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query-laysum | 2026 | [
{
"role": "user",
"content": "Abstract: Background\nTension-type headache (TTH) affects about 1 person in 5 worldwide. It is divided into infrequent episodic TTH (fewer than one headache per month), frequent episodic TTH (two to 14 headaches per month), and chronic TTH (15 headache days a month or more). Paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic TTH.\nObjectives\nTo assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic TTH in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (CRSO), MEDLINE, EMBASE, and the Oxford Pain Relief Database to October 2015, and also reference lists of relevant published studies and reviews. We sought unpublished studies by asking personal contacts and searching online clinical trial registers and manufacturers' websites.\nSelection criteria\nWe included randomised, double-blind, placebo-controlled studies (parallel-group or cross-over) using oral paracetamol for symptomatic relief of an acute episode of TTH. Studies had to be prospective, with participants aged 18 years or over, and include at least 10 participants per treatment arm.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and extracted data. We used the numbers of participants achieving each outcome to calculate the risk ratio (RR) and number needed to treat for one additional beneficial outcome (NNT) or one additional harmful outcome (NNH) for oral paracetamol compared to placebo or an active intervention for a range of outcomes, predominantly those recommended by the International Headache Society (IHS).\nWe assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created 'Summary of findings' tables.\nMain results\nWe included 23 studies, all of which enrolled adults with frequent episodic TTH. Twelve studies used the IHS diagnostic criteria or similar, six used the older classification of the Ad Hoc Committee, and five did not describe specific diagnostic criteria but generally excluded participants with migraines. Participants had moderate or severe pain at the start of treatment. While 8079 people with TTH participated in these studies, the numbers available for any analysis were lower than this because outcomes were inconsistently reported and because many participants received active comparators.\nNone of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged five studies to be at high risk of bias for incomplete outcome reporting, and seven due to small size.\nFor the IHS preferred outcome of being pain free at two hours the NNT for paracetamol 1000 mg compared with placebo was 22 (95% confidence interval (CI) 15 to 40) in eight studies (5890 participants; high quality evidence), with no significant difference from placebo at one hour. The NNT was 10 (7.9 to 14) for pain-free or mild pain at two hours in five studies (5238 participants; high quality evidence). The use of rescue medication was lower with paracetamol 1000 mg than with placebo, with an NNTp to prevent an event of 7.8 (6.0 to 11) in six studies (1856 participants; moderate quality evidence). On limited data, the efficacy of paracetamol 500 mg to 650 mg was not superior to placebo, and paracetamol 1000 mg was not different from either ketoprofen 25 mg or ibuprofen 400 mg (low quality evidence).\nAdverse events were not different between paracetamol 1000 mg and placebo (RR 1.1 (0.94 to 1.3); 5605 participants; 11 studies; high quality evidence). Studies reported no serious adverse events.\nThe quality of the evidence using GRADE comparing paracetamol 1000 mg with placebo was moderate to high. Where evidence was downgraded it was because a minority of studies reported the outcome. For comparisons of paracetamol 500 mg to 650 mg with placebo, and of paracetamol 1000 mg with active comparators, we downgraded the evidence to low quality or very low quality because of the small number of studies and events.\nAuthors' conclusions\nParacetamol 1000 mg provided a small benefit in terms of being pain free at two hours for people with frequent episodic TTH who have an acute headache of moderate or severe intensity.\n\nGiven the provided abstract, please respond to the following query: \"Bottom line\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review found that few people with two to 14 tension-type headaches a month get good pain relief from taking paracetamol 1000 mg. There are questions about how studies of this type of headache are conducted. These questions involve the type of people chosen for the studies, and the types of outcomes reported. This limits the usefulness of the results, especially for people who just have an occasional headache."
}
]
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query-laysum | 2027 | [
{
"role": "user",
"content": "Abstract: Background\nNon-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines recommend exercise therapy. Yoga is a mind–body exercise sometimes used for non-specific low back pain.\nObjectives\nTo evaluate the benefits and harms of yoga for treating chronic non-specific low back pain in adults compared to sham yoga, no specific treatment, a minimal intervention (e.g. education), or another active treatment, focusing on pain, function, quality of life, and adverse events.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 31 August 2021 without language or publication status restrictions.\nSelection criteria\nWe included randomized controlled trials of yoga compared to sham yoga, no intervention, any other intervention and yoga added to other therapies.\nData collection and analysis\nWe followed standard Cochrane methods. Our major outcomes were 1. back-specific function, 2. pain, 3. clinical improvement, 4. mental and physical quality of life, 5. depression, and 6. adverse events. Our minor outcome was 1. work disability. We used GRADE to assess certainty of evidence for the major outcomes.\nMain results\nWe included 21 trials (2223 participants) from the USA, India, the UK, Croatia, Germany, Sweden, and Turkey. Participants were recruited from both clinical and community settings. Most were women in their 40s or 50s. Most trials used iyengar, hatha, or viniyoga yoga. Trials compared yoga to a non-exercise control including waiting list, usual care, or education (10 trials); back-focused exercise such as physical therapy (five trials); both exercise and non-exercise controls (four trials); both non-exercise and another mind–body exercise (qigong) (one trial); and yoga plus exercise to exercise alone (one trial). One trial comparing yoga to exercise was an intensive residential one-week program, and we analyzed this trial separately. All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment, and outcomes were self-assessed.\nWe found no trials comparing yoga to sham yoga.\nLow-certainty evidence from 11 trials showed that there may be a small clinically unimportant improvement in back-specific function with yoga (mean difference [MD] −1.69, 95% confidence interval [CI] −2.73 to −0.65 on the 0- to 24-point Roland-Morris Disability Questionnaire [RMDQ], lower = better, minimal clinically important difference [MCID] 5 points; 1155 participants) and moderate-certainty evidence from nine trials showed a clinically unimportant improvement in pain (MD −4.53, 95% CI −6.61 to −2.46 on a 0 to 100 scale, 0 no pain, MCID 15 points; 946 participants) compared to no exercise at three months. Low-certainty evidence from four trials showed that there may be a clinical improvement with yoga (risk ratio [RR] 2.33, 95% CI 1.46 to 3.71; assessed as participant rating that back pain was improved or resolved; 353 participants). Moderate-certainty evidence from six trials showed that there is probably a small improvement in physical and mental quality of life (physical: MD 1.80, 95% CI 0.27 to 3.33 on the 36-item Short Form [SF-36] physical health scale, higher = better; mental: MD 2.38, 95% CI 0.60 to 4.17 on the SF-36 mental health scale, higher = better; both 686 participants). Low-certainty evidence from three trials showed little to no improvement in depression (MD −1.25, 95% CI −2.90 to 0.46 on the Beck Depression Inventory, lower = better; 241 participants). There was low-certainty evidence from eight trials that yoga increased the risk of adverse events, primarily increased back pain, at six to 12 months (RR 4.76, 95% CI 2.08 to 10.89; 43/1000 with yoga and 9/1000 with no exercise; 1037 participants).\nFor yoga compared to back-focused exercise controls (8 trials, 912 participants) at three months, we found moderate-certainty evidence from four trials for little or no difference in back-specific function (MD −0.38, 95% CI −1.33 to 0.62 on the RMDQ, lower = better; 575 participants) and very low-certainty evidence from two trials for little or no difference in pain (MD 2.68, 95% CI −2.01 to 7.36 on a 0 to 100 scale, lower = better; 326 participants). We found very low-certainty evidence from three trials for no difference in clinical improvement assessed as participant rating that back pain was improved or resolved (RR 0.97, 95% CI 0.72 to 1.31; 433 participants) and very low-certainty evidence from one trial for little or no difference in physical and mental quality of life (physical: MD 1.30, 95% CI −0.95 to 3.55 on the SF-36 physical health scale, higher = better; mental: MD 1.90, 95% CI −1.17 to 4.97 on the SF-36 mental health scale, higher = better; both 237 participants). No studies reported depression. Low-certainty evidence from five trials showed that there was little or no difference between yoga and exercise in the risk of adverse events at six to 12 months (RR 0.93, 95% CI 0.56 to 1.53; 84/1000 with yoga and 91/1000 with non-yoga exercise; 640 participants).\nAuthors' conclusions\nThere is low- to moderate-certainty evidence that yoga compared to no exercise results in small and clinically unimportant improvements in back-related function and pain. There is probably little or no difference between yoga and other back-related exercise for back-related function at three months, although it remains uncertain whether there is any difference between yoga and other exercise for pain and quality of life. Yoga is associated with more adverse events than no exercise, but may have the same risk of adverse events as other exercise. In light of these results, decisions to use yoga instead of no exercise or another exercise may depend on availability, cost, and participant or provider preference. Since all studies were unblinded and at high risk of performance and detection bias, it is unlikely that blinded comparisons would find a clinically important benefit.\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": "Because we did not find any trials comparing yoga to sham yoga, we cannot say how yoga would affect low back pain if people did not know they were doing yoga. Participants in all the trials were aware of whether they were practicing yoga or not, and this may have influenced their interpretation of whether their back pain had changed. In addition, some trials were very small, there were few trials in some comparisons, and the trials in some comparisons had inconsistent results. Therefore, we downgraded the quality of the evidence to moderate, low, or very low."
}
]
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query-laysum | 2028 | [
{
"role": "user",
"content": "Abstract: Background\nIn the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens.\nObjectives\nTo evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment.\nSearch methods\nWe searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020.\nSelection criteria\nRandomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods.\nMain results\nThirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision.\nLNG-IUS versus non-intrauterine progestogens\nPrimary outcomes\nRegression of endometrial hyperplasia\nThe LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence),\nAdverse effects associated with LNG-IUS\nThere was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis.\nSecondary outcomes\nThe LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use.\nLNG-IUS versus no treatment\nRegression of endometrial hyperplasia\nOne study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome.\nAuthors' conclusions\nThere is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.\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": "Researchers in Cochrane reviewed the evidence about the effectiveness and safety of the levonorgestrel-intrauterine system (LNG-IUS) compared with other forms of treatment in women with endometrial hyperplasia."
}
]
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query-laysum | 2029 | [
{
"role": "user",
"content": "Abstract: Background\nDeep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors, which have characteristics that may be favourable compared to conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or dose adjustment and few known drug interactions. DOACs are now commonly being used for treating DVT: recent guidelines recommended DOACs over conventional anticoagulants for both DVT and PE treatment. This Cochrane Review was first published in 2015. It was the first systematic review to measure the effectiveness and safety of these drugs in the treatment of DVT. This is an update of the 2015 review.\nObjectives\nTo assess the effectiveness and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of DVT.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 March 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which people with a DVT, confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with conventional anticoagulation or compared with each other for the treatment of DVT.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent venous thromboembolism (VTE), recurrent DVT and PE. Secondary outcomes included all-cause mortality, major bleeding, post-thrombotic syndrome (PTS) and quality of life (QoL). We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe identified 10 new studies with 2950 participants for this update. In total, we included 21 RCTs involving 30,895 participants. Three studies investigated oral DTIs (two dabigatran and one ximelagatran), 17 investigated oral factor Xa inhibitors (eight rivaroxaban, five apixaban and four edoxaban) and one three-arm trial investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban). Overall, the studies were of good methodological quality.\nMeta-analysis comparing DTIs to conventional anticoagulation showed no clear difference in the rate of recurrent VTE (odds ratio (OR) 1.17, 95% confidence interval (CI) 0.83 to 1.65; 3 studies, 5994 participants; moderate-certainty evidence), recurrent DVT (OR 1.11, 95% CI 0.74 to 1.66; 3 studies, 5994 participants; moderate-certainty evidence), fatal PE (OR 1.32, 95% CI 0.29 to 6.02; 3 studies, 5994 participants; moderate-certainty evidence), non-fatal PE (OR 1.29, 95% CI 0.64 to 2.59; 3 studies, 5994 participants; moderate-certainty evidence) or all-cause mortality (OR 0.66, 95% CI 0.41 to 1.08; 1 study, 2489 participants; moderate-certainty evidence). DTIs reduced the rate of major bleeding (OR 0.58, 95% CI 0.38 to 0.89; 3 studies, 5994 participants; high-certainty evidence).\nFor oral factor Xa inhibitors compared with conventional anticoagulation, meta-analysis demonstrated no clear difference in recurrent VTE (OR 0.85, 95% CI 0.71 to 1.01; 13 studies, 17,505 participants; moderate-certainty evidence), recurrent DVT (OR 0.70, 95% CI 0.49 to 1.01; 9 studies, 16,439 participants; moderate-certainty evidence), fatal PE (OR 1.18, 95% CI 0.69 to 2.02; 6 studies, 15,082 participants; moderate-certainty evidence), non-fatal PE (OR 0.93, 95% CI 0.68 to 1.27; 7 studies, 15,166 participants; moderate-certainty evidence) or all-cause mortality (OR 0.87, 95% CI 0.67 to 1.14; 9 studies, 10,770 participants; moderate-certainty evidence). Meta-analysis showed a reduced rate of major bleeding with oral factor Xa inhibitors compared with conventional anticoagulation (OR 0.63, 95% CI 0.45 to 0.89; 17 studies, 18,066 participants; high-certainty evidence).\nAuthors' conclusions\nThe current review suggests that DOACs may be superior to conventional therapy in terms of safety (major bleeding), and are probably equivalent in terms of efficacy. There is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent VTE, recurrent DVT, pulmonary embolism and all-cause mortality. DOACs reduced the rate of major bleeding compared to conventional anticoagulation. The certainty of evidence was moderate or high.\n\nGiven the provided abstract, please respond to the following query: \"What is deep vein thrombosis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Deep vein thrombosis (DVT) is when a blood clot forms, usually in a deep vein of the leg or pelvis. Approximately 1 in 1000 people will develop a DVT. If it is not treated, the clot can travel in the blood and block the blood vessels in the lungs. This life-threatening condition is called a pulmonary embolism. It occurs in approximately 3 to 4 people per 10,000 people. The chances of getting a DVT are increased if you have certain risk factors. These include previous clots, prolonged periods of immobility (such as travelling on aeroplanes or taking bed rest), cancer, exposure to oestrogens (pregnancy, oral contraceptives or hormone replacement therapy), trauma and blood disorders such as thrombophilia (abnormal blood clotting). A DVT is diagnosed by determining the risk factors and performing an ultrasound of the leg veins."
}
]
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query-laysum | 2030 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotic resistance is a worldwide health threat. Interventions that reduce antibiotic prescribing by clinicians are expected to reduce antibiotic resistance. Disparate interventions to change antibiotic prescribing behaviour for acute respiratory infections (ARIs) have been trialled and meta-analysed, but not yet synthesised in an overview. This overview synthesises evidence from systematic reviews, rather than individual trials.\nObjectives\nTo systematically review the existing evidence from systematic reviews on the effects of interventions aimed at influencing clinician antibiotic prescribing behaviour for ARIs in primary care.\nMethods\nWe searched the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), MEDLINE, Embase, CINAHL, PsycINFO, and Science Citation Index to June 2016. We also searched the reference lists of all included reviews. We ran a pre-publication search in May 2017 and placed additional studies in 'awaiting classification'.\nWe included both Cochrane and non-Cochrane reviews of randomised controlled trials evaluating the effect of any clinician-focussed intervention on antibiotic prescribing behaviour in primary care. Two overview authors independently extracted data and assessed the methodological quality of included reviews using the ROBIS tool, with disagreements reached by consensus or by discussion with a third overview author. We used the GRADE system to assess the quality of evidence in included reviews. The results are presented as a narrative overview.\nMain results\nWe included eight reviews in this overview: five Cochrane Reviews (33 included trials) and three non-Cochrane reviews (11 included trials). Three reviews (all Cochrane Reviews) scored low risk across all the ROBIS domains in Phase 2 and low risk of bias overall. The remaining five reviews scored high risk on Domain 4 of Phase 2 because the 'Risk of bias' assessment had not been specifically considered and discussed in the review Results and Conclusions. The trials included in the reviews varied in both size and risk of bias. Interventions were compared to usual care.\nModerate-quality evidence indicated that C-reactive protein (CRP) point-of-care testing (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92, 3284 participants, 6 trials), shared decision making (odds ratio (OR) 0.44, 95% CI 0.26 to 0.75, 3274 participants, 3 trials; RR 0.64, 95% CI 0.49 to 0.84, 4623 participants, 2 trials; risk difference -18.44, 95% CI -27.24 to -9.65, 481,807 participants, 4 trials), and procalcitonin-guided management (adjusted OR 0.10, 95% CI 0.07 to 0.14, 1008 participants, 2 trials) probably reduce antibiotic prescribing in general practice. We found moderate-quality evidence that procalcitonin-guided management probably reduces antibiotic prescribing in emergency departments (adjusted OR 0.34, 95% CI 0.28 to 0.43, 2605 participants, 7 trials). The overall effect of these interventions was small (few achieving greater than 50% reduction in antibiotic prescribing, most about a quarter or less), but likely to be clinically important.\nCompared to usual care, shared decision making probably makes little or no difference to reconsultation for the same illness (RR 0.87, 95% CI 0.74 to 1.03, 1860 participants, 4 trials, moderate-quality evidence), and may make little or no difference to patient satisfaction (RR 0.86, 95% CI 0.57 to 1.30, 1110 participants, 2 trials, low-quality evidence). Similarly, CRP testing probably has little or no effect on patient satisfaction (RR 0.79, 95% CI 0.57 to 1.08, 689 participants, 2 trials, moderate-quality evidence) or reconsultation (RR 1.08, 95% CI 0.93 to 1.27, 5132 participants, 4 trials, moderate-quality evidence). Procalcitonin-guided management probably results in little or no difference in treatment failure in general practice compared to normal care (adjusted OR 0.95, 95% CI 0.73 to 1.24, 1008 participants, 2 trials, moderate-quality evidence), however it probably reduces treatment failure in the emergency department compared to usual care (adjusted OR 0.76, 95% CI 0.61 to 0.95, 2605 participants, 7 trials, moderate-quality evidence).\nThe quality of evidence for interventions focused on clinician educational materials and decision support in reducing antibiotic prescribing in general practice was either low or very low (no pooled result reported) and trial results were highly heterogeneous, therefore we were unable draw conclusions about the effects of these interventions. The use of rapid viral diagnostics in emergency departments may have little or no effect on antibiotic prescribing (RR 0.86, 95% CI 0.61 to 1.22, 891 participants, 3 trials, low-quality evidence) and may result in little to no difference in reconsultation (RR 0.86, 95% CI 0.59 to 1.25, 200 participants, 1 trial, low-quality evidence).\nNone of the trials in the included reviews reported on management costs for the treatment of an ARI or any associated complications.\nAuthors' conclusions\nWe found evidence that CRP testing, shared decision making, and procalcitonin-guided management reduce antibiotic prescribing for patients with ARIs in primary care. These interventions may therefore reduce overall antibiotic consumption and consequently antibiotic resistance. There do not appear to be negative effects of these interventions on the outcomes of patient satisfaction and reconsultation, although there was limited measurement of these outcomes in the trials. This should be rectified in future trials.\nWe could gather no information about the costs of management, and this along with the paucity of measurements meant that it was difficult to weigh the benefits and costs of implementing these interventions in practice.\nMost of this research was undertaken in high-income countries, and it may not generalise to other settings. The quality of evidence for the interventions of educational materials and tools for patients and clinicians was either low or very low, which prevented us from drawing any conclusions. High-quality trials are needed to further investigate these interventions.\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-quality evidence that three types of strategies probably help to reduce antibiotic prescribing in primary care. Strategies that encourage the use of shared decision making between doctors and their patients, C-reactive protein tests, and procalcitonin-guided management (both tests that measure the amount of proteins in the blood, which may be raised in the case of infection) all probably reduce antibiotic prescribing in general practice. Procalcitonin-guided management also probably reduces antibiotic prescribing in emergency departments. These strategies seem to change antibiotic prescribing whilst keeping patients happy with their consultation and ensuring that they did not need to return to their doctor for the same illness. There was no information about the cost of these strategies, so it was difficult to weigh up the benefits and costs.\nThe quality of the evidence for strategies that aim to educate doctors about antibiotic prescribing, that provide decision aids for doctors to help them change their prescribing, and for the use of rapid viral diagnostics in emergency departments was either low or very low, meaning that we were unable to draw firm conclusions about the effects of these strategies.\nIn conclusion, we determined that some strategies aimed at doctors can probably help to reduce antibiotic prescribing in primary care. Further studies are needed for other types of strategies where there is less information about whether they can change prescribing."
}
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query-laysum | 2031 | [
{
"role": "user",
"content": "Abstract: Background\nTibolone is a synthetic steroid used for the treatment of menopausal symptoms, on the basis of short-term data suggesting its efficacy. We considered the balance between the benefits and risks of tibolone.\nObjectives\nTo evaluate the effectiveness and safety of tibolone for treatment of postmenopausal and perimenopausal women.\nSearch methods\nIn October 2015, we searched the Gynaecology and Fertility Group (CGF) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and PsycINFO (from inception), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and clinicaltrials.gov. We checked the reference lists in articles retrieved.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing tibolone versus placebo, oestrogens and/or combined hormone therapy (HT) in postmenopausal and perimenopausal women.\nData collection and analysis\nWe used standard methodological procedures of The Cochrane Collaboration. Primary outcomes were vasomotor symptoms, unscheduled vaginal bleeding and long-term adverse events. We evaluated safety outcomes and bleeding in studies including women either with or without menopausal symptoms.\nMain results\nWe included 46 RCTs (19,976 women). Most RCTs evaluated tibolone for treating menopausal vasomotor symptoms. Some had other objectives, such as assessment of bleeding patterns, endometrial safety, bone health, sexuality and safety in women with a history of breast cancer. Two included women with uterine leiomyoma or lupus erythematosus.\nTibolone versus placebo\nVasomotor symptoms\nTibolone was more effective than placebo (standard mean difference (SMD) -0.99, 95% confidence interval (CI) -1.10 to -0.89; seven RCTs; 1657 women; moderate-quality evidence), but removing trials at high risk of attrition bias attenuated this effect (SMD -0.61, 95% CI -0.73 to -0.49; odds ratio (OR) 0.33, 85% CI 0.27 to 0.41). This suggests that if 67% of women taking placebo experience vasomotor symptoms, between 35% and 45% of women taking tibolone will do so.\nUnscheduled bleeding\nTibolone was associated with greater likelihood of bleeding (OR 2.79, 95% CI 2.10 to 3.70; nine RCTs; 7814 women; I2 = 43%; moderate-quality evidence). This suggests that if 18% of women taking placebo experience unscheduled bleeding, between 31% and 44% of women taking tibolone will do so.\nLong-term adverse events\nMost of the studies reporting these outcomes provided follow-up of two to three years (range three months to three years).\nBreast cancer\nWe found no evidence of differences between groups among women with no history of breast cancer (OR 0.52, 95% CI 0.21 to 1.25; four RCTs; 5500 women; I2= 17%; very low-quality evidence). Among women with a history of breast cancer, tibolone was associated with increased risk (OR 1.5, 95% CI 1.21 to 1.85; two RCTs; 3165 women; moderate-quality evidence).\nCerebrovascular events\nWe found no conclusive evidence of differences between groups in cerebrovascular events (OR 1.74, 95% CI 0.99 to 3.04; four RCTs; 7930 women; I2 = 0%; very low-quality evidence). We obtained most data from a single RCT (n = 4506) of osteoporotic women aged 60 to 85 years, which was stopped prematurely for increased risk of stroke.\nOther outcomes\nEvidence on other outcomes was of low or very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:\n• Endometrial cancer: OR 2.04, 95% CI 0.79 to 5.24; nine RCTs; 8504 women; I2 = 0%.\n• Cardiovascular events: OR 1.38, 95% CI 0.84 to 2.27; four RCTs; 8401 women; I2 = 0%.\n• Venous thromboembolic events: OR 0.85, 95% CI 0.37 to 1.97; 9176 women; I2 = 0%.\n• Mortality from any cause: OR 1.06, 95% CI 0.79 to 1.41; four RCTs; 8242 women; I2 = 0%.\nTibolone versus combined HT\nVasomotor symptoms\nCombined HT was more effective than tibolone (SMD 0.17, 95% CI 0.06 to 0.28; OR 1.36, 95% CI 1.11 to 1.66; nine studies; 1336 women; moderate-quality evidence). This result was robust to a sensitivity analysis that excluded trials with high risk of attrition bias, suggesting a slightly greater disadvantage of tibolone (SMD 0.25, 95% CI 0.09 to 0.41; OR 1.57, 95% CI 1.18 to 2.10). This suggests that if 7% of women taking combined HT experience vasomotor symptoms, between 8% and 14% of women taking tibolone will do so.\nUnscheduled bleeding\nTibolone was associated with a lower rate of bleeding (OR 0.32, 95% CI 0.24 to 0.41; 16 RCTs; 6438 women; I2 = 72%; moderate-quality evidence). This suggests that if 47% of women taking combined HT experience unscheduled bleeding, between 18% and 27% of women taking tibolone will do so.\nLong-term adverse events\nMost studies reporting these outcomes provided follow-up of two to three years (range three months to three years). Evidence was of very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:\n• Endometrial cancer: OR 1.47, 95% CI 0.23 to 9.33; five RCTs; 3689 women; I2 = 0%.\n• Breast cancer: OR 1.69, 95% CI 0.78 to 3.67; five RCTs; 4835 women; I2 = 0%.\n• Venous thromboembolic events: OR 0.44, 95% CI 0.09 to 2.14; four RCTs; 4529 women; I2 = 0%.\n• Cardiovascular events: OR 0.63, 95% CI 0.24 to 1.66; two RCTs; 3794 women; I2 = 0%.\n• Cerebrovascular events: OR 0.76, 95% CI 0.16 to 3.66; four RCTs; 4562 women; I2 = 0%.\n• Mortality from any cause: only one event reported (two RCTs; 970 women).\nAuthors' conclusions\nModerate-quality evidence suggests that tibolone is more effective than placebo but less effective than HT in reducing menopausal vasomotor symptoms, and that tibolone is associated with a higher rate of unscheduled bleeding than placebo but with a lower rate than HT.\nCompared with placebo, tibolone increases recurrent breast cancer rates in women with a history of breast cancer, and may increase stroke rates in women over 60 years of age. No evidence indicates that tibolone increases the risk of other long-term adverse events, or that it differs from HT with respect to long-term safety.\nMuch of the evidence was of low or very low quality. Limitations included high risk of bias and imprecision. Most studies were financed by drug manufacturers or failed to disclose their funding source.\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 46 randomised controlled trials (RCTs), which included 19,976 postmenopausal women. Most studies evaluated tibolone for treatment of menopausal vasomotor symptoms. Some studies reported other objectives: Four RCTs aimed to assess endometrial safety, four bleeding patterns, five bone loss or fracture prevention, one sexual outcomes and three safety in women with a history of breast cancer; two studies examined use of tibolone in women with fibroids or lupus erythematosus. The evidence is current to October 2015."
}
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query-laysum | 2032 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom in people with cancer; 30% to 50% of people with cancer will experience moderate-to-severe pain. This can have a major negative impact on their quality of life. Opioid (morphine-like) medications are commonly used to treat moderate or severe cancer pain, and are recommended for this purpose in the World Health Organization (WHO) pain treatment ladder. Pain is not sufficiently relieved by opioid medications in 10% to 15% of people with cancer. In people with insufficient relief of cancer pain, new analgesics are needed to effectively and safely supplement or replace opioids.\nObjectives\nTo evaluate the benefits and harms of cannabis-based medicines, including medical cannabis, for treating pain and other symptoms in adults with cancer compared to placebo or any other established analgesic for cancer pain.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 26 January 2023.\nSelection criteria\nWe selected double-blind randomised, controlled trials (RCT) of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment for cancer pain in adults, with any treatment duration and at least 10 participants per treatment arm.\nData collection and analysis\nWe used standard Cochrane methods. The primary outcomes were 1. proportions of participants reporting no worse than mild pain; 2. Patient Global Impression of Change (PGIC) of much improved or very much improved and 3. withdrawals due to adverse events. Secondary outcomes were 4. number of participants who reported pain relief of 30% or greater and overall opioid use reduced or stable; 5. number of participants who reported pain relief of 30% or greater, or 50% or greater; 6. pain intensity; 7. sleep problems; 8. depression and anxiety; 9. daily maintenance and breakthrough opioid dosage; 10. dropouts due to lack of efficacy; 11. all central nervous system adverse events. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified 14 studies involving 1823 participants. No study assessed the proportions of participants reporting no worse than mild pain on treatment by 14 days after start of treatment.\nWe found five RCTs assessing oromucosal nabiximols (tetrahydrocannabinol (THC) and cannabidiol (CBD)) or THC alone involving 1539 participants with moderate or severe pain despite opioid therapy. The double-blind periods of the RCTs ranged between two and five weeks. Four studies with a parallel design and 1333 participants were available for meta-analysis.\nThere was moderate-certainty evidence that there was no clinically relevant benefit for proportions of PGIC much or very much improved (risk difference (RD) 0.06, 95% confidence interval (CI) 0.01 to 0.12; number needed to treat for an additional beneficial outcome (NNTB) 16, 95% CI 8 to 100). There was moderate-certainty evidence for no clinically relevant difference in the proportion of withdrawals due to adverse events (RD 0.04, 95% CI 0 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 16 to endless). There was moderate-certainty evidence for no difference between nabiximols or THC and placebo in the frequency of serious adverse events (RD 0.02, 95% CI −0.03 to 0.07). There was moderate-certainty evidence that nabiximols and THC used as add-on treatment for opioid-refractory cancer pain did not differ from placebo in reducing mean pain intensity (standardised mean difference (SMD) −0.19, 95% CI −0.40 to 0.02).\nThere was low-certainty evidence that a synthetic THC analogue (nabilone) delivered over eight weeks was not superior to placebo in reducing pain associated with chemotherapy or radiochemotherapy in people with head and neck cancer and non-small cell lung cancer (2 studies, 89 participants, qualitative analysis). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that synthetic THC analogues were superior to placebo (SMD −0.98, 95% CI −1.36 to −0.60), but not superior to low-dose codeine (SMD 0.03, 95% CI −0.25 to 0.32; 5 single-dose trials; 126 participants) in reducing moderate-to-severe cancer pain after cessation of previous analgesic treatment for three to four and a half hours (2 single-dose trials; 66 participants). Analyses of tolerability and safety were not possible for these studies.\nThere was low-certainty evidence that CBD oil did not add value to specialist palliative care alone in the reduction of pain intensity in people with advanced cancer. There was no difference in the number of dropouts due to adverse events and serious adverse events (1 study, 144 participants, qualitative analysis).\nWe found no studies using herbal cannabis.\nAuthors' conclusions\nThere is moderate-certainty evidence that oromucosal nabiximols and THC are ineffective in relieving moderate-to-severe opioid-refractory cancer pain. There is low-certainty evidence that nabilone is ineffective in reducing pain associated with (radio-) chemotherapy in people with head and neck cancer and non-small cell lung cancer. There is low-certainty evidence that a single dose of synthetic THC analogues is not superior to a single low-dose morphine equivalent in reducing moderate-to-severe cancer pain. There is low-certainty evidence that CBD does not add value to specialist palliative care alone in the reduction of pain in people with advanced cancer.\n\nGiven the provided abstract, please respond to the following query: \"Do medicines based on cannabis help adults with cancer pain?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
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query-laysum | 2033 | [
{
"role": "user",
"content": "Abstract: Background\nChronic inflammatory demyelinating polyradiculoneuropathy (CIDP) causes progressive or relapsing weakness and numbness of the limbs, developing over at least two months. Uncontrolled studies suggest that intravenous immunoglobulin (IVIg) helps. This review was first published in 2002 and has since been updated, most recently in 2013.\nObjectives\nTo review systematically the evidence from randomised controlled trials (RCTs) concerning the efficacy and safety of IVIg in CIDP.\nSearch methods\nOn 4 December 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, issue 11 in the Cochrane Library), MEDLINE and EMBASE to December 2012 and ISI from January 1985 to May 2008. We searched for ongoing trials through two metaRegistries (World Health Organization International Clinical Trials Registry Platform Search Portal and Current Controlled Trials).\nSelection criteria\nWe selected RCTs testing any dose of IVIg versus placebo, plasma exchange or corticosteroids in definite or probable CIDP.\nData collection and analysis\nTwo authors reviewed literature searches to identify potentially relevant RCTs, scored their quality and extracted data independently. We contacted authors for additional information.\nMain results\nWe considered eight RCTs, including 332 participants, to be eligible for inclusion in the review. These trials were homogeneous and the overall risk of bias low. Five studies, in a total of 235 participants compared IVIg against placebo. One trial with 20 participants compared IVIg with plasma exchange, one trial compared IVIg with prednisolone in 32 participants, and one trial, newly included at this update, compared IVIg with intravenous methylprednisolone in 46 participants.\nA significantly higher proportion of participants improved in disability within one month after IVIg treatment as compared with placebo (risk ratio (RR) 2.40, 95% confidence interval (CI) 1.72 to 3.36; number needed to treat for an additional beneficial outcome 3.03 (95% CI 2.33 to 4.55), high quality evidence). Whether all these improvements are equally clinically relevant cannot be deduced from this analysis because each trial used different disability scales and definitions of significant improvement. In three trials, including 84 participants, the disability score could be transformed to the modified Rankin score, on which improvement of one point after IVIg treatment compared to placebo was barely significant (RR 2.40, 95% CI 0.98 to 5.83) (moderate quality evidence). Only one placebo-controlled study included in this review had a long-term follow-up. The results of this study suggest that IVIg improves disability more than placebo over 24 and 48 weeks.\nThe mean disability score revealed no significant difference between IVIg and plasma exchange at six weeks (moderate quality evidence). There was no significant difference in improvement in disability on prednisolone compared with IVIg after two or six weeks, or on methylprednisolone compared to IVIg after two weeks or six months (moderate quality evidence).\nThere were no statistically significant differences in frequencies of side effects between the three types of treatment for which data were available (IVg versus placebo or steroids). (moderate or high quality evidence) Mild and transient adverse events were found in 49% of participants treated with IVIg, while serious adverse events were found in six per cent.\nAuthors' conclusions\nThe evidence from RCTs shows that IVIg improves disability for at least two to six weeks compared with placebo, with an NNTB of three. During this period it has similar efficacy to plasma exchange, oral prednisolone and intravenous methylprednisolone. In one large trial, the benefit of IVIg persisted for 24 and possibly 48 weeks. Further research is needed to compare the long-term benefits as well as side effects of IVIg with other treatments.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eight randomised controlled trials including 332 participants with CIDP were eligible for this review. These compared IVIg with placebo (dummy treatment), plasma exchange, or steroid drugs."
}
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query-laysum | 2034 | [
{
"role": "user",
"content": "Abstract: Background\nMinor oral surgery or dental extractions (oral or dental procedures) are widely performed and can be complicated by hazardous oral bleeding, especially in people with an inherited bleeding disorder such as haemophilia or Von Willebrand disease (VWD). The amount and severity of singular bleedings depend on disease-related factors, such as the severity of the haemophilia, both local and systemic patient factors (such as periodontal inflammation, vasculopathy or platelet dysfunction) and intervention-related factors (such as the type and number of teeth extracted or the dimension of the wound surface). Similar to local haemostatic measures and suturing, antifibrinolytic therapy is a cheap, safe and potentially effective treatment to prevent bleeding complications in individuals with bleeding disorders undergoing oral or dental procedures. However, a systematic review of trials reporting outcomes after oral surgery or a dental procedure in people with an inherited bleeding disorder, with or without, the use of antifibrinolytic agents has not been performed to date. This is an update of a previously published Cochrane Review.\nObjectives\nPrimarily, we aim to assess the efficacy of antifibrinolytic agents to prevent bleeding complications in people with haemophilia or VWD undergoing oral or dental procedures.\nSecondary objectives are to assess if antifibrinolytic agents can replace or reduce the need for clotting factor concentrate therapy in people with haemophilia or VWD and to establish the effects of these agents on bleeding in oral or dental procedures for each of these patient populations.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches of the Cochrane Central Register of Controlled Trials (CENTRAL), of MEDLINE and from handsearching of journals and conference abstract books. We additionally searched the reference lists of relevant articles and reviews. We searched PubMed, Embase, Cinahl and the Cochrane Library. Additional searches were performed in ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP).\nDate of last search of the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register: 01 March 2019.\nSelection criteria\nRandomised and quasi-randomised controlled trials in people with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo.\nData collection and analysis\nTwo authors independently screened the titles and abstracts of all identified articles. Full texts were obtained for potentially relevant abstracts and two authors independently assessed these for inclusion based on the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardised forms.\nMain results\nWhile there were no eligible trials in people with VWD identified, two randomised, double-blind, placebo-controlled trials (total of 59 participants) in people with haemophilia undergoing dental extraction were included. One trial of tranexamic acid published in 1972 included 28 participants with mild, moderate or severe haemophilia A and B and one of EACA published in 1971 included 31 people with haemophilia with factor VIII or factor IX levels less than 15%. Overall, the two included trials showed a beneficial effect of tranexamic acid and EACA, administered systemically, in reducing the number of bleedings, the amount of blood loss and the need for therapeutic clotting factor concentrates. Regarding postoperative bleeding, the tranexamic acid trial showed a risk difference (RD) of -0.64 (95% confidence interval (CI) -0.93 to - 0.36) and the EACA trial a RD of -0.50 (95% CI 0.77 to -0.22). The combined RD of both trials was -0.57 (95% CI -0.76 to -0.37), with the quality of the evidence (GRADE) for this outcome is rated as moderate. Side effects occurred once and required stopping EACA (combined RD of -0.03 (95% CI -0.08 to 0.13). There was heterogeneity between the two trials regarding the proportion of people with severe haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used. We cannot exclude that a selection bias has occurred in the EACA trial, but overall the risk of bias appeared to be low for both trials.\nAuthors' conclusions\nDespite the discovery of a beneficial effect of systemically administered tranexamic acid and EACA in preventing postoperative bleeding in people with haemophilia undergoing dental extraction, the limited number of randomised controlled trials identified, in combination with the small sample sizes and heterogeneity regarding standard therapy and treatment regimens between the two trials, do not allow us to conclude definite efficacy of antifibrinolytic therapy in oral or dental procedures in people with haemophilia. No trials were identified in people with VWD.\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": "In the epsilon aminocaproic acid trial, the trial physicians assigned each person to receive a placebo or the active treatment based on a pair-matching technique for age, factor-assay and the number of extractions. The fact that the trial physicians made this decision may have introduced a selection bias. However, we do not think that this had a major impact on the trial's conclusions. Overall, the two trials were small and differed from each other in terms of how many of the people taking part had severe haemophilia, the simultaneous use of clotting factor concentrates and the different antifibrinolytic treatment schedules. We rated the overall quality of the evidence as low for using antifibrinolytic medicine to prevent bleeding in people with haemophilia after minor oral surgery or dental extractions. No evidence was found for people with Von Willebrand disease. It could however be argued that, if antifibrinolytic medicine works for people with haemophilia, it is likely that the medicine will also work for people with other bleeding disorders undergoing dental extractions or minor oral surgery."
}
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query-laysum | 2035 | [
{
"role": "user",
"content": "Abstract: Background\nProstaglandin E1 (PGE1) is used to keep the ductus arteriosus patent and can be life-saving in neonates with ductal-dependent cardiac lesions. PGE1 is used to promote mixing of pulmonary and systemic blood flow or improve pulmonary or systemic circulations, prior to balloon atrial septostomy or surgery. PGE1 therapy may cause several short-term and long-term adverse effects. The efficacy and safety of PGE1 in neonates with ductal-dependent cardiac lesions has not been systematically reviewed.\nObjectives\nTo determine the efficacy and safety of both short-term (< 120 hours) and long-term (≥120 hours) PGE1 therapy in maintaining patency of the ductus arteriosus and decreasing mortality in ductal-dependent cardiac lesions.\nSearch methods\nWe searched the literature in October 2017, using the search strategy recommended by Cochrane Neonatal. We searched electronic databases (CENTRAL (in the Cochrane Library), MEDLINE, CINAHL, Embase); abstracts of the Pediatric Academic Societies; websites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com; and in the reference list of identified articles.\nSelection criteria\nRandomized or quasi-randomized trials using PGE1 at any dose or duration to maintain ductal patency in term or late preterm (≥ 34 weeks' gestation) infants with ductal-dependent cardiac lesions and which reported effectiveness and safety in the short term or long term.\nData collection and analysis\nWe followed the standard Cochrane methods for conducting a systematic review. Two review authors (SA and MP) independently assessed the titles and abstracts of studies identified by the search strategy to determine eligibility for inclusion. We obtained the full-text version if eligibility could not be done reliably by title and abstract. We resolved any differences by discussion. We designed electronic forms for trial inclusion/exclusion, data extraction, and for requesting additional published information from authors of the original reports.\nMain results\nOur search did not identify any completed or ongoing trials that met our inclusion criteria.\nAuthors' conclusions\nThere is insufficient evidence from randomized controlled trials to determine the safety and efficacy of PGE1 in neonates with ductal-dependent cardiac lesions. Evidence from observational trials have informed clinical practice on the use of PGE, which is now considered the standard of care for ductal-dependent cardiac lesions. It is unlikely that randomized controlled studies will be performed for this indication but comparative efficacy of newer formulations of PGE1, different doses of PGE1 and studies comparing PGE with PDA stents or other measures to keep the ductus open may be ethical and necessary.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched the literature for studies that used chance selection (randomization) that used PGE1 in neonates born at greater than 34 weeks of gestation to keep the ductus arteriosus open in newborn heart conditions and which reported on effectiveness and safety."
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query-laysum | 2036 | [
{
"role": "user",
"content": "Abstract: Background\nChest X-ray (CXR) is a longstanding method for the diagnosis of pneumothorax but chest ultrasonography (CUS) may be a safer, more rapid, and more accurate modality in trauma patients at the bedside that does not expose the patient to ionizing radiation. This may lead to improved and expedited management of traumatic pneumothorax and improved patient safety and clinical outcomes.\nObjectives\nTo compare the diagnostic accuracy of chest ultrasonography (CUS) by frontline non-radiologist physicians versus chest X-ray (CXR) for diagnosis of pneumothorax in trauma patients in the emergency department (ED).\nTo investigate the effects of potential sources of heterogeneity such as type of CUS operator (frontline non-radiologist physicians), type of trauma (blunt vs penetrating), and type of US probe on test accuracy.\nSearch methods\nWe conducted a comprehensive search of the following electronic databases from database inception to 10 April 2020: Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus, Database of Abstracts of Reviews of Effects, Web of Science Core Collection and Clinicaltrials.gov. We handsearched reference lists of included articles and reviews retrieved via electronic searching; and we carried out forward citation searching of relevant articles in Google Scholar and looked at the \"Related articles\" on PubMed.\nSelection criteria\nWe included prospective, paired comparative accuracy studies comparing CUS performed by frontline non-radiologist physicians to supine CXR in trauma patients in the emergency department (ED) suspected of having pneumothorax, and with computed tomography (CT) of the chest or tube thoracostomy as the reference standard.\nData collection and analysis\nTwo review authors independently extracted data from each included study using a data extraction form. We included studies using patients as the unit of analysis in the main analysis and we included those using lung fields in the secondary analysis. We performed meta-analyses by using a bivariate model to estimate and compare summary sensitivities and specificities.\nMain results\nWe included 13 studies of which nine (410 traumatic pneumothorax patients out of 1271 patients) used patients as the unit of analysis; we thus included them in the primary analysis. The remaining four studies used lung field as the unit of analysis and we included them in the secondary analysis. We judged all studies to be at high or unclear risk of bias in one or more domains, with most studies (11/13, 85%) being judged at high or unclear risk of bias in the patient selection domain. There was substantial heterogeneity in the sensitivity of supine CXR amongst the included studies.\nIn the primary analysis, the summary sensitivity and specificity of CUS were 0.91 (95% confidence interval (CI) 0.85 to 0.94) and 0.99 (95% CI 0.97 to 1.00); and the summary sensitivity and specificity of supine CXR were 0.47 (95% CI 0.31 to 0.63) and 1.00 (95% CI 0.97 to 1.00). There was a significant difference in the sensitivity of CUS compared to CXR with an absolute difference in sensitivity of 0.44 (95% CI 0.27 to 0.61; P < 0.001). In contrast, CUS and CXR had similar specificities: comparing CUS to CXR, the absolute difference in specificity was −0.007 (95% CI −0.018 to 0.005, P = 0.35). The findings imply that in a hypothetical cohort of 100 patients if 30 patients have traumatic pneumothorax (i.e. prevalence of 30%), CUS would miss 3 (95% CI 2 to 4) cases (false negatives) and overdiagnose 1 (95% CI 0 to 2) of those without pneumothorax (false positives); while CXR would miss 16 (95% CI 11 to 21) cases with 0 (95% CI 0 to 2) overdiagnosis of those who do not have pneumothorax.\nAuthors' conclusions\nThe diagnostic accuracy of CUS performed by frontline non-radiologist physicians for the diagnosis of pneumothorax in ED trauma patients is superior to supine CXR, independent of the type of trauma, type of CUS operator, or type of CUS probe used. These findings suggest that CUS for the diagnosis of traumatic pneumothorax could be incorporated into trauma protocols and algorithms in future medical training programmes. In addition, CUS may beneficially change routine management of trauma\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The numbers shown in the results are averages across all studies in the review. While CUS results were fairly consistent, CXR results were quite varied; thus, we cannot be sure that CXR will always produce the same results. In the included studies, the diagnosis of traumatic pneumothorax was confirmed by CT or tube thoracostomy. Although there were some problems with how some of the studies were conducted, their results did not differ from the more reliable studies."
}
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query-laysum | 2037 | [
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is an inflammatory bowel disease that causes inflammation and stricture, of any part of the mucosa and the gut wall. It forms skip lesions, sparing the areas in between the affected parts of the gastrointestinal tract. Crohn's disease could have one of three complications; fistula, intestinal obstruction due to stricture, or gastrointestinal inflammation presenting as severe diarrhoea.\nStem cell therapy (SCT) is an innovative treatment that has been recently used in CD. The exact role of SCT in CD is still unclear. Stem cells modify the immunity of the patients or act as a “reset tool” for the immune system as in the case of systemically-injected stem cells, or regenerate the affected area of necrotic and inflammatory tissue as in the case of local injection into the lesion. Stem cells are a wide variety of cells including pluripotent stem cells or differentiated stem cells. The hazards range from rejection to symptomatic manifestations as fever or increase infection.\nObjectives\nThe objective of this Cochrane systematic review is to assess the effects of stem cell transplantation compared to standard of care alone or with placebo on efficacy and safety outcomes in patients with refractory CD.\nSearch methods\nWe searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and clinical trial registries (Clinicaltrials.gov, World Health Organization-International Clinical Trials Registry Platform WHO ICTRP) from inception to 19 March 2021, without any language, publication year, or publication status restrictions. In addition, we searched references of included studies and review articles for further references. An update of the published studies was done during the writing of the review.\nSelection criteria\nWe included only randomised controlled trials (RCTs) that assessed the effectiveness and safety of SCT in refractory CD versus standard care alone (control) or with placebo.\nData collection and analysis\nTwo review authors (SEN and SFA) independently screened the studies retrieved from the search results for inclusion, extracted data and assessed the risk of bias. Any disagreement was resolved through a consensus between the authors. We used standard methodological procedures expected by Cochrane.\nMain results\nWe conducted our search on 19 March 2021 and identified 639 records. We added two records by a manual search of the published reviews on the topic to a total of 641 records. The Covidence program removed 125 duplicates making a total of 516 reports. Two review authors (SEN and SFA) screened titles and abstracts and excluded 451 records with the remaining 65 for full-text records screened independently by the two authors; only 18 studies were considered for inclusion.\nWe included seven RCTs with a total of 442 participants for the meta-analysis. The intervention group included 234 patients, and the control group included 208 patients. Nine trials are ongoing and, two abstracts are awaiting classification.\nAll patients in the control and intervention groups received the standard therapy for CD. Only three studies used blinding methods for the control group in the form of a placebo, with one study of the three stated that the blinding method was inefficient. The patients and personnel were aware of the intervention in the rest of the four studies as they were open-label trials. However, the effect of unblinding was balanced by the low risk of detection bias in five of the included studies.\nThe evidence is uncertain about the effect of SCT on achieving clinical remission as compared to control/placebo (risk ratio (RR) 1.88, 95% Confidence Interval (CI) 0.80 to 4.41; 3 studies; low-certainty evidence).\nThe evidence is very uncertain about the effect of SCT on achieving Crohn’s Disease Activity Index (CDAI) <150 at 24 weeks compared to control (RR1.02 95% CI 0.67 to 1.56; 4 studies; very-low certainty evidence).\nSCT is likely to achieve fistula closure as compared to the control/placebo both in the short term (RR 1.48, 95% CI 1.12 to 1.96); low-certainty evidence) and in the long term (RR 1.42, 95% CI 1.09 to 1.87; 4 studies; low-certainty evidence) follow-up.\nThe evidence is very uncertain about the effect of SCT to cause no difference in the number of total adverse events as compared to the control/placebo (RR 0.99, 95% CI [0.88 to 1.13); 4 studies; very-low-certainty evidence). However, SCT is likely to increase the number of serious adverse events as compared to the control/placebo (RR 1.22, 95% CI 0.88 to 1.67; 7 studies; low-certainty evidence).\nThe evidence is very uncertain about the effect of SCT to decrease the withdrawal due to adverse events as compared to the control/placebo (RR 0.78, 95% CI 0.32 to 1.89; 3 studies; very-low certainty evidence).\nFunding by pharmaceutical companies was found in three studies, with one including more than 50% of our studied population.\nAuthors' conclusions\nSCT shows an uncertain effect on clinical remission with low certainty of evidence. SCT shows an uncertain effect on CDAI score to reach <150 after 24 weeks of treatment, with very low certainty evidence. SCT shows beneficial effects on fistula-closure during short and long-term follow-up with low-certainty evidence in both outcomes. There was no change in the total number of adverse events with SCT as compared to control, with very low certainty evidence. While there was a moderate effect on increasing the number of serious adverse events in the SCT group, as compared to the control with low-certainty evidence. Withdrawal due to adverse events was slightly higher in the control group with very low certainty evidence.\nAll the participants were refractory to standard medical treatment, but the number of participants was small, this may limit the generalizability of the results. Further research is needed for validation. More objective outcomes are needed in the assessment of stem cell effectiveness in the treatment of Crohn's disease, especially the intestinal CD subtype; with standardization of the dose, methods of stem cell preparation, route of administration, and inclusion criteria to the studies to achieve clear results.\n\nGiven the provided abstract, please respond to the following query: \"What are our main results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In patients who did not respond to standard medical treatment for CD, we found that: when using SCs combined with medical treatment compared to medical treatment alone or with placebo, it is unclear whether they cause an achievement of improvement in the clinical remission, or in the clinical score CDAI to <150 after 24 weeks. SCs combined with medical treatment, when compared to the standard medical treatment, are likely to lead to improvement in the rate of fistula closure in both the short and long term. SCs combined with medical treatment, when compared to the standard medical treatment, are less likely to change the number of total adverse events. SCs combined with medical treatment, when compared to the standard medical treatment, are more probable to increase the number of occurrences of serious adverse events, but are less likely to decrease the number of patients who withdrew due to adverse events."
}
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query-laysum | 2038 | [
{
"role": "user",
"content": "Abstract: Background\nSystem change interventions for smoking cessation are policies and practices designed by organizations to integrate the identification of smokers and the subsequent offering of evidence-based nicotine dependence treatments into usual care. Such strategies have the potential to improve the provision of smoking cessation support in healthcare settings, and cessation outcomes among those who use them.\nObjectives\nTo assess the effectiveness of system change interventions within healthcare settings, for increasing smoking cessation or the provision of smoking cessation care, or both.\nSearch methods\nWe searched databases including the Cochrane Tobacco Addiction Group Specialized Register, CENTRAL, MEDLINE, Embase, CINAHL, and PsycINFO in February 2016. We also searched clinical trial registries: WHO clinical trial registry, US National Institute of Health (NIH) clinical trial registry. We checked ‘grey' literature, and handsearched bibliographies of relevant papers and publications.\nSelection criteria\nRandomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs and interrupted time series studies that evaluated a system change intervention, which included identification of all smokers and subsequent offering of evidence-based nicotine dependence treatment.\nData collection and analysis\nUsing a standardized form, we extracted data from eligible studies on study settings, participants, interventions and outcomes of interest (both cessation and system-level outcomes). For cessation outcomes, we used the strictest available criteria to define abstinence. System-level outcomes included assessment and documentation of smoking status, provision of advice to quit or cessation counselling, referral and enrolment in quitline services, and prescribing of cessation medications. We assessed risks of bias according to the Cochrane Handbook and categorized each study as being at high, low or unclear risk of bias. We used a narrative synthesis to describe the effectiveness of the interventions on various outcomes, because of significant heterogeneity among studies.\nMain results\nWe included seven cluster-randomized controlled studies in this review. We rated the quality of evidence as very low or low, depending on the outcome, according to the GRADE standard. Evidence of efficacy was equivocal for abstinence from smoking at the longest follow-up (four studies), and for the secondary outcome ‘prescribing of smoking cessation medications' (two studies). Four studies evaluated changes in provision of smoking cessation counselling and three favoured the intervention. There were significant improvements in documentation of smoking status (one study), quitline referral (two studies) and quitline enrolment (two studies). Other secondary endpoints, such as asking about tobacco use (three studies) and advising to quit (three studies), also indicated some positive effects.\nAuthors' conclusions\nThe available evidence suggests that system change interventions for smoking cessation may not be effective in achieving increased cessation rates, but have been shown to improve process outcomes, such as documentation of smoking status, provision of cessation counselling and referral to smoking cessation services. However, as the available research is limited we are not able to draw strong conclusions. There is a need for additional high-quality research to explore the impact of system change interventions on both cessation and system-level outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Smoking is a cause of many health problems, including cancers, heart and lung diseases. Health professionals (e.g. doctors, nurses, pharmacists, dentists, etc.) may be able to reduce this harm by helping smokers to quit during a clinic visit. However, it may be difficult for health care providers to recognize smokers. They may also feel they cannot deliver good support as they do not have enough time, skills, training, budget or resources. A change within health professionals' wider organization may help to improve their involvement in care to help people to stop smoking, and in turn improve the chances of them quitting smoking. These changes may include introducing a system for asking patients if they smoke and recording smoking status on the patient health records; providing health care providers with training, budget or resources to help them deliver more effective quitting support; identifying a dedicated staff member to provide quitting support; introducing new rules to restrict smoking or support quitting activities; introducing advice to quit smoking into routine care; and paying health workers for delivering cessation support. This review aimed to find out whether implementing these organizational changes improves health professionals’ involvement in quit smoking activities, and whether it helps smokers stop smoking. We assessed the following activities by health professionals to evaluate their involvement in quit smoking activities: 1) asking about tobacco use; 2) documenting smoking status on patient health records; 3) advising smokers to quit; 4) counselling to quit; 5) providing medicines to quit smoking; and 6) referring to other centers such as quitlines (a telephone support service for smokers to quit) where smokers can obtain further help."
