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query-laysum | 1417 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original review published in the Cochrane Database of Systematic Reviews Issue 10, 2015.\nInvasive aspergillosis (IA) is the most common life-threatening opportunistic invasive mould infection in immunocompromised people. Early diagnosis of IA and prompt administration of appropriate antifungal treatment are critical to the survival of people with IA. Antifungal drugs can be given as prophylaxis or empirical therapy, instigated on the basis of a diagnostic strategy (the pre-emptive approach) or for treating established disease. Consequently, there is an urgent need for research into both new diagnostic tools and drug treatment strategies. Increasingly, newer methods such as polymerase chain reaction (PCR) to detect fungal nucleic acids are being investigated.\nObjectives\nTo provide an overall summary of the diagnostic accuracy of PCR-based tests on blood specimens for the diagnosis of IA in immunocompromised people.\nSearch methods\nWe searched MEDLINE (1946 to June 2015) and Embase (1980 to June 2015). We also searched LILACS, DARE, Health Technology Assessment, Web of Science and Scopus to June 2015. We checked the reference lists of all the studies identified by the above methods and contacted relevant authors and researchers in the field. For this review update we updated electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid (June 2015 to March week 2 2018); and Embase via Ovid (June 2015 to 2018 week 12).\nSelection criteria\nWe included studies that: i) compared the results of blood PCR tests with the reference standard published by the European Organisation for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG); ii) reported data on false-positive, true-positive, false-negative and true-negative results of the diagnostic tests under investigation separately; and iii) evaluated the test(s) prospectively in cohorts of people from a relevant clinical population, defined as a group of individuals at high risk for invasive aspergillosis. Case-control and retrospective studies were excluded from the analysis.\nData collection and analysis\nAuthors independently assessed quality and extracted data. For PCR assays, we evaluated the requirement for either one or two consecutive samples to be positive for diagnostic accuracy. We investigated heterogeneity by subgroup analyses. We plotted estimates of sensitivity and specificity from each study in receiver operating characteristics (ROC) space and constructed forest plots for visual examination of variation in test accuracy. We performed meta-analyses using the bivariate model to produce summary estimates of sensitivity and specificity.\nMain results\nWe included 29 primary studies (18 from the original review and 11 from this update), corresponding to 34 data sets, published between 2000 and 2018 in the meta-analyses, with a mean prevalence of proven or probable IA of 16.3 (median prevalence 11.1% , range 2.5% to 57.1%). Most patients had received chemotherapy for haematological malignancy or had undergone hematopoietic stem cell transplantation. Several PCR techniques were used among the included studies. The sensitivity and specificity of PCR for the diagnosis of IA varied according to the interpretative criteria used to define a test as positive. The summary estimates of sensitivity and specificity were 79.2% (95% confidence interval (CI) 71.0 to 85.5) and 79.6% (95% CI 69.9 to 86.6) for a single positive test result, and 59.6% (95% CI 40.7 to 76.0) and 95.1% (95% CI 87.0 to 98.2) for two consecutive positive test results.\nAuthors' conclusions\nPCR shows moderate diagnostic accuracy when used as screening tests for IA in high-risk patient groups. Importantly the sensitivity of the test confers a high negative predictive value (NPV) such that a negative test allows the diagnosis to be excluded. Consecutive positives show good specificity in diagnosis of IA and could be used to trigger radiological and other investigations or for pre-emptive therapy in the absence of specific radiological signs when the clinical suspicion of infection is high. When a single PCR positive test is used as the diagnostic criterion for IA in a population of 100 people with a disease prevalence of 16.3% (overall mean prevalence), three people with IA would be missed (sensitivity 79.2%, 20.8% false negatives), and 17 people would be unnecessarily treated or referred for further tests (specificity of 79.6%, 21.4% false positives). If we use the two positive test requirement in a population with the same disease prevalence, it would mean that nine IA people would be missed (sensitivity 59.6%, 40.4% false negatives) and four people would be unnecessarily treated or referred for further tests (specificity of 95.1%, 4.9% false positives). Like galactomannan, PCR has good NPV for excluding disease, but the low prevalence of disease limits the ability to rule in a diagnosis. As these biomarkers detect different markers of disease, combining them is likely to prove more useful.\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": "Several PCR techniques were used in the studies. Pooling the data from the studies showed that sensitivity and specificity of PCR for the diagnosis of IA varied (from 59% to 79.2% and from 79% to 95.2%, respectively) depending on the interpretative criteria used to define a test as positive. When used as a diagnostic criterion for IA in a population of 100 people with a disease prevalence of 16.3% (overall mean prevalence), a single PCR positive test would have missed three people with the disease, and falsely classified 17 people as having the disease, who would be treated unnecessarily or referred for further tests. A requirement of two positive tests as a diagnostic criterion in a population with the same disease prevalence would miss nine people with the disease and falsely classify four people as having the disease. These numbers should be interpreted with caution because the reference standard is based on the degree of certainty of diagnosis and is rarely proven so cannot provide consistent assessment of cases as being IA or not.\nOverall, PCR shows moderate diagnostic accuracy when used as a screening test for IA in high-risk patient groups. Importantly, when the rate of sensitivity is low, the sensitivity of the tests means that a negative result allows the diagnosis to be excluded with confidence except when the patient is receiving certain antifungal drugs. With the low prevalence of the disease, a high negative predictive value such that a negative test allows the diagnosis to be excluded."
}
]
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query-laysum | 1418 | [
{
"role": "user",
"content": "Abstract: Background\nLung volume reduction surgery (LVRS) performed to treat patients with severe diffuse emphysema was reintroduced in the nineties. Lung volume reduction surgery aims to resect damaged emphysematous lung tissue, thereby increasing elastic properties of the lung. This treatment is hypothesised to improve long-term daily functioning and quality of life, although it may be costly and may be associated with risks of morbidity and mortality. Ten years have passed since the last version of this review was prepared, prompting us to perform an update.\nObjectives\nThe objective of this review was to gather all available evidence from randomised controlled trials comparing the effectiveness of lung volume reduction surgery (LVRS) versus non-surgical standard therapy in improving health outcomes for patients with severe diffuse emphysema. Secondary objectives included determining which subgroup of patients benefit from LVRS and for which patients LVRS is contraindicated, to establish the postoperative complications of LVRS and its morbidity and mortality, to determine which surgical approaches for LVRS are most effective and to calculate the cost-effectiveness of LVRS.\nSearch methods\nWe identified RCTs by using the Cochrane Airways Group Chronic Obstructive Pulmonary Disease (COPD) register, in addition to the online clinical trials registers. Searches are current to April 2016.\nSelection criteria\nWe included RCTs that studied the safety and efficacy of LVRS in participants with diffuse emphysema. We excluded studies that investigated giant or bullous emphysema.\nData collection and analysis\nTwo independent review authors assessed trials for inclusion and extracted data. When possible, we combined data from more than one study in a meta-analysis using RevMan 5 software.\nMain results\nWe identified two new studies (89 participants) in this updated review. A total of 11 studies (1760 participants) met the entry criteria of the review, one of which accounted for 68% of recruited participants. The quality of evidence ranged from low to moderate owing to an unclear risk of bias across many studies, lack of blinding and low participant numbers for some outcomes. Eight of the studies compared LVRS versus standard medical care, one compared two closure techniques (stapling vs laser ablation), one looked at the effect of buttressing the staple line on the effectiveness of LVRS and one compared traditional 'resectional' LVRS with a non-resectional surgical approach. Participants completed a mandatory course of pulmonary rehabilitation/physical training before the procedure commenced. Short-term mortality was higher for LVRS (odds ratio (OR) 6.16, 95% confidence interval (CI) 3.22 to 11.79; 1489 participants; five studies; moderate-quality evidence) than for control, but long-term mortality favoured LVRS (OR 0.76, 95% CI 0.61 to 0.95; 1280 participants; two studies; moderate-quality evidence). Participants identified post hoc as being at high risk of death from surgery were those with particularly impaired lung function, poor diffusing capacity and/or homogenous emphysema. Participants with upper lobe-predominant emphysema and low baseline exercise capacity showed the most favourable outcomes related to mortality, as investigators reported no significant differences in early mortality between participants treated with LVRS and those in the control group (OR 0.87, 95% CI 0.23 to 3.29; 290 participants; one study), as well as significantly lower mortality at the end of follow-up for LVRS compared with control (OR 0.45, 95% CI 0.26 to 0.78; 290 participants; one study). Trials in this review furthermore provided evidence of low to moderate quality showing that improvements in lung function parameters other than forced expiratory volume in one second (FEV1), quality of life and exercise capacity were more likely with LVRS than with usual follow-up. Adverse events were more common with LVRS than with control, specifically the occurrence of (persistent) air leaks, pulmonary morbidity (e.g. pneumonia) and cardiovascular morbidity. Although LVRS leads to an increase in quality-adjusted life-years (QALYs), the procedure is relatively costly overall.\nAuthors' conclusions\nLung volume reduction surgery, an effective treatment for selected patients with severe emphysema, may lead to better health status and lung function outcomes, specifically for patients who have upper lobe-predominant emphysema with low exercise capacity, but the procedure is associated with risks of early mortality and 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"
},
{
"role": "assistant",
"content": "Emphysema causes severe damage to the lungs, which leads to breathing problems. Lung volume reduction surgery (LVRS) may help improve symptoms by removing the most diseased and non-functioning parts of the lung. However, this procedure has been the centre of much controversy with its possible benefit being outweighed by potential harms and costs."
