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query-laysum
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7478
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[
{
"role": "user",
"content": "Abstract: Background\nAlvimopan is used in abdominal surgery to reduce postoperative ileus in patients undergoing small bowel resections with primary anastomosis. The role and efficacy of alvimopan in patients undergoing radical cystectomy with urinary diversion is not well understood.\nObjectives\nTo assess the effects of alvimopan in the context of enhanced recovery pathways compared to enhanced recovery pathways alone for perioperative bowel dysfunction in patients undergoing radical cystectomy.\nSearch methods\nThe terms alvimopan and cystectomy were used to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase. We also reviewed abstracts from the past four years (2013 to 2016) of the American Urologic Association, Society of Urologic Oncology, and American Society of Clinical Oncology Genitourinary Cancers.\nSelection criteria\nWe searched for randomized controlled trials that compared alvimopan to placebo.\nData collection and analysis\nThis study was based on a published protocol. We performed a comprehensive search of multiple databases including CENTRAL in the Cochrane Library, MEDLINE, Embase, LILACS, Web of Science, Scopus and Biosis, which we last updated on 6 February 2017. We also searched abstract proceedings for major relevant meetings (2013 to 2016), databases of the grey literature, trial registries, citations of relevant reviews and contacted clinical experts and the drug manufacturer.\nTwo independent reviewers screened the literature in two stages (title and abstract, full-text) using Covidence software. Two independent reviewers assessed the risk of bias on a 'per outcome' basis using the Cochrane 'Risk of bias; tool and rated the quality of evidence according to GRADE. Results of the single eligible trial were reported in a 'Summary of findings' table based on an intention-to-treat analysis.\nMain results\nBased on a single trial and moderate-quality evidence, alvimopan reduced the time to reach a composite endpoint of tolerance of solid food and documented bowel movements (hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.41 to 2.23). This represents 165 more patients (109 more to 207 more) per 1000 meeting this endpoint within 10 days of surgery. Based on moderate-quality evidence, alvimopan reduced the time to hospital discharge (HR 1.67, 95% CI 1.38 to 2.01). This represents 138 more patients (82 more to 198 more) per 1000 being discharged within 10 days of surgery. Also based on moderate-quality evidence, alvimopan was associated with a reduced risk of major adverse events (risk ratio (RR) 0.28, 95% CI 0.18 to 0.44) representing 355 fewer patients (404 fewer to 276 fewer) with major adverse events per 1000. We downgraded this outcome for indirectness as it included adverse events that we did not consider major.\nIn terms of secondary outcomes, alvimopan did not appear to alter the rate of readmission (RR 0.89, 95% CI 0.59 to 1.33), change the rate of any cardiovascular event (RR 0.54, 95% CI 0.27 to 1.05) or alter the mean narcotic pain medication use (mean difference 0, 95% CI 14.08 fewer to 14.08 more morphine equivalents). The quality of evidence was moderate for all three outcomes. Based on high-quality evidence, alvimopan reduced the rate of nasogastric tube replacement (RR 0.31, 95% CI 0.16 to 0.59). We did not find evidence for the drug's impact on rates of parenteral nutrition. All outcomes were short term and limited to a 30-day time horizon.\nBased on the existence of only one trial, we were unable to perform any subgroup or sensitivity analyses.\nAuthors' conclusions\nIn patients undergoing radical cystectomy and urinary diversion, the use of alvimopan administered as part of an enhanced recovery pathway for a limited duration (up to 15 doses for up to seven days) probably reduces the time to tolerance of solid food, time to hospital discharge and rates of major adverse events. Readmission rates, rates of cardiovascular events and narcotic pain requirements are probably similar. The need for reinsertion of nasogastric tubes is reduced. We found no evidence for the impact on rates of parenteral nutrition within 30 postoperative days.\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 patients who receive alvimopan short-term probably tolerate solid food faster, are discharged from the hospital more quickly and have fewer major adverse events. We did not find any differences with regards to these patients' need to be readmitted to hospital, their risk of heart problems or their need for narcotic pain medications. Patients taking alvimopan were less likely to have a tube placed back into their stomach."
}
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query-laysum
|
7479
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[
{
"role": "user",
"content": "Abstract: Background\nXpert MTB/RIF and Xpert MTB/RIF Ultra (Xpert Ultra) are World Health Organization (WHO)-recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. This review builds on our recent extensive Cochrane Review of Xpert MTB/RIF accuracy.\nObjectives\nTo compare the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for the detection of pulmonary tuberculosis and detection of rifampicin resistance in adults with presumptive pulmonary tuberculosis. For pulmonary tuberculosis and rifampicin resistance, we also investigated potential sources of heterogeneity.\nWe also summarized the frequency of Xpert Ultra trace-positive results, and estimated the accuracy of Xpert Ultra after repeat testing in those with trace-positive results.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, LILACS, Scopus, the WHO ICTRP, the ISRCTN registry, and ProQuest to 28 January 2020 with no language restriction.\nSelection criteria\nWe included diagnostic accuracy studies using respiratory specimens in adults with presumptive pulmonary tuberculosis that directly compared the index tests. For pulmonary tuberculosis detection, the reference standards were culture and a composite reference standard. For rifampicin resistance, the reference standards were culture-based drug susceptibility testing and line probe assays.\nData collection and analysis\nTwo review authors independently extracted data using a standardized form, including data by smear and HIV status. We assessed risk of bias using QUADAS-2 and QUADAS-C. We performed meta-analyses comparing pooled sensitivities and specificities, separately for pulmonary tuberculosis detection and rifampicin resistance detection, and separately by reference standard. Most analyses used a bivariate random-effects model. For tuberculosis detection, we estimated accuracy in studies in participants who were not selected based on prior microscopy testing or history of tuberculosis. We performed subgroup analyses by smear status, HIV status, and history of tuberculosis. We summarized Xpert Ultra trace results.\nMain results\nWe identified nine studies (3500 participants): seven had unselected participants (2834 participants). All compared Xpert Ultra and Xpert MTB/RIF for pulmonary tuberculosis detection; seven studies used a paired comparative accuracy design, and two studies used a randomized design. Five studies compared Xpert Ultra and Xpert MTB/RIF for rifampicin resistance detection; four studies used a paired design, and one study used a randomized design. Of the nine included studies, seven (78%) were mainly or exclusively in high tuberculosis burden countries. For pulmonary tuberculosis detection, most studies had low risk of bias in all domains.\nPulmonary tuberculosis detection\nXpert Ultra pooled sensitivity and specificity (95% credible interval) against culture were 90.9% (86.2 to 94.7) and 95.6% (93.0 to 97.4) (7 studies, 2834 participants; high-certainty evidence) versus Xpert MTB/RIF pooled sensitivity and specificity of 84.7% (78.6 to 89.9) and 98.4% (97.0 to 99.3) (7 studies, 2835 participants; high-certainty evidence). The difference in the accuracy of Xpert Ultra minus Xpert MTB/RIF was estimated at 6.3% (0.1 to 12.8) for sensitivity and −2.7% (−5.7 to −0.5) for specificity. If the point estimates for Xpert Ultra and Xpert MTB/RIF are applied to a hypothetical cohort of 1000 patients, where 10% of those presenting with symptoms have pulmonary tuberculosis, Xpert Ultra will miss 9 cases, and Xpert MTB/RIF will miss 15 cases. The number of people wrongly diagnosed with pulmonary tuberculosis would be 40 with Xpert Ultra and 14 with Xpert MTB/RIF.\nIn smear-negative, culture-positive participants, pooled sensitivity was 77.5% (67.6 to 85.6) for Xpert Ultra versus 60.6% (48.4 to 71.7) for Xpert MTB/RIF; pooled specificity was 95.8% (92.9 to 97.7) for Xpert Ultra versus 98.8% (97.7 to 99.5) for Xpert MTB/RIF (6 studies).\nIn people living with HIV, pooled sensitivity was 87.6% (75.4 to 94.1) for Xpert Ultra versus 74.9% (58.7 to 86.2) for Xpert MTB/RIF; pooled specificity was 92.8% (82.3 to 97.0) for Xpert Ultra versus 99.7% (98.6 to 100.0) for Xpert MTB/RIF (3 studies).\nIn participants with a history of tuberculosis, pooled sensitivity was 84.2% (72.5 to 91.7) for Xpert Ultra versus 81.8% (68.7 to 90.0) for Xpert MTB/RIF; pooled specificity was 88.2% (70.5 to 96.6) for Xpert Ultra versus 97.4% (91.7 to 99.5) for Xpert MTB/RIF (4 studies).\nThe proportion of Ultra trace-positive results ranged from 3.0% to 30.4%. Data were insufficient to estimate the accuracy of Xpert Ultra repeat testing in individuals with initial trace-positive results.\nRifampicin resistance detection\nPooled sensitivity and specificity were 94.9% (88.9 to 97.9) and 99.1% (97.7 to 99.8) (5 studies, 921 participants; high-certainty evidence) for Xpert Ultra versus 95.3% (90.0 to 98.1) and 98.8% (97.2 to 99.6) (5 studies, 930 participants; high-certainty evidence) for Xpert MTB/RIF. The difference in the accuracy of Xpert Ultra minus Xpert MTB/RIF was estimated at −0.3% (−6.9 to 5.7) for sensitivity and 0.3% (−1.2 to 2.0) for specificity. If the point estimates for Xpert Ultra and Xpert MTB/RIF are applied to a hypothetical cohort of 1000 patients, where 10% of those presenting with symptoms have rifampicin resistance, Xpert Ultra will miss 5 cases, and Xpert MTB/RIF will miss 5 cases. The number of people wrongly diagnosed with rifampicin resistance would be 8 with Xpert Ultra and 11 with Xpert MTB/RIF.\nWe identified a higher number of rifampicin resistance indeterminate results with Xpert Ultra, pooled proportion 7.6% (2.4 to 21.0) compared to Xpert MTB/RIF pooled proportion 0.8% (0.2 to 2.4). The estimated difference in the pooled proportion of indeterminate rifampicin resistance results for Xpert Ultra versus Xpert MTB/RIF was 6.7% (1.4 to 20.1).\nAuthors' conclusions\nXpert Ultra has higher sensitivity and lower specificity than Xpert MTB/RIF for pulmonary tuberculosis, especially in smear-negative participants and people living with HIV. Xpert Ultra specificity was lower than that of Xpert MTB/RIF in participants with a history of tuberculosis. The sensitivity and specificity trade-off would be expected to vary by setting. For detection of rifampicin resistance, Xpert Ultra and Xpert MTB/RIF had similar sensitivity and specificity. Ultra trace-positive results were common.\nXpert Ultra and Xpert MTB/RIF provide accurate results and can allow rapid initiation of treatment for rifampicin-resistant and multidrug-resistant tuberculosis.\n\nGiven the provided abstract, please respond to the following query: \"What are the implications of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of these studies indicate that, in theory, for a population of 1000 people where 100 of those presenting with symptoms have pulmonary tuberculosis, Xpert Ultra will miss 9 cases, and Xpert MTB/RIF will miss 15 cases. The number of people wrongly diagnosed with pulmonary tuberculosis would be 40 with Xpert Ultra, and 14 with Xpert MTB/RIF.\nThe results of these studies indicate that, in theory, for a population of 1000 people where 100 of those have rifampicin resistance, Xpert Ultra will miss 5 cases, and Xpert MTB/RIF will miss 5 cases. The number of people wrongly diagnosed with rifampicin resistance would be 8 with Xpert Ultra, and 11 with Xpert MTB/RIF."
}
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query-laysum
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7480
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[
{
"role": "user",
"content": "Abstract: Background\nSevere acute pancreatitis is associated with high rates of mortality and life-threatening complications. Continuous veno-venous hemofiltration (CVVH) has been used in some centers to reduce mortality and avoid local or systemic complications; however, its efficacy and safety are uncertain.\nObjectives\nTo assess the benefits and harms of CVVH in patients suffering from severe acute pancreatitis; to compare the effects of different CVVH techniques; and to evaluate the optimal time for delivery of CVVH.\nSearch methods\nWe searched the Cochrane Library (2019, Issue 8), MEDLINE (1946 to 13 September 2019), Embase (1974 to 13 September 2019), and Science Citation Index Expanded (1982 to 13 September 2019).\nSelection criteria\nWe included all randomized controlled trials (RCTs) that compared CVVH versus no CVVH in participants with severe acute pancreatitis. We also included RCTs that compared different types of CVVH and different schedules for CVVH in participants with severe acute pancreatitis.\nData collection and analysis\nTwo review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed the meta-analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes, and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). We used GRADE to assess the certainty of the evidence for all outcomes.\nMain results\nWe included three RCTs, involving a total of 219 adults with severe acute pancreatitis with various etiologies, including alcoholic abuse, biliary disease, high-fat diet, hyperlipidemia, etc. All of the participants had single or multiple organ failure. All of the RCTs were single-center studies conducted in China. The mean age of participants was 47.4 years. The mean proportion of females was 42.0%. All RCTs were at high risk of bias.\nCVVH versus no CVVH\nWe included two RCTs in which 189 participants with severe acute pancreatitis were randomized to undergo CVVH (97 participants) or no CVVH (92 participants). The evidence is very uncertain about the effect of CVVH on in-hospital mortality (RR 0.62, 95% CI 0.27 to 1.40; 2 studies, 189 participants; very low-certainty evidence) compared with no CVVH. The evidence suggests that CVVH may reduce length of stay in the intensive care unit (ICU) (MD -8.80 days, 95% CI -10.24 to -7.36 days; 1 study, 125 participants; very low-certainty evidence), length of hospital stay (MD -26.40 days, 95% CI -30.17 to -22.63 days; 1 study, 125 participants; very low-certainty evidence), and total hospital cost (MD -2800.00 dollars, 95% CI -3881.74 to -1718.26 dollars; 1 study, 125 participants; very low-certainty evidence) compared with no CVVH but the evidence is very uncertain. Adverse events and quality of life were not reported in the studies.\nOne type ofCVVH versus a different type of CVVH\nWe included one RCT in which 30 participants with severe acute pancreatitis were randomized to undergo high-volume CVVH (15 participants) or standard CVVH (15 participants). High-volume CVVH may result in little to no difference in in-hospital mortality compared with standard CVVH (RR 0.60, 95% CI 0.17 to 2.07; 1 study, 30 participants; low-certainty evidence). The evidence is very uncertain about the effect of high-volume CVVH on adverse events compared with standard CVVH (RR 1.00, 95% CI 0.16 to 6.20; 1 study, 30 participants; very low-certainty evidence). Length of ICU stay, length of hospital stay, total hospital cost, and quality of life were not reported in the study.\nAuthors' conclusions\nThe certainty of the current evidence is very low or low. For both comparisons addressed in this review, data are sparse. The evidence is very uncertain about the effect of CVVH on mortality in patients with severe acute pancreatitis. Very low-certainty evidence suggests CVVH may reduce length of ICU stay, length of hospital stay, and total hospital cost but the evidence is very uncertain. The evidence is also very uncertain whether high-volume CVVH is superior, equivalent or inferior to standard CVVH in patients with severe acute pancreatitis.\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 all relevant, well-conducted studies conducted up to September 2019. We included three randomized controlled trials (experiments in which participants are randomly allocated to two or more interventions, possibly including a control intervention or no intervention, and the results are compared). We included three studies, involving a total of 219 adults with severe acute pancreatitis due to various reasons, including alcoholic abuse, biliary disease, high-fat diet, excess lipids in the blood, etc. All people had single or multiple organ failure. All of the studies were single-center studies conducted in China. The mean age of participants was 47.4 years. The mean proportion of females was 42.0%. Two studies randomized 189 people with severe acute pancreatitis to receive either CVVH (97 people) or no CVVH (92 people). One study randomized 30 people with severe acute pancreatitis to receive either high-volume (high-speed) CVVH (15 people) or standard CVVH (15 people)."
}
] |
query-laysum
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7481
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[
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for individuals with fibromyalgia. This review is one of a series of reviews about exercise training for people with fibromyalgia that will replace the \"Exercise for treating fibromyalgia syndrome\" review first published in 2002.\nObjectives\n• To evaluate the benefits and harms of aerobic exercise training for adults with fibromyalgia\n• To assess the following specific comparisons\n० Aerobic versus control conditions (eg, treatment as usual, wait list control, physical activity as usual)\n० Aerobic versus aerobic interventions (eg, running vs brisk walking)\n० Aerobic versus non-exercise interventions (eg, medications, education)\n\nWe did not assess specific comparisons involving aerobic exercise versus other exercise interventions (eg, resistance exercise, aquatic exercise, flexibility exercise, mixed exercise). Other systematic reviews have examined or will examine these comparisons (Bidonde 2014; Busch 2013).\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Physiotherapy Evidence Database (PEDro), Thesis and Dissertation Abstracts, the Allied and Complementary Medicine Database (AMED), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and the ClinicalTrials.gov registry up to June 2016, unrestricted by language, and we reviewed the reference lists of retrieved trials to identify potentially relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with a diagnosis of fibromyalgia that compared aerobic training interventions (dynamic physical activity that increases breathing and heart rate to submaximal levels for a prolonged period) versus no exercise 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 a risk of bias assessment, and assessed the quality of the body of evidence for major outcomes using the GRADE approach. We used a 15% threshold for calculation of clinically relevant differences between groups.\nMain results\nWe included 13 RCTs (839 people). Studies were at risk of selection, performance, and detection bias (owing to lack of blinding for self-reported outcomes) and had low risk of attrition and reporting bias. We prioritized the findings when aerobic exercise was compared with no exercise control and present them fully here.\nEight trials (with 456 participants) provided low-quality evidence for pain intensity, fatigue, stiffness, and physical function; and moderate-quality evidence for withdrawals and HRQL at completion of the intervention (6 to 24 weeks). With the exception of withdrawals and adverse events, major outcome measures were self-reported and were expressed on a 0 to 100 scale (lower values are best, negative mean differences (MDs)/standardized mean differences (SMDs) indicate improvement). Effects for aerobic exercise versus control were as follows: HRQL: mean 56.08; five studies; N = 372; MD -7.89, 95% CI -13.23 to -2.55; absolute improvement of 8% (3% to 13%) and relative improvement of 15% (5% to 24%); pain intensity: mean 65.31; six studies; N = 351; MD -11.06, 95% CI -18.34 to -3.77; absolute improvement of 11% (95% CI 4% to 18%) and relative improvement of 18% (7% to 30%); stiffness: mean 69; one study; N = 143; MD -7.96, 95% CI -14.95 to -0.97; absolute difference in improvement of 8% (1% to 15%) and relative change in improvement of 11.4% (21.4% to 1.4%); physical function: mean 38.32; three studies; N = 246; MD -10.16, 95% CI -15.39 to -4.94; absolute change in improvement of 10% (15% to 5%) and relative change in improvement of 21.9% (33% to 11%); and fatigue: mean 68; three studies; N = 286; MD -6.48, 95% CI -14.33 to 1.38; absolute change in improvement of 6% (12% improvement to 0.3% worse) and relative change in improvement of 8% (16% improvement to 0.4% worse). Pooled analysis resulted in a risk ratio (RR) of moderate quality for withdrawals (17 per 100 and 20 per 100 in control and intervention groups, respectively; eight studies; N = 456; RR 1.25, 95%CI 0.89 to 1.77; absolute change of 5% more withdrawals with exercise (3% fewer to 12% more).\nThree trials provided low-quality evidence on long-term effects (24 to 208 weeks post intervention) and reported that benefits for pain and function persisted but did not for HRQL or fatigue. Withdrawals were similar, and investigators did not assess stiffness and adverse events.\nWe are uncertain about the effects of one aerobic intervention versus another, as the evidence was of low to very low quality and was derived from single trials only, precluding meta-analyses. Similarly, we are uncertain of the effects of aerobic exercise over active controls (ie, education, three studies; stress management training, one study; medication, one study) owing to evidence of low to very low quality provided by single trials. Most studies did not measure adverse events; thus we are uncertain about the risk of adverse events associated with aerobic exercise.\nAuthors' conclusions\nWhen compared with control, moderate-quality evidence indicates that aerobic exercise probably improves HRQL and all-cause withdrawal, and low-quality evidence suggests that aerobic exercise may slightly decrease pain intensity, may slightly improve physical function, and may lead to little difference in fatigue and stiffness. Three of the reported outcomes reached clinical significance (HRQL, physical function, and pain). Long-term effects of aerobic exercise may include little or no difference in pain, physical function, and all-cause withdrawal, and we are uncertain about long-term effects on remaining outcomes. We downgraded the evidence owing to the small number of included trials and participants across trials, and because of issues related to unclear and high risks of bias (performance, selection, and detection biases). Aerobic exercise appears to be well tolerated (similar withdrawal rates across groups), although evidence on adverse events is scarce, so we are uncertain about its safety.\n\nGiven the provided abstract, please respond to the following query: \"Physical function after 8 to 24 weeks\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aerobic exercise group was 10% better (or 10 points, ranging from 15 to 5) and participants rated their physical function as 37 points versus 46 points in the control group."
}
] |
query-laysum
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7482
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[
{
"role": "user",
"content": "Abstract: Background\nPerineal trauma, due to spontaneous tears, surgical incision (episiotomy), or in association with operative vaginal birth, is common after vaginal birth, and is often associated with postpartum perineal pain. Birth over an intact perineum may also lead to perineal pain. There are adverse health consequences associated with perineal pain for the women and their babies in the short- and long-term, and the pain may interfere with newborn care and the establishment of breastfeeding. Aspirin has been used in the management of postpartum perineal pain, and its effectiveness and safety should be assessed. This is an update of the review, last published in 2017.\nObjectives\nTo determine the effects of a single dose of aspirin (acetylsalicylic acid), including at different doses, in the relief of acute postpartum perineal pain.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register (4 October 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (4 October 2019) and screened reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (RCTs), assessing single dose aspirin compared with placebo, no treatment, a different dose of aspirin, or single dose paracetamol or acetaminophen, for women with perineal pain in the early postpartum period. We planned to include cluster-RCTs, but none were identified. We excluded quasi-RCTs and cross-over studies.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included RCTs. Data were checked for accuracy. The certainty of the evidence for the main comparison (aspirin versus placebo) was assessed using the GRADE approach.\nMain results\nWe included 17 RCTs, 16 of which randomised 1132 women to aspirin or placebo; one RCT did not report numbers of women. Two RCTs (of 16) did not contribute data to meta-analyses. All women had perineal pain post-episiotomy, and were not breastfeeding. Studies were published between 1967 and 1997, and the risk of bias was often unclear, due to poor reporting.\nWe included four comparisons: aspirin versus placebo (15 RCTs); 300 mg versus 600 mg aspirin (1 RCT); 600 mg versus 1200 mg aspirin (2 RCTs); and 300 mg versus 1200 mg aspirin (1 RCT).\nAspirin versus placebo\nAspirin may result in more women reporting adequate pain relief four to eight hours after administration compared with placebo (risk ratio (RR) 2.03, 95% confidence interval (CI) 1.69 to 2.42; 13 RCTs, 1001 women; low-certainty evidence). It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration. Analyses based on dose did not reveal any clear subgroup differences.\n300 mg versus 600 mg aspirin\nIt is uncertain whether over four hours after administration, 300 mg compared with 600 mg aspirin has an effect on adequate pain relief (RR 0.82, 95% CI 0.36 to 1.86; 1 RCT, 81 women) or the need for additional pain relief (RR 0.68, 95% CI 0.12 to 3.88; 1 RCT, 81 women). There were no maternal adverse effects in either aspirin group.\n600 mg versus 1200 mg aspirin\nIt is uncertain whether over four to eight hours after administration, 600 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.85, 95% CI 0.52 to 1.39; 2 RCTs, 121 women), the need for additional pain relief (RR 1.32, 95% CI 0.30 to 5.68; 2 RCTs, 121 women), or maternal adverse effects (RR 3.00, 95% CI 0.13 to 69.52; 2 RCTs, 121 women).\n300 mg versus 1200 mg aspirin\nIt is uncertain whether over four hours after administration, 300 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.62, 95% CI 0.29 to 1.32; 1 RCT, 80 women) or need for additional pain relief (RR 2.00, 95% CI 0.19 to 21.18; 1 RCT, 80 women). There were no maternal adverse effects in either aspirin group.\nNone of the included RCTs reported on neonatal adverse effects.\nNo RCTs reported on secondary review outcomes of: prolonged hospitalisation due to perineal pain; re-hospitalisation due to perineal pain; fully breastfeeding at discharge; mixed feeding at discharge; fully breastfeeding at six weeks; mixed feeding at six weeks; perineal pain at six weeks; maternal views; or maternal postpartum depression.\nAuthors' conclusions\nSingle dose aspirin may increase adequate pain relief in women with perineal pain post-episiotomy compared with placebo. It is uncertain whether aspirin has an effect on the need for additional analgesia, or on maternal adverse effects, compared with placebo. We downgraded the certainty of the evidence because of study limitations (risk of bias), imprecision, and publication bias.\nAspirin may be considered for use in non-breastfeeding women with post-episiotomy perineal pain. Included RCTs excluded breastfeeding women, so there was no evidence to assess the effects of aspirin on neonatal adverse effects or breastfeeding.\nFuture RCTs should be designed to ensure low risk of bias, and address gaps in the evidence, such as the secondary outcomes established for this review. Current research has focused on women with post-episiotomy pain; future RCTs could be extended to include women with perineal pain associated with spontaneous tears or operative birth.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A single dose of aspirin may help with perineal pain following episiotomy for women who are not breastfeeding, when measured four to eight hours after administration.\nWe found no information to assess the effects of aspirin for women who are breastfeeding."
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query-laysum
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7483
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[
{
"role": "user",
"content": "Abstract: Background\nAlthough delirium is typically an acute reversible cognitive impairment, its presence is associated with devastating impact on both short-term and long-term outcomes for critically ill patients. Advances in our understanding of the negative impact of delirium on patient outcomes have prompted trials evaluating multiple pharmacological interventions. However, considerable uncertainty surrounds the relative benefits and safety of available pharmacological interventions for this population.\nObjectives\nPrimary objective\n1. To assess the effects of pharmacological interventions for treatment of delirium on duration of delirium in critically ill adults with confirmed or documented high risk of delirium\nSecondary objectives\nTo assess the following:\n1. effects of pharmacological interventions on delirium-free and coma-free days; days with coma; delirium relapse; duration of mechanical ventilation; intensive care unit (ICU) and hospital length of stay; mortality; and long-term outcomes (e.g. cognitive; discharge disposition; health-related quality of life); and\n2. the safety of such treatments for critically ill adult patients.\nSearch methods\nWe searched the following databases from their inception date to 21 March 2019: Ovid MEDLINE®, Ovid MEDLINE® In-Process & Other Non-Indexed Citations, Embase Classic+Embase, and PsycINFO using the Ovid platform. We also searched the Cochrane Library on Wiley, the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/PROSPERO/), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science. We performed a grey literature search of relevant databases and websites using the resources listed in Grey Matters developed by the Canadian Agency for Drugs and Technologies in Health (CADTH). We also searched trial registries and abstracts from annual scientific critical care and delirium society meetings.\nSelection criteria\nWe sought randomized controlled trials (RCTs), including quasi-RCTs, of any pharmacological (drug) for treatment of delirium in critically ill adults. The drug intervention was to be compared to another active drug treatment, placebo, or a non-pharmacological intervention (e.g. mobilization). We did not apply any restrictions in terms of drug class, dose, route of administration, or duration of delirium or drug exposure. We defined critically ill patients as those treated in an ICU of any specialty (e.g. burn, cardiac, medical, surgical, trauma) or high-dependency unit.\nData collection and analysis\nTwo review authors independently identified studies from the search results; four review authors (in pairs) performed data extraction and assessed risk of bias independently. We performed data synthesis through pairwise meta-analysis and network meta-analysis (NMA). Our hypothetical network structure was designed to be analysed at the drug class level and illustrated a network diagram of 'nodes' (i.e. drug classes) and 'edges' (i.e. comparisons between different drug classes from existing trials), thus describing a treatment network of all possible comparisons between drug classes. We assessed the quality of the body of evidence according to GRADE, as very low, low, moderate, or high.\nMain results\nWe screened 7674 citations, from which 14 trials with 1844 participants met our inclusion criteria. Ten RCTs were placebo-controlled, and four reported comparisons of different drugs. Drugs examined in these trials were the following: antipsychotics (n = 10), alpha2 agonists (n = 3; all dexmedetomidine), statins (n = 2), opioids (n = 1; morphine), serotonin antagonists (n = 1; ondansetron), and cholinesterase (CHE) inhibitors (n = 1; rivastigmine). Only one of these trials consistently used non-pharmacological interventions that are known to improve patient outcomes in both intervention and control groups.\nEleven studies (n = 1153 participants) contributed to analysis of the primary outcome. Results of the NMA showed that the intervention with the smallest ratio of means (RoM) (i.e. most preferred) compared with placebo was the alpha2 agonist dexmedetomidine (0.58; 95% credible interval (CrI) 0.26 to 1.27; surface under the cumulative ranking curve (SUCRA) 0.895; moderate-quality evidence). In order of descending SUCRA values (best to worst), the next best interventions were atypical antipsychotics (RoM 0.80, 95% CrI 0.50 to 1.11; SUCRA 0.738; moderate-quality evidence), opioids (RoM 0.88, 95% CrI 0.37 to 2.01; SUCRA 0.578; very-low quality evidence), and typical antipsychotics (RoM 0.96, 95% CrI 0.64 to1.36; SUCRA 0.468; high-quality evidence).\nThe NMAs of multiple secondary outcomes revealed that only the alpha2 agonist dexmedetomidine was associated with a shorter duration of mechanical ventilation (RoM 0.55, 95% CrI 0.34 to 0.89; moderate-quality evidence), and the CHE inhibitor rivastigmine was associated with a longer ICU stay (RoM 2.19, 95% CrI 1.47 to 3.27; moderate-quality evidence). Adverse events often were not reported in these trials or, when reported, were rare; pair-wise analysis of QTc prolongation in seven studies did not show significant differences between antipsychotics, ondansetron, dexmedetomidine, and placebo.\nAuthors' conclusions\nWe identified trials of varying quality that examined six different drug classes for treatment of delirium in critically ill adults. We found evidence that the alpha2 agonist dexmedetomidine may shorten delirium duration, although this small effect (compared with placebo) was seen in pairwise analyses based on a single study and was not seen in the NMA results. Alpha2 agonists also ranked best for duration of mechanical ventilation and length of ICU stay, whereas the CHE inhibitor rivastigmine was associated with longer ICU stay. We found no evidence of a difference between placebo and any drug in terms of delirium-free and coma-free days, days with coma, physical restraint use, length of stay, long-term cognitive outcomes, or mortality. No studies reported delirium relapse, resolution of symptoms, or quality of life. The ten ongoing studies and the six studies awaiting classification that we identified, once published and assessed, may alter the conclusions of the review.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Delirium is commonly associated with surgery, infection, or critical illness. It is experienced as new-onset, generally short-term inability to think clearly. Patients with delirium shift between periods of clear thinking and periods of agitation and/or great sleepiness and confusion. Lack of sleep, pain, a noisy environment, physical restraint, and the use of sedatives and strong analgesics are some of the contributing factors. Delirium affects both immediate and longer-term health outcomes of critically ill patients as it can increase the length of time a breathing machine is required, time spent in the ICU and in hospital, and the chance of functional weakening and death. The odds of a poor outcome with delirium are increased with frail patients and those of advanced age and already present cognitive difficulties. Frequently, delirious ICU patients are given medicines to help treat symptoms such as agitation."
}
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query-laysum
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7484
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[
{
"role": "user",
"content": "Abstract: Background\nSubarachnoid haemorrhage has an incidence of up to nine per 100,000 person-years. It carries a mortality of 30% to 45% and leaves 20% dependent in activities of daily living. The major causes of death or disability after the haemorrhage are delayed cerebral ischaemia and rebleeding. Interventions aimed at lowering blood pressure may reduce the risk of rebleeding, while the induction of hypertension may reduce the risk of delayed cerebral ischaemia. Despite the fact that medical alteration of blood pressure has been clinical practice for more than three decades, no previous systematic reviews have assessed the beneficial and harmful effects of altering blood pressure (induced hypertension or lowered blood pressure) in people with acute subarachnoid haemorrhage.\nObjectives\nTo assess the beneficial and harmful effects of altering arterial blood pressure (induced hypertension or lowered blood pressure) in people with acute subarachnoid haemorrhage.\nSearch methods\nWe searched the following from inception to 8 September 2020 (Chinese databases to 27 January 2019): Cochrane Stroke Group Trials register; CENTRAL; MEDLINE; Embase; five other databases, and five trial registries. We screened reference lists of review articles and relevant randomised clinical trials.\nSelection criteria\nRandomised clinical trials assessing the effects of inducing hypertension or lowering blood pressure in people with acute subarachnoid haemorrhage. We included trials irrespective of publication type, status, date, and language.\nData collection and analysis\nTwo review authors independently extracted data. We assessed the risk of bias of all included trials to control for the risk of systematic errors. We performed trial sequential analysis to control for the risks of random errors. We also applied GRADE. Our primary outcomes were death from all causes and death or dependency. Our secondary outcomes were serious adverse events, quality of life, rebleeding, delayed cerebral ischaemia, and hydrocephalus. We assessed all outcomes closest to three months' follow-up (primary point of interest) and maximum follow-up.\nMain results\nWe included three trials: two trials randomising 61 participants to induced hypertension versus no intervention, and one trial randomising 224 participants to lowered blood pressure versus placebo. All trials were at high risk of bias. The certainty of the evidence was very low for all outcomes.\nInduced hypertension versus control\nTwo trials randomised participants to induced hypertension versus no intervention. Meta-analysis showed no evidence of a difference between induced hypertension versus no intervention on death from all causes (risk ratio (RR) 1.60, 95% confidence interval (CI) 0.57 to 4.42; P = 0.38; I2 = 0%; 2 trials, 61 participants; very low-certainty evidence). Trial sequential analyses showed that we had insufficient information to confirm or reject our predefined relative risk reduction of 20% or more.\nMeta-analysis showed no evidence of a difference between induced hypertension versus no intervention on death or dependency (RR 1.29, 95% CI 0.78 to 2.13; P = 0.33; I2 = 0%; 2 trials, 61 participants; very low-certainty evidence). Trial sequential analyses showed that we had insufficient information to confirm or reject our predefined relative risk reduction of 20% or more.\nMeta-analysis showed no evidence of a difference between induced hypertension and control on serious adverse events (RR 2.24, 95% CI 1.01 to 4.99; P = 0.05; I2 = 0%; 2 trials, 61 participants; very low-certainty evidence). Trial sequential analysis showed that we had insufficient information to confirm or reject our predefined relative risk reduction of 20% or more.\nOne trial (41 participants) reported quality of life using the Stroke Specific Quality of Life Scale. The induced hypertension group had a median of 47 points (interquartile range 35 to 55) and the no-intervention group had a median of 49 points (interquartile range 35 to 55). The certainty of evidence was very low.\nOne trial (41 participants) reported rebleeding. Fisher's exact test (P = 1.0) showed no evidence of a difference between induced hypertension and no intervention on rebleeding. The certainty of evidence was very low. Trial sequential analysis showed that we had insufficient information to confirm or reject our predefined relative risk reduction of 20% or more.\nOne trial (20 participants) reported delayed cerebral ischaemia. Fisher's exact test (P = 1.0) showed no evidence of a difference between induced hypertension and no intervention on delayed cerebral ischaemia. The certainty of the evidence was very low. Trial sequential analysis showed that we had insufficient information to confirm or reject our predefined relative risk reduction of 20% or more.\nNone of the trials randomising participants to induced hypertension versus no intervention reported on hydrocephalus. No subgroup analyses could be conducted for trials randomising participants to induced hypertension versus no intervention.\nLowered blood pressure versus control\nOne trial randomised 224 participants to lowered blood pressure versus placebo. The trial only reported on death from all causes. Fisher's exact test (P = 0.058) showed no evidence of a difference between lowered blood pressure versus placebo on death from all causes. The certainty of evidence was very low.\nAuthors' conclusions\nBased on the current evidence, there is a lack of information needed to confirm or reject minimally important intervention effects on patient-important outcomes for both induced hypertension and lowered blood pressure. There is an urgent need for trials assessing the effects of altering blood pressure in people with acute subarachnoid haemorrhage. Such trials should use the SPIRIT statement for their design and the CONSORT statement for their reporting. Moreover, such trials should use methods allowing for blinded altering of blood pressure and report on patient-important outcomes such as mortality, rebleeding, delayed cerebral ischaemia, quality of life, hydrocephalus, and serious adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified three randomised clinical trials (studies where people are randomly put into one of two or more treatment groups) assessing blood pressure alterations in people with acute subarachnoid haemorrhage. Two randomised clinical trials enrolling 61 participants compared induced hypertension with placebo (a pretend treatment) or no treatment. One randomised clinical trial enrolling 224 participants compared lowered blood pressure with placebo. We used trial sequential analysis to estimate the number of participants (amount of information) needed to reject or detect important treatment effects. Trial sequential analysis showed that there was a lack of information for all outcomes. All trials were at high risk of bias and we were very unsure about the results."
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query-laysum
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7485
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[
{
"role": "user",
"content": "Abstract: Background\nRebleeding is an important cause of death and disability in people with aneurysmal subarachnoid haemorrhage. Rebleeding is probably related to the dissolution of the blood clot at the site of the aneurysm rupture by natural fibrinolytic activity. This review is an update of previously published Cochrane Reviews.\nObjectives\nTo assess the effects of antifibrinolytic treatment in people with aneurysmal subarachnoid haemorrhage.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2022), CENTRAL (in the Cochrane Library 2021, Issue 1), MEDLINE (December 2012 to May 2022), and Embase (December 2012 to May 2022). In an effort to identify further published, unpublished, and ongoing studies, we searched reference lists and trial registers, performed forward tracking of relevant references, and contacted drug companies (the latter in previous versions of this review).\nSelection criteria\nRandomised trials comparing oral or intravenous antifibrinolytic drugs (tranexamic acid, epsilon amino-caproic acid, or an equivalent) with control in people with subarachnoid haemorrhage of suspected or proven aneurysmal cause.\nData collection and analysis\nTwo review authors (MRG & WJD) independently selected trials for inclusion, and extracted the data for the current update. In total, three review authors (MIB & MRG in the previous update; MRG & WJD in the current update) assessed risk of bias. For the primary outcome, we dichotomised the outcome scales into good and poor outcome, with poor outcome defined as death, vegetative state, or (moderate) severe disability, assessed with either the Glasgow Outcome Scale or the Modified Rankin Scale. We assessed death from any cause, rates of rebleeding, delayed cerebral ischaemia, and hydrocephalus per treatment group. We expressed effects as risk ratios (RR) with 95% confidence intervals (CI). We used random-effects models for all analyses. We assessed the quality of the evidence with GRADE.\nMain results\nWe included one new trial in this update, for a total of 11 included trials involving 2717 participants. The risk of bias was low in six studies. Five studies were open label, and we rated them at high risk of performance bias. We also rated one of these studies at high risk for attrition and reporting bias.\nFive trials reported on poor outcome (death, vegetative state, or (moderate) severe disability), with a pooled risk ratio (RR) of 1.03 (95% confidence interval (CI) 0.94 to 1.13; P = 0.53; 5 trials, 2359 participants; high-quality evidence), which showed no difference between groups. All trials reported on death from all causes, which showed no difference between groups, with a pooled RR of 1.02 (95% CI 0.90 to 1.16; P = 0.77; 11 trials, 2717 participants; high-quality evidence). In trials that combined short-term antifibrinolytic treatment (< 72 hours) with preventative measures for delayed cerebral ischaemia, the RR for poor outcome was 0.98 (95% CI 0.81 to 1.18; P = 0.83; 2 trials, 1318 participants; high-quality evidence).\nAntifibrinolytic treatment reduced the risk of rebleeding, reported at the end of follow-up (RR 0.65, 95% CI 0.47 to 0.91; P = 0.01; 11 trials, 2717 participants; absolute risk reduction 7%, 95% CI 3 to 12%; moderate-quality evidence), but there was heterogeneity (I² = 59%) between the trials. The pooled RR for delayed cerebral ischaemia was 1.27 (95% CI 1.00 to 1.62; P = 0.05; 7 trials, 2484 participants; moderate-quality evidence). However, this effect was less extreme after the implementation of ischaemia preventative measures and < 72 hours of treatment (RR 1.10, 95% CI 0.83 to 1.46; P = 0.49; 2 trials, 1318 participants; high-quality evidence). Antifibrinolytic treatment showed no effect on the reported rate of hydrocephalus (RR 1.09, 95% CI 0.99 to 1.20; P = 0.09; 6 trials, 1992 participants; high-quality evidence).\nAuthors' conclusions\nThe current evidence does not support the routine use of antifibrinolytic drugs in the treatment of people with aneurysmal subarachnoid haemorrhage. More specifically, early administration with concomitant treatment strategies to prevent delayed cerebral ischaemia does not improve clinical outcome. There is sufficient evidence from multiple randomised controlled trials to incorporate this conclusion in treatment guidelines.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to May 2022. This review included 11 trials, with a total of 2717 participants, which investigated the effect of antifibrinolytic drugs in people with a subarachnoid haemorrhage caused by a ruptured aneurysm."
}
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query-laysum
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7486
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[
{
"role": "user",
"content": "Abstract: Background\nHepatic encephalopathy is a common complication of cirrhosis, with high related morbidity and mortality. Its presence is associated with a wide spectrum of change ranging from clinically obvious neuropsychiatric features, known as 'overt' hepatic encephalopathy, to abnormalities manifest only on psychometric or electrophysiological testing, 'minimal' hepatic encephalopathy. The exact pathogenesis of the syndrome is unknown but ammonia plays a key role. Drugs that specifically target ammonia include sodium benzoate, glycerol phenylbutyrate, ornithine phenylacetate, AST-120 (spherical carbon adsorbent), and polyethylene glycol.\nObjectives\nTo evaluate the beneficial and harmful effects of pharmacotherapies that specifically target ammonia versus placebo, no intervention, or other active interventions, for the prevention and treatment of hepatic encephalopathy in people with cirrhosis.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Controlled Trials Register, CENTRAL, MEDLINE, Embase, and three other databases to March 2019. We also searched online trials registries such as ClinicalTrials.gov, European Medicines Agency, WHO International Clinical Trial Registry Platform, and the Food and Drug Administration for ongoing or unpublished trials. In addition, we searched conference proceedings, checked bibliographies, and corresponded with investigators.\nSelection criteria\nWe included randomised clinical trials comparing sodium benzoate, glycerol phenylbutyrate, ornithine phenylacetate, AST-120, and polyethylene glycol versus placebo or non-absorbable disaccharides, irrespective of blinding, language, or publication status. We included participants with minimal or overt hepatic encephalopathy or participants who were at risk of developing hepatic encephalopathy.\nData collection and analysis\nTwo review authors independently extracted data from the included reports. The primary outcomes were mortality, hepatic encephalopathy, and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RR) or mean differences (MD), both with 95% confidence intervals (CIs), and I2 statistic values as a marker of heterogeneity. We assessed bias control using the Cochrane Hepato-Biliary domains and the certainty of the evidence using GRADE.\nMain results\nEleven randomised clinical trials fulfilled our inclusion criteria. Two trials evaluated the prevention of hepatic encephalopathy while nine evaluated the treatment of hepatic encephalopathy. The trials assessed sodium benzoate (three trials), glycerol phenylbutyrate (one trial), ornithine phenylacetate (two trials), AST-120 (two trials), and polyethylene glycol (three trials). Overall, 499 participants received these pharmacotherapies while 444 participants received a placebo preparation or a non-absorbable disaccharide. We classified eight of the 11 trials as at 'high risk of bias' and downgraded the certainty of the evidence to very low for all outcomes.\nEleven trials, involving 943 participants, reported mortality data, although there were no events in five trials. Our analyses found no beneficial or harmful effects of sodium benzoate versus non-absorbable disaccharides (RR 1.26, 95% CI 0.49 to 3.28; 101 participants; 2 trials; I2 = 0%), glycerol phenylbutyrate versus placebo (RR 0.65, 95% CI 0.11 to 3.81; 178 participants; 1 trial), ornithine phenylacetate versus placebo (RR 0.73, 95% CI 0.35 to 1.51; 269 participants; 2 trials; I2 = 0%), AST-120 versus lactulose (RR 1.05, 95% CI 0.59 to 1.85; 41 participants; 1 trial), or polyethylene glycol versus lactulose (RR 0.50, 95% CI 0.09 to 2.64; 190 participants; 3 trials; I2 = 0%).\nSeven trials involving 521 participants reported data on hepatic encephalopathy. Our analyses showed a beneficial effect of glycerol phenylbutyrate versus placebo (RR 0.57, 95% CI 0.36 to 0.90; 178 participants; 1 trial; number needed to treat for an additional beneficial outcome (NNTB) 6), and of polyethylene glycol versus lactulose (RR 0.19, 95% CI 0.08 to 0.44; 190 participants; 3 trials; NNTB 4). We did not observe beneficial effects in the remaining three trials with extractable data: sodium benzoate versus non-absorbable disaccharides (RR 1.22, 95% CI 0.51 to 2.93; 74 participants; 1 trial); ornithine phenylacetate versus placebo (RR 2.71, 95% CI 0.12 to 62.70; 38 participants; 1 trial); or AST-120 versus lactulose (RR 1.05, 95% CI 0.59 to 1.85; 41 participants; 1 trial).\nTen trials, involving 790 participants, reported a total of 130 serious adverse events. Our analyses found no evidence of beneficial or harmful effects of sodium benzoate versus non-absorbable disaccharides (RR 1.08, 95% CI 0.44 to 2.68; 101 participants; 2 trials), glycerol phenylbutyrate versus placebo (RR 1.63, 95% CI 0.85 to 3.13; 178 participants; 1 trial), ornithine phenylacetate versus placebo (RR 0.92, 95% CI 0.62 to 1.36; 264 participants; 2 trials; I2 = 0%), or polyethylene glycol versus lactulose (RR 0.57, 95% CI 0.18 to 1.82; 190 participants; 3 trials; I2 = 0%). Likewise, eight trials, involving 782 participants, reported a total of 374 non-serious adverse events and again our analyses found no beneficial or harmful effects of the pharmacotherapies under review when compared to placebo or to lactulose/lactitol.\nNine trials, involving 733 participants, reported data on blood ammonia. We observed significant reductions in blood ammonia in placebo-controlled trials evaluating sodium benzoate (MD −32.00 µg/dL, 95% CI −46.85 to −17.15; 16 participants; 1 trial), glycerol phenylbutyrate (MD −12.00 µmol/L*week, 95% CI −23.37 to −0.63; 178 participants; 1 trial), ornithine phenylacetate (MD −27.10 µmol/L, 95% CI −48.55 to −5.65; 231 participants; 1 trial), and AST-120 (MD −22.00 µg/dL, 95% CI −26.75 to −17.25; 98 participants; 1 trial). However, there were no significant differences in blood ammonia concentrations in comparison with lactulose/lactitol with sodium benzoate (MD 9.00, 95% CI −1.10 to 19.11; 85 participants; 2 trials; I2 = 0% ), AST-120 (MD 5.20 units not specified, 95% CI −2.75 to 13.15; 35 participants; 1 trial), and polyethylene glycol (MD −29.28 µmol/L, 95% CI −95.96 to 37.39; 90 participants; 2 trials; I2 = 88%).\nFive trials received support from pharmaceutical companies while four did not; two did not provide this information.\nAuthors' conclusions\nThere is insufficient evidence to determine the effects of these pharmacotherapies on the prevention and treatment of hepatic encephalopathy in adults with cirrhosis. They have the potential to reduce blood ammonia concentrations when compared to placebo, but their overall effects on clinical outcomes of interest and the potential harms associated with their use remain uncertain. Further evidence is needed to evaluate the potential beneficial and harmful effects of these pharmacotherapies in this clinical setting.\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": "Cirrhosis is a chronic disorder of the liver. People with cirrhosis may develop hepatic encephalopathy, a condition that results in poor brain functioning. Some people with hepatic encephalopathy show clear evidence of brain dysfunction and are said to have 'overt' hepatic encephalopathy. They may have a poor memory, difficulty concentrating, speech problems, a tremor, particularly of their hands, or stiffness of their limbs. These changes may occur in bouts or may be persistent. Other people with cirrhosis may not show any obvious signs of brain dysfunction, but some aspects of their brain function, such as attention and the ability to perform complex tasks are found to be impaired when tested. They are said to have 'minimal' hepatic encephalopathy. The reason why people develop hepatic encephalopathy is complex, but the build up in the blood of toxins from the gut, particularly of a compound called ammonia, plays a key role. Certain drugs have been developed specifically to lower blood ammonia levels and may help prevent people from developing hepatic encephalopathy and have beneficial effects in those already suffering from this disorder. However, the evidence that they are beneficial is unclear. The five drugs (pharmacotherapies) considered in this review are sodium benzoate, glycerol phenylbutyrate, ornithine phenylacetate, AST-120 (spherical carbon adsorbent), and polyethylene glycol."
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query-laysum
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7487
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[
{
"role": "user",
"content": "Abstract: Background\nMany women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined the evidence currently available on manual methods, including massage and reflexology, for pain management in labour. This review is an update of the review first published in 2012.\nObjectives\nTo assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (30 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017), the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trial Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017) and reference lists of retrieved trials.\nSelection criteria\nWe included randomised controlled trials comparing manual methods with standard care, other non-pharmacological forms of pain management in labour, no treatment or placebo. We searched for trials of the following modalities: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo-skeletal manipulation, deep tissue massage, neuro-muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We excluded trials for pain management relating to hypnosis, aromatherapy, acupuncture and acupressure; these are included in other Cochrane reviews.\nData collection and analysis\nTwo review authors independently assessed trial quality, extracted data and checked data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included a total of 14 trials; 10 of these (1055 women) contributed data to meta-analysis. Four trials, involving 274 women, met our inclusion criteria but did not contribute data to the review. Over half the trials had a low risk of bias for random sequence generation and attrition bias. The majority of trials had a high risk of performance bias and detection bias, and an unclear risk of reporting bias. We found no trials examining the effectiveness of reflexology.\nMassage\nWe found low-quality evidence that massage provided a greater reduction in pain intensity (measured using self-reported pain scales) than usual care during the first stage of labour (standardised mean difference (SMD) −0.81, 95% confidence interval (CI) −1.06 to −0.56, six trials, 362 women). Two trials reported on pain intensity during the second and third stages of labour, and there was evidence of a reduction in pain scores in favour of massage (SMD −0.98, 95% CI −2.23 to 0.26, 124 women; and SMD −1.03, 95% CI −2.17 to 0.11, 122 women). There was very low-quality evidence showing no clear benefit of massage over usual care for the length of labour (in minutes) (mean difference (MD) 20.64, 95% CI −58.24 to 99.52, six trials, 514 women), and pharmacological pain relief (average risk ratio (RR) 0.81, 95% CI 0.37 to 1.74, four trials, 105 women). There was very low-quality evidence showing no clear benefit of massage for assisted vaginal birth (average RR 0.71, 95% CI 0.44 to 1.13, four trials, 368 women) and caesarean section (RR 0.75, 95% CI 0.51 to 1.09, six trials, 514 women). One trial reported less anxiety during the first stage of labour for women receiving massage (MD -16.27, 95% CI −27.03 to −5.51, 60 women). One trial found an increased sense of control from massage (MD 14.05, 95% CI 3.77 to 24.33, 124 women, low-quality evidence). Two trials examining satisfaction with the childbirth experience reported data on different scales; both found more satisfaction with massage, although the evidence was low quality in one study and very low in the other.\nWarm packs\nWe found very low-quality evidence for reduced pain (Visual Analogue Scale/VAS) in the first stage of labour (SMD −0.59, 95% CI −1.18 to −0.00, three trials, 191 women), and the second stage of labour (SMD −1.49, 95% CI −2.85 to −0.13, two trials, 128 women). Very low-quality evidence showed reduced length of labour (minutes) in the warm-pack group (MD −66.15, 95% CI −91.83 to −40.47; two trials; 128 women).\nThermal manual methods\nOne trial evaluated thermal manual methods versus usual care and found very low-quality evidence of reduced pain intensity during the first phase of labour for women receiving thermal methods (MD −1.44, 95% CI −2.24 to −0.65, one trial, 96 women). There was a reduction in the length of labour (minutes) (MD −78.24, 95% CI −118.75 to −37.73, one trial, 96 women, very low-quality evidence). There was no clear difference for assisted vaginal birth (very low-quality evidence). Results were similar for cold packs versus usual care, and intermittent hot and cold packs versus usual care, for pain intensity, length of labour and assisted vaginal birth.\nMusic\nOne trial that compared manual methods with music found very low-quality evidence of reduced pain intensity during labour in the massage group (RR 0.40, 95% CI 0.18 to 0.89, 101 women). There was no evidence of benefit for reduced use of pharmacological pain relief (RR 0.41, 95% CI 0.16 to 1.08, very low-quality evidence).\nOf the seven outcomes we assessed using GRADE, only pain intensity was reported in all comparisons. Satisfaction with the childbirth experience, sense of control, and caesarean section were rarely reported in any of the comparisons.\nAuthors' conclusions\nMassage, warm pack and thermal manual methods may have a role in reducing pain, reducing length of labour and improving women's sense of control and emotional experience of labour, although the quality of evidence varies from low to very low and few trials reported on the key GRADE outcomes. Few trials reported on safety as an outcome. There is a need for further research to address these outcomes and to examine the effectiveness and efficacy of these manual methods for pain management.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Massage may help women cope with pain in labour and may give them a better birth experience, and warm packs and thermal methods may help with pain. However, the quality of the evidence was generally low or very low, partly due to the trials being small and without sufficient numbers of women participating. These findings highlight a need for further research on this topic."