}
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query-laysum | 2039 | [
{
"role": "user",
"content": "Abstract: Background\nUrgent-start peritoneal dialysis (PD), defined as initiation of PD within two weeks of catheter insertion, has been emerging as an alternative mode of dialysis initiation for patients with chronic kidney disease (CKD) requiring urgent dialysis without established permanent dialysis access. Recently, several small studies have reported comparable patient outcomes between urgent-start and conventional-start PD.\nObjectives\nTo examine the benefits and harms of urgent-start PD compared with conventional-start PD in adults and children with CKD requiring long-term kidney replacement therapy.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 25 May 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nFor non-randomised controlled trials, MEDLINE (OVID) (1946 to 27 June 2019), EMBASE (OVID) (1980 to 27 June 2019), Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov (up to 27 June 2019) were searched.\nSelection criteria\nAll randomised controlled trials (RCTs) and non-RCTs comparing the outcomes of urgent-start PD (within 2 weeks of catheter insertion) and conventional-start PD ( ≥ 2 weeks of catheter insertion) treatment in children and adults CKD patients requiring long-term dialysis were included. Studies without a control group were excluded.\nData collection and analysis\nData were extracted and quality of studies were examined by two independent authors. The authors contacted investigators for additional information. Summary estimates of effect were examined using random-effects model and results were presented as risk ratios (RR) with 95% confidence intervals (CI) as appropriate for the data. The certainty of evidence for individual outcome was assessed using the GRADE approach.\nMain results\nA total of 16 studies (2953 participants) were included in this review, which included one multicentre RCT (122 participants) and 15 non-RCTs (2831 participants): 13 cohort studies (2671 participants) and 2 case-control studies (160 participants). The review included unadjusted data for analyses due to paucity of studies reporting adjusted data.\nIn low certainty evidence, urgent-start PD may increase dialysate leak (1 RCT, 122 participants: RR 3.90, 95% CI 1.56 to 9.78) compared with conventional-start PD which translated into an absolute number of 210 more leaks per 1000 (95% CI 40 to 635).\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases catheter blockage (4 cohort studies, 1214 participants: RR 1.33, 95% CI 0.40 to 4.43; 2 case-control studies, 160 participants: RR 1.89, 95% CI 0.58 to 6.13), catheter malposition (6 cohort studies, 1353 participants: RR 1.63, 95% CI 0.80 to 3.32; 1 case-control study, 104 participants: RR 3.00, 95% CI 0.64 to 13.96), and PD dialysate flow problems (3 cohort studies, 937 participants: RR 1.44, 95% CI 0.34 to 6.14) compared to conventional-start PD.\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases exit-site infection (2 cohort studies, 337 participants: RR 1.43, 95% CI 0.24 to 8.61; 1 case-control study, 104 participants RR 1.20, 95% CI 0.41 to 3.50), exit-site bleeding (1 RCT, 122 participants: RR 0.70, 95% CI 0.03 to 16.81; 1 cohort study, 27 participants: RR 1.58, 95% CI 0.07 to 35.32), peritonitis (7 cohort studies, 1497 participants: RR 1.00, 95% CI 0.68 to 1.46; 2 case-control studies, 160 participants: RR 1.09, 95% CI 0.12 to 9.51), catheter readjustment (2 cohort studies, 739 participants: RR 1.27, 95% CI 0.40 to 4.02), or reduces technique survival (1 RCT, 122 participants: RR 1.09, 95% CI 1.00 to 1.20; 8 cohort studies, 1668 participants: RR 0.90, 95% CI 0.76 to 1.07; 2 case-control studies, 160 participants: RR 0.92, 95% CI 0.79 to 1.06).\nIn very low certainty evidence, it is uncertain whether urgent-start PD compared with conventional-start PD increased death (any cause) (1 RCT, 122 participants: RR 1.49, 95% CI 0.87 to 2.53; 7 cohort studies, 1509 participants: RR 1.89, 95% CI 1.07 to 3.3; 1 case-control study, 104 participants: RR 0.90, 95% CI 0.27 to 3.02; very low certainty evidence). None of the included studies reported on tunnel tract infection.\nAuthors' conclusions\nIn patients with CKD who require dialysis urgently without ready-to-use dialysis access in place, urgent-start PD may increase the risk of dialysate leak and has uncertain effects on catheter blockage, malposition or readjustment, PD dialysate flow problems, infectious complications, exit-site bleeding, technique survival, and patient survival compared with conventional-start PD.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In patients with chronic kidney disease who require dialysis urgently without ready-to-use dialysis access in place, peritoneal dialysis may increase dialysate leak. However, the overall risks of infectious and other non-infectious complications between urgent-start peritoneal dialysis and conventional-start peritoneal dialysis remains unclear."
}
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query-laysum | 2040 | [
{
"role": "user",
"content": "Abstract: Background\nA significant number of patients who suffer with anxiety and related disorders (that is post-traumatic stress disorder (PTSD), social anxiety disorder (SAnD), panic disorder with or without agoraphobia (PD), specific phobia (SPh) and obsessive compulsive disorder (OCD)) fail to respond optimally to first-line treatment with medication or cognitive and behavioural therapies. The addition of d-cycloserine (DCS) to cognitive and behavioural therapies may improve treatment response by impacting the glutamatergic system. This systematic review aimed to investigate the effects of adding DCS to cognitive and behavioural therapies by synthesising data from relevant randomised controlled trials and following the guidelines recommended by Cochrane.\nObjectives\nTo assess the effect of DCS augmentation of cognitive and behavioural therapies compared to placebo augmentation of cognitive and behavioural therapies in the treatment of anxiety and related disorders. Additionally, to assess the efficacy and tolerability of DCS across different anxiety and related disorders.\nSearch methods\nThis review fully incorporates studies identified from a search of the Cochrane Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR) to 12 March 2015. This register includes relevant randomised controlled trials (RCTs) from: the Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date), PsycINFO (1967 to date), the World Health Organization’s trials portal (ICTRP) and ClinicalTrials.gov . Reference lists from previous meta-analyses and reports of RCTs were also checked. No restrictions were placed on language, setting, date or publication status.\nSelection criteria\nAll RCTs of DCS augmentation of cognitive and behavioural therapies versus placebo augmentation of cognitive and behavioural therapies for anxiety and related disorders were included.\nData collection and analysis\nTwo authors (RO and TA) independently assessed RCTs for eligibility and inclusion, extracted outcomes and risk of bias data and entered these into a customised extraction form. Investigators were contacted to obtain missing data. In addition, data entry and analysis were performed by two review authors (KSW and HB).\nMain results\nTwenty-one published RCTs, with 788 participants in outpatient settings, were included in the review. Sixteen studies had an age range of 18 to 75 years, while four investigated paediatric populations aged 8 to 17 years and one included children, adolescents and adults. The 21 RCTs investigated OCD (number of RCTs (N) = 6), PTSD (N = 5), SAnD (N = 5), SPh (N = 3) and PD (N = 2). Most information from the studies was rated as having either low risk or unclear risk of bias.\nThere was no evidence of a difference between DCS augmentation of cognitive and behavioural therapies and placebo augmentation of cognitive and behavioural therapies for the treatment of anxiety and related disorders in adults at the endpoint (treatment responders, N = 9, risk ratio (RR) 1.10; 95% confidence interval (CI) 0.89 to 1.34; number of participants (n) = 449; low quality evidence) and between 1 and 12 months follow-up (N = 7, RR 1.08; 95% CI 0.90 to 1.31; n = 383). DCS augmentation of cognitive and behavioural therapies was not superior to placebo augmentation of cognitive and behavioural therapies for children and adolescents, both at the endpoint (N = 4, RR 1.01; 95% CI 0.78 to 1.31; n = 121; low quality evidence) and between 3 and 12 months follow-up (N = 3, RR 0.86; 95% CI 0.67 to 1.09; n = 91).\nThere was no evidence of a difference in treatment acceptability for DCS augmentation of cognitive and behavioural therapies compared with placebo augmentation of cognitive and behavioural therapies in adults (N = 16, RR 0.88; 95% CI 0.61 to 1.25; n = 740), nor in children and adolescents (N = 4, RR 0.90; 95% CI 0.17 to 4.69; n = 131). These conclusions were based on moderate quality evidence for adults, and very low quality evidence for children and adolescents. Although the observed difference was small, it is noteworthy that there was a high efficacy of exposure-based therapies alone in the included trials. Due to the limited number of studies, subgroup analysis of moderating factors for clinical and methodological effect could not take place.\nAuthors' conclusions\nThis review found no evidence of a difference between DCS augmentation of cognitive and behavioural therapies and placebo augmentation of cognitive and behavioural therapies for treating anxiety and related disorders in children, adolescents and adults. These findings are based on low quality evidence from heterogenous studies with small sample sizes and incomplete data for clinical response, which precludes us from drawing conclusions on the use of DCS augmentation of cognitive and behavioural therapies at this stage. Given there is some promising preliminary data from individual studies, further research is necessary to assess DCS compared with placebo augmentation of cognitive and behavioural therapies, and determine mechanisms of action as well as magnitude of effect in anxiety and related disorders.\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": "Many people suffer from anxiety and related disorders (post-traumatic stress disorder, social anxiety disorder, panic disorder with or without agoraphobia, specific phobia and obsessive compulsive disorder). These disorders are disabling and can affect a person’s ability to function well at work and in social situations. Current treatment options include talking therapies such as cognitive and behavioural therapies. Many patients, however, do not respond as well as hoped to these treatments. Using cognitive and behavioural therapies in combination with certain medicines, for example d-cycloserine (DCS), is one option that may improve treatment response. In this review we examined the evidence for DCS combined with cognitive behavioural therapies as a treatment for anxiety and related disorders in children, adolescents and adults."
}
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query-laysum | 2041 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane Review published in the Cochrane Library 2013, Issue 9. Despite good evidence for the health benefits of regular exercise for people living with or beyond cancer, understanding how to promote sustainable exercise behaviour change in sedentary cancer survivors, particularly over the long term, is not as well understood. A large majority of people living with or recovering from cancer do not meet current exercise recommendations. Hence, reviewing the evidence on how to promote and sustain exercise behaviour is important for understanding the most effective strategies to ensure benefit in the patient population and identify research gaps.\nObjectives\nTo assess the effects of interventions designed to promote exercise behaviour in sedentary people living with and beyond cancer and to address the following secondary questions: Which interventions are most effective in improving aerobic fitness and skeletal muscle strength and endurance? Which interventions are most effective in improving exercise behaviour amongst patients with different cancers? Which interventions are most likely to promote long-term (12 months or longer) exercise behaviour? What frequency of contact with exercise professionals and/or healthcare professionals is associated with increased exercise behaviour? What theoretical basis is most often associated with better behavioural outcomes? What behaviour change techniques (BCTs) are most often associated with increased exercise behaviour? What adverse effects are attributed to different exercise interventions?\nSearch methods\nWe used standard methodological procedures expected by Cochrane. We updated our 2013 Cochrane systematic review by updating the searches of the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, Embase, AMED, CINAHL, PsycLIT/PsycINFO, SportDiscus and PEDro up to May 2018. We also searched the grey literature, trial registries, wrote to leading experts in the field and searched reference lists of included studies and other related recent systematic reviews.\nSelection criteria\nWe included only randomised controlled trials (RCTs) that compared an exercise intervention with usual care or 'waiting list' control in sedentary people over the age of 18 with a homogenous primary cancer diagnosis.\nData collection and analysis\nIn the update, review authors independently screened all titles and abstracts to identify studies that might meet the inclusion criteria, or that could not be safely excluded without assessment of the full text (e.g. when no abstract is available). We extracted data from all eligible papers with at least two members of the author team working independently (RT, LS and RG). We coded BCTs according to the CALO-RE taxonomy. Risk of bias was assessed using the Cochrane's tool for assessing risk of bias. When possible, and if appropriate, we performed a fixed-effect meta-analysis of study outcomes. If statistical heterogeneity was noted, a meta-analysis was performed using a random-effects model. For continuous outcomes (e.g. cardiorespiratory fitness), we extracted the final value, the standard deviation (SD) of the outcome of interest and the number of participants assessed at follow-up in each treatment arm, to estimate the standardised mean difference (SMD) between treatment arms. SMD was used, as investigators used heterogeneous methods to assess individual outcomes. If a meta-analysis was not possible or was not appropriate, we narratively synthesised studies. The quality of the evidence was assessed using the GRADE approach with the GRADE profiler.\nMain results\nWe included 23 studies in this review, involving a total of 1372 participants (an addition of 10 studies, 724 participants from the original review); 227 full texts were screened in the update and 377 full texts were screened in the original review leaving 35 publications from a total of 23 unique studies included in the review. We planned to include all cancers, but only studies involving breast, prostate, colorectal and lung cancer met the inclusion criteria. Thirteen studies incorporated a target level of exercise that could meet current recommendations for moderate-intensity aerobic exercise (i.e.150 minutes per week); or resistance exercise (i.e. strength training exercises at least two days per week).\nAdherence to exercise interventions, which is crucial for understanding treatment dose, is still reported inconsistently. Eight studies reported intervention adherence of 75% or greater to an exercise prescription that met current guidelines. These studies all included a component of supervision: in our analysis of BCTs we designated these studies as 'Tier 1 trials'. Six studies reported intervention adherence of 75% or greater to an aerobic exercise goal that was less than the current guideline recommendations: in our analysis of BCTs we designated these studies as 'Tier 2 trials.' A hierarchy of BCTs was developed for Tier 1 and Tier 2 trials, with programme goal setting, setting of graded tasks and instruction of how to perform behaviour being amongst the most frequent BCTs. Despite the uncertainty surrounding adherence in some of the included studies, interventions resulted in improvements in aerobic exercise tolerance at eight to 12 weeks (SMD 0.54, 95% CI 0.37 to 0.70; 604 participants, 10 studies; low-quality evidence) versus usual care. At six months, aerobic exercise tolerance was also improved (SMD 0.56, 95% CI 0.39 to 0.72; 591 participants; 7 studies; low-quality evidence).\nAuthors' conclusions\nSince the last version of this review, none of the new relevant studies have provided additional information to change the conclusions. We have found some improved understanding of how to encourage previously inactive cancer survivors to achieve international physical activity guidelines. Goal setting, setting of graded tasks and instruction of how to perform behaviour, feature in interventions that meet recommendations targets and report adherence of 75% or more. However, long-term follow-up data are still limited, and the majority of studies are in white women with breast cancer. There are still a considerable number of published studies with numerous and varied issues related to high risk of bias and poor reporting standards. Additionally, the meta-analyses were often graded as consisting of low- to very low-certainty evidence. A very small number of serious adverse effects were reported amongst the studies, providing reassurance exercise is safe for this population.\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 main conclusions from this review are that exercise is generally safe for cancer survivors. We have a better understanding of how to encourage cancer survivors to meet current exercise recommendations. However, there is still a lack of evidence of how to encourage exercise in cancer survivors over six months."
}
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query-laysum | 2042 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD, including bronchitis and emphysema) is a chronic condition causing shortness of breath, cough, and exacerbations leading to poor health outcomes. Face-to-face visits with health professionals can be hindered by severity of COPD or frailty, and by people living at a distance from their healthcare provider and having limited access to services. Telehealth technologies aimed at providing health care remotely through monitoring and consultations could help to improve health outcomes of people with COPD.\nObjectives\nTo assess the effectiveness of telehealth interventions that allow remote monitoring and consultation and multi-component interventions for reducing exacerbations and improving quality of life, while reducing dyspnoea symptoms, hospital service utilisation, and death among people with COPD.\nSearch methods\nWe identified studies from the Cochrane Airways Trials Register. Additional sources searched included the US National Institutes of Health Ongoing Trials Register, the World Health Organization International Clinical Trials Registry Platform, and the IEEEX Xplore Digital Library. The latest search was conducted in April 2020. We used the GRADE approach to judge the certainty of evidence for outcomes.\nSelection criteria\nEligible randomised controlled trials (RCTs) included adults with diagnosed COPD. Asthma, cystic fibrosis, bronchiectasis, and other respiratory conditions were excluded. Interventions included remote monitoring or consultation plus usual care, remote monitoring or consultation alone, and mult-component interventions from all care settings. Quality of life scales included St George's Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT). The dyspnoea symptom scale used was the Chronic Respiratory Disease Questionnaire Self-Administered Standardized Scale (CRQ-SAS).\nData collection and analysis\nWe used standard Cochrane methodological procedures. We assessed confidence in the evidence for each primary outcome using the GRADE method. Primary outcomes were exacerbations, quality of life, dyspnoea symptoms, hospital service utilisation, and mortality; a secondary outcome consisted of adverse events.\nMain results\nWe included 29 studies in the review (5654 participants; male proportion 36% to 96%; female proportion 4% to 61%). Most remote monitoring interventions required participants to transfer measurements using a remote device and later health professional review (asynchronous). Only five interventions transferred data and allowed review by health professionals in real time (synchronous). Studies were at high risk of bias due to lack of blinding, and certainty of evidence ranged from moderate to very low. We found no evidence on comparison of remote consultations with or without usual care.\nRemote monitoring plus usual care (8 studies, 1033 participants)\nVery uncertain evidence suggests that remote monitoring plus usual care may have little to no effect on the number of people experiencing exacerbations at 26 weeks or 52 weeks. There may be little to no difference in effect on quality of life (SGRQ) at 26 weeks (very low to low certainty) or on hospitalisation (all-cause or COPD-related; very low certainty). COPD-related hospital re-admissions are probably reduced at 26 weeks (hazard ratio 0.42, 95% confidence interval (CI) 0.19 to 0.93; 106 participants; moderate certainty). There may be little to no difference in deaths between intervention and usual care (very low certainty). We found no evidence for dyspnoea symptoms or adverse events.\nRemote monitoring alone (10 studies, 2456 participants)\nVery uncertain evidence suggests that remote monitoring may result in little to no effect on the number of people experiencing exacerbations at 41 weeks (odds ratio 1.02, 95% CI 0.67 to 1.55). There may be little to no effect on quality of life (SGRQ total at 17 weeks, or CAT at 38 and 52 weeks; very low certainty). There may be little to no effect on dyspnoea symptoms on the CRQ-SAS at 26 weeks (low certainty). There may be no difference in effects on the number of people admitted to hospital (very low certainty) or on deaths (very low certainty). We found no evidence for adverse events.\nMulti-component interventions with remote monitoring or consultation component (11 studies, 2165 participants)\nVery uncertain evidence suggests that multi-component interventions may have little to no effect on the number of people experiencing exacerbations at 52 weeks. Quality of life at 13 weeks may improve as seen in SGRQ total score (mean difference -9.70, 95% CI -18.32 to -1.08; 38 participants; low certainty) but not at 26 or 52 weeks (very low certainty). COPD assessment test (CAT) scores may improve at a mean of 38 weeks, but evidence is very uncertain and interventions are varied.\nThere may be little to no effect on the number of people admitted to hospital at 33 weeks (low certainty). Multi-component interventions are likely to result in fewer people re-admitted to hospital at a mean of 39 weeks (OR 0.50, 95% CI 0.31 to 0.81; 344 participants, 3 studies; moderate certainty). There may be little to no difference in death at a mean of 40 weeks (very low certainty). There may be little to no effect on people experiencing adverse events (very low certainty). We found no evidence for dyspnoea symptoms.\nAuthors' conclusions\nRemote monitoring plus usual care provided asynchronously may not be beneficial overall compared to usual care alone. Some benefit is seen in reduction of COPD-related hospital re-admissions, but moderate-certainty evidence is based on one study. We have not found any evidence for dyspnoea symptoms nor harms, and there is no difference in fatalities when remote monitoring is provided in addition to usual care.\nRemote monitoring interventions alone are no better than usual care overall for health outcomes.\nMulti-component interventions with asynchronous remote monitoring are no better than usual care but may provide short-term benefit for quality of life and may result in fewer re-admissions to hospital for any cause. We are uncertain whether remote monitoring is responsible for the positive impact on re-admissions, and we are unable to discern the long-term benefits of receiving remote monitoring as part of patient care.\nOwing to paucity of evidence, it is unclear which COPD severity subgroups would benefit from telehealth interventions. Given there is no evidence of harm, telehealth interventions may be beneficial as an additional health resource depending on individual needs based on professional assessment. Larger studies can determine long-term effects of these interventions.\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": "Chronic obstructive pulmonary disease (COPD) includes a group of lung conditions that cause breathing difficulties. Symptoms include shortness of breath (dyspnoea), coughing, and increased mucus. COPD causes limited airflow in the lungs when breathing out; this can be measured by spirometry (a measure to assess how well the lungs function). The spirometer takes two measurements: volume of air when breathing out forcefully in one second, and total amount of air breathed out. When COPD gets worse over time, this leads to greater symptom severity and can reduce quality of life. Disease progression and sudden flare-ups (exacerbations) of symptoms can increase someone's risks of hospitalisation and death. Telehealth technologies could improve delivery of health care for people with COPD, which could reduce exacerbations, improve quality of life, and lower rates of hospitalisation. However, it is unclear whether providing telehealth care improves health-related outcomes for people with COPD. We wanted to explore whether telehealth technologies were helpful for people with COPD."
}
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query-laysum | 2043 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple pregnancy is a strong risk factor for preterm birth, and more than 50% of women with a twin pregnancy will give birth prior to 37 weeks' gestation. Infants born preterm are recognised to be at increased risk of many adverse health outcomes, contributing to more than half of overall perinatal mortality. Progesterone is produced naturally in the body and has a role in maintaining pregnancy, although it is not clear whether administering progestogens to women with multiple pregnancy at high risk of early birth is effective and safe.\nSince publication of this new review in Issue 10, 2017, we have now moved one study (El-Refaie 2016) from included to studies awaiting classification, pending clarification about the study data.\nObjectives\nTo assess the benefits and harms of progesterone administration for the prevention of preterm birth in women with a multiple pregnancy.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2016) and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials examining the administration of a progestogen by any route for the prevention of preterm birth in women with multiple pregnancy. We did not include quasi-randomised or cross-over studies.\nData collection and analysis\nTwo review authors independently assessed reports identified by the search for eligibility, extracted data, assessed risk of bias and graded the quality of the evidence.\nMain results\nWe included 16 trials, which all compared either vaginal or intramuscular (IM) progesterone with a placebo or no treatment, and involved a total of 4548 women. The risk of bias for the majority of included studies was low, with the exception of three studies that had inadequate blinding, or significant loss to follow-up or both, or were not reported well enough for us to make a judgement. We graded the evidence low to high quality, with downgrading for statistical heterogeneity, design limitations in some of the studies contributing data, and imprecision of the effect estimate.\n1 IM progesterone versus no treatment or placebo\nMore women delivered at less than 34 weeks' gestation in the IM progesterone group compared with placebo (risk ratio (RR) 1.54, 95% confidence interval (CI) 1.06 to 2.26; women = 399; studies = 2; low-quality evidence). Although the incidence of perinatal death in the progesterone group was higher, there was considerable uncertainty around the effect estimate and high heterogeneity between studies (average RR 1.45, 95% CI 0.60 to 3.51; infants = 3089; studies = 6; I2 = 71%; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up.\nThere were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (RR 1.05, 95% CI 0.98 to 1.13; women = 2010; studies = 5; high-quality evidence); preterm birth less than 28 weeks (RR 1.08, 95% CI 0.75 to 1.55; women = 1920; studies = 5; moderate-quality evidence); infant birthweight less than 2500 g (RR 0.99, 95% CI 0.90 to 1.08; infants = 4071; studies = 5; I2 = 76%, moderate-quality evidence)). No childhood outcomes were reported in the trials.\n2 Vaginal progesterone versus no treatment or placebo by dose\nThere were no clear group differences in incidence of preterm birth before 34 weeks (average RR 0.90, 95% CI 0.66 to 1.23; women = 1503; studies = 5; I2 = 36%; low-quality evidence). Although fewer births before 34 weeks appeared to occur in the progesterone group, the CIs crossed the line of no effect. Incidence of perinatal death was higher in the progesterone group, although there was considerable uncertainty in the effect estimate and the quality of the evidence was low for this outcome (RR 1.23, 95% CI 0.74 to 2.06; infants = 2287; studies = 3; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up.\nThere were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (average RR 0.97, 95% CI 0.89 to 1.06; women = 1597; studies = 6; moderate-quality evidence); preterm birth less than 28 weeks (RR 1.53, 95% CI 0.79 to 2.97; women = 1345; studies = 3; low-quality evidence); infant birthweight less than 2500 g (average RR 0.95, 95% CI 0.84 to 1.07; infants = 2640; studies = 3; I2 = 66%, moderate-quality evidence)). No childhood outcomes were reported in the trials.\nFor secondary outcomes, there were no clear group differences found in any of the other maternal outcomes except for caesarean section, where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group, although the difference between groups was not large (8%) (RR 0.92, 95% CI 0.86 to 0.98; women = 1919; studies = 5; I2 = 0%). There were no clear group differences found in any of the infant outcomes except for mechanical ventilation, which was required by fewer infants whose mothers had received the vaginal progesterone (RR 0.70, 95% CI 0.52 to 0.94; infants = 2695; studies = 4).\nAuthors' conclusions\nOverall, for women with a multiple pregnancy, the administration of progesterone (either IM or vaginal) does not appear to be associated with a reduction in risk of preterm birth or improved neonatal outcomes.\nFuture research could focus on a comprehensive individual participant data meta-analysis including all of the available data relating to both IM and vaginal progesterone administration in women with a multiple pregnancy, before considering the need to conduct trials in subgroups of high-risk women (for example, women with a multiple pregnancy and a short cervical length identified on ultrasound).\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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"role": "assistant",
"content": "More than half of women with a twin pregnancy give birth before the 37th week of pregnancy (preterm), and women expecting triplets are even more likely to have a preterm birth. Infants born preterm are more likely to die or have health problems compared with babies born at term. Progesterone is produced naturally in the body and is thought to help to maintain pregnancy.\nSince publication of this new review in Issue 10, 2017, we have now moved one study (El-Refaie 2016) from included to studies awaiting classification, pending clarification about the study data."
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query-laysum | 2044 | [
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"role": "user",
"content": "Abstract: Background\nCaries is one of the most prevalent and preventable conditions worldwide. If identified early enough then non-invasive techniques can be applied, and therefore this review focusses on early caries involving the enamel surface of the tooth. The cornerstone of caries detection and diagnosis is a visual and tactile dental examination, although alternative approaches are available. These include illumination-based devices that could potentially support the dental examination. There are three categories of illumination devices that exploit various methods of application and interpretation, each primarily defined by different wavelengths, optical coherence tomography (OCT), near-infrared (NIR), and fibre-optic technology, which incorporates more recently developed digital fibre optics (FOTI/DIFOTI).\nObjectives\nTo estimate the diagnostic test accuracy of different illumination tests for the detection and diagnosis of enamel caries in children or adults. We also planned to explore the following potential sources of heterogeneity: in vitro or in vivo studies with different reference standards; tooth surface (occlusal, proximal, smooth surface, or adjacent to a restoration); single or multiple sites of assessment on a tooth surface; and the prevalence of caries into dentine.\nSearch methods\nCochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 15 February 2019); Embase Ovid (1980 to 15 February 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 15 February 2019); and the World Health Organization International Clinical Trials Registry Platform (to 15 February 2019). We studied reference lists as well as published systematic review articles.\nSelection criteria\nWe included diagnostic accuracy study designs that compared the use of illumination-based devices with a reference standard (histology, enhanced visual examination with or without radiographs, or operative excavation). These included prospective studies that evaluated the diagnostic accuracy of a single index test and studies that directly compared two or more index tests. Both in vitro and in vivo studies of primary and permanent teeth were eligible for inclusion. We excluded studies that explicitly recruited participants with caries into dentine or frank cavitation. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.\nData collection and analysis\nTwo review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. The comparative accuracy of different illumination devices was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.\nMain results\nWe included 24 datasets from 23 studies that evaluated 16,702 tooth surfaces. NIR was evaluated in 6 datasets (673 tooth surfaces), OCT in 10 datasets (1171 tooth surfaces), and FOTI/DIFOTI in 8 datasets (14,858 tooth surfaces). The participant selection domain had the largest number of studies judged at high risk of bias (16 studies). Conversely, for the index test, reference standard, and flow and timing domains the majority of studies were judged to be at low risk of bias (16, 12, and 16 studies respectively). Concerns regarding the applicability of the evidence were judged as high or unclear for all domains. Notably, 14 studies were judged to be of high concern for participant selection, due to selective participant recruitment, a lack of independent examiners, and the use of an in vitro study design. The summary estimate across all the included illumination devices was sensitivity 0.75 (95% confidence interval (CI) 0.62 to 0.85) and specificity 0.87 (95% CI 0.82 to 0.92), with a diagnostic odds ratio of 21.52 (95% CI 10.89 to 42.48). In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 57%, this would result in 142 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 56 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). A formal comparison of the accuracy according to device type indicated a difference in sensitivity and/or specificity (Chi2(4) = 34.17, P < 0.01). Further analysis indicated a difference in the sensitivity of the different devices (Chi2(2) = 31.24, P < 0.01) with a higher sensitivity of 0.94 (95% CI 0.88 to 0.97) for OCT compared to NIR 0.58 (95% CI 0.46 to 0.68) and FOTI/DIFOTI 0.47 (95% CI 0.35 to 0.59), but no meaningful difference in specificity (Chi2(2) = 3.47, P = 0.18).\nIn light of these results, we planned to formally assess potential sources of heterogeneity according to device type, but due to the limited number of studies for each device type we were unable to do so. For interpretation, we presented the coupled forest plots for each device type according to the potential source of heterogeneity.\nWe rated the certainty of the evidence as low and downgraded two levels in total due to avoidable and unavoidable study limitations in the design and conduct of studies, indirectness arising from the in vitro studies, and imprecision of the estimates.\nAuthors' conclusions\nOf the devices evaluated, OCT appears to show the most potential, with superior sensitivity to NIR and fibre-optic devices. Its benefit lies as an add-on tool to support the conventional oral examination to confirm borderline cases in cases of clinical uncertainty. OCT is not currently available to the general dental practitioner, and so further research and development are necessary. FOTI and NIR are more readily available and easy to use; however, they show limitations in their ability to detect enamel caries but may be considered successful in the identification of sound teeth.\nFuture studies should strive to avoid research waste by ensuring that recruitment is conducted in such a way as to minimise selection bias and that studies are clearly and comprehensively reported. In terms of applicability, any future studies should be undertaken in a clinical setting that is reflective of the complexities encountered in caries assessment within the oral cavity.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The review authors searched for and used studies published up to 15 February 2019."
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query-laysum | 2045 | [
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"role": "user",
"content": "Abstract: Background\nDiffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the lymphatic system. About 30% to 40% of people with DLBCL experience relapse and 10% are refractory to first-line treatment usually consisting of R-CHOP chemotherapy. Of those eligible for second-line treatment, commonly consisting of salvage chemotherapy followed by autologous stem-cell transplantation (ASCT), around 50% experience relapse. With a median overall survival of less than six to 12 months, the prognosis of individuals who relapse or are refractory (r/r) to advanced lines of treatment or of those who are ineligible for ASCT, is very poor. With the introduction of chimeric antigen receptor (CAR) T-cell therapy, a novel treatment option for these people is available.\nObjectives\nTo assess the benefits and harms of chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory (r/r) DLBCL.\nSearch methods\nAn experienced information specialist performed a systematic database search for relevant articles on CENTRAL, MEDLINE and Embase until September 11th, 2020. We also searched trial registries and reference lists of identified studies up to this date. All search results were screened by two authors independently and a third author was involved in case of discrepancies.\nSelection criteria\nWe included prospectively planned trials evaluating CAR T-cell therapy for people with r/r DLBCL. We had planned to include randomised controlled trials (RCTs) and we flexibly adapted eligibility criteria to the most reliable study designs available. We excluded studies involving fewer than 10 participants with r/r DLBCL and studies with a proportion of participants with r/r DLBCL below 70%, unless data were reported separately for this subgroup.\nData collection and analysis\nTwo review authors extracted data and performed risk of bias ratings independently. A third author was involved in case of disagreements. As our search did not yield any completed RCTs, prospective controlled non-randomised studies of interventions (NRSIs) or prospective observational studies with a control group, we did not meta-analyse data and reported all results narratively. We adopted the GRADE approach to assess the certainty of the evidence for prioritised outcomes.\nMain results\nWe identified 13 eligible uncontrolled studies evaluating a single or multiple arms of CAR T-cell therapies. We also identified 38 ongoing studies, including three RCTs. Ten studies are awaiting classification due to completion with no retrievable results data or insufficient data to justify inclusion. The mean number of participants enrolled, treated with CAR T-cell therapy and evaluated in the included studies were 79 (range 12 to 344; data unavailable for two studies), 61 (range 12 to 294; data unavailable for one study) and 52 (range 11 to 256), respectively.\nMost studies included people with r/r DLBCL among people with other haematological B-cell malignancies. Participants had received at least a median of three prior treatment lines (data unavailable for four studies), 5% to 50% had undergone ASCT (data unavailable for five studies) and, except for two studies, 3% to 18% had undergone allogenic stem-cell transplantation (data unavailable for eight studies).\nThe overall risk of bias was high for all studies, in particular, due to incomplete follow-up and the absence of blinding. None of the included studies had a control group so that no adequate comparative effect measures could be calculated. The duration of follow-up varied substantially between studies, in particular, for harms. Our certainty in the evidence is very low for all outcomes.\nOverall survival was reported by eight studies (567 participants). Four studies reported survival rates at 12 months which ranged between 48% and 59%, and one study reported an overall survival rate of 50.5% at 24 months. The evidence is very uncertain about the effect of CAR T-cell therapy on overall survival.\nTwo studies including 294 participants at baseline and 59 participants at the longest follow-up (12 months or 18 months) described improvements of quality of life measured with the EuroQol 5-Dimension 5-Level visual analogue scale (EQ-5D-5L VAS) or Function Assessment of Cancer Therapy-Lymphoma (FACT-Lym). The evidence is very uncertain about the effect of CAR T-cell therapy on quality of life.\nNone of the studies reported treatment-related mortality.\nFive studies (550 participants) reported the occurrence of adverse events among participants, ranging between 99% and 100% for any grade adverse events and 68% to 98% for adverse events grade ≥ 3. In three studies (253 participants), 56% to 68% of participants experienced serious adverse events, while in one study (28 participants), no serious adverse events occurred. CAR T-cell therapy may increase the risk of adverse events and serious adverse events but the evidence is very uncertain about the exact risk.\nThe occurrence of cytokine release syndrome (CRS) was reported in 11 studies (675 participants) under use of various grading criteria. Five studies reported between 42% and 100% of participants experiencing CRS according to criteria described in Lee 2014. CAR T-cell therapy may increase the risk of CRS but the evidence is very uncertain about the exact risk.\nNine studies (575 participants) reported results on progression-free survival, disease-free survival or relapse-free survival. Twelve-month progression-free survival rates were reported by four studies and ranged between 44% and 75%. In one study, relapse-free survival remained at a rate of 64% at both 12 and 18 months. The evidence is very uncertain about the effect of CAR T-cell therapy on progression-free survival.\nThirteen studies (620 participants) provided data on complete response rates. At six months, three studies reported complete response rates between 40% and 45%. The evidence is very uncertain about the effect of CAR T-cell therapy on complete response rates.\nAuthors' conclusions\nThe available evidence on the benefits and harms of CAR T-cell therapy for people with r/r DLBCL is limited, mainly because of the absence of comparative clinical trials. The results we present should be regarded in light of this limitation and conclusions should be drawn very carefully. Due to the uncertainty in the current evidence, a large number of ongoing investigations and a risk of substantial and potentially life-threatening complications requiring supplementary treatment, it is critical to continue evaluating the evidence on this new therapy.\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": "Diffuse large B-cell lymphoma (DLBCL) is a fast-growing cancer of the lymphatic system, an important part of the immune system. It affects blood cells that produce antibodies to fight infections.\nDLBCL is potentially curable. Most people with DLBCL respond well to initial therapies such as chemotherapy. For some people, the disease becomes refractory, which means it no longer responds to treatment, or it relapses, which means it returns after treatment. As a second-line treatment, people with DLBCL can receive chemotherapy coupled with stem-cell transplantation, but not all people are candidates for this therapy. From those who are, around 50% experience relapse after treatment. People who relapse or are refractory to advanced lines of treatment and those who are not candidates for a stem-cell transplant have a very poor prognosis: Only half of them survive longer than six to 12 months.\nA promising treatment for these people is 'chimeric antigen receptor' (CAR) T-cell therapy, which utilises the body's own immune cells (T-cells) to fight DLBCL. T-cells are removed from the person's blood, equipped with so-called 'chimeric antigen receptors' (CARs), that help to recognise and destroy the cancer cells, in the laboratory and then delivered back into the person's blood."
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query-laysum | 2046 | [
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"role": "user",
"content": "Abstract: Background\nEnuresis (bedwetting) affects up to 20% of five-year-olds and can have considerable social, emotional and psychological effects. Treatments include alarms (activated by urination), behavioural interventions and drugs.\nObjectives\nTo assess the effects of enuresis alarms for treating enuresis in children.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, and handsearching of journals and conference proceedings (searched 25 June 2018), and reference lists of relevant articles.\nSelection criteria\nWe included randomised or quasi-randomised trials of enuresis alarms or alarms combined with another intervention for treating nocturnal enuresis in children between 5 and 16 years old.\nData collection and analysis\nTwo review authors independently assessed risk of bias and extracted data.\nMain results\nWe included 74 trials (5983 children).\nAt treatment completion, alarms may reduce the number of wet nights a week compared to control or no treatment (mean difference (MD) −2.68, 95% confidence interval (CI) −4.59 to −0.78; 4 trials, 127 children; low-quality evidence). Low-quality evidence suggests more children may achieve complete response (14 consecutive dry nights) with alarms compared to control or no treatment (RR 7.23, 95% CI 1.40 to 37.33; 18 trials, 827 children) and that more children may remain dry post-treatment (RR 9.67, 95% CI 4.74 to 19.76; 10 trials, 366 children; low-quality evidence).\nAt treatment completion, we are uncertain whether there is any difference between alarms and placebo drugs in the number of wet nights a week (MD −0.96, 95% CI −2.32 to 0.41; 1 trial, 47 children; very low-quality evidence). Alarms may result in more children achieving complete response than with placebo drugs (RR 1.59, 95% CI 1.16 to 2.17; 2 trials, 181 children; low-quality evidence). No trials comparing alarms to placebo reported the number of children remaining dry post-treatment.\nCompared with control alarms, code-word alarms probably slightly increase the number of children achieving complete response at treatment completion (RR 1.11, 95% CI 0.97 to 1.27; 1 trial, 353 children; moderate-quality evidence) but there is probably little to no difference in the number of children remaining dry post-treatment (RR 0.91, 95% CI 0.79 to 1.05; moderate-quality evidence). Very low-quality evidence means we are uncertain if there are any differences in effectiveness between the other different types of alarm.\nAt treatment completion, alarms may reduce the number of wet nights a week compared with behavioural interventions (waking, bladder training, dry-bed training, and star chart plus rewards) (MD -0.81, 95% CI -2.01 to 0.38; low-quality evidence) and may increase the number of children achieving complete response (RR 1.77, 95% CI 0.98 to 3.19; low-quality evidence) and may slightly increase the number of children remaining dry post-treatment (RR 1.39, 95% CI 0.81 to 2.41; low-quality evidence).\nThe evidence relating to alarms compared with desmopressin in the number of wet nights a week (MD −0.64, 95% CI −1.77 to 0.49; 4 trials, 285 children) and the number of children achieving complete response at treatment completion (RR 1.12, 95% CI 0.93 to 1.36; 12 trials, 1168 children) is low-quality, spanning possible harms and possible benefits. Alarms probably slightly increase the number of children remaining dry post-treatment compared with desmopressin (RR 1.30, 95% CI 0.92 to 1.84; 5 trials, 565 children; moderate-quality evidence).\nAt treatment completion, we are uncertain if there is any difference between alarms and tricyclics in the number of wet nights a week, the number of children achieving complete response or the number of children remaining dry post-treatment, because the quality of evidence is very low.\nDue to very low-quality evidence we are uncertain about any differences in effectiveness between alarms and cognitive behavioural therapy, psychotherapy, hypnotherapy and restricted diet.\nAlarm plus desmopressin may reduce the number of wet nights a week compared with desmopressin monotherapy (MD −0.88, 95% CI −0.38 to −1.38; 2 trials, 156 children; low-quality evidence). Alarm plus desmopressin may increase the number of children achieving complete response (RR 1.32, 95% CI 1.08 to 1.62; 5 trials, 359 children; low-quality evidence) and the number of children remaining dry post-treatment (RR 2.33, 95% CI 1.26 to 4.29; 2 trials, 161 children; low-quality evidence) compared with desmopressin alone.\nAlarm plus dry-bed training may increase the number of children achieving a complete response compared to dry-bed training alone (RR 3.79, 95% CI 1.85 to 7.77; 1 trial, 80 children; low-quality evidence). It is unclear if there is any difference in the number of children remaining dry post-treatment because of the wide confidence interval (RR 0.56, 95% CI 0.15 to 2.12; low-quality evidence). Due to very low-quality evidence, we are uncertain about any differences in effectiveness between alarm plus bladder training versus bladder training alone.\nOf the 74 included trials, 17 reported one or more adverse events, nine reported no adverse events and 48 did not mention adverse events. Adverse events attributed to alarms included failure to wake the child, ringing without urination, waking others, causing discomfort, frightening the child and being too difficult to use. Adverse events of comparator interventions included nose bleeds, headaches and abdominal pain.\nThere is probably a slight increase in adverse events between code-word alarm and standard alarm (RR 1.34, 95% CI 0.75 to 2.38; moderate-quality evidence), although we are uncertain because of the wide confidence interval. Alarms probably reduce the number of children experiencing adverse events compared with desmopressin (RR 0.38, 95% CI 0.20 to 0.71; 5 trials, 565 children; moderate-quality evidence). Very low-quality evidence means we cannot be certain whether the adverse event rate for alarms is lower than for other treatments.\nAuthors' conclusions\nAlarm therapy may be more effective than no treatment in reducing enuresis in children. We are uncertain if alarm therapy is more effective than desmopressin but there is probably a lower risk of adverse events with alarms than with desmopressin. Despite the large number of trials included in this review, further adequately-powered trials with robust randomisation are still needed to determine the full effect of alarm therapy.\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": "Alarms may be better than no treatment in terms of reducing the number of wet nights a week and increasing the number of children achieving 14 consecutive dry nights. Alarms may increase the number of children remaining dry after stopping treatment, compared to no treatment.\nWe are uncertain if there is any difference between alarms and behavioural interventions (such as bladder training), or between alarms and desmopressin medication in terms of reducing the number of wet nights a week, increasing the number of children achieving 14 consecutive dry nights and increasing the number of children remaining dry after stopping treatment.\nWe are uncertain whether alarms reduce the number of wet nights more than placebo drugs, other types of alarms, tricyclics medication, or various treatments such as hypnotherapy or restricted diet.\nAlarm plus desmopressin may reduce the number of wet nights a week compared with desmopressin alone. It may increase the number of children achieving 14 consecutive dry nights and increase the number of children remaining dry after stopping treatment. Alarm plus dry-bed training may increase the number of children achieving 14 consecutive dry nights compared to dry-bed training alone, but we are uncertain if the response is maintained after stopping treatment.\nDue to very low-quality evidence, we are uncertain about any differences in effectiveness between alarm plus bladder training versus bladder training alone.\nAlarm therapy probably reduces the number of children experiencing adverse events compared with desmopressin. We think there is probably a slight increase in adverse events between code-word alarms and standard alarms but until we have more evidence from more children we cannot be certain about this. We are uncertain about the safety of alarm therapy compared to other treatments, because the quality of evidence is very low."
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query-laysum | 2047 | [
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"role": "user",
"content": "Abstract: Background\nMobilization of community first responders (CFRs) to the scene of an out-of-hospital cardiac arrest (OHCA) event has been proposed as a means of shortening the interval from occurrence of cardiac arrest to performance of cardiopulmonary resuscitation (CPR) and defibrillation, thereby increasing patient survival.\nObjectives\nTo assess the effect of mobilizing community first responders (CFRs) to out-of-hospital cardiac arrest events in adults and children older than four weeks of age, in terms of survival and neurological function.\nSearch methods\nWe searched the following databases for relevant trials in January 2019: CENTRAL, MEDLINE (Ovid SP), Embase (Ovid SP), and Web of Science. We also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov, and we scanned the abstracts of conference proceedings of the American Heart Association and the European Resuscitation Council.\nSelection criteria\nWe included randomized and quasi-randomized trials (RCTs and q-RCTs) that compared routine emergency medical services (EMS) care versus EMS care plus mobilization of CFRs in instances of OHCA.Trials with randomization by cluster were eligible for inclusion, including cluster-design studies with intervention cross-over.\nIn some communities, the statutory ambulance service/EMS is routinely provided by the local fire service. For the purposes of this review, this group represents the statutory ambulance service/EMS, as distinct from CFRs, and was not included as an eligible intervention.\nWe did not include studies primarily focused on opportunistic bystanders. Individuals who were present at the scene of an OHCA event and who performed CPR according to telephone instruction provided by EMS call takers were not considered to be CFRs.\nStudies primarily assessing the impact of specific additional interventions such as administration of naloxone in narcotic overdose or adrenaline in anaphylaxis were also excluded.\nWe included adults and children older than four weeks of age who had experienced an OHCA.\nData collection and analysis\nTwo review authors independently reviewed all titles and abstracts received to assess potential eligibility, using set inclusion criteria. We obtained and examined in detail full-text copies of all papers considered potentially eligible, and we approached authors of trials for additional information when necessary. We summarized the process of study selection in a PRISMA flowchart.\nThree review authors independently extracted relevant data using a standard data extraction form and assessed the validity of each included trial using the Cochrane 'Risk of bias' tool. We resolved disagreements by discussion and consensus.\nWe synthesized findings in narrative fashion due to the heterogeneity of the included studies. We used the principles of the GRADE system to assess the certainty of the body of evidence associated with specific outcomes and to construct a 'Summary of findings' table.\nMain results\nWe found two completed studies involving a total of 1136 participants that ultimately met our inclusion criteria. We also found one ongoing study and one planned study. We noted significant heterogeneity in the characteristics of interventions and outcomes measured or reported across these studies, thus we could not pool study results.\nOne completed study considered the dispatch of police and fire service CFRs equipped with automatic external defibrillators (AEDs) in an EMS system in Amsterdam and surrounding areas. This study was an RCT with allocation made by cluster according to non-overlapping geographical regions. It was conducted between 5 January 2000 and 5 January 2002. All participants were 18 years of age or older and had experienced witnessed OHCA. The study found no difference in survival at hospital discharge (odds ratio (OR) 1.3, 95% confidence interval (CI) 0.8 to 2.2; 1 RCT; 469 participants; low-certainty evidence), despite the observation that all 72 incidences of defibrillation performed before EMS arrival occurred in the intervention group (OR and 95% CI - not applicable; 1 RCT; 469 participants; moderate-certainty evidence). This study reported increased survival to hospital admission in the intervention group (OR 1.5, 95% CI 1.1 to 2.0; 1 RCT; 469 participants; moderate-certainty evidence).\nThe second completed study considered the dispatch of nearby lay volunteers in Stockholm, Sweden, who were trained to perform cardiopulmonary resuscitation (CPR). This represented a supplementary CFR intervention in an EMS system where police and fire services were already routinely dispatched to OHCA in addition to EMS ambulances. This study, an RCT, included both witnessed and unwitnessed OHCA and was conducted between 1 April 2012 and 1 December 2013. Participants included adults and children eight years of age and older. Researchers found no difference in 30-day survival (OR 1.34, 95% CI 0.79 to 2.29; 1 RCT; 612 participants; low-certainty evidence), despite a significant increase in CPR performed before EMS arrival (OR 1.49, 95% CI 1.09 to 2.03; 1 RCT; 665 participants; moderate-certainty evidence).\nNeither of the included completed studies considered neurological function at hospital discharge or at 30 days, measured by cerebral performance category or by any other means. Neither of the included completed studies considered health-related quality of life. The overall certainty of evidence for the outcomes of included studies was low to moderate.\nAuthors' conclusions\nModerate-certainty evidence shows that context-specific CFR interventions result in increased rates of CPR or defibrillation performed before EMS arrival. It remains uncertain whether this can translate to significantly increased rates of overall patient survival. When possible, further high-quality RCTs that are adequately powered to measure changes in survival should be conducted.\nThe included studies did not consider survival with good neurological function. This outcome is likely to be important to patients and should be included routinely wherever survival is measured.\nWe identified one ongoing study and one planned trial whose results once available may change the results of this review. As this review was limited to randomized and quasi-randomized trials, we may have missed some important data from other study types.\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"
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"content": "The certainty of available evidence in terms of overall patient survival was considered low. The certainty of available evidence in terms of performance of CPR and defibrillation before arrival of emergency medical services and in terms of survival to hospital admission was considered moderate. This evidence is current to January 2019."
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query-laysum | 2048 | [
{
"role": "user",
"content": "Abstract: Background\nHip fractures are a major healthcare problem, presenting a huge challenge and burden to individuals and healthcare systems. The number of hip fractures globally is rising rapidly. The majority of hip fractures are treated surgically. This review evaluates evidence for types of arthroplasty: hemiarthroplasties (HAs), which replace part of the hip joint; and total hip arthroplasties (THAs), which replace all of it.\nObjectives\nTo determine the effects of different designs, articulations, and fixation techniques of arthroplasties for treating hip fractures in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, seven other databases and one trials register in July 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing different arthroplasties for treating fragility intracapsular hip fractures in older adults. We included THAs and HAs inserted with or without cement, and comparisons between different articulations, sizes, and types of prostheses. We excluded studies of people with specific pathologies other than osteoporosis and with hip fractures resulting from high-energy trauma.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We collected data for seven outcomes: activities of daily living, functional status, health-related quality of life, mobility (all early: within four months of surgery), early mortality and at 12 months after surgery, delirium, and unplanned return to theatre at the end of follow-up.\nMain results\nWe included 58 studies (50 RCTs, 8 quasi-RCTs) with 10,654 participants with 10,662 fractures. All studies reported intracapsular fractures, except one study of extracapsular fractures. The mean age of participants in the studies ranged from 63 years to 87 years, and 71% were women.\nWe report here the findings of three comparisons that represent the most substantial body of evidence in the review. Other comparisons were also reported, but with many fewer participants.\nAll studies had unclear risks of bias in at least one domain and were at high risk of detection bias. We downgraded the certainty of many outcomes for imprecision, and for risks of bias where sensitivity analysis indicated that bias sometimes influenced the size or direction of the effect estimate.\nHA: cemented versus uncemented (17 studies, 3644 participants)\nThere was moderate-certainty evidence of a benefit with cemented HA consistent with clinically small to large differences in health-related quality of life (HRQoL) (standardised mean difference (SMD) 0.20, 95% CI 0.07 to 0.34; 3 studies, 1122 participants), and reduction in the risk of mortality at 12 months (RR 0.86, 95% CI 0.78 to 0.96; 15 studies, 3727 participants). We found moderate-certainty evidence of little or no difference in performance of activities of daily living (ADL) (SMD -0.03, 95% CI -0.21 to 0.16; 4 studies, 1275 participants), and independent mobility (RR 1.04, 95% CI 0.95 to 1.14; 3 studies, 980 participants). We found low-certainty evidence of little or no difference in delirium (RR 1.06, 95% CI 0.55 to 2.06; 2 studies, 800 participants), early mortality (RR 0.95, 95% CI 0.80 to 1.13; 12 studies, 3136 participants) or unplanned return to theatre (RR 0.70, 95% CI 0.45 to 1.10; 6 studies, 2336 participants). For functional status, there was very low-certainty evidence showing no clinically important differences.\nThe risks of most adverse events were similar. However, cemented HAs led to less periprosthetic fractures intraoperatively (RR 0.20, 95% CI 0.08 to 0.46; 7 studies, 1669 participants) and postoperatively (RR 0.29, 95% CI 0.14 to 0.57; 6 studies, 2819 participants), but had a higher risk of pulmonary embolus (RR 3.56, 95% CI 1.26 to 10.11, 6 studies, 2499 participants).\nBipolar HA versus unipolar HA (13 studies, 1499 participants)\nWe found low-certainty evidence of little or no difference between bipolar and unipolar HAs in early mortality (RR 0.94, 95% CI 0.54 to 1.64; 4 studies, 573 participants) and 12-month mortality (RR 1.17, 95% CI 0.89 to 1.53; 8 studies, 839 participants). We are unsure of the effect for delirium, HRQoL, and unplanned return to theatre, which all indicated little or no difference between articulation, because the certainty of the evidence was very low. No studies reported on early ADL, functional status and mobility.\nThe overall risk of adverse events was similar. The absolute risk of dislocation was low (approximately 1.6%) and there was no evidence of any difference between treatments.\nTHA versus HA (17 studies, 3232 participants)\nThe difference in the risk of mortality at 12 months was consistent with clinically relevant benefits and harms (RR 1.00, 95% CI 0.83 to 1.22; 11 studies, 2667 participants; moderate-certainty evidence). There was no evidence of a difference in unplanned return to theatre, but this effect estimate includes clinically relevant benefits of THA (RR 0.63, 95% CI 0.37 to 1.07, favours THA; 10 studies, 2594 participants; low-certainty evidence). We found low-certainty evidence of little or no difference between THA and HA in delirium (RR 1.41, 95% CI 0.60 to 3.33; 2 studies, 357 participants), and mobility (MD -0.40, 95% CI -0.96 to 0.16, favours THA; 1 study, 83 participants). We are unsure of the effect for early functional status, ADL, HRQoL, and mortality, which indicated little or no difference between interventions, because the certainty of the evidence was very low.\nThe overall risks of adverse events were similar. There was an increased risk of dislocation with THA (RR 1.96, 95% CI 1.17 to 3.27; 12 studies, 2719 participants) and no evidence of a difference in deep infection.\nAuthors' conclusions\nFor people undergoing HA for intracapsular hip fracture, it is likely that a cemented prosthesis will yield an improved global outcome, particularly in terms of HRQoL and mortality. There is no evidence to suggest a bipolar HA is superior to a unipolar prosthesis. Any benefit of THA compared with hemiarthroplasty is likely to be small and not clinically appreciable. We encourage researchers to focus on alternative implants in current clinical practice, such as dual-mobility bearings, for which there is limited available evidence.\n\nGiven the provided abstract, please respond to the following query: \"Cemented HAs compared to uncemented HAs (17 studies, 3644 participants)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that cemented HAs improve health-related quality of life (HRQoL) and reduce the risk of death at 12 months after surgery. The sizes of these benefits ranged from a small to a large effect. There may be little or no difference between treatments in the ability to use the hip (functional status), but this evidence was very uncertain. Whether or not the HA is cemented probably makes little or no difference to performance in activities of daily living (ADL) or the ability to walk independently, how many people experience confusion after surgery (delirium), die within four months of surgery, or need additional surgery. Most complication risks were similar, but we noted that some risks related directly to hip replacement surgery (such as causing a break during surgery) were increased with uncemented HAs."
