUS versus control (20 studies, 1459 participants)\nWe found very low-certainty evidence for the effect of LIPUS on Health-related quality of life (HRQoL) measured by SF-36 at up to one year after surgery for lower limb fractures (mean difference (MD) 0.06, 95% confidence interval (CI) -3.85 to 3.97, favours LIPUS; 3 studies, 393 participants). This result was compatible with a clinically important difference of 3 units with both LIPUS or control. There may be little to no difference in time to return to work after people had complete fractures of the upper or lower limbs (MD 1.96 days, 95% CI -2.13 to 6.04, favours control; 2 studies, 370 participants; low-certainty evidence).\nThere is probably little or no difference in delayed union or non-union up to 12 months after surgery (RR 1.25, 95% CI 0.50 to 3.09, favours control; 7 studies, 746 participants; moderate-certainty evidence). Although data for delayed and non-union included both upper and lower limbs, we noted that there were no incidences of delayed or non-union in upper limb fractures. We did not pool data for time to fracture union (11 studies, 887 participants; very low-certainty evidence) because of substantial statistical heterogeneity which we could not explain. In upper limb fractures, MDs ranged from 0.32 to 40 fewer days to fracture union with LIPUS. In lower limb fractures, MDs ranged from 88 fewer days to 30 more days to fracture union. We also did not pool data for pain experienced at one month after surgery in people with upper limb fractures (2 studies, 148 participants; very low-certainty evidence) because of substantial unexplained statistical heterogeneity. Using a 10-point visual analogue scale, one study reported less pain with LIPUS (MD -1.7, 95% CI -3.03 to -0.37; 47 participants), and the effect was less precise in the other study (MD -0.4, 95% CI -0.61 to 0.53; 101 participants). We found little or no difference in skin irritation (a possible treatment-related adverse event) between groups but judged the certainty of the evidence from this small study to be very low (RR 0.94, 95% CI 0.06 to 14.65; 1 study, 101 participants). No studies reported data for functional recovery. Data for treatment adherence were inconsistently reported across studies, but was generally described to be good. Data for costs were reported for one study, with higher direct costs, as well as combined direct and indirect costs, for LIPUS use.\nECSW versus control (1 study, 56 participants)\nWe are uncertain whether ECSW reduces pain at 12 months after surgery in fractures of the lower limb (MD -0.62, 95% CI -0.97 to -0.27, favours ECSW); the difference between pain scores was unlikely to be clinically important, and the certainty of the evidence was very low. We are also uncertain of the effect of ECSW on delayed or non-union at 12 months because the certainty of this evidence is very low (RR 0.56, 95% CI 0.15 to 2.01; 1 study, 57 participants). There were no treatment-related adverse events. This study reported no data for HRQoL, functional recovery, time to return to normal activities, or time to fracture union. In addition, no data were available for adherence or cost.\nAuthors' conclusions\nWe were uncertain of the effectiveness of ultrasound and shock wave therapy for acute fractures in terms of patient-reported outcome measures (PROMS), for which few studies reported data. It is probable that LIPUS makes little or no difference to delayed union or non-union. Future trials should be double-blind, randomised, placebo-controlled trials recording validated PROMs and following up all trial participants. Whilst time to union is difficult to measure, the proportion of participants achieving clinical and radiographic union at each follow-up point should be ascertained, alongside adherence with the study protocol and cost of treatment in order to better inform clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"Why is treating recently broken bones important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Sometimes, broken bones take longer to heal or may not even fully heal. This can reduce people's quality of life, and increase the time needed to return to their normal activities (such as work). A treatment that can help bone to heal would be beneficial to ensure broken bones heal. Sound waves may help broken bones to form new bone by stimulating the area. People can be treated using sound waves by ultrasound or shockwave therapy. Both treatments involve placing a special device in contact with the skin overlying the fracture site for around 20 minutes on a daily basis. Ultrasound therapy using low-energy sound waves, compared to shockwave therapy which uses high-energy sound waves that feel like vibrations on the area that it is applied to."
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query-laysum | 3263 | [
{
"role": "user",
"content": "Abstract: Background\nFetal fibronectin (FFN) is an extracellular matrix glycoprotein localized at the maternal-fetal interface of the amniotic membranes, between chorion and decidua, where it is concentrated in this area between decidua and trophoblast. In normal conditions, FFN is found at very low levels in cervicovaginal secretions. Levels greater than or equal to 50 ng/mL at or after 22 weeks have been associated with an increased risk of spontaneous preterm birth. In fact, FFN is one of the best predictors of preterm birth in all populations studied so far, and can help in selecting which women are at significant risk for preterm birth. This is an update of a review first published in 2008.\nObjectives\nTo assess the effectiveness of management based on knowledge of FFN testing results for preventing preterm birth.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register (7 September 2018), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 September 2018), and reference lists of retrieved studies.\nSelection criteria\nRandomized controlled trials of pregnant women screened with FFN for risk of preterm birth. Studies included are based exclusively on knowledge of FFN results versus no such knowledge, and we have excluded studies including women with only positive or only negative FFN results.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach.\nMain results\nWe identified 16 trials, of which six were eligible for inclusion. The six included studies randomized 546 women with singleton gestations and threatened preterm labor (PTL) at 23 0/7 to 34 6/7 weeks. A total of 277 women were randomized to knowledge and 269 to no knowledge of FFN. No trials were identified on asymptomatic women or multiple gestations.\nThe risk of bias of included studies was mixed. For selected important outcomes, preterm birth before 37, 34, and 32 weeks, and maternal hospitalization, we graded the quality of the evidence and created a 'Summary of findings' table. For these outcomes, the evidence was graded as mainly low quality due to the imprecision of effect estimates.\nManagement based on knowledge of FFN results may reduce preterm birth before 37 weeks (20.7%) versus controls without such knowledge (29.2%) (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.52 to 1.01; 5 trials; 434 women; low-quality evidence). However, management based on knowledge of FFN results may make little or no difference to preterm birth before 34 (RR 1.09, 95% CI 0.54 to 2.18; 4 trials; 357 women; low-quality evidence) or maternal hospitalization (RR 1.06, 95% CI 0.79 to 1.43; 5 trials; 441 women; low-quality evidence). The evidence for preterm birth before 32 weeks is uncertain because the quality was found to be very low (average RR 0.79, 95% CI 0.16 to 3.96; 4 trials; 357 women; very low-quality evidence).\nFor all other outcomes, for which there were available data (preterm birth less than 28 weeks; gestational age at delivery (weeks); birthweight less than 2500 g; perinatal death; tocolysis; steroids for fetal lung maturity; time to evaluate; respiratory distress syndrome; neonatal intensive care unit (NICU) admission; and NICU days), knowledge of FFN results may make little or no difference to the outcomes.\nAuthors' conclusions\nThe evidence from this review suggests that management based on knowledge of FFN results may reduce preterm birth before 37 weeks. However, our confidence in this result is limited as the evidence was found to be of low quality. Effects on other substantive outcomes are uncertain due to serious concerns in study design, inconsistency, and imprecision of effect estimates. No trials were identified on asymptomatic women, or multiple gestations.\nFuture studies are needed that include specific populations (e.g. singleton gestations with symptoms of preterm labor), a study group managed with a protocol based on the FFN results, and that report not only maternal but also important perinatal outcomes. Cost-effectiveness analyses are also needed.\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": "To assess the effectiveness of management of pregnant women based on a knowledge of fetal fibronectin test results for preventing preterm birth, compared with not having that knowledge. Fetal fibronectin (FFN) acts as a ‘glue’ between the pregnancy and the uterus. Normally very low levels of FFN can be found in secretions of the vagina and cervix. Raised levels at or after 22 weeks have been associated with an increased risk of spontaneous preterm birth."
}
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query-laysum | 3264 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculosis causes more deaths than any other infectious disease globally. Bacillus Calmette-Guérin (BCG) is the only available vaccine, but protection is incomplete and variable. The modified Vaccinia Ankara virus expressing antigen 85A (MVA85A) is a viral vector vaccine produced to prevent tuberculosis.\nObjectives\nTo assess and summarize the effects of the MVA85A vaccine boosting BCG in humans.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); and four other databases. We searched the WHO ICTRP and ClinicalTrials.gov. All searches were run up to 10 May 2018.\nSelection criteria\nWe evaluated randomized controlled trials of MVA85A vaccine given with BCG in people regardless of age or HIV status.\nData collection and analysis\nTwo review authors independently assessed the eligibility and risk of bias of trials, and extracted and analyzed data. The primary outcome was active tuberculosis disease. We summarized dichotomous outcomes using risk ratios (RR) and risk differences (RD), with 95% confidence intervals (CI). Where appropriate, we combined data in meta-analyses. Where meta-analysis was inappropriate, we summarized results narratively.\nMain results\nThe search identified six studies relating to four Phase 2 randomized controlled trials enrolling 3838 participants. Funding was by government bodies, charities, and philanthropic donors. Five studies included infants, one of them infants born to HIV-positive mothers. One study included adults living with HIV. All trials included authors from Oxford University who led the laboratory development of the vaccine. Participants received intradermal MVA85A after BCG in some studies, and before selective deferred BCG in HIV-exposed infants.\nThe largest trial in 2797 African children was well conducted with low risk of bias for most parameters. Risk of bias was uncertain for selective reporting because there were no precise case definition endpoints for active tuberculosis published prior to the trial analysis.\nMVA85A added to BCG compared to BCG alone probably has no effect on the risk of developing microbiologically confirmed tuberculosis (RR 0.97, 95% CI 0.58 to 1.62; 3439 participants, 2 trials; moderate-certainty evidence), or the risk of starting on tuberculosis treatment (RR 1.10, 95% CI 0.92 to 1.33; 3687 participants, 3 trials; moderate-certainty evidence). MVA85A probably has no effect on the risk of developing latent tuberculosis (RR 1.01, 95% CI 0.85 to 1.21; 3831 participants, 4 trials; moderate-certainty evidence). Vaccinating people with MVA85A in addition to BCG did not cause life-threatening serious adverse effects (RD 0.00, 95% CI –0.00 to 0.00; 3692 participants, 3 trials; high-certainty evidence). Vaccination with MVA85A is probably associated with an increased risk of local skin adverse effects (3187 participants, 3 trials; moderate-certainty evidence), but not systemic adverse effect related to vaccination (144 participants, 1 trial; low-certainty evidence). This safety profile is consistent with Phase 1 studies which outlined a transient, superficial reaction local to the injection site and mild short-lived symptoms such as malaise and fever.\nAuthors' conclusions\nMVA85A delivered by intradermal injection in addition to BCG is safe but not effective in reducing the risk of developing tuberculosis.\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": "The aim of this Cochrane review was to evaluate the effectiveness and safety of using MVA85A in addition to BCG compared to using BCG alone for prevention of tuberculosis."
}
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query-laysum | 3265 | [
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics are the most common treatment for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be administered both topically and systemically, and can be used alone or in addition to other treatments for CSOM such as ear cleaning (aural toileting).\nObjectives\nTo assess the effects of topical versus systemic antibiotics for people with CSOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks.\nThe studies compared topical antibiotics against systemic (oral, injection) antibiotics. We separated studies according to whether they compared the same type of antibiotic in both treatment groups, or different types of antibiotics. For each comparison we considered whether there was background treatment for both treatment groups, for example aural toileting (ear cleaning).\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not, measured at between one week and up to two weeks, two weeks up to four weeks, and after four weeks), health-related quality of life using a validated instrument, ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.\nMain results\nSix studies (445 participants), all with high risk of bias, were included. All but two studies included patients with confirmed CSOM, where perforation of the ear drum was clearly documented. None of the studies reported results for resolution of ear discharge after four weeks or health-related quality of life.\n1. Topical versus systemic administration of the same type of antibiotics (quinolones)\nFour studies (325 participants) compared topical versus systemic (oral) administration of ciprofloxacin. Three studies reported resolution of ear discharge at one to two weeks and found that the topical administration may slightly increase resolution (risk ratio (RR) 1.48, 95% confidence interval (CI) 1.24 to 1.76; 285 participants; 3 studies; I2 = 0%; low-certainty evidence). In these studies, aural toileting was either not mentioned, or limited to the first visit.\nThree studies (265 participants) reported that they did not suspect ototoxicity in any participants, but it is unclear how this was measured (very low-certainty evidence). No studies reported the outcomes of ear pain or serious complications. No studies reported results for hearing, despite it being measured in three studies.\n2. Topical versus systemic administration of different types of antibiotics (quinolones versus aminoglycosides)\nOne study (60 participants) compared topical ciprofloxacin versus gentamicin injected intramuscularly. No aural toileting was reported. Resolution of ear discharge was not measured at one to two weeks. The study did not report any 'side effects' from which we assumed that no ear pain, suspected ototoxicity or serious complications occurred (very low-certainty evidence). The study stated that \"no worsening of the audiometric function related to local or parenteral therapy was observed\".\n3. Topical versus systemic administration of different types of antibiotics (quinolones versus amoxicillin-clavulanic acid)\nOne study compared topical ofloxacin with amoxicillin-clavulanic acid with all participants receiving suction ear cleaning at the first visit. It is uncertain if there is a difference between the two groups in resolution of ear discharge at one to two weeks due to study limitations and the very small sample size (RR 2.93, 95% CI 1.50 to 5.72; 56 participants; very low-certainty evidence). It is unclear if there is a difference between topical quinolone compared with oral amoxicillin-clavulanic acid with regards to ear pain, hearing or suspected ototoxicity (very low-certainty evidence). No studies reported the outcome of serious complications.\nAuthors' conclusions\nThere was a limited amount of low-quality evidence available, from studies completed over 15 years ago, to examine whether topical or systemic antibiotics are more effective in achieving resolution of ear discharge for people with CSOM. However, amongst this uncertainty there is some evidence to suggest that the topical administration of antibiotics may be more effective than systemic administration of antibiotics in achieving resolution of ear discharge (dry ear). There is limited evidence available regarding different types of antibiotics. It is not possible to determine with any certainty whether or not topical quinolones are better or worse than systemic aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.\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": "Chronic suppurative otitis media (CSOM), also known as chronic otitis media (COM), is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent discharge – fluid that leaks out from a hole or tear in the eardrum – and hearing loss.\nAntibiotics (medicines that fight bacterial infections) are the most common treatment for CSOM. Antibiotics can:\n- be applied to part of the body (locally) in the form of drops, sprays, ointments or creams (topical antibiotics); or\n- treat the whole body (systemic antibiotics) when injected, or taken orally (by mouth).\nTo find out whether topical or systemic antibiotics are better for treating CSOM, and whether they have different adverse (unwanted) effects, we reviewed the evidence from research studies."
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query-laysum | 3266 | [
{
"role": "user",
"content": "Abstract: Background\nProducts sweetened with non-nutritive sweeteners (NNS) are widely available. Many people with type 1 or type 2 diabetes use NNS as a replacement for nutritive sweeteners to control their carbohydrate and energy intake. Health outcomes associated with NNS use in diabetes are unknown.\nObjectives\nTo assess the effects of non-nutritive sweeteners in people with diabetes mellitus.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Scopus, the WHO ICTRP, and ClinicalTrials.gov. The date of the last search of all databases (except for Scopus) was May 2019. We last searched Scopus in January 2019. We did not apply any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of four weeks or more comparing any type of NNS with usual diet, no intervention, placebo, water, a different NNS, or a nutritive sweetener in individuals with type 1 or type 2 diabetes. Trials with concomitant behaviour-changing interventions, such as diet, exercise, or both, were eligible for inclusion, given that the concomitant interventions were the same in the intervention and comparator groups.\nData collection and analysis\nTwo review authors independently screened abstracts, full texts, and records retrieved from trials registries, assessed the certainty of the evidence, and extracted data. We used a random-effects model to perform meta-analysis, and calculated effect estimates as risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs). We assessed risk of bias using the Cochrane 'Risk of bias' tool and the certainty of evidence using the GRADE approach.\nMain results\nWe included nine RCTs that randomised a total of 979 people with type 1 or type 2 diabetes. The intervention duration ranged from 4 to 10 months. We judged none of these trials as at low risk of bias for all ’Risk of bias’ domains; most of the included trials did not report the method of randomisation.\nThree trials compared the effects of a dietary supplement containing NNS with sugar: glycosylated haemoglobin A1c (HbA1c) was 0.4% higher in the NNS group (95% CI −0.5 to 1.2; P = 0.44; 3 trials; 72 participants; very low-certainty evidence). The MD in weight change was −0.1 kg (95% CI −2.7 to 2.6; P = 0.96; 3 trials; 72 participants; very low-certainty evidence). None of the trials with sugar as comparator reported on adverse events.\nFive trials compared NNS with placebo. The MD for HbA1c was 0%, 95% CI −0.1 to 0.1; P = 0.99; 4 trials; 360 participants; very low-certainty evidence. The 95% prediction interval ranged between −0.3% and 0.3%. The comparison of NNS versus placebo showed a MD in body weight of −0.2 kg, 95% CI −1 to 0.6; P = 0.64; 2 trials; 184 participants; very low-certainty evidence. Three trials reported the numbers of participants experiencing at least one non-serious adverse event: 36/113 participants (31.9%) in the NNS group versus 42/118 participants (35.6%) in the placebo group (RR 0.78, 95% CI 0.39 to 1.56; P = 0.48; 3 trials; 231 participants; very low-certainty evidence).\nOne trial compared NNS with a nutritive low-calorie sweetener (tagatose). HbA1c was 0.3% higher in the NNS group (95% CI 0.1 to 0.4; P = 0.01; 1 trial; 354 participants; very low-certainty evidence). This trial did not report body weight data and adverse events.\nThe included trials did not report data on health-related quality of life, diabetes complications, all-cause mortality, or socioeconomic effects.\nAuthors' conclusions\nThere is inconclusive evidence of very low certainty regarding the effects of NNS consumption compared with either sugar, placebo, or nutritive low-calorie sweetener consumption on clinically relevant benefit or harm for HbA1c, body weight, and adverse events in people with type 1 or type 2 diabetes. Data on health-related quality of life, diabetes complications, all-cause mortality, and socioeconomic effects are lacking.\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": "Non-nutritive sweeteners are sweetening agents having higher sweetening intensity and lower calorie content per gram compared to caloric sweeteners like sucrose or corn syrups. Both the general population and diabetic people use non-nutritive sweeteners as a caloric sweetener replacement to control their carbohydrate and energy intake. Most of the non-nutritive sweeteners approved for human consumption are synthetic (artificial sweeteners); however, increasing numbers of natural non-caloric sweeteners are becoming available for human consumption. Products sweetened with non-nutritive sweeteners are widely available on the market: diet beverages, diet yoghourts, desserts, and chewing gums are the most common products containing non-nutritive sweeteners. Non-nutritive sweeteners are also available as table-top sweeteners for use by consumers at home as a sweetening agent for beverages and for cooking and baking.\nThere is very little information about the health consequences of this intensified non-nutritive sweeteners consumption in people with diabetes. We wanted to find out whether non-nutritive sweeteners consumption in people with diabetes has an effect on long-term average blood sugar levels (glycosylated haemoglobin A1c - HbA1c), body weight, side effects, diabetes complications (such as heart attack, eye or kidney disease), and health-related quality of life."
}
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query-laysum | 3267 | [
{
"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: \"Routine vaginal examinations versus vaginal examinations as indicated (one study, 204 women and babies)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Study in Malaysia involving women having their first baby and being induced at term. Compared with vaginal examinations as indicated, routine four-hourly vaginal examinations may result in more women having their labour augmented. There may be little or no effect on spontaneous vaginal birth, chorioamnionitis, neonatal infection, or admission to NICU.\nThe study did not assess our other primary outcomes of positive birth experience or maternal pain."
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query-laysum | 3268 | [
{
"role": "user",
"content": "Abstract: Background\nA blood transfusion is an acute intervention, implemented to solve life and health-threatening conditions on a short-term basis. However, blood transfusions have adverse events, some of them potentially related to immune modulation or to a direct transmission of infectious agents (e.g. cytomegalovirus). Leukoreduction is a process in which the white blood cells are intentionally reduced in packed red blood cells (PRBCs) in order to reduce the risk of adverse reactions. The potential benefits of leukoreduced PRBCs in all types of transfused patients for decreasing infectious and non-infectious complications remain unclear.\nObjectives\nTo determine the clinical effectiveness of leukoreduction of packed red blood cells for preventing adverse reactions following allogeneic blood transfusion.\nSearch methods\nWe ran the most recent search on 10th November 2015. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP), Embase(OvidSP), CINAHL Plus (EBSCO), LILACS (BIREME), and clinical trials registers. In addition, we checked the reference lists of all relevant trials and reviews identified in the literature searches.\nSelection criteria\nRandomised clinical trials including patients of all ages requiring PRBC allogeneic transfusion. Any study was eligible for inclusion, regardless of the length of participant follow-up or country where the study was performed. The primary outcome was transfusion-related acute lung injury (TRALI). Secondary outcomes were death from any cause, infection from any cause, non-infectious complications and any other adverse event.\nData collection and analysis\nAt least two review authors independently performed study selection, 'Risk of bias' assessments and data extraction. We estimated pooled relative risk for dichotomous outcomes, and we measured statistical heterogeneity using I² statistic. The random-effects model was used to synthesise results. We conducted a trial sequential analysis to assess the risk of random errors in cumulative meta-analyses.\nMain results\nThirteen studies, most including adult patients, met the eligibility criteria. We found no clear evidence of an effect of leukoreduced PRBC versus non-leukoreduced PRBC in patients that were randomised to receive transfusion for the following outcomes:\nTRALI: RR 0.96, 95% CI 0.67 to 1.36, P = 0.80 from one trial reporting data on 1864 trauma patients. The accrued information of 1864 participants constituted only 28.5% of the diversity-adjusted required information size (DARIS) of 6548 participants. The quality of evidence was low.\nDeath from any cause: RR 0.81, 95% CI 0.58 to 1.12, I² statistic = 63%, P = 0.20 from nine trials reporting data on 6485 cardiovascular surgical patients, gastro-oncology surgical patients, trauma patients and HIV infected patients. The accrued information of 6485 participants constituted only 55.3% of the DARIS of 11,735 participants. The quality of evidence was very low.\nInfection from any cause: RR 0.80, 95% CI 0.62 to 1.03, I² statistic = 84%, P = 0.08 from 10 trials reporting data on 6709 cardiovascular surgical patients, gastro-oncology surgical patients, trauma patients and HIV infected patients. The accrued information of 6709 participants constituted only 60.6% of the DARIS of 11,062 participants. The quality of evidence was very low.\nAdverse events: The only adverse event reported as an adverse event was fever (RR 0.81, 95% CI 0.64 to 1.02; I² statistic= 0%, P = 0.07). Fever was reported in two trials on 634 cardiovascular surgical and gastro-oncology surgical patients. The accrued information of 634 participants constituted only 84.4% of the DARIS of 751 participants. The quality of evidence was low.\nIncidence of other non-infectious complications: This outcome was not assessed in any included trial.\nAuthors' conclusions\nThere is no clear evidence for supporting or rejecting the routine use of leukoreduction in all patients requiring PRBC transfusion for preventing TRALI, death, infection, non-infectious complications and other adverse events. As the quality of evidence is very low to low, more evidence is needed before a definitive conclusion can be drawn.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The overall quality of evidence of the included studies ranges from very low to low. None of the studies included enough people to give a definitive answer about the usefulness of removing white blood cells from donated blood. New high-quality studies, involving a few thousand people, are needed to enable us to know the true benefits and harms of this procedure."
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query-laysum | 3269 | [
{
"role": "user",
"content": "Abstract: Background\nPrevious Cochrane Reviews have shown that cognitive behavioural therapy (CBT) is effective in treating childhood anxiety disorders. However, questions remain regarding the following: up-to-date evidence of the relative efficacy and acceptability of CBT compared to waiting lists/no treatment, treatment as usual, attention controls, and alternative treatments; benefits across a range of outcomes; longer-term effects; outcomes for different delivery formats; and amongst children with autism spectrum disorders (ASD) and children with intellectual impairments.\nObjectives\nTo examine the effect of CBT for childhood anxiety disorders, in comparison with waitlist/no treatment, treatment as usual (TAU), attention control, alternative treatment, and medication.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (all years to 2016), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO (each to October 2019), international trial registries, and conducted grey literature searches.\nSelection criteria\nWe included randomised controlled trials of CBT that involved direct contact with the child, parent, or both, and included non-CBT comparators (waitlist/no treatment, treatment as usual, attention control, alternative treatment, medication). Participants were younger than age 19, and met diagnostic criteria for an anxiety disorder diagnosis. Primary outcomes were remission of primary anxiety diagnosis post-treatment, and acceptability (number of participants lost to post-treatment assessment), and secondary outcomes included remission of all anxiety diagnoses, reduction in anxiety symptoms, reduction in depressive symptoms, improvement in global functioning, adverse effects, and longer-term effects.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane. We used GRADE to assess the quality of the evidence.\nMain results\nWe included 87 studies and 5964 participants in quantitative analyses.\nCompared with waitlist/no treatment, CBT probably increases post-treatment remission of primary anxiety diagnoses (CBT: 49.4%, waitlist/no treatment: 17.8%; OR 5.45, 95% confidence interval (CI) 3.90 to 7.60; n = 2697, 39 studies, moderate quality); NNTB 3 (95% CI 2.25 to 3.57) and all anxiety diagnoses (OR 4.43, 95% CI 2.89 to 6.78; n = 2075, 28 studies, moderate quality).\nLow-quality evidence did not show a difference between CBT and TAU in post-treatment primary anxiety disorder remission (OR 3.19, 95% CI 0.90 to 11.29; n = 487, 8 studies), but did suggest CBT may increase remission from all anxiety disorders compared to TAU (OR 2.74, 95% CI 1.16 to 6.46; n = 203, 5 studies).\nCompared with attention control, CBT may increase post-treatment remission of primary anxiety disorders (OR 2.28, 95% CI 1.33 to 3.89; n = 822, 10 studies, low quality) and all anxiety disorders (OR 2.75, 95% CI 1.22 to 6.17; n = 378, 5 studies, low quality).\nThere was insufficient available data to compare CBT to alternative treatments on post-treatment remission of primary anxiety disorders, and low-quality evidence showed there may be little to no difference between these groups on post-treatment remission of all anxiety disorders (OR 0.89, 95% CI 0.35 to 2.23; n = 401, 4 studies)\nLow-quality evidence did not show a difference for acceptability between CBT and waitlist/no treatment (OR 1.09, 95% CI 0.85 to 1.41; n=3158, 45 studies), treatment as usual (OR 1.37, 95% CI 0.73 to 2.56; n = 441, 8 studies), attention control (OR 1.00, 95% CI 0.68 to 1.49; n = 797, 12 studies) and alternative treatment (OR 1.58, 95% CI 0.61 to 4.13; n=515, 7 studies).\nNo adverse effects were reported across all studies; however, in the small number of studies where any reference was made to adverse effects, it was not clear that these were systematically monitored.\nResults from the anxiety symptom outcomes, broader outcomes, longer-term outcomes and subgroup analyses are provided in the text.\nWe did not find evidence of consistent differences in outcomes according to delivery formats (e.g. individual versus group; amount of therapist contact time) or amongst samples with and without ASD, and no studies included samples of children with intellectual impairments.\nAuthors' conclusions\nCBT is probably more effective in the short-term than waiting lists/no treatment, and may be more effective than attention control. We found little to no evidence across outcomes that CBT is superior to usual care or alternative treatments, but our confidence in these findings are limited due to concerns about the amount and quality of available evidence, and we still know little about how best to efficiently improve outcomes.\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"
},
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"role": "assistant",
"content": "We rated the overall quality of the evidence as 'moderate’ or 'low'. There is evidence that CBT is more effective than a waiting list or no treatment in reducing anxiety in children and young people, although the findings did vary across studies. There is no clear evidence that CBT is more effective than other treatments. A small number of studies looked at outcomes six months after CBT was given and showed that reductions in anxiety continued. We found no clear evidence that one way of providing CBT is more effective than another (e.g. in a group, longer treatments, with parents) or that CBT is more or less effective for any specific group of children (e.g. children with autism spectrum disorders)."
}
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query-laysum | 3270 | [
{
"role": "user",
"content": "Abstract: Background\nAcute bacterial conjunctivitis is an infection of the conjunctiva and is one of the most common ocular disorders in primary care. Antibiotics are generally prescribed on the basis that they may speed recovery, reduce persistence, and prevent keratitis. However, many cases of acute bacterial conjunctivitis are self-limited, resolving without antibiotic therapy. This Cochrane Review was first published in The Cochrane Library in 1999, then updated in 2006, 2012, and 2022.\nObjectives\nTo assess the benefits and side effects of antibiotic therapy in the management of acute bacterial conjunctivitis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2022, Issue 5), MEDLINE (January 1950 to May 2022), Embase (January 1980 to May 2022), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), 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 in May 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which any form of antibiotic treatment, with or without steroid, had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical and systemic antibiotic treatments.\nData collection and analysis\nTwo authors independently reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies and determined the included RCTs, which were further assessed for risk of bias using Cochrane methodology. We performed data extraction in a standardized manner and conducted random-effects meta-analyses using RevMan Web.\nMain results\nWe included 21 eligible RCTs, 10 of which were newly identified in this update. A total of 8805 participants were randomized. All treatments were topical in the form of drops or ointment. The trials were heterogeneous in terms of their eligibility criteria, the nature of the intervention (antibiotic drug class, which included fluoroquinolones [FQs] and non-FQs; dosage frequency; duration of treatment), the outcomes assessed and the time points of assessment. We judged one trial to be of high risk of bias, four as low risk of bias, and the others as raising some concerns.\nBased on intention-to-treat (ITT) population, antibiotics likely improved clinical cure (resolution of clinical symptoms or signs) by 26% (RR 1.26, 95% CI 1.09 to 1.46; 5 trials, 1474 participants; moderate certainty) as compared with placebo. Subgroup analysis showed no differences by antibiotic class (P = 0.67) or treatment duration (P = 0.60). In the placebo group, 55.5% (408/735) of participants had spontaneous clinical resolution by days 4 to 9 versus 68.2% (504/739) of participants treated with an antibiotic. Based on modified ITT population, in which participants were analyzed after randomization on the basis of positive microbiological culture, antibiotics likely increased microbiological cure (RR 1.53, 95% CI 1.34 to 1.74; 10 trials, 2827 participants) compared with placebo at the end of therapy; there were no subgroup differences by drug class (P = 0.60). No study evaluated the cost-effectiveness of antibiotic treatment. Patients receiving antibiotics had a lower risk of treatment incompletion than those in the placebo group (RR 0.64, 95% CI 0.52 to 0.78; 13 trials, 5573 participants; moderate certainty) and were 27% less likely to have persistent clinical infection (RR 0.73, 95% CI 0.65 to 0.81; 19 trials, 5280 participants; moderate certainty).\nThere was no evidence of serious systemic side effects reported in either the antibiotic or placebo group (very low certainty). When compared with placebo, FQs (RR 0.70, 95% CI 0.54 to 0.90) but not non-FQs (RR 4.05, 95% CI 1.36 to 12.00) may result in fewer participants with ocular side effects. However, the estimated effects were of very low certainty.\nAuthors' conclusions\nThe findings of this update suggest that the use of topical antibiotics is associated with a modestly improved chance of resolution in comparison to the use of placebo. Since no evidence of serious side effects was reported, use of antibiotics may therefore be considered to achieve better clinical and microbiologic efficacy than placebo. Increasing the proportion of participants with clinical cure or increasing the speed of recovery or both are important for individual return to work or school, allowing people to regain quality of life. Future studies may examine antiseptic treatments with topical antibiotics for reasons of cost and growing antibiotic resistance.\n\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"
},
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"role": "assistant",
"content": "Topical antibiotics may improve signs and symptoms as well as bacterial clearance in participants with acute bacterial conjunctivitis. However, some antibiotics can cause unwanted effects on the eyes or eyelids; no evidence suggests that antibiotics cause unwanted effects in other parts of the body."
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query-laysum | 3271 | [
{
"role": "user",
"content": "Abstract: Background\nAn occlusion or stenosis of intracranial large arteries can be detected in the acute phase of ischaemic stroke in about 42% of patients. The approved therapies for acute ischaemic stroke are thrombolysis with intravenous recombinant tissue plasminogen activator (rt-PA), and mechanical thrombectomy; both aim to recanalise an occluded intracranial artery. The reference standard for the diagnosis of intracranial stenosis and occlusion is intra-arterial angiography (IA) and, recently, computed tomography angiography (CTA) and magnetic resonance angiography (MRA), or contrast-enhanced MRA. Transcranial Doppler (TCD) and transcranial colour Doppler (TCCD) are useful, rapid, noninvasive tools for the assessment of intracranial large arteries pathology. Due to the current lack of consensus regarding the use of TCD and TCCD in clinical practice, we systematically reviewed the literature for studies assessing the diagnostic accuracy of these techniques compared with intra-arterial IA, CTA, and MRA for the detection of intracranial stenosis and occlusion in people presenting with symptoms of ischaemic stroke.\nObjectives\nTo assess the diagnostic accuracy of TCD and TCCD for detecting stenosis and occlusion of intracranial large arteries in people with acute ischaemic stroke.\nSearch methods\nWe limited our searches from January 1982 onwards as the transcranial Doppler technique was only introduced into clinical practice in the 1980s. We searched MEDLINE (Ovid) (from 1982 to 2018); Embase (Ovid) (from 1982 to 2018); Database of Abstracts of Reviews of Effects (DARE); and Health Technology Assessment Database (HTA) (from 1982 to 2018). Moreover, we perused the reference lists of all retrieved articles and of previously published relevant review articles, handsearched relevant conference proceedings, searched relevant websites, and contacted experts in the field.\nSelection criteria\nWe included all studies comparing TCD or TCCD (index tests) with IA, CTA, MRA, or contrast-enhanced MRA (reference standards) in people with acute ischaemic stroke, where all participants underwent both the index test and the reference standard within 24 hours of symptom onset. We included prospective cohort studies and randomised studies of test comparisons. We also considered retrospective studies eligible for inclusion where the original population sample was recruited prospectively but the results were analysed retrospectively.\nData collection and analysis\nAt least two review authors independently screened the titles and abstracts identified by the search strategies, applied the inclusion criteria, extracted data, assessed methodological quality (using QUADAS-2), and investigated heterogeneity. We contacted study authors for missing data.\nMain results\nA comprehensive search of major relevant electronic databases (MEDLINE and Embase) from 1982 to 13 March 2018 yielded 13,534 articles, of which nine were deemed eligible for inclusion. The studies included a total of 493 participants. The mean age of included participants was 64.2 years (range 55.8 to 69.9 years). The proportion of men and women was similar across studies. Six studies recruited participants in Europe, one in south America, one in China, and one in Egypt. Risk of bias was high for participant selection but low for flow, timing, index and reference standard. The summary sensitivity and specificity estimates for TCD and TCCD were 95% (95% CI = 0.83 to 0.99) and 95% (95% CI = 0.90 to 0.98), respectively. Considering a prevalence of stenosis or occlusion of 42% (as reported in the literature), for every 1000 people who receive a TCD or TCCD test, stenosis or occlusion will be missed in 21 people (95% CI = 4 to 71) and 29 (95% CI = 12 to 58) will be wrongly diagnosed as harbouring an intracranial occlusion. However, there was substantial heterogeneity between studies, which was no longer evident when only occlusion of the MCA was considered, or when the analysis was limited to participants investigated within six hours. The performance of either TCD or TCCD in ruling in and ruling out a MCA occlusion was good. Limitations of this review were the small number of identified studies and the lack of data on the use of ultrasound contrast medium.\nAuthors' conclusions\nThis review provides evidence that TCD or TCCD, administered by professionals with adequate experience and skills, can provide useful diagnostic information for detecting stenosis or occlusion of intracranial vessels in people with acute ischaemic stroke, or guide the request for more invasive vascular neuroimaging, especially where CT or MR-based vascular imaging are not immediately available. More studies are needed to confirm or refute the results of this review in a larger sample of stroke patients, to verify the role of contrast medium and to evaluate the clinical advantage of the use of ultrasound.\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"
},
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"role": "assistant",
"content": "A comprehensive search of major relevant electronic databases from 1982 to 13 March 2018 identified 13,534 articles but only nine studies met the prespecified inclusion criteria. The nine identified studies included a total of 493 stroke patients with similar proportions of men and women. The average age of included participants was 64.2 years (range 55.8 to 69.9 years). Six studies recruited participants in Europe, one in South America, one in China, and one in Egypt. The results of this review indicate that if TCD or TCCD were to be used in a group of 1000 people with symptoms of acute stroke, which in 420 (42%) of them is caused by a blockage of large arteries in the brain, then 428 would have a positive test result but 29 of these (29/428, 7%) would be wrongly identified as positives even though they would not have a blockage of large arteries. Similarly, an estimated 572 would have a negative test result indicating that their symptoms are not caused by a blockage of large arteries in the brain but 21 (21/572, 4%) of these negative cases would actually have a blockage of the large arteries, which TCD or TCCD have missed. In brief, for people with acute ischaemic stroke, TCD or TCCD can provide clinically helpful information for detecting blockage of large arteries in the brain compared with IA, CTA and MRA. Both tests studied in the review (TCD and TCCD) have shown similar accuracy."
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query-laysum | 3272 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. Before BtA, anticholinergics were the most widely accepted treatment.\nObjectives\nTo compare the efficacy, safety, and tolerability of BtA versus anticholinergic drugs in adults with cervical dystonia.\nSearch methods\nWe searched the Cochrane Movement Disorders' Trials Register to June 2003, screened reference lists of articles and conference proceedings to September 2018, and searched CENTRAL, MEDLINE, and Embase, with no language restrictions, to July 2020.\nSelection criteria\nDouble-blind, parallel, randomised trials (RCTs) of BtA versus anticholinergic drugs in adults with cervical dystonia.\nData collection and analysis\nTwo review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias and quality of the evidence. We resolved disagreements by consensus or by consulting a third review author. If enough data had been available, we were to perform meta-analyses using a random-effects model for the comparison of BtA versus anticholinergic drugs to estimate pooled effects and corresponding 95% confidence intervals (95% CI). The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event.\nMain results\nWe included one RCT of moderate overall risk of bias (as multiple domains were at unclear risk of bias), which included 66 BtA-naive participants with cervical dystonia. Two doses of BtA (Dysport; week 0 and 8; mean dose 262 to 292 U) were compared with daily trihexyphenidyl (up to 24 mg daily). The trial was sponsored by the BtA producer.\nBtA reduced cervical dystonia severity by an average of 2.5 points (95% CI 0.68 to 4.32) on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale 12 weeks after injection, compared to trihexyphenidyl. More participants reported adverse events in the trihexyphenidyl treatment group (76 events), compared with the BtA group (31 events); however, the difference in dropouts due to adverse events was inconclusive between groups. There was a decreased risk of dry mouth, and memory problems with BtA, but the differences were inconclusive between groups for the other reported side effects (blurred vision, dizziness, depression, fatigue, pain at injection site, dysphagia, and neck weakness).\nAuthors' conclusions\nWe found very low-certainty evidence that BtA is more effective, better tolerated, and safer than trihexyphenidyl.\nWe found no information on a dose-response relationship with BtA, differences between BtA formulations or different anticholinergics, the utility of electromyography-guided injections, or the duration of treatment 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": "Cervical dystonia, also called spasmodic torticollis, is a disorder that causes undesired, uncontrollable, often painful, abnormal placement of the head. It is a relatively uncommon condition, affecting 57 to 280 people per million. It can be very disabling, and have a negative affect on a person's quality of life. In most cases, the cause is unknown; there is no cure. Since cervical dystonia is normally a long-term disorder, it requires long-term treatment.\nBotulinum toxin type A and anticholinergic drugs are powerful chemical substances that cause a diverse range of responses in the human body. BtA causes severe localised paralysis (an inability to move in the part of the body where it is injected). Anticholinergics, usually taken by mouth, cause more widespread symptoms, and can result in a dry mouth, visual disturbances, bowel and bladder difficulties, increased heart rate, sedation, and confusion or disorientation. Both can be used to treat many conditions, in particular, those with involuntary muscle contractions, such as cervical dystonia."