}
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query-laysum
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7488
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[
{
"role": "user",
"content": "Abstract: Background\nAsthma guidelines aim to guide health practitioners to optimise treatment for patients so as to minimise symptoms, improve or maintain good lung function, and prevent acute exacerbations or flare-ups. The principle of asthma guidelines is based on a step-up or step-down regimen of asthma medications to maximise good health outcomes using minimum medications. Asthma maintenance therapies reduce airway inflammation that is usually eosinophilic. Tailoring asthma medications in accordance with airway eosinophilic levels may improve asthma outcomes such as indices of control or reduce exacerbations or both. Fractional exhaled nitric oxide (FeNO) is a marker of eosinophilic inflammation, and as it is easy to measure, has an advantage over other measurements of eosinophilic inflammation (for example sputum eosinophils).\nObjectives\nTo evaluate the efficacy of tailoring asthma interventions based on exhaled nitric oxide (FeNO), in comparison to not using FeNO, that is management based on clinical symptoms (with or without spirometry/peak flow) or asthma guidelines or both, for asthma-related outcomes in adults.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of Trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and reference lists of articles. The last searches were undertaken in June 2016.\nSelection criteria\nAll randomised controlled trials (RCTs) comparing adjustment of asthma medications based on exhaled nitric oxide levels compared to not using FeNO, that is management based on clinical symptoms (with or without spirometry/peak flow) or asthma guidelines or both.\nData collection and analysis\nWe reviewed results of searches against predetermined criteria for inclusion. We independently selected relevant studies in duplicate. Two review authors independently assessed trial quality and extracted data. We contacted study authors for further information, receiving responses from four.\nMain results\nWe included seven adult studies; these studies differed in a variety of ways including definition of asthma exacerbations, FeNO cutoff levels used (15 to 35 ppb), the way in which FeNO was used to adjust therapy, and duration of study (4 to 12 months). Of 1700 randomised participants, 1546 completed the trials. The mean ages of the participants ranged from 28 to 54 years old. The inclusion criteria for the participants in each study varied, but all had a diagnosis of asthma and required asthma medications. In the meta-analysis, there was a significant difference in the primary outcome of asthma exacerbations between the groups, favouring the FeNO group. The number of people having one or more asthma exacerbations was significantly lower in the FeNO group compared to the control group (odds ratio (OR) 0.60, 95% confidence interval (CI) 0.43 to 0.84). The number needed to treat to benefit (NNTB) over 52 weeks was 12 (95% CI 8 to 32). Those in the FeNO group were also significantly more likely to have a lower exacerbation rate than the controls (rate ratio 0.59, 95% CI 0.45 to 0.77). However, we did not find a difference between the groups for exacerbations requiring hospitalisation (OR 0.14, 95% CI 0.01 to 2.67) or rescue oral corticosteroids (OR 0.86, 95% CI 0.50 to 1.48). There was also no significant difference between groups for any of the secondary outcomes (FEV1, FeNO levels, symptoms scores, or inhaled corticosteroid doses at final visit).\nWe considered three included studies that had inadequate blinding to have a high risk of bias. However, when these studies were excluded from the meta-analysis, the difference between the groups for the primary outcomes (exacerbations) remained statistically significant. The GRADE quality of the evidence ranged from moderate (for the outcome 'exacerbations') to very low (for the outcome 'inhaled corticosteroid dose at final visit') based on the lack of blinding and statistical heterogeneity. Six of the seven studies were industry supported, but the company had no role in the study design or data analyses.\nAuthors' conclusions\nWith new studies included since the last version of this review, which included adults and children, this updated meta-analysis in adults with asthma showed that tailoring asthma medications based on FeNO levels (compared with primarily on clinical symptoms) decreased the frequency of asthma exacerbations but did not impact on day-to-day clinical symptoms, end-of-study FeNO levels, or inhaled corticosteroid dose. Thus, the universal use of FeNO to help guide therapy in adults with asthma cannot be advocated. As the main benefit shown in the studies in this review was a reduction in asthma exacerbations, the intervention may be most useful in adults who have frequent exacerbations. Further RCTs encompassing different asthma severity, ethnic groups in less affluent settings, and taking into account different FeNO cutoffs are required.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence ranged from moderate when comparing the two groups for the exacerbation outcomes, to very low when comparing the groups for inhaled corticosteroid dose at final visit."
}
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query-laysum
|
7489
|
[
{
"role": "user",
"content": "Abstract: Background\nPeriampullary cancer includes cancer of the head and neck of the pancreas, cancer of the distal end of the bile duct, cancer of the ampulla of Vater, and cancer of the second part of the duodenum. Surgical resection is the only established potentially curative treatment for pancreatic and periampullary cancer. A considerable proportion of patients undergo unnecessary laparotomy because of underestimation of the extent of the cancer on computed tomography (CT) scanning. Other imaging methods such as magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, and endoscopic ultrasound (EUS) have been used to detect local invasion or distant metastases not visualised on CT scanning which could prevent unnecessary laparotomy. No systematic review or meta-analysis has examined the role of different imaging modalities in assessing the resectability with curative intent in patients with pancreatic and periampullary cancer.\nObjectives\nTo determine the diagnostic accuracy of MRI, PET scan, and EUS performed as an add-on test or PET-CT as a replacement test to CT scanning in detecting curative resectability in pancreatic and periampullary cancer.\nSearch methods\nWe searched MEDLINE, Embase, Science Citation Index Expanded, and Health Technology Assessment (HTA) databases up to 5 November 2015. Two review authors independently screened the references and selected the studies for inclusion. We also searched for articles related to the included studies by performing the \"related search\" function in MEDLINE (OvidSP) and Embase (OvidSP) and a \"citing reference\" search (by searching the articles that cite the included articles).\nSelection criteria\nWe included diagnostic accuracy studies of MRI, PET scan, PET-CT, and EUS in patients with potentially resectable pancreatic and periampullary cancer on CT scan. We accepted any criteria of resectability used in the studies. We included studies irrespective of language, publication status, or study design (prospective or retrospective). We excluded case-control studies.\nData collection and analysis\nTwo review authors independently performed data extraction and quality assessment using the QUADAS-2 (quality assessment of diagnostic accuracy studies - 2) tool. Although we planned to use bivariate methods for analysis of sensitivities and specificities, we were able to fit only the univariate fixed-effect models for both sensitivity and specificity because of the paucity of data. We calculated the probability of unresectability in patients who had a positive index test (post-test probability of unresectability in people with a positive test result) and in those with negative index test (post-test probability of unresectability in people with a positive test result) using the mean probability of unresectability (pre-test probability) from the included studies and the positive and negative likelihood ratios derived from the model. The difference between the pre-test and post-test probabilities gave the overall added value of the index test compared to the standard practice of CT scan staging alone.\nMain results\nOnly two studies (34 participants) met the inclusion criteria of this systematic review. Both studies evaluated the diagnostic test accuracy of EUS in assessing the resectability with curative intent in pancreatic cancers. There was low concerns about applicability for most domains in both studies. The overall risk of bias was low in one study and unclear or high in the second study. The mean probability of unresectable disease after CT scan across studies was 60.5% (that is 61 out of 100 patients who had resectable cancer after CT scan had unresectable disease on laparotomy). The summary estimate of sensitivity of EUS for unresectability was 0.87 (95% confidence interval (CI) 0.54 to 0.97) and the summary estimate of specificity for unresectability was 0.80 (95% CI 0.40 to 0.96). The positive likelihood ratio and negative likelihood ratio were 4.3 (95% CI 1.0 to 18.6) and 0.2 (95% CI 0.0 to 0.8) respectively. At the mean pre-test probability of 60.5%, the post-test probability of unresectable disease for people with a positive EUS (EUS indicating unresectability) was 86.9% (95% CI 60.9% to 96.6%) and the post-test probability of unresectable disease for people with a negative EUS (EUS indicating resectability) was 20.0% (5.1% to 53.7%). This means that 13% of people (95% CI 3% to 39%) with positive EUS have potentially resectable cancer and 20% (5% to 53%) of people with negative EUS have unresectable cancer.\nAuthors' conclusions\nBased on two small studies, there is significant uncertainty in the utility of EUS in people with pancreatic cancer found to have resectable disease on CT scan. No studies have assessed the utility of EUS in people with periampullary cancer.\nThere is no evidence to suggest that it should be performed routinely in people with pancreatic cancer or periampullary cancer found to have resectable disease on CT scan.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The pancreas is an organ situated in the abdomen close to the junction of the stomach and small bowel. It secretes digestive juices that are necessary for the digestion of all food materials. The digestive juices secreted in the pancreas drain into the upper part of the small bowel via the pancreatic duct. The bile duct is a tube which drains bile from the liver and gallbladder. The pancreatic and bile ducts share a common path just before they drain into the small bowel. This area is called the periampullary region. Surgical removal is the only potentially curative treatment for cancers arising from the pancreatic and periampullary regions. A considerable proportion of patients undergo unnecessary major open abdominal exploratory operation (laparotomy) because their CT scan has underestimated the spread of cancer. If the cancer is spread within the abdomen as identified during the major open operation, the main treatment is chemotherapy which does not cure the cancer but may improve survival. Thus the major open abdominal operation with its associated risks can be avoided if the spread of cancer within the abdomen is known before the major operation. Determining the extent of cancer is called \"staging\" the cancer. Usually the minimum test used for staging is the CT scan. However, CT scan can understage the cancer, i.e. it can underestimate the spread of cancer. Various other scans can be used in addition to CT scan in order to find out if pancreatic cancer is resectable (able to be surgically removed). These include the following tests.\n1. Magnetic resonance imaging (MRI): use of a powerful magnet to produce images of different tissues of the body.\n2. Positron emission tomography (PET scan): small amount of radioactive glucose (sugar) is used to differentiate between different tissues. It utilises the property that cancer cells often use more glucose than normal cells).\n3. Endoscopic ultrasound (EUS); the use of an endoscope, a camera introduced into the body cavities to view the inside of the body. An ultrasound (high-energy sound waves) probe at the end of the endoscope is used to differentiate different tissues.\nIn addition, a combination of PET-CT may be performed instead of CT.\nDifferent studies report different accuracy of these tests in assessing whether the cancer can be removed. In this review, we identified all such studies and used appropriate mathematical methods to identify the average diagnostic accuracy of these tests for staging pancreatic and periampullary cancers considered to be removable after a CT scan."
}
] |
query-laysum
|
7490
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[
{
"role": "user",
"content": "Abstract: Background\nFractures of the olecranon (the bony tip of the elbow) account for approximately 1% of all upper extremity fractures. Surgical intervention is often required to restore elbow function. Two key methods of surgery are tension band wire fixation and plate fixation.\nObjectives\nTo assess the effects (benefits and harms) of different surgical interventions in the treatment of olecranon fractures in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (22 September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL, 2014, Issue 8), MEDLINE (1946 to September week 2 2014), EMBASE (1980 to 19 September 2014), trial registers, conference proceedings and reference lists of articles.\nSelection criteria\nRandomised controlled trials (RCT) and quasi-RCTs that compared different surgical interventions for the treatment of olecranon fractures in adults.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction. The primary outcomes of this review were function, pain and adverse events.\nMain results\nWe included six small trials involving 244 adults with olecranon fractures. Of these, four were RCTs and two were quasi-RCTs; both of were at high risk of selection bias. All six trials were at high risk of performance bias, reflecting lack of blinding, and four trials were at high risk of detection bias. The quality of the evidence for most outcomes was generally very low because of limitations in study design and implementation, and either imprecision of the results or inadequate outcome measures. Thus, we are very uncertain about the estimates of effect.\nOne trial (41 participants) comparing plate fixation with standard tension band wiring provided very low quality evidence at 16 to 86 weeks' follow-up of a better clinical outcome after plate fixation (good outcome (little pain or loss of elbow motion): 19/22 versus 9/19, risk ratio (RR) 1.82 favouring plate fixation, 95% confidence interval (CI) 1.10 to 3.01). There was very low quality evidence of less symptomatic prominent metalwork after plate fixation (1/22 versus 8/19; RR 0.11, 95% CI 0.01 to 0.79). The results for other adverse effects (infection and delayed or non-union) were inconclusive. Evidence is pending from a newly (September 2014) completed trial (67 participants) making the same comparison.\nFour trials compared four different modified techniques of tension band wiring (i.e. additional intramedullary screw fixation, biodegradable pins, Netz pins and cable pin system) versus standard tension band wiring. There was very low quality evidence of little difference at six to 14 months in function assessed by a non-validated scoring tool from the addition of an intramedullary screw. However, there were fewer cases of metalwork prominence in the intramedullary screw group (1/15 versus 8/15; RR 2.00, 95% CI 1.15 to 3.49; one trial; 30 participants). There was very low quality evidence from one trial (25 participants) of little difference in subjectively or objectively assessed good outcome at a mean of 20 months between tension band wiring with biodegradable implants versus metal implants. There were no adverse events, either non-union or sinus or fluid accumulation, reported. All 10 participants in the metalwork group had an extra operation to remove their metalwork at one year. One trial, which did not report on function or pain, provided very low quality evidence of lower rates of metalwork for any reason or for symptoms after Netz pin tension band wiring compared with standard tension band wiring (11/21 with Netz pin versus 17/25 with standard tension band wiring; RR 0.77, 95% CI 0.47 to 1.26; 46 participants); this evidence also supports the possibility of higher rates of metalwork removal for Netz pins. Two intra-operative complications occurred in the Netz pin group. The fourth trial, which compared the cable pin system with standard procedure, found low quality evidence that cable pin improved functional outcome at a mean of 21 months (Mayo Elbow Performance Score (MEPS), range 0 to 100: best outcome: mean difference (MD) 7.89 favouring cable pin, 95% CI 3.14 to 12.64; one trial; 62 participants). It also found low quality evidence of fewer postoperative complications in the cable pin group (1/30 with cable pin system versus 7/32 standard tension band wiring; RR 0.15, 95% CI 0.02 to 1.17), although the evidence did not rule out the converse.\nOne trial provided very low quality evidence of similar patient-reported function using the Disabilities of the Arm, Shoulder and Hand questionnaire (0 to 100: worst function) at two or more years after fixation using a novel olecranon memory connector (OMC) compared with locking plate fixation (MD -0.70 favouring OMC, 95% CI -4.20 to 2.80; 40 participants). The only adverse event was a superficial infection in the locking plate group.\nAuthors' conclusions\nThere is insufficient evidence to draw robust conclusions on the relative effects of the surgical interventions evaluated by the included trials. Further evidence, including patient-reported data, on the relative effects of plate versus tension band wiring is already pending from one recently completed RCT. Further RCTs, using good quality methods and reporting validated patient-reported measures of function, pain and activities of daily living at set follow-ups, are needed, including checking positive findings such as those relating to the use of an intramedullary screw and the cable pin system. Such trials should also include the systematic assessment of complications, further treatment including routine removal of metalwork and use of resources.\n\nGiven the provided abstract, please respond to the following query: \"Surgical treatment of olecranon fracture\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The bony tip of the elbow is called the olecranon. It is shaped to allow bending and straightening of the arm at the elbow. The olecranon sits directly under the skin of the elbow, which makes it vulnerable to injury and fracture (break) following a fall. When this happens, people are sometimes unable to straighten their arms. Treating this fracture usually involves an operation to re-position the broken parts of the bone and then fix them in place using wires, pins, plates, screws and other devices."
}
] |
query-laysum
|
7491
|
[
{
"role": "user",
"content": "Abstract: Background\nStuttering, or stammering as it is referred to in some countries, affects a child's ability to speak fluently. It is a common communication disorder, affecting 11% of children by four years of age. Stuttering can be characterized by sound, part word or whole word repetitions, sound prolongations, or blocking of sounds or airflow. Moments of stuttering can also be accompanied by non-verbal behaviours, including visible tension in the speaker's face, eye blinks or head nods. Stuttering can also negatively affect behavioural, social and emotional functioning.\nObjectives\nPrimary objective\nTo assess the immediate and long-term effects of non-pharmacological interventions for stuttering on speech outcomes, communication attitudes, quality of life and potential adverse effects in children aged six years and younger.\nSecondary objective\nTo describe the relationship between intervention effects and participant characteristics (i.e. child age, IQ, severity, sex and time since stuttering onset) at pretest.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, nine other databases and two trial registers on 16 September 2020, and Open Grey on 20 October 2020. There were no limits in regards to language, year of publication or type of publication. We also searched the reference lists of included studies and requested data on unpublished trials from authors of published studies. We handsearched conference proceedings and programmes from relevant conferences.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs that assessed non-pharmacological interventions for stuttering in young children aged six years and younger. Eligible comparators were no intervention, wait list or management as usual.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe identified four eligible RCTs, all of which compared the Lidcombe Program to a wait-list control group. In total, 151 children aged between two and six years participated in the four included studies. In the Lidcombe Program, the parent and their child visit a speech and language therapist (SLT) in a clinic. One study conducted clinic visits by telephone. In each clinic visit, parents were taught how to conduct treatment at home. Two studies took place in Australia, one in New Zealand and one in Germany. Two studies were conducted for nine months, one for 16 weeks and one for 12 weeks. The frequency of clinic visits and practice sessions at home varied within the programme. One study was partially funded by the Rotary Club, Wiesbaden, Germany; and one was funded by the National Health and Medical Research Council of Australia. One study did not report funding sources and another reported that they did not receive any funding for the trial.\nAll four studies reported the outcome of stuttering frequency. One study also reported on speech efficiency, defined as articulation rate. No studies reported the other predetermined outcomes of this review, namely stuttering severity; communication attitudes; emotional, cognitive or psychosocial domains; or adverse effects.\nThe Lidcombe Program resulted in a lower stuttering frequency percentage syllables stuttered (% SS) than a wait-list control group at post-test, 12 weeks, 16 weeks and nine months postrandomization (mean difference (MD) −2.16, 95% confidence interval (CI) −3.48 to −0.84, 4 studies, 151 participants; P = 0.001; very low-certainty evidence).\nHowever, as the Lidcombe Program is designed to take one to two years to complete, none of the participants in these studies had finished the complete intervention programme at any of the data collection points.\nWe assessed stuttering frequency to have a high risk of overall bias due to high risk of bias in at least one domain within three of four included studies, and to have some concern of overall bias in the fourth, due to some concern in at least one domain.\nWe found moderate-certainty evidence from one study showing that the Lidcombe Program may increase speech efficiency in young children.\nOnly one study reported outcomes at long-term follow-up. The long-term effect of intervention could not be summarized, as the results for most of the children in the control group were missing. However, a within-group comparison was performed between the mean % SS at randomization and the mean % SS at the time of extended follow-up, and showed a significant reduction in frequency of stuttering.\nAuthors' conclusions\nThis systematic review indicates that the Lidcombe Program may result in lower stuttering frequency and higher speech efficiency than a wait-list control group in children aged up to six years at post-test. However, these results should be interpreted with caution due to the very low and moderate certainty of the evidence and the high risk of bias identified in the included studies. Thus, there is a need for further studies from independent researchers, to evaluate the immediate and long-term effects of other non-pharmacological interventions for stuttering compared to no intervention or a wait-list control group.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The Lidcombe Program may result in lower stuttering frequency and higher speech efficiency (i.e. number of words or syllables spoken per minute) for young children after receiving the amount of treatment included in the studies. We do not yet know the impact of the programme delivered in its entirety, as no study reported outcomes for children who had completed the programme, which is designed to last for one to two years.\nOnly one study reported how treatment worked in the long run, but the effect of treatment could not be summarized, as the results for most children in the control group were missing.\nWe require more high-quality studies assessing stuttering treatments for young children, including studies that report on a broader range of outcomes and that assess treatments other than the Lidcombe Program."
}
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query-laysum
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7492
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[
{
"role": "user",
"content": "Abstract: Background\nSkin-sparing mastectomy (SSM) is a surgical technique that aims to maximize skin preservation, facilitate breast reconstruction, and improve cosmetic outcomes. Despite its use in clinical practice, the benefits and harms related to SSM are not well established.\nObjectives\nTo assess the effectiveness and safety of skin-sparing mastectomy for the treatment of breast cancer.\nSearch methods\nWe searched Cochrane Breast Cancer's Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov on 9 August 2019.\nSelection criteria\nRandomized controlled trials (RCTs), quasi-randomized or non-randomized studies (cohort and case-control) comparing SSM to conventional mastectomy for treating ductal carcinoma in situ (DCIS) or invasive breast cancer.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome was overall survival. Secondary outcomes were local recurrence free-survival, adverse events (including overall complications, breast reconstruction loss, skin necrosis, infection and hemorrhage), cosmetic results, and quality of life. We performed a descriptive analysis and meta-analysis of the data.\nMain results\nWe found no RCTs or quasi-RCTs. We included two prospective cohort studies and twelve retrospective cohort studies. These studies included 12,211 participants involving 12,283 surgeries (3183 SSM and 9100 conventional mastectomies). It was not possible to perform a meta-analysis for overall survival and local recurrence free-survival due to clinical heterogeneity across studies and a lack of data to calculate hazard ratios (HR).\nBased on one study, the evidence suggests that SSM may not reduce overall survival for participants with DCIS tumors (HR 0.41, 95% CI 0.17 to 1.02; P = 0.06; 399 participants; very low-certainty evidence) or for participants with invasive carcinoma (HR 0.81, 95% CI 0.48 to 1.38; P = 0.44; 907 participants; very low-certainty evidence). For local recurrence-free survival, meta-analysis was not possible, due to high risk of bias in nine of the ten studies that measured this outcome. Informal visual examination of effect sizes from nine studies suggested the size of the HR may be similar between groups. Based on one study that adjusted for confounders, SSM may not reduce local recurrence-free survival (HR 0.82, 95% CI 0.47 to 1.42; P = 0.48; 5690 participants; very low-certainty evidence).\nThe effect of SSM on overall complications is unclear (RR 1.55, 95% CI 0.97 to 2.46; P = 0.07, I2 = 88%; 4 studies, 677 participants; very low-certainty evidence). Skin-sparing mastectomy may not reduce the risk of breast reconstruction loss (RR 1.79, 95% CI 0.31 to 10.35; P = 0.52; 3 studies, 475 participants; very low-certainty evidence), skin necrosis (RR 1.15, 95% CI 0.62 to 2.12; P = 0.22, I2 = 33%; 4 studies, 677 participants; very low-certainty evidence), local infection (RR 2.04, 95% CI 0.03 to 142.71; P = 0.74, I2 = 88%; 2 studies, 371 participants; very low-certainty evidence), nor hemorrhage (RR 1.23, 95% CI 0.47 to 3.27; P = 0.67, I2 = 0%; 4 studies, 677 participants; very low-certainty evidence). We downgraded the certainty of the evidence due to the risk of bias, imprecision, and inconsistency among the studies. There were no data available on the following outcomes: systemic surgical complications, local complications, explantation of implant/expander, hematoma, seroma, rehospitalization, skin necrosis with revisional surgery, and capsular contracture of the implant.\nIt was not possible to perform a meta-analysis for cosmetic and quality of life outcomes due to a lack of data. One study performed an evaluation of aesthetic outcome after SSM: 77.7% of participants with immediate breast reconstruction had an overall aesthetic result of excellent or good versus 87% of participants with delayed breast reconstruction.\nAuthors' conclusions\nBased on very low-certainty evidence from observational studies, it was not possible to draw definitive conclusions on the effectiveness and safety of SSM for breast cancer treatment. The decision for this technique of breast surgery for treatment of DCIS or invasive breast cancer must be individualized and shared between the physician and the patient while considering the potential risks and benefits of available surgical options.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 14 cohort studies (longitudinal studies that follow people over time) involving 12,283 surgeries where 3183 people underwent an SSM and 9100 underwent a conventional mastectomy.\nPeople who had an SSM or conventional mastectomy may have similar:\n- chance of cancer returning after surgery (1 study)\n- survival (2 studies)\n- risk of overall complications (4 studies)\n- risk of removing the breast reconstruction flap or implant due to complications (3 studies)\n- risk of skin necrosis (4 studies)\n- risk of infection (2 studies)\n- risk of hemorrhage (4 studies)\nHowever, the evidence is very unclear.\nBased on one study, there did not appear to be a difference in aesthetic outcomes between SSM with immediate breast reconstruction compared to conventional mastectomy and delayed breast reconstruction. One study evaluated the quality of life. The study suggested similar patient satisfaction, social activity, physical aspects, and general condition in people who have an SSM followed by breast reconstruction and those who have a mastectomy without breast reconstruction."
}
] |
query-laysum
|
7493
|
[
{
"role": "user",
"content": "Abstract: Background\nSmoking is the leading preventable cause of illness and premature death worldwide. Some medications have been proven to help people to quit, with three licensed for this purpose in Europe and the USA: nicotine replacement therapy (NRT), bupropion, and varenicline. Cytisine (a treatment pharmacologically similar to varenicline) is also licensed for use in Russia and some of the former socialist economy countries. Other therapies, including nortriptyline, have also been tested for effectiveness.\nObjectives\nHow do NRT, bupropion and varenicline compare with placebo and with each other in achieving long-term abstinence (six months or longer)?\nHow do the remaining treatments compare with placebo in achieving long-term abstinence?\nHow do the risks of adverse and serious adverse events (SAEs) compare between the treatments, and are there instances where the harms may outweigh the benefits?\nMethods\nThe overview is restricted to Cochrane reviews, all of which include randomised trials. Participants are usually adult smokers, but we exclude reviews of smoking cessation for pregnant women and in particular disease groups or specific settings. We cover nicotine replacement therapy (NRT), antidepressants (bupropion and nortriptyline), nicotine receptor partial agonists (varenicline and cytisine), anxiolytics, selective type 1 cannabinoid receptor antagonists (rimonabant), clonidine, lobeline, dianicline, mecamylamine, Nicobrevin, opioid antagonists, nicotine vaccines, and silver acetate. Our outcome for benefit is continuous or prolonged abstinence at least six months from the start of treatment. Our outcome for harms is the incidence of serious adverse events associated with each of the treatments.\nWe searched the Cochrane Database of Systematic Reviews (CDSR) in The Cochrane Library, for any reviews with 'smoking' in the title, abstract or keyword fields. The last search was conducted in November 2012. We assessed methodological quality using a revised version of the AMSTAR scale. For NRT, bupropion and varenicline we conducted network meta-analyses, comparing each with the others and with placebo for benefit, and varenicline and bupropion for risks of serious adverse events.\nMain results\nWe identified 12 treatment-specific reviews. The analyses covered 267 studies, involving 101,804 participants. Both NRT and bupropion were superior to placebo (odds ratios (OR) 1.84; 95% credible interval (CredI) 1.71 to 1.99, and 1.82; 95% CredI 1.60 to 2.06 respectively). Varenicline increased the odds of quitting compared with placebo (OR 2.88; 95% CredI 2.40 to 3.47). Head-to-head comparisons between bupropion and NRT showed equal efficacy (OR 0.99; 95% CredI 0.86 to 1.13). Varenicline was superior to single forms of NRT (OR 1.57; 95% CredI 1.29 to 1.91), and to bupropion (OR 1.59; 95% CredI 1.29 to 1.96).\nVarenicline was more effective than nicotine patch (OR 1.51; 95% CredI 1.22 to 1.87), than nicotine gum (OR 1.72; 95% CredI 1.38 to 2.13), and than 'other' NRT (inhaler, spray, tablets, lozenges; OR 1.42; 95% CredI 1.12 to 1.79), but was not more effective than combination NRT (OR 1.06; 95% CredI 0.75 to 1.48). Combination NRT also outperformed single formulations. The four categories of NRT performed similarly against each other, apart from 'other' NRT, which was marginally more effective than NRT gum (OR 1.21; 95% CredI 1.01 to 1.46).\nCytisine (a nicotine receptor partial agonist) returned positive findings (risk ratio (RR) 3.98; 95% CI 2.01 to 7.87), without significant adverse events or SAEs.\nAcross the 82 included and excluded bupropion trials, our estimate of six seizures in the bupropion arms versus none in the placebo arms was lower than the expected rate (1:1000), at about 1:1500. SAE meta-analysis of the bupropion studies demonstrated no excess of neuropsychiatric (RR 0.88; 95% CI 0.31 to 2.50) or cardiovascular events (RR 0.77; 95% CI 0.37 to 1.59). SAE meta-analysis of 14 varenicline trials found no difference between the varenicline and placebo arms (RR 1.06; 95% CI 0.72 to 1.55), and subgroup analyses detected no significant excess of neuropsychiatric events (RR 0.53; 95% CI 0.17 to 1.67), or of cardiac events (RR 1.26; 95% CI 0.62 to 2.56).\nNortriptyline increased the chances of quitting (RR 2.03; 95% CI 1.48 to 2.78). Neither nortriptyline nor bupropion were shown to enhance the effect of NRT compared with NRT alone. Clonidine increased the chances of quitting (RR 1.63; 95% CI 1.22 to 2.18), but this was offset by a dose-dependent rise in adverse events. Mecamylamine in combination with NRT may increase the chances of quitting, but the current evidence is inconclusive. Other treatments failed to demonstrate a benefit compared with placebo. Nicotine vaccines are not yet licensed for use as an aid to smoking cessation or relapse prevention. Nicobrevin's UK license is now revoked, and the manufacturers of rimonabant, taranabant and dianicline are no longer supporting the development or testing of these treatments.\nAuthors' conclusions\nNRT, bupropion, varenicline and cytisine have been shown to improve the chances of quitting. Combination NRT and varenicline are equally effective as quitting aids. Nortriptyline also improves the chances of quitting. On current evidence, none of the treatments appear to have an incidence of adverse events that would mitigate their use.\nFurther research is warranted into the safety of varenicline and into cytisine's potential as an effective and affordable treatment, but not into the efficacy and safety of NRT.\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": "Smoking is a main cause of early death throughout the world. There are a number of medications which can help people to quit smoking. Three of these, nicotine replacement therapy (NRT), bupropion and varenicline, are licensed for this purpose in the USA and Europe. Cytisine (similar to varenicline) is licensed for use in Russia and Eastern Europe. We reviewed studies of these and other treatments, including nortriptyline, to compare their benefits and risks.MethodsWe found 12 Cochrane reviews of different treatments. The treatments include nicotine replacement therapy (NRT); antidepressants (bupropion and nortriptyline); nicotine receptor partial agonists (varenicline and cytisine); anxiolytics; selective type 1 cannabinoid receptor antagonists (rimonabant); clonidine; lobeline; dianicline; mecamylamine; Nicobrevin; opioid antagonists; nicotine vaccines; and silver acetate. The reviews were conducted between 2008 and 2012, and analysed 267 trials, covering more than 101,000 smokers. All the reviews used randomised controlled trials, and compared the active treatment with a placebo, and sometimes with other treatments. The outcomes were measured at least six months from the start of treatment, and the results were usually checked by testing breath, blood or urine. We also assessed the risk of harms from each treatment. We then compared NRT, bupropion and varenicline with each other, using a network meta-analysis.ResultsNRT and bupropion helped about 80% more people to quit than placebo; this means that for every 10 people who quit with placebo about 18 could be expected to quit with NRT or with bupropion. Varenicline more than doubled the chances of quitting compared with placebo, so that for every 10 who quit with placebo about 28 could be expected to quit with varenicline.Varenicline helped about 50% more people to quit than nicotine patch and 'other' NRT (tablets, sprays, lozenges and inhalers), and about 70% more people than nicotine gum. So for every 10 people who quit with NRT patch or with 'other' NRT, about 15 could be expected to quit with varenicline, and for every 10 who quit with NRT gum about 17 could be expected to quit with varenicline. Combining two type of NRT was as effective as using varenicline, and helped more people to quit than single types of NRT. There was little to choose between different types of NRT, apart from 'other' NRT, which helped slightly more people than nicotine gum; for every 10 people who quit with NRT gum, about 12 could be expected to quit with 'other' NRT.NRT combined with nortriptyline or with bupropion was not more effective than NRT alone.Both cytisine and nortriptyline compared with placebo improved the chances of quitting, with minimal risk of harms.Bupropion carries a known risk of seizures (about 1 per 1000 users), but we found fewer than expected in the included and excluded trials, at about 1 in 1500. Although there may be a marginal increase in the likelihood of any serious adverse event while taking bupropion, we did not find increased risks of neuropsychiatric or heart and circulatory problems in the bupropion studies. The evidence for the safety of varenicline is still under investigation; we found no evidence from the trials that it is linked to an increase in neuropsychiatric problems, or with increased heart and circulatory problems.Clonidine helped people to quit, but caused side effects. It is not clear whether or not mecamylamine used with NRT helps people to quit. Other treatments did not seem to help. So far, nicotine vaccines are not licensed for use anywhere in the world. Nicobrevin is no longer available in the UK, and rimonabant, taranabant and dianicline have all been withdrawn from the market.ConclusionsNRT, bupropion and varenicline all improve the chances of quitting, with a low risk of harms.Combination use of NRT is as effective as varenicline, and more effective than single types of NRT.Cytisine has potential as a safe, effective and affordable treatment.Nortriptyline improves the chances of quitting, with little evidence of harmful events.We need continued monitoring of the safety of varenicline.More research into NRT versus placebo is unlikely to change our understanding of the treatment."
}
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query-laysum
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7494
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[
{
"role": "user",
"content": "Abstract: Background\nAggression occurs frequently within health and social care settings. It can result in injury to patients and staff and can adversely affect staff performance and well-being. De-escalation is a widely used and recommended intervention for managing aggression, but the efficacy of the intervention as a whole and the specific techniques that comprise it are unclear.\nObjectives\nTo assess the effects of de-escalation techniques for managing non-psychosis-induced aggression in adults in care settings, in both staff and service users.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and 14 other databases in September 2017, plus three trials registers in October 2017. We also checked references, and contacted study authors and authorities in the field to identify additional published and unpublished studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing de-escalation techniques with standard practice or alternative techniques for managing aggressive behaviour in adult care settings. We excluded studies in which participants had psychosis.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nThis review includes just one cluster-randomised study of 306 older people with dementia and an average age of 86 years, conducted across 16 nursing homes in France. The study did not measure any of our primary or secondary outcomes but did measure behavioural change using three measurement scales: the Cohen-Mansfield Agitation Inventory (CMAI; 29-item scale), the Neuropsychiatric Inventory (NPI; 12-item scale), and the Observation Scale (OS; 25-item scale). For the CMAI, the study reports a Global score (29 items rated on a seven-point scale (1 = never occurs to 7 = occurs several times an hour) and summed to give a total score ranging from 29 to 203) and mean scores (evaluable items (rated on the same 7-point scale) divided by the theoretical total number of items) for the following four domains: Physically Non-Aggressive Behaviour, such as pacing (13 items); Verbally Non-Aggressive Behaviour, such as repetition (four items); Physically Aggressive Behaviour, such as hitting (nine items); and Verbally Aggressive Behaviour, such as swearing (three items). Four of the five CMAI scales improved in the intervention group (Global: change mean difference (MD) −5.69 points, 95% confidence interval (CI) −9.59 to −1.79; Physically Non-Aggressive: change MD −0.32 points, 95% CI −0.49 to −0.15; Verbally Non-Aggressive: change MD −0.44 points, 95% CI −0.69 to −0.19; and Verbally Aggressive: change MD −0.16 points, 95% CI −0.31 to −0.01). There was no difference in change scores on the Physically Aggressive scale (MD −0.08 points, 95% CI −0.37 to 0.21). Using GRADE guidelines, we rated the quality of this evidence as very low due to high risk of bias and indirectness of the outcome measures. There were no differences in NPI or OS change scores between groups by the end of the study.\nWe also identified one ongoing study.\nAuthors' conclusions\nThe limited evidence means that uncertainty remains around the effectiveness of de-escalation and the relative efficacy of different techniques. High-quality research on the effectiveness of this intervention is therefore urgently needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The reliability of evidence available in the one included trial is very low and did not address important questions such as injury. Therefore, we cannot say whether de-escalation techniques are effective."
}
] |
query-laysum
|
7495
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[
{
"role": "user",
"content": "Abstract: Background\nPostoperative administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces patient opioid requirements and, in turn, reduces the incidence and severity of opioid-induced adverse events (AEs).\nObjectives\nTo assess the analgesic efficacy and adverse effects of single-dose intravenous diclofenac, compared with placebo or an active comparator, for moderate to severe postoperative pain in adults.\nSearch methods\nWe searched the following databases without language restrictions: the Cochrane Central Register of Controlled Trials (Cochrane Register of Studies Online), MEDLINE, and Embase on 22 May 2018. We checked clinical trials registers and reference lists of retrieved articles for additional studies.\nSelection criteria\nWe included randomized trials that compared a single postoperative dose of intravenous diclofenac with placebo or another active treatment, for treating acute postoperative pain in adults following any surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for review inclusion, assessed risk of bias, and extracted data.\nOur primary outcome was the number of participants in each arm achieving at least 50% pain relief over a four- and six-hour period.\nOur secondary outcomes were time to, and number of participants using rescue medication; withdrawals due to lack of efficacy, AEs, and for any cause; and number of participants experiencing any AE, serious AEs (SAEs), and NSAID-related AEs. We performed a post hoc analysis of opioid-related AEs, to enable indirect comparisons with other analyses of postoperative analgesics.\nFor subgroup analysis, we planned to analyze different doses and formulations of parenteral diclofenac separately.\nWe assessed the overall quality of the evidence for each outcome using GRADE and created two 'Summary of findings' tables.\nMain results\nWe included eight studies, involving 1756 participants undergoing various surgeries (dental, mixed minor, abdominal, and orthopedic), with 20 to 175 participants receiving intravenous diclofenac in each study. Mean study population ages ranged from 24.5 years to 54.5 years. Intravenous diclofenac doses varied among and within studies, ranging from 3.75 mg to 75 mg. Five studies assessed newer formulations of parenteral diclofenac that could be administered as an undiluted intravenous bolus. Most studies had an unclear risk of bias for several domains and a high risk of bias due to small sample size. The overall quality of evidence for each outcome was generally low for reasons including unclear risk of bias in studies, imprecision, and low event numbers.\nPrimary outcome\nThree studies (277 participants) produced a number needed to treat for an additional beneficial outcome (NNTB) for at least 50% of maximum pain relief versus placebo of 2.4 (95% confidence interval (CI) 1.9 to 3.1) over four hours (low-quality evidence). Four studies (436 participants) produced an NNTB of 3.8 versus placebo (95% CI 2.9 to 5.9) over six hours (low-quality evidence). No studies provided data for the comparison of intravenous diclofenac with another NSAID over four hours. At six hours there was no difference between intravenous diclofenac and another NSAID (low-quality evidence).\nSecondary outcomes\nFor secondary efficacy outcomes, intravenous diclofenac was generally superior to placebo and similar to other NSAIDs.\nFor time to rescue medication, comparison of intravenous diclofenac versus placebo demonstrated a median of 226 minutes for diclofenac versus 80 minutes for placebo (5 studies, 542 participants, low-quality evidence). There were insufficient data for pooled analysis for comparisons of diclofenac with another NSAID (very low-quality evidence).\nFor the number of participants using rescue medication, two studies (235 participants) compared diclofenac with placebo. The number needed to treat to prevent one additional harmful event (NNTp) (here, the need for rescue medication) compared with placebo was 3.0 (2.2 to 4.5, low-quality evidence). The comparison of diclofenac with another NSAID included only one study (98 participants). The NNTp was 4.5 (2.5 to 33) for ketorolac versus diclofenac (very low-quality evidence).\nThe numbers of participants withdrawing were generally low and inconsistently reported (very low-quality evidence). Participant withdrawals were: 6% (8/140) diclofenac versus 5% (7/128) placebo, and 9% (8/87) diclofenac versus 7% (6/82) another NSAID for lack of efficacy; 2% (4/211) diclofenac versus 0% (0/198) placebo, and 3% (4/138) diclofenac versus 2% (2/129) another NSAID due to AEs; and 11% (21/191) diclofenac versus 17% (30/179) placebo, and 18% (21/118) diclofenac versus 15% (17/111) another NSAID for any cause.\nOverall adverse event rates were similar between intravenous diclofenac and placebo (71% in both groups, 2 studies, 296 participants) and between intravenous diclofenac and another NSAID (55% and 58%, respectively, 2 studies, 265 participants) (low-quality evidence for both comparisons). Serious and specific AEs were rare, preventing meta-analysis.\nThere were sufficient data for a dose-effect analysis for our primary outcome for only one alternative dose, 18.75 mg. Analysis of the highest dose employed in each study demonstrated a relative benefit compared with placebo of 1.9 (1.4 to 2.4), whereas for the group receiving 18.75 mg, the relative benefit versus placebo was 1.6 (1.2 to 2.1, 2 studies). Compared to another NSAID, the high-dose analysis demonstrated a relative benefit of 0.9 (0.8 to 1.1), for the group receiving 18.75 mg, the relative benefit was 0.78 (0.65 to 0.93). For direct comparison of high dose versus 18.75 mg, the proportion of participants with at least 50% pain relief was 66% (90/137) for the high-dose arm versus 57% (77/135) in the low-dose arm. There were insufficient data for subgroup meta-analysis of different diclofenac formulations.\nAuthors' conclusions\nThe amount and quality of evidence for the use of intravenous diclofenac as a treatment for postoperative pain is low. The available evidence indicates that postoperative intravenous diclofenac administration offers good pain relief for the majority of patients, but further research may impact this estimate. Adverse events appear to occur at a similar rate to other NSAIDs. Insufficient information is available to assess whether intravenous diclofenac has a different rate of bleeding, renal dysfunction, or cardiovascular events versus other NSAIDs. There was insufficient information to evaluate the efficacy and safety of newer versus traditional formulations of intravenous diclofenac. There was a lack of studies in major and cardiovascular surgeries and in elderly populations, which may be at increased risk for adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In May 2018, we searched for clinical trials where intravenous diclofenac was used to treat pain after surgery in adults. We found eight studies enrolling a total of 1756 people that met our requirements. The studies were similar in their design, although they were carried out in different surgeries (dental, mixed minor surgeries, abdominal, and orthopedic). The dose of intravenous diclofenac used also varied. Intravenous diclofenac was mostly compared to placebo (a sham treatment, such as a bag of saline administered into a vein) or another NSAID."
}
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query-laysum
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7496
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[
{
"role": "user",
"content": "Abstract: Background\nTreatment guidelines for asthma recommend inhaled corticosteroids (ICS) as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, the potential systemic adverse effects related to regular use of these drugs have been and continue to be a matter of concern, especially the effects on linear growth.\nObjectives\nTo assess the impact of ICS on the linear growth of children with persistent asthma and to explore potential effect modifiers such as characteristics of available treatments (molecule, dose, length of exposure, inhalation device) and of treated children (age, disease severity, compliance with treatment).\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register of trials (CAGR), which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED and PsycINFO; we handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases to look for potential relevant unpublished studies. The literature search was conducted in January 2014.\nSelection criteria\nParallel-group randomised controlled trials comparing daily use of ICS, delivered by any type of inhalation device for at least three months, versus placebo or non-steroidal drugs in children up to 18 years of age with persistent asthma.\nData collection and analysis\nTwo review authors independently performed study selection, data extraction and assessment of risk of bias in included studies. We conducted meta-analyses using the Cochrane statistical package RevMan 5.2 and Stata version 11.0. We used the random-effects model for meta-analyses. We used mean differences (MDs) and 95% CIs as the metrics for treatment effects. A negative value for MD indicates that ICS have suppressive effects on linear growth compared with controls. We performed a priori planned subgroup analyses to explore potential effect modifiers, such as ICS molecule, daily dose, inhalation device and age of the treated child.\nMain results\nWe included 25 trials involving 8471 (5128 ICS-treated and 3343 control) children with mild to moderate persistent asthma. Six molecules (beclomethasone dipropionate, budesonide, ciclesonide, flunisolide, fluticasone propionate and mometasone furoate) given at low or medium daily doses were used during a period of three months to four to six years. Most trials were blinded and over half of the trials had drop out rates of over 20%.\nCompared with placebo or non-steroidal drugs, ICS produced a statistically significant reduction in linear growth velocity (14 trials with 5717 participants, MD -0.48 cm/y, 95% CI -0.65 to -0.30, moderate quality evidence) and in the change from baseline in height (15 trials with 3275 participants; MD -0.61 cm/y, 95% CI -0.83 to -0.38, moderate quality evidence) during a one-year treatment period.\nSubgroup analysis showed a statistically significant group difference between six molecules in the mean reduction of linear growth velocity during one-year treatment (Chi² = 26.1, degrees of freedom (df) = 5, P value < 0.0001). The group difference persisted even when analysis was restricted to the trials using doses equivalent to 200 μg/d hydrofluoroalkane (HFA)-beclomethasone. Subgroup analyses did not show a statistically significant impact of daily dose (low vs medium), inhalation device or participant age on the magnitude of ICS-induced suppression of linear growth velocity during a one-year treatment period. However, head-to-head comparisons are needed to assess the effects of different drug molecules, dose, inhalation device or patient age. No statistically significant difference in linear growth velocity was found between participants treated with ICS and controls during the second year of treatment (five trials with 3174 participants; MD -0.19 cm/y, 95% CI -0.48 to 0.11, P value 0.22). Of two trials that reported linear growth velocity in the third year of treatment, one trial involving 667 participants showed similar growth velocity between the budesonide and placebo groups (5.34 cm/y vs 5.34 cm/y), and another trial involving 1974 participants showed lower growth velocity in the budesonide group compared with the placebo group (MD -0.33 cm/y, 95% CI -0.52 to -0.14, P value 0.0005). Among four trials reporting data on linear growth after treatment cessation, three did not describe statistically significant catch-up growth in the ICS group two to four months after treatment cessation. One trial showed accelerated linear growth velocity in the fluticasone group at 12 months after treatment cessation, but there remained a statistically significant difference of 0.7 cm in height between the fluticasone and placebo groups at the end of the three-year trial.\nOne trial with follow-up into adulthood showed that participants of prepubertal age treated with budesonide 400 μg/d for a mean duration of 4.3 years had a mean reduction of 1.20 cm (95% CI -1.90 to -0.50) in adult height compared with those treated with placebo.\nAuthors' conclusions\nRegular use of ICS at low or medium daily doses is associated with a mean reduction of 0.48 cm/y in linear growth velocity and a 0.61-cm change from baseline in height during a one-year treatment period in children with mild to moderate persistent asthma. The effect size of ICS on linear growth velocity appears to be associated more strongly with the ICS molecule than with the device or dose (low to medium dose range). ICS-induced growth suppression seems to be maximal during the first year of therapy and less pronounced in subsequent years of treatment. However, additional studies are needed to better characterise the molecule dependency of growth suppression, particularly with newer molecules (mometasone, ciclesonide), to specify the respective role of molecule, daily dose, inhalation device and patient age on the effect size of ICS, and to define the growth suppression effect of ICS treatment over a period of several years in children with persistent asthma.\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": "Twenty-five trials involving 8471 children with mild to moderate persistent asthma (5128 treated with ICS and 3343 treated with placebo or non-steroidal drugs) were included in this review. Eighty percent of these trials were conducted in more than two different centres and were called multi-centre studies; five were international multi-centre studies conducted in high-income and low-income countries across Africa,Asia-Pacifica, Europe and the Americas. Sixty-eight percent were financially supported by pharmaceutical companies.\nMeta-analysis (a statistical technique that combines the results of several studies and provides a high level of evidence) suggests that children treated daily with ICS may grow approximately half a centimeter per year less than those not treated with these medications during the first year of treatment. The magnitude of ICS-related growth reduction may depend on the type of drug. Growth reduction seems to be maximal during the first year of therapy and less pronounced in subsequent years of treatment. Evidence provided by this review allows us to conclude that daily use of ICS can cause a small reduction in height in children up to 18 years of age with persistent asthma; this effect seems minor compared with the known benefit of these medications for asthma control."
}
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query-laysum
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7497
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[
{
"role": "user",
"content": "Abstract: Background\nForty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.\nObjectives\nTo evaluate efficacy of acupuncture for relief of cancer-related pain in adults.\nSearch methods\nFor this update CENTRAL, MEDLINE, EMBASE, PsycINFO, AMED, and SPORTDiscus were searched up to July 2015 including non-English language papers.\nSelection criteria\nRandomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.\nData collection and analysis\nWe planned to pool data to provide an overall measure of effect and to calculate the number needed to treat to benefit, but this was not possible due to heterogeneity. Two review authors (CP, OT) independently extracted data adding it to data extraction sheets. Data sheets were compared and discussed with a third review author (MJ) who acted as arbiter. Data analysis was conducted by CP, OT and MJ.\nMain results\nWe included five RCTs (285 participants). Three studies were included in the original review and two more in the update. The authors of the included studies reported benefits of acupuncture in managing pancreatic cancer pain; no difference between real and sham electroacupuncture for pain associated with ovarian cancer; benefits of acupuncture over conventional medication for late stage unspecified cancer; benefits for auricular (ear) acupuncture over placebo for chronic neuropathic pain related to cancer; and no differences between conventional analgesia and acupuncture within the first 10 days of treatment for stomach carcinoma. All studies had a high risk of bias from inadequate sample size and a low risk of bias associated with random sequence generation. Only three studies had low risk of bias associated with incomplete outcome data, while two studies had low risk of bias associated with allocation concealment and one study had low risk of bias associated with inadequate blinding. The heterogeneity of methodologies, cancer populations and techniques used in the included studies precluded pooling of data and therefore meta-analysis was not carried out. A subgroup analysis on acupuncture for cancer-induced bone pain was not conducted because none of the studies made any reference to bone pain. Studies either reported that there were no adverse events as a result of treatment, or did not report adverse events at all.\nAuthors' conclusions\nThere is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "None of the studies described in this review were big enough to produce reliable results. None of the studies reported any harm to the participants. We conclude that there is insufficient evidence to judge whether acupuncture is effective in relieving cancer pain in adults. Larger, well-designed studies are needed to provide evidence in this area."
}
] |
query-laysum
|
7498
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[
{
"role": "user",
"content": "Abstract: Background\nHarmful alcohol use is defined as unhealthy alcohol use that results in adverse physical, psychological, social, or societal consequences and is among the leading risk factors for disease, disability and premature mortality globally. The burden of harmful alcohol use is increasing in low- and middle-income countries (LMICs) and there remains a large unmet need for indicated prevention and treatment interventions to reduce harmful alcohol use in these settings. Evidence regarding which interventions are effective and feasible for addressing harmful and other patterns of unhealthy alcohol use in LMICs is limited, which contributes to this gap in services.\nObjectives\nTo assess the efficacy and safety of psychosocial and pharmacologic treatment and indicated prevention interventions compared with control conditions (wait list, placebo, no treatment, standard care, or active control condition) aimed at reducing harmful alcohol use in LMICs.\nSearch methods\nWe searched for randomized controlled trials (RCTs) indexed in the Cochrane Drugs and Alcohol Group (CDAG) Specialized Register, the Cochrane Clinical Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, Embase, PsycINFO, CINAHL, and the Latin American and Caribbean Health Sciences Literature (LILACS) through 12 December 2021. We searched clinicaltrials.gov, the World Health Organization International Clinical Trials Registry Platform, Web of Science, and Opengrey database to identify unpublished or ongoing studies. We searched the reference lists of included studies and relevant review articles for eligible studies.\nSelection criteria\nAll RCTs comparing an indicated prevention or treatment intervention (pharmacologic or psychosocial) versus a control condition for people with harmful alcohol use in LMICs were included.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 66 RCTs with 17,626 participants. Sixty-two of these trials contributed to the meta-analysis. Sixty-three studies were conducted in middle-income countries (MICs), and the remaining three studies were conducted in low-income countries (LICs). Twenty-five trials exclusively enrolled participants with alcohol use disorder. The remaining 51 trials enrolled participants with harmful alcohol use, some of which included both cases of alcohol use disorder and people reporting hazardous alcohol use patterns that did not meet criteria for disorder.\nFifty-two RCTs assessed the efficacy of psychosocial interventions; 27 were brief interventions primarily based on motivational interviewing and were compared to brief advice, information, or assessment only. We are uncertain whether a reduction in harmful alcohol use is attributable to brief interventions given the high levels of heterogeneity among included studies (Studies reporting continuous outcomes: Tau² = 0.15, Q =139.64, df =16, P<.001, I² = 89%, 3913 participants, 17 trials, very low certainty; Studies reporting dichotomous outcomes: Tau²=0.18, Q=58.26, df=3, P<.001, I² =95%, 1349 participants, 4 trials, very low certainty). The other types of psychosocial interventions included a range of therapeutic approaches such as behavioral risk reduction, cognitive-behavioral therapy, contingency management, rational emotive therapy, and relapse prevention. These interventions were most commonly compared to usual care involving varying combinations of psychoeducation, counseling, and pharmacotherapy. We are uncertain whether a reduction in harmful alcohol use is attributable to psychosocial treatments due to high levels of heterogeneity among included studies (Heterogeneity: Tau² = 1.15; Q = 444.32, df = 11, P<.001; I²=98%, 2106 participants, 12 trials, very low certainty).\nEight trials compared combined pharmacologic and psychosocial interventions with placebo, psychosocial intervention alone, or another pharmacologic treatment. The active pharmacologic study conditions included disulfiram, naltrexone, ondansetron, or topiramate. The psychosocial components of these interventions included counseling, encouragement to attend Alcoholics Anonymous, motivational interviewing, brief cognitive-behavioral therapy, or other psychotherapy (not specified). Analysis of studies comparing a combined pharmacologic and psychosocial intervention to psychosocial intervention alone found that the combined approach may be associated with a greater reduction in harmful alcohol use (standardized mean difference (standardized mean difference (SMD))=-0.43, 95% confidence interval (CI): -0.61 to -0.24; 475 participants; 4 trials; low certainty).\nFour trials compared pharmacologic intervention alone with placebo and three with another pharmacotherapy. Drugs assessed were: acamprosate, amitriptyline, baclofen disulfiram, gabapentin, mirtazapine, and naltrexone. None of these trials evaluated the primary clinical outcome of interest, harmful alcohol use.\n\nThirty-one trials reported rates of retention in the intervention. Meta-analyses revealed that rates of retention between study conditions did not differ in any of the comparisons (pharmacologic risk ratio (RR) = 1.13, 95% CI: 0.89 to 1.44, 247 participants, 3 trials, low certainty; pharmacologic in addition to psychosocial intervention: RR = 1.15, 95% CI: 0.95 to 1.40, 363 participants, 3 trials, moderate certainty). Due to high levels of heterogeneity, we did not calculate pooled estimates comparing retention in brief (Heterogeneity: Tau² = 0.00; Q = 172.59, df = 11, P<.001; I2 = 94%; 5380 participants; 12 trials, very low certainty) or other psychosocial interventions (Heterogeneity: Tau² = 0.01; Q = 34.07, df = 8, P<.001; I2 = 77%; 1664 participants; 9 trials, very low certainty). Two pharmacologic trials and three combined pharmacologic and psychosocial trials reported on side effects. These studies found more side effects attributable to amitriptyline relative to mirtazapine, naltrexone and topiramate relative to placebo, yet no differences in side effects between placebo and either acamprosate or ondansetron.\nAcross all intervention types there was substantial risk of bias. Primary threats to validity included lack of blinding and differential/high rates of attrition.\nAuthors' conclusions\nIn LMICs there is low-certainty evidence supporting the efficacy of combined psychosocial and pharmacologic interventions on reducing harmful alcohol use relative to psychosocial interventions alone. There is insufficient evidence to determine the efficacy of pharmacologic or psychosocial interventions on reducing harmful alcohol use largely due to the substantial heterogeneity in outcomes, comparisons, and interventions that precluded pooling of these data in meta-analyses. The majority of studies are brief interventions, primarily among men, and using measures that have not been validated in the target population. Confidence in these results is reduced by the risk of bias and significant heterogeneity among studies as well as the heterogeneity of results on different outcome measures within studies. More evidence on the efficacy of pharmacologic interventions, specific types of psychosocial interventions are needed to increase the certainty of these results.\n\nGiven the provided abstract, please respond to the following query: \"What does the research say?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified 66 randomized controlled trials that evaluated the effect of interventions on reducing harmful alcohol use. Most of these studies assessed psychosocial interventions (n = 52 studies), six assessed pharmacologic interventions alone, and eight assessed combined pharmacologic and psychosocial interventions.\nThe majority of included trials were funded by government agencies (36 trials) followed by multiple public and private funders (8 trials) or private foundations (5 trials). Seventeen trials did not report the funding source.\nWe are uncertain whether brief psychosocial interventions and other psychosocial interventions reduce harmful alcohol use. Combined pharmacologic and psychosocial interventions may reduce harmful alcohol use relative to psychosocial interventions combined with placebo, yet the certainty of the evidence has been assessed as low. No studies were found that looked at the effect of pharmacologic interventions alone on harmful alcohol use. We did not find evidence that rates of retention differed between study conditions for any of the intervention types."