}
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query-laysum | 2049 | [
{
"role": "user",
"content": "Abstract: Background\nOmega-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish and plant sources are commonly considered as a promising non-medical alternative to improve brain functions and slow down the progression of dementia. This assumption is mostly based on findings of preclinical studies and epidemiological research. Resulting explanatory models aim at the role omega-3 PUFAs play in the development and integrity of the brain's neurons, their protective antioxidative effect on cell membranes and potential neurochemical mechanisms directly related to Alzheimer-specific pathology. Epidemiological research also found evidence of malnutrition in people with dementia. Considering this and the fact that omega-3 PUFA cannot be synthesised by humans, omega-3 PUFAs might be a promising treatment option for dementia.\nObjectives\nTo assess the efficacy and safety of omega-3 polyunsaturated fatty acid (PUFA) supplementation for the treatment of people with dementia.\nSearch methods\nWe searched the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (ALOIS), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 10 December 2015. We contacted manufacturers of omega-3 supplements and scanned reference lists of landmark papers and included articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which omega-3 PUFA in the form of supplements or enriched diets were administered to people with Alzheimer's disease (AD), vascular dementia (VaD), dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD) or frontotemporal dementia (FTD).\nData collection and analysis\nThe primary outcome measures of interest were changes in global and specific cognitive functions, functional performance, dementia severity and adverse effects. Two review authors independently selected studies, extracted data and assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We received unpublished data from the trial authors and collected adverse effects information from the published articles. We conducted meta-analyses for available outcome measures at six months.\nMain results\nWe included three comparable randomised, placebo-controlled trials investigating omega-3 PUFA supplements in 632 participants with mild to moderate AD over six, 12 and 18 months. We found no studies investigating other types of dementia. All trials were of high methodological quality. The overall quality of evidence for most of the outcomes was high.\nThere was no evidence of a benefit from omega-3 PUFAs on cognitive function when measured at six months with the Alzheimer's Disease Assessment Scale - Cognitive subscale (standardised mean difference (SMD) -0.02, 95% confidence interval (CI) -0.19 to 0.15; 566 participants; 3 studies; high quality evidence) or Mini-Mental State Examination (mean difference (MD) 0.18, 95% CI -1.05 to 1.41; 202 participants; 2 studies; high quality evidence) or on activities of daily living (SMD -0.02, 95% CI -0.19 to 0.16; 544 participants; 2 studies; high quality evidence). There was also no effect at six months of treatment on severity of dementia measured with the Clinical Dementia Rating - Sum of Boxes (MD -0.00, 95% CI -0.58 to 0.57; 542 participants; 2 studies; high quality evidence) or on quality of life measured with the Quality of Life Alzheimer's Disease scale (MD -0.10, 95% CI -1.28 to 1.08; 322 participants; 1 study; high quality evidence). There was no difference at six months on mental health measured with the Montgomery-Åsberg Depression Rating Scale (MD -0.10, 95% CI -0.74 to 0.54; 178 participants: 1 study; high quality of evidence) or the Neuropsychiatric Inventory (SMD 0.10, 95% CI -0.07 to 0.27; 543 participants; 2 studies; high quality of evidence). One very small study showed a benefit for omega-3 PUFAs in instrumental activities of daily living after 12 months of treatment (MD -3.50, 95% CI -4.30 to -2.70; 22 participants; moderate quality evidence). The included studies did not measure specific cognitive function. The studies did not report adverse events well. Two studies stated that all adverse events were mild and that they did not differ in overall frequency between omega-3 PUFA and placebo groups. Data from one study showed no difference between groups in frequency of any adverse event (risk ratio (RR) 1.02, 95% CI 0.95 to 1.10; 402 participants; 1 study; moderate quality evidence) or any serious adverse event (RR 1.05, 95% CI 0.78 to 1.41; 402 participants; 1 study; high quality evidence) at 18 months of treatment.\nAuthors' conclusions\nWe found no convincing evidence for the efficacy of omega-3 PUFA supplements in the treatment of mild to moderate AD. This result was consistent for all outcomes relevant for people with dementia. Adverse effects of omega-3 PUFAs seemed to be low, but based on the evidence synthesised in this review, we cannot make a final statement on tolerability. The effects on other populations remain unclear.\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": "Altogether, the quality of the evidence was moderate or high for most of the effects that we measured, but we found no evidence for either benefit or harm from omega-3 PUFA supplements in people with mild to moderate Alzheimer's disease. The effects on people with other types of dementia remain unclear."
}
]
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query-laysum | 2050 | [
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of reproductive-aged women suffer from endometriosis, a costly chronic disease causing pelvic pain and subfertility. Laparoscopy is the gold standard diagnostic test for endometriosis, but is expensive and carries surgical risks. Currently, there are no non-invasive or minimally invasive tests available in clinical practice to accurately diagnose endometriosis. Although other reviews have assessed the ability of blood tests to diagnose endometriosis, this is the first review to use Cochrane methods, providing an update on the rapidly expanding literature in this field.\nObjectives\nTo evaluate blood biomarkers as replacement tests for diagnostic surgery and as triage tests to inform decisions on surgery for endometriosis. Specific objectives include:\n1. To provide summary estimates of the diagnostic accuracy of blood biomarkers for the diagnosis of peritoneal, ovarian and deep infiltrating pelvic endometriosis, compared to surgical diagnosis as a reference standard.\n2. To assess the diagnostic utility of biomarkers that could differentiate ovarian endometrioma from other ovarian masses.\nSearch methods\nWe did not restrict the searches to particular study designs, language or publication dates. We searched CENTRAL to July 2015, MEDLINE and EMBASE to May 2015, as well as these databases to 20 April 2015: CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP, ClinicalTrials.gov, DARE and PubMed.\nSelection criteria\nWe considered published, peer-reviewed, randomised controlled or cross-sectional studies of any size, including prospectively collected samples from any population of reproductive-aged women suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of one or more blood biomarkers with the findings of surgical visualisation of endometriotic lesions.\nData collection and analysis\nTwo authors independently collected and performed a quality assessment of data from each study. For each diagnostic test, we classified the data as positive or negative for the surgical detection of endometriosis, and we calculated sensitivity and specificity estimates. We used the bivariate model to obtain pooled estimates of sensitivity and specificity whenever sufficient datasets were available. The predetermined criteria for a clinically useful blood test to replace diagnostic surgery were a sensitivity of 0.94 and a specificity of 0.79 to detect endometriosis. We set the criteria for triage tests at a sensitivity of ≥ 0.95 and a specificity of ≥ 0.50, which 'rules out' the diagnosis with high accuracy if there is a negative test result (SnOUT test), or a sensitivity of ≥ 0.50 and a specificity of ≥ 0.95, which 'rules in' the diagnosis with high accuracy if there is a positive result (SpIN test).\nMain results\nWe included 141 studies that involved 15,141 participants and evaluated 122 blood biomarkers. All the studies were of poor methodological quality. Studies evaluated the blood biomarkers either in a specific phase of the menstrual cycle or irrespective of the cycle phase, and they tested for them in serum, plasma or whole blood. Included women were a selected population with a high frequency of endometriosis (10% to 85%), in which surgery was indicated for endometriosis, infertility work-up or ovarian mass. Seventy studies evaluated the diagnostic performance of 47 blood biomarkers for endometriosis (44 single-marker tests and 30 combined tests of two to six blood biomarkers). These were angiogenesis/growth factors, apoptosis markers, cell adhesion molecules, high-throughput markers, hormonal markers, immune system/inflammatory markers, oxidative stress markers, microRNAs, tumour markers and other proteins. Most of these biomarkers were assessed in small individual studies, often using different cut-off thresholds, and we could only perform meta-analyses on the data sets for anti-endometrial antibodies, interleukin-6 (IL-6), cancer antigen-19.9 (CA-19.9) and CA-125. Diagnostic estimates varied significantly between studies for each of these biomarkers, and CA-125 was the only marker with sufficient data to reliably assess sources of heterogeneity.\nThe mean sensitivities and specificities of anti-endometrial antibodies (4 studies, 759 women) were 0.81 (95% confidence interval (CI) 0.76 to 0.87) and 0.75 (95% CI 0.46 to 1.00). For IL-6, with a cut-off value of > 1.90 to 2.00 pg/ml (3 studies, 309 women), sensitivity was 0.63 (95% CI 0.52 to 0.75) and specificity was 0.69 (95% CI 0.57 to 0.82). For CA-19.9, with a cut-off value of > 37.0 IU/ml (3 studies, 330 women), sensitivity was 0.36 (95% CI 0.26 to 0.45) and specificity was 0.87 (95% CI 0.75 to 0.99).\nStudies assessed CA-125 at different thresholds, demonstrating the following mean sensitivities and specificities: for cut-off > 10.0 to 14.7 U/ml: 0.70 (95% CI 0.63 to 0.77) and 0.64 (95% CI 0.47 to 0.82); for cut-off > 16.0 to 17.6 U/ml: 0.56 (95% CI 0.24, 0.88) and 0.91 (95% CI 0.75, 1.00); for cut-off > 20.0 U/ml: 0.67 (95% CI 0.50 to 0.85) and 0.69 (95% CI 0.58 to 0.80); for cut-off > 25.0 to 26.0 U/ml: 0.73 (95% CI 0.67 to 0.79) and 0.70 (95% CI 0.63 to 0.77); for cut-off > 30.0 to 33.0 U/ml: 0.62 (95% CI 0.45 to 0.79) and 0.76 (95% CI 0.53 to 1.00); and for cut-off > 35.0 to 36.0 U/ml: 0.40 (95% CI 0.32 to 0.49) and 0.91 (95% CI 0.88 to 0.94).\nWe could not statistically evaluate other biomarkers meaningfully, including biomarkers that were assessed for their ability to differentiate endometrioma from other benign ovarian cysts.\nEighty-two studies evaluated 97 biomarkers that did not differentiate women with endometriosis from disease-free controls. Of these, 22 biomarkers demonstrated conflicting results, with some studies showing differential expression and others no evidence of a difference between the endometriosis and control groups.\nAuthors' conclusions\nOf the biomarkers that were subjected to meta-analysis, none consistently met the criteria for a replacement or triage diagnostic test. A subset of blood biomarkers could prove useful either for detecting pelvic endometriosis or for differentiating ovarian endometrioma from other benign ovarian masses, but there was insufficient evidence to draw meaningful conclusions. Overall, none of the biomarkers displayed enough accuracy to be used clinically outside a research setting. We also identified blood biomarkers that demonstrated no diagnostic value in endometriosis and recommend focusing research resources on evaluating other more clinically useful biomarkers.\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": "How accurate are blood tests in detecting endometriosis? Can any blood test be accurate enough to replace or reduce the need for surgery in the diagnosis of endometriosis?"
}
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query-laysum | 2051 | [
{
"role": "user",
"content": "Abstract: Background\nNew minimal invasive surgeries have been suggested as alternative options to transurethral resection of the prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Convective radiofrequency water vapour thermal therapy is a new technology that uses targeted, controlled water vapour energy (steam) to create necrotic tissue in the prostate.\nObjectives\nTo assess the effects of convective radiofrequency water vapour thermal therapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.\nSearch methods\nWe performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Latin American and the Caribbean Health Sciences Literature, Scopus, Web of Science), trials registries, other sources of grey literature, and conference proceedings published up to 18 February 2020, with no restriction on the language or status of publication.\nSelection criteria\nWe included parallel-group randomised controlled trials (RCTs), cluster-RCTs, and non-randomised observational prospective studies with concurrent comparison groups, in which men with BPH underwent convective radiofrequency water vapour thermal therapy, another active therapy, or a sham procedure.\nData collection and analysis\nTwo review authors independently screened the literature, extracted data, and assessed risk of bias. We had planned to perform statistical analyses using a random-effects model, and interpret them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the certainty of the evidence according to the GRADE approach.\nMain results\nWe included a single, industry-sponsored RCT, with 197 randomised men, that compared convective radiofrequency water vapour thermal therapy to a sham procedure. The mean age 62.9 years, the International Prostate Symptom Score (IPSS) was 21.97, and the mean prostate volume was 45.4 mL. We only found short-term data, measured up to three months.\nPrimary outcomes\nConvective radiofrequency water vapour thermal therapy may improve urologic symptom scores more than a sham procedure, measured on a IPSS scale (0 to 35; higher score represents worse urological symptoms) by a mean difference (MD) of -6.9 (95% confidence interval (CI) -9.06 to -4.74; 195 men; low-certainty evidence), and likely improves quality of life (QoL), measured on a IPSS-QoL scale (0 to 6; higher score represents worse QoL), by a MD of -1.2 (95% CI -1.66 to -0.74; 195 men; moderate-certainty evidence). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on major adverse events (risk ratio (RR) 6.79, 95% CI 0.39 to 117.00; 197 men; very low-certainty evidence) assessed by the Clavien-Dindo classification system of III, IV, and V complications.\nSecondary outcomes\nWe are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on retreatment (RR 1.36, 95% CI 0.06 to 32.86; 197 men; very low-certainty evidence). Convective radiofrequency water vapour thermal therapy may have little to no effect on erectile function (MD 0.4, 95% CI -1.91 to 2.71; 130 men; low-certainty evidence) and ejaculatory function (MD 0.5, 95% CI -0.83 to 1.83; 130 men; low-certainty evidence). Convective radiofrequency water vapour thermal therapy may increase minor adverse events assessed by the Clavien-Dindo classification system of Grade I and II complications (RR 1.89, 95% CI 1.15 to 3.11; 197 men; low-certainty evidence). This would correspond to 434 minor adverse events per 1000 men (95% CI 264 more to 714 more). We are very uncertain about the effects of convective radiofrequency water vapour thermal therapy on acute urinary retention (RR 4.98, 95% CI 0.28 to 86.63; 197 men; very low-certainty evidence). It likely greatly increases the rate of men requiring indwelling urinary catheters (RR 35.58, 95% CI 15.37 to 82.36; 197 men; moderate-certainty evidence).\nWe were unable to perform any of the predefined secondary analyses.\nWe found no evidence for other comparisons, such as convective radiofrequency water vapour thermal therapy versus TURP or other minimal invasive procedures.\nAuthors' conclusions\nCompared to a sham procedure, urologic symptom scores and quality of life appear to improve with convective radiofrequency water vapour thermal therapy, but we are very uncertain about major adverse events. The certainty of evidence ranged from moderate to very low, with study limitations and imprecision being the most common reasons for rating down. These findings are based on a single industry-sponsored study, with three-month short-term follow-up. We did not find any studies comparing convective radiofrequency water vapour thermal therapy to any other active treatment form, such as TURP.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged the certainty of the evidence for the outcomes to be moderate, low or very low. Reasons for not being so confident had to do with the study design and the study size."
}
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query-laysum | 2052 | [
{
"role": "user",
"content": "Abstract: Background\nInfants born at term by elective caesarean section are more likely to develop respiratory morbidity than infants born vaginally. Prophylactic corticosteroids in singleton preterm pregnancies accelerate lung maturation and reduce the incidence of respiratory complications. It is unclear whether administration at term gestations, prior to caesarean section, improves the respiratory outcomes for these babies without causing any unnecessary morbidity to the mother or the infant.\nObjectives\nThe objective of this review was to assess the effect of prophylactic corticosteroid administration before elective caesarean section at term, as compared to usual care (which could be placebo or no treatment), on fetal, neonatal and maternal morbidity. We also assessed the impact of the treatment on the child in later life.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov (20 January 2021) and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials comparing prophylactic antenatal corticosteroid administration (betamethasone or dexamethasone) with placebo or with no treatment, given before elective caesarean section at term (at or after 37 weeks of gestation). Quasi-randomised and cluster-randomised controlled trials were also eligible for inclusion.\nData collection and analysis\nWe used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two review authors independently assessed trials for inclusion, assessed risk of bias, evaluated trustworthiness (based on predefined criteria developed by Cochrane Pregnancy and Childbirth), extracted data and checked them for accuracy and assessed the certainty of the evidence using the GRADE approach. Our primary outcomes were respiratory distress syndrome (RDS), transient tachypnoea of the neonate (TTN), admission to neonatal special care for respiratory morbidity and need for mechanical ventilation.\nWe planned to perform subgroup analyses for the primary outcomes according to gestational age at randomisation and type of corticosteroid (betamethasone or dexamethasone). We also planned to perform sensitivity analysis, including only studies at low risk of bias.\nMain results\nWe included one trial in which participants were randomised to receive either betamethasone or usual care. The trial included 942 women and 942 neonates recruited from 10 UK hospitals between 1995 and 2002. This review includes only trials that met predefined criteria for trustworthiness. We removed three trials from the analysis that were included in the previous version of this review.\nThe risk of bias was low for random sequence generation, allocation concealment and incomplete outcome data. The risk of bias for selective outcome reporting was unclear because there was no published trial protocol, and therefore it is unclear whether all the planned outcomes were reported in full. Due to a lack of blinding we judged there to be high risk of performance bias and detection bias. We downgraded the certainty of the evidence because of concerns about risk of bias and because of imprecision due to low event rates and wide 95% confidence intervals (CIs), which are consistent with possible benefit and possible harm\nCompared with usual care, it is uncertain if antenatal corticosteroids reduce the risk of RDS (relative risk (RR) 0.34 95% CI 0.07 to 1.65; 1 study; 942 infants) or TTN (RR 0.52, 95% CI 0.25 to 1.11; 1 study; 938 infants) because the certainty of evidence is low and the 95% CIs are consistent with possible benefit and possible harm.\nAntenatal corticosteroids probably reduce the risk of admission to neonatal special care for respiratory complications, compared with usual care (RR 0.45, 95% CI 0.22 to 0.90; 1 study; 942 infants; moderate-certainty evidence). The proportion of infants admitted to neonatal special care for respiratory morbidity after treatment with antenatal corticosteroids was 2.3% compared with 5.1% in the usual care group.\nIt is uncertain if antenatal steroids have any effect on the risk of needing mechanical ventilation, compared with usual care (RR 4.07, 95% CI 0.46 to 36.27; 1 study; 942 infants; very low-certainty evidence). The effect of antenatal corticosteroids on the maternal development of postpartum infection/pyrexia in the first 72 hours is unclear due to the very low certainty of the evidence; one study (942 women) reported zero cases. The included studies did not report any data for neonatal hypoglycaemia or maternal mortality/severe morbidity.\nAuthors' conclusions\nEvidence from one randomised controlled trial suggests that prophylactic corticosteroids before elective caesarean section at term probably reduces admission to the neonatal intensive care unit for respiratory morbidity. It is uncertain if administration of antenatal corticosteroids reduces the rates of respiratory distress syndrome (RDS) or transient tachypnoea of the neonate (TTN). The overall certainty of the evidence for the primary outcomes was found to be low or very low, apart from the outcome of admission to neonatal special care (all levels) for respiratory morbidity, for which the evidence was of moderate certainty. Therefore, there is currently insufficient data to draw any firm conclusions.\nMore evidence is needed to investigate the effect of prophylactic antenatal corticosteroids on the incidence of recognised respiratory morbidity such as RDS. Any future trials should assess the balance between respiratory benefit and potential immediate adverse effects (e.g. hypoglycaemia) and long-term adverse effects (e.g. academic performance) for the infant. There is very limited information on maternal health outcomes to provide any assurances that corticosteroids do not pose any increased risk of harm to the mother.\nFurther research should consider investigating the effectiveness of antenatal steroids at different gestational ages prior to caesarean section. There are nine potentially eligible studies that are currently ongoing and could be included in future updates of this review.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Babies born at term (at or after 37 weeks of pregnancy) by planned (elective) caesarean section, before onset of labour, are more likely to develop breathing complications than babies born vaginally. Giving injections called corticosteroids to the mother has been shown to reduce the risk of breathing problems in babies born before 34 weeks of pregnancy, but it is not clear if they are also useful for babies born by caesarean section at term."
}
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query-laysum | 2053 | [
{
"role": "user",
"content": "Abstract: Background\nAcute splenic sequestration crises are a complication of sickle cell disease, with high mortality rates and frequent recurrence in survivors of first attacks. Splenectomy and blood transfusion, with their consequences, are the mainstay of long-term management used in different parts of the world. This is a 2017 update of a Cochrane Review first published in 2002, and previously updated, most recently in 2015.\nObjectives\nTo assess whether splenectomy (total or partial), to prevent acute splenic sequestration crises in people with sickle cell disease, improved survival and decreased morbidity in people with sickle cell disease, as compared with regular blood transfusions.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, which comprises of references identified from comprehensive electronic database searches and handsearching relevant journals and abstract books of conference proceedings. We also searched clinical trial registries. Additional trials were sought from the reference lists of the trials and reviews identified by the search strategy.\nDate of the most recent search: 14 August 2017.\nSelection criteria\nAll randomized or quasi-randomized controlled trials comparing splenectomy (total or partial) to prevent recurrence of acute splenic sequestration crises with no treatment or blood transfusions in people with sickle cell disease.\nData collection and analysis\nNo trials of splenectomy for acute splenic sequestration were found.\nMain results\nNo trials of splenectomy for acute splenic sequestration were found.\nAuthors' conclusions\nSplenectomy, if full, will prevent further sequestration and if partial, may reduce the recurrence of acute splenic sequestration crises. However, there is a lack of evidence from trials showing that splenectomy improves survival and decreases morbidity in people with sickle cell disease. There is a need for a well-designed, adequately-powered, randomized controlled trial to assess the benefits and risks of splenectomy compared to transfusion programmes, as a means of improving survival and decreasing mortality from acute splenic sequestration in people with sickle cell disease.\nThere are no trials included in the review and we have not identified any relevant trials up to August 2017. We will continue to run searches to identify any potentially relevant trials; however, we do not plan to update other sections of the review until new trials are published.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence to see whether removing all, of part of, the spleen to prevent acute splenic sequestration improved survival and decreased illness in people with sickle cell disease, as compared with regular blood transfusion. This is a 2017 update of a Cochrane Review first published in 2002, and previously updated, most recently in 2015."
}
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query-laysum | 2054 | [
{
"role": "user",
"content": "Abstract: Background\nBreathlessness is a common and disabling symptom which affects many people with advanced cardiorespiratory disease and cancer. The most effective treatments are aimed at treating the underlying disease. However, this may not always be possible, and symptomatic treatment is often required in addition to maximal disease-directed therapy. Opioids are increasingly being used to treat breathlessness, although their mechanism of action is still not completely known. A few good sized, high quality trials have been conducted in this area.\nObjectives\nTo determine the effectiveness of opioid drugs in relieving the symptom of breathlessness in people with advanced disease due to malignancy, respiratory or cardiovascular disease, or receiving palliative care for any other disease.\nSearch methods\nWe performed searches on CENTRAL, MEDLINE, EMBASE, CINAHL, and Web of Science up to 19 October 2015. We handsearched review articles, clinical trial registries, and reference lists of retrieved articles.\nSelection criteria\nWe included randomised double-blind controlled trials that compared the use of any opioid drug against placebo or any other intervention for the relief of breathlessness. The intervention was any opioid, given by any route, in any dose.\nData collection and analysis\nWe imported studies identified by the search into a reference manager database. We retrieved the full-text version of relevant studies, and two review authors independently extracted data. The primary outcome measure was breathlessness and secondary outcome measures included exercise tolerance, oxygen saturations, adverse events, and mortality. We analysed all studies together and also performed subgroup analyses, by route of administration, type of opioid administered, and cause of breathlessness. Where appropriate, we performed meta-analysis. We assessed the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and created three 'Summary of findings' tables.\nMain results\nWe included 26 studies with 526 participants. We assessed the studies as being at high or unclear risk of bias overall. We only included randomised controlled trials (RCTs), although the description of randomisation was incomplete in some included studies. We aimed to include double blind RCTs, but two studies were only single blinded. There was inconsistency in the reporting of outcome measures. We analysed the data using a fixed-effect model, and for some outcomes heterogeneity was high. There was a risk of imprecise results due to the low numbers of participants in the included studies. For these reasons we downgraded the quality of the evidence from high to either low or very low.\nFor the primary outcome of breathlessness, the standardised mean post-treatment dyspnoea score was 0.32 points better in the opioid group compared to the placebo group (ranging from a 0.53 point reduction to a 0.10 point reduction) (12 RCTs, 338 participants, low quality evidence). The standardised mean change from baseline dyspnoea score was 0.11 points better in the opioids group compared to the placebo group (ranging from a 0.40 point reduction to a 0.19 increase) (six RCTs, 194 participants, very low quality evidence). A lower score indicates an improvement in breathlessness.\nThe evidence for the six-minute walk test (6MWT) was conflicting. The total distance in 6MWT was 28 metres (m) better in the opioids group compared to placebo (ranging from 113 m to 58 m) (one RCT, 11 participants, very low quality evidence). However, the change in baseline was 48 m worse in the opioids group (ranging from 36 m to 60 m) (two RCTs, 26 participants, very low quality evidence).\nThe adverse effects reported included drowsiness, nausea and vomiting, and constipation. In those studies, participants were 4.73 times more likely to experience nausea and vomiting compared to placebo, three times more likely to experience constipation, and 2.86 times more likely to experience drowsiness (nine studies, 162 participants, very low quality evidence).\nOnly four studies assessed quality of life, and none demonstrated any significant change.\nAuthors' conclusions\nThere is some low quality evidence that shows benefit for the use of oral or parenteral opioids to palliate breathlessness, although the number of included participants was small. We found no evidence to support the use of nebulised opioids. Further research with larger numbers of participants, using standardised protocols and with quality of life measures included, is needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies up to 19 October 2015, and we included 26 studies with 526 people. These people had breathlessness from different types of lung disease. Some were given opioid drugs and some were given other drugs or a placebo, and studies compared the reporting of breathlessness to see if there was any difference. Some studies also looked at the amount of time people could exercise to see if there were any differences. Some people came from home, and some came from the hospital setting."
}
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query-laysum | 2055 | [
{
"role": "user",
"content": "Abstract: Background\nInfectious morbidities contribute to considerable maternal and perinatal morbidity and mortality, including women at no apparent increased risk of infection. To reduce the incidence of infections, antibiotics are often administered to women after uncomplicated childbirth, particularly in settings where women are at higher risk of puerperal infectious morbidities.\nObjectives\nTo assess whether routine administration of prophylactic antibiotics to women after normal (uncomplicated) vaginal birth, compared with placebo or no antibiotic prophylaxis, reduces postpartum maternal infectious morbidities and improves outcomes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2017), LILACS, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (22 August 2017) and reference lists of retrieved studies.\nSelection criteria\nWe planned to include randomised or quasi-randomised trials evaluating the use of prophylactic antibiotics versus placebo or no antibiotic prophylaxis. Trials using a cluster-randomised design would have been eligible for inclusion, but we found none.\nIn future updates of this review, we will include studies published in abstract form only, provided sufficient information is available to assess risks of bias. We will consider excluded abstracts for inclusion once the full publication is available, or the authors provide more information.\nTrials using a cross-over design are not eligible for inclusion in this review.\nData collection and analysis\nTwo review authors conducted independent assessment of trials for inclusion and risks of bias. They independently extracted data and checked them for accuracy, resolving differences in assessments by discussion. They evaluated methodological quality using standard Cochrane criteria and the GRADE approach.\nWe present the summaries as risk ratios (RRs) and mean difference (MDs) using fixed- or random-effect models. For one primary outcome we found considerable heterogeneity and interaction. We explored further using subgroup analysis to investigate the effects of the randomisation unit. All review authors discussed and interpreted the results.\nMain results\nOne randomised controlled trial (RCT) and two quasi-RCTs contributed data on 1779 women who had uncomplicated vaginal births, comparing different antibiotic regimens with placebo or no treatment. The included trials took place in the 1960s (one trial) and 1990s (two trials). The trials were conducted in France, the USA and Brazil. Antibiotics administered included: oral sulphamethoxypyridazine or chloramphenicol for three to five days, and intravenous amoxicillin and clavulanic acid in a single dose one hour after birth. We rated most of the domains for risk of bias as high risk, with the exception of reporting bias and other potential bias.\nThe quality of evidence ranged from low to very low, based on the GRADE quality assessment, given very serious design limitations of the included studies, few events and wide confidence intervals (CIs) of effect estimates.\nWe found a decrease in the risk of endometritis (RR 0.28, 95% CI 0.09 to 0.83, two trials, 1364 women,very low quality). However, one trial reported zero events for this outcome and we rate the evidence as very low quality. There was little or no difference between groups for the risk of urinary tract infection (RR 0.25, 95% CI 0.05 to 1.19, two trials, 1706 women,low quality), wound infection after episiotomy (reported as wound dehiscence in the included trials) (RR 0.78, 95% CI 0.31 to 1.96, two trials, 1364 women, very low quality) and length of maternal hospital stay in days (MD -0.15, 95% CI -0.31 to 0.01, one trial, 1291 women, very low quality). Cost of care in US dollar equivalent was 2½ times higher in the control group compared to the group receiving antibiotics prophylaxis (USD 3600: USD 9000, one trial, 1291 women). There were few or no differences between treated and control groups for adverse effects of antibiotics (skin rash) reported in one woman in each of the two trials (RR 3.03, 95% CI 0.32 to 28.95, two trials, 1706 women, very low quality). The incidence of severe maternal infectious morbidity, antimicrobial resistance or women's satisfaction with care were not addressed by any of the included studies.\nAuthors' conclusions\nRoutine administration of antibiotics may reduce the risk of endometritis after uncomplicated vaginal birth. The small number and nature of the trials limit the interpretation of the evidence for application in practice, particularly in settings where women may be at higher risk of developing endometritis. The use of antibiotics did not reduce the incidence of urinary tract infections, wound infection or the length of maternal hospital stay. Antibiotics are not a substitute for infection prevention and control measures around the time of childbirth and the postpartum period. The decision to routinely administer prophylactic antibiotics after normal vaginal births needs to be balanced by patient features, childbirth setting and provider experience, including considerations of the contribution of indiscriminate use of antibiotics to raising antimicrobial resistance. Well-designed and high-powered randomised controlled trials would help to evaluate the added value of routine antibiotic administration as a measure to prevent maternal infections after normal vaginal delivery.\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": "Infections that occur during childbirth can result in considerable ill health and even death for the mother or her infant. The risk of infection is believed to be higher for births in healthcare facilities in low-resource settings than in well-resourced settings, as a result of poor hygienic conditions, inadequate water and sanitation systems, overcrowding and low health professional-to-patient ratios. The prescription of antibiotics after an uncomplicated vaginal birth has become routine practice to overcome this situation in some low-resource settings."
}
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query-laysum | 2056 | [
{
"role": "user",
"content": "Abstract: Background\nEczema is a common chronic skin condition. Probiotics have been proposed as an effective treatment for eczema; their use is increasing, as numerous clinical trials are under way. This is an update of a Cochrane Review first published in 2008, which suggested that probiotics may not be an effective treatment for eczema but identified areas in which evidence was lacking.\nObjectives\nTo assess the effects of probiotics for treating patients of all ages with eczema.\nSearch methods\nWe updated our searches of the following databases to January 2017: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, the Global Resource of Eczema Trials (GREAT) database, MEDLINE, Embase, PsycINFO, the Allied and Complementary Medicine Database (AMED), and Latin American Caribbean Health Sciences Literature (LILACS). We searched five trials registers and checked the reference lists of included studies and relevant reviews for further references to relevant randomised controlled trials (RCTs). We also handsearched a number of conference proceedings. We updated the searches of the main databases in January 2018 and of trials registries in March 2018, but we have not yet incorporated these results into the review.\nSelection criteria\nRandomised controlled trials of probiotics (live orally ingested micro-organisms) compared with no treatment, placebo, or other active intervention with no probiotics for the treatment of eczema diagnosed by a doctor.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. We recorded adverse events from the included studies and from a separate adverse events search conducted for the first review. We formally assessed reporting bias by preparing funnel plots, and we performed trial sequential analysis for the first primary outcome - eczema symptoms at the end of active treatment.\nWe used GRADE to assess the quality of the evidence for each outcome (in italic font).\nMain results\nWe included 39 randomised controlled trials involving 2599 randomised participants. We included participants of either gender, aged from the first year of life through to 55 years (only six studies assessed adults), who had mild to severe eczema. Trials were undertaken in primary and secondary healthcare settings, mainly in Europe or Asia. Duration of treatment ranged from four weeks to six months, and duration of follow-up after end of treatment ranged from zero to 36 months. We selected no standard dose: researchers used a variety of doses and concentrations of probiotics. The probiotics used were bacteria of the Lactobacillus and Bifidobacteria species, which were taken alone or combined with other probiotics, and were given with or without prebiotics. Comparators were no treatment, placebo, and other treatments with no probiotics.\nFor all results described in this abstract, the comparator was no probiotics. Active treatment ranged from six weeks to three months for all of the following results, apart from the investigator-rated eczema severity outcome, for which the upper limit of active treatment was 16 weeks. With regard to score, the higher the score, the more severe were the symptoms. All key results reported in this abstract were measured at the end of active treatment, except for adverse events, which were measured during the active treatment period.\nProbiotics probably make little or no difference in participant- or parent-rated symptoms of eczema (13 trials; 754 participants): symptom severity on a scale from 0 to 20 was 0.44 points lower after probiotic treatment (95% confidence interval (CI) -1.22 to 0.33; moderate-quality evidence). Trial sequential analysis shows that target sample sizes of 258 and 456, which are necessary to demonstrate a minimum mean difference of -2 and -1.5, respectively, with 90% power, have been exceeded, suggesting that further trials with similar probiotic strains for this outcome at the end of active treatment may be futile.\nWe found no evidence suggesting that probiotics make a difference in QoL for patients with eczema (six studies; 552 participants; standardised mean difference (SMD) 0.03, 95% CI -0.36 to 0.42; low-quality evidence) when measured by the participant or the parent using validated disease-specific QoL instruments.\nProbiotics may slightly reduce investigator-rated eczema severity scores (24 trials; 1596 participants). On a scale of 0 to 103 for total Severity Scoring of Atopic Dermatitis (SCORAD), a score combining investigator-rated eczema severity score and participant scoring for eczema symptoms of itch and sleep loss was 3.91 points lower after probiotic treatment than after no probiotic treatment (95% CI -5.86 to -1.96; low-quality evidence). The minimum clinically important difference for SCORAD has been estimated to be 8.7 points.\nWe noted significant to extreme levels of unexplainable heterogeneity between the results of individual studies. We judged most studies to be at unclear risk of bias; six studies had high attrition bias, and nine were at low risk of bias overall.\nWe found no evidence to show that probiotics make a difference in the risk of adverse events during active treatment (risk ratio (RR) 1.54, 95% CI 0.90 to 2.63; seven trials; 402 participants; low-quality evidence). Studies in our review that reported adverse effects described gastrointestinal symptoms.\nAuthors' conclusions\nEvidence suggests that, compared with no probiotic, currently available probiotic strains probably make little or no difference in improving patient-rated eczema symptoms. Probiotics may make little or no difference in QoL for people with eczema nor in investigator-rated eczema severity score (combined with participant scoring for eczema symptoms of itch and sleep loss); for the latter, the observed effect was small and of uncertain clinical significance. Therefore, use of probiotics for the treatment of eczema is currently not evidence-based. This update found no evidence of increased adverse effects with probiotic use during studies, but a separate adverse events search from the first review revealed that probiotic treatment carries a small risk of adverse events.\nResults show significant, unexplainable heterogeneity between individual trial results. Only a small number of studies measured some outcomes.\nFuture studies should better measure QoL scores and adverse events, and should report on new probiotics. Researchers should also consider studying subgroups of patients (e.g. patients with atopy or food allergies, adults) and standardising doses/concentrations of probiotics given.\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": "Please note that results in this summary are based on the following: a comparison of probiotic against no probiotic; treatment over six weeks to three months, except for the investigator-rated eczema severity outcome, for which participants were treated longer (16 weeks); and outcomes measured at the end of the treatment period, apart from adverse events, which were assessed throughout treatment. Unless otherwise stated, outcomes were measured by participants or parents. The included studies assessed a variety of probiotics of differing concentrations or doses. With regard to score, the higher the score, the more severe were the symptoms.\nWe found that currently available probiotics probably make little or no difference in reducing eczema symptoms, such as itching and sleep loss (moderate-quality evidence).\nHowever, we did find that these probiotics may slightly reduce the severity of eczema scored by patients and their healthcare professionals in combination (low-quality evidence), although it is uncertain if such a change is meaningful for patients.\nIn terms of patient quality of life, we found no evidence that probiotics make a difference (low-quality evidence).\nWe found no evidence of an increase in adverse events; those reported in included studies that were related to treatment were tummy and gut upset with diarrhoea, constipation, vomiting, and colic pains (low-quality evidence).\nAnalysis suggests that further probiotic studies assessing the effects of eczema symptoms may not be worthwhile, as they are unlikely to change the outcome at the end of active treatment."
}
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query-laysum | 2057 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a highly prevalent neurological condition characterised by repeated unprovoked seizures with various aetiologies. Although antiepileptic medications produce clinical improvement in many individuals, nearly a third of individuals have drug-resistant epilepsy that carries significant morbidity and mortality, and even individuals who have clinical improvement from antiepileptic medications often report iatrogenic symptoms. There remains a need for non-invasive and more effective therapies for this population. Transcranial magnetic stimulation (TMS) uses electromagnetic coils to excite or inhibit neurons, with repetitive pulses at low-frequency producing an inhibitory effect that could conceivably reduce cortical excitability associated with epilepsy.\nThis is an updated version of the original Cochrane Review published in 2016.\nObjectives\nTo assess the evidence for the use of TMS in individuals with drug-resistant epilepsy compared with other available treatments in reducing seizure frequency, improving quality of life, reducing epileptiform discharges, antiepileptic medication use, and side effects.\nSearch methods\nFor the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid 1946 to 2 June 2020). CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Epilepsy.\nSelection criteria\nWe included randomised controlled trials that were double-blinded, single-blinded, or unblinded, and placebo controlled, no treatment, or active controlled, which used repetitive transcranial magnetic stimulation (rTMS) without restriction of frequency, coil, duration or intensity on participants with drug-resistant epilepsy.\nData collection and analysis\nWe extracted information from each trial including methodological data; participant demographics including baseline seizure frequency, type of epileptic drugs taken; intervention details and intervention groups for comparison; potential biases; and outcomes and time points, primarily change in seizure frequency or responder rates, as well as quality of life and epileptiform discharges, adverse effects, and changes in medication use.\nMain results\nThe original search revealed 274 records from the databases that after selection provided seven full-text relevant studies for inclusion. The latest search identified 179 new records from the databases that after evaluation against the inclusion and exclusion criteria provided one additional full-text relevant study. The eight included studies (241 participants) were all randomised trials; seven of the studies were blinded. Methodological and design information in the included studies was unclear, particularly relating to randomisation and allocation concealment methods. We were not able to combine the results of the trials in analysis due to differences in the studies' designs.\nFor the current update, two of the eight studies analysed showed a statistically significant reduction in seizure rate from baseline (72% and 78.9% reduction of seizures per week from the baseline rate, respectively), whilst the other six studies showed no statistically significant difference in seizure frequency following rTMS treatment compared with controls (low-certainty evidence). One study assessed quality of life and found that more participants showed improvement in quality of life scores with active treatments compared to the sham treatment, but this only involved seven participants (very low-certainty evidence).\nFour studies evaluated our secondary endpoint of mean number of epileptic discharges, three of which showed a statistically significant reduction in discharges after active rTMS treatment. Adverse effects were uncommon in the studies and typically involved headache, dizziness, and tinnitus; however increased seizure frequency did occur in a small number of individuals. The included trials reported no significant changes in medication use. Overall the risk of bias was either low or unclear, and the certainty of the evidence was low to very low.\nAuthors' conclusions\nOverall, we judged the certainty of evidence for the primary outcomes of this review to be low to very low. We found some evidence to suggest that rTMS is safe but some adverse events were experienced. The variability in technique and outcome reporting prevented meta-analysis, and the evidence for efficacy of rTMS for seizure reduction is still lacking, despite reasonable evidence that it is effective at reducing epileptiform discharges.\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": "Epilepsy is a common neurological disorder that appears in various forms. Many individuals with epilepsy have satisfactory seizure control with the use of antiepileptic medications. Yet, nearly a third of people with epilepsy suffer from frequent and uncontrolled seizures despite the use of medication, or are unable to tolerate the side effects of those medications. Surgery is an option for some people with uncontrolled seizures, but it is invasive and not suitable for all individuals. As a result, there remains a substantial unmet need for safe, effective therapies for these harder-to-treat epilepsies.\nTranscranial magnetic stimulation (TMS) is one of several newer treatments that can potentially offer people with epilepsy a safe and non-invasive alternative to surgery. Long used as a research tool to study brain function, TMS has also been studied as a possible treatment for a number of nervous system conditions, including epilepsy. This non-surgical and painless treatment uses induced magnetic currents to regulate brain function in order to reduce the tendency to have seizures."
}
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query-laysum | 2058 | [
{
"role": "user",
"content": "Abstract: Background\nCircuit class therapy (CCT) offers a supervised group forum for people after stroke to practise tasks, enabling increased practice time without increasing staffing. This is an update of the original review published in 2010.\nObjectives\nTo examine the effectiveness and safety of CCT on mobility in adults with stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched January 2017), CENTRAL (the Cochrane Library, Issue 12, 2016), MEDLINE (1950 to January 2017), Embase (1980 to January 2017), CINAHL (1982 to January 2017), and 14 other electronic databases (to January 2017). We also searched proceedings from relevant conferences, reference lists, and unpublished theses; contacted authors of published trials and other experts in the field; and searched relevant clinical trials and research registers.\nSelection criteria\nRandomised controlled trials (RCTs) including people over 18 years old, diagnosed with stroke of any severity, at any stage, or in any setting, receiving CCT.\nData collection and analysis\nReview authors independently selected trials for inclusion, assessed risk of bias in all included studies, and extracted data.\nMain results\nWe included 17 RCTs involving 1297 participants. Participants were stroke survivors living in the community or receiving inpatient rehabilitation. Most could walk 10 metres without assistance. Ten studies (835 participants) measured walking capacity (measuring how far the participant could walk in six minutes) demonstrating that CCT was superior to the comparison intervention (Six-Minute Walk Test: mean difference (MD), fixed-effect, 60.86 m, 95% confidence interval (CI) 44.55 to 77.17, GRADE: moderate). Eight studies (744 participants) measured gait speed, again finding in favour of CCT compared with other interventions (MD 0.15 m/s, 95% CI 0.10 to 0.19, GRADE: moderate). Both of these effects are considered clinically meaningful. We were able to pool other measures to demonstrate the superior effects of CCT for aspects of walking and balance (Timed Up and Go: five studies, 488 participants, MD -3.62 seconds, 95% CI -6.09 to -1.16; Activities of Balance Confidence scale: two studies, 103 participants, MD 7.76, 95% CI 0.66 to 14.87). Two other pooled balance measures failed to demonstrate superior effects (Berg Blance Scale and Step Test). Independent mobility, as measured by the Stroke Impact Scale, Functional Ambulation Classification and the Rivermead Mobility Index, also improved more in CCT interventions compared with others. Length of stay showed a non-significant effect in favour of CCT (two trials, 217 participants, MD -16.35, 95% CI -37.69 to 4.99). Eight trials (815 participants) measured adverse events (falls during therapy): there was a non-significant effect of greater risk of falls in the CCT groups (RD 0.03, 95% CI -0.02 to 0.08, GRADE: very low). Time after stroke did not make a difference to the positive outcomes, nor did the quality or size of the trials. Heterogeneity was generally low; risk of bias was variable across the studies with poor reporting of study conduct in several of the trials.\nAuthors' conclusions\nThere is moderate evidence that CCT is effective in improving mobility for people after stroke - they may be able to walk further, faster, with more independence and confidence in their balance. The effects may be greater later after the stroke, and are of clinical significance. Further high-quality research is required, investigating quality of life, participation and cost-benefits, that compares CCT with standard care and that also investigates the influence of factors such as stroke severity and age. The potential risk of increased falls during CCT needs to be monitored.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This is an update of the original review in 2010. We considered studies comparing circuit class therapy with conventional therapy for people with stroke, and included only high-quality studies with a low risk of being biased. We were interested in studies that compared these two approaches and their effects on the way people walk, how far, how fast, and how independently. We also looked for studies that investigated if the circuit classes were more or less likely to be harmful than conventional approaches. The evidence is current to January 2017."
}
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query-laysum | 2059 | [
{
"role": "user",
"content": "Abstract: Background\nThis an update of a Cochrane Review.\nParaquat is a widely used herbicide, but is also a lethal poison. In some low- and middle-income countries (LMICs) paraquat is commonly available and inexpensive, making poisoning prevention difficult. Most of the people poisoned by paraquat have taken it as a means of self-poisoning.\nStandard treatment for paraquat poisoning prevents further absorption and reduces the load of paraquat in the blood through haemoperfusion or haemodialysis. The effectiveness of standard treatments is extremely limited.\nThe immune system plays an important role in exacerbating paraquat-induced lung fibrosis. Immunosuppressive treatment using glucocorticoid and cyclophosphamide in combination has been developed and studied as an intervention for paraquat poisoning.\nObjectives\nTo assess the effects of glucocorticoid with cyclophosphamide for moderate to severe oral paraquat poisoning.\nSearch methods\nThe most recent searches were run in September 2020. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Injuries Trials Register), Ovid MEDLINE(R), Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily and Ovid OLDMEDLINE, Embase Classic + Embase (Ovid), ISI WOS (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), and trials registries. We also searched the following three resources: China National Knowledge Infrastructure database (CNKI 数据库); Wanfang Data (万方数据库); and VIP (维普数据库) on 12 November 2020. We examined the reference lists of included studies and review papers.\nSelection criteria\nWe included randomised controlled trials (RCTs). For this update, in accordance with Cochrane Injuries' Group policy (2015), we included only prospectively registered RCTs for trials published after 2010. We included trials which assessed the effects of glucocorticoid with cyclophosphamide delivered in combination. Eligible comparators were standard care (with or without a placebo), or any other therapy in addition to standard care. Outcomes of interest included mortality and infections.\nData collection and analysis\nWe calculated the mortality risk ratio (RR) and 95% confidence interval (CI). Where possible, we summarised data for all-cause mortality at relevant time periods (from hospital discharge to three months after discharge) in meta-analysis, using a fixed-effect model. We conducted sensitivity analyses based on factors including whether participants were assessed at baseline for plasma paraquat levels. We also reported data on infections within one week after initiation of treatment.\nMain results\nWe included four trials with a total of 463 participants. The included studies were conducted in Taiwan (Republic of China), Iran, and Sri Lanka. Most participants were male. The mean age of participants was 28 years.\nWe judged two of the four included studies, including the largest and most recently conducted study (n = 299), to be at low risk of bias for key domains including sequence generation. We assessed one study to be at high risk of selection bias and another at unclear risk, since allocation concealment was either not mentioned in the trial report or explicitly not undertaken. We assessed three of the four studies to be at unclear risk of selective reporting, as no protocols could be identified. An important source of heterogeneity amongst the included studies was the method of assessment of participants' baseline severity using analysis of plasma levels (two studies employed this method, whilst the other two did not).\nNo studies assessed the outcome of mortality at 30 days following ingestion of paraquat.\nLow-certainty evidence from two studies indicates that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce the risk of death in hospital compared to standard care alone ((RR 0.82, 95% CI 0.68 to 0.99; participants = 322); results come from sensitivity analysis excluding studies not assessing plasma at baseline). However, we have limited confidence in this finding as heterogeneity was high (I2 = 77%) and studies varied in terms of size and comparators. A single large study provided data showing that there may be little or no effect of treatment at three months post discharge from hospital (RR 0.98, 95% CI 0.85 to 1.13; 1 study, 293 participants; low-certainty evidence); however, analysis of long-term results amongst participants whose injuries arose from self-poisoning must be interpreted with caution.\nWe remain uncertain of the effect of glucocorticoids with cyclophosphamide on infection within one week after initiation of the treatment; this outcome was assessed by two small studies only (31 participants, very low-certainty evidence) that considered leukopenia as a proxy or risk factor for infection. Neither study reported infections in any participants.\nAuthors' conclusions\nLow-certainly evidence suggests that glucocorticoids with cyclophosphamide in addition to standard care may slightly reduce mortality in hospitalised people with oral paraquat poisoning. However, we have limited confidence in this finding because of substantial heterogeneity and concerns about imprecision. Glucocorticoids with cyclophosphamide in addition to standard care may have little or no effect on mortality at three months after hospital discharge. We are uncertain whether glucocorticoid with cyclophosphamide puts patients at an increased risk of infection due to the limited evidence available for this outcome. Future research should be prospectively registered and CONSORT-compliant. Investigators should attempt to ensure an adequate sample size, screen participants for inclusion rigorously, and seek long-term follow-up of participants. Investigators may wish to research the effects of glucocorticoid in combination with other treatments.\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 four studies that involved 463 people with confirmed paraquat poisoning. Two studies were conducted in Taiwan (Republic of China), one in Iran, and one in Sri Lanka.\nAll participants were given either:\n- usual care only, or\n- steroids (methylprednisolone alone, or with dexamethasone) plus cyclophosphamide, as well as usual care. Cyclophosphamide was given before the steroid(s) or at the same time as them.\nTwo of the studies measured the severity of poisoning by testing patients’ plasma (a component of blood) at the start of the study. Plasma tests provide the best assessment of how seriously a person is affected by paraquat poisoning.\nOne study used a placebo (sham) treatment in addition to usual care. Two studies gave patients a steroid (dexamethasone) as part of the usual care."
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query-laysum | 2060 | [
{
"role": "user",
"content": "Abstract: Background\nGenital herpes is caused by herpes simplex virus 1 (HSV-1) or 2 (HSV-2). Some infected people experience outbreaks of genital herpes, typically, characterized by vesicular and erosive localized painful genital lesions.\nObjectives\nTo compare the effectiveness and safety of three oral antiviral drugs (acyclovir, famciclovir and valacyclovir) prescribed to suppress genital herpes outbreaks in non-pregnant patients.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the search portal of the World Health Organization International Clinical Trials Registry Platform and pharmaceutical company databases up to February 2014. We also searched US Food and Drug Administration databases and proceedings of seven congresses to a maximum of 10 years. We contacted trial authors and pharmaceutical companies.\nSelection criteria\nWe selected parallel-group and cross-over randomized controlled trials including patients with recurrent genital herpes caused by HSV, whatever the type (HSV-1, HSV-2, or undetermined), with at least four recurrences per year (trials concerning human immunodeficiency virus (HIV)-positive patients or pregnant women were not eligible) and comparing suppressive oral antiviral treatment with oral acyclovir, famciclovir, and valacyclovir versus placebo or another suppressive oral antiviral treatment.\nData collection and analysis\nTwo review authors independently selected eligible trials and extracted data. The Risk of bias tool was used to assess risk of bias. Treatment effect was measured by the risk ratio (RR) of having at least one genital herpes recurrence. Pooled RRs were derived by conventional pairwise meta-analyses. A network meta-analysis allowed for estimation of all possible two-by-two comparisons between antiviral drugs.\nMain results\nA total of 26 trials (among which six had a cross-over design) were included. Among the 6950 randomly assigned participants, 54% (range 0 to100%) were female, mean age was 35 years (range 26 to 45.1), and the mean number of recurrences per year was 11 (range 6.3 to 17.8). Duration of treatment was two to 12 months. Risk of bias was considered high for half of the studies and unclear for the other half. A total of 14 trials compared acyclovir versus placebo, four trials compared valacyclovir versus placebo and 2 trials compared valacyclovir versus no treatment. Three trials compared famciclovir versus placebo. Two trials compared valacyclovir versus famciclovir and one trial compared acyclovir versus valacyclovir versus placebo.\nWe analyzed data from 22 trials for the outcome: risk of having at least one clinical recurrence. We could not obtain the outcome data for four trials. In placebo-controlled trials, there was a low quality evidence that the risk of having at least one clinical recurrence was reduced with acyclovir (nine parallel-group trials, n = 2049; pooled RR 0.48, 95% confidence interval (CI) 0.39 to 0.58), valacyclovir (four trials, n = 1788; pooled RR 0.41, 95% CI 0.24 to 0.69), or famciclovir (two trials, n = 732; pooled RR 0.57, 95% CI 0.50 to 0.64). The six cross-over trials showed larger treatment effects on average than the parallel-group trials. We found evidence of a small-study effect for acyclovir placebo-controlled trials (adjusted pooled RR 0.61, 95% CI 0.49 to 0.75). In analyzing parallel-group trials by daily dose, no clear evidence was found of a dose-response relationship for any drug. In head-to-head trials, the risk of having at least one recurrence was increased with valacyclovir rather than acyclovir (one trial, n = 1345; RR 1.16, 95% CI 1.01 to 1.34) and was not significantly different from that seen with famciclovir as compared with valacyclovir (one trial, n = 320; RR 1.18, 95% CI 0.86 to 1.63).\nWe included 16 parallel-arm trials in a network meta-analysis and we were unable to determine which of the drugs was most effective in reducing the risk of at least one clinical recurrence (after adjustment for small-study effects, pooled RR 0.83, 95% CI 0.61 to 1.11 for valacyclovir vs acyclovir; pooled RR 1.04, 95% CI, 0.71 to 1.49 for famciclovir vs acyclovir; and pooled RR 1.26, 95% CI 0.89 to 1.75 for famciclovir vs valacyclovir). Safety data were sought but were reported as total numbers of adverse events.\nAuthors' conclusions\nOwing to risk of bias and inconsistency, there is low quality evidence that suppressive antiviral therapy with acyclovir, valacyclovir or famciclovir in pacients experiencing at least four recurrences of genital herpes per year decreases the number of pacients with at least one recurrence as compared with placebo. Network meta-analysis of the few direct comparisons and the indirect comparisons did not show superiority of one drug over another.\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": "Suppressive antiviral therapy with acyclovir, valacyclovir, or famciclovir in patients experiencing at least four recurrences per year decreases the number of patients having at least one recurrence compared with placebo. There is no evidence that suggests that any of these drugs is superior to the others."