}
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query-laysum | 3273 | [
{
"role": "user",
"content": "Abstract: Background\nThe occurrence of factor inhibitory antibodies, or inhibitors, is a significant complication in the care of individuals with congenital haemophilia A or B. Currently, immune tolerance induction is the only known intervention to successfully eradicate inhibitors. However, ideal dosing regimens, and the comparative safety and efficacy of different immune tolerance induction regimens have not yet been established.\nObjectives\nThe objective of this review was to assess the effects of immune tolerance induction (different protocols of this therapy versus each other, or versus only bypassing agents) for treating inhibitors in people with congenital haemophilia A or B.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched: MEDLINE (from 1946 to 15 July 2013); Embase (from 1980 to 15 July 2013) via the OVID platform; CINAHL (from conception to 15 July 2013); and ClinicalTrials.gov (most recent search: 15 July 2013). We also searched the reference lists of relevant articles and reviews.\nSelection criteria\nRandomised controlled trials comparing either different immune tolerance induction regimens or immune tolerance induction versus only bypassing therapy for the eradication of factor inhibitory antibodies in patients with congenital haemophilia A or B.\nData collection and analysis\nTwo review authors independently completed data collection, extraction and assessment of the risk of bias of trials.\nMain results\nOne methodologically sound randomised controlled trial met the inclusion criteria and was included in the review. One further randomised controlled trial has been recently stopped, but it has not yet been reported.\nThe included multinational trial randomised 115 paediatric participants with severe haemophilia A and high-responding inhibitors, for whom this was the first attempt at immune tolerance induction, to receive either a low dose (50 IU/kg of factor VIII concentrate three times per week) or a high dose (200 IU/kg of factor VIII daily). Although, there was no statistically significant difference in the success of immune tolerance induction between treatment arms, the confidence intervals were too wide to infer no effect: 24 out of 58 participants (46.6%) in the low-dose group and 22 out of 57 (38.6%) in the high-dose group experiencing full tolerance, risk ratio 1.07 (95% CI 0.68 to 1.68) (moderate quality evidence). The rate of infection was not statistically different between groups, but again confidence intervals were too wide. Of those patients who had a central venous catheter device, 19 out of 47 participants (40.4%) in the low-dose arm had 69 infections, and 22 out of 52 participants (42.3%) in the high-dose arm had 55 infections, risk ratio 0.96 (95% CI 0.60 to 1.53) (moderate quality evidence). However, participants in the low-dose immune tolerance induction group experienced significantly more bleeding episodes (50 out of 58 participants (86.2%) experienced one or more bleeding events) than those in the high-dose group (36 out of 57 participants (63.1%) experienced one or more bleeding events), risk ratio 1.36 (95% CI 1.09 to 1.71) (low quality evidence). One factor VIII reaction, one incidence of trauma and 13 incidences of needing to insert or remove the catheter were reported as trial-related serious adverse events; however, the treatment group where these events occurred was not specified. No incidence of nephrotic syndrome was reported.\nAuthors' conclusions\nWe did not find any randomised controlled trial-based comparison of immune tolerance induction with alternate treatment schemes (i.e. bypassing agents for bleeding only). In a single randomised trial, there were no significant differences in the immune tolerance induction success rate between different dosing regimens, which may have been due to imprecision of the estimate. There is low-quality evidence to suggest that high-dose immune tolerance induction may induce tolerance more quickly which is associated with fewer bleeding complications. The choice of immune tolerance induction regimen should be considered individually for each case, until further research provides additional evidence.\n\nGiven the provided abstract, please respond to the following query: \"Key results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The single included trial was too small to be certain that both doses of immune tolerance induction were equally successful at removing inhibitors. However, the high-dose treatment destroyed all inhibitors faster and with less bleeding events than the low-dose treatment. Since there was only one available trial, further trials are needed to establish the best immune tolerance induction regimen with respect to starting time, dosing intensity and frequency."
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query-laysum | 3274 | [
{
"role": "user",
"content": "Abstract: Background\nSurvival rates have greatly improved as a result of more effective treatments for childhood cancer. Unfortunately, the improved prognosis has been accompanied by the occurrence of late, treatment-related complications. Liver complications are common during and soon after treatment for childhood cancer. However, among long-term childhood cancer survivors, the risk of hepatic late adverse effects is largely unknown. To make informed decisions about future cancer treatment and follow-up policies, it is important to know the risk of, and associated risk factors for, hepatic late adverse effects. This review is an update of a previously published Cochrane review.\nObjectives\nTo evaluate all the existing evidence on the association between antineoplastic treatment (that is, chemotherapy, radiotherapy involving the liver, surgery involving the liver and BMT) for childhood cancer and hepatic late adverse effects.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2018, Issue 1), MEDLINE (1966 to January 2018) and Embase (1980 to January 2018). In addition, we searched reference lists of relevant articles and scanned the conference proceedings of the International Society of Paediatric Oncology (SIOP) (from 2005 to 2017) and American Society of Pediatric Hematology/Oncology (ASPHO) (from 2013 to 2018) electronically.\nSelection criteria\nAll studies, except case reports, case series, and studies including fewer than 10 patients that examined the association between antineoplastic treatment for childhood cancer (aged 18 years or less at diagnosis) and hepatic late adverse effects (one year or more after the end of treatment).\nData collection and analysis\nTwo review authors independently performed the study selection and 'risk of bias' assessment. The 'risk of bias' assessment was based on earlier checklists for observational studies. For the original version of the review, two review authors independently performed data extraction. For the update of the review, the data extraction was performed by one reviewer and checked by another reviewer.\nMain results\nThirteen new studies were identified for the update of this review. In total, we included 33 cohort studies including 7876 participants investigating hepatic late adverse effects after antineoplastic treatment (especially chemotherapy and radiotherapy) for different types of childhood cancer, both haematological and solid malignancies. All studies had methodological limitations. The prevalence of hepatic late adverse effects, all defined in a biochemical way, varied widely, between 0% and 84.2%. Selecting studies where the outcome of hepatic late adverse effects was well-defined as alanine aminotransferase (ALT) above the upper limit of normal, indicating cellular liver injury, resulted in eight studies. In this subgroup, the prevalence of hepatic late adverse effects ranged from 5.8% to 52.8%, with median follow-up durations varying from three to 23 years since cancer diagnosis in studies that reported the median follow-up duration. A more stringent selection process using the outcome definition of ALT as above twice the upper limit of normal, resulted in five studies, with a prevalence ranging from 0.9% to 44.8%. One study investigated biliary tract injury, defined as gamma-glutamyltransferase (γGT) above the upper limit of normal and above twice the upper limit of normal and reported a prevalence of 5.3% and 0.9%, respectively. Three studies investigated disturbance in biliary function, defined as bilirubin above the upper limit of normal and reported prevalences ranging from 0% to 8.7%. Two studies showed that treatment with radiotherapy involving the liver (especially after a high percentage of the liver irradiated), higher BMI, and longer follow-up time or older age at evaluation increased the risk of cellular liver injury in multivariable analyses. In addition, there was some suggestion that busulfan, thioguanine, hepatic surgery, chronic viral hepatitis C, metabolic syndrome, use of statins, non-Hispanic white ethnicity, and higher alcohol intake (> 14 units per week) increase the risk of cellular liver injury in multivariable analyses. Chronic viral hepatitis was shown to increase the risk of cellular liver injury in six univariable analyses as well. Moreover, one study showed that treatment with radiotherapy involving the liver, higher BMI, higher alcohol intake (> 14 units per week), longer follow-up time, and older age at cancer diagnosis increased the risk of biliary tract injury in a multivariable analysis.\nAuthors' conclusions\nThe prevalence of hepatic late adverse effects among studies with an adequate outcome definition varied considerably from 1% to 53%. Evidence suggests that radiotherapy involving the liver, higher BMI, chronic viral hepatitis and longer follow-up time or older age at follow-up increase the risk of hepatic late adverse effects. In addition, there may be a suggestion that busulfan, thioguanine, hepatic surgery, higher alcohol intake (>14 units per week), metabolic syndrome, use of statins, non-Hispanic white ethnicity, and older age at cancer diagnosis increase the risk of hepatic late adverse effects. High-quality studies are needed to evaluate the effects of different therapy doses, time trends, and associated risk factors after antineoplastic treatment for childhood cancer.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is current to January 2018.\nWe found 33 cohort studies examining liver adverse effects after treatment for childhood cancer. There were 7876 cancer patients included that were treated for different types of childhood cancer, especially with chemotherapy, radiotherapy, and bone marrow transplantation. The average follow-up duration in the studies that reported this varied from two years after the end of treatment to 25 years since primary cancer diagnosis."
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query-laysum | 3275 | [
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"role": "user",
"content": "Abstract: Background\nLactoferrin, a normal component of human colostrum and milk, can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis (NEC) in preterm neonates.\nObjectives\nTo assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates. Secondarily, we assessed the effects of lactoferrin supplementation to enteral feeds on the duration of positive-pressure ventilation, development of chronic lung disease (CLD) or periventricular leukomalacia (PVL), length of hospital stay to discharge among survivors, and adverse neurological outcomes at two years of age or later.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to update our search. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 9), MEDLINE via PubMed (1966 to 20 January 2020), PREMEDLINE (1996 to 20 January 2020), Embase (1980 to 20 January 2020), and CINAHL (1982 to 20 January 2020). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.\nSelection criteria\nIn our search, we included randomized controlled trials (RCTs) evaluating enteral lactoferrin supplementation at any dose or duration to prevent sepsis or NEC in preterm neonates.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal and the GRADE approach to assess the certainty of evidence.\nMain results\nMeta-analysis of data from twelve randomized controlled trials showed that lactoferrin supplementation to enteral feeds decreased suspected or confirmed late-onset sepsis (typical RR 0.80, 95% CI 0.72 to 0.89; typical RD -0.05, 95% CI, -0.07 to -0.02; NNTB 20, 95% CI 14 to 50; 12 studies, 5425 participants, low-certainty evidence) and decreased length of hospital stay (MD -2.38 to 95% CI, -4.67 to -0.09; 3 studies, 1079 participants, low-certainty evidence). A subgroup analysis including data of infants with confirmed sepsis demonstrates a decrease in confirmed late-onset sepsis (typical RR 0.83, 95% CI 0.73 to 0.94; typical RD -0.03, 95% CI, -0.04 to -0.01; NNTB 33, 95% CI 25 to 100; 12 studies, 5425 participants, low-certainty evidence).\nSensitivity analysis including only good methodological certainty studies suggested a decrease in late-onset sepsis (both suspected and confirmed) with enteral lactoferrin supplementation (typical RR 0.82, 95% CI, 0.74 to 0.91; typical RD -0.04, 95% CI, -0.06 to -0.02; NNTB 20, 95% CI 14 to 50; 9 studies, 4702 participants, low-certainty evidence).\nThere were no differences in NEC stage II or III (typical RR 1.10, 95% CI, 0.86 to 1.41; typical RD -0.00, 95% CI, -0.02 to 0.01; 7 studies, 4874 participants; low-certainty evidence) or 'all-cause mortality' (typical RR 0.90, 95% CI 0.69 to 1.17; typical RD -0.00, 95% CI, -0.01 to 0.01; 11 studies, 5510 participants; moderate-certainty evidence). One study reported no differences in neurodevelopmental testing by Mullen's or Bayley III at 24 months of age after enteral lactoferrin supplementation (one study, 292 participants, low-certainty evidence).\nLactoferrin supplementation to enteral feeds with probiotics decreased late-onset sepsis (RR 0.25, 95% CI 0.14 to 0.46; RD -0.13, 95% CI -0.18 to -0.08; NNTB 8, 95% CI 6 to 13; 3 studies, 564 participants; low-certainty evidence) and NEC stage II or III (RR 0.04, 95% CI 0.00 to 0.62; RD -0.05, 95% CI -0.08 to -0.03; NNTB 20, 95% CI 12.5 to 33.3; 1 study, 496 participants; very low-certainty evidence), but not 'all-cause mortality' (very low-certainty evidence).\nLactoferrin supplementation to enteral feeds with or without probiotics had no effect on CLD, duration of mechanical ventilation or threshold retinopathy of prematurity (low-certainty evidence). Investigators reported no adverse effects in the included studies.\nAuthors' conclusions\nWe found low-certainty evidence from studies of good methodological quality that lactoferrin supplementation of enteral feeds decreases late-onset sepsis (both suspected and confirmed, and confirmed only) but not NEC ≥ stage II or 'all cause mortality' or neurodevelopmental outcomes at 24 months of age in preterm infants without adverse effects. Low- to very low-certainty evidence suggests that lactoferrin supplementation of enteral feeds in combination with probiotics decreases late-onset sepsis (data from confirmed sepsis only) and NEC ≥ stage II in preterm infants without adverse effects, however, there were few included studies of poor methodological quality. The presence of publication bias and small studies of poor methodology that may inflate the effect size make recommendations for clinical practice difficult.\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": "Does administering lactoferrin with feeds decrease the risk of sepsis or necrotizing enterocolitis in preterm babies?"
}
]
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query-laysum | 3276 | [
{
"role": "user",
"content": "Abstract: Background\nThere is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment).\nObjectives\nTo evaluate the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two trials registers up to 15 August 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review included five RCTs with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events.\nMcKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention - main comparison)\nThere is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.30, 95% CI -12.04 to -2.56; 2 trials, 328 participants) but not in the intermediate term (MD -5.00, 95% CI -14.29 to 4.29; 1 trial, 180 participants).\nThere is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.74, 95% CI -7.52 to 2.04; 2 trials, 328 participants) nor in the intermediate term (MD -0.87, 95% CI -7.31 to 5.57; 1 trial, 180 participants).\nMcKenzie method versus manual therapy\nThere is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.67, 95% CI -27.37 to 10.02; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.00, 95% CI 0.70 to 13.30; 1 trial, 235 participants).\nThere is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -4.98, 95% CI -15.00 to 5.04; 3 trials, 298 participants) nor in the intermediate term (MD 4.30, 95% CI -0.72 to 9.32; 1 trial, 235 participants).\nMcKenzie method versus other interventions (massage and advice)\nThere is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.00, 95% CI -15.44 to 23.44; 1 trial, 30 participants) nor in the intermediate term (MD 10.00, 95% CI -8.95 to 28.95; 1 trial, 25 participants).\nAuthors' conclusions\nBased on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review included trials published up to 15 August 2022."
}
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query-laysum | 3277 | [
{
"role": "user",
"content": "Abstract: Background\nHepatorenal syndrome is a potentially reversible renal failure associated with severe liver disease. The disease is relatively common among people with decompensated cirrhosis. Terlipressin is a drug that increases the blood flow to the kidneys by constricting blood vessels. The previous version of this systematic review found a potential beneficial effect of terlipressin on mortality and renal function in people with cirrhosis and hepatorenal syndrome.\nObjectives\nTo assess the beneficial and harmful effects of terlipressin versus placebo/no intervention for people with cirrhosis and hepatorenal syndrome.\nSearch methods\nWe identified eligible trials through searches of the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, and Science Citation Index Expanded, and manual searches until 21 November 2016.\nSelection criteria\nRandomised clinical trials (RCTs) involving participants with cirrhosis and type 1 or type 2 hepatorenal syndrome allocated to terlipressin versus placebo or no intervention. We allowed co-administration with albumin administered to both comparison groups.\nData collection and analysis\nTwo review authors independently extracted data from trial reports and undertook correspondence with the authors. Primary outcomes were mortality, hepatorenal syndrome, and serious adverse events. We conducted sensitivity analyses of RCTs in which participants received albumin, subgroup analyses of participants with type 1 or type 2 hepatorenal syndrome, and Trial Sequential Analyses to control random errors. We reported random-effects meta-analyses with risk ratios (RR) and 95% confidence intervals (CI). We assessed the risk of bias based on the Cochrane Hepato-Biliary Group domains. We graded the quality of the evidence using GRADE.\nMain results\nWe included nine RCTs with a total of 534 participants with cirrhosis and ascites. One RCT had a low risk of bias for mortality and a high risk of bias for the remaining outcomes. All included trials had a high risk of bias for non-mortality outcomes. In total, 473 participants had type 1 hepatorenal syndrome. Seven RCTs specifically evaluated terlipressin and albumin. Terlipressin was associated with a beneficial effect on mortality when including all RCTs (RR 0.85, 95% CI 0.73 to 0.98; 534 participants; number needed to treat for an additional beneficial outcome (NNTB) 10.3 people; low-quality evidence). Trial Sequential Analysis including all RCTs also found a beneficial effect of terlipressin. Additional analyses showed a beneficial effect of terlipressin and albumin on reversal of hepatorenal syndrome (RR 0.63, 95% CI 0.48 to 0.82; 510 participants; 8 RCTs; NNTB 4 people; low-quality evidence). Terlipressin increased the risk of serious cardiovascular adverse events (RR 7.26, 95% CI 1.70 to 31.05; 234 participants; 4 RCTs), but it had no effect on the risk of serious adverse events when analysed as a composite outcome (RR 0.91, 95% CI 0.68 to 1.21; 534 participants; 9 RCTs; number needed to treat for an additional harmful outcome 24.5 people; low-quality evidence). Non-serious adverse events were mainly gastrointestinal, including diarrhoea (RR 5.76, 95% CI 2.19 to 15.15; 240 participants; low-quality evidence) and abdominal pain (RR 1.54, 95% CI 0.97 to 2.43; 294 participants; low-quality evidence).\nWe identified one ongoing trial on terlipressin versus placebo in participants with cirrhosis, ascites, and hepatorenal syndrome type 1.\nThree RCTs reported funding from a pharmaceutical company. The remaining trials did not report funding or did not receive funding from pharmaceutical companies.\nAuthors' conclusions\nThis review suggests that terlipressin may be associated with beneficial effects on mortality and renal function in people with cirrhosis and type 1 hepatorenal syndrome, but it is also associated with serious adverse effects. We downgraded the strength of the evidence due to methodological issues including bias control, clinical heterogeneity, and imprecision. Consequently, additional evidence is needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review includes nine randomised clinical trials (RCTs) and a total of 534 participants. The trials originated from six countries. Seven trials included only participants with type 1 hepatorenal syndrome. Two trials included a total of 96 participants with type 1 or type 2 hepatorenal syndrome."
}
]
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query-laysum | 3278 | [
{
"role": "user",
"content": "Abstract: Background\nEnhancing health equity is endorsed in the Sustainable Development Goals. The failure of systematic reviews to consider potential differences in effects across equity factors is cited by decision-makers as a limitation to their ability to inform policy and program decisions.\nObjectives\nTo explore what methods systematic reviewers use to consider health equity in systematic reviews of effectiveness.\nSearch methods\nWe searched the following databases up to 26 February 2021: MEDLINE, PsycINFO, the Cochrane Methodology Register, CINAHL, Education Resources Information Center, Education Abstracts, Criminal Justice Abstracts, Hein Index to Foreign Legal Periodicals, PAIS International, Social Services Abstracts, Sociological Abstracts, Digital Dissertations and the Health Technology Assessment Database. We searched SCOPUS to identify articles that cited any of the included studies on 10 June 10 2021. We contacted authors and searched the reference lists of included studies to identify additional potentially relevant studies.\nSelection criteria\nWe included empirical studies of cohorts of systematic reviews that assessed methods for measuring effects on health inequalities. We define health inequalities as unfair and avoidable differences across socially stratifying factors that limit opportunities for health. We operationalised this by assessing studies which evaluated differences in health across any component of the PROGRESS-Plus acronym, which stands for Place of residence, Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status, Social capital. \"Plus\" stands for other factors associated with discrimination, exclusion, marginalisation or vulnerability such as personal characteristics (e.g. age, disability), relationships that limit opportunities for health (e.g. children in a household with parents who smoke) or environmental situations which provide limited control of opportunities for health (e.g. school food environment).\nData collection and analysis\nTwo review authors independently extracted data using a pre-tested form. Risk of bias was appraised for included studies according to the potential for bias in selection and detection of systematic reviews.\nMain results\nIn total, 48,814 studies were identified and the titles and abstracts were screened in duplicate. In this updated review, we identified an additional 124 methodological studies published in the 10 years since the first version of this review, which included 34 studies. Thus, 158 methodological studies met our criteria for inclusion. The methods used by these studies focused on evidence relevant to populations experiencing health inequity (108 out of 158 studies), assess subgroup analysis across PROGRESS-Plus (26 out of 158 studies), assess analysis of a gradient in effect across PROGRESS-Plus (2 out of 158 studies) or use a combination of subgroup analysis and focused approaches (20 out of 158 studies). The most common PROGRESS-Plus factors assessed were age (43 studies), socioeconomic status in 35 studies, low- and middle-income countries in 24 studies, gender or sex in 22 studies, race or ethnicity in 17 studies, and four studies assessed multiple factors across which health inequity may exist.\nOnly 16 studies provided a definition of health inequity. Five methodological approaches to consider health equity in systematic reviews of effectiveness were identified: 1) descriptive assessment of reporting and analysis in systematic reviews (140 of 158 studies used a type of descriptive method); 2) descriptive assessment of reporting and analysis in original trials (50 studies); 3) analytic approaches which assessed differential effects across one or more PROGRESS-Plus factors (16 studies); 4) applicability assessment (25 studies) and 5) stakeholder engagement (28 studies), which is a new finding in this update and examines the appraisal of whether relevant stakeholders with lived experience of health inequity were included in the design of systematic reviews or design and delivery of interventions. Reporting for both approaches (analytic and applicability) lacked transparency and was insufficiently detailed to enable the assessment of credibility.\nAuthors' conclusions\nThere is a need for improvement in conceptual clarity about the definition of health equity, describing sufficient detail about analytic approaches (including subgroup analyses) and transparent reporting of judgments required for applicability assessments in order to consider health equity in systematic reviews of effectiveness.\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 up to date to February 2021.\n"
}
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query-laysum | 3279 | [
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for adults with fibromyalgia. We defined whole body vibration (WBV) exercise as use of a vertical or rotary oscillating platform as an exercise stimulus while the individual engages in sustained static positioning or dynamic movements. The individual stands on the platform, and oscillations result in vibrations transmitted to the subject through the legs. This review is one of a series of reviews that replaces the first review published in 2002.\nObjectives\nTo evaluate benefits and harms of WBV exercise training in adults with fibromyalgia.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, CINAHL, PEDro, Thesis and Dissertation Abstracts, AMED, WHO ICTRP, and ClinicalTrials.gov up to December 2016, unrestricted by language, to identify potentially relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with the diagnosis of fibromyalgia based on published criteria including a WBV intervention versus control or another intervention. Major outcomes were health-related quality of life (HRQL), pain intensity, stiffness, fatigue, physical function, withdrawals, and adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, performed risk of bias assessments, and assessed the quality of evidence for major outcomes using the GRADE approach. We used a 15% threshold for calculation of clinically relevant differences.\nMain results\nWe included four studies involving 150 middle-aged female participants from one country. Two studies had two treatment arms (71 participants) that compared WBV plus mixed exercise plus relaxation versus mixed exercise plus relaxation and placebo WBV versus control, and WBV plus mixed exercise versus mixed exercise and control; two studies had three treatment arms (79 participants) that compared WBV plus mixed exercise versus control and mixed relaxation placebo WBV. We judged the overall risk of bias as low for selection (random sequence generation), detection (objectively measured outcomes), attrition, and other biases; as unclear for selection bias (allocation concealment); and as high for performance, detection (self-report outcomes), and selective reporting biases.\nThe WBV versus control comparison reported on three major outcomes assessed at 12 weeks post intervention based on the Fibromyalgia Impact Questionnaire (FIQ) (0 to 100 scale, lower score is better). Results for HRQL in the control group at end of treatment (59.13) showed a mean difference (MD) of -3.73 (95% confidence interval [CI] -10.81 to 3.35) for absolute HRQL, or improvement of 4% (11% better to 3% worse) and relative improvement of 6.7% (19.6% better to 6.1% worse). Results for withdrawals indicate that 14 per 100 and 10 per 100 in the intervention and control groups, respectively, withdrew from the intervention (RR 1.43, 95% CI 0.27 to 7.67; absolute change 4%, 95% CI 16% fewer to 24% more; relative change 43% more, 95% CI 73% fewer to 667% more). The only adverse event reported was acute pain in the legs, for which one participant dropped out of the program. We judged the quality of evidence for all outcomes as very low. This study did not measure pain intensity, fatigue, stiffness, or physical function. No outcomes in this comparison met the 15% threshold for clinical relevance.\nThe WBV plus mixed exercise (aerobic, strength, flexibility, and relaxation) versus control study (N = 21) evaluated symptoms at six weeks post intervention using the FIQ. Results for HRQL at end of treatment (59.64) showed an MD of -16.02 (95% CI -31.57 to -0.47) for absolute HRQL, with improvement of 16% (0.5% to 32%) and relative change in HRQL of 24% (0.7% to 47%). Data showed a pain intensity MD of -28.22 (95% CI -43.26 to -13.18) for an absolute difference of 28% (13% to 43%) and a relative change of 39% improvement (18% to 60%); as well as a fatigue MD of -33 (95% CI -49 to -16) for an absolute difference of 33% (16% to 49%) and relative difference of 47% (95% CI 23% to 60%); and a stiffness MD of -26.27 (95% CI -42.96 to -9.58) for an absolute difference of 26% (10% to 43%) and a relative difference of 36.5% (23% to 60%). All-cause withdrawals occurred in 8 per 100 and 33 per 100 withdrawals in the intervention and control groups, respectively (two studies, N = 46; RR 0.25, 95% CI 0.06 to 1.12) for an absolute risk difference of 24% (3% to 51%). One participant exhibited a mild anxiety attack at the first session of WBV. No studies in this comparison reported on physical function. Several outcomes (based on the findings of one study) in this comparison met the 15% threshold for clinical relevance: HRQL, pain intensity, fatigue, and stiffness, which improved by 16%, 39%, 46%, and 36%, respectively. We found evidence of very low quality for all outcomes.\nThe WBV plus mixed exercise versus other exercise provided very low quality evidence for all outcomes. Investigators evaluated outcomes on a 0 to 100 scale (lower score is better) for pain intensity (one study, N = 23; MD -16.36, 95% CI -29.49 to -3.23), HRQL (two studies, N = 49; MD -6.67, 95% CI -14.65 to 1.31), fatigue (one study, N = 23; MD -14.41, 95% CI -29.47 to 0.65), stiffness (one study, N = 23; MD -12.72, 95% CI -26.90 to 1.46), and all-cause withdrawal (three studies, N = 77; RR 0.72, 95% CI -0.17 to 3.11). Adverse events reported for the three studies included one anxiety attack at the first session of WBV and one dropout from the comparison group (\"other exercise group\") due to an injury that was not related to the program. No studies reported on physical function.\nAuthors' conclusions\nWhether WBV or WBV in addition to mixed exercise is superior to control or another intervention for women with fibromyalgia remains uncertain. The quality of evidence is very low owing to imprecision (few study participants and wide confidence intervals) and issues related to risk of bias. These trials did not measure major outcomes such as pain intensity, stiffness, fatigue, and physical function. Overall, studies were few and were very small, which prevented meaningful estimates of harms and definitive conclusions about WBV safety.\n\nGiven the provided abstract, please respond to the following query: \"Stiffness\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Vibration training plus exercise was 26% better than control (or 26 points, ranging from 10 to 43).\n• People who had training rated their fatigue at 42 points.\n• People who had no training rated their fatigue at 69 points."
}
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query-laysum | 3280 | [
{
"role": "user",
"content": "Abstract: Background\nLand-based exercise training improves exercise capacity and quality of life in people with chronic obstructive pulmonary disease (COPD). Water-based exercise training is an alternative mode of physical exercise training that may appeal to the older population attending pulmonary rehabilitation programmes, those who are unable to complete land-based exercise programmes and people with COPD with comorbid physical and medical conditions.\nObjectives\nTo assess the effects of water-based exercise training in people with COPD.\nSearch methods\nA search of the Cochrane Airways Group Specialised Register of trials, which is derived from systematic searches of bibliographic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED and PsycINFO, was conducted (from inception to August 2013). Handsearching was done to identify further qualifying studies from reference lists of relevant studies.\nSelection criteria\nReview authors included randomised or quasi-randomised controlled trials in which water-based exercise training of at least four weeks' duration was compared with no exercise training or any other form of exercise training in people with COPD. Swimming was excluded.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nFive studies were included with a total of 176 participants (71 people participated in water-based exercise training and 54 in land-based exercise training; 51 completed no exercise training). All studies compared supervised water-based exercise training versus land-based exercise training and/or no exercise training in people with COPD (with average forced expiratory volume in one second (FEV1) %predicted ranging from 39% to 62%). Sample sizes ranged from 11 to 53 participants. The exercise training programmes lasted from four to 12 weeks, and the mean age of participants ranged from 57 to 73 years. A moderate risk of bias was due to lack of reporting of randomisation, allocation and blinding procedures in some studies, as well as small sample sizes.\nCompared with no exercise, water-based exercise training improved the six-minute walk distance (mean difference (MD) 62 metres; 95% confidence interval (CI) 44 to 80 metres; three studies; 99 participants; moderate quality evidence), the incremental shuttle walk distance (MD 50 metres; 95% CI 20 to 80 metres; one study; 30 participants; high quality evidence) and the endurance shuttle walk distance (MD 371 metres; 95% CI 121 to 621 metres; one study; 30 participants; high quality evidence). Quality of life was also improved after water-based exercise training compared with no exercise (standardised mean difference (SMD) -0.97, 95% CI -0.37 to -1.57; two studies; 49 participants; low quality evidence). Compared with land-based exercise training, water-based exercise training did not significantly change the six-minute walk distance (MD 11 metres; 95% CI -11 to 33 metres; three studies; 62 participants; moderate quality evidence) or the incremental shuttle walk distance (MD 9 metres; 95% CI -15 to 34 metres; two studies; 59 participants; low quality evidence). However, the endurance shuttle walk distance improved following water-based exercise training compared with land-based exercise training (MD 313 metres; 95% CI 232 to 394 metres; two studies; 59 participants; moderate quality evidence). No significant differences were found between water-based exercise training and land-based exercise training for quality of life, as measured by the St George's Respiratory Questionnaire or by three of four domains of the Chronic Respiratory Disease Questionnaire (CRDQ); however, the fatigue domain of the CRDQ showed a statistically significant difference in favour of water-based exercise (MD -3.00; 95% CI -5.26 to -0.74; one study; 30 participants). Only one study reported long-term outcomes after water-based exercise training for quality of life and body composition, and no significant change was observed between baseline results and six-month follow-up results. One minor adverse event was reported for water-based exercise training (based on reporting from two studies; 20 participants). Impact of disease severity could not be examined because data were insufficient.\nAuthors' conclusions\nThere is limited quality evidence that water-based exercise training is safe and improves exercise capacity and quality of life in people with COPD immediately after training. There is limited quality evidence that water-based exercise training offers advantages over land-based exercise training in improving endurance exercise capacity, but we remain uncertain as to whether it leads to better quality of life. Little evidence exists examining the long-term effect of water-based exercise training.\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": "Land-based exercise training (such as walking or cycling) improves exercise capacity and quality of life in people with COPD. Water-based exercise training is an alternative mode of physical exercise training that may appeal to the older population, those who are unable to complete land-based exercise programmes and people with COPD who also have other physical and medical conditions. We did not include swimming interventions."
}
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query-laysum | 3281 | [
{
"role": "user",
"content": "Abstract: Background\nThe common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8 ºC). Whilst the common cold is generally not harmful, it is a cause of economic burden due to school and work absenteeism. In the United States, economic loss due to the common cold is estimated at more than USD 40 billion per year, including an estimate of 70 million workdays missed by employees, 189 million school days missed by children, and 126 million workdays missed by parents caring for children with a cold. Additionally, data from Europe show that the total cost per episode may be up to EUR 1102. There is also a large expenditure due to inappropriate antimicrobial prescription. Vaccine development for the common cold has been difficult due to antigenic variability of the common cold viruses; even bacteria can act as infective agents. Uncertainty remains regarding the efficacy and safety of interventions for preventing the common cold in healthy people, thus we performed an update of this Cochrane Review, which was first published in 2011 and updated in 2013 and 2017.\nObjectives\nTo assess the clinical effectiveness and safety of vaccines for preventing the common cold in healthy people.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (April 2022), MEDLINE (1948 to April 2022), Embase (1974 to April 2022), CINAHL (1981 to April 2022), and LILACS (1982 to April 2022). We also searched three trials registers for ongoing studies, and four websites for additional trials (April 2022). We did not impose any language or date restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) of any virus vaccine compared with placebo to prevent the common cold in healthy people.\nData collection and analysis\nWe used Cochrane’s Screen4Me workflow to assess the initial search results. Four review authors independently performed title and abstract screening to identify potentially relevant studies. We retrieved the full-text articles for those studies deemed potentially relevant, and the review authors independently screened the full-text reports for inclusion in the review, recording reasons for exclusion of the excluded studies. Any disagreements were resolved by discussion or by consulting a third review author when needed. Two review authors independently collected data on a data extraction form, resolving any disagreements by consensus or by involving a third review author. We double-checked data transferred into Review Manager 5 software. Three review authors independently assessed risk of bias using RoB 1 tool as outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We carried out statistical analysis using Review Manager 5. We did not conduct a meta-analysis, and we did not assess publication bias. We used GRADEpro GDT software to assess the certainty of the evidence and to create a summary of findings table.\nMain results\nWe did not identify any new RCTs for inclusion in this update. This review includes one RCT conducted in 1965 with an overall high risk of bias. The RCT included 2307 healthy young men in a military facility, all of whom were included in the analyses, and compared the effect of three adenovirus vaccines (live, inactivated type 4, and inactivated type 4 and 7) against a placebo (injection of physiological saline or gelatin capsule). There were 13 (1.14%) events in 1139 participants in the vaccine group, and 14 (1.19%) events in 1168 participants in the placebo group. Overall, we do not know if there is a difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; very low-certainty evidence). Furthermore, no difference in adverse events when comparing live vaccine preparation with placebo was reported. We downgraded the certainty of the evidence to very low due to unclear risk of bias, indirectness because the population of this study was only young men, and imprecision because confidence intervals were wide and the number of events was low. The included study did not assess vaccine-related or all-cause mortality.\nAuthors' conclusions\nThis Cochrane Review was based on one study with very low-certainty evidence, which showed that there may be no difference between the adenovirus vaccine and placebo in reducing the incidence of the common cold. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Future trials on interventions for preventing the common cold should assess a variety of virus vaccines for this condition, and should measure such outcomes as common cold incidence, vaccine safety, and mortality (all-cause and related to the vaccine).\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We assessed the certainty of the evidence as very low due to high risk of bias; because the study population was only young men; and due to the small number of people included in the study and low numbers of colds."
}
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query-laysum | 3282 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However, gastrointestinal problems such as constipation and distal intestinal obstruction syndrome (DIOS) are also important and well-recognised complications in CF. They share similar symptoms e.g. bloating, abdominal pain, but are distinct conditions. Constipation occurs when there is gradual faecal impaction of the colon, but DIOS occurs when there is an accumulation of faeces and sticky mucus, forming a mass in the distal part of the small intestine. The mass may partially block the intestine (incomplete DIOS) or completely block the intestine (complete DIOS). Symptoms of DIOS can affect quality of life and other aspects of CF health, such as airway clearance, exercise, sleep and nutritional status. Treatment of constipation and prevention of complete bowel obstruction are required for gastrointestinal management in CF. However, many different strategies are used in clinical practice and there is a lack of consensus. The importance of this topic was highlighted in a recent research priority setting exercise by the James Lind Alliance.\nObjectives\nTo evaluate the effectiveness and safety of laxative agents of differing types for preventing DIOS (complete and incomplete) in children and adults with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of search: 09 September 2021.\nWe also searched online trial registries. Date of last search: 12 October 2021.\nSelection criteria\nRandomised and quasi-randomised controlled parallel trials comparing laxative therapy for preventing DIOS (including osmotic agents, stimulants, mucolytics and substances with more than one action) at any dose to placebo, no treatment or an alternative laxative therapy, in people of any age with pancreatic sufficient or insufficient CF and any stage of lung disease. Randomised cross-over trials were judged on an individual basis.\nData collection and analysis\nTwo authors independently assessed trials for inclusion, extracted outcome data and performed a risk of bias assessment for the included data. We judged the certainty of the evidence using GRADE criteria.\nMain results\nWe included one cross-over trial (17 participants) with a duration of 12 months, in which participants were randomly allocated to either cisapride (a gastro-prokinetic agent) or placebo for six months each. The trial had an unclear risk of bias for most domains but had a high risk of reporting bias.\nRadiograph scores revealed no difference in occurrence of DIOS between cisapride and placebo (narrative report, no data provided). There were no adverse effects. Symptom scores were the only secondary outcome within the review that were reported. Total gastrointestinal symptom scores favoured cisapride with a statistically significant mean difference (MD) of -7.60 (95% confidence interval (CI) -14.73 to -0.47). There was no significant difference at six months between cisapride and placebo for abdominal distension, MD -0.90 (95% CI -2.39 to 0.59) or abdominal pain, MD -0.4 (95% CI -2.05 to 1.25). The global symptom scores (whether individuals felt better or worse) were reported in the paper to favour cisapride and be statistically significant (P < 0.05).\nWe assessed the available data to be very low certainty. There was a great deal of missing data from the included trial and the investigators failed to report numerical data for many outcomes. The overall risk of bias of the trial was unclear and it had a high risk for reporting bias. There was also indirectness; the trial drug (cisapride) has since been removed from the market in several countries due to adverse effects, thus it has no current applicability for preventing DIOS. The included trial also had very few participants, which downgraded the certainty a further level for precision.\nAuthors' conclusions\nThere is an absence of evidence for interventions for the prevention of DIOS. As there was only one included trial, we could not perform a meta-analysis of the data. Furthermore, the included trial compared a prokinetic agent (cisapride) that is no longer licensed for use in a number of countries due to the risk of serious cardiac events, a finding that came to light after the trial was conducted. Therefore, the limited findings from the trial are not applicable in current clinical practice.\nOverall, a great deal more research needs to be undertaken on gastrointestinal complications in CF, as this is a very poorly studied area compared to respiratory complications in CF.\n\nGiven the provided abstract, please respond to the following query: \"Trial characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included one trial in the review, which included 17 people aged between 13 to 35 years. These people were randomly put into groups to take either a placebo drug (with no active medication) or cisapride for six months each and then to cross over and take the alternative treatment for a further six months."