}
] |
query-laysum
|
7499
|
[
{
"role": "user",
"content": "Abstract: Background\nPrimary autoimmune haemolytic anaemia (AIHA) is an autoantibody mediated condition characterised by a variable disease course. A myriad of immunomodulatory agents have been employed but there is a paucity of evidence to support their use or compare their effectiveness.\nObjectives\nTo determine the effects of various disease-modifying treatment modalities in people with AHIHA.\nSearch methods\nWe searched MEDLINE (Ovid) (1946 to 2021), Embase (Ovid) (1974 to 2021), Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to 2021), and the Cochrane Library (CENTRAL). Clinical trial registries and relevant conference proceedings were also reviewed. Records were included as of 7 March 2021. We did not impose any language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing immunosuppressive or immunomodulatory treatments against no treatment, placebo, or another immunosuppressive or immunomodulatory treatment, for people of all age with idiopathic AIHA.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The prioritised pre-defined outcomes included complete haematological response at 12 months, frequency of adverse events at two, six and 12 months, partial haematological response at 12 months, overall survival at six and 12 months, relapse-free survival (RFS) at six and 12 months, red blood cel (RBC) transfusion requirement after treatment at 12 months, and quality of life (QOL) as measured by validated instruments at 12 months. Based on data availability, we were only able to perform meta-analysis on frequency of complete haematological response.\nMain results\nTwo trials were included, enrolling a total of 104 adult participants (96 randomised) with warm AIHA in the setting of tertiary referral centres, both comparing the effectiveness between rituximab (375 mg/m2 weekly for four weeks, or 1000 mg for two doses two weeks apart) plus glucocorticoid (prednisolone 1.5 or 1mg/kg/day with taper) and glucocorticoid monotherapy. The average age of participants in the two trials were 67 and 71, respectively. One of the included studies had good methodological quality with low risk of bias, whereas the other study had high risk of performance and detection bias due to lack of blinding. Compared with glucocorticoid alone, adding rituximab may result in a large increase of complete response at 12 months (n = 96, risk ratio (RR) 2.13, 95% confidence interval (CI) 1.34 to 3.40, GRADE: low-certainty evidence).\nRates of adverse effects at prespecified time-points were not reported.\nLimited data on partial haematological response were reported. The evidence is very uncertain about the effect of adding rituximab to glucocorticoids on partial haematological response at 12 months (n = 32; study = 1; RR 3.00, 95% CI 0.13 to 68.57; GRADE very low-certainty evidence).\nRBC transfusion need at 12 months was reported in one study, with four participants (mean number of packed red cell units 4.0 ± 2.82) from the rituximab group and five participants from the placebo (corticosteroid only) (mean number of packed red cell units 5.6 ± 4.15) group requiring transfusion, indicating very uncertain evidence about the effect of adding rituximab to glucocorticoids (n = 32, RR 0.80, 95% CI 0.26 to 2.45, GRADE very low-certainty evidence). The other study did not report transfusion requirement at prespecified time points but reported no difference in transfusion requirement between the two groups when comparing responders from enrolment to end of response or to the end of study follow-up (34 units versus 30 units, median [range]: 0 [1 to 6] versus 0 [1 to 5], P = 0·81).\nOverall survival and RFS rates at prespecified time-points were not explicitly reported in either study. Data on QOL were not available.\nAuthors' conclusions\nAvailable literature on the effectiveness of immunomodulatory therapy for primary AIHA is restricted to comparison between rituximab plus glucocorticoid and glucocorticoid alone, in patients with newly diagnosed warm AIHA, calling for need for additional studies. The current result suggests that combinatory therapy with rituximab and glucocorticoid may increase the rate of complete haematological response over glucocorticoid monotherapy.\n\nGiven the provided abstract, please respond to the following query: \"What studies did the review find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We looked at studies that were finished by 7 March 2021. We found two studies that looked at an immune modulating agent called rituximab, which targets immune cells, called B-cells.\nThe studies compared two groups of adults with primary AIHA who were treated:\n· with rituximab and steroid\n· with steroid alone\nIt’s important to know that these studies were very small, including a total of 96 people. And the design of one study had a problem that may have affected the results."
}
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query-laysum
|
7500
|
[
{
"role": "user",
"content": "Abstract: Background\nMobile health (mHealth), refers to healthcare practices supported by mobile devices, such as mobile phones and tablets. Within primary care, health workers often use mobile devices to register clients, track their health, and make decisions about care, as well as to communicate with clients and other health workers. An understanding of how health workers relate to, and experience mHealth, can help in its implementation.\nObjectives\nTo synthesise qualitative research evidence on health workers' perceptions and experiences of using mHealth technologies to deliver primary healthcare services, and to develop hypotheses about why some technologies are more effective than others.\nSearch methods\nWe searched MEDLINE, Embase, CINAHL, Science Citation Index and Social Sciences Citation Index in January 2018. We searched Global Health in December 2015. We screened the reference lists of included studies and key references and searched seven sources for grey literature (16 February to 5 March 2018). We re-ran the search strategies in February 2020. We screened these records and any studies that we identified as potentially relevant are awaiting classification.\nSelection criteria\nWe included studies that used qualitative data collection and analysis methods. We included studies of mHealth programmes that were part of primary healthcare services. These services could be implemented in public or private primary healthcare facilities, community and workplace, or the homes of clients. We included all categories of health workers, as well as those persons who supported the delivery and management of the mHealth programmes. We excluded participants identified as technical staff who developed and maintained the mHealth technology, without otherwise being involved in the programme delivery. We included studies conducted in any country.\nData collection and analysis\nWe assessed abstracts, titles and full-text papers according to the inclusion criteria. We found 53 studies that met the inclusion criteria and sampled 43 of these for our analysis. For the 43 sampled studies, we extracted information, such as country, health worker category, and the mHealth technology. We used a thematic analysis process. We used GRADE-CERQual to assess our confidence in the findings.\nMain results\nMost of the 43 included sample studies were from low- or middle-income countries. In many of the studies, the mobile devices had decision support software loaded onto them, which showed the steps the health workers had to follow when they provided health care. Other uses included in-person and/or text message communication, and recording clients' health information. Almost half of the studies looked at health workers' use of mobile devices for mother, child, and newborn health.\nWe have moderate or high confidence in the following findings.\nmHealth changed how health workers worked with each other : health workers appreciated being more connected to colleagues, and thought that this improved co-ordination and quality of care. However, some described problems when senior colleagues did not respond or responded in anger. Some preferred face-to-face connection with colleagues. Some believed that mHealth improved their reporting, while others compared it to \"big brother watching\".\nmHealth changed how health workers delivered care : health workers appreciated how mHealth let them take on new tasks, work flexibly, and reach clients in difficult-to-reach areas. They appreciated mHealth when it improved feedback, speed and workflow, but not when it was slow or time consuming. Some health workers found decision support software useful; others thought it threatened their clinical skills. Most health workers saw mHealth as better than paper, but some preferred paper. Some health workers saw mHealth as creating more work.\nmHealth led to new forms of engagement and relationships with clients and communities : health workers felt that communicating with clients by mobile phone improved care and their relationships with clients, but felt that some clients needed face-to-face contact. Health workers were aware of the importance of protecting confidential client information when using mobile devices. Some health workers did not mind being contacted by clients outside working hours, while others wanted boundaries. Health workers described how some community members trusted health workers that used mHealth while others were sceptical. Health workers pointed to problems when clients needed to own their own phones.\nHealth workers' use and perceptions of mHealth could be influenced by factors tied to costs, the health worker, the technology, the health system and society, poor network access, and poor access to electricity : some health workers did not mind covering extra costs. Others complained that phone credit was not delivered on time. Health workers who were accustomed to using mobile phones were sometimes more positive towards mHealth. Others with less experience, were sometimes embarrassed about making mistakes in front of clients or worried about job security. Health workers wanted training, technical support, user-friendly devices, and systems that were integrated into existing electronic health systems. The main challenges health workers experienced were poor network connections, access to electricity, and the cost of recharging phones. Other problems included damaged phones. Factors outside the health system also influenced how health workers experienced mHealth, including language, gender, and poverty issues. Health workers felt that their commitment to clients helped them cope with these challenges.\nAuthors' conclusions\nOur findings propose a nuanced view about mHealth programmes. The complexities of healthcare delivery and human interactions defy simplistic conclusions on how health workers will perceive and experience their use of mHealth. Perceptions reflect the interplay between the technology, contexts, and human attributes. Detailed descriptions of the programme, implementation processes and contexts, alongside effectiveness studies, will help to unravel this interplay to formulate hypotheses regarding the effectiveness of mHealth.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Health workers often use mobile phones and tablets to provide services. It is important to understand what health workers think about these devices, as this can affect the quality of services. We looked for studies that explored health workers' views and experiences of using mobile devices in primary care."
}
] |
query-laysum
|
7501
|
[
{
"role": "user",
"content": "Abstract: Background\nHeart failure is a condition in which the heart does not pump enough blood to meet all the needs of the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention. Outcomes for patients with heart failure are highly variable; however on average, these patients have a poor prognosis. Prognosis can be improved with early diagnosis and appropriate use of medical treatment, use of devices and transplantation. Patients with heart failure are high users of healthcare resources, not only due to drug and device treatments, but due to high costs of hospitalisation care. B-type natriuretic peptide levels are already used as biomarkers for diagnosis and prognosis of heart failure, but could offer to clinicians a possible tool to guide drug treatment. This could optimise drug management in heart failure patients whilst allaying concerns over potential side effects due to drug intolerance.\nObjectives\nTo assess whether treatment guided by serial BNP or NT-proBNP (collectively referred to as NP) monitoring improves outcomes compared with treatment guided by clinical assessment alone.\nSearch methods\nSearches were conducted up to 15 March 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (OVID), Embase (OVID), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database in the Cochrane Library. Searches were also conducted in the Science Citation Index Expanded, the Conference Proceedings Citation Index on Web of Science (Thomson Reuters), World Health Organization International Clinical Trials Registry and ClinicalTrials.gov. We applied no date or language restrictions.\nSelection criteria\nWe included randomised controlled trials of NP-guided treatment of heart failure versus treatment guided by clinical assessment alone with no restriction on follow-up. Adults treated for heart failure, in both in-hospital and out-of-hospital settings, and trials reporting a clinical outcome were included.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data and evaluated risk of bias. Risk ratios (RR) were calculated for dichotomous data, and pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated for continuous data. We contacted trial authors to obtain missing data. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table.\nMain results\nWe included 18 randomised controlled trials with 3660 participants (range of mean age: 57 to 80 years) comparing NP-guided treatment with clinical assessment alone. The evidence for all-cause mortality using NP-guided treatment showed uncertainty (RR 0.87, 95% CI 0.76 to 1.01; patients = 3169; studies = 15; low quality of the evidence), and for heart failure mortality (RR 0.84, 95% CI 0.54 to 1.30; patients = 853; studies = 6; low quality of evidence).\nThe evidence suggested heart failure admission was reduced by NP-guided treatment (38% versus 26%, RR 0.70, 95% CI 0.61 to 0.80; patients = 1928; studies = 10; low quality of evidence), but the evidence showed uncertainty for all-cause admission (57% versus 53%, RR 0.93, 95% CI 0.84 to 1.03; patients = 1142; studies = 6; low quality of evidence).\nSix studies reported on adverse events, however the results could not be pooled (patients = 1144; low quality of evidence). Only four studies provided cost of treatment results, three of these studies reported a lower cost for NP-guided treatment, whilst one reported a higher cost (results were not pooled; patients = 931, low quality of evidence). The evidence showed uncertainty for quality of life data (MD -0.03, 95% CI -1.18 to 1.13; patients = 1812; studies = 8; very low quality of evidence).\nWe completed a 'Risk of bias' assessment for all studies. The impact of risk of bias from lack of blinding of outcome assessment and high attrition levels was examined by restricting analyses to only low 'Risk of bias' studies.\nAuthors' conclusions\nIn patients with heart failure low-quality evidence showed a reduction in heart failure admission with NP-guided treatment while low-quality evidence showed uncertainty in the effect of NP-guided treatment for all-cause mortality, heart failure mortality, and all-cause admission. Uncertainty in the effect was further shown by very low-quality evidence for patient's quality of life. The evidence for adverse events and cost of treatment was low quality and we were unable to pool results.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall evidence for death from all causes, from heart failure alone and for hospital admission was of low quality. For harm to patients and cost outcomes the quality of evidence was low, whilst evidence for patients' quality of life surveys was very low. For all outcomes there was little evidence due to the way the studies were conducted. In addition, for harm to patients and cost of treatment there were differences in the type of information available."
}
] |
query-laysum
|
7502
|
[
{
"role": "user",
"content": "Abstract: Background\nVenous ulcers (also known as varicose or venous stasis ulcers) are a chronic, recurring and debilitating condition that affects up to 1% of the population. Best practice documents and expert opinion suggests that the removal of devitalised tissue from venous ulcers (debridement) by any one of six methods helps to promote healing. However, to date there has been no review of the evidence from randomised controlled trials (RCTs) to support this.\nObjectives\nTo determine the effects of different debriding methods or debridement versus no debridement, on the rate of debridement and wound healing in venous leg ulcers.\nSearch methods\nIn February 2015 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting. In addition we handsearched conference proceedings, journals not cited in MEDLINE, and the bibliographies of all retrieved publications to identify potential studies. We made contact with the pharmaceutical industry to enquire about any completed studies.\nSelection criteria\nWe included RCTs, either published or unpublished, which compared two methods of debridement or compared debridement with no debridement. We presented study results in a narrative form, as meta-analysis was not possible.\nData collection and analysis\nIndependently, two review authors completed all study selection, data extraction and assessment of trial quality; resolution of disagreements was completed by a third review author.\nMain results\nWe identified 10 RCTs involving 715 participants. Eight RCTs evaluated autolytic debridement and included the following agents or dressings: biocellulose wound dressing (BWD), non-adherent dressing, honey gel, hydrogel (gel formula), hydrofibre dressing, hydrocolloid dressings, dextranomer beads, Edinburgh University Solution of Lime (EUSOL) and paraffin gauze. Two RCTs evaluated enzymatic preparations and one evaluated biosurgical debridement. No RCTs evaluated surgical, sharp or mechanical methods of debridement, or debridement versus no debridement. Most trials were at a high risk of bias.\nThree RCTs assessed the number of wounds completely debrided. All three of these trials compared two different methods of autolytic debridement (234 participants), with two studies reporting statistically significant results: one study (100 participants) reported that 40/50 (80%) ulcers treated with dextranomer beads and 7/50 (14%) treated with EUSOL achieved complete debridement (RR 5.71, 95% CI 2.84 to 11.52); while the other trial (86 participants) reported the number of ulcers completely debrided as 31/46 (76%) for hydrogel versus 18/40 (45%) for paraffin gauze (RR 0.67, 95% CI 0.45 to 0.99). One study (48 participants) reported that by 12 weeks, 15/18 (84%) ulcers treated with BWD had achieved a 75% to 100% clean, granulating wound bed versus 4/15 (26%) treated with non-adherent petrolatum emulsion-impregnated gauze.\nFour trials assessed the mean time to achieve debridement: one (86 participants) compared two autolytic debridement methods, two compared autolytic methods with enzymatic debridement (71 participants), and the last (12 participants) compared autolytic with biosurgical debridement; none of the results achieved statistical significance.\nTwo trials that assessed autolytic debridement methods reported the number of wounds healed at 12 weeks. One trial (108 participants) reported that 24/54 (44%) ulcers treated with honey healed versus 18/54 (33%) treated with hydrogel (RR (adjusted for baseline wound diameter) 1.38, 95% CI 1.02 to 1.88; P value 0.037). The second trial (48 participants) reported that 7/25 (28%) ulcers treated with BWD healed versus 7/23 (30%) treated with non-adherent dressing.\nReduction in wound size was assessed in five trials (444 participants) in which two autolytic methods were compared. Results were statistically significant in one three-armed trial (153 participants) when cadexomer iodine was compared to paraffin gauze (mean difference 24.9 cm², 95% CI 7.27 to 42.53, P value 0.006) and hydrocolloid compared to paraffin gauze (mean difference 23.8 cm², 95% CI 5.48 to 42.12, P value 0.01). A second trial that assessed reduction in wound size based its results on median differences and, at four weeks, produced a statistically significantly result that favoured honey over hydrogel (P value < 0.001). The other three trials reported no statistically significant results for reduction in wound size, although one trial reported that the mean percentage reduction in wound area was greater at six and 12 weeks for BWD versus a non-adherent dressing (44% versus 24% week 6; 74% versus 54% week 12).\nPain was assessed in six trials (544 participants) that compared two autolytic debridement methods, but the results were not statistically significant. No serious adverse events were reported in any trial.\nAuthors' conclusions\nThere is limited evidence to suggest that actively debriding a venous leg ulcer has a clinically significant impact on healing. The overall small number of participants, low number of studies and lack of meta-analysis in this review precludes any strong conclusions of benefit. Comparisons of different autolytic agents (hydrogel versus paraffin gauze; Dextranomer beads versus EUSOL and BWD versus non-adherent dressings) and Larvae versus hydrogel all showed statistically significant results for numbers of wounds debrided. Larger trials with follow up to healing are required.\n\nGiven the provided abstract, please respond to the following query: \"Search methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched a wide range of electronic databases and also reports from conferences up to 10 February 2015. We included studies written in any language that included men and women of any age, cared for in any setting, from any country, and we did not set a limit on the years in which studies were published. We were only interested in robust research, and so restricted our search to randomised controlled trials (in which people are randomly allocated to the methods being tested). All trial participants were required to have a venous ulcer with dead tissue (slough) present in the wound."
}
] |
query-laysum
|
7503
|
[
{
"role": "user",
"content": "Abstract: Background\nInhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in children, the potential adverse effects of these drugs on growth remains a matter of concern for parents and physicians.\nObjectives\nTo assess the impact of different inhaled corticosteroid drugs and delivery devices on the linear growth of children with persistent asthma.\nSearch methods\nWe searched the Cochrane Airways Trials Register, which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, Embase, CINAHL, AMED and PsycINFO. We handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases, or contacted the manufacturer, to search for potential relevant unpublished studies. The literature search was initially conducted in September 2014, and updated in November 2015, September 2018, and April 2019.\nSelection criteria\nWe selected parallel-group randomized controlled trials of at least three months' duration. To be included, trials had to compare linear growth between different inhaled corticosteroid molecules at equivalent doses, delivered by the same type of device, or between different devices used to deliver the same inhaled corticosteroid molecule at the same dose, in children up to 18 years of age with persistent asthma.\nData collection and analysis\nAt least two review authors independently selected studies and assessed risk of bias in included studies. The data were extracted by one author and checked by another. The primary outcome was linear growth velocity. We conducted meta-analyses using Review Manager 5.3 software. We used mean differences (MDs) and 95% confidence intervals (CIs ) as the metrics for treatment effects, and the random-effects model for meta-analyses. We did not perform planned subgroup analyses due to there being too few included trials.\nMain results\nWe included six randomized trials involving 1199 children aged from 4 to 12 years (per-protocol population: 1008), with mild-to-moderate persistent asthma. Two trials were from single hospitals, and the remaining four trials were multicentre studies. The duration of trials varied from six to 20 months.\nOne trial with 23 participants compared fluticasone with beclomethasone, and showed that fluticasone given at an equivalent dose was associated with a significant greater linear growth velocity (MD 0.81 cm/year, 95% CI 0.46 to 1.16, low certainty evidence). Three trials compared fluticasone with budesonide. Fluticasone given at an equivalent dose had a less suppressive effect than budesonide on growth, as measured by change in height over a period from 20 weeks to 12 months (MD 0.97 cm, 95% CI 0.62 to 1.32; 2 trials, 359 participants; moderate certainty evidence). However, we observed no significant difference in linear growth velocity between fluticasone and budesonide at equivalent doses (MD 0.39 cm/year, 95% CI -0.94 to 1.73; 2 trials, 236 participants; very low certainty evidence).\nTwo trials compared inhalation devices. One trial with 212 participants revealed a comparable linear growth velocity between beclomethasone administered via hydrofluoroalkane-metered dose inhaler (HFA-MDI) and beclomethasone administered via chlorofluorocarbon-metered dose inhaler (CFC-MDI) at an equivalent dose (MD -0.44 cm/year, 95% CI -1.00 to 0.12; low certainty evidence). Another trial with 229 participants showed a small but statistically significant greater increase in height over a period of six months in favour of budesonide via Easyhaler, compared to budesonide given at the same dose via Turbuhaler (MD 0.37 cm, 95% CI 0.12 to 0.62; low certainty evidence).\nAuthors' conclusions\nThis review suggests that the drug molecule and delivery device may impact the effect size of ICS on growth in children with persistent asthma. Fluticasone at an equivalent dose seems to inhibit growth less than beclomethasone and budesonide. Easyhaler is likely to have less adverse effect on growth than Turbuhaler when used for delivery of budesonide. However, the evidence from this systematic review of head-to-head trials is not certain enough to inform the selection of inhaled corticosteroid or inhalation device for the treatment of children with persistent asthma. Further studies are needed, and pragmatic trials and real-life observational studies seem more attractive and feasible.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The type of drug and inhalation device may affect the size of negative effects of ICS on growth in children with persistent asthma. Fluticasone seems to inhibit growth less than beclomethasone and budesonide. Easyhaler is likely to have less a negative effect on growth than Turbuhaler when used for delivery of budesonide. However, the evidence from this review is not certain enough to help people select which inhaled corticosteroid or inhalation device to use for the treatment of children with asthma. Further studies are needed.\nThe well-established benefits of ICS in controlling asthma outweigh the potential risk of a relatively small suppression in growth. Fear of drug side effects means some children do not take their steroid inhalers as prescribed, leading to poor asthma control. Uncontrolled asthma can also impair children's growth, and can cause significant morbidity and mortality. Good communication between healthcare professionals and parents is essential to reduce people's concerns about using steroids and to improve treatment adherence.\nThis review is current to April 2019."
}
] |
query-laysum
|
7504
|
[
{
"role": "user",
"content": "Abstract: Background\nEczema and food allergy are common health conditions that usually begin in early childhood and often occur in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective for preventing eczema or food allergy.\nObjectives\nPrimary objective\nTo assess the effects of skin care interventions such as emollients for primary prevention of eczema and food allergy in infants.\nSecondary objective\nTo identify features of study populations such as age, hereditary risk, and adherence to interventions that are associated with the greatest treatment benefit or harm for both eczema and food allergy.\nSearch methods\nWe performed an updated search of the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase in September 2021. We searched two trials registers in July 2021. We checked the reference lists of included studies and relevant systematic reviews, and scanned conference proceedings to identify further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nWe included RCTs of skin care interventions that could potentially enhance skin barrier function, reduce dryness, or reduce subclinical inflammation in healthy term (> 37 weeks) infants (≤ 12 months) without pre-existing eczema, food allergy, or other skin condition. Eligible comparisons were standard care in the locality or no treatment. Types of skin care interventions could include moisturisers/emollients; bathing products; advice regarding reducing soap exposure and bathing frequency; and use of water softeners. No minimum follow-up was required.\nData collection and analysis\nThis is a prospective individual participant data (IPD) meta-analysis. We used standard Cochrane methodological procedures, and primary analyses used the IPD dataset. Primary outcomes were cumulative incidence of eczema and cumulative incidence of immunoglobulin (Ig)E-mediated food allergy by one to three years, both measured at the closest available time point to two years. Secondary outcomes included adverse events during the intervention period; eczema severity (clinician-assessed); parent report of eczema severity; time to onset of eczema; parent report of immediate food allergy; and allergic sensitisation to food or inhalant allergen.\nMain results\nWe identified 33 RCTs comprising 25,827 participants. Of these, 17 studies randomising 5823 participants reported information on one or more outcomes specified in this review. We included 11 studies, randomising 5217 participants, in one or more meta-analyses (range 2 to 9 studies per individual meta-analysis), with 10 of these studies providing IPD; the remaining 6 studies were included in the narrative results only.\nMost studies were conducted at children's hospitals. Twenty-five studies, including all those contributing data to meta-analyses, randomised newborns up to age three weeks to receive a skin care intervention or standard infant skin care. Eight of the 11 studies contributing to meta-analyses recruited infants at high risk of developing eczema or food allergy, although the definition of high risk varied between studies. Durations of intervention and follow-up ranged from 24 hours to three years. All interventions were compared against no skin care intervention or local standard care. Of the 17 studies that reported information on our prespecified outcomes, 13 assessed emollients.\nWe assessed most of the evidence in the review as low certainty and had some concerns about risk of bias. A rating of some concerns was most often due to lack of blinding of outcome assessors or significant missing data, which could have impacted outcome measurement but was judged unlikely to have done so. We assessed the evidence for the primary food allergy outcome as high risk of bias due to the inclusion of only one trial, where findings varied based on different assumptions about missing data.\nSkin care interventions during infancy probably do not change the risk of eczema by one to three years of age (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.81 to 1.31; risk difference 5 more cases per 1000 infants, 95% CI 28 less to 47 more; moderate-certainty evidence; 3075 participants, 7 trials) or time to onset of eczema (hazard ratio 0.86, 95% CI 0.65 to 1.14; moderate-certainty evidence; 3349 participants, 9 trials). Skin care interventions during infancy may increase the risk of IgE-mediated food allergy by one to three years of age (RR 2.53, 95% CI 0.99 to 6.49; low-certainty evidence; 976 participants, 1 trial) but may not change risk of allergic sensitisation to a food allergen by age one to three years (RR 1.05, 95% CI 0.64 to 1.71; low-certainty evidence; 1794 participants, 3 trials). Skin care interventions during infancy may slightly increase risk of parent report of immediate reaction to a common food allergen at two years (RR 1.27, 95% CI 1.00 to 1.61; low-certainty evidence; 1171 participants, 1 trial); however, this was only seen for cow’s milk, and may be unreliable due to over-reporting of milk allergy in infants. Skin care interventions during infancy probably increase risk of skin infection over the intervention period (RR 1.33, 95% CI 1.01 to 1.75; risk difference 17 more cases per 1000 infants, 95% CI one more to 38 more; moderate-certainty evidence; 2728 participants, 6 trials) and may increase the risk of infant slippage over the intervention period (RR 1.42, 95% CI 0.67 to 2.99; low-certainty evidence; 2538 participants, 4 trials) and stinging/allergic reactions to moisturisers (RR 2.24, 95% 0.67 to 7.43; low-certainty evidence; 343 participants, 4 trials), although CIs for slippages and stinging/allergic reactions were wide and include the possibility of no effect or reduced risk.\nPreplanned subgroup analyses showed that the effects of interventions were not influenced by age, duration of intervention, hereditary risk, filaggrin (FLG) mutation, chromosome 11 intergenic variant rs2212434, or classification of intervention type for risk of developing eczema. We could not evaluate these effects on risk of food allergy. Evidence was insufficient to show whether adherence to interventions influenced the relationship between skin care interventions and eczema or food allergy development.\nAuthors' conclusions\nBased on low- to moderate-certainty evidence, skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema; may increase risk of food allergy; and probably increase risk of skin infection. Further study is needed to understand whether different approaches to infant skin care might prevent eczema or food allergy.\n\nGiven the provided abstract, please respond to the following query: \"What are allergies?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "An immune response is how the body recognises and defends itself against substances that appear harmful. An allergy is a reaction of the body's immune system to a particular food or substance (an allergen) that is usually harmless. Different allergies affect different parts of the body, and their effects can be mild or serious."
}
] |
query-laysum
|
7505
|
[
{
"role": "user",
"content": "Abstract: Background\nThe treatment of people with clinically significant postoperative pancreatic leaks is different from those without clinically significant pancreatic leaks. It is important to know the diagnostic accuracy of drain fluid amylase as a triage test for the detection of clinically significant pancreatic leaks, so that an informed decision can be made as to whether the patient with a suspected pancreatic leak needs further investigations and treatment. There is currently no systematic review of the diagnostic test accuracy of drain fluid amylase for the diagnosis of clinically relevant pancreatic leak.\nObjectives\nTo determine the diagnostic accuracy of amylase in drain fluid at 48 hours or more for the diagnosis of pancreatic leak in people who had undergone pancreatic resection.\nSearch methods\nWe searched MEDLINE, Embase, the Science Citation Index Expanded, and the National Institute for Health Research Health Technology Assessment (NIHR HTA) websites up to 20 February 2017. We searched the references of the included studies to identify additional studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively. We also performed a 'related search' and 'citing reference' search in MEDLINE and Embase.\nSelection criteria\nWe included all studies that evaluated the diagnostic test accuracy of amylase in the drain fluid at 48 hours or more for the diagnosis of pancreatic leak in people who had undergone pancreatic resection excluding total pancreatectomy. We planned to exclude case-control studies because these studies are prone to bias, but did not find any. At least two authors independently searched and screened the references produced by the search to identify relevant studies.\nData collection and analysis\nTwo review authors independently extracted data from the included studies. The included studies reported drain fluid amylase on different postoperative days and measured at different cut-off levels, so it was not possible to perform a meta-analysis using the bivariate model as planned. We have reported the sensitivity, specificity, post-test probability of a positive and negative drain fluid amylase along with 95% confidence interval (CI) on each of the different postoperative days and measured at different cut-off levels.\nMain results\nA total of five studies including 868 participants met the inclusion criteria for this review. The five studies included in this review reported the value of drain fluid amylase at different thresholds and different postoperative days. The sensitivities and specificities were variable; the sensitivities ranged between 0.72 and 1.00 while the specificities ranged between 0.73 and 0.99 for different thresholds on different postoperative days. At the median prevalence (pre-test probability) of 15.9%, the post-test probabilities for pancreatic leak ranged between 35.9% and 95.4% for a positive drain fluid amylase test and ranged between 0% and 5.5% for a negative drain fluid amylase test.\nNone of the studies used the reference standard of confirmation by surgery or by a combination of surgery and clinical follow-up, but used the International Study Group on Pancreatic Fistula (ISGPF) grade B and C as the reference standard. The overall methodological quality was unclear or high in all the studies.\nAuthors' conclusions\nBecause of the paucity of data and methodological deficiencies in the studies, we are uncertain whether drain fluid amylase should be used as a method for testing for pancreatic leak in an unselected population after pancreatic resection; and we judge that the optimal cut-off of drain fluid amylase for making the diagnosis of pancreatic leak is also not clear. Further well-designed diagnostic test accuracy studies with pre-specified index test threshold of drain fluid amylase (at three times more on postoperative day 5 or another suitable pre-specified threshold), appropriate follow-up (for at least six to eight weeks to ensure that there are no pancreatic leaks), and clearly defined reference standards (of surgical, clinical, and radiological confirmation of pancreatic leak) are important to reliably determine the diagnostic accuracy of drain fluid amylase in the diagnosis of pancreatic leak.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The pancreas is an organ in the abdomen that secretes pancreatic juice that aids digestion; and it contains cells that produce important hormones such as insulin. Partial removal of the pancreas (pancreatic resection) is performed to remove cancerous and non-cancerous growths in the pancreas. During this process, new connections (anastomoses) are made between the pancreas and intestines and bile duct (a tube that transports bile from the liver to the intestines). These connections may break down and result in leakage of pancreatic content into the abdomen; this can lead to severe infections within the abdomen and in the blood stream, which can even lead to the death of the patient.\nAt the end of the operation, a drainage tube is inserted into the abdomen for two purposes: firstly, the detection of any fluid collections within the abdomen (intra-abdominal collections), usually resulting from the pancreatic leaks; and secondly, as the treatment of intra-abdominal collections, so that fluid collection decreases or, at least, does not worsen within the abdomen. The fluids from the drain can be tested for amylase (one of the contents of the pancreatic juice which digests carbohydrates) to find out whether the fluid in the drain is because of a pancreatic leak. If there is a high suspicion of a pancreatic leak, further scans are performed to confirm it or to rule it out. If the leak is major and the patient is unwell, urgent reoperation may be required. Moderate leaks can lead to intra-abdominal infections: patients may need antibiotics, drugs that decrease pancreatic secretion, insertion of a new drainage tube or repositioning of the existing drainage tube to drain the infected collection, and supportive care to recover. Currently, it is unclear whether measuring the amylase content in the fluid from the drain inserted after pancreatic resection is useful in identifying pancreatic leaks."
}
] |
query-laysum
|
7506
|
[
{
"role": "user",
"content": "Abstract: Background\nProton pump inhibitors (PPIs) are the most effective drugs to reduce gastric acid secretion. PPIs are one of the most commonly prescribed classes of medications worldwide. Apart from short-term application, maintenance therapy with PPIs is recommended and increasingly used in certain diseases, such as Zollinger-Ellison syndrome and gastro-oesophageal reflux disease, especially for people with erosive oesophagitis or Barrett's oesophagus. Although PPIs are generally safe, their efficacy and safety of long-term use remains unclear. The question of whether the long-term use of PPIs could promote the development of gastric pre-malignant lesions has been widely investigated, but results are inconsistent. Limited insight on this problem leads to a dilemma in decision making for long-term PPI prescription.\nObjectives\nTo compare the development or progression of gastric pre-malignant lesions, such as atrophic gastritis, intestinal metaplasia, enterochromaffin-like (ECL) cell hyperplasia, and dysplasia, in people taking long-term (six months or greater) PPI maintenance therapy.\nSearch methods\nWe searched the following databases (from inception to 6 August 2013): the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL. In addition, we searched the reference lists of included trials and contacted experts in the field.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) in adults (aged 18 years or greater) concerning the effects of long-term (six months or greater) PPI use on gastric mucosa changes, confirmed by endoscopy or biopsy sampling (or both).\nData collection and analysis\nTwo review authors independently performed selection of eligible trials, assessment of trial quality, and data extraction. We calculated odds ratios (OR) for analysis of dichotomous data and mean differences for continuous data, with 95% confidence intervals (CI).\nMain results\nWe included seven trials (1789 participants). Four studies had high risk of bias and the risk of bias in the other three trials was unclear. In addition, it was difficult to assess possible reporting bias. We pooled 1070 participants from four RCTs to evaluate corporal atrophy development revealing an insignificantly increased OR of 1.50 (95% CI 0.59 to 3.80; P value = 0.39; low-quality evidence) for long-term PPI users relative to non-PPI users. In five eligible trials, corporal intestinal metaplasia was assessed among 1408 participants, also with uncertain results (OR 1.46; 95% CI 0.43 to 5.03; P value = 0.55; low-quality evidence). However, by pooling data of 1705 participants from six RCTs, our meta-analysis showed that participants with PPI maintenance treatment were more likely to experience either diffuse (simple) (OR 5.01; 95% CI 1.54 to 16.26; P value = 0.007; very-low-quality evidence) or linear/micronodular (focal) ECL hyperplasia (OR 3.98; 95% CI 1.31 to 12.16; P value = 0.02; low-quality evidence) than controls. No participant showed any dysplastic or neoplastic change in any included studies.\nAuthors' conclusions\nThere is presently no clear evidence that the long-term use of PPIs can cause or accelerate the progression of corpus gastric atrophy or intestinal metaplasia, although results were imprecise. People with PPI maintenance treatment may have a higher possibility of experiencing either diffuse (simple) or linear/micronodular (focal) ECL cell hyperplasia. However, the clinical importance of this outcome is currently uncertain.\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 databases in August 2013 for randomised controlled trials (clinical trials where people are randomly allocated to one of two or more treatment groups) conducted in adults (aged 18 years or over) who did not have gastric cancer at the start of the trial. Treatment had to be with PPI for six months or more and be compared with no treatment, surgery/endoscopic treatment (where a tube is passed down the food pipe and into the stomach), or any other antacid treatment.\nWe found seven randomised controlled trials with 1789 participants. Some trials only partially reported gastric pre-cancerous lesions, and there was a substantial proportion of participants with missing data."
}
] |
query-laysum
|
7507
|
[
{
"role": "user",
"content": "Abstract: Background\nSpine surgery may be associated with severe acute postoperative pain. Compared with systemic analgesia alone, epidural analgesia may offer better pain control. However, epidural analgesia has sometimes been associated with rare but serious complications. Therefore, it is critical to quantify the real benefits of epidural analgesia over other modes of pain treatment.\nObjectives\nTo assess the effectiveness and safety of epidural analgesia compared with systemic analgesia for acute postoperative pain control after thoraco-lumbar spine surgery in children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied Health Literature on 14 November 2018, together with the references lists of related reviews and retained trials, and two trials registers.\nSelection criteria\nWe included all randomized controlled trials performed in children undergoing any type of thoraco-lumbar spine surgery comparing epidural analgesia with systemic analgesia for postoperative pain. We applied no language or publication status restriction.\nData collection and analysis\nWe assessed risk of bias of included trials using the Cochrane tool. We analysed data using random-effects models. We rated the quality of the evidence according to the GRADE scale.\nMain results\nWe included 11 trials (559 participants) in the review, and seven trials (249 participants) in the analysis: 140 participants received epidural analgesia and 109 received systemic analgesia.\nMost studies included adolescents. Three trials included in the analysis contained some participants older than 18 years. The types of surgery were posterior spinal fusion for idiopathic scoliosis (nine trials), anterior correction for idiopathic scoliosis (one trial), or selective dorsal rhizotomy in children with cerebral palsy (one trial). The mean numbers of vertebrae operated on were between nine and 14.5 and the mean numbers of spinal levels were between three and four and a half. The length of surgery varied between three and six and a half hours.\nCompared with systemic analgesia, epidural analgesia reduced pain at rest at all time points. At six to eight hours, the mean pain score on a 0 to 10 scale with systemic analgesia was 3.1 (standard deviation 0.7) and with epidural analgesia was –1.32 points (95% confidence interval (CI) –1.83 to –0.82; 4 studies, 116 participants; moderate-quality evidence). At 72 hours, the mean pain score with epidural analgesia was equivalent to a –0.8 point reduction on a 0 to 10 scale (standardized mean difference (SMD) –0.65, 95% CI –1.19 to –0.10; 5 studies, 157 participants; moderate-quality evidence).\nReturn of gastrointestinal function\nThere was no difference for nausea and vomiting between groups (risk ratio (RR) 0.87, 95% CI 0.58 to 1.30; 6 studies, 215 participants; low-quality evidence). One study found epidural analgesia with local anaesthetics may have increased the number of participants who had their first flatus within 48 hours (RR 1.63, 95% CI 1.08 to 2.47; 30 participants; very low-quality evidence). Two studies found epidural analgesia with local anaesthetics may have increased the number of participants in whom first bowel movement occurred within 48 hours (RR 11.52, 95% CI 2.36 to 56.26; 60 participants; low-quality evidence). It was uncertain whether epidural analgesia reduced the time to first bowel movement (MD 0.09 days, 95% CI –0.32 to 0.50; 1 study, 60 participants; very low-quality evidence) and time to first liquid ingestion following epidural infusion of an opioid alone or a local anaesthetic plus an opioid (mean difference (MD) –5.02 hours, 95% CI –13.15 to 3.10; 2 studies, 56 participants; very low-quality evidence). Epidural analgesia with local anaesthetics may have increased the risk of having first solid food ingestion within 48 hours (RR 7.00, 95% CI 1.91 to 25.62; 1 study, 30 participants; very low-quality evidence).\nSecondary outcomes\nIt was uncertain whether there was a difference in time to ambulate (MD 0.08 days, 95% CI –0.24 to 0.39; 1 study, 60 participants; very low-quality evidence) and hospital length of stay (MD –0.29 days, 95% CI –0.69 to 0.10; 2 studies, 89 participants; very low-quality evidence). Two studies found participants were more satisfied when treated with epidural analgesia (MD 1.62 on a scale from 0 to 10, 95% CI 1.26 to 1.97; 60 participants; very low-quality evidence). It was unclear whether there was a difference in parent satisfaction for epidural analgesia with an opioid alone (MD 0.60, 95% CI –0.81 to 2.01; 1 trial, 27 participants; very low-quality evidence).\nComplications\nIt was uncertain whether there was a difference in the risk of complications such as: respiratory depression (risk difference (RD) –0.05, 95% CI –0.16 to 0.05; 4 studies, 126 participants; very low-quality evidence); wound infection (RD 0.01, 95% CI –0.05 to 0.08; 2 trials, 93 participants; very low-quality evidence); epidural abscess (RD 0, 95% CI –0.05 to 0.05; 3 trials, 120 participants; very low-quality evidence); and neurological complications (RD 0.01, 95% CI –0.04 to 0.06; 4 studies, 151 participants; very low-quality evidence).\nAuthors' conclusions\nThere is moderate- and low-quality evidence that there may be a small additional reduction in pain up to 72 hours after surgery with epidural analgesia compared with systemic analgesia. Two very small studies showed epidural analgesia with local anaesthetic alone may accelerate the return of gastrointestinal function. The safety of this technique in children undergoing thoraco-lumbar surgery is uncertain due to the very low-quality of the evidence. The study in 'Studies awaiting classification' may alter the conclusions of the review once assessed.\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": "Some children need extensive spinal bone surgery. This is a very painful procedure. Traditionally, this pain has mostly been treated with an opioid such as systemic morphine (or morphine like medicine) given via an in injection into the veins, skin or muscles. Epidural analgesia involves giving pain relief medicine into a catheter inserted in the spine to block pain transmission to the brain. The catheter is a small tube usually placed by the surgeon, at the end of the surgery, in the space in the spinal canal known as the epidural space."
}
] |
query-laysum
|
7508
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic neck pain with radicular signs or symptoms is a common condition. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms.\nObjectives\nTo assess the efficacy of Chinese herbal medicines in treating chronic neck pain with radicular signs or symptoms.\nSearch methods\nWe electronically searched CENTRAL (The Cochrane Library 2009, issue 3), MEDLINE, EMBASE, CINAHL and AMED (beginning to October 1, 2009), the Chinese Biomedical Database and related herbal medicine databases in Japan and South Korea (1979 to 2007). We also contacted content experts and handsearched a number of journals published in China.\nSelection criteria\nWe included randomized controlled trials with adults with a clinical diagnosis of cervical degenerative disc disease, cervical radiculopathy or myelopathy supported by appropriate radiological findings. The interventions were Chinese herbal medicines, defined as products derived from raw or refined plants or parts of plants, minerals and animals that are used for medicinal purposes in any form. The primary outcome was pain relief, measured with a visual analogue scale, numeric scale or other validated tool.\nData collection and analysis\nThe data were independently extracted and recorded by two review authors on a pre-developed form. Risk of bias and clinical relevance were assessed separately by two review authors using the twelve criteria and the five questions recommended by the Cochrane Back Review Group. Disagreements were resolved by consensus.\nMain results\nAll four included studies were in Chinese; two of which were unpublished. Effect sizes were not clinically relevant and there was low quality evidence for all outcomes due to study limitations and sparse data (single studies). Two trials (680 participants) found that Compound Qishe Tablets relieved pain better in the short-term than either placebo or Jingfukang; one trial (60 participants) found than an oral herbal formula of Huangqi ((Radix Astragali)18 g, Dangshen (Radix Codonopsis) 9 g, Sanqi (Radix Notoginseng) 9 g, Chuanxiong (Rhizoma Chuanxiong)12 g, Lujiao (Cornu Cervi Pantotrichum) 12 g, and Zhimu (Rhizoma Anemarrhenae)12 g) relieved pain better than Mobicox or Methycobal and one trial (360 participants) showed that a topical herbal medicine, Compound Extractum Nucis Vomicae, relieved pain better than Diclofenac Diethylamine Emulgel.\nAuthors' conclusions\nThere is low quality evidence that an oral herbal medication, Compound Qishe Tablet, reduced pain more than placebo or Jingfukang and a topical herbal medicine, Compound Extractum Nucis Vomicae, reduced pain more than Diclofenac Diethylamine Emulgel. Further research is very likely to change both the effect size and our confidence in the results.\n\nGiven the provided abstract, please respond to the following query: \"Significance of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Degenerative changes of the cervical spine are quite common and can cause severe neck pain, impairment and decreased quality of life. Degenerative disc disease of the cervical spine can result in severe pain, instability and radiculopathy (pain spreading down the arms and into the head), myelopathy (spasticity and weakness of arms or hands, which may include \"numb and clumsy\" hands) or both. Chinese oral and topical herbal medicines are being used to treat many neck disorders. Some have been tested in clinical trials."
}
] |
query-laysum
|
7509
|
[
{
"role": "user",
"content": "Abstract: Background\nTobacco smoking is the leading preventable cause of death and disease worldwide. Stopping smoking can reduce this harm and many people would like to stop. There are a number of medicines licenced to help people quit globally, and e-cigarettes are used for this purpose in many countries. Typically treatments work by reducing cravings to smoke, thus aiding initial abstinence and preventing relapse. More information on comparative effects of these treatments is needed to inform treatment decisions and policies.\nObjectives\nTo investigate the comparative benefits, harms and tolerability of different smoking cessation pharmacotherapies and e-cigarettes, when used to help people stop smoking tobacco.\nSearch methods\nWe identified studies from recent updates of Cochrane Reviews investigating our interventions of interest. We updated the searches for each review using the Cochrane Tobacco Addiction Group (TAG) specialised register to 29 April 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs and factorial RCTs, which measured smoking cessation at six months or longer, recruited adults who smoked combustible cigarettes at enrolment (excluding pregnant people) and randomised them to approved pharmacotherapies and technologies used for smoking cessation worldwide (varenicline, cytisine, nortriptyline, bupropion, nicotine replacement therapy (NRT) and e-cigarettes) versus no pharmacological intervention, placebo (control) or another approved pharmacotherapy. Studies providing co-interventions (e.g. behavioural support) were eligible if the co-intervention was provided equally to study arms.\nData collection and analysis\nWe followed standard Cochrane methods for screening, data extraction and risk of bias (RoB) assessment (using the RoB 1 tool). Primary outcome measures were smoking cessation at six months or longer, and the number of people reporting serious adverse events (SAEs). We also measured withdrawals due to treatment. We used Bayesian component network meta-analyses (cNMA) to examine intervention type, delivery mode, dose, duration, timing in relation to quit day and tapering of nicotine dose, using odds ratios (OR) and 95% credibility intervals (CrIs). We calculated an effect estimate for combination NRT using an additive model. We evaluated the influence of population and study characteristics, provision of behavioural support and control arm rates using meta-regression. We evaluated certainty using GRADE.\nMain results\nOf our 332 eligible RCTs, 319 (835 study arms, 157,179 participants) provided sufficient data to be included in our cNMA. Of these, we judged 51 to be at low risk of bias overall, 104 at high risk and 164 at unclear risk, and 118 reported pharmaceutical or e-cigarette/tobacco industry funding. Removing studies at high risk of bias did not change our interpretation of the results.\nBenefits\nWe found high-certainty evidence that nicotine e-cigarettes (OR 2.37, 95% CrI 1.73 to 3.24; 16 RCTs, 3828 participants), varenicline (OR 2.33, 95% CrI 2.02 to 2.68; 67 RCTs, 16,430 participants) and cytisine (OR 2.21, 95% CrI 1.66 to 2.97; 7 RCTs, 3848 participants) were associated with higher quit rates than control. In absolute terms, this might lead to an additional eight (95% CrI 4 to 13), eight (95% CrI 6 to 10) and seven additional quitters per 100 (95% CrI 4 to 12), respectively. These interventions appeared to be more effective than the other interventions apart from combination NRT (patch and a fast-acting form of NRT), which had a lower point estimate (calculated additive effect) but overlapping 95% CrIs (OR 1.93, 95% CrI 1.61 to 2.34). There was also high-certainty evidence that nicotine patch alone (OR 1.37, 95% CrI 1.20 to 1.56; 105 RCTs, 37,319 participants), fast-acting NRT alone (OR 1.41, 95% CrI 1.29 to 1.55; 120 RCTs, 31,756 participants) and bupropion (OR 1.43, 95% CrI 1.26 to 1.62; 71 RCTs, 14,759 participants) were more effective than control, resulting in two (95% CrI 1 to 3), three (95% CrI 2 to 3) and three (95% CrI 2 to 4) additional quitters per 100 respectively.\nNortriptyline is probably associated with higher quit rates than control (OR 1.35, 95% CrI 1.02 to 1.81; 10 RCTs, 1290 participants; moderate-certainty evidence), resulting in two (CrI 0 to 5) additional quitters per 100. Non-nicotine/placebo e-cigarettes (OR 1.16, 95% CrI 0.74 to 1.80; 8 RCTs, 1094 participants; low-certainty evidence), equating to one additional quitter (95% CrI -2 to 5), had point estimates favouring the intervention over control, but CrIs encompassed the potential for no difference and harm. There was low-certainty evidence that tapering the dose of NRT prior to stopping treatment may improve effectiveness; however, 95% CrIs also incorporated the null (OR 1.14, 95% CrI 1.00 to 1.29; 111 RCTs, 33,156 participants). This might lead to an additional one quitter per 100 (95% CrI 0 to 2).\nHarms\nThere were insufficient data to include nortriptyline and non-nicotine EC in the final SAE model. Overall rates of SAEs for the remaining treatments were low (average 3%). Low-certainty evidence did not show a clear difference in the number of people reporting SAEs for nicotine e-cigarettes, varenicline, cytisine or NRT when compared to no pharmacotherapy/e-cigarettes or placebo. Bupropion may slightly increase rates of SAEs, although the CrI also incorporated no difference (moderate certainty). In absolute terms bupropion may cause one more person in 100 to experience an SAE (95% CrI 0 to 2).\nAuthors' conclusions\nThe most effective interventions were nicotine e-cigarettes, varenicline and cytisine (all high certainty), as well as combination NRT (additive effect, certainty not rated). There was also high-certainty evidence for the effectiveness of nicotine patch, fast-acting NRT and bupropion. Less certain evidence of benefit was present for nortriptyline (moderate certainty), non-nicotine e-cigarettes and tapering of nicotine dose (both low certainty).\nThere was moderate-certainty evidence that bupropion may slightly increase the frequency of SAEs, although there was also the possibility of no increased risk. There was no clear evidence that any other tested interventions increased SAEs. Overall, SAE data were sparse with very low numbers of SAEs, and so further evidence may change our interpretation and certainty.\nFuture studies should report SAEs to strengthen certainty in this outcome. More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these. Future work should unify data from behavioural and pharmacological interventions to inform approaches to combined support for smoking cessation.\n\nGiven the provided abstract, please respond to the following query: \"Why we did this Cochrane Review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out:\n- which treatments (medicines and e-cigarettes) help people to stop smoking;\n- how these treatments compare to each other;\n- whether there are ways of providing these treatments that mean they are more likely to help people stop smoking (e.g. different doses or treatment lengths);\n- whether these treatments are likely to cause serious harms; and\n- whether certain treatments are better tolerated, as indicated by fewer people leaving a study due to treatment."
}
] |
query-laysum
|
7510
|
[
{
"role": "user",
"content": "Abstract: Background\nPolicies and protocols vary widely for fetal surveillance in a pregnancy where the fetus is suspected to be large-for-gestational-age (LGA). All ultimately culminate in decisions about the mode and timing of birth. LGA is known to be associated with increased risks to both the mother and baby. Interventions based on surveillance regimen findings may be associated with risks to the mother and baby.\nObjectives\nTo assess the effectiveness or efficacy of different antenatal surveillance methods for the suspected LGA fetus on important health outcomes for the mother and baby.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 August 2015), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (21 August 2015).\nSelection criteria\nPublished and unpublished randomised, quasi-randomised and cluster-randomised trials comparing the effects of described antenatal fetal surveillance regimens for women with suspected LGA infants.\nData collection and analysis\nWe identified no studies that met the inclusion criteria for this review.\nMain results\nThere are no included trials.\nAuthors' conclusions\nWe found no randomised controlled trials that assessed the effect of antenatal fetal surveillance regimens of a suspected LGA fetus on important health outcomes for the mother and baby.\nThere has been a rise in the prevalence of LGA babies over the past few decades in many countries. Research is therefore required on regimens of antenatal surveillance of suspected LGA infants, in order to guide practice and improve the health outcomes for the mother and infant. In particular, randomised control trials to investigate whether serial antenatal clinic and ultrasound assessments of suspected LGA infants (including liquor volume and markers of fetal adiposity) would be useful, to assess whether surveillance methods improve health outcomes. In addition, as there are concerns that identifying suspected LGA fetuses may lead to unnecessary maternal anxiety, investigations and interventions, any such trial would need to assess the risks as well as benefits of regimens of fetal surveillance for suspected LGA fetuses.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A baby may sometimes grow to be bigger than expected and be born with a high birthweight. When overgrowth of the baby is suspected during a pregnancy the mother can have extra scheduled antenatal visits and tests to assess her health and the health of her developing baby."