}
]
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query-laysum | 2061 | [
{
"role": "user",
"content": "Abstract: Background\nAcute ischemic stroke (AIS) is the abrupt reduction of blood flow to a certain area of the brain which causes neurologic dysfunction. Different types of percutaneous arterial endovascular interventions have been developed, but as yet there is no consensus on the optimal therapy for people with AIS.\nObjectives\nTo compare the safety and efficacy of different types of percutaneous arterial endovascular interventions for treating people with AIS.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4 of 12, 2022), MEDLINE Ovid (1946 to 13 May 2022), Embase (1947 to 15 May 2022), Science Citation Index Web of Science (1900 to 15 May 2022), Scopus (1960 to 15 May 2022), and China Biological Medicine Database (CBM; 1978 to 16 May 2022). We also searched the ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 16 May 2022.\nSelection criteria\nRandomized controlled trials (RCTs) comparing one percutaneous arterial endovascular intervention with another in treating adult patients who have a clinical diagnosis of AIS due to large vessel occlusion and confirmed by imaging evidence, including thrombo-aspiration, stent-retrieval thrombectomy, aspiration-retriever combined technique, and thrombus mechanical fragmentation.\nData collection and analysis\nTwo review authors independently performed the literature searches, identified eligible trials, and extracted data. A third review author participated in discussions to reach consensus decisions when any disputes occurred. We assessed risk of bias and applied the GRADE approach to evaluate the quality of the evidence. The primary outcome was rate of modified Rankin Scale (mRS) of 0 to 2 at three months. Secondary outcomes included the rate of modified Thrombolysis In Cerebral Infarction (mTICI) of 2b to 3 postprocedure, all-cause mortality within three months, rate of intracranial hemorrhage on imaging at 24 hours, rate of symptomatic intracranial hemorrhage at 24 hours, and rate of procedure-related adverse events within three months.\nMain results\nFour RCTs were eligible. The current meta-analysis included two trials with 651 participants comparing thrombo-aspiration with stent-retrieval thrombectomy. We judged the quality of evidence to be high in both trials according to Cochrane's risk of bias tool RoB 2.\nThere were no significant differences between thrombo-aspiration and stent-retrieval thrombectomy in rate of mRS of 0 to 2 at three months (risk ratio [RR] 0.97, 95% confidence interval [CI] 0.82 to 1.13; P = 0.68; 633 participants; 2 RCTs); rate of mTICI of 2b to 3 postprocedure (RR 1.01, 95% CI 0.95 to 1.07; P = 0.77; 650 participants; 2 RCTs); all-cause mortality within three months (RR 1.01, 95% CI 0.74 to 1.37; P = 0.95; 633 participants; 2 RCTs); rate of intracranial hemorrhage on imaging at 24 hours (RR 1.03, 95% CI 0.86 to 1.24; P = 0.73; 645 participants; 2 RCTs); rate of symptomatic intracranial hemorrhage at 24 hours (RR 0.90, 95% CI 0.49 to 1.68; P = 0.75; 645 participants; 2 RCTs); and rate of procedure-related adverse events within three months (RR 0.98, 95% CI 0.68 to 1.41; P = 0.90; 651 participants; 2 RCTs).\nAnother two included studies reported no differences for the comparisons of combined therapy versus stent-retrieval thrombectomy or thrombo-aspiration. One RCT is ongoing.\nAuthors' conclusions\nThis review did not establish any difference in safety and effectiveness between the thrombo-aspiration approach and stent-retrieval thrombectomy for treating people with AIS. Furthermore, the combined group did not show any obvious advantage over either intervention applied alone.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There was no clear difference in safety and effectiveness of the two approaches (thrombo-aspiration and stent-retrieval thrombectomy) in the management of AIS patients."
}
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query-laysum | 2062 | [
{
"role": "user",
"content": "Abstract: Background\nAcupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library.\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 other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials.\nSelection criteria\nWe included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache.\nData collection and analysis\nTwo review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation).\nMain results\nTwelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.\nAcupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.\nAcupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).\nAcupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.\nOverall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes.\nAuthors' conclusions\nThe available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - 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": "Tension-type headache is a common type of headache. Mild episodes may be treated adequately by pain-killers. In some individuals, however, tension-type headache occurs frequently and significantly impairs their quality of life. 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 tension-type headache. We found randomised controlled trials to evaluate whether acupuncture prevents tension-type headache. We looked mainly at the numbers of people who responded to treatment, which means a halving of the number of days on which they experienced a headache."
}
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query-laysum | 2063 | [
{
"role": "user",
"content": "Abstract: Background\nPreterm birth (PTB) remains the foremost global cause of perinatal morbidity and mortality. Thus, the prevention of spontaneous PTB still remains of critical importance. In an attempt to prevent PTB in singleton pregnancies, cervical cerclage, in combination with other treatments, has been advocated. This is because, cervical cerclage is an intervention that is commonly recommended in women with a short cervix at high risk of preterm birth but, despite this, many women still deliver prematurely, as the biological mechanism is incompletely understood. Additionally, previous Cochrane Reviews have been published on the effectiveness of cervical cerclage in singleton and multiple pregnancies, however, none has evaluated the effectiveness of using cervical cerclage in combination with other treatments.\nObjectives\nTo assess whether antibiotics administration, vaginal pessary, reinforcing or second cerclage placement, tocolytic, progesterone, or other interventions at the time of cervical cerclage placement prolong singleton gestation in women at high risk of pregnancy loss based on prior history and/or ultrasound finding of ’short cervix’ and/or physical examination.\nHistory-indicated cerclage is defined as a cerclage placed usually between 12 and 15 weeks gestation based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation for transvaginal ultrasound cervical length < 20 mm in a woman without cervical dilatation.\nPhysical exam-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation because of cervical dilatation of one or more centimetres detected on physical (manual) examination.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (26 September 2019), and reference lists of retrieved studies.\nSelection criteria\nWe included published, unpublished or ongoing randomised controlled trial (RCTs). Studies using a cluster-RCT design were also eligible for inclusion in this review but none were identified. We excluded quasi-RCTs (e.g. those randomised by date of birth or hospital number) and studies using a cross-over design. We also excluded studies that specified addition of the combination therapy after cervical cerclage because the woman subsequently became symptomatic. We included studies comparing cervical cerclage in combination with one, two or more interventions with cervical cerclage alone in singleton pregnancies.\nData collection and analysis\nTwo review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias, and evaluated the certainty of the evidence for this review's main outcomes. Data were checked for accuracy. Standard Cochrane review methods were used throughout.\nMain results\nWe identified two studies (involving a total of 73 women) comparing cervical cerclage alone to a different comparator. We also identified three ongoing studies (one investigating vaginal progesterone after cerclage, and two investigating cerclage plus pessary).\nOne study (20 women), conducted in the UK, comparing cervical cerclage in combination with a tocolytic (salbutamol) with cervical cerclage alone in women with singleton pregnancy did not provide any useable data for this review. The other study (involving 53 women, with data from 50 women) took place in the USA and compared cervical cerclage in combination with a tocolytic (indomethacin) and antibiotics (cefazolin or clindamycin) versus cervical cerclage alone - this study did provide useable data for this review (and the study authors also provided additional data on request) but meta-analyses were not possible. This study was generally at a low risk of bias, apart from issues relating to blinding. We downgraded the certainty of evidence for serious risk of bias and imprecision (few participants, few events and wide 95% confidence intervals).\nCervical cerclage in combination with an antibiotic and tocolytic versus cervical cerclage alone (one study, 50 women/babies)\nWe are unclear about the effect of cervical cerclage in combination with antibiotics and a tocolytic compared with cervical cerclage alone on the risk of serious neonatal morbidity (RR 0.62, 95% CI 0.31 to 1.24; very low-certainty evidence); perinatal loss (data for miscarriage and stillbirth only - data not available for neonatal death) (RR 0.46, 95% CI 0.13 to 1.64; very low-certainty evidence) or preterm birth < 34 completed weeks of pregnancy (RR 0.78, 95% CI 0.44 to 1.40; very low-certainty evidence). There were no stillbirths (intrauterine death at 24 or more weeks).\nThe trial authors did not report on the numbers of babies discharged home healthy (without obvious pathology) or on the risk of neonatal death.\nAuthors' conclusions\nCurrently, there is insufficient evidence to evaluate the effect of combining a tocolytic (indomethacin) and antibiotics (cefazolin/clindamycin) with cervical cerclage compared with cervical cerclage alone for preventing spontaneous PTB in women with singleton pregnancies.\nFuture studies should recruit sufficient numbers of women to provide meaningful results and should measure neonatal death and numbers of babies discharged home healthy, as well as other important outcomes listed in this review.\nWe did not identify any studies looking at other treatments in combination with cervical cerclage. Future research needs to focus on the role of other interventions such as vaginal support pessary, reinforcing or second cervical cerclage placement, 17-alpha-hydroxyprogesterone caproate or dydrogesterone or vaginal micronised progesterone, omega-3 long chain polyunsaturated fatty acid supplementation and bed rest.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cervical weakness is diagnosed through a woman’s history of pregnancy losses or premature births in the second trimester, ultrasound examination or physical examination. Preventing preterm birth is a healthcare priority because it is the leading cause of infant ill health and death worldwide. A cervical stitch in combination with other treatments could help prevent preterm birth in women carrying a single baby as a single stitch may not be sufficient for pregnant women with prior premature births and short cervical length or weakness."
}
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query-laysum | 2064 | [
{
"role": "user",
"content": "Abstract: Background\nDespite advances in treatment, the increasing and ageing population makes heart failure an important cause of morbidity and death worldwide. It is associated with high healthcare costs, partly driven by frequent hospital readmissions. Disease management interventions may help to manage people with heart failure in a more proactive, preventative way than drug therapy alone. This is the second update of a review published in 2005 and updated in 2012.\nObjectives\nTo compare the effects of different disease management interventions for heart failure (which are not purely educational in focus), with usual care, in terms of death, hospital readmissions, quality of life and cost-related outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and CINAHL for this review update on 9 January 2018 and two clinical trials registries on 4 July 2018. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least six months' follow-up, comparing disease management interventions to usual care for adults who had been admitted to hospital at least once with a diagnosis of heart failure. There were three main types of intervention: case management; clinic-based interventions; multidisciplinary interventions.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Outcomes of interest were mortality due to heart failure, mortality due to any cause, hospital readmission for heart failure, hospital readmission for any cause, adverse effects, quality of life, costs and cost-effectiveness.\nMain results\nWe found 22 new RCTs, so now include 47 RCTs (10,869 participants). Twenty-eight were case management interventions, seven were clinic-based models, nine were multidisciplinary interventions, and three could not be categorised as any of these. The included studies were predominantly in an older population, with most studies reporting a mean age of between 67 and 80 years. Seven RCTs were in upper-middle-income countries, the rest were in high-income countries.\nOnly two multidisciplinary-intervention RCTs reported mortality due to heart failure. Pooled analysis gave a risk ratio (RR) of 0.46 (95% confidence interval (CI) 0.23 to 0.95), but the very low-quality evidence means we are uncertain of the effect on mortality due to heart failure. Based on this limited evidence, the number needed to treat for an additional beneficial outcome (NNTB) is 12 (95% CI 9 to 126).\nTwenty-six case management RCTs reported all-cause mortality, with low-quality evidence indicating that these may reduce all-cause mortality (RR 0.78, 95% CI 0.68 to 0.90; NNTB 25, 95% CI 17 to 54). We pooled all seven clinic-based studies, with low-quality evidence suggesting they may make little to no difference to all-cause mortality. Pooled analysis of eight multidisciplinary studies gave moderate-quality evidence that these probably reduce all-cause mortality (RR 0.67, 95% CI 0.54 to 0.83; NNTB 17, 95% CI 12 to 32).\nWe pooled data on heart failure readmissions from 12 case management studies. Moderate-quality evidence suggests that they probably reduce heart failure readmissions (RR 0.64, 95% CI 0.53 to 0.78; NNTB 8, 95% CI 6 to 13). We were able to pool only two clinic-based studies, and the moderate-quality evidence suggested that there is probably little or no difference in heart failure readmissions between clinic-based interventions and usual care (RR 1.01, 95% CI 0.87 to 1.18). Pooled analysis of five multidisciplinary interventions gave low-quality evidence that these may reduce the risk of heart failure readmissions (RR 0.68, 95% CI 0.50 to 0.92; NNTB 11, 95% CI 7 to 44).\nMeta-analysis of 14 RCTs gave moderate-quality evidence that case management probably slightly reduces all-cause readmissions (RR 0.92, 95% CI 0.83 to 1.01); a decrease from 491 to 451 in 1000 people (95% CI 407 to 495). Pooling four clinic-based RCTs gave low-quality and somewhat heterogeneous evidence that these may result in little or no difference in all-cause readmissions (RR 0.90, 95% CI 0.72 to 1.12). Low-quality evidence from five RCTs indicated that multidisciplinary interventions may slightly reduce all-cause readmissions (RR 0.85, 95% CI 0.71 to 1.01); a decrease from 450 to 383 in 1000 people (95% CI 320 to 455).\nNeither case management nor clinic-based intervention RCTs reported adverse effects. Two multidisciplinary interventions reported that no adverse events occurred. GRADE assessment of moderate quality suggested that there may be little or no difference in adverse effects between multidisciplinary interventions and usual care.\nQuality of life was generally poorly reported, with high attrition. Low-quality evidence means we are uncertain about the effect of case management and multidisciplinary interventions on quality of life. Four clinic-based studies reported quality of life but we could not pool them due to differences in reporting. Low-quality evidence indicates that clinic-based interventions may result in little or no difference in quality of life.\nFour case management programmes had cost-effectiveness analyses, and seven reported cost data. Low-quality evidence indicates that these may reduce costs and may be cost-effective. Two clinic-based studies reported cost savings. Low-quality evidence indicates that clinic-based interventions may reduce costs slightly. Low-quality data from one multidisciplinary intervention suggested this may be cost-effective from a societal perspective but less so from a health-services perspective.\nAuthors' conclusions\nWe found limited evidence for the effect of disease management programmes on mortality due to heart failure, with few studies reporting this outcome. Case management may reduce all-cause mortality, and multidisciplinary interventions probably also reduce all-cause mortality, but clinic-based interventions had little or no effect on all-cause mortality. Readmissions due to heart failure or any cause were probably reduced by case-management interventions. Clinic-based interventions probably make little or no difference to heart failure readmissions and may result in little or no difference in readmissions for any cause. Multidisciplinary interventions may reduce the risk of readmission for heart failure or for any cause. There was a lack of evidence for adverse effects, and conclusions on quality of life remain uncertain due to poor-quality data. Variations in study location and time of occurrence hamper attempts to review costs and cost-effectiveness.\nThe potential to improve quality of life is an important consideration but remains poorly reported. Improved reporting in future trials would strengthen the evidence for this patient-relevant outcome.\n\nGiven the provided abstract, please respond to the following query: \"Results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 47 studies, with a total of 10,869 participants. Twenty-eight studies were case management interventions, seven were clinic-based models, nine were multidisciplinary interventions and three could not be categorised as any of these. The average age of the people in most of the studies was between 67 and 80 years old, although 10 studies had younger participants on average, and one included mostly very elderly people. Most trials were in Europe and North America, but others took place in China, Taiwan, Iran and Japan.\nWe found limited evidence for an effect on mortality due to heart failure, as few studies reported this outcome. There was some evidence that case management may reduce all-cause mortality, and multidisciplinary interventions probably do, but clinic-based studies appeared to have little or no effect on this. Readmissions due to heart failure and due to any cause were probably reduced by case management interventions. Clinic-based interventions probably make little or no difference to heart failure readmissions and may result in little or no difference in readmissions for any cause. Multidisciplinary interventions may reduce the risk of readmission for heart failure or any cause.\nOnly two studies mentioned adverse events, both stating that none occurred. Many studies measured quality of life, but it is difficult to draw conclusions for any effect because they tended to report this in different ways and did not report it for all their participants. Data on costs and cost-effectiveness were limited, but indicated a slight benefit of disease management programmes, mostly due to reduced hospital readmission costs."
}
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query-laysum | 2065 | [
{
"role": "user",
"content": "Abstract: Background\nManaging hemophilia is challenging both in terms of medical treatment and its broad impact on many aspects of the individual's life, including self-perception. Several psychosocial issues are potentially relevant in the clinical management of hemophilia, including it being a chronic and incurable condition; e.g. people with hemophilia must adapt to optimally interact with peers and to practice sports - even choosing a sport represents an issue for perceived limitations, expectations and cultural influences on the individual and their family. People with hemophilia can react by denying their condition and its manifestations and not adhering to treatment. Due to the complexity of relationships surrounding genetic diseases, parents and relatives may have their own issues that contribute to making life easier or more difficult for the person with hemophilia. Anxiety, sadness and depression resulting in mental health disorders are reported in this population and may influence quality of life (QoL) depending on cultural background, religious beliefs, family support and other variables.\nObjectives\nPrimarily to assess the effectiveness of psychological therapies for improving the ability of people with hemophilia to cope with their chronic condition.\nSearch methods\nWe aimed to identify trials from the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, Embase and PsycINFO, CINAHL, MEDLINE and trial registries. We searched reference lists of included publications.\nMost recent search of the Group's register: 13 June 2019.\nSelection criteria\nRandomized controlled trials (RCTs) and quasi-RCTs in people with hemophilia of any age or gender, type A or B, any severity, with or without inhibitors, with or without HIV or hepatitis C virus. All psychological interventions for promoting emotional, intellectual and spiritual wellness. Individual, group or family group therapy interventions were eligible.\nData collection and analysis\nWe independently assessed trials, extracted data and assessed the risk of bias and assessed the quality of the evidence using GRADE.\nMain results\nSeven trials were included (362 participants randomized, data from 264 participants available for analysis); six of parallel design and one a partial cross-over design. One multicenter trial was conducted in Canada; the remaining six were single centre undertaken in the UK, USA, Iran and in the Netherlands.\nAll trials had a high risk of bias for participant blinding and use of patient-reported outcomes.\nEvidence was retrieved on four interventions: psycho-education (DVD plus information booklet versus information booklet alone; computerised learning versus no intervention); cognitive therapy (auto-hypnosis (self-hypnosis) versus control); and behavioural therapy (relaxation (progressive or self control) versus no treatment). We also aimed to assess psychodynamic therapy and systemic therapy, but no trials were identified.\nHeterogeneity of the outcome measures and measurements precluded meta-analyses. No trial reported the cost of the psychological intervention and family adjustment.\nDVD plus information booklet compared to information booklet alone\nOne trial (108 participants) showed coping strategies may lower pre-contemplation scores and negative thoughts, mean difference (MD) -0.24 (95%CI -0.48 - 0.00, low-certainty evidence), however, other measures of coping strategies in the same trial suggest little or no difference between groups, e.g. contemplation, MD (-0.09, 95%CI -0.32 – 0.14, low-certainty evidence). The same trial measured QoL and showed little or no difference between treatment groups for the physical domain, MD 0.59 (95% CI -3.66 to 4.84, low-certainty evidence), but may improve scores in the mental health domain for those receiving the booklet plus DVD compared to booklet alone, MD (4.70, 95% CI 0.33 to 9.07, low-certainty evidence). Mood or personal well-being were not reported.\nComputerised learning compared to no intervention\nTwo trials (57 participants) reported on interventions aimed at children and adolescents and their impact on promoting a sense of self-efficacy (primary outcome 'Mood and personal well-being'), but only one showed an increase, MD 7.46 (95%CI 3.21 to 11.71, 17 participants, very low-certainty evidence); the second did not report control group data. One trial (30 participants) showed the intervention did not improve self-efficacy in adults, but appropriate data could not be extracted. Two trials (47 participants) reported coping strategies; one only reported within-group differences from baseline, the second showed an increase from baseline in coping strategies in the Internet program group compared to the no intervention group (disease-specific knowledge, MD 2.45 (95% CI 0.89 to 4.01); self-management ability and transition readiness, MD 19.90 (95% CI 3.61 to 36.19; low-certainty evidence).\nOne trial reported QoL but with insufficient information to calculate changes from baseline; no difference in post-treatment scores was seen between groups, MD -8.65, 95% CI -18.30 to 1.00, very low-certainty evidence).\nAuto-hypnosis (self-hypnosis) compared to control\nThere were two older trials that reported on this intervention (50 participants) focusing mainly on the secondary outcome 'physical health'; only one trial reported the primary outcome ‘mood and personal well-being’ (only within-group differences in the treatment group). Coping strategies and QoL were not assessed in the trials.\nRelaxation (progressive or self control) compared to no treatment\nOnly one trial (seven participants) from 1985, was included which focused on 'physical health' and did not report on any of our primary outcomes.\nAuthors' conclusions\nNot all of the seven included trials analysed the effects of the interventions on our primary outcomes (mood and personal well-being, coping strategies and QoL).\nThree trials were conducted in the 1970s and 1980s using techniques of auto-hypnosis or relaxation and, in accordance with the needs and therapeutic possibilities of the time, they focused on secondary outcomes, e.g. frequency of bleeding (physical health) and adherence to the intervention.\nThe four newer trials assessed psycho-educational interventions all mediated by the use of technologies (DVD or computer) and often created according to age needs of the target group. In these cases, attention was shifted to our pre-defined primary outcomes.\nThis review has identified low- and very low-certainty evidence, prompting caution in its interpretation. The major problem we encountered was the heterogeneity of trial designs, of interventions and of outcome measures used across the trials. We strongly suggest that researchers consider developing a core outcome set to streamline future research; randomization was proven to be safe and acceptable, and blinding should be considered for those assessing patient-reported outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included trials comparing people with hemophilia receiving any psychological intervention compared with other individuals receiving a different intervention or no intervention at all.\nWe found seven trials with 362 people with hemophilia aged between 6 and 65 years of age. Trials compared either a DVD plus information booklet or computerised learning or auto-hypnosis (self-hypnosis) or relaxation techniques to no treatment and people were selected for one treatment or the other randomly. The trials lasted from one to six months."
}
]
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query-laysum | 2066 | [
{
"role": "user",
"content": "Abstract: Background\nDespite considerable improvement in outcomes for preterm infants, rates of bronchopulmonary dysplasia (BPD) remain high, affecting an estimated 33% of very low birthweight infants, with corresponding long-term respiratory and neurosensory issues. Systemic corticosteroids can address the inflammation underlying BPD, but the optimal regimen for prevention of this disease, balancing of the benefits with the potentially meaningful risks of systemic corticosteroids, continues to be a medical quandary.\nNumerous studies have shown that systemic corticosteroids, particularly dexamethasone and hydrocortisone, effectively treat or prevent BPD. However, concerning short and long-term side effects have been reported and the optimal approach to corticosteroid treatment remains unclear.\nObjectives\nTo determine whether differences in efficacy and safety exist between high-dose dexamethasone, moderate-dose dexamethasone, low-dose dexamethasone, hydrocortisone, and placebo in the prevention of BPD, death, the composite outcome of death or BPD, and other relevant morbidities, in preterm infants through a network meta-analysis, generating both pairwise comparisons between all treatments and rankings of the treatments.\nSearch methods\nWe searched the Cochrane Library for all systematic reviews of systemic corticosteroids for the prevention of BPD and searched for completed and ongoing studies in the following databases in January 2023: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and clinical trial databases.\nSelection criteria\nWe included randomized controlled trials (RCTs) in preterm infants (< 37 weeks’ gestation) at risk for BPD that evaluated systemic corticosteroids (high-dose [≥ 4 mg/kg cumulative dose] dexamethasone, moderate-dose [≥ 2 to < 4 mg/kg] dexamethasone, low-dose [< 2 mg/kg] dexamethasone, or hydrocortisone) versus control or another systemic corticosteroid.\nData collection and analysis\nOur main information sources were the systematic reviews, with reference to the original manuscript only for data not included in these reviews. Teams of two paired review authors independently performed data extraction, with disagreements resolved by discussion. Data were entered into Review Manager 5 and exported to R software for network meta-analysis (NMA). NMA was performed using a frequentist model with random-effects. Two separate networks were constructed, one for early (< seven days) initiation of treatment and one for late (≥ seven days) treatment initiation, to reflect the different patient populations evaluated. We assessed the certainty of evidence derived from the NMA for our primary outcomes using principles of the GRADE framework modified for application to NMA.\nMain results\nWe included 59 studies, involving 6441 infants, in our analyses.\nOnly six of the included studies provided direct comparisons between any of the treatment (dexamethasone or hydrocortisone) groups, forcing network comparisons between treatments to rely heavily on indirect evidence through comparisons with placebo/no treatment groups. Thirty-one studies evaluated early corticosteroid treatment, 27 evaluated late corticosteroid treatment, and one study evaluated both early and late corticosteroid treatments.\nEarly treatment (prior to seven days after birth):\nBenefits:NMA for early treatment showed only moderate-dose dexamethasone to decrease the risk of BPD at 36 weeks' postmenstrual age (PMA) compared with control (RR 0.56, 95% CI 0.39 to 0.80; moderate-certainty evidence), although the other dexamethasone dosing regimens may have similar effects compared with control (high-dose dexamethasone, RR 0.71, 95% CI 0.50 to 1.01; low-certainty evidence; low-dose dexamethasone, RR 0.83, 95% CI 0.67 to 1.03; low-certainty evidence). Other early treatment regimens may have little or no effect on the risk of death at 36 weeks' PMA. Only moderate-dose dexamethasone decreased the composite outcome of death or BPD at 36 weeks' PMA compared with control (RR 0.77, 95% CI 0.60 to 0.98; moderate-certainty evidence).\nHarms: Low-dose dexamethasone increased the risk for cerebral palsy (RR 1.92, 95% CI 1.12 to 3.28; moderate-certainty evidence) compared with control. Hydrocortisone may decrease the risk of major neurosensory disability versus low-dose dexamethasone (RR 0.65, 95% CI 0.41 to 1.01; low-certainty evidence).\nLate treatment (at seven days or later after birth):\nBenefits: NMA for late treatment showed high-dose dexamethasone to decrease the risk of BPD both versus hydrocortisone (RR 0.66, 95% CI 0.51 to 0.85; low-certainty evidence) and versus control (RR 0.72, CI 0.59 to 0.87; moderate-certainty evidence). The late treatment regimens evaluated may have little or no effect on the risk of death at 36 weeks' PMA. High-dose dexamethasone decreased risk for the composite outcome of death or BPD compared with all other treatments (control, RR 0.69, 95% CI 0.59 to 0.80, high-certainty evidence; hydrocortisone, RR 0.69, 95% CI 0.58 to 0.84, low-certainty evidence; low-dose dexamethasone, RR 0.73, 95% CI 0.60 to 0.88, low-certainty evidence; moderate-dose dexamethasone, RR 0.76, 95% CI 0.62 to 0.93, low-certainty evidence).\nHarms: No effect was observed for the outcomes of major neurosensory disability or cerebral palsy.\nThe evidence for the primary outcomes was of overall low certainty, with notable deductions for imprecision and heterogeneity across the networks.\nAuthors' conclusions\nWhile early treatment with moderate-dose dexamethasone or late treatment with high-dose dexamethasone may lead to the best effects for survival without BPD, the certainty of the evidence is low. There is insufficient evidence to guide this therapy with regard to plausible adverse long-term outcomes. Further RCTs with direct comparisons between systemic corticosteroid treatments are needed to determine the optimal treatment approach, and these studies should be adequately powered to evaluate survival without major neurosensory disability.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this review, we wanted to compare the benefits and risks of different corticosteroid treatment regimens (the type of corticosteroid, dose, and timing) delivered to premature infants systemically, that is through the vein."
}
]
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query-laysum | 2067 | [
{
"role": "user",
"content": "Abstract: Background\nMénière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. First-line treatments often involve dietary or lifestyle changes, medication or local (intratympanic) treatments. However, surgery may also be considered for people with persistent or severe symptoms. The efficacy of different surgical interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.\nObjectives\nTo evaluate the benefits and harms of surgical interventions versus placebo or no treatment in people with Ménière's disease.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable Ménière's disease comparing ventilation tubes, endolymphatic sac surgery, semi-circular canal plugging/obliteration, vestibular nerve section or labyrinthectomy with either placebo (sham surgery) or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two studies with a total of 178 participants. One evaluated ventilation tubes compared to no treatment, the other evaluated endolymphatic sac decompression compared to sham surgery.\nVentilation tubes\nWe included a single RCT of 148 participants with definite Ménière's disease. It was conducted in a single centre in Japan from 2010 to 2013. Participants either received ventilation tubes with standard medical treatment, or standard medical treatment alone, and were followed up for two years. Some data were reported on the number of participants in whom vertigo resolved, and the effect of the intervention on hearing. Our other primary and secondary outcomes were not reported in this study. This is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results.\nEndolymphatic sac decompression\nWe also included one RCT of 30 participants that compared endolymphatic sac decompression with sham surgery. This was a single-centre study conducted in Denmark during the 1980s. Follow-up was predominantly conducted at one year, but additional follow-up continued for up to nine years in some participants. Some data were reported on hearing and vertigo (both improvement in vertigo and change in vertigo), but our other outcomes of interest were not reported. Again, this is a single, very small study and we rated the certainty of the evidence as very low for all outcomes. We are therefore unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nWe are unable to draw clear conclusions about the efficacy of these surgical interventions for Ménière's disease. We identified evidence for only two of our five proposed comparisons, and we assessed all the evidence as low- or very low-certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Many of the outcomes that we planned to assess were not reported by the studies, such as the impact on quality of life, and adverse effects of the interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared different types of surgery to either no treatment or sham surgery."
}
]
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query-laysum | 2068 | [
{
"role": "user",
"content": "Abstract: Background\nVenous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE), is the leading cause of preventable death in hospitalised people and the third most common cause of mortality in surgical patients. People undergoing bariatric surgery have the additional risk factor of being overweight. Although VTE prophylaxis in surgical patients is well established, the best way to prevent VTE in those undergoing bariatric surgery is less clear.\nObjectives\nTo evaluate the benefits and harms of pharmacological interventions (alone or in combination) on venous thromboembolism and other health outcomes in people undergoing bariatric surgery compared to the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention or started at a different time point, another pharmacological intervention, no intervention or placebo.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 1 November 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in males and females of any age undergoing bariatric surgery comparing pharmacological interventions for VTE (alone or in combination) with the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention started at a different time point, a different pharmacological intervention, no treatment or placebo.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. VTE and 2. major bleeding. Our secondary outcomes were 1. all-cause mortality, 2. VTE-related mortality, 3. PE, 4. DVT, 5. adverse effects and 6. quality of life. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe included seven RCTs with 1045 participants. Data for meta-analysis were available from all participants.\nFour RCTs (597 participants) compared higher-dose heparin to standard-dose heparin: one of these studies (139 participants) used unfractionated heparin (UFH) and the other three (458 participants) used low-molecular-weight heparin (LMWH). One study compared heparin versus pentasaccharide (198 participants), and one study compared starting heparin before versus after bariatric surgery (100 participants). One study (150 participants) compared combined mechanical and pharmacological (enoxaparin) prophylaxis versus mechanical prophylaxis alone. The duration of the interventions ranged from seven to 15 days, and follow-up ranged from 10 to 180 days.\nHigher-dose heparin versus standard-dose heparin\nCompared to standard-dose heparin, higher-dose heparin may result in little or no difference in the risk of VTE (RR 0.55, 95% CI 0.05 to 5.99; 4 studies, 597 participants) or major bleeding (RR 1.19, 95% CI 0.48 to 2.96; I2 = 8%; 4 studies, 597 participants; low-certainty) in people undergoing bariatric surgery. The evidence on all-cause mortality, VTE-related mortality, PE, DVT and adverse events (thrombocytopenia) is uncertain (effect not estimable or very low-certainty evidence).\nHeparin versus pentasaccharide\nHeparin compared to a pentasaccharide after bariatric surgery may result in little or no difference in the risk of VTE (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants) or DVT (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants). The evidence on major bleeding, PE and mortality is uncertain (effect not estimable or very low-certainty evidence).\nHeparin started before versus after the surgical procedure\nStarting prophylaxis with heparin 12 hours before surgery versus after surgery may result in little or no difference in the risk of VTE (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants) or DVT (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants). The evidence on major bleeding, all-cause mortality and VTE-related mortality is uncertain (effect not estimable or very low-certainty evidence). We were unable to assess the effect of this intervention on PE or adverse effects, as the study did not measure these outcomes.\nCombined mechanical and pharmacological prophylaxis versus mechanical prophylaxis alone\nCombining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery compared to mechanical prophylaxis alone (RR 0.05, 95% CI 0.00 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) = 9; 1 study, 150 participants; low-certainty). We were unable to assess the effect of this intervention on major bleeding or morality (effect not estimable), or on PE or adverse events (not measured).\nNo studies measured quality of life.\nAuthors' conclusions\nHigher-dose heparin may make little or no difference to venous thromboembolism or major bleeding in people undergoing bariatric surgery when compared to standard-dose heparin.\nHeparin may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to pentasaccharide. There are inadequate data to draw conclusions about the effects of heparin compared to pentasaccharide on major bleeding.\nStarting prophylaxis with heparin 12 hours before bariatric surgery may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to starting heparin after bariatric surgery. There are inadequate data to draw conclusions about the effects of heparin started before versus after surgery on major bleeding.\nCombining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery when compared to mechanical prophylaxis alone. No data are available relating to major bleeding.\nThe certainty of the evidence is limited by small sample sizes, few or no events, and risk of bias concerns. Future trials must be sufficiently large to enable analysis of relevant clinical outcomes, and should standardise the time of treatment and follow-up. They should also address the effect of direct oral anticoagulants and antiplatelets, preferably grouping them according to the type of intervention.\n\nGiven the provided abstract, please respond to the following query: \"How can venous thromboembolism be prevented?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "VTE prophylaxis (preventive interventions) can be mechanical (e.g. elastic stockings or external compressive devices) or pharmacological (involving medicines that reduce blood clot formation, such as heparins, pentasaccharides or antiplatelet agents), or can combine both approaches."
}
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query-laysum | 2069 | [
{
"role": "user",
"content": "Abstract: Background\nApproximately 40% to 95% of people with liver cirrhosis have oesophageal varices. About 15% to 20% of oesophageal varices bleed within about one to three years after diagnosis. Several different treatments are available, including, among others, endoscopic sclerotherapy, variceal band ligation, somatostatin analogues, vasopressin analogues, and balloon tamponade. However, there is uncertainty surrounding the individual and relative benefits and harms of these treatments.\nObjectives\nTo compare the benefits and harms of different initial treatments for variceal bleeding from oesophageal varices in adults with decompensated liver cirrhosis, through a network meta-analysis; and to generate rankings of the different treatments for acute bleeding oesophageal varices, according to their benefits and harms.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and trials registers until 17 December 2019, to identify randomised clinical trials (RCTs) in people with cirrhosis and acute bleeding from oesophageal varices.\nSelection criteria\nWe included only RCTs (irrespective of language, blinding, or status) in adults with cirrhosis and acutely bleeding oesophageal varices. We excluded RCTs in which participants had bleeding only from gastric varices, those who failed previous treatment (refractory bleeding), those in whom initial haemostasis was achieved before inclusion into the trial, and those who had previously undergone liver transplantation.\nData collection and analysis\nWe performed a network meta-analysis with OpenBUGS software, using Bayesian methods, and calculated the differences in treatments using odds ratios (OR) and rate ratios with 95% credible intervals (CrI) based on an available-case analysis, according to National Institute of Health and Care Excellence Decision Support Unit guidance. We performed also the direct comparisons from RCTs using the same codes and the same technical details.\nMain results\nWe included a total of 52 RCTs (4580 participants) in the review. Forty-eight trials (4042 participants) were included in one or more comparisons in the review. The trials that provided the information included people with cirrhosis due to varied aetiologies and those with and without a previous history of bleeding. We included outcomes assessed up to six weeks. All trials were at high risk of bias.\nA total of 19 interventions were compared in the trials (sclerotherapy, somatostatin analogues, vasopressin analogues, sclerotherapy plus somatostatin analogues, variceal band ligation, balloon tamponade, somatostatin analogues plus variceal band ligation, nitrates plus vasopressin analogues, no active intervention, sclerotherapy plus variceal band ligation, balloon tamponade plus sclerotherapy, balloon tamponade plus somatostatin analogues, balloon tamponade plus vasopressin analogues, variceal band ligation plus vasopressin analogues, balloon tamponade plus nitrates plus vasopressin analogues, balloon tamponade plus variceal band ligation, portocaval shunt, sclerotherapy plus transjugular intrahepatic portosystemic shunt (TIPS), and sclerotherapy plus vasopressin analogues). We have reported the effect estimates for the primary and secondary outcomes when there was evidence of differences between the interventions against the reference treatment of sclerotherapy, but reported the other results of the primary and secondary outcomes versus the reference treatment of sclerotherapy without the effect estimates when there was no evidence of differences in order to provide a concise summary of the results.\nOverall, 15.8% of the trial participants who received the reference treatment of sclerotherapy (chosen because this was the commonest treatment compared in the trials) died during the follow-up periods, which ranged from three days to six weeks. Based on moderate-certainty evidence, somatostatin analogues alone had higher mortality than sclerotherapy (OR 1.57, 95% CrI 1.04 to 2.41; network estimate; direct comparison: 4 trials; 353 participants) and vasopressin analogues alone had higher mortality than sclerotherapy (OR 1.70, 95% CrI 1.13 to 2.62; network estimate; direct comparison: 2 trials; 438 participants).\nNone of the trials reported health-related quality of life. Based on low-certainty evidence, a higher proportion of people receiving balloon tamponade plus sclerotherapy had more serious adverse events than those receiving only sclerotherapy (OR 4.23, 95% CrI 1.22 to 17.80; direct estimate; 1 RCT; 60 participants).\nBased on moderate-certainty evidence, people receiving vasopressin analogues alone and those receiving variceal band ligation had fewer adverse events than those receiving only sclerotherapy (rate ratio 0.59, 95% CrI 0.35 to 0.96; network estimate; direct comparison: 1 RCT; 219 participants; and rate ratio 0.40, 95% CrI 0.21 to 0.74; network estimate; direct comparison: 1 RCT; 77 participants; respectively). Based on low-certainty evidence, the proportion of people who developed symptomatic rebleed was smaller in people who received sclerotherapy plus somatostatin analogues than those receiving only sclerotherapy (OR 0.21, 95% CrI 0.03 to 0.94; direct estimate; 1 RCT; 105 participants).\nThe evidence suggests considerable uncertainty about the effect of the interventions in the remaining comparisons where sclerotherapy was the control intervention.\nAuthors' conclusions\nBased on moderate-certainty evidence, somatostatin analogues alone and vasopressin analogues alone (with supportive therapy) probably result in increased mortality, compared to endoscopic sclerotherapy. Based on moderate-certainty evidence, vasopressin analogues alone and band ligation alone probably result in fewer adverse events compared to endoscopic sclerotherapy. Based on low-certainty evidence, balloon tamponade plus sclerotherapy may result in large increases in serious adverse events compared to sclerotherapy. Based on low-certainty evidence, sclerotherapy plus somatostatin analogues may result in large decreases in symptomatic rebleed compared to sclerotherapy. In the remaining comparisons, the evidence indicates considerable uncertainty about the effects of the interventions, compared to sclerotherapy.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The 52 trials included a small number of participants (4580 participants). Forty-eight trials with 4042 participants provided data for analyses. The follow-up of the trial participants ranged from less than one week to six weeks. The funding source for the research was unclear in 31 studies; commercial organisations funded 11 studies. There were no concerns regarding the source of funding for the remaining 10 studies. The review shows the following.\n- None of the studies were conducted without flaws, and because of this, there is moderate to very high uncertainty in the findings.\n- Approximately one in six people with cirrhosis and bleeding oesophageal varices who received the standard treatment of sclerotherapy died within six weeks.\n- Somatostatin analogues alone and vasopressin analogues alone probably result in increased mortality, compared to sclerotherapy.\n- Vasopressin analogues alone and band ligation alone probably result in fewer adverse events (complications), compared to sclerotherapy.\n- Balloon tamponade plus sclerotherapy may result in large increase in serious adverse events compared to sclerotherapy.\n- Sclerotherapy plus somatostatin analogues may result in large decrease in symptomatic rebleed compared to sclerotherapy.\n- The evidence indicates considerable uncertainty about the effect of the interventions in the remaining comparisons.\n- None of the trials reported health-related quality of life.\n- Future well-designed randomised clinical trials are needed to find out the best treatment for people with cirrhosis and bleeding oesophageal varices."
}
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query-laysum | 2070 | [
{
"role": "user",
"content": "Abstract: Background\nAntibiotic resistance is a worldwide health threat. Interventions that reduce antibiotic prescribing by clinicians are expected to reduce antibiotic resistance. Disparate interventions to change antibiotic prescribing behaviour for acute respiratory infections (ARIs) have been trialled and meta-analysed, but not yet synthesised in an overview. This overview synthesises evidence from systematic reviews, rather than individual trials.\nObjectives\nTo systematically review the existing evidence from systematic reviews on the effects of interventions aimed at influencing clinician antibiotic prescribing behaviour for ARIs in primary care.\nMethods\nWe searched the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), MEDLINE, Embase, CINAHL, PsycINFO, and Science Citation Index to June 2016. We also searched the reference lists of all included reviews. We ran a pre-publication search in May 2017 and placed additional studies in 'awaiting classification'.\nWe included both Cochrane and non-Cochrane reviews of randomised controlled trials evaluating the effect of any clinician-focussed intervention on antibiotic prescribing behaviour in primary care. Two overview authors independently extracted data and assessed the methodological quality of included reviews using the ROBIS tool, with disagreements reached by consensus or by discussion with a third overview author. We used the GRADE system to assess the quality of evidence in included reviews. The results are presented as a narrative overview.\nMain results\nWe included eight reviews in this overview: five Cochrane Reviews (33 included trials) and three non-Cochrane reviews (11 included trials). Three reviews (all Cochrane Reviews) scored low risk across all the ROBIS domains in Phase 2 and low risk of bias overall. The remaining five reviews scored high risk on Domain 4 of Phase 2 because the 'Risk of bias' assessment had not been specifically considered and discussed in the review Results and Conclusions. The trials included in the reviews varied in both size and risk of bias. Interventions were compared to usual care.\nModerate-quality evidence indicated that C-reactive protein (CRP) point-of-care testing (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.66 to 0.92, 3284 participants, 6 trials), shared decision making (odds ratio (OR) 0.44, 95% CI 0.26 to 0.75, 3274 participants, 3 trials; RR 0.64, 95% CI 0.49 to 0.84, 4623 participants, 2 trials; risk difference -18.44, 95% CI -27.24 to -9.65, 481,807 participants, 4 trials), and procalcitonin-guided management (adjusted OR 0.10, 95% CI 0.07 to 0.14, 1008 participants, 2 trials) probably reduce antibiotic prescribing in general practice. We found moderate-quality evidence that procalcitonin-guided management probably reduces antibiotic prescribing in emergency departments (adjusted OR 0.34, 95% CI 0.28 to 0.43, 2605 participants, 7 trials). The overall effect of these interventions was small (few achieving greater than 50% reduction in antibiotic prescribing, most about a quarter or less), but likely to be clinically important.\nCompared to usual care, shared decision making probably makes little or no difference to reconsultation for the same illness (RR 0.87, 95% CI 0.74 to 1.03, 1860 participants, 4 trials, moderate-quality evidence), and may make little or no difference to patient satisfaction (RR 0.86, 95% CI 0.57 to 1.30, 1110 participants, 2 trials, low-quality evidence). Similarly, CRP testing probably has little or no effect on patient satisfaction (RR 0.79, 95% CI 0.57 to 1.08, 689 participants, 2 trials, moderate-quality evidence) or reconsultation (RR 1.08, 95% CI 0.93 to 1.27, 5132 participants, 4 trials, moderate-quality evidence). Procalcitonin-guided management probably results in little or no difference in treatment failure in general practice compared to normal care (adjusted OR 0.95, 95% CI 0.73 to 1.24, 1008 participants, 2 trials, moderate-quality evidence), however it probably reduces treatment failure in the emergency department compared to usual care (adjusted OR 0.76, 95% CI 0.61 to 0.95, 2605 participants, 7 trials, moderate-quality evidence).\nThe quality of evidence for interventions focused on clinician educational materials and decision support in reducing antibiotic prescribing in general practice was either low or very low (no pooled result reported) and trial results were highly heterogeneous, therefore we were unable draw conclusions about the effects of these interventions. The use of rapid viral diagnostics in emergency departments may have little or no effect on antibiotic prescribing (RR 0.86, 95% CI 0.61 to 1.22, 891 participants, 3 trials, low-quality evidence) and may result in little to no difference in reconsultation (RR 0.86, 95% CI 0.59 to 1.25, 200 participants, 1 trial, low-quality evidence).\nNone of the trials in the included reviews reported on management costs for the treatment of an ARI or any associated complications.\nAuthors' conclusions\nWe found evidence that CRP testing, shared decision making, and procalcitonin-guided management reduce antibiotic prescribing for patients with ARIs in primary care. These interventions may therefore reduce overall antibiotic consumption and consequently antibiotic resistance. There do not appear to be negative effects of these interventions on the outcomes of patient satisfaction and reconsultation, although there was limited measurement of these outcomes in the trials. This should be rectified in future trials.\nWe could gather no information about the costs of management, and this along with the paucity of measurements meant that it was difficult to weigh the benefits and costs of implementing these interventions in practice.\nMost of this research was undertaken in high-income countries, and it may not generalise to other settings. The quality of evidence for the interventions of educational materials and tools for patients and clinicians was either low or very low, which prevented us from drawing any conclusions. High-quality trials are needed to further investigate these interventions.\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 five Cochrane Reviews and three non-Cochrane reviews. The reviews varied in how many trials they included and the number of participants within trials. The quality of both the reviews and trials varied."
}
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query-laysum | 2071 | [
{
"role": "user",
"content": "Abstract: Background\nHypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II.\nObjectives\nTo quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension.\nTo determine the change in BP variability, pulse pressure, and heart rate and to evaluate adverse events (mortality, non-fatal serious adverse events, total adverse events, withdrawal due to adverse effects and specific adverse events such as dry cough, diarrhoea and angioedema).\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to February 2017: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. There was no restriction by language or publication status. We also searched the European Medicines Agency (EMA) for clinical study reports, the Novartis Clinical Study Results Database, bibliographic citations from retrieved references, and contacted authors of relevant papers regarding further published and unpublished work.\nSelection criteria\nWe included randomized, double-blinded, placebo-controlled studies evaluating BP lowering efficacy of fixed-dose monotherapy with renin inhibitor compared with placebo for a minimum duration of three to 12 weeks in adult patients with primary hypertension.\nData collection and analysis\nThis systematic review is a comprehensive update which includes four additional studies and extensive detail from nine clinical study reports (CSRs) of previously included studies obtained from EMA. The remaining three CSRs are not available.\nTwo review authors independently assessed study eligibility and extracted data. In all cases where there was a difference between the CSR and the published report, data from the CSR was used. Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence intervals (CIs) and continuous outcomes as mean difference (MD) with 95% CIs.\nMain results\n12 studies (mean duration of eight weeks) in 7439 mostly Caucasian patients (mean age 54 years) with mild-to-moderate uncomplicated hypertension were eligible for inclusion in the review. Aliskiren was the only renin inhibitor evaluated. All included studies were assessed to have high likelihood of attrition, reporting and funding bias.\nAliskiren has a dose-related systolic/diastolic blood pressure (SBP/DBP) lowering effect as compared with placebo MD with 95% CI: aliskiren 75 mg (MD -2.97, 95% CI -4.76 to -1.18)/(MD -2.05, 95% CI -3.13 to -0.96) mm Hg (moderate-quality evidence), aliskiren 150 mg (MD -5.95, 95% CI -6.85 to -5.06)/ (MD -3.16, 95% CI -3.74 to -2.58) mm Hg (moderate-quality evidence), aliskiren 300 mg (MD -7.88, 95% CI -8.94 to -6.82)/ (MD -4.49, 95% CI -5.17 to -3.82) mm Hg (moderate-quality evidence), aliskiren 600 mg (MD -11.35, 95% CI -14.43 to -8.27)/ (MD -5.86, 95% CI -7.73 to -3.99) mm Hg (low-quality evidence). There was a dose-dependent decrease in blood pressure for aliskiren 75 mg, 150 mg and 300 mg. The blood pressure lowering effect of aliskiren 600 mg was not different from 300 mg (MD -0.61, 95% CI -2.78 to 1.56)/(MD -0.68, 95% CI -2.03 to 0.67). Aliskiren had no effect on blood pressure variability. Due to very limited information available regarding change in heart rate and pulse pressure, it was not possible to meta-analyze these outcomes.\nMortality and non-fatal serious adverse events were not increased. This review found that in studies of eight week duration aliskiren may not increase withdrawal due to adverse events (low-quality evidence). Diarrhoea was increased in a dose-dependent manner (RR 7.00, 95% CI 2.48 to 19.72) with aliskiren 600 mg (low-quality evidence). The most frequent adverse events reported were headache, nasopharyngitis, diarrhoea, dizziness and fatigue.\nAuthors' conclusions\nCompared to placebo, aliskiren lowered BP and this effect is dose-dependent. This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). There is no difference in mortality, nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy. Diarrhoea was considerably increased with aliskiren 600 mg.\n\nGiven the provided abstract, please respond to the following query: \"Review Question(s)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "\nWe wanted to determine if aliskiren was better than placebo for reducing blood pressure in adult patients with raised blood pressure, and whether this drug had increased adverse effects. We also wanted to determine if there was a change in blood pressure variability, pulse pressure, heart rate and withdrawal due to side effects.\nWe searched the available medical literature to find all the trials that had assessed these questions. The data included in this review is up to date as of February 2017."
}
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query-laysum | 2072 | [
{
"role": "user",
"content": "Abstract: Background\nMedications with anticholinergic properties are commonly prescribed to older adults with a pre-existing diagnosis of dementia or cognitive impairment. The cumulative anticholinergic effect of all the medications a person takes is referred to as the anticholinergic burden because of its potential to cause adverse effects. It is possible that a high anticholinergic burden may be a risk factor for further cognitive decline or neuropsychiatric disturbances in people with dementia. Neuropsychiatric disturbances are the most frequent complication of dementia that require hospitalisation, accounting for almost half of admissions; hence, identification of modifiable prognostic factors for these outcomes is crucial. There are various scales available to measure anticholinergic burden but agreement between them is often poor.\nObjectives\nOur primary objective was to assess whether anticholinergic burden, as defined at the level of each individual scale, was a prognostic factor for further cognitive decline or neuropsychiatric disturbances in older adults with pre-existing diagnoses of dementia or cognitive impairment. Our secondary objective was to investigate whether anticholinergic burden was a prognostic factor for other adverse clinical outcomes, including mortality, impaired physical function, and institutionalisation.\nSearch methods\nWe searched these databases from inception to 29 November 2021: MEDLINE OvidSP, Embase OvidSP, PsycINFO OvidSP, CINAHL EBSCOhost, and ISI Web of Science Core Collection on ISI Web of Science.\nSelection criteria\nWe included prospective and retrospective longitudinal cohort and case-control observational studies, with a minimum of one-month follow-up, which examined the association between an anticholinergic burden measurement scale and the above stated adverse clinical outcomes, in older adults with pre-existing diagnoses of dementia or cognitive impairment.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, and undertook data extraction, risk of bias assessment, and GRADE assessment. We summarised risk associations between anticholinergic burden and all clinical outcomes in a narrative fashion. We also evaluated the risk association between anticholinergic burden and mortality using a random-effects meta-analysis. We established adjusted pooled rates for the anticholinergic cognitive burden (ACB) scale; then, as an exploratory analysis, established pooled rates on the prespecified association across scales.\nMain results\nWe identified 18 studies that met our inclusion criteria (102,684 older adults). Anticholinergic burden was measured using five distinct measurement scales: 12 studies used the ACB scale; 3 studies used the Anticholinergic Risk Scale (ARS); 1 study used the Anticholinergic Drug Scale (ADS); 1 study used the Anticholinergic Effect on Cognition (AEC) Scale; and 2 studies used a list developed by Tune and Egeli.\nRisk associations between anticholinergic burden and adverse clinical outcomes were highly heterogenous. Four out of 10 (40%) studies reported a significantly increased risk of greater long-term cognitive decline for participants with an anticholinergic burden compared to participants with no or minimal anticholinergic burden. No studies investigated neuropsychiatric disturbance outcomes. One out of four studies (25%) reported a significant association with reduced physical function for participants with an anticholinergic burden versus participants with no or minimal anticholinergic burden. No study (out of one investigating study) reported a significant association between anticholinergic burden and risk of institutionalisation. Six out of 10 studies (60%) found a significantly increased risk of mortality for those with an anticholinergic burden compared to those with no or minimal anticholinergic burden. Pooled analysis of adjusted mortality hazard ratios (HR) measured anticholinergic burden with the ACB scale, and suggested a significantly increased risk of death for those with a high ACB score relative to those with no or minimal ACB scores (HR 1.153, 95% confidence interval (CI) 1.030 to 1.292; 4 studies, 48,663 participants). An exploratory pooled analysis of adjusted mortality HRs across anticholinergic burden scales also suggested a significantly increased risk of death for those with a high anticholinergic burden (HR 1.102, 95% CI 1.044 to 1.163; 6 studies, 68,381 participants).\nOverall GRADE evaluation of results found low- or very low-certainty evidence for all outcomes.\nAuthors' conclusions\nThere is low-certainty evidence that older adults with dementia or cognitive impairment who have a significant anticholinergic burden may be at increased risk of death. No firm conclusions can be drawn for risk of accelerated cognitive decline, neuropsychiatric disturbances, decline in physical function, or institutionalisation.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to 29 November 2021."