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query-laysum | 3283 | [
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"role": "user",
"content": "Abstract: Background\nConstruction workers are frequently exposed to various types of injury-inducing hazards. There are a number of injury prevention interventions, yet their effectiveness is uncertain.\nObjectives\nTo assess the effects of interventions for preventing injuries in construction workers.\nSearch methods\nWe searched the Cochrane Injuries Group's specialised register, CENTRAL (issue 3), MEDLINE, Embase and PsycINFO up to April 2017. The searches were not restricted by language or publication status. We also handsearched the reference lists of relevant papers and reviews.\nSelection criteria\nRandomised controlled trials, controlled before-after (CBA) studies and interrupted time-series (ITS) of all types of interventions for preventing fatal and non-fatal injuries among workers at construction sites.\nData collection and analysis\nTwo review authors independently selected studies, extracted data and assessed their risk of bias. For ITS studies, we re-analysed the studies and used an initial effect, measured as the change in injury rate in the year after the intervention, as well as a sustained effect, measured as the change in time trend before and after the intervention.\nMain results\nSeventeen studies (14 ITS and 3 CBA studies) met the inclusion criteria in this updated version of the review. The ITS studies evaluated the effects of: introducing or changing regulations that laid down safety and health requirements for the construction sites (nine studies), a safety campaign (two studies), a drug-free workplace programme (one study), a training programme (one study), and safety inspections (one study) on fatal and non-fatal occupational injuries. One CBA study evaluated the introduction of occupational health services such as risk assessment and health surveillance, one evaluated a training programme and one evaluated the effect of a subsidy for upgrading to safer scaffoldings. The overall risk of bias of most of the included studies was high, as it was uncertain for the ITS studies whether the intervention was independent from other changes and thus could be regarded as the main reason of change in the outcome. Therefore, we rated the quality of the evidence as very low for all comparisons.\nCompulsory interventions\nRegulatory interventions at national or branch level may or may not have an initial effect (effect size (ES) of −0.33; 95% confidence interval (CI) −2.08 to 1.41) and may or may not have a sustained effect (ES −0.03; 95% CI −0.30 to 0.24) on fatal and non-fatal injuries (9 ITS studies) due to highly inconsistent results (I² = 98%). Inspections may or may not have an effect on non-fatal injuries (ES 0.07; 95% CI −2.83 to 2.97; 1 ITS study).\nEducational interventions\nSafety training interventions may result in no significant reduction of non-fatal injuries (1 ITS study and 1 CBA study).\nInformational interventions\nWe found no studies that had evaluated informational interventions alone such as campaigns for risk communication.\nPersuasive interventions\nWe found no studies that had evaluated persuasive interventions alone such as peer feedback on workplace actions to increase acceptance of safe working methods.\nFacilitative interventions\nMonetary subsidies to companies may lead to a greater decrease in non-fatal injuries from falls to a lower level than no subsidies (risk ratio (RR) at follow-up: 0.93; 95% CI 0.30 to 2.91 from RR 3.89 at baseline; 1 CBA study).\nMultifaceted interventions\nA safety campaign intervention may result in an initial (ES −1.82; 95% CI −2.90 to −0.74) and sustained (ES −1.30; 95% CI −1.79 to −0.81) decrease in injuries at the company level (1 ITS study), but not at the regional level (1 ITS study). A multifaceted drug-free workplace programme at the company level may reduce non-fatal injuries in the year following implementation by −7.6 per 100 person-years (95% CI −11.2 to −4.0) and in the years thereafter by −2.0 per 100 person-years (95% CI −3.5 to −0.5) (1 ITS study). Introducing occupational health services may result in no decrease in fatal or non-fatal injuries (one CBA study).\nAuthors' conclusions\nThe vast majority of interventions to adopt safety measures recommended by standard texts on safety, consultants and safety courses have not been adequately evaluated. There is very low-quality evidence that introducing regulations as such may or may not result in a decrease in fatal and non-fatal injuries. There is also very low-quality evidence that regionally oriented safety campaigns, training, inspections or the introduction of occupational health services may not reduce non-fatal injuries in construction companies. There is very low-quality evidence that company-oriented safety interventions such as a multifaceted safety campaign, a multifaceted drug workplace programme and subsidies for replacement of scaffoldings may reduce non-fatal injuries among construction workers. More studies, preferably cluster-randomised controlled trials, are needed to evaluate different strategies to increase the employers' and workers' adherence to the safety measures prescribed by regulation.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for studies that had been published up to 1 April 2017."
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query-laysum | 3284 | [
{
"role": "user",
"content": "Abstract: Background\nA combination of weekly pegylated interferon (peginterferon) alpha and daily ribavirin still represents standard treatment of chronic hepatitis C infection in the majority of patients. However, it is not established which of the two licensed peginterferon products, peginterferon alpha-2a or peginterferon alpha-2b, is the most effective and has a better safety profile.\nObjectives\nTo systematically evaluate the benefits and harms of peginterferon alpha-2a versus peginterferon alpha-2b in head-to-head randomised clinical trials in 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) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and LILACS until October 2013. We also searched conference abstracts, journals, and grey literature.\nSelection criteria\nWe included randomised clinical trials comparing peginterferon alpha-2a versus peginterferon alpha-2b given with or without co-intervention(s) (for example, ribavirin) for chronic hepatitis C. Quasi-randomised studies and observational studies as identified by the searches were also considered for assessment of harms. Our primary outcomes were all-cause mortality, liver-related morbidity, serious adverse events, adverse events leading to treatment discontinuation, other adverse events, and quality of life. The secondary outcome was sustained virological response in the blood serum.\nData collection and analysis\nTwo authors independently used a standardised data collection form. We meta-analysed data with both the fixed-effect and the random-effects models. For each outcome we calculated the relative risk (RR) 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 risks of random errors (play of chance). Intervention effects on the outcomes were assessed according to GRADE.\nMain results\nWe included 17 randomised clinical trials which compared peginterferon alpha-2a plus ribavirin versus peginterferon alpha-2b plus ribavirin in 5847 patients. All trials had a high risk of bias. Very few trials reported data on very few patients for the patient-relevant outcomes all-cause mortality, liver-related morbidity, serious adverse events, and quality of life. Accordingly, we were unable to conduct meta-analyses on all-cause mortality, liver-related morbidity, and quality of life. Twelve trials reported on adverse events leading to discontinuation of treatment without clear evidence of a difference between the two peginterferons (197/2171 (9.1%) versus 311/3169 (9.9%); RR 0.84, 95% CI 0.57 to 1.22; I2 = 44%; low quality evidence). A trial sequential analysis showed that we could exclude a relative risk reduction of 20% or more on this outcome. Peginterferon alpha-2a significantly increased the number of patients who achieved a sustained virological response in the blood serum compared with peginterferon alpha-2b (1069/2099 (51%) versus 1327/3075 (43%); RR 1.12, 95% CI 1.06 to 1.18; I2= 0%, 12 trials; moderate quality evidence). Trial sequential analyses supported this result. Subgroup analyses based on risk of bias, viral genotype, and treatment history yielded similar results. Trial sequential analyses supported the results in patients with genotypes 1 and 4, but not in patients with genotypes 2 and 3.\nAuthors' conclusions\nThere is lack of evidence on patient-important outcomes and paucity of evidence on adverse events. Moderate quality evidence suggests that peginterferon alpha-2a is associated with a higher sustained virological response in serum than with peginterferon alpha-2b. This finding may be affected by the high risk of bias of the included studies . The clinical consequences of peginterferon alpha-2a versus peginterferon alpha-2b are unknown, and we cannot translate an effect on sustained virological response into comparable clinical effects because sustained virological response is still an unvalidated surrogate outcome for patient-important outcomes. The lack of evidence on patient-important outcomes and the paucity of evidence on adverse events means that we are unable to draw any conclusions about the effects of one peginterferon over the other.\n\nGiven the provided abstract, please respond to the following query: \"Importance of the review or background on the condition\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Hepatitis C is a disease of the liver caused by the hepatitis C virus. Globally, an estimated 170 million people are chronically infected with hepatitis C virus. Chronic hepatitis C can cause liver damage in the form of inflammation and scarring of the liver (cirrhosis). Liver damage can lead to liver failure and other complications, including liver cancer. The aim of the treatment for chronic hepatitis C is to prevent complications of hepatitis C infection. This might be achieved by clearing the virus from the blood of the patient. However, we still need to understand if clearance of virus from blood has any association with patient-relevant and clinically-relevant outcomes. A combination of weekly injections of peginterferon alpha and daily oral ribavirin still represents the standard of care for the majority of patients with chronic hepatitis C. Currently, there are two licensed products of peginterferon, peginterferon alpha-2a and peginterferon alpha-2b, on the market."
}
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query-laysum | 3285 | [
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"role": "user",
"content": "Abstract: Background\nVascular endothelial growth factor (VEGF) plays a key role in angiogenesis in foetal life. Researchers have recently attempted to use anti-VEGF agents for the treatment of retinopathy of prematurity (ROP), a vasoproliferative disorder. The safety and efficacy of these agents in preterm infants with ROP is currently uncertain.\nObjectives\nTo evaluate the efficacy and safety of anti-VEGF drugs when used either as monotherapy, that is without concomitant cryotherapy or laser therapy, or in combination with planned cryo/laser therapy in preterm infants with type 1 ROP (defined as zone I any stage with plus disease, zone I stage 3 with or without plus disease, or zone II stage 2 or 3 with plus disease).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 11), MEDLINE (1966 to 11 December 2016), Embase (1980 to 11 December 2016), CINAHL (1982 to 11 December 2016), and conference proceedings.\nSelection criteria\nRandomised or quasi-randomised controlled trials that evaluated the efficacy or safety of administration, or both, of anti-VEGF agents compared with conventional therapy in preterm infants with ROP.\nData collection and analysis\nWe used standard Cochrane and Cochrane Neonatal methods for data collection and analysis. We used the GRADE approach to assess the quality of the evidence.\nMain results\nSix trials involving a total of 383 infants fulfilled the inclusion criteria. Five trials compared intravitreal bevacizumab (n = 4) or ranibizumab (n = 1) with conventional laser therapy (monotherapy), while the sixth study compared intravitreal pegaptanib plus conventional laser therapy with laser/cryotherapy (combination therapy).\nWhen used as monotherapy, bevacizumab/ranibizumab did not reduce the risk of complete or partial retinal detachment (3 studies; 272 infants; risk ratio (RR) 1.04, 95% confidence interval (CI) 0.21 to 5.13; risk difference (RD) 0.00, 95% CI -0.04 to 0.04; very low-quality evidence), mortality before discharge (2 studies; 229 infants; RR 1.50, 95% CI 0.26 to 8.75), corneal opacity requiring corneal transplant (1 study; 286 eyes; RR 0.34, 95% CI 0.01 to 8.26), or lens opacity requiring cataract removal (3 studies; 544 eyes; RR 0.15, 95% CI 0.01 to 2.79). The risk of recurrence of ROP requiring retreatment also did not differ between groups (2 studies; 193 infants; RR 0.88, 95% CI 0.47 to 1.63; RD -0.02, 95% CI -0.12 to 0.07; very low-quality evidence). Subgroup analysis showed a significant reduction in the risk of recurrence in infants with zone I ROP (RR 0.15, 95% CI 0.04 to 0.62), but an increased risk of recurrence in infants with zone II ROP (RR 2.53, 95% CI 1.01 to 6.32). Pooled analysis of studies that reported eye-level outcomes also revealed significant increase in the risk of recurrence of ROP in the eyes that received bevacizumab (RR 5.36, 95% CI 1.22 to 23.50; RD 0.10, 95% CI 0.03 to 0.17). Infants who received intravitreal bevacizumab had a significantly lower risk of refractive errors (very high myopia) at 30 months of age (1 study; 211 eyes; RR 0.06, 95% CI 0.02 to 0.20; RD -0.40, 95% CI -0.50 to -0.30; low-quality evidence).\nWhen used in combination with laser therapy, intravitreal pegaptanib was found to reduce the risk of retinal detachment when compared to laser/cryotherapy alone (152 eyes; RR 0.26, 95% CI 0.12 to 0.55; RD -0.29, 95% CI -0.42 to -0.16; low-quality evidence). The incidence of recurrence of ROP by 55 weeks' postmenstrual age was also lower in the pegaptanib + laser therapy group (76 infants; RR 0.29, 95% CI 0.12 to 0.7; RD -0.35, 95% CI -0.55 to -0.16; low-quality evidence). There was no difference in the risk of perioperative retinal haemorrhages between the two groups (152 eyes; RR 0.62, 95% CI 0.24 to 1.56; RD -0.05, 95% CI -0.16 to 0.05; very low-quality evidence). However, the risk of delayed systemic adverse effects with any of the three anti-VEGF drugs is not known.\nAuthors' conclusions\nImplications for practice: Intravitreal bevacizumab/ranibizumab, when used as monotherapy, reduces the risk of refractive errors during childhood but does not reduce the risk of retinal detachment or recurrence of ROP in infants with type 1 ROP. While the intervention might reduce the risk of recurrence of ROP in infants with zone I ROP, it can potentially result in higher risk of recurrence requiring retreatment in those with zone II ROP. Intravitreal pegaptanib, when used in conjunction with laser therapy, reduces the risk of retinal detachment as well as the recurrence of ROP in infants with type 1 ROP. However, the quality of the evidence was very low to low for most outcomes due to risk of detection bias and other biases. The effects on other critical outcomes and, more importantly, the long-term systemic adverse effects of the drugs are not known. Insufficient data precludes strong conclusions favouring routine use of intravitreal anti-VEGF agents - either as monotherapy or in conjunction with laser therapy - in preterm infants with type 1 ROP.\nImplications for research: Further studies are needed to evaluate the effect of anti-VEGF agents on structural and functional outcomes in childhood and delayed systemic effects including adverse neurodevelopmental outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched scientific databases in December 2016 for studies evaluating the efficacy and safety of intravitreal therapy with anti-VEGF agents in preterm infants with ROP. We identified six randomised controlled trials involving 383 infants. Five trials compared intravitreal bevacizumab or ranibizumab with conventional laser therapy. One trial compared intravitreal pegaptanib plus laser therapy with laser/cryotherapy alone."
}
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query-laysum | 3286 | [
{
"role": "user",
"content": "Abstract: Background\nSevoflurane is an inhaled volatile anaesthetic that is widely used in paediatric anaesthetic practice. Since its introduction, postoperative behavioural disturbance known as emergence agitation (EA) or emergence delirium (ED) has been recognized as a problem that may occur during recovery from sevoflurane anaesthesia. For the purpose of this systematic review, EA has been used to describe this clinical entity. A child with EA may be restless, may cause self-injury or may disrupt the dressing, surgical site or indwelling devices, leading to the potential for parents to be dissatisfied with their child's anaesthetic. To prevent such outcomes, the child may require pharmacological or physical restraint. Sevoflurane may be a major contributing factor in the development of EA. Therefore, an evidence-based understanding of the risk/benefit profile regarding sevoflurane compared with other general anaesthetic agents and adjuncts would facilitate its rational and optimal use.\nObjectives\nTo compare sevoflurane with other general anaesthetic (GA) agents, with or without pharmacological or non-pharmacological adjuncts, with regard to risk of EA in children during emergence from anaesthesia. The primary outcome was risk of EA; secondary outcome was agitation score.\nSearch methods\nWe searched the following databases from the date of inception to 19 January 2013: CENTRAL, Ovid MEDLINE, Ovid EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (EBSCOhost), Evidence-Based Medicine Reviews (EBMR) and the Web of Science, as well as the reference lists of other relevant articles and online trial registers.\nSelection criteria\nWe included all randomized (or quasi-randomized) controlled trials investigating children < 18 years of age presenting for general anaesthesia with or without surgical intervention. We included any study in which a sevoflurane anaesthetic was compared with any other GA, and any study in which researchers investigated adjuncts (pharmacological or non-pharmacological) to sevoflurane anaesthesia compared with no adjunct or placebo.\nData collection and analysis\nTwo review authors independently searched the databases, decided on inclusion eligibility of publications, ascertained study quality and extracted data. They then resolved differences between their results by discussion. Data were entered into RevMan 5.2 for analyses and presentation. Comparisons of the risk of EA were presented as risk ratios (RRs) with 95% confidence intervals (CIs). Sevoflurane is treated as the control anaesthesia in this review. Sensitivity analyses were performed as appropriate, to exclude studies with a high risk of bias and to investigate heterogeneity.\nMain results\nWe included 158 studies involving 14,045 children. Interventions to prevent EA fell into two broad groups. First, alternative GA compared with sevoflurane anaesthesia (69 studies), and second, use of an adjunct with sevoflurane anaesthesia versus sevoflurane without an adjunct (100 studies). The overall risk of bias in included studies was low. The overall Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) assessment of the quality of the evidence was moderate to high. A wide range of EA scales were used, as were different levels of cutoff, to determine the presence or absence of EA. Some studies involved children receiving potentially inadequate or no analgesia intraoperatively during painful procedures.\nHalothane (RR 0.51, 95% CI 0.41 to 0.63, 3534 participants, high quality of evidence) and propofol anaesthesia were associated with a lower risk of EA than sevoflurane anaesthesia. Propofol was effective when used throughout anaesthesia (RR 0.35, 95% CI 0.25 to 0.51, 1098 participants, high quality of evidence) and when used only during the maintenance phase of anaesthesia after sevoflurane induction (RR 0.59, 95% CI 0.46 to 0.76, 738 participants, high quality of evidence). No clear evidence was found of an effect on risk of EA of desflurane (RR 1.46, 95% CI 0.92 to 2.31, 408 participants, moderate quality of evidence) or isoflurane (RR 0.76, 95% CI 0.46 to 1.23, 379 participants, moderate quality of evidence) versus sevoflurane.\nCompared with no adjunct, effective adjuncts for reducing the risk of EA during sevoflurane anaesthesia included dexmedetomidine (RR 0.37, 95% CI 0.29 to 0.47, 851 participants, high quality of evidence), clonidine (RR 0.45, 95% CI 0.31 to 0.66, 739 participants, high quality of evidence), opioids, in particular fentanyl (RR 0.37, 95% CI 0.27 to 0.50, 1247 participants, high quality of evidence) and a bolus of propofol (RR 0.58, 95% CI 0.38 to 0.89, 394 participants, moderate quality of evidence), ketamine (RR 0.30, 95% CI 0.13 to 0.69, 231 participants, moderate quality of evidence) or midazolam (RR 0.57, 95% CI 0.41 to 0.81, 116 participants, moderate quality of evidence) at the end of anaesthesia. Midazolam oral premedication (RR 0.81, 95% CI 0.59 to 1.12, 370 participants, moderate quality of evidence) and parental presence at emergence (RR 0.91, 95% CI 0.51 to 1.60, 180 participants, moderate quality of evidence) did not reduce the risk of EA.\nOne or more factors designated as high risk of bias were noted in less than 10% of the included studies. Sensitivity analyses of these studies showed no clinically relevant changes in the risk of EA. Heterogeneity was significant with respect to these comparisons: halothane; clonidine; fentanyl; midazolam premedication; propofol 1 mg/kg bolus at end; and ketamine 0.25 mg/kg bolus at end of anaesthesia. With investigation of heterogeneity, the only clinically relevant changes to findings were seen in the context of potential pain, namely, the setting of adenoidectomy/adenotonsillectomy (propofol bolus; midazolam premedication) and the absence of a regional block (clonidine).\nAuthors' conclusions\nPropofol, halothane, alpha-2 agonists (dexmedetomidine, clonidine), opioids (e.g. fentanyl) and ketamine reduce the risk of EA compared with sevoflurane anaesthesia, whereas no clear evidence shows an effect for desflurane, isoflurane, midazolam premedication and parental presence at emergence. Therefore anaesthetists can consider several effective strategies to reduce the risk of EA in their clinical practice. Future studies should ensure adequate analgesia in the control group, for which pain may be a contributing or confounding factor in the diagnosis of EA. Regardless of the EA scale used, it would be helpful for study authors to report the risk of EA, so that this might be included in future meta-analyses. Researchers should also consider combining effective interventions as a multi-modal approach to further reduce the risk of EA.\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": "Sevoflurane is a commonly used anaesthetic gas for children because it can be breathed in by face mask and works very quickly in getting children off to sleep. Sevoflurane is given continuously during an operation to keep the child asleep, and it is turned off when it is time for the child to wake up. It is very common for children, especially preschool children, to wake up restless, agitated, delirious or thrashing around after receiving a sevoflurane anaesthetic. We call this \"emergence agitation.\" It can occur even when no pain is present and usually resolves within 30 minutes of waking up. Children with emergence agitation may injure themselves, bump the operation wound and pull out drips or wound drains. Emergence agitation can be distressing for parents and caregivers. We wanted to discover whether the rate of emergence agitation is lowered when different anaesthetics are used. We also wanted to know whether treatments can be given to reduce the rate of emergence agitation when sevoflurane is used."
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"role": "user",
"content": "Abstract: Background\nBenign prostatic hyperplasia (BPH) refers to non-malignant enlargement of the prostate gland that may cause bothersome lower urinary tract symptoms (LUTS). Alpha-blockers (ABs) and 5-alpha reductase inhibitors (5-ARIs) are the mainstay of medical treatment. Recently, phosphodiesterase inhibitors (PDEIs) that so far have been used mainly to treat erectile dysfunction were introduced to treat male LUTS.\nObjectives\nTo assess the effects of PDEIs compared to placebo and other standard of care drugs (ABs and 5-ARIs) in men with LUTS consistent with BPH.\nSearch methods\nWe conducted a systematic search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and clinical trials registries of the World Health Organization (WHO) and the National Institutes of Health (NIH) (updated 2 August 2018). We performed citation tracking and handsearching of abstracts and conference proceedings. We also contacted study authors to ask for additional information.\nSelection criteria\nWe considered for inclusion in this systematic review randomised controlled trials (RCTs) comparing PDEIs versus placebo, ABs, or 5-ARIs for at least four weeks in men with BPH-LUTS.\nData collection and analysis\nThree review authors independently screened the literature and extracted data. Primary outcomes were effects on urinary symptoms as assessed by the International Prostate Symptom Score (IPSS-total; score ranging from 0 to 35, with higher values reflecting more symptoms), urinary bother as assessed by the Benign Prostatic Hyperplasia Impact Index (BPHII; score ranging from 0 to 13, with higher values reflecting more bother), and adverse events (AEs). We used GRADE to rate the quality of evidence. We considered short-term (up to 12 weeks) and long-term (12 weeks or longer) results separately.\nMain results\nWe included a total of 16 randomised trials in this review. The results for primary outcomes are as follows.\nPDEI versus placebo: PDEIs may result in a small improvement in IPSS-total score (mean difference (MD) 1.89 lower, 95% confidence interval (CI) 2.27 lower to 1.50 lower; n = 4293; low-quality evidence) compared to placebo, and may reduce the BPHII score slightly (MD 0.52 lower, 95% CI 0.71 lower to 0.33 lower; n = 3646; low-quality evidence). Rates of AEs may be increased (risk ratio (RR) 1.42, 95% CI 1.21 to 1.67; n = 4386; low-quality evidence). This corresponds to 95 more AEs per 1000 participants (95% CI 47 more to 151 more per 1000). Study results were limited to a treatment duration of six to 12 weeks.\nPDEI versus AB: PDEIs and ABs probably provide similar improvement in IPSS-total score (MD 0.22 higher, 95% CI 0.49 lower to 0.93 higher; n = 933; moderate-quality evidence) and may have a similar effect on BPHII score (MD 0.03 higher, 95% CI 1.10 lower to 1.16 higher; n = 550; low-quality evidence) and AEs (RR 1.35, 95% CI 0.80 to 2.30; n = 936; low-quality evidence). This corresponds to 71 more AEs per 1000 participants (95% CI 41 fewer to 264 more per 1000). Study results were limited to a treatment duration of six to 12 weeks.\nPDEI and AB versus AB alone: the combination of PDEI and AB may provide a small improvement in IPSS-total score (MD 2.56 lower, 95% CI 3.92 lower to 1.19 lower; n = 193; low-quality evidence) compared to AB alone. We found no evidence for BPHII scores. AEs may be increased (RR 2.81, 95% CI 1.53 to 5.17; n = 194; moderate-quality evidence). This corresponds to 235 more AEs per 1000 participants (95% CI 69 more to 542 more per 1000). Study results were limited to treatment duration of four to 12 weeks.\nPDEI and AB versus PDEI alone: the combination of PDEI and AB may provide a small improvement in IPSS-total (MD 2.4 lower, 95% CI 6.47 lower to 1.67 higher; n = 40; low-quality evidence) compared to PDEI alone. We found no data on BPHII or AEs. Study results were limited to a treatment duration of four weeks.\nPDEI and 5-ARI versus 5-ARI alone: in the short term (up to 12 weeks), the combination of PDEI and 5-ARI probably results in a small improvement in IPSS-total score (MD 1.40 lower, 95% CI 2.24 lower to 0.56 lower; n = 695; moderate-quality evidence) compared to 5-ARI alone. We found no evidence on BPHII scores or AEs. In the long term (13 to 26 weeks), the combination of PDEI and 5-ARI likely results in a small reduction in IPSS-total score (MD 1.00 less, 95% CI 1.83 lower to 0.17 lower; n = 695; moderate-quality evidence). We found no evidence about effects on BPHII scores. There may be no difference in rates of AEs (RR 1.07, 95% CI 0.84 to 1.36; n = 695; low-quality evidence). This corresponds to 19 more AEs per 1000 participants (95% CI 43 fewer to 98 more per 1000).\nWe found no trials comparing other combinations of treatments or comparing different PDEI agents.\nAuthors' conclusions\nCompared to placebo, PDEI likely leads to a small reduction in IPSS-total and BPHII sores, with a possible increase in AEs. There may be no differences between PDEI and AB with regards to improvement in IPSS-total, BPHII, and incidence of AEs. There appears to be no added benefit of PDEI combined with AB compared to PDEI or AB alone or PDEI combined with 5-ARI compared to ARI alone with regards to urinary symptoms. Most evidence was limited to short-term treatment up to 12 weeks and of moderate or low certainty.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched randomised trials, that studied these treatments, up to August 2, 2018."
}
]
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query-laysum | 3288 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is a very common condition associated with significant morbidity, mortality, and costs. Current critical care guidelines recommend first and foremost the use of nonpharmacological strategies in both the prevention and treatment of delirium. Pharmacological interventions may augment these approaches and they are currently used widely in clinical practice to manage the symptoms of delirium. Benzodiazepines are currently used in clinical practice to treat behavioural disturbances associated with delirium but current guidelines do not recommend their use for this indication. The use of these medicines is controversial because there is uncertainty about whether they are effective for patients or have the potential to harm them.\nObjectives\nTo assess the effectiveness and safety of benzodiazepines in the treatment of delirium (excluding delirium related to withdrawal from alcohol or benzodiazepines) in any healthcare settings other than intensive care units (ICU).\nSearch methods\nWe searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group's Specialized Register up to 10 April 2019. ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases (including MEDLINE, Embase, PsycINFO, CINAHL, LILACS), numerous trial registries (including national, international and pharmaceutical registries), and grey literature sources.\nSelection criteria\nWe included randomised controlled trials (RCTs) conducted in healthcare settings that ranged from nursing homes and long-term care facilities to any hospital setting except for ICUs, involving adult patients with delirium excluding those with delirium related to alcohol or benzodiazepine withdrawal. Included RCTs had to assess the effect of benzodiazepines, at any dose and given by any route, compared with placebo or another drug intended to treat delirium.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed the risk of bias of included studies. We decided whether or not to pool data on the basis of clinical heterogeneity between studies. We used GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods to assess the quality of evidence.\nMain results\nWe identified only two trials that satisfied the selection criteria. We did not pool the data because of the substantial clinical differences between the trials.\nIn one trial, participants (n = 58) were patients in an acute palliative care unit with advanced cancer who had a mean age of 64 years. All of the participants had delirium, were treated with haloperidol, and were randomised to receive either lorazepam or placebo in combination with it. Due to very serious imprecision, all evidence was of low certainty. We were unable to determine whether there were clinically important differences in the severity of delirium (mean difference (MD) 2.10, 95% CI -0.96 to 5.16; n = 50), length of hospital admission (MD 0.00, 95% CI -3.45 to 3.45; n = 58), mortality from all causes (risk ratio (RR) 0.33, 95% CI 0.04 to 3.02; participants = 58) or any of a number of adverse events. Important effects could not be confirmed or excluded. The study authors did not report the length of the delirium episode.\nIn the other trial, participants (n = 30) were patients in general medical wards with acquired immune deficiency syndrome (AIDS) who had a mean age of 39.2 years. Investigators compared three drug treatments: all participants had delirium, and were randomised to receive lorazepam, chlorpromazine, or haloperidol. Very low-certainty evidence was identified, and we could not determine whether lorazepam differed from either of the other treatments in the effect on severity of delirium, any adverse event, or mortality from all causes. The study authors did not report the length of the delirium episode or the length of hospital admission.\nAuthors' conclusions\nThere is no enough evidence to determine whether benzodiazepines are effective when used to treat patients with delirium who are cared for in non-ICU settings. The available evidence does not support their routine use for this indication. Because of the scarcity of data from randomised controlled trials, further research is required to determine whether or not there is a role for benzodiazepines in the treatment of delirium in non-ICU settings.\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 only two small studies which were suitable to include in our review. In one study, the 58 patients who took part all had advanced cancer. They were treated in a specialist palliative care unit. The study compared lorazepam (a benzodiazepine) to placebo. In the second study, the 30 patients all had AIDS (acquired immune deficiency syndrome). They were treated in general medical wards. This study compared lorazepam to two different drugs that are sometimes used to treat delirium."
}
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query-laysum | 3289 | [
{
"role": "user",
"content": "Abstract: Background\nZinc is a vital micronutrient for humans and is essential for protein synthesis, cell growth, and differentiation. Severe zinc deficiency can lead to slower physical, cognitive and sexual growth, cause skin disorders, decrease immunity, increase incidence of acute illnesses in infants and children and contribute to childhood stunting. By estimation, 17.3% of the world population is at risk of inadequate zinc intake. Such nutritional impairment increases the risk of diarrhoea and pneumonia by 20%, as well as leads to a global loss of more than 16 million disability-adjusted life years in children less than five years of age. Not only does zinc deficiency affect lives, it adds to the considerable financial burden on depleted resources in countries that are most affected. By preventing or curing this deficiency, we can improve childhood mortality, morbidity and growth.\nObjectives\nTo assess the effectiveness of zinc supplementation for the promotion of growth, reduction in mortality, and the prevention of infections in infants less than six months of age.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 4), MEDLINE via PubMed (1966 to 18 May 2018), Embase (1980 to 18 May 2018), and CINAHL (1982 to 18 May 2018). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. An updated search from 1 January 2018 to 29 January 2020 was run in the following databases: CENTRAL via CRS Web, MEDLINE via Ovid, and CINAHL via EBSCOhost.\nSelection criteria\nAll randomised controlled (individual and cluster randomised) and quasi-randomised trials of zinc supplementation in healthy, term infants, less than six months of age comparing infant mortality, incidence of diarrhoea or respiratory illnesses, growth and/or serum zinc levels were eligible.\nData collection and analysis\nTwo review authors screened search results (title and abstracts) and relevant full texts. Studies fulfilling prespecified inclusion criteria were included with any disagreements resolved by consensus. Extraction and analysis were then conducted. We used the GRADE approach to assess the quality of evidence as indicated by certainty in effect estimates.\nMain results\nEight studies (with 85,629 infants) were included and five studies were meta-analysed, out of which four studies compared zinc with placebo, and one compared zinc plus riboflavin versus riboflavin. Certain growth outcomes after six months of intervention (Weight for Age Z-scores (WAZ) (standardised mean difference) (SMD) 0.16, 95% CI 0.03 to 0.29; three studies, n = 955; fixed-effect; heterogeneity Chi² P = 0.96); I² = 0%); change in WAZ (SMD 0.16, 95% CI 0.07 to 0.25; one study, n = 386; fixed-effect); (Weight-for-Length Z-score (WLZ) (SMD 0.15, 95% CI 0.02 to 0.28; three studies, n = 955; fixed-effect; heterogeneity: Chi² P = 0.81); I² = 0%); (change in WLZ (SMD 0.17, 95% CI 0.06 to 0.28; one study, n = 386; fixed-effect)) were positively affected by zinc supplementation compared to placebo. A single study reported no difference in the incidence of diarrhoea and lower respiratory tract infection with zinc supplementation. Zinc had no effect on mortality in children younger than 12 months.\nWhen zinc plus riboflavin was compared to riboflavin only, significant improvement was observed in the incidence of wasting at 24 months (risk ratio (RR) 0.59, 95% CI 0.37 to 0.96; one study, n = 296; fixed-effect), but significant worsening of incidence of stunting was present at 21 months (RR 1.53, 95% CI 1.09 to 2.16; one study, n = 298; fixed-effect).\nAuthors' conclusions\nThere was a significant positive impact of zinc supplementation on WAZ and WLZ after six months of intervention in infants compared to placebo. When a combined supplement of zinc and riboflavin was compared to riboflavin, there was a significant reduction in wasting at 24 months, but stunting at 21 months was negatively affected. Although included trials were of good-to-moderate quality, evidence that could be meta-analysed was based on a few studies which affected the overall quality of results. Regardless, there is a need for strong trials conducted in infants younger than six months before a strong recommendation can be made supporting zinc supplementation in this age group.\n\nGiven the provided abstract, please respond to the following query: \"Key results and certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "zinc had no effect on decreasing deaths or illnesses in children younger than 12 months. Moderate- to good-certainty evidence from three studies suggested an increase in weight-for-age Z-scores and weight-for-length Z-scores after zinc supplementation for six months compared to placebo only. Only one study could be analysed for zinc and riboflavin supplementation compared to riboflavin only, and the results suggested a decrease in wasting after 24 months of supplementation and an increase in stunting after 21 months."
}
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query-laysum | 3290 | [
{
"role": "user",
"content": "Abstract: Background\nCurrent cancer care increasingly incorporates psychosocial interventions. Cancer patients use dance/movement therapy to learn to accept and reconnect with their bodies, build new self-confidence, enhance self-expression, address feelings of isolation, depression, anger and fear and to strengthen personal resources.\nObjectives\nTo update the previously published review that examined the effects of dance/movement therapy and standard care versus standard care alone or standard care and other interventions on psychological and physical outcomes in patients with cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE (OvidSP, 1950 to June week 4, 2014), EMBASE (OvidSP, 1980 to 2014 week 26), CINAHL (EBSCOhost, 1982 to July 15 2014), PsycINFO (EBSCOhost, 1806 to July 15 2014), LILACS (Virual Health Library, 1982 to July 15 2014), Science Citation Index (ISI, 1974 to July 15 2014), CancerLit (1983 to 2003), International Bibliography of Theatre and Dance (1989 to July 15 2014), the National Research Register (2000 to September 2007), Proquest Digital Dissertations, ClinicalTrials.gov, and Current Controlled Trials (all to July 15 2014). We handsearched dance/movement therapy and related topics journals, reviewed reference lists and contacted experts. There was no language restriction.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials of dance/movement therapy interventions for improving psychological and physical outcomes in patients with cancer. We considered studies only if dance/movement therapy was provided by a formally trained dance/movement therapist or by trainees in a formal dance/movement therapy program.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the methodological quality, seeking additional information from the trial researchers when necessary. Results were presented using standardized mean differences.\nMain results\nWe identified one new trial for inclusion in this update. In total, the evidence for this review rests on three studies with a total of 207 participants.\nWe found no evidence for an effect of dance/movement therapy on depression (standardized mean difference (SMD) = 0.02, 95% confidence interval (CI) -0.28 to 0.32, P = 0.89, I2 = 0%) (two studies, N = 170), stress (SMD = -0.18, 95% CI -0.48 to 0.12, P = 0.24, I2 = 0%) (two studies, N = 170), anxiety (SMD = 0.21, 95% CI -0.09 to 0.51 P = 0.18, I2 = 0%) (two studies, N = 170), fatigue (SMD = -0.36, 95% -1.26 to 0.55, P = 0.44, I² = 80%) (two studies, N = 170) and body image (SMD = -0.13, 95% CI -0.61 to 0.34, P = 0.58, I2 = 0%) (two studies, N = 68) in women with breast cancer. The data of one study with moderate risk of bias suggested that dance/movement therapy had a large beneficial effect on 37 participants' quality of life (QoL) (SMD = 0.89, 95% CI 0.21 to 1.57). One study with a high risk of bias reported greater improvements in vigor and greater reduction in somatization in the dance/movement therapy group compared to a standard care control group (N = 31). The individual studies did not find support for an effect of dance/movement therapy on mood, mental health, and pain. It is unclear whether this was due to ineffectiveness of the treatment, inappropriate outcome measures or limited power of the trials. Finally, the results of one study did not find evidence for an effect of dance/movement therapy on shoulder range of motion (ROM) or arm circumference in 37 women who underwent a lumpectomy or breast surgery. However, this was likely due to large within-group variability for shoulder ROM and a limited number of participants with lymphedema.\nTwo studies presented moderate risk of bias and one study high risk of bias. Therefore, overall, the quality of the evidence is very low.\nAuthors' conclusions\nWe did not find support for an effect of dance/movement therapy on depression, stress, anxiety, fatigue and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on QoL, somatization, and vigor. However, the limited number of studies prevents us from drawing conclusions concerning the effects of dance/movement therapy on psychological and physical outcomes in cancer patients.\n\nGiven the provided abstract, please respond to the following query: \"What are the conclusions?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "No conclusions could be drawn regarding the effect of dance/movement therapy on psychological and physical outcomes in cancer patients because of an insufficient number of studies. More research is needed. We did not identify any conflicts of interests in the included studies."
}
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query-laysum | 3291 | [
{
"role": "user",
"content": "Abstract: Background\nSteroids have been used widely since the early 1970s for the treatment of adult-onset minimal change disease (MCD). Recently, newer agents have been used in adult MCD aiming to reduce the risk of adverse effects. The response rates to immunosuppressive agents in adult MCD are more variable than in children. The optimal agent, dose, and duration of treatment for the first episode of nephrotic syndrome, or for disease relapse(s) have not been determined. This is an update of a review first published in 2008.\nObjectives\nWe aimed to 1) evaluate the benefits and harms of different agents, including both immunosuppressive and non-immunosuppressive agents, in adults with MCD causing the nephrotic syndrome; and 2) evaluate the efficacy of interventions on 'time-to-remission' of nephrotic syndrome, in adults with MCD causing the nephrotic syndrome.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 21 July 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs of any intervention for MCD with nephrotic syndrome in adults over 18 years were included. Studies comparing different types, routes, frequencies, and duration of immunosuppressive agents and non-immunosuppressive agents were assessed.\nData collection and analysis\nTwo authors independently assessed study quality and extracted data. Statistical analyses were performed using the random-effects model and results were expressed as a risk ratio (RR) for dichotomous outcomes, or mean difference (MD) for continuous data with 95% confidence intervals (CI). Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFifteen RCTs (769 randomised participants) were identified; four studies evaluated different prednisolone regimens, eight studies evaluated the calcineurin inhibitors (CNIs) (tacrolimus or cyclosporin), two studies evaluated enteric-coated mycophenolate sodium (EC-MPS) and one study evaluated levamisole. In all but two studies of non-corticosteroid agents, reduced-dose prednisolone was given with the treatment agent and the comparator was high-dose prednisolone. In the risk of bias assessment, 11 and seven studies were at low risk of bias for sequence generation and allocation concealment, respectively. No studies were at low risk of performance bias and eight studies were at low risk of detection bias. Thirteen, 10 and six studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nCompared with no specific treatment, it is uncertain whether prednisolone increases the number with complete remission (1 study, 28 participants: RR 1.44, 95% CI 0.95 to 2.19), complete or partial remission (1 study, 28 participants: RR 1.38, 95% CI 0.98 to 1.95), subsequent relapse (1 study, 28 participants: RR 0.75, 95% CI 0.48 to 1.17), or reduces the adverse effects because the certainty of the evidence is very low. Compared with oral prednisolone alone, it is uncertain whether intravenous methylprednisolone and prednisolone increase the number with complete remission (2 studies, 35 participants: RR 1.76, 95% CI 0.17 to 18.32; I² = 90%), relapse (two studies, 19 participants. RR 1.18, 95% CI 0.65 to 2.15; I² = 0%) or adverse events because the certainty of the evidence is very low.\nCompared with prednisolone alone, CNIs with reduced-dose prednisolone or without prednisolone probably make little or no difference to the number achieving complete remission (8 studies; 492 participants: RR 0.99, 95% CI 0.93 to 1.05; I² = 0%), complete or partial remission (4 studies, 269 participants: RR 1.01, 95% CI 0.96 to 1.05; I² = 0%), or relapse (7 studies; 422 participants: RR 0.73, 95% CI 0.51 to 1.03; I² = 0%) (moderate certainty evidence), may reduce the risk of obesity or Cushing's Syndrome (5 studies; 388 participants: RR 0.11, 95% CI 0.02 to 0.59; I² = 45%) and the risk of acne (4 studies; 270 participants: RR 0.15, 95% CI 0.03 to 0.67; I² = 0%) (low certainty evidence); and had uncertain effects on diabetes or hyperglycaemia, hypertension, and acute kidney injury (AKI) (low certainty evidence).\nCompared with prednisolone alone, EC-MPS with reduced-dose prednisolone probably make little or no difference to the number undergoing complete remission at 4 weeks (1 study, 114 participants: RR 1.12, 95% CI 0.84 to 1.50), and at 24 weeks probably make little or no difference to the number undergoing complete remission (2 studies, 134 participants: RR 1.12, 95% CI 0.84 to 1.38; I² = 0%) (moderate certainty evidence), complete or partial remission (2 studies 134 participants: RR 0.92, 95% CI 0.75 to 1.12; I² = 0%), relapse (2 studies, 83 participants: RR 0.50, 95% CI 0.07 to 3.74; I² = 56%) (low certainty evidence); or to the adverse events of new-onset glucose intolerance, death, or AKI (low certainty evidence).\nOne study (24 participants) compared levamisole and prednisolone with prednisolone in patients with relapsing disease. The authors identified no differences in mean relapse rate or adverse effects but no standard deviations were provided.\nAuthors' conclusions\nThis updated review has identified evidence for the efficacy and adverse effects of CNIs and EC-MPS with or without reduced-dose prednisolone compared with prednisolone alone for the induction of remission in adults with MCD and nephrotic syndrome with some reductions in steroid-associated adverse events. RCT data on the efficacy and adverse effects of rituximab in adults with MCD are awaited. Further, adequately powered RCTs are required to determine the relative efficacies of CNIs and EC-MPS and to evaluate these medications in patients with relapsing or steroid-resistant disease.\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": "Nephrotic syndrome is a condition where the kidneys leak protein from the blood into the urine. Minimal change disease defined on kidney biopsy is the third most common primary kidney disease in adults with unexplained nephrotic syndrome (10% to 15%). The most effective treatment regimens have not been determined."