}
]
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query-laysum | 1419 | [
{
"role": "user",
"content": "Abstract: Background\nAcute kidney injury (AKI) is a common complication amongst people who are critically ill, and it is associated with an increased risk of death. For people with severe AKI, continuous kidney replacement therapy (CKRT), which is delivered over 24 hours, is needed when they become haemodynamically unstable. When CKRT is interrupted due to clotting of the extracorporeal circuit, the delivered dose is decreased and thus leading to undertreatment.\nObjectives\nThis review assessed the efficacy of non-pharmacological measures to maintain circuit patency in CKRT.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 25 January 2021 which includes records identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nSelection criteria\nWe included all randomised controlled trials (RCTs) (parallel-group and cross-over studies), cluster RCTs and quasi-RCTs that examined non-pharmacological interventions to prevent clotting of extracorporeal circuits during CKRT.\nData collection and analysis\nThree pairs of review authors independently extracted information including participants, interventions/comparators, outcomes, study methods, and risk of bias. The primary outcomes were circuit lifespan and death due to any cause at day 28. We used a random-effects model to perform quantitative synthesis (meta-analysis). We assessed the risk of bias in included studies using the Cochrane Collaboration’s tool for assessing the risk of bias. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.\nMain results\nA total of 20 studies involving 1143 randomised participants were included in the review. The methodological quality of the included studies was low, mainly due to the unclear randomisation process and blinding of the intervention. We found evidence on the following 11 comparisons: (i) continuous venovenous haemodialysis (CVVHD) versus continuous venovenous haemofiltration (CVVH) or continuous venovenous haemodiafiltration (CVVHDF); (ii) CVVHDF versus CVVH; (iii) higher blood flow (≥ 250 mL/minute) versus standard blood flow (< 250 mL/minute); (iv) AN69 membrane (AN69ST) versus other membranes; (v) pre-dilution versus post-dilution; (vi) a longer catheter (> 20 cm) placing the tip targeting the right atrium versus a shorter catheter (≤ 20 cm) placing the tip in the superior vena cava; (vii) surface-modified double-lumen catheter versus standard double-lumen catheter with identical geometry and flow design; (viii) single-site infusion anticoagulation versus double-site infusion anticoagulation; (ix) flat plate filter versus hollow fibre filter of the same membrane type; (x) a filter with a larger membrane surface area versus a smaller one; and (xi) a filter with more and shorter hollow fibre versus a standard filter of the same membrane type.\nCircuit lifespan was reported in 9 comparisons. Low certainty evidence indicated that CVVHDF (versus CVVH: MD 10.15 hours, 95% CI 5.15 to 15.15; 1 study, 62 circuits), pre-dilution haemofiltration (versus post-dilution haemofiltration: MD 9.34 hours, 95% CI -2.60 to 21.29; 2 studies, 47 circuits; I² = 13%), placing the tip of a longer catheter targeting the right atrium (versus placing a shorter catheter targeting the tip in the superior vena cava: MD 6.50 hours, 95% CI 1.48 to 11.52; 1 study, 420 circuits), and surface-modified double-lumen catheter (versus standard double-lumen catheter: MD 16.00 hours, 95% CI 13.49 to 18.51; 1 study, 262 circuits) may prolong circuit lifespan. However, higher blood flow may not increase circuit lifespan (versus standard blood flow: MD 0.64, 95% CI -3.37 to 4.64; 2 studies, 499 circuits; I² = 70%). More and shorter hollow fibre filters (versus standard filters: MD -5.87 hours, 95% CI -10.18 to -1.56; 1 study, 6 circuits) may reduce circuit lifespan.\nDeath from any cause was reported in four comparisons We are uncertain whether CVVHDF versus CVVH, CVVHD versus CVVH or CVVHDF, longer versus a shorter catheter, or surface-modified double-lumen catheters versus standard double-lumen catheters reduced death due to any cause, in very low certainty evidence.\nRecovery of kidney function was reported in three comparisons. We are uncertain whether CVVHD versus CVVH or CVVHDF, CVVHDF versus CVVH, or surface-modified double-lumen catheters versus standard double-lumen catheters increased recovery of kidney function.\nVascular access complications were reported in two comparisons. Low certainty evidence indicated using a longer catheter (versus a shorter catheter: RR 0.40, 95% CI 0.22 to 0.74) may reduce vascular access complications, however, the use of surface-modified double lumen catheters versus standard double-lumen catheters may make little or no difference to vascular access complications.\nAuthors' conclusions\nThe use of CVVHDF as compared with CVVH, pre-dilution haemofiltration, a longer catheter, and surface-modified double-lumen catheter may prolong the circuit lifespan, while higher blood flow and more and shorter hollow fibre filter may reduce circuit life. The overall certainty of the evidence was assessed to be low to very low due to the small sample size of the included studies.\nData from future rigorous and transparent research are much needed in order to fully understand the effects of non-pharmacological interventions in preventing circuit coagulation amongst people with AKI receiving CKRT.\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 available evidence from the Cochrane Kidney and Transplant Specialised Register up to 25 January 2021. Our review summarised the results of 20 randomised studies involving a total of 1143 people."
}
]
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query-laysum | 1420 | [
{
"role": "user",
"content": "Abstract: Background\nShared decision making is an important component of patient-centred care. It is a set of communication and evidence-based practice skills that elicits patients' expectations, clarifies any misperceptions and discusses the best available evidence for benefits and harms of treatment. Acute respiratory infections (ARIs) are one of the most common reasons for consulting in primary care and obtaining prescriptions for antibiotics. However, antibiotics offer few benefits for ARIs, and their excessive use contributes to antibiotic resistance – an evolving public health crisis. Greater explicit consideration of the benefit-harm trade-off within shared decision making may reduce antibiotic prescribing for ARIs in primary care.\nObjectives\nTo assess whether interventions that aim to facilitate shared decision making increase or reduce antibiotic prescribing for ARIs in primary care.\nSearch methods\nWe searched CENTRAL (2014, Issue 11), MEDLINE (1946 to November week 3, 2014), EMBASE (2010 to December 2014) and Web of Science (1985 to December 2014). We searched for other published, unpublished or ongoing trials by searching bibliographies of published articles, personal communication with key trial authors and content experts, and by searching trial registries at the National Institutes of Health and the World Health Organization.\nSelection criteria\nRandomised controlled trials (RCTs) (individual level or cluster-randomised), which evaluated the effectiveness of interventions that promote shared decision making (as the focus or a component of the intervention) about antibiotic prescribing for ARIs in primary care.\nData collection and analysis\nTwo review authors independently extracted and collected data. Antibiotic prescribing was the primary outcome, and secondary outcomes included clinically important adverse endpoints (e.g. re-consultations, hospital admissions, mortality) and process measures (e.g. patient satisfaction). We assessed the risk of bias of all included trials and the quality of evidence. We contacted trial authors to obtain missing information where available.\nMain results\nWe identified 10 published reports of nine original RCTs (one report was a long-term follow-up of the original trial) in over 1100 primary care doctors and around 492,000 patients.\nThe main risk of bias came from participants in most studies knowing whether they had received the intervention or not, and we downgraded the rating of the quality of evidence because of this.\nWe meta-analysed data using a random-effects model on the primary and key secondary outcomes and formally assessed heterogeneity. Remaining outcomes are presented narratively.\nThere is moderate quality evidence that interventions that aim to facilitate shared decision making reduce antibiotic use for ARIs in primary care (immediately after or within six weeks of the consultation), compared with usual care, from 47% to 29%: risk ratio (RR) 0.61, 95% confidence interval (CI) 0.55 to 0.68. Reduction in antibiotic prescribing occurred without an increase in patient-initiated re-consultations (RR 0.87, 95% CI 0.74 to 1.03, moderate quality evidence) or a decrease in patient satisfaction with the consultation (OR 0.86, 95% CI 0.57 to 1.30, low quality evidence). There were insufficient data to assess the effects of the intervention on sustained reduction in antibiotic prescribing, adverse clinical outcomes (such as hospital admission, incidence of pneumonia and mortality), or measures of patient and caregiver involvement in shared decision making (such as satisfaction with the consultation; regret or conflict with the decision made; or treatment compliance following the decision). No studies assessed antibiotic resistance in colonising or infective organisms.\nAuthors' conclusions\nInterventions that aim to facilitate shared decision making reduce antibiotic prescribing in primary care in the short term. Effects on longer-term rates of prescribing are uncertain and more evidence is needed to determine how any sustained reduction in antibiotic prescribing affects hospital admission, pneumonia and death.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to see if shared decision making was better or worse than usual care in reducing antibiotic prescribing for an acute respiratory infection in primary care."
}
]
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query-laysum | 1421 | [
{
"role": "user",
"content": "Abstract: Background\nVisceral leishmaniasis (VL) is a disease caused by a parasite, which can lead to death if untreated. Poor nutritional status hastens the progression of VL infection, and VL worsens malnutrition status. Malnutrition is one of the poor prognostic factors identified for leishmaniasis. However, the effects of nutritional supplementation in people treated for VL are not known.\nObjectives\nTo assess the effects of oral nutritional supplements in people being treated with anti-leishmanial drug therapy for VL.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and two trial registers up to 12 September 2017. We checked conference proceedings and WHO consultative meeting reports, the reference lists of key documents and existing reviews, and contacted experts and nutritional supplement companies.\nSelection criteria\nRandomized controlled trials (RCTs), quasi-randomized controlled trials (quasi-RCTs), and non-randomized controlled trials (NRCTs) of any oral nutritional supplement, compared to no nutritional intervention, placebo, or dietary advice alone, in people being treated for VL.\nData collection and analysis\nTwo review authors independently screened the literature search results for studies that met the inclusion criteria. We had planned for two review authors to independently extract data and assess the risk of bias of the included studies. We planned to follow the Cochrane standard methodological procedures for assessing risk of bias and analysing the data.\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 oral nutritional supplements in people with VL who were being treated with anti-leishmanial drug therapy. Thus, we could not draw any conclusions on the impact of these interventions on primary cure of VL, definitive cure of VL, treatment completion, self-reported recovery from illness or resolution of symptoms, weight gain, increased skinfold thickness, other measures of lean or total mass, or growth in children.\nThis absence of evidence should not be interpreted as evidence of no effect for nutritional supplements in people under VL treatment. It means that we did not identify research that fulfilled our review inclusion criteria.\nThe effects of oral nutritional supplements in people with VL who are being treated with anti-leishmanial drug therapy have yet to be determined by rigorous experimental studies, such as cluster-randomized trials, that focus on outcomes relevant for patients.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane review was to find out whether oral nutritional supplements could help people who were being treated for visceral leishmaniasis (VL). We tried to collect and analyse all relevant studies that answered this question."