}
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query-laysum | 2073 | [
{
"role": "user",
"content": "Abstract: Background\nDiabetes mellitus, a metabolic disorder characterised by hyperglycaemia and associated with a heavy burden of microvascular and macrovascular complications, frequently remains undiagnosed. Screening of apparently healthy individuals may lead to early detection and treatment of type 2 diabetes mellitus and may prevent or delay the development of related complications.\nObjectives\nTo assess the effects of screening for type 2 diabetes mellitus.\nSearch methods\nWe searched CENTRAL, MEDLINE, LILACS, the WHO ICTRP, and ClinicalTrials.gov from inception. The date of the last search was May 2019 for all databases. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials involving adults and children without known diabetes mellitus, conducted over at least three months, that assessed the effect of diabetes screening (mass, targeted, or opportunistic) compared to no diabetes screening.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for potential relevance and reviewed the full-texts of potentially relevant studies, extracted data, and carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool. We assessed the overall certainty of the evidence using the GRADE approach.\nMain results\nWe screened 4651 titles and abstracts identified by the search and assessed 92 full-texts/records for inclusion. We included one cluster-randomised trial, the ADDITION-Cambridge study, which involved 20,184 participants from 33 general practices in Eastern England and assessed the effects of inviting versus not inviting high-risk individuals to screening for diabetes. The diabetes risk score was used to identify high-risk individuals; it comprised variables relating to age, sex, body mass index, and the use of prescribed steroid and anti-hypertensive medication. Twenty-seven practices were randomised to the screening group (11,737 participants actually attending screening) and 5 practices to the no-screening group (4137 participants). In both groups, 36% of participants were women; the average age of participants was 58.2 years in the screening group and 57.9 years in the no-screening group. Almost half of participants in both groups were on antihypertensive medication. The findings from the first phase of this study indicate that screening compared to no screening for type 2 diabetes did not show a clear difference in all-cause mortality (hazard ratio (HR) 1.06, 95% confidence interval (CI) 0.90 to 1.25, low-certainty evidence). Screening compared to no screening for type 2 diabetes mellitus showed an HR of 1.26, 95% CI 0.75 to 2.12 (low-certainty evidence) for diabetes-related mortality (based on whether diabetes was reported as a cause of death on the death certificate). Diabetes-related morbidity and health-related quality of life were only reported in a subsample and did not show a substantial difference between the screening intervention and control. The included study did not report on adverse events, incidence of type 2 diabetes, glycosylated haemoglobin A1c (HbA1c), and socioeconomic effects.\nAuthors' conclusions\nWe are uncertain about the effects of screening for type 2 diabetes on all-cause mortality and diabetes-related mortality. Evidence was available from one study only. We are therefore unable to draw any firm conclusions relating to the health outcomes of early type 2 diabetes mellitus screening. Furthermore, the included study did not assess all of the outcomes prespecified in the review (diabetes-related morbidity, incidence of type 2 diabetes, health-related quality of life, adverse events, socioeconomic effects).\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Type 2 diabetes mellitus is a metabolic disorder characterised by high blood sugar which can lead to complications like kidney and eye disease. It can develop at any age but usually peaks in adults 65 years of age and above and may be treated in the beginning through diet and exercise. Type 2 diabetes mellitus may have no or few symptoms at the start and thus may go undiagnosed. Screening of apparently healthy people could lead to early detection and treatment of type 2 diabetes mellitus as well as prevent or delay the development of related complications."
}
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query-laysum | 2074 | [
{
"role": "user",
"content": "Abstract: Background\nIntraventricular haemorrhage (IVH) is a major complication of preterm birth. Large haemorrhages are associated with a high risk of disability and hydrocephalus. Instability of blood pressure and cerebral blood in the newborn flow are postulated as causative factors. Another mechanism may involve reperfusion damage from oxygen free radicals. It has been suggested that phenobarbital stabilises blood pressure and may protect against free radicals. This is an update of a review first published in 2001 and updated in 2007 and 2013.\nObjectives\nTo assess the benefits and harms of the postnatal administration of phenobarbital in preterm infants at risk of developing IVH compared to control (i.e. no intervention or placebo).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, CINAHL and clinical trial registries in January 2022. A new, more sensitive search strategy was developed, and searches were conducted without date limits.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs in which phenobarbital was given within the first 24 hours of life to preterm infants identified as being at risk of IVH because of gestational age below 34 weeks, birth weight below 1500 g or respiratory failure. Phenobarbital was compared to no intervention or placebo. We excluded infants with serious congenital malformations.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were all grades of IVH and severe IVH (i.e. grade III and IV); secondary outcomes were ventricular dilation or hydrocephalus, hypotension, pneumothorax, hypercapnia, acidosis, mechanical ventilation, neurodevelopmental impairment and death. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 10 RCTs (792 infants).\nThe evidence suggests that phenobarbital results in little to no difference in the incidence of IVH of any grade compared with control (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.84 to 1.19; risk difference (RD) 0.00, 95% CI -0.06 to 0.07; I² for RD = 65%; 10 RCTs, 792 participants; low certainty evidence) and in severe IVH (RR 0.88, 95% CI 0.64 to 1.21; 10 RCTs, 792 participants; low certainty evidence).\nThe evidence is very uncertain about the effect of phenobarbital on posthaemorrhagic ventricular dilation or hydrocephalus (RR 0.62, 95% CI 0.31 to 1.26; 4 RCTs, 271 participants; very low certainty evidence), mild neurodevelopmental impairment (RR 0.57, 95% CI 0.15 to 2.17; 1RCT, 101 participants; very low certainty evidence), and severe neurodevelopmental impairment (RR 1.12, 95% CI 0.44 to 2.82; 2 RCTs, 153 participants; very low certainty evidence). Phenobarbital may result in little to no difference in death before discharge (RR 0.88, 95% CI 0.64 to 1.21; 9 RCTs, 740 participants; low certainty evidence) and mortality during study period (RR 0.98, 95% CI 0.72 to 1.33; 10 RCTs, 792 participants; low certainty evidence) compared with control.\nWe identified no ongoing trials.\nAuthors' conclusions\nThe evidence suggests that phenobarbital results in little to no difference in the incidence of IVH (any grade or severe) compared with control (i.e. no intervention or placebo). The evidence is very uncertain about the effects of phenobarbital on ventricular dilation or hydrocephalus and on neurodevelopmental impairment. The evidence suggests that phenobarbital results in little to no difference in death before discharge and all deaths during the study period compared with control.\nSince 1993, no randomised studies have been published on phenobarbital for the prevention of IVH in preterm infants, and no trials are ongoing. The effects of postnatal phenobarbital might be assessed in infants with both neonatal seizures and IVH, in both randomised and observational studies. The assessment of benefits and harms should include long-term outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What is bleeding to the brain (intraventricular haemorrhage)?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Large bleeds in the centre of the brain can cause disability or death in babies born too early. Unstable blood pressure and blood flow to the brain are believed to cause bleeding into the fluid-filled cavities of the brain (ventricles)."
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query-laysum | 2075 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane review first published in 2002. Osteoarthritis is a disease that affects the synovial joints, causing degeneration and destruction of hyaline cartilage and subchondral bone. Electromagnetic field therapy is currently used by physiotherapists and may promote growth and repair of bone and cartilage. It is based on principles of physics which include Wolff's law, the piezoelectric effect and the concept of streaming potentials.\nObjectives\nTo assess the benefits and harms of electromagnetic fields for the treatment of osteoarthritis as compared to placebo or sham.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), PreMEDLINE for trials published before 1966, MEDLINE from 1966 to October 2013, CINAHL and PEDro up to and including October 2013. Electronic searches were complemented by handsearches.\nSelection criteria\nRandomised controlled trials of electromagnetic fields in osteoarthritis, with four or more weeks treatment duration. We included papers in any language.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review and resolved differences by consensus with a third review author. We extracted data using pre-developed data extraction forms. The same review authors assessed the risk of bias of the trials independently using the Cochrane 'Risk of bias' tool. We extracted outcomes for osteoarthritis from the publications according to Outcome Measures in Rheumatology Clinical Trials (OMERACT) guidelines. We expressed results for continuous outcome measures as mean difference (MD) or standardised mean difference (SMD) with 95% confidence interval (CI). We pooled dichotomous outcome measures using risk ratio (RR) and calculated the number needed to treat (NNT).\nMain results\nNine studies with a total of 636 participants with osteoarthritis were included, six of which were added in this update of the review. Selective outcome reporting was unclear in all nine included studies due to inadequate reporting of study design and conduct, and there was high risk of bias for incomplete outcome data in three studies. The overall risk of bias across the nine studies was low for the other domains.\nParticipants who were randomised to electromagnetic field treatment rated their pain relief 15.10 points more on a scale of 0 to 100 (MD 15.10, 95% CI 9.08 to 21.13; absolute improvement 15%) after 4 to 26 weeks' treatment compared with placebo. Electromagnetic field treatment had no statistically significant effect on physical function (MD 4.55, 95% CI -2.23 to 11.32; absolute improvement 4.55%) based on the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scale from 0 to 100 after 12 to 26 weeks' treatment. We also found no statistically significant difference in quality of life on a scale from 0 to 100 (SMD 0.09, 95% CI -0.36 to 0.54; absolute improvement 0.09%) after four to six weeks' treatment, based on the SF-36. No data were available for analysis of radiographic changes. Safety was evaluated in four trials including up to 288 participants: there was no difference in the experience of any adverse event after 4 to 12 weeks of treatment compared with placebo (RR 1.17, 95% CI 0.72 to 1.92). There was no difference in participants who withdrew because of adverse events (measured in one trial) after four weeks of treatment (RR 0.90, 95% CI 0.06 to 13.92). No participants experienced any serious adverse events.\nAuthors' conclusions\nCurrent evidence suggests that electromagnetic field treatment may provide moderate benefit for osteoarthritis sufferers in terms of pain relief. Further studies are required to confirm whether this treatment confers clinically important benefits in terms of physical function and quality of life. Our conclusions are unchanged from the previous review conducted in 2002.\n\nGiven the provided abstract, please respond to the following query: \"Pain (on a 0 to 100 scale; higher scores mean worse or more severe pain)\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "- Electromagnetic fields probably relieve pain in osteoarthritis.\n- People who received electromagnetic field treatment experienced pain relief of 15 points more compared with people who received fake treatment (15% improvement).\n- People who received electromagnetic field treatment rated their pain to be 26 points lower on a scale of 0 to 100.\n- People who received fake treatment rated their pain to be 11 points lower on a scale of 0 to 100."
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query-laysum | 2076 | [
{
"role": "user",
"content": "Abstract: Background\nLateral elbow pain, or tennis elbow, is a common condition that causes pain in the elbow and forearm. Although self-limiting, it can be associated with significant disability and often results in work absence. It is often treated with topical and oral non-steroidal anti-inflammatory drugs (NSAIDs). This is an update of a review first published in 2002 (search date October 11, 2012).\nObjectives\nTo assess the benefits and harms of topical and oral NSAIDs for treating people with lateral elbow pain.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, EMBASE and SciSearch up to October 11, 2012. No language restriction was applied.\nSelection criteria\nStudies were included if they were randomised or quasi-randomised controlled trials (RCTs or CCTs) that compared topical or oral NSAIDs with placebo or another intervention, or compared two NSAIDs in adults with lateral elbow pain. Outcomes of interest were pain, function, quality of life, pain-free grip strength, overall treatment success, work loss and adverse effects.\nData collection and analysis\nTwo review authors independently selected the studies for inclusion, extracted the data, and performed a risk of bias assessment.\nMain results\nFifteen trials, involving 759 participants and reporting 17 comparisons, were included in the review. Four new trials identified from the updated search were included, along with 11 of 14 trials included in the original review (three trials included in the previous review were found not to meet inclusion criteria). Of eight trials that studied topical NSAIDs (301 participants), five compared topical NSAIDs with placebo, one compared manipulative therapy and topical NSAIDs with manipulative therapy alone, one compared leech therapy with topical NSAIDs and one compared two different topical NSAIDs. Of seven trials that investigated oral NSAIDs (437 participants), two compared oral NSAIDs with placebo, one compared oral NSAIDs and bandaging with bandaging alone, three compared oral NSAIDs with glucocorticoid injection, one compared oral NSAIDs with a vasodilator and two compared two different oral NSAIDs. No trials directly compared topical NSAIDs with oral NSAIDs. Few trials used intention-to-treat analysis, and the sample size of most was small. The median follow-up was 2 weeks (range 1 week to 1 year).\nLow-quality evidence was obtained from three trials (153 participants) suggesting that topical NSAIDs were significantly more effective than placebo with respect to pain in the short term (mean difference -1.64, 95% confidence interval (CI) -2.42 to -0.86) and number needed to treat to benefit (7 (95% CI 3 to 21) on a 0 to 10 scale). Low-quality evidence was obtained from one trial (85 participants) indicating that significantly more participants report fair, good or excellent effectiveness with topical NSAIDs versus placebo at 28 days (14 days of therapy) (risk ratio (RR) 1.49, 95% CI 1.04 to 2.14). No participants withdrew as the result of adverse events, but some studies reported mild adverse effects such as rash in 2.5% of those exposed to topical NSAIDs compared with 1.3% of those exposed to placebo.\nLow-quality and conflicting evidence regarding the benefits of oral NSAIDs obtained from two trials could not be pooled. One trial found significantly greater improvement in pain compared with placebo, and the other trial found no between-group differences; neither trial found differences in function. One trial reported a withdrawal due to adverse effects for a participant in the NSAIDs group. Use of oral NSAIDs was associated with increased risk of gastrointestinal side effects compared with placebo in one trial in the review. Another trial reported discontinuation of treatment due to gastrointestinal side effects in four participants taking NSAIDs, and another participant developed an allergic reaction in response to oral NSAIDs.\nVery scant and conflicting evidence regarding the comparative effects of oral NSAIDs and glucocorticoid injection was obtained. One trial reported a significant improvement in pain with glucocorticoid injection, and another found no between-group differences; treatment success was similar between groups (RR of fair, good or excellent effectiveness 0.74; 95% CI 0.43 to 1.26). Transient pain may occur following injection.\nAuthors' conclusions\nThere remains limited evidence from which to draw firm conclusions about the benefits or harms of topical or oral NSAIDs in treating lateral elbow pain. Although data from five placebo-controlled trials suggest that topical NSAIDs may be beneficial in improving pain (for up to 4 weeks), non-normal distribution of data and other methodological issues precluded firm conclusions. Some people may expect a mild transient skin rash. Evidence about the benefits of oral NSAIDs has been conflicting, although oral NSAID use may result in gastrointestinal adverse effects in some people. No direct comparisons between oral and topical NSAIDs were available. Some trials demonstrated greater benefit from glucocorticoid injection than from NSAIDs in the short term, but this was not apparent in all studies and was not apparent by 6 months in the only study that included longer-term outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Side effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "- 1 more person using NSAID gel out of 100 had minor side effects such as skin rash at the site of application (0% absolute difference, ranging from 5% fewer to 6% more).\n- 2 out of 100 using NSAID gel had side effects,\n- 1 out of 100 people using placebo gel had side effects."
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query-laysum | 2077 | [
{
"role": "user",
"content": "Abstract: Background\nAssisted reproductive technologies (ART) including in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), combine gametes to enhance the probability of fertilisation and pregnancy. Advanced sperm selection techniques are increasingly employed in ART, most commonly in cycles utilising ICSI. Advanced sperm selection techniques are proposed to improve the chance that structurally intact and mature sperm with high DNA integrity are selected for fertilisation. Strategies include selection according to surface charge; sperm apoptosis; sperm birefringence; ability to bind to hyaluronic acid; and sperm morphology under ultra-high magnification. These techniques are intended to improve ART outcomes.\nObjectives\nTo evaluate the effectiveness and safety of advanced sperm selection techniques on ART outcomes.\nSearch methods\nWe conducted a systematic search of electronic databases (Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL via the Cochrane Register of Studies Online, MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL); trials registers (ClinicalTrials.gov, Current Controlled Trials, and the World Health Organization International Clinical Trials Registry Platform); conference abstracts (Web of Knowledge); and grey literature (OpenGrey) for relevant randomised controlled trials (RCTs). We handsearched the reference lists of included studies and similar reviews. The search was conducted in June 2018.\nSelection criteria\nWe included RCTs comparing advanced sperm selection techniques versus standard IVF, ICSI, or another technique. We excluded studies of intracytoplasmic morphologically selected sperm injection (IMSI), as they are subject to a separate Cochrane Review. Primary outcomes measured were live birth and miscarriage per woman randomly assigned. Secondary outcome measures included clinical pregnancy per woman randomly assigned. Secondary adverse events measured included miscarriage per clinical pregnancy and foetal abnormality.\nData collection and analysis\nTwo review authors independently assessed study eligibility and risk of bias and extracted data. Any disagreements were resolved by consultation with a third review author. We consulted study investigators to resolve queries. Risk ratios (RRs) were calculated with 95% confidence intervals (CIs). We combined studies using a fixed-effect model. We evaluated the quality of the evidence using GRADE methods.\nMain results\nWe included eight RCTs (4147 women). The quality of evidence ranged from very low to low. The main limitations were imprecision, performance bias, and attrition bias.\nHyaluronic acid selected sperm-intracytoplasmic sperm injection (HA-ICSI) compared to ICSI\nTwo RCTs compared the effects of HA-ICSI versus ICSI on live birth. The quality of the evidence was low. There may be little or no difference between groups: 25% chance of live birth with ICSI versus 24.5% to 31% with HA-ICSI (RR 1.09, 95% CI 0.97 to 1.23, 2903 women, I2 = 0%, low-quality evidence). Three RCTs reported on miscarriage. HA-ICSI may decrease miscarriage per woman randomly assigned: 7% chance of miscarriage with ICSI versus 3% to 6% chance with HA-ICSI (RR 0.61, 95% CI 0.45 to 0.83, 3005 women, I2 = 0%, low-quality evidence) and per clinical pregnancy: 20% chance of miscarriage with ICSI compared to 9% to 16% chance with HA-ICSI (RR 0.62, 95% CI 0.46 to 0.82, 1065 women, I2 = 0%, low-quality evidence). Four RCTs reported on clinical pregnancy. There may be little or no difference between groups: 37% chance of pregnancy with ICSI versus 34% to 40% chance with HA-ICSI (RR 1.00, 95% CI 0.92 to 1.09, 3492 women, I2 = 0%, low-quality evidence).\nHA-ICSI compared to SpermSlow\nOne RCT compared HA-ICSI to SpermSlow. The quality of the evidence was very low. We are uncertain whether HA-ICSI improves live birth compared to SpermSlow (RR 1.13, 95% CI 0.64 to 2.01, 100 women) or clinical pregnancy (RR 1.05, 95% CI 0.66 to 1.68, 100 women). We are uncertain whether HA-ICSI reduces miscarriage per woman (RR 0.80, 95% CI 0.23 to 2.81, 100 women) or per clinical pregnancy (RR 0.76, 95% CI 0.24 to 2.44, 41 women).\nMagnetic-activated cell sorting (MACS) compared to ICSI\nOne RCT compared MACS to ICSI for live birth; three reported clinical pregnancy; and two reported miscarriage. The quality of the evidence was very low. We are uncertain whether MACS improves live birth (RR 1.95, 95% CI 0.89 to 4.29, 62 women) or clinical pregnancy (RR 1.05, 95% CI 0.84 to 1.31, 413 women, I2 = 81%). We are also uncertain if MACS reduces miscarriage per woman (RR 0.95, 95% CI 0.16 to 5.63, 150 women, I2 = 0%) or per clinical pregnancy (RR 0.51, 95%CI 0.09 to 2.82, 53 women, I2=0)\nZeta sperm selection compared to ICSI\nOne RCT evaluated Zeta sperm selection. The quality of the evidence was very low. We are uncertain of the effect of Zeta sperm selection on live birth (RR 2.48, 95% CI 1.34 to 4.56, 203 women) or clinical pregnancy (RR 1.82, 95% CI 1.20 to 2.75, 203 women). We are also uncertain if Zeta sperm selection reduces miscarriage per woman (RR 0.73, 95% CI 0.16 to 3.37, 203 women) or per clinical pregnancy (RR 0.41, 95% CI 0.10 to 1.68, 1 RCT, 62 women).\nMACS compared to HA-ICSI\nOne RCT compared MACS to HA-ICSI. This study did not report on live birth. The quality of the evidence was very low. We are uncertain of the effect on miscarriage per woman (RR 1.52, 95% CI 0.10 to 23.35, 78 women) or per clinical pregnancy (RR 1.06, 95% CI 0.07 to 15.64, 37 women). We are also uncertain of the effect on clinical pregnancy (RR 1.44, 95% CI 0.91 to 2.27, 78 women).\nAuthors' conclusions\nThe evidence suggests that sperm selected by hyaluronic acid binding may have little or no effect on live birth or clinical pregnancy but may reduce miscarriage. We are uncertain of the effect of Zeta sperm selection on live birth, clinical pregnancy, and miscarriage due principally to the very low quality of the evidence for this intervention. We are uncertain of the effect of the other selection techniques on live birth, miscarriage, or pregnancy.\nFurther high-quality studies, including the awaited data from the identified ongoing studies, are required to evaluate whether any of these advanced sperm selection techniques can be recommended for use in routine 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": "We sought to determine if any advanced sperm selection techniques used for assisted reproduction, except for ultra-high magnification, alter the rates of live birth, clinical pregnancy, miscarriage, or foetal abnormalities."
}
]
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query-laysum | 2078 | [
{
"role": "user",
"content": "Abstract: Background\nPerioperative fluid strategies influence clinical outcomes following major surgery. Many intravenous fluid preparations are based on simple solutions, such as normal saline, that feature an electrolyte composition that differs from that of physiological plasma. Buffered fluids have a theoretical advantage of containing a substrate that acts to maintain the body’s acid-base status - typically a bicarbonate or a bicarbonate precursor such as maleate, gluconate, lactate, or acetate. Buffered fluids also provide additional electrolytes, including potassium, magnesium, and calcium, more closely matching the electrolyte balance of plasma. The putative benefits of buffered fluids have been compared with those of non-buffered fluids in the context of clinical studies conducted during the perioperative period. This review was published in 2012, and was updated in 2017.\nObjectives\nTo review effects of perioperative intravenous administration of buffered versus non-buffered fluids for plasma volume expansion or maintenance, or both, on clinical outcomes in adults undergoing all types of surgery.\nSearch methods\nWe electronically searched the Clinicaltrials.gov major trials registry, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 6) in the Cochrane Library, MEDLINE (1966 to June 2016), Embase (1980 to June 2016), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to June 2016). We handsearched conference abstracts and, when possible, contacted leaders in the field. We reran the search in May 2017. We added one potential new study of interest to the list of ‘Studies awaiting classification' and will incorporate this trial into formal review findings when we prepare the review update.\nSelection criteria\nOnly randomized controlled trials that compared buffered versus non-buffered intravenous fluids for surgical patients were eligible for inclusion. We excluded other forms of comparison such as crystalloids versus colloids and colloids versus different colloids.\nData collection and analysis\nTwo review authors screened references for eligibility, extracted data, and assessed risks of bias. We resolved disagreements by discussion and consensus, in collaboration with a third review author. We contacted trial authors to request additional information when appropriate. We presented pooled estimates for dichotomous outcomes as odds ratios (ORs) and for continuous outcomes as mean differences (MDs), with 95% confidence intervals (CIs). We analysed data via Review Manager 5.3 using fixed-effect models, and when heterogeneity was high (I² > 40%), we used random-effects models.\nMain results\nThis review includes, in total, 19 publications of 18 randomized controlled trials with a total of 1096 participants. We incorporated five of those 19 studies (330 participants) after the June 2016 update. Outcome measures in the included studies were thematically similar, covering perioperative electrolyte status, renal function, and acid-base status; however, we found significant clinical and statistical heterogeneity among the included studies. We identified variable protocols for fluid administration and total volumes of fluid administered to patients intraoperatively. Trial authors variably reported outcome data at disparate time points and with heterogeneous patient groups. Consequently, many outcome measures are reported in small group sizes, reducing overall confidence in effect size, despite relatively low inherent bias in the included studies. Several studies reported orphan outcome measures. We did not include in the results of this review one large, ongoing study of saline versus Ringer's solution.\nWe found insufficient evidence on effects of fluid therapies on mortality and postoperative organ dysfunction (defined as renal insufficiency leading to renal replacement therapy); confidence intervals were wide and included both clinically relevant benefit and harm: mortality (Peto OR 1.85, 95% CI 0.37 to 9.33; I² = 0%; 3 trials, 6 deaths, 276 participants; low-quality evidence); renal insufficiency (OR 0.82, 95% CI 0.34 to 1.98; I² = 0%; 4 trials, 22 events, 276 participants; low-quality evidence).\nWe noted several metabolic differences, including a difference in postoperative pH measured at end of surgery of 0.05 units - lower in the non-buffered fluid group (12 studies with a total of 720 participants; 95% CI 0.04 to 0.07; I² = 61%). However, this difference was not maintained on postoperative day one. We rated the quality of evidence for this outcome as moderate. We observed a higher postoperative serum chloride level immediately after operation, with use of non-buffered fluids reported in 10 studies with a total of 530 participants (MD 6.77 mmol/L, 95% CI 3.38 to 10.17), and this difference persisted until day one postoperatively (five studies with a total of 258 participants; MD 8.48 mmol/L, 95% CI 1.08 to 15.88). We rated the quality of evidence for this outcome as moderate.\nAuthors' conclusions\nCurrent evidence is insufficient to show effects of perioperative administration of buffered versus non-buffered crystalloid fluids on mortality and organ system function in adult patients following surgery. Benefits of buffered fluid were measurable in biochemical terms, particularly a significant reduction in postoperative hyperchloraemia and metabolic acidosis. Small effect sizes for biochemical outcomes and lack of correlated clinical follow-up data mean that robust conclusions on major morbidity and mortality associated with buffered versus non-buffered perioperative fluid choices are still lacking. Larger studies are needed to assess these relevant clinical outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To review evidence from randomized controlled trials on safety and effects of administration of buffered versus non-buffered fluids into the veins of adult patients undergoing surgery."
}
]
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query-laysum | 2079 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for rheumatoid arthritis (RA).\nObjectives\nTo assess the benefits and harms of nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib, versus comparator (MTX, DMARD, placebo (PL), or a combination) in adults with rheumatoid arthritis who have failed to respond to methotrexate (MTX) or other disease-modifying anti-rheumatic drugs (DMARDs), i.e., MTX/DMARD incomplete responders (MTX/DMARD-IR).\nMethods\nWe searched for randomized controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (via The Cochrane Library Issue 6, June 2015), MEDLINE (via OVID 1946 to June 2015), and EMBASE (via OVID 1947 to June 2015). Data extraction, risk of bias and GRADE assessments were done in duplicate. We calculated both direct estimates using standard meta-analysis and used Bayesian mixed treatment comparisons approach for NMA estimates to calculate odds ratios (OR) and 95% credible intervals (CrI). We converted OR to risk ratios (RR) which are reported in the abstract for the ease of interpretation.\nMain results\nThis update included 73 new RCTs for a total of 90 RCTs; 79 RCTs with 32,874 participants provided usable data. Few trials were at high risk of bias for blinding of assessors/participants (13% to 21%), selective reporting (4%) or major baseline imbalance (8%); a large number had unclear risk of bias for random sequence generation (68%) or allocation concealment (74%).\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a statistically significant and clinically meaningful improvement in ACR50 versus comparator (RR 2.71 (95% confidence interval (CI) 2.36 to 3.10); absolute benefit 24% more patients (95% CI 19% to 29%), number needed to treat for an additional beneficial outcome (NNTB) = 5 (4 to 6). NMA estimates for ACR50 in tumor necrosis factor (TNF) biologic+MTX/DMARD (RR 3.23 (95% credible interval (Crl) 2.75 to 3.79), non-TNF biologic+MTX/DMARD (RR 2.99; 95% Crl 2.36 to 3.74), and anakinra + MTX/DMARD (RR 2.37 (95% Crl 1.00 to 4.70) were similar to the direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a clinically and statistically important improvement in function measured by the Health Assessment Questionnaire (0 to 3 scale, higher = worse function) with a mean difference (MD) based on direct evidence of -0.25 (95% CI -0.28 to -0.22); absolute benefit of -8.3% (95% CI -9.3% to -7.3%), NNTB = 3 (95% CI 2 to 4). NMA estimates for TNF biologic+MTX/DMARD (absolute benefit, -10.3% (95% Crl -14% to -6.7%) and non-TNF biologic+MTX/DMARD (absolute benefit, -7.3% (95% Crl -13.6% to -0.67%) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with clinically and statistically significantly greater proportion of participants achieving remission in RA (defined by disease activity score DAS < 1.6 or DAS28 < 2.6) versus comparator (RR 2.81 (95% CI, 2.23 to 3.53); absolute benefit 18% more patients (95% CI 12% to 25%), NNTB = 6 (4 to 9)). NMA estimates for TNF biologic+MTX/DMARD (absolute improvement 17% (95% Crl 11% to 23%)) and non-TNF biologic+MTX/DMARD (absolute improvement 19% (95% Crl 12% to 28%) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for inconsistency), radiographic progression (scale 0 to 448) was statistically significantly reduced in those on biologics + MTX/DMARDs versus comparator, MD -2.61 (95% CI -4.08 to -1.14). The absolute reduction was small, -0.58% (95% CI -0.91% to -0.25%) and we are unsure of the clinical relevance of this reduction. NMA estimates of TNF biologic+MTX/DMARD (absolute reduction -0.67% (95% Crl -1.4% to -0.12%) and non-TNF biologic+MTX/DMARD (absolute reduction, -0.68% (95% Crl -2.36% to 0.92%)) were similar to respective direct estimates.\nBased on direct evidence of moderate quality (downgraded for imprecision), results for withdrawals due to adverse events were inconclusive, with wide confidence intervals encompassing the null effect and evidence of an important increase in withdrawals, RR 1.11 (95% CI 0.96 to 1.30). The NMA estimates of TNF biologic+MTX/DMARD (RR 1.24 (95% Crl 0.99 to 1.57)) and non-TNF biologic+MTX/DMARD (RR 1.20 (95% Crl 0.87 to 1.67)) were similarly inconclusive and downgraded to low for both imprecision and indirectness.\nBased on direct evidence of high quality, biologic+MTX/DMARD was associated with clinically significantly increased risk (statistically borderline significant) of serious adverse events on biologic+MTX/DMARD (Peto OR [can be interpreted as RR due to low event rate] 1.12 (95% CI 0.99 to 1.27); absolute risk 1% (0% to 2%), As well, the NMA estimate for TNF biologic+MTX/DMARD (Peto OR 1.20 (95% Crl 1.01 to 1.43)) showed moderate quality evidence of an increase in the risk of serious adverse events. The other two NMA estimates were downgraded to low quality due to imprecision and indirectness and had wide confidence intervals resulting in uncertainty around the estimates: non-TNF biologics + MTX/DMARD: 1.07 (95% Crl 0.89 to 1.29) and anakinra: RR 1.06 (95% Crl 0.65 to 1.75).\nBased on direct evidence of low quality (downgraded for serious imprecision), results were inconclusive for cancer (Peto OR 1.07 (95% CI 0.68 to 1.68) for all biologic+MTX/DMARD combinations. The NMA estimates of TNF biologic+MTX/DMARD (Peto OR 1.21 (95% Crl 0.63 to 2.38) and non-TNF biologic+MTX/DMARD (Peto OR 0.99 (95% Crl 0.58 to 1.78)) were similarly inconclusive and downgraded to low quality for both imprecision and indirectness.\nMain results text shows the results for tofacitinib and differences between medications.\nAuthors' conclusions\nBased primarily on RCTs of 6 months' to 12 months' duration, there is moderate quality evidence that the use of biologic+MTX/DMARD in people with rheumatoid arthritis who have failed to respond to MTX or other DMARDs results in clinically important improvement in function and higher ACR50 and remission rates, and increased risk of serious adverse events than the comparator (MTX/DMARD/PL; high quality evidence). Radiographic progression is slowed but its clinical relevance is uncertain. Results were inconclusive for whether biologics + MTX/DMARDs are associated with an increased risk of cancer or withdrawals due to adverse events.\n\nGiven the provided abstract, please respond to the following query: \"The review shows that in people with rheumatoid arthritis\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Biologics in combination with methotrexate (MTX) or other DMARDs:\n- probably improve signs and symptoms of RA (tender or swollen joints), function, the chances of RA remission (disappearance of symptoms) and slow down X-ray disease progression. However, we are not sure of the importance of the amount of slowing of disease progression as seen on X-rays. We downgraded our confidence in the results because of concerns about the inconsistency of some results.\n- probably slightly increase the number of serious adverse events, though there are few events.\nWe often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Because of the lack of data, we are uncertain of the effect of biologics on the risk of cancer and withdrawals due to adverse events."
}
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query-laysum | 2080 | [
{
"role": "user",
"content": "Abstract: Background\nFoot ulcers are a major complication of diabetes mellitus, often leading to amputation. Growth factors derived from blood platelets, endothelium, or macrophages could potentially be an important treatment for these wounds but they may also confer risks.\nObjectives\nTo assess the benefits and harms of growth factors for foot ulcers in patients with type 1 or type 2 diabetes mellitus.\nSearch methods\nIn March 2015 we searched the Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), 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.\nSelection criteria\nRandomised clinical trials in any setting, recruiting people with type 1 or type 2 diabetes mellitus diagnosed with a foot ulcer. Trials were eligible for inclusion if they compared a growth factor plus standard care (e.g., antibiotic therapy, debridement, wound dressings) versus placebo or no growth factor plus standard care, or compared different growth factors against each other. We considered lower limb amputation (minimum of one toe), complete healing of the foot ulcer, and time to complete healing of the diabetic foot ulcer as the primary outcomes.\nData collection and analysis\nIndependently, we selected randomised clinical trials, assessed risk of bias, and extracted data in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We measured statistical heterogeneity using the I2 statistic. We subjected our analyses to both fixed-effect and random-effects model analyses.\nMain results\nWe identified 28 randomised clinical trials involving 2365 participants. The cause of foot ulcer (neurologic, vascular, or combined) was poorly defined in all trials. The trials were conducted in ten countries. The trials assessed 11 growth factors in 30 comparisons: platelet-derived wound healing formula, autologous growth factor, allogeneic platelet-derived growth factor, transforming growth factor β2, arginine-glycine-aspartic acid peptide matrix, recombinant human platelet-derived growth factor (becaplermin), recombinant human epidermal growth factor, recombinant human basic fibroblast growth factor, recombinant human vascular endothelial growth factor, recombinant human lactoferrin, and recombinant human acidic fibroblast growth factor. Topical intervention was the most frequent route of administration. All the trials were underpowered and had a high risk of bias. Pharmaceutical industry sponsored 50% of the trials.\nAny growth factor compared with placebo or no growth factor increased the number of participants with complete wound healing (345/657 (52.51%) versus 167/482 (34.64%); RR 1.51, 95% CI 1.31 to 1.73; I2 = 51%, 12 trials; low quality evidence). The result is mainly based on platelet-derived wound healing formula (36/56 (64.28%) versus 7/27 (25.92%); RR 2.45, 95% 1.27 to 4.74; I2 = 0%, two trials), and recombinant human platelet-derived growth factor (becaplermin) (205/428 (47.89%) versus 109/335 (32.53%); RR 1.47, 95% CI 1.23 to 1.76, I2= 74%, five trials).\nIn terms of lower limb amputation (minimum of one toe), there was no clear evidence of a difference between any growth factor and placebo or no growth factor (19/150 (12.66%) versus 12/69 (17.39%); RR 0.74, 95% CI 0.39 to 1.39; I2 = 0%, two trials; very low quality evidence). One trial involving 55 participants showed no clear evidence of a difference between recombinant human vascular endothelial growth factor and placebo in terms of ulcer-free days following treatment for diabetic foot ulcers (RR 0.64, 95% CI 0.14 to 2.94; P value 0.56, low quality of evidence)\nAlthough 11 trials reported time to complete healing of the foot ulcers in people with diabetes , meta-analysis was not possible for this outcome due to the unique comparisons within each trial, failure to report data, and high number of withdrawals. Data on quality of life were not reported. Growth factors showed an increasing risk of overall adverse event rate compared with compared with placebo or no growth factor (255/498 (51.20%) versus 169/332 (50.90%); RR 0.83; 95% CI 0.72 to 0.96; I2 = 48%; eight trials; low quality evidence). Overall, safety data were poorly reported and adverse events may have been underestimated.\nAuthors' conclusions\nThis Cochrane systematic review analysed a heterogeneous group of trials that assessed 11 different growth factors for diabetic foot ulcers. We found evidence suggesting that growth factors may increase the likelihood that people will have complete healing of foot ulcers in people with diabetes. However, this conclusion is based on randomised clinical trials with high risk of systematic errors (bias). Assessment of the quality of the available evidence (GRADE) showed that further trials investigating the effect of growth factors are needed before firm conclusions can be drawn. The safety profiles of the growth factors are unclear. Future trials should be conducted according to SPIRIT statement and reported according to the CONSORT statement by independent investigators and using the Foundation of Patient-Centered Outcomes Research recommendations.\n\nGiven the provided abstract, please respond to the following query: \"Shortcomings of the trials included in this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "None of the trials reported data on participants’ quality of life. Harms caused by treatments were poorly reported, so the safety profile of growth factors remains unclear.\nIt is clear that more trials are required to assess the benefits and harms of growth factors in the treatment of diabetic foot ulcers. These trials should be well-designed, conducted by independent researchers (not industry-sponsored), and have large numbers of participants. They should report outcomes that are of interest to patients, such as: how many of the participants’ ulcers healed, and how long the healing took; any level of amputation in the foot; quality of life; ulcer-free days following treatment; and harms caused by treatment, including whether there are any potential cancer risks."
}
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query-laysum | 2081 | [
{
"role": "user",
"content": "Abstract: Background\nConcerns exist regarding antibiotic prescribing for respiratory tract infections (RTIs) owing to adverse reactions, cost and antibacterial resistance. One proposed strategy to reduce antibiotic prescribing is to provide prescriptions, but to advise delay in antibiotic use with the expectation that symptoms will resolve first. This is an update of a Cochrane Review originally published in 2007, and updated in 2010, 2013 and 2017.\nObjectives\nTo evaluate the effects on duration and/or severity of clinical outcomes (pain, malaise, fever, cough and rhinorrhoea), antibiotic use, antibiotic resistance and patient satisfaction of advising a delayed prescription of antibiotics in respiratory tract infections.\nSearch methods\nFrom May 2017 until 20 August 2022, this was a living systematic review with monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL and Web of Science. We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov on 20 August 2022. Due to the abundance of evidence supporting the review's key findings, it ceased being a living systematic review on 21 August 2022.\nSelection criteria\nRandomised controlled trials involving participants of all ages with an RTI, where delayed antibiotics were compared to immediate or no antibiotics. We defined a delayed antibiotic as advice to delay the filling of an antibiotic prescription by at least 48 hours. We considered all RTIs regardless of whether antibiotics were recommended or not.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nFor this 2022 update, we added one new trial enrolling 448 children (436 analysed) with uncomplicated acute RTIs. Overall, this review includes 12 studies with a total of 3968 participants, of which data from 3750 are available for analysis. These 12 studies involved acute RTIs including acute otitis media (three studies), streptococcal pharyngitis (three studies), cough (two studies), sore throat (one study), common cold (one study) and a variety of RTIs (two studies). Six studies involved only children, two only adults and four included both adults and children. Six studies were conducted in primary care, four in paediatric clinics and two in emergency departments.\nStudies were well reported and appeared to provide moderate-certainty evidence. Randomisation was not adequately described in two trials. Four trials blinded the outcome assessor, and three included blinding of participants and doctors. We conducted meta-analyses for pain, malaise, fever, adverse effects, antibiotic use and patient satisfaction.\nCough (four studies): we found no differences amongst delayed, immediate and no prescribed antibiotics for clinical outcomes in any of the four studies.\nSore throat (six studies): for the outcome of fever with sore throat, four of the six studies favoured immediate antibiotics, and two found no difference. For the outcome of pain related to sore throat, two studies favoured immediate antibiotics, and four found no difference. Two studies compared delayed antibiotics with no antibiotic for sore throat, and found no difference in clinical outcomes.\nAcute otitis media (four studies): two studies compared immediate with delayed antibiotics - one found no difference for fever, and the other favoured immediate antibiotics for pain and malaise severity on Day 3. Two studies compared delayed with no antibiotics: one found no difference for pain and fever severity on Day 3, and the other found no difference for the number of children with fever on Day 3.\nCommon cold (two studies): neither study found differences for clinical outcomes between delayed and immediate antibiotic groups. One study found delayed antibiotics were probably favoured over no antibiotics for pain, fever and cough duration (moderate-certainty evidence).\nAdverse effects: there were either no differences for adverse effects or results may have favoured delayed over immediate antibiotics with no significant differences in complication rates (low-certainty evidence).\nAntibiotic use: delayed antibiotics probably resulted in a reduction in antibiotic use compared to immediate antibiotics (odds ratio (OR) 0.03, 95% confidence interval (CI) 0.01 to 0.07; 8 studies, 2257 participants; moderate-certainty evidence). However, a delayed antibiotic was probably more likely to result in reported antibiotic use than no antibiotics (OR 2.52, 95% CI 1.69 to 3.75; 5 studies, 1529 participants; moderate-certainty evidence).\nPatient satisfaction: patient satisfaction probably favoured delayed over no antibiotics (OR 1.45, 1.08 to 1.96; 5 studies, 1523 participants; moderate-certainty evidence). There was probably no difference in patient satisfaction between delayed and immediate antibiotics (OR 0.77, 95% CI 0.45 to 1.29; 7 studies, 1927 participants; moderate-certainty evidence).\nNo studies evaluated antibiotic resistance. Reconsultation rates and use of alternative medicines were similar for delayed, immediate and no antibiotic strategies. In one of the four studies reporting use of alternative medicines, less paracetamol was used in the immediate group compared to the delayed group.\nAuthors' conclusions\nFor many clinical outcomes, there were no differences between prescribing strategies. Symptoms for acute otitis media and sore throat were modestly improved by immediate antibiotics compared with delayed antibiotics. There were no differences in complication rates. Delaying prescribing did not result in significantly different levels of patient satisfaction compared with immediate provision of antibiotics (86% versus 91%; moderate-certainty evidence). However, delay was favoured over no antibiotics (87% versus 82%). Delayed antibiotics achieved lower rates of antibiotic use compared to immediate antibiotics (30% versus 93%). The strategy of no antibiotics further reduced antibiotic use compared to delaying prescription for antibiotics (13% versus 27%).\nDelayed antibiotics for people with acute respiratory infection reduced antibiotic use compared to immediate antibiotics, but was not shown to be different to no antibiotics in terms of symptom control and disease complications. Where clinicians feel it is safe not to prescribe antibiotics immediately for people with RTIs, no antibiotics with advice to return if symptoms do not resolve is likely to result in the least antibiotic use while maintaining similar patient satisfaction and clinical outcomes to delayed antibiotics. Where clinicians are not confident in not prescribing antibiotics, delayed antibiotics may be an acceptable compromise in place of immediate prescribing to significantly reduce unnecessary antibiotic use for RTIs, while maintaining patient safety and satisfaction levels.\nFurther research into antibiotic prescribing strategies for RTIs may best be focused on identifying patient groups at high risk of disease complications, enhancing doctors' communication with patients to maintain satisfaction, ways of increasing doctors' confidence to not prescribe antibiotics for RTIs, and policy measures to reduce unnecessary antibiotic prescribing for RTIs.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to 20 August 2022."
}
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query-laysum | 2082 | [
{
"role": "user",
"content": "Abstract: Background\nThe role of postoperative radiotherapy (PORT) in the treatment of patients with completely resected non-small cell lung cancer (NSCLC) was not clear. A systematic review and individual participant data meta-analysis was undertaken to evaluate available evidence from randomised controlled trials (RCTs). These results were first published in Lung Cancer in 2013.\nObjectives\nTo evaluate the effects of PORT on survival and recurrence in patients with completely resected NSCLC. To investigate whether predefined patient subgroups benefit more or less from PORT.\nSearch methods\nWe supplemented MEDLINE and CANCERLIT searches (1965 to 8 July 2016) with information from trial registers, handsearching of relevant meeting proceedings and discussion with trialists and organisations.\nSelection criteria\nWe included trials of surgery versus surgery plus radiotherapy, provided they randomised participants with NSCLC using a method that precluded prior knowledge of treatment assignment.\nData collection and analysis\nWe carried out a quantitative meta-analysis using updated information from individual participants from all randomised trials. We sought data on all participants from those responsible for the trial. We obtained updated individual participant data (IPD) on survival and date of last follow-up, as well as details on treatment allocation, date of randomisation, age, sex, histological cell type, stage, nodal status and performance status. To avoid potential bias, we requested information on all randomised participants, including those excluded from investigators' original analyses. We conducted all analyses on intention-to-treat on the endpoint of survival.\nMain results\nWe identified 14 trials evaluating surgery versus surgery plus radiotherapy. Individual participant data were available for 11 of these trials, and our analyses are based on 2343 participants (1511 deaths). Results show a significant adverse effect of PORT on survival, with a hazard ratio of 1.18, or an 18% relative increase in risk of death. This is equivalent to an absolute detriment of 5% at two years (95% confidence interval (CI) 2% to 9%), reducing overall survival from 58% to 53%. Subgroup analyses showed no differences in effects of PORT by any participant subgroup covariate.\nWe did not undertake analysis of the effects of PORT on quality of life and adverse events. Investigators did not routinely collect quality of life information during these trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. We considered risk of bias in the included trials to be low.\nAuthors' conclusions\nResults from 11 trials and 2343 participants show that PORT is detrimental to those with completely resected non-small cell lung cancer and should not be used in the routine treatment of such patients. Results of ongoing RCTs will clarify the effects of modern radiotherapy in patients with N2 tumours.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do patients with non-small cell lung cancer live longer if they are given radiotherapy after surgery?"
}
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query-laysum | 2083 | [
{
"role": "user",
"content": "Abstract: Background\nNasal continuous positive airway pressure (NCPAP) is a useful method for providing respiratory support after extubation. Nasal intermittent positive pressure ventilation (NIPPV) can augment NCPAP by delivering ventilator breaths via nasal prongs.\nObjectives\nPrimary objective\nTo determine the effects of management with NIPPV versus NCPAP on the need for additional ventilatory support in preterm infants whose endotracheal tube was removed after a period of intermittent positive pressure ventilation.\nSecondary objectives\nTo compare rates of abdominal distension, gastrointestinal perforation, necrotising enterocolitis, chronic lung disease, pulmonary air leak, mortality, duration of hospitalisation, rates of apnoea and neurodevelopmental status at 18 to 24 months for NIPPV and NCPAP.\nTo compare the effect of NIPPV versus NCPAP delivered via ventilators versus bilevel devices, and assess the effects of the synchronisation of ventilation, and the strength of interventions in different economic settings.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was January 2023.\nSelection criteria\nWe included randomised and quasi-randomised trials of ventilated preterm infants (less than 37 weeks' gestational age (GA)) ready for extubation to non-invasive respiratory support. Interventions were NIPPV and NCPAP.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was 1. respiratory failure. Our secondary outcomes were 2. endotracheal reintubation, 3. abdominal distension, 4. gastrointestinal perforation, 5. necrotising enterocolitis (NEC), 6. chronic lung disease, 7. pulmonary air leak, 8. mortality, 9. hospitalisation, 10. apnoea and bradycardia, and 11. neurodevelopmental status.\nWe used GRADE to assess the certainty of evidence.\nMain results\nWe included 19 trials (2738 infants). Compared to NCPAP, NIPPV likely reduces the risk of respiratory failure postextubation (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.67 to 0.84; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 8 to 17; 19 trials, 2738 infants; moderate-certainty evidence) and endotracheal reintubation (RR 0.78, 95% CI 0.70 to 0.87; NNTB 12, 95% CI 9 to 25; 17 trials, 2608 infants, moderate-certainty evidence), and may reduce pulmonary air leaks (RR 0.57, 95% CI 0.37 to 0.87; NNTB 50, 95% CI 33 to infinite; 13 trials, 2404 infants; low-certainty evidence). NIPPV likely results in little to no difference in gastrointestinal perforation (RR 0.89, 95% CI 0.58 to 1.38; 8 trials, 1478 infants, low-certainty evidence), NEC (RR 0.86, 95% CI 0.65 to 1.15; 10 trials, 2069 infants; moderate-certainty evidence), chronic lung disease defined as oxygen requirement at 36 weeks (RR 0.93, 95% CI 0.84 to 1.05; 9 trials, 2001 infants; moderate-certainty evidence) and mortality prior to discharge (RR 0.81, 95% CI 0.61 to 1.07; 11 trials, 2258 infants; low-certainty evidence).\nWhen considering subgroup analysis, ventilator-generated NIPPV likely reduces respiratory failure postextubation (RR 0.49, 95% CI 0.40 to 0.62; 1057 infants; I2 = 47%; moderate-certainty evidence), while bilevel devices (RR 0.95, 95% CI 0.77 to 1.17; 716 infants) or a mix of both ventilator-generated and bilevel devices likely results in little to no difference (RR 0.87, 95% CI 0.73 to 1.02; 965 infants).\nAuthors' conclusions\nNIPPV likely reduces the incidence of extubation failure and the need for reintubation within 48 hours to one-week postextubation more effectively than NCPAP in very preterm infants (GA 28 weeks and above). There is a paucity of data for infants less than 28 weeks' gestation. Pulmonary air leaks were also potentially reduced in the NIPPV group. However, it has no effect on other clinically relevant outcomes such as gastrointestinal perforation, NEC, chronic lung disease or mortality. Ventilator-generated NIPPV appears superior to bilevel devices in reducing the incidence of respiratory failure postextubation failure and need for reintubation. Synchronisation used to deliver NIPPV may be important; however, data are insufficient to support strong conclusions.\nFuture trials should enrol a sufficient number of infants, particularly those less than 28 weeks' GA, to detect differences in death or chronic lung disease and should compare different categories of devices, establish the impact of synchronisation of NIPPV on safety and efficacy of the technique as well as the best combination of settings for NIPPV (rate, peak pressure and positive end-expiratory). Trials should strive to match the mean airway pressure between the intervention groups to allow a better comparison. Neurally adjusted ventilatory assist needs further assessment with properly powered randomised trials.\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 19 trials comparing NCPAP versus NIPPV. When compiling the results of the trials, we found that NIPPV likely reduces the need for reinsertion of the endotracheal tube for very preterm infants (time since first day of the woman's last menstrual cycle to 28 weeks and above). NIPPV may also lead to a reduced number of air leaks from the air spaces of the lungs. There was little to no difference in other outcomes measured in this review."
}
]
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query-laysum | 2084 | [
{
"role": "user",
"content": "Abstract: Background\nAcquired brain injury (ABI) can result in impairments in motor function, language, cognition, and sensory processing, and in emotional disturbances, which can severely reduce a survivor's quality of life. Music interventions have been used in rehabilitation to stimulate brain functions involved in movement, cognition, speech, emotions, and sensory perceptions. An update of the systematic review published in 2010 was needed to gauge the efficacy of music interventions in rehabilitation for people with ABI.\nObjectives\nTo assess the effects of music interventions for functional outcomes in people with ABI. We expanded the criteria of our existing review to: 1) examine the efficacy of music interventions in addressing recovery in people with ABI including gait, upper extremity function, communication, mood and emotions, cognitive functioning, social skills, pain, behavioural outcomes, activities of daily living, and adverse events; 2) compare the efficacy of music interventions and standard care with a) standard care alone, b) standard care and placebo treatments, or c) standard care and other therapies; 3) compare the efficacy of different types of music interventions (music therapy delivered by trained music therapists versus music interventions delivered by other professionals).\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE (1946 to June 2015), Embase (1980 to June 2015), CINAHL (1982 to June 2015), PsycINFO (1806 to June 2015), LILACS (1982 to January 2016), and AMED (1985 to June 2015). We handsearched music therapy journals and conference proceedings, searched dissertation and specialist music databases, trials and research registers, reference lists, and contacted relevant experts and music therapy associations to identify unpublished research. We imposed no language restriction. We performed the original search in 2009.\nSelection criteria\nWe included all randomised controlled trials and controlled clinical trials that compared music interventions and standard care with standard care alone or combined with other therapies. We examined studies that included people older than 16 years of age who had ABI of a non-degenerative nature and were participating in treatment programmes offered in hospital, outpatient, or community settings. We included studies in any language, published and unpublished.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of the included studies. We contacted trial researchers to obtain missing data or for additional information when necessary. Where possible, we presented results for continuous outcomes in meta-analyses using mean differences (MDs) and standardised mean differences (SMDs). We used post-test scores. In cases of significant baseline difference, we used change scores. We conducted a sensitivity analysis to assess the impact of the randomisation method.\nMain results\nWe identified 22 new studies for this update. The evidence for this update is based on 29 trials involving 775 participants. A music intervention known as rhythmic auditory stimulation may be beneficial for improving the following gait parameters after stroke. We found a reported increase in gait velocity of 11.34 metres per minute (95% confidence interval (CI) 8.40 to 14.28; 9 trials; 268 participants; P < 0.00001; moderate-quality evidence). Stride length of the affected side may also benefit, with a reported average of 0.12 metres more (95% CI 0.04 to 0.20; 5 trials; 129 participants; P = 0.003; moderate-quality evidence). We found a reported average improvement for general gait of 7.67 units on the Dynamic Gait Index (95% CI 5.67 to 9.67; 2 trials; 48 participants; P < 0.00001). There may also be an improvement in gait cadence, with a reported average increase of 10.77 steps per minute (95% CI 4.36 to 17.18; 7 trials; 223 participants; P = 0.001; low-quality evidence).\nMusic interventions may be beneficial for improving the timing of upper extremity function after stroke as scored by a reduction of 1.08 seconds on the Wolf Motor Function Test (95% CI -1.69 to -0.47; 2 trials; 122 participants; very low-quality evidence).\nMusic interventions may be beneficial for communication outcomes in people with aphasia following stroke. Overall, communication improved by 0.75 standard deviations in the intervention group, a moderate effect (95% CI 0.11 to 1.39; 3 trials; 67 participants; P = 0.02; very low-quality evidence). Naming was reported as improving by 9.79 units on the Aachen Aphasia Test (95% CI 1.37 to 18.21; 2 trials; 35 participants; P = 0.02). Music interventions may have a beneficial effect on speech repetition, reported as an average increase of 8.90 score on the Aachen Aphasia Test (95% CI 3.25 to 14.55; 2 trials; 35 participants; P = 0.002).\nThere may be an improvement in quality of life following stroke using rhythmic auditory stimulation, reported at 0.89 standard deviations improvement on the Stroke Specific Quality of Life Scale, which is considered to be a large effect (95% CI 0.32 to 1.46; 2 trials; 53 participants; P = 0.002; low-quality evidence). We found no strong evidence for effects on memory and attention. Data were insufficient to examine the effect of music interventions on other outcomes.\nThe majority of studies included in this review update presented a high risk of bias, therefore the quality of the evidence is low.\nAuthors' conclusions\nMusic interventions may be beneficial for gait, the timing of upper extremity function, communication outcomes, and quality of life after stroke. These results are encouraging, but more high-quality randomised controlled trials are needed on all outcomes before recommendations can be made for clinical practice.\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 aimed to identify research studies that tested music interventions combined with standard care for adults with acquired brain injury who were receiving rehabilitation in hospital or community settings. We looked for research that tested the effects of music interventions on walking, moving, communicating, thinking, emotions, pain, and well-being. Interventions included moving to music, singing, listening to music, composing, playing musical instruments, or a combination of these. We identified and included 29 trials involving 775 adult participants. The evidence is current to June 2015."