}
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query-laysum | 3292 | [
{
"role": "user",
"content": "Abstract: Background\nChronic kidney disease (CKD) is a long-term condition that occurs as a result of damage to the kidneys. Early recognition of CKD is becoming increasingly common due to widespread laboratory estimated glomerular filtration rate (eGFR) reporting, raised clinical awareness, and international adoption of the Kidney Disease Improving Global Outcomes (KDIGO) classifications. Early recognition and management of CKD affords the opportunity to prepare for progressive kidney impairment and impending kidney replacement therapy and for intervention to reduce the risk of progression and cardiovascular disease. Angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) are two classes of antihypertensive drugs that act on the renin-angiotensin-aldosterone system. Beneficial effects of ACEi and ARB on kidney outcomes and survival in people with a wide range of severity of kidney impairment have been reported; however, their effectiveness in the subgroup of people with early CKD (stage 1 to 3) is less certain.\nThis is an update of a review that was last published in 2011.\nObjectives\nTo evaluate the benefits and harms of ACEi and ARB or both in the management of people with early (stage 1 to 3) CKD who do not have diabetes mellitus (DM).\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 6 July 2023 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and Embase, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials (RCTs) reporting the effect of ACEi or ARB in people with early (stage 1 to 3) CKD who did not have DM were selected for inclusion. Only studies of at least four weeks duration were selected. Authors independently assessed the retrieved titles and abstracts and, where necessary, the full text to determine which satisfied the inclusion criteria.\nData collection and analysis\nData extraction was carried out by two authors independently, using a standard data extraction form. The methodological quality of included studies was assessed using the Cochrane risk of bias tool. Data entry was carried out by one author and cross-checked by another. When more than one study reported similar outcomes, data were pooled using the random-effects model. Heterogeneity was analysed using a Chi² test and the I² test. Results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach\nMain results\nSix studies randomising 9379 participants with CKD stages 1 to 3 (without DM) met our inclusion criteria. Participants were adults with hypertension; 79% were male from China, Europe, Japan, and the USA. Treatment periods ranged from 12 weeks to three years. Overall, studies were judged to be at unclear or high risk of bias across all domains, and the quality of the evidence was poor, with GRADE rated as low or very low certainty.\nIn low certainty evidence, ACEi (benazepril 10 mg or trandolapril 2 mg) compared to placebo may make little or no difference to death (any cause) (2 studies, 8873 participants): RR 2.00, 95% CI 0.26 to 15.37; I² = 76%), total cardiovascular events (2 studies, 8873 participants): RR 0.97, 95% CI 0.90 to 1.05; I² = 0%), cardiovascular-related death (2 studies, 8873 participants): RR 1.73, 95% CI 0.26 to 11.66; I² = 54%), stroke (2 studies, 8873 participants): RR 0.76, 95% CI 0.56 to 1.03; I² = 0%), myocardial infarction (2 studies, 8873 participants): RR 1.00, 95% CI 0.84 to 1.20; I² = 0%), and adverse events (2 studies, 8873 participants): RR 1.33, 95% CI 1.26 to 1.41; I² = 0%).\nIt is uncertain whether ACEi (benazepril 10 mg or trandolapril 2 mg) compared to placebo reduces congestive heart failure (1 study, 8290 participants): RR 0.75, 95% CI 0.59 to 0.95) or transient ischaemic attack (1 study, 583 participants): RR 0.94, 95% CI 0.06 to 15.01; I² = 0%) because the certainty of the evidence is very low.\nIt is uncertain whether ARB (losartan 50 mg) compared to placebo (1 study, 226 participants) reduces: death (any-cause) (no events), adverse events (RR 19.34, 95% CI 1.14 to 328.30), eGFR rate of decline (MD 5.00 mL/min/1.73 m2, 95% CI 3.03 to 6.97), presence of proteinuria (MD -0.65 g/24 hours, 95% CI -0.78 to -0.52), systolic blood pressure (MD -0.80 mm Hg, 95% CI -3.89 to 2.29), or diastolic blood pressure (MD -1.10 mm Hg, 95% CI -3.29 to 1.09) because the certainty of the evidence is very low.\nIt is uncertain whether ACEi (enalapril 20 mg, perindopril 2 mg or trandolapril 1 mg) compared to ARB (olmesartan 20 mg, losartan 25 mg or candesartan 4 mg) (1 study, 26 participants) reduces: proteinuria (MD -0.40, 95% CI -0.60 to -0.20), systolic blood pressure (MD -3.00 mm Hg, 95% CI -6.08 to 0.08) or diastolic blood pressure (MD -1.00 mm Hg, 95% CI -3.31 to 1.31) because the certainty of the evidence is very low.\nAuthors' conclusions\nThere is currently insufficient evidence to determine the effectiveness of ACEi or ARB in patients with stage 1 to 3 CKD who do not have DM. The available evidence is overall of very low certainty and high risk of bias. We have identified an area of large uncertainty for a group of patients who account for most of those diagnosed as having CKD.\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": "Chronic kidney disease (CKD) is a long-term condition that occurs when the kidneys are damaged. It is important to diagnose and treat CKD in the early stages to prevent or delay the more serious stages of CKD (dialysis or transplant). People with CKD are at risk of cardiovascular disease (heart and lung disease). It is reported that blood pressure-lowering medications can reduce or delay cardiovascular problems in adults with CKD (across early stages, dialysis, and transplant). However, we are less certain about these benefits in adults with early CKD (stages 1 to 3 only) who do not have diabetes.\nWe wanted to discover whether taking blood pressure-lowering medications is better or worse than placebo, and if so, which type of blood pressure-lowering medication works best."
}
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query-laysum | 3293 | [
{
"role": "user",
"content": "Abstract: Background\nHealth workers move between public and private organizations in both urban and rural areas during the course of their career. Depending on the proportion of the population served by public or private organizations in a particular setting, this movement may result in imbalances in the number of healthcare providers available relative to the population receiving care from that sector. However, both public and private organizations are needed as each sector has unique contributions to make to the effective delivery of health services.\nObjectives\nTo assess the effects of financial incentives and movement restriction interventions to manage the movement of health workers between public and private organizations in low- and middle-income countries.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (10 November 2012); EMBASE (7 June 2011); LILACS (9 June 2011); MEDLINE (10 November 2012); CINAHL (13 August 2012); and the British Nursing Index (13 August 2012).\nSelection criteria\nRandomized controlled trials and non-randomized controlled trials; controlled before-and-after studies if pre- and post-intervention periods for study and control groups were the same and there were at least two units included in both the intervention and control groups; uncontrolled and controlled interrupted time series studies if the point in time when the intervention occurred was clearly defined and there were at least three or more data points before and after the intervention. Interventions included payment of special allowances, increasing salaries, bonding health workers, offering bursary schemes, scholarships or lucrative terminal benefits, and hiring people on contract basis.\nData collection and analysis\nTwo review authors independently applied the criteria for inclusion and exclusion of studies to the titles and abstracts of all articles obtained from the search. The same two review authors independently screened the full reports of the selected citations. At each stage, we compared the results and resolved discrepancies through discussion with a third review author.\nMain results\nWe found no studies that were eligible for inclusion in this review.\nAuthors' conclusions\nWe identified no rigorous studies on the effects of interventions to manage the movement of health workers between public and private organizations in low- and middle-income countries. Health worker availability is a key obstacle in delivery of health services. Interventions to make the health sector more responsive to the expectations of populations by having more health workers in the sector that serves most people would contribute to the more efficient use of the health workforce. More research is needed to assess the effect of increase in salaries, offering scholarships or bonding on movement of health workers in one sector compared with another.\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": "Many countries have a severe lack of health workers. In addition, the health workers that are available are often not distributed in the best possible way. Most health workers work in urban areas, leaving rural areas underserved. Problems also occur in urban areas as health workers here often prefer to work in the private healthcare sector, which is often too expensive for many people. In rural areas, governments may not have built health facilities and the only available health care in these areas may, therefore, be private. However, private facilities in rural areas are not only expensive but may also struggle to attract qualified health workers.\nTo address these problems, governments need to find ways of ensuring that more health workers work in the areas and facilities where most people seek care. This might, for instance, involve encouraging health workers to work in public healthcare facilities in towns and cities or to work in public or private facilities in rural areas. One approach governments could take is to give extra incentives to health workers serving in particular facilities. These incentives could include higher salaries, special allowances, or higher retirement packages. Another approach is to give health workers bursaries or scholarships during training on the condition that they work in particular facilities for a fixed period of time after they have finished their training."
}
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query-laysum | 3294 | [
{
"role": "user",
"content": "Abstract: Background\nArterial vascular access is a frequently performed procedure, with a high possibility for adverse events (e.g. pneumothorax, haemothorax, haematoma, amputation, death), and additional techniques such as ultrasound may be useful for improving outcomes. However, ultrasound guidance for arterial access in adults is still under debate.\nObjectives\nTo assess the effects of ultrasound guidance for arterial (other than femoral) catheterisation in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS, and CINAHL on 21 May 2021. We also searched IBECS, WHO ICTRP, and ClinicalTrials.gov on 16 June 2021, and we checked the reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials (RCTs), including cross-over trials and cluster-RCTs, comparing ultrasound guidance, alone or associated with other forms of guidance, versus other interventions or palpation and landmarks for arterial (other than femoral) guidance in adults.\nData collection and analysis\nTwo review authors independently performed study selection, extracted data, assessed risk of bias, and assessed the certainty of evidence using GRADE.\nMain results\nWe included 48 studies (7997 participants) that tested palpation and landmarks, Doppler auditory ultrasound assistance (DUA), direct ultrasound guidance with B-mode, or any other modified ultrasound technique for arterial (axillary, dorsalis pedis, and radial) catheterisation in adults.\nRadial artery\nReal-time B-mode ultrasound versus palpation and landmarks\nReal-time B-mode ultrasound guidance may improve first attempt success rate (risk ratio (RR) 1.44, 95% confidence interval (CI) 1.29 to 1.61; 4708 participants, 27 studies; low-certainty evidence) and overall success rate (RR 1.11, 95% CI 1.06 to 1.16; 4955 participants, 28 studies; low-certainty evidence), and may decrease time needed for a successful procedure (mean difference (MD) -0.33 minutes, 95% CI -0.54 to -0.13; 4902 participants, 26 studies; low-certainty evidence) up to one hour compared to palpation and landmarks. Real-time B-mode ultrasound guidance probably decreases major haematomas (RR 0.35, 95% CI 0.23 to 0.56; 2504 participants, 16 studies; moderate-certainty evidence). It is uncertain whether real-time B-mode ultrasound guidance has any effect on pseudoaneurysm, pain, and quality of life (QoL) compared to palpation and landmarks (very low-certainty evidence).\nReal-time B-mode ultrasound versus DUA\nOne study (493 participants) showed that real-time B-mode ultrasound guidance probably improves first attempt success rate (RR 1.35, 95% CI 1.11 to 1.64; moderate-certainty evidence) and time needed for a successful procedure (MD -1.57 minutes, 95% CI -1.78 to -1.36; moderate-certainty evidence) up to 72 hours compared to DUA. Real-time B-mode ultrasound guidance may improve overall success rate (RR 1.13, 95% CI 0.99 to 1.29; low-certainty evidence) up to 72 hours compared to DUA. Pseudoaneurysm, major haematomas, pain, and QoL were not reported.\nReal-time B-mode ultrasound versus modified real-time B-mode ultrasound\nReal-time B-mode ultrasound guidance may decrease first attempt success rate (RR 0.68, 95% CI 0.55 to 0.84; 153 participants, 2 studies; low-certainty evidence), may decrease overall success rate (RR 0.93, 95% CI 0.86 to 1.01; 153 participants, 2 studies; low-certainty evidence), and may lead to no difference in time needed for a successful procedure (MD 0.04 minutes, 95% CI -0.01 to 0.09; 153 participants, 2 studies; low-certainty evidence) up to one hour compared to modified real-time B-mode ultrasound guidance. It is uncertain whether real-time B-mode ultrasound guidance has any effect on major haematomas compared to modified real-time B-mode ultrasound (very low-certainty evidence). Pseudoaneurysm, pain, and QoL were not reported.\nIn-plane versus out-of-plane B-mode ultrasound\nIn-plane real-time B-mode ultrasound guidance may lead to no difference in overall success rate (RR 1.00, 95% CI 0.96 to 1.05; 1051 participants, 8 studies; low-certainty evidence) and in time needed for a successful procedure (MD -0.06 minutes, 95% CI -0.16 to 0.05; 1134 participants, 9 studies; low-certainty evidence) compared to out-of-plane B-mode ultrasound up to one hour. It is uncertain whether in-plane real-time B-mode ultrasound guidance has any effect on first attempt success rate or major haematomas compared to out-of-plane B-mode ultrasound (very low-certainty evidence). Pseudoaneurysm, pain, and QoL were not reported.\nDUA versus palpation and landmarks\nDUA may lead to no difference in first attempt success rate (RR 1.01, 95% CI 0.90 to 1.14; 666 participants, 2 studies; low-certainty evidence) or overall success rate (RR 0.99, 95% CI 0.92 to 1.07; 666 participants, 2 studies; low-certainty evidence) and probably increases time needed for a successful procedure (MD 0.45 minutes, 95% CI 0.20 to 0.70; 500 participants, 1 study; moderate-certainty evidence) up to 72 hours compared to palpation and landmarks. Pseudoaneurysm, major haematomas, pain, and QoL were not reported.\nOblique-axis versus long-axis in-plane B-mode ultrasound\nOblique-axis in-plane B-mode ultrasound guidance may increase overall success rate (RR 1.27, 95% CI 1.05 to 1.53; 215 participants, 2 studies; low-certainty evidence) up to 72 hours compared to long-axis in-plane B-mode ultrasound. It is uncertain whether oblique-axis in-plane B-mode ultrasound guidance has any effect on first attempt success rate, time needed for a successful procedure, and major haematomas compared to long-axis in-plane B-mode ultrasound. Pseudoaneurysm, pain, and QoL were not reported.\nWe are uncertain about effects in the following comparisons due to very low-certainty evidence and unreported outcomes: real-time B-mode ultrasound versus palpation and landmarks (axillary and dorsalis pedis arteries), real-time B-mode ultrasound versus near-infrared laser (radial artery), and dynamic versus static out-of-plane B-mode ultrasound (radial artery).\nAuthors' conclusions\nReal-time B-mode ultrasound guidance may improve first attempt success rate, overall success rate, and time needed for a successful procedure for radial artery catheterisation compared to palpation, or DUA. In addition, real-time B-mode ultrasound guidance probably decreases major haematomas compared to palpation. However, we are uncertain about the evidence on major haematomas and pain for other comparisons due to very low-certainty evidence and unreported outcomes. We are also uncertain about the effects on pseudoaneurysm and QoL for axillary and dorsalis pedis arteries catheterisation. Given that first attempt success rate and pseudoaneurysm are the most relevant outcomes for people who underwent arterial catheterisation, future studies must measure both. Future trials must be large enough to detect effects, use validated scales, and report longer-term follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found very low- to moderate-certainty evidence comparing real-time visual ultrasound guidance versus palpation, and comparing one ultrasound guidance type versus another."
}
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query-laysum | 3295 | [
{
"role": "user",
"content": "Abstract: Background\nIntussusception is a common abdominal emergency in children with significant morbidity. Prompt diagnosis and management reduces associated risks and the need for surgical intervention. Despite widespread agreement on the use of contrast enema as opposed to surgery for initial management in most cases, debate persists on the appropriate contrast medium, imaging modality, pharmacological adjuvant, and protocol for delayed repeat enema, and on the best approach for surgical management for intussusception in children.\nObjectives\nTo assess the safety and effectiveness of non-surgical and surgical approaches in the management of intussusception in children.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8) in the Cochrane Library; Ovid MEDLINE (1950 to September 2016); Ovid Embase (1974 to September 2016); Science Citation Index Expanded (via Web of Science) (1900 to September 2016); and BIOSIS Previews (1969 to September 2016).\nWe examined the reference lists of all eligible trials to identify additional studies. To locate unpublished studies, we contacted content experts, searched the World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (September 2016), and explored proceedings from meetings of the British Association of Paedatric Surgeons (BAPS), the American Soceity of Pediatric Surgery, and the World Congress of Pediatric Surgery.\nSelection criteria\nWe included all randomised controlled trials comparing contrast media, imaging modalities, pharmacological adjuvants, protocols for delayed repeat enema, and/or surgical approaches for the management of intussusception in children. We applied no language, publication date, or publication status restrictions.\nData collection and analysis\nTwo review authors independently conducted study selection and data extraction and assessed risk of bias using a standardised form. We resolved disagreements by consensus with a third review author when necessary. We reported dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We analysed data on an intention-to-treat basis and evaluated the overall quality of evidence supporting the outcomes by using GRADE criteria.\nMain results\nWe included six randomised controlled trials (RCTs) with a total of 822 participants. Two trials compared liquid enema reduction plus glucagon versus liquid enema alone. One trial compared liquid enema plus dexamethasone versus liquid enema alone. Another trial compared air enema plus dexamethasone versus air enema alone, and two trials compared use of liquid enema versus air enema.\n\nWe identified three ongoing trials.\nWe judged all included trials to be at risk of bias owing to omissions in reported methods. We judged five of six trials as having high risk of bias in at least one domain. Therefore, the quality of the evidence (GRADE) for outcomes was low. Interventions and data presentation varied greatly across trials; therefore meta-analysis was not possible for most review outcomes.\nEnema plus glucagon versus enema alone\nIt is uncertain whether use of glucagon improves the rate of successful reduction of intussusception when compared with enema alone (reported in two trials, 218 participants; RR 1.09, 95% CI 0.94 to 1.26;low quality of evidence). No trials in this comparison reported on the number of children with bowel perforation(s) nor on the number of children with recurrent intussusception.\nEnema plus dexamethasone versus enema alone\nUse of the adjunct, dexamethasone, may be beneficial in reducing intussusception recurrence with liquid or air enema (two trials, 299 participants; RR 0.14, 95% CI 0.03 to 0.60; low quality of evidence). This equates to a number needed to treat for an additional beneficial outcome of 13 (95% CI 8 to 37). It is uncertain whether use of the adjunct, dexamethasone, improves the rate of successful reduction of intussusception when compared with enema alone (reported in two trials, 356 participants; RR 1.01, 95% CI 0.92 to 1.10;low quality of evidence).\nAir enema versus liquid enema\nAir enema may be more successful than liquid enema for reducing intussusception (two trials, 199 participants; RR 1.28, 95% CI 1.10 to 1.49; low quality of evidence). This equates to a number needed to treat for an additional beneficial outcome of 6 (95% CI 4 to 19). No trials in this comparison reported on the number of children with bowel perforation(s) or on the number of children with recurrent intussusception nor any intraoperative complications, such as bowel perforation, or other adverse effects. Only one trial reported postoperative complications, but owing to the method of reporting used, a quantitative analysis was not possible. We identified no studies that exclusively evaluated surgical interventions for management of intussusception.\nAuthors' conclusions\nThis review identified a small number of trials that assessed a variety of interventions. All included trials provided evidence of low quality and were subject to serious concerns about imprecision, high risk of bias, or both. Air enema may be superior to liquid enema for successfully reducing intussusception in children; however, this finding is based on a few studies including small numbers of participants. Dexamethasone as an adjuvant may be more effective in reducing intussusception recurrence rates following air enema or liquid enema, but these results are also based on a few studies of small numbers of participants. This review highlights several points that need to be addressed in future studies, including reducing the risk of bias and including relevant outcomes. Specifically, surgical trials are lacking, and future research is needed to address this evidence gap.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Of the six trials identified, we considered all to be potentially biased owing to lack of detail in reporting of how each study was undertaken. We found lack of consistency in how outcomes were defined and measured. All included studies were subject to serious concerns of imprecision based on few events, wide confidence intervals,or high risk of bias, Overall, we concluded that the quality of evidence provided by these studies was low, and that the real effects may differ significantly from those noted in these studies.\n\nFurther research is needed to help doctors better understand the most effective way to manage intussusception in children."
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query-laysum | 3296 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections (IFIs) are life-threatening opportunistic infections that occur in immunocompromised or critically ill people. Early detection and treatment of IFIs is essential to reduce morbidity and mortality in these populations. (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in the serum of infected individuals. The serum BDG test is a way to quickly detect these infections and initiate treatment before they become life-threatening. Five different versions of the BDG test are commercially available: Fungitell, Glucatell, Wako, Fungitec-G, and Dynamiker Fungus.\nObjectives\nTo compare the diagnostic accuracy of commercially available tests for serum BDG to detect selected invasive fungal infections (IFIs) among immunocompromised or critically ill people.\nSearch methods\nWe searched MEDLINE (via Ovid) and Embase (via Ovid) up to 26 June 2019. We used SCOPUS to perform a forward and backward citation search of relevant articles. We placed no restriction on language or study design.\nSelection criteria\nWe included all references published on or after 1995, which is when the first commercial BDG assays became available. We considered published, peer-reviewed studies on the diagnostic test accuracy of BDG for diagnosis of fungal infections in immunocompromised people or people in intensive care that used the European Organization for Research and Treatment of Cancer (EORTC) criteria or equivalent as a reference standard. We considered all study designs (case-control, prospective consecutive cohort, and retrospective cohort studies). We excluded case studies and studies with fewer than ten participants. We also excluded animal and laboratory studies. We excluded meeting abstracts because they provided insufficient information.\nData collection and analysis\nWe followed the standard procedures outlined in the Cochrane Handbook for Diagnostic Test Accuracy Reviews. Two review authors independently screened studies, extracted data, and performed a quality assessment for each study. For each study, we created a 2 × 2 matrix and calculated sensitivity and specificity, as well as a 95% confidence interval (CI). We evaluated the quality of included studies using the Quality Assessment of Studies of Diagnostic Accuracy-Revised (QUADAS-2). We were unable to perform a meta-analysis due to considerable variation between studies, with the exception of Candida, so we have provided descriptive statistics such as receiver operating characteristics (ROCs) and forest plots by test brand to show variation in study results.\nMain results\nWe included in the review 49 studies with a total of 6244 participants. About half of these studies (24/49; 49%) were conducted with people who had cancer or hematologic malignancies. Most studies (36/49; 73%) focused on the Fungitell BDG test. This was followed by Glucatell (5 studies; 10%), Wako (3 studies; 6%), Fungitec-G (3 studies; 6%), and Dynamiker (2 studies; 4%). About three-quarters of studies (79%) utilized either a prospective or a retrospective consecutive study design; the remainder used a case-control design.\nBased on the manufacturer's recommended cut-off levels for the Fungitell test, sensitivity ranged from 27% to 100%, and specificity from 0% to 100%. For the Glucatell assay, sensitivity ranged from 50% to 92%, and specificity ranged from 41% to 94%. Limited studies have used the Dynamiker, Wako, and Fungitec-G assays, but individual sensitivities and specificities ranged from 50% to 88%, and from 60% to 100%, respectively. Results show considerable differences between studies, even by manufacturer, which prevented a formal meta-analysis. Most studies (32/49; 65%) had no reported high risk of bias in any of the QUADAS-2 domains. The QUADAS-2 domains that had higher risk of bias included participant selection and flow and timing.\nAuthors' conclusions\nWe noted considerable heterogeneity between studies, and these differences precluded a formal meta-analysis. Because of wide variation in the results, it is not possible to estimate the diagnostic accuracy of the BDG test in specific settings. Future studies estimating the accuracy of BDG tests should be linked to the way the test is used in clinical practice and should clearly describe the sampling protocol and the relationship of time of testing to time of diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In the included studies, the diagnosis of invasive fungal infection was made using criteria developed by the European Organization for Research and Treatment of Cancer (EORTC)*. The EORTC criteria are considered reliable and the studies were generally well conducted, so it is likely that the reference diagnoses were accurate. Accuracy of blood tests for invasive fungal infections varied widely. Some studies found that the blood test was accurate, but others found that the blood test was not very accurate. The reason for this variation is not understood.\n*The EORTC criteria provide the reference diagnosis. Results of the blood test are compared to the reference diagnosis."
}
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query-laysum | 3297 | [
{
"role": "user",
"content": "Abstract: Background\nHuman milk banking has been available in many countries for the last three decades. The milk provided from milk banking is predominantly term breast milk, but some milk banks provide preterm breast milk. There are a number of differences between donor term and donor preterm human milk.\nObjectives\nTo determine the effect of banked donor preterm milk compared with banked donor term milk regarding growth and developmental outcomes in very low birth weight infants (infants weighing less than 1500 grams).\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 7), MEDLINE via PubMed (1966 to 23 October 2018), Embase (1980 to 23 October 2018), and CINAHL (1982 to 23 October 2018). We also searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised and quasi-randomised trials comparing banked donor preterm milk with banked donor term milk regarding growth and developmental outcomes in very low birth weight infants\nData collection and analysis\nWe planned to perform assessment of methodology regarding blinding of randomisation, intervention and outcome measurements as well as completeness of follow-up. We planned to evaluate treatment effect using a fixed-effect model using relative risk (RR), relative risk reduction, risk difference (RD) and number needed to treat for an additional beneficial outcome (NNTB) or the number needed to treat for an additional harmful outcome (NNTH) for categorical data; and using mean, standard deviation and weighted mean difference (WMD) for continuous data. We planned to use the GRADE approach to assess the quality of evidence.\nMain results\nNo studies met the inclusion criteria.\nAuthors' conclusions\nWe found no evidence to support or refute the effect of banked donor preterm milk compared to banked term milk regarding growth and developmental outcomes in very low birth weight infants.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There were no studies to make an assessment of quality of evidence."
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query-laysum | 3298 | [
{
"role": "user",
"content": "Abstract: Background\nMechanical ventilation is a life-saving intervention for critically ill newborn infants with respiratory failure admitted to a neonatal intensive care unit (NICU). Ventilating newborn infants can be challenging due to small tidal volumes, high breathing frequencies, and the use of uncuffed endotracheal tubes. Mechanical ventilation has several short-term, as well as long-term complications. To prevent complications, weaning from the ventilator is started as soon as possible. Weaning aims to support the transfer from full mechanical ventilation support to spontaneous breathing activity.\nObjectives\nTo assess the efficacy of protocolized versus non-protocolized ventilator weaning for newborn infants in reducing the duration of invasive mechanical ventilation, the duration of weaning, and shortening the NICU and hospital length of stay. To determine efficacy in predefined subgroups including: gestational age and birth weight; type of protocol; and type of protocol delivery. To establish whether protocolized weaning is safe and clinically effective in reducing the duration of mechanical ventilation without increasing the risk of adverse events.\nSearch methods\nWe searched the Cochrane Central Register of Controlled trials (CENTRAL; the Cochrane Library; 2015, Issue 7); MEDLINE In-Process and other Non-Indexed Citations and OVID MEDLINE (1950 to 31 July 2015); CINAHL (1982 to 31 July 2015); EMBASE (1988 to 31 July 2015); and Web of Science (1990 to 15 July 2015). We did not restrict language of publication. We contacted authors of studies with a subgroup of newborn infants in their study, and experts in the field regarding this subject. In addition, we searched abstracts from conference proceedings, theses, dissertations, and reference lists of all identified studies for further relevant studies.\nSelection criteria\nRandomized, quasi-randomized or cluster-randomized controlled trials that compared protocolized with non-protocolized ventilator weaning practices in newborn infants with a gestational age of 24 weeks or more, who were enrolled in the study before the postnatal age of 28 completed days after the expected date of birth.\nData collection and analysis\nFour authors, in pairs, independently reviewed titles and abstracts identified by electronic searches. We retrieved full-text versions of potentially relevant studies.\nMain results\nOur search yielded 1752 records. We removed duplicates (1062) and irrelevant studies (843). We did not find any randomized, quasi-randomized or cluster-randomized controlled trials conducted on weaning from mechanical ventilation in newborn infants. Two randomized controlled trials met the inclusion criteria on type of study and type of intervention, but only included a proportion of newborns. The study authors could not provide data needed for subgroup analysis; we excluded both studies.\nAuthors' conclusions\nBased on the results of this review, there is no evidence to support or refute the superiority or inferiority of weaning by protocol over non-protocol weaning on duration of invasive mechanical ventilation in newborn infants.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Study characteristics"
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query-laysum | 3299 | [
{
"role": "user",
"content": "Abstract: Background\nMany dentists or hygienists provide scaling and polishing for patients at regular intervals, even for those at low risk of developing periodontal disease. There is debate over the clinical and cost effectiveness of 'routine scaling and polishing' and the optimal frequency at which it should be provided for healthy adults.\nA 'routine scale and polish' treatment is defined as scaling or polishing, or both, of the crown and root surfaces of teeth to remove local irritational factors (plaque, calculus, debris and staining), which does not involve periodontal surgery or any form of adjunctive periodontal therapy such as the use of chemotherapeutic agents or root planing. Routine scale and polish treatments are typically provided in general dental practice settings. The technique may also be referred to as prophylaxis, professional mechanical plaque removal or periodontal instrumentation.\nThis review updates a version published in 2013.\nObjectives\n1. To determine the beneficial and harmful effects of routine scaling and polishing for periodontal health.\n2. To determine the beneficial and harmful effects of routine scaling and polishing at different recall intervals for periodontal health.\n3. To determine the beneficial and harmful effects of routine scaling and polishing for periodontal health when the treatment is provided by dentists compared with dental care professionals (dental therapists or dental hygienists).\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 10 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 12), MEDLINE Ovid (1946 to 10 January 2018), and Embase Ovid (1980 to 10 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials of routine scale and polish treatments, with or without oral hygiene instruction, in healthy dentate adults without severe periodontitis. We excluded split-mouth trials.\nData collection and analysis\nTwo review authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MDs) (or standardised mean differences (SMDs) when different scales were reported) and 95% confidence intervals (CIs) for continuous data. We calculated risk ratios (RR) and 95% CIs for dichotomous data. We used a fixed-effect model for meta-analyses. We contacted study authors when necessary to obtain missing information. We rated the certainty of the evidence using the GRADE approach.\nMain results\nWe included two studies with 1711 participants in the analyses. Both studies were conducted in UK general dental practices and involved adults without severe periodontitis who were regular attenders at dental appointments. One study measured outcomes at 24 months and the other at 36 months. Neither study measured adverse effects, changes in attachment level, tooth loss or halitosis.\nComparison 1: routine scaling and polishing versus no scheduled scaling and polishing\nTwo studies compared planned, regular interval (six- and 12-monthly) scale and polish treatments versus no scheduled treatment. We found little or no difference between groups over a two- to three-year period for gingivitis, probing depths, oral health-related quality of life (all high-certainty evidence) and plaque (low-certainty evidence). The SMD for gingivitis when comparing six-monthly scale and polish treatment versus no scheduled treatment was –0.01 (95% CI –0.13 to 0.11; two trials, 1087 participants), and for 12-monthly scale and polish versus no scheduled treatment was –0.04 (95% CI –0.16 to 0.08; two trials, 1091 participants).\nRegular planned scale and polish treatments produced a small reduction in calculus levels over two to three years when compared with no scheduled scale and polish treatments (high-certainty evidence). The SMD for six-monthly scale and polish versus no scheduled treatment was –0.32 (95% CI –0.44 to –0.20; two trials, 1088 participants) and for 12-monthly scale and polish versus no scheduled treatment was –0.19 (95% CI –0.31 to –0.07; two trials, 1088 participants). The clinical importance of these small reductions is unclear.\nParticipants' self-reported levels of oral cleanliness were higher when receiving six- and 12-monthly scale and polish treatments compared to no scheduled treatment, but the certainty of the evidence is low.\nComparison 2: routine scaling and polishing at different recall intervals\nTwo studies compared routine six-monthly scale and polish treatments versus 12-monthly treatments. We found little or no difference between groups over two to three years for the outcomes of gingivitis, probing depths, oral health-related quality of life (all high-certainty evidence) and plaque (low-certainty evidence). The SMD for gingivitis was 0.03 (95% CI -0.09 to 0.15; two trials, 1090 participants; I2 = 0%). Six- monthly scale and polish treatments produced a small reduction in calculus levels over a two- to three-year period when compared with 12-monthly treatments (SMD –0.13 (95% CI –0.25 to –0.01; 2 trials, 1086 participants; high-certainty evidence). The clinical importance of this small reduction is unclear.\nThe comparative effects of six- and 12-monthly scale and polish treatments on patients' self-reported levels of oral cleanliness were uncertain (very low-certainty evidence).\nComparison 3: routine scaling and polishing provided by dentists compared with dental care professionals (dental therapists or hygienists)\nNo studies evaluated this comparison.\nThe review findings in relation to costs were uncertain (very low-certainty evidence).\nAuthors' conclusions\nFor adults without severe periodontitis who regularly access routine dental care, routine scale and polish treatment makes little or no difference to gingivitis, probing depths and oral health-related quality of life over two to three years follow-up when compared with no scheduled scale and polish treatments (high-certainty evidence). There may also be little or no difference in plaque levels over two years (low-certainty evidence). Routine scaling and polishing reduces calculus levels compared with no routine scaling and polishing, with six-monthly treatments reducing calculus more than 12-monthly treatments over two to three years follow-up (high-certainty evidence), although the clinical importance of these small reductions is uncertain. Available evidence on the costs of the treatments is uncertain. The studies did not assess adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review examined evidence for effects of routine scale and polish treatment. It was carried out by authors working with Cochrane Oral Health to assess the effects of routine scale and polish treatments for healthy adults; to establish whether different time intervals between treatments influence these effects; and to compare the effectiveness of the treatment when given by a dentist compared to a dental therapist or hygienist.\nThis review updates the version published in 2013 and the evidence was up-to-date as of 10 January 2018."
}
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query-laysum | 3300 | [
{
"role": "user",
"content": "Abstract: Background\nBupivacaine is an amide local anaesthetic used in hyperbaric and isobaric forms. These are administered intrathecally into the spine to provide regional anaesthesia for caesarean section. Several trials have compared hyperbaric and isobaric bupivacaine but none have conclusively shown the benefit of either. This review was first published in 2013 and updated in 2016.\nObjectives\nOur objectives were to:\n1. Determine the effectiveness of hyperbaric bupivacaine compared to isobaric bupivacaine for spinal anaesthesia in women undergoing caesarean section;\n2. Determine the safety of hyperbaric bupivacaine compared to isobaric bupivacaine for spinal anaesthesia in women undergoing caesarean section.\nSearch methods\nWe originally searched the following databases to January 2011: CENTRAL, MEDLINE and Embase.\nFor this update, we reran our search in the above databases from January 2011 to March 2016; two studies are awaiting a response from authors for assessment and will be dealt with when we next update the review.\nWe imposed no language restriction.\nSelection criteria\nWe included all randomized controlled trials (RCTs) involving parturients undergoing spinal anaesthesia for elective caesarean section that compared the use of hyperbaric with isobaric bupivacaine.\nData collection and analysis\nTwo authors independently extracted the data. The data that were extracted included the number of events and the sample sizes in both the intervention and control groups. For continuous outcomes, we extracted mean and standard deviation.\nWe reported odds ratios (ORs) and risk ratios (RRs) for binary outcomes, and mean differences (MDs) for continuous outcomes.\nMain results\nWe included three new RCTs in this update, which now comprises 10 studies with a total of 614 participants. We judged most trials as having uncertain risk of bias regarding randomization. Other than this, the overall risk of bias was low. Most included trials had small sample sizes. All of the trials assessed the primary outcome of conversion to general anaesthesia. Ten trials comparing anaesthesia performed with hyperbaric and isobaric bupivacaine failed to show any difference in need for conversion to general anaesthesia (RR 0.33, 95% CI 0.09 to 1.17, 614 participants, very low quality of evidence). Nine trials also failed to show a difference in the need for supplemental analgesics (RR 0.61, 95% CI 0.26 to 1.41, 554 participants, very low quality of evidence). Four trials comparing requirement for ephedrine did not show any difference (RR 0.89, 95% CI 0.57 to 1.38, 256 participants, very low quality of evidence). Seven trials did not provide convincing evidence of difference in nausea and vomiting (RR 0.99, 95% CI 0.57 to 1.72, 433 participants, low quality of evidence). Three trials failed to show a difference in headache (OR 1.82, 95% CI 0.47 to 6.99, 234 participants, low quality of evidence). Two trials showed that the time until sensory block to the thoracic 4th (T4) spinal level was shorter with hyperbaric bupivacaine (MD -1.06 minutes, 95% CI -1.80 to -0.31, 128 participants, moderate quality of evidence). Six trials showed no difference in the amount of ephedrine used (RR 0.23, 95% CI -1.65 to 2.12, 386 participants, moderate quality of evidence). Three trials failed to show any difference in high block (RR 0.88, 95% CI 0.16 to 4.90, 205 participants).\nAuthors' conclusions\nData are limited for some of the outcomes. Reporting of the included trials is less than optimal. For these reasons the overall quality of evidence is low or very low for most of the outcomes, based on the GRADE method of assessment. This review found that intrathecal hyperbaric bupivacaine had a more rapid onset of sensory blockade at the 4th thoracic vertebra (T4) level than isobaric bupivacaine. Hower, despite incorporating more data in the analysis, we found little evidence that the need for conversion to general anaesthesia and supplemental analgesia differed between the hyperbaric or isobaric bupivacaine groups. This is mainly due to the rarity of these outcomes, variability in the dose, use of adjuvant drugs and differences in the technique used for regional anaesthesia. There were no differences in the adverse effects studied. Any possible advantage of hyperbaric bupivacaine needs to be confirmed in larger randomized trials. In future research, criteria for conversion to general anaesthesia need to be defined objectively and applied uniformly.\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 there is insufficient evidence to establish whether denser or normal bupivacaine is the more effective in reducing the need for: a) switching to general anaesthesia; b) additional pain relief medication. Denser bupivacaine had a more rapid onset of pain relief."