}
] |
query-laysum
|
7511
|
[
{
"role": "user",
"content": "Abstract: Background\nHeart failure (HF) is a chronic disease with significant impact on quality of life and presents many challenges to those diagnosed with the condition, due to a seemingly complex daily regimen of self-care which includes medications, monitoring of weight and symptoms, identification of signs of deterioration and follow-up and interaction with multiple healthcare services. Education is vital for understanding the importance of this regimen, and adhering to it. Traditionally, education has been provided to people with heart failure in a face-to-face manner, either in a community or a hospital setting, using paper-based materials or video/DVD presentations. In an age of rapidly-evolving technology and uptake of smartphones and tablet devices, mHealth-based technology (defined by the World Health Organization as mobile and wireless technologies to achieve health objectives) is an innovative way to provide health education which has the benefit of being able to reach people who are unable or unwilling to access traditional heart failure education programmes and services.\nObjectives\nTo systematically review and quantify the potential benefits and harms of mHealth-delivered education for people with heart failure.\nSearch methods\nWe performed an extensive search of bibliographic databases and registries (CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, IEEE Xplore, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) Search Portal), using terms to identify HF, education and mHealth. We searched all databases from their inception to October 2019 and imposed no restriction on language of publication.\nSelection criteria\nWe included studies if they were conducted as a randomised controlled trial (RCT), involving adults (≥ 18 years) with a diagnosis of HF. We included trials comparing mHealth-delivered education such as internet and web-based education programmes for use on smartphones and tablets (including apps) and other mobile devices, SMS messages and social media-delivered education programmes, versus usual HF care.\nData collection and analysis\nTwo review authors independently selected studies, assessed risks of bias, and extracted data from all included studies. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the odds ratio (OR) for dichotomous data with a 95% confidence interval (CI). We assessed heterogeneity using the I2 statistic and assessed the quality of evidence using GRADE criteria.\nMain results\nWe include five RCTs (971 participants) of mHealth-delivered education interventions for people with HF in this review. The number of trial participants ranged from 28 to 512 participants. Mean age of participants ranged from 60 years to 75 years, and 63% of participants across the studies were men. Studies originated from Australia, China, Iran, Sweden, and The Netherlands. Most studies included participants with symptomatic HF, NYHA Class II - III.\nThree studies addressed HF knowledge, revealing that the use of mHealth-delivered education programmes showed no evidence of a difference in HF knowledge compared to usual care (MD 0.10, 95% CI −0.2 to 0.40, P = 0.51, I2 = 0%; 3 studies, 411 participants; low-quality evidence). One study assessing self-efficacy reported that both study groups had high levels of self-efficacy at baseline and uncertainty in the evidence for the intervention (MD 0.60, 95% CI −0.57 to 1.77; P = 0.31; 1 study, 29 participants; very low-quality evidence).Three studies evaluated HF self-care using different scales. We did not pool the studies due to the heterogenous nature of the outcome measures, and the evidence is uncertain. None of the studies reported adverse events. Four studies examined health-related quality of life (HRQoL). There was uncertainty in the evidence for the use of mHealth-delivered education on HRQoL (MD −0.10, 95% CI −2.35 to 2.15; P = 0.93, I2 = 61%; 4 studies, 942 participants; very low-quality evidence). Three studies reported on HF-related hospitalisation. The use of mHealth-delivered education may result in little to no difference in HF-related hospitalisation (OR 0.74, 95% CI 0.52 to 1.06; P = 0.10, I2 = 0%; 3 studies, 894 participants; low-quality evidence). We downgraded the quality of the studies due to limitations in study design and execution, heterogeneity, wide confidence intervals and fewer than 500 participants in the analysis.\nAuthors' conclusions\nWe found that the use of mHealth-delivered educational interventions for people with HF shows no evidence of a difference in HF knowledge; uncertainty in the evidence for self-efficacy, self-care and health-related quality of life; and may result in little to no difference in HF-related hospitalisations. The identification of studies currently underway and those awaiting classification indicate that this is an area of research from which further evidence will emerge in the short and longer term.\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": "What is the randomised controlled trial evidence for mHealth-delivered education interventions in heart failure (HF) knowledge, self-care and self-efficacy for people with HF when compared to traditional methods of patient education?"
}
] |
query-laysum
|
7512
|
[
{
"role": "user",
"content": "Abstract: Background\nTwo major determinants of cardiovascular disease (CVD) are a sedentary lifestyle and stress. Qigong involves physical exercise, mind regulation and breathing control to restore the flow of Qi (a pivotal life energy). As it is thought to help reduce stress and involves exercise, qigong may be an effective strategy for the primary prevention of CVD.\nObjectives\nTo determine the effectiveness of qigong for the primary prevention of CVD.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2014, Issue 10 of 12); MEDLINE (Ovid) (1946 to 2014 October week 4); EMBASE Classic + EMBASE (Ovid) (1947 to 2014 November 4); Web of Science Core Collection (1970 to 31 October 2014); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (November 2014, Issue 4 of 4). We searched several Asian databases (inception to July 2013) and the Allied and Complementary Medicine Database (AMED) (inception to December 2013), as well as trial registers and reference lists of reviews and articles; we also approached experts in the field and applied no language restrictions in our search.\nSelection criteria\nRandomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of qigong, and comparison groups provided no intervention or minimal intervention. Outcomes of interest included clinical CVD events and major CVD risk factors. We did not include trials that involved multi-factorial lifestyle interventions or weight loss.\nData collection and analysis\nTwo review authors independently selected trials for inclusion. Two review authors extracted data from included studies and assessed the risk of bias.\nMain results\nWe identified 11 completed trials (1369 participants) and one ongoing trial. Trials were heterogeneous in participants recruited, qigong duration and length of follow-up periods. We were unable to ascertain the risk of bias in nine trials published in Chinese, as insufficient methodological details were reported and we were unable to contact the study authors to clarify this.\nWe performed no meta-analyses, as trials were small and were at significant risk of bias. Clinical events were detailed in subsequent reports of two trials when statistically significant effects of qigong were seen for all-cause mortality, stroke mortality and stroke incidence at 20 to 30 years after completion of the trials. However, these trials were designed to examine outcomes in the short term, and it is not clear whether qigong was practised during extended periods of follow-up; therefore effects cannot be attributed to the intervention. None of the included studies reported other non-fatal CVD events.\nSix trials provided data that could be used to examine the effects of qigong on blood pressure. Reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were seen in three and two trials, respectively. Three trials examined the effects of qigong on blood lipids when favourable effects were seen in one trial for total cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides, and two trials showed favourable effects on high-density lipoprotein (HDL) cholesterol. The only trial considered at low risk of selection and detection bias did not demonstrate statistically significant effects on CVD risk factors with qigong, but this study was small and was underpowered. None of the included studies reported incidence of type 2 diabetes (T2D), adverse events, quality of life or costs.\nAuthors' conclusions\nCurrently, very limited evidence is available on the effectiveness of qigong for the primary prevention of CVD. Most of the trials included in this review are likely to be at high risk of bias, so we have very low confidence in the validity of the results. Publication of the ongoing trial will add to the limited evidence base, but further trials of high methodological quality with sufficient sample size and follow-up are needed to be incorporated in an update of this review before the effectiveness of qigong for CVD prevention can be established.\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 assessed the effectiveness of qigong interventions for reducing cardiovascular events and cardiovascular risk factors among healthy adults and those at high risk of cardiovascular disease."
}
] |
query-laysum
|
7513
|
[
{
"role": "user",
"content": "Abstract: Background\nAnorexia nervosa is a psychological condition characterised by self-starvation and fear or wait gain or other body image disturbance. The first line of treatment is specific psychological therapy; however, there is no consensus on best practice for treating people who develop severe and enduring anorexia nervosa (SEAN). Notably, there is no universal definition of SEAN.\nObjectives\nTo evaluate the benefits and harms of specific psychological therapies for severe and enduring anorexia nervosa compared with other specific therapies, non-specific therapies, no treatment/waiting list, antidepressant medication, dietary counselling alone, or treatment as usual.\nSearch methods\nWe used standard, extensive Cochrane search methods. The last search date was 22 July 2022.\nSelection criteria\nWe included parallel randomised controlled trials (RCTs) of people (any age) with anorexia nervosa of at least three years' duration. Eligible experimental interventions were any specific psychological therapy for improved physical and psychological health in anorexia nervosa, conducted in any treatment setting with no restrictions in terms of number of sessions, modality, or duration of therapy. Eligible comparator interventions included any other specific psychological therapy for anorexia nervosa, non-specific psychological therapy for mental health disorders, no treatment or waiting list, antipsychotic treatment (with or without psychological therapy), antidepressant treatment (with or without psychological therapy), dietary counselling, and treatment as usual as defined by the individual trials.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcomes were clinical improvement (weight restoration to within the normal weight range for participant sample) and treatment non-completion. Results were presented using the GRADE appraisal tool.\nMain results\nWe found two eligible studies, but only one study provided usable data. This was a parallel-group RCT of 63 adults with SEAN who had an illness duration of at least seven years. The trial compared outpatient cognitive behaviour therapy for SEAN (CBT-SEAN) with specialist supportive clinical management for SEAN (SSCM-SE) over eight months. It is unclear if there is any difference between the effect of CBT-SEAN versus SSCM-SE on clinical improvement at 12 months (risk ratio (RR) 1.42, 95% confidence interval (CI) 0.66 to 3.05) or treatment non-completion (RR 1.72, 95% CI 0.45 to 6.59). There were no reported data on adverse effects. The trial was at high risk of performance and detection bias.\nWe rated the GRADE level of evidence as very low-certainty for both primary outcomes, downgrading for imprecision and risk of bias concerns.\nAuthors' conclusions\nThis review reports evidence from one trial that evaluated CBT-SEAN versus SSCM-SE. There was very low-certainty evidence of little or no difference in clinical improvement and treatment non-completion between the two therapies. There is a need for larger high-quality trials to determine the benefits of specific psychological therapies for people with SEAN. These should take into account the duration of illness as well as participants' previous experience with evidence-based psychological therapy for anorexia nervosa.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Anorexia nervosa is an eating disorder and serious mental illness. People with anorexia nervosa normally have a very low bodyweight, an intense fear of gaining weight, and a distorted perception of their weight. The main treatment for anorexia nervosa is specific psychological therapy combined with multidisciplinary physical and nutritional health care. The main available therapies are cognitive behaviour therapy (CBT), specialist supportive clinical management (SSCM), the Maudsley therapy for adults with anorexia nervosa (MANTRA), and focal psychodynamic therapy (FPT). They all provide advice and counselling on nutrition and physical care, but they differ in their psychological focus. CBT addresses the thoughts (cognitions) that underpin the behaviours of anorexia nervosa, such as fear of fatness, and provides active behavioural strategies (e.g. gentle reintroduction of foods that cause anxiety). SSCM provides supportive therapy and goal setting. MANTRA focusses on helping the person think more freely and finding reasons for change. FPT helps the person work through past relational experiences and explore parts of their identity that underpin the eating disorder. Some people with anorexia nervosa do not improve with usual treatments and develop a severe and enduring form of the illness that is very debilitating. There is very little published evidence to help clinicians manage people with severe and enduring anorexia nervosa (SEAN); in fact, there is not even a universal definition for this condition."
}
] |
query-laysum
|
7514
|
[
{
"role": "user",
"content": "Abstract: Background\nDry eye disease (DED), arising from various etiologic factors, leads to tear film instability, ocular surface damage, and neurosensory changes. DED causes symptoms such as ocular dryness, burning, itching, pain, and visual impairment. Given their well-established anti-inflammatory effects, topical steroid preparations have been widely used as a short-term treatment option for DED. Because of potential risks of ocular hypertension, cataracts, and infections associated with the long-term use of topical steroids, published trials comparing the efficacy and safety of topical steroids (versus placebo) have mostly been of short duration (three to eight weeks).\nObjectives\nTo evaluate the effectiveness and safety of topical corticosteroids compared with no treatment, placebo, other steroidal or non-steroidal therapies, or a combination of therapies for DED.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 8); Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Sciences database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), without restriction on language or year of publication. The date of the last search was 20 August 2021.\nSelection criteria\nWe included randomized controlled trials (RCTs) in which topical corticosteroids, alone or in combination with tobramycin, were compared with no treatment, artificial tears (AT), vehicles, AT plus tobramycin, or cyclosporine A (CsA).\nData collection and analysis\nWe applied standard Cochrane methodology.\nMain results\nWe identified 22 RCTs conducted in the USA, Italy, Spain, China, South Korea, and India. These RCTs reported outcome data from a total of 4169 participants with DED.\nStudy characteristics and risk of bias\nAll trials recruited adults aged 18 years or older, except one trial that enrolled children and adolescents aged between 3 and 14 years. Half of these trials involved predominantly female participants (median 79%, interquartile range [IQR] 76% to 80%). On average, each trial enrolled 86 participants (IQR 40 to 158). The treatment duration of topical steroids ranged between one week and three months; trial duration lasted between one week and six months. Eight trials were sponsored exclusively by industry, and four trials were co-sponsored by industry and institutional or governmental funds. We assessed the risk of bias of both subjective and objective outcomes using RoB 2, finding nearly half of the trials to be at high risk of bias associated with selective outcome reporting.\nFindings\nOf the 22 trials, 16 evaluated effects of topical steroids, alone or in combination with tobramycin, as compared with lubricants (AT, vehicle), AT plus tobramycin, or no treatment. Corticosteroids probably have a small to moderate effect on improving patient-reported symptoms by 0.29 standardized mean difference (SMD) (95% confidence interval [CI] 0.16 to 0.42) as compared with lubricants (moderate certainty evidence). Topical steroids also likely have a small to moderate effect on lowering corneal staining scores by 0.4 SMDs (95% CI 0.18 to 0.62) (moderate certainty evidence). However, steroids may increase tear film break-up time (TBUT) slightly (mean difference [MD] 0.70 s, 95% CI 0.06 to 1.34; low certainty evidence) but not tear osmolarity (MD 1.60 mOsm/kg, 95% CI −10.47 to 13.67; very low certainty evidence).\nSix trials examined topical steroids, either alone or in combination with CsA, against CsA alone. Low certainty evidence indicates that steroid-based interventions may have a small to moderate effect on improving participants' symptoms (SMD −0.33, 95% CI −0.51 to −0.15), but little to no effect on corneal staining scores (SMD 0.05, 95% CI −0.25 to 0.35) as compared with CsA. The effect of topical steroids compared to CsA alone on TBUT (MD 0.37 s, 95% CI −0.13 to 0.87) or tear osmolarity (MD 5.80 mOsm/kg, 95% CI −0.94 to 12.54; loteprednol etabonate alone) is uncertain because the certainty of the evidence is low or very low. None of the included trials reported on quality of life scores.\nAdverse effects\nThe evidence for adverse ocular effects of topical corticosteroids is very uncertain. Topical corticosteroids may increase participants' risk of intraocular pressure (IOP) elevation (risk ratio [RR] 5.96, 95% CI 1.30 to 27.38) as compared with lubricants. However, when compared with CsA, steroids alone or combined with CsA may decrease or increase IOP elevation (RR 1.45, 95% CI 0.25 to 8.33). It is also uncertain whether topical steroids may increase risk of cataract formation when compared with lubricants (RR 0.34, 95% CI 0.01 to 8.22), given the short-term use and study duration (four weeks or less) to observe longer-term adverse effects.\nAuthors' conclusions\nOverall, the evidence for the specified review outcomes was of moderate to very low certainty, mostly due to high risk of bias associated with selective results reporting. For dry eye patients whose symptoms require anti-inflammatory control, topical corticosteroids probably provide small to moderate degrees of symptom relief beyond lubricants, and may provide small to moderate degrees of symptom relief beyond CsA. However, the current evidence is less certain about the effects of steroids on improved tear film quality or quantity. The available evidence is also very uncertain regarding the adverse effects of topical corticosteroids on IOP elevation or cataract formation or progression. Future trials should generate high certainty evidence to inform physicians and patients of the optimal treatment strategies with topical corticosteroids in terms of regimen (types, formulations, dosages), duration, and its time-dependent adverse profile.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "More than half of the included trials had flawed study methods or did not report their results fully. These deficiencies led to concerns about the study findings and decreased our confidence in the evidence generated in this systematic review."
}
] |
query-laysum
|
7515
|
[
{
"role": "user",
"content": "Abstract: Background\nBetween 40% and 70% of people with treatment-resistant schizophrenia do not respond to clozapine, despite adequate blood levels. For these people, a number of treatment strategies have emerged, including the prescription of a second anti-psychotic drug in combination with clozapine.\nObjectives\nTo determine the clinical effects of various clozapine combination strategies with antipsychotic drugs in people with treatment-resistant schizophrenia both in terms of efficacy and tolerability.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Study-Based Register of Trials (to 28 August 2015) and MEDLINE (November 2008). We checked the reference lists of all identified randomised controlled trials (RCT). For the first version of the review, we also contacted pharmaceutical companies to identify further trials.\nSelection criteria\nWe included only RCTs recruiting people of both sexes, aged 18 years or more, with a diagnosis of treatment-resistant schizophrenia (or related disorders) and comparing clozapine plus another antipsychotic drug with clozapine plus a different antipsychotic drug.\nData collection and analysis\nWe extracted data independently. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CI) on an intention-to-treat basis using a random-effects meta-analysis. For continuous data, we calculated mean differences (MD) and 95% CIs. We used GRADE to create 'Summary of findings' tables and assessed risk of bias for included studies.\nMain results\nWe identified two further studies with 169 participants that met our inclusion criteria. This review now includes five studies with 309 participants. The quality of evidence was low, and, due to the high degree of heterogeneity between studies, we were unable to undertake a formal meta-analysis to increase the statistical power.\nFor this update, we specified seven main outcomes of interest: clinical response in mental state (clinically significant response, mean score/change in mental state), clinical response in global state (mean score/change in global state), weight gain, leaving the study early (acceptability of treatment), service utilisation outcomes (hospital days or admissions to hospital) and quality of life.\nWe found some significant differences between clozapine combination strategies for global and mental state (clinically significant response and change), and there were data for leaving the study early and weight gain. We found no data for service utilisation and quality of life.\nClozapine plus aripiprazole versus clozapine plus haloperidol\nThere was no long-term significant difference between aripiprazole and haloperidol combination strategies in change of mental state (1 RCT, n = 105, MD 0.90, 95% CI -4.38 to 6.18, low quality evidence). There were no adverse effect data for weight gain but there was a benefit of aripiprazole for adverse effects measured by the LUNSERS at 12 weeks (1 RCT, n = 105, MD -4.90, 95% CI -8.48 to -1.32) and 24 weeks (1 RCT, n = 105, MD -4.90, 95% CI -8.25 to -1.55), but not 52 weeks (1 RCT, n = 105, MD -4.80, 95% CI -9.79 to 0.19). Similar numbers of participants from each group left the study early (1 RCT, n = 106, RR 1.27, 95% CI 0.72 to 2.22, very low quality evidence).\nClozapine plus amisulpride versus clozapine plus quetiapine\nOne study showed a significant benefit of amisulpride over quetiapine in the short term, for both change in global state (Clinical Global Impression (CGI): 1 RCT, n = 50, MD -0.90, 95% CI -1.38 to -0.42, very low quality evidence) and mental state (Brief Psychiatric Rating Scale (BPRS): 1 RCT, n = 50, MD -4.00, 95% CI -5.86 to -2.14, low quality evidence). Similar numbers of participants from each group left the study early (1 RCT, n = 56, RR 0.20, 95% CI 0.02 to 1.60, very low quality evidence)\nClozapine plus risperidone versus clozapine plus sulpiride\nThere was no difference between risperidone and sulpiride for clinically significant response, defined by the study as 20% to 50% reduction in Positive and Negative Syndrome Scale (PANSS) (1 RCT, n = 60, RR 0.82, 95% CI 0.40 to 1.68, very low quality evidence). There were similar equivocal results for weight gain (1 RCT, n = 60, RR 0.40, 95% CI 0.08 to 1.90, very low quality evidence) and mental state (PANSS total: 1 RCT, n = 60, MD -2.28, 95% CI -7.41 to 2.85, very low quality evidence). No-one left the study early.\nClozapine plus risperidone versus clozapine plus ziprasidone\nThere was no difference between risperidone and ziprasidone for clinically significant response (1 RCT, n = 24, RR 0.80, 95% CI 0.28 to 2.27, very low quality evidence), change in global state CGI-II score (1 RCT, n = 22, MD -0.30, 95% CI -0.82 to 0.22, very low quality evidence), change in PANSS total score (1 RCT, n = 16, MD 1.00, 95% CI -7.91 to 9.91, very low quality evidence) or leaving the study early (1 RCT, n = 24, RR 1.60, 95% CI 0.73 to 3.49, very low quality evidence).\nClozapine plus ziprasidone versus clozapine plus quetiapine\nOne study found, in the medium term, a superior effect for ziprasidone combination compared with quetiapine combination for clinically significant response in mental state (> 50% reduction PANSS: 1 RCT, n = 63, RR 0.54, 95% CI 0.35 to 0.81, low quality evidence), global state (CGI - Severity score: 1 RCT, n = 60, MD -0.70, 95% CI -1.18 to -0.22, low quality evidence) and mental state (PANSS total score: 1 RCT, n = 60, MD -12.30, 95% CI -22.43 to -2.17, low quality evidence). There was no effect for leaving the study early (1 RCT, n = 63, RR 0.52, CI 0.05 to 5.41, very low quality evidence).\nAuthors' conclusions\nThe reliability of results from this review is limited, evidence is of low or very low quality. Furthermore, due to the limited number of included studies, we were unable to undertake formal meta-analyses. As a consequence, any conclusions drawn from these findings are based on single, small-sized RCTs with high risk of type II error. Properly conducted and adequately powered RCTs are required. Future trialists should seek to measure patient-important outcomes such as quality of life, as well as clinical response and adverse effects.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the Cochrane Schizophrenia Group Trial's Register in August 2015 and January 2016 and found five clinical studies involving 309 adults diagnosed with schizophrenia or related illnesses who were resistant to treatment but had shown some response to clozapine. The studies compared clozapine combined with the antipsychotic medicines (haloperidol, aripiprazole, amisulpride, quetiapine, sulpiride, ziprasidone and risperidone)."
}
] |
query-laysum
|
7516
|
[
{
"role": "user",
"content": "Abstract: Background\nHereditary angioedema (HAE) is a serious and potentially life-threatening condition that causes acute attacks of swelling, pain and reduced quality of life. People with Type I HAE (approximately 80% of all HAE cases) have insufficient amounts of C1 esterase inhibitor (C1-INH) protein; people with Type II HAE (approximately 20% of all cases) may have normal C1-INH concentrations, but, due to genetic mutations, these do not function properly. A few people, predominantly females, experience HAE despite having normal C1-INH levels and C1-INH function (rare Type III HAE). Several new drugs have been developed to treat acute attacks and prevent recurrence of attacks. There is currently no systematic review and meta-analysis that included all preventive medications for HAE.\nObjectives\nTo assess the benefits and harms of interventions for the long-term prevention of HAE attacks in people with Type I, Type II or Type III HAE.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 3 August 2021.\nSelection criteria\nWe included randomised controlled trials in children or adults with HAE that used medications to prevent HAE attacks. The comparators could be placebo or active comparator, or both; approved and experimental drug trials were eligible for inclusion. There were no restrictions on dose, frequency or intensity of treatment. The minimum length of four weeks of treatment was required for inclusion; this criterion excluded the acute treatment of HAE attacks.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. HAE attacks (number of attacks per person, per population) and change in number of HAE attacks; 2. mortality and 3. serious adverse events (e.g. hepatic dysfunction, hepatic toxicity and deleterious changes in blood tests). Our secondary outcomes were 4. quality of life; 5. severity of breakthrough attacks; 6. disability and 7. adverse events (e.g. weight gain, mild psychological changes and body hair). We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified 15 studies (912 participants) that met the inclusion criteria. The studies included people with Type I and II HAE. The studies investigated avoralstat, berotralstat, subcutaneous C1-INH, plasma-derived C1-INH, nanofiltered C1-INH, recombinant human C1-INH, danazol, and lanadelumab for the prevention of HAE attacks. We did not find any studies on the use of tranexamic acid for prevention of HAE attacks.\nAll drugs except avoralstat reduced the number of HAE attacks compared with placebo. For breakthrough attacks that occurred despite prophylactic treatment, intravenous and subcutaneous forms of C1-INH and lanadelumab reduced attack severity. It is not known whether other drugs have a similar effect, as the severity of breakthrough attacks in people taking drugs other than C1-INH and lanadelumab was not reported.\nFor quality of life, avoralstat, berotralstat, C1-INH (all forms) and lanadelumab increased quality of life compared with placebo; there were no data for danazol. Four studies reported on changes in disability during treatment with C1-INH, berotralstat and lanadelumab; all three drugs decreased disability compared with placebo.\nAdverse events, including serious adverse events, did not occur at a rate higher than placebo. However, serious adverse event data and other adverse event data were not available for danazol, which prevented us from drawing conclusions about the absolute or relative safety of this drug. No deaths were reported in the included studies.\nThe analysis was limited by the small number of studies, the small number of participants in each study and the lack of data on older drugs, therefore the certainty of the evidence is low. Given the rarity of HAE, it is not surprising that drugs were rarely directly compared, which does not allow conclusions on the comparative efficacy of the various drugs for people with HAE.\nFinally, we did not identify any studies that included people with Type III HAE. Therefore, we cannot draw any conclusions about the efficacy or safety of any drug in people with this form of HAE.\nAuthors' conclusions\nThe available data suggest that berotralstat, C1-INH (subcutaneous, plasma-derived, nanofiltered and recombinant), danazol and lanadelumab are effective in lowering the risk or incidence (or both) of HAE attacks. In addition, C1-INH and lanadelumab decrease the severity of breakthrough attacks (data for other drugs were not available). Avoralstat, berotralstat, C1-INH (all forms) and lanadelumab increase quality of life and do not increase the risk of adverse events, including serious adverse events. It is possible that danazol, subcutaneous C1-INH and recombinant human C1-INH are more effective than berotralstat and lanadelumab in reducing the risk of breakthrough attacks, but the small number of studies and the small size of the studies means that the certainty of the evidence is low. This and the lack of head-to-head trials prevented us from drawing firm conclusions on the relative efficacy of the drugs.\n\nGiven the provided abstract, please respond to the following query: \"What is hereditary angioedema and how is it treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Hereditary angioedema (HAE) is a serious and potentially life-threatening condition that causes acute (sudden onset) attacks of swelling, pain and reduced quality of life. Several new medicines have been developed to treat acute attacks and prevent attacks from occurring. Some medicines are taken by mouth, whereas others are injected under the skin, or given by a vein directly into the blood.\nThe medicines currently given for preventing HAE attacks are human C1 esterase inhibitor (often abbreviated as C1-INH), berotralstat, lanadelumab, tranexamic acid, and danazol. In addition, we found a further medicine (avoralstat) that is currently being studied for its ability to prevent HAE attacks."
}
] |
query-laysum
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7517
|
[
{
"role": "user",
"content": "Abstract: Background\nBipolar disorder is one of the most common serious mental illnesses, affecting approximately 60 million people worldwide. Characterised by extreme alterations in mood, cognition, and behaviour, bipolar disorder can have a significant negative impact on the functioning and quality of life of the affected individual. Compared with the general population, the prevalence of comorbid obesity is significantly higher in bipolar disorder. Approximately 68% of treatment seeking bipolar patients are overweight or obese. Clinicians are aware that obesity has the potential to contribute to other physical health conditions in people with bipolar disorder, including diabetes, hypertension, metabolic syndrome, cardiovascular disease, and coronary heart disease. Cardiovascular disease is the leading cause of premature death in bipolar disorder, happening a decade or more earlier than in the general population. Contributing factors include illness-related factors (mood-related factors, i.e. mania or depression), treatment-related factors (weight implications and other side effects of medications), and lifestyle factors (physical inactivity, poor diet, smoking, substance abuse). Approaches to the management of obesity in individuals with bipolar disorder are diverse and include non-pharmacological interventions (i.e. dietary, exercise, behavioural, or multi-component), pharmacological interventions (i.e. weight loss drugs or medication switching), and bariatric surgery.\nObjectives\nTo assess the effectiveness of interventions for the management of obesity in people with bipolar disorder.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) and the Cochrane Central Register for Controlled Trials (CENTRAL) to February 2019. We ran additional searches via Ovid databases including MEDLINE, Embase, and PsycInfo to May 2020. We searched the World Health Organization (WHO) trials portal (International Clinical Trials Registry Platform (ICTRP)) and ClinicalTrials.gov. We also checked the reference lists of all papers brought to full-text stage and all relevant systematic reviews.\nSelection criteria\nRandomised controlled trials (RCTs), randomised at the level of the individual or cluster, and cross-over designs of interventions for management of obesity, in which at least 80% of study participants had a clinical diagnosis of bipolar disorder and comorbid obesity (body mass index (BMI) ≥ 30 kg/m²), were eligible for inclusion. No exclusions were based on type of bipolar disorder, stage of illness, age, or gender. We included non-pharmacological interventions comprising dietary, exercise, behavioural, and multi-component interventions; pharmacological interventions consisting of weight loss medications and medication switching interventions; and surgical interventions such as gastric bypass, gastric bands, biliopancreatic diversion, and vertical banded gastroplasty. Comparators included the following approaches: dietary intervention versus inactive comparator; exercise intervention versus inactive comparator; behavioural intervention versus inactive comparator; multi-component lifestyle intervention versus inactive comparator; medication switching intervention versus inactive comparator; weight loss medication intervention versus inactive comparator; and surgical intervention versus inactive comparator. Primary outcomes of interest were changes in body mass, patient-reported adverse events, and quality of life.\nData collection and analysis\nFour review authors were involved in the process of selecting studies. Two review authors independently screened the titles and abstracts of studies identified in the search. Studies brought to the full-text stage were then screened by another two review authors working independently. However, none of the full-text studies met the inclusion criteria. Had we included studies, we would have assessed their methodological quality by using the criteria recommended in the Cochrane Handbook for Systematic Reviews of Interventions. We intended to combine dichotomous data using risk ratios (RRs), and continuous data using mean differences (MDs). For each outcome, we intended to calculate overall effect size with 95% confidence intervals (CIs).\nMain results\nNone of the studies that were screened met the inclusion criteria.\nAuthors' conclusions\nNone of the studies that were assessed met the inclusion criteria of this review. Therefore we were unable to determine the effectiveness of interventions for the management of obesity in individuals with bipolar disorder. Given the extent and impact of the problem and the absence of evidence, this review highlights the need for research in this area. We suggest the need for RCTs that will focus only on populations with bipolar disorder and comorbid obesity. We identified several ongoing studies that may be included in the update of this review.\n\nGiven the provided abstract, please respond to the following query: \"Authors' conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
7518
|
[
{
"role": "user",
"content": "Abstract: Background\nDysmenorrhoea (painful menstrual cramps) is common and a major cause of pain in women. Combined oral contraceptives (OCPs) are often used in the management of primary dysmenorrhoea, but there is a need for reporting the benefits and harms. Primary dysmenorrhoea is defined as painful menstrual cramps without pelvic pathology.\nObjectives\nTo evaluate the benefits and harms of combined oral contraceptive pills for the management of primary dysmenorrhoea.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date 28 March 2023.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing all combined OCPs with other combined OCPs, placebo, or management with non-steroidal anti-inflammatory drugs (NSAIDs). Participants had to have primary dysmenorrhoea, diagnosed by ruling out pelvic pathology through pelvic examination or ultrasound.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary outcomes were pain score after treatment, improvement in pain, and adverse events.\nMain results\nWe included 21 RCTs (3723 women). Eleven RCTs compared combined OCP with placebo, eight compared different dosages of combined OCP, one compared two OCP regimens with placebo, and one compared OCP with NSAIDs.\nOCP versus placebo or no treatment\nOCPs reduce pain in women with dysmenorrhoea more effectively than placebo. Six studies reported treatment effects on different scales; the result can be interpreted as a moderate reduction in pain (standardised mean difference (SMD) −0.58, 95% confidence interval (CI) −0.74 to −0.41; I² = 28%; 6 RCTs, 588 women; high-quality evidence). Six studies also reported pain improvement as a dichotomous outcome (risk ratio (RR) 1.65, 95% CI 1.29 to 2.10; I² = 69%; 6 RCTs, 717 women; low-quality evidence). The data suggest that in women with a 28% chance of improvement in pain with placebo or no treatment, the improvement in women using combined OCP will be between 37% and 60%.\nCompared to placebo or no treatment, OCPs probably increase the risk of any adverse events (RR 1.31, 95% CI 1.20 to 1.43; I² = 79%; 7 RCTs, 1025 women; moderate-quality evidence), and may also increase the risk of serious adverse events (RR 1.77, 95% CI 0.49 to 6.43; I² = 22%; 4 RCTs, 512 women; low-quality evidence).\nWomen who received OCPs had an increased risk of irregular bleeding compared to women who received placebo or no treatment (RR 2.63, 95% CI 2.11 to 3.28; I² = 29%; 7 RCTs, 1025 women; high-quality evidence). In women with a risk of irregular bleeding of 18% if using placebo or no treatment, the risk would be between 39% and 60% if using combined OCP. OCPs probably increase the risk of headaches (RR 1.51, 95% CI 1.11 to 2.04; I² = 44%; 5 RCTs, 656 women; moderate-quality evidence), and nausea (RR 1.64, 95% CI 1.17 to 2.30; I² = 39%; 8 RCTs, 948 women; moderate-quality evidence). We are uncertain of the effect of OCP on weight gain (RR 1.83, 95% CI 0.75 to 4.45; 1 RCT, 76 women; low-quality evidence). OCPs may slightly reduce requirements for additional medication (RR 0.63, 95% CI 0.40 to 0.98; I² = 0%; 2 RCTs, 163 women; low-quality evidence), and absence from work (RR 0.63, 95% CI 0.41 to 0.97; I² = 0%; 2 RCTs, 148 women; low-quality evidence).\nOne OCP versus another OCP\nContinuous use of OCPs (no pause or inactive tablets after the usual 21 days of hormone pills) may reduce pain in women with dysmenorrhoea more effectively than the standard regimen (SMD −0.73, 95% CI −1.13 to 0.34; 2 RCTs, 106 women; low-quality evidence). There was insufficient evidence to determine if there was a difference in pain improvement between ethinylestradiol 20 μg and ethinylestradiol 30 μg OCPs (RR 1.06, 95% CI 0.65 to 1.74; 1 RCT, 326 women; moderate-quality evidence). There is probably little or no difference between third- and fourth-generation and first- and second-generation OCPs (RR 0.99, 95% CI 0.93 to 1.05; 1 RCT, 178 women; moderate-quality evidence). The standard regimen of OCPs may slightly increase the risk of any adverse events over the continuous regimen (RR 1.11, 95% CI 1.01 to 1.22; I² = 76%; 3 RCTs, 602 women; low-quality evidence), and probably increases the risk of irregular bleeding (RR 1.38, 95% CI 1.14 to 1.69; 2 RCTs, 379 women; moderate-quality evidence). Due to lack of studies, it is uncertain if there is a difference between continuous and standard regimen OCPs in serious adverse events (RR 0.34, 95% CI 0.01 to 8.24; 1 RCT, 212 women), headaches (RR 0.94, 95% CI 0.50 to 1.76; I² = 0%; 2 RCTs, 435 women), or nausea (RR 1.08, 95% CI 0.51 to 2.30; I² = 23%; 2 RCTs, 435 women) (all very low-quality evidence).\nWe are uncertain if one type of OCP reduces absence from work more than the other (RR 1.12, 95% CI 0.64 to 1.99; 1 RCT, 445 women; very low-quality evidence).\nOCPs versus NSAIDs\nThere were insufficient data to determine whether OCPs were more effective than NSAIDs for pain (mean difference −0.30, 95% CI −5.43 to 4.83; 1 RCT, 91 women; low-quality evidence). The study did not report on adverse events.\nAuthors' conclusions\nOCPs are effective for treating dysmenorrhoea, but they cause irregular bleeding, and probably headache and nausea. Long-term effects were not covered in this review. Continuous use of OCPs was probably more effective than the standard regimen but safety should be ensured with long-term data. Due to lack of data, we are uncertain whether NSAIDs are better than OCPs for treating dysmenorrhoea.\n\nGiven the provided abstract, please respond to the following query: \"OCP compared to a non-steroidal anti-inflammatory medicine\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Due to low-quality evidence, we were unable to determine whether OCPs were more effective than non-steroidal anti-inflammatory medicines. Side effects were not reported."
}
] |
query-laysum
|
7520
|
[
{
"role": "user",
"content": "Abstract: Background\nFolate is a B-vitamin required for DNA synthesis, methylation, and cellular division. Wheat and maize (corn) flour are staple crops consumed widely throughout the world and have been fortified with folic acid in over 80 countries to prevent neural tube defects. Folic acid fortification may be an effective strategy to improve folate status and other health outcomes in the overall population.\nObjectives\nTo evaluate the health benefits and safety of folic acid fortification of wheat and maize flour (i.e. alone or in combination with other micronutrients) on folate status and health outcomes in the overall population, compared to wheat or maize flour without folic acid (or no intervention).\nSearch methods\nWe searched the following databases in March and May 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, Embase, CINAHL, Web of Science (SSCI, SCI), BIOSIS, Popline, Bibliomap, TRoPHI, ASSIA, IBECS, SCIELO, Global Index Medicus-AFRO and EMRO, LILACS, PAHO, WHOLIS, WPRO, IMSEAR, IndMED, and Native Health Research Database. We searched the International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing or planned studies in June 2018, and contacted authors for further information.\nSelection criteria\nWe included randomised controlled trials (RCTs), with randomisation at the individual or cluster level. We also included non-RCTs and prospective observational studies with a control group; these studies were not included in meta-analyses, although their characteristics and findings were described. Interventions included wheat or maize flour fortified with folic acid (i.e. alone or in combination with other micronutrients), compared to unfortified flour (or no intervention). Participants were individuals over two years of age (including pregnant and lactating women), from any country.\nData collection and analysis\nTwo review authors independently assessed study eligibility, extracted data, and assessed risk of bias.\nMain results\nWe included 10 studies: four provided data for quantitative analyses (437 participants); five studies were randomised trials (1182 participants); three studies were non-RCTs (1181 participants, 8037 live births); two studies were interrupted time series (ITS) studies (1 study population of 2,242,438, 1 study unreported). Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada). Seven studies examined wheat flour fortified with folic acid alone or with other micronutrients. Three studies included maize flour fortified with folic acid alone or with other micronutrients. The duration of interventions ranged from two weeks to 36 months, and the ITS studies included postfortification periods of up to seven years. Most studies had unclear risk of bias for randomisation, blinding, and reporting, and low/unclear risk of bias for attrition and contamination.\nNeural tube defects: none of the included RCTs reported neural tube defects as an outcome. In one non-RCT, wheat flour fortified with folic acid and other micronutrients was associated with significantly lower occurrence of total neural tube defects, spina bifida, and encephalocoele, but not anencephaly, compared to unfortified flour (total neural tube defects risk ratio (RR) 0.32, 95% confidence interval (CI) 0.21 to 0.48; 1 study, 8037 births; low-certainty evidence).\nFolate status: pregnant women who received folic acid-fortified maize porridge had significantly higher erythrocyte folate concentrations (mean difference (MD) 238.90 nmol/L, 95% CI 149.40 to 328.40); 1 study, 38 participants; very low-certainty evidence) and higher plasma folate (MD 14.98 nmol/L, 95% CI 9.63 to 20.33; 1 study, 38 participants; very low-certainty evidence), compared to no intervention. Women of reproductive age consuming maize flour fortified with folic acid and other micronutrients did not have higher erythrocyte folate (MD -61.80 nmol/L, 95% CI -152.98 to 29.38; 1 study, 35 participants; very low-certainty evidence) or plasma folate (MD 0.00 nmol/L, 95% CI -0.00 to 0.00; 1 study, 35 participants; very low-certainty evidence) concentrations, compared to women consuming unfortified maize flour. Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour. In two non-RCTs, serum folate concentrations were significantly higher among women who consumed flour fortified with folic acid and other micronutrients compared to women who consumed unfortified flour (MD 2.92 nmol/L, 95% CI 1.99 to 3.85; 2 studies, 657 participants; very low-certainty evidence).\nHaemoglobin or anaemia: in a cluster-randomised trial among children, there were no significant effects of fortified wheat flour flatbread on haemoglobin concentrations (MD 0.00 nmol/L, 95% CI -2.08 to 2.08; 1 study, 334 participants; low-certainty evidence) or anaemia (RR 1.07, 95% CI 0.74 to 1.55; 1 study, 334 participants; low-certainty evidence), compared to unfortified wheat flour flatbread.\nAuthors' conclusions\nFortification of wheat flour with folic acid may reduce the risk of neural tube defects; however, this outcome was only reported in one non-RCT. Fortification of wheat or maize flour with folic acid (i.e. alone or with other micronutrients) may increase erythrocyte and serum/plasma folate concentrations. Evidence is limited for the effects of folic acid-fortified wheat or maize flour on haemoglobin levels or anaemia. The effects of folic acid fortification of wheat or maize flour on other primary outcomes assessed in this review is not known. No studies reported on the occurrence of adverse effects. Limitations of this review were the small number of studies and participants, limitations in study design, and low-certainty of evidence due to how included studies were designed and reported.\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 conducted the literature search in March and May 2018. We included 10 studies; four studies provided data for meta-analyses. Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada). Seven studies examined the effects of wheat flour fortified with folic acid alone (3 studies) or with other micronutrients (4 studies). Three studies assessed the effects of maize flour fortified with folic acid alone (1 study) or with other micronutrients (two studies)."
}
] |
query-laysum
|
7521
|
[
{
"role": "user",
"content": "Abstract: Background\nRehabilitation based upon research evidence gives stroke survivors the best chance of recovery. There is substantial research to guide practice in stroke rehabilitation, yet uptake of evidence by healthcare professionals is typically slow and patients often do not receive evidence-based care. Implementation interventions are an important means to translate knowledge from research to practice and thus optimise the care and outcomes for stroke survivors. A synthesis of research evidence is required to guide the selection and use of implementation interventions in stroke rehabilitation.\nObjectives\nTo assess the effects of implementation interventions to promote the uptake of evidence-based practices (including clinical assessments and treatments recommended in evidence-based guidelines) in stroke rehabilitation and to assess the effects of implementation interventions tailored to address identified barriers to change compared to non-tailored interventions in stroke rehabilitation.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and eight other databases to 17 October 2019. We searched OpenGrey, performed citation tracking and reference checking for included studies and contacted authors of included studies to obtain further information and identify potentially relevant studies.\nSelection criteria\nWe included individual and cluster randomised trials, non-randomised trials, interrupted time series studies and controlled before-after studies comparing an implementation intervention to no intervention or to another implementation approach in stroke rehabilitation. Participants were qualified healthcare professionals working in stroke rehabilitation and the patients they cared for. Studies were considered for inclusion regardless of date, language or publication status. Main outcomes were healthcare professional adherence to recommended treatment, patient adherence to recommended treatment, patient health status and well-being, healthcare professional intention and satisfaction, resource use outcomes and adverse effects.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and certainty of evidence using GRADE. The primary comparison was any implementation intervention compared to no intervention.\nMain results\nNine cluster randomised trials (12,428 patient participants) and three ongoing trials met our selection criteria. Five trials (8865 participants) compared an implementation intervention to no intervention, three trials (3150 participants) compared one implementation intervention to another implementation intervention, and one three-arm trial (413 participants) compared two different implementation interventions to no intervention. Eight trials investigated multifaceted interventions; educational meetings and educational materials were the most common components. Six trials described tailoring the intervention content to identified barriers to change. Two trials focused on evidence-based stroke rehabilitation in the acute setting, four focused on the subacute inpatient setting and three trials focused on stroke rehabilitation in the community setting.\nWe are uncertain if implementation interventions improve healthcare professional adherence to evidence-based practice in stroke rehabilitation compared with no intervention as the certainty of the evidence was very low (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.53 to 2.64; 2 trials, 39 clusters, 1455 patient participants; I2 = 0%). Low-certainty evidence indicates implementation interventions in stroke rehabilitation may lead to little or no difference in patient adherence to recommended treatment (number of recommended performed outdoor journeys adjusted mean difference (MD) 0.5, 95% CI –1.8 to 2.8; 1 trial, 21 clusters, 100 participants) and patient psychological well-being (standardised mean difference (SMD) –0.02, 95% CI –0.54 to 0.50; 2 trials, 65 clusters, 1273 participants; I2 = 0%) compared with no intervention. Moderate-certainty evidence indicates implementation interventions in stroke rehabilitation probably lead to little or no difference in patient health-related quality of life (MD 0.01, 95% CI –0.02 to 0.05; 2 trials, 65 clusters, 1242 participants; I2 = 0%) and activities of daily living (MD 0.29, 95% CI –0.16 to 0.73; 2 trials, 65 clusters, 1272 participants; I2 = 0%) compared with no intervention.\nNo studies reported the effects of implementation interventions in stroke rehabilitation on healthcare professional intention to change behaviour or satisfaction.\nFive studies reported economic outcomes, with one study reporting cost-effectiveness of the implementation intervention. However, this was assessed at high risk of bias. The other four studies did not demonstrate the cost-effectiveness of interventions.\nTailoring interventions to identified barriers did not alter results.\nWe are uncertain of the effect of one implementation intervention versus another given the limited very low-certainty evidence.\nAuthors' conclusions\nWe are uncertain if implementation interventions improve healthcare professional adherence to evidence-based practice in stroke rehabilitation compared with no intervention as the certainty of the evidence is very low.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found nine studies from five countries; Australia, Canada, Malaysia, the UK and the US. Four studies reported on whether healthcare professionals increased their use of evidence in their work with stroke survivors. Studies compared healthcare professionals who received support to use evidence in stroke rehabilitation with healthcare professionals who did not receive support or received a different type of support.\nWe are uncertain if implementation strategies to support healthcare professionals to use evidence in stroke rehabilitation improve their practice compared to no support as the quality of the evidence is very low. The review found that strategies to encourage healthcare professionals to use evidence in stroke rehabilitation may make little or no difference to patient adherence to recommended treatment and patient psychological well-being compared to no intervention (low-quality evidence). Additionally, we found these strategies probably lead to little or no difference in patient health-related quality of life and activities of daily living compared with no intervention (moderate certainty evidence).\nWe found no studies that reported healthcare professional intention to change their behaviour or satisfaction."
}
] |
query-laysum
|
7522
|
[
{
"role": "user",
"content": "Abstract: Background\nMost disabling strokes are due to a blockage of a large artery in the brain by a blood clot. Prompt removal of the clot with intra-arterial thrombolytic drugs or mechanical devices, or both, can restore blood flow before major brain damage has occurred, leading to improved recovery. However, these so-called endovascular interventions can cause bleeding in the brain. This is a review of randomised controlled trials of endovascular thrombectomy or intra-arterial thrombolysis, or both, for acute ischaemic stroke.\nObjectives\nTo assess whether endovascular thrombectomy or intra-arterial interventions, or both, plus medical treatment are superior to medical treatment alone in people with acute ischaemic stroke.\nSearch methods\nWe searched the Trials Registers of the Cochrane Stroke Group and Cochrane Vascular Group (last searched 1 September 2020), CENTRAL (the Cochrane Library, 1 September 2020), MEDLINE (May 2010 to 1 September 2020), and Embase (May 2010 to 1 September 2020). We also searched trials registers, screened reference lists, and contacted researchers.\nSelection criteria\nRandomised controlled trials (RCTs) of any endovascular intervention plus medical treatment compared with medical treatment alone in people with definite ischaemic stroke.\nData collection and analysis\nTwo review authors (MBR and MJ) applied the inclusion criteria, extracted data, and assessed trial quality. Two review authors (MBR and HL) assessed risk of bias, and the certainty of the evidence using GRADE. We obtained both published and unpublished data if available. Our primary outcome was favourable functional outcome at the end of the scheduled follow-up period, defined as a modified Rankin Scale score of 0 to 2. Eighteen trials (i.e. all but one included trial) reported their outcome at 90 days. Secondary outcomes were death from all causes at in the acute phase and by the end of follow-up, symptomatic intracranial haemorrhage in the acute phase and by the end of follow-up, neurological status at the end of follow-up, and degree of recanalisation.\nMain results\nWe included 19 studies with a total of 3793 participants. The majority of participants had large artery occlusion in the anterior circulation, and were treated within six hours of symptom onset with endovascular thrombectomy. Treatment increased the chance of achieving a good functional outcome, defined as a modified Rankin Scale score of 0 to 2: risk ratio (RR) 1.50 (95% confidence interval (CI) 1.37 to 1.63; 3715 participants, 18 RCTs; high-certainty evidence). Treatment also reduced the risk of death at end of follow-up: RR 0.85 (95% CI 0.75 to 0.97; 3793 participants, 19 RCTs; high-certainty evidence) without increasing the risk of symptomatic intracranial haemorrhage in the acute phase: RR 1.46 (95% CI 0.91 to 2.36; 1559 participants, 6 RCTs; high-certainty evidence) or by end of follow-up: RR 1.05 (95% CI 0.72 to 1.52; 1752 participants, 10 RCTs; high-certainty evidence); however, the wide confidence intervals preclude any firm conclusion. Neurological recovery to National Institutes of Health Stroke Scale (NIHSS) score 0 to 1 and degree of recanalisation rates were better in the treatment group: RR 2.03 (95% CI 1.21 to 3.40; 334 participants, 3 RCTs; moderate-certainty evidence) and RR 8.25 (95% CI 1.63 to 41.90; 198 participants, 2 RCTs; moderate-certainty evidence), respectively.\nAuthors' conclusions\nIn individuals with acute ischaemic stroke due to large artery occlusion in the anterior circulation, endovascular thrombectomy can increase the chance of survival with a good functional outcome without increasing the risk of intracerebral haemorrhage or death.\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 addressed whether endovascular thrombectomy (removal of a blood clot in a blood vessel using a mechanical device) or intra-arterial thrombolysis (injecting clot-dissolving drugs directly into the clot), or both, provide better outcomes than standard treatment alone in stroke caused by a blocked blood vessel."
}
] |
query-laysum
|
7523
|
[
{
"role": "user",
"content": "Abstract: Background\nRenin inhibitors (RIs) reduce blood pressure more than placebo, with the magnitude of this effect thought to be similar to that for angiotensin converting enzyme (ACE) inhibitors. However, a drug's efficacy in lowering blood pressure cannot be considered as a definitive indicator of its effectiveness in reducing mortality and morbidity. The effectiveness and safety of RIs compared to ACE inhibitors in treating hypertension is unknown.\nObjectives\nTo evaluate the benefits and harms of renin inhibitors compared to ACE inhibitors in people with primary hypertension.\nSearch methods\nThe Cochrane Hypertension Group Information Specialist searched the following databases for randomized controlled trials up to August 2020: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers about further published and unpublished work. The searches had no language restrictions.\nSelection criteria\nWe included randomized, active-controlled, double-blinded studies (RCTs) with at least four weeks follow-up in people with primary hypertension, which compared renin inhibitors with ACE inhibitors and reported morbidity, mortality, adverse events or blood pressure outcomes. We excluded people with proven secondary hypertension.\nData collection and analysis\nTwo review authors independently selected the included trials, evaluated the risks of bias and entered the data for analysis.\nMain results\nWe include 11 RCTs involving 13,627 participants, with a mean baseline age from 51.5 to 74.2 years. Follow-up duration ranged from four weeks to 36.6 months.\nThere was no difference between RIs and ACE inhibitors for the outcomes: all-cause mortality: risk ratio (RR) 1.05, 95% confidence interval (CI) 0.93 to 1.18; 5 RCTs, 5962 participants; low-certainty evidence; total myocardial infarction: RR 0.86, 95% CI 0.22 to 3.39; 2 RCTs, 957 participants; very low-certainty evidence; adverse events: RR 0.98, 95% CI 0.93 to 1.03; 10 RTCs, 6007 participants; moderate-certainty evidence; serious adverse events: RR 1.21, 95% CI 0.89 to 1.64; 10 RTCs, 6007 participants; low-certainty evidence; and withdrawal due to adverse effects: RR 0.85, 95% CI 0.68 to 1.06; 10 RTCs, 6008 participants; low-certainty evidence. No data were available for total cardiovascular events, heart failure, stroke, end-stage renal disease or change in heart rate. Low-certainty evidence suggested that RIs reduced systolic blood pressure: mean difference (MD) −1.72, 95% CI −2.47 to −0.97; 9 RCTs, 5001 participants; and diastolic blood pressure: MD −1.18, 95% CI −1.65 to −0.72; 9 RCTs, 5001 participants, to a greater extent than ACE inhibitors, but we judged this to be more likely due to bias than a true effect.\nAuthors' conclusions\nFor the treatment of hypertension, we have low certainty that renin inhibitors (RI) and angiotensin converting enzyme (ACE) inhibitors do not differ for all-cause mortality and myocardial infarction. We have low to moderate certainty that they do not differ for adverse events. Small reductions in blood pressure with renin inhibitors compared to ACE inhibitors are of low certainty. More independent, large, long-term trials are needed to compare RIs with ACE inhibitors, particularly assessing morbidity and mortality outcomes, but also on blood pressure-lowering effect.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence up to August 2020."