}
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query-laysum | 2085 | [
{
"role": "user",
"content": "Abstract: Background\nRotavirus is a common cause of diarrhoea, diarrhoea-related hospital admissions, and diarrhoea-related deaths worldwide. Rotavirus vaccines prequalified by the World Health Organization (WHO) include Rotarix (GlaxoSmithKline), RotaTeq (Merck), and, more recently, Rotasiil (Serum Institute of India Ltd.), and Rotavac (Bharat Biotech Ltd.).\nObjectives\nTo evaluate rotavirus vaccines prequalified by the WHO for their efficacy and safety in children.\nSearch methods\nOn 30 November 2020, we searched PubMed, the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index-Science, Conference Proceedings Citation Index-Social Science & Humanities. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies, and relevant systematic reviews.\nSelection criteria\nWe selected randomized controlled trials (RCTs) conducted in children that compared rotavirus vaccines prequalified for use by the WHO with either placebo or no intervention.\nData collection and analysis\nTwo authors independently assessed trial eligibility and assessed risk of bias. One author extracted data and a second author cross-checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analyses by under-five country mortality rate and used GRADE to evaluate evidence certainty.\nMain results\nSixty trials met the inclusion criteria and enrolled a total of 228,233 participants. Thirty-six trials (119,114 participants) assessed Rotarix, 15 trials RotaTeq (88,934 participants), five trials Rotasiil (11,753 participants), and four trials Rotavac (8432 participants).\nRotarix\nInfants vaccinated and followed up for the first year of life\nIn low-mortality countries, Rotarix prevented 93% of severe rotavirus diarrhoea cases (14,976 participants, 4 trials; high-certainty evidence), and 52% of severe all-cause diarrhoea cases (3874 participants, 1 trial; moderate-certainty evidence).\nIn medium-mortality countries, Rotarix prevented 79% of severe rotavirus diarrhoea cases (31,671 participants, 4 trials; high-certainty evidence), and 36% of severe all-cause diarrhoea cases (26,479 participants, 2 trials; high-certainty evidence).\nIn high-mortality countries, Rotarix prevented 58% of severe rotavirus diarrhoea cases (15,882 participants, 4 trials; high-certainty evidence), and 27% of severe all-cause diarrhoea cases (5639 participants, 2 trials; high-certainty evidence).\nChildren vaccinated and followed up for two years\nIn low-mortality countries, Rotarix prevented 90% of severe rotavirus diarrhoea cases (18,145 participants, 6 trials; high-certainty evidence), and 51% of severe all-cause diarrhoea episodes (6269 participants, 2 trials; moderate-certainty evidence).\nIn medium-mortality countries, Rotarix prevented 77% of severe rotavirus diarrhoea cases (28,834 participants, 3 trials; high-certainty evidence), and 26% of severe all-cause diarrhoea cases (23,317 participants, 2 trials; moderate-certainty evidence).\nIn high-mortality countries, Rotarix prevented 35% of severe rotavirus diarrhoea cases (13,768 participants, 2 trials; moderate-certainty evidence), and 17% of severe all-cause diarrhoea cases (2764 participants, 1 trial; high-certainty evidence).\nRotaTeq\nInfants vaccinated and followed up for the first year of life\nIn low-mortality countries, RotaTeq prevented 97% of severe rotavirus diarrhoea cases (5442 participants, 2 trials; high-certainty evidence).\nIn medium-mortality countries, RotaTeq prevented 79% of severe rotavirus diarrhoea cases (3863 participants, 1 trial; low-certainty evidence).\nIn high-mortality countries, RotaTeq prevented 57% of severe rotavirus diarrhoea cases (6775 participants, 2 trials; high-certainty evidence), but there is probably little or no difference between vaccine and placebo for severe all-cause diarrhoea (1 trial, 4085 participants; moderate-certainty evidence).\nChildren vaccinated and followed up for two years\nIn low-mortality countries, RotaTeq prevented 96% of severe rotavirus diarrhoea cases (5442 participants, 2 trials; high-certainty evidence).\nIn medium-mortality countries, RotaTeq prevented 79% of severe rotavirus diarrhoea cases (3863 participants, 1 trial; low-certainty evidence).\nIn high-mortality countries, RotaTeq prevented 44% of severe rotavirus diarrhoea cases (6744 participants, 2 trials; high-certainty evidence), and 15% of severe all-cause diarrhoea cases (5977 participants, 2 trials; high-certainty evidence).\nWe did not identify RotaTeq studies reporting on severe all-cause diarrhoea in low- or medium-mortality countries.\nRotasiil\nRotasiil has not been assessed in any RCT in countries with low or medium child mortality.\nInfants vaccinated and followed up for the first year of life\nIn high-mortality countries, Rotasiil prevented 48% of severe rotavirus diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence), and resulted in little to no difference in severe all-cause diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence).\nChildren vaccinated and followed up for two years\nIn high-mortality countries, Rotasiil prevented 44% of severe rotavirus diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence), and resulted in little to no difference in severe all-cause diarrhoea cases (11,008 participants, 2 trials; high-certainty evidence).\nRotavac\nRotavac has not been assessed in any RCT in countries with low or medium child mortality.\nInfants vaccinated and followed up for the first year of life\nIn high-mortality countries, Rotavac prevented 57% of severe rotavirus diarrhoea cases (6799 participants, 1 trial; moderate-certainty evidence), and 16% of severe all-cause diarrhoea cases (6799 participants, 1 trial; moderate-certainty evidence).\nChildren vaccinated and followed up for two years\nIn high-mortality countries, Rotavac prevented 54% of severe rotavirus diarrhoea cases (6541 participants, 1 trial; moderate-certainty evidence); no Rotavac studies have reported on severe all-cause diarrhoea at two-years follow-up.\nSafety\nNo increased risk of serious adverse events (SAEs) was detected with Rotarix (103,714 participants, 31 trials; high-certainty evidence), RotaTeq (82,502 participants, 14 trials; moderate to high-certainty evidence), Rotasiil (11,646 participants, 3 trials; high-certainty evidence), or Rotavac (8210 participants, 3 trials; moderate-certainty evidence).\nDeaths were infrequent and the analysis had insufficient evidence to show an effect on all-cause mortality. Intussusception was rare.\nAuthors' conclusions\nRotarix, RotaTeq, Rotasiil, and Rotavac prevent episodes of rotavirus diarrhoea. The relative effect estimate is smaller in high-mortality than in low-mortality countries, but more episodes are prevented in high-mortality settings as the baseline risk is higher. In high-mortality countries some results suggest lower efficacy in the second year. We found no increased risk of serious adverse events, including intussusception, from any of the prequalified rotavirus vaccines.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Rotavirus infection is a common cause of diarrhoea in infants and young children, and can cause mild illness, hospitalization, and death. Since 2009, the World Health Organization (WHO) has recommended that a rotavirus vaccine be included in all national infant and child immunization programmes. To date, 96 countries have followed this recommendation. In the years before infants and children started receiving rotavirus vaccine, rotavirus infection resulted in about half a million deaths a year in children aged under five years, mainly in low- and middle-income countries.\nIn this review, we included randomized controlled trials in infants and young children that evaluated rotavirus vaccination with Rotarix (GlaxoSmithKline) or RotaTeq (Merck). These vaccines have been evaluated in several large trials and are approved for use in many countries. We also included trials that evaluated Rotavac (Bharat Biotech Ltd.) and Rotasiil (Serum Institute of India Ltd.), rotavirus vaccines which are currently used in India only. The rotavirus vaccines were compared with placebo or with no vaccine. The included studies did not allow comparisons between the different rotavirus vaccines."
}
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query-laysum | 2086 | [
{
"role": "user",
"content": "Abstract: Background\nDelirium is a common clinical syndrome defined as alterations in attention with an additional disturbance in cognition or perception, which develop over a short period of time and tend to fluctuate during the course of the episode. Delirium is commonly treated in hospitals or community settings and is often associated with multiple adverse outcomes such as increased cost, morbidity, and even mortality. The first-line intervention involves a multicomponent non-pharmacological approach that includes ensuring effective communication and reorientation in addition to providing reassurance or a suitable care environment. There are currently no drugs approved specifically for the treatment of delirium. Clinically, however, various medications are employed to provide symptomatic relief, such as antipsychotic medications and cholinesterase inhibitors, among others.\nObjectives\nTo evaluate the effectiveness and safety of cholinesterase inhibitors for treating people with established delirium in a non-intensive care unit (ICU) setting.\nSearch methods\nWe searched ALOIS, which is the Cochrane Dementia and Cognitive Improvement Group's Specialised Register, on 26 October 2017. We also cross-checked the reference lists of included studies to identify any potentially eligible trials.\nSelection criteria\nWe included randomised controlled trials, published or unpublished, reported in English or Chinese, which compared cholinesterase inhibitors to placebo or other drugs intended to treat people with established delirium in a non-ICU setting.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. The primary outcomes were duration of delirium, severity of delirium, and adverse events. The secondary outcomes were use of rescue medications, persistent cognitive impairment, length of hospitalisation, institutionalisation, mortality, cost of intervention, leaving the study early, and quality of life. For dichotomous outcomes, we calculated the risk ratio (RR) with 95% confidence intervals (CIs); for continuous outcomes we calculated the mean difference (MD) with 95% CIs. We assessed the quality of evidence using GRADE to generate a 'Summary of findings' table.\nMain results\nWe included one study involving 15 participants from the UK. The included participants were diagnosed with delirium based on the Confusion Assessment Method (CAM) criteria. Eight males and seven females were included, with a mean age of 82.5 years. Seven of the 15 participants had comorbid dementia at baseline. The risk of bias was low in all domains.\nThe study compared rivastigmine with placebo. We did not find any clear differences between the two groups in terms of duration of delirium (MD -3.6, 95% CI -15.6 to 8.4), adverse events (nausea, RR 0.30, 95% CI 0.01 to 6.29), use of rescue medications (RR 0.13, 95% CI 0.01 to 2.1), mortality (RR 0.10, 95% CI 0.01 to 1.56), and leaving the study early (RR 0.88, 95% CI 0.07 to 11.54). Evidence was not available regarding the severity of delirium, persistent cognitive impairment, length of hospitalisation, cost of intervention, or other predefined secondary outcomes.\nThe quality of evidence is low due to the very small sample size.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the use of cholinesterase inhibitors for the treatment of delirium in non-ICU settings. No clear benefits or harms associated with cholinesterase inhibitors were observed when compared with placebo due to the lack of data. More trials are required.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found one trial from the UK, which included 15 participants with delirium. The average age of the participants was 82.5 years; eight participants were male and seven were female. Seven participants also had a history of dementia. This trial compared rivastigmine (a type of cholinesterase inhibitor used in the treatment of dementia) with an inactive treatment (placebo)."
}
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query-laysum | 2087 | [
{
"role": "user",
"content": "Abstract: Background\nExposure to rape, sexual assault and sexual abuse has lifelong impacts for mental health and well-being. Prolonged Exposure (PE), Cognitive Processing Therapy (CPT) and Eye Movement Desensitisation and Reprocessing (EMDR) are among the most common interventions offered to survivors to alleviate post-traumatic stress disorder (PTSD) and other psychological impacts. Beyond such trauma-focused cognitive and behavioural approaches, there is a range of low-intensity interventions along with new and emerging non-exposure based approaches (trauma-sensitive yoga, Reconsolidation of Traumatic Memories and Lifespan Integration). This review presents a timely assessment of international evidence on any type of psychosocial intervention offered to individuals who experienced rape, sexual assault or sexual abuse as adults.\nObjectives\nTo assess the effects of psychosocial interventions on mental health and well-being for survivors of rape, sexual assault or sexual abuse experienced during adulthood.\nSearch methods\nIn January 2022, we searched CENTRAL, MEDLINE, Embase, 12 other databases and three trials registers. We also checked reference lists of included studies, contacted authors and experts, and ran forward citation searches.\nSelection criteria\nAny study that allocated individuals or clusters of individuals by a random or quasi-random method to a psychosocial intervention that promoted recovery and healing following exposure to rape, sexual assault or sexual abuse in those aged 18 years and above compared with no or minimal intervention, usual care, wait-list, pharmacological only or active comparison(s). We classified psychosocial interventions according to Cochrane Common Mental Disorders Group’s psychological therapies list.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe included 36 studies (1991 to 2021) with 3992 participants randomly assigned to 60 experimental groups (3014; 76%) and 23 inactive comparator conditions (978, 24%).\nThe experimental groups consisted of: 32 Cognitive Behavioural Therapy (CBT); 10 behavioural interventions; three integrative therapies; three humanist; five other psychologically oriented interventions; and seven other psychosocial interventions. Delivery involved 1 to 20 (median 11) sessions of traditional face-to-face (41) or other individual formats (four); groups (nine); or involved computer-only interaction (six). Most studies were conducted in the USA (n = 26); two were from South Africa; two from the Democratic Republic of the Congo; with single studies from Australia, Canada, the Netherlands, Spain, Sweden and the UK. Five studies did not disclose a funding source, and all disclosed sources were public funding.\nParticipants were invited from a range of settings: from the community, through the media, from universities and in places where people might seek help for their mental health (e.g. war veterans), in the aftermath of sexual trauma (sexual assault centres and emergency departments) or for problems that accompany the experience of sexual violence (e.g. sexual health/primary care clinics). Participants randomised were 99% women (3965 participants) with just 27 men. Half were Black, African or African-American (1889 participants); 40% White/Caucasian (1530 participants); and 10% represented a range of other ethnic backgrounds (396 participants). The weighted mean age was 35.9 years (standard deviation (SD) 9.6). Eighty-two per cent had experienced rape or sexual assault in adulthood (3260/3992). Twenty-two studies (61%) required fulfilling a measured PTSD diagnostic threshold for inclusion; however, 94% of participants (2239/2370) were reported as having clinically relevant PTSD symptoms at entry.\nThe comparison of psychosocial interventions with inactive controls detected that there may be a beneficial effect at post-treatment favouring psychosocial interventions in reducing PTSD (standardised mean difference (SMD) -0.83, 95% confidence interval (CI) -1.22 to -0.44; 16 studies, 1130 participants; low-certainty evidence; large effect size based on Cohen’s D); and depression (SMD -0.82, 95% CI -1.17 to -0.48; 12 studies, 901 participants; low-certainty evidence; large effect size). Psychosocial interventions, however, may not increase the risk of dropout from treatment compared to controls, with a risk ratio of 0.85 (95% CI 0.51 to 1.44; 5 studies, 242 participants; low-certainty evidence). Seven of the 23 studies (with 801 participants) comparing a psychosocial intervention to an inactive control reported on adverse events, with 21 events indicated. Psychosocial interventions may not increase the risk of adverse events compared to controls, with a risk ratio of 1.92 (95% CI 0.30 to 12.41; 6 studies; 622 participants; very low-certainty evidence).\nWe conducted an assessment of risk of bias using the RoB 2 tool on a total of 49 reported results. A high risk of bias affected 43% of PTSD results; 59% for depression symptoms; 40% for treatment dropout; and one-third for adverse events. The greatest sources of bias were problems with randomisation and missing outcome data. Heterogeneity was also high, ranging from I2 = 30% (adverse events) to I2 = 87% (PTSD).\nAuthors' conclusions\nOur review suggests that survivors of rape, sexual violence and sexual abuse during adulthood may experience a large reduction in post-treatment PTSD symptoms and depressive symptoms after experiencing a psychosocial intervention, relative to comparison groups. Psychosocial interventions do not seem to increase dropout from treatment or adverse events/effects compared to controls. However, the number of dropouts and study attrition were generally high, potentially missing harms of exposure to interventions and/or research participation. Also, the differential effects of specific intervention types needs further investigation.\nWe conclude that a range of behavioural and CBT-based interventions may improve the mental health of survivors of rape, sexual assault and sexual abuse in the short term. Therefore, the needs and preferences of individuals must be considered in selecting suitable approaches to therapy and support. The primary outcome in this review focused on the post-treatment period and the question about whether benefits are sustained over time persists. However, attaining such evidence from studies that lack an active comparison may be impractical and even unethical. Thus, we suggest that studies undertake head-to-head comparisons of different intervention types; in particular, of novel, emerging therapies, with one-year plus follow-up periods. Additionally, researchers should focus on the therapeutic benefits and costs for subpopulations such as male survivors and those living with complex PTSD.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to January 2022."
}
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query-laysum | 2088 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) causes progressive and irreversible damage to the retina, resulting in loss of central vision. AMD is the third leading cause of irreversible visual impairment worldwide and the leading cause of blindness in industrialized countries. Since AMD is more common in older individuals, the number of affected individuals will increase significantly as the population ages. The implantable miniature telescope (IMT) is an ophthalmic device developed to improve vision in individuals who have lost vision due to AMD. Once implanted, the IMT is used to enlarge objects in the central visual field and focus them onto healthy areas of the retina not affected by AMD, allowing individuals to recognize objects that they otherwise could not see. It is unclear whether and how much the IMT can improve vision in individuals with end-stage AMD.\nObjectives\nTo assess the effectiveness and safety of the IMT in improving visual acuity and quality of life in people with late or advanced AMD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 11); Ovid MEDLINE; Embase.com; PubMed; LILACS; AMED; Web of Science Conference Proceedings Citation Index-Science; OpenSIGLE; the metaRegister of Controlled Trials (mRCT) (last searched 27 June 2014); ClinicalTrials.gov; the ICTRP and the US Food and Drug Administration (FDA) Medical Devices database. The date of the search was 2 November 2017, with the exception of mRCT which is no longer in service.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) and quasi-randomized trials that compared the IMT versus no IMT.\nData collection and analysis\nTwo review authors independently assessed all studies for inclusion, using standard methodological procedures expected by Cochrane.\nMain results\nOur search yielded 1042 unique records. We removed irrelevant studies after screening titles and abstracts, and evaluated five full-text reports from four studies; three were non-randomized studies. There was one ongoing RCT that compared the OriLens intraocular telescope with standard low vision training in eyes with end-stage AMD. Results for this study are expected in 2020.\nAuthors' conclusions\nWe found no RCT or quasi-RCT and can draw no conclusion about the effectiveness and safety of the IMT in improving visual acuity in individuals with late or advanced AMD. Since the IMT is typically implanted monocularly based upon which eye has better best-corrected distance visual acuity, randomization between eyes within an individual may not be acceptable. Studies are needed that compare outcomes between individuals randomized to the device versus individuals not implanted, at least during study follow-up, who serve as controls.\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": "It is uncertain whether and how much the IMT can improve vision in individuals with end-stage AMD."
}
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query-laysum | 2089 | [
{
"role": "user",
"content": "Abstract: Background\nThere are various reasons why weaning and extubation failure occur, but ineffective cough and secretion retention can play a significant role. Cough augmentation techniques, such as lung volume recruitment or manually- and mechanically-assisted cough, are used to prevent and manage respiratory complications associated with chronic conditions, particularly neuromuscular disease, and may improve short- and long-term outcomes for people with acute respiratory failure. However, the role of cough augmentation to facilitate extubation and prevent post-extubation respiratory failure is unclear.\nObjectives\nOur primary objective was to determine extubation success using cough augmentation techniques compared to no cough augmentation for critically-ill adults and children with acute respiratory failure admitted to a high-intensity care setting capable of managing mechanically-ventilated people (such as an intensive care unit, specialized weaning centre, respiratory intermediate care unit, or high-dependency unit).\nSecondary objectives were to determine the effect of cough augmentation techniques on reintubation, weaning success, mechanical ventilation and weaning duration, length of stay (high-intensity care setting and hospital), pneumonia, tracheostomy placement and tracheostomy decannulation, and mortality (high-intensity care setting, hospital, and after hospital discharge). We evaluated harms associated with use of cough augmentation techniques when applied via an artificial airway (or non-invasive mask once extubated/decannulated), including haemodynamic compromise, arrhythmias, pneumothorax, haemoptysis, and mucus plugging requiring airway change and the type of person (such as those with neuromuscular disorders or weakness and spinal cord injury) for whom these techniques may be efficacious.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2016), MEDLINE (OvidSP) (1946 to April 2016), Embase (OvidSP) (1980 to April 2016), CINAHL (EBSCOhost) (1982 to April 2016), and ISI Web of Science and Conference Proceedings. We searched the PROSPERO and Joanna Briggs Institute databases, websites of relevant professional societies, and conference abstracts from five professional society annual congresses (2011 to 2015). We did not impose language or other restrictions. We performed a citation search using PubMed and examined reference lists of relevant studies and reviews. We contacted corresponding authors for details of additional published or unpublished work. We searched for unpublished studies and ongoing trials on the International Clinical Trials Registry Platform (apps.who.int/trialsearch) (April 2016).\nSelection criteria\nWe included randomized and quasi-randomized controlled trials that evaluated cough augmentation compared to a control group without this intervention. We included non-randomized studies for assessment of harms. We included studies of adults and of children aged four weeks or older, receiving invasive mechanical ventilation in a high-intensity care setting.\nData collection and analysis\nTwo review authors independently screened titles and abstracts identified by our search methods. Two review authors independently evaluated full-text versions, independently extracted data and assessed risks of bias.\nMain results\nWe screened 2686 citations and included two trials enrolling 95 participants and one cohort study enrolling 17 participants. We assessed one randomized controlled trial as being at unclear risk of bias, and the other at high risk of bias; we assessed the non-randomized study as being at high risk of bias. We were unable to pool data due to the small number of studies meeting our inclusion criteria and therefore present narrative results rather than meta-analyses. One trial of 75 participants reported that extubation success (defined as no need for reintubation within 48 hours) was higher in the mechanical insufflation-exsufflation (MI-E) group (82.9% versus 52.5%, P < 0.05) (risk ratio (RR) 1.58, 95% confidence interval (CI) 1.13 to 2.20, very low-quality evidence). No study reported weaning success or reintubation as distinct from extubation success. One trial reported a statistically significant reduction in mechanical ventilation duration favouring MI-E (mean difference -6.1 days, 95% CI -8.4 to -3.8, very low-quality evidence). One trial reported mortality, with no participant dying in either study group. Adverse events (reported by two trials) included one participant receiving the MI-E protocol experiencing haemodynamic compromise. Nine (22.5%) of the control group compared to two (6%) MI-E participants experienced secretion encumbrance with severe hypoxaemia requiring reintubation (RR 0.25, 95% CI 0.06 to 1.10). In the lung volume recruitment trial, one participant experienced an elevated blood pressure for more than 30 minutes. No participant experienced new-onset arrhythmias, heart rate increased by more than 25%, or a pneumothorax.\nFor outcomes assessed using GRADE, we based our downgrading decisions on unclear risk of bias, inability to assess consistency or publication bias, and uncertainty about the estimate of effect due to the limited number of studies contributing outcome data.\nAuthors' conclusions\nThe overall quality of evidence on the efficacy of cough augmentation techniques for critically-ill people is very low. Cough augmentation techniques when used in mechanically-ventilated critically-ill people appear to result in few adverse events.\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": "Very low-quality evidence from single trial findings suggests that cough-promoting techniques might increase successful removal of the breathing tube and decrease the time spent on mechanical ventilation, while not causing harm. The limited participant numbers made it difficult to determine the likelihood of harms."
}
]
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query-laysum | 2090 | [
{
"role": "user",
"content": "Abstract: Background\nCarotid artery stenting is an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis. This review updates a previous version first published in 1997 and subsequently updated in 2004, 2007, and 2012.\nObjectives\nTo assess the benefits and risks of stenting compared with endarterectomy in people with symptomatic or asymptomatic carotid stenosis.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched August 2018) and the following databases: CENTRAL, MEDLINE, Embase, and Science Citation Index to August 2018. We also searched ongoing trials registers (August 2018) and reference lists, and contacted researchers in the field.\nSelection criteria\nRandomised controlled trials (RCTs) comparing stenting with endarterectomy for symptomatic or asymptomatic atherosclerotic carotid stenosis. In addition, we included RCTs comparing carotid artery stenting with medical therapy alone.\nData collection and analysis\nOne review author selected trials for inclusion, assessed trial quality and risk of bias, and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with endarterectomy as the reference group. We quantified heterogeneity using the I² statistic and used GRADE to assess the overall certainty of evidence.\nMain results\nWe included 22 trials involving 9753 participants. In participants with symptomatic carotid stenosis, compared with endarterectomy stenting was associated with a higher risk of periprocedural death or stroke (the primary safety outcome; OR 1.70, 95% CI 1.31 to 2.19; P < 0.0001, I² = 5%; 10 trials, 5396 participants; high-certainty evidence); and periprocedural death, stroke, or myocardial infarction (OR 1.43, 95% CI 1.14 to 1.80; P = 0.002, I² = 0%; 6 trials, 4861 participants; high-certainty evidence). The OR for the primary safety outcome was 1.11 (95% CI 0.74 to 1.64) in participants under 70 years old and 2.23 (95% CI 1.61 to 3.08) in participants 70 years old or more (interaction P = 0.007). There was a non-significant increase in periprocedural death or major or disabling stroke with stenting (OR 1.36, 95% CI 0.97 to 1.91; P = 0.08, I² = 0%; 7 trials, 4983 participants; high-certainty evidence). Compared with endarterectomy, stenting was associated with lower risks of myocardial infarction (OR 0.47, 95% CI 0.24 to 0.94; P = 0.03, I² = 0%), cranial nerve palsy (OR 0.09, 95% CI 0.06 to 0.16; P < 0.00001, I² = 0%), and access site haematoma (OR 0.32, 95% CI 0.15 to 0.68; P = 0.003, I² = 27%).\nThe combination of periprocedural death or stroke or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured endarterectomy (OR 1.51, 95% CI 1.24 to 1.85; P < 0.0001, I² = 0%; 8 trials, 5080 participants; high-certainty evidence). The rate of ipsilateral stroke after the periprocedural period did not differ between treatments (OR 1.05, 95% CI 0.75 to 1.47; P = 0.77, I² = 0%).\nIn participants with asymptomatic carotid stenosis, there was a non-significant increase in periprocedural death or stroke with stenting compared with endarterectomy (OR 1.72, 95% CI 1.00 to 2.97; P = 0.05, I² = 0%; 7 trials, 3378 participants; moderate-certainty evidence). The risk of periprocedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR 1.27, 95% CI 0.87 to 1.84; P = 0.22, I² = 0%; 6 trials, 3315 participants; moderate-certainty evidence).\nModerate or higher carotid artery restenosis (50% or greater) or occlusion during follow-up was more common after stenting (OR 2.00, 95% CI 1.12 to 3.60; P = 0.02, I² = 44%), but the difference in risk of severe restenosis was not significant (70% or greater; OR 1.26, 95% CI 0.79 to 2.00; P = 0.33, I² = 58%; low-certainty evidence).\nAuthors' conclusions\nStenting for symptomatic carotid stenosis is associated with a higher risk of periprocedural stroke or death than endarterectomy. This extra risk is mostly attributed to an increase in minor, non-disabling strokes occurring in people older than 70 years. Beyond the periprocedural period, carotid stenting is as effective in preventing recurrent stroke as endarterectomy. However, combining procedural safety and long-term efficacy in preventing recurrent stroke still favours endarterectomy.\nIn people with asymptomatic carotid stenosis, there may be a small increase in the risk of periprocedural stroke or death with stenting compared with endarterectomy. However, CIs of treatment effects were wide and further data from randomised trials in people with asymptomatic stenosis are needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In general, the quality of the evidence was high. The main factor reducing our confidence in the evidence was in studies comparing both treatments in people who had never experienced symptoms from the narrowing in the carotid artery. For these people, more studies are needed to draw firm conclusions about the risks and benefits of stenting compared to surgery."
}
]
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query-laysum | 2091 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in 2010 (Issue 7).\nCarcinoma of the uterine cervix is the second most common cancer and the third leading cause of cancer death among women. Radiotherapy has been used successfully to treat cervical cancer for nearly a century. The combination of external beam radiotherapy (EBRT) and intracavity brachytherapy (ICBT) has become a standard treatment for cervical cancer. Whether high dose rate (HDR) or low dose rate (LDR) brachytherapy improves outcomes in terms of local control rates, survival and complications for women with cervical cancer remains controversial.\nObjectives\nTo assess the efficacy and safety of HDR versus LDR ICBT in combination with EBRT for women with uterine cervical cancer.\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE (1966 to March 2014), EMBASE (1974 to March 2014), and the Chinese Biomedical Literature Database (CBM) (1978 to March 2014) for relevant original, published trials.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs that compared HDR with LDR ICBT, combined with EBRT, for women with locally advanced uterine cervical cancer.\nData collection and analysis\nTwo authors independently extracted the data using standardised forms. Primary outcome measures included overall survival (OS), relapse-free survival (RFS) and pelvic control rate, while secondary outcomes included rates of recurrence and complications.\nMain results\nFour studies involving 1265 women met the inclusion criteria. In our meta-analysis to compare HDR and LDR ICBT, the pooled risk ratios (RRs) were 0.95 (95% confidence interval (CI) 0.79 to 1.15), 0.93 (95% CI 0.84 to 1.04) and 0.79 (95% CI 0.52 to 1.20) for 3-, 5- and 10-year overall survival rates respectively; and 0.95 (95% CI 0.84 to 1.07) and 1.02 (0.88 to 1.19) for 5- and 10-year disease-specific survival (DSS) rates respectively. The RR for RFS was 1.04 (95% CI 0.71 to 1.52) and 0.96 (95% CI 0.81 to 1.14) at 3- and 5- years. For local control rates the RR was 0.95 (95% CI 0.86 to 1.05) and 0.95 (95% CI 0.87 to 1.05) at 3- and 5- years; with a RR of 1.09 (95% CI 0.83 to 1.43) for locoregional recurrence, 0.79 (95% CI 0.40 to 1.53) for local and distant recurrence, 2.23 (95% CI 0.78 to 6.34) for para-aortic lymph node metastasis, and 0.99 (95% CI 0.72 to 1.35) for distance metastasis. For bladder, rectosigmoid and small bowel complications, the RR was 1.33 (95% CI 0.53 to 3.34), 1.00 (95% CI 0.52 to 1.91) and 3.37 (95% CI 1.06 to 10.72) respectively. These results indicated that there were no significant differences except for increased small bowel complications with HDRs (P = 0.04).\nAuthors' conclusions\nSince the last version of this review, no new studies were identified for inclusion in this review to provide additional information. This review showed no significant differences between HDR and LDR ICBT when considering OS, DSS, RFS, local control rate, recurrence, metastasis and treatment related complications for women with cervical carcinoma. Due to some potential advantages of HDR ICBT (rigid immobilization, outpatient treatment, patient convenience, accuracy of source and applicator positioning, individualized treatment) we recommend the use of HDR ICBT for all clinical stages of cervix cancer. The overall risk of bias was high for the included studies as many of the items were either of high or unclear risk. The GRADE assessment of the quality of the evidence was low to moderate.\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": "Radiotherapy has been successfully used to treat cervical cancer for nearly a century as cervical tissue is very sensitive to radiation. Improved survival and local control rates of the disease have made the combination of external beam radiotherapy (EBRT) and intracavity brachytherapy (ICBT) the standard treatment for locally advanced uterine cervix cancer. ICBT is divided into three modalities, low dose rate (LDR), high dose rate (HDR), and medium dose rate (MDR). Many studies have concluded that the LDR was superior to the HDR as the post-treatment repair of normal tissue was better. Nevertheless, due to some potential advantages of HDRs in modern afterloading ICBT, HDR ICBT has increasingly been used, instead of LDR ICBT, over the past 20 years."
}
]
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query-laysum | 2092 | [
{
"role": "user",
"content": "Abstract: Background\nInfectious keratitis is an infection of the cornea that can be caused by bacteria, viruses, fungi, protozoa, or parasites. It may be associated with ocular surgery, trauma, contact lens wear, or conditions that cause deficiency or loss of corneal sensation, or suppression of the immune system, such as diabetes, chronic use of topical steroids, or immunomodulatory therapies. Photoactivated chromophore for collagen cross-linking (PACK-CXL) of the cornea is a therapy that has been successful in treating eye conditions such as keratoconus and corneal ectasia. More recently, PACK-CXL has been explored as a treatment option for infectious keratitis.\nObjectives\nTo determine the comparative effectiveness and safety of PACK-CXL with standard therapy versus standard therapy alone for the treatment of bacterial keratitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 7); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Science Information database (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 8 July 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, and controlled clinical trials (CCTs) of PACK-CXL for bacterial keratitis. We included quasi-RCTs and CCTs as we anticipated that there would not be many RCTs eligible for inclusion.\nData collection and analysis\nTwo review authors working independently selected studies for inclusion in the review, assessed trials for risk of bias, and extracted data. The primary outcome was proportion of participants with complete healing at four to eight weeks. Secondary outcomes included visual acuity, morphology, adverse events, and treatment failure at four to eight weeks.\nMain results\nWe included three trials (two RCTs and one quasi-RCT) in this review for a total of 59 participants (59 eyes) with bacterial keratitis. Trials were all single-center and were conducted in Egypt, Iran, and Thailand between 2010 and 2014. It is very uncertain whether PACK-CXL with standard antibiotic therapy is more effective than standard antibiotic therapy alone for re-epithelialization and complete healing (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.88 to 2.66; participants = 15). We judged the certainty of the evidence to be very low due to the small sample size and high risk of selection and performance bias. The high risk of selection bias reflects the overall review. Masking of participants was not possible for the surgical arm. No participant had a best-corrected visual acuity of 20/100 or better at eight weeks (very low certainty evidence). There is also no evidence that use of PACK-CXL with standard therapy results in fewer instances of treatment failure than standard therapy alone (RR 0.50, 95% CI 0.05 to 4.98; participants = 32). We judged the certainty of evidence to be low due to the small sample size and high risk of selection bias. There were no adverse events reported at 14 days (low certainty evidence). Data on other outcomes, such as visual acuity and morphological characteristics, could not be compared because of variable time points and specific metrics.\nAuthors' conclusions\nThe current evidence on the effectiveness of PACK-CXL for bacterial keratitis is of low certainty and clinically heterogenous in regard to outcomes. There are five ongoing RCTs enrolling 1136 participants that may provide better answers in the next update of this review. Any future research should include subgroup analyses based on etiology. A core outcomes set would benefit healthcare decision-makers in comparing and understanding study data.\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": "PACK-CXL uses ultraviolet light from a special machine to strengthen the cornea. This treatment is called 'cross-linking' because it promotes the binding of collagen fibers in the eye. The collagen fibers work like support beams to keep the cornea stable."
}
]
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query-laysum | 2093 | [
{
"role": "user",
"content": "Abstract: Background\nTo support patient-centred care, healthcare organisations increasingly offer patients access to data stored in the institutional electronic health record (EHR).\nObjectives\nPrimary objective\n1. To assess the effects of providing adult patients with access to electronic health records (EHRs) alone or with additional functionalities on a range of patient, patient-provider, and health resource consumption outcomes, including patient knowledge and understanding, patient empowerment, patient adherence, patient satisfaction with care, adverse events, health-related quality of life, health-related outcomes, psychosocial health outcomes, health resource consumption, and patient-provider communication.\nSecondary objective\n1. To assess whether effects of providing adult patients with EHR access alone versus EHR access with additional functionalities differ among patient groups according to age, educational level, or different status of disease (chronic or acute).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and Scopus in June 2017 and in April 2020.\nSelection criteria\nRandomised controlled trials and cluster-randomised trials of EHR access with or without additional functionalities for adults with any medical condition.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 10 studies with 78 to 4500 participants and follow-up from 3 to 24 months. Nine studies assessed the effects of EHR with additional functionalities, each addressing a subset of outcomes sought by this review. Five studies focused on patients with diabetes mellitus, four on patients with specific diseases, and one on all patients. All studies compared EHR access alone or with additional functionalities plus usual care versus usual care only. No studies assessing the effects of EHR access alone versus EHR access with additional functionalities were identified. Interventions required a variety of data within the EHR, such as patient history, problem list, medication, allergies, and lab results. In addition to EHR access, eight studies allowed patients to share self-documented data, seven offered individualised disease management functions, seven offered educational disease-related information, six supported secure communication, and one offered preventive reminders.\nOnly two studies were at low or unclear risk of bias across domains. Meta-analysis could not be performed, as participants, interventions, and outcomes were too heterogeneous, and most studies presented results based on different adjustment methods or variables. The quality of evidence was rated as low or very low across outcomes. Overall differences between intervention and control groups, if any, were small. The relevance of any small effects remains unclear for most outcomes because in most cases, trial authors did not define a minimal clinically important difference. Overall, results suggest that the effects of EHR access alone and with additional functionalities are mostly uncertain when compared with usual care.\nPatient knowledge and understanding: very low-quality evidence is available from one study, so we are uncertain about effects of the intervention on patient knowledge about diabetes and blood glucose testing.\nPatient empowerment: low-quality evidence from three studies suggests that the intervention may have little or no effect on patient empowerment measures.\nPatient adherence: low-quality evidence from two studies suggests that the intervention may slightly improve adherence to the process of monitoring risk factors and preventive services. Effects on medication adherence are conflicting in two studies; this may or may not improve to a clinically relevant degree.\nPatient satisfaction with care: low-quality evidence from three studies suggests that the intervention may have little or no effect on patient satisfaction, with conflicting results.\nAdverse events: two small studies reported on mortality; one of these also reported on serious and other adverse events, but sample sizes were too small for small differences to be detected. Therefore, low-quality evidence suggests that the intervention may have little to no effect on mortality and other adverse events.\nHealth-related quality of life: only very low-quality evidence from one study is available. We are uncertain whether the intervention improves disease-specific quality of life of patients with asthma.\nHealth-related outcomes: low-quality evidence from eight studies suggests that the intervention may have little to no effect on asthma control, glycosylated haemoglobin (HbA1c) levels, blood pressure, low-density lipoprotein or total cholesterol levels, body mass index or weight, or 10-year Framingham risk scores. Low-quality evidence from one study suggests that the composite scores of risk factors for diabetes mellitus may improve slightly with the intervention, but there is uncertainty about effects on ophthalmic medications or intraocular pressure.\nPsychosocial health outcomes: no study investigated psychosocial health outcomes in a more than anecdotal way.\nHealth resource consumption: low-quality evidence for adult patients in three studies suggests that there may be little to no effect of the intervention on different measures of healthcare use.\nPatient-provider communication: very low-quality evidence is available from a single small study, and we are uncertain whether the intervention improves communication measures, such as the number of messages sent.\nAuthors' conclusions\nThe effects of EHR access with additional functionalities in comparison with usual care for the most part are uncertain. Only adherence to the process of monitoring risk factors and providing preventive services as well as a composite score of risk factors for diabetes mellitus may improve slightly with EHR access with additional functionalities. Due to inconsistent terminology in this area, our search may have missed relevant studies.\nAs the overall quality of evidence is very low to low, future research is likely to change these results. Further trials should investigate the impact of EHR access in a broader range of countries and clinical settings, including more patients over a longer period of follow-up, as this may increase the likelihood of detecting effects of the intervention, should these exist. More studies should focus on assessing outcomes such as patient empowerment and behavioural outcomes, rather than concentrating on health-related outcomes alone. Future studies should distinguish between effects of EHR access only and effects of additional functionalities, and investigate the impact of mobile EHR tools. Future studies should include information on usage patterns, and consider the potential for widening health inequalities with implementation of EHR access. A taxonomy for EHR access and additional functionalities should be developed to promote consistency and comparability of outcome measures, and facilitate future reviews by better enabling cross-study comparisons.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we included evidence published from 2000 up to April 2020."
}
]
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query-laysum | 2094 | [
{
"role": "user",
"content": "Abstract: Background\nGastro-oesophageal reflux (GOR) is characterised by the regurgitation of gastric contents into the oesophagus. GOR is a common presentation in infancy, both in primary and secondary care, affecting approximately 50% of infants under three months old. The natural history of GOR in infancy is generally of a self-limiting condition that improves with age, but older children and children with co-existing medical conditions can have more protracted symptoms. The distinction between gastro-oesophageal reflux disease (GORD) and GOR is debated. Current National Institute of Health and Care Excellence (NICE) guidelines define GORD as GOR causing symptoms severe enough to merit treatment. This is an update of a review first published in 2014.\nObjectives\nTo assess the effects of pharmacological treatments for GOR in infants and children.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE, Embase, and Web of Science up to 17 September 2022. We also searched for ongoing trials in clinical trials registries, contacted experts in the field, and searched the reference lists of trials and reviews for any additional trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared any currently-available pharmacological treatment for GOR in children with placebo or another medication. We excluded studies assessing dietary management of GORD and studies of thickened feeds. We included studies in infants and children up to 16 years old.\nData collection and analysis\nWe used standard methodology expected by Cochrane.\nMain results\nWe included 36 RCTs involving 2251 children and infants. We were able to extract summary data from 14 RCTs; the remaining trials had insufficient data for extraction. We were unable to pool results in a meta-analysis due to methodological differences in the included studies (including heterogeneous outcomes, study populations, and study design).\nWe present the results in two groups by age: infants up to 12 months old, and children aged 12 months to 16 years old.\nInfants\nOmeprazole versus placebo: there is no clear effect on symptoms from omeprazole. One study (30 infants; very low-certainty evidence) showed cry/fuss time in infants aged three to 12 months had altered from 246 ± 105 minutes/day at baseline (mean +/- standard deviation (SD)) to 191 ± 120 minutes/day in the omeprazole group and from 287 ± 132 minutes/day to 201 ± 100 minutes/day in the placebo group (mean difference (MD) 10 minutes/day lower (95% confidence interval (CI) -89.1 to 69.1)). The reflux index changed in the omeprazole group from 9.9 ± 5.8% in 24 hours to 1.0 ± 1.3% and in the placebo group from 7.2 ± 6.0% to 5.3 ± 4.9% in 24 hours (MD 7% lower, 95% CI -4.7 to -9.3).\nOmeprazole versus ranitidine: one study (76 infants; very low-certainty evidence) showed omeprazole may or may not provide symptomatic benefit equivalent to ranitidine. Symptom scores in the omeprazole group changed from 51.9 ± 5.4 to 2.4 ± 1.2, and in the ranitidine group from 47 ± 5.6 to 2.5 ± 0.6 after two weeks: MD -4.97 (95% CI -7.33 to -2.61).\nEsomeprazole versus placebo: esomeprazole appeared to show no additional reduction in the number of GORD symptoms compared to placebo (1 study, 52 neonates; very low-certainty evidence): both the esomeprazole group (184.7 ± 78.5 to 156.7 ± 75.1) and placebo group (183.1 ± 77.5 to 158.3 ± 75.9) improved: MD -3.2 (95% CI -4.6 to -1.8).\nChildren\nProton pump inhibitors (PPIs) at different doses may provide little to no symptomatic and endoscopic benefit.\nRabeprazole given at different doses (0.5 mg/kg and 1 mg/kg) may provide similar symptom improvement (127 children in total; very low-certainty evidence). In the lower-dose group (0.5 mg/kg), symptom scores improved in both a low-weight group of children (< 15 kg) (mean -10.6 ± SD 11.13) and a high-weight group of children (> 15 kg) (mean -13.6 ± 13.1). In the higher-dose groups (1 mg/kg), scores improved in the low-weight (-9 ± 11.2) and higher-weight groups (-8.3 ± 9.2). For the higher-weight group, symptom score mean difference between the two different dosing regimens was 2.3 (95% CI -2 to 6.6), and for the lower-weight group, symptom score MD was 4.6 (95% CI -2.9 to 12).\nPantoprazole: pantoprazole may or may not improve symptom scores at 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg pantoprazole in children aged one to five years by week eight, with no difference between 0.3 mg/kg and 1.2 mg/kg dosing (0.3 mg/kg mean −2.4 ± 1.7; 1.2 mg/kg −1.7 ± 1.2: MD 0.7 (95% CI -0.4 to 1.8)) (one study, 60 children; very low-certainty evidence).\nThere were insufficient summary data to assess other medications.\nAuthors' conclusions\nThere is very low-certainty evidence about symptom improvements and changes in pH indices for infants. There are no summary data for endoscopic changes. Medications may or may not provide a benefit (based on very low-certainty evidence) for infants whose symptoms remain bothersome, despite nonmedical interventions or parental reassurance. If a medication is required, there is no clear evidence based on summary data for omeprazole, esomeprazole (in neonates), H₂antagonists, and alginates for symptom improvements (very low-certainty evidence). Further studies with longer follow-up are needed.\nIn older children with GORD, in studies with summary data extracted, there is very low-certainty evidence that PPIs (rabeprazole and pantoprazole) may or may not improve GORD outcomes. No robust data exist for other medications.\nFurther RCT evidence is required in all areas, including subgroups (preterm babies and children with neurodisabilities).\n\nGiven the provided abstract, please respond to the following query: \"Babies.\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is no clear effect on symptoms or measured acidity (one measure is reflux index, which is the percentage of time in 24 hours the oesophagus is exposed to stomach acid) between babies given omeprazole or placebo. One study (30 babies) showed cry/fuss time went down from 287 to 201 minutes/day in the placebo group and 246 to 191 minutes/day in the omeprazole group. Reflux index changed in the omeprazole group from 9.9% to 1.0% in 24 hours, and in the placebo group from 7.2% to 5.3%. One study (76 babies) showed that omeprazole and ranitidine may have a similar benefit for symptoms after 2 weeks: symptom scores (higher scores mean worse symptoms) in the omeprazole group dropped from 51.9 to 2.4, and in the ranitidine group, from 47 to 2.5. In one study of 52 newborn babies, esomeprazole appeared to show no reduction in the number of symptoms (184.7 to 156.7) compared to placebo (183.1 to 158.3). None of the studies reported harmful events or results about changes to babies' oesophaguses."
}
]
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query-laysum | 2095 | [
{
"role": "user",
"content": "Abstract: Background\nSafe interventions to enhance cognitive function in cognitively healthy people would be very valuable for several reasons, including a better quality of life and professional success. While L-carnitine has been reported to enhance cognitive function in some conditions, its efficacy is disputed. The evidence of its efficacy for cognitively healthy people has not previously been systematically reviewed.\nObjectives\nTo assess the efficacy and safety of L-carnitine for the enhancement of cognitive function in people without cognitive impairment.\nSearch methods\nWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, on 4 November 2016. We used the search terms 'L-carnitine' or 'acetyl-L-carnitine' or 'propionyl-L-carnitine' or 'ALC' or 'PLC' or 'ALCAR' or 'ALPAR'. We ran additional separate searches in several other sources to ensure that we retrieved the most up-to-date results. We also reviewed the bibliographies of the randomised controlled trials identified and contacted the authors and known experts in the field and pharmaceutical companies to identify additional published or unpublished data.\nSelection criteria\nEligible trials were randomised controlled trials (RCTs) or quasi-RCTs, parallel-group or cross-over, that compared L-carnitine or its derivatives, acetyl-L-carnitine or propionyl-L-carnitine, at any dose and for any length of treatment, with placebo or no treatment in cognitively healthy people of any age and either gender.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently selected trials and evaluated the methodological quality, then extracted and analysed data from the included trials.\nMain results\nOnly two RCTs were eligible. One was a cross-over trial with 18 participants. The other randomised 400 participants to one of four treatments, of which two (L-carnitine and placebo) were relevant to this review, but the exact numbers of participants in these two treatment groups was not reported. All participants were young adults. Methodological details were poorly reported, and we considered the risk of bias in both studies to be unclear. The trials assessed different cognitive outcomes. We could extract cognitive data on approximately 200 participants from one trial. We found no evidence that L-carnitine has any effect on reaction time, vigilance, immediate memory, or delayed recall after three days of treatment. This trial report stated that there was a small number of adverse effects, none of which were serious. The small cross-over trial also reported no effect of L-carnitine on cognition, but did not provide data; no information was provided on adverse effects. We considered the available evidence to be of very low quality for all reported outcomes.\nAuthors' conclusions\nDue to the limited number of included trials, short-term treatment, and inadequate reporting, we were unable to draw any conclusions about the efficacy or safety of L-carnitine for cognitive enhancement in healthy adults. Well-designed, randomised, placebo-controlled trials of L-carnitine for cognition enhancement in cognitively healthy people, with large samples and relatively long-term follow-up, are still needed.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Given the limited amount of evidence of very low quality, we were not able to draw any conclusions about the effect of L-carnitine on cognitive function or its safety in healthy people. Larger, better-quality studies conducted over a longer period of time are needed to answer our review question."
}
]
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query-laysum | 2096 | [
{
"role": "user",
"content": "Abstract: Background\nBefore extraction and synthetic chemistry were invented, musculoskeletal complaints were treated with preparations from medicinal plants. They were either administered orally or topically. In contrast to the oral medicinal plant products, topicals act in part as counterirritants or are toxic when given orally.\nObjectives\nTo update the previous Cochrane review of herbal therapy for osteoarthritis from 2000 by evaluating the evidence on effectiveness for topical medicinal plant products.\nSearch methods\nDatabases for mainstream and complementary medicine were searched using terms to include all forms of arthritis combined with medicinal plant products. We searched electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to February 2013, unrestricted by language. We also searched the reference lists from retrieved trials.\nSelection criteria\nRandomised controlled trials of herbal interventions used topically, compared with inert (placebo) or active controls, in people with osteoarthritis were included.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, assessed the risk of bias of included studies and extracted data.\nMain results\nSeven studies (seven different medicinal plant interventions; 785 participants) were included. Single studies (five studies, six interventions) and non-comparable studies (two studies, one intervention) precluded pooling of results.\nModerate evidence from a single study of 174 people with hand osteoarthritis indicated that treatment with Arnica extract gel probably results in similar benefits as treatment with ibuprofen (non-steroidal anti-inflammatory drug) with a similar number of adverse events. Mean pain in the ibuprofen group was 44.2 points on a 100 point scale; treatment with Arnica gel reduced the pain by 4 points after three weeks: mean difference (MD) -3.8 points (95% confidence intervals (CI) -10.1 to 2.5), absolute reduction 4% (10% reduction to 3% increase). Hand function was 7.5 points on a 30 point scale in the ibuprofen-treated group; treatment with Arnica gel reduced function by 0.4 points (MD -0.4, 95% CI -1.75 to 0.95), absolute improvement 1% (6% improvement to 3% decline)). Total adverse events were higher in the Arnica gel group (13% compared to 8% in the ibuprofen group): relative risk (RR) 1.65 (95% CI 0.72 to 3.76).\nModerate quality evidence from a single trial of 99 people with knee osteoarthritis indicated that compared with placebo, Capsicum extract gel probably does not improve pain or knee function, and is commonly associated with treatment-related adverse events including skin irritation and a burning sensation. At four weeks follow-up, mean pain in the placebo group was 46 points on a 100 point scale; treatment with Capsicum extract reduced pain by 1 point (MD -1, 95% CI -6.8 to 4.8), absolute reduction of 1% (7% reduction to 5% increase). Mean knee function in the placebo group was 34.8 points on a 96 point scale at four weeks; treatment with Capsicum extract improved function by a mean of 2.6 points (MD -2.6, 95% CI -9.5 to 4.2), an absolute improvement of 3% (10% improvement to 4% decline). Adverse event rates were greater in the Capsicum extract group (80% compared with 20% in the placebo group, rate ratio 4.12, 95% CI 3.30 to 5.17). The number needed to treat to result in adverse events was 2 (95% CI 1 to 2).\nModerate evidence from a single trial of 220 people with knee osteoarthritis suggested that comfrey extract gel probably improves pain without increasing adverse events. At three weeks, the mean pain in the placebo group was 83.5 points on a 100 point scale. Treatment with comfrey reduced pain by a mean of 41.5 points (MD -41.5, 95% CI -48 to -34), an absolute reduction of 42% (34% to 48% reduction). Function was not reported. Adverse events were similar: 6% (7/110) reported adverse events in the comfrey group compared with 14% (15/110) in the placebo group (RR 0.47, 95% CI 0.20 to 1.10).\nAlthough evidence from a single trial indicated that adhesive patches containing Chinese herbal mixtures FNZG and SJG may improve pain and function, the clinical applicability of these findings are uncertain because participants were only treated and followed up for seven days. We are also uncertain if other topical herbal products (Marhame-Mafasel compress, stinging nettle leaf) improve osteoarthritis symptoms due to the very low quality evidence from single trials.\nNo serious side effects were reported.\nAuthors' conclusions\nAlthough the mechanism of action of the topical medicinal plant products provides a rationale basis for their use in the treatment of osteoarthritis, the quality and quantity of current research studies of effectiveness are insufficient. Arnica gel probably improves symptoms as effectively as a gel containing non-steroidal anti-inflammatory drug, but with no better (and possibly worse) adverse event profile. Comfrey extract gel probably improves pain, and Capsicum extract gel probably will not improve pain or function at the doses examined in this review. Further high quality, fully powered studies are required to confirm the trends of effectiveness identifed in studies so far.\n\nGiven the provided abstract, please respond to the following query: \"Chinese herbal medicine patches\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Adhesive patches containing the Chinese herbal mixtures FNZG and SJG were compared to placebo. We are uncertain whether Chinese herbal patches affect osteoarthritis because this intervention was tested over seven days only.\nPain (higher scores mean worse or more severe pain): people who applied FNZG rated their pain to be 1.44 points lower (9.28 points lower to 6.40 points higher) and people who applied SJG rated their pain to be 1.08 points lower (6.28 points lower to 8.40 points higher) than people who applied placebo. People who applied FNZG rated their pain to be lower by 19.20 points from baseline, people who applied SJG rated their pain to be lower by 16.04 points from baseline, and people who applied placebo rated their pain to be lower by 17.68 points from baseline on a scale of 0 to 100.\nPhysical function (lower scores mean better function): people who applied FNZG rated their function to be 2.61 points lower (9.50 points lower to 4.28 points higher) and people who applied SJG rated their function to be 2.97 points lower (9.60 points lower to 3.66 points higher) than people who applied placebo. People who applied FNZG rated their physical function to be lower (better) by 5.04 points from baseline, people who applied SJG rated their physical function to be lower (better) by 6.71 points from baseline, and people who applied placebo rated their physical function to be lower (better) by 6.10 points from baseline on a scale of 0 to 96.\nSide effects: a greater proportion of people who applied herbal patches reported side effects than did those who applied placebo patches. Five out of 60 people reported side effects with FNZG, 4 out of 60 people reported side effects with SJG, and 0 out of 30 people reported side effects with placebo."