}
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query-laysum | 3301 | [
{
"role": "user",
"content": "Abstract: Background\nMeningococcal disease can lead to death or disability within hours after onset. Pre-admission antibiotics aim to reduce the risk of serious disease and death by preventing delays in starting therapy before confirmation of the diagnosis.\nObjectives\nTo study the effectiveness and safety of pre-admission antibiotics versus no pre-admission antibiotics or placebo, and different pre-admission antibiotic regimens in decreasing mortality, clinical failure, and morbidity in people suspected of meningococcal disease.\nSearch methods\nWe searched CENTRAL (6 January 2017), MEDLINE (1966 to 6 January 2017), Embase (1980 to 6 January 2017), Web of Science (1985 to 6 January 2017), LILACS (1982 to 6 January 2017), and prospective trial registries to January 2017. We previously searched CAB Abstracts from 1985 to June 2015, but did not update this search in January 2017.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing antibiotics versus placebo or no intervention, in people with suspected meningococcal infection, or different antibiotics administered before admission to hospital or confirmation of the diagnosis.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data from the search results. We calculated the risk ratio (RR) and 95% confidence interval (CI) for dichotomous data. We included only one trial and so did not perform data synthesis. We assessed the overall quality of the evidence using the GRADE approach.\nMain results\nWe found no RCTs comparing pre-admission antibiotics versus no pre-admission antibiotics or placebo. We included one open-label, non-inferiority RCT with 510 participants, conducted during an epidemic in Niger, evaluating a single dose of intramuscular ceftriaxone versus a single dose of intramuscular long-acting (oily) chloramphenicol. Ceftriaxone was not inferior to chloramphenicol in reducing mortality (RR 1.21, 95% CI 0.57 to 2.56; N = 503; 308 confirmed meningococcal meningitis; 26 deaths; moderate-quality evidence), clinical failures (RR 0.83, 95% CI 0.32 to 2.15; N = 477; 18 clinical failures; moderate-quality evidence), or neurological sequelae (RR 1.29, 95% CI 0.63 to 2.62; N = 477; 29 with sequelae; low-quality evidence). No adverse effects of treatment were reported. Estimated treatment costs were similar. No data were available on disease burden due to sequelae.\nAuthors' conclusions\nWe found no reliable evidence to support the use pre-admission antibiotics for suspected cases of non-severe meningococcal disease. Moderate-quality evidence from one RCT indicated that single intramuscular injections of ceftriaxone and long-acting chloramphenicol were equally effective, safe, and economical in reducing serious outcomes. The choice between these antibiotics should be based on affordability, availability, and patterns of antibiotic resistance.\nFurther RCTs comparing different pre-admission antibiotics, accompanied by intensive supportive measures, are ethically justified in people with less severe illness, and are needed to provide reliable evidence in different clinical settings.\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 studies comparing giving versus not giving empiric antibiotics or comparing different antibiotics in those with suspected meningococcal disease. We found one randomised trial comparing single intramuscular doses of two different long-acting antibiotics. The evidence is current to January 2017.\nThe included study was conducted in nine primary care facilities in Niger during an outbreak of meningococcal disease in 2003. Of 510 adults and children studied, 251 received ceftriaxone and 259 received chloramphenicol. The study was funded by Médecins Sans Frontières."
}
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query-laysum | 3302 | [
{
"role": "user",
"content": "Abstract: Background\nHidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterised by recurrent painful boils in flexural sites, such as the axillae and groin, that affects about 1% of the population, with onset in early adulthood.\nObjectives\nTo assess the effects of interventions for HS in people of all ages.\nSearch methods\nWe searched the following databases up to 13 August 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 7, 2015), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers and handsearched the conference proceedings of eight dermatology meetings. We checked the reference lists of included and excluded studies for further references to relevant trials.\nSelection criteria\nRandomised controlled trials (RCTs) of all interventions for hidradenitis suppurativa.\nData collection and analysis\nTwo review authors independently assessed study eligibility and methodological quality and performed data extraction. Our primary outcomes were quality of life, measured by a validated dermatology-specific scale, and adverse effects of the interventions.\nMain results\nTwelve trials, with 615 participants, met our inclusion criteria. The median number of participants in each trial was 27, and median trial duration was 16 weeks. The included studies were conducted over a 32-year time period, from 1983 to 2015. A single RCT that was underpowered to detect clinically meaningful differences investigated most interventions.\nThere were four trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) score in participants with moderate to severe HS by 4.0 points relative to placebo (95% confidence interval (CI) -6.5 to -1.5 points), an effect size approximately equal to the DLQI minimal clinically important difference. We reduced the evidence quality to 'moderate' because the effect size was based on the results of only one study. In a meta-analysis of two studies with 124 participants, standard dose adalimumab 40 mg every other week was ineffective compared with placebo (moderate quality evidence). In a smaller study of 38 participants, of whom only 33 provided efficacy data, infliximab 5 mg/kg treatment improved DLQI by 8.4 DLQI points after eight weeks. Etanercept 50 mg twice weekly was well tolerated but ineffective.\nIn a RCT of 200 participants, no difference was found in surgical complications (week one: risk ratio (RR) 0.78, 95% CI 0.58 to 1.05, moderate quality evidence) or risk of recurrence (after three months: RR 0.96, 95% CI 0.68 to 1.34, moderate quality evidence) in those randomised to receive a gentamicin-collagen sponge prior to primary closure compared with primary closure alone.\nRCTs of other interventions, including topical clindamycin 1% solution; oral tetracycline; oral ethinylestradiol 50 mcg with either cyproterone acetate 50 mg or norgestrel 500 mcg; intense pulsed light; neodymium-doped yttrium aluminium garnet (Nd:YAG) laser; methylene blue gel photodynamic therapy; and staphage lysate, were relatively small studies, preventing firm conclusions due to imprecision.\nAuthors' conclusions\nMany knowledge gaps exist in RCT evidence for HS. Moderate quality evidence exists for adalimumab, which improves DLQI score when 40 mg is given weekly, twice the standard psoriasis dose. However, the 95% confidence interval includes an effect size of only 1.5 DLQI points, which may not be clinically relevant, and the safety profile of weekly dosing has not been fully established. Infliximab also improves quality of life, based on moderate quality evidence.\nMore RCTs are needed in most areas of HS care, particularly oral treatments and the type and timing of surgical procedures. Outcomes should be validated, ideally, including a minimal clinically important difference for HS.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our review has highlighted a need for more clinical trials to give better evidence to guide treatment choices in HS. More trials of oral treatments are required as well as surgical studies. Future trials should include patient-reported outcomes, such as quality of life and pain."
}
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query-laysum | 3303 | [
{
"role": "user",
"content": "Abstract: Background\nMechanical ventilation often causes major distress and anxiety in patients. The sensation of breathlessness, frequent suctioning, inability to talk, uncertainty regarding surroundings or condition, discomfort, isolation from others, and fear contribute to high levels of anxiety. Side effects of analgesia and sedation may lead to the prolongation of mechanical ventilation and, subsequently, to a longer length of hospitalization and increased cost. Therefore, non-pharmacological interventions should be considered for anxiety and stress management. Music interventions have been used to reduce anxiety and distress and improve physiological functioning in medical patients; however, their efficacy for mechanically ventilated patients needs to be evaluated. This review was originally published in 2010 and was updated in 2014.\nObjectives\nTo update the previously published review that examined the effects of music therapy or music medicine interventions (as defined by the authors) on anxiety and other outcomes in mechanically ventilated patients. Specifically, the following objectives are addressed in this review.\n1. To conduct a meta-analysis to compare the effects of participation in standard care combined with music therapy or music medicine interventions with standard care alone.\n2. To compare the effects of patient-selected music with researcher-selected music.\n3. To compare the effects of different types of music interventions (e.g., music therapy versus music medicine).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 2), MEDLINE (1950 to March 2014), CINAHL (1980 to March 2014), EMBASE (1980 to March 2014), PsycINFO (1967 to March 2014), LILACS (1982 to March 2014), Science Citation Index (1980 to March 2014), www.musictherapyworld.net (1 March 2008) (database is no longer functional), CAIRSS for Music (to March 2014), Proquest Digital Dissertations (1980 to March 2014), ClinicalTrials.gov (2000 to March 2014), Current Controlled Trials (1998 to March 2014), the National Research Register (2000 to September 2007), and NIH CRISP (all to March 2014). We handsearched music therapy journals and reference lists, and contacted relevant experts to identify unpublished manuscripts. There was no language restriction. The original search was performed in January 2010.\nSelection criteria\nWe included all randomized and quasi-randomized controlled trials that compared music interventions and standard care with standard care alone for mechanically ventilated patients.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the methodological quality of included studies. We contacted authors to obtain missing data where needed. Where possible, results for continuous outcomes were presented in meta-analyses using mean differences and standardized mean differences. Post-test scores were used. In cases of significant baseline difference, we used change scores. For dichotomous outcomes, we presented the results as risk ratios.\nMain results\nWe identified six new trials for this update. In total, the evidence for this review rests on 14 trials (805 participants). Music listening was the main intervention used, and 13 of the studies did not include a trained music therapist. Results indicated that music listening may be beneficial for anxiety reduction in mechanically ventilated patients. Specifically, music listening resulted, on average, in an anxiety reduction that was 1.11 standard deviation units greater (95% CI -1.75 to -0.47, P = 0.0006) than in the standard care group. This is considered a large and clinically significant effect. Findings indicated that listening to music consistently reduced respiratory rate and systolic blood pressure, suggesting a relaxation response. Furthermore, one large-scale study reported greater reductions in sedative and analgesic intake in the music listening group compared to the control group, and two other studies reported trends for reduction in sedative and analgesic intake for the music group. One study found significantly higher sedation scores in the music listening group compared to the control group.\nNo strong evidence was found for reduction in diastolic blood pressure and mean arterial pressure. Furthermore, inconsistent results were found for reduction in heart rate with seven studies reporting greater heart rate reductions in the music listening group and one study a slightly greater reduction in the control group. Music listening did not improve oxygen saturation levels.\nFour studies examined the effects of music listening on hormone levels but the results were mixed and no conclusions could be drawn.\nNo strong evidence was found for an effect of music listening on mortality rate but this evidence rested on only two trials.\nMost trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution.\nNo studies could be found that examined the effects of music interventions on quality of life, patient satisfaction, post-discharge outcomes, or cost-effectiveness. No adverse events were identified.\nAuthors' conclusions\nThis updated systematic review indicates that music listening may have a beneficial effect on anxiety in mechanically ventilated patients. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. The review furthermore suggests that music listening consistently reduces respiratory rate and systolic blood pressure. Finally, results indicate a possible beneficial impact on the consumption of sedatives and analgesics. Therefore, we conclude that music interventions may provide a viable anxiety management option to mechanically ventilated patients.\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 March 2014."
}
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query-laysum | 3304 | [
{
"role": "user",
"content": "Abstract: Background\nAmyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is terminal, progressive neurological condition for which there are no curative treatments. Among people with ALS/MND, fatigue is a common and debilitating symptom, which is characterised by reversible motor weakness and whole-body tiredness that is only partially relieved by rest. The effectiveness of pharmacological or non-pharmacological treatments for fatigue in ALS/MND is not yet established.\nObjectives\nTo assess the effects of pharmacological and non-pharmacological interventions for fatigue in ALS/MND.\nSearch methods\nWe searched the following databases on 5 September 2017: Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL Plus, and ERIC. We also searched two clinical trials registries.\nSelection criteria\nWe selected randomised and quasi-randomised controlled trials of any intervention which sought to reduce fatigue for people with ALS/MND. We included studies if reduction in fatigue was a primary or secondary outcome of the trial.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe included one pharmacological (modafinil) study and three non-pharmacological studies (resistance exercise, respiratory exercise, and repetitive transcranial magnetic stimulation (rTMS)), involving a total of 86 participants with ALS/MND. None of the included studies were free from risk of bias. Since there was only one trial for each intervention, no meta-analysis was possible. All studies assessed fatigue using the Fatigue Severity Scale (FSS; scale from 9 to 63, higher scores indicate more fatigue). Information for assessing bias was often lacking in study reports, making the risk of bias unclear across several domains in all trials. Blinding of participants was not possible in exercise trials, but the outcome assessment was blinded.\nWe found very low-quality evidence suggesting possible improvements in fatigue for modafinil treatment versus placebo (MD -11.00, 95% CI -23.08 to 1.08), respiratory exercise versus a sham intervention (MD -9.65, 95% CI -22.04 to 2.73), and rTMS versus sham rTMS (data not provided), which warrant further investigation to clarify the efficacy of these treatments for fatigue in ALS/MND. We found no clear improvements in fatigue for resistance exercise versus usual care (MD 0.20, 95% CI -10.98 to 11.38; very low-quality evidence).\nThree participants in the modafinil group dropped out of the modafinil study, two citing issues with headache and one with chest tightness; other adverse effects were anxiety, nausea, dizziness, and sialorrhoea (probably ALS-related). The trials reported no adverse effects of exercise or rTMS.\nWe cannot be certain about the effects of any of the interventions studied because of imprecision (small numbers of participants, wide CI), and possible study limitations.\nAuthors' conclusions\nIt is impossible to draw firm conclusions about the effectiveness of interventions to improve fatigue for people with ALS/MND as there are few randomised studies, and the quality of available evidence is very low.\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": "ALS, which is also known as motor neuron disease (MND), is a condition in which the nerves that control movement stop working. People experience problems moving their limbs, maintaining posture, swallowing, and breathing, which worsen over time and shorten life. The cause is unknown, and there is no cure. People living with ALS/MND often experience fatigue, which can cause distress and reduce quality of life. Fatigue can have many causes, including respiratory problems, medication, malnutrition, and depression. Our focus in this review was on treatments for fatigue that arises from the condition itself. Different treatments may improve symptoms of fatigue in ALS/MND. These include medicines, which may help people feel more awake, and other treatments, such as exercise. It is unclear whether any of these treatments are effective for improving fatigue in ALS/MND. We reviewed the available studies on the effects of treatments for fatigue in ALS/MND."
}
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query-laysum | 3305 | [
{
"role": "user",
"content": "Abstract: Background\nRoutine use of whole-cell pertussis (wP) vaccines was suspended in some countries in the 1970s and 1980s because of concerns about adverse effects. Following this action, there was a resurgence of whooping cough. Acellular pertussis (aP) vaccines, containing purified or recombinant Bordetella pertussis (B. pertussis) antigens, were developed in the hope that they would be as effective, but less reactogenic than the whole-cell vaccines. This is an update of a Cochrane review first published in 1999, and previously updated in 2012. In this update, we included no new studies.\nObjectives\nTo assess the efficacy and safety of acellular pertussis vaccines in children and to compare them with the whole-cell vaccines.\nSearch methods\nWe searched CENTRAL (2013, Issue 12), MEDLINE (1950 to January week 2, 2014), EMBASE (1974 to January 2014), Biosis Previews (2009 to January 2014) and CINAHL (2009 to January 2014).\nSelection criteria\nWe selected double-blind randomised efficacy and safety trials of aP vaccines in children up to six years old, with active follow-up of participants and laboratory verification of pertussis cases.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias in the studies. Differences in trial design precluded a meta-analysis of the efficacy data. We pooled the safety data from individual trials using a random-effects meta-analysis model.\nMain results\nWe included six efficacy trials with a total of 46,283 participants and 52 safety trials with a total of 136,541 participants. Most of the safety trials did not report the methods for random sequence generation, allocation concealment and blinding, which made it difficult to assess the risk of bias in the studies. The efficacy of multi-component (≥ three) vaccines varied from 84% to 85% in preventing typical whooping cough (characterised by 21 or more consecutive days of paroxysmal cough with confirmation of B. pertussis infection by culture, appropriate serology or contact with a household member who has culture-confirmed pertussis), and from 71% to 78% in preventing mild pertussis disease (characterised by seven or more consecutive days of cough with confirmation of B. pertussis infection by culture or appropriate serology). In contrast, the efficacy of one- and two-component vaccines varied from 59% to 78% against typical whooping cough and from 41% to 58% against mild pertussis disease. Multi-component acellular vaccines are more effective than low-efficacy whole-cell vaccines, but may be less effective than the highest-efficacy whole-cell vaccines. Most systemic and local adverse events were significantly less common with aP vaccines than with wP vaccines for the primary series as well as for the booster dose.\nAuthors' conclusions\nMulti-component (≥ three) aP vaccines are effective in preventing whooping cough in children. Multi-component aP vaccines have higher efficacy than low-efficacy wP vaccines, but they may be less efficacious than the highest-efficacy wP vaccines. Acellular vaccines have fewer adverse effects than whole-cell vaccines for the primary series as well as for booster doses.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We aimed to answer the question of whether acellular pertussis vaccines are as effective as the whole-cell vaccines at protecting children against whooping cough (pertussis), but with fewer side effects."
}
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query-laysum | 3306 | [
{
"role": "user",
"content": "Abstract: Background\nCataract and glaucoma are leading causes of blindness worldwide, and their co-existence is common in elderly people. Glaucoma surgery can accelerate cataract progression, and performing both surgeries may increase the rate of postoperative complications and compromise the success of either surgery. However, cataract surgery may independently lower intraocular pressure (IOP), which may allow for greater IOP control among patients with co-existing cataract and glaucoma. The decision between undergoing combined glaucoma and cataract surgery versus cataract surgery alone is complex. Therefore, it is important to compare the effectiveness of these two interventions to aid clinicians and patients in choosing the better treatment approach.\nObjectives\nTo assess the relative effectiveness and safety of combined surgery versus cataract surgery (phacoemulsification) alone for co-existing cataract and glaucoma. The secondary objectives include cost analyses for different surgical techniques for co-existing cataract and glaucoma.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), PubMed (January 1948 to October 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (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 3 October 2014.\nWe checked the reference lists of the included trials to identify further relevant trials. We used the Science Citation Index to search for references to publications that cited the studies included in the review. We also contacted investigators and experts in the field to identify additional trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) of participants who had open-angle, pseudoexfoliative, or pigmentary glaucoma and age-related cataract. The comparison of interest was combined cataract surgery (phacoemulsification) and any type of glaucoma surgery versus cataract surgery (phacoemulsification) alone.\nData collection and analysis\nTwo review authors independently assessed study eligibility, collected data, and judged risk of bias for included studies. We used standard methodological procedures expected by the Cochrane Collaboration.\nMain results\nWe included nine RCTs, with a total of 655 participants (657 eyes), and follow-up periods ranging from 12 to 30 months. Seven trials were conducted in Europe, one in Canada and South Africa, and one in the United States. We graded the overall quality of the evidence as low due to observed inconsistency in study results, imprecision in effect estimates, and risks of bias in the included studies.\nGlaucoma surgery type varied among the studies: three studies used trabeculectomy, three studies used iStent® implants, one study used trabeculotomy, and two studies used trabecular aspiration. All of these studies found a statistically significant greater decrease in mean IOP postoperatively in the combined surgery group compared with cataract surgery alone; the mean difference (MD) was -1.62 mmHg (95% confidence interval (CI) -2.61 to -0.64; 489 eyes) among six studies with data at one year follow-up. No study reported the proportion of participants with a reduction in the number of medications used after surgery, but two studies found the mean number of medications used postoperatively at one year was about one less in the combined surgery group than the cataract surgery alone group (MD -0.69, 95% CI -1.28 to -0.10; 301 eyes). Five studies showed that participants in the combined surgery group were about 50% less likely compared with the cataract surgery alone group to use one or more IOP-lowering medications one year postoperatively (risk ratio (RR) 0.47, 95% CI 0.28 to 0.80; 453 eyes). None of the studies reported the mean change in visual acuity or visual fields. However, six studies reported no significant differences in visual acuity and two studies reported no significant differences in visual fields between the two intervention groups postoperatively (data not analyzable). The effect of combined surgery versus cataract surgery alone on the need for reoperation to control IOP at one year was uncertain (RR 1.13, 95% CI 0.15 to 8.25; 382 eyes). Also uncertain was whether eyes in the combined surgery group required more interventions for surgical complications than those in the cataract surgery alone group (RR 1.06, 95% CI 0.34 to 3.35; 382 eyes). No study reported any vision-related quality of life data or cost outcome. Complications were reported at 12 months (two studies), 12 to 18 months (one study), and two years (four studies) after surgery. Due to the small number of events reported across studies and treatment groups, the difference between groups was uncertain for all reported adverse events.\nAuthors' conclusions\nThere is low quality evidence that combined cataract and glaucoma surgery may result in better IOP control at one year compared with cataract surgery alone. The evidence was uncertain in terms of complications from the surgeries. Furthermore, this Cochrane review has highlighted the lack of data regarding important measures of the patient experience, such as visual field tests, quality of life measurements, and economic outcomes after surgery, and long-term outcomes (five years or more). Additional high-quality RCTs measuring clinically meaningful and patient-important outcomes are required to provide evidence to support treatment recommendations.\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 concluded from the available evidence that combined glaucoma and cataract surgery may lead to slightly greater decreases in IOP one year after surgery compared with cataract surgery alone. However, due to differences in the effects among the individual studies and potential for bias in the study results, this conclusion is not definitive. The effect between combined surgery and cataract surgery alone on the rate of complications was uncertain. No information was available for long-term outcomes (five or more years after surgery)."
}
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query-laysum | 3307 | [
{
"role": "user",
"content": "Abstract: Background\nSickle cell disease (SCD) includes a group of inherited haemoglobinopathies affecting multiple organs including the eyes. Some people with SCD develop ocular manifestations. Vision-threatening complications are mainly due to proliferative sickle retinopathy, which is characterised by proliferation of new blood vessels. Laser photocoagulation is widely applicable in proliferative retinopathies. It is important to evaluate the efficacy and safety of laser photocoagulation in the treatment of proliferative sickle retinopathy (PSR) to prevent sight-threatening complications.\nObjectives\nTo evaluate the effectiveness of various techniques of laser photocoagulation therapy in SCD-related proliferative retinopathy.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group’s Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 4 July 2022.\nWe also searched the following resources (26 June 2022): Latin American and Caribbean Health Science Literature Database (LILACS); WHO International Clinical Trials Registry Platforms (ICTRP); and ClinicalTrials.gov.\nSelection criteria\nRandomised controlled trials comparing laser photocoagulation to no treatment in children and adults with SCD.\nData collection and analysis\nTwo review authors independently assessed eligibility and risk of bias of the included trials; we extracted and analysed data, contacting trial authors for additional information. We assessed the certainty of the evidence using the GRADE criteria.\nMain results\nWe included three trials (414 eyes of 339 children and adults) comparing the efficacy and safety of laser photocoagulation to no therapy in people with PSR. There were 160 males and 179 females ranging in age from 13 to 67 years. The trials used different laser photocoagulation techniques; one single-centre trial employed sectoral scatter laser photocoagulation using an argon laser; a two-centre trial employed feeder vessel coagulation using argon laser in one centre and xenon arc in the second centre; while a third trial employed focal scatter laser photocoagulation using argon laser. The mean follow-up periods were 21 to 32 months in one trial, 42 to 47 months in a second, and 48 months in the third. Two trials had a high risk of allocation bias due to the randomisation method for participants with bilateral disease; the third trial had an unclear risk of selection bias. One trial was at risk of reporting bias. Given the unit of analysis is the eye rather than the individual, we chose to report the data narratively.\nUsing sectoral scatter laser photocoagulation, one trial (174 eyes) reported no difference between groups for complete regression of PSR: 30.2% in the laser group and 22.4% in the control group. The same trial also reported no difference between groups in the development of new PSR: 34.3% of lasered eyes and 41.3% of control eyes (very low-certainty evidence). The two-centre trial using feeder vessel coagulation, only presented data at follow-up for one centre (mean period of nine years) and reported the development of new sea fan in 48.0% in the treated and 45.0% in the control group; no statistical significance (P = 0.64). A third trial reported regression in 55% of the laser group versus 28.6% of controls and progression of PSR in 10.5% of treated versus 25.7% of control eyes. We graded the evidence for these two primary outcomes as very low-certainty evidence.\nThe sectoral scatter laser photocoagulation trial reported visual loss in 3.0% of treated eyes (mean follow-up 47 months) versus 12.0% of controlled eyes (mean follow-up 42 months) (P = 0.019). The feeder vessel coagulation trial reported visual loss in 1.14% of the laser group and 7.5% of the control group (mean follow-up 26 months at one site and 32 months in another) (P = 0.07). The focal scatter laser photocoagulation trial (mean follow-up of four years) reported that 72/73 eyes had the same visual acuity, while visual loss was seen in only one eye from the control group. We graded the certainty of the evidence as very low.\nThe sectoral scatter laser trial detected vitreous haemorrhage in 12.0% of the laser group and 25.3% of control with a mean follow-up of 42 (control) to 47 months (treated) (P ≤ 0.5). The two-centre feeder vessel coagulation trial observed vitreous haemorrhage in 3.4% treated eyes (mean follow-up 26 months) versus 27.5% control eyes (mean follow-up 32 months); one centre (mean follow-up nine years) reported vitreous haemorrhage in 1/25 eyes (4.0%) in the treatment group and 9/20 eyes (45.0%) in the control group (P = 0.002). The scatter laser photocoagulation trial reported that vitreous haemorrhage was not seen in the treated group compared to 6/35 (17.1%) eyes in the control group and appeared only in the grades B and (PSR) stage III) (P < 0.05). We graded evidence for this outcome as low-certainty.\nRegarding adverse effects, only one occurrence of retinal tear was reported. All three trials reported on retinal detachment, with no significance across the treatment and control groups (low-certainty evidence). One trial reported on choroidal neovascularization, with treatment with xenon arc found to be associated with a significantly higher risk, but visual loss related to this complication is uncommon with long-term follow-up of three years or more.\nThe included trials did not report on other adverse effects or quality of life.\nAuthors' conclusions\nOur conclusions are based on the data from three trials (two of which were conducted over 30 years ago). Given the limited evidence available, which we assessed to be of low- or very low-certainty, we are uncertain whether laser therapy for sickle cell retinopathy improves the outcomes measured in this review. This treatment does not appear to have an effect on clinical outcomes such as regression of PSR and development of new incidences. No evidence is available assessing efficacy in relation to patient-important outcomes (such as quality of life or the loss of a driving licence). Further research is needed to examine the safety of laser treatment compared to other interventions such as intravitreal injection of anti-vascular endothelial growth factors (VEGFs) . Patient-important outcomes as well as cost-effectiveness should be addressed.\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": "Sickle cell disease is a genetic disorder affecting many organs including the eyes. The back of the eye (retina) can develop problems due to sickle cell disease. A certain number of people with sickle cell disease develop sight-threatening complications due to excessive blood vessel growth in the retina which is known as proliferative sickle retinopathy. Laser therapy is used to control the growth of new blood vessels in affected eyes. There are different types and techniques of laser used in treatment. However, we do not know whether these various laser treatments offer advantages compared to no treatment or other interventions with regards to effectiveness and safety."
}
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query-laysum | 3308 | [
{
"role": "user",
"content": "Abstract: Background\nRoutine outcome monitoring of common mental health disorders (CMHDs), using patient reported outcome measures (PROMs), has been promoted across primary care, psychological therapy and multidisciplinary mental health care settings, but is likely to be costly, given the high prevalence of CMHDs. There has been no systematic review of the use of PROMs in routine outcome monitoring of CMHDs across these three settings.\nObjectives\nTo assess the effects of routine measurement and feedback of the results of PROMs during the management of CMHDs in 1) improving the outcome of CMHDs; and 2) in changing the management of CMHDs.\nSearch methods\nWe searched the Cochrane Depression Anxiety and Neurosis group specialised controlled trials register (CCDANCTR-Studies and CCDANCTR-References), the Oxford University PROMS Bibliography (2002-5), Ovid PsycINFO, Web of Science, The Cochrane Library, and International trial registries, initially to 30 May 2014, and updated to 18 May 2015.\nSelection criteria\nWe selected cluster and individually randomised controlled trials (RCTs) including participants with CMHDs aged 18 years and over, in which the results of PROMs were fed back to treating clinicians, or both clinicians and patients. We excluded RCTs in child and adolescent treatment settings, and those in which more than 10% of participants had diagnoses of eating disorders, psychoses, substance use disorders, learning disorders or dementia.\nData collection and analysis\nAt least two authors independently identified eligible trials, assessed trial quality, and extracted data. We conducted meta-analysis across studies, pooling outcome measures which were sufficiently similar to each other to justify pooling.\nMain results\nWe included 17 studies involving 8787 participants: nine in multidisciplinary mental health care, six in psychological therapy settings, and two in primary care. Pooling of outcome data to provide a summary estimate of effect across studies was possible only for those studies using the compound Outcome Questionnaire (OQ-45) or Outcome Rating System (ORS) PROMs, which were all conducted in multidisciplinary mental health care or psychological therapy settings, because both primary care studies identified used single symptom outcome measures, which were not directly comparable to the OQ-45 or ORS.\nMeta-analysis of 12 studies including 3696 participants using these PROMs found no evidence of a difference in outcome in terms of symptoms, between feedback and no-feedback groups (standardised mean difference (SMD) -0.07, 95% confidence interval (CI) -0.16 to 0.01; P value = 0.10). The evidence for this comparison was graded as low quality however, as all included studies were considered at high risk of bias, in most cases due to inadequate blinding of assessors and significant attrition at follow-up.\nQuality of life was reported in only two studies, social functioning in one, and costs in none. Information on adverse events (thoughts of self-harm or suicide) was collected in one study, but differences between arms were not reported.\nIt was not possible to pool data on changes in drug treatment or referrals as only two studies reported these. Meta-analysis of seven studies including 2608 participants found no evidence of a difference in management of CMHDs between feedback and no-feedback groups, in terms of the number of treatment sessions received (mean difference (MD) -0.02 sessions, 95% CI -0.42 to 0.39; P value = 0.93). However, the evidence for this comparison was also graded as low quality.\nAuthors' conclusions\nWe found insufficient evidence to support the use of routine outcome monitoring using PROMs in the treatment of CMHDs, in terms of improving patient outcomes or in improving management. The findings are subject to considerable uncertainty however, due to the high risk of bias in the large majority of trials meeting the inclusion criteria, which means further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate. More research of better quality is therefore required, particularly in primary care where most CMHDs are treated.\nFuture research should address issues of blinding of assessors and attrition, and measure a range of relevant symptom outcomes, as well as possible harmful effects of monitoring, health-related quality of life, social functioning, and costs. Studies should include people treated with drugs as well as psychological therapies, and should follow them up for longer than six months.\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": "Trial databases were searched to find all high-quality studies of the use of PROMs to monitor the treatment of CMHDs published up to May 2015. Included studies had to be randomised controlled trials in adult participants, where the majority diagnosed had a CMHD.\nSeventeen studies involving 8787 participants were included in the review, nine from mental health, six from psychological therapy, and two from primary care settings.\nThe quality of the studies was rated ‘low’ to 'moderate'."
}
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query-laysum | 3309 | [
{
"role": "user",
"content": "Abstract: Background\nGlucocorticoid use in rheumatoid arthritis (RA) is widespread. Two Cochrane Reviews have been published examining the short term clinical benefit of low dose glucocorticoids compared to non-steroidal anti-inflammatory drugs and demonstrate good short term and medium term clinical benefits. The possibility that glucocorticoids may have a fundamental 'disease modifying' effect in RA, which would be seen by a reduction in the rate of radiological progression, has been raised by several authors.\nObjectives\nTo perform a systematic review of studies evaluating glucocorticoid efficacy in inhibiting the progression of radiological damage in rheumatoid arthritis.\nSearch methods\nA search of MEDLINE (from 1966 to 22 February 2005) and the Cochrane Central Register of Controlled Trials was undertaken, using the terms 'corticosteroids' and 'rheumatoid arthritis' expanded according to the Cochrane Collaboration recommendations. Identified abstracts were reviewed and appropriate reports obtained in full. Additional reports were identified from the reference lists and from expert knowledge.\nSelection criteria\nRandomized controlled or cross-over trials in adults with a diagnosis of rheumatoid arthritis in which prednisone or a similar glucocorticoid preparation was compared to either placebo controls or active controls (i.e. comparative studies) and where there was evaluation of radiographs of hands, or hands and feet, or feet by any standardised technique. Eligible studies had at least one treatment arm with glucocorticoids and one without glucocorticoids.\nData collection and analysis\nStandardised data extraction obtained the mean and standard deviation (SD) of change in erosion scores over 1 year or 2 years. (Where SD for change was not given a conservative estimate was taken from baseline data.) At least two authors selected the studies and extracted the data. Radiographic erosion scores were expressed as a percentage of the maximum possible score for the method used. The results were pooled after weighting in a random effects model to provide a standardised mean difference (SMD).\nMain results\nThe initial search produced 217 citations, and 15 were added from experts, abstracts and review of reference lists. Authors of 4 trials being prepared for publication (and subsequently published) kindly shared their data. After application of eligibility criteria 15 studies and 1,414 patients were included. The majority of trials studied early RA (disease duration up to 2 years), and the mean cumulative dose of glucocorticoid was 2,300 mg prednisone equivalent (range 270 mg - 5,800 mg) over the first year. Glucocorticoids were mostly added to other disease modifying anti-rheumatoid drug (DMARD) treatment. The standardised mean difference in progression was 0.40 in favour of glucocorticoids (95% CI 0.27, 0.54). In studies lasting 2 years (806 patients included), the standardised mean difference in progression in favour of glucocorticoids at 1 year was 0.45 (0.24, 0.66) and at 2 years was 0.42 (0.30, 0.55). All studies except one showed a numerical treatment effect in favour of glucocorticoids. The beneficial effects of glucocorticoids were generally achieved when used in conjunction with other DMARD treatment.\nAuthors' conclusions\nEven in the most conservative estimate, the evidence that glucocorticoids given in addition to standard therapy can substantially reduce the rate of erosion progression in rheumatoid arthritis is convincing. There remains concern about potential long-term adverse reactions to glucocorticoid therapy, such as increased cardiovascular risk, and this issue requires further research.\n\nGiven the provided abstract, please respond to the following query: \"What are the effects of glucocorticoids on the progress of rheumatoid arthritis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The studies looked at people who had rheumatoid for up to 2 years. Low doses of glucocorticoid pills were taken and usually with a disease-modifying anti-rheumatoid drug (DMARD).\nGlucocorticoids reduce progression of the disease on x-rays over 1 to 2 years. This result is based on high quality evidence.\nHarms were not reviewed. We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects and long term side effects. Low doses of glucocorticoids may not lead to side effects, but possible side effects may include osteoporosis or heart problems."
}
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query-laysum | 3310 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetic ketoacidosis (DKA) is an acute, life-threatening complication of uncontrolled diabetes that mainly occurs in individuals with autoimmune type 1 diabetes, but it is not uncommon in some people with type 2 diabetes. The treatment of DKA is traditionally accomplished by the administration of intravenous infusion of regular insulin that is initiated in the emergency department and continued in an intensive care unit or a high-dependency unit environment. It is unclear whether people with DKA should be treated with other treatment modalities such as subcutaneous rapid-acting insulin analogues.\nObjectives\nTo assess the effects of subcutaneous rapid-acting insulin analogues for the treatment of diabetic ketoacidosis.\nSearch methods\nWe identified eligible trials by searching MEDLINE, PubMed, EMBASE, LILACS, CINAHL, and the Cochrane Library. We searched the trials registers WHO ICTRP Search Portal and ClinicalTrials.gov. The date of last search for all databases was 27 October 2015. We also examined reference lists of included randomised controlled trials (RCTs) and systematic reviews, and contacted trial authors.\nSelection criteria\nWe included trials if they were RCTs comparing subcutaneous rapid-acting insulin analogues versus standard intravenous infusion in participants with DKA of any age or sex with type 1 or type 2 diabetes, and in pregnant women.\nData collection and analysis\nTwo review authors independently extracted data, assessed studies for risk of bias, and evaluated overall study quality utilising the GRADE instrument. We assessed the statistical heterogeneity of included studies by visually inspecting forest plots and quantifying the diversity using the I² statistic. We synthesised data using random-effects model meta-analysis or descriptive analysis, as appropriate.\nMain results\nFive trials randomised 201 participants (110 participants to subcutaneous rapid-acting insulin analogues and 91 to intravenous regular insulin). The criteria for DKA were consistent with the American Diabetes Association criteria for mild or moderate DKA. The underlying cause of DKA was mostly poor compliance with diabetes therapy. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Four trials evaluated the effects of the rapid-acting insulin analogue lispro, and one the effects of the rapid-acting insulin analogue aspart. The mean follow-up period as measured by mean hospital stay ranged between two and seven days. Overall, risk of bias of the evaluated trials was unclear in many domains and high for performance bias for the outcome measure time to resolution of DKA.\nNo deaths were reported in the included trials (186 participants; 3 trials; moderate- (insulin lispro) to low-quality evidence (insulin aspart)). There was very low-quality evidence to evaluate the effects of subcutaneous insulin lispro versus intravenous regular insulin on the time to resolution of DKA: mean difference (MD) 0.2 h (95% CI -1.7 to 2.1); P = 0.81; 90 participants; 2 trials. In one trial involving children with DKA, the time to reach a glucose level of 250 mg/dL was similar between insulin lispro and intravenous regular insulin. There was very low-quality evidence to evaluate the effects of subcutaneous insulin aspart versus intravenous regular insulin on the time to resolution of DKA: MD -1 h (95% CI -3.2 to 1.2); P = 0.36; 30 participants; 1 trial. There was low-quality evidence to evaluate the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin on hypoglycaemic episodes: 6 of 80 insulin lispro-treated participants compared with 9 of 76 regular insulin-treated participants reported hypoglycaemic events; risk ratio (RR) 0.59 (95% CI 0.23 to 1.52); P = 0.28; 156 participants; 4 trials. For insulin aspart compared with regular insulin, RR for hypoglycaemic episodes was 1.00 (95% CI 0.07 to 14.55); P = 1.0; 30 participants; 1 trial; low-quality evidence. Socioeconomic effects as measured by length of mean hospital stay for insulin lispro compared with regular insulin showed a MD of -0.4 days (95% CI -1 to 0.2); P = 0.22; 90 participants; 2 trials; low-quality evidence and for insulin aspart compared with regular insulin 1.1 days (95% CI -3.3 to 1.1); P = 0.32; low-quality evidence. Data on morbidity were limited, but no specific events were reported for the comparison of insulin lispro with regular insulin. No trial reported on adverse events other than hypoglycaemic episodes, and no trial investigated patient satisfaction.\nAuthors' conclusions\nOur review, which provided mainly data on adults, suggests on the basis of mostly low- to very low-quality evidence that there are neither advantages nor disadvantages when comparing the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin for treating mild or moderate DKA.\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": "Our results are most relevant for adults with mild or moderate diabetic ketoacidosis due to undertreatment of diabetes. No deaths occurred. Time to resolution of diabetic ketoacidosis from the start of therapy did not differ substantially between the two insulin treatment schemes (approximately 11 hours). Hypoglycaemic (low blood sugar) episodes were comparable: 118 per 1000 participants for intravenous insulin compared with 70 per 1000 participants for subcutaneous insulin lispro (no statistically significant difference). The mean length of hospital stay also showed no marked differences. No trial reported on side effects other than hypoglycaemic episodes or investigated patient satisfaction. No serious events associated with diabetic ketoacidosis were seen during insulin lispro treatment."