}
] |
query-laysum
|
7524
|
[
{
"role": "user",
"content": "Abstract: Background\nInterventions by specialist breast cancer nurses (SBCNs) aim to support women and help them cope with the impact of the disease on their quality of life.\nObjectives\nTo assess the effects of individual interventions carried out by SBCNs on indicators of quality of life, anxiety, depression, and participant satisfaction.\nSearch methods\nIn June 2020, we searched MEDLINE, Embase, CENTRAL (Trials only), Cochrane Breast Cancer Group's Specialist Register (CBCG SR), CINAHL, PsycINFO, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and Clinicaltrials.gov.\nSelection criteria\nWe selected randomised controlled trials (RCTs) of interventions carried out by SBCNs for women with breast cancer, which reported indicators of quality of life, anxiety, depression, and participant satisfaction.\nData collection and analysis\nThe certainty of the evidence was evaluated using the GRADE approach. A narrative description of the results including structured tabulation was carried out.\nMain results\nWe included 14 RCTs involving 2905 women. With the exception of one study (women with advanced breast cancer), all the women were diagnosed with primary breast cancer. Mean age ranged from 48 to 64 years.\nPsychosocial nursing interventions compared with standard care for women with primary breast cancer\nEight studies (1328 women, low-quality evidence) showed small improvements in general health-related quality of life or no difference in effect between nine weeks and 18 months. Six studies (897 women, low-quality evidence) showed small improvements in cancer-specific quality of life or no difference in effect between nine weeks and 18 months. Six studies (951 women, low-quality evidence) showed small improvements in anxiety and depression between nine weeks and 18 months. Two studies (320 women, low-quality evidence) measured satisfaction during survivorship; one study measured satisfaction only in the intervention group and showed high levels of satisfaction with care; the second study showed equal satisfaction with care in both groups at six months.\nPsychosocial nursing interventions compared with other supportive care interventions for women with primary breast cancer\nTwo studies (351 women, very-low quality evidence) measured general health-related quality of life. One study reported that psychological morbidity reduced over the 12-month period; scores were consistently lower in women supported by SBCNs alone compared to support from a voluntary organisation. The other study reported that at six months, women receiving psychosocial support by either SBCNs or psychologists clinically improved from \"higher levels of distress\" to \"lower levels of distress\".\nOne study (179 women, very-low quality evidence) showed no between-group differences on subscales at all time points up to six months measured using cancer-specific quality of life questionnaires. There were significant group-by-time changes in the global quality of life, nausea and vomiting, and systemic therapy side effects subscales, for women receiving psychosocial support by either SBCNs or psychologists at six months. There were improvements in other subscales over time in both groups. Systemic therapy side effects increased significantly in the psychologist group but not in the SBCN group. Sexual functioning decreased in both groups.\nTwo studies (351 women, very-low quality evidence) measured anxiety and depression. One study reported that anxiety subscale scores and state anxiety scores improved over six months but there was no effect on depression subscale scores in the SBCN group compared to the psychologist group. There was no group-by-time interaction on the anxiety and depression or state anxiety subscales. The other study reported that anxiety and depression scores reduced over the 12-month post-surgery period in the SBCN group; scores were consistently lower in women supported by SBCNs compared to support from a voluntary organisation.\nSBCN-led telephone interventions delivering follow-up care compared with usual care for women with primary breast cancer\nThree studies (931 women, moderate-quality evidence) reported general health-related quality of life outcomes. Two studies reported no difference in psychological morbidity scores between SBCN-led follow-up care and standard care at 18 to 24 months. One trial reported no change in feelings of control scores between SBCN-led follow-up care and standard care at 12 months.\nTwo studies (557 women, moderate-quality evidence) reported no between-group difference in cancer-specific quality of life at 18 to 24 months. A SBCN intervention conducted by telephone, as a point-of-need access to specialist care, did not change psychological morbidity compared to routine clinical review at 18 months. Scores for both groups on the breast cancer subscale improved over time, with lower scores at nine and 18 months compared to baseline. The adjusted mean differences between groups at 18 months was 0.7 points in favour of the SBCN intervention (P = 0.058). A second study showed no differences between groups for role and emotional functioning measured using cancer-specific quality of life questionnaires in a SBCN-led telephone intervention compared with standard hospital care, both with and without an educational group programme at 12 months. At 12 months, mean scores were 78.4 (SD = 16.2) and 77.7 (SD = 16.2) respectively for SBCN-led telephone and standard hospital follow-up. The 95% confidence interval difference at 12 months was -1.93 to 4.64.\nThree studies (1094 women, moderate-quality evidence) reported no between-group difference in anxiety between 12 and 60 months follow-up. One of these studies also measured depression and reported no difference in depression scores between groups at five years (anxiety: RR 1.8; 95% CI 0.6 to 5.1; depression: RR 1.7 95% CI 0.4 to 7.2).\nFour studies (1331 women, moderate-quality evidence) demonstrated high levels of satisfaction with SBCN-led follow-up care by telephone between 12 and 60 months.\nPsychosocial nursing interventions compared with usual care for women with advanced breast cancer\nOne study (105 women, low-quality evidence) showed no difference in cancer-specific quality of life outcomes at 3 months.\nAuthors' conclusions\nEvidence suggests that psychosocial interventions delivered by SBCNs for women with primary breast cancer may improve or are at least as effective as standard care and other supportive interventions, during diagnosis, treatment and survivorship. SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence suggests that psychosocial interventions carried out by SBCNs for women with a primary diagnosis of breast cancer, may improve or are at least as effective as standard care for general health-related quality of life, cancer-specific quality of life, anxiety and depression outcomes and satisfaction with care. In future studies, the expertise of the SBCN needs to be better articulated for there to be a meaningful and successful translation to practice, and for SBCNs to have more impact in the area of psychosocial support. Qualification and training of the SBCN needs to be more clearly reported as well as the description of the intervention."
}
] |
query-laysum
|
7525
|
[
{
"role": "user",
"content": "Abstract: Background\nFibromyalgia (FM) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment. This is an update of a review published in Issue 2, 2002.\nObjectives\nThe primary objective of this systematic review was to evaluate the effects of exercise training including cardiorespiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FM.\nSearch methods\nWe searched MEDLINE, EMBASE, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 3, 2005) up to and including July 2005. We also reviewed reference lists from reviews and meta-analyses of treatment studies.\nSelection criteria\nRandomized trials that were selected focused on cardiorespiratory endurance, muscle strength and/or flexibility as treatment for FM.\nData collection and analysis\nTwo of four reviewers independently extracted data for each study. All discrepancies were rechecked and consensus was achieved by discussion. Methodological quality was assessed by two instruments: the van Tulder and the Jadad methodological quality criteria. We used the American College of Sport Medicine (ACSM) guidelines to evaluate whether interventions had provided a training stimulus that would effect changes in physical fitness. Due to significant clinical heterogeneity among the studies we were only able to meta-analyze six aerobic-only studies and two strength-only studies.\nMain results\nThere were a total of 2276 subjects across the 34 included studies; 1264 subjects were assigned to exercise interventions. The 34 studies comprised 47 interventions that included exercise. Effects of several disparate interventions on global well-being, selected FM signs and symptoms, and physical function in individuals with FM were summarized using standardized mean differences (SMD). There is moderate quality evidence that aerobic-only exercise training at recommended intensity levels has positive effects global well-being (SMD 0.49, 95% CI: 0.23 to 0.75) and physical function (SMD 0.66, 95% CI: 0.41 to 0.92) and possibly on pain (SMD 0.65, 95% CI: -0.09 to 1.39) and tender points (SMD 0.23, 95% CI: -0.18 to 0.65). Strength and flexibility remain under-evaluated.\nAuthors' conclusions\nThere is 'gold' level evidence (www.cochranemsk.org) that supervised aerobic exercise training has beneficial effects on physical capacity and FM symptoms. Strength training may also have benefits on some FM symptoms. Further studies on muscle strengthening and flexibility are needed. Research on the long-term benefit of exercise for FM is needed.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with fibromyalgia who take part in strength training\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When compared to no exercise, strength training may:\n- reduce pain by 49 fewer points on scale of 0 to 100.\n- improve overall well-being by 41 points on a scale of 0 to 100.\n- lead to 2 fewer active tender points on a scale of 0-18.\nThese results are based on low quality evidence.\nThe numbers given are our best estimate. When possible, we have also presented a range because there is a 95 percent chance that the true effect of the treatment lies somewhere within that range."
}
] |
query-laysum
|
7526
|
[
{
"role": "user",
"content": "Abstract: Background\nEnteral feeding for very preterm or very low birth weight (VLBW) infants is often delayed for several days after birth due to concern that early introduction of feeding may not be tolerated and may increase the risk of necrotising enterocolitis. Concerns exist, however, that delaying enteral feeding may diminish the functional adaptation of the gastrointestinal tract and prolong the need for parenteral nutrition with its attendant infectious and metabolic risks.\nObjectives\nTo determine the effects of delayed introduction of progressive enteral feeds on the risk of necrotising enterocolitis, mortality and other morbidities in very preterm or VLBW infants.\nSearch methods\nSearch strategies were developed by an information specialist in consultation with the review authors. The following databases were searched in October 2021 without date or language restrictions: CENTRAL (2021, Issue 10), MEDLINE via OVID (1946 to October 2021), Embase via OVID (1974 to October 2021), Maternity and Infant Care via OVID (1971 to October 2021), CINAHL (1982 to October 2021). We also searched for eligible trials in clinical trials databases, conference proceedings, previous reviews, and reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials that assessed the effects of delayed (four or more days after birth) versus earlier introduction of progressive enteral feeds on necrotising enterocolitis, mortality and other morbidities in very preterm or VLBW infants.\nData collection and analysis\nTwo review authors separately evaluated trial risk of bias, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference. We used the GRADE approach to assess the certainty of evidence for effects on necrotising enterocolitis, mortality, feed intolerance, and invasive infection.\nMain results\nWe included 14 trials in which a total of 1551 infants participated. Potential sources of bias were lack of clarity on methods to generate random sequences and conceal allocation in half of the trials, and lack of masking of caregivers or investigators in all of the trials. Trials typically defined delayed introduction of progressive enteral feeds as later than four to seven days after birth and early introduction as four days or fewer after birth. Infants in six trials (accounting for about half of all of the participants) had intrauterine growth restriction or circulatory redistribution demonstrated by absent or reversed end-diastolic flow velocities in the fetal aorta or umbilical artery.\nMeta-analyses showed that delayed introduction of progressive enteral feeds may not reduce the risk of necrotising enterocolitis (RR 0.81, 95% confidence interval (CI) 0.58 to 1.14; RD -0.02, 95% CI -0.04 to 0.01; 13 trials, 1507 infants; low-certainty evidence due risk of bias and imprecision) nor all-cause mortality before hospital discharge (RR 0.97, 95% CI 0.70 to 1.36; RD -0.00, 95% CI -0.03 to 0.03; 12 trials, 1399 infants; low-certainty evidence due risk of bias and imprecision). Delayed introduction of progressive enteral feeds may slightly reduce the risk of feed intolerance (RR 0.81, 95% CI 0.68 to 0.97; RD -0.09, 95% CI -0.17 to -0.02; number needed to treat for an additional beneficial outcome = 11, 95% CI 6 to 50; 6 trials, 581 infants; low-certainty evidence due to risk of bias and imprecision) and probably increases the risk of invasive infection (RR 1.44, 95% CI 1.15 to 1.80; RD 0.10, 95% CI 0.04 to 0.15; number needed to treat for a harmful outcome = 10, 95% CI 7 to 25; 7 trials, 872 infants; moderate-certainty evidence due to risk of bias).\nAuthors' conclusions\nDelaying the introduction of progressive enteral feeds beyond four days after birth (compared with earlier introduction) may not reduce the risk of necrotising enterocolitis or death in very preterm or VLBW infants. Delayed introduction may slightly reduce feed intolerance, and probably increases the risk of invasive infection.\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 14 trials with 1551 infants participating. About half of these infants had evidence of compromised growth while in the womb. Combined analysis of these trials showed that delayed introduction of progressive enteral feeds may not reduce the risk of necrotising enterocolitis or death. Delayed feeding may slightly reduce the risk of feed intolerance, but probably increases the risk of serious infection occurring."
}
] |
query-laysum
|
7527
|
[
{
"role": "user",
"content": "Abstract: Background\nSpecific diagnostic tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and resulting COVID-19 disease are not always available and take time to obtain results. Routine laboratory markers such as white blood cell count, measures of anticoagulation, C-reactive protein (CRP) and procalcitonin, are used to assess the clinical status of a patient. These laboratory tests may be useful for the triage of people with potential COVID-19 to prioritize them for different levels of treatment, especially in situations where time and resources are limited.\nObjectives\nTo assess the diagnostic accuracy of routine laboratory testing as a triage test to determine if a person has COVID-19.\nSearch methods\nOn 4 May 2020 we undertook electronic searches in the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern, which is updated daily with published articles from PubMed and Embase and with preprints from medRxiv and bioRxiv. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions.\nSelection criteria\nWe included both case-control designs and consecutive series of patients that assessed the diagnostic accuracy of routine laboratory testing as a triage test to determine if a person has COVID-19. The reference standard could be reverse transcriptase polymerase chain reaction (RT-PCR) alone; RT-PCR plus clinical expertise or and imaging; repeated RT-PCR several days apart or from different samples; WHO and other case definitions; and any other reference standard used by the study authors.\nData collection and analysis\nTwo review authors independently extracted data from each included study. They also assessed the methodological quality of the studies, using QUADAS-2. We used the 'NLMIXED' procedure in SAS 9.4 for the hierarchical summary receiver operating characteristic (HSROC) meta-analyses of tests for which we included four or more studies. To facilitate interpretation of results, for each meta-analysis we estimated summary sensitivity at the points on the SROC curve that corresponded to the median and interquartile range boundaries of specificities in the included studies.\nMain results\nWe included 21 studies in this review, including 14,126 COVID-19 patients and 56,585 non-COVID-19 patients in total. Studies evaluated a total of 67 different laboratory tests. Although we were interested in the diagnotic accuracy of routine tests for COVID-19, the included studies used detection of SARS-CoV-2 infection through RT-PCR as reference standard. There was considerable heterogeneity between tests, threshold values and the settings in which they were applied. For some tests a positive result was defined as a decrease compared to normal vaues, for other tests a positive result was defined as an increase, and for some tests both increase and decrease may have indicated test positivity. None of the studies had either low risk of bias on all domains or low concerns for applicability for all domains. Only three of the tests evaluated had a summary sensitivity and specificity over 50%. These were: increase in interleukin-6, increase in C-reactive protein and lymphocyte count decrease.\nBlood count\nEleven studies evaluated a decrease in white blood cell count, with a median specificity of 93% and a summary sensitivity of 25% (95% CI 8.0% to 27%; very low-certainty evidence). The 15 studies that evaluated an increase in white blood cell count had a lower median specificity and a lower corresponding sensitivity. Four studies evaluated a decrease in neutrophil count. Their median specificity was 93%, corresponding to a summary sensitivity of 10% (95% CI 1.0% to 56%; low-certainty evidence). The 11 studies that evaluated an increase in neutrophil count had a lower median specificity and a lower corresponding sensitivity. The summary sensitivity of an increase in neutrophil percentage (4 studies) was 59% (95% CI 1.0% to 100%) at median specificity (38%; very low-certainty evidence). The summary sensitivity of an increase in monocyte count (4 studies) was 13% (95% CI 6.0% to 26%) at median specificity (73%; very low-certainty evidence). The summary sensitivity of a decrease in lymphocyte count (13 studies) was 64% (95% CI 28% to 89%) at median specificity (53%; low-certainty evidence). Four studies that evaluated a decrease in lymphocyte percentage showed a lower median specificity and lower corresponding sensitivity. The summary sensitivity of a decrease in platelets (4 studies) was 19% (95% CI 10% to 32%) at median specificity (88%; low-certainty evidence).\nLiver function tests\nThe summary sensitivity of an increase in alanine aminotransferase (9 studies) was 12% (95% CI 3% to 34%) at median specificity (92%; low-certainty evidence). The summary sensitivity of an increase in aspartate aminotransferase (7 studies) was 29% (95% CI 17% to 45%) at median specificity (81%) (low-certainty evidence). The summary sensitivity of a decrease in albumin (4 studies) was 21% (95% CI 3% to 67%) at median specificity (66%; low-certainty evidence). The summary sensitivity of an increase in total bilirubin (4 studies) was 12% (95% CI 3.0% to 34%) at median specificity (92%; very low-certainty evidence).\nMarkers of inflammation\nThe summary sensitivity of an increase in CRP (14 studies) was 66% (95% CI 55% to 75%) at median specificity (44%; very low-certainty evidence). The summary sensitivity of an increase in procalcitonin (6 studies) was 3% (95% CI 1% to 19%) at median specificity (86%; very low-certainty evidence). The summary sensitivity of an increase in IL-6 (four studies) was 73% (95% CI 36% to 93%) at median specificity (58%) (very low-certainty evidence).\nOther biomarkers\nThe summary sensitivity of an increase in creatine kinase (5 studies) was 11% (95% CI 6% to 19%) at median specificity (94%) (low-certainty evidence). The summary sensitivity of an increase in serum creatinine (four studies) was 7% (95% CI 1% to 37%) at median specificity (91%; low-certainty evidence). The summary sensitivity of an increase in lactate dehydrogenase (4 studies) was 25% (95% CI 15% to 38%) at median specificity (72%; very low-certainty evidence).\nAuthors' conclusions\nAlthough these tests give an indication about the general health status of patients and some tests may be specific indicators for inflammatory processes, none of the tests we investigated are useful for accurately ruling in or ruling out COVID-19 on their own. Studies were done in specific hospitalized populations, and future studies should consider non-hospital settings to evaluate how these tests would perform in people with milder symptoms.\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 all COVID-19 studies up to 4 May 2020."
}
] |
query-laysum
|
7528
|
[
{
"role": "user",
"content": "Abstract: Background\nEducation of family members about infant weaning practices could affect nutrition, growth, and development of children in different settings across the world.\nObjectives\nTo compare effects of family nutrition educational interventions for infant weaning with conventional management on growth and neurodevelopment in childhood.\nSearch methods\nWe used the standard strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 5), MEDLINE via PubMed (1966 to 26 June 2018), Embase (1980 to 26 June 2018), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 26 June 2018). We searched clinical trials databases, conference proceedings, and references of retrieved articles.\nWe ran an updated search from 1 January 2018 to 12 December 2019 in the following databases: CENTRAL via CRS Web, MEDLINE via Ovid, and CINAHL via EBSCOhost.\nSelection criteria\nWe included randomised controlled trials that examined effects of nutrition education for weaning practices delivered to families of infants born at term compared to conventional management (standard care in the population) up to one year of age.\nData collection and analysis\nTwo review authors independently identified eligible trial reports from the literature search and performed data extraction and quality assessments for each included trial. We synthesised effect estimates using risk ratios (RRs), risk differences (RDs), and mean differences (MDs), with 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included 21 trials, recruiting 14,241 infants. Five of the trials were conducted in high-income countries and the remaining 16 were conducted in middle- and low-income countries. Meta-analysis showed that nutrition education targeted at improving weaning-related feeding practices probably increases both weight-for-age z scores (WAZ) (MD 0.15 standard deviations, 95% CI 0.07 to 0.22; 6 studies; 2551 infants; I² = 32%; moderate-certainty evidence) and height-for-age z scores (0.12 standard deviations, 95% CI 0.05 to 0.19; 7 studies; 3620 infants; I² = 49%; moderate-certainty evidence) by 12 months of age. Meta-analysis of outcomes at 18 months of age was heterogeneous and inconsistent in the magnitude of effects of nutrition education on WAZ and weight-for-height z score across studies. One trial that assessed effects of nutrition education on growth at six years reported an uncertain effect on change in height and body mass index z score. Two studies investigated effects of nutrition education on neurodevelopment at 12 to 24 months of age with conflicting results. No trials assessed effects of nutrition education on long-term neurodevelopmental outcomes.\nAuthors' conclusions\nNutrition education for families of infants may reduce the risk of undernutrition in term-born infants (evidence of low to moderate certainty due to limitations in study design and substantial heterogeneity of included studies). Modest effects on growth during infancy may not be of clinical significance. However, it is unclear whether these small improvements in growth parameters in the first two years of life affect long-term childhood growth and development. Further studies are needed to resolve this 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"
},
{
"role": "assistant",
"content": "We reviewed the evidence for effects of nutrition education about appropriate feeding practices during weaning on growth and development in children born at term gestation."
}
] |
query-laysum
|
7529
|
[
{
"role": "user",
"content": "Abstract: Background\nTonsillectomy is a very common operation and is performed using various surgical methods. Coblation is a popular method because it purportedly causes less pain than other surgical methods. However, the superiority of coblation is unproven.\nObjectives\nTo compare the effects of coblation tonsillectomy for chronic tonsillitis or tonsillar hypertrophy with other surgical techniques, both hot and cold, on intraoperative morbidity, postoperative morbidity and procedural cost.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2017, Issue 3); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 April 2017.\nSelection criteria\nRandomised controlled trials (RCTs) of children and adults undergoing tonsillectomy with coblation compared with any other surgical technique. This review is limited to trials of extracapsular (traditional) tonsillectomy and excludes trials of intracapsular tonsil removal (tonsillotomy).\nData collection and analysis\nWe used the standard Cochrane methods. Our primary outcomes were: patient-reported pain using a validated pain scale at postoperative days 1, 3 and 7; intraoperative blood loss; primary postoperative bleeding (within 24 hours) and secondary postoperative bleeding (more than 24 hours after surgery). Secondary outcomes were: time until resumption of normal diet, time until resumption of normal activity, duration of surgery and adverse effects including blood transfusion and the need for reoperation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 29 studies, with a total of 2561 participants. All studies had moderate or high risk of bias. Sixteen studies used an adequate randomisation technique, however the inability to mask the surgical teams and/or provide adequate methods to mitigate the risk of bias put nearly all studies at moderate or high risk of detection and measurement bias for intraoperative blood loss, and primary and secondary bleeding. In contrast most studies (20) were at low risk of bias for pain assessment. Most studies did not report data in a manner permitting meta-analysis.\nMost studies did not clearly report the participant characteristics, surgical indications or whether patients underwent tonsillectomy or adenotonsillectomy. Most studies reported that tonsillitis (infection) and/or tonsillar hypertrophy (obstruction) were the indication for surgery. Seven studies included only adults, 16 studies included only children and six studies included both.\nPain\nAt postoperative day 1 there is very low quality evidence that patients in the coblation group had less pain, with a standardised mean difference (SMD) of -0.79 (95% confidence interval (CI) -1.38 to -0.19; 538 participants; six studies). This effect is reduced a SMD of -0.44 (95% CI -0.97 to 0.09; 401 participants; five studies; very low-quality evidence) at day 3, and at day 7 there is low quality evidence of little or no difference in pain (SMD -0.01, 95% CI -0.22 to 0.19; 420 participants; five studies). Although this suggests that pain may be slightly less in the coblation group between days 1 and 3, the clinical significance is unclear.\nIntraoperative blood loss\nMethodological differences between studies in the measurement of intraoperative blood loss precluded meta-analysis.\nPrimary and secondary bleeding\nThe risk of primary bleeding was similar (risk ratio (RR) 0.99, 95% CI 0.48 to 2.05; 2055 participants; 25 studies; low-quality evidence). The risk of secondary bleeding was greater in the coblation group with a risk ratio of 1.36 (95% CI 0.95 to 1.95; 2118 participants; 25 studies; low-quality evidence). Using the median of the control group as the baseline risk, the absolute risk in the coblation group was 5% versus 3.6% in the control group. The difference of 1.3% has a 95% CI of 0.2% lower in the coblation group to 3.5% higher.\nSecondary outcomes\nDifferences in study design and data reporting precluded the identification of differences in the time to resumption of normal diet or activity, or whether there was a difference in the duration of surgery.\nAlthough we could not feasibly compare the costs of equipment or operative facility, anaesthetic and surgical fees across different healthcare systems we used duration of surgery as a proxy for cost. Although this outcome was commonly reported in studies, it was not possible to pool the data to determine whether there was a difference.\nAdverse events other than bleeding were not well reported. It is unclear whether there is a difference in postoperative infections or the need for reoperation.\nAuthors' conclusions\nThe coblation technique may cause less pain on postoperative day 1, but the difference is small and may be clinically meaningless. By postoperative day 3, the difference decreases further and by postoperative day 7 there appears to be little or no difference. We found similar rates of primary bleeding but we cannot rule out a small increased risk of secondary bleeding with coblation. The evidence supporting these findings is of low or very low quality, i.e. there is a very high degree of uncertainty about the results. Moreover, for most outcomes data were only available from a few of the 29 included studies.\nThe current evidence is of very low quality, therefore it is uncertain whether or not the coblation technique has any advantages over traditional tonsillectomy techniques. Despite the large number of studies, failure to use standardised or validated outcome measures precludes the ability to pool data across studies. Therefore, well-conducted RCTs using consistent, validated outcome measures are needed to establish whether the coblation technique has a benefit over other methods. In the included studies we identified no clear difference in adverse events. However, given the rarity of these events, randomised trials lack the power to detect a difference. Data from large-scale registries will provide a better estimate of any difference in these rare 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": "This review included evidence available up to April 2017. We included 29 studies, with a total of 2561 participants. All studies had a moderate or high risk of bias. Seven studies included adults, 16 studies included children and six included both adults and children.\nMost studies measured pain using a patient-reported scale (for example, asking people to rate their pain on a scale of 1 to 10)."
}
] |
query-laysum
|
7530
|
[
{
"role": "user",
"content": "Abstract: Background\nCervical intra-epithelial neoplasia (CIN) typically occurs in young women of reproductive age. Although several studies have reported the impact that cervical conservative treatment may have on obstetric outcomes, there is much less evidence for fertility and early pregnancy outcomes.\nObjectives\nTo assess the effect of cervical treatment for CIN (excisional or ablative) on fertility and early pregnancy outcomes.\nSearch methods\nWe searched in January 2015 the following databases: the Cochrane Gynaecological Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, Issue 12, 2014), MEDLINE (up to November week 3, 2014) and EMBASE (up to week 52, 2014).\nSelection criteria\nWe included all studies reporting on fertility and early pregnancy outcomes (less than 24 weeks of gestation) in women with a history of CIN treatment (excisional or ablative) as compared to women that had not received treatment.\nData collection and analysis\nStudies were classified according to the treatment method used and the fertility or early pregnancy endpoint. Pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated using a random-effects model and inter-study heterogeneity was assessed with I2. Two review authors (MK, AM) independently assessed the eligibility of retrieved papers and risk of bias. The two review authors then compared their results and any disagreements were resolved by discussion. If still unresolved, a third review author (MA) was involved until consensus was reached.\nMain results\nFifteen studies (2,223,592 participants - 25,008 treated and 2,198,584 untreated) that fulfilled the inclusion criteria for this review were identified from the literature search. The meta-analysis demonstrated that treatment for CIN did not adversely affect the chances of conception. The overall pregnancy rate was higher for treated (43%) versus untreated women (38%; RR 1.29, 95% CI 1.02 to 1.64; 4 studies, 38,050 participants, very low quality), although the inter-study heterogeneity was considerable (P < 0.01). The pregnancy rates in treated and untreated women with an intention to conceive (88% versus 95%, RR 0.93, 95% CI 0.80 to 1.08; 2 studies, 70 participants, very low quality) and the number of women requiring more than 12 months to conceive (14% versus 9%, RR 1.45, 95% CI 0.89 to 2.37; 3 studies, 1348 participants, very low quality) were no different. Although the total miscarriage rate (4.6% versus 2.8%, RR 1.04, 95% CI 0.90 to 1.21; 10 studies, 39,504 participants, low quality) and first trimester miscarriage rate (9.8% versus 8.4%, RR 1.16, 95% CI 0.80 to 1.69, 4 studies, 1103 participants, low quality) was similar for treated and untreated women, CIN treatment was associated with an increased risk of second trimester miscarriage, (1.6% versus 0.4%, RR 2.60, 95% CI 1.45 to 4.67; 8 studies, 2,182,268 participants, low quality). The number of ectopic pregnancies (1.6% versus 0.8%, RR 1.89, 95% CI 1.50 to 2.39; 6 studies, 38,193 participants, low quality) and terminations (12.2% versus 7.4%, RR 1.71, 95% CI 1.31 to 2.22; 7 studies, 38,208 participants, low quality) were also higher in treated women.\nThe results should be interpreted with caution. The included studies were often small with heterogenous design. Most of these studies were retrospective and of low or very low quality (GRADE assessment) and were therefore prone to bias. Subgroup analyses for the individual treatment methods and comparison groups and analysis to stratify for the cone length was not possible.\nAuthors' conclusions\nThis meta-analysis suggests that treatment for CIN does not adversely affect fertility, although treatment was associated with an increased risk of miscarriage in the second trimester. These results should be interpreted with caution as the included studies were non-randomised and many were of low or very low quality and therefore at high risk of bias. Research should explore mechanisms that may explain the increase in mid-trimester miscarriage risk and stratify this impact of treatment by the length of the cone and the treatment method used.\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": "The results suggest that treatment for CIN does not adversely affect the chances of a successful conception, although treatment is associated with an increased risk of miscarriage in the second trimester. These conclusions should be interpreted with caution as the quality of the included studies was low or very low. Future research should investigate the impact related to the extent of the treatment and the treatment method used."
}
] |
query-laysum
|
7531
|
[
{
"role": "user",
"content": "Abstract: Background\nDelirium is an acute neuropsychological disorder that is common in hospitalised patients. It can be distressing to patients and carers and it is associated with serious adverse outcomes. Treatment options for established delirium are limited and so prevention of delirium is desirable. Non-pharmacological interventions are thought to be important in delirium prevention.\nObjectives\nTo assess the effectiveness of non-pharmacological interventions designed to prevent delirium in hospitalised patients outside intensive care units (ICU).\nSearch methods\nWe searched ALOIS, the specialised register of the Cochrane Dementia and Cognitive Improvement Group, with additional searches conducted in MEDLINE, Embase, PsycINFO, CINAHL, LILACS, Web of Science Core Collection, ClinicalTrials.gov and the World Health Organization Portal/ICTRP to 16 September 2020. There were no language or date restrictions applied to the electronic searches, and no methodological filters were used to restrict the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) of single and multicomponent non-pharmacological interventions for preventing delirium in hospitalised adults cared for outside intensive care or high dependency settings. We only included non-pharmacological interventions which were designed and implemented to prevent delirium.\nData collection and analysis\nTwo review authors independently examined titles and abstracts identified by the search for eligibility and extracted data from full-text articles. Any disagreements on eligibility and inclusion were resolved by consensus. We used standard Cochrane methodological procedures. The primary outcomes were: incidence of delirium; inpatient and later mortality; and new diagnosis of dementia. We included secondary and adverse outcomes as pre-specified in the review protocol. We used risk ratios (RRs) as measures of treatment effect for dichotomous outcomes and between-group mean differences for continuous outcomes. The certainty of the evidence was assessed using GRADE. A complementary exploratory analysis was undertaker using a Bayesian component network meta-analysis fixed-effect model to evaluate the comparative effectiveness of the individual components of multicomponent interventions and describe which components were most strongly associated with reducing the incidence of delirium.\nMain results\nWe included 22 RCTs that recruited a total of 5718 adult participants. Fourteen trials compared a multicomponent delirium prevention intervention with usual care. Two trials compared liberal and restrictive blood transfusion thresholds. The remaining six trials each investigated a different non-pharmacological intervention. Incidence of delirium was reported in all studies.\nUsing the Cochrane risk of bias tool, we identified risks of bias in all included trials. All were at high risk of performance bias as participants and personnel were not blinded to the interventions. Nine trials were at high risk of detection bias due to lack of blinding of outcome assessors and three more were at unclear risk in this domain.\nPooled data showed that multi-component non-pharmacological interventions probably reduce the incidence of delirium compared to usual care (10.5% incidence in the intervention group, compared to 18.4% in the control group, risk ratio (RR) 0.57, 95% confidence interval (CI) 0.46 to 0.71, I2 = 39%; 14 studies; 3693 participants; moderate-certainty evidence, downgraded due to risk of bias).\nThere may be little or no effect of multicomponent interventions on inpatient mortality compared to usual care (5.2% in the intervention group, compared to 4.5% in the control group, RR 1.17, 95% CI 0.79 to 1.74, I2 = 15%; 10 studies; 2640 participants; low-certainty evidence downgraded due to inconsistency and imprecision).\nNo studies of multicomponent interventions reported data on new diagnoses of dementia.\nMulticomponent interventions may result in a small reduction of around a day in the duration of a delirium episode (mean difference (MD) -0.93, 95% CI -2.01 to 0.14 days, I2 = 65%; 351 participants; low-certainty evidence downgraded due to risk of bias and imprecision). The evidence is very uncertain about the effect of multicomponent interventions on delirium severity (standardised mean difference (SMD) -0.49, 95% CI -1.13 to 0.14, I2=64%; 147 participants; very low-certainty evidence downgraded due to risk of bias and serious imprecision). Multicomponent interventions may result in a reduction in hospital length of stay compared to usual care (MD -1.30 days, 95% CI -2.56 to -0.04 days, I2=91%; 3351 participants; low-certainty evidence downgraded due to risk of bias and inconsistency), but little to no difference in new care home admission at the time of hospital discharge (RR 0.77, 95% CI 0.55 to 1.07; 536 participants; low-certainty evidence downgraded due to risk of bias and imprecision). Reporting of other adverse outcomes was limited.\nOur exploratory component network meta-analysis found that re-orientation (including use of familiar objects), cognitive stimulation and sleep hygiene were associated with reduced risk of incident delirium. Attention to nutrition and hydration, oxygenation, medication review, assessment of mood and bowel and bladder care were probably associated with a reduction in incident delirium but estimates included the possibility of no benefit or harm. Reducing sensory deprivation, identification of infection, mobilisation and pain control all had summary estimates that suggested potential increases in delirium incidence, but the uncertainty in the estimates was substantial.\nEvidence from two trials suggests that use of a liberal transfusion threshold over a restrictive transfusion threshold probably results in little to no difference in incident delirium (RR 0.92, 95% CI 0.62 to 1.36; I2 = 9%; 294 participants; moderate-certainty evidence downgraded due to risk of bias).\nSix other interventions were examined, but evidence for each was limited to single studies and we identified no evidence of delirium prevention.\nAuthors' conclusions\nThere is moderate-certainty evidence regarding the benefit of multicomponent non-pharmacological interventions for the prevention of delirium in hospitalised adults, estimated to reduce incidence by 43% compared to usual care. We found no evidence of an effect on mortality. There is emerging evidence that these interventions may reduce hospital length of stay, with a trend towards reduced delirium duration, although the effect on delirium severity remains uncertain. Further research should focus on implementation and detailed analysis of the components of the interventions to support more effective, tailored practice recommendations.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Multicomponent approaches probably reduce occurrence of delirium by 43% compared to usual hospital care. This means that two in five cases of delirium in adults in hospital wards (other than ICU) can be prevented by multicomponent, non-pharmacological approaches. These interventions may also reduce the length of time people stay in hospital and, if delirium does occur, they may reduce the duration of the delirium episode by about a day. However, these approaches may have little or no effect on the risk of dying in hospital. The studies did not investigate the effect of multicomponent interventions on the development or worsening of dementia. There was little information about whether the interventions had any harmful effects.\nUsing a new statistical technique, we found that the following components within each intervention were most important for preventing delirium: (a) trying to keep people well-oriented to their surroundings and making their surroundings more familiar, (b) providing stimulation to memory and thinking skills, and (c) trying to improve sleep (through sleep hygiene measures). We could not be so certain about the effect of other components, largely because not enough evidence was available. More research is needed comparing the specific components included in multicomponent interventions to help determine the most effective and efficient ways to prevent delirium.\nThe evidence for other, single-component, non-pharmacological interventions was very limited."
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query-laysum
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7532
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[
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"role": "user",
"content": "Abstract: Background\nExperiencing anxiety and depression is very common in people living with dementia and mild cognitive impairment (MCI). There is uncertainty about the best treatment approach. Drug treatments may be ineffective and associated with adverse effects. Guidelines recommend psychological treatments. In this updated systematic review, we investigated the effectiveness of different psychological treatment approaches.\nObjectives\nPrimary objective\nTo assess the clinical effectiveness of psychological interventions in reducing depression and anxiety in people with dementia or MCI.\nSecondary objectives\nTo determine whether psychological interventions improve individuals' quality of life, cognition, activities of daily living (ADL), and reduce behavioural and psychological symptoms of dementia, and whether they improve caregiver quality of life or reduce caregiver burden.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, four other databases, and three trials registers on 18 February 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared a psychological intervention for depression or anxiety with treatment as usual (TAU) or another control intervention in people with dementia or MCI.\nData collection and analysis\nA minimum of two authors worked independently to select trials, extract data, and assess studies for risk of bias. We classified the included psychological interventions as cognitive behavioural therapies (cognitive behavioural therapy (CBT), behavioural activation (BA), problem-solving therapy (PST)); 'third-wave' therapies (such as mindfulness-based cognitive therapy (MBCT)); supportive and counselling therapies; and interpersonal therapies. We compared each class of intervention with control. We expressed treatment effects as standardised mean differences or risk ratios. Where possible, we pooled data using a fixed-effects model. We used GRADE methods to assess the certainty of the evidence behind each result.\nMain results\nWe included 29 studies with 2599 participants. They were all published between 1997 and 2020. There were 15 trials of cognitive behavioural therapies (4 CBT, 8 BA, 3 PST), 11 trials of supportive and counselling therapies, three trials of MBCT, and one of interpersonal therapy. The comparison groups received either usual care, attention-control education, or enhanced usual care incorporating an active control condition that was not a specific psychological treatment. There were 24 trials of people with a diagnosis of dementia, and five trials of people with MCI. Most studies were conducted in community settings. We considered none of the studies to be at low risk of bias in all domains.\nCognitive behavioural therapies (CBT, BA, PST)\nCognitive behavioural therapies are probably slightly better than treatment as usual or active control conditions for reducing depressive symptoms (standardised mean difference (SMD) -0.23, 95% CI -0.37 to -0.10; 13 trials, 893 participants; moderate-certainty evidence). They may also increase rates of depression remission at the end of treatment (risk ratio (RR) 1.84, 95% CI 1.18 to 2.88; 2 studies, with one study contributing 2 independent comparisons, 146 participants; low-certainty evidence). We were very uncertain about the effect of cognitive behavioural therapies on anxiety at the end of treatment (SMD -0.03, 95% CI -0.36 to 0.30; 3 trials, 143 participants; very low-certainty evidence). Cognitive behavioural therapies probably improve patient quality of life (SMD 0.31, 95% CI 0.13 to 0.50; 7 trials, 459 participants; moderate-certainty evidence) and activities of daily living at end of treatment compared to treatment as usual or active control (SMD -0.25, 95% CI -0.40 to -0.09; 7 trials, 680 participants; moderate-certainty evidence).\nSupportive and counselling interventions\nMeta-analysis showed that supportive and counselling interventions may have little or no effect on depressive symptoms in people with dementia compared to usual care at end of treatment (SMD -0.05, 95% CI -0.18 to 0.07; 9 trials, 994 participants; low-certainty evidence). We were very uncertain about the effects of these treatments on anxiety, which was assessed only in one small pilot study.\nOther interventions\nThere were very few data and very low-certainty evidence on MBCT and interpersonal therapy, so we were unable to draw any conclusions about the effectiveness of these interventions.\nAuthors' conclusions\nCBT-based treatments added to usual care probably slightly reduce symptoms of depression for people with dementia and MCI and may increase rates of remission of depression. There may be important effect modifiers (degree of baseline depression, cognitive diagnosis, or content of the intervention). CBT-based treatments probably also have a small positive effect on quality of life and activities of daily living. Supportive and counselling interventions may not improve symptoms of depression in people with dementia. Effects of both types of treatment on anxiety symptoms are very uncertain. We are also uncertain about the effects of other types of psychological treatments, and about persistence of effects over time. To inform clinical guidelines, future studies should assess detailed components of these interventions and their implementation in different patient populations and in different settings.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Depression and anxiety are common in people with dementia and MCI, but the best way to treat them is unclear. Medicines often used to treat these problems may not be effective for people with dementia and may cause side effects, so many guidelines recommend trying psychological treatments first. We were interested in psychological therapies that aim to reduce symptoms of anxiety or depression or to improve the emotional well-being of people with dementia or MCI. There are a variety of different types of psychological treatment. We wanted to find out how effective each treatment is for symptoms of depression and anxiety in people with dementia or MCI. We also wanted to find out about effects on quality of life, ability to manage daily activities and thinking skills, and to know if the treatments had any unwanted effects."
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query-laysum
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7533
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[
{
"role": "user",
"content": "Abstract: Background\nChronic subdural haematoma (CSDH) is one of the most common types of intracranial haematoma, and often occurs in older people. Burr-hole craniostomy, which is an evacuation through one or two burr holes drilled over the site of the haematoma, has been widely accepted as the most effective way to manage CSDH. Recurrences are a major problem and need reoperation, sometimes repeatedly.\nObjectives\nTo assess the effects and safety of the use of external drains versus no drains after burr-hole evacuation for the treatment of CSDH in adults.\nSearch methods\nWe ran our first search on 27 November 2014. We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP), Embase Classic+Embase (OvidSP), PubMed, ISI WOS (SCI-EXPANDED, SSCI, CPCI-S and CPSI-SSH), Chinese databases, and clinical trials registers, and screened reference lists. In compliance with the MECIR conduct standard 37, the Cochrane Injuries Group Information Specialist ran an update search within 12 months of publication (25 April 2016). We have screened these results but not incorporated the findings into the current review; as a result of the update search, one trial is awaiting classification.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared external subdural drains with no drains after burr-hole evacuation for the treatment of CSDH in adults.\nData collection and analysis\nTwo review authors identified potential articles from the literature search, extracted data independently using a data extraction form and assessed risk of bias using the Cochrane ‘Risk of bias' tool. For dichotomous data, where statistical heterogeneity was low, we calculated summary risk ratios with 95% confidence intervals using a fixed-effect model.\nMain results\nNine RCTs, including a total of 968 participants, reported outcomes specified by this review. Only one RCT reported the use of an adequate method of allocation concealment; this trial was a large, single-centre, high quality study and was adequately reported. All included trials reported a reduced recurrence of CSDH with external subdural drains. We found a significant reduction in the risk of recurrence with subdural drains (RR 0.45, 95% CI 0.32 to 0.61, I2 = 38%; 9 studies, 968 participants; moderate-quality evidence). There was no strong evidence of any increase in complications (RR 1.15; 95% CI 0.77 to 1.72, I2 = 0%; 7 studies, 710 participants; low-quality evidence), mortality (RR 0.78, 95% CI 0.45 to 1.33, I2 = 22%; 5 studies, 539 participants; low-quality evidence), or poor functional outcome (which included deaths) (RR 0.68, 95% CI 0.44 to 1.05, I2 = 31%; 5 studies, 490 participants; low-quality evidence).\nAuthors' conclusions\nThere is some evidence that postoperative drainage is effective in reducing the symptomatic recurrence of CSDH. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Due to the low quality of the evidence for the secondary outcomes, the effect of drainage on the occurrence of surgical complications, mortality and poor functional outcome is uncertain. This uncertainty can be clarified with data from high-quality studies which may be conducted in the future. There is no strong evidence of any increase in complications when drains are used.\n\nGiven the provided abstract, please respond to the following query: \"What is a chronic subdural haematoma (CSDH)?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A chronic subdural haematoma (CSDH) is the slow accumulation of blood between the brain and the membrane that surrounds it. CSDH is a common type of brain (intracranial) haematoma and occurs more frequently in older people. Up to 75% of CSDHs are caused by trauma to the head, though this trauma can be trivial, with no loss of consciousness, vomiting or seizures, or any other post-trauma symptoms. Symptoms of CSDH depend upon the size of the haematoma and the parts of the brain on which it exerts pressure, but may include confusion or coma; memory problems; difficulty speaking, swallowing or walking; drowsiness; headaches; seizures; and weakness or numbness of limbs and face."
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query-laysum
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7534
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[
{
"role": "user",
"content": "Abstract: Background\nCranberries contain proanthocyanidins (PACs), which inhibit the adherence of p-fimbriated Escherichia coli to the urothelial cells lining the bladder. Cranberry products have been used widely for several decades to prevent urinary tract infections (UTIs). This is the fifth update of a review first published in 1998 and updated in 2003, 2004, 2008, and 2012.\nObjectives\nTo assess the effectiveness of cranberry products in preventing UTIs in susceptible populations.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Specialised Register up to 13 March 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 Register Search Portal (ICTRP) and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) or quasi-RCTs of cranberry products compared with placebo, no specific treatment or other intervention (antibiotics, probiotics) for the prevention of UTIs were included.\nData collection and analysis\nTwo authors independently assessed and extracted data. Information was collected on methods, participants, interventions and outcomes (incidence of symptomatic UTIs, positive culture results, side effects, adherence to therapy). Risk ratios (RR) with 95% confidence intervals (CI) were calculated where appropriate. Study quality was assessed using the Cochrane risk of bias assessment tool. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nFor this update 26 new studies were added, bringing the total number of included studies to 50 (8857 randomised participants). The risk of bias for sequence generation and allocation concealment was low for 29 and 28 studies, respectively. Thirty-six studies were at low risk of performance bias, and 23 studies were at low risk of detection bias. Twenty-seven, 41, and 17 studies were at low risk of attrition bias, reporting bias and other bias, respectively.\nForty-five studies compared cranberry products with placebo or no specific treatment in six different groups of participants. Twenty-six of these 45 studies could be meta-analysed for the outcome of symptomatic, culture-verified UTIs. In moderate certainty evidence, cranberry products reduced the risk of UTIs (6211 participants: RR 0.70, 95% CI 0.58 to 0.84; I² = 69%). When studies were divided into groups according to the treatment indication, cranberry products probably reduced the risk of symptomatic, culture-verified UTIs in women with recurrent UTIs (8 studies, 1555 participants: RR 0.74, 95% CI 0.55 to 0.99; I² = 54%), in children (5 studies, 504 participants: RR 0.46, 95% CI 0.32 to 0.68; I² = 21%) and in people with a susceptibility to UTIs due to an intervention (6 studies, 1434 participants: RR 0.47, 95% CI 0.37 to 0.61; I² = 0%). However, in low certainty evidence, there may be little or no benefit in elderly institutionalised men and women (3 studies, 1489 participants: RR 0.93, 95% CI 0.67 to 1.30; I² = 9%), pregnant women (3 studies, 765 participants: RR 1.06, 95% CI 0.75 to 1.50; I² = 3%), or adults with neuromuscular bladder dysfunction with incomplete bladder emptying (3 studies, 464 participants: RR 0.97, 95% CI 0.78 to 1.19; I² = 0%).\nOther comparisons were cranberry products with probiotics (three studies) or antibiotics (six studies), cranberry tablets with cranberry liquid (one study), and different doses of PACs (two studies).\nCompared to antibiotics, cranberry products may make little or no difference to the risk of symptomatic, culture-verified UTIs (2 studies, 385 participants: RR 1.03, 95% CI 0.80 to 1.33; I² = 0%) or the risk of clinical symptoms without culture (2 studies, 336 participants: RR 1.30, 95% CI 0.79 to 2.14; I² = 68%). Compared to probiotics, cranberry products may reduce the risk of symptomatic, culture-verified UTIs (3 studies, 215 participants: RR 0.39, 95% CI 0.27 to 0.56; I = 0%). It is unclear whether efficacy differs between cranberry juice and tablets or between different doses of PACs as the certainty of the evidence was very low.\nThe number of participants with gastrointestinal side effects probably does not differ between those taking cranberry products and those receiving placebo or no specific treatment (10 studies, 2166 participants: RR 1.33, 95% CI 1.00 to 1.77; I² = 0%; moderate certainty evidence). There was no clear relationship between compliance with therapy and the risk for repeat UTIs. No difference in the risk for UTIs could be demonstrated between low, moderate and high doses of PACs.\nAuthors' conclusions\nThis update adds a further 26 studies taking the total number of studies to 50 with 8857 participants. These data support the use of cranberry products to reduce the risk of symptomatic, culture-verified UTIs in women with recurrent UTIs, in children, and in people susceptible to UTIs following interventions. The evidence currently available does not support its use in the elderly, patients with bladder emptying problems, or pregnant women.\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 analysed the results of randomised controlled trials (RCTs), which compared the occurrence of UTIs in people taking a cranberry product with those taking a placebo or no treatment. We also analysed the results of RCTs comparing a cranberry product with other treatments such as antibiotics or probiotics."
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query-laysum
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7535
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[
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"role": "user",
"content": "Abstract: Background\nOvereating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention.\nObjectives\n1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children.\n2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions.\nSelection criteria\nRandomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco.\nData collection and analysis\nWe applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics.\nMain results\nThe current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results.\nA meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65).\nOne included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants.\nA meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34).\nIn addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65).\nAuthors' conclusions\nThis review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Effects of size on consumption\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found evidence that people consistently ate more food or drank more non-alcoholic drinks when offered larger-sized portions, packages or items of tableware than when offered smaller-sized versions. We estimate the size of this effect to be small to moderate among both children and adults. If an effect of this size were sustained across the whole diet it would be equivalent to around a 12% to 16% change in average daily energy intake from food among UK adults. We rated the overall quality of the evidence for this effect as moderate, due to concern about study limitations arising from incomplete or unclear reporting of methods and procedures. From three tobacco studies, we found no effect of longer compared with shorter cigarettes on the amounts of tobacco consumed. We rated the overall quality of evidence for this effect as low due to concerns about study limitations and not having enough evidence."
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query-laysum
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7536
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[
{
"role": "user",
"content": "Abstract: Background\nObservational evidence suggests a potential benefit with several anti-adhesion therapies in women undergoing operative hysteroscopy (e.g. insertion of an intrauterine device or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) for decreasing intrauterine adhesions (IUAs).\nObjectives\nTo assess the effectiveness of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy, following operative hysteroscopy for treatment of female subfertility.\nSearch methods\nWe searched the following databases from inception to June 2017: the Cochrane Gynaecology and Fertility Group Specialised Register; the Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; CINAHL and other electronic sources of trials, including trial registers, sources of unpublished literature and reference lists. We handsearched the Journal of Minimally Invasive Gynecology, and we contacted experts in the field. We also searched reference lists of appropriate papers.\nSelection criteria\nRandomised controlled trials (RCTs) of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy following operative hysteroscopy in subfertile women. The primary outcome was live birth. Secondary outcomes were clinical pregnancy, miscarriage and IUAs present at second-look hysteroscopy, along with mean adhesion scores and severity of IUAs.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data and evaluated quality of evidence using the GRADE method.\nMain results\nThe overall quality of the evidence was low to very low. The main limitations were serious risk of bias related to blinding of participants and personnel, indirectness and imprecision. We identified 16 RCTs comparing a device versus no treatment (two studies; 90 women), hormonal treatment versus no treatment or placebo (two studies; 136 women), device combined with hormonal treatment versus no treatment (one study; 20 women), barrier gel versus no treatment (five studies; 464 women), device with graft versus device without graft (three studies; 190 women), one type of device versus another device (one study; 201 women), gel combined with hormonal treatment and antibiotics versus hormonal treatment with antibiotics (one study; 52 women) and device combined with gel versus device (one study; 120 women). The total number of participants was 1273, but data on 1133 women were available for analysis. Only two of 16 studies included 100% infertile women; in all other studies, the proportion was variable or unknown.\nNo study reported live birth, but some (five studies) reported outcomes that were used as surrogate outcomes for live birth (term delivery or ongoing pregnancy).\nAnti-adhesion therapy versus placebo or no treatment following operative hysteroscopy.\nThere was insufficient evidence to determine whether there was a difference between the use of a device or hormonal treatment compared to no treatment or placebo with respect to term delivery or ongoing pregnancy rates (odds ratio (OR) 0.94, 95% confidence interval (CI) 0.42 to 2.12; 107 women; 2 studies; I² = 0%; very-low-quality evidence).\nThere were fewer IUAs at second-look hysteroscopy using a device with or without hormonal treatment or hormonal treatment or barrier gels compared with no treatment or placebo (OR 0.35, 95% CI 0.21 to 0.60; 560 women; 8 studies; I² = 0%; low-quality evidence). The number needed to treat for an additional beneficial outcome (NNTB) was 9 (95% CI 5 to 17).\nComparisons of different anti-adhesion therapies following operative hysteroscopy\nIt was unclear whether there was a difference between the use of a device combined with graft versus device only for the outcome of ongoing pregnancy (OR 1.48, 95% CI 0.57 to 3.83; 180 women; 3 studies; I² = 0%; low-quality evidence). There were fewer IUAs at second-look hysteroscopy using a device with or without graft/gel or gel combined with hormonal treatment and antibiotics compared with using a device only or hormonal treatment combined with antibiotics, but the findings of this meta-analysis were affected by evidence quality (OR 0.55, 95% CI 0.36 to 0.83; 451 women; 5 studies; I² = 0%; low-quality evidence).\nAuthors' conclusions\nImplications for clinical practice\nThe quality of the evidence ranged from very low to low. The effectiveness of anti-adhesion treatment for improving key reproductive outcomes or for decreasing IUAs following operative hysteroscopy in subfertile women remains uncertain.\nImplications for research\nMore research is needed to assess the comparative safety and (cost-)effectiveness of different anti-adhesion treatments compared to no treatment or other interventions for improving key reproductive outcomes in subfertile women.\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": "Abdominal adhesions are web-like structures where two normally separate surfaces in the tummy (abdomen) stick together due to damage to the lining of the abdomen. They commonly form after surgery to the abdomen. They can cause multiple conditions such as chronic pelvic pain and infertility. The present practice is based on tradition or observational studies."
}
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query-laysum
|
7537
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[
{
"role": "user",
"content": "Abstract: Background\nResections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure.\nObjectives\nTo compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure.\nSearch methods\nWe searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status).\nData collection and analysis\nTwo authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).\nMain results\nIn two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate.\nAuthors' conclusions\nThe quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The statistical analyses resulted in similar rates of pancreatic fistula (about 35%), deaths after surgery (about 1%) and average operation time between the two operation methods.\nIndividual surgeons can choose which closure technique to use after removing of the tail of the pancreas according to their preferences and the participant's anatomic characteristics."
}
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query-laysum
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7538
|
[
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not respond to an initially prescribed antipsychotic drug. In such cases, one treatment strategy could be to increase the antipsychotic dose; and another strategy could be to switch to a different antipsychotic drug.\nObjectives\nTo examine the efficacy of increasing the antipsychotic dose versus switching the antipsychotic drug in the treatment of non-responsive people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (10 June 2014, 6 October 2015, and 30 March 2017). We examined references of all included studies for further trials.\nSelection criteria\nAll relevant randomised controlled trials (RCTs) comparing increasing the antipsychotic dose versus switching to a different antipsychotic drug for people with schizophrenia who have not responded to their initial antipsychotic treatment.\nData collection and analysis\nAt least two review authors independently extracted data. We analysed dichotomous data using relative risks (RR) and their 95% confidence intervals (CIs). We analysed continuous data using mean differences (MD) and their 95% CIs. We assessed risk of bias for included studies and used GRADE to create a 'Summary of findings' table.\nMain results\nWe include one RCT with relevant data on 29 participants in this review. The trial had a parallel design and was double-blind, but blinding procedures were not described. The trial included people who were non-responsive to fluphenazine 20 mg/day administered for 4 weeks. Participants were randomly assigned to continuing treatment with fluphenazine 20 mg/day, increasing the dose to fluphenazine 80 mg/day or switching to haloperidol 20 mg/day for four additional weeks. Data were reported only for 47 out of 58 initially randomised participants. The trial was published in 1993. The fact that only one RCT with a small sample size (N = 29) was included in the analysis limits the quality of the evidence. Overall, no clear difference was found between groups in terms of the three available outcomes: global state (number of participants with clinically relevant response (RR 1.63, 95% CI 0.17 to 15.99, very low quality evidence); general mental state (endpoint score, BPRS total) (MD 2.00, 95% CI −4.20 to 8.20, very low quality evidence); and negative symptoms (endpoint score, SANS) (MD 3.40, 95% CI −12.56 to 19.36). No data were reported for leaving the study early, adverse effects, time in hospital, quality of life, satisfaction with care and functioning.\nAuthors' conclusions\nThere is extremely limited evidence and no clear conclusions can be drawn. There is an urgent need for further trials in order to determine the optimal treatment strategy for people with schizophrenia who do not respond to their initial antipsychotic treatment.\n\nGiven the provided abstract, please respond to the following query: \"Searching for evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The Information Specialist of Cochrane Schizophrenia ran an electronic search (up to 30 March 2017) for trials that randomised people with schizophrenia who were not responding to their initial antipsychotic treatment to receive either an increased antipsychotic dose or switch to a different antipsychotic drug. Nine hundred and two records were found and checked by the review authors."