}
]
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query-laysum | 2097 | [
{
"role": "user",
"content": "Abstract: Background\nThe morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a person's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture by stimulating osteoblasts and other bone-forming proteins. This is an update of a review previously published in February 2014.\nObjectives\nTo assess the effects of low-intensity ultrasound (LIPUS), high-intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase (1980 to March 2022), Orthopaedic Proceedings, trial registers and reference lists of articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs including participants over 18 years of age with acute fractures (complete or stress fractures) treated with either LIPUS, HIFUS or ECSW versus a control or placebo-control.\nData collection and analysis\nWe used standard methodology expected by Cochrane. We collected data for the following critical outcomes: participant-reported quality of life, quantitative functional improvement, time to return to normal activities, time to fracture union, pain, delayed or non-union of fracture. We also collected data for treatment-related adverse events. We collected data in the short term (up to three months after surgery) and in the medium term (later than three months after surgery).\nMain results\nWe included 21 studies, involving 1543 fractures in 1517 participants; two studies were quasi-RCTs. Twenty studies tested LIPUS and one trial tested ECSW; no studies tested HIFUS. Four studies did not report any of the critical outcomes.\nAll studies had unclear or high risk of bias in at least one domain. The certainty of the evidence was downgraded for imprecision, risk of bias and inconsistency.\nLIPUS versus control (20 studies, 1459 participants)\nWe found very low-certainty evidence for the effect of LIPUS on Health-related quality of life (HRQoL) measured by SF-36 at up to one year after surgery for lower limb fractures (mean difference (MD) 0.06, 95% confidence interval (CI) -3.85 to 3.97, favours LIPUS; 3 studies, 393 participants). This result was compatible with a clinically important difference of 3 units with both LIPUS or control. There may be little to no difference in time to return to work after people had complete fractures of the upper or lower limbs (MD 1.96 days, 95% CI -2.13 to 6.04, favours control; 2 studies, 370 participants; low-certainty evidence).\nThere is probably little or no difference in delayed union or non-union up to 12 months after surgery (RR 1.25, 95% CI 0.50 to 3.09, favours control; 7 studies, 746 participants; moderate-certainty evidence). Although data for delayed and non-union included both upper and lower limbs, we noted that there were no incidences of delayed or non-union in upper limb fractures. We did not pool data for time to fracture union (11 studies, 887 participants; very low-certainty evidence) because of substantial statistical heterogeneity which we could not explain. In upper limb fractures, MDs ranged from 0.32 to 40 fewer days to fracture union with LIPUS. In lower limb fractures, MDs ranged from 88 fewer days to 30 more days to fracture union. We also did not pool data for pain experienced at one month after surgery in people with upper limb fractures (2 studies, 148 participants; very low-certainty evidence) because of substantial unexplained statistical heterogeneity. Using a 10-point visual analogue scale, one study reported less pain with LIPUS (MD -1.7, 95% CI -3.03 to -0.37; 47 participants), and the effect was less precise in the other study (MD -0.4, 95% CI -0.61 to 0.53; 101 participants). We found little or no difference in skin irritation (a possible treatment-related adverse event) between groups but judged the certainty of the evidence from this small study to be very low (RR 0.94, 95% CI 0.06 to 14.65; 1 study, 101 participants). No studies reported data for functional recovery. Data for treatment adherence were inconsistently reported across studies, but was generally described to be good. Data for costs were reported for one study, with higher direct costs, as well as combined direct and indirect costs, for LIPUS use.\nECSW versus control (1 study, 56 participants)\nWe are uncertain whether ECSW reduces pain at 12 months after surgery in fractures of the lower limb (MD -0.62, 95% CI -0.97 to -0.27, favours ECSW); the difference between pain scores was unlikely to be clinically important, and the certainty of the evidence was very low. We are also uncertain of the effect of ECSW on delayed or non-union at 12 months because the certainty of this evidence is very low (RR 0.56, 95% CI 0.15 to 2.01; 1 study, 57 participants). There were no treatment-related adverse events. This study reported no data for HRQoL, functional recovery, time to return to normal activities, or time to fracture union. In addition, no data were available for adherence or cost.\nAuthors' conclusions\nWe were uncertain of the effectiveness of ultrasound and shock wave therapy for acute fractures in terms of patient-reported outcome measures (PROMS), for which few studies reported data. It is probable that LIPUS makes little or no difference to delayed union or non-union. Future trials should be double-blind, randomised, placebo-controlled trials recording validated PROMs and following up all trial participants. Whilst time to union is difficult to measure, the proportion of participants achieving clinical and radiographic union at each follow-up point should be ascertained, alongside adherence with the study protocol and cost of treatment in order to better inform clinical practice.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review updates our previous review. The evidence is up to date to March 2022."
}
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query-laysum | 2098 | [
{
"role": "user",
"content": "Abstract: Background\nHeparin-induced thrombocytopenia (HIT) is an adverse drug reaction presenting as a prothrombotic disorder related to antibody-mediated platelet activation. It is a paradoxical immune reaction resulting in thrombin generation in vivo, which leads to a hypercoagulable state and the potential to initiate venous or arterial thrombosis. A number of factors are thought to influence the incidence of HIT including the type and preparation of heparin (unfractionated heparin (UFH) or low molecular weight heparin (LMWH)) and the heparin-exposed patient population, with the postoperative patient population at higher risk.\nAlthough LMWH has largely replaced UFH as a front-line therapy, there is evidence supporting a lack of superiority of LMWH compared with UFH regarding prevention of deep vein thrombosis and pulmonary embolism following surgery, and similar frequencies of bleeding have been described with LMWH and UFH. The decision as to which of these two preparations of heparin to use may thus be influenced by harmful effects such as HIT. We therefore sought to determine the relative impact of UFH and LMWH on HIT in postoperative patients receiving thromboembolism prophylaxis. This is an update of a review first published in 2012.\nObjectives\nThe objective of this review was to compare the incidence of heparin-induced thrombocytopenia (HIT) and HIT complicated by venous thromboembolism in postoperative patients exposed to unfractionated heparin (UFH) versus low molecular weight heparin (LMWH).\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register (May 2016), CENTRAL (2016, Issue 4) and trials registries. The authors searched Lilacs (June 2016) and additional trials were sought from reference lists of relevant publications.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which participants were postoperative patients allocated to receive prophylaxis with UFH or LMWH, in a blinded or unblinded fashion. Studies were excluded if they did not use the accepted definition of HIT. This was defined as a relative reduction in the platelet count of 50% or greater from the postoperative peak (even if the platelet count at its lowest remained greater than 150 x 109/L) occurring within five to 14 days after the surgery, with or without a thrombotic event occurring in this timeframe. Additionally, we required circulating antibodies associated with the syndrome to have been investigated through laboratory assays.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias. Disagreements were resolved by consensus with participation of a third author.\nMain results\nIn this update, we included three trials involving 1398 postoperative participants. Participants were submitted to general surgical procedures, minor and major, and the minimum mean age was 49 years. Pooled analysis showed a significant reduction in the risk of HIT with LMWH compared with UFH (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.07 to 0.73); low-quality evidence. The number needed to treat for an additional beneficial outcome (NNTB) was 59. The risk of HIT was consistently reduced comparing participants undergoing major surgical procedures exposed to LMWH or UFH (RR 0.22, 95% CI 0.06 to 0.75); low-quality evidence. The occurrence of HIT complicated by venous thromboembolism was significantly lower in participants receiving LMWH compared with UFH (RR 0.22, 95% CI 0.06 to 0.84); low-quality evidence. The NNTB was 75. Arterial thrombosis occurred in only one participant who received UFH. There were no amputations or deaths documented. Although limited evidence is available, it appears that HIT induced by both types of heparins is common in people undergoing major surgical procedures (incidence greater than 1% and less than 10%).\nAuthors' conclusions\nThis updated review demonstrated low-quality evidence of a lower incidence of HIT, and HIT complicated by venous thromboembolism, in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH. Similarily, the risk of HIT in people undergoing major surgical procedures was lower when treated with LMWH compared to UFH (low-quality evidence). The quality of the evidence was downgraded due to concerns about the risk of bias in the included studies and imprecision of the study results. These findings may support current clinical use of LMWH over UFH as front-line heparin therapy. However, our conclusions are limited and there was an unexpected paucity of RCTs including HIT as an outcome. To address the scarcity of clinically-relevant information on HIT, HIT must be included as a core harmful outcome in future RCTs of heparin.\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 the incidence of heparin-induced thrombocytopenia lower in postoperative patients receiving thromboprophylaxis with low molecular weight heparin in comparison with patients receiving unfractionated heparin?"
}
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query-laysum | 2099 | [
{
"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: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We generally rated the quality of the evidence for each assessment as low due to issues with the design of many of the studies, and low overall numbers of people enrolled. Low-quality evidence means that further research may have an important impact on our findings."
}
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query-laysum | 2100 | [
{
"role": "user",
"content": "Abstract: Background\nEnhancing health equity is endorsed in the Sustainable Development Goals. The failure of systematic reviews to consider potential differences in effects across equity factors is cited by decision-makers as a limitation to their ability to inform policy and program decisions.\nObjectives\nTo explore what methods systematic reviewers use to consider health equity in systematic reviews of effectiveness.\nSearch methods\nWe searched the following databases up to 26 February 2021: MEDLINE, PsycINFO, the Cochrane Methodology Register, CINAHL, Education Resources Information Center, Education Abstracts, Criminal Justice Abstracts, Hein Index to Foreign Legal Periodicals, PAIS International, Social Services Abstracts, Sociological Abstracts, Digital Dissertations and the Health Technology Assessment Database. We searched SCOPUS to identify articles that cited any of the included studies on 10 June 10 2021. We contacted authors and searched the reference lists of included studies to identify additional potentially relevant studies.\nSelection criteria\nWe included empirical studies of cohorts of systematic reviews that assessed methods for measuring effects on health inequalities. We define health inequalities as unfair and avoidable differences across socially stratifying factors that limit opportunities for health. We operationalised this by assessing studies which evaluated differences in health across any component of the PROGRESS-Plus acronym, which stands for Place of residence, Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status, Social capital. \"Plus\" stands for other factors associated with discrimination, exclusion, marginalisation or vulnerability such as personal characteristics (e.g. age, disability), relationships that limit opportunities for health (e.g. children in a household with parents who smoke) or environmental situations which provide limited control of opportunities for health (e.g. school food environment).\nData collection and analysis\nTwo review authors independently extracted data using a pre-tested form. Risk of bias was appraised for included studies according to the potential for bias in selection and detection of systematic reviews.\nMain results\nIn total, 48,814 studies were identified and the titles and abstracts were screened in duplicate. In this updated review, we identified an additional 124 methodological studies published in the 10 years since the first version of this review, which included 34 studies. Thus, 158 methodological studies met our criteria for inclusion. The methods used by these studies focused on evidence relevant to populations experiencing health inequity (108 out of 158 studies), assess subgroup analysis across PROGRESS-Plus (26 out of 158 studies), assess analysis of a gradient in effect across PROGRESS-Plus (2 out of 158 studies) or use a combination of subgroup analysis and focused approaches (20 out of 158 studies). The most common PROGRESS-Plus factors assessed were age (43 studies), socioeconomic status in 35 studies, low- and middle-income countries in 24 studies, gender or sex in 22 studies, race or ethnicity in 17 studies, and four studies assessed multiple factors across which health inequity may exist.\nOnly 16 studies provided a definition of health inequity. Five methodological approaches to consider health equity in systematic reviews of effectiveness were identified: 1) descriptive assessment of reporting and analysis in systematic reviews (140 of 158 studies used a type of descriptive method); 2) descriptive assessment of reporting and analysis in original trials (50 studies); 3) analytic approaches which assessed differential effects across one or more PROGRESS-Plus factors (16 studies); 4) applicability assessment (25 studies) and 5) stakeholder engagement (28 studies), which is a new finding in this update and examines the appraisal of whether relevant stakeholders with lived experience of health inequity were included in the design of systematic reviews or design and delivery of interventions. Reporting for both approaches (analytic and applicability) lacked transparency and was insufficiently detailed to enable the assessment of credibility.\nAuthors' conclusions\nThere is a need for improvement in conceptual clarity about the definition of health equity, describing sufficient detail about analytic approaches (including subgroup analyses) and transparent reporting of judgments required for applicability assessments in order to consider health equity in systematic reviews of effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included empirical studies of collections of systematic reviews that assessed methods for measuring effects on health inequalities. We define health inequalities as unfair and avoidable differences across socially stratifying factors that limit opportunities for health. We evaluated differences in health across any component of the PROGRESS-Plus acronym, which stands for Place of residence, Race/ethnicity/culture/language, Occupation, Gender or sex, Religion, Education, Socioeconomic status, Social capital. \"Plus\" stands for other factors associated with discrimination, exclusion, marginalisation or vulnerability such as personal characteristics (e.g. age, disability), relationships that limit opportunities for health (e.g. children in a household with smoking parents) or environmental situations which provide limited control of opportunities for health (e.g. school, food, environment)."
}
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query-laysum | 2101 | [
{
"role": "user",
"content": "Abstract: Background\nInternational dietary recommendations include guidance on healthy eating and weight management for people who have survived cancer; however dietary interventions are not provided routinely for people living beyond cancer.\nObjectives\nTo assess the effects of dietary interventions for adult cancer survivors on morbidity and mortality, changes in dietary behaviour, body composition, health-related quality of life, and clinical measurements.\nSearch methods\nWe ran searches on 18 September 2019 and searched the Cochrane Central Register of Controlled trials (CENTRAL), in the Cochrane Library; MEDLINE via Ovid; Embase via Ovid; the Allied and Complementary Medicine Database (AMED); the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and the Database of Abstracts of Reviews of Effects (DARE). We searched other resources including reference lists of retrieved articles, other reviews on the topic, the International Trials Registry for ongoing trials, metaRegister, Physicians Data Query, and appropriate websites for ongoing trials. We searched conference abstracts and WorldCat for dissertations.\nSelection criteria\nWe included randomised controlled trials (RCTs) that recruited people following a cancer diagnosis. The intervention was any dietary advice provided by any method including group sessions, telephone instruction, written materials, or a web-based approach. We included comparisons that could be usual care or written information, and outcomes measured included overall survival, morbidities, secondary malignancies, dietary changes, anthropometry, quality of life (QoL), and biochemistry.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Two people independently assessed titles and full-text articles, extracted data, and assessed risk of bias. For analysis, we used a random-effects statistical model for all meta-analyses, and the GRADE approach to rate the certainty of evidence, considering limitations, indirectness, inconsistencies, imprecision, and bias.\nMain results\nWe included 25 RCTs involving 7259 participants including 977 (13.5%) men and 6282 (86.5%) women. Mean age reported ranged from 52.6 to 71 years, and range of age of included participants was 23 to 85 years. The trials reported 27 comparisons and included participants who had survived breast cancer (17 trials), colorectal cancer (2 trials), gynaecological cancer (1 trial), and cancer at mixed sites (5 trials).\nFor overall survival, dietary intervention and control groups showed little or no difference in risk of mortality (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.77 to 1.23; 1 study; 3107 participants; low-certainty evidence). For secondary malignancies, dietary interventions versus control trials reported little or no difference (risk ratio (RR) 0.99, 95% CI 0.84 to 1.15; 1 study; 3107 participants; low-certainty evidence). Co-morbidities were not measured in any included trials.\nSubsequent outcomes reported after 12 months found that dietary interventions versus control probably make little or no difference in energy intake at 12 months (mean difference (MD) -59.13 kcal, 95% CI -159.05 to 37.79; 5 studies; 3283 participants; moderate-certainty evidence). Dietary interventions versus control probably led to slight increases in fruit and vegetable servings (MD 0.41 servings, 95% CI 0.10 to 0.71; 5 studies; 834 participants; moderate-certainty evidence); mixed results for fibre intake overall (MD 5.12 g, 95% CI 0.66 to 10.9; 2 studies; 3127 participants; very low-certainty evidence); and likely improvement in Diet Quality Index (MD 3.46, 95% CI 1.54 to 5.38; 747 participants; moderate-certainty evidence).\nFor anthropometry, dietary intervention versus control probably led to a slightly decreased body mass index (BMI) (MD -0.79 kg/m², 95% CI -1.50 to -0.07; 4 studies; 777 participants; moderate-certainty evidence). Dietary interventions versus control probably had little or no effect on waist-to-hip ratio (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; 106 participants; low-certainty evidence).\nFor QoL, there were mixed results; several different quality assessment tools were used and evidence was of low to very low-certainty. No adverse events were reported in any of the included studies.\nAuthors' conclusions\nEvidence demonstrated little effects of dietary interventions on overall mortality and secondary cancers. For comorbidities, no evidence was identified. For nutritional outcomes, there was probably little or no effect on energy intake, although probably a slight increase in fruit and vegetable intake and Diet Quality Index. Results were mixed for fibre. For anthropometry, there was probably a slight decrease in body mass index (BMI) but probably little or no effect on waist-to-hip ratio. For QoL, results were highly varied. Additional high-quality research is needed to examine the effects of dietary interventions for different cancer sites, and to evaluate important outcomes including comorbidities and body composition. Evidence on new technologies used to deliver dietary interventions was limited.\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": "Available evidence shows that dietary interventions can be helpful in modifying fruit and vegetable servings and diet quality; modification of fibre intake was variable, and some benefits were seen for anthropometric measurements, including BMI. Most of the evidence is based on women with breast cancer, so more research is needed for patients with other cancers. Gaps identified in the evidence involved the use of new technologies, comorbidities, and body composition data."
}
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query-laysum | 2102 | [
{
"role": "user",
"content": "Abstract: Background\nSystemic androgen deprivation therapy (ADT), also referred to as hormone therapy, has long been the primary treatment for metastatic prostate cancer. Additional agents have been reserved for the castrate-resistant disease stage when ADT start becoming less effective. Abiraterone is an agent with an established role in that disease stage, which has only recently been evaluated in the hormone-sensitive setting.\nObjectives\nTo assess the effects of early abiraterone acetate, in combination with systemic ADT, for newly diagnosed metastatic hormone-sensitive prostate cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, six other databases, two trials registries, grey literature, and conference proceedings, up to 15 May 2020. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized trials, in which men diagnosed with hormone-sensitive prostate cancer were administered abiraterone acetate and prednisolone with ADT or ADT alone.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses\nusing a random-effects model. We rated the quality of evidence according to the GRADE approach.\nMain results\nThe search identified two randomized controlled trials (RCT), with 2201 men, who were assigned to receive either abiraterone acetate 1000 mg once daily and low dose prednisone (5mg) in addition to ADT, or ADT alone. In the LATITUDE trial, the median age and range of men in the intervention group was 68 (38 to 89) years, and 67 (33 to 92) years in the control group. Nearly all of the men in this study (97.6%) had prostate cancer with a Gleason score of at least 8 (ISUP grade group 4).\nPrimary outcomes\nThe addition of abiraterone acetate to ADT reduces the probability of death from any cause compared to ADT alone (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.56 to 0.73; 2 RCTs, 2201 men; high certainty of evidence); this corresponds to 163 fewer deaths per 1000 men with hormone-sensitive metastatic prostate cancer (210 fewer to 115 fewer) at five years.\nAbiraterone acetate in addition to ADT probably results in little to no difference in quality of life compared to ADT alone, measured with the Functional Assessment of Cancer Therapy-prostate total score (FACT-P; range 0 to 156; higher values indicates better quality of life), at 12 months (mean difference [MD] 2.90 points, 95% CI 0.11 to 5.60; 1 RCT, 838 men; moderate certainty of evidence).\nSecondary outcomes\nAbiraterone plus ADT increases the risk of grades III to V adverse events compared to ADT alone (risk ratio [RR] 1.34, 95% CI 1.22 to 1.47; 1 RCT, 1199 men; high certainty of evidence); this corresponds to 162 more grade III to V events per 1000 men with hormone-sensitive metastatic prostate cancer (105 more to 224 more) at a median follow-up of 30 months.\nAbiraterone acetate in addition to ADT probably reduces the probability of death due to prostate cancer compared to ADT alone (HR 0.58, 95% CI 0.50 to 0.68; 2 RCTs, 2201 men; moderate certainty of evidence). This corresponds to 120 fewer death from prostate cancer per 1000 men with hormone-sensitive metastatic prostate cancer (95% CI 145 fewer to 90 fewer) after a median follow-up of 30 months.\nThe addition of abiraterone acetate to ADT probably decreases the probability of disease progression compared to ADT alone (HR 0.35, 95%CI 0.26 to 0.49; 2 RCTs, 2097 men; moderate certainty of evidence). This corresponds to 369 fewer incidences of disease progression per 1000 men with hormone-sensitive metastatic prostate cancer (456 fewer to 256 fewer) after a median follow-up of 30 months.\nThe addition of abiraterone acetate to ADT probably increases the risk of discontinuing treatment due to adverse events compared to ADT alone (RR 1.50, 95% CI 1.17 to 1.92; 1 RCT, 1199 men; moderate certainty of evidence). This corresponds to 51 more men (95% CI 17 more to 93 more) discontinuing treatment because of adverse events per 1000 men treated with abiraterone acetate and ADT compared to ADT alone after a median follow-up of 30 months.\nAuthors' conclusions\nThe addition of abiraterone acetate to androgen deprivation therapy improves overall survival but probably not quality of life. It probably also extends disease-specific survival, and delays disease progression compared to androgen deprivation therapy alone. However, the risk of grades III to V adverse events is increased, and probably, so is the risk of discontinuing treatment due to adverse events.\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": "Abiraterone acetate is a medication that blocks the effect of male sex hormones, and thereby, slows down prostate cancer growth.\nMore than 15% of men diagnosed with prostate cancer present with disease that has spread beyond the prostate. Another 15% to 30% of men who undergo primary treatment will experience a return of their cancer. Hormone therapy (drugs to reduce the level of male hormones) has been the main treatment for advanced disease, but this does not work forever. Recent studies have looked at whether drugs that block the growth of prostate cancer cells, such as abiraterone acetate, can improve how men do."
}
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query-laysum | 2103 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is a life-limiting genetic condition in which thick mucus builds up in the lungs, leading to infections, inflammation, and eventually, deterioration in lung function. To clear their lungs of mucus, people with cystic fibrosis perform airway clearance techniques daily. There are various airway clearance techniques, which differ in terms of the need for assistance or equipment, and cost.\nObjectives\nTo summarise the evidence from Cochrane Reviews on the effectiveness and safety of various airway clearance techniques in people with cystic fibrosis.\nMethods\nFor this overview, we included Cochrane Reviews of randomised or quasi-randomised controlled trials (including cross-over trials) that evaluated an airway clearance technique (conventional chest physiotherapy, positive expiratory pressure (PEP) therapy, high-pressure PEP therapy, active cycle of breathing techniques, autogenic drainage, airway oscillating devices, external high frequency chest compression devices and exercise) in people with cystic fibrosis.\nWe searched the Cochrane Database of Systematic Reviews on 29 November 2018.\nTwo review authors independently evaluated reviews for eligibility. One review author extracted data from included reviews and a second author checked the data for accuracy. Two review authors independently graded the quality of reviews using the ROBIS tool. We used the GRADE approach for assessing the overall strength of the evidence for each primary outcome (forced expiratory volume in one second (FEV1), individual preference and quality of life).\nMain results\nWe included six Cochrane Reviews, one of which compared any type of chest physiotherapy with no chest physiotherapy or coughing alone and the remaining five reviews included head-to-head comparisons of different airway clearance techniques. All the reviews were considered to have a low risk of bias. However, the individual trials included in the reviews often did not report sufficient information to adequately assess risk of bias. Many trials did not sufficiently report on outcome measures and had a high risk of reporting bias.\nWe are unable to draw definitive conclusions for comparisons of airway clearance techniques in terms of FEV1, except for reporting no difference between PEP therapy and oscillating devices after six months of treatment, mean difference -1.43% predicted (95% confidence interval -5.72 to 2.87); the quality of the body of evidence was graded as moderate. The quality of the body of evidence comparing different airway clearance techniques for other outcomes was either low or very low.\nAuthors' conclusions\nThere is little evidence to support the use of one airway clearance technique over another. People with cystic fibrosis should choose the airway clearance technique that best meets their needs, after considering comfort, convenience, flexibility, practicality, cost, or some other factor. More long-term, high-quality randomised controlled trials comparing airway clearance techniques among people with cystic fibrosis are needed.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 29 November 2018."
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query-laysum | 2104 | [
{
"role": "user",
"content": "Abstract: Background\nAge-related macular degeneration (AMD) is a common eye disease and leading cause of sight loss worldwide. Despite its high prevalence and increasing incidence as populations age, AMD remains incurable and there are no treatments for most patients. Mounting genetic and molecular evidence implicates complement system overactivity as a key driver of AMD development and progression. The last decade has seen the development of several novel therapeutics targeting complement in the eye for the treatment of AMD. This review update encompasses the results of the first randomised controlled trials in this field.\nObjectives\nTo assess the effects and safety of complement inhibitors in the prevention or treatment of AMD.\nSearch methods\nWe searched CENTRAL on the Cochrane Library, MEDLINE, Embase, LILACS, Web of Science, ISRCTN registry, ClinicalTrials.gov, and the WHO ICTRP to 29 June 2022 with no language restrictions. We also contacted companies running clinical trials for unpublished data.\nSelection criteria\nWe included randomised controlled trials (RCTs) with parallel groups and comparator arms that studied complement inhibition for advanced AMD prevention/treatment.\nData collection and analysis\nTwo authors independently assessed search results and resolved discrepancies through discussion. Outcome measures evaluated at one year included change in best-corrected visual acuity (BCVA), untransformed and square root-transformed geographic atrophy (GA) lesion size progression, development of macular neovascularisation (MNV) or exudative AMD, development of endophthalmitis, loss of ≥ 15 letters of BCVA, change in low luminance visual acuity, and change in quality of life. We assessed risk of bias and evidence certainty using Cochrane risk of bias and GRADE tools.\nMain results\nTen RCTs with 4052 participants and eyes with GA were included. Nine evaluated intravitreal (IVT) administrations against sham, and one investigated an intravenous agent against placebo. Seven studies excluded patients with prior MNV in the non-study eye, whereas the three pegcetacoplan studies did not. The risk of bias in the included studies was low overall. We also synthesised results of two intravitreal agents (lampalizumab, pegcetacoplan) at monthly and every-other-month (EOM) dosing intervals.\nEfficacy and safety of IVT lampalizumab versus sham for GA\nFor 1932 participants in three studies, lampalizumab did not meaningfully change BCVA given monthly (+1.03 letters, 95% confidence interval (CI) −0.19 to 2.25) or EOM (+0.22 letters, 95% CI −1.00 to 1.44) (high-certainty evidence). For 1920 participants, lampalizumab did not meaningfully change GA lesion growth given monthly (+0.07 mm², 95% CI −0.09 to 0.23; moderate-certainty due to imprecision) or EOM (+0.07 mm², 95% CI −0.05 to 0.19; high-certainty). For 2000 participants, lampalizumab may have also increased MNV risk given monthly (RR 1.77, 95% CI 0.73 to 4.30) and EOM (RR 1.70, 95% CI 0.67 to 4.28), based on low-certainty evidence. The incidence of endophthalmitis in patients treated with monthly and EOM lampalizumab was 4 per 1000 (0 to 87) and 3 per 1000 (0 to 62), respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT pegcetacoplan versus sham for GA\nFor 242 participants in one study, pegcetacoplan probably did not meaningfully change BCVA given monthly (+1.05 letters, 95% CI −2.71 to 4.81) or EOM (−1.42 letters, 95% CI −5.25 to 2.41), as supported by moderate-certainty evidence. In contrast, for 1208 participants across three studies, pegcetacoplan meaningfully reduced GA lesion growth when given monthly (−0.38 mm², 95% CI −0.57 to −0.19) and EOM (−0.29 mm², 95% CI −0.44 to −0.13), with high certainty. These reductions correspond to 19.2% and 14.8% versus sham, respectively. A post hoc analysis showed possibly greater benefits in 446 participants with extrafoveal GA given monthly (−0.67 mm², 95% CI −0.98 to −0.36) and EOM (−0.60 mm², 95% CI −0.91 to −0.30), representing 26.1% and 23.3% reductions, respectively. However, we did not have data on subfoveal GA growth to undertake a formal subgroup analysis. In 1502 participants, there is low-certainty evidence that pegcetacoplan may have increased MNV risk when given monthly (RR 4.47, 95% CI 0.41 to 48.98) or EOM (RR 2.29, 95% CI 0.46 to 11.35). The incidence of endophthalmitis in patients treated with monthly and EOM pegcetacoplan was 6 per 1000 (1 to 53) and 8 per 1000 (1 to 70) respectively, based on moderate-certainty evidence.\nEfficacy and safety of IVT avacincaptad pegol versus sham for GA\nIn a study of 260 participants with extrafoveal or juxtafoveal GA, monthly avacincaptad pegol probably did not result in a clinically meaningful change in BCVA at 2 mg (+1.39 letters, 95% CI −5.89 to 8.67) or 4 mg (−0.28 letters, 95% CI −8.74 to 8.18), based on moderate-certainty evidence. Despite this, the drug was still found to have probably reduced GA lesion growth, with estimates of 30.5% reduction at 2 mg (−0.70 mm², 95% CI −1.99 to 0.59) and 25.6% reduction at 4 mg (−0.71 mm², 95% CI −1.92 to 0.51), based on moderate-certainty evidence. Avacincaptad pegol may have also increased the risk of developing MNV (RR 3.13, 95% CI 0.93 to 10.55), although this evidence is of low certainty. There were no cases of endophthalmitis reported in this study.\nAuthors' conclusions\nDespite confirmation of the negative findings of intravitreal lampalizumab across all endpoints, local complement inhibition with intravitreal pegcetacoplan meaningfully reduces GA lesion growth relative to sham at one year. Inhibition of complement C5 with intravitreal avacincaptad pegol is also an emerging therapy with probable benefits on anatomical endpoints in the extrafoveal or juxtafoveal GA population. However, there is currently no evidence that complement inhibition with any agent improves functional endpoints in advanced AMD; further results from the phase 3 studies of pegcetacoplan and avacincaptad pegol are eagerly awaited. Progression to MNV or exudative AMD is a possible emergent adverse event of complement inhibition, requiring careful consideration should these agents be used clinically. Intravitreal administration of complement inhibitors is probably associated with a small risk of endophthalmitis, which may be higher than that of other intravitreal therapies. Further research is likely to have an important impact on our confidence in the estimates of adverse effects and may change these. The optimal dosing regimens, treatment duration, and cost-effectiveness of such therapies are yet to be established.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "This review updates our previous review. The evidence is up-to-date to 29 June 2022."
}
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query-laysum | 2105 | [
{
"role": "user",
"content": "Abstract: Background\nFeeding practices around the time of packed red blood cell transfusion have been implicated in the subsequent development of necrotising enterocolitis (NEC) in preterm infants. Specifically, it has been suggested that withholding feeds around the time of transfusion may reduce the risk of subsequent NEC. It is important to determine if withholding feeds around transfusion reduces the risk of subsequent NEC and associated mortality.\nObjectives\n• To assess the benefits and risks of stopping compared to continuing feed management before, during, and after blood transfusion in preterm infants\n• To assess the effects of stopping versus continuing feeds in the following subgroups of infants: infants of different gestations; infants with symptomatic and asymptomatic anaemia; infants who received different feeding schedules, types of feed, and methods of feed delivery; infants who were transfused with different blood products, at different blood volumes, via different routes of delivery; and those who received blood transfusion with and without co-interventions such as use of diuretics\n• To determine the effectiveness and safety of stopping feeds around the time of a blood transfusion in reducing the risk of subsequent necrotising enterocolitis (NEC) in preterm infants\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11), in the Cochrane Library; MEDLINE (1966 to 14 November 2018); Embase (1980 to 14 November 2018); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 14 November 2018). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials (RCTs), cluster-RCTs, and quasi-RCTs.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared stopping feeds versus continuing feeds around the time of blood transfusion in preterm infants.\nData collection and analysis\nTwo review authors independently selected trials, assessed trial quality, and extracted data from the included studies.\nMain results\nThe search revealed seven studies that assessed effects of stopping feeds during blood transfusion. However, only one RCT involving 22 preterm infants was eligible for inclusion in the review. This RCT had low risk of selection bias but high risk of performance bias, as care personnel were not blinded to the study allocation. The primary objective of this trial was to investigate changes in mesenteric blood flow, and no cases of NEC were reported in any of the infants included in the trial. We were unable to draw any conclusions from this single study. The overall GRADE rating for quality of evidence was very low.\nAuthors' conclusions\nRandomised controlled trial evidence is insufficient to show whether stopping feeds has an effect on the incidence of subsequent NEC or death. Large, adequately powered RCTs are needed to address this issue.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In preterm infants, does stopping feeds around the time of a packed red blood cell transfusion result in decreased risk of developing necrotising enterocolitis (NEC) or death?"
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query-laysum | 2106 | [
{
"role": "user",
"content": "Abstract: Background\nLeg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings.\nObjectives\nTo assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population.\nSearch methods\nIn June 2020 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting.\nData collection and analysis\nAt least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology.\nMain results\nWe included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm2. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias.\nPrimary outcomes\nThere is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I2 = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I2 = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants).\nIt is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants).\nSecondary outcomes\nModerate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference −1.39, 95% CI −1.79 to −0.98; I2 = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence).\nIt is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence).\nAuthors' conclusions\nIf using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness.\nFuture research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.\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"
},
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"role": "assistant",
"content": "We found 14 studies (1391 people, average age: 70.1 years) that lasted on average for 12 weeks. People in eight of the 14 studies were treated in outpatient and community settings. People had venous leg ulcers that had lasted for 22 months on average, and most ulcers had an area between 5 and 20 cm2.\nThe studies used three types of compression therapy: short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of compression bandage containing zinc oxide). These therapies were compared with no compression in forms of 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where only some participants received compression (but it was not the norm)."
}
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query-laysum | 2107 | [
{
"role": "user",
"content": "Abstract: Background\nLumbosacral radicular pain (commonly called sciatica) is a syndrome involving patients who report radiating leg pain. Epidural corticosteroid injections deliver a corticosteroid dose into the epidural space, with the aim of reducing the local inflammatory process and, consequently, relieving the symptoms of lumbosacral radicular pain. This Cochrane Review is an update of a review published in Annals of Internal Medicine in 2012. Some placebo-controlled trials have been published recently, which highlights the importance of updating the previous review.\nObjectives\nTo investigate the efficacy and safety of epidural corticosteroid injections compared with placebo injection on pain and disability in patients with lumbosacral radicular pain.\nSearch methods\nWe searched the following databases without language limitations up to 25 September 2019: Cochrane Back and Neck group trial register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and two trial registers. We also performed citation tracking of included studies and relevant systematic reviews in the field.\nSelection criteria\nWe included studies that compared epidural corticosteroid injections of any corticosteroid drug to placebo injections in patients with lumbosacral radicular pain. We accepted all three anatomical approaches (caudal, interlaminar, and transforaminal) to delivering corticosteroids into the epidural space. We considered trials that included a placebo treatment as delivery of an inert substance (i.e. one with no pharmacologic activity), an innocuous substance (e.g. normal saline solution), or a pharmacologically active substance but not one considered to provide sustained benefit (e.g. local anaesthetic), either into the epidural space (i.e. to mimic epidural corticosteroid injection) or adjacent spinal tissue (i.e. subcutaneous, intramuscular, or interspinous tissue). We also included trials in which a local anaesthetic with a short duration of action was used as a placebo and injected together with corticosteroid in the intervention group.\nData collection and analysis\nTwo authors independently performed the screening, data extraction, and 'Risk of bias' assessments. In case of insufficient information, we contacted the authors of the original studies or estimated the data. We grouped the outcome data into four time points of assessment: immediate (≤ 2 weeks), short term (> 2 weeks but ≤ 3 months), intermediate term (> 3 months but < 12 months), and long term (≥ 12 months). We assessed the overall quality of evidence for each outcome and time point using the GRADE approach.\nMain results\nWe included 25 clinical trials (from 29 publications) investigating the effects of epidural corticosteroid injections compared to placebo in patients with lumbosacral radicular pain. The included studies provided data for a total of 2470 participants with a mean age ranging from 37.3 to 52.8 years. Seventeen studies included participants with lumbosacral radicular pain with a diagnosis based on clinical assessment and 15 studies included participants with mixed duration of symptoms. The included studies were conducted mainly in North America and Europe. Fifteen studies did not report funding sources, five studies reported not receiving funding, and five reported receiving funding from a non-profit or government source. Eight trials reported data on pain intensity, 12 reported data on disability, and eight studies reported data on adverse events. The duration of the follow-up assessments ranged from 12 hours to 1 year. We considered eight trials to be of high quality because we judged them as having low risk of bias in four out of the five bias domains. We identified one ongoing trial in a trial registry.\nEpidural corticosteroid injections were probably slightly more effective compared to placebo in reducing leg pain at short-term follow-up (mean difference (MD) −4.93, 95% confidence interval (CI) −8.77 to –1.09 on a 0 to 100 scale; 8 trials, n = 949; moderate-quality evidence (downgraded for risk of bias)). For disability, epidural corticosteroid injections were probably slightly more effective compared to placebo in reducing disability at short-term follow-up (MD −4.18, 95% CI −6.04 to −2.17, on a 0 to 100 scale; 12 trials, n = 1367; moderate-quality evidence (downgraded for risk of bias)). The treatment effects are small, however, and may not be considered clinically important by patients and clinicians (i.e. MD lower than 10%).\nMost trials provided insufficient information on how or when adverse events were assessed (immediate or short-term follow-up) and only reported adverse drug reactions — that is, adverse events that the trialists attributed to the study treatment. We are very uncertain that epidural corticosteroid injections make no difference compared to placebo injection in the frequency of minor adverse events (risk ratio (RR) 1.14, 95% CI 0.91 to 1.42; 8 trials, n = 877; very low quality evidence (downgraded for risk of bias, inconsistency and imprecision)). Minor adverse events included increased pain during or after the injection, non-specific headache, post-dural puncture headache, irregular periods, accidental dural puncture, thoracic pain, non-local rash, sinusitis, vasovagal response, hypotension, nausea, and tinnitus. One study reported a major drug reaction for one patient on anticoagulant therapy who had a retroperitoneal haematoma as a complication of the corticosteroid injection.\nAuthors' conclusions\nThis study found that epidural corticosteroid injections probably slightly reduced leg pain and disability at short-term follow-up in people with lumbosacral radicular pain. In addition, no minor or major adverse events were reported at short-term follow-up after epidural corticosteroid injections or placebo injection. Although the current review identified additional clinical trials, the available evidence still provides only limited support for the use of epidural corticosteroid injections in people with lumbosacral radicular pain as the treatment effects are small, mainly evident at short-term follow-up and may not be considered clinically important by patients and clinicians (i.e. mean difference lower than 10%). According to GRADE, the quality of the evidence ranged from very low to moderate, suggesting that further studies are likely to play an important role in clarifying the efficacy and tolerability of this treatment. We recommend that further trials should attend to methodological features such as appropriate allocation concealment and blinding of care providers to minimise the potential for biased estimates of treatment and harmful effects.\n\nGiven the provided abstract, please respond to the following query: \".\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "."
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query-laysum | 2108 | [
{
"role": "user",
"content": "Abstract: Background\nPremenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.\nObjectives\nTo evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group trial register, CENTRAL (now containing output from two trials registers and CINAHL), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar, and Epistemonikos on 29 June 2022. We checked included studies' reference lists and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. The primary review outcomes were effects on premenstrual symptoms that were prospectively recorded, and withdrawal due to adverse events. Secondary outcomes included effects on mood, adverse events, and response rate to study medications.\nMain results\nWe included five RCTs (858 women analysed, most diagnosed with PMDD). The evidence was very low to moderate quality; the main limitations were serious risk of bias due to poor reporting of study methods, and serious inconsistency and imprecision.\nCOCs containing drospirenone and ethinylestradiol (EE) versus placebo\nCOCs containing drospirenone and EE may improve overall premenstrual symptoms (standardised mean difference (SMD) -0.41, 95% confidence interval (CI) -0.59 to -0.24; 2 RCTs, N = 514; I2 = 64%; low-quality evidence); and functional impairment due to premenstrual symptoms in terms of productivity (mean difference (MD) -0.31, 95% CI -0.55 to -0.08; 2 RCTs, N = 432; I2 = 47%; low-quality evidence), social activities (MD -0.29, 95% CI -0.54 to -0.04; 2 RCTs, N = 432; I2 = 53%; low-quality evidence), and relationships (MD -0.30, 95% CI -0.54 to -0.06; 2 RCTs, N = 432; I2 = 45%; low-quality evidence). The effects from COCs containing drospirenone may be small to moderate.\nCOCs containing drospirenone and EE may increase withdrawal from trials due to adverse effects (odds ratio (OR) 3.41, 95% CI 2.01 to 5.78; 4 RCT, N = 776; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of withdrawal due to adverse effects from placebo is 3%, the risk from drospirenone plus EE will be between 6% and 16%.\nWe are uncertain of the effect of drospirenone plus EE on premenstrual mood symptoms, when measured by validated tools that were not developed to assess premenstrual symptoms.\nCOCs containing drospirenone may lead to more adverse effects in total (OR 2.31, 95% CI 1.71 to 3.11; 3 RCT, N = 739; I2 = 0%; low-quality evidence). This suggests that if you assume the risk of having adverse effects from placebo is 28%, the risk from drospirenone plus EE will be between 40% and 54%. It probably leads to more breast pain, and may lead to more nausea, intermenstrual bleeding, and menstrual disorder. Its effect on nervousness, headache, asthenia, and pain is uncertain. There was no report of any rare but serious adverse effects, such as venous thromboembolism in any of the included studies.\nCOCs containing drospirenone may improve response rate (OR 1.65, 95% CI 1.13 to 2.40; 1 RCT, N = 449; I2 not applicable; low-quality evidence). This suggests that if you assume the response rate from placebo is 36%, the risk from drospirenone plus EE will be between 39% and 58%.\nWe did not identify any studies that compared COCs containing drospirenone with other COCs.\nAuthors' conclusions\nCOCs containing drospirenone and EE may improve premenstrual symptoms that result in functional impairments in women with PMDD. The placebo also had a significant effect. COCs containing drospirenone and EE may lead to more adverse effects compared to placebo. We do not know whether it works after three cycles, helps women with less severe symptoms, or is better than other combined oral contraceptives that contain a different progestogen.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found five trials with 858 women. All the trials compared a dummy pill to a drospirenone with low oestrogen pill. A majority of the women had PMDD, the severe form of PMS, before the trial. The evidence is current to June 2022."
}
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query-laysum | 2109 | [
{
"role": "user",
"content": "Abstract: Background\nOlfactory dysfunction is a common consequence of COVID-19 infection and persistent symptoms can have a profound impact on quality of life. At present there is little guidance on how best to treat this condition. A variety of interventions have been suggested to promote recovery, including medication and olfactory training. However, it is uncertain whether any intervention is of benefit. This is an update of the 2021 review with one additional study added.\nObjectives\n1) To evaluate the benefits and harms of any intervention versus no treatment for people with persisting olfactory dysfunction due to COVID-19 infection.\n2) To keep the evidence up-to-date, using a living systematic review approach.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the latest search was 20 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) in people with COVID-19 related olfactory disturbance that had persisted for at least four weeks. We included any intervention compared to no treatment or placebo.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were the recovery of sense of smell, disease-related quality of life and serious adverse effects. Secondary outcomes were the change in sense of smell, general quality of life, prevalence of parosmia and other adverse effects (including nosebleeds/bloody discharge). We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included two studies with 30 participants. The studies evaluated the following interventions: systemic corticosteroids plus intranasal corticosteroid/mucolytic/decongestant and palmitoylethanolamide plus luteolin.\nSystemic corticosteroids plus intranasal corticosteroid/mucolytic/decongestant compared to no intervention\nWe included a single RCT with 18 participants who had anosmia for at least 30 days following COVID-19 infection. Participants received a 15-day course of oral corticosteroids combined with nasal irrigation (consisting of an intranasal corticosteroid/mucolytic/decongestant solution) or no intervention. Psychophysical testing was used to assess olfactory function at 40 days. This is a single, small study and for all outcomes the certainty of evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nPalmitoylethanolamide plus luteolin compared to no intervention\nWe included a single RCT with 12 participants who had anosmia or hyposmia for at least 90 days following COVID-19 infection. Participants received a 30-day course of palmitoylethanolamide and luteolin or no intervention. Psychophysical testing was used to assess olfactory function at 30 days. This is a single, small study and for all outcomes the certainty of evidence was very low. We are unable to draw meaningful conclusions from the numerical results.\nAuthors' conclusions\nThere is very limited evidence available on the efficacy and harms of treatments for persistent olfactory dysfunction following COVID-19 infection. However, we have identified a number of ongoing trials in this area. As this is a living systematic review we will update the data regularly, as new results become available.\n\nGiven the provided abstract, please respond to the following query: \"Why this is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The sense of smell is critical to one's enjoyment of odours and tastes, and is important for safety. During the COVID-19 pandemic there has been an increasing focus on change in sense of smell as one of the early symptoms associated with infection. This can be a reduction, change or complete loss of the sense of smell. For most people this is temporary, however for some this lasts weeks or even months. If a person has lost their sense of smell for a long time (over four weeks after having COVID-19), we do not know if there are any treatments that might help it to recover."
}
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query-laysum | 2110 | [
{
"role": "user",
"content": "Abstract: Background\nA glioblastoma is a fatal type of brain tumour for which the standard of care is maximum surgical resection followed by chemoradiotherapy, when possible. Age is an important consideration in this disease, as older age is associated with shorter survival and a higher risk of treatment-related toxicity.\nObjectives\nTo determine the most effective and best-tolerated approaches for the treatment of elderly people with newly diagnosed glioblastoma. To summarise current evidence for the incremental resource use, utilities, costs and cost-effectiveness associated with these approaches.\nSearch methods\nWe searched electronic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase to 3 April 2019, and the NHS Economic Evaluation Database (EED) up to database closure. We handsearched clinical trial registries and selected neuro-oncology society conference proceedings from the past five years.\nSelection criteria\nRandomised trials (RCTs) of treatments for glioblastoma in elderly people. We defined ‘elderly' as 70+ years but included studies defining ‘elderly' as over 65+ years if so reported.\nData collection and analysis\nWe used standard Cochrane methods for study selection and data extraction. Where sufficient data were available, treatment options were compared in a network meta-analysis (NMA) using Stata software (version 15.1). For outcomes with insufficient data for NMA, pairwise meta-analysis were conducted in RevMan. The GRADE approach was used to grade the evidence.\nMain results\nWe included 12 RCTs involving approximately 1818 participants. Six were conducted exclusively among elderly people (either defined as 65 years or older or 70 years or older) with newly diagnosed glioblastoma, the other six reported data for an elderly subgroup among a broader age range of participants. Most participants were capable of self-care. Study quality was commonly undermined by lack of outcome assessor blinding and attrition. NMA was only possible for overall survival; other analyses were pair-wise meta-analyses or narrative syntheses.\nSeven trials contributed to the NMA for overall survival, with interventions including supportive care only (one trial arm); hypofractionated radiotherapy (RT40; four trial arms); standard radiotherapy (RT60; five trial arms); temozolomide (TMZ; three trial arms); chemoradiotherapy (CRT; three trial arms); bevacizumab with chemoradiotherapy (BEV_CRT; one trial arm); and bevacizumab with radiotherapy (BEV_RT). Compared with supportive care only, NMA evidence suggested that all treatments apart from BEV_RT prolonged survival to some extent.\nOverall survival\nHigh-certainty evidence shows that CRT prolongs overall survival (OS) compared with RT40 (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.56 to 0.80) and low-certainty evidence suggests that CRT may prolong overall survival compared with TMZ (TMZ versus CRT: HR 1.42, 95% CI 1.01 to 1.98). Low-certainty evidence also suggests that adding BEV to CRT may make little or no difference (BEV_CRT versus CRT: HR 0.83, 95% CrI 0.48 to 1.44). We could not compare the survival effects of CRT with different radiotherapy fractionation schedules (60 Gy/30 fractions and 40 Gy/15 fractions) due to a lack of data. When treatments were ranked according to their effects on OS, CRT ranked higher than TMZ, RT and supportive care only, with the latter ranked last. BEV plus RT was the only treatment for which there was no clear benefit in OS over supportive care only.\nOne trial comparing tumour treating fields (TTF) plus adjuvant chemotherapy (TTF_AC) with adjuvant chemotherapy alone could not be included in the NMA as participants were randomised after receiving concomitant chemoradiotherapy, not before. Findings from the trial suggest that the intervention probably improves overall survival in this selected patient population.\nWe were unable to perform NMA for other outcomes due to insufficient data. Pairwise analyses were conducted for the following.\nQuality of life\nModerate-certainty narrative evidence suggests that overall, there may be little difference in QoL between TMZ and RT, except for discomfort from communication deficits, which are probably more common with RT (1 study, 306 participants, P = 0.002). Data on QoL for other comparisons were sparse, partly due to high dropout rates, and the certainty of the evidence tended to be low or very low.\nProgression-free survival\nHigh-certainty evidence shows that CRT increases time to disease progression compared with RT40 (HR 0.50, 95% CI 0.41 to 0.61); moderate-certainty evidence suggests that RT60 probably increases time to disease progression compared with supportive care only (HR 0.28, 95% CI 0.17 to 0.46), and that BEV_RT probably increases time to disease progression compared with RT40 alone (HR 0.46, 95% CI 0.27 to 0.78). Evidence for other treatment comparisons was of low- or very low-certainty.\nSevere adverse events\nModerate-certainty evidence suggests that TMZ probably increases the risk of grade 3+ thromboembolic events compared with RT60 (risk ratio (RR) 2.74, 95% CI 1.26 to 5.94; participants = 373; studies = 1) and also the risk of grade 3+ neutropenia, lymphopenia, and thrombocytopenia. Moderate-certainty evidence also suggests that CRT probably increases the risk of grade 3+ neutropenia, leucopenia and thrombocytopenia compared with hypofractionated RT alone. Adding BEV to CRT probably increases the risk of thromboembolism (RR 16.63, 95% CI 1.00 to 275.42; moderate-certainty evidence).\nEconomic evidence\nThere is a paucity of economic evidence regarding the management of newly diagnosed glioblastoma in the elderly. Only one economic evaluation on two short course radiotherapy regimen (25 Gy versus 40 Gy) was identified and its findings were considered unreliable.\nAuthors' conclusions\nFor elderly people with glioblastoma who are self-caring, evidence suggests that CRT prolongs survival compared with RT and may prolong overall survival compared with TMZ alone. For those undergoing RT or TMZ therapy, there is probably little difference in QoL overall. Systemic anti-cancer treatments TMZ and BEV carry a higher risk of severe haematological and thromboembolic events and CRT is probably associated with a higher risk of these events. Current evidence provides little justification for using BEV in elderly patients outside a clinical trial setting. Whilst the novel TTF device appears promising, evidence on QoL and tolerability is needed in an elderly population. QoL and economic assessments of CRT versus TMZ and RT are needed. More high-quality economic evaluations are needed, in which a broader scope of costs (both direct and indirect) and outcomes should be included.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We found 12 studies evaluating different options including radiotherapy, chemotherapy, supportive (palliative) care, combinations of treatments, and a medical device that is worn on the head and emits an electric field (known as tumour treating fields). Most people enrolled in these studies did not have serious disabilities. In the NMA, we compared the effects of seven treatments on patients overall survival. All treatments tested in the NMA apart from one, in which an agent called bevacizumab (BEV) was combined with radiotherapy, clearly prolonged survival compared with supportive care only. The strongest evidence we found showed that CRT leads to a longer survival time than short-course radiotherapy only; but weaker evidence suggested that CRT also prolongs survival compared with TMZ only. When we ranked all treatments according to their effectiveness in prolonging survival time, CRT ranked higher than TMZ, RT and supportive care only, with the latter ranked last.\nA study of tumour treating fields could not be included in the NMA because it was conducted among fitter elderly patients who had already received part of their CRT. Evidence from this study suggested that adding tumour treating fields after radiotherapy probably improves survival in this fitter group of patients.\nWith regard to quality of life, evidence suggested that the impact of TMZ and radiotherapy-only treatments is probably not very different, except for greater discomfort from communication deficits with radiotherapy. Quality of life evidence was hard to interpret for other treatment options because it tended to be limited by high dropout rates, as people with glioblastoma do not live very long and may not feel like filling out questionnaires when they feel unwell.\nWith regard to other outcomes, high-certainty evidence showed that CRT delays disease progression compared with radiotherapy only. Evidence also suggested that adding BEV to short-course radiotherapy probably delays disease progression, but may not improve overall survival. TMZ and BEV are more toxic to blood cells than radiotherapy and are associated with an increased risk of blood clots and blood vessel blockages (thromboembolism)."