}
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query-laysum | 1422 | [
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of obesity is increasing worldwide, yet nutritional management remains contentious. It has been suggested that low glycaemic index (GI) or low glycaemic load (GL) diets may stimulate greater weight loss than higher GI/GL diets or other weight reduction diets. The previous version of this review, published in 2007, found mainly short-term intervention studies. Since then, randomised controlled trials (RCTs) with longer-term follow-up have become available, warranting an update of this review.\nObjectives\nTo assess the effects of low glycaemic index or low glycaemic load diets on weight loss in people with overweight or obesity.\nSearch methods\nWe searched CENTRAL, MEDLINE, one other database, and two clinical trials registers from their inception to 25 May 2022. We did not apply any language restrictions.\nSelection criteria\nWe included RCTs with a minimum duration of eight weeks comparing low GI/GL diets to higher GI/GL diets or any other diets in people with overweight or obesity.\nData collection and analysis\nWe used standard Cochrane methods. We conducted two main comparisons: low GI/GL diets versus higher GI/GL diets and low GI/GL diets versus any other diet. Our main outcomes included change in body weight and body mass index, adverse events, health-related quality of life, and mortality. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nIn this updated review, we included 10 studies (1210 participants); nine were newly-identified studies. We included only one study from the previous version of this review, following a revision of inclusion criteria. We listed five studies as 'awaiting classification' and one study as 'ongoing'. Of the 10 included studies, seven compared low GI/GL diets (233 participants) with higher GI/GL diets (222 participants) and three studies compared low GI/GL diets (379 participants) with any other diet (376 participants). One study included children (50 participants); one study included adults aged over 65 years (24 participants); the remaining studies included adults (1136 participants). The duration of the interventions varied from eight weeks to 18 months. All trials had an unclear or high risk of bias across several domains.\nLow GI/GL diets versus higher GI/GL diets\nLow GI/GL diets probably result in little to no difference in change in body weight compared to higher GI/GL diets (mean difference (MD) -0.82 kg, 95% confidence interval (CI) -1.92 to 0.28; I2 = 52%; 7 studies, 403 participants; moderate-certainty evidence). Evidence from four studies reporting change in body mass index (BMI) indicated low GI/GL diets may result in little to no difference in change in BMI compared to higher GI/GL diets (MD -0.45 kg/m2, 95% CI -1.02 to 0.12; I2 = 22%; 186 participants; low-certainty evidence)at the end of the study periods. One study assessing participants' mood indicated that low GI/GL diets may improve mood compared to higher GI/GL diets, but the evidence is very uncertain (MD -3.5, 95% CI -9.33 to 2.33; 42 participants; very low-certainty evidence). Two studies assessing adverse events did not report any adverse events; we judged this outcome to have very low-certainty evidence. No studies reported on all-cause mortality.\nFor the secondary outcomes, low GI/GL diets may result in little to no difference in fat mass compared to higher GI/GL diets (MD -0.86 kg, 95% CI -1.52 to -0.20; I2 = 6%; 6 studies, 295 participants; low certainty-evidence). Similarly, low GI/GL diets may result in little to no difference in fasting blood glucose level compared to higher GI/GL diets (MD 0.12 mmol/L, 95% CI 0.03 to 0.21; I2 = 0%; 6 studies, 344 participants; low-certainty evidence).\nLow GI/GL diets versus any other diet\nLow GI/GL diets probably result in little to no difference in change in body weight compared to other diets (MD -1.24 kg, 95% CI -2.82 to 0.34; I2 = 70%; 3 studies, 723 participants; moderate-certainty evidence). The evidence suggests that low GI/GL diets probably result in little to no difference in change in BMI compared to other diets (MD -0.30 kg in favour of low GI/GL diets, 95% CI -0.59 to -0.01; I2 = 0%; 2 studies, 650 participants; moderate-certainty evidence). Two adverse events were reported in one study: one was not related to the intervention, and the other, an eating disorder, may have been related to the intervention. Another study reported 11 adverse events, including hypoglycaemia following an oral glucose tolerance test. The same study reported seven serious adverse events, including kidney stones and diverticulitis. We judged this outcome to have low-certainty evidence. No studies reported on health-related quality of life or all-cause mortality.\nFor the secondary outcomes, none of the studies reported on fat mass. Low GI/GL diets probably do not reduce fasting blood glucose level compared to other diets (MD 0.03 mmol/L, 95% CI -0.05 to 0.12; I2 = 0%; 3 studies, 732 participants; moderate-certainty evidence).\nAuthors' conclusions\nThe current evidence indicates there may be little to no difference for all main outcomes between low GI/GL diets versus higher GI/GL diets or any other diet. There is insufficient information to draw firm conclusions about the effect of low GI/GL diets on people with overweight or obesity. Most studies had a small sample size, with only a few participants in each comparison group. We rated the certainty of the evidence as moderate to very low. More well-designed and adequately-powered studies are needed. They should follow a standardised intervention protocol, adopt objective outcome measurement since blinding may be difficult to achieve, and make efforts to minimise loss to follow-up. Furthermore, studies in people from a wide range of ethnicities and with a wide range of dietary habits, as well as studies in low- and middle-income countries, are needed.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to May 2022."
}
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query-laysum | 1423 | [
{
"role": "user",
"content": "Abstract: Background\nStevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome are rare, severe cutaneous adverse reactions usually triggered by medications. In addition to tertiary-level supportive care, various systemic therapies have been used including glucocorticoids, intravenous immunoglobulins (IVIGs), cyclosporin, N-acetylcysteine, thalidomide, infliximab, etanercept, and plasmapheresis. There is an unmet need to understand the efficacy of these interventions.\nObjectives\nTo assess the effects of systemic therapies (medicines delivered orally, intramuscularly, or intravenously) for the treatment of SJS, TEN, and SJS/TEN overlap syndrome.\nSearch methods\nWe searched the following databases up to March 2021: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched five clinical trial registers, the reference lists of all included studies and of key review articles, and a number of drug manufacturer websites. We searched for errata or retractions of included studies.\nSelection criteria\nWe included only randomised controlled trials (RCTs) and prospective observational comparative studies of participants of any age with a clinical diagnosis of SJS, TEN, or SJS/TEN overlap syndrome. We included all systemic therapies studied to date and permitted comparisons between each therapy, as well as between therapy and placebo.\nData collection and analysis\nWe used standard methodological procedures as specified by Cochrane. Our primary outcomes were SJS/TEN-specific mortality and adverse effects leading to discontinuation of SJS/TEN therapy. Secondary outcomes included time to complete re-epithelialisation, intensive care unit length of stay, total hospital length of stay, illness sequelae, and other adverse effects attributed to systemic therapy. We rated the certainty of the evidence for each outcome using GRADE.\nMain results\nWe included nine studies with a total of 308 participants (131 males and 155 females) from seven countries. We included two studies in the quantitative meta-analysis.\nWe included three RCTs and six prospective, controlled observational studies. Sample sizes ranged from 10 to 91. Most studies did not report study duration or time to follow-up. Two studies reported a mean SCORe of Toxic Epidermal Necrosis (SCORTEN) of 3 and 1.9. Seven studies did not report SCORTEN, although four of these studies reported average or ranges of body surface area (BSA) (means ranging from 44% to 51%). Two studies were set in burns units, two in dermatology wards, one in an intensive care unit, one in a paediatric ward, and three in unspecified inpatient units. Seven studies reported a mean age, which ranged from 29 to 56 years. Two studies included paediatric participants (23 children).\nWe assessed the results from one of three RCTs as low risk of bias in all domains, one as high, and one as some concerns. We judged the results from all six prospective observational comparative studies to be at a high risk of bias. We downgraded the certainty of the evidence because of serious risk of bias concerns and for imprecision due to small numbers of participants.\nThe interventions assessed included systemic corticosteroids, tumour necrosis factor-alpha (TNF-alpha) inhibitors, cyclosporin, thalidomide, N-acetylcysteine, IVIG, and supportive care. No data were available for the main comparisons of interest as specified in the review protocol: etanercept versus cyclosporin, etanercept versus IVIG, IVIG versus supportive care, IVIG versus cyclosporin, and cyclosporin versus corticosteroids.\nCorticosteroids versus no corticosteroids\nIt is uncertain if there is any difference between corticosteroids (methylprednisolone 4 mg/kg/day for two more days after fever had subsided and no new lesions had developed) and no corticosteroids on disease-specific mortality (risk ratio (RR) 2.55, 95% confidence interval (CI) 0.72 to 9.03; 2 studies; 56 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported.\nIVIG versus no IVIG\nIt is uncertain if there is any difference between IVIG (0.2 to 0.5 g/kg cumulative dose over three days) and no IVIG in risk of disease-specific mortality (RR 0.33, 95% CI 0.04 to 2.91); time to complete re-epithelialisation (mean difference (MD) −2.93 days, 95% CI −4.4 to −1.46); or length of hospital stay (MD −2.00 days, 95% CI −5.81 to 1.81). All results in this comparison were based on one study with 36 participants, and very low-certainty evidence. Adverse effects leading to discontinuation of therapy were not reported.\nEtanercept (TNF-alpha inhibitor) versus corticosteroids\nEtanercept (25 mg (50 mg if weight > 65 kg) twice weekly \"until skin lesions healed\") may reduce disease-specific mortality compared to corticosteroids (intravenous prednisolone 1 to 1.5 mg/kg/day \"until skin lesions healed\") (RR 0.51, 95% CI 0.16 to 1.63; 1 study; 91 participants; low-certainty evidence); however, the CIs were consistent with possible benefit and possible harm. Serious adverse events, such as sepsis and respiratory failure, were reported in 5 of 48 participants with etanercept and 9 of 43 participants with corticosteroids, but it was not clear if they led to discontinuation of therapy. Time to complete re-epithelialisation and length of hospital stay were not reported.\nCyclosporin versus IVIG\nIt is uncertain if there is any difference between cyclosporin (3 mg/kg/day or intravenous 1 mg/kg/day until complete re-epithelialisation, then tapered off (10 mg/day reduction every 48 hours)) and IVIG (continuous infusion 0.75 g/kg/day for 4 days (total dose 3 g/kg) in participants with normal renal function) in risk of disease-specific mortality (RR 0.13, 95% CI 0.02 to 0.98, 1 study; 22 participants; very low-certainty evidence). Time to complete re-epithelialisation, length of hospital stay, and adverse effects leading to discontinuation of therapy were not reported.\nNo studies measured intensive care unit length of stay.\nAuthors' conclusions\nWhen compared to corticosteroids, etanercept may result in mortality reduction. For the following comparisons, the certainty of the evidence for disease-specific mortality is very low: corticosteroids versus no corticosteroids, IVIG versus no IVIG and cyclosporin versus IVIG. There is a need for more multicentric studies, focused on the most important clinical comparisons, to provide reliable answers about the best treatments for SJS/TEN.\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": "Treating severe skin reactions with etanercept (a medicine that acts to reduce a specific part of the immune system), rather than steroids (which broadly reduces the immune system), may result in a lower number of deaths from Stevens-Johnson syndrome and toxic epidermal necrolysis.\nWe are uncertain about the effectiveness of other treatments, such as steroids and cyclosporin (medicines that act on the immune system) or immunoglobulins (naturally produced antibodies). We need more studies set across multiple sites that compare the effectiveness and safety of the most important treatments."