}
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query-laysum
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7539
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[
{
"role": "user",
"content": "Abstract: Background\nAngiostrongylus cantonensis (A. cantonensis) is the major cause of infectious eosinophilic meningitis. Dead larvae of this parasite cause inflammation and exacerbate symptoms of meningitis. Corticosteroids are drugs used to reduce the inflammation caused by this parasite.\nObjectives\nTo assess the efficacy and safety of corticosteroids for the treatment of eosinophilic meningitis.\nSearch methods\nWe searched CENTRAL (2014, Issue 11), MEDLINE (1950 to November Week 3, 2014), EMBASE (1974 to December 2014), Scopus (1960 to December 2014), Web of Science (1955 to December 2014), LILACS (1982 to December 2014) and CINAHL (1981 to December 2014).\nSelection criteria\nRandomised controlled trials (RCTs) of corticosteroids versus placebo for eosinophilic meningitis.\nData collection and analysis\nTwo review authors (SiT, SaT) independently collected and extracted study data. We graded the methodological quality of the RCTs. We identified and analysed outcomes and adverse effects.\nMain results\nWe did not identifiy any new trials for inclusion or exclusion in this 2014 update. One study involving 110 participants (55 participants in each group) met our inclusion criteria. The corticosteroid (prednisolone) showed a benefit in shortening the median time to resolution of headaches (five days in the treatment group versus 13 days in the control group, P value < 0.0001). Corticosteroids were also associated with smaller numbers of participants who still had headaches after a two-week course of treatment (9.1% versus 45.5%, P value < 0.0001). The number of patients who needed repeat lumbar puncture was also smaller in the treatment group (12.7% versus 40%, P value = 0.002). There was a reduction in the median time of analgesic use in participants receiving corticosteroids (10.5 versus 25.0, P value = 0.038). There were no reported adverse effects from prednisolone in the treatment group.\nAuthors' conclusions\nCorticosteroids significantly help relieve headache in patients with eosinophilic meningitis, who have a pain score of four or more on a visual analogue scale. However, there is only one RCT supporting this benefit and this trial did not clearly mention allocation concealment and stratification. Therefore, we agreed to grade our included study as a moderate quality trial. Future well-designed RCTs are necessary.\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": "Given the lack of allocation concealment and blinding (especially in a trial with subjective outcomes), and the attrition (loss of participants), we graded our evidence as moderate quality."
}
] |
query-laysum
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7540
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[
{
"role": "user",
"content": "Abstract: Background\nEvidence from systematic reviews demonstrates that multi-disciplinary rehabilitation is effective in the stroke population, in which older adults predominate. However, the evidence base for the effectiveness of rehabilitation following acquired brain injury (ABI) in younger adults has not been established, perhaps because this scenario presents different methodological challenges in research.\nObjectives\nTo assess the effects of multi-disciplinary rehabilitation following ABI in adults 16 to 65 years of age.\nSearch methods\nWe ran the most recent search on 14 September 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic+Embase (OvidSP), Web of Science (ISI WOS) databases, clinical trials registers, and we screened reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) comparing multi-disciplinary rehabilitation versus routinely available local services or lower levels of intervention; or trials comparing an intervention in different settings, of different intensities or of different timing of onset. Controlled clinical trials were included, provided they met pre-defined methodological criteria.\nData collection and analysis\nThree review authors independently selected trials and rated their methodological quality. A fourth review author would have arbitrated if consensus could not be reached by discussion, but in fact, this did not occur. As in previous versions of this review, we used the method described by Van Tulder 1997 to rate the quality of trials and to perform a 'best evidence' synthesis by attributing levels of evidence on the basis of methodological quality. Risk of bias assessments were performed in parallel using standard Cochrane methodology. However, the Van Tulder system provided a more discriminative evaluation of rehabilitation trials, so we have continued to use it for our primary synthesis of evidence. We subdivided trials in terms of severity of brain injury, setting and type and timing of rehabilitation offered.\nMain results\nWe identified a total of 19 studies involving 3480 people. Twelve studies were of good methodological quality and seven were of lower quality, according to the van Tulder scoring system. Within the subgroup of predominantly mild brain injury, 'strong evidence' suggested that most individuals made a good recovery when appropriate information was provided, without the need for additional specific interventions. For moderate to severe injury, 'strong evidence' showed benefit from formal intervention, and 'limited evidence' indicated that commencing rehabilitation early after injury results in better outcomes. For participants with moderate to severe ABI already in rehabilitation, 'strong evidence' revealed that more intensive programmes are associated with earlier functional gains, and 'moderate evidence' suggested that continued outpatient therapy could help to sustain gains made in early post-acute rehabilitation. The context of multi-disciplinary rehabilitation appears to influence outcomes. 'Strong evidence' supports the use of a milieu-oriented model for patients with severe brain injury, in which comprehensive cognitive rehabilitation takes place in a therapeutic environment and involves a peer group of patients. 'Limited evidence' shows that specialist in-patient rehabilitation and specialist multi-disciplinary community rehabilitation may provide additional functional gains, but studies serve to highlight the particular practical and ethical restraints imposed on randomisation of severely affected individuals for whom no realistic alternatives to specialist intervention are available.\nAuthors' conclusions\nProblems following ABI vary. Consequently, different interventions and combinations of interventions are required to meet the needs of patients with different problems. Patients who present acutely to hospital with mild brain injury benefit from follow-up and appropriate information and advice. Those with moderate to severe brain injury benefit from routine follow-up so their needs for rehabilitation can be assessed. Intensive intervention appears to lead to earlier gains, and earlier intervention whilst still in emergency and acute care has been supported by limited evidence. The balance between intensity and cost-effectiveness has yet to be determined. Patients discharged from in-patient rehabilitation benefit from access to out-patient or community-based services appropriate to their needs. Group-based rehabilitation in a therapeutic milieu (where patients undergo neuropsychological rehabilitation in a therapeutic environment with a peer group of individuals facing similar challenges) represents an effective approach for patients requiring neuropsychological rehabilitation following severe brain injury. Not all questions in rehabilitation can be addressed by randomised controlled trials or other experimental approaches. For example, trial-based literature does not tell us which treatments work best for which patients over the long term, and which models of service represent value for money in the context of life-long care. In the future, such questions will need to be considered alongside practice-based evidence gathered from large systematic longitudinal cohort studies conducted in the context of routine clinical practice.\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": "The authors of this Cochrane review looked for studies of MD rehabilitation in adults, 16 to 65 years of age, with acquired brain injury (ABI) from any cause."
}
] |
query-laysum
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7541
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[
{
"role": "user",
"content": "Abstract: Background\nCatheter malfunction, including thrombosis, is associated with reduced dialysis adequacy, as well as an increased risk of catheter-related bacteraemia and mortality. The role of anticoagulants in the prevention of catheter malfunction remains uncertain.\nObjectives\nThis review aimed to compare the prophylactic effect of different anticoagulant agents, preparations, doses and administration on the incidence of central venous haemodialysis catheter-related malfunction and sepsis in patients with end-stage kidney disease (ESKD).\nSearch methods\nWe searched the Cochrane Renal Group's Specialised Register to 7 January 2016 through contact with the Trials' Search Co-ordinator using search terms relevant to this review.\nSelection criteria\nWe included all randomised controlled trials (RCT) assessing anticoagulants compared with conventional care for the prevention of catheter malfunction in adult patients receiving haemodialysis for ESKD.\nData collection and analysis\nThe primary outcome was catheter malfunction defined as a catheter blood flow of 200 mL/min or less, or as defined by study authors. Secondary outcomes were catheter-related bacteraemia, all-cause mortality and bleeding events. Relative risks (RR) with 95% confidence intervals (CI) for individual studies were pooled using random effects models within treatment classes. Analyses were conducted by class, with subgroup analyses performed of individual agents within classes.\nMain results\nWe included 27 studies (3003 participants) that were followed up for a median of six months. Study interventions included alternative anticoagulant locking solutions (19 studies, 2216 patients), systemic agents (6 studies, 664 patients) and low or no dose heparin (2 studies, 123 patients). The most common comparison treatment was a locking solution of heparin 5000 IU/mL, used in 17 studies. No significant effect on catheter malfunction was observed for alternative anticoagulant locking solutions (RR 0.96, 95% CI 0.74 to 1.26), systemic agents (RR 0.59, 95% CI 0.28 to 1.23), or low or no dose heparin (RR 0.90, 95% CI 0.10 to 8.31). A significant reduction on incidence of catheter-related bacteraemia was observed for alternative anticoagulant locking solutions (RR 0.46, 95% CI 0.32 to 0.66) but not systemic agents (RR 2.41, 95% CI 0.89 to 6.55), and could not be assessed in reports of low or no dose heparin studies. No significant effect on all-cause mortality was observed for alternative anticoagulant locking solutions (RR 0.88, 95% CI 0.54 to 1.43) or systemic agents (RR 0.78, 95% CI 0.37 to 1.65), and was not reported in studies of low or no dose heparin. Bleeding events were only reported in eight studies, including only 2/5 studies of systemic warfarin, with no clear effect demonstrated (RR 1.43, 95% CI 0.86 to 2.39). For individual agents, recombinant tissue plasminogen (rt-PA) was the only locking solution shown to reduce catheter malfunction (RR 0.58, 95% CI 0.37 to 0.91) based on the results of a single study. No significant on catheter malfunction was observed for other individual classes of alternative anticoagulant locking solutions (citrate: RR 1.14, 95% CI 0.76 to 1.69; antibiotic: RR 1.48, 95% CI 0.79 to 2.77; ethanol: RR 0.88, 95% CI 0.21 to 3.67). On the other hand, all individual classes of alternative anticoagulant locking solutions, except ethanol, reduced catheter-related bacteraemia (citrate: RR 0.49, 95% CI 0.36 to 0.68; antibiotic: RR 0.27, 95% CI 0.11 to 0.70; rt-PA: RR 0.35, 95% CI 0.13 to 0.93; ethanol: RR 0.33, 95% CI 0.03 to 4.05). No significant effect on all-cause mortality was observed for any individual agent within the class of alternative locking solutions. Studies were mainly of low quality and underpowered with an average participant number of 75 and study duration of six months. The interpretation of the study evidence was further limited by the variation in tested interventions and outcome reporting.\nAuthors' conclusions\nThe relative net benefit of anticoagulant therapies for prevention of catheter malfunction remains uncertain. Multiple agents appear to reduce catheter-related bacteraemia although the lack of clear assessment of harms and the limitations of study quality mean these results should be interpreted with caution. Methodological approaches can be used to avoid methods of reporting unduly affecting on the results of meta-analyses incorporating studies employed mixed reporting methods. Further high quality randomised studies, including safety outcomes, are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Patients with end-stage kidney disease require vascular access during haemodialysis. Central venous haemodialysis catheters are frequently used when permanent vascular access is not available. Catheter problems contribute to greater morbidity and mortality. Catheter malfunction leads to requirements for additional interventions, increased risk of catheter-related infection and hospitalisation.\nStandard care for the prevention of catheter malfunction is the use of heparin solutions as a post dialysis ‘lock’ in the catheter ports. The potential impact of heparin treatment on bleeding risk is an acknowledged concern. Therefore newer approaches have been proposed to seek improvements in catheter patency or treatment-associated harm rates."
}
] |
query-laysum
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7542
|
[
{
"role": "user",
"content": "Abstract: Background\nAcupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009.\nObjectives\nTo investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than sham (placebo) acupuncture; and c) as effective as prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials.\nSelection criteria\nWe included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine.\nData collection and analysis\nTwo reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created 'Summary of findings' tables.\nMain results\nTwenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate.\nComparison with no acupuncture\nAcupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) -0.56; 95% CI -0.65 to -0.48); findings were statistically heterogeneous (I² = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I² = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence).\nComparison with sham acupuncture\nBoth after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was -0.18 (95% CI -0.28 to -0.08; I² = 47%) after treatment and -0.19 (95% CI -0.30 to -0.09; I² = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I² = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39; I² = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups.\nComparison with prophylactic drug treatment\nAcupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment ( SMD -0.25; 95% CI -0.39 to -0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD -0.13; 95% CI -0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I² being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence).\nAuthors' conclusions\nThe available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, 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"
},
{
"role": "assistant",
"content": "Individuals with migraine have repeated attacks of severe headache, usually just on one side and often with vomiting. Acupuncture is a therapy in which thin needles are inserted into the skin at particular points. It originated in China, and is now used in many countries to treat people with migraine. We evaluated whether acupuncture reduces the number of episodes of migraine. We looked at the number of people in whom the number of migraine days per month was reduced by half or more than half."
}
] |
query-laysum
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7543
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[
{
"role": "user",
"content": "Abstract: Background\nAlcohol-related liver disease is due to excessive alcohol consumption. It includes a spectrum of liver diseases such as alcohol-related fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. Mortality associated with alcoholic hepatitis is high. The optimal pharmacological treatment of alcoholic hepatitis and other alcohol-related liver disease remains controversial.\nObjectives\nTo assess the comparative benefits and harms of different pharmacological interventions in the management of alcohol-related liver disease through a network meta-analysis and to generate rankings of the available pharmacological interventions according to their safety and efficacy in order to identify potential treatments. However, even in the subgroup of participants when the potential effect modifiers appeared reasonably similar across comparisons, there was evidence of inconsistency by one or more methods of assessment of inconsistency. Therefore, we did not report the results of the network meta-analysis and reported the comparative benefits and harms of different interventions using standard Cochrane methodology.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform and randomised controlled trials registers until February 2017 to identify randomised clinical trials on pharmacological treatments for alcohol-related liver diseases.\nSelection criteria\nRandomised clinical trials (irrespective of language, blinding, or publication status) including participants with alcohol-related liver disease. We excluded trials that included participants who had previously undergone liver transplantation and those with co-existing chronic viral diseases. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.\nData collection and analysis\nTwo review authors independently identified trials and independently extracted data. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CIs) using both fixed-effect and random-effects models based on available-participant analysis with Review Manager. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.\nMain results\nWe identified a total of 81 randomised clinical trials. All the trials were at high risk of bias, and the overall quality of the evidence was low or very low for all outcomes.\nAlcoholic hepatitis\nFifty randomised clinical trials included 4484 participants with alcoholic hepatitis. The period of follow-up ranged from one to 12 months. Because of concerns about transitivity assumption, we did not perform the network meta-analysis. None of the active interventions showed any improvement in any of the clinical outcomes reported in the trials, which includes mortality (at various time points), cirrhosis, decompensated cirrhosis, liver transplantation. None of the trials reported health-related quality of life or incidence of hepatocellular carcinoma.\nSevere alcoholic hepatitis\nOf the trials on alcoholic hepatitis, 19 trials (2545 participants) included exclusively participants with severe alcoholic hepatitis (Maddrey Discriminat Function > 32). The period of follow-up ranged from one to 12 months. There was no alteration in the conclusions when only people with severe alcoholic hepatitis were included in the analysis.\nSource of funding: Eleven trials were funded by parties with vested interest in the results. Sixteen trials were funded by parties without vested interest in the results. The source of funding was not reported in 23 trials.\nOther alcohol-related liver diseases\nThirty-one randomised clinical trials included 3695 participants with other alcohol-related liver diseases (with a wide spectrum of alcohol-related liver diseases). The period of follow-up ranged from one to 48 months. The mortality at maximal follow-up was lower in the propylthiouracil group versus the no intervention group (OR 0.45, 95% CI 0.26 to 0.78; 423 participants; 2 trials; low-quality evidence). However, this result is based on two small trials at high risk of bias and further confirmation in larger trials of low risk of bias is necessary to recommend propylthiouracil routinely in people with other alcohol-related liver diseases. The mortality at maximal follow-up was higher in the ursodeoxycholic acid group versus the no intervention group (OR 2.09, 95% CI 1.12 to 3.90; 226 participants; 1 trial; low-quality evidence).\nSource of funding: Twelve trials were funded by parties with vested interest in the results. Three trials were funded by parties without vested interest in the results. The source of funding was not reported in 16 trials.\nAuthors' conclusions\nBecause of very low-quality evidence, there is uncertainty in the effectiveness of any pharmacological intervention versus no intervention in people with alcoholic hepatitis or severe alcoholic hepatitis. Based on low-quality evidence, propylthiouracil may decrease mortality in people with other alcohol-related liver diseases. However, these results must be confirmed by adequately powered trials with low risk of bias before propylthiouracil can be considered effective.\nFuture randomised clinical trials should be conducted with approximately 200 participants in each group and follow-up of one to two years in order to compare the benefits and harms of different treatments in people with alcoholic hepatitis. Randomised clinical trials should include health-related quality of life and report serious adverse events separately from adverse events. Future randomised clinical trials should have a low risk of bias and low risk of random errors.\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": ""
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query-laysum
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7544
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[
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"role": "user",
"content": "Abstract: Background\nThe diagnosis of bronchiectasis is defined by abnormal dilation of the airways related to a pathological mechanism of progressive airway destruction that is due to a 'vicious cycle' of recurrent bacterial infection, inflammatory mediator release, airway damage, and subsequent further infection. Antibiotics are the main treatment option for reducing bacterial burden in people with exacerbations of bronchiectasis and for longer-term eradication, but their use is tempered against potential adverse effects and concerns regarding antibiotic resistance. The comparative effectiveness, cost-effectiveness, and safety of different antibiotics have been highlighted as important issues, but currently little evidence is available to help resolve uncertainty on these questions.\nObjectives\nTo evaluate the comparative effects of different antibiotics in the treatment of adults and children with bronchiectasis.\nSearch methods\nWe identified randomised controlled trials (RCTs) through searches of the Cochrane Airways Group Register of trials and online trials registries, run 30 April 2018. We augmented these with searches of the reference lists of published studies.\nSelection criteria\nWe included RCTs reported as full-text articles, those published as abstracts only, and unpublished data. We included adults and children (younger than 18 years) with a diagnosis of bronchiectasis by bronchography or high-resolution computed tomography who reported daily signs and symptoms, such as cough, sputum production, or haemoptysis, and those with recurrent episodes of chest infection; we included studies that compared one antibiotic versus another when they were administered by the same delivery method.\nData collection and analysis\nTwo review authors independently assessed trial selection, data extraction, and risk of bias. We assessed overall quality of the evidence using GRADE criteria. We made efforts to collect missing data from trial authors. We have presented results with their 95% confidence intervals (CIs) as mean differences (MDs) or odds ratios (ORs).\nMain results\nFour randomised trials were eligible for inclusion in this systematic review - two studies with 83 adults comparing fluoroquinolones with β-lactams and two studies with 55 adults comparing aminoglycosides with polymyxins.\nNone of the included studies reported information on exacerbations - one of our primary outcomes. Included studies reported no serious adverse events - another of our primary outcomes - and no deaths. We graded this evidence as low or very low quality. Included studies did not report quality of life. Comparison between fluoroquinolones and β-lactams (amoxicillin) showed fewer treatment failures in the fluoroquinolone group than in the amoxicillin group (OR 0.07, 95% CI 0.01 to 0.32; low-quality evidence) after 7 to 10 days of therapy. Researchers reported that Pseudomonas aeruginosa infection was eradicated in more participants treated with fluoroquinolones (Peto OR 20.09, 95% CI 2.83 to 142.59; low-quality evidence) but provided no evidence of differences in the numbers of participants showing improvement in sputum purulence (OR 2.35, 95% CI 0.96 to 5.72; very low-quality evidence). Study authors presented no evidence of benefit in relation to forced expiratory volume in one second (FEV₁). The two studies that compared polymyxins versus aminoglycosides described no clear differences between groups in the proportion of participants with P aeruginosa eradication (OR 1.40. 95% CI 0.36 to 5.35; very low-quality evidence) or improvement in sputum purulence (OR 0.16, 95% CI 0.01 to 3.85; very low-quality evidence). The evidence for changes in FEV₁ was inconclusive. Two of three trials reported adverse events but did not report the proportion of participants experiencing one or more adverse events, so we were unable to interpret the information.\nAuthors' conclusions\nLimited low-quality evidence favours short-term oral fluoroquinolones over beta-lactam antibiotics for patients hospitalised with exacerbations. Very low-quality evidence suggests no benefit from inhaled aminoglycosides verus polymyxins. RCTs have presented no evidence comparing other modes of delivery for each of these comparisons, and no RCTs have included children. Overall, current evidence from a limited number of head-to-head trials in adults or children with bronchiectasis is insufficient to guide the selection of antibiotics for short-term or long-term therapy. More research on this topic is needed.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Four randomised trials were eligible for inclusion in this systematic review. None of the included studies reported information on flare-ups (exacerbations). Included studies reported no deaths and no serious adverse events. Treatment failures were fewer with fluoroquinolone antibiotics than with amoxicillin antibiotics."
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query-laysum
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7545
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[
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"role": "user",
"content": "Abstract: Background\nGlobal prevalence of overweight and obesity are alarming. For tackling this public health problem, preventive public health and policy actions are urgently needed. Some countries implemented food taxes in the past and some were subsequently abolished. Some countries, such as Norway, Hungary, Denmark, Bermuda, Dominica, St. Vincent and the Grenadines, and the Navajo Nation (USA), specifically implemented taxes on unprocessed sugar and sugar-added foods. These taxes on unprocessed sugar and sugar-added foods are fiscal policy interventions, implemented to decrease their consumption and in turn reduce adverse health-related, economic and social effects associated with these food products.\nObjectives\nTo assess the effects of taxation of unprocessed sugar or sugar-added foods in the general population on the consumption of unprocessed sugar or sugar-added foods, the prevalence and incidence of overweight and obesity, and the prevalence and incidence of other diet-related health outcomes.\nSearch methods\nWe searched CENTRAL, Cochrane Database of Systematic Reviews, MEDLINE, Embase and 15 other databases and trials registers on 12 September 2019. We handsearched the reference list of all records of included studies, searched websites of international organisations and institutions, and contacted review advisory group members to identify planned, ongoing or unpublished studies.\nSelection criteria\nWe included studies with the following populations: children (0 to 17 years) and adults (18 years or older) from any country and setting. Exclusion applied to studies with specific subgroups, such as people with any disease who were overweight or obese as a side-effect of the disease. The review included studies with taxes on or artificial increases of selling prices for unprocessed sugar or food products that contain added sugar (e.g. sweets, ice cream, confectionery, and bakery products), or both, as intervention, regardless of the taxation level or price increase. In line with Cochrane Effective Practice and Organisation of Care (EPOC) criteria, we included randomised controlled trials (RCTs), cluster-randomised controlled trials (cRCTs), non-randomised controlled trials (nRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) studies. We included controlled studies with more than one intervention or control site and ITS studies with a clearly defined intervention time and at least three data points before and three after the intervention. Our primary outcomes were consumption of unprocessed sugar or sugar-added foods, energy intake, overweight, and obesity. Our secondary outcomes were substitution and diet, expenditure, demand, and other health outcomes.\nData collection and analysis\nTwo review authors independently screened all eligible records for inclusion, assessed the risk of bias, and performed data extraction.Two review authors independently assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe retrieved a total of 24,454 records. After deduplicating records, 18,767 records remained for title and abstract screening. Of 11 potentially relevant studies, we included one ITS study with 40,210 household-level observations from the Hungarian Household Budget and Living Conditions Survey. The baseline ranged from January 2008 to August 2011, the intervention was implemented on September 2011, and follow-up was until December 2012 (16 months). The intervention was a tax - the so-called 'Hungarian public health product tax' - on sugar-added foods, including selected foods exceeding a specific sugar threshold value. The intervention includes co-interventions: the taxation of sugar-sweetened beverages (SSBs) and of foods high in salt or caffeine.\nThe study provides evidence on the effect of taxing foods exceeding a specific sugar threshold value on the consumption of sugar-added foods. After implementation of the Hungarian public health product tax, the mean consumption of taxed sugar-added foods (measured in units of kg) decreased by 4.0% (standardised mean difference (SMD) −0.040, 95% confidence interval (CI) −0.07 to −0.01; very low-certainty evidence).\nThe study was at low risk of bias in terms of performance bias, detection bias and reporting bias, with the shape of effect pre-specified and the intervention unlikely to have any effect on data collection. The study was at unclear risk of attrition bias and at high risk in terms of other bias and the independence of the intervention. We rated the certainty of the evidence as very low for the primary and secondary outcomes.\nThe Hungarian public health product tax included a tax on sugar-added foods but did not include a tax on unprocessed sugar. We did not find eligible studies reporting on the taxation of unprocessed sugar. No studies reported on the primary outcomes of consumption of unprocessed sugar, energy intake, overweight, and obesity. No studies reported on the secondary outcomes of substitution and diet, demand, and other health outcomes. No studies reported on differential effects across population subgroups.\nWe could not perform meta-analyses or pool study results.\nAuthors' conclusions\nThere was very limited evidence and the certainty of the evidence was very low. Despite the reported reduction in consumption of taxed sugar-added foods, we are uncertain whether taxing unprocessed sugar or sugar-added foods has an effect on reducing their consumption and preventing obesity or other adverse health outcomes. Further robustly conducted studies are required to draw concrete conclusions on the effectiveness of taxing unprocessed sugar or sugar-added foods for reducing their consumption and preventing obesity or other adverse health outcomes.\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": "Further research is needed to assess the effectiveness of taxing unprocessed sugar or foods with added sugar for reducing their consumption and preventing obesity or other adverse health outcomes. Studies should take place in countries that have implemented these taxes and should look at cost-effectiveness as well as the health benefits of taxing unprocessed sugar or foods with added sugar as a public health policy for preventing overweight, obesity or other adverse health outcomes. Countries that have implemented these taxes are Bermuda, Dominica, Hungary, India, Norway, the Navajo Nation (USA), and St. Vincent and Grenadines."
}
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query-laysum
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7546
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[
{
"role": "user",
"content": "Abstract: Background\nApproximately 50% of patients with newly diagnosed non-small cell lung cancer (NSCLC) are over 70 years of age at diagnosis. Despite this fact, these patients are underrepresented in randomized controlled trials (RCTs). As a consequence, the most appropriate regimens for these patients are controversial, and the role of single-agent or combination therapy is unclear. In this setting, a critical systematic review of RCTs in this group of patients is warranted.\nObjectives\nTo assess the effectiveness and safety of different cytotoxic chemotherapy regimens for previously untreated elderly patients with advanced (stage IIIB and IV) NSCLC. To also assess the impact of cytotoxic chemotherapy on quality of life.\nSearch methods\nWe searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to 31 October 2014), EMBASE (1974 to 31 October 2014), and Latin American Caribbean Health Sciences Literature (LILACS) (1982 to 31 October 2014). In addition, we handsearched the proceedings of major conferences, reference lists from relevant resources, and the ClinicalTrial.gov database.\nSelection criteria\nWe included only RCTs that compared non-platinum single-agent therapy versus non-platinum combination therapy, or non-platinum therapy versus platinum combination therapy in patients over 70 years of age with advanced NSCLC. We allowed inclusion of RCTs specifically designed for the elderly population and those designed for elderly subgroup analyses.\nData collection and analysis\nTwo review authors independently assessed search results, and a third review author resolved disagreements. We analyzed the following endpoints: overall survival (OS), one-year survival rate (1yOS), progression-free survival (PFS), objective response rate (ORR), major adverse events, and quality of life (QoL).\nMain results\nWe included 51 trials in the review: non-platinum single-agent therapy versus non-platinum combination therapy (seven trials) and non-platinum combination therapy versus platinum combination therapy (44 trials).\nNon-platinum single-agent versus non-platinum combination therapy\nLow-quality evidence suggests that these treatments have similar effects on overall survival (hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.72 to 1.17; participants = 1062; five RCTs), 1yOS (risk ratio (RR) 0.88, 95% CI 0.73 to 1.07; participants = 992; four RCTs), and PFS (HR 0.94, 95% CI 0.83 to 1.07; participants = 942; four RCTs). Non-platinum combination therapy may better improve ORR compared with non-platinum single-agent therapy (RR 1.79, 95% CI 1.41 to 2.26; participants = 1014; five RCTs; low-quality evidence).\nDifferences in effects on major adverse events between treatment groups were as follows: anemia: RR 1.10, 95% 0.53 to 2.31; participants = 983; four RCTs; very low-quality evidence; neutropenia: RR 1.26, 95% CI 0.96 to 1.65; participants = 983; four RCTs; low-quality evidence; and thrombocytopenia: RR 1.45, 95% CI 0.73 to 2.89; participants = 914; three RCTs; very low-quality evidence. Only two RCTs assessed quality of life; however, we were unable to perform a meta-analysis because of the paucity of available data.\nNon-platinum therapy versus platinum combination therapy\nPlatinum combination therapy probably improves OS (HR 0.76, 95% CI 0.69 to 0.85; participants = 1705; 13 RCTs; moderate-quality evidence), 1yOS (RR 0.89, 95% CI 0.82 to 0.96; participants = 813; 13 RCTs; moderate-quality evidence), and ORR (RR 1.57, 95% CI 1.32 to 1.85; participants = 1432; 11 RCTs; moderate-quality evidence) compared with non-platinum therapies. Platinum combination therapy may also improve PFS, although our confidence in this finding is limited because the quality of evidence was low (HR 0.76, 95% CI 0.61 to 0.93; participants = 1273; nine RCTs).\nEffects on major adverse events between treatment groups were as follows: anemia: RR 2.53, 95% CI 1.70 to 3.76; participants = 1437; 11 RCTs; low-quality evidence; thrombocytopenia: RR 3.59, 95% CI 2.22 to 5.82; participants = 1260; nine RCTs; low-quality evidence; fatigue: RR 1.56, 95% CI 1.02 to 2.38; participants = 1150; seven RCTs; emesis: RR 3.64, 95% CI 1.82 to 7.29; participants = 1193; eight RCTs; and peripheral neuropathy: RR 7.02, 95% CI 2.42 to 20.41; participants = 776; five RCTs; low-quality evidence. Only five RCTs assessed QoL; however, we were unable to perform a meta-analysis because of the paucity of available data.\nAuthors' conclusions\nIn people over the age of 70 with advanced NSCLC who do not have significant co-morbidities, increased survival with platinum combination therapy needs to be balanced against higher risk of major adverse events when compared with non-platinum therapy. For people who are not suitable candidates for platinum treatment, we have found low-quality evidence suggesting that non-platinum combination and single-agent therapy regimens have similar effects on survival. We are uncertain as to the comparability of their adverse event profiles. Additional evidence on quality of life gathered from additional studies is needed to help inform decision making.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We performed a systematic search (up to 31 October 2014) for trials that compared non-platinum single-agent therapy versus non-platinum combination therapy or non-platinum combination therapy versus platinum combination therapy in patients over 70 years of age who have advanced non-small cell lung cancer. We included in the review a total of 51 studies (seven studies in the non-platinum single-agent therapy vs non-platinum combination therapy group and 44 studies in the non-platinum combination therapy vs platinum combination therapy group); however, we were able to include only 19 studies in the meta-analysis."
}
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7547
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[
{
"role": "user",
"content": "Abstract: Background\nAmputation is described as the removal of an external part of the body by trauma, medical illness or surgery. Amputations caused by vascular diseases (dysvascular amputations) are increasingly frequent, commonly due to peripheral arterial disease (PAD), associated with an ageing population, and increased incidence of diabetes and atherosclerotic disease. Interventions for motor rehabilitation might work as a precursor to enhance the rehabilitation process and prosthetic use. Effective rehabilitation can improve mobility, allow people to take up activities again with minimum functional loss and may enhance the quality of life (QoL). Strength training is a commonly used technique for motor rehabilitation following transtibial (below-knee) amputation, aiming to increase muscular strength. Other interventions such as motor imaging (MI), virtual environments (VEs) and proprioceptive neuromuscular facilitation (PNF) may improve the rehabilitation process and, if these interventions can be performed at home, the overall expense of the rehabilitation process may decrease. Due to the increased prevalence, economic impact and long-term rehabilitation process in people with dysvascular amputations, a review investigating the effectiveness of motor rehabilitation interventions in people with dysvascular transtibial amputations is warranted.\nObjectives\nTo evaluate the benefits and harms of interventions for motor rehabilitation in people with transtibial (below-knee) amputations resulting from peripheral arterial disease or diabetes (dysvascular causes).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 9 January 2023.\nSelection criteria\nWe included randomised controlled trials (RCT) in people with transtibial amputations resulting from PAD or diabetes (dysvascular causes) comparing interventions for motor rehabilitation such as strength training (including gait training), MI, VEs and PNF against each other.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. prosthesis use, and 2. adverse events. Our secondary outcomes were 3. mortality, 4. QoL, 5. mobility assessment and 6. phantom limb pain. We use GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included two RCTs with a combined total of 30 participants. One study evaluated MI combined with physical practice of walking versus physical practice of walking alone. One study compared two different gait training protocols. The two studies recruited people who already used prosthesis; therefore, we could not assess prosthesis use. The studies did not report mortality, QoL or phantom limb pain. There was a lack of blinding of participants and imprecision as a result of the small number of participants, which downgraded the certainty of the evidence.\nWe identified no studies that compared VE or PNF with usual care or with each other.\nMI combined with physical practice of walking versus physical practice of walking (one RCT, eight participants) showed very low-certainty evidence of no difference in mobility assessment assessed using walking speed, step length, asymmetry of step length, asymmetry of the mean amount of support on the prosthetic side and on the non-amputee side and Timed Up-and-Go test. The study did not assess adverse events.\nOne study compared two different gait training protocols (one RCT, 22 participants). The study used change scores to evaluate if the different gait training strategies led to a difference in improvement between baseline (day three) and post-intervention (day 10). There were no clear differences using velocity, Berg Balance Scale (BBS) or Amputee Mobility Predictor with PROsthesis (AMPPRO) in training approaches in functional outcome (very low-certainty evidence). There was very low-certainty evidence of little or no difference in adverse events comparing the two different gait training protocols.\nAuthors' conclusions\nOverall, there is a paucity of research in the field of motor rehabilitation in dysvascular amputation. We identified very low-certainty evidence that gait training protocols showed little or no difference between the groups in mobility assessments and adverse events. MI combined with physical practice of walking versus physical practice of walking alone showed no clear difference in mobility assessment (very low-certainty evidence). The included studies did not report mortality, QoL, and phantom limb pain, and evaluated participants already using prosthesis, precluding the evaluation of prosthesis use.\nDue to the very low-certainty evidence available based on only two small trials, it remains unclear whether these interventions have an effect on the prosthesis use, adverse events, mobility assessment, mortality, QoL and phantom limb pain. Further well-designed studies that address interventions for motor rehabilitation in dysvascular transtibial amputation may be important to clarify this uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are not confident in the evidence because it was based on only two trials with a small number of participants. People knew which treatment they received, which could have affected the study's results."
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query-laysum
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7548
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[
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"role": "user",
"content": "Abstract: Background\nCritically ill people may lose fluid because of serious conditions, infections (e.g. sepsis), trauma, or burns, and need additional fluids urgently to prevent dehydration or kidney failure. Colloid or crystalloid solutions may be used for this purpose. Crystalloids have small molecules, are cheap, easy to use, and provide immediate fluid resuscitation, but may increase oedema. Colloids have larger molecules, cost more, and may provide swifter volume expansion in the intravascular space, but may induce allergic reactions, blood clotting disorders, and kidney failure. This is an update of a Cochrane Review last published in 2013.\nObjectives\nTo assess the effect of using colloids versus crystalloids in critically ill people requiring fluid volume replacement on mortality, need for blood transfusion or renal replacement therapy (RRT), and adverse events (specifically: allergic reactions, itching, rashes).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two other databases on 23 February 2018. We also searched clinical trials registers.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs of critically ill people who required fluid volume replacement in hospital or emergency out-of-hospital settings. Participants had trauma, burns, or medical conditions such as sepsis. We excluded neonates, elective surgery and caesarean section. We compared a colloid (suspended in any crystalloid solution) versus a crystalloid (isotonic or hypertonic).\nData collection and analysis\nIndependently, two review authors assessed studies for inclusion, extracted data, assessed risk of bias, and synthesised findings. We assessed the certainty of evidence with GRADE.\nMain results\nWe included 69 studies (65 RCTs, 4 quasi-RCTs) with 30,020 participants. Twenty-eight studied starch solutions, 20 dextrans, seven gelatins, and 22 albumin or fresh frozen plasma (FFP); each type of colloid was compared to crystalloids.\nParticipants had a range of conditions typical of critical illness. Ten studies were in out-of-hospital settings. We noted risk of selection bias in some studies, and, as most studies were not prospectively registered, risk of selective outcome reporting. Fourteen studies included participants in the crystalloid group who received or may have received colloids, which might have influenced results.\nWe compared four types of colloid (i.e. starches; dextrans; gelatins; and albumin or FFP) versus crystalloids.\nStarches versus crystalloids\nWe found moderate-certainty evidence that there is probably little or no difference between using starches or crystalloids in mortality at: end of follow-up (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.86 to 1.09; 11,177 participants; 24 studies); within 90 days (RR 1.01, 95% CI 0.90 to 1.14; 10,415 participants; 15 studies); or within 30 days (RR 0.99, 95% CI 0.90 to 1.09; 10,135 participants; 11 studies).\nWe found moderate-certainty evidence that starches probably slightly increase the need for blood transfusion (RR 1.19, 95% CI 1.02 to 1.39; 1917 participants; 8 studies), and RRT (RR 1.30, 95% CI 1.14 to 1.48; 8527 participants; 9 studies). Very low-certainty evidence means we are uncertain whether either fluid affected adverse events: we found little or no difference in allergic reactions (RR 2.59, 95% CI 0.27 to 24.91; 7757 participants; 3 studies), fewer incidences of itching with crystalloids (RR 1.38, 95% CI 1.05 to 1.82; 6946 participants; 2 studies), and fewer incidences of rashes with crystalloids (RR 1.61, 95% CI 0.90 to 2.89; 7007 participants; 2 studies).\nDextrans versus crystalloids\nWe found moderate-certainty evidence that there is probably little or no difference between using dextrans or crystalloids in mortality at: end of follow-up (RR 0.99, 95% CI 0.88 to 1.11; 4736 participants; 19 studies); or within 90 days or 30 days (RR 0.99, 95% CI 0.87 to 1.12; 3353 participants; 10 studies). We are uncertain whether dextrans or crystalloids reduce the need for blood transfusion, as we found little or no difference in blood transfusions (RR 0.92, 95% CI 0.77 to 1.10; 1272 participants, 3 studies; very low-certainty evidence). We found little or no difference in allergic reactions (RR 6.00, 95% CI 0.25 to 144.93; 739 participants; 4 studies; very low-certainty evidence). No studies measured RRT.\nGelatins versus crystalloids\nWe found low-certainty evidence that there may be little or no difference between gelatins or crystalloids in mortality: at end of follow-up (RR 0.89, 95% CI 0.74 to 1.08; 1698 participants; 6 studies); within 90 days (RR 0.89, 95% CI 0.73 to 1.09; 1388 participants; 1 study); or within 30 days (RR 0.92, 95% CI 0.74 to 1.16; 1388 participants; 1 study). Evidence for blood transfusion was very low certainty (3 studies), with a low event rate or data not reported by intervention. Data for RRT were not reported separately for gelatins (1 study). We found little or no difference between groups in allergic reactions (very low-certainty evidence).\nAlbumin or FFP versus crystalloids\nWe found moderate-certainty evidence that there is probably little or no difference between using albumin or FFP or using crystalloids in mortality at: end of follow-up (RR 0.98, 95% CI 0.92 to 1.06; 13,047 participants; 20 studies); within 90 days (RR 0.98, 95% CI 0.92 to 1.04; 12,492 participants; 10 studies); or within 30 days (RR 0.99, 95% CI 0.93 to 1.06; 12,506 participants; 10 studies). We are uncertain whether either fluid type reduces need for blood transfusion (RR 1.31, 95% CI 0.95 to 1.80; 290 participants; 3 studies; very low-certainty evidence). Using albumin or FFP versus crystalloids may make little or no difference to the need for RRT (RR 1.11, 95% CI 0.96 to 1.27; 3028 participants; 2 studies; very low-certainty evidence), or in allergic reactions (RR 0.75, 95% CI 0.17 to 3.33; 2097 participants, 1 study; very low-certainty evidence).\nAuthors' conclusions\nUsing starches, dextrans, albumin or FFP (moderate-certainty evidence), or gelatins (low-certainty evidence), versus crystalloids probably makes little or no difference to mortality. Starches probably slightly increase the need for blood transfusion and RRT (moderate-certainty evidence), and albumin or FFP may make little or no difference to the need for renal replacement therapy (low-certainty evidence). Evidence for blood transfusions for dextrans, and albumin or FFP, is uncertain. Similarly, evidence for adverse events is uncertain. Certainty of evidence may improve with inclusion of three ongoing studies and seven studies awaiting classification, in future updates.\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 moderate-certainty evidence that using colloids (starches; dextrans; or albumin or FFP) compared to crystalloids for fluid replacement probably makes little or no difference to the number of critically ill people who die within 30 or 90 days, or by the end of study follow-up. We also found low-certainty evidence that using gelatins or crystalloids may make little or no difference to the number of deaths within each of these time points.\nWe found moderate-certainty evidence that using starches probably slightly increases the need for blood transfusion. However, we are uncertain whether using other types of colloids, compared to crystalloids, makes a difference to whether people need a blood transfusion because the certainty of the evidence is very low.\nWe found moderate-certainty evidence that using starches for fluid replacement probably slightly increases the need for renal replacement therapy. Using albumin or FFP compared to crystalloids may make little or no difference to the need for renal replacement therapy. One study comparing gelatins did not report results for renal replacement therapy according to the type of fluid given, and no studies comparing dextrans assessed renal replacement therapy.\nFew studies reported adverse events (specifically, allergic reactions, itching, or rashes), so we are uncertain whether either fluid type causes fewer adverse events (very low-certainty evidence). We found little or no difference between starches or crystalloids in allergic reactions, but fewer participants given crystalloids reported itching or rashes. We found little or no difference in allergic reactions for the use of dextrans (four studies), gelatins (one study), and albumin or FFP (one study)."
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query-laysum
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7549
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[
{
"role": "user",
"content": "Abstract: Background\nAnterior cruciate ligament (ACL) tears are frequently treated with surgical reconstruction with grafts, frequently patella tendon or hamstrings. Interference screws are often used to secure the graft in bone tunnels in the femur and tibia. This review examines whether bioabsorbable interference screws give better results than metal interference screws when used for graft fixation in ACL reconstruction.\nObjectives\nTo assess the effects (benefits and harms) of bioabsorbable versus metallic interference screws for graft fixation in ACL reconstruction.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, LILACS, trial registers and reference lists of articles. Date of search: January 2016.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised trials comparing bioabsorbable with metallic interferences screws in ACL reconstruction. The main outcomes sought were subjective-rated knee function, failure of treatment, and activity level.\nData collection and analysis\nAt least two review authors selected eligible trials, independently assessed risk of bias, and cross-checked data. Data were pooled whenever relevant and possible. Requests for further information were sent to the original study authors.\nMain results\nWe included 12 trials (11 randomised and one quasi-randomised) involving a total of 944 participants, and reporting follow-up results for 774. Participants in the 12 trials underwent ACL reconstruction with either hamstring tendon grafts (five trials) or patellar tendon grafts (seven trials). Trials participants were randomly allocated to bioabsorbable or metallic interference screws for graft fixation in both femur and tibia (seven trials); femur only (three trials); tibia only (one trial); location was not reported in the remaining trial. A variety of materials was used for the bioabsorbable screws, Poly-L-lactic acid (PLLA) being the most common. The metallic screws, where reported, were titanium.\nAll trials were at high risk of bias, which invariably included performance bias. Seven trials were at high risk of attrition bias and eight at high risk of reporting bias. The quasi-randomised trial was assessed as being at high risk for selection bias. Based on these study limitations and insufficiency of the available data, we judged the quality of evidence for all outcomes was very low.\nThe majority of the available data for patient-reported knee function was presented as Lysholm scores (0 to 100; higher scores = better function). There was very low quality but consistent evidence of no clinically important differences between the two groups in Lysholm scores at 12 months follow-up (mean difference (MD) -0.08, 95% confidence interval (CI) -1.48 to 1.32; three trials, 168 participants); 24 months (MD 0.35, 95% CI -1.27 to 1.98; three trials, 113 participants) or five or more years follow-up (MD 1.23, 95% CI -2.00 to 4.47; two trials, 71 participants). This lack of between-group differences was also reported for Lysholm scores in several trials that did not provide sufficient data for pooling as well as for other self-reported knee function scores reported in several trials.\nTreatment failure was represented by the summed data for implant breakage during surgery and major postoperative complications (implant failure, graft rupture, symptomatic foreign body reactions, effusion and treated arthrofibrosis and related conditions) that were usually described in the trial reports as requiring further substantive treatment. There is very low-quality evidence of greater treatment failure in the bioabsorbable screw group (60/451 versus 29/434; risk ratio (RR) 1.94 favouring metallic screw fixation, 95% CI 1.29 to 2.93; 885 participants, 11 studies). In a population with an assumed risk (based on the median control group risk) of 56 participants per 1000 having treatment failure after metallic screw fixation, this equates to 53 more (95% CI 17 to 108 more) per 1000 participants having treatment failure after bioabsorbable screw fixation. All 16 intraoperative complications in the bioabsorbable screw group were implant breakages upon screw insertion. Treatment failure defined as postoperative complications only still favoured the metallic screw group but the 95% CI also included the potential for a greater risk of treatment failure after metallic screw fixation: 44/451 versus 29/434; RR 1.44, 95% CI 0.93 to 2.23. Based on the assumed risk of 56 participants per 1000 having postoperative treatment failure after metallic screw fixation, this equates to 25 more (95% CI 4 fewer and 69 more) per 1000 participants having this outcome after bioabsorbable screw fixation.\nThere was very low-quality evidence of very similar activity levels in the two groups at 12 and 24 months follow-up measured via the Tegner score (0 to 10; higher scores = greater activity): 12 months (MD 0.08, 95% CI -0.39 to 0.55; 122 participants, two studies); 24 months (MD 0.01, 95% CI -0.54 to 0.57; 72 participants, two studies).\nAuthors' conclusions\nThere is very low-quality evidence of no difference in self-reported knee function and levels of activity between bioabsorbable and metallic interference screws for graft fixation in ACL reconstruction. There is very low-quality evidence that bioabsorbable screws may be associated with more overall treatment failures, including implant breakage during surgery. Further research does not appear to be a priority, but if undertaken, should also examine costs.\n\nGiven the provided abstract, please respond to the following query: \"Results of the search\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"content": "We searched medical databases up to January 2016 for randomised studies comparing bioabsorbable with metal screws for graft fixation. We included 12 studies involving 944 participants undergoing surgery (ACL reconstruction)."
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"content": "Abstract: Background\nEmbryo transfer (ET) is a crucial step of in vitro fertilisation (IVF) treatment, and involves placing the embryo(s) in the woman’s uterus. There is a negative association between endometrial wave-like activity (contractile activities) at the time of ET and clinical pregnancy, but no specific treatment is currently used in clinical practice to counteract their effects. Oxytocin is a hormone produced by the hypothalamus and released by the posterior pituitary. Its main role involves generating uterine contractions during and after childbirth. Atosiban is the best known oxytocin antagonist (and is also a vasopressin antagonist), and it is commonly used to delay premature labour by halting uterine contractions. Other oxytocin antagonists include barusiban, nolasiban, epelsiban, and retosiban. Administration of oxytocin antagonists around the time of ET has been proposed as a means to reduce uterine contractions that may interfere with embryo implantation. The intervention involves administering the medication before, during, or after the ET (or a combination).\nObjectives\nTo evaluate the effectiveness and safety of oxytocin antagonists around the time of ET in women undergoing assisted reproduction.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in March 2021; and checked references and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the use of oxytocin antagonists for women undergoing ET, compared with the non-use of this intervention, the use of placebo, or the use of another similar drug.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy and other adverse events.\nMain results\nWe included nine studies (including one comprising three separate trials, 3733 women analysed in total) investigating the role of three different oxytocin antagonists administered intravenously (atosiban), subcutaneously (barusiban), or orally (nolasiban). We found very low- to high-certainty evidence: the main limitations were serious risk of bias due to poor reporting of study methods, and serious or very serious imprecision.\nIntravenous atosiban versus normal saline or no intervention\nWe are uncertain of the effect of intravenous atosiban on live birth rate (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.88 to 1.24; 1 RCT, N = 800; low-certainty evidence). In a clinic with a live birth rate of 38% per cycle, the use of intravenous atosiban would be associated with a live birth rate ranging from 33.4% to 47.1%.\nWe are uncertain whether intravenous atosiban influences miscarriage rate (RR 1.08, 95% CI 0.75 to 1.56; 5 RCTs, N = 1424; I² = 0%; very low-certainty evidence). In a clinic with a miscarriage rate of 7.2% per cycle, the use of intravenous atosiban would be associated with a miscarriage rate ranging from 5.4% to 11.2%.\nIntravenous atosiban may increase clinical pregnancy rate (RR 1.50, 95% CI 1.18 to 1.89; 7 RCTs, N = 1646; I² = 69%; low-certainty evidence), and we are uncertain whether multiple or ectopic pregnancy and other complication rates were influenced by the use of intravenous atosiban (very low-certainty evidence).\nSubcutaneous barusiban versus placebo\nOne study investigated barusiban, but did not report on live birth or miscarriage.\nWe are uncertain whether subcutaneous barusiban influences clinical pregnancy rate (RR 0.96, 95% CI 0.69 to 1.35; 1 RCT, N = 255; very low-certainty evidence). Trialists reported more mild to moderate injection site reactions with barusiban than with placebo, but there was no difference in severe reactions. They reported no serious drug reactions; and comparable neonatal outcome between groups.\nOral nolasiban versus placebo\nNolasiban does not increase live birth rate (RR 1.13, 95% CI 0.99 to 1.28; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence). In a clinic with a live birth rate of 33% per cycle, the use of oral nolasiban would be associated with a live birth rate ranging from 32.7% to 42.2%.\nWe are uncertain of the effect of oral nolasiban on miscarriage rate (RR 1.45, 95% CI 0.73 to 2.88; 3 RCTs, N = 1832; I² = 0%; low-certainty evidence). In a clinic with a miscarriage rate of 1.5% per cycle, the use of oral nolasiban would be associated with a miscarriage rate ranging from 1.1% to 4.3%.\nOral nolasiban improves clinical pregnancy rate (RR 1.15, 95% CI 1.02 to 1.30; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence), and probably does not increase multiple or ectopic pregnancy, or other complication rates (moderate-certainty evidence).\nAuthors' conclusions\nWe are uncertain whether intravenous atosiban improves pregnancy outcomes for women undergoing assisted reproductive technology. This conclusion is based on currently available data from seven RCTs, which provided very low- to low-certainty evidence across studies.\nWe could draw no clear conclusions about subcutaneous barusiban, based on limited data from one RCT.\nFurther large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of atosiban and barusiban before ET.\nOral nolasiban appears to improve clinical pregnancy rate but not live birth rate, with an uncertain effect on miscarriage and adverse events. This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention.\n\nGiven the provided abstract, please respond to the following query: \"Medication given by mouth (nolasiban) versus no medication\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence suggests that nolasiban does not improve live birth rates when compared to those not taking medication to block oxytocin. In a clinic with a live birth rate of 33% per cycle without medication to block oxytocin, the use of nolasiban would be associated with a live birth rate ranging from 33% to 42%.\nWe are uncertain of the effect of oral nolasiban on miscarriage rate. In a clinic with a miscarriage rate of 2% per cycle without medication to block oxytocin, the use of nolasiban would be associated with a miscarriage rate ranging from 1% to 4%.\nThe evidence suggests that nolasiban improves clinical pregnancy rates compared to not taking medication to block oxytocin. In a clinic with a clinical pregnancy of 35% per cycle without medication to block oxytocin, the use of nolasiban would be associated with a clinical pregnancy rate ranging from 35% to 45%.\nEvidence for all types of medication on other adverse events such as multiple pregnancy (pregnant with twins, triplets or more), pregnancy growing outside the womb, adverse reaction to medication or congenital anomalies (defects present from birth) was poorly reported or inconclusive."
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"content": "Abstract: Background\nPoor medication adherence decreases treatment efficacy and worsens clinical outcomes, but average rates of adherence to long-term pharmacological treatments for chronic illnesses are only about 50%. Interventions for improving medication adherence largely focus on patients rather than on physicians; however, the strategies shown to be effective are complex and difficult to implement in clinical practice. There is a need for new care models addressing the problem of medication adherence, integrating this problem into the patient care process. Physicians tend to overestimate how well patients take their medication as prescribed. This can lead to missed opportunities to change medications, solve adverse effects, or propose the use of reminders in order to improve patients' adherence. Thus, providing physicians with feedback on medication adherence has the potential to prompt changes that improve their patients' adherence to prescribed medications.\nObjectives\nTo assess the effects of providing physicians with feedback about their patients' medication adherence for improving adherence. We also assessed the effects of the intervention on patient outcomes, health resource use, and processes of care.\nSearch methods\nWe conducted a systematic search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase, all from database inception to December 2016 and without any language restriction. We also searched ISI Web of Science, two trials registers, and grey literature.\nSelection criteria\nWe included randomised trials, controlled before-after studies, and interrupted time series studies that compared the effects of providing feedback to physicians about their patients' adherence to prescribed long-term medications for chronic diseases versus usual care. We included published or unpublished studies in any language. Participants included any physician and any patient prescribed with long-term medication for chronic disease. We included interventions providing the prescribing physician with information about patient adherence to medication. Only studies in which feedback to the physician was the sole intervention or the essential component of a multifaceted intervention were eligible. In the comparison groups, the physicians should not have had access to information about their patients' adherence to medication. We considered the following outcomes: medication adherence, patient outcomes, health resource use, processes of care, and adverse events.\nData collection and analysis\nTwo independent review authors extracted and analysed all data using standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care group. Due to heterogeneity in study methodology, comparison groups, intervention settings, and measurements of outcomes, we did not carry out meta-analysis. We describe the impact of interventions on outcomes in tabular form and make a qualitative assessment of the effects of studies.\nMain results\nWe included nine studies (23,255 patient participants): eight randomised trials and one interrupted time series analysis. The studies took place in primary care and other outpatient settings in the USA and Canada. Seven interventions involved the systematic provision of feedback to physicians concerning all their patients' adherence to medication, and two interventions involved issuing an alert for non-adherent patients only. Seven studies used pharmacy refill data to assess medication adherence, and two used an electronic device or self-reporting. The definition of adherence differed across studies, making comparisons difficult. Eight studies were at high risk of bias, and one study was at unclear risk of bias. The most frequent source of bias was lack of protection against contamination.\nProviding physicians with feedback may lead to little or no difference in medication adherence (seven studies, 22,924 patients), patient outcomes (two studies, 1292 patients), or health resource use (two studies, 4181 patients). Providing physicians with feedback on medication adherence may improve processes of care (e.g. more medication changes, dialogue with patient, management of uncontrolled hypertension) compared to usual care (four studies, 2780 patients). None of the studies reported an adverse event due to the intervention. The certainty of evidence was low for all outcomes, mainly due to high risk of bias, high heterogeneity across studies, and indirectness of evidence.\nAuthors' conclusions\nAcross nine studies, we observed little or no evidence that provision of feedback to physicians regarding their patients adherence to prescribed medication improved medication adherence, patient outcomes, or health resource use. Feedback about medication adherence may improve processes of care, but due to the small number of studies assessing this outcome and high risk of bias, we cannot draw firm conclusions on the effect of feedback on this outcome. Future research should use a clear, standardised definition of medication adherence and cluster-randomisation to avoid the risk of contamination.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Physicians tend to overestimate how well their patients take medication as prescribed and therefore miss opportunities to improve adherence. These opportunities include actions such as changing medications, solving adverse effects, and proposing the use of medication reminders. Thus, informing physicians about their patients' medication adherence could change physician behaviour and in turn improve medication adherence."