}
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query-laysum | 3311 | [
{
"role": "user",
"content": "Abstract: Background\nInitial goal-directed resuscitation for hypotensive shock usually includes administration of intravenous fluids, followed by initiation of vasopressors. Despite obvious immediate effects of vasopressors on haemodynamics, their effect on patient-relevant outcomes remains controversial. This review was published originally in 2004 and was updated in 2011 and again in 2016.\nObjectives\nOur objective was to compare the effect of one vasopressor regimen (vasopressor alone, or in combination) versus another vasopressor regimen on mortality in critically ill participants with shock. We further aimed to investigate effects on other patient-relevant outcomes and to assess the influence of bias on the robustness of our effect estimates.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2015 Issue 6), MEDLINE, EMBASE, PASCAL BioMed, CINAHL, BIOSIS and PsycINFO (from inception to June 2015). We performed the original search in November 2003. We also asked experts in the field and searched meta-registries to identify ongoing trials.\nSelection criteria\nRandomized controlled trials (RCTs) comparing various vasopressor regimens for hypotensive shock.\nData collection and analysis\nTwo review authors abstracted data independently. They discussed disagreements between them and resolved differences by consulting with a third review author. We used a random-effects model to combine quantitative data.\nMain results\nWe identified 28 RCTs (3497 participants) with 1773 mortality outcomes. Six different vasopressors, given alone or in combination, were studied in 12 different comparisons.\nAll 28 studies reported mortality outcomes; 12 studies reported length of stay. Investigators reported other morbidity outcomes in a variable and heterogeneous way. No data were available on quality of life nor on anxiety and depression outcomes. We classified 11 studies as having low risk of bias for the primary outcome of mortality; only four studies fulfilled all trial quality criteria.\nIn summary, researchers reported no differences in total mortality in any comparisons of different vasopressors or combinations in any of the pre-defined analyses (evidence quality ranging from high to very low). More arrhythmias were observed in participants treated with dopamine than in those treated with norepinephrine (high-quality evidence). These findings were consistent among the few large studies and among studies with different levels of within-study bias risk.\nAuthors' conclusions\nWe found no evidence of substantial differences in total mortality between several vasopressors. Dopamine increases the risk of arrhythmia compared with norepinephrine and might increase mortality. Otherwise, evidence of any other differences between any of the six vasopressors examined is insufficient. We identified low risk of bias and high-quality evidence for the comparison of norepinephrine versus dopamine and moderate to very low-quality evidence for all other comparisons, mainly because single comparisons occasionally were based on only a few participants. Increasing evidence indicates that the treatment goals most often employed are of limited clinical value. Our findings suggest that major changes in clinical practice are not needed, but that selection of vasopressors could be better individualised and could be based on clinical variables reflecting hypoperfusion.\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 June 2015."
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query-laysum | 3312 | [
{
"role": "user",
"content": "Abstract: Background\nColorectal cancer is the third most commonly diagnosed cancer worldwide. A diagnosis of colorectal cancer and subsequent treatment can adversely affect an individuals physical and mental health. Benefits of physical activity interventions in alleviating treatment side effects have been demonstrated in other cancer populations. Given that regular physical activity can decrease the risk of colorectal cancer, and cardiovascular fitness is a strong predictor of all-cause and cancer mortality risk, physical activity interventions may have a role to play in the colorectal cancer control continuum. Evidence of the efficacy of physical activity interventions in this population remains unclear.\nObjectives\nTo assess the effectiveness and safety of physical activity interventions on the disease-related physical and mental health of individuals diagnosed with non-advanced colorectal cancer, staged as T1-4 N0-2 M0, treated surgically or with neoadjuvant or adjuvant therapy (i.e. chemotherapy, radiotherapy or chemoradiotherapy), or both.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 6), along with OVID MEDLINE, six other databases and four trial registries with no language or date restrictions. We screened reference lists of relevant publications and handsearched meeting abstracts and conference proceedings of relevant organisations for additional relevant studies. All searches were completed between 6 June and 14 June 2019.\nSelection criteria\nWe included randomised control trials (RCTs) and cluster-RCTs comparing physical activity interventions, to usual care or no physical activity intervention in adults with non-advanced colorectal cancer.\nData collection and analysis\nTwo review authors independently selected studies, performed the data extraction, assessed the risk of bias and rated the quality of the studies using GRADE criteria. We pooled data for meta-analyses by length of follow-up, reported as mean differences (MDs) or standardised mean differences (SMDs) using random-effects wherever possible, or the fixed-effect model, where appropriate. If a meta-analysis was not possible, we synthesised studies narratively.\nMain results\nWe identified 16 RCTs, involving 992 participants; 524 were allocated to a physical activity intervention group and 468 to a usual care control group. The mean age of participants ranged between 51 and 69 years. Ten studies included participants who had finished active treatment, two studies included participants who were receiving active treatment, two studies included both those receiving and finished active treatment. It was unclear whether participants were receiving or finished treatment in two studies. Type, setting and duration of physical activity intervention varied between trials. Three studies opted for supervised interventions, five for home-based self-directed interventions and seven studies opted for a combination of supervised and self-directed programmes. One study did not report the intervention setting. The most common intervention duration was 12 weeks (7 studies). Type of physical activity included walking, cycling, resistance exercise, yoga and core stabilisation exercise.\nMost of the uncertainty in judging study bias came from a lack of clarity around allocation concealment and blinding of outcome assessors. Blinding of participants and personnel was not possible. The quality of the evidence ranged from very low to moderate overall. We did not pool physical function results at immediate-term follow-up due to considerable variation in results and inconsistency of direction of effect. We are uncertain whether physical activity interventions improve physical function compared with usual care. We found no evidence of effect of physical activity interventions compared to usual care on disease-related mental health (anxiety: SMD -0.11, 95% confidence interval (CI) -0.40 to 0.18; 4 studies, 198 participants; I2 = 0%; and depression: SMD -0.21, 95% CI -0.50 to 0.08; 4 studies, 198 participants; I2 = 0%; moderate-quality evidence) at short- or medium-term follow-up. Seven studies reported on adverse events. We did not pool adverse events due to inconsistency in reporting and measurement. We found no evidence of serious adverse events in the intervention or usual care groups. Minor adverse events, such as neck, back and muscle pain were most commonly reported. No studies reported on overall survival or recurrence-free survival and no studies assessed outcomes at long-term follow-up\nWe found evidence of positive effects of physical activity interventions on the aerobic fitness component of physical fitness (SMD 0.82, 95% CI 0.34 to 1.29; 7 studies, 295; I2 = 68%; low-quality evidence), cancer-related fatigue (MD 2.16, 95% CI 0.18 to 4.15; 6 studies, 230 participants; I2 = 18%; low-quality evidence) and health-related quality of life (SMD 0.36, 95% CI 0.10 to 0.62; 6 studies, 230 participants; I2 = 0%; moderate-quality evidence) at immediate-term follow-up. These positive effects were also observed at short-term follow-up but not medium-term follow-up. Only three studies reported medium-term follow-up for cancer-related fatigue and health-related quality of life.\nAuthors' conclusions\nThe findings of this review should be interpreted with caution due to the low number of studies included and the quality of the evidence. We are uncertain whether physical activity interventions improve physical function. Physical activity interventions may have no effect on disease-related mental health. Physical activity interventions may be beneficial for aerobic fitness, cancer-related fatigue and health-related quality of life up to six months follow-up. Where reported, adverse events were generally minor. Adequately powered RCTs of high methodological quality with longer-term follow-up are required to assess the effect of physical activity interventions on the disease-related physical and mental health and on survival of people with non-advanced colorectal cancer. Adverse events should be adequately reported.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the quality of the evidence from very low to moderate mainly because of the small number of studies and low number of participants, as well as study limitations.ConclusionThe findings of this review should be interpreted with caution due to the low number of studies included and the quality of the evidence. This review shows the need for future high quality research with longer-term follow-up to assess the effects of physical activity interventions on the physical and mental health of people with bowel cancer, especially in relation to safety and survival."
}
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query-laysum | 3313 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections (IFIs) are life-threatening opportunistic infections that occur in immunocompromised or critically ill people. Early detection and treatment of IFIs is essential to reduce morbidity and mortality in these populations. (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in the serum of infected individuals. The serum BDG test is a way to quickly detect these infections and initiate treatment before they become life-threatening. Five different versions of the BDG test are commercially available: Fungitell, Glucatell, Wako, Fungitec-G, and Dynamiker Fungus.\nObjectives\nTo compare the diagnostic accuracy of commercially available tests for serum BDG to detect selected invasive fungal infections (IFIs) among immunocompromised or critically ill people.\nSearch methods\nWe searched MEDLINE (via Ovid) and Embase (via Ovid) up to 26 June 2019. We used SCOPUS to perform a forward and backward citation search of relevant articles. We placed no restriction on language or study design.\nSelection criteria\nWe included all references published on or after 1995, which is when the first commercial BDG assays became available. We considered published, peer-reviewed studies on the diagnostic test accuracy of BDG for diagnosis of fungal infections in immunocompromised people or people in intensive care that used the European Organization for Research and Treatment of Cancer (EORTC) criteria or equivalent as a reference standard. We considered all study designs (case-control, prospective consecutive cohort, and retrospective cohort studies). We excluded case studies and studies with fewer than ten participants. We also excluded animal and laboratory studies. We excluded meeting abstracts because they provided insufficient information.\nData collection and analysis\nWe followed the standard procedures outlined in the Cochrane Handbook for Diagnostic Test Accuracy Reviews. Two review authors independently screened studies, extracted data, and performed a quality assessment for each study. For each study, we created a 2 × 2 matrix and calculated sensitivity and specificity, as well as a 95% confidence interval (CI). We evaluated the quality of included studies using the Quality Assessment of Studies of Diagnostic Accuracy-Revised (QUADAS-2). We were unable to perform a meta-analysis due to considerable variation between studies, with the exception of Candida, so we have provided descriptive statistics such as receiver operating characteristics (ROCs) and forest plots by test brand to show variation in study results.\nMain results\nWe included in the review 49 studies with a total of 6244 participants. About half of these studies (24/49; 49%) were conducted with people who had cancer or hematologic malignancies. Most studies (36/49; 73%) focused on the Fungitell BDG test. This was followed by Glucatell (5 studies; 10%), Wako (3 studies; 6%), Fungitec-G (3 studies; 6%), and Dynamiker (2 studies; 4%). About three-quarters of studies (79%) utilized either a prospective or a retrospective consecutive study design; the remainder used a case-control design.\nBased on the manufacturer's recommended cut-off levels for the Fungitell test, sensitivity ranged from 27% to 100%, and specificity from 0% to 100%. For the Glucatell assay, sensitivity ranged from 50% to 92%, and specificity ranged from 41% to 94%. Limited studies have used the Dynamiker, Wako, and Fungitec-G assays, but individual sensitivities and specificities ranged from 50% to 88%, and from 60% to 100%, respectively. Results show considerable differences between studies, even by manufacturer, which prevented a formal meta-analysis. Most studies (32/49; 65%) had no reported high risk of bias in any of the QUADAS-2 domains. The QUADAS-2 domains that had higher risk of bias included participant selection and flow and timing.\nAuthors' conclusions\nWe noted considerable heterogeneity between studies, and these differences precluded a formal meta-analysis. Because of wide variation in the results, it is not possible to estimate the diagnostic accuracy of the BDG test in specific settings. Future studies estimating the accuracy of BDG tests should be linked to the way the test is used in clinical practice and should clearly describe the sampling protocol and the relationship of time of testing to time of diagnosis.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The aim of this review is to find out how accurate a blood test is for diagnosis of fungal infections in people who are unable to fight infection. Review authors included 49 studies to answer this question."
}
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query-laysum | 3314 | [
{
"role": "user",
"content": "Abstract: Background\nHirsutism occurs in 5% to 10% of women of reproductive age when there is excessive terminal hair growth in androgen-sensitive areas (male pattern). It is a distressing disorder with a major impact on quality of life. The most common cause is polycystic ovary syndrome. There are many treatment options, but it is not clear which are most effective.\nObjectives\nTo assess the effects of interventions (except laser and light-based therapies alone) for hirsutism.\nSearch methods\nWe searched the Cochrane Skin Group Specialised Register, CENTRAL (2014, Issue 6), MEDLINE (from 1946), EMBASE (from 1974), and five trials registers, and checked reference lists of included studies for additional trials. The last search was in June 2014.\nSelection criteria\nRandomised controlled trials (RCTs) in hirsute women with polycystic ovary syndrome, idiopathic hirsutism, or idiopathic hyperandrogenism.\nData collection and analysis\nTwo independent authors carried out study selection, data extraction, 'Risk of bias' assessment, and analyses.\nMain results\nWe included 157 studies (sample size 30 to 80) comprising 10,550 women (mean age 25 years). The majority of studies (123/157) were 'high', 30 'unclear', and four 'low' risk of bias. Lack of blinding was the most frequent source of bias. Treatment duration was six to 12 months. Forty-eight studies provided no usable or retrievable data, i.e. lack of separate data for hirsute women, conference proceedings, and losses to follow-up above 40%.\nPrimary outcomes, 'participant-reported improvement of hirsutism' and 'change in health-related quality of life', were addressed in few studies, and adverse events in only half. In most comparisons there was insufficient evidence to determine if the number of reported adverse events differed. These included known adverse events: gastrointestinal discomfort, breast tenderness, reduced libido, dry skin (flutamide and finasteride); irregular bleeding (spironolactone); nausea, diarrhoea, bloating (metformin); hot flushes, decreased libido, vaginal dryness, headaches (gonadotropin-releasing hormone (GnRH) analogues)).\nClinician's evaluation of hirsutism and change in androgen levels were addressed in most comparisons, change in body mass index (BMI) and improvement of other clinical signs of hyperandrogenism in one-third of studies.\nThe quality of evidence was moderate to very low for most outcomes.\nThere was low quality evidence for the effect of two oral contraceptive pills (OCPs) (ethinyl estradiol + cyproterone acetate versus ethinyl estradiol + desogestrel) on change from baseline of Ferriman-Gallwey scores. The mean difference (MD) was -1.84 (95% confidence interval (CI) -3.86 to 0.18).\nThere was very low quality evidence that flutamide 250 mg, twice daily, reduced Ferriman-Gallwey scores more effectively than placebo (MD -7.60, 95% CI -10.53 to -4.67 and MD -7.20, 95% CI -10.15 to -4.25). Participants' evaluations in one study with 20 participants confirmed these results (risk ratio (RR) 17.00, 95% CI 1.11 to 259.87).\nSpironolactone 100 mg daily was more effective than placebo in reducing Ferriman-Gallwey scores (MD -7.69, 95% CI -10.12 to -5.26) (low quality evidence). It showed similar effectiveness to flutamide in two studies (MD -1.90, 95% CI -5.01 to 1.21 and MD 0.49, 95% CI -1.99 to 2.97) (very low quality evidence), as well as to finasteride in two studies (MD 1.49, 95% CI -0.58 to 3.56 and MD 0.40, 95% CI -1.18 to 1.98) (low quality evidence).\nAlthough there was very low quality evidence of a difference in reduction of Ferriman-Gallwey scores for finasteride 5 mg to 7.5 mg daily versus placebo (MD -5.73, 95% CI -6.87 to -4.58), it was unlikely it was clinically meaningful. These results were reinforced by participants' assessments (RR 2.06, 95% CI 0.99 to 4.29 and RR 11.00, 95% CI 0.69 to 175.86). However, finasteride showed inconsistent results in comparisons with other treatments, and no firm conclusions could be reached.\nMetformin demonstrated no benefit over placebo in reduction of Ferriman-Gallwey scores (MD 0.05, 95% CI -1.02 to 1.12), but the quality of evidence was low. Results regarding the effectiveness of GnRH analogues were inconsistent, varying from minimal to important improvements.\nWe were unable to pool data for OCPs with cyproterone acetate 20 mg to 100 mg due to clinical and methodological heterogeneity between studies. However, addition of cyproterone acetate to OCPs provided greater reductions in Ferriman-Gallwey scores.\nTwo studies, comparing finasteride 5 mg and spironolactone 100 mg, did not show differences in participant assessments and reduction of Ferriman-Gallwey scores (low quality evidence). Ferriman-Gallwey scores from three studies comparing flutamide versus metformin could not be pooled (I² = 62%). One study comparing flutamide 250 mg twice daily with metformin 850 mg twice daily for 12 months, which reached a higher cumulative dosage than two other studies evaluating this comparison, showed flutamide to be more effective (MD -6.30, 95% CI -9.83 to -2.77) (very low quality evidence). Data showing reductions in Ferriman-Gallwey scores could not be pooled for four studies comparing finasteride with flutamide as the results were inconsistent (I² = 67%).\nStudies examining effects of hypocaloric diets reported reductions in BMI, but which did not result in reductions in Ferriman-Gallwey scores. Although certain cosmetic measures are commonly used, we did not identify any relevant RCTs.\nAuthors' conclusions\nTreatments may need to incorporate pharmacological therapies, cosmetic procedures, and psychological support. For mild hirsutism there is evidence of limited quality that OCPs are effective. Flutamide 250 mg twice daily and spironolactone 100 mg daily appeared to be effective and safe, albeit the evidence was low to very low quality. Finasteride 5 mg daily showed inconsistent results in different comparisons, therefore no firm conclusions can be made. As the side effects of antiandrogens and finasteride are well known, these should be accounted for in any clinical decision-making. There was low quality evidence that metformin was ineffective for hirsutism and although GnRH analogues showed inconsistent results in reducing hirsutism they do have significant side effects.\nFurther research should consist of well-designed, rigorously reported, head-to-head trials examining OCPs combined with antiandrogens or 5α-reductase inhibitor against OCP monotherapy, as well as the different antiandrogens and 5α-reductase inhibitors against each other. Outcomes should be based on standardised scales of participants' assessment of treatment efficacy, with a greater emphasis on change in quality of life as a result of treatment.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Up to 5% to 10% of women are hirsute (hair in areas where normally only men have hairs such as moustache, beard area, chest, belly, back etc). The most common cause is polycystic ovary syndrome. Hirsutism can lead to psychological distress, low self esteem, decreased self image, depression, feelings of shame and social difficulties."
}
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query-laysum | 3315 | [
{
"role": "user",
"content": "Abstract: Background\nMacular oedema (MO) is the accumulation of extracellular fluid in the central retina (the macula). It may occur after cataract surgery and may give rise to poor visual outcome, with reduced visual acuity and distortion of the central vision. MO is often self-limiting with spontaneous resolution, but a small proportion of people with chronic persistent MO may be difficult to treat. Chronic oedema may lead to the formation of cystic spaces in the retina termed 'cystoid macular oedema' (CMO). Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used in cataract surgery and may reduce the chances of developing MO.\nObjectives\nThe aim of this review is to answer the question: is there evidence to support the prophylactic use of topical NSAIDs either in addition to, or instead of, topical steroids postoperatively to reduce the incidence of macular oedema (MO) and associated visual morbidity.\nSearch methods\nWe searched a number of electronic databases including CENTRAL, MEDLINE and Embase. Date last searched 2 September 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which adult participants had undergone surgery for age-related cataract. We included participants irrespective of their baseline risk of MO, in particular we included people with diabetes and uveitis. We included trials of preoperative and/or postoperative topical NSAIDs in conjunction with postoperative topical steroids. The comparator was postoperative topical steroids alone. A secondary comparison was preoperative and/or postoperative topical NSAIDs alone versus postoperative topical steroids alone.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, assessed risk of bias and extracted data using standard methods expected by Cochrane. We pooled data using a random-effects model. We graded the certainty of the evidence using GRADE and considered the following: risk of bias of included studies, precision of the effect estimate, consistency of effects between studies, directness of the outcome measure and publication bias.\nMain results\nWe identified 34 studies that were conducted in the Americas, Europe, the Eastern Mediterranean region and South-East Asia. Over 5000 people were randomised in these trials. The majority of studies enrolled one eye per participant; a small subset (4 trials) enrolled a proportion of people with bilateral surgery. Twenty-eight studies compared NSAIDs plus steroids with steroids alone. Six studies compared NSAIDs with steroids. A variety of NSAIDs were used, including ketorolac, diclofenac, nepafenac, indomethacin, bromfenac, flurbiprofen and pranopfen. Follow-up ranged from one to 12 months. In general, the studies were poorly reported. We did not judge any of the studies at low risk of bias in all domains. Six studies were funded by industry, seven studies were funded from non-industry sources, and the rest of the studies did not report the source of funding.\nThere was low-certainty evidence that people receiving topical NSAIDs in combination with steroids may have a lower risk of poor vision due to MO at three months after cataract surgery compared with people receiving steroids alone (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.23 to 0.76; eyes = 1360; studies = 5; I2 = 5%). We judged this to be low-certainty evidence because of risk of bias in the included studies and indirectness, as the extent of visual loss was not always clear. Only one study reported poor vision due to MO at 12 months and we judged this to be very low-certainty evidence as there were only two events. Quality of life was only reported in one of the 34 studies comparing NSAIDs plus steroids versus steroids alone, and it was not fully reported, other than to comment on lack of differences between groups. There was evidence of a reduced risk of MO with NSAIDs at three months after surgery, but we judged this to be low-certainty due to risk of bias and publication bias (RR 0.40, 95% CI 0.32 to 0.49; eyes = 3638; studies = 21). There was inconsistent evidence on central retinal thickness at three months (I2 = 87%). Results ranged from -30.9 µm in favour of NSAIDs plus steroids to 7.44 µm in favour of steroids alone. Similarly, data on best corrected visual acuity (BCVA) were inconsistent, but nine out of 10 trials reporting this outcome found between-group differences in visual acuity of less than 0.1 logMAR.\nNone of the six studies comparing NSAIDs alone with steroids reported on poor vision due to MO at three or 12 months. There was low-certainty evidence that central retinal thickness was lower in the NSAIDs group at three months (mean difference (MD) -22.64 µm, 95% CI -38.86 to -6.43; eyes = 121; studies = 2). Five studies reported on MO and showed a reduced risk with NSAIDs, but we judged this evidence to be of low-certainty (RR 0.27, 95% CI 0.18 to 0.41; eyes = 520). Three studies reported BCVA at three months and the results of these trials were inconsistent, but all three studies found differences of less than 0.1 logMAR between groups.\nWe did not note any major adverse events - the main consistent observation was burning or stinging sensation with the use of NSAIDs.\nAuthors' conclusions\nUsing topical NSAIDs may reduce the risk of developing macular oedema after cataract surgery, although it is possible that current estimates as to the size of this reduction are exaggerated. It is unclear the extent to which this reduction has an impact on the visual function and quality of life of patients. There is little evidence to suggest any important effect on vision after surgery. The value of adding topical NSAIDs to steroids, or using them as an alternative to topical steroids, with a view to reducing the risk of poor visual outcome after cataract surgery is therefore uncertain. Future trials should address the remaining clinical uncertainty of whether prophylactic topical NSAIDs are of benefit, particularly with respect to longer-term follow-up (at least to 12 months), and should be large enough to detect reduction in the risk of the outcome of most interest to patients, which is chronic macular oedema leading to visual loss.\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 2 September 2016."
}
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query-laysum | 3316 | [
{
"role": "user",
"content": "Abstract: Background\nTraumatic wounds (wounds caused by injury) range from abrasions and minor skin incisions or tears, to wounds with extensive tissue damage or loss as well as damage to bone and internal organs. Two key types of traumatic wounds considered in this review are those that damage soft tissue only and those that involve a broken bone, that is, open fractures. In some cases these wounds are left open and negative pressure wound therapy (NPWT) is used as a treatment. This medical device involves the application of a wound dressing through which negative pressure is applied and tissue fluid drawn away from the area. The treatment aims to support wound management, to prepare wounds for further surgery, to reduce the risk of infection and potentially to reduce time to healing (with or without surgical intervention). There are no systematic reviews assessing the effectiveness of NPWT for traumatic wounds.\nObjectives\nTo assess the effects of NPWT for treating open traumatic wounds in people managed in any care setting.\nSearch methods\nIn June 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. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished and unpublished randomised controlled trials that used NPWT for open traumatic wounds involving either open fractures or soft tissue wounds. Wound healing, wound infection and adverse events were our primary outcomes.\nData collection and analysis\nTwo review authors independently selected eligible studies, extracted data, carried out a 'Risk of bias' assessment and rated the certainty of the evidence. Data were presented and analysed separately for open fracture wounds and other open traumatic wounds (not involving a broken bone).\nMain results\nSeven RCTs (1377 participants recruited) met the inclusion criteria of this review. Study sample sizes ranged from 40 to 586 participants. One study had three arms, which were all included in the review. Six studies compared NPWT at 125 mmHg with standard care: one of these studies did not report any relevant outcome data. One further study compared NPWT at 75 mmHg with standard care and NPWT 125mmHg with NPWT 75 mmHg.\nOpen fracture wounds (four studies all comparing NPWT 125 mmHg with standard care)\nOne study (460 participants) comparing NPWT 125 mmHg with standard care reported the proportions of wounds healed in each arm. At six weeks there was no clear difference between groups in the number of participants with a healed, open fracture wound: risk ratio (RR) 1.01 (95% confidence interval (CI) 0.81 to 1.27); moderate-certainty evidence, downgraded for imprecision.\nWe pooled data on wound infection from four studies (596 participants). Follow-up varied between studies but was approximately 30 days. On average, it is uncertain whether NPWT at 125 mmHg reduces the risk of wound infection compared with standard care (RR 0.48, 95% CI 0.20 to 1.13; I2 = 56%); very low-certainty evidence downgraded for risk of bias, inconsistency and imprecision.\nData from one study shows that there is probably no clear difference in health-related quality of life between participants treated with NPWT 125 mmHg and those treated with standard wound care (EQ-5D utility scores mean difference (MD) -0.01, 95% CI -0.08 to 0.06; 364 participants, moderate-certainty evidence; physical component summary score of the short-form 12 instrument MD -0.50, 95% CI -4.08 to 3.08; 329 participants; low-certainty evidence downgraded for imprecision).\nModerate-certainty evidence from one trial (460 participants) suggests that NPWT is unlikely to be a cost-effective treatment for open fractures in the UK. On average, NPWT was more costly and conferred few additional quality-adjusted life years (QALYs) when compared with standard care. The incremental cost-effectiveness ratio was GBP 267,910 and NPWT was shown to be unlikely to be cost effective at a range of cost-per-QALYs thresholds. We downgraded the certainty of the evidence for imprecision.\nOther open traumatic wounds (two studies, one comparing NPWT 125 mmHg with standard care and a three-arm study comparing NPWT 125 mmHg, NPWT 75 mmHg and standard care)\nPooled data from two studies (509 participants) suggests no clear difference in risk of wound infection between open traumatic wounds treated with NPWT at 125 mmHg or standard care (RR 0.61, 95% CI 0.31 to 1.18); low-certainty evidence downgraded for risk of bias and imprecision.\nOne trial with 463 participants compared NPWT at 75 mmHg with standard care and with NPWT at 125 mmHg. Data on wound infection were reported for each comparison. It is uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and standard care (RR 0.44, 95% CI 0.17 to 1.10; 463 participants) and uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and 125 mmHg (RR 1.04, 95% CI 0.31 to 3.51; 251 participants. We downgraded the certainty of the evidence for risk of bias and imprecision.\nAuthors' conclusions\nThere is moderate-certainty evidence for no clear difference between NPWT and standard care on the proportion of wounds healed at six weeks for open fracture wounds. There is moderate-certainty evidence that NPWT is not a cost-effective treatment for open fracture wounds. Moderate-certainty evidence means that the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. It is uncertain whether there is a difference in risk of wound infection, adverse events, time to closure or coverage surgery, pain or health-related quality of life between NPWT and standard care for any type of open traumatic wound.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that had been published up to June 2018."
}
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query-laysum | 3317 | [
{
"role": "user",
"content": "Abstract: Background\nGlioblastoma (GBM) is a highly malignant brain tumour that almost inevitably progresses or recurs after first line standard of care. There is no consensus regarding the best treatment/s to offer people upon disease progression or recurrence. For the purposes of this review, progression and recurrence are considered as one entity.\nObjectives\nTo evaluate the effectiveness of further treatment/s for first and subsequent progression or recurrence of glioblastoma (GBM) among people who have received the standard of care (Stupp protocol) for primary treatment of the disease; and to prepare a brief economic commentary on the available evidence.\nSearch methods\nWe searched MEDLINE and Embase electronic databases from 2005 to December 2019 and the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library; Issue 12, 2019). Economic searches included the National Health Service Economic Evaluation Database (NHS EED) up to 2015 (database closure) and MEDLINE and Embase from 2015 to December 2019.\nSelection criteria\nRandomised controlled trials (RCTs) and comparative non-randomised studies (NRSs) evaluating effectiveness of treatments for progressive/recurrent GBM. Eligible studies included people with progressive or recurrent GBM who had received first line radiotherapy with concomitant and adjuvant temozolomide (TMZ).\nData collection and analysis\nTwo review authors independently selected studies and extracted data to a pre-designed data extraction form. We conducted network meta-analyses (NMA) and ranked treatments according to effectiveness for each outcome using the random-effects model and Stata software (version 15). We rated the certainty of evidence using the GRADE approach.\nMain results\nWe included 42 studies: these comprised 34 randomised controlled trials (RCTs) and 8 non-randomised studies (NRSs) involving 5236 participants. We judged most RCTs to be at a low risk of bias and NRSs at high risk of bias. Interventions included chemotherapy, re-operation, re-irradiation and novel therapies either used alone or in combination. For first recurrence, we included 11 interventions in the network meta-analysis (NMA) for overall survival (OS), and eight in the NMA for progression-free survival (PFS). Lomustine (LOM; also known as CCNU) was the most common comparator and was used as the reference treatment. No studies in the NMA evaluated surgery, re-irradiation, PCV (procarbazine, lomustine, vincristine), TMZ re-challenge or best supportive care. We could not perform NMA for second or later recurrence due to insufficient data. Quality-of-life data were sparse.\nFirst recurrence (NMA findings)\nMedian OS across included studies in the NMA ranged from 5.5 to 12.6 months and median progression-free survival (PFS) ranged from 1.5 months to 4.2 months. We found no high-certainty evidence that any treatments tested were better than lomustine. These treatments included the following.\nBevacizumab plus lomustine: Evidence suggested probably little or no difference in OS between bevacizumab (BEV) combined with lomustine (LOM) and LOM monotherapy (hazard ratio (HR) 0.91, 0.75 to 1.10; moderate-certainty evidence), although BEV + LOM may improve PFS (HR 0.57, 95% confidence interval (CI) 0.44 to 0.74; low-certainty evidence).\nBevacizumab monotherapy: Low-certainty evidence suggested there may be little or no difference in OS (HR 1.22, 95% CI 0.84 to 1.76) and PFS (HR 0.90, 95% CI 0.58 to 1.38; low-certainty evidence) between BEV and LOM monotherapies; more evidence on BEV is needed.\nRegorafenib (REG): REG may improve OS compared with LOM (HR 0.50, 95% CI 0.33 to 0.76; low-certainty evidence). Evidence on PFS was very low certainty and more evidence on REG is needed.\nTemozolomide (TMZ) plus Depatux-M (ABT414): For OS, low-certainty evidence suggested that TMZ plus ABT414 may be more effective than LOM (HR 0.66, 95% CI 0.47 to 0.92) and may be more effective than BEV (HR 0.54, 95% CI 0.33 to 0.89; low-certainty evidence). This may be due to the TMZ component only and more evidence is needed.\nFotemustine (FOM): FOM and LOM may have similar effects on OS (HR 0.89, 95% CI 0.51 to 1.57, low-certainty evidence).\nBevacizumab and irinotecan (IRI): Evidence on BEV + irinotecan (IRI) versus LOM for both OS and PFS is very uncertain and there is probably little or no difference between BEV + IRI versus BEV monotherapy (OS: HR 0.95, 95% CI 0.70 to 1.30; moderate-certainty evidence).\nWhen treatments were ranked for OS, FOM ranked first, BEV + LOM second, LOM third, BEV + IRI fourth, and BEV fifth. Ranking does not take into account the certainty of the evidence, which also suggests there may be little or no difference between FOM and LOM.\nOther treatments\nThree studies evaluated re-operation versus no re-operation, with or without re-irradiation and chemotherapy, and these suggested possible survival advantages with re-operation within the context of being able to select suitable candidates for re-operation. A cannabinoid treatment in the early stages of evaluation, in combination with TMZ, merits further evaluation.\nSecond or later recurrence\nLimited evidence from three heterogeneous studies suggested that radiotherapy with or without BEV may have a beneficial effect on survival but more evidence is needed. Evidence was insufficient to draw conclusions about the best radiotherapy dosage. Other evidence suggested that there may be little difference in survival with tumour-treating fields compared with physician's best choice of treatment. We found no reliable evidence on best supportive care.\nSevere adverse events (SAEs)\nThe BEV+LOM combination was associated with significantly greater risk of SAEs than LOM monotherapy (RR 2.51, 95% CI 1.72 to 3.66, high-certainty evidence), and ranked joint worst with cediranib + LOM (RR 2.51, 95% CI 1.29 to 4.90; high-certainty evidence). LOM ranked best and REG ranked second best. Adding novel treatments to BEV was generally associated with a higher risk of severe adverse events compared with BEV alone.\nAuthors' conclusions\nFor treatment of first recurrence of GBM, among people previously treated with surgery and standard chemoradiotherapy, the combination treatments evaluated did not improve overall survival compared with LOM monotherapy and were often associated with a higher risk of severe adverse events. Limited evidence suggested that re-operation with or without re-irradiation and chemotherapy may be suitable for selected candidates. Evidence on second recurrence is sparse. Re-irradiation with or without bevacizumab may be of value in selected individuals, but more evidence is needed.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 42 studies (34 randomised controlled trials (RCTs) and 8 non-randomised studies) involving 5236 people. Interventions included chemotherapy, re-operation, re-irradiation and newly developed treatments either used alone or in combination. NMA could not be performed for second or later recurrence due to insufficient data.\nSurvival outcomes for people with a first recurrence\nWe found no good evidence that any of the treatments tested were better than lomustine (also known as CCNU). Adding bevacizumab to lomustine (BEV + LOM) did not improve overall survival compared with lomustine alone. Other chemotherapy and novel agents either did not work, or the evidence on them was uncertain. Unfortunately, we did not find any studies on several commonly used treatments, such as PCV (procarbazine, CCNU, vincristine) and TMZ re-challenge, to include.\nLimited evidence suggested that a second operation with or without other treatments may have survival advantages for some individuals with a first recurrence. A small study of a cannabinoid treatment suggests this merits further investigation.\nSurvival outcomes for people with a second or later recurrence\nFor second or later recurrence, insufficient evidence meant that we were not able to carry out statistical analysis. Findings suggested that radiotherapy with or without BEV may have some survival advantages but this evidence is uncertain. We found no reliable evidence on best supportive care.\nSerious adverse events (SAEs) from treatment\nMost treatments caused some serious side effects (SAEs). The BEV + LOM combination was associated with a significantly greater risk of SAEs than lomustine alone. In general, adding treatments to bevacizumab was associated with more SAEs compared with BEV alone."
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query-laysum | 3318 | [
{
"role": "user",
"content": "Abstract: Background\nPost-traumatic stress disorder (PTSD) is a severe and debilitating condition. Several pharmacological interventions have been proposed with the aim to prevent or mitigate it. These interventions should balance efficacy and tolerability, given that not all individuals exposed to a traumatic event will develop PTSD. There are different possible approaches to preventing PTSD; universal prevention is aimed at individuals at risk of developing PTSD on the basis of having been exposed to a traumatic event, irrespective of whether they are showing signs of psychological difficulties.\nObjectives\nTo assess the efficacy and acceptability of pharmacological interventions for universal prevention of PTSD in adults exposed to a traumatic event.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trial Register (CCMDCTR), CENTRAL, MEDLINE, Embase, two other databases and two trials registers (November 2020). We checked the reference lists of all included studies and relevant systematic reviews. The search was last updated on 13 November 2020.\nSelection criteria\nWe included randomised clinical trials on adults exposed to any kind of traumatic event. We considered comparisons of any medication with placebo or with another medication. We excluded trials that investigated medications as an augmentation to psychotherapy.\nData collection and analysis\nWe used standard Cochrane methodological procedures. In a random-effects model, we analysed dichotomous data as risk ratios (RR) and number needed to treat for an additional beneficial/harmful outcome (NNTB/NNTH). We analysed continuous data as mean differences (MD) or standardised mean differences (SMD).\nMain results\nWe included 13 studies which considered eight interventions (hydrocortisone, propranolol, dexamethasone, omega-3 fatty acids, gabapentin, paroxetine, PulmoCare enteral formula, Oxepa enteral formula and 5-hydroxytryptophan) and involved 2023 participants, with a single trial contributing 1244 participants. Eight studies enrolled participants from emergency departments or trauma centres or similar settings. Participants were exposed to a range of both intentional and unintentional traumatic events. Five studies considered participants in the context of intensive care units with traumatic events consisting of severe physical illness. Our concerns about risk of bias in the included studies were mostly due to high attrition and possible selective reporting. We could meta-analyse data for two comparisons: hydrocortisone versus placebo, but limited to secondary outcomes; and propranolol versus placebo. No study compared hydrocortisone to placebo at the primary endpoint of three months after the traumatic event.\nThe evidence on whether propranolol was more effective in reducing the severity of PTSD symptoms compared to placebo at three months after the traumatic event is inconclusive, because of serious risk of bias amongst the included studies, serious inconsistency amongst the studies' results, and very serious imprecision of the estimate of effect (SMD -0.51, 95% confidence interval (CI) -1.61 to 0.59; I2 = 83%; 3 studies, 86 participants; very low-certainty evidence). No study provided data on dropout rates due to side effects at three months post-traumatic event. The evidence on whether propranolol was more effective than placebo in reducing the probability of experiencing PTSD at three months after the traumatic event is inconclusive, because of serious risk of bias amongst the included studies, and very serious imprecision of the estimate of effect (RR 0.77, 95% CI 0.31 to 1.92; 3 studies, 88 participants; very low-certainty evidence). No study assessed functional disability or quality of life.\nOnly one study compared gabapentin to placebo at the primary endpoint of three months after the traumatic event, with inconclusive evidence in terms of both PTSD severity and probability of experiencing PTSD, because of imprecision of the effect estimate, serious risk of bias and serious imprecision (very low-certainty evidence). We found no data on dropout rates due to side effects, functional disability or quality of life.\nFor the remaining comparisons, the available data are inconclusive or missing in terms of PTSD severity reduction and dropout rates due to adverse events. No study assessed functional disability.\nAuthors' conclusions\nThis review provides uncertain evidence only regarding the use of hydrocortisone, propranolol, dexamethasone, omega-3 fatty acids, gabapentin, paroxetine, PulmoCare formula, Oxepa formula, or 5-hydroxytryptophan as universal PTSD prevention strategies. Future research might benefit from larger samples, better reporting of side effects and inclusion of quality of life and functioning measures.\n\nGiven the provided abstract, please respond to the following query: \"What should happen next?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence we found does not support the use of any medicines for the prevention of PTSD in people exposed to a traumatic event, regardless of whether or not they have psychological symptoms. More higher quality studies involving more people are needed to draw conclusions about these treatments."