}
]
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query-laysum | 1424 | [
{
"role": "user",
"content": "Abstract: Background\nThe reduction of lung inflammation is one of the goals of cystic fibrosis therapy. Inhaled corticosteroids are often used in this respect to treat children and adults with cystic fibrosis. The rationale for this is their potential to reduce lung damage arising from inflammation, as well as their effect on symptomatic wheezing. It is important to establish the current level of evidence for the risks and benefits of inhaled corticosteroids, especially in the light of their known adverse effects on growth. This is an update of a previously published review; however, due to the lack of research in this area, we do not envisage undertaking any further updates.\nObjectives\nTo assess the effectiveness of taking regular inhaled corticosteroids compared to not taking them in children and adults with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We requested information from pharmaceutical companies manufacturing inhaled corticosteroids and authors of identified trials.\nDate of most recent search of the Group's Trials Register: 19 November 2018.\nSelection criteria\nRandomised or quasi-randomised trials, published and unpublished, comparing inhaled corticosteroids to placebo or standard treatment in individuals with cystic fibrosis.\nData collection and analysis\nTwo independent authors assessed methodological quality and risk of bias in trials using established criteria and extracted data using standard pro formas. The quality of the evidence was assessed using the GRADE criteria.\nMain results\nThe searches identified 35 citations, of which 27 (representing 13 trials) were eligible for inclusion. These 13 trials reported the use of inhaled corticosteroids in 525 people with cystic fibrosis aged between 6 and 55 years. One was a withdrawal trial in 171 individuals who were already taking inhaled corticosteroids. Methodological quality and risk of bias were difficult to assess from published information.\nObjective measures of airway function were reported in most trials but were often incomplete and reported at different time points. We found no difference in forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) % predicted in any of the trials, although the quality of the evidence was low due to risks of bias within the included trials and low participant numbers. We are uncertain whether inhaled corticosteroids result in an improvement in exercise tolerance, bronchial hyperreactivity or exacerbations as the quality of the evidence was very low. Data from one trial suggested that inhaled corticosteroids may make little or no difference to quality of life (low-quality evidence).\nThree trials reported adverse effects, but the quality of the evidence is low and so we are uncertain whether inhaled corticosteroids increase the risk of adverse effects. However, one study did show that growth was adversely affected by high doses of inhaled corticosteroids.\nAuthors' conclusions\nEvidence from these trials is of low to very low quality and insufficient to establish whether inhaled corticosteroids are beneficial in cystic fibrosis, but withdrawal in those already taking them has been shown to be safe. There is some evidence they may cause harm in terms of growth. It has not been established whether long-term use is beneficial in reducing lung inflammation, which should improve survival, but it is unlikely this will be proven conclusively in a randomised controlled trial.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this updated review, 13 trials reported the use of inhaled corticosteroids in 525 people with cystic fibrosis. In most of the trials participants started taking steroids or placebo (treatment that appeared the same as the steroids, but did not have any active medicine in it) at the start of the trial, but one trial was a withdrawal trial (171 participants), where everyone was already taking steroids and while half of them carried on, the rest took a placebo, in effect stopping the treatment. Participants were aged between 6 and 55 years; three of the trials were in children only, four in adults only and four were mixed ages; two trials did not describe the ages of the people taking part. The lung function and severity of disease of the participants varied across trials and only two trials gave information about their genetic mutations. All trials took place in Europe. In 10 of the trials, all those taking part remained in the same group up to the end of the trial (either a treatment group or a group receiving no treatment or a placebo), but in three trials they swapped groups halfway through the trial. The trials lasted between three weeks and two years."
}
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query-laysum | 1425 | [
{
"role": "user",
"content": "Abstract: Background\nAcute bilirubin encephalopathy (ABE) and the other serious complications of severe hyperbilirubinemia in the neonate occur far more frequently in low- and middle-income countries (LMIC). This is due to several factors that place babies in LMIC at greater risk for hyperbilirubinemia, including increased prevalence of hematologic disorders leading to hemolysis, increased sepsis, less prenatal or postnatal care, and a lack of resources to treat jaundiced babies. Hospitals and clinics face frequent shortages of functioning phototherapy machines and inconsistent access to electricity to run the machines. Sunlight has the potential to treat hyperbilirubinemia: it contains the wavelengths of light that are produced by phototherapy machines. However, it contains harmful ultraviolet light and infrared radiation, and prolonged exposure has the potential to lead to sunburn, skin damage, and hyperthermia or hypothermia.\nObjectives\nTo evaluate the efficacy of sunlight administered alone or with filtering or amplifying devices for the prevention and treatment of clinical jaundice or laboratory-diagnosed hyperbilirubinemia in term and late preterm neonates.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search CENTRAL (2019, Issue 5), MEDLINE, Embase, and CINAHL on 2 May 2019. We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials (RCTs), quasi-RCTs, and cluster RCTs.\nWe updated the searches on 1 June 2020.\nSelection criteria\nWe included RCTs, quasi-RCTs, and cluster RCTs. We excluded crossover RCTs. Included studies must have evaluated sunlight (with or without filters or amplification) for the prevention and treatment of hyperbilirubinemia or jaundice in term or late preterm neonates. Neonates must have been enrolled in the study by one-week postnatal age.\nData collection and analysis\nWe used standard methodologic procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence. Our primary outcomes were: use of conventional phototherapy, treatment failure requiring exchange transfusion, ABE, chronic bilirubin encephalopathy, and death.\nMain results\nWe included three RCTs (1103 infants). All three studies had small sample sizes, were unblinded, and were at high risk of bias. We planned to undertake four comparisons, but only found studies reporting on two.\nSunlight with or without filters or amplification compared to no treatment for the prevention and treatment of hyperbilirubinemia in term and late preterm neonates\nOne study of twice-daily sunlight exposure (30 to 60 minutes) compared to no treatment reported the incidence of jaundice may be reduced (risk ratio [RR] 0.61, 95% confidence interval [CI] 0.45 to 0.82; risk difference [RD] −0.14, 95% CI −0.22 to −0.06; number needed to treat for an additional beneficial outcome [NNTB] 7, 95% CI 5 to 17; 1 study, 482 infants; very low-certainty evidence) and the number of days that an infant was jaundiced may be reduced (mean difference [MD] −2.20 days, 95% CI −2.60 to −1.80; 1 study, 482 infants; very low-certainty evidence). There were no data on safety or potential harmful effects of the intervention. The study did not assess use of conventional phototherapy, treatment failure requiring exchange transfusion, ABE, and long-term consequences of hyperbilirubinemia. The study showed that sunlight therapy may reduce rehospitalization rates within seven days of discharge for treatment for hyperbilirubinemia, but the evidence was very uncertain (RR 0.55, 95% CI 0.27 to 1.11; RD −0.04, −0.08 to 0.01; 1 study, 482 infants; very low-certainty evidence).\nSunlight with or without filters or amplification compared to other sources of phototherapy for the treatment of hyperbilirubinemia in infants with confirmed hyperbilirubinemia\nTwo studies (621 infants) compared the effect of filtered-sunlight exposure to other sources of phototherapy in infants with confirmed hyperbilirubinemia. Filtered-sunlight phototherapy (FSPT) and conventional or intensive electric phototherapy led to a similar number of days of effective treatment (broadly defined as a minimal increase of total serum bilirubin in infants less than 72 hours old and a decrease in total serum bilirubin in infants more than 72 hours old on any day that at least four to five hours of sunlight therapy was available). There may be little or no difference in treatment failure requiring exchange transfusion (typical RR 1.00, 95% CI 0.06 to 15.73; typical RD 0.00, 95% CI −0.01 to 0.01; 2 studies, 621 infants; low-certainty evidence). One study reported ABE, and no infants developed this outcome (RR not estimable; RD 0.00, 95% CI −0.02 to 0.02; 1 study, 174 infants; low-certainty evidence). One study reported death as a reason for study withdrawal; no infants were withdrawn due to death (RR not estimable; typical RD 0.00, 95% CI −0.01 to 0.01; 1 study, 447 infants; low-certainty evidence). Neither study assessed long-term outcomes.\nPossible harms: both studies showed a probable increased risk for hyperthermia (body temperature greater than 37.5 °C) with FSPT (typical RR 4.39, 95% CI 2.98 to 6.47; typical RD 0.30, 95% CI 0.23 to 0.36; number needed to treat for an additional harmful outcome [NNTH] 3, 95% CI 2 to 4; 2 studies, 621 infants; moderate-certainty evidence). There was probably no difference in hypothermia (body temperature less than 35.5 °C) (typical RR 1.06, 95% CI 0.55 to 2.03; typical RD 0.00, 95% CI −0.03 to 0.04; 2 studies, 621 infants; moderate-certainty evidence).\nAuthors' conclusions\nSunlight may be an effective adjunct to conventional phototherapy in LMIC settings, may allow for rotational use of limited phototherapy machines, and may be preferable to families as it can allow for increased bonding. Filtration of sunlight to block harmful ultraviolet light and frequent temperature checks for babies under sunlight may be warranted for safety. Sunlight may be effective in preventing hyperbilirubinemia in some cases, but these studies have not demonstrated that sunlight alone is effective for the treatment of hyperbilirubinemia given its sporadic availability and the low or very low certainty of the evidence in these studies.\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": "The certainty of the evidence for outcomes in all three studies was very low to moderate. It was very low for all the main outcomes in each study. We are uncertain whether sunlight is effective for the prevention or treatment of hyperbilirubinemia in term or late preterm neonates."