}
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query-laysum | 2111 | [
{
"role": "user",
"content": "Abstract: Background\nAmong people who have suffered a traumatic brain injury, increased intracranial pressure continues to be a major cause of early death; it is estimated that about 11 people per 100 with traumatic brain injury die.\nIndomethacin (also known as indometacin) is a powerful cerebral vasoconstrictor that can reduce intracranial pressure and, ultimately, restore cerebral perfusion and oxygenation. Thus, indomethacin may improve the recovery of a person with traumatic brain injury.\nObjectives\nTo assess the effects of indomethacin for adults with severe traumatic brain injury.\nSearch methods\nWe ran the searches from inception to 23 August 2019. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8) in the Cochrane Library, Ovid MEDLINE, Ovid Embase, CINAHL Plus (EBSCO), four other databases, and clinical trials registries. We also screened reference lists and conference abstracts, and contacted experts in the field.\nSelection criteria\nOur search criteria included randomised controlled trials (RCTs) that compared indomethacin with any control in adults presenting with severe traumatic brain injury associated with elevated intracranial pressure, with no previous decompressive surgery.\nData collection and analysis\nTwo review authors independently decided on the selection of the studies. We followed standard Cochrane methods.\nMain results\nWe identified no eligible studies for this review, either completed or ongoing.\nAuthors' conclusions\nWe found no studies, either completed or ongoing, that assessed the effects of indomethacin in controlling intracranial hypertension secondary to severe traumatic brain injury. Thus, we cannot draw any conclusions about the effects of indomethacin on intracranial pressure, mortality rates, quality of life, disability or adverse effects.\nThis absence of evidence should not be interpreted as evidence of no effect for indomethacin in controlling intracranial hypertension secondary to severe traumatic brain injury. It means that we have not identified eligible research for this review.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched for randomised controlled studies, which provide the most reliable evidence, up to 23 August 2019."
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query-laysum | 2112 | [
{
"role": "user",
"content": "Abstract: Background\nInsufficient consumption of fruits and vegetables in childhood increases the risk of future non-communicable diseases, including cardiovascular disease. Testing the effects of interventions to increase consumption of fruit and vegetables, including those focused on specific child-feeding strategies or broader multicomponent interventions targeting the home or childcare environment is required to assess the potential to reduce this disease burden.\nObjectives\nTo assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and two clinical trials registries to identify eligible trials on 25 January 2020. We searched Proquest Dissertations and Theses in November 2019. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included trials to identify further potentially relevant trials.\nSelection criteria\nWe included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risks of bias of included trials; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures.\nMain results\nWe included 80 trials with 218 trial arms and 12,965 participants. Fifty trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Fifteen trials examined the impact of parent nutrition education only in increasing child fruit and vegetable intake. Fourteen trials examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. Two trials examined the effect of a nutrition education intervention delivered to children in increasing child fruit and vegetable intake. One trial examined the impact of a child-focused mindfulness intervention in increasing vegetable intake.\nWe judged 23 of the 80 included trials as free from high risks of bias across all domains. Performance, detection and attrition bias were the most common domains judged at high risk of bias for the remaining trials.\nThere is low-quality evidence that child-feeding practices versus no intervention may have a small positive effect on child vegetable consumption, equivalent to an increase of 5.30 grams as-desired consumption of vegetables (SMD 0.50, 95% CI 0.29 to 0.71; 19 trials, 2140 participants; mean post-intervention follow-up = 8.3 weeks). Multicomponent interventions versus no intervention has a small effect on child consumption of fruit and vegetables (SMD 0.32, 95% CI 0.09 to 0.55; 9 trials, 2961 participants; moderate-quality evidence; mean post-intervention follow-up = 5.4 weeks), equivalent to an increase of 0.34 cups of fruit and vegetables a day. It is uncertain whether there are any short-term differences in child consumption of fruit and vegetables in meta-analyses of trials examining parent nutrition education versus no intervention (SMD 0.13, 95% CI −0.02 to 0.28; 11 trials, 3050 participants; very low-quality evidence; mean post-intervention follow-up = 13.2 weeks). We were unable to pool child nutrition education interventions in meta-analysis; both trials reported a positive intervention effect on child consumption of fruit and vegetables (low-quality evidence).\nVery few trials reported long-term effectiveness (6 trials), cost effectiveness (1 trial) or unintended adverse consequences of interventions (2 trials), limiting our ability to assess these outcomes. Trials reported receiving governmental or charitable funds, except for four trials reporting industry funding.\nAuthors' conclusions\nDespite identifying 80 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains limited in terms of quality of evidence and magnitude of effect. Of the types of interventions identified, there was moderate-quality evidence that multicomponent interventions probably lead to, and low-quality evidence that child-feeding practice may lead to, only small increases in fruit and vegetable consumption in children aged five years and under. It is uncertain whether parent nutrition education or child nutrition education interventions alone are effective in increasing fruit and vegetable consumption in children aged five years and under. Our confidence in effect estimates for all intervention approaches, with the exception of multicomponent interventions, is limited on the basis of the very low to low-quality evidence. Long-term follow-up of at least 12 months is required and future research should adopt more rigorous methods to advance the field.\nThis is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "To assess the impact of interventions designed to increase eating of fruit or vegetables or both among children aged five years and under."
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query-laysum | 2113 | [
{
"role": "user",
"content": "Abstract: Background\nOvarian cancer is seventh most common cancer in women worldwide. Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their life time. The majority of tumours arise from surface of the ovary (epithelial). Two thirds of these women will present with advanced disease, requiring aggressive treatment, which includes debulking surgery (removal of as much disease as possible) and chemotherapy. However, most women (75%) with advanced epithelial ovarian cancer (EOC) will relapse following surgery and chemotherapy. Patients who relapse are treated with either platinum or non-platinum drugs and this is dependent on the platinum-sensitivity and platinum-free interval. These drug regimens are generally well-tolerated although there are potential severe side effects. New treatments that can be used to treat recurrence or prevent disease progression after first-line or subsequent chemotherapy are important, especially those with a low toxicity profile. Hormones such as luteinising hormone releasing hormone (LHRH) agonists have been used in the treatment of relapsed EOC. Some studies have shown objective remissions, while other studies have shown little or no benefit. Most small studies report a better side-effect profile for LHRH agonists when compared to standard chemotherapeutic agents used in EOC.\nObjectives\nTo compare the effectiveness and safety of luteinising hormone releasing hormone (LHRH) agonists with chemotherapeutic agents or placebo in relapsed epithelial ovarian cancer (EOC).\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group trials register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase up to January 2016. We also searched registers of clinical trials and abstracts of scientific meetings.\nSelection criteria\nRandomised controlled trials (RCTs) that compared LHRH agonists with chemotherapeutic agents or placebo in relapsed EOC.\nData collection and analysis\nTwo review authors independently assessed whether relevant studies met the inclusion criteria, retrieved data and assessed risk of bias.\nMain results\nTwo studies, including 97 women, met our inclusion criteria: one assessed LHRH agonist (leuprorelin) use in relapsed (platinum-resistant and platinum-refractory) EOC in comparison with a chemotherapeutic agent (treosulfan) (Du Bois 2002); the other examined LHRH agonist (decapeptyl) versus a placebo (Currie 1994). Since both studies had different control groups, a meta-analysis was not possible.\nThere may be little or no difference between treatment with leuprorelin or treosulfan in overall survival (OS) (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.58 to 1.67; verylow-quality evidence) or progression-free survival (PFS) at six and 12 months (risk ratio (RR) 0.61, 95% CI 0.22 to 1.68, and RR 0.65, 95% CI 0.12 to 3.66; verylow-quality evidence), respectively (Du Bois 2002). The duration of follow-up was 2.5 years and quality of life (QoL) was not reported in this study.\nAlopecia and fatigue were probably more common with treosulfan than leuprorelin (alopecia RR 0.32, 95% CI 0.12 to 0.91 (very low-quality evidence)). There may be little or no difference in other Grade 3/4 side effects: nausea and vomiting (RR 0.65, 95% CI 0.12 to 3.66 (very low-quality evidence)); neurotoxicity (RR 0.32, 95% CI 0.01 to 7.71 (very low-quality evidence)) and neutropenia (RR 0.97, 95% 0.06 to 14.97 (very low-quality evidence)),\nThe Currie 1994 study, which compared decapeptyl treatment with placebo, reported mean PFS of 16 weeks verus 11.2 weeks, respectively. No relative effects measures or P value at a particular time point were reported. Overall survival (OS) and QoL outcomes were not reported. In addition, adverse events were only mentioned for the decapeptyl group.\nAdverse events were incompletely reported (no adverse events in decapeptyl group, but not reported for the placebo group).\nAuthors' conclusions\nBased on this review of two small RCTs, there is not enough evidence to comment on the safety and effectiveness of LHRH agonists in the treatment of platinum-refractory and platinum-resistant (relapsed) EOC. Overall, the quality of evidence for all outcomes (including OS, PFS, QoL and adverse events) is very low.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Currently, the quality of evidence is very low regarding the effectiveness and safety of LHRH agonists in women who relapse within six months of initial platinum chemotherapy treatment."
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query-laysum | 2114 | [
{
"role": "user",
"content": "Abstract: Background\nAll major guidelines for antihypertensive therapy recommend weight loss. Dietary interventions that aim to reduce body weight might therefore be a useful intervention to reduce blood pressure and adverse cardiovascular events associated with hypertension.\nObjectives\nPrimary objectives\nTo assess the long-term effects of weight-reducing diets in people with hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events).\nSecondary objectives\nTo assess the long-term effects of weight-reducing diets in people with hypertension on change from baseline in systolic blood pressure, change from baseline in diastolic blood pressure, and body weight reduction.\nSearch methods\nFor this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to April 2020: the Cochrane Hypertension Specialised Register, CENTRAL (2020, Issue 3), Ovid MEDLINE, Ovid Embase, 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 randomised controlled trials (RCTs) of at least 24 weeks' duration that compared weight-reducing dietary interventions to no dietary intervention in adults with primary hypertension.\nData collection and analysis\nTwo review authors independently assessed risks of bias and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. In case of moderate or larger heterogeneity as measured by Higgins I2, we used a random-effects model.\nMain results\nThis second review update did not reveal any new trials, so the number of included trials remains the same: eight RCTs involving a total of 2100 participants with high blood pressure and a mean age of 45 to 66 years. Mean treatment duration was 6 to 36 months. We judged the risks of bias as unclear or high for all but two trials. No study included mortality as a predefined outcome. One RCT evaluated the effects of dietary weight loss on a combined endpoint consisting of the necessity of reinstating antihypertensive therapy and severe cardiovascular complications. In this RCT, weight-reducing diet lowered the endpoint compared to no diet: hazard ratio 0.70 (95% confidence interval (CI) 0.57 to 0.87). None of the trials evaluated adverse events as designated in our protocol. The certainty of the evidence was low for a blood pressure reduction in participants assigned to weight-loss diets as compared to controls: systolic blood pressure: mean difference (MD) −4.5 mm Hg (95% CI −7.2 to −1.8 mm Hg) (3 studies, 731 participants), and diastolic blood pressure: MD −3.2 mm Hg (95% CI −4.8 to −1.5 mm Hg) (3 studies, 731 participants). We judged the certainty of the evidence to be high for weight reduction in dietary weight loss groups as compared to controls: MD −4.0 kg (95% CI −4.8 to −3.2) (5 trials, 880 participants). Two trials used withdrawal of antihypertensive medication as their primary outcome. Even though we did not consider this a relevant outcome for our review, the results of these RCTs strengthen the finding of a reduction of blood pressure by dietary weight-loss interventions.\nAuthors' conclusions\nIn this second update, the conclusions remain unchanged, as we found no new trials. In people with primary hypertension, weight-loss diets reduced body weight and blood pressure, but the magnitude of the effects are uncertain due to the small number of participants and studies included in the analyses. Whether weight loss reduces mortality and morbidity is unknown. No useful information on adverse effects was reported in the relevant trials.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found eight studies in 2100 people with high blood pressure (average age 45 to 66 years). The studies were conducted in the USA (4 studies) and Europe (4 studies), and lasted 6 months to 36 months.\nNone of the studies reported useful information about any unwanted effects of following a weight-loss diet."
}
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query-laysum | 2115 | [
{
"role": "user",
"content": "Abstract: Background\nThe use of botulinum toxin as an investigative and treatment modality for strabismus is well reported in the medical literature. However, it is unclear how effective it is in comparison with other treatment options for strabismus.\nObjectives\nThe primary objective was to examine the efficacy of botulinum toxin therapy in the treatment of strabismus compared with alternative conservative or surgical treatment options. This review sought to ascertain those types of strabismus that particularly benefit from the use of botulinum toxin as a treatment option (such as small angle strabismus or strabismus with binocular potential, i.e. the potential to use both eyes together as a pair). The secondary objectives were to investigate the dose effect and complication rates associated with botulinum toxin.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, LILACS and three trials registers on 6 July 2022, together with reference checking to identify additional studies. We did not use any date or language restrictions in the electronic searches for trials.\nSelection criteria\nWe planned to include randomized controlled trials (RCTs) comparing botulinum toxin with strabismus surgery, botulinum toxin alternatives (i.e. bupivacaine) and conservative therapy such as orthoptic exercises, prisms, or lens therapy for people of any age with strabismus. All relevant RCTs identified in this update compared botulinum toxin with strabismus surgery.\nData collection and analysis\nWe used standard methods expected by Cochrane and assessed the certainty of the body of evidence using GRADE.\nMain results\nWe included four RCTs with 242 participants that enrolled adults with esotropia or exotropia, children with acquired esotropia, and children with infantile esotropia. The follow-up period ranged from six to 36 months. Two studies were conducted in Spain, and one each in Canada and South Africa. We judged the included studies to have a mixture of low, unclear and high risk of bias. We did not consider any of the included studies to be at low risk of bias for all domains.\nAll four studies reported the proportion of participants who improved or corrected strabismus, defined as ≤ 10 prism diopters (PD) at six months (two studies) or ≤ 8 PD at one year (two studies). Low-certainty evidence suggested that participants treated with the surgery may be more likely to improve or correct strabismus compared with those who treated with botulinum toxin (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.53 to 0.99; I² = 50%; 4 studies, 242 participants; low-certainty evidence).\nOne study, which enrolled 110 children with infantile esotropia, suggested that surgery may reduce the incidence of additional surgical intervention required, but the evidence was very uncertain (RR 3.05, 95% CI 1.34 to 6.91; 1 study, 101 participants; very low-certainty evidence).\nTwo studies conducted in Spain compared botulinum toxin with surgery in children who required retreatment for acquired or infantile esotropia. These two studies provided low-certainty evidence that botulinum toxin may have little to no effect on achieving sensory fusion (RR 0.88, 95% CI 0.63 to 1.23; I² = 0%; 2 studies, 102 participants) and stereopsis (RR 0.86, 95% CI 0.59 to 1.25; I² = 0%; 2 studies, 102 participants) compared with surgery.\nThree studies reported non-serious adverse events. Partial transient ptosis (range 16.7% to 37.0%) and transient vertical deviation (range 5.6% to 18.5%) were observed among participants treated with botulinum toxin in three studies. In one study, 44.7% participants in the surgery group experienced discomfort. No studies reported serious adverse events or postintervention quality of life.\nAuthors' conclusions\nIt remains unclear whether botulinum toxin may be an alternative to strabismus surgery as an independent treatment modality among certain types of strabismus because we found only low and very low-certainty evidence in this review update.\nLow-certainty evidence suggests that strabismus surgery may be preferable to botulinum toxin injection to improve or correct strabismus when types of strabismus and different age groups are combined. We found low-certainty evidence suggesting botulinum toxin may have little to no effect on achievement of binocular single vision compared with surgery in children with acquired or infantile esotropia. We did not find sufficient evidence to draw any meaningful conclusions with respect to need for additional surgery, quality of life, and serious adverse events.\nWe identified three ongoing trials comparing botulinum toxin with conventional surgeries in the varying types of strabismus, whose results will provide relevant evidence for our stated objectives. Future trials should be rigorously designed, and investigators should analyze outcome data appropriately and report adequate information to provide evidence of high certainty. Quality of life and cost-effectiveness should be examined in addition to clinical and safety outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have little or no confidence in the evidence because there are not enough studies to be certain about the results of our outcomes, studies are small, and they are not designed and conducted well."
}
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query-laysum | 2116 | [
{
"role": "user",
"content": "Abstract: Background\nThalassaemia is a quantitative abnormality of haemoglobin caused by mutations in genes controlling production of alpha or beta globins. Abnormally unpaired globin chains cause membrane damage and cell death within organ systems and destruction of erythroid precursors in the bone marrow, leading to haemolytic anaemia. The life-long management of the general health effects of thalassaemia is highly challenging, and failure to deal with dental and orthodontic complications exacerbates the public health, financial and personal burden of the condition. There is a lack of evidence-based guidelines to help care seekers and providers manage such dental and orthodontic complications. This review aimed to evaluate the available evidence on methods for treating dental and orthodontic complications in people with thalassaemia to inform future recommendations. This is an update of a Cochrane Review first published in 2019.\nObjectives\nTo assess different methods for treating dental and orthodontic complications in people with thalassaemia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register in September 2022, and we searched nine online databases and trials registries in January 2022. We searched the reference lists of relevant articles and reviews and contacted haematologists, experts in fields of dentistry, organisations, pharmaceutical companies and researchers working in this field.\nSelection criteria\nWe searched for published or unpublished randomised controlled trials (RCTs) that evaluated treatment of dental and orthodontic complications in individuals diagnosed with thalassaemia, irrespective of phenotype, severity, age, sex and ethnic origin.\nData collection and analysis\nTwo review authors independently screened the 37,242 titles retrieved by the search. After deduplication, we identified two potentially relevant RCTs. On assessing their eligibility against our inclusion and exclusion criteria, we excluded one and included the other.\nMain results\nWe included one parallel-design RCT conducted in Saudi Arabia and involving 29 participants (19 males, 10 females) with thalassaemia. It aimed to assess the effectiveness of photodynamic therapy as an adjuvant to conventional full-mouth ultrasonic scaling for the treatment of gingivitis. The average age of participants was around 23 years.\nThere is very low-certainty evidence from this trial that full-mouth ultrasonic scaling plus photodynamic therapy compared to full-mouth ultrasonic scaling alone may improve gingival index score and bleeding on probing after 12 weeks in people with thalassaemia.\nWe found no studies that assessed other interventions for the various dental or orthodontic complications of thalassaemia.\nAuthors' conclusions\nAlthough the included study showed greater reduction in gingivitis in the group treated with full-mouth ultrasonic scaling plus photodynamic therapy, the evidence is of very low certainty. The study had unclear risk of bias, a short follow-up period and no data on safety or adverse effects. We cannot make definitive recommendations for clinical practice based on the limited evidence of a single trial. Future studies will very likely affect the conclusions of this review.\nThis review highlights the need for high-quality RCTs that investigate the effectiveness of various treatment modalities for dental and orthodontic complications in people with thalassaemia. It is crucial that future trials assess adverse effects of interventions.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that evaluated any treatment for dental or orthodontic problems in people with thalassaemia. We summarised the results and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
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query-laysum | 2117 | [
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for adults with fibromyalgia. We defined whole body vibration (WBV) exercise as use of a vertical or rotary oscillating platform as an exercise stimulus while the individual engages in sustained static positioning or dynamic movements. The individual stands on the platform, and oscillations result in vibrations transmitted to the subject through the legs. This review is one of a series of reviews that replaces the first review published in 2002.\nObjectives\nTo evaluate benefits and harms of WBV exercise training in adults with fibromyalgia.\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, CINAHL, PEDro, Thesis and Dissertation Abstracts, AMED, WHO ICTRP, and ClinicalTrials.gov up to December 2016, unrestricted by language, to identify potentially relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with the diagnosis of fibromyalgia based on published criteria including a WBV intervention versus control or another intervention. Major outcomes were health-related quality of life (HRQL), pain intensity, stiffness, fatigue, physical function, withdrawals, and adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, performed risk of bias assessments, and assessed the quality of evidence for major outcomes using the GRADE approach. We used a 15% threshold for calculation of clinically relevant differences.\nMain results\nWe included four studies involving 150 middle-aged female participants from one country. Two studies had two treatment arms (71 participants) that compared WBV plus mixed exercise plus relaxation versus mixed exercise plus relaxation and placebo WBV versus control, and WBV plus mixed exercise versus mixed exercise and control; two studies had three treatment arms (79 participants) that compared WBV plus mixed exercise versus control and mixed relaxation placebo WBV. We judged the overall risk of bias as low for selection (random sequence generation), detection (objectively measured outcomes), attrition, and other biases; as unclear for selection bias (allocation concealment); and as high for performance, detection (self-report outcomes), and selective reporting biases.\nThe WBV versus control comparison reported on three major outcomes assessed at 12 weeks post intervention based on the Fibromyalgia Impact Questionnaire (FIQ) (0 to 100 scale, lower score is better). Results for HRQL in the control group at end of treatment (59.13) showed a mean difference (MD) of -3.73 (95% confidence interval [CI] -10.81 to 3.35) for absolute HRQL, or improvement of 4% (11% better to 3% worse) and relative improvement of 6.7% (19.6% better to 6.1% worse). Results for withdrawals indicate that 14 per 100 and 10 per 100 in the intervention and control groups, respectively, withdrew from the intervention (RR 1.43, 95% CI 0.27 to 7.67; absolute change 4%, 95% CI 16% fewer to 24% more; relative change 43% more, 95% CI 73% fewer to 667% more). The only adverse event reported was acute pain in the legs, for which one participant dropped out of the program. We judged the quality of evidence for all outcomes as very low. This study did not measure pain intensity, fatigue, stiffness, or physical function. No outcomes in this comparison met the 15% threshold for clinical relevance.\nThe WBV plus mixed exercise (aerobic, strength, flexibility, and relaxation) versus control study (N = 21) evaluated symptoms at six weeks post intervention using the FIQ. Results for HRQL at end of treatment (59.64) showed an MD of -16.02 (95% CI -31.57 to -0.47) for absolute HRQL, with improvement of 16% (0.5% to 32%) and relative change in HRQL of 24% (0.7% to 47%). Data showed a pain intensity MD of -28.22 (95% CI -43.26 to -13.18) for an absolute difference of 28% (13% to 43%) and a relative change of 39% improvement (18% to 60%); as well as a fatigue MD of -33 (95% CI -49 to -16) for an absolute difference of 33% (16% to 49%) and relative difference of 47% (95% CI 23% to 60%); and a stiffness MD of -26.27 (95% CI -42.96 to -9.58) for an absolute difference of 26% (10% to 43%) and a relative difference of 36.5% (23% to 60%). All-cause withdrawals occurred in 8 per 100 and 33 per 100 withdrawals in the intervention and control groups, respectively (two studies, N = 46; RR 0.25, 95% CI 0.06 to 1.12) for an absolute risk difference of 24% (3% to 51%). One participant exhibited a mild anxiety attack at the first session of WBV. No studies in this comparison reported on physical function. Several outcomes (based on the findings of one study) in this comparison met the 15% threshold for clinical relevance: HRQL, pain intensity, fatigue, and stiffness, which improved by 16%, 39%, 46%, and 36%, respectively. We found evidence of very low quality for all outcomes.\nThe WBV plus mixed exercise versus other exercise provided very low quality evidence for all outcomes. Investigators evaluated outcomes on a 0 to 100 scale (lower score is better) for pain intensity (one study, N = 23; MD -16.36, 95% CI -29.49 to -3.23), HRQL (two studies, N = 49; MD -6.67, 95% CI -14.65 to 1.31), fatigue (one study, N = 23; MD -14.41, 95% CI -29.47 to 0.65), stiffness (one study, N = 23; MD -12.72, 95% CI -26.90 to 1.46), and all-cause withdrawal (three studies, N = 77; RR 0.72, 95% CI -0.17 to 3.11). Adverse events reported for the three studies included one anxiety attack at the first session of WBV and one dropout from the comparison group (\"other exercise group\") due to an injury that was not related to the program. No studies reported on physical function.\nAuthors' conclusions\nWhether WBV or WBV in addition to mixed exercise is superior to control or another intervention for women with fibromyalgia remains uncertain. The quality of evidence is very low owing to imprecision (few study participants and wide confidence intervals) and issues related to risk of bias. These trials did not measure major outcomes such as pain intensity, stiffness, fatigue, and physical function. Overall, studies were few and were very small, which prevented meaningful estimates of harms and definitive conclusions about WBV safety.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study that reported on this comparison provided very low-quality evidence because of study design flaws and small numbers of participants."
}
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query-laysum | 2118 | [
{
"role": "user",
"content": "Abstract: Background\nMany women experience fear of childbirth (FOC). While fears about childbirth may be normal during pregnancy, some women experience high to severe FOC. At the extreme end of the fear spectrum is tocophobia, which is considered a specific condition that may cause distress, affect well-being during pregnancy and impede the transition to parenthood. Various interventions have been trialled, which support women to reduce and manage high to severe FOC, including tocophobia.\nObjectives\nTo investigate the effectiveness of non-pharmacological interventions for reducing fear of childbirth (FOC) compared with standard maternity care in pregnant women with high to severe FOC, including tocophobia.\nSearch methods\nIn July 2020, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies. We contacted researchers of trials which were registered and appeared to be ongoing.\nSelection criteria\nWe included randomised clinical trials which recruited pregnant women with high or severe FOC (as defined by the individual trial), for treatment intended to reduce FOC. Two review authors independently screened and selected titles and abstracts for inclusion. We excluded quasi-randomised and cross-over trials.\nData collection and analysis\nWe used standard methodological approaches as recommended by Cochrane. Two review authors independently extracted data and assessed the studies for risk of bias. A third review author checked the data analysis for accuracy. We used GRADE to assess the certainty of the evidence. The primary outcome was a reduction in FOC. Secondary outcomes were caesarean section, depression, birth preference for caesarean section or spontaneous vaginal delivery, and epidural use.\nMain results\nWe included seven trials with a total of 1357 participants. The interventions included psychoeducation, cognitive behavioural therapy, group discussion, peer education and art therapy.\nWe judged four studies as high or unclear risk of bias in terms of allocation concealment; we judged three studies as high risk in terms of incomplete outcome data; and in all studies, there was a high risk of bias due to lack of blinding. We downgraded the certainty of the evidence due to concerns about risk of bias, imprecision and inconsistency. None of the studies reported data about women's anxiety.\nParticipating in non-pharmacological interventions may reduce levels of fear of childbirth, as measured by the Wijma Delivery Expectancy Questionnaire (W-DEQ), but the reduction may not be clinically meaningful (mean difference (MD) -7.08, 95% confidence interval (CI) -12.19 to -1.97; 7 studies, 828 women; low-certainty evidence). The W-DEQ tool is scored from 0 to 165 (higher score = greater fear).\nNon-pharmacological interventions probably reduce the number of women having a caesarean section (RR 0.70, 95% CI 0.55 to 0.89; 5 studies, 557 women; moderate-certainty evidence).\nThere may be little to no difference between non-pharmacological interventions and usual care in depression scores measured with the Edinburgh Postnatal Depression Scale (EPDS) (MD 0.09, 95% CI -1.23 to 1.40; 2 studies, 399 women; low-certainty evidence). The EPDS tool is scored from 0 to 30 (higher score = greater depression).\nNon-pharmacological interventions probably lead to fewer women preferring a caesarean section (RR 0.37, 95% CI 0.15 to 0.89; 3 studies, 276 women; moderate-certainty evidence).\nNon-pharmacological interventions may increase epidural use compared with usual care, but the 95% CI includes the possibility of a slight reduction in epidural use (RR 1.21, 95% CI 0.98 to 1.48; 2 studies, 380 women; low-certainty evidence).\nAuthors' conclusions\nThe effect of non-pharmacological interventions for women with high to severe fear of childbirth in terms of reducing fear is uncertain. Fear of childbirth, as measured by W-DEQ, may be reduced but it is not certain if this represents a meaningful clinical reduction of fear. There may be little or no difference in depression, but there may be a reduction in caesarean section delivery. Future trials should recruit adequate numbers of women and measure birth satisfaction and anxiety.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence in this review is up to date to July 2020."
}
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query-laysum | 2119 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pain is a major health and socioeconomic burden, which is prevalent in children and adolescents. Among the most widely used interventions in children and adolescents are physical activity (including exercises) and education about physical activity.\nObjectives\nTo evaluate the effectiveness of physical activity, education about physical activity, or both, compared with usual care (including waiting-list, and minimal interventions, such as advice, relaxation classes, or social group meetings) or active medical care in children and adolescents with chronic musculoskeletal pain.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PEDro, and LILACS from the date of their inception to October 2022. We also searched the reference lists of eligible papers, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared physical activity or education about physical activity, or both, with usual care (including waiting-list and minimal interventions) or active medical care, in children and adolescents with chronic musculoskeletal pain.\nData collection and analysis\nTwo review authors independently determined the eligibility of the included studies. Our primary outcomes were pain intensity, disability, and adverse events. Our secondary outcomes were depression, anxiety, fear avoidance, quality of life, physical activity level, and caregiver distress. We extracted data at postintervention assessment, and long-term follow-up. Two review authors independently assessed risk of bias for each study, using the RoB 1. We assessed the overall certainty of the evidence using the GRADE approach. We reported continuous outcomes as mean differences, and determined clinically important differences from the literature, or 10% of the scale.\nMain results\nWe included four studies (243 participants with juvenile idiopathic arthritis). We judged all included studies to be at unclear risk of selection bias, performance bias, and detection bias, and at high risk of attrition bias. We downgraded the certainty of the evidence for each outcome to very low due to serious or very serious study limitations, inconsistency, and imprecision.\nPhysical activity compared with usual care\nPhysical activity may slightly reduce pain intensity (0 to 100 scale; 0 = no pain) compared with usual care at postintervention (standardised mean difference (SMD) -0.45, 95% confidence interval (CI) -0.82 to -0.08; 2 studies, 118 participants; recalculated as a mean difference (MD) -12.19, 95% CI -21.99 to -2.38; I² = 0%; very low-certainty evidence). Physical activity may slightly improve disability (0 to 3 scale; 0 = no disability) compared with usual care at postintervention assessment (MD -0.37, 95% CI -0.56 to -0.19; I² = 0%; 3 studies, 170 participants; very low-certainty evidence). We found no clear evidence of a difference in quality of life (QoL; 0 to 100 scale; lower scores = better QoL) between physical activity and usual care at postintervention assessment (SMD -0.46, 95% CI -1.27 to 0.35; 4 studies, 201 participants; very low-certainty evidence; recalculated as MD -6.30, 95% CI -18.23 to 5.64; I² = 91%).\nNone of the included studies measured adverse events, depression, or anxiety for this comparison.\nPhysical activity compared with active medical care\nWe found no studies that could be analysed in this comparison.\nEducation about physical activity compared with usual care or active medical care\nWe found no studies that could be analysed in this comparison.\nPhysical activity and education about physical activity compared with usual care or active medical care\nWe found no studies that could be analysed in this comparison.\nAuthors' conclusions\nWe are unable to confidently state whether interventions based on physical activity and education about physical activity are more effective than usual care for children and adolescents with chronic musculoskeletal pain.\nWe found very low-certainty evidence that physical activity may reduce pain intensity and improve disability postintervention compared with usual care, for children and adolescents with juvenile idiopathic arthritis.\nWe did not find any studies reporting educational interventions; it remains unknown how these interventions influence the outcomes in children and adolescents with chronic musculoskeletal pain.\nTreatment decisions should consider the current best evidence, the professional's experience, and the young person's preferences.\nFurther randomised controlled trials in other common chronic musculoskeletal pain conditions, with high methodological quality, large sample size, and long-term follow-up are urgently needed.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if physical activity, education about physical activity, or both, was better than usual care or medical care treatment (also known as active medical care) for improving:\n- Pain\n- Disability\n- Quality of life\nWe also wanted to find out if physical activity, education about physical activity, or both, led to any unwanted side effects."
}
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query-laysum | 2120 | [
{
"role": "user",
"content": "Abstract: Background\nBypass surgery using a large saphenous vein graft, or another autologous venous graft, is a well-recognised treatment option for managing peripheral arterial disease of the lower limb, including chronic limb-threatening ischaemia (CLTI) and intermittent claudication, peripheral limb aneurysms, and major limb arterial trauma. Bypass surgery has good results in terms of limb preservation rates and long-term graft patency but is limited by the possibility of vein graft failure due to stenoses of the graft. Detection of stenoses through clinical and ultrasonographic surveillance, followed by treatment, is used to avoid graft occlusion. The conventional approach to treatment of patients with graft stenosis following infrainguinal bypass consists of open surgical repair, which usually is performed under general anaesthesia. Endoluminal treatment with angioplasty is less invasive and uses local anaesthesia. Both methods aim to improve blood flow to the limb.\nObjectives\nTo assess the effectiveness of endoluminal interventions versus surgical intervention for people with vein graft stenosis following infrainguinal bypass.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to 25 August 2020.\nSelection criteria\nWe aimed to include all published and unpublished randomised controlled trials (RCTs) that compared endoluminal interventions versus surgical intervention for people with vein graft stenosis following infrainguinal bypass.\nData collection and analysis\nTwo review authors independently assessed all identified studies for potential inclusion in the review. We aimed to use standard methodological procedures in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. The main outcomes of interest were primary patency, primary assisted patency, and all-cause mortality.\nMain results\nWe identified no RCTs that met the inclusion criteria for this review.\nAuthors' conclusions\nWe found no RCTs that compared endoluminal interventions versus surgical intervention for stenosis in vein grafts following infrainguinal bypass. Currently, there is no high-certainty evidence to support the use of one type of intervention over another. High-quality studies are needed to provide evidence on managing vein graft stenosis following infrainguinal bypass.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics and key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence that directly compared endoluminal interventions with open surgical intervention for stenosis in vein grafts following infrainguinal bypass (good to 25 August 2020). We did not find any randomised controlled trials (clinical studies in which people are divided by chance between two or more treatment groups) on this topic. Further research is needed to help vascular and endovascular surgeons and their patients in choosing the best option for treatment of vein graft stenosis following leg bypass."
}
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query-laysum | 2121 | [
{
"role": "user",
"content": "Abstract: Background\nHealth care-associated infection is a major cause of morbidity and mortality. Hand hygiene is regarded as an effective preventive measure. This is an update of a previously published review.\nObjectives\nTo assess the short- and long-term success of strategies to improve compliance to recommendations for hand hygiene, and to determine whether an increase in hand hygiene compliance can reduce rates of health care-associated infection.\nSearch methods\nWe conducted electronic searches of the Cochrane Register of Controlled Trials, PubMed, Embase, and CINAHL. We conducted the searches from November 2009 to October 2016.\nSelection criteria\nWe included randomised trials, non-randomised trials, controlled before-after studies, and interrupted time series analyses (ITS) that evaluated any intervention to improve compliance with hand hygiene using soap and water or alcohol-based hand rub (ABHR), or both.\nData collection and analysis\nTwo review authors independently screened citations for inclusion, extracted data, and assessed risks of bias for each included study. Meta-analysis was not possible, as there was substantial heterogeneity across studies. We assessed the certainty of evidence using the GRADE approach and present the results narratively in a 'Summary of findings' table.\nMain results\nThis review includes 26 studies: 14 randomised trials, two non-randomised trials and 10 ITS studies. Most studies were conducted in hospitals or long-term care facilities in different countries, and collected data from a variety of healthcare workers. Fourteen studies assessed the success of different combinations of strategies recommended by the World Health Organization (WHO) to improve hand hygiene compliance. Strategies consisted of the following: increasing the availability of ABHR, different types of education for staff, reminders (written and verbal), different types of performance feedback, administrative support, and staff involvement. Six studies assessed different types of performance feedback, two studies evaluated education, three studies evaluated cues such as signs or scent, and one study assessed placement of ABHR. Observed hand hygiene compliance was measured in all but three studies which reported product usage. Eight studies also reported either infection or colonisation rates. All studies had two or more sources of high or unclear risks of bias, most often associated with blinding or independence of the intervention.\nMultimodal interventions that include some but not all strategies recommended in the WHO guidelines may slightly improve hand hygiene compliance (five studies; 56 centres) and may slightly reduce infection rates (three studies; 34 centres), low certainty of evidence for both outcomes.\nMultimodal interventions that include all strategies recommended in the WHO guidelines may slightly reduce colonisation rates (one study; 167 centres; low certainty of evidence). It is unclear whether the intervention improves hand hygiene compliance (five studies; 184 centres) or reduces infection (two studies; 16 centres) because the certainty of this evidence is very low.\nMultimodal interventions that contain all strategies recommended in the WHO guidelines plus additional strategies may slightly improve hand hygiene compliance (six studies; 15 centres; low certainty of evidence). It is unclear whether this intervention reduces infection rates (one study; one centre; very low certainty of evidence).\nPerformance feedback may improve hand hygiene compliance (six studies; 21 centres; low certainty of evidence). This intervention probably slightly reduces infection (one study; one centre) and colonisation rates (one study; one centre) based on moderate certainty of evidence.\nEducation may improve hand hygiene compliance (two studies; two centres), low certainty of evidence.\nCues such as signs or scent may slightly improve hand hygiene compliance (three studies; three centres), low certainty of evidence.\nPlacement of ABHR close to point of use probably slightly improves hand hygiene compliance (one study; one centre), moderate certainty of evidence.\nAuthors' conclusions\nWith the identified variability in certainty of evidence, interventions, and methods, there remains an urgent need to undertake methodologically robust research to explore the effectiveness of multimodal versus simpler interventions to increase hand hygiene compliance, and to identify which components of multimodal interventions or combinations of strategies are most effective in a particular context.\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 included 26 studies in the review. Fourteen studies assessed the success of different combinations of strategies recommended by WHO to improve hand hygiene compliance. Strategies consisted of the following: increasing the availability of alcohol-based hand hygiene products, different types of education for staff, reminders (written and verbal), different types of performance feedback, administrative support and staff involvement. Six studies assessed different types of performance feedback, two studies evaluated education, three studies evaluated cues such as signs or scent, and one study assessed placement of ABHR.\nMultimodal (combinations of) strategies that include some but not all strategies recommended by WHO may slightly improve hand hygiene compliance and slightly reduce infection rates (low certainty of evidence). Multimodal interventions that include all strategies recommended by WHO may lead to little or no difference in methicillin-resistant Staphylococcus aureus (MRSA) infection rates (low certainty of evidence), but it is uncertain whether such WHO-based approaches improve hand hygiene compliance or reduce colonisation rates because the certainty of this evidence is very low. Multimodal interventions that contain all recommended strategies plus additional strategies may slightly improve hand hygiene compliance (low certainty of evidence). It is unclear whether such WHO-enhanced interventions reduce infection rates because the certainty of this evidence is very low.\nPerformance feedback may improve hand hygiene compliance (low certainty of evidence) and probably slightly reduces infection and colonisation rates (moderate certainty of evidence). Education may improve hand hygiene compliance (low certainty of evidence). Cues, such as signs or scent, may slightly improve hand hygiene compliance (low certainty of evidence). Placement of ABHR close to the point of use probably slightly improves hand hygiene compliance (moderate certainty of evidence)."
}
]
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query-laysum | 2122 | [
{
"role": "user",
"content": "Abstract: Background\nOne to eight per cent of women suffer third-degree perineal tear (anal sphincter injury) and fourth-degree perineal tear (rectal mucosa injury) during vaginal birth, and these tears are more common after forceps delivery (28%) and midline episiotomies. Third- and fourth-degree tears can become contaminated with bacteria from the rectum and this significantly increases in the chance of perineal wound infection. Prophylactic antibiotics might have a role in preventing this infection.\nObjectives\nTo assess the effectiveness of antibiotic prophylaxis for reducing maternal morbidity and side effects in third- and fourth-degree perineal tear during vaginal birth.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2014) and the reference lists of retrieved articles.\nSelection criteria\nRandomised controlled trials comparing outcomes of prophylactic antibiotics versus placebo or no antibiotics in third- and fourth-degree perineal tear during vaginal birth.\nData collection and analysis\nTwo review authors independently assessed the trial reports for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nWe identified and included one trial (147 women from a pre-planned sample size of 310 women) that compared the effect of prophylactic antibiotic (single-dose, second-generation cephalosporin - cefotetan or cefoxitin, 1 g intravenously) on postpartum perineal wound complications in third- or fourth-degree perineal tears compared with placebo. Perineal wound complications (wound disruption and purulent discharge) at the two-week postpartum check up were 8.20% and 24.10% in the treatment and the control groups respectively (risk ratio (RR) 0.34, 95% confidence interval (CI) 0.12 to 0.96). However, the high failed-appointment rate may limit the generalisability of the results. The overall risk of bias was low except for incomplete outcome data. The quality of the evidence using GRADE was moderate for infection rate at two weeks' postpartum, and low for infection rate at six weeks' postpartum.\nAuthors' conclusions\nAlthough the data suggest that prophylactic antibiotics help to prevent perineal wound complications following third- or fourth-degree perineal tear, loss to follow-up was very high. The results should be interpreted with caution as they are based on one small trial.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To assess how effective antibiotic prophylaxis is to prevent perineal wound infection compared with placebo or no treatment to prevent perineal wound infection and to compare different antibiotic regimens."
}
]
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query-laysum | 2123 | [
{
"role": "user",
"content": "Abstract: Background\nUnilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects presented on the side contralateral to the lesioned side of the brain and has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Pharmacological interventions (medical interventions only, use of drugs to improve the health condition), such as dopamine and noradrenergic agonists or pro-cholinergic treatment, have been used in people affected by USN after stroke, and effects of these treatments could provide new insights for health professionals and policy makers.\nObjectives\nTo evaluate the effectiveness and safety of pharmacological interventions for USN after stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (April 2015), the Cochrane Central Register of Controlled Trials (April 2015), MEDLINE (1946 to April 2015), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to April 2015), EMBASE (1980 to April 2015), PsycINFO (1806 to April 2015) and Latin American Caribbean Health Sciences Literature (LILACS) (1982 to April 2015). We also searched trials and research registers, screened reference lists, and contacted study authors and pharmaceutical companies (April 2015).\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) of pharmacological interventions for USN after stroke.\nData collection and analysis\nTwo review authors independently assessed risk of bias in the included studies and extracted data.\nMain results\nWe included in the review two studies with a total of 30 randomly assigned participants. We rated the quality of the evidence as very low as the result of study limitations, small numbers of events, and small sample sizes, with imprecision in the confidence interval (CI). We were not able to perform meta-analysis because of heterogeneity related to the different interventions evaluated between included studies. Very low-quality evidence from one trial (20 participants) comparing effects of rivastigmine plus rehabilitation versus rehabilitation on overall USN at discharge showed the following: Barrage (mean difference (MD) 0.30, 95% confidence interval (CI) -0.18 to 0.78); Letter Cancellation (MD 10.60, 95% CI 2.07 to 19.13); Sentence Reading (MD 0.20, 95% CI -0.69 to 1.09), and the Wundt-Jastrow Area Illusion Test (MD -4.40, 95% CI -8.28 to -0.52); no statistical significance was observed for the same outcomes at 30 days' follow-up. In another trial (10 participants), study authors showed statistically significant reduction in omissions in the three cancellation tasks under transdermal nicotine treatment (mean number of omissions 2.93 ± 0.5) compared with both baseline (4.95 ± 0.8) and placebo (5.14 ± 0.9) (main effect of treatment condition: F (2.23) = 11.06; P value < 0.0001). One major adverse event occurred in the transdermal nicotine treatment group, and treatment was discontinued in the affected participant. None of the included trials reported data on several of the prespecified outcomes (falls, balance, depression or anxiety, poststroke fatigue, and quality of life).\nAuthors' conclusions\nThe quality of the evidence from available RCTs was very low. The effectiveness and safety of pharmacological interventions for USN after stroke are therefore uncertain. Additional large RCTs are needed to evaluate these treatments.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We considered the quality of included studies to be reasonable. Given the small sample size and methodological limitations (participants were assigned in a successive manner in one study), no conclusions can be drawn regarding the effectiveness of pharmacological medications in USN after stroke."
}
]
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query-laysum | 2124 | [
{
"role": "user",
"content": "Abstract: Background\nCollective leadership is strongly advocated by international stakeholders as a key approach for health service delivery, as a response to increasingly complex forms of organisation defined by rapid changes in health technology, professionalisation and growing specialisation. Inadequate leadership weakens health systems and can contribute to adverse events, including refusal to prioritise and implement safety recommendations consistently, and resistance to addressing staff burnout. Globally, increases in life expectancy and the number of people living with multiple long-term conditions contribute to greater complexity of healthcare systems. Such a complex environment requires the contribution and leadership of multiple professionals sharing viewpoints and knowledge.\nObjectives\nTo assess the effects of collective leadership for healthcare providers on professional practice, healthcare outcomes and staff well-being, when compared with usual centralised leadership approaches.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, five other databases and two trials registers on 5 January 2021. We also searched grey literature, checked references for additional citations and contacted study authors to identify additional studies. We did not apply any limits on language.\nSelection criteria\nTwo groups of two authors independently reviewed, screened and selected studies for inclusion; the principal author was part of both groups to ensure consistency. We included randomised controlled trials (RCTs) that compared collective leadership interventions with usual centralised leadership or no intervention.\nData collection and analysis\nThree groups of two authors independently extracted data from the included studies and evaluated study quality; the principal author took part in all groups. We followed standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care (EPOC) Group. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe identified three randomised trials for inclusion in our synthesis. All studies were conducted in acute care inpatient settings; the country settings were Canada, Iran and the USA. A total of 955 participants were included across all the studies. There was considerable variation in participants, interventions and measures for quantifying outcomes. We were only able to complete a meta-analysis for one outcome (leadership) and completed a narrative synthesis for other outcomes. We judged all studies as having an unclear risk of bias overall.\nCollective leadership interventions probably improve leadership (3 RCTs, 955 participants). Collective leadership may improve team performance (1 RCT, 164 participants). We are uncertain about the effect of collective leadership on clinical performance (1 RCT, 60 participants). We are uncertain about the intervention effect on healthcare outcomes, including health status (inpatient mortality) (1 RCT, 60 participants). Collective leadership may slightly improve staff well-being by reducing work-related stress (1 RCT, 164 participants). We identified no direct evidence concerning burnout and psychological symptoms. We are uncertain of the intervention effects on unintended consequences, specifically on staff absence (1 RCT, 60 participants).\nAuthors' conclusions\nCollective leadership involves multiple professionals sharing viewpoints and knowledge with the potential to influence positively the quality of care and staff well-being. Our confidence in the effects of collective leadership interventions on professional practice, healthcare outcomes and staff well-being is moderate in leadership outcomes, low in team performance and work-related stress, and very low for clinical performance, inpatient mortality and staff absence outcomes. The evidence was of moderate, low and very low certainty due to risk of bias and imprecision, meaning future evidence may change our interpretation of the results. There is a need for more high-quality studies in this area, with consistent reporting of leadership, team performance, clinical performance, health status and staff well-being outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found three relevant studies (955 participants). The studies were carried out in hospitals in Canada, Iran and the USA. Collective leadership interventions probably improve leadership (3 studies, 955 participants), may improve teamwork (1 study, 164 participants), and may slightly decrease work-related stress (1 study, 164 participants). We do not know if collective leadership has an effect on these outcomes: clinical performance (1 study, 60 participants), inpatient deaths (1 study, 60 participants), and staff absence (1 study, 60 participants)."
}
]
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query-laysum | 2125 | [
{
"role": "user",
"content": "Abstract: Background\nPeople living in humanitarian settings in low- and middle-income countries (LMICs) are exposed to a constellation of stressors that make them vulnerable to developing mental disorders. Mental disorders with a higher prevalence in these settings include post-traumatic stress disorder (PTSD) and major depressive, anxiety, somatoform (e.g. medically unexplained physical symptoms (MUPS)), and related disorders. A range of psychological therapies are used to manage symptoms of mental disorders in this population.\nObjectives\nTo compare the effectiveness and acceptability of psychological therapies versus control conditions (wait list, treatment as usual, attention placebo, psychological placebo, or no treatment) aimed at treating people with mental disorders (PTSD and major depressive, anxiety, somatoform, and related disorders) living in LMICs affected by humanitarian crises.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), the Cochrane Central Register of Controlled Trials (Wiley), MEDLINE (OVID), Embase (OVID), and PsycINFO (OVID), with results incorporated from searches to 3 February 2016. We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov to identify any unpublished or ongoing studies. We checked the reference lists of relevant studies and reviews.\nSelection criteria\nAll randomised controlled trials (RCTs) comparing psychological therapies versus control conditions (including no treatment, usual care, wait list, attention placebo, and psychological placebo) to treat adults and children with mental disorders living in LMICs affected by humanitarian crises.\nData collection and analysis\nWe used standard Cochrane procedures for collecting data and evaluating risk of bias. We calculated standardised mean differences for continuous outcomes and risk ratios for dichotomous data, using a random-effects model. We analysed data at endpoint (zero to four weeks after therapy); at medium term (one to four months after therapy); and at long term (six months or longer). GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) was used to assess the quality of evidence for post-traumatic stress disorder (PTSD), depression, anxiety and withdrawal outcomes.\nMain results\nWe included 36 studies (33 RCTs) with a total of 3523 participants. Included studies were conducted in sub-Saharan Africa, the Middle East and North Africa, and Asia. Studies were implemented in response to armed conflicts; disasters triggered by natural hazards; and other types of humanitarian crises. Together, the 33 RCTs compared eight psychological treatments against a control comparator.\nFour studies included children and adolescents between 5 and 18 years of age. Three studies included mixed populations (two studies included participants between 12 and 25 years of age, and one study included participants between 16 and 65 years of age). Remaining studies included adult populations (18 years of age or older).\nIncluded trials compared a psychological therapy versus a control intervention (wait list in most studies; no treatment; treatment as usual). Psychological therapies were categorised mainly as cognitive-behavioural therapy (CBT) in 23 comparisons (including seven comparisons focused on narrative exposure therapy (NET), two focused on common elements treatment approach (CETA), and one focused on brief behavioural activation treatment (BA)); eye movement desensitisation and reprocessing (EMDR) in two comparisons; interpersonal psychotherapy (IPT) in three comparisons; thought field therapy (TFT) in three comparisons; and trauma or general supportive counselling in two comparisons. Although interventions were described under these categories, several psychotherapeutic elements were common to a range of therapies (i.e. psychoeducation, coping skills).\nIn adults, psychological therapies may substantially reduce endpoint PTSD symptoms compared to control conditions (standardised mean difference (SMD) -1.07, 95% confidence interval (CI) -1.34 to -0.79; 1272 participants; 16 studies; low-quality evidence). The effect is smaller at one to four months (SMD -0.49, 95% CI -0.68 to -0.31; 1660 participants; 18 studies) and at six months (SMD -0.37, 95% CI -0.61 to -0.14; 400 participants; five studies). Psychological therapies may also substantially reduce endpoint depression symptoms compared to control conditions (SMD -0.86, 95% CI -1.06 to -0.67; 1254 participants; 14 studies; low-quality evidence). Similar to PTSD symptoms, follow-up data at one to four months showed a smaller effect on depression (SMD -0.42, 95% CI -0.63 to -0.21; 1386 participants; 16 studies). Psychological therapies may moderately reduce anxiety at endpoint (SMD -0.74, 95% CI -0.98 to -0.49; 694 participants; five studies; low-quality evidence) and at one to four months' follow-up after treatment (SMD -0.53, 95% CI -0.66 to -0.39; 969 participants; seven studies). Dropout rates are probably similar between study conditions (19.5% with control versus 19.1% with psychological therapy (RR 0.98 95% CI 0.82 to 1.16; 2930 participants; 23 studies, moderate quality evidence)).\nIn children and adolescents, we found very low quality evidence for lower endpoint PTSD symptoms scores in psychotherapy conditions (CBT) compared to control conditions, although the confidence interval is wide (SMD -1.56, 95% CI -3.13 to 0.01; 130 participants; three studies;). No RCTs provided data on major depression or anxiety in children. The effect on withdrawal was uncertain (RR 1.87 95% CI 0.47 to 7.47; 138 participants; 3 studies, low quality evidence).\nWe did not identify any studies that evaluated psychological treatments on (symptoms of) somatoform disorders or MUPS in LMIC humanitarian settings.\nAuthors' conclusions\nThere is low quality evidence that psychological therapies have large or moderate effects in reducing PTSD, depressive, and anxiety symptoms in adults living in humanitarian settings in LMICs. By one to four month and six month follow-up assessments treatment effects were smaller. Fewer trials were focused on children and adolescents and they provide very low quality evidence of a beneficial effect of psychological therapies in reducing PTSD symptoms at endpoint. Confidence in these findings is influenced by the risk of bias in the studies and by substantial levels of heterogeneity. More research evidence is needed, particularly for children and adolescents over longer periods of follow-up.\n\nGiven the provided abstract, please respond to the following query: \"Which studies were included in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors searched databases up to February 2016 to find and include all relevant published and unpublished trials. Studies had to include children and/or adults living in LMICs affected by humanitarian crises. Studies also had to be randomised controlled trials (RCTs), which means that people were allocated at random (by chance alone) to receive the treatment or comparator condition.\nWe included 33 trials with a total of 3523 participants that examined a range of psychological therapies."
}
]
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