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query-laysum | 3319 | [
{
"role": "user",
"content": "Abstract: Background\nDifficult cannulation is a risk factor for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It has been postulated that the pancreatic duct guidewire (PGW) technique may improve biliary cannulation success and reduce the risk of PEP in people with difficult cannulation.\nObjectives\nTo systematically review evidence from randomised controlled trials (RCTs) assessing the effectiveness and safety of the PGW technique compared to persistent conventional cannulation (CC) (contrast- or guidewire-assisted cannulation) or other advanced techniques in people with difficult biliary cannulation for the prevention of PEP.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL databases, major conference proceedings, and for ongoing trials on the ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) up to March 2016, using the Cochrane Upper Gastrointestinal and Pancreatic Diseases model with no language restrictions.\nSelection criteria\nRCTs comparing the PGW technique versus persistent CC or other advanced techniques in people undergoing ERCP with difficult biliary cannulation.\nData collection and analysis\nTwo review authors independently conducted study selection, data extraction, and methodological quality assessment. Using intention-to-treat analysis with random-effects models, we combined dichotomous data to obtain risk ratios (RR) with 95% confidence intervals (CI). We assessed heterogeneity using the Chi2 test (P < 0.15) and I2 test (> 25%). To explore sources of heterogeneity, we conducted a priori subgroup analyses according to trial design, use of pancreatic duct (PD) stent, involvement of trainees in cannulation, publication type, and risk of bias. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR versus odds ratio (OR)) and meta-analytic models (fixed-effect versus random-effects).\nMain results\nWe included seven RCTs comprising 577 participants. There was no significant heterogeneity among trials for the outcome of PEP (P = 0.32; I2 = 15%). The PGW technique significantly increased PEP compared to other endoscopic techniques (RR 1.98, 95% CI 1.14 to 3.42; low-quality evidence). The number needed to treat for an additional harmful outcome was 13 (95% CI 5 to 89). Among the three studies that compared the PGW technique with persistent CC, the incidence of PEP was 13.5% for the PGW technique and 8.7% for persistent CC (RR 1.58, 95% CI 0.83 to 3.01; low-quality evidence). Among the two studies that compared the PGW technique with precut sphincterotomy, the incidence of PEP was 29.8% in the PGW group versus 10.3% in the precut group (RR 2.92, 95% CI 1.24 to 6.88; low-quality evidence). Among the two studies that compared the PGW technique with PD stent placement, the incidence of PEP was 11.7% for the PGW technique and 5.0% for PD stent placement (RR 1.75, 95% CI 0.08 to 37.50; very low-quality evidence). There was no significant difference in common bile duct (CBD) cannulation success with the randomised technique (RR 1.04, 95% CI 0.87 to 1.24; low-quality evidence) or overall CBD cannulation success (RR 1.04, 95% CI 0.91 to 1.18; low-quality evidence) between the PGW technique and other endoscopic techniques. There was also no statistically significant difference in the risk of other ERCP-related complications (bleeding, perforation, cholangitis, and mortality). The results were robust in sensitivity analyses. The overall quality of evidence for the outcome of PEP was low or very low because of study limitations and imprecision.\nAuthors' conclusions\nIn people with difficult CBD cannulation, sole use of the PGW technique appears to be associated with an increased risk of PEP. Prophylactic PD stenting after use of the PGW technique may reduce the risk of PEP. However, the PGW technique is not superior to persistent attempts with CC, precut sphincterotomy, or PD stent in achieving CBD cannulation. The influence of co-intervention in the form of rectal peri-procedural nonsteroidal anti-inflammatory drug administration is unclear.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We conducted a search of the literature on 15 April 2016. We identified seven randomised controlled trials conducted in China, Japan, South Korea, Spain, Thailand, and the United States including a total of 577 participants. These trials compared the PGW technique versus persistent use of traditional techniques or other advanced techniques in people undergoing ERCP in whom access to the bile duct using traditional techniques was considered by the endoscopists to be difficult. As in clinical practice, the criteria used to define difficult access to the bile duct were highly variable among studies. We assessed outcomes of post-ERCP pancreatitis (PEP), success rates in accessing the bile duct, and other post-ERCP complications (bleeding, infection, hole in the bowel wall, death)."
}
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query-laysum | 3320 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is one of the most common life-shortening autosomal-recessive genetic conditions with around 100,000 people affected globally. CF mainly affects the respiratory system, but cystic fibrosis-related diabetes (CFRD) is a common extrapulmonary co-morbidity and causes excess morbidity and mortality in this population. Continuous glucose monitoring systems (CGMS) are a relatively new technology and, as yet, the impact of these on the monitoring and subsequent management of CFRD remains undetermined.\nObjectives\nTo establish the impact of insulin therapy guided by continuous glucose monitoring compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of latest search: 23 September 2021.\nWe also searched the reference lists of relevant articles and reviews and online trials registries. Date of last search: 23 September 2021.\nSelection criteria\nRandomised controlled studies comparing insulin regimens led by data from CGMS (including real-time or retrospective data, or both) with insulin regimens guided by abnormal blood glucose measurements collected through other means of glycaemic data collection in people with CFRD. Studies with a cross-over design, even with a washout period between intervention arms, are not eligible for inclusion due to the potential long-term impact of each of the interventions and the potential to compromise the outcomes of the second intervention.\nData collection and analysis\nNo studies were included in the review, meaning that no data were available to be collected for analysis.\nMain results\nReview authors screened 14 studies at the full-text stage against the review's inclusion criteria. Consequently, seven were excluded due to the study type being ineligible (not randomised), two studies were excluded due to their cross-over design, and two studies was excluded since the intervention used was not eligible and one was a literature review. One study in participants hospitalised for a pulmonary exacerbation is ongoing. Investigators are comparing insulin dosing via insulin pump with blood sugar monitoring by a CGMS to conventional diabetes management with daily insulin injections (or on an insulin pump if already on an insulin pump in the outpatient setting) and capillary blood glucose monitoring. The participants in the control arm will wear a blinded continuous glucose monitoring system for outcome assessment.\nIn addition to this, one further study is still awaiting classification, and will be screened to determine whether it is eligible for inclusion, or is to be excluded, in an update of this review.\nAuthors' conclusions\nNo studies were included in the review, indicating that there is currently insufficient evidence to determine the impact of insulin therapy guided by CGMS compared to insulin therapy guided by other forms of glucose data collection on the lives of people with CFRD, nor on potential adverse effects of continuous glucose monitoring in this context. Randomised controlled studies are needed to generate evidence on the efficacy and safety of continuous glucose monitoring in people with CFRD. There is one relevant ongoing study that may be eligible for inclusion in a future update of this Cochrane Review, and whose results may help answer the review question.\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": "Cystic fibrosis (CF) is a life-shortening genetic condition. Many people with CF also develop CFRD, where their blood glucose, or the amount of sugar in their blood, can rise to harmful levels. People with CFRD seem to experience more frequent chest infections and a shorter life expectancy than people with CF who do not have diabetes.\nCFRD can be managed with injections of insulin to help keep blood sugar in the normal range. To do this safely, people with CFRD need to routinely check blood sugar levels to make sure that they are taking the right amount of insulin. They usually do this by pricking their fingers and measuring a drop of blood on a machine. CGMS are devices that can be worn by a person and which closely estimate blood sugar levels without the need for regular pin-prick testing. They are a relatively new technology and we still do not know how they affect the monitoring and management of CFRD.\nWe wanted to find out whether using CGMS was better or worse than other methods, such as using the traditional 'finger stick' method, for monitoring blood sugar levels inpeople with CFRD. The main outcomes we wanted to look at were quality of life, any problems the CGMS might cause, and the amount of time a person's blood sugar stayed in the normal range. We decided that theseoutcomes were most important afterasking people with CFRD and their families what mattered most to them."
}
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query-laysum | 3321 | [
{
"role": "user",
"content": "Abstract: Background\nGlobally, children under 15 years represent approximately 12% of new tuberculosis cases, but 16% of the estimated 1.4 million deaths. This higher share of mortality highlights the urgent need to develop strategies to improve case detection in this age group and identify children without tuberculosis disease who should be considered for tuberculosis preventive treatment. One such strategy is systematic screening for tuberculosis in high-risk groups.\nObjectives\nTo estimate the sensitivity and specificity of the presence of one or more tuberculosis symptoms, or symptom combinations; chest radiography (CXR); Xpert MTB/RIF; Xpert Ultra; and combinations of these as screening tests for detecting active pulmonary childhood tuberculosis in the following groups.\n– Tuberculosis contacts, including household contacts, school contacts, and other close contacts of a person with infectious tuberculosis.\n– Children living with HIV.\n– Children with pneumonia.\n– Other risk groups (e.g. children with a history of previous tuberculosis, malnourished children).\n– Children in the general population in high tuberculosis burden settings.\nSearch methods\nWe searched six databases, including the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase, on 14 February 2020 without language restrictions and contacted researchers in the field.\nSelection criteria\nCross-sectional and cohort studies where at least 75% of children were aged under 15 years. Studies were eligible if conducted for screening rather than diagnosing tuberculosis. Reference standards were microbiological (MRS) and composite reference standard (CRS), which may incorporate symptoms and CXR.\nData collection and analysis\nTwo review authors independently extracted data and assessed study quality using QUADAS-2. We consolidated symptom screens across included studies into groups that used similar combinations of symptoms as follows: one or more of cough, fever, or poor weight gain and one or more of cough, fever, or decreased playfulness. For combination of symptoms, a positive screen was the presence of one or more than one symptom.\nWe used a bivariate model to estimate pooled sensitivity and specificity with 95% confidence intervals (CIs) and performed analyses separately by reference standard. We assessed certainty of evidence using GRADE.\nMain results\nNineteen studies assessed the following screens: one symptom (15 studies, 10,097 participants); combinations of symptoms (12 studies, 29,889 participants); CXR (10 studies, 7146 participants); and Xpert MTB/RIF (2 studies, 787 participants). Several studies assessed more than one screening test. No studies assessed Xpert Ultra. For 16 studies (84%), risk of bias for the reference standard domain was unclear owing to concern about incorporation bias. Across other quality domains, risk of bias was generally low.\nSymptom screen (verified by CRS)\nOne or more of cough, fever, or poor weight gain in tuberculosis contacts (4 studies, tuberculosis prevalence 2% to 13%): pooled sensitivity was 89% (95% CI 52% to 98%; 113 participants; low-certainty evidence) and pooled specificity was 69% (95% CI 51% to 83%; 2582 participants; low-certainty evidence). Of 1000 children where 50 have pulmonary tuberculosis, 339 would be screen-positive, of whom 294 (87%) would not have pulmonary tuberculosis (false positives); 661 would be screen-negative, of whom five (1%) would have pulmonary tuberculosis (false negatives).\nOne or more of cough, fever, or decreased playfulness in children aged under five years, inpatient or outpatient (3 studies, tuberculosis prevalence 3% to 13%): sensitivity ranged from 64% to 76% (106 participants; moderate-certainty evidence) and specificity from 37% to 77% (2339 participants; low-certainty evidence). Of 1000 children where 50 have pulmonary tuberculosis, 251 to 636 would be screen-positive, of whom 219 to 598 (87% to 94%) would not have pulmonary tuberculosis; 364 to 749 would be screen-negative, of whom 12 to 18 (2% to 3%) would have pulmonary tuberculosis.\nOne or more of cough, fever, poor weight gain, or tuberculosis close contact (World Health Organization four-symptom screen) in children living with HIV, outpatient (2 studies, tuberculosis prevalence 3% and 8%): pooled sensitivity was 61% (95% CI 58% to 64%; 1219 screens; moderate-certainty evidence) and pooled specificity was 94% (95% CI 86% to 98%; 201,916 screens; low-certainty evidence). Of 1000 symptom screens where 50 of the screens are on children with pulmonary tuberculosis, 88 would be screen-positive, of which 57 (65%) would be on children who do not have pulmonary tuberculosis; 912 would be screen-negative, of which 19 (2%) would be on children who have pulmonary tuberculosis.\nCXR (verified by CRS)\nCXR with any abnormality in tuberculosis contacts (8 studies, tuberculosis prevalence 2% to 25%): pooled sensitivity was 87% (95% CI 75% to 93%; 232 participants; low-certainty evidence) and pooled specificity was 99% (95% CI 68% to 100%; 3281 participants; low-certainty evidence). Of 1000 children, where 50 have pulmonary tuberculosis, 63 would be screen-positive, of whom 19 (30%) would not have pulmonary tuberculosis; 937 would be screen-negative, of whom 6 (1%) would have pulmonary tuberculosis.\nXpert MTB/RIF (verified by MRS)\nXpert MTB/RIF, inpatient or outpatient (2 studies, tuberculosis prevalence 1% and 4%): sensitivity was 43% and 100% (16 participants; very low-certainty evidence) and specificity was 99% and 100% (771 participants; moderate-certainty evidence). Of 1000 children, where 50 have pulmonary tuberculosis, 31 to 69 would be Xpert MTB/RIF-positive, of whom 9 to 19 (28% to 29%) would not have pulmonary tuberculosis; 931 to 969 would be Xpert MTB/RIF-negative, of whom 0 to 28 (0% to 3%) would have tuberculosis.\nStudies often assessed more symptoms than those included in the index test and symptom definitions varied. These differences complicated data aggregation and may have influenced accuracy estimates. Both symptoms and CXR formed part of the CRS (incorporation bias), which may have led to overestimation of sensitivity and specificity.\nAuthors' conclusions\nWe found that in children who are tuberculosis contacts or living with HIV, screening tests using symptoms or CXR may be useful, but our review is limited by design issues with the index test and incorporation bias in the reference standard.\nFor Xpert MTB/RIF, we found insufficient evidence regarding screening accuracy.\nProspective evaluations of screening tests for tuberculosis in children will help clarify their use. In the meantime, screening strategies need to be pragmatic to address the persistent gaps in prevention and case detection that exist in resource-limited settings.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diagnosing tuberculosis in children is difficult. This may lead to screening tests appearing more or less accurate than they actually are. For Xpert MTB/RIF, there were few studies and children tested to be confident about results."
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query-laysum | 3322 | [
{
"role": "user",
"content": "Abstract: Background\nHepatocellular carcinoma occurs mostly in people with chronic liver disease and ranks sixth in terms of global incidence of cancer, and third in terms of cancer deaths. In clinical practice, magnetic resonance imaging (MRI) is used as a second-line diagnostic imaging modality to confirm the presence of focal liver lesions suspected as hepatocellular carcinoma on prior diagnostic test such as abdominal ultrasound or alpha-fetoprotein, or both, either in surveillance programmes or in clinical settings. According to current guidelines, a single contrast-enhanced imaging study (computed tomography (CT) or MRI) showing typical hallmarks of hepatocellular carcinoma in people with cirrhosis is considered valid to diagnose hepatocellular carcinoma. The detection of hepatocellular carcinoma amenable to surgical resection could improve the prognosis. However, a significant number of hepatocellular carcinomas do not show typical hallmarks on imaging modalities, and hepatocellular carcinoma may, therefore, be missed. There is no clear evidence of the benefit of surveillance programmes in terms of overall survival: the conflicting results can be a consequence of inaccurate detection, ineffective treatment, or both. Assessing the diagnostic accuracy of MRI may clarify whether the absence of benefit could be related to underdiagnosis. Furthermore, an assessment of the accuracy of MRI in people with chronic liver disease who are not included in surveillance programmes is needed for either ruling out or diagnosing hepatocellular carcinoma.\nObjectives\nPrimary: to assess the diagnostic accuracy of MRI for the diagnosis of hepatocellular carcinoma of any size and at any stage in adults with chronic liver disease.\nSecondary: to assess the diagnostic accuracy of MRI for the diagnosis of resectable hepatocellular carcinoma in adults with chronic liver disease, and to identify potential sources of heterogeneity in the results.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Hepato-Biliary Group Diagnostic Test of Accuracy Studies Register, the Cochrane Library, MEDLINE, Embase, and three other databases to 9 November 2021. We manually searched articles retrieved, contacted experts, handsearched abstract books from meetings held during the last 10 years, and searched for literature in OpenGrey (9 November 2021). Further information was requested by e-mails, but no additional information was provided. No data was obtained through correspondence with investigators. We applied no language or document-type restrictions.\nSelection criteria\nStudies assessing the diagnostic accuracy of MRI for the diagnosis of hepatocellular carcinoma in adults with chronic liver disease, with cross-sectional designs, using one of the acceptable reference standards, such as pathology of the explanted liver and histology of resected or biopsied focal liver lesion with at least a six-month follow-up.\nData collection and analysis\nAt least two review authors independently screened studies, extracted data, and assessed the risk of bias and applicability concerns, using the QUADAS-2 checklist. We presented the results of sensitivity and specificity, using paired forest plots, and we tabulated the results. We used a hierarchical meta-analysis model where appropriate. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs). We double-checked all data extractions and analyses.\nMain results\nWe included 34 studies, with 4841 participants. We judged all studies to be at high risk of bias in at least one domain because most studies used different reference standards, often inappropriate to exclude the presence of the target condition, and the time interval between the index test and the reference standard was rarely defined. Regarding applicability, we judged 15% (5/34) of studies to be at low concern and 85% (29/34) of studies to be at high concern mostly owing to characteristics of the participants, most of whom were on waiting lists for orthotopic liver transplantation, and due to pathology of the explanted liver being the only reference standard.\nMRI for hepatocellular carcinoma of any size and stage: sensitivity 84.4% (95% CI 80.1% to 87.9%) and specificity 93.8% (95% CI 90.1% to 96.1%) (34 studies, 4841 participants; low-certainty evidence).\nMRI for resectable hepatocellular carcinoma: sensitivity 84.3% (95% CI 77.6% to 89.3%) and specificity 92.9% (95% CI 88.3% to 95.9%) (16 studies, 2150 participants; low-certainty evidence).\nThe observed heterogeneity in the results remains mostly unexplained. The sensitivity analyses, which included only studies with clearly prespecified positivity criteria and only studies in which the reference standard results were interpreted without knowledge of the results of the index test, showed no variation in the results.\nAuthors' conclusions\nWe found that using MRI as a second-line imaging modality to diagnose hepatocellular carcinoma of any size and stage, 16% of people with hepatocellular carcinoma would be missed, and 6% of people without hepatocellular carcinoma would be unnecessarily treated. For resectable hepatocellular carcinoma, we found that 16% of people with resectable hepatocellular carcinoma would improperly not be resected, while 7% of people without hepatocellular carcinoma would undergo inappropriate surgery. The uncertainty resulting from the high risk of bias in the included studies and concerns regarding their applicability limit our ability to confidently draw conclusions based on our results.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In people with chronic liver disease, magnetic resonance imaging (MRI: cross-sectional scans inside the body) probably misses liver cancer in 16% of people, who would not receive timely or appropriate treatment, and incorrectly finds liver cancer in 6% of people, who would receive unnecessary treatment.\nMRI probably misses liver cancer in 16% of people with liver cancer who could have surgery to remove part of their liver, and incorrectly finds liver cancer in 7% of people who undergo inappropriate surgery.\nThe studies were at high risk of bias and too different from each other to allow us to draw firm conclusions based on the evidence."
}
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query-laysum | 3323 | [
{
"role": "user",
"content": "Abstract: Background\nExcess dietary sodium consumption is a risk factor for high blood pressure, stroke and cardiovascular disease. Currently, dietary sodium consumption in almost every country is too high. Excess sodium intake is associated with high blood pressure, which is common and costly and accounts for significant burden of disease. A large number of jurisdictions worldwide have implemented population-level dietary sodium reduction initiatives. No systematic review has examined the impact of these initiatives.\nObjectives\n• To assess the impact of population-level interventions for dietary sodium reduction in government jurisdictions worldwide.\n• To assess the differential impact of those initiatives by social and economic indicators.\nSearch methods\nWe searched the following electronic databases from their start date to 5 January 2015: the Cochrane Central Register of Controlled Trials (CENTRAL); Cochrane Public Health Group Specialised Register; MEDLINE; MEDLINE In Process & Other Non-Indexed Citations; EMBASE; Effective Public Health Practice Project Database; Web of Science; Trials Register of Promoting Health Interventions (TRoPHI) databases; and Latin American Caribbean Health Sciences Literature (LILACS). We also searched grey literature, other national sources and references of included studies.\nThis review was conducted in parallel with a comprehensive review of national sodium reduction efforts under way worldwide (Trieu 2015), through which we gained additional information directly from country contacts.\nWe imposed no restrictions on language or publication status.\nSelection criteria\nWe included population-level initiatives (i.e. interventions that target whole populations, in this case, government jurisdictions, worldwide) for dietary sodium reduction, with at least one pre-intervention data point and at least one post-intervention data point of comparable jurisdiction. We included populations of all ages and the following types of study designs: cluster-randomised, controlled pre-post, interrupted time series and uncontrolled pre-post. We contacted study authors at different points in the review to ask for missing information.\nData collection and analysis\nTwo review authors extracted data, and two review authors assessed risk of bias for each included initiative.\nWe analysed the impact of initiatives by using estimates of sodium consumption from dietary surveys or urine samples. All estimates were converted to a common metric: salt intake in grams per day. We analysed impact by computing the mean change in salt intake (grams per day) from pre-intervention to post-intervention.\nMain results\nWe reviewed a total of 881 full-text documents. From these, we identified 15 national initiatives, including more than 260,000 people, that met the inclusion criteria. None of the initiatives were provided in lower-middle-income or low-income countries. All initiatives except one used an uncontrolled pre-post study design.\nBecause of high levels of study heterogeneity (I2 > 90%), we focused on individual initiatives rather than on pooled results.\nTen initiatives provided sufficient data for quantitative analysis of impact (64,798 participants). As required by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) method, we graded the evidence as very low due to the risk of bias of the included studies, as well as variation in the direction and size of effect across the studies. Five of these showed mean decreases in average daily salt intake per person from pre-intervention to post-intervention, ranging from 1.15 grams/day less (Finland) to 0.35 grams/day less (Ireland). Two initiatives showed mean increase in salt intake from pre-intervention to post-intervention: Canada (1.66) and Switzerland (0.80 grams/day more per person); however in both countries the pre-intervention data point was from several years prior to the initiation of the intervention. The remaining initiatives did not show a statistically significant mean change.\nSeven of the 10 initiatives were multi-component and incorporated intervention activities of a structural nature (e.g. food product reformulation, food procurement policy in specific settings). Of those seven initiatives, four showed a statistically significant mean decrease in salt intake from pre-intervention to post-intervention, ranging from Finland to Ireland (see above), and one showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention (Switzerland; see above).\nNine initiatives permitted quantitative analysis of differential impact by sex (men and women separately). For women, three initiatives (China, Finland, France) showed a statistically significant mean decrease, four (Austria, Netherlands, Switzerland, United Kingdom) showed no significant change and two (Canada, United States) showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention. For men, five initiatives (Austria, China, Finland, France, United Kingdom) showed a statistically significant mean decrease, three (Netherlands, Switzerland, United States) showed no significant change and one (Canada) showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention.\nInformation was insufficient to indicate whether a differential change in mean salt intake occurred from pre-intervention to post-intervention by other axes of equity included in the PROGRESS framework (e.g. education, place of residence).\nWe identified no adverse effects of these initiatives.\nThe number of initiatives was insufficient to permit other subgroup analyses, including stratification by intervention type, economic status of country and duration (or start year) of the initiative.\nMany studies had methodological strengths, including large, nationally representative samples of the population and rigorous measurement of dietary sodium intake. However, all studies were scored as having high risk of bias, reflecting the observational nature of the research and the use of an uncontrolled study design. The quality of evidence for the main outcome was low. We could perform a sensitivity analysis only for impact.\nAuthors' conclusions\nPopulation-level interventions in government jurisdictions for dietary sodium reduction have the potential to result in population-wide reductions in salt intake from pre-intervention to post-intervention, particularly if they are multi-component (more than one intervention activity) and incorporate intervention activities of a structural nature (e.g. food product reformulation), and particularly amongst men. Heterogeneity across studies was significant, reflecting different contexts (population and setting) and initiative characteristics. Implementation of future initiatives should embed more effective means of evaluation to help us better understand the variation in the effects.\n\nGiven the provided abstract, please respond to the following query: \"The problem\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In almost all countries worldwide, most people eat too much salt. This is a problem because eating too much salt can cause high blood pressure, which can lead to health problems such as heart disease and stroke. To reduce the amount of salt eaten, governments in many countries have developed national salt reduction initiatives."
}
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query-laysum | 3324 | [
{
"role": "user",
"content": "Abstract: Background\nMelanoma has one of the fastest rising incidence rates of any cancer. It accounts for a small percentage of skin cancer cases but is responsible for the majority of skin cancer deaths. Early detection and treatment is key to improving survival; however, anxiety around missing early cases needs to be balanced against appropriate levels of referral and excision of benign lesions. Used in conjunction with clinical or dermoscopic suspicion of malignancy, or both, reflectance confocal microscopy (RCM) may reduce unnecessary excisions without missing melanoma cases.\nObjectives\nTo determine the diagnostic accuracy of reflectance confocal microscopy for the detection of cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in adults with any lesion suspicious for melanoma and lesions that are difficult to diagnose, and to compare its accuracy with that of dermoscopy.\nSearch methods\nWe undertook a comprehensive search of the following databases from inception up to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; and seven other databases. We studied reference lists and published systematic review articles.\nSelection criteria\nStudies of any design that evaluated RCM alone, or RCM in comparison to dermoscopy, in adults with lesions suspicious for melanoma or atypical intraepidermal melanocytic variants, compared with a reference standard of either histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). We contacted authors of included studies where information related to the target condition or diagnostic threshold were missing. We estimated summary sensitivities and specificities per algorithm and threshold using the bivariate hierarchical model. To compare RCM with dermoscopy, we grouped studies by population (defined by difficulty of lesion diagnosis) and combined data using hierarchical summary receiver operating characteristic (SROC) methods. Analysis of studies allowing direct comparison between tests was undertaken. To facilitate interpretation of results, we computed values of specificity at the point on the SROC curve with 90% sensitivity as this value lies within the estimates for the majority of analyses. We investigated the impact of using a purposely developed RCM algorithm and in-person test interpretation.\nMain results\nThe search identified 18 publications reporting on 19 study cohorts with 2838 lesions (including 658 with melanoma), which provided 67 datasets for RCM and seven for dermoscopy. Studies were generally at high or unclear risk of bias across almost all domains and of high or unclear concern regarding applicability of the evidence. Selective participant recruitment, lack of blinding of the reference test to the RCM result, and differential verification were particularly problematic. Studies may not be representative of populations eligible for RCM, and test interpretation was often undertaken remotely from the patient and blinded to clinical information.\nMeta-analysis found RCM to be more accurate than dermoscopy in studies of participants with any lesion suspicious for melanoma and in participants with lesions that were more difficult to diagnose (equivocal lesion populations). Assuming a fixed sensitivity of 90% for both tests, specificities were 82% for RCM and 42% for dermoscopy for any lesion suspicious for melanoma (9 RCM datasets; 1452 lesions and 370 melanomas). For a hypothetical population of 1000 lesions at the median observed melanoma prevalence of 30%, this equated to a reduction in unnecessary excisions with RCM of 280 compared to dermoscopy, with 30 melanomas missed by both tests. For studies in equivocal lesions, specificities of 86% would be observed for RCM and 49% for dermoscopy (7 RCM datasets; 1177 lesions and 180 melanomas). At the median observed melanoma prevalence of 20%, this reduced unnecessary excisions by 296 with RCM compared with dermoscopy, with 20 melanomas missed by both tests. Across all populations, algorithms and thresholds assessed, the sensitivity and specificity of the Pellacani RCM score at a threshold of three or greater were estimated at 92% (95% confidence interval (CI) 87 to 95) for RCM and 72% (95% CI 62 to 81) for dermoscopy.\nAuthors' conclusions\nRCM may have a potential role in clinical practice, particularly for the assessment of lesions that are difficult to diagnose using visual inspection and dermoscopy alone, where the evidence suggests that RCM may be both more sensitive and specific in comparison to dermoscopy. Given the paucity of data to allow comparison with dermoscopy, the results presented require further confirmation in prospective studies comparing RCM with dermoscopy in a real-world setting in a representative population.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The review included 18 publications reporting data for 19 groups of participants with lesions suspected of melanoma. The main results were based on 16 of the 19 datasets (sets of information and results).\nThe review included nine datasets with 1452 lesions in people with any suspicious skin lesion, three of which compared RCM to dermoscopy. The results suggested that in 1000 lesions, of which 300 (30%) actually are melanoma:\n- an estimated 396 would have an RCM result indicating melanoma was present, and of these, 126 (32%) would not be melanoma (false positive results);\n- in the same group of 1000 lesions, dermoscopy would produce 406 false positive results, meaning RCM would avoid unnecessary surgery in 280 lesions compared to dermoscopy;\n- of the 604 lesions with an RCM result indicating that melanoma was not present (and 324 lesions with a dermoscopy result indicating that melanoma was not present), 30 would actually be melanoma (false negative results). This equated to a false negative rate of 5% for RCM and 9% for dermoscopy.\nThe review also included seven datasets with 1177 lesions in people with particularly difficult to diagnose skin lesions, three of which compared RCM to dermoscopy. The results suggested that if skin specialists used RCM in a group of 1000 lesions, of which 200 (20%) were actually melanoma:\n- an estimated 292 would have an RCM result indicating melanoma was present, and of these, 112 (38%) would not be melanoma (false positive results);\n- in the same group of 1000 lesions, dermoscopy would produce 408 false positive results, meaning RCM would avoid unnecessary surgery in 296 lesions compared to dermoscopy;\n- of the 708 lesions with an RCM result indicating that melanoma was not present (and 412 lesions with a dermoscopy result indicating that melanoma was not present), 20 would actually have melanoma (false negative results). This equates to a false negative rate of 3% for RCM and 5% for dermoscopy."
}
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query-laysum | 3325 | [
{
"role": "user",
"content": "Abstract: Background\nAlcohol use disorder (AUD) is one of the most widespread psychiatric disorders leading to detrimental consequences to people with this disorder and others. Worldwide, the prevalence of heavy episodic drinking (30-day prevalence of at least one occasion of 60 g of pure alcohol intake among current drinkers) is estimated at 20% and the prevalence of AUD at 5% of the adult general population, with highest prevalence in Europe and North America. Therapeutic approaches, including pharmacotherapy, play an important role in treating people with AUD.\nThis is an update of a Cochrane Review first published in 2018.\nObjectives\nTo evaluate the benefits and harms of baclofen on achieving and maintaining abstinence or reducing alcohol consumption in people with AUD compared to placebo, no treatment or any other pharmacological relapse prevention treatment.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search was 22 November 2021.\nSelection criteria\nRandomised controlled trials (RCTs) of at least four weeks' treatment duration and 12 weeks' overall study duration comparing baclofen for AUD treatment with placebo, no treatment or other treatments.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. relapse, 2. frequency of use, 3. amount of use, 4. adverse events, 5. dropouts from treatment and 6. dropouts from treatment due to adverse events. Our secondary outcomes were 7. craving, 8. anxiety, 9. depression and 10. frequency of most relevant adverse events.\nMain results\nWe included 17 RCTs (1818 participants) with a diagnosis of alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition or International Classification of Diseases 10th edition criteria. Mean age was 46.5 years and 70% were men. Ten studies compared baclofen to placebo or another medication; seven compared two baclofen doses to placebo or another medication. Globally, 15 studies compared baclofen to placebo, two baclofen to acamprosate and two baclofen to naltrexone. In 16 studies, participants received psychosocial treatments.\nWe judged most studies at low risk of selection, performance, detection (subjective outcome), attrition and reporting bias.\nTen studies detoxified participants before treatment; in seven studies, participants were still drinking at the beginning of treatment. Treatment duration was 12 weeks for 15 RCTs and longer in two studies. Baclofen daily dose was 30 mg to 300 mg: 10 RCTs used low doses (30 mg or less); eight RCTs medium doses (above 30 and 100 mg or less) and four RCTs high doses (above 100 mg).\nCompared to placebo, moderate-certainty evidence found that baclofen probably decreases the risk to relapse (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.77 to 0.99; 12 studies, 1057 participants). This result was confirmed among detoxified participants but not among other subgroups of participants.\nHigh-certainty evidence found that baclofen increases the percentage of days abstinent (mean difference (MD) 9.07, 95% CI 3.30 to 14.85; 16 studies, 1273 participants). This result was confirmed among all subgroups of participants except non-detoxified or those who received medium doses.\nThere was no difference between baclofen and placebo in the other primary outcomes: heavy drinking days (standardised mean difference (SMD) −0.18, 95% CI −0.48 to 0.11; 13 studies, 840 participants; moderate-certainty evidence); number of drinks per drinking days (MD −0.45, 95% CI −1.20 to 0.30; 9 studies, 392 participants; moderate-certainty evidence); number of participants with at least one adverse event (RR 1.05, 95% CI 0.99 to 1.11; 10 studies, 738 participants; high-certainty evidence); dropouts (RR 0.88, 95% CI 0.74 to 1.03; 17 studies, 1563 participants; high-certainty evidence); dropouts due to adverse events (RR 1.39, 95% CI 0.89 to 2.18; 16 studies, 1499 participants; high-certainty evidence). These results were confirmed by subgroup analyses except than for the dropouts that resulted lower among participants who received high doses of baclofen and studies longer than 12 weeks.\nCompared to placebo, there was no difference in craving (SMD −0.16, 95% CI −0.37 to 0.04; 17 studies, 1275 participants), anxiety (MD −0.01, 95% CI −0.14 to 0.11; 15 studies, 1123 participants) and depression (SMD 0.07, 95% CI −0.12 to 0.27; 11 studies, 1029 participants).\nConcerning the specific adverse events, baclofen increases fatigue, dizziness, somnolence/sedation, dry mouth, paraesthesia and muscle spasms/rigidity. There was no difference in the other adverse events.\nCompared to acamprosate, one study (60 participants) found no differences in any outcomes but the evidence was very uncertain: relapse (RR 1.25, 95% CI 0.71 to 2.20; very low-certainty evidence); number of participants with at least one adverse event (RR 0.63, 95% CI 0.23 to 1.69; very low-certainty evidence); dropouts (RR 0.56, 95% CI 0.21 to 1.46; very low-certainty evidence); dropouts due to adverse events (RR 0.33, 95% CI 0.01 to 7.87; very low-certainty evidence) and craving (MD 5.80, 95% CI −11.84 to 23.44); and all the adverse events evaluated.\nCompared to naltrexone, baclofen may increase the risk of relapse (RR 2.50, 95% CI 1.12 to 5.56; 1 study, 60 participants; very low-certainty evidence) and decrease the number of participants with at least one adverse event (RR 0.35, 95% CI 0.15 to 0.80; 2 studies, 80 participants; very low-certainty evidence) but the evidence is very uncertain. One study (60 participants) found no difference between baclofen and naltrexone in the dropouts at the end of treatment (RR 1.00, 95% CI 0.32 to 3.10; very low-certainty evidence), craving (MD 2.08, 95% CI −3.71 to 7.87), and all the adverse events evaluated.\nAuthors' conclusions\nBaclofen likely reduces the risk of relapse to any drinking and increases the percentage of abstinent days, mainly among detoxified participants. It does not increase the number of participants with at least one adverse event, those who dropout for any reason or due to adverse events. It probably does not reduce number of heavy drinking days and the number of drinks per drinking days. Current evidence suggests that baclofen may help people with AUD in maintaining abstinence. The results of comparisons of baclofen with acamprosate and naltrexone were mainly based on only one study.\n\nGiven the provided abstract, please respond to the following query: \"Review topics and aims\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "AUD is one of the most widespread psychiatric disorders, leading to specific physical, mood, learning and memory problems, and consequences for overall well-being and health. The misuse of alcohol is one of the biggest risks to health worldwide, causing 20% to 30% of oesophageal (food pipe) cancer, liver disease, epilepsy (fits), motor vehicle accidents, murders and other intentional injuries.\nFor many years, the main treatments for AUD have been psychosocial strategies (helping people to recognise that they need help), but using only psychosocial treatments has limited success. A high proportion of people with AUD do not respond to treatment at all, and those who do respond do not stay alcohol-free in the long-term. Medications such as baclofen could play an important role in treating people with AUD."
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query-laysum | 3326 | [
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"role": "user",
"content": "Abstract: Background\nThis is an updated version of an original Cochrane Review published in 2013 (Walker 2013).\nEpilepsy is a common neurological disorder affecting 0.5% to 1% of the population. Pharmacological treatment remains the first choice to control epilepsy. However, up to 30% of people do not respond to drug treatment, and therefore do not achieve seizure remission. Experimental and clinical evidence supports a role for inflammatory pathway activation in the pathogenesis of epilepsy which, if effectively targeted by immunomodulatory interventions, highlights a potentially novel therapeutic strategy.\nObjectives\nTo assess the efficacy and tolerability of immunomodulatory interventions on seizures, adverse effect profile, cognition, and quality of life, compared to placebo controls, when used as additional therapy for focal epilepsy in children and adults.\nSearch methods\nFor the latest update, we searched the following databases on 11 November 2021: Cochrane Register of Studies (CRS Web) and Medline (Ovid) 1946 to 10 November 2021. CRS Web includes randomised or quasi-randomised, 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. We placed no language restrictions. We reviewed the bibliographies of retrieved studies to search for additional reports of relevant studies.\nSelection criteria\nRandomised placebo-controlled trials of add-on immunomodulatory drug interventions, in which an adequate method of concealment of randomisation was used. The studies were double-, single- or unblinded. Eligible participants were children (aged over 2 years) and adults with focal epilepsy.\nData collection and analysis\nWe used standard methodological procedures expected by the Cochrane Collaboration.\nWe assessed the following outcomes.\n1. 50% or greater reduction in seizure frequency.\n2. Seizure freedom.\n3. Treatment withdrawal for any reason.\n4. Quality of life.\n5. Adverse effects.\nWe used an intention-to-treat (ITT) population for all primary analyses, and we presented results as risk ratios (RRs) with 95% confidence intervals (95% Cl).\nMain results\nWe included three randomised, double-blind, placebo-controlled trials on a total of 172 participants. All trials included children and adults over two years of age with focal epilepsy. Treatment phases lasted six weeks and follow-up from six weeks to six months. One of the three included trials described an adequate method of concealment of randomisation, whilst the other two trials were rated as having an unclear risk of bias due to lack of reported information around study design. Effective blinding of studies was reported in all three trials. All analyses were by ITT. One trial was sponsored by the manufacturer of an immunomodulatory agent and therefore was at high risk of funding bias.\nImmunomodulatory interventions were significantly more effective than placebo in reducing seizure frequency (risk ratio (RR) 2.30, 95% confidence interval (CI) 1.15 to 4.60; 3 studies, 172 participants; moderate-certainty evidence). For treatment withdrawal, there was insufficient evidence to conclude that people were more likely to discontinue immunomodulatory intervention than placebo (RR 1.04, 95% CI 0.28 to 3.80; 3 studies, 172 participants; low-certainty evidence). The RR for adverse effects was 1.16 (95% CI 0.84 to 1.59; 1 study, 66 participants; low-certainty evidence). Certain adverse effects such as dizziness, headache, fatigue, and gastrointestinal disorders were more often associated with immunomodulatory interventions. There were little to no data on cognitive effects and quality of life. No important heterogeneity between studies was found for any of the outcomes. We judged the overall certainty of evidence (using the GRADE approach) as low to moderate due to potential attrition bias resulting from missing outcome data and imprecise results with wide confidence intervals.\nAuthors' conclusions\nImmunomodulatory interventions as add-on treatment for children and adults with focal epilepsy appear to be effective in reducing seizure frequency. It is not possible to draw any conclusions about the tolerability of these agents in children and adults with epilepsy. Further randomised controlled trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for studies that looked at treatments that target the immune system in children and adults with focal epilepsy. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
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query-laysum | 3327 | [
{
"role": "user",
"content": "Abstract: Background\nCervical cerclage is a surgical intervention involving placing a stitch around the uterine cervix. The suture material aims to prevent cervical shortening and opening, thereby reducing the risk of preterm birth. The effectiveness and safety of this procedure in multiple gestations remains controversial.\nObjectives\nTo assess whether the use of a cervical cerclage in multiple gestations, either at high risk of pregnancy loss based on just the multiple gestation (history-indicated cerclage), the ultrasound findings of 'short cervix' (ultrasound-indicated cerclage), or the physical exam changes in the cervix (physical exam-indicated cerclage), improves obstetrical and perinatal outcomes. The primary outcomes assessed were perinatal deaths, serious neonatal morbidity, and perinatal deaths and serious neonatal morbidity.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2014) and reference lists of retrieved studies.\nSelection criteria\nAll randomised controlled trials (RCTs) of cervical cerclage in multiple pregnancies. Quasi-RCTs and RCTs using a cluster-randomised design were eligible for inclusion (but none were identified). Studies using a cross-over design and those presented only as abstracts were not eligible for inclusion.\nWe included studies comparing cervical cerclage with no cervical cerclage in multiple pregnancies.\nStudies comparing cervical stitch versus any other preventative therapy (e.g. progesterone) in multiple pregnancies, and studies involving comparisons between different cerclage protocols (history-indicated versus ultrasound-indicated versus physical exam-indicated cerclage) were also eligible for inclusion but none were identified.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias. Two review authors extracted data. Data were checked for accuracy.\nMain results\nWe included five trials, which in total randomised 1577 women, encompassing both singleton and multiple gestations. After excluding singletons, the final analysis included 128 women, of which 122 women had twin gestations, and six women had triplet gestations. Two trials (n = 73 women) assessed history-indicated cerclage, while three trials (n = 55 women) assessed ultrasound-indicated cerclage. The five trials were judged to be of average to above average quality, with three of the trials at unclear risk regarding selection and detection biases.\nConcerning the primary outcomes, when outcomes for cerclage were pooled together for all indications and compared with no cerclage, there was no statistically significant differences in perinatal deaths (19.2% versus 9.5%; risk ratio (RR) 1.74, 95% confidence intervals (CI) 0.92 to 3.28, five trials, n = 262), serious neonatal morbidity (15.8% versus 13.6%; average RR 0.96, 95% CI 0.13 to 7.10, three trials, n = 116), or composite perinatal death and neonatal morbidity (40.4% versus 20.3%; average RR 1.54, 95% CI 0.58 to 4.11, three trials, n = 116).\nAmong the secondary outcomes, there were no significant differences between the cerclage and the no cerclage groups. To name a few, there were no significant differences among the following: preterm birth less than 34 weeks (average RR 1.16, 95% CI 0.44 to 3.06, four trials, n = 83), preterm birth less than 35 weeks (average RR 1.11, 95% CI 0.58 to 2.14, four trials, n = 83), low birthweight less than 2500 g (average RR 1.10, 95% CI 0.82 to 1.48, four trials, n = 172), very low birthweight less than 1500 g (average RR 1.42, 95% CI 0.52 to 3.85, four trials, n = 172), and respiratory distress syndrome (average RR 1.70, 95% CI 0.15 to 18.77, three trials, n = 116). There were also no significant differences between the cerclage and no cerclage groups when examining caesarean section (elective and emergency) (RR 1.24, 95% CI 0.65 to 2.35, three trials, n = 77) and maternal side-effects (RR 3.92, 95% CI 0.17 to 88.67, one trial, n = 28).\nExamining the differences between prespecified subgroups, ultrasound-indicated cerclage was associated with an increased risk of low birthweight (average RR 1.39, 95% CI 1.06 to 1.83, Tau² = 0.01, I² = 15%, three trials, n = 98), very low birthweight (average RR 3.31, 95% CI 1.58 to 6.91, Tau² = 0, I² = 0%, three trials, n = 98), and respiratory distress syndrome (average RR 5.07, 95% CI 1.75 to 14.70, Tau² = 0, I² = 0%, three trials, n = 98). However, given the low number of trials, as well as substantial heterogeneity and subgroup differences, these data must be interpreted cautiously.\nNo trials reported on long-term infant neurodevelopmental outcomes. There were no physical exam-indicated cerclages available for comparison among the studies included.\nAuthors' conclusions\nThis review is based on limited data from five small studies of average to above average quality. For multiple gestations, there is no evidence that cerclage is an effective intervention for preventing preterm births and reducing perinatal deaths or neonatal morbidity.\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": "Carrying more than one baby increases a woman's risk of delivering preterm. The risks increase with the number of babies being carried. Babies born prematurely are more likely to experience poor outcomes including serious ill health and death. Cervical cerclage is a surgical procedure carried out during pregnancy to try to prevent preterm birth by limiting shortening and opening of the cervix. It is performed by placing suture material around the cervix, which is accessed either by the vagina or through the mother’s abdomen. The effectiveness and safety of this procedure for multiple gestations remains uncertain. The likelihood of spontaneous preterm birth can be assessed by looking at the mother’s obstetric history, a physical examination, or transvaginal ultrasound examination in the second trimester."