}
]
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query-laysum | 1426 | [
{
"role": "user",
"content": "Abstract: Background\nMajor depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness. Depressive symptoms, even in subthreshold manifestations, have a negative impact in terms of quality of life, compliance with anticancer treatment, suicide risk and possibly the mortality rate for the cancer itself. Randomised controlled trials (RCTs) on the efficacy, tolerability and acceptability of antidepressants in this population are few and often report conflicting results.\nObjectives\nTo evaluate the efficacy, tolerability and acceptability of antidepressants for treating depressive symptoms in adults (aged 18 years or older) with cancer (any site and stage).\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was November 2022.\nSelection criteria\nWe included RCTs comparing antidepressants versus placebo, or antidepressants versus other antidepressants, in adults (aged 18 years or above) with any primary diagnosis of cancer and depression (including major depressive disorder, adjustment disorder, dysthymic disorder or depressive symptoms in the absence of a formal diagnosis).\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcome was 1. efficacy as a continuous outcome. Our secondary outcomes were 2. efficacy as a dichotomous outcome, 3. Social adjustment, 4. health-related quality of life and 5. dropouts. We used GRADE to assess certainty of evidence for each outcome.\nMain results\nWe identified 14 studies (1364 participants), 10 of which contributed to the meta-analysis for the primary outcome. Six of these compared antidepressants and placebo, three compared two antidepressants, and one three-armed study compared two antidepressants and placebo. In this update, we included four additional studies, three of which contributed data for the primary outcome.\nFor acute-phase treatment response (six to 12 weeks), antidepressants may reduce depressive symptoms when compared with placebo, even though the evidence is very uncertain. This was true when depressive symptoms were measured as a continuous outcome (standardised mean difference (SMD) −0.52, 95% confidence interval (CI) −0.92 to −0.12; 7 studies, 511 participants; very low-certainty evidence) and when measured as a proportion of people who had depression at the end of the study (risk ratio (RR) 0.74, 95% CI 0.57 to 0.96; 5 studies, 662 participants; very low-certainty evidence). No studies reported data on follow-up response (more than 12 weeks). In head-to-head comparisons, we retrieved data for selective serotonin reuptake inhibitors (SSRIs) versus tricyclic antidepressants (TCAs) and for mirtazapine versus TCAs. There was no difference between the various classes of antidepressants (continuous outcome: SSRI versus TCA: SMD −0.08, 95% CI −0.34 to 0.18; 3 studies, 237 participants; very low-certainty evidence; mirtazapine versus TCA: SMD −4.80, 95% CI −9.70 to 0.10; 1 study, 25 participants).\nThere was a potential beneficial effect of antidepressants versus placebo for the secondary efficacy outcomes (continuous outcome, response at one to four weeks; very low-certainty evidence). There were no differences for these outcomes when comparing two different classes of antidepressants, even though the evidence was very uncertain.\nIn terms of dropouts due to any cause, we found no difference between antidepressants compared with placebo (RR 0.85, 95% CI 0.52 to 1.38; 9 studies, 889 participants; very low-certainty evidence), and between SSRIs and TCAs (RR 0.83, 95% CI 0.53 to 1.22; 3 studies, 237 participants).\nWe downgraded the certainty of the evidence because of the heterogeneous quality of the studies, imprecision arising from small sample sizes and wide CIs, and inconsistency due to statistical or clinical heterogeneity.\nAuthors' conclusions\nDespite the impact of depression on people with cancer, the available studies were few and of low quality. This review found a potential beneficial effect of antidepressants against placebo in depressed participants with cancer. However, the certainty of evidence is very low and, on the basis of these results, it is difficult to draw clear implications for practice. The use of antidepressants in people with cancer should be considered on an individual basis and, considering the lack of head-to-head data, the choice of which drug to prescribe may be based on the data on antidepressant efficacy in the general population of people with major depression, also taking into account that data on people with other serious medical conditions suggest a positive safety profile for the SSRIs. Furthermore, this update shows that the usage of the newly US Food and Drug Administration-approved antidepressant esketamine in its intravenous formulation might represent a potential treatment for this specific population of people, since it can be used both as an anaesthetic and an antidepressant. However, data are too inconclusive and further studies are needed. We conclude that to better inform clinical practice, there is an urgent need for large, simple, randomised, pragmatic trials comparing commonly used antidepressants versus placebo in people with cancer who have depressive symptoms, with or without a formal diagnosis of a depressive disorder.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our certainty in the evidence was very low because of a lack of information about how the studies were designed, low numbers of people in the analysis of results, and differences between the characteristics of the studies and their results."
}
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query-laysum | 1427 | [
{
"role": "user",
"content": "Abstract: Background\nPrevention of relapse is a major issue in the management of quiescent Crohn's disease (CD). Current therapies (e.g. methotrexate, biologics, 6-mercaptopurine and azathioprine) may be effective for maintaining remission in CD, but these drugs may cause significant adverse events. Interventions that are effective and safe for maintenance of remission in CD are desirable.\nObjectives\nThe primary objectives were to evaluate the efficacy and safety of enteral nutrition for the maintenance of remission in CD and to assess the impact of formula composition on effectiveness.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register and clinicaltrials.gov from inception to 27 July 2018. We also searched references of retrieved studies and reviews.\nSelection criteria\nRandomised controlled trials (RCTs) including participants of any age with quiescent CD were considered for inclusion. Studies that compared enteral nutrition with no intervention, placebo or any other intervention were selected for review.\nData collection and analysis\nTwo authors independently screened studies for inclusion, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was clinical or endoscopic relapse as defined by the primary studies. Secondary outcomes included anthropometric measures (i.e. height and weight), quality of life (QoL), adverse events, serious adverse events and withdrawal due to adverse events. We calculated the risk ratio and 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference and 95% CI. A random-effects model was used for the statistical analysis. We used the GRADE criteria to assess the overall certainty of the evidence supporting the primary outcome and selected secondary outcomes.\nMain results\nFour RCTs (262 adult participants) met the inclusion criteria. One study (N = 33) compared an elemental diet to a non-elemental (polymeric) diet. One study (N = 51) compared a half elemental diet to a regular free diet. Another study (N = 95) compared an elemental diet to 6-mercaptopurine (6-MP) or a no treatment control group. One study (N= 83) compared a polymeric diet to mesalamine. Two studies were rated as high risk of bias due to lack of blinding or incomplete outcome data. The other two studies were judged to have an unclear risk of bias. The studies were not pooled due to differences in control interventions and the way outcomes were assessed.\nThe effect of an elemental diet compared to a polymeric diet on remission rates or withdrawal due to adverse events is uncertain. Fifty-eight per cent (11/19) of participants in the elemental diet group relapsed at 12 months compared to 57% (8/14) of participants in the polymeric diet group (RR 1.01, 95% CI 0.56 to 1.84; very low certainty evidence). Thirty-two per cent (6/19) of participants in the elemental diet group were intolerant to the enteral nutritional formula because of taste or smell and were withdrawn from the study in the first 2 weeks compared to zero participants (0/14) in the polymeric diet group (RR 9.75, 95% CI 0.59 to 159.93; low certainty evidence). Anthropometric measures, QoL, adverse events and serious adverse events were not reported as outcomes.\nThe effect of an elemental diet (half of total daily calorie requirements) compared to a normal free diet on relapse rates is uncertain. Thirty-five per cent (9/26) of participants in the elemental diet group relapsed at 12 months compared to 64% (16/25) of participants in the free diet group (RR 0.54, 95% CI 0.30 to 0.99; very low certainty evidence). No adverse events were reported. This study reported no differences in weight change between the two diet groups. Height and QoL were not reported as outcomes.\nThe effect of an elemental diet compared to 6-MP on relapse rates or adverse events is uncertain. Thirty-eight per cent (12/32) of participants in the elemental diet group relapsed at 12 months compared to 23% (7/30) of participants in the 6-MP group (RR 1.61; 95% CI 0.73 to 3.53; very low certainty evidence). Three per cent (1/32) of participants in the elemental diet group had an adverse event compared to 13% (4/30) of participants in the 6-MP group (RR 0.23, 95% CI 0.03 to 1.98; low certainty evidence). Adverse events in the elemental diet group included surgery due to worsening CD. Adverse events in the 6-MP group included liver injury (n = 2), hair loss (n = 1) and surgery due to an abscess (n = 1). No serious adverse events or withdrawals due to adverse events were reported. Weight, height and QoL were not reported as outcomes\nThe effect of a polymeric diet compared to mesalamine on relapse rates and weight is uncertain. Forty-two per cent (18/43) of participants in the polymeric diet group relapsed at 6 months compared to 55% (22/40) of participants in the mesalamine group (RR 0.76; 95% CI 0.49 to 1.19; low certainty evidence). The mean difference in weight gain over the study period was 1.9 kg higher in the polymeric diet group compared to mesalamine (95% CI -4.62 to 8.42; low certainty evidence). Two participants in the polymeric diet group experienced nausea and four had diarrhoea. It is unclear if any participants in the mesalamine group had an adverse event. Height, QoL, serious adverse events and withdrawal due to adverse events were not reported as outcomes.\nAuthors' conclusions\nThe results for the outcomes assessed in this review are uncertain and no firm conclusions regarding the efficacy and safety of enteral nutrition in quiescent CD can be drawn. More research is needed to determine the efficacy and safety of using enteral nutrition as maintenance therapy in CD. Currently, there are four ongoing studies (estimated enrolment of 280 participants). This review will be updated when the results of these studies are available.\n\nGiven the provided abstract, please respond to the following query: \"What is mesalamine?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Mesalamine is a 5-aminosalicylic acid drug. 5-Aminosalicylic drugs are thought to treat Crohn's disease by reducing inflammation in the gastrointestinal tract. These drugs are usually taken by mouth."