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"content": "Abstract: Background\nDystonia is a painful and disabling disorder, characterised by painful, involuntary posturing of the affected body region(s). Deep brain stimulation is an intervention typically reserved for severe and drug-refractory cases, although uncertainty exists regarding its efficacy, safety, and tolerability.\nObjectives\nTo compare the efficacy, safety, and tolerability of deep brain stimulation (DBS) versus placebo, sham intervention, or best medical care, including botulinum toxin and resective or lesional surgery, in adults with dystonia.\nSearch methods\nWe identified studies by searching the CENTRAL, MEDLINE, Embase, three other databases, four clinical trial registries, four grey literature databases, and reference lists of included articles. We ran the last search of all elements of the search strategy, with no language restrictions, on 29 May 2018.\nSelection criteria\nDouble-blind, parallel, randomised, controlled trials (RCTs) comparing DBS with sham stimulation, best medical care, or placebo in adults with dystonia.\nData collection and analysis\nTwo independent review authors assessed records, selected included studies, extracted data onto a standardised (or prespecified) data extraction form, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third review author. We conducted meta-analyses using a random-effects model, to estimate pooled effects and corresponding 95% confidence intervals (95% CI). We assessed the quality of the evidence with GRADE methods. The primary efficacy outcome was symptom improvement on any validated symptomatic rating scale, and the primary safety outcome was adverse events.\nMain results\nWe included two RCTs, enrolling a total of 102 participants. Both trials evaluated the effect of DBS on the internal globus pallidus nucleus, and assessed outcomes after three and six months of stimulation. One of the studies included participants with generalised and segmental dystonia; the other included participants with focal (cervical) dystonia. We assessed both studies at high risk for performance and for-profit bias. One study was retrospectively registered with a clinical trial register, we judged the second at high risk of detection bias.\nLow-quality evidence suggests that DBS of the internal globus pallidus nucleus may improve overall cervical dystonia-related symptoms (mean difference (MD) 9.8 units, 95% CI 3.52 to 16.08 units; 1 RCT, 59 participants), cervical dystonia-related functional capacity (MD 3.8 units, 95% CI 1.41 to 6.19; 1 RCT, 61 participants), and mood at three months (MD 3.1 units, 95% CI 0.73 to 5.47; 1 RCT, 61 participants).\nLow-quality evidence suggests that In people with cervical dystonia, DBS may slightly improve the overall clinical status (MD 2.3 units, 95% CI 1.15 to 3.45; 1 RCT, 61 participants). We are uncertain whether DBS improves quality of life in cervical dystonia (MD 3 units, 95% CI -7.71 to 13.71; 1 RCT, 57 participants; very low-quality evidence), or emotional state (MD 2.4 units, 95% CI -6.2 to 11.00; 1 RCT, 56 participants; very low-quality evidence).\nLow-quality evidence suggests that DBS of the internal globus pallidus nucleus may improve generalised or segmental dystonia-related symptoms (MD 14.4 units, 95% CI 8.0 to 20.8; 1 RCT, 40 participants), overall clinical status (MD 3.5 units, 95% CI 2.33 to 4.67; 1 RCT, 37 participants), physical functioning-related quality of life (MD 6.3 units, 95% CI 1.06 to 11.54; 1 RCT, 33 participants), and overall dystonia-related functional capacity at three months (MD 3.1 units, 95% CI 1.71 to 4.48; 1 RCT, 39 participants). We are uncertain whether DBS improves physical functioning-related quality of life (MD 5.0 units, 95% CI -2.14 to 12.14, 1 RCT, 33 participants; very low-quality evidence), or mental health-related quality of life (MD -4.6 units, 95% CI -11.26 to 2.06; 1 RCT, 30 participants; very low-quality evidence) in generalised or segmental dystonia.\nWe pooled outcomes related to safety and tolerability, since both trials used the same intervention and comparison. We found very low-quality evidence of inconclusive results for risk of adverse events (relative risk (RR) 1.58, 95% 0.98 to 2.54; 2 RCTs, 102 participants), and tolerability (RR 1.86, 95% CI 0.16 to 21.57; 2 RCTs,102 participants).\nAuthors' conclusions\nDBS of the internal globus pallidus nucleus may reduce symptom severity and improve functional capacity in adults with cervical, segmental or generalised moderate to severe dystonia (low-quality evidence), and may improve quality of life in adults with generalised or segmental dystonia (low-quality evidence). We are uncertain whether the procedure improves quality of life in cervical dystonia (very low-quality evidence). We are also uncertain about the safety and tolerability of the procedure in adults with either cervical and generalised, or segmental dystonia (very-low quality evidence).\nWe could draw no conclusions for other populations with dystonia (i.e. children and adolescents, and adults with other types of dystonia), or for other DBS protocols (i.e. other target nuclei or stimulation paradigms). Further research is needed to establish the long-term efficacy and safety of DBS of the internal globus pallidus nucleus.\n\nGiven the provided abstract, please respond to the following query: \"The review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We reviewed the evidence about the effect of deep brain stimulation (DBS) for adults with dystonia. We assessed the efficacy, safety, and tolerability of this procedure."
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"role": "user",
"content": "Abstract: Background\nEarly accurate detection of all skin cancer types is essential to guide appropriate management and to improve morbidity and survival. Melanoma and squamous cell carcinoma (SCC) are high-risk skin cancers, which have the potential to metastasise and ultimately lead to death, whereas basal cell carcinoma (BCC) is usually localised, with potential to infiltrate and damage surrounding tissue. Anxiety around missing early cases needs to be balanced against inappropriate referral and unnecessary excision of benign lesions. Optical coherence tomography (OCT) is a microscopic imaging technique, which magnifies the surface of a skin lesion using near-infrared light. Used in conjunction with clinical or dermoscopic examination of suspected skin cancer, or both, OCT may offer additional diagnostic information compared to other technologies.\nObjectives\nTo determine the diagnostic accuracy of OCT for the detection of cutaneous invasive melanoma and atypical intraepidermal melanocytic variants, basal cell carcinoma (BCC), or cutaneous squamous cell carcinoma (cSCC) in adults.\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; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.\nSelection criteria\nWe included studies of any design evaluating OCT in adults with lesions suspicious for invasive melanoma and atypical intraepidermal melanocytic variants, BCC or cSCC, compared with a reference standard of histological confirmation or clinical follow-up.\nData collection and analysis\nTwo review authors independently extracted data using a standardised data extraction and quality assessment form (based on QUADAS-2). Our unit of analysis was lesions. Where possible, we estimated summary sensitivities and specificities using the bivariate hierarchical model.\nMain results\nWe included five studies with 529 cutaneous lesions (282 malignant lesions) providing nine datasets for OCT, two for visual inspection alone, and two for visual inspection plus dermoscopy. Studies were of moderate to unclear quality, using data-driven thresholds for test positivity and giving poor accounts of reference standard interpretation and blinding. Studies may not have been representative of populations eligible for OCT in practice, for example due to high disease prevalence in study populations, and may not have reflected how OCT is used in practice, for example by using previously acquired OCT images.\nIt was not possible to make summary statements regarding accuracy of detection of melanoma or of cSCC because of the paucity of studies, small sample sizes, and for melanoma differences in the OCT technologies used (high-definition versus conventional resolution OCT), and differences in the degree of testing performed prior to OCT (i.e. visual inspection alone or visual inspection plus dermoscopy).\nPooled data from two studies using conventional swept-source OCT alongside visual inspection and dermoscopy for the detection of BCC estimated the sensitivity of OCT as 95% (95% confidence interval (CI) 91% to 97%) and specificity of 77% (95% CI 69% to 83%).\nWhen applied to a hypothetical population of 1000 lesions at the mean observed BCC prevalence of 60%, OCT would miss 31 BCCs (91 fewer than would be missed by visual inspection alone and 53 fewer than would be missed by visual inspection plus dermoscopy), and OCT would lead to 93 false-positive results for BCC (a reduction in unnecessary excisions of 159 compared to using visual inspection alone and of 87 compared to visual inspection plus dermoscopy).\nAuthors' conclusions\nInsufficient data are available on the use of OCT for the detection of melanoma or cSCC. Initial data suggest conventional OCT may have a role for the diagnosis of BCC in clinically challenging lesions, with our meta-analysis showing a higher sensitivity and higher specificity when compared to visual inspection plus dermoscopy. However, the small number of studies and varying methodological quality means implications to guide practice cannot currently be drawn.\nAppropriately designed prospective comparative studies are required, given the paucity of data comparing OCT with dermoscopy and other similar diagnostic aids such as reflectance confocal microscopy.\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": "The review included five studies: two studies with 97 participants with 133 skin lesions suspected of being melanoma, and three studies with 305 participants with 396 lesions suspected of being BCC of which one (50 lesions) also analysed cSCCs (nine lesions).\nThe studies investigating the accuracy of OCT for diagnosing melanoma were small and too different from each other to allow a reliable estimate of the accuracy of OCT for melanoma to be made. Similarly, only one small, low-quality study investigated the accuracy of OCT for diagnosing cSCC.\nFor identifying BCC, two studies showed the effects of skin specialists using OCT after visual inspection alone, or visual inspection with dermoscopic examination. These two studies indicated that in theory, if OCT were to be used in a group of 1000 people with skin lesions that were particularly difficult to diagnose, of whom 600 (60%) actually had BCC, then:\n- an estimated 662 people would have an OCT result confirming that a BCC was present and of these 93 (14%) would not actually have had a BCC (false-positive result);\n- of the 338 people with an OCT result indicating that no BCC was present, 31 (9%) would actually have a BCC (false-negative result).\nCompared to making a diagnosis of BCC using visual inspection plus dermoscopy, the addition of OCT in this group would reduce the number of false-positive results by 87 (thus reducing unnecessary surgical procedures) and would miss 53 fewer BCCs."
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"content": "Abstract: Background\nTrachoma is the world's leading infectious cause of blindness. In 1996, WHO launched the Alliance for the Global Elimination of Trachoma by the year 2020, based on the 'SAFE' strategy (surgery, antibiotics, facial cleanliness, and environmental improvement).\nObjectives\nTo assess the evidence supporting the antibiotic arm of the SAFE strategy by assessing the effects of antibiotics on both active trachoma (primary objective), Chlamydia trachomatis infection of the conjunctiva, antibiotic resistance, and adverse effects (secondary objectives).\nSearch methods\nWe searched relevant electronic databases and trials registers. The date of the last search was 4 January 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) that satisfied either of two criteria: (a) trials in which topical or oral administration of an antibiotic was compared to placebo or no treatment in people or communities with trachoma, (b) trials in which a topical antibiotic was compared with an oral antibiotic in people or communities with trachoma. We also included studies addressing different dosing strategies in the population.\nData collection and analysis\nWe used standard methods expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe identified 14 studies where individuals with trachoma were randomised and 12 cluster-randomised studies.\nAny antibiotic versus control (individuals)\nNine studies (1961 participants) randomised individuals with trachoma to antibiotic or control (no treatment or placebo). All of these studies enrolled children and young people with active trachoma. The antibiotics used in these studies included topical (oxy)tetracycline (5 studies), doxycycline (2 studies), and sulfonamides (4 studies). Four studies had more than two study arms. In general these studies were poorly reported, and it was difficult to judge risk of bias.\nThese studies provided low-certainty evidence that people with active trachoma treated with antibiotics experienced a reduction in active trachoma at three months (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.69 to 0.89; 1961 people; 9 RCTs; I2 = 73%) and 12 months (RR 0.74, 95% CI 0.55 to 1.00; 1035 people; 4 RCTs; I2 = 90%). Low-certainty evidence was available for ocular infection at three months (RR 0.81, 95% CI 0.63 to 1.04; 297 people; 4 RCTs; I2 = 0%) and 12 months (RR 0.25, 95% CI 0.08 to 0.78; 129 people; 1 RCT). None of these studies assessed antimicrobial resistance. In those studies that reported harms, no serious adverse effects were reported (low-certainty evidence).\nOral versus topical antibiotics (individuals)\nEight studies (1583 participants) compared oral and topical antibiotics. Only one study included people older than 21 years of age. Oral antibiotics included azithromycin (5 studies), sulfonamides (2 studies), and doxycycline (1 study). Topical antibiotics included (oxy)tetracycline (6 studies), azithromycin (1 study), and sulfonamide (1 study). These studies were poorly reported, and it was difficult to judge risk of bias.\nThere was low-certainty evidence of little or no difference in effect between oral and topical antibiotics on active trachoma at three months (RR 0.97, 95% CI 0.81 to 1.16; 953 people; 6 RCTs; I2 = 63%) and 12 months (RR 0.93, 95% CI 0.75 to 1.15; 886 people; 5 RCTs; I2 = 56%). There was very low-certainty evidence for ocular infection at three or 12 months. Antimicrobial resistance was not assessed. In those studies that reported adverse effects, no serious adverse effects were reported; one study reported abdominal pain with azithromycin; one study reported a couple of cases of nausea with azithromycin; and one study reported three cases of reaction to sulfonamides (low-certainty evidence).\nOral azithromycin versus control (communities)\nFour cluster-randomised studies compared antibiotic with no or delayed treatment. Data were available on active trachoma at 12 months from two studies but could not be pooled because of reporting differences. One study at low risk of bias found a reduced prevalence of active trachoma 12 months after a single dose of azithromycin in communities with a high prevalence of infection (RR 0.58, 95% CI 0.52 to 0.65; 1247 people). The other, lower quality, study in low-prevalence communities reported similar median prevalences of infection at 12 months: 9.3% in communities treated with azithromycin and 8.2% in untreated communities. We judged this moderate-certainty evidence for a reduction in active trachoma with treatment, downgrading one level for inconsistency between the two studies. Two studies reported ocular infection at 12 months and data could be pooled. There was a reduction in ocular infection (RR 0.36, 0.31 to 0.43; 2139 people) 12 months after mass treatment with a single dose compared with no treatment (moderate-certainty evidence). There was high-certainty evidence of an increased risk of resistance of Streptococcus pneumoniae, Staphylococcus aureus, and Escherichia coli to azithromycin, tetracycline, and clindamycin in communities treated with azithromycin, with approximately 5-fold risk ratios at 12 months. The evidence did not support increased resistance to penicillin or trimethoprim-sulfamethoxazole. None of the studies measured resistance to C trachomatis. No serious adverse events were reported. The main adverse effect noted for azithromycin (˜10%) was abdominal pain, vomiting, and nausea.\nOral azithromycin versus topical tetracycline (communities)\nThree cluster-randomised studies compared oral azithromycin with topical tetracycline. The evidence was inconsistent for active trachoma and ocular infection at three and 12 months (low-certainty evidence) and was not pooled due to considerable heterogeneity. Antimicrobial resistance and adverse effects were not reported.\nDifferent dosing strategies\nSix studies compared different strategies for dosing. There were: mass treatment at different dosing intervals; applying cessation or stopping rules to mass treatment; strategies to increase mass treatment coverage. There was no strong evidence to support any variation in the recommended annual mass treatment.\nAuthors' conclusions\nAntibiotic treatment may reduce the risk of active trachoma and ocular infection in people infected with C trachomatis, compared to no treatment/placebo, but the size of the treatment effect in individuals is uncertain. Mass antibiotic treatment with single dose oral azithromycin reduces the prevalence of active trachoma and ocular infection in communities. There is no strong evidence to support any variation in the recommended periodicity of annual mass treatment. There is evidence of an increased risk of antibiotic resistance at 12 months in communities treated with antibiotics.\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 find out if antibiotics work for treating trachoma, either in individuals or communities. Cochrane researchers collected and analysed all relevant studies to answer this question and found 26 studies."
}
] |
query-laysum
|
7555
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute respiratory infections (ARIs) last for less than 30 days and are the most common acute diseases affecting people. Exercise has been shown to improve health generally, but it is uncertain whether exercise may be effective in reducing the occurrence, severity, and duration of ARIs. This is an update of our review published in 2015.\nObjectives\nTo evaluate the effectiveness of exercise for altering the occurrence, severity, or duration of acute respiratory infections.\nSearch methods\nWe searched CENTRAL (2020, Issue 2), MEDLINE (1948 to March week 1, 2020), Embase (1974 to 05 March 2020), CINAHL (1981 to 05 March 2020), LILACS (1982 to 05 March 2020), SPORTDiscus (1985 to 05 March 2020), PEDro (searched 05 March 2020), OTseeker (searched 05 March 2020), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (searched 05 March 2020).\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs (method of allocation that is not truly random, e.g. based on date of birth, medical record number) of exercise for ARIs in the general population.\nData collection and analysis\nTwo review authors independently extracted data from the included trials using a standard form. One review author entered data, which a second review author checked. We contacted trial authors to request missing data. There were sufficient differences in the populations trialed and in the nature of the interventions to use the random-effects model (which makes fewer assumptions than the fixed-effect model) in the analysis.\nMain results\nWe included three new trials for this update (473 participants) for a total of 14 trials involving 1377 adults, published between 1990 and 2018. Nine trials were conducted in the USA, and one each in Brazil, Canada, Portugal, Spain, and Turkey.\nSample sizes ranged from 16 to 419 participants, aged from 18 to 85 years. The proportion of female participants ranged from 52% to 100%. Follow-up duration ranged from 1 to 36 weeks (median = 12 weeks).\nModerate-intensity aerobic exercise (walking, bicycling, treadmill, or a combination) was evaluated in 11 trials, and was most commonly prescribed at least three times a week for 30 to 45 minutes.\nThere was no difference between exercise and no exercise in the number of ARI episodes per person per year (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.77 to 1.30; 4 trials; 514 participants; low-certainty evidence); proportion of participants who experienced at least one ARI over the study period (RR 0.88, 95% CI 0.72 to 1.08; 5 trials; 520 participants; low-certainty evidence); and the number of symptom days per episode of illness (mean difference (MD) −0.44 day, 95% CI −2.33 to 1.46; 6 trials; 557 participants; low-certainty evidence). Exercise reduced the severity of ARI symptoms measured on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) (MD −103.57, 95% CI −198.28 to −8.87; 2 trials; 373 participants; moderate-certainty evidence) and the number of symptom days during follow-up period (MD −2.24 days, 95% CI −3.50 to −0.98; 4 trials; 483 participants; low-certainty evidence).\nExcercise did not have a significant effect on laboratory parameters (blood lymphocytes, salivary secretory immunoglobulin, and neutrophils), quality of life outcomes, cost-effectiveness, and exercise-related injuries. There was no difference in participant dropout between the intervention and control groups.\nOverall, the certainty of the evidence was low, downgraded mainly due to limitations in study design and implementation, imprecision, and inconsistency.\nSeven trials were funded by public agencies; five trials did not report funding; and two trials were funded by private companies.\nAuthors' conclusions\nExercise did not reduce the number of ARI episodes, proportion of participants experiencing at least one ARI during the study, or the number of symptom days per episode of illness. However, exercise reduced the severity of ARI symptoms (two studies) and the number of symptom days during the study follow-up period (four studies). Small study size, risk of bias, and heterogeneity in the populations studied contributed to the uncertainty of the findings. Larger trials that are designed to avoid risk of bias associated with participant selection, blinding of outcomes assessors, and with adequate reporting of all outcomes proposed for measurement in trials, would help to provide more robust evidence.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Seven studies were funded by public agencies; five studies did not report funding; and two studies were funded by private companies."
}
] |
query-laysum
|
7556
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic infection with Burkholderia cepacia complex species remains a significant problem for clinicians treating people with cystic fibrosis. Colonisation with Burkholderia cepacia complex species is linked to a more rapid decline in lung function and increases morbidity and mortality. There remain no objective guidelines for strategies to eradicate Burkholderia cepacia complex in cystic fibrosis lung disease, as these are inherently resistant to the majority of antibiotics and there has been very little research in this area. This review aims to examine the current treatment options for people with cystic fibrosis with acute infection with Burkholderia cepacia complex and to identify an evidence-based strategy that is both safe and effective. This is an updated version of the review.\nObjectives\nTo identify whether treatment of Burkholderia cepacia complex infections can achieve eradication, or if treatment can prevent or delay the onset of chronic infection. To establish whether following eradication, clinical outcomes are improved and if there are any adverse effects.\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 the reference lists of relevant articles and reviews.\nLast search: 12 March 2019.\nWe also searched electronic clinical trials registers for the USA and Europe.\nDate of last search: 12 March 2019.\nSelection criteria\nRandomised or quasi-randomised studies in people with cystic fibrosis of antibiotics or alternative therapeutic agents used alone or in combination, using any method of delivery and any treatment duration, to eradicate Burkholderia cepacia complex infections compared to another antibiotic, placebo or no treatment.\nData collection and analysis\nTwo authors independently assessed for inclusion in the review the eligibility of 52 studies (79 references) identified by the search of the Group's Trial Register and the other electronic searches.\nMain results\nNo studies looking at the eradication of Burkholderia cepacia complex species were identified.\nAuthors' conclusions\nThe authors have concluded that there was an extreme lack of evidence in this area of treatment management for people with cystic fibrosis. Without further comprehensive studies, it is difficult to draw conclusions about a safe and effective management strategy for Burkholderia cepacia complex eradication in cystic fibrosis. Thus, while the review could not offer clinicians evidence of an effective eradication protocol for Burkholderia cepacia complex, it has highlighted an urgent need for exploration and research in this area, specifically the need for well-designed multi-centre randomised controlled studies of a variety of (novel) antibiotic agents.\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": "Cystic fibrosis is an inherited disease and people who have this disease produce large amounts of thick mucus which is difficult to clear. This mucus blocks up their lungs and digestive systems. People with cystic fibrosis suffer from lots of chest infections, which cause scarring of their airways. Eventually, they develop infections that can't be cured with antibiotics, so their lungs always contain lots of bugs, this is described as being chronically infected. One of these bugs, Burkholderia cepacia, causes a lot of problems for people with cystic fibrosis because it is very difficult to treat and makes their lung disease deteriorate faster than it otherwise would. This is an updated version of the review."
}
] |
query-laysum
|
7557
|
[
{
"role": "user",
"content": "Abstract: Background\nThe Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant’s nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks.\nObjectives\nTo determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device.\nSearch methods\nSearches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR.\nData collection and analysis\nEach review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials.\nThe evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence).\nResuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence).\nWe identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another.\nAuthors' conclusions\nNasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR.\nResuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for clinical trials that examined babies who received different types of breathing supports in the delivery room. 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."
}
] |
query-laysum
|
7558
|
[
{
"role": "user",
"content": "Abstract: Background\nVertebral artery stenosis (narrowing of the vertebral artery) is an important cause of posterior circulation ischaemic stroke. Medical treatment (MT) e.g. controlling risk-factors and drug treatment, surgery, and endovascular treatment (ET) are the prevailing treatment strategies for symptomatic vertebral artery stenosis. ET consist s of percutaneous transluminal angioplasty (balloon catheter through the skin), with or without stenting. However, optimal management of people with symptomatic vertebral artery stenosis has not yet been established.\nObjectives\nTo assess the safety and efficacy of percutaneous transluminal angioplasty, with or without stenting, combined with MT, compared to MT alone, in people with episodes of cerebral ischaemia due to vertebral artery stenosis.\nSearch methods\nWe searched the Cochrane Stroke Group, MEDLINE, Embase, BIOSIS, and two other indexes in Web of Science, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Knowledge Infrastructure and Wanfang Data, as well as ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 23 July 2021.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared ET plus MT with MT alone in treating people aged 18 years or over with symptomatic vertebral artery stenosis. We included all types of ET modalities (e.g. angioplasty alone, balloon-mounted stenting, and angioplasty followed by placement of a self-expanding stent). MT included risk factor control, antiplatelet therapy, lipid-lowering therapy, and individualised management for people with hypertension or diabetes.\nData collection and analysis\nTwo review authors independently screened potentially eligible studies, extracted data, and assessed trial quality and risk of bias. We applied the GRADE approach to assess the certainty of evidence. The primary outcomes were 30-day post-randomisation death/stroke (short-term outcome) and fatal/non-fatal stroke after 30 days post-randomisation to completion of follow-up (long-term outcome).\nMain results\nWe included three RCTs with 349 participants with symptomatic vertebral artery stenosis with a mean age of 64.4 years. The included RCTs were at low risk of bias overall. However, all included studies had a high risk of performance bias because blinding of the ET was not feasible.\nThere was no significant difference in 30-day post-randomisation deaths/strokes between ET plus MT and MT alone (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.77 to 7.07; 3 studies, 349 participants; low-certainty evidence). There were no significant differences between ET plus MT and MT alone in fatal/non-fatal strokes in the territory of the treated vertebral artery stenosis after 30 days post-randomisation to completion of follow-up (RR 0.51, 95% CI 0.26 to 1.01; 3 studies, 349 participants; moderate-certainty evidence), ischaemic or haemorrhagic stroke during the entire follow-up period (RR 0.77, 95% CI 0.44 to 1.32; 3 studies, 349 participants; moderate-certainty evidence), death during the entire follow-up period (RR 0.78, 95% CI 0.37 to 1.62; 3 studies, 349 participants; low-certainty evidence), and stroke or transient ischaemic attack (TIA) during the entire follow-up period (RR 0.65, 95% CI 0.39 to 1.06; 2 studies, 234 participants; moderate-certainty evidence).\nAuthors' conclusions\nThis Cochrane Review provides low- to moderate-certainty evidence indicating that there are no significant differences in either short- or long-term risks of stroke, death, or TIA between people with symptomatic vertebral artery stenosis treated with ET plus MT and those treated with MT alone.\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 have low to moderate confidence in the results of the studies: our confidence is not higher because people knew who was having which treatment and some outcomes have a wide confidence interval due to a small number of patients with endpoint events."
}
] |
query-laysum
|
7559
|
[
{
"role": "user",
"content": "Abstract: Background\nMultiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system that affects millions of people worldwide. The disease course varies greatly across individuals and many disease-modifying treatments with different safety and efficacy profiles have been developed recently. Prognostic models evaluated and shown to be valid in different settings have the potential to support people with MS and their physicians during the decision-making process for treatment or disease/life management, allow stratified and more precise interpretation of interventional trials, and provide insights into disease mechanisms. Many researchers have turned to prognostic models to help predict clinical outcomes in people with MS; however, to our knowledge, no widely accepted prognostic model for MS is being used in clinical practice yet.\nObjectives\nTo identify and summarise multivariable prognostic models, and their validation studies for quantifying the risk of clinical disease progression, worsening, and activity in adults with MS.\nSearch methods\nWe searched MEDLINE, Embase, and the Cochrane Database of Systematic Reviews from January 1996 until July 2021. We also screened the reference lists of included studies and relevant reviews, and references citing the included studies.\nSelection criteria\nWe included all statistically developed multivariable prognostic models aiming to predict clinical disease progression, worsening, and activity, as measured by disability, relapse, conversion to definite MS, conversion to progressive MS, or a composite of these in adult individuals with MS. We also included any studies evaluating the performance of (i.e. validating) these models. There were no restrictions based on language, data source, timing of prognostication, or timing of outcome.\nData collection and analysis\nPairs of review authors independently screened titles/abstracts and full texts, extracted data using a piloted form based on the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS), assessed risk of bias using the Prediction Model Risk Of Bias Assessment Tool (PROBAST), and assessed reporting deficiencies based on the checklist items in Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD). The characteristics of the included models and their validations are described narratively. We planned to meta-analyse the discrimination and calibration of models with at least three external validations outside the model development study but no model met this criterion. We summarised between-study heterogeneity narratively but again could not perform the planned meta-regression.\nMain results\nWe included 57 studies, from which we identified 75 model developments, 15 external validations corresponding to only 12 (16%) of the models, and six author-reported validations. Only two models were externally validated multiple times. None of the identified external validations were performed by researchers independent of those that developed the model. The outcome was related to disease progression in 39 (41%), relapses in 8 (8%), conversion to definite MS in 17 (18%), and conversion to progressive MS in 27 (28%) of the 96 models or validations. The disease and treatment-related characteristics of included participants, and definitions of considered predictors and outcome, were highly heterogeneous amongst the studies. Based on the publication year, we observed an increase in the percent of participants on treatment, diversification of the diagnostic criteria used, an increase in consideration of biomarkers or treatment as predictors, and increased use of machine learning methods over time.\nUsability and reproducibility\nAll identified models contained at least one predictor requiring the skills of a medical specialist for measurement or assessment. Most of the models (44; 59%) contained predictors that require specialist equipment likely to be absent from primary care or standard hospital settings. Over half (52%) of the developed models were not accompanied by model coefficients, tools, or instructions, which hinders their application, independent validation or reproduction. The data used in model developments were made publicly available or reported to be available on request only in a few studies (two and six, respectively).\nRisk of bias\nWe rated all but one of the model developments or validations as having high overall risk of bias. The main reason for this was the statistical methods used for the development or evaluation of prognostic models; we rated all but two of the included model developments or validations as having high risk of bias in the analysis domain. None of the model developments that were externally validated or these models' external validations had low risk of bias. There were concerns related to applicability of the models to our research question in over one-third (38%) of the models or their validations.\nReporting deficiencies\nReporting was poor overall and there was no observable increase in the quality of reporting over time. The items that were unclearly reported or not reported at all for most of the included models or validations were related to sample size justification, blinding of outcome assessors, details of the full model or how to obtain predictions from it, amount of missing data, and treatments received by the participants. Reporting of preferred model performance measures of discrimination and calibration was suboptimal.\nAuthors' conclusions\nThe current evidence is not sufficient for recommending the use of any of the published prognostic prediction models for people with MS in clinical routine today due to lack of independent external validations. The MS prognostic research community should adhere to the current reporting and methodological guidelines and conduct many more state-of-the-art external validation studies for the existing or newly developed models.\n\nGiven the provided abstract, please respond to the following query: \"Why is it important to study multiple sclerosis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Multiple sclerosis (MS) is a chronic disease of the brain, spine, and nerves. Millions of people worldwide suffer from this disease, but the disease and how it progresses can be very different from person to person. Although MS cannot be cured, different treatments are available that can help reduce symptoms and slow the worsening of the disease. These treatments work differently, with some having more severe side effects than others. Understanding the severity of an individual’s MS is important to patients and medical professionals."
}
] |
query-laysum
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7560
|
[
{
"role": "user",
"content": "Abstract: Background\nThe use of systemic immunotherapy targets is emerging as an important treatment option for metastatic urothelial carcinoma, particularly for patients who cannot tolerate or who fail cisplatin-based chemotherapy. One such target is the inhibition of the checkpoint protein programmed cell death-1 (PD-1) receptor and its ligand (PD-L1) by monoclonal antibodies.\nObjectives\nTo assess the effects of pembrolizumab monotherapy versus chemotherapy for treatment of advanced urothelial carcinoma with disease progression during or following platinum-containing chemotherapy.\nSearch methods\nWe performed a Cochrane Rapid Review, limiting our search to published studies in the English language. We searched databases of the medical literature, including the Cochrane Central Register of Controlled Trials and MEDLINE, as well as trial registries including ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP). Our search extended from January 2000 to June 2018.\nSelection criteria\nWe included randomised controlled trials except cross-over trials and cluster randomised trials. We excluded all other study designs. Participants included had locally advanced or metastatic urothelial carcinoma of the bladder, with disease progression during or following platinum-containing chemotherapy (synonymous with second-/third-/fourth-line therapy). This review focused on pembrolizumab (synonyms: MK-3475, lambrolizumab, Keytruda).\nData collection and analysis\nTwo review authors independently classified and abstracted data from the included study. The certainty of evidence was rated according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nWe identified one randomised controlled trial that included 542 participants, which compared the use of pembrolizumab monotherapy versus chemotherapy for the treatment of advanced urothelial carcinoma with disease progression during or following platinum-containing chemotherapy. Results were reported after a median follow-up of 14.1 months (range 9.9 to 22.1 months).\nPrimary outcomes\nPembrolizumab probably reduces the risk of death from any cause (hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.59 to 0.90; moderate certainty evidence). This corresponds to 115 fewer deaths (191 fewer to 38 fewer) per 1000 participants with pembrolizumab at 12 months. We downgraded the certainty of evidence one level for imprecision.\nPembrolizumab may slightly improve quality of life (change from baseline to week 15 assessed with the Core Quality of Life Questionnaire; higher value reflects better quality of life; scale 0 to 100) with a mean difference (MD) of 9.05, 95% CI 4.61 to 13.50; low certainty evidence). We downgraded the certainty of evidence two levels for study limitations and imprecision.\nSecondary outcomes\nPembrolizumab may have little or no effect on disease progression (HR 0.98, 95% CI 0.81 to 1.19; low certainty evidence). This corresponds to three fewer patients (42 fewer to 24 more) whose disease progressed per 1000 participants at 12 months. We downgraded the certainty of evidence two levels for study limitations and imprecision.\nPembrolizumab probably improves treatment response (based on complete or partial radiologic response) with a risk ratio (RR) of 1.85, 95% CI 1.24 to 2.77; moderate certainty evidence). This corresponds to 97 more respondents (27 more to 202 more) per 1000 participants with pembrolizumab. We downgraded the certainty of evidence one level for imprecision.\nPembrolizumab may have little or no effect on treatment-related mortality (RR 0.96, 95% CI 0.24 to 3.79; low certainty evidence). This corresponds to one fewer (12 fewer to 44 more) treatment-related deaths per 1000 participants with pembrolizumab. We downgraded the certainty of evidence two levels for study limitations and imprecision.\nPembrolizumab may have little or no effect on discontinuations due to adverse events (RR 0.66, 95% CI 0.39 to 1.10). This corresponds to 54 fewer discontinuations per 1000 participants (95% CI 79 fewer to 7 more). We downgraded the certainty of evidence for study limitations and imprecision.\nPembrolizumab may reduce serious adverse events (RR 0.83, 95 CI 0.72 to 0.97; low certainty evidence). This corresponds to 107 fewer serious averse events per 1000 participants (95% CI 19 fewer to 176 fewer). We downgraded two levels for study limitations and imprecision.\nAuthors' conclusions\nThe use of pembrolizumab in men with advanced urothelial carcinoma with disease progression during or following platinum-containing chemotherapy probably improves overall survival when compared with chemotherapy alone. At 12 months follow-up about 70% of those in the chemotherapy group had died, compared with 59% of those treated with pembrolizumab. We are very uncertain about the effects of pembolizumab on quality of life. Pembolizumab may also improve treatment response rates, and reduce the risk of serious adverse events, but may make little or no difference to discontinuations of treatment due to adverse events. These conclusions are based on a single trial that was sponsored by the producer of pembrolizumab.\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": "Medications that target the body's immune system have been used for a long time to treat urothelial cancer. When the cancer has spread to other organs outside the urinary tract, patients are often treated with chemotherapy using medicines called cisplatin or carboplatin (platinum-containing chemotherapy). However, often the cancer comes back or becomes worse despite treatment. This review considers the evidence for pembrolizumab, which is a member of a new class of medications that work through the immune sytem, and compares it to chemotherapy."
}
] |
query-laysum
|
7561
|
[
{
"role": "user",
"content": "Abstract: Background\nWhen human milk is not available for feeding preterm infants, protein hydrolysate, rather than standard cow's milk formulas (with intact proteins), is often used because it is perceived as being tolerated better and less likely to lead to complications. However, protein hydrolysate formulas are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence.\nObjectives\nTo assess the effects of feeding preterm infants hydrolysed formula (vs standard cow's milk formula) on risk of feed intolerance, necrotising enterocolitis, and other morbidity and mortality.\nSearch methods\nWe used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; Ovid MEDLINE (1966 to 28 January 2019); Ovid Embase (1980 to 28 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (28 January 2019), as well as conference proceedings and previous reviews.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared feeding preterm infants protein hydrolysate versus standard (non-hydrolysed) cow's milk formula.\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses. We assessed quality of evidence at the outcome level using the GRADE approach.\nMain results\nWe identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses).\nAuthors' conclusions\nThe identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In searches of medical databases up to 28 January 2019, we found 11 relevant trials; most were small (involving 665 infants in total) and had methodological weaknesses."
}
] |
query-laysum
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7562
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update to the review published in the Cochrane Library (2012, Issue 4).\nIt is estimated that 20% to 40% of people with cancer will develop brain metastases during the course of their illness. The burden of brain metastases impacts quality and length of survival.\nObjectives\nTo assess the effectiveness and adverse effects of whole brain radiotherapy (WBRT) given alone or in combination with other therapies to adults with newly diagnosed multiple brain metastases.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase to May 2017 and the National Cancer Institute Physicians Data Query for ongoing trials.\nSelection criteria\nWe included phase III randomised controlled trials (RCTs) comparing WBRT versus other treatments for adults with newly diagnosed multiple brain metastases.\nData collection and analysis\nTwo review authors independently assessed trial quality and abstracted information in accordance with Cochrane methods.\nMain results\nWe added 10 RCTs to this updated review. The review now includes 54 published trials (45 fully published reports, four abstracts, and five subsets of data from previously published RCTs) involving 11,898 participants.\nLower biological WBRT doses versus control \nThe hazard ratio (HR) for overall survival (OS) with lower biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 1.21 (95% confidence interval (CI) 1.04 to 1.40; P = 0.01; moderate-certainty evidence) in favour of control. The HR for neurological function improvement (NFI) was 1.74 (95% CI 1.06 to 2.84; P = 0.03; moderate-certainty evidence) in favour of control fractionation.\nHigher biological WBRT doses versus control\nThe HR for OS with higher biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 0.97 (95% CI 0.83 to 1.12; P = 0.65; moderate-certainty evidence). The HR for NFI was 1.14 (95% CI 0.92 to 1.42; P = 0.23; moderate-certainty evidence).\nWBRT and radiosensitisers \nThe addition of radiosensitisers to WBRT did not confer additional benefit for OS (HR 1.05, 95% CI 0.99 to 1.12; P = 0.12; moderate-certainty evidence) or for brain tumour response rates (odds ratio (OR) 0.84, 95% CI 0.63 to 1.11; P = 0.22; high-certainty evidence).\nRadiosurgery and WBRT versus WBRT alone \nThe HR for OS with use of WBRT and radiosurgery boost as compared with WBRT alone for selected participants was 0.61 (95% CI 0.27 to 1.39; P = 0.24; moderate-certainty evidence). For overall brain control at one year, the HR was 0.39 (95% CI 0.25 to 0.60; P < 0.0001; high-certainty evidence) favouring the WBRT and radiosurgery boost group.\nRadiosurgery alone versus radiosurgery and WBRT\nThe HR for local brain control was 2.73 (95% CI 1.87 to 3.99; P < 0.00001; high-certainty evidence)favouring the addition of WBRT to radiosurgery. The HR for distant brain control was 2.34 (95% CI 1.73 to 3.18; P < 0.00001; high-certainty evidence) favouring WBRT and radiosurgery. The HR for OS was 1.00 (95% CI 0.80 to 1.25; P = 0.99; moderate-certainty evidence). Two trials reported worse neurocognitive outcomes and one trial reported worse quality of life outcomes when WBRT was added to radiosurgery.\nWe could not pool data from trials related to chemotherapy, optimal supportive care (OSC), molecular targeted agents, neurocognitive protective agents, and hippocampal sparing WBRT. However, one trial reported no differences in quality-adjusted life-years for selected participants with brain metastases from non-small-cell lung cancer randomised to OSC and WBRT versus OSC alone.\nAuthors' conclusions\nNone of the trials with altered higher biological WBRT dose-fractionation schemes reported benefit for OS, NFI, or symptom control compared with standard care. However, OS and NFI were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules.\nThe addition of WBRT to radiosurgery improved local and distant brain control in selected people with brain metastases, but data show worse neurocognitive outcomes and no differences in OS.\nSelected people with multiple brain metastases from non-small-cell lung cancer may show no difference in OS when OSC is given and WBRT is omitted.\nUse of radiosensitisers, chemotherapy, or molecular targeted agents in conjunction with WBRT remains experimental.\nFurther trials are needed to evaluate the use of neurocognitive protective agents and hippocampal sparing with WBRT. As well, future trials should examine homogeneous participants with brain metastases with focus on prognostic features and molecular markers.\n\nGiven the provided abstract, please respond to the following query: \"What are the main findings?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review includes 54 published trials involving 11,898 participants.\nData show no apparent additional benefit of altered WBRT dose schedules compared with standard dose schedules.\nUse of other treatments such as chemotherapy, radiosensitisers, and molecular targeted agents in conjunction with WBRT has not yet been shown to be of benefit.\nRadiosurgery boost with WBRT does not improve survival among selected people with multiple brain metastases. WBRT when added to radiosurgery improves local and distant brain control. However, neurocognitive outcomes are better for selected people treated with radiosurgery alone as compared with WBRT and radiosurgery.\nFor selected individuals with metastatic non-small-cell lung cancer to brain, survival may not be better with WBRT and optimal supportive care than with optimal supportive care alone."
}
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query-laysum
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7563
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[
{
"role": "user",
"content": "Abstract: Background\nFractures of the tibial plateau, which are intra-articular injuries of the knee joint, are often difficult to treat and have a high complication rate, including early-onset osteoarthritis. Surgical fixation is usually used for more complex tibial plateau fractures. Additionally, bone void fillers are often used to address bone defects caused by the injury. Currently there is no consensus on either the best method of fixation or bone void filler.\nObjectives\nTo assess the effects (benefits and harms) of different surgical interventions, and the use of bone void fillers, for treating tibial plateau fractures.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (12 September 2014), the Cochrane Central Register of Controlled Trials (2014 Issue 8), MEDLINE (1946 to September Week 1 2014), EMBASE (1974 to 2014 Week 36), trial registries (4 July 2014), conference proceedings and grey literature (4 July 2014).\nSelection criteria\nWe included randomised and quasi-randomised controlled clinical trials comparing surgical interventions for treating tibial plateau fractures and the different types of filler for filling bone defects.\nData collection and analysis\nTwo review authors independently screened search results, selected studies, extracted data and assessed risk of bias. We calculated risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CIs). Only very limited pooling, using the fixed-effect model, was possible. Our primary outcomes were quality of life measures, patient-reported outcome measures of lower limb function and serious adverse events.\nMain results\nWe included six trials in the review, with a total of 429 adult participants, the majority of whom were male (63%). Three trials evaluated different types of fixation and three analysed different types of bone graft substitutes. All six trials were small and at substantial risk of bias. We judged the quality of most of the available evidence to be very low, meaning that we are very uncertain about these results.\nOne trial compared the use of a circular fixator combined with insertion of percutaneous screws (hybrid fixation) versus standard open reduction and internal fixation (ORIF) in people with open or closed Schatzker types V or VI tibial plateau fractures. Results (66 participants) for quality of life scores using the 36-item Short Form Health Survey (SF-36)), Hospital for Special Surgery (HSS) scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores tended to favour hybrid fixation, but a benefit of ORIF could not be ruled out. Participants in the hybrid fixation group had a lower risk for an unplanned reoperation (351 per 1000 people compared with 450 in the ORIF group; 95% CI 197 fewer to 144 more) and were more likely to have returned to their pre-injury activity level (303 per 1000 people, compared with 121 in the ORIF group; 95% CI 15 fewer to 748 more). Results of the two groups were comparable for the WOMAC pain subscale and stiffness scores, but mean knee range of motion values were higher in the hybrid group.\nAnother trial compared the use of a minimally invasive plate (LISS system) versus double-plating ORIF in 84 people who had open or closed bicondylar tibial plateau fractures. Nearly twice as many participants (22 versus 12) in the ORIF group had a bone graft. Quality of life, pain, knee range of motion and return to pre-injury activity were not reported. The trial provided no evidence of differences in HSS knee scores, complications or reoperation entailing implant removal or revision fixation. A quasi-randomised trial comparing arthroscopically-assisted percutaneous reduction and internal fixation versus standard ORIF reported results at 14 months in 58 people with closed Schatzker types II or III tibial plateau fracture. Quality of life, pain and return to pre-injury activity were not reported. There was very low quality evidence of higher HSS knee scores and higher knee range of motion values in the arthroscopically assisted group. No reoperations were reported.\nThree trials compared different types of bone substitute versus autologous bone graft (autograft) for managing bone defects. Quality of life, pain and return to pre-injury activity were not reported. Only one trial (25 participants) reported on lower limb function, finding good or excellent results in both groups for walking, climbing stairs, squatting and jumping at 12 months. The incidences of individual complications were similar between groups in all three trials. One trial found no cases of inflammatory response in the 20 participants receiving bone substitute, and two found no complications associated with the donor site in the autograft group (58 participants). However, all 38 participants in the autologous iliac bone graft group of one trial reported prolonged pain from the harvest site. Two trials reported similar range of motion results in the two groups, whereas the third trial favoured the bone substitute group.\nAuthors' conclusions\nCurrently, there is insufficient evidence to ascertain the best method of fixation or the best method of addressing bone defects during surgery. However, the evidence does not contradict approaches aiming to limit soft-tissue dissection and damage or to avoid autograft donor site complications through using bone substitutes. Further well-designed, larger randomised trials are warranted.\n\nGiven the provided abstract, please respond to the following query: \"What treatments are available?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Often, complex fractures are set surgically through open reduction and internal fixation (ORIF), which entails exposing the fracture to direct view and then fastening the bone fragments into place with metal plates and screws. Another method is external fixation, where wires and pins are placed into the bone around the fracture site to secure the fragments in place until they heal. External fixation can be coupled with the use of small plates or screws to hold some of the fracture fragments in position; this is called hybrid fixation.\nTo correct possible bone defects, bone void fillers, either bone grafts taken from the patients themselves or bone substitutes, may be used."
}
] |
query-laysum
|
7564
|
[
{
"role": "user",
"content": "Abstract: Background\nParents and carers have a major influence on children's learning and development from birth, through the school years, and into adulthood. Parental contributions to education include providing a secure environment in which to learn, providing intellectual stimulation, transmitting social norms and values, shaping the child’s resilience through fostering literacy and problem-solving, and encouraging personal and social aspiration. Increasingly, providers of formalised education are recognising the primary role of parents, carers, and the wider family, as well as peers and the environment, in shaping children's education, health, and life experiences.\nObjectives\nTo assess the effectiveness of the Families and Schools Together (FAST) programme in improving outcomes among children and their families.\nSearch methods\nBetween October 2018 and December 2018, we searched CENTRAL, MEDLINE, Embase, PsycINFO, 11 additional databases, and three trial registers. We handsearched the reference lists of included studies and relevant reports and reviews, contacted the programme developer and independent researchers, and searched relevant websites to identify other eligible studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs examining the effects of FAST, relative to waiting list, usual or alternative services, or no intervention, on outcomes for children (aged from birth to completion of compulsory education) and their families.\nData collection and analysis\nAt least two review authors independently evaluated the records retrieved from the search for relevance. One review author (JV) extracted data from eligible studies with a second independent review author (AF, DK, or SL). Review authors consulted with one another to resolve disagreements. We used a fixed-effect model for meta-analysis. We presented results as standardised mean differences (SMDs) because all outcomes were continuously scaled, and we accompanied these with 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence for each outcome.\nMain results\nWe identified 10 completed RCTs, most of which were relatively recent (2007 or later) and were conducted with at least some involvement from the intervention developer or the FAST organisation. Nine of the 10 trials were from the USA; the other was from the UK. Children were young (five to nine years old; mean age approximately six years), and therefore, whilst not so named in the reports, evaluations consisted of what is sometimes referred to as 'Kids FAST' and sometimes 'Elementary Level FAST'). Among the USA-based studies, at least 62% of participants were members of a racial/ethnic minority group (most commonly, African American or Latino). FAST was usually delivered in schools after the school day. Trials lasted about eight weeks and usually examined the effects of FAST relative to no additional intervention. Most studies were funded by agencies in the US federal government. We judged the certainty of evidence in the included studies to be moderate or low for the main review outcomes. Failure to include all families in outcome analyses (attrition) and possible bias in recruitment of families into the trials were the main limitations in the evidence.\nWe included over 9000 children and their families in at least one meta-analysis. The follow results relate to meta-analyses of data at long-term follow-up.\nPrimary outcomes\nFour studies (approximately 6276 children) assessed child school performance at long-term follow-up. The effect size was very small, and the CI did not include effects that, if real, suggest possibly important positive or negative effects if viewed from an individual perspective (SMD -0.02, 95% CI -0.11 to 0.08). We assessed the certainty of evidence for this outcome as moderate. No studies assessed child adverse events, parental substance use, or parental stress.\nSecondary outcomes\nParent reports of child internalising behaviour (SMD -0.03, 95% CI -0.11 to 0.17; 4 RCTs, approximately 908 children; low-certainty evidence) and family relationships (SMD 0.08, 95% CI -0.03 to 0.19; 4 RCTs, approximately 2569 children; moderate-certainty evidence) also yielded CIs that did not include effects that, if real, suggest possibly important positive or negative effects.\nThe CI for parent reports of child externalising behaviour, however, did include effects that, if real, were possibly large enough to be important (SMD -0.19, 95% CI -0.32 to -0.05; 4 RCTs, approximately 754 children; low-certainty evidence).\nAuthors' conclusions\nGiven these results, it is hard to support the assertion that assignment to FAST is associated with important positive outcomes for children and their parents.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A meta-analysis is a statistical method of combining data from several studies to reach a single, more robust conclusion. We were able to use data from nine studies in a meta-analysis measuring the impact of FAST for children aged between five and eight years. Although individual studies reported some positive findings, there was little evidence to suggest that being involved in a FAST programme results in important improvements in the primary outcomes of child school performance, parental substance abuse, or parental stress. No study measured child adverse outcomes. Furthermore, there was little evidence to suggest that FAST leads to important improvements in child behaviour or family relations."
}
] |
query-laysum
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7565
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[
{
"role": "user",
"content": "Abstract: Background\nOver the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears.\nObjectives\nTo evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches.\nSelection criteria\nThis review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy.\nData collection and analysis\nWe followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text.\nMain results\nWe included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias.\nAuthors' conclusions\nOTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.\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": "This review analyzed many OTC artificial tear formulations, and most of the literature indicates uncertainty as to which OTC artificial tear works best. The literature also shows that OTC artificial tears may be effective at treating dry eye symptoms and that OTC artificial tears are generally safe, although not without side effects.\nWe also identified an additional 18 potentially eligible trials that were registered, but did not provide any results or publications. These trials may have enrolled 2079 total participants for whom no data are available. Without the results of these trials, the effects of the OTC artificial tears that they evaluated are unknown."
}
] |
query-laysum
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7566
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with fragile X syndrome (FXS) have an intellectual dysfunction that can range from very mild to severe. Symptoms can include speech and language delays and behavioural difficulties such as aggression or self injurious behaviours, emotional lability, and anxiety-related problems (for example obsessive-compulsive symptoms and perseverative behaviours). In some cases, affected people may have an additional diagnosis of attention deficit hyperactivity disorder or an autism spectrum disorder.\nObjectives\nTo review the efficacy and safety of L-acetylcarnitine in improving the psychological, intellectual, and social performance of people with FXS.\nSearch methods\nIn May 2015 we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, Web of Science, and two other databases. We also searched three trials registers, four theses databases, and the reference lists of relevant studies and reviews.\nSelection criteria\nRandomised controlled trials (RCTs) that assessed the efficacy of L-acetylcarnitine, at any dose, in people of any age diagnosed with FXS compared with placebo.\nData collection and analysis\nFor each trial, two review authors independently extracted data on the children included and interventions compared, and assessed the risk of bias of the studies across the following domains: randomisation sequence generation, allocation concealment, blinding (of participants, personnel, and outcome assessors), incomplete outcome data, selective outcome reporting, and other potential sources of bias.\nMain results\nWe found only two RCTs that compared oral L-acetylcarnitine (LAC) with oral placebo in children with FXS. The studies included a total of 83 participants, all of them male, who were treated and followed for one year. The age of participants at the start of treatment ranged from 6 to 13 years, with a mean age of 9 years. Neither study provided information on randomisation, allocation concealment procedures, or blinding of outcome assessment, and we received no responses from the authors we emailed for clarification. We therefore rated studies as being at unclear risk of bias on these domains. We judged both studies to be at low risk of bias for blinding of participants and personnel, incomplete outcome data, and selective reporting, but to be at high risk of other bias, as at least one study was funded by a drug company, and in both studies people working for the company were part of the research team.\nWe used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate the quality of the available evidence. Overall, the quality of the evidence was low due to the imprecision of results and high risk of other bias.\nRegarding the primary outcome of psychological and learning capabilities, both studies assessed the effect of interventions on children's verbal and non-verbal intellectual functioning using the Wechsler Intelligence Scale for Children - Revised. The authors did not provide detailed data on those results but said that they found no important differences between treatment and placebo.\nBoth studies evaluated the impact of the treatment on hyperactive behaviour using the Conners' Abbreviated Parent-Teacher Questionnaire. In one study, teachers' assessments of the children found no clear evidence of a difference (mean difference (MD) 0.50, 95% confidence interval (CI) -5.08 to 6.08, n = 51; low-quality evidence). The other study stated that there were no differences between treated and untreated participants, but did not provide detailed data for inclusion in the meta-analysis.\nParents' assessments favoured LAC in one study (MD -0.57, 95% CI -0.94 to -0.19, n = 17; low-quality evidence), but not in the other (MD -2.80, 95% CI -7.61 to 2.01, n = 51; low-quality evidence), though changes were not large enough to be considered clinically relevant.\nRegarding social skills, one study reported no clear evidence of a difference in Vineland Adaptive Behavior composite scores (MD 8.20, 95% CI -0.02 to 16.42, n = 51; low-quality evidence), yet results in the socialisation domain favoured LAC (MD 11.30, 95% CI 2.52 to 20.08, n = 51; low-quality evidence).\nBoth studies assessed the safety of the active treatment and recorded no side effects. Neither of the included studies assessed the secondary outcome of caregiver burden.\nAuthors' conclusions\nLow-quality evidence from two small trials showed that when compared to placebo, LAC may not improve intellectual functioning or hyperactive behaviour in children with FXS.\n\nGiven the provided abstract, please respond to the following query: \"Funding of the studies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "At least one of the studies was funded by a drug manufacturer with a commercial interest in the results. One of the studies was also funded by charitable monies."