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query-laysum | 3328 | [
{
"role": "user",
"content": "Abstract: Background\nThere are controversies about the amount of calories and the type of nutritional support that should be given to critically-ill people. Several authors advocate the potential benefits of hypocaloric nutrition support, but the evidence is inconclusive.\nObjectives\nTo assess the effects of prescribed hypocaloric nutrition support in comparison with standard nutrition support for critically-ill adults\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, Cochrane Library), MEDLINE, Embase and LILACS (from inception to 20 June 2017) with a specific strategy for each database. We also assessed three websites, conference proceedings and reference lists, and contacted leaders in the field and the pharmaceutical industry for undetected/unpublished studies. There was no restriction by date, language or publication status.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials comparing hypocaloric nutrition support to normo- or hypercaloric nutrition support or no nutrition support (e.g. fasting) in adults hospitalized in intensive care units (ICUs).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We meta-analysed data for comparisons in which clinical heterogeneity was low. We conducted prespecified subgroup and sensitivity analyses, and post hoc analyses, including meta-regression. Our primary outcomes were: mortality (death occurred during the ICU and hospital stay, or 28- to 30-day all-cause mortality); length of stay (days stayed in the ICU and in the hospital); and Infectious complications. Secondary outcomes included: length of mechanical ventilation. We assessed the quality of evidence with GRADE.\nMain results\nWe identified 15 trials, with a total of 3129 ICU participants from university-associated hospitals in the USA, Colombia, Saudi Arabia, Canada, Greece, Germany and Iran. There are two ongoing studies. Participants suffered from medical and surgical conditions, with a variety of inclusion criteria. Four studies used parenteral nutrition and nine studies used only enteral nutrition; it was unclear whether the remaining two used parenteral nutrition. Most of them could not achieve the proposed caloric targets, resulting in small differences in the administered calories between intervention and control groups. Most studies were funded by the US government or non-governmental associations, but three studies received funding from industry. Five studies did not specify their funding sources.\nThe included studies suffered from important clinical and statistical heterogeneity. This heterogeneity did not allow us to report pooled estimates of the primary and secondary outcomes, so we have described them narratively.\nWhen comparing hypocaloric nutrition support with a control nutrition support, for hospital mortality (9 studies, 1775 participants), the risk ratios ranged from 0.23 to 5.54; for ICU mortality (4 studies, 1291 participants) the risk ratios ranged from 0.81 to 5.54, and for mortality at 30 days (7 studies, 2611 participants) the risk ratios ranged from 0.79 to 3.00. Most of these estimates included the null value. The quality of the evidence was very low due to unclear or high risk of bias, inconsistency and imprecision.\nParticipants who received hypocaloric nutrition support compared to control nutrition support had a range of mean hospital lengths of stay of 15.70 days lower to 10.70 days higher (10 studies, 1677 participants), a range of mean ICU lengths of stay 11.00 days lower to 5.40 days higher (11 studies, 2942 participants) and a range of mean lengths of mechanical ventilation of 13.20 days lower to 8.36 days higher (12 studies, 3000 participants). The quality of the evidence for this outcome was very low due to unclear or high risk of bias in most studies, inconsistency and imprecision.\nThe risk ratios for infectious complications (10 studies, 2804 participants) of each individual study ranged from 0.54 to 2.54. The quality of the evidence for this outcome was very low due to unclear or high risk of bias, inconsistency and imprecision\nWe were not able to explain the causes of the observed heterogeneity using subgroup and sensitivity analyses or meta-regression.\nAuthors' conclusions\nThe included studies had substantial clinical heterogeneity. We found very low-quality evidence about the effects of prescribed hypocaloric nutrition support on mortality in hospital, in the ICU and at 30 days, as well as in length of hospital and ICU stay, infectious complications and the length of mechanical ventilation. For these outcomes there is uncertainty about the effects of prescribed hypocaloric nutrition, since the range of estimates includes both appreciable benefits and harms.\nGiven these limitations, results must be interpreted with caution in the clinical field, considering the unclear balance of the risks and harms of this intervention. Future research addressing the clinical heterogeneity of participants and interventions, study limitations and sample size could clarify the effects of this intervention.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We included 15 trials with 3129 ICU surgical or medical participants from academic hospitals. Four studies used parenteral nutrition and nine studies used only enteral nutrition. The route was unclear in the remaining two studies. While the studies planned to give different amounts of calories in the experimental and control groups, the actual difference in calories was small. Most studies were funded by the US government or non-governmental associations, but three studies received funding from the industry. Five studies did not state how they were funded."
}
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{
"role": "user",
"content": "Abstract: Background\nPersistent pulmonary hypertension of the newborn (PPHN) is a disease entity that describes a physiology in which there is persistence of increased pulmonary arterial pressure. PPHN is characterised by failure to adapt to a functional postnatal circulation with a fall in pulmonary vascular resistance. PPHN is responsible for impairment in oxygenation and significant neonatal mortality and morbidity. Prostanoids and their analogues may be useful therapeutic interventions due to their pulmonary vasodilatory and immunomodulatory effects.\nObjectives\nPrimary objective\n• To determine the efficacy and safety of prostanoids and their analogues (iloprost, treprostinil, and beraprost) in decreasing mortality and the need for extracorporeal membrane oxygenation (ECMO) among neonates with PH\nSecondary objective\n• To determine the efficacy and safety of prostanoids and their analogues (iloprost, treprostinil, and beraprost) in decreasing neonatal morbidity (necrotizing enterocolitis (NEC), chronic lung disease (CLD), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), length of hospital stay, and duration of mechanical ventilation) and improving neurodevelopmental outcomes among neonates with PH\nComparisons\n• Prostanoids and their analogues at any dosage or duration used to treat PPHN versus ‘standard treatment without these agents’, placebo, or inhaled nitric oxide (iNO) therapy\n• Prostanoids and their analogues at any dosage or duration used to treat refractory PPHN as an ‘add-on’ therapy to iNO versus iNO alone\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9), MEDLINE via PubMed (1966 to 16 September 2018), Embase (1980 to 16 September 2018), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 16 September 2018). We also searched clinical trials databases, conference proceedings of the Pediatric Academic Societies (1990 to 16 September 2018), and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. We contacted authors who have published in this field as discerned from the reference lists of identified clinical trials and review authors' personal files.\nSelection criteria\nRandomized and quasi-randomized controlled trials evaluating prostanoids or their analogues (at any dose, route of administration, or duration) used in neonates at any gestational age less than 28 days' postnatal age for confirmed or suspected PPHN.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal to conduct a systematic review and to assess the methodological quality of included studies (neonatal.cochrane.org/en/index.html). Three review authors independently assessed the titles and abstracts of studies identified by the search strategy and obtained full-text versions for assessment if necessary. We designed forms for trial inclusion or exclusion and for data extraction. We planned to use the GRADE approach to assess the quality of evidence.\nMain results\nWe did not identify any eligible neonatal trials evaluating prostanoids or their analogues as sole agents in the treatment of PPHN.\nAuthors' conclusions\nImplications for practice\nCurrently, no evidence shows the use of prostanoids or their analogues as pulmonary vasodilators and sole therapeutic agents for the treatment of PPHN in neonates (age 28 days or less).\nImplications for research\nThe safety and efficacy of different preparations and doses and routes of administration of prostacyclins and their analogues in neonates must be established. Well-designed, adequately powered, randomized, multi-center trials are needed to address the efficacy and safety of prostanoids and their analogues in the treatment of PPHN. These trials should evaluate long-term neurodevelopmental and pulmonary outcomes, in addition to short-term outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the literature for studies that used prostanoids or their derivatives for the treatment of PPHN by injection or inhalation. We found no ongoing or completed randomized controlled studies. We found one small study that ended prematurely due to poor enrolment. Currently, no evidence for or against the use of prostanoids in newborn PPHN is available, and we recommend future studies to establish the safety and efficacy of these medicines."
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"role": "user",
"content": "Abstract: Background\nPreterm birth remains the major risk factor for the development of intraventricular hemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular hemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Antithrombin, a glycoprotein synthesized in the liver, is the major plasma inhibitor of thrombin thus modulating blood coagulation. Very low birth weight newborn infants have low levels of antithrombin and the risk of developing intraventricular hemorrhage is increased by the presence of hypercoagulability in the first hours of life. The administration of anticoagulants such as antithrombin may offset the increased risk of developing intraventricular hemorrhage. Anticoagulants may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular hemorrhage.\nObjectives\nTo assess whether the prophylactic administration of antithrombin (started within the first 24 hours after birth) reduces the incidence of germinal matrix-intraventricular hemorrhage in very preterm neonates when compared to placebo, no treatment, or heparin.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015), and CINAHL (1982 to 22 November 2015). No language restrictions were applied. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015.\nSelection criteria\nRandomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, antithrombin in very preterm infants (gestational age < 32 weeks, any birth weight).\nData collection and analysis\nFor each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, antithrombin formulation (plasma-derived or recombinant), mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review are intraventricular hemorrhage and severe intraventricular hemorrhage.\nMain results\nTwo randomized controlled trials, for a total of 182 infants, met the inclusion criteria of this review. Both trials compared antithrombin with placebo. We found no significant differences in the rates of intraventricular hemorrhage (typical RR 1.30, CI 95% 0.87 to 1.93, typical RD 0.09, 95% CI −0.05 to 0.23; 2 studies, 175 infants; I² = 18% for RR and I² = 42% for RD) and severe intraventricular hemorrhage (typical RR 1.04, CI 95% 0.55 to 1.94; typical RD 0.01, 95% CI −0.11 to 0.12; 2 studies, 175 infants; I² = 0% for RR and I² = 0% for RD). Among secondary outcomes, we found no significant differences in terms of neonatal mortality (typical RR 2.00, CI 95% 0.62 to 6.45; typical RD 0.04, 95% CI −0.03 to 0.12; 2 studies, 182 infants; I² = 46% for RR and I² = 61% for RD) and in the other specified outcomes, such as bronchopulmonary dysplasia. The quality of the evidence supporting these findings is limited due to the imprecision of the estimates.\nAuthors' conclusions\nThe administration of antithrombin seems not to reduce the incidence and severity of intraventricular hemorrhage in very preterm infants. Limited evidence is available on other clinically relevant outcomes. Given the imprecision of the estimate, the results of this systematic review are consistent with either a benefit or a detrimental effect of antithrombin and do not provide a definitive answer to the review question.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Does antithrombin reduce the risk of intraventricular hemorrhage (i.e. bleeding in the brain) and mortality in very preterm infants?"
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query-laysum | 3331 | [
{
"role": "user",
"content": "Abstract: Background\nMindfulness interventions are increasingly popular as an approach to improve mental well-being. To date, no Cochrane Review examines the effectiveness of mindfulness in medical students and junior doctors. Thus, questions remain regarding the efficacy of mindfulness interventions as a preventative mechanism in this population, which is at high risk for poor mental health.\nObjectives\nTo assess the effects of psychological interventions with a primary focus on mindfulness on the mental well-being and academic performance of medical students and junior doctors.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and five other databases (to October 2021) and conducted grey literature searches.\nSelection criteria\nWe included randomised controlled trials of mindfulness that involved medical students of any year level and junior doctors in postgraduate years one, two or three. We included any psychological intervention with a primary focus on teaching the fundamentals of mindfulness as a preventative intervention. Our primary outcomes were anxiety and depression, and our secondary outcomes included stress, burnout, academic performance, suicidal ideation and quality of life.\nData collection and analysis\nWe used standard methods as recommended by Cochrane, including Cochrane's risk of bias 2 tool (RoB2).\nMain results\nWe included 10 studies involving 731 participants in quantitative analysis.\nCompared with waiting-list control or no intervention, mindfulness interventions did not result in a substantial difference immediately post-intervention for anxiety (standardised mean difference (SMD) 0.09, 95% CI -0.33 to 0.52; P = 0.67, I2 = 57%; 4 studies, 255 participants; very low-certainty evidence). Converting the SMD back to the Depression, Anxiety and Stress Scale 21-item self-report questionnaire (DASS-21) showed an estimated effect size which is unlikely to be clinically important. Similarly, there was no substantial difference immediately post-intervention for depression (SMD 0.06, 95% CI -0.19 to 0.31; P = 0.62, I2 = 0%; 4 studies, 250 participants; low-certainty evidence). Converting the SMD back to DASS-21 showed an estimated effect size which is unlikely to be clinically important. No studies reported longer-term assessment of the impact of mindfulness interventions on these outcomes.\nFor the secondary outcomes, the meta-analysis showed a small, substantial difference immediately post-intervention for stress, favouring the mindfulness intervention (SMD -0.36, 95% CI -0.60 to -0.13; P < 0.05, I2 = 33%; 8 studies, 474 participants; low-certainty evidence); however, this difference is unlikely to be clinically important. The meta-analysis found no substantial difference immediately post-intervention for burnout (SMD -0.42, 95% CI -0.84 to 0.00; P = 0.05, I² = 0%; 3 studies, 91 participants; very low-certainty evidence). The meta-analysis found a small, substantial difference immediately post-intervention for academic performance (SMD -0.60, 95% CI -1.05 to -0.14; P < 0.05, I² = 0%; 2 studies, 79 participants; very low-certainty evidence); however, this difference is unlikely to be clinically important. Lastly, there was no substantial difference immediately post-intervention for quality of life (mean difference (MD) 0.02, 95% CI -0.28 to 0.32; 1 study, 167 participants; low-certainty evidence). There were no data available for three pre-specified outcomes of this review: deliberate self-harm, suicidal ideation and suicidal behaviour.\nWe assessed the certainty of evidence to range from low to very low across all outcomes. Across most outcomes, we most frequently judged the risk of bias as having 'some concerns'. There were no studies with a low risk of bias across all domains.\nAuthors' conclusions\nThe effectiveness of mindfulness in our target population remains unconfirmed. There have been relatively few studies of mindfulness interventions for junior doctors and medical students. The available studies are small, and we have some concerns about their risk of bias. Thus, there is not much evidence on which to draw conclusions on effects of mindfulness interventions in this population. There was no evidence to determine the effects of mindfulness in the long term.\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": "Medical students and junior doctors; other medical professionals at different levels of training and expertise; and institutions such as universities and hospitals involved in the education and training of medical students."
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query-laysum | 3332 | [
{
"role": "user",
"content": "Abstract: Background\nSacrococcygeal pilonidal sinus disease is a common debilitating condition that predominantly affects young adults, with a profound impact on their activities of daily living. The condition is treated surgically, and in some cases the wound in the natal cleft is left open to heal by itself. Many dressings and topical agents are available to aid healing of these wounds.\nObjectives\nTo assess the effects of dressings and topical agents for the management of open wounds following surgical treatment for sacrococcygeal pilonidal sinus in any care setting.\nSearch methods\nIn March 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and we scanned reference lists of included studies, 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 included parallel-group randomised controlled trials (RCTs) only. We included studies with participants who had undergone any type of sacrococcygeal pilonidal sinus disease surgery and were left with an open wound.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs comprising 932 participants. Two studies compared topical negative pressure wound therapy (TNPWT) with conventional open wound healing, two studies compared platelet-rich plasma with sterile absorbent gauze, and the other seven studies compared various dressings and topical agents. All studies were at high risk of bias in at least one domain, whilst one study was judged to be at low risk of bias in all but one domain. All studies were conducted in secondary care. Mean participant ages were between 20 and 30 years, and nearly 80% of participants were male. No studies provided data on quality of life, cost-effectiveness, pain at first dressing change or proportion of wounds healed at 6 or 12 months, and very few adverse effects were recorded in any study.\nIt is unclear whether TNPWT reduces time to wound healing compared with conventional open wound healing (comparison 1), as the certainty of evidence is very low. The two studies provided conflicting results, with one study showing benefit (mean difference (MD) −24.01 days, 95% confidence interval (CI) −35.65 to −12.37; 19 participants), whilst the other reported no difference. It is also unclear whether TNPWT has any effect on the proportion of wounds healed by 30 days (risk ratio (RR) 3.60, 95% CI 0.49 to 26.54; 19 participants, 1 study; very low-certainty evidence). Limited data were available for our secondary outcomes time to return to normal daily activities and recurrence rate; we do not know whether TNPWT has any effect on these outcomes.\nLietofix cream may increase the proportion of wounds that heal by 30 days compared with an iodine dressing (comparison 4; RR 8.06, 95% CI 1.05 to 61.68; 205 participants, 1 study; low-certainty evidence). The study did not provide data on time to wound healing.\nWe do not know whether hydrogel dressings reduce time to wound healing compared with wound cleaning with 10% povidone iodine (comparison 5; MD −24.54 days, 95% CI −47.72 to −1.36; 31 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed. It is unclear whether hydrogel dressings have any effect on adverse effects as the certainty of the evidence is very low.\nPlatelet-rich plasma may reduce time to wound healing compared with sterile absorbent gauze (comparison 6; MD −19.63 days, 95% CI −34.69 to −4.57; 210 participants, 2 studies; low-certainty evidence). No studies provided data on the proportion of wounds healed. Platelet-rich plasma may reduce time to return to normal daily activities (MD −15.49, 95% CI −28.95 to −2.02; 210 participants, 2 studies; low-certainty evidence).\nZinc oxide mesh may make little or no difference to time to wound healing compared with placebo (comparison 2; median 54 days in the zinc oxide mesh group versus 62 days in the placebo mesh group; low-certainty evidence). We do not know whether zinc oxide mesh has an effect on the proportion of wounds healed by 30 days as the certainty of the evidence is very low (RR 2.35, 95% CI 0.49 to 11.23).\nIt is unclear whether gentamicin-impregnated collagen sponge reduces time to wound healing compared with no dressing (comparison 7; MD −1.40 days, 95% CI −5.05 to 2.25; 50 participants, 1 study; very low-certainty evidence). The study did not provide data on the proportion of wounds healed.\nDialkylcarbamoyl chloride (DACC)-coated dressings may make little or no difference to time to wound healing compared with alginate dressings (comparison 8; median 69 (95% CI 62 to 72) days in the DACC group versus 71 (95% CI 69 to 85) days in the alginate group; 1 study, 246 participants; low-certainty evidence).\nOne study compared a polyurethane foam hydrophilic dressing with an alginate dressing (comparison 3) whilst another study compared a hydrocolloid dressing with an iodine dressing (comparison 9). It is unclear whether either intervention has any effect on time to wound healing as the certainty of evidence is very low.\nAuthors' conclusions\nAt present, the evidence that any of the dressings or topical agents contained in this review have a benefit on time to wound healing, the proportion of wounds that heal at a specific time point or on any of the secondary outcomes of our review ranges from low certainty to very low certainty. There is low-certainty evidence on the benefit on wound healing of platelet-rich plasma from two studies and of Lietofix cream and hydrogel dressings from single studies. Further studies are required to investigate these interventions further.\n\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence in this review is up to date to March 2021."
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query-laysum | 3333 | [
{
"role": "user",
"content": "Abstract: Background\nHalitosis or bad breath is a symptom in which a noticeably unpleasant breath odour is present due to an underlying oral or systemic disease. 50% to 60% of the world population has experienced this problem which can lead to social stigma and loss of self-confidence. Multiple interventions have been tried to control halitosis ranging from mouthwashes and toothpastes to lasers. This new Cochrane Review incorporates Cochrane Reviews previously published on tongue scraping and mouthrinses for halitosis.\nObjectives\nThe objectives of this review were to assess the effects of various interventions used to control halitosis due to oral diseases only. We excluded studies including patients with halitosis secondary to systemic disease and halitosis-masking interventions.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 8 April 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 3) in the Cochrane Library (searched 8 April 2019), MEDLINE Ovid (1946 to 8 April 2019), and Embase Ovid (1980 to 8 April 2019). We also searched LILACS BIREME (1982 to 19 April 2019), the National Database of Indian Medical Journals (1985 to 19 April 2019), OpenGrey (1992 to 19 April 2019), and CINAHL EBSCO (1937 to 19 April 2019). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (8 April 2019), the World Health Organization International Clinical Trials Registry Platform (8 April 2019), the ISRCTN Registry (19 April 2019), the Clinical Trials Registry - India (19 April 2019), were searched for ongoing trials. We also searched the cross-references of included studies and systematic reviews published on the topic. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (RCTs) which involved adults over the age of 16, and any intervention for managing halitosis compared to another or placebo, or no intervention. The active interventions or controls were administered over a minimum of one week and with no upper time limit. We excluded quasi-randomised trials, trials comparing the results for less than one week follow-up, and studies including advanced periodontitis.\nData collection and analysis\nTwo pairs of review authors independently selected trials, extracted data, and assessed risk of bias. We estimated mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 44 trials in the review with 1809 participants comparing an intervention with a placebo or a control. The age of participants ranged from 17 to 77 years. Most of the trials reported on short-term follow-up (ranging from one week to four weeks). Only one trial reported long-term follow-up (three months).\nThree studies were at low overall risk of bias, 16 at high overall risk of bias, and the remaining 25 at unclear overall risk of bias.\nWe compared different types of interventions which were categorised as mechanical debridement, chewing gums, systemic deodorising agents, topical agents, toothpastes, mouthrinse/mouthwash, tablets, and combination methods.\nMechanical debridement: for mechanical tongue cleaning versus no tongue cleaning, the evidence was very uncertain for the outcome dentist-reported organoleptic test (OLT) scores (MD -0.20, 95% CI -0.34 to -0.07; 2 trials, 46 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nChewing gums: for 0.6% eucalyptus chewing gum versus placebo chewing gum, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.10, 95% CI -0.31 to 0.11; 1 trial, 65 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nSystemic deodorising agents: for 1000 mg champignon versus placebo, the evidence was very uncertain for the outcome patient-reported visual analogue scale (VAS) scores (MD -1.07, 95% CI -14.51 to 12.37; 1 trial, 40 participants; very low-certainty evidence). No data were reported for dentist-reported OLT score or adverse events.\nTopical agents: for hinokitiol gel versus placebo gel, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.27, 95% CI -1.26 to 0.72; 1 trial, 18 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nToothpastes: for 0.3% triclosan toothpaste versus control toothpaste, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -3.48, 95% CI -3.77 to -3.19; 1 trial, 81 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nMouthrinse/mouthwash: for mouthwash containing chlorhexidine and zinc acetate versus placebo mouthwash, the evidence was very uncertain for the outcome dentist-reported OLT scores (MD -0.20, 95% CI -0.58 to 0.18; 1 trial, 44 participants; very low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nTablets: no data were reported on key outcomes for this comparison.\nCombination methods: for brushing plus cetylpyridium mouthwash versus brushing, the evidence was uncertain for the outcome dentist-reported OLT scores (MD -0.48, 95% CI -0.72 to -0.24; 1 trial, 70 participants; low-certainty evidence). No data were reported for patient-reported OLT score or adverse events.\nAuthors' conclusions\nWe found low- to very low-certainty evidence to support the effectiveness of interventions for managing halitosis compared to placebo or control for the OLT and patient-reported outcomes tested. We were unable to draw any conclusions regarding the superiority of any intervention or concentration. Well-planned RCTs need to be conducted by standardising the interventions and concentrations.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up-to-date as of 8 April 2019. The review includes 44 studies involving 1809 people who were 17 to 77 years old. The review compared an intervention with another intervention, a placebo or a control. It looked at eight different ways to control bad breath: mechanical cleaning (e.g. tongue cleaners and toothbrushes), chewing gums, systemic deodorising agents (e.g. mushroom extract that you eat), topical agents (e.g. gel that you apply), toothpastes, mouthrinse/mouthwash, tablets, and combination of different treatments."
}
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query-laysum | 3334 | [
{
"role": "user",
"content": "Abstract: Background\nBranch retinal vein occlusion (BRVO) is the second most common cause of retinal vascular abnormality after diabetic retinopathy. Persistent macular oedema develops in 60% of eyes with a BRVO. Untreated, only 14% of eyes with chronic macular oedema will have a visual acuity (VA) of 20/40 or better. Macular grid laser photocoagulation is used for chronic non-ischaemic macular oedema following BRVO and has been the mainstay of treatment for over 20 years. New treatments are available and a systematic review is necessary to ensure that the most up-to-date evidence is considered objectively.\nObjectives\nTo examine the effects of macular grid laser photocoagulation in the treatment of macular oedema following BRVO.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, EMBASE, Web of Science Conference Proceedings Citation Index, the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 21 August 2014.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing macular grid laser photocoagulation treatment to another treatment, sham treatment or no treatment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included five studies conducted in Europe and North America. Four separate trials compared grid laser to no treatment, sham treatment, intravitreal bevacizumab and intravitreal triamcinolone. One further trial compared subthreshold to threshold laser. Two of these trials were judged to be at high risk of bias in one or more domains.\nIn one trial of grid laser versus observation, people receiving grid laser were more likely to gain visual acuity (VA) (10 or more ETDRS letters) at 36 months (RR 1.75, 95% confidence interval (CI) 1.08 to 2.84, 78 participants, moderate-quality evidence). The effect of grid laser on loss of VA (10 or more letters) was uncertain as the results were imprecise (RR 0.68, 95% CI 0.23 to 2.04, 78 participants, moderate-quality evidence). On average, people receiving grid laser had better improvement in VA (mean difference (MD) 0.11 logMAR, 95% CI 0.05 to 0.17, high-quality evidence). In a trial of early and delayed grid laser treatment versus sham laser (n = 108, data available for 99 participants), no participant gained or lost VA (15 or more ETDRS letters). At 12 months, there was no evidence for a difference in change in VA (from baseline) between early grid laser and sham laser (MD -0.03 logMAR, 95% confidence interval (CI) -0.07 to 0.01, 68 participants, low-quality evidence) or between delayed grid laser and sham laser (MD 0.00, 95% CI -0.04 to 0.04, 66 participants, low-quality evidence).\nThe relative effects of subthreshold and threshold laser were uncertain. In one trial, the RR for gain of VA (15 or more letters) at 12 months was 1.68 (95% CI 0.57 to 4.95, 36 participants, moderate-quality evidence); the RR for loss of VA (15 or more letters) was 0.56 (95% CI 0.06 to 5.63, moderate-quality evidence); and at 24 months the change in VA from baseline was MD 0.07 (95% CI -0.10 to 0.24, moderate-quality evidence).\nThe relative effects of macular grid laser and intravitreal bevacizumab were uncertain. In one trial, the RR for gain of 15 or more letters at 12 months was 0.67 (95% CI 0.39 to 1.14, 30 participants, low-quality evidence). Loss of 15 or more letters was not reported. Change in VA at 12 months was MD 0.11 logMAR (95% CI -0.36 to 0.14, low-quality evidence).\nThe relative effects of grid laser and 1mg triamcinolone were uncertain at 12 months. RR for gain of VA (15 or more letters) was 1.13 (95% CI 0.75 to 1.71, 1 RCT, 242 participants, moderate-quality evidence); RR for loss of VA (15 or more letters) was 1.20 (95% CI 0.63 to 2.27, moderate-quality evidence); MD for change in VA was -0.03 letters (95% CI -0.12 to 0.06, moderate-quality evidence). Similar results were seen for the comparison with 4mg triamcinolone. Beyond 12 months, the visual outcomes were in favour of grid laser at 24 months and 36 months with people in the macular grid group gaining more VA.\nFour studies reported on adverse effects. Laser photocoagulation appeared to be well tolerated in the studies. One participant (out of 71) suffered a perforation of Bruch's membrane, but this did not affect visual acuity.\nAuthors' conclusions\nModerate-quality evidence from one RCT supports the use of grid laser photocoagulation to treat macular oedema following BRVO. There was insufficient evidence to support the use of early grid laser or subthreshold laser. There was insufficient evidence to show a benefit of intravitreal triamcinolone or anti-vascular endothelial growth factor (VEGF) over macular grid laser photocoagulation in BRVO. With recent interest in the use of intravitreal anti-VEGF or steroid therapy, assessment of treatment efficacy (change in visual acuity and foveal or central macular thickness using optical coherence tomography (OCT)) and the number of treatments needed for maintenance and long-term safety will be important for future studies.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Good-quality evidence was available from one trial to support macular grid laser treatment for macular swelling following a blocked vein. There is insufficient evidence to recommend early grid laser, subthreshold laser, bevacizumab injections or triamcinolone injections over grid laser. Anti-VEGF and steroid treatments are becoming increasingly popular for treating eye conditions. However, more studies are needed to assess the longer-term outcome of these treatments against grid laser treatment in the management of macular oedema after branch retinal vein occlusions."
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query-laysum | 3335 | [
{
"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: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The review authors searched for studies that were published up to August 2020."
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query-laysum | 3336 | [
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"role": "user",
"content": "Abstract: Background\nFebrile neutropenia (FN) and other infectious complications are some of the most serious treatment-related toxicities of chemotherapy for cancer, with a mortality rate of 2% to 21%. The two main types of prophylactic regimens are granulocyte (macrophage) colony-stimulating factors (G(M)-CSF) and antibiotics, frequently quinolones or cotrimoxazole. Current guidelines recommend the use of colony-stimulating factors when the risk of febrile neutropenia is above 20%, but they do not mention the use of antibiotics. However, both regimens have been shown to reduce the incidence of infections. Since no systematic review has compared the two regimens, a systematic review was undertaken.\nObjectives\nTo compare the efficacy and safety of G(M)-CSF compared to antibiotics in cancer patients receiving myelotoxic chemotherapy.\nSearch methods\nWe searched The Cochrane Library, MEDLINE, EMBASE, databases of ongoing trials, and conference proceedings of the American Society of Clinical Oncology and the American Society of Hematology (1980 to December 2015). We planned to include both full-text and abstract publications. Two review authors independently screened search results.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing prophylaxis with G(M)-CSF versus antibiotics for the prevention of infection in cancer patients of all ages receiving chemotherapy. All study arms had to receive identical chemotherapy regimes and other supportive care. We included full-text, abstracts, and unpublished data if sufficient information on study design, participant characteristics, interventions and outcomes was available. We excluded cross-over trials, quasi-randomised trials and post-hoc retrospective trials.\nData collection and analysis\nTwo review authors independently screened the results of the search strategies, extracted data, assessed risk of bias, and analysed data according to standard Cochrane methods. We did final interpretation together with an experienced clinician.\nMain results\nIn this updated review, we included no new randomised controlled trials. We included two trials in the review, one with 40 breast cancer patients receiving high-dose chemotherapy and G-CSF compared to antibiotics, a second one evaluating 155 patients with small-cell lung cancer receiving GM-CSF or antibiotics.\nWe judge the overall risk of bias as high in the G-CSF trial, as neither patients nor physicians were blinded and not all included patients were analysed as randomised (7 out of 40 patients). We considered the overall risk of bias in the GM-CSF to be moderate, because of the risk of performance bias (neither patients nor personnel were blinded), but low risk of selection and attrition bias.\nFor the trial comparing G-CSF to antibiotics, all cause mortality was not reported. There was no evidence of a difference for infection-related mortality, with zero events in each arm. Microbiologically or clinically documented infections, severe infections, quality of life, and adverse events were not reported. There was no evidence of a difference in frequency of febrile neutropenia (risk ratio (RR) 1.22; 95% confidence interval (CI) 0.53 to 2.84). The quality of the evidence for the two reported outcomes, infection-related mortality and frequency of febrile neutropenia, was very low, due to the low number of patients evaluated (high imprecision) and the high risk of bias.\nThere was no evidence of a difference in terms of median survival time in the trial comparing GM-CSF and antibiotics. Two-year survival times were 6% (0 to 12%) in both arms (high imprecision, low quality of evidence). There were four toxic deaths in the GM-CSF arm and three in the antibiotics arm (3.8%), without evidence of a difference (RR 1.32; 95% CI 0.30 to 5.69; P = 0.71; low quality of evidence). There were 28% grade III or IV infections in the GM-CSF arm and 18% in the antibiotics arm, without any evidence of a difference (RR 1.55; 95% CI 0.86 to 2.80; P = 0.15, low quality of evidence). There were 5 episodes out of 360 cycles of grade IV infections in the GM-CSF arm and 3 episodes out of 334 cycles in the cotrimoxazole arm (0.8%), with no evidence of a difference (RR 1.55; 95% CI 0.37 to 6.42; P = 0.55; low quality of evidence). There was no significant difference between the two arms for non-haematological toxicities like diarrhoea, stomatitis, infections, neurologic, respiratory, or cardiac adverse events. Grade III and IV thrombopenia occurred significantly more frequently in the GM-CSF arm (60.8%) compared to the antibiotics arm (28.9%); (RR 2.10; 95% CI 1.41 to 3.12; P = 0.0002; low quality of evidence). Neither infection-related mortality, incidence of febrile neutropenia, nor quality of life were reported in this trial.\nAuthors' conclusions\nAs we only found two small trials with 195 patients altogether, no conclusion for clinical practice is possible. More trials are necessary to assess the benefits and harms of G(M)-CSF compared to antibiotics for infection prevention in cancer patients receiving chemotherapy.\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": "Cancer treatment with chemotherapy (anti-cancer drugs) disrupts the immune system and lowers white blood cell counts. This increases a person's risk of infection. Both G(M)-CSF and antibiotics can reduce the risk of infection associated with cancer treatments. The review compared the efficacy of antibiotics to G(M)-CSFs for the prevention of infection."
}
]
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query-laysum | 3337 | [
{
"role": "user",
"content": "Abstract: Background\nNon-nutritive sucking (NNS) is used during gavage feeding and in the transition from gavage to breast/bottle feeding in preterm infants to improve the development of sucking behavior and the digestion of enteral feedings.\nObjectives\nTo assess the effects of non-nutritive sucking on physiologic stability and nutrition in preterm infants.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1), MEDLINE via PubMed (1966 to 25 February 2016), Embase (1980 to 25 February 2016), and CINAHL (1982 to 25 February 2016). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials.\nSelection criteria\nRandomised controlled trials and quasi-randomised trials that compared non-nutritive sucking versus no provision of non-nutritive sucking in preterm infants. We excluded cross-over trials.\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and undertook data extraction independently. We analysed the treatment effects in the individual trials and reported mean differences (MD) for continuous data, with 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses. We did not perform subgroup analyses because of the small number of studies related to the relevant outcomes. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe identified 12 eligible trials enrolling a total of 746 preterm infants. Meta-analysis, though limited by data quality, demonstrated a significant effect of NNS on transition from gavage to full oral feeding (MD −5.51 days, 95% CI −8.20 to −2.82; N = 87), transition from start of oral feeding to full oral feeding (MD −2.15 days, 95% CI −3.12 to −1.17; N = 100), and the length of hospital stay (MD −4.59 days, 95% CI −8.07 to −1.11; N = 501). Meta-analysis revealed no significant effect of NNS on weight gain. One study found that the NNS group had a significantly shorter intestinal transit time during gavage feeding compared to the control group (MD −10.50 h, 95% CI −13.74 to −7.26; N = 30). Other individual studies demonstrated no clear positive effect of NNS on age of infant at full oral feeds, days from birth to full breastfeeding, rates and proportion of infants fully breastfeeding at discharge, episodes of bradycardia, or episodes of oxygen desaturation. None of the studies reported any negative outcomes. These trials were generally small and contained various methodological weaknesses including lack of blinding of intervention and outcome assessors and variability on outcome measures. The quality of the evidence on outcomes assessed according to GRADE was low to very low.\nAuthors' conclusions\nMeta-analysis demonstrated a significant effect of NNS on the transition from gavage to full oral feeding, transition from start of oral feeding to full oral feeding, and length of hospital stay. None of the trials reported any adverse effects. Well-designed, adequately powered studies using reliable methods of randomisation, concealment of treatment allocation and blinding of the intervention and outcome assessors are needed. In order to facilitate meta-analysis of these data, future research should involve outcome measures consistent with those used in previous studies.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Participants numbers in these studies were small, and we judged the quality of the evidence on outcomes assessed to be low or very low. Large well-designed randomised controlled trials are necessary for further evaluating the effectiveness and safety of non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants."
}
]
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