}
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query-laysum | 1428 | [
{
"role": "user",
"content": "Abstract: Background\nMedications with anticholinergic properties are commonly prescribed to older adults. 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 high anticholinergic burden may be a risk factor for development of cognitive decline or dementia. There are various scales available to measure anticholinergic burden but agreement between them is often poor.\nObjectives\nTo assess whether anticholinergic burden, as defined at the level of each individual scale, is a prognostic factor for future cognitive decline or dementia in cognitively unimpaired older adults.\nSearch methods\nWe searched the following databases from inception to 24 March 2021: MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), and ISI Web of Science Core Collection (ISI Web of Science).\nSelection criteria\nWe included prospective and retrospective longitudinal cohort and case-control observational studies with a minimum of one year' follow-up that examined the association between an anticholinergic burden measurement scale and future cognitive decline or dementia in cognitively unimpaired older adults.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, and undertook data extraction, assessment of risk of bias, and GRADE assessment. We extracted odds ratios (OR) and hazard ratios, with 95% confidence intervals (CI), and linear data on the association between anticholinergic burden and cognitive decline or dementia. We intended to pool each metric separately; however, only OR-based data were suitable for pooling via a random-effects meta-analysis. We initially established adjusted and unadjusted pooled rates for each available anticholinergic scale; then, as an exploratory analysis, established pooled rates on the prespecified association across scales. We examined variability based on severity of anticholinergic burden.\nMain results\nWe identified 25 studies that met our inclusion criteria (968,428 older adults). Twenty studies were conducted in the community care setting, two in primary care clinics, and three in secondary care settings. Eight studies (320,906 participants) provided suitable data for meta-analysis. The Anticholinergic Cognitive Burden scale (ACB scale) was the only scale with sufficient data for 'scale-based' meta-analysis. Unadjusted ORs suggested an increased risk for cognitive decline or dementia in older adults with an anticholinergic burden (OR 1.47, 95% CI 1.09 to 1.96) and adjusted ORs similarly suggested an increased risk for anticholinergic burden, defined according to the ACB scale (OR 2.63, 95% CI 1.09 to 6.29). Exploratory analysis combining adjusted ORs across available scales supported these results (OR 2.16, 95% CI 1.38 to 3.38), and there was evidence of variability in risk based on severity of anticholinergic burden (ACB scale 1: OR 2.18, 95% CI 1.11 to 4.29; ACB scale 2: OR 2.71, 95% CI 2.01 to 3.56; ACB scale 3: OR 3.27, 95% CI 1.41 to 7.61); however, overall GRADE evaluation of certainty of the evidence was low.\nAuthors' conclusions\nThere is low-certainty evidence that older adults without cognitive impairment who take medications with anticholinergic effects may be at increased risk of cognitive decline or dementia.\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": "There are more than 40 million older people worldwide living with dementia. These numbers are expected to rise to over 100 million by 2050 and at present there are very limited treatment options available. Therefore, it is important to identify factors that may increase the risk of dementia.\nBecause the cholinergic system in the brain plays an important role in learning and memory, there are theoretical reasons to believe that medications with anticholinergic effects could cause future dementia. Research has suggested that these medications may have unintended effects on memory and thinking, potentially resulting in dementia. If this is the case, one way to reduce the numbers of older people who develop dementia may be to avoid prescribing these medicines. Many commonly used medications have anticholinergic effects, for example medications for hay fever, insomnia (difficulty getting to sleep or staying asleep for long enough to feel refreshed), and depression.\nIn this review, we investigated the link between anticholinergic medicines, as measured by various measurement scales, and future dementia."
}
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query-laysum | 1429 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral neuropathy is the most common neurologic complication of hepatitis C virus (HCV) infection. The pathophysiology of the neuropathy associated with HCV is not definitively known; however, proposed mechanisms include cryoglobulin deposition in the vasa nervorum and HCV-mediated vasculitis. The optimal treatment for HCV-related peripheral neuropathy has not been established.\nObjectives\nTo assess the effects of interventions (including interferon alfa, interferon alfa plus ribavirin, corticosteroids, cyclophosphamide, plasma exchange, and rituximab) for cryoglobulinemic or non-cryoglobulinemic peripheral neuropathy associated with HCV infection.\nSearch methods\nOn 26 August 2014, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE, and EMBASE. We also searched two trials registers, the Networked Digital Library of Theses and Dissertations (NDLTD) (October 2014), and three other databases. We checked references in identified trials and requested information from trial authors to identify any additional published or unpublished data.\nSelection criteria\nWe included all randomized controlled trials (RCTs) and quasi-RCTs involving participants with cryoglobulinemic or non-cryoglobulinemic peripheral neuropathy associated with HCV infection. We considered any intervention (including interferon alfa, interferon alfa plus ribavirin, corticosteroids, cyclophosphamide, plasma exchange, and rituximab) alone or in combination versus placebo or another intervention ('head-to-head' comparison study design) evaluated after a minimum interval to follow-up of at least six months.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration. The planned primary outcome was change in sensory impairment (using any validated sensory neuropathy scale or quantitative sensory testing) at the end of the follow-up period. Other planned outcomes were: change in impairment (any validated combined sensory and motor neuropathy scale), change in disability (any validated disability scale), electrodiagnostic measures, number of participants with improved symptoms of neuropathy (global impression of change), and severe adverse events.\nMain results\nFour trials of HCV-related cryoglobulinemia fulfiled selection criteria and the review authors included three in quantitative synthesis. All studies were at high risk of bias. No trial addressed the primary outcome of change in sensory impairment. No trial addressed secondary outcomes of change in combined sensory and motor impairment, disability, or electrodiagnostic measures. A single trial of HCV-related mixed cryoglobulinemia treated with pegylated interferon alfa (peginterferon alfa), ribavirin, and rituximab versus peginterferon alfa and ribavirin did not show a significant difference in the number of participants with improvement in neuropathy at 36 months post treatment (risk ratio (RR) 4.00, 95% confidence interval (CI) 0.27 to 59.31, n = 9). One study of interferon alfa (n = 22) and two studies of rituximab (n = 61) provided adverse event data. Severe adverse events were no more common with interferon alfa (RR 7.00, 95% CI 0.38 to 128.02) or rituximab (RR 3.00, 95% CI 0.13 to 67.06) compared to the control group.\nAuthors' conclusions\nThere is a lack of RCTs and quasi-RCTs addressing the effects of interventions for peripheral neuropathy associated with HCV infection. At present, there is insufficient evidence from RCTs and quasi-RCTs to make evidence-based decisions about treatment.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found only four trials from this search of the literature. All four trials in this review included participants with peripheral neuropathy and HCV-related cryoglobulinemia. There were no studies of HCV-related non-cryoglobulinemic peripheral neuropathy. Only one trial, in which there were results for 37 participants, reported effects on neuropathy. This study compared 48 weeks of rituximab and antiviral therapy versus antiviral therapy alone. Three trials, two of rituximab and one of interferon alfa (83 participants in total), reported adverse events."