}
] |
query-laysum
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7567
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[
{
"role": "user",
"content": "Abstract: Background\nThe unanticipated difficult airway is a potentially life-threatening event during anaesthesia or acute conditions. An unsuccessfully managed upper airway is associated with serious morbidity and mortality. Several bedside screening tests are used in clinical practice to identify those at high risk of difficult airway. Their accuracy and benefit however, remains unclear.\nObjectives\nThe objective of this review was to characterize and compare the diagnostic accuracy of the Mallampati classification and other commonly used airway examination tests for assessing the physical status of the airway in adult patients with no apparent anatomical airway abnormalities. We performed this individually for each of the four descriptors of the difficult airway: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation.\nSearch methods\nWe searched major electronic databases including CENTRAL, MEDLINE, Embase, ISI Web of Science, CINAHL, as well as regional, subject specific, and dissertation and theses databases from inception to 16 December 2016, without language restrictions. In addition, we searched the Science Citation Index and checked the references of all the relevant studies. We also handsearched selected journals, conference proceedings, and relevant guidelines. We updated this search in March 2018, but we have not yet incorporated these results.\nSelection criteria\nWe considered full-text diagnostic test accuracy studies of any individual index test, or a combination of tests, against a reference standard. Participants were adults without obvious airway abnormalities, who were having laryngoscopy performed with a standard laryngoscope and the trachea intubated with a standard tracheal tube. Index tests included the Mallampati test, modified Mallampati test, Wilson risk score, thyromental distance, sternomental distance, mouth opening test, upper lip bite test, or any combination of these. The target condition was difficult airway, with one of the following reference standards: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation.\nData collection and analysis\nWe performed screening and selection of the studies, data extraction and assessment of methodological quality (using QUADAS-2) independently and in duplicate. We designed a Microsoft Access database for data collection and used Review Manager 5 and R for data analysis. For each index test and each reference standard, we assessed sensitivity and specificity. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where possible, we performed meta-analyses to calculate pooled estimates and compare test accuracy indirectly using bivariate models. We investigated heterogeneity and performed sensitivity analyses.\nMain results\nWe included 133 (127 cohort type and 6 case-control) studies involving 844,206 participants. We evaluated a total of seven different prespecified index tests in the 133 studies, as well as 69 non-prespecified, and 32 combinations. For the prespecified index tests, we found six studies for the Mallampati test, 105 for the modified Mallampati test, six for the Wilson risk score, 52 for thyromental distance, 18 for sternomental distance, 34 for the mouth opening test, and 30 for the upper lip bite test. Difficult face mask ventilation was the reference standard in seven studies, difficult laryngoscopy in 92 studies, difficult tracheal intubation in 50 studies, and failed intubation in two studies. Across all studies, we judged the risk of bias to be variable for the different domains; we mostly observed low risk of bias for patient selection, flow and timing, and unclear risk of bias for reference standard and index test. Applicability concerns were generally low for all domains. For difficult laryngoscopy, the summary sensitivity ranged from 0.22 (95% confidence interval (CI) 0.13 to 0.33; mouth opening test) to 0.67 (95% CI 0.45 to 0.83; upper lip bite test) and the summary specificity ranged from 0.80 (95% CI 0.74 to 0.85; modified Mallampati test) to 0.95 (95% CI 0.88 to 0.98; Wilson risk score). The upper lip bite test for diagnosing difficult laryngoscopy provided the highest sensitivity compared to the other tests (P < 0.001). For difficult tracheal intubation, summary sensitivity ranged from 0.24 (95% CI 0.12 to 0.43; thyromental distance) to 0.51 (95% CI 0.40 to 0.61; modified Mallampati test) and the summary specificity ranged from 0.87 (95% CI 0.82 to 0.91; modified Mallampati test) to 0.93 (0.87 to 0.96; mouth opening test). The modified Mallampati test had the highest sensitivity for diagnosing difficult tracheal intubation compared to the other tests (P < 0.001). For difficult face mask ventilation, we could only estimate summary sensitivity (0.17, 95% CI 0.06 to 0.39) and specificity (0.90, 95% CI 0.81 to 0.95) for the modified Mallampati test.\nAuthors' conclusions\nBedside airway examination tests, for assessing the physical status of the airway in adults with no apparent anatomical airway abnormalities, are designed as screening tests. Screening tests are expected to have high sensitivities. We found that all investigated index tests had relatively low sensitivities with high variability. In contrast, specificities were consistently and markedly higher than sensitivities across all tests. The standard bedside airway examination tests should be interpreted with caution, as they do not appear to be good screening tests. Among the tests we examined, the upper lip bite test showed the most favourable diagnostic test accuracy properties. Given the paucity of available data, future research is needed to develop tests with high sensitivities to make them useful, and to consider their use for screening difficult face mask ventilation and failed intubation. The 27 studies in 'Studies awaiting classification' may alter the conclusions of the review, once we have assessed them.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The bedside screening tests examined in this review are not well suited for the purpose of detecting unanticipated difficult airways because they missed a large number of people who had a difficult airway."
}
] |
query-laysum
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7568
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[
{
"role": "user",
"content": "Abstract: Background\nAntidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2019.\nObjectives\nTo evaluate the benefits and harms of pharmaceutical treatment in people with emotionalism after stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Register, CENTRAL, MEDLINE, Embase, four other databases, and three trials registers (May 2022).\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect).\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, extracted data from all included trials, and used GRADE to assess the certainty of the body of evidence. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on the Center for Neurologic Study - Lability Scale (CNS-LS) or Clinician Interview-Based Impression of Change (CIBIC), or diminished tearfulness.\nMain results\nWe did not identify any new trials for this update. We included seven trials with a total of 239 participants. Two trials had a cross-over design, but outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with a total of 213 participants. It is uncertain whether fluoxetine increases the number of people who have a 50% reduction in emotionalism when compared to placebo (risk ratio (RR) 0.26, 95% CI 0.09 to 0.77; P = 0.02; 1 trial, 19 participants) because the certainty of evidence is very low.\nSertraline may lead to little to no difference in Center for Neurologic Study - Lability Scale (CNS-LS) scores and Clinician Interview-Based Impression of Change (CIBIC) scores when compared to placebo (RR 0.20, 95% CI 0.03 to 1.50; P = 0.12; 1 trial, 28 participants; low-certainty evidence). Antidepressants probably increase the number of people who experience a reduction in tearfulness (RR 0.32, 95% CI 0.12 to 0.86; P = 0.02; 3 trials, 164 participants; moderate-certainty evidence). No trials were found that evaluated the impact of other pharmaceutical interventions.\nOnly two trial authors systematically recorded and reported adverse events, resulting in limited data on the potential harms of treatment. Six trials reported death as an adverse event and found no difference between the groups (antidepressants versus placebo) in the number of deaths reported (RR 0.59, 95% CI 0.08 to 4.50; P = 0.61; 172 participants; moderate-certainty evidence).\nThis review provides very low- to moderate-certainty evidence that antidepressants may reduce the frequency and severity of emotionalism. The included trials were small and had some degree of bias.\nAuthors' conclusions\nAntidepressants may reduce the frequency and severity of crying or laughing episodes when compared to placebo, based on very low-certainty evidence. Our conclusions must be qualified by several methodological deficiencies in the trials and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity, and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance; and include careful assessment and complete reporting of adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 7 randomised controlled trials, involving 239 people with emotionalism, in the review, which reported on the use of antidepressants for treating emotionalism. The numbers of people included in the studies ranged from 10 to 92. The mean/median ages ranged from 57.8 years to 73 years. Studies were from Europe (UK: 1; Denmark: 1; Scotland: 1; and Sweden: 1); Asia (South Korea: 1 and Japan: 1); and the USA (1)."
}
] |
query-laysum
|
7569
|
[
{
"role": "user",
"content": "Abstract: Background\nShared decision making (SDM) is a process by which a healthcare choice is made by the patient, significant others, or both with one or more healthcare professionals. However, it has not yet been widely adopted in practice. This is the second update of this Cochrane review.\nObjectives\nTo determine the effectiveness of interventions for increasing the use of SDM by healthcare professionals. We considered interventions targeting patients, interventions targeting healthcare professionals, and interventions targeting both.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and five other databases on 15 June 2017. We also searched two clinical trials registries and proceedings of relevant conferences. We checked reference lists and contacted study authors to identify additional studies.\nSelection criteria\nRandomized and non-randomized trials, controlled before-after studies and interrupted time series studies evaluating interventions for increasing the use of SDM in which the primary outcomes were evaluated using observer-based or patient-reported measures.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nWe used GRADE to assess the certainty of the evidence.\nMain results\nWe included 87 studies (45,641 patients and 3113 healthcare professionals) conducted mainly in the USA, Germany, Canada and the Netherlands. Risk of bias was high or unclear for protection against contamination, low for differences in the baseline characteristics of patients, and unclear for other domains.\nForty-four studies evaluated interventions targeting patients. They included decision aids, patient activation, question prompt lists and training for patients among others and were administered alone (single intervention) or in combination (multifaceted intervention). The certainty of the evidence was very low. It is uncertain if interventions targeting patients when compared with usual care increase SDM whether measured by observation (standardized mean difference (SMD) 0.54, 95% confidence interval (CI) -0.13 to 1.22; 4 studies; N = 424) or reported by patients (SMD 0.32, 95% CI 0.16 to 0.48; 9 studies; N = 1386; risk difference (RD) -0.09, 95% CI -0.19 to 0.01; 6 studies; N = 754), reduce decision regret (SMD -0.10, 95% CI -0.39 to 0.19; 1 study; N = 212), improve physical (SMD 0.00, 95% CI -0.36 to 0.36; 1 study; N = 116) or mental health-related quality of life (QOL) (SMD 0.10, 95% CI -0.26 to 0.46; 1 study; N = 116), affect consultation length (SMD 0.10, 95% CI -0.39 to 0.58; 2 studies; N = 224) or cost (SMD 0.82, 95% CI 0.42 to 1.22; 1 study; N = 105).\nIt is uncertain if interventions targeting patients when compared with interventions of the same type increase SDM whether measured by observation (SMD 0.88, 95% CI 0.39 to 1.37; 3 studies; N = 271) or reported by patients (SMD 0.03, 95% CI -0.18 to 0.24; 11 studies; N = 1906); (RD 0.03, 95% CI -0.02 to 0.08; 10 studies; N = 2272); affect consultation length (SMD -0.65, 95% CI -1.29 to -0.00; 1 study; N = 39) or costs. No data were reported for decision regret, physical or mental health-related QOL.\nFifteen studies evaluated interventions targeting healthcare professionals. They included educational meetings, educational material, educational outreach visits and reminders among others. The certainty of evidence is very low. It is uncertain if these interventions when compared with usual care increase SDM whether measured by observation (SMD 0.70, 95% CI 0.21 to 1.19; 6 studies; N = 479) or reported by patients (SMD 0.03, 95% CI -0.15 to 0.20; 5 studies; N = 5772); (RD 0.01, 95%C: -0.03 to 0.06; 2 studies; N = 6303); reduce decision regret (SMD 0.29, 95% CI 0.07 to 0.51; 1 study; N = 326), affect consultation length (SMD 0.51, 95% CI 0.21 to 0.81; 1 study, N = 175), cost (no data available) or physical health-related QOL (SMD 0.16, 95% CI -0.05 to 0.36; 1 study; N = 359). Mental health-related QOL may slightly improve (SMD 0.28, 95% CI 0.07 to 0.49; 1 study, N = 359; low-certainty evidence).\nIt is uncertain if interventions targeting healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.30, 95% CI -1.19 to 0.59; 1 study; N = 20) or reported by patients (SMD 0.24, 95% CI -0.10 to 0.58; 2 studies; N = 1459) as the certainty of the evidence is very low. There was insufficient information to determine the effect on decision regret, physical or mental health-related QOL, consultation length or costs.\nTwenty-eight studies targeted both patients and healthcare professionals. The interventions used a combination of patient-mediated and healthcare professional directed interventions. Based on low certainty evidence, it is uncertain whether these interventions, when compared with usual care, increase SDM whether measured by observation (SMD 1.10, 95% CI 0.42 to 1.79; 6 studies; N = 1270) or reported by patients (SMD 0.13, 95% CI -0.02 to 0.28; 7 studies; N = 1479); (RD -0.01, 95% CI -0.20 to 0.19; 2 studies; N = 266); improve physical (SMD 0.08, -0.37 to 0.54; 1 study; N = 75) or mental health-related QOL (SMD 0.01, -0.44 to 0.46; 1 study; N = 75), affect consultation length (SMD 3.72, 95% CI 3.44 to 4.01; 1 study; N = 36) or costs (no data available) and may make little or no difference to decision regret (SMD 0.13, 95% CI -0.08 to 0.33; 1 study; low-certainty evidence).\nIt is uncertain whether interventions targeting both patients and healthcare professionals compared to interventions of the same type increase SDM whether measured by observation (SMD -0.29, 95% CI -1.17 to 0.60; 1 study; N = 20); (RD -0.04, 95% CI -0.13 to 0.04; 1 study; N = 134) or reported by patients (SMD 0.00, 95% CI -0.32 to 0.32; 1 study; N = 150 ) as the certainty of the evidence was very low. There was insuffient information to determine the effects on decision regret, physical or mental health-related quality of life, or consultation length or costs.\nAuthors' conclusions\nIt is uncertain whether any interventions for increasing the use of SDM by healthcare professionals are effective because the certainty of the evidence is low or very low.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A great variety of activities exist to increase shared decision making by healthcare professionals, but we cannot be confident about which of these activities work best because the certainty (or the confidence) of the evidence has been assessed as very low."
}
] |
query-laysum
|
7570
|
[
{
"role": "user",
"content": "Abstract: Background\nNewborn infants have the ability to experience pain. Hospitalised infants are exposed to numerous painful procedures. Healthy newborns are exposed to pain if the birth process consists of assisted vaginal birth by vacuum extraction or by forceps and during blood sampling for newborn screening tests.\nObjectives\nTo determine the efficacy and safety of paracetamol for the prevention or treatment of procedural/postoperative pain or pain associated with clinical conditions in neonates. To review the effects of various doses and routes of administration (enteral, intravenous or rectal) of paracetamol for the prevention or treatment of pain in neonates.\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 4), MEDLINE via PubMed (1966 to 9 May 2016), Embase (1980 to 9 May 2016), and CINAHL (1982 to 9 May 2016). We searched clinical trials' databases, Google Scholar, conference proceedings, and the reference lists of retrieved articles.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials of paracetamol for the prevention/treatment of pain in neonates (≤ 28 days of age).\nData collection and analysis\nTwo review authors independently extracted data from the articles using pre-designed forms. We used this form to decide trial inclusion/exclusion, to extract data from eligible trials and to request additional published information from authors of the original reports. We entered and cross-checked data using RevMan 5 software. When noted, we resolved differences by mutual discussion and consensus. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe included nine trials with low risk of bias, which assessed paracetamol for the treatment of pain in 728 infants. Painful procedures studied included heel lance, assisted vaginal birth, eye examination for retinopathy of prematurity assessment and postoperative care. Results of individual studies could not be combined in meta-analyses as the painful conditions, the use of paracetamol and comparison interventions and the outcome measures differed. Paracetamol compared with water, cherry elixir or EMLA cream (eutectic mixture of lidocaine and prilocaine) did not significantly reduce pain following heel lance. The Premature Infant Pain Profile score (PIPP) within three minutes following lancing was higher in the paracetamol group than in the oral glucose group (mean difference (MD) 2.21, 95% confidence interval (CI) 0.72 to 3.70; one study, 38 infants). Paracetamol did not reduce \"modified facies scores\" after assisted vaginal birth (one study, 119 infants). In another study (n = 123), the Échelle de Douleur et d'Inconfort du Nouveau-Né score at two hours of age was significantly higher in the group that received paracetamol suppositories than in the placebo suppositories group (MD 1.00, 95% CI 0.60 to 1.40). In that study, when infants were subjected to a heel lance at two to three days of age, Bernese Pain Scale for Neonates scores were higher in the paracetamol group than in the placebo group, and infants spent a longer time crying (MD 19 seconds, 95% CI 14 to 24). For eye examinations, no significant reduction in PIPP scores in the first or last 45 seconds of eye examination was reported, nor at five minutes after the eye examination. In one study (n = 81), the PIPP score was significantly higher in the paracetamol group than in the 24% sucrose group (MD 3.90, 95% CI 2.92 to 4.88). In one study (n = 114) the PIPP score during eye examination was significantly lower in the paracetamol group than in the water group (MD −2.70, 95% CI −3.55 to 1.85). For postoperative care following major surgery, the total amount of morphine (µg/kg) administered over 48 hours was significantly less among infants assigned to the paracetamol group than to the morphine group (MD −157 µg/kg, 95% CI −27 to −288). No adverse events were noted in any study. The quality of evidence according to GRADE was low.\nAuthors' conclusions\nThe paucity and low quality of existing data do not provide sufficient evidence to establish the role of paracetamol in reducing the effects of painful procedures in neonates. Paracetamol given after assisted vaginal birth may increase the response to later painful exposures. Paracetamol may reduce the total need for morphine following major surgery, and for this aspect of paracetamol use, further research is needed.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Is paracetamol effective and safe for the prevention or treatment of procedural or postoperative pain or pain associated with clinical conditions in newborn infants?"
}
] |
query-laysum
|
7571
|
[
{
"role": "user",
"content": "Abstract: Background\nReduced cardiorespiratory fitness (cardiorespiratory deconditioning) is a common consequence of traumatic brain injury (TBI). Fitness training may be implemented to address this impairment.\nObjectives\nThe primary objective of this updated review was to evaluate whether fitness training improves cardiorespiratory fitness in people who have sustained a TBI. The secondary objectives were to evaluate whether fitness training improves body function and structure (physical and cognitive impairments, psychological responses resulting from the injury), activity limitations and participation restrictions in people who have sustained a TBI as well as to evaluate its safety, acceptance, feasibility and suitability.\nSearch methods\nWe searched 10 electronic databases (the Cochrane Injuries Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Embase; PubMed (MEDLINE); CINAHL; AMED; SPORTDiscus; PsycINFO; PEDro and PsycBITE) and the International Clinical Trials Registry Platform for relevant trials. In addition we screened reference lists from systematic reviews related to the topic that we identified from our search, and from the included studies, and contacted trialists to identify further studies. The search was run in August 2017.\nSelection criteria\nRandomised controlled studies with TBI participants were eligible if they compared an exercise programme incorporating cardiorespiratory fitness training to usual care, a non-exercise intervention, or no intervention.\nData collection and analysis\nTwo authors independently screened the search results, extracted data and assessed bias. We contacted all trialists for additional information. We calculated mean difference (MD) or standardised mean difference (SMD) and 95% confidence intervals (CI) for continuous data, and odds ratio with 95% CI for dichotomous data. We pooled data when there were sufficient studies with homogeneity.\nMain results\nTwo new studies incorporating 96 participants were identified in this update and were added to the six previously included studies. A total of eight studies incorporating 399 participants are included in the updated review. The participants were primarily men aged in their mid-thirties who had sustained a severe TBI. No studies included children. The studies were clinically diverse with regard to the interventions, time postinjury and the outcome measures used. At the end of intervention, the mean difference in peak power output was 35.47 watts (W) in favour of fitness training (MD 35.47 W, 95% CI 2.53 to 68.41 W; 3 studies, 67 participants; low-quality evidence). The CIs include both a possible clinically important effect and a possible negligible effect, and there was moderate heterogeneity among the studies.\nFive of the secondary outcomes had sufficient data at the end of intervention to enable meta-analysis: body composition (SMD 0.29 standard deviations (favouring control), 95% CI -0.22 to 0.79; 2 studies, 61 participants; low-quality evidence), strength (SMD -0.02 (favouring control), 95% CI -0.86 to 0.83; 2 studies, 23 participants; very low-quality evidence), fatigue (SMD -0.32 (favouring fitness training), 95% CI -0.90 to 0.26; 3 studies, 130 participants; very low-quality evidence), depression (SMD -0.43 (favouring fitness training), 95% CI -0.92 to 0.06; 4 studies, 220 participants; very low-quality evidence), and neuromotor function (MD 0.01 m (favouring fitness training), 95% CI -0.25 to 0.27; 2 studies, 109 participants; moderate-quality evidence). It was uncertain whether fitness training was more or less effective at improving these secondary outcomes compared to the control interventions. Quality of life was assessed in three trials, but we did not pool the data because of substantial heterogeneity. Five of the eight included studies had no dropouts from their intervention group and no adverse events were reported in any study.\nAuthors' conclusions\nThere is low-quality evidence that fitness training is effective at improving cardiorespiratory deconditioning after TBI; there is insufficient evidence to draw any definitive conclusions about the other outcomes. Whilst the intervention appears to be accepted by people with TBI, and there is no evidence of harm, more adequately powered and well-designed studies are required to determine a more precise estimate of the effect on cardiorespiratory fitness, as well as the effects across a range of important outcome measures and in people with different characteristics (e.g. children). In the absence of high quality evidence, clinicians may be guided by pre-exercise screening checklists to ensure the person with traumatic brain injury is safe to exercise, and set training parameters using guidelines established by the American College of Sports Medicine for people who have suffered a brain injury.\n\nGiven the provided abstract, please respond to the following query: \"Authors’ conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "It is unclear whether fitness training after a traumatic brain injury improves physical fitness. There is not enough evidence to understand the effect of fitness training on other important outcomes. Whilst fitness training appears to be well attended by people with traumatic brain injury, particularly when supervised, and there is no evidence of harm, further well-designed studies are required before we can draw any definite conclusions. In the absence of high quality evidence, health professionals may be guided by pre-exercise screening checklists to ensure the person with traumatic brain injury is safe to exercise, and to set training parameters using guidelines established by the American College of Sports Medicine for people who have suffered a brain injury."
}
] |
query-laysum
|
7572
|
[
{
"role": "user",
"content": "Abstract: Background\nPyrethroid long-lasting insecticidal nets (LLINs) have been important in the large reductions in malaria cases in Africa, but insecticide resistance in Anopheles mosquitoes threatens their impact. Insecticide synergists may help control insecticide-resistant populations. Piperonyl butoxide (PBO) is such a synergist; it has been incorporated into pyrethroid-LLINs to form pyrethroid-PBO nets, which are currently produced by five LLIN manufacturers and, following a recommendation from the World Health Organization (WHO) in 2017, are being included in distribution campaigns. This review examines epidemiological and entomological evidence on the addition of PBO to pyrethroid nets on their efficacy.\nObjectives\nTo compare effects of pyrethroid-PBO nets currently in commercial development or on the market with effects of their non-PBO equivalent in relation to:\n1. malaria parasite infection (prevalence or incidence); and\n2. entomological outcomes.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, Web of Science, CAB Abstracts, and two clinical trial registers (ClinicalTrials.gov and WHO International Clinical Trials Registry Platform) up to 25 September 2020. We contacted organizations for unpublished data. We checked the reference lists of trials identified by these methods.\nSelection criteria\nWe included experimental hut trials, village trials, and randomized controlled trials (RCTs) with mosquitoes from the Anopheles gambiae complex or the Anopheles funestus group.\nData collection and analysis\nTwo review authors assessed each trial for eligibility, extracted data, and determined the risk of bias for included trials. We resolved disagreements through discussion with a third review author. We analysed data using Review Manager 5 and assessed the certainty of evidence using the GRADE approach.\nMain results\nSixteen trials met the inclusion criteria: 10 experimental hut trials, four village trials, and two cluster-RCTs (cRCTs). Three trials are awaiting classification, and four trials are ongoing.\nTwo cRCTs examined the effects of pyrethroid-PBO nets on parasite prevalence in people living in areas with highly pyrethroid-resistant mosquitoes (< 30% mosquito mortality in discriminating dose assays). At 21 to 25 months post intervention, parasite prevalence was lower in the intervention arm (odds ratio (OR) 0.79, 95% confidence interval (CI) 0.67 to 0.95; 2 trials, 2 comparisons; moderate-certainty evidence).\nIn highly pyrethroid-resistant areas, unwashed pyrethroid-PBO nets led to higher mosquito mortality compared to unwashed standard-LLINs (risk ratio (RR) 1.84, 95% CI 1.60 to 2.11; 14,620 mosquitoes, 5 trials, 9 comparisons; high-certainty evidence) and lower blood feeding success (RR 0.60, 95% CI 0.50 to 0.71; 14,000 mosquitoes, 4 trials, 8 comparisons; high-certainty evidence). However, in comparisons of washed pyrethroid-PBO nets to washed LLINs, we do not know if PBO nets had a greater effect on mosquito mortality (RR 1.20, 95% CI 0.88 to 1.63; 10,268 mosquitoes, 4 trials, 5 comparisons; very low-certainty evidence), although the washed pyrethroid-PBO nets did decrease blood-feeding success compared to standard-LLINs (RR 0.81, 95% CI 0.72 to 0.92; 9674 mosquitoes, 3 trials, 4 comparisons; high-certainty evidence).\nIn areas where pyrethroid resistance is moderate (31% to 60% mosquito mortality), mosquito mortality was higher with unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs (RR 1.68, 95% CI 1.33 to 2.11; 1007 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence), but there was little to no difference in effects on blood-feeding success (RR 0.90, 95% CI 0.72 to 1.11; 1006 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence). For washed pyrethroid-PBO nets compared to washed standard-LLINs, we found little to no evidence for higher mosquito mortality or reduced blood feeding (mortality: RR 1.07, 95% CI 0.74 to 1.54; 329 mosquitoes, 1 trial, 1 comparison, low-certainty evidence; blood feeding success: RR 0.91, 95% CI 0.74 to 1.13; 329 mosquitoes, 1 trial, 1 comparison; low-certainty evidence).\nIn areas where pyrethroid resistance is low (61% to 90% mosquito mortality), studies reported little to no difference in the effects of unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs on mosquito mortality (RR 1.25, 95% CI 0.99 to 1.57; 1580 mosquitoes, 2 trials, 3 comparisons; moderate-certainty evidence), and we do not know if there was any effect on blood-feeding success (RR 0.75, 95% CI 0.27 to 2.11; 1580 mosquitoes, 2 trials, 3 comparisons; very low-certainty evidence). For washed pyrethroid-PBO nets compared to washed standard-LLINs, we do not know if there was any difference in mosquito mortality (RR 1.39, 95% CI 0.95 to 2.04; 1774 mosquitoes, 2 trials, 3 comparisons; very low-certainty evidence) or on blood feeding (RR 1.07, 95% CI 0.49 to 2.33; 1774 mosquitoes, 2 trials, 3 comparisons; low-certainty evidence).\nIn areas where mosquito populations are susceptible to insecticides (> 90% mosquito mortality), there may be little to no difference in the effects of unwashed pyrethroid-PBO nets compared to unwashed standard-LLINs on mosquito mortality (RR 1.20, 95% CI 0.64 to 2.26; 2791 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence). This is similar for washed nets (RR 1.07, 95% CI 0.92 to 1.25; 2644 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence). We do not know if unwashed pyrethroid-PBO nets had any effect on the blood-feeding success of susceptible mosquitoes (RR 0.52, 95% CI 0.12 to 2.22; 2791 mosquitoes, 2 trials, 2 comparisons; very low-certainty evidence). The same applies to washed nets (RR 1.25, 95% CI 0.82 to 1.91; 2644 mosquitoes, 2 trials, 2 comparisons; low-certainty evidence).\nIn village trials comparing pyrethroid-PBO nets to LLINs, there was no difference in sporozoite rate (4 trials, 5 comparisons) nor in mosquito parity (3 trials, 4 comparisons).\nAuthors' conclusions\nIn areas of high insecticide resistance, pyrethroid-PBO nets have greater entomological and epidemiological efficacy compared to standard LLINs, with sustained reduction in parasite prevalence, higher mosquito mortality and reduction in mosquito blood feeding rates 21 to 25 months post intervention. Questions remain about the durability of PBO on nets, as the impact of pyrethroid-PBO nets on mosquito mortality was not sustained over 20 washes in experimental hut trials, and epidemiological data on pyrethroid-PBO nets for the full intended three-year life span of the nets is not available. Little evidence is available to support greater entomological efficacy of pyrethroid-PBO nets in areas where mosquitoes show lower levels of resistance to pyrethroids.\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 find out if pyrethroid-PBO nets provide additional protection against malaria when compared to standard pyrethroid-only nets."
}
] |
query-laysum
|
7573
|
[
{
"role": "user",
"content": "Abstract: Background\nDelirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary.\nThis is the second update of the review first published in 2004.\nObjectives\nTo evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries.\nSelection criteria\nWe included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older).\nData collection and analysis\nWe independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables.\nMain results\nWe included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events.\n1. Haloperidol versus placebo\nThere may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) −0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium).\nHaloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD −0.14, 95% −0.28 to −0.00; 123 participants with mild- to moderate-severity delirium).\nHaloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium).\n2. Haloperidol versus risperidone\nThere may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD −0.42, 95% CI −0.90 to 0.06; 126 participants) or 48 hours (MD −0.36, 95% CI −0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison.\n3. Haloperidol versus olanzapine\nWe are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI −0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI −1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison.\n4. Risperidone versus placebo\nRisperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium).\nThere may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD −0.05, 95% CI −0.19 to 0.09; 111 participants with mild- to moderate-severity delirium).\nRisperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium).\n5. Lorazepam plus haloperidol versus placebo plus haloperidol\nWe are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI −1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI −0.19 to 2.63; 31 participants with moderate to severe delirium).\n6. Haloperidol versus chlorpromazine\nWe are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI −4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI −4.22 to 5.14; 24 participants).\n7. Haloperidol versus lorazepam\nWe are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD −4.88, 95% CI −9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD −6.66, 95% CI −14.85 to 1.53; 17 participants).\n8. Lorazepam versus chlorpromazine\nWe are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported.\nSecondary outcomes: use of rescue medication, cognitive impairment, survival\nThere were insufficient data to draw conclusions or assess GRADE.\nAuthors' conclusions\nWe found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.\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": "Delirium is common in people with a terminal illness. A person experiencing delirium may be confused, lack concentration, have disturbed patterns of sleep and waking, and experience hallucinations. Delirium can start suddenly and can cause distress to both the person and their family. Delirium may be caused by the underlying disease with which the person is affected, or as a side effect of drugs or other symptoms. Often it is not clear why a person has delirium. The multifaceted nature of delirium makes its management challenging. When it is not possible to identify the underlying cause, drug treatments are sometimes used to manage the symptoms."
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"content": "Abstract: Background\nGestational weight gain is positively associated with fetal growth, and observational studies of food supplementation in pregnancy have reported increases in gestational weight gain and fetal growth.\nObjectives\nTo assess the effects of education during pregnancy to increase energy and protein intake, or of actual energy and protein supplementation, on energy and protein intake, and the effect on maternal and infant health outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2015), reference lists of retrieved studies and contacted researchers in the field.\nSelection criteria\nRandomised controlled trials of dietary education to increase energy and protein intake, or of actual energy and protein supplementation, during pregnancy.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and checked for accuracy. Extracted data were supplemented by additional information from the trialists we contacted.\nMain results\nWe examined 149 reports corresponding to 65 trials. Of these trials, 17 were included, 46 were excluded, and two are ongoing. Overall, 17 trials involving 9030 women were included. For this update, we assessed methodological quality of the included trials using the standard Cochrane criteria (risk of bias) and the GRADE approach. The overall risk of bias was unclear.\nNutritional education (five trials, 1090 women)\nWomen given nutritional education had a lower relative risk of having a preterm birth (two trials, 449 women) (risk ratio (RR) 0.46, 95% CI 0.21 to 0.98, low-quality evidence), and low birthweight (one trial, 300 women) (RR 0.04, 95% CI 0.01 to 0.14). Head circumference at birth was increased in one trial (389 women) (mean difference (MD) 0.99 cm, 95% CI 0.43 to 1.55), while birthweight was significantly increased among undernourished women in two trials (320 women) (MD 489.76 g, 95% CI 427.93 to 551.59, low-quality evidence), but did not significantly increase for adequately nourished women (MD 15.00, 95% CI -76.30 to 106.30, one trial, 406 women). Protein intake increased significantly (three trials, 632 women) (protein intake: MD +6.99 g/day, 95% CI 3.02 to 10.97). No significant differences were observed on any other outcomes such as neonatal death (RR 1.28, 95% CI 0.35 to 4.72, one trial, 448 women, low-quality evidence), stillbirth (RR 0.37, 95% CI 0.07 to 1.90, one trial, 431 women, low-quality evidence), small-for-gestational age (RR 0.97, 95% CI 0.45 to 2.11, one trial, 404 women, low-quality evidence) and total gestational weight gain (MD -0.41, 95% CI -4.41 to 3.59, two trials, 233 women). There were no data on perinatal death.\nBalanced energy and protein supplementation (12 trials, 6705 women)\nRisk of stillbirth was significantly reduced for women given balanced energy and protein supplementation (RR 0.60, 95% CI 0.39 to 0.94, five trials, 3408 women, moderate-quality evidence), and the mean birthweight was significantly increased (random-effects MD +40.96 g, 95% CI 4.66 to 77.26, Tau² = 1744, I² = 44%, 11 trials, 5385 women, moderate-quality evidence). There was also a significant reduction in the risk of small-for-gestational age (RR 0.79, 95% CI 0.69 to 0.90, I² = 16%, seven trials, 4408 women, moderate-quality evidence). No significant effect was detected for preterm birth (RR 0.96, 95% CI 0.80 to 1.16, five trials, 3384 women, moderate-quality evidence) or neonatal death (RR 0.68, 95% CI 0.43 to 1.07, five trials, 3381 women, low-quality evidence). Weekly gestational weight gain was not significantly increased (MD 18.63, 95% CI -1.81 to 39.07, nine trials, 2391 women, very low quality evidence). There were no data reported on perinatal death and low birthweight.\nHigh-protein supplementation (one trial, 1051 women)\nHigh-protein supplementation (one trial, 505 women), was associated with a significantly increased risk of small-for-gestational age babies (RR 1.58, 95% CI 1.03 to 2.41, moderate-quality evidence). There was no significant effect for stillbirth (RR 0.81, 95% CI 0.31 to 2.15, one trial, 529 women), neonatal death (RR 2.78, 95% CI 0.75 to 10.36, one trial, 529 women), preterm birth (RR 1.14, 95% CI 0.83 to 1.56, one trial, 505 women), birthweight (MD -73.00, 95% CI -171.26 to 25.26, one trial, 504 women) and weekly gestational weight gain (MD 4.50, 95% CI -33.55 to 42.55, one trial, 486 women, low-quality evidence). No data were reported on perinatal death.\nIsocaloric protein supplementation (two trials, 184 women)\nIsocaloric protein supplementation (two trials, 184 women) had no significant effect on birthweight (MD 108.25, 95% CI -220.89 to 437.40) and weekly gestational weight gain (MD 110.45, 95% CI -82.87 to 303.76, very low-quality evidence). No data reported on perinatal mortality, stillbirth, neonatal death, small-for-gestational age, and preterm birth.\nAuthors' conclusions\nThis review provides encouraging evidence that antenatal nutritional education with the aim of increasing energy and protein intake in the general obstetric population appears to be effective in reducing the risk of preterm birth, low birthweight, increasing head circumference at birth, increasing birthweight among undernourished women, and increasing protein intake. There was no evidence of benefit or adverse effect for any other outcome reported.\nBalanced energy and protein supplementation seems to improve fetal growth, and may reduce the risk of stillbirth and infants born small-for-gestational age. High-protein supplementation does not seem to be beneficial and may be harmful to the fetus. Balanced-protein supplementation alone had no significant effects on perinatal outcomes.\nThe results of this review should be interpreted with caution. The risk of bias was either unclear or high for at least one category examined in several of the included trials, and the quality of the evidence was low for several important outcomes. Also, as the anthropometric characteristics of the general obstetric population is changing, those developing interventions aimed at altering energy and protein intake should ensure that only those women likely to benefit are included. Large, well-designed randomised trials are needed to assess the effects of increasing energy and protein intake during pregnancy in women whose intake is below recommended levels.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "This review includes 17 randomised controlled trials, involving 9030 women. The quality of the included trials is low to moderate. We, examined several aspects of dietary advice and supplementation and produced the following four main findings.\n(1) Providing nutritional advice resulted in an increase in the mother's protein intake, there were fewer babies born too early (two trials involving 449 women) and fewer babies with low birthweight (one trial involving 300 women), One study of 389 women showed increases in some babies birth head circumference (in one trial involving 389 women) There were also more babies with a higher birthweight among undernourished women (two trials involving 320 women).\n(2) Giving the mothers balanced energy and protein supplements was associated with fewer babies dying during labour (five trials, 3408 women), clear increases in birthweight (11 trials, 5385 women) and fewer babies who were small-for-gestational age (seven trials, 4408 women). However, the impact on the long-term health of the baby was uncertain, including among undernourished women.\n(3) High-protein supplementation (one trial involving 1051 women) showed no benefit for women and potential harm for the baby through an increase in the number of babies small for their gestational age at birth.\n(4) Isocaloric protein supplementations (i.e. balanced supplements in which the protein replaces an equal quantity of other nutrients, e.g. fat and carbohydrate): in birthweight and weekly gestational weight gain, showed no benefit for women or their babies (two trials involving 184 women)."
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"content": "Abstract: Background\nAssociations between nursing home residents’ oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents’ oral health.\nObjectives\nTo assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents.\nSearch methods\nWe searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention.\nData collection and analysis\nTwo review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information.\nMain results\nWe included nine RCTs involving 3253 nursing home residents in this review; seven of these trials used cluster randomisation. The mean resident age ranged from 78 to 86 years across studies, and most participants were women (more than 66% in all studies). The proportion of residents with dental protheses ranged from 62% to 87%, and the proportion of edentulous residents ranged from 32% to 90% across studies.\nEight studies compared educational interventions with information and practical components versus (optimised) usual care, while the ninth study compared educational interventions with information only versus usual care. All interventions included educational sessions on oral health for nursing staff (five trials) or for both staff and residents (four trials), and used more than one active component. Follow-up of included studies ranged from three months to five years.\nNo study showed overall low risk of bias. Four studies had a high risk of bias, and the other five studies were at unclear risk of bias.\nNone of the trials assessed our predefined primary outcomes 'oral health' and 'oral health-related quality of life'. All trials assessed our third primary outcome, 'dental or denture plaque'. Meta-analyses showed no evidence of a difference between interventions and usual care for dental plaque (mean difference -0.04, 95% confidence interval (CI) -0.26 to 0.17; six trials; 437 participants; low quality evidence) or denture plaque (standardised mean difference -0.60, 95% CI -1.25 to 0.05; five trials; 816 participants; low quality evidence). None of the studies assessed adverse events of the intervention.\nAuthors' conclusions\nWe found insufficient evidence to draw robust conclusions about the effects of oral health educational interventions for nursing home staff and residents. We did not find evidence of meaningful effects of educational interventions on any measure of residents' oral health; however, the quality of the available evidence is low. More adequately powered and high-quality studies using relevant outcome measures are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Nursing home residents are often unable to carry out proper oral care, which is an important factor in maintaining the health of the mouth, teeth, and gums. Nursing home staff may not be prepared to provide adequate care. Therefore, oral health care education for residents and/or nursing staff may be one strategy to improve this situation."
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"role": "user",
"content": "Abstract: Background\nMany women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute to the popularity of complementary methods of pain management. This review examined currently available evidence on the use of relaxation therapies for pain management in labour. This is an update of a review first published in 2011.\nObjectives\nTo examine the effects of mind-body relaxation techniques for pain management in labour on maternal and neonatal well-being during and after labour.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (9 May 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 5 2017), MEDLINE (1966 to 24 May 2017), CINAHL (1980 to 24 May 2017), the Australian New Zealand Clinical Trials Registry (18 May 2017), ClinicalTrials.gov (18 May 2017), the ISRCTN Register (18 May 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (18 May 2017), and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials (including quasi randomised and cluster trials) comparing relaxation methods with standard care, no treatment, other non-pharmacological forms of pain management in labour or placebo.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We attempted to contact study authors for additional information. We assessed evidence quality with GRADE methodology.\nMain results\nThis review update includes 19 studies (2519 women), 15 of which (1731 women) contribute data. Interventions examined included relaxation, yoga, music and mindfulness. Approximately half of the studies had a low risk of bias for random sequence generation and attrition bias. The majority of studies had a high risk of bias for performance and detection bias, and unclear risk of bias for, allocation concealment, reporting bias and other bias. We assessed the evidence from these studies as ranging from low to very low quality, and therefore the effects below should be interpreted with caution.\nRelaxation\nWe found that relaxation compared to usual care provided lowered the intensity of pain (measured on a scale of 0 to 10 with low scores indicating less pain) during the latent phase of labour (mean difference (MD) -1.25, 95% confidence interval (CI) -1.97 to -0.53, one trial, 40 women). Four trials reported pain intensity in the active phase; there was high heterogeneity between trials and very low-quality evidence suggested that there was no strong evidence that the effects were any different between groups for this outcome (MD -1.08, 95% CI -2.57 to 0.41, four trials, 271 women, random-effects analysis). Very low-quality evidence showed that women receiving relaxation reported greater satisfaction with pain relief during labour (risk ratio (RR) 8.00, 95% CI 1.10 to 58.19, one trial, 40 women), and showed no clear benefit for satisfaction with childbirth experience (assessed using different scales) (standard mean difference (SMD) -0.03, 95% CI -0.37 to 0.31, three trials, 1176 women). For safety outcomes there was very low-quality evidence of no clear reduction in assisted vaginal birth (average RR 0.61, 95% CI 0.20 to 1.84, four trials, 1122 women) or in caesarean section rates (average RR 0.73, 95% CI 0.26 to 2.01, four trials, 1122 women). Sense of control in labour, and breastfeeding were not reported under this comparison.\nYoga\nWhen comparing yoga to control interventions there was low-quality evidence that yoga lowered pain intensity (measured on a scale of 0 to 10) with low scores indicating less pain) (MD -6.12, 95% CI -11.77 to -0.47, one trial, 66 women), greater satisfaction with pain relief (MD 7.88, 95% CI 1.51 to 14.25, one trial, 66 women) and greater satisfaction with childbirth experience (MD 6.34, 95% CI 0.26 to 12.42 one trial, 66 women (assessed using the Maternal Comfort Scale with higher score indicating greater comfort). Sense of control in labour, breastfeeding, assisted vaginal birth, and caesarean section were not reported under this comparison.\nMusic\nWhen comparing music to control interventions there was evidence of lower pain intensity in the latent phase for women receiving music (measured on a scale of 0 to 10 with low scores indicating less pain) (MD -0.73, 95% CI -1.01 to -0.45, random-effects analysis, two trials, 192 women) and very low-quality evidence of no clear benefit in the active phase (MD -0.51, 95% CI -1.10 to 0.07, three trials, 217 women). Very low-quality evidence suggested no clear benefit in terms of reducing assisted vaginal birth (RR 0.41, 95% CI 0.08 to 2.05, one trial, 156 women) or caesarean section rate (RR 0.78, 95% CI 0.36 to 1.70, two trials, 216 women). Satisfaction with pain relief, sense of control in labour, satisfaction with childbirth experience, and breastfeeding were not reported under this comparison.\nAudio analgesia\nOne trial evaluating audio analgesia versus control only reported one outcome and showed no evidence of benefit in satisfaction with pain relief.\nMindfulness\nOne trial evaluating mindfulness versus usual care found an increase in sense of control for the mindfulness group (using the Childbirth Self-Efficacy Inventory) (MD 31.30, 95% CI 1.61 to 60.99, 26 women). There is no strong evidence that the effects were any different between groups for satisfaction in childbirth, or for caesarean section rate, need for assisted vaginal delivery or need for pharmacological pain relief. No other outcomes were reported in this trial.\nAuthors' conclusions\nRelaxation, yoga and music may have a role with reducing pain, and increasing satisfaction with pain relief, although the quality of evidence varies between very low to low. There was insufficient evidence for the role of mindfulness and audio-analgesia. The majority of trials did not report on the safety of the interventions. Further randomised controlled trials of relaxation modalities for pain management in labour are needed. Trials should be adequately powered and include clinically relevant outcomes such as those described in this review.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"content": "We found 15 studies involving 1731 women that contributed data to the analyses. Studies were undertaken across the world, including countries in Europe and Scandinavia, and Iran, Taiwan, Thailand, Turkey and USA.\nWe found that relaxation techniques, yoga and music may help women manage labour pain, although the quality of the evidence varied between low and very low, and more data are needed. Also, in these trials there were variations in how these techniques were used. There was no clear evidence that these therapies had an impact on assisted vaginal or caesarean birth. There were insufficient data to say if these techniques influenced the baby’s condition at birth."
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"role": "user",
"content": "Abstract: Background\nChagas disease-related cardiomyopathy is a major cause of morbidity and mortality in Latin America. Despite the substantial burden to the healthcare system, there is uncertainty regarding the efficacy and safety of pharmacological interventions for treating heart failure in people with Chagas disease. This is an update of a Cochrane review published in 2012.\nObjectives\nTo assess the clinical benefits and harms of current pharmacological interventions for treating heart failure in people with Chagas cardiomyopathy.\nSearch methods\nWe updated the searches in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 1), MEDLINE (Ovid; 1946 to to February Week 1 2016), EMBASE (Ovid; 1947 to 2016 Week 07), LILACS (1982 to 15 February 2016), and Web of Science (Thomson Reuters; 1970 to 15 February 2016). We checked the reference lists of included papers. We applied no language restrictions.\nSelection criteria\nWe included randomised clinical trials (RCTs) that assessed the effects of pharmacological interventions to treat heart failure in adult patients (18 years or older) with symptomatic heart failure (New York Heart Association classes II to IV), regardless of the left ventricular ejection fraction stage (reduced or preserved), with Chagas cardiomyopathy. We did not apply limits to the length of follow-up. Primary outcomes were all-cause mortality, cardiovascular mortality at 30 days, time-to-heart decompensation, disease-free period (at 30, 60, and 90 days), and adverse events.\nData collection and analysis\nTwo authors independently performed study selection, 'Risk of bias' assessment and data extraction. We estimated relative risk (RR) and 95% confidence intervals (CIs) for dichotomous outcomes. We measured statistical heterogeneity using the I² statistic. We used a fixed-effect model to synthesize the findings. We contacted authors for additional data. We developed 'Summary of findings' (SoF) tables and used GRADE methodology to assess the quality of the evidence.\nMain results\nIn this update, we identified one new trial. Therefore, this version includes three trials (108 participants). Two trials compared carvedilol against placebo and another assessed rosuvastatin versus placebo. All trials had a high risk of bias.\nMeta-analysis of two trials showed a lower proportion of all-cause mortality in the carvedilol groups compared with the placebo groups (RR 0.69; 95% CI 0.12 to 3.88, I² = 0%; 69 participants; very low-quality evidence). Neither of the trials reported on cardiovascular mortality, time-to-heart decompensation, or disease-free periods.\nOne trial (30 participants) found no difference in hospital readmissions (RR 1.00; 95% CI 0.31 to 3.28; very low-quality of evidence) or reported adverse events (RR 0.92; 95% CI 0.67 to 1.27; very low-quality of evidence) between the carvedilol and placebo groups.\nThere was very low-quality evidence from two trials of inconclusive effects on quality of life (QoL) between the carvedilol and placebo groups. One trial (30 participants) assessed QoL with the Minnesota Living With Heart Failure Questionnaire (21 items; item scores range from 0 to 5; a lower MLHFQ score is better). The MD was -14.74; 95% CI -24.75 to -4.73. The other trial (39 participants) measured QoL with the Medical Outcomes Study 36-item short-form health survey (SF-36; item scores range from 0 to 100; higher SF-36 score is better). Data were not provided.\nOne trial (39 participants) assessed the effect of rosuvastatin versus placebo. The trial did not report on any primary outcomes or adverse events. There was very low-quality evidence of uncertain effects on QoL (no data were provided).\nAuthors' conclusions\nThis first update of our review found very low-quality evidence for the effects of either carvedilol or rosuvastatin, compared with placebo, for treating heart failure in people with Chagas disease. The three included trials were underpowered and had a high risk of bias. There were no conclusive data to support or reject the use of either carvedilol or rosuvastatin for treating Chagas cardiomyopathy. Unless randomised clinical trials provide evidence of a treatment effect, and the trade-off between potential benefits and harms is established, policy-makers, clinicians, and academics should be cautious when recommending or administering either carvedilol or rosuvastatin to treat heart failure in people with Chagas disease. The efficacy and safety of other pharmacological interventions for treating heart failure in people with Chagas disease remains unknown.\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": "The results were inconclusive that carvedilol reduced all-cause mortality or improved quality of life more than placebo. The safety profile of carvedilol for Chagas cardiomyopathy remains unclear. One study assessed the effect of rosuvastatin versus placebo, but did not show an effect size. Therefore, the results from available clinical trials neither support nor reject the use of carvedilol or rosuvastatin in treating this clinical entity. Further investigation is warranted to investigate the exact applicability of conventional heart failure treatment agents in Chagas cardiomyopathy."
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"content": "Abstract: Background\nSince the early 2010s, there has been a push to enhance the capacity to effectively treat wasting in children through community-based service delivery models and thus reduce morbidity and mortality.\nObjectives\nTo assess the effectiveness of identification and treatment of moderate and severe wasting in children aged five years or under by lay health workers working in the community compared with health providers working in health facilities.\nSearch methods\nWe searched MEDLINE, CENTRAL, two other databases, and two ongoing trials registers to 24 September 2021. We also screened the reference lists of related systematic reviews and all included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised studies in children aged five years or under with moderate wasting (defined as weight-for-height Z-score (WHZ) below −2 but no lower than ≥ −3, or mid-upper-arm circumference (MUAC) below 125 mm but no lower than 115 mm, and no nutritional oedema) or severe wasting (WHZ below −3 or MUAC below 115 mm or nutritional oedema).\nEligible interventions were:\n• identification by lay health workers (LHWs) of children with wasting (intervention 1);\n• identification by LHWs of children with wasting and medical complications needing referral (intervention 2); and\n• identification by LHWs of children with wasting without medical complications needing referral (intervention 3).\nEligible comparators were:\n• identification and treatment of wasting by health professionals such as nurses or doctors (at health facilities); and\n• identification and treatment of wasting by health facility-based teams, including health professionals and LHWs.\nData collection and analysis\nTwo review authors independently screened trials, extracted data and assessed risk of bias using the Cochrane risk of bias tool (RoB 2) and Cochrane Effective Practice and Organisation of Care (EPOC) guidelines. We used a random-effects model to meta-analyse data, producing risk ratios (RRs) for dichotomous outcomes in trials with individual allocation, adjusted RRs for dichotomous outcomes in trials with cluster allocation (using the generic inverse variance method in Review Manager 5), and mean differences (MDs) for continuous outcomes. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included two RCTs and five non-RCTs. Six studies were from African countries, and one was from Pakistan. Six studies included children with severe wasting, and one included children with moderate wasting. All studies offered home-based ready-to-use therapeutic food treatment and monitoring. Children received antibiotics in three studies, vitamins or micronutrients in three studies, and deworming treatment in two studies. In three studies, the comparison arm involved LHWs screening children for malnutrition and referring them to health facilities for diagnosis and treatment.\nAll the non-randomised studies had a high overall risk of bias.\nInterventions 1 and 2\nIdentification and referral for treatment by LHWs, compared with treatment by health professionals following self-referral, may result in little or no difference in the percentage of children who recover from moderate or severe wasting (MD 1.00%, 95% confidence interval (CI) −2.53 to 4.53; 1 RCT, 29,475 households; low certainty).\nIntervention 3\nCompared with treatment by health professionals following identification by LHWs, identification and treatment of severe wasting in children by LHWs:\n• may slightly reduce improvement from severe wasting (RR 0.93, 95% CI 0.86 to 0.99; 1 RCT, 789 participants; low certainty);\n• may slightly increase non-response to treatment (RR 1.44, 95% CI 1.04 to 2.01; 1 RCT, 789 participants; low certainty);\n• may result in little or no difference in the number of children with WHZ above −2 on discharge (RR 0.94, 95% CI 0.28 to 3.18; 1 RCT, 789 participants; low certainty);\n• probably results in little or no difference in the number of children with WHZ between −3 and −2 on discharge (RR 1.09, 95% CI 0.87 to 1.36; 1 RCT, 789 participants; moderate certainty);\n• probably results in little or no difference in the number of children with WHZ below −3 (severe wasting) on discharge (RR 1.23, 95% CI 0.75 to 2.04; 1 RCT, 789 participants; moderate certainty);\n• probably results in little or no difference in the number of children with MUAC equal to or greater than 115 mm on discharge (RR 0.99, 95% CI 0.93 to 1.06; 1 RCT, 789 participants; moderate certainty);\n• results in little or no difference in weight gain per day (mean weight gain 0.50 g/kg/day higher, 95% CI 1.74 lower to 2.74 higher; 1 RCT, 571 participants; high certainty);\n• probably has little or no effect on relapse of severe wasting (RR 1.03, 95% CI 0.69 to 1.54; 1 RCT, 649 participants; moderate certainty);\n• may have little or no effect on mortality among children with severe wasting (RR 0.46, 95% CI 0.04 to 5.98; 1 RCT, 829 participants; low certainty);\n• probably has little or no effect on the transfer of children with severe wasting to inpatient care (RR 3.71, 95% CI 0.36 to 38.23; 1 RCT, 829 participants; moderate certainty); and\n• probably has little or no effect on the default of children with severe wasting (RR 1.48, 95% CI 0.65 to 3.40; 1 RCT, 829 participants; moderate certainty).\nThe evidence was very uncertain for total MUAC gain, MUAC gain per day, total weight gain, treatment coverage, and transfer to another LHW site or health facility.\nNo studies examined sustained recovery, deterioration to severe wasting, appropriate identification of children with wasting or oedema, appropriate referral of children with moderate or severe wasting, adherence, or adverse effects and other harms.\nAuthors' conclusions\nIdentification and treatment of severe wasting in children who do not require inpatient care by LHWs, compared with treatment by health professionals, may lead to similar or slightly poorer outcomes. We found only two RCTs, and the evidence from non-randomised studies was of very low certainty for all outcomes due to serious risks of bias and imprecision. No studies included children aged under 6 months. Future studies must address these methodological issues.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of this review suggest that children who receive care from lay health workers for severe wasting may have similar or slightly poorer results than children who receive care from health professionals."
}
] |
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