}
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query-laysum | 1430 | [
{
"role": "user",
"content": "Abstract: Background\nAnnually, infections contribute to approximately 25% of the 2.8 million neonatal deaths worldwide. Over 95% of sepsis-related neonatal deaths occur in low- and middle-income countries. Hand hygiene is an inexpensive and cost-effective method of preventing infection in neonates, making it an affordable and practicable intervention in low- and middle-income country settings. Therefore, hand hygiene practices may hold strong prospects for reducing the occurrence of infection and infection-related neonatal death.\nObjectives\nTo determine the effectiveness of different hand hygiene agents for preventing neonatal infection in both community and health facility settings.\nSearch methods\nSearches were conducted without date or language limits in December 2022 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and Cumulated Index to Nursing and Allied Health Literature (CINAHL), clinicaltrials.gov and International Clinical Trials Registry Platform (ICTRP) trial registries. The reference lists of retrieved studies or related systematic reviews were screened for studies not identified by the searches.\nSelection criteria\nWe included randomized controlled trials (RCTs), cross-over trials, and cluster trials that included pregnant women, mothers, other caregivers, and healthcare workers who received interventions within either the community setting or in health facility settings, and the neonates in the neonatal care units or community settings.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and the GRADE approach to assess the certainty of evidence. Primary outcomes were incidence of suspected infection (author-defined in study) within the first 28 days of life, bacteriologically confirmed infection within the first 28 days of life, all-cause mortality within the first seven days of life (early neonatal death), and all-cause mortality from the 8th to the 28th day of life (late neonatal death).\nMain results\nOur review included six studies: two RCTs, one cluster-RCT, and three cross-over trials. Three studies involved 3281 neonates; the remaining three did not specify the actual number of neonates included in their study. Three studies involved 279 nurses working in neonatal intensive care units (NICUs). The number of nurses included was not specified by one study. A cluster-RCT included 103 pregnant women of over 34 weeks gestation from 10 villages in a community setting (sources of data: 103 mother-neonate pairs) and another community-based study included 258 married pregnant women at 32 to 34 weeks of gestation (the trial reported adverse events on 258 mothers and 246 neonates). Studies examined the effectiveness of different hand hygiene practices for the incidence of suspected infection (author-defined in study) within the first 28 days of life. Three studies were rated as having low risk for allocation bias, two studies were rated as unclear risk, and one was rated as having high risk. One study was rated as having a low risk of bias for allocation concealment, one study was rated as unclear risk, and four werw rated as having high risk. Two studies were rated as having low risk for performance bias and two were rated as having low risk for attrition bias.\nOne class of agent versus another class of agent: 2% chlorhexidine gluconate (CHG) compared to alcohol hand sanitiser (61% alcohol and emollients)\nFor this comparison, no study assessed the effect of the intervention on the incidence of suspected infection within the first 28 days of life. Two percent chlorhexidine gluconate (CHG) probably reduces the risk of all infection in neonates compared to 61% alcohol hand sanitiser in regard to the incidence of all bacteriologically confirmed infection within the first 28 days of life (RR 0.79, 95% confidence interval (CI) 0.66 to 0.93; 2932 participants, 1 study; moderate-certainty evidence), number needed to treat for an additional beneficial outcome (NNTB): 385.\nThe adverse outcome was reported as mean self-reported skin change and mean observer-reported skin change. There may be little to no difference between the effects of 2% CHG on nurses’ skin compared to alcohol hand sanitiser, based on very low-certainty evidence for mean self-reported skin change (mean difference (MD) -0.80, 95% CI -1.59 to 0.01; 119 participants, 1 study) and on mean observer reported skin change (MD -0.19, CI -0.35 to -0.03; 119 participants, 1 study), respectively.\nWe identified no study that reported on all-cause mortality and other outcomes for this comparison.\nNone of the included studies assessed all-cause mortality within the first seven days of life nor the duration of hospital stay.\nOne class of agent versus two or more other classes of agent: CHG compared to plain liquid soap + hand sanitiser\nWe identified no studies that reported on our primary and secondary outcomes for this comparison except for author-defined adverse events. We are very uncertain whether plain soap plus hand sanitiser is better than CHG for nurses’ skin based on very low-certainty evidence (MD -1.87, 95% CI -3.74 to -0.00; 16 participants, 1 study; very low-certainty evidence).\nOne agent versus standard care: alcohol-based handrub (hand sanitiser) versus usual care\nThe evidence is very uncertain whether alcohol-based handrub is better than 'usual care' in the prevention of suspected infections, as reported by mothers (RR 0.98, CI 0.69 to 1.39; 103 participants, 1 study, very low-certainty evidence). We are uncertain whether alcohol-based hand sanitiser is better than 'usual care' in reducing the occurrence of early and late neonatal mortality (RR 0.29, 95% CI 0.01 to 7.00; 103 participants, 1 study; very low-certainty evidence) and (RR 0.29, CI 0.01 to 7.00; 103 participants, 1 study; very low-certainty evidence), respectively. We identified no studies that reported on other outcomes for this comparison.\nAuthors' conclusions\nWe found a paucity of data that would allow us to reach meaningful conclusions pertaining to the superiority of one form of antiseptic hand hygiene agent over another for the prevention of neonatal infection. Also, the sparse available data were of moderate- to very low-certainty. We are uncertain as to the superiority of one hand hygiene agent over another because this review included very few studies with very serious study limitations.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included six studies that involved nurses working in intensive care units of hospitals, all neonates on admission, and pregnant women in community settings. Three of the studies involved 279 nurses, and one study did not clearly report how many nurses were recruited into the study; two other studies included 361 pregnant women from community settings. Studies compared 'antiseptic detergent' versus alcohol hand rub (sanitiser); 'antiseptic detergent' versus plain soap; alcohol hand sanitiser versus 'usual care'; antiseptic detergent versus 'usual care' and antiseptic that contained iodine versus another (prepodyne versus betadine).\nTwo percent antiseptic detergent may reduce the risk of bacteria infections in neonates compared to alcohol hand sanitiser within the first 28 days of life. Overall, our review provides no strong evidence to support better effectiveness of one hand hygiene intervention compared to another for preventing infection in newborns. None of the five included studies examined other important issues such as the duration of hospital stay. There was not much difference in the undesirable effects of various hand hygiene interventions on the skin of caregivers.\nIn conclusion, we are not sure of the hand hygiene intervention that is better for preventing infection in newborn babies. We assessed only a few studies that involved small numbers of nurses and babies. In addition, most of the assessed studies had high risk of bias. Larger studies with low risk of bias are needed so reliable conclusions can be reached."
}
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query-laysum | 1431 | [
{
"role": "user",
"content": "Abstract: Background\nChemotherapy is the treatment of choice in patients with advanced or metastatic colorectal cancer (CRC) where surgical resection of metastases is not an option. Both irinotecan (IRI) and fluoropyrimidines are often included in first- or second- line chemotherapy treatment regimens in such patients. However, it is not clear whether combining these agents is superior to irinotecan alone.\nObjectives\nTo compare the efficacy and safety of two chemotherapeutic regimens, irinotecan monotherapy or irinotecan in combination with fluoropyrimidines, for patients with advanced CRC when administered in the first or second-line settings.\nSearch methods\nWe searched the following electronic databases to identify randomized controlled trials: Cochrane Colorectal Cancer Group Specialised Register (January 13, 2016), Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library Issue 12, 2016), Ovid MEDLINE (1950 to January 13, 2016), Ovid EMBASE (1974 to January 13, 2016), registers of controlled trials in progress, references cited in relevant publications and conference proceedings in related fields (BioMed Central and Medscape's Conference). The key authors or investigators of all eligible studies, and professionals in the field were contacted when necessary. The search from January 2016 identified one eligible study, an ongoing trial currently presented as an abstract, to be considered in an update of this review.\nSelection criteria\nRandomized controlled trials (RCTs) investigating the efficacy and safety of IRI chemotherapy combined with fluoropyrimidine compared with IRI alone for the treatment of patients with advanced CRC, regardless of treatment line settings.\nData collection and analysis\nStudy eligibility and methodological quality were assessed independently by the two authors, and any disagreement was solved by a third author. The data collected from the studies were reviewed qualitatively and quantitatively using the Cochrane Collaboration statistical software RevMan 5.3.\nMain results\nFive studies were included in this review with a total of 1,726 patients. The top-up search resulted in an additional ongoing trial, the results of which have not been incorporated in this review. Among five included studies, no reduction in all-cause mortality was observed in the combination arm, with a summary hazard ratio (HR) of 0.91 (95% CI: 0.81-1.02). Longer progression-free survival was observed in those treated with the combination chemotherapy (HR: 0.68, 95% CI: 0.53-0.87), however, this result may have been driven by findings from the single first-line treatment setting study.\nThe quality of evidence for overall survival was low and for progression-free survival was moderate, mainly due to study limitation from the lack of information on randomisation methods and allocation concealment.\nThere were higher risks of toxicity outcomes grade 3 or 4 diarrhoea and grade 1 or 2 alopecia, and a lower risk of grade 3 or 4 neutropenia in controls compared to the invervention group. Evidence for toxicity has been assessed to be low to moderate quality.\nAuthors' conclusions\nThere was no overall survival benefit of the irinotecan and fluoropyrimidine treatment over irinotecan alone, thus both regimens remain reasonable options in treating patients with advanced or metastatic CRC. Given the low and moderate quality of the evidence, future studies with sufficient numbers of patients in each treatment arms are needed to clarify the benefit observed in progression-free survival with combination irinotecan and fluoropyrimidines.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There is no evidence to suggest any superiority of the combination of IRI and fluoropyrimidine over IRI alone, but our results on overall survival are limited by the number of studies available to date. Longer progression-free survival was seen from adding fluoropyrimidines to IRI. Based on current evidence, both the combination regimens and IRI alone seem equally effective for treating advanced or metastatic patients. Patients in the intervention arm were less likely to develop grade 3 or 4 diarrhea and grade 1 or 2 alopecia, and more likely to have grade 3 or 4 neutropenia, compared to patients receiving IRI alone."
}
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query-laysum | 1432 | [
{
"role": "user",
"content": "Abstract: Background\nResearch evidence suggests that both mental health professionals and people with severe mental health illness such as schizophrenia or schizoaffective disorder find it difficult to communicate with each other effectively about symptoms, treatments and their side effects so that they reach a shared understanding about diagnosis, prognosis and treatment. Effective use of communication skills in mental health interactions could be associated with increased patient satisfaction and adherence to treatment.\nObjectives\nTo review the effectiveness of communication skills training for mental health professionals who work with people with severe mental illness.\nSearch methods\nWe searched the Cochrane Schizophrenia Trials Register (latest search 17 February, 2016) which is compiled by systematic searches of major resources (including AMED, BIOSIS, CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings. There are no language, date, document type, or publication status limitations for inclusion of records into the register.\nSelection criteria\nAll relevant randomised clinical trials (RCTs) that focused on communication skills training (CST) for mental health professionals who work with people with severe mental illness compared with those who received standard or no training. We sought a number of primary (patient adherence to treatment and attendance at scheduled appointments as well as mental health professionals' satisfaction with the training programme) and secondary outcomes (patients' global state, service use, mental state, patient satisfaction, social functioning, quality of life). RCTs where the unit of randomisation was by cluster (e.g. healthcare facility) were also eligible for inclusion. We included one trial that met our inclusion criteria and reported useable data.\nData collection and analysis\nWe independently selected studies, quality assessed them and extracted data. For binary outcomes, we planned to calculate standard estimates of the risk ratio (RR) and their 95% confidence intervals (CI) using a fixed-effect model. For continuous outcomes, we planned to estimate the mean difference (MD) between groups, or obtain the adjusted mean difference (aMD) where available for cluster-randomised trials. If heterogeneity had been identified, we would have explored this using a random-effects model. We used GRADE to create a 'Summary of findings' table and we assessed risk of bias for the one included study.\nMain results\nWe included one pilot cluster-RCT that recruited a total of 21 psychiatrists and 97 patients. The psychiatrists were randomised to a training programme in communication skills, compared to a no specific training (NST) programme. The trial provided useable data for only one of our prestated outcomes of interest, patient satisfaction. The trial did not report global state but did report mental state and, as global state data were not available, we included these mental state data in the 'Summary of findings' table. There was high risk of bias from attrition because of substantial losses to follow-up and incomplete outcome data.\nPatient satisfaction was measured as satisfaction with treatment and 'experience of therapeutic relationship' at medium term (five months). Satisfaction with treatment was similar between the CST and NST group using the Client Satisfaction Questionnaire (CSQ-8) (1 RCT, n = 66/97*, aMD 1.77 95% CI - 0.13 to 3.68, low-quality evidence). When comparing patient experience of the therapeutic relationship using the STAR-P scale, participants in the CST group rated the therapeutic relationship more positively than participants in the NST group (1 RCT, n = 63/97, aMD 0.21 95% CI 0.01 to 0.41, low-quality evidence).\nMental state scores on the Positive and Negative Syndrome Scale (PANSS) were similar between treatment groups for general symptoms (1 RCT, n = 59/97, aMD 4.48 95% CI -2.10 to 11.06, low-quality evidence), positive symptoms (1 RCT, n = 59/97, aMD -0.23, 95% CI -2.91 to 2.45, low-quality evidence) and negative symptoms (1 RCT, n = 59/97, aMD 3.42, 95%C CI -0.24 to 7.09, low-quality evidence).\nNo data were available for adherence to treatment, service use or quality of life.\n* Of the total of 97 randomised participants, 66 provided data.\nAuthors' conclusions\nThe evidence available is from one pilot cluster-randomised controlled trial, it is not adequate enough to draw any robust conclusions. There were relatively few good quality data and the trial is too small to highlight differences in most outcome measures. Adding a CST programme appears to have a modest positive effect on patients' experiences of the therapeutic relationship. More high-quality research is needed in this area.\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": "Severe mental illness (such as schizophrenia or schizoaffective disorder) is a mental, behavioural or emotional disorder which severely interferes with, or limits a person’s life activities for a prolonged time (e.g. from a few months to a few years).\nPeople with severe mental health problems do not always follow their treatment plans. Effective communication between health professionals and their patients is an essential part of ensuring that vital information about treatment options and maintaining contact with services is understood and followed to by the patient. For patients with severe mental health problems, and their carers, this interaction can be challenging. There are many negative outcomes for patients with severe mental health problems who experience ineffective communication with health professionals, which include alienation, increase of symptoms and possible compulsory hospitalisation. It is thought that when effective communication skills are used by mental health professionals, their patients are more satisfied and adhere to their treatment plans. Moreover, professional-patient rapport is a necessary part of giving the patient the confidence to be pro-active in their treatment regimens. However, there is a lack of evidence from randomised controlled trials (RCTs) to guide practice in this area for people with severe mental illness."
}
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query-laysum | 1433 | [
{
"role": "user",
"content": "Abstract: Background\nAntidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2019.\nObjectives\nTo evaluate the benefits and harms of pharmaceutical treatment in people with emotionalism after stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Register, CENTRAL, MEDLINE, Embase, four other databases, and three trials registers (May 2022).\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect).\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, extracted data from all included trials, and used GRADE to assess the certainty of the body of evidence. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on the Center for Neurologic Study - Lability Scale (CNS-LS) or Clinician Interview-Based Impression of Change (CIBIC), or diminished tearfulness.\nMain results\nWe did not identify any new trials for this update. We included seven trials with a total of 239 participants. Two trials had a cross-over design, but outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with a total of 213 participants. It is uncertain whether fluoxetine increases the number of people who have a 50% reduction in emotionalism when compared to placebo (risk ratio (RR) 0.26, 95% CI 0.09 to 0.77; P = 0.02; 1 trial, 19 participants) because the certainty of evidence is very low.\nSertraline may lead to little to no difference in Center for Neurologic Study - Lability Scale (CNS-LS) scores and Clinician Interview-Based Impression of Change (CIBIC) scores when compared to placebo (RR 0.20, 95% CI 0.03 to 1.50; P = 0.12; 1 trial, 28 participants; low-certainty evidence). Antidepressants probably increase the number of people who experience a reduction in tearfulness (RR 0.32, 95% CI 0.12 to 0.86; P = 0.02; 3 trials, 164 participants; moderate-certainty evidence). No trials were found that evaluated the impact of other pharmaceutical interventions.\nOnly two trial authors systematically recorded and reported adverse events, resulting in limited data on the potential harms of treatment. Six trials reported death as an adverse event and found no difference between the groups (antidepressants versus placebo) in the number of deaths reported (RR 0.59, 95% CI 0.08 to 4.50; P = 0.61; 172 participants; moderate-certainty evidence).\nThis review provides very low- to moderate-certainty evidence that antidepressants may reduce the frequency and severity of emotionalism. The included trials were small and had some degree of bias.\nAuthors' conclusions\nAntidepressants may reduce the frequency and severity of crying or laughing episodes when compared to placebo, based on very low-certainty evidence. Our conclusions must be qualified by several methodological deficiencies in the trials and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity, and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance; and include careful assessment and complete reporting of adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To evaluate the benefits and harms of medicine in people with emotionalism after stroke."
}
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query-laysum | 1434 | [
{
"role": "user",
"content": "Abstract: Background\nExercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by multiple micro re-entry circuits within the atrial tissue, which result in chaotic rapid activity in the atria.\nObjectives\nTo assess the benefits and harms of exercise-based rehabilitation programmes, alone or with another intervention, compared with no-exercise training controls in adults who currently have AF, or have been treated for AF.\nSearch methods\nWe searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and three clinical trial registers on 14 July 2016. We also checked the bibliographies of relevant systematic reviews identified by the searches. We imposed no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCT) that investigated exercise-based interventions compared with any type of no-exercise control. We included trials that included adults aged 18 years or older with atrial fibrillation, or post-treatment for atrial fibrillation.\nData collection and analysis\nTwo authors independently extracted data. We assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics. We performed meta-analyses using fixed-effect and random-effects models; we used standardised mean differences where different scales were used for the same outcome. We assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the 'Summary of findings' table.\nMain results\nWe included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.\nFor mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low.\nAuthors' conclusions\nDue to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant 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": "Atrial fibrillation (AF) is the most common irregular heart beat a person can experience. It affects the heart by 'taking over' and sending out electric pulses that makes the heartbeat irregular and inefficient. Symptoms can include irregular heartbeat, shortness of breath, weakness, dizziness, and fainting. Exercise-based cardiac rehabilitation aims to restore health in people with atrial fibrillation or those who have been treated for atrial fibrillation, through regular exercise."
}
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query-laysum | 1435 | [
{
"role": "user",
"content": "Abstract: Background\nCocaine misuse is a disorder for which no pharmacological treatment of proven efficacy exists. Advances in neurobiology could guide future medication development.\nObjectives\nTo investigate the efficacy and acceptability of dopamine agonists alone or in combination with any psychosocial intervention for the treatment of of people who misuse cocaine.\nSearch methods\nWe run the search on 12 January 2015. We searched the Cochrane Drugs and Alcohol Group (CDAG) Specialized Register, PubMed, EMBASE, CINAHL, PsycINFO, ICTRP, clinicaltrials.gov and screened reference lists.\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing dopamine agonists alone or associated with psychosocial intervention with placebo, no treatment or other pharmacological interventions.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nTwenty four studies, including 2147 participants, met the inclusion criteria. Comparing any dopamine agonist versus placebo, we found no differences for any of the outcomes considered: dropout (moderate quality of evidence), abstinence (low quality of evidence), severity of dependence (low quality of evidence), adverse events (moderate quality of evidence). This was also observed when single dopamine agonists were compared against placebo. Comparing amantadine versus antidepressants, we found low quality of evidence that antidepressants performed better for abstinence (RR 0.25, 95% CI 0.12 to 0.53) based on two studies with 44 participants. No differences were found for dropout or adverse events, for both moderate quality of evidence.\nThe major flaws of the included studies concerned selection bias because most studies did not report information about sequence generation (80%) and allocation concealment methods (86%): half of the included studies were judged at unclear risk of performance bias and 62.5% at unclear risk of detection bias for what concerns subjective outcomes.\nAuthors' conclusions\nCurrent evidence from RCTs does not support the use of dopamine agonists for treating cocaine misuse. This absence of evidence may leave to clinicians the alternative of balancing the possible benefits against the potential adverse effects of the treatment. Even the potential benefit of combining a dopamine agonist with a more potent psychosocial intervention, which was suggested by the previous Cochrane Review (Soares 2003), is not supported by the results of this Cochrane Review update.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 24 studies with 2147 participants, who were all addicted to cocaine. Most were men (82.%)with an average age of 37 years. The mean duration of the included trials was seven weeks (range 1.5 to 16 weeks) Twenty-two studies were conducted in USA, one in Brazil and one in Spain; all but four were outpatients.\nThe included trials studied the following drugs: amantadine, bromocriptine, L dopa/Carbidopa, pergolide, cabergoline hydergine, and pramipexole. All compared dopamine agonist versus placebo. Four studies compared amantidine versus antidepressants.\nNo differences were found between the drugs and placebo for any of the outcomes considered: dropout (moderate quality of evidence), abstinence (low quality of evidence), severity of dependence (low quality of evidence), adverse events (moderate quality of evidence). Antidepressants was found to be better than the dopamine agonist amantidine for abstinence, but this was based on two studies with very few participants and low quality of evidence. There is no current evidence supporting the clinical use of dopamine agonist medications in the treatment of cocaine misuse. The evidence is current to 12 January 2015."
}
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query-laysum | 1436 | [
{
"role": "user",
"content": "Abstract: Background\nThere is evidence that the process of transition from paediatric (child) to adult health services is often associated with deterioration in the health of adolescents with chronic conditions.Transitional care is the term used to describe services that seek to bridge this care gap. It has been defined as ‘the purposeful, planned movement of adolescents and young adults with chronic physical and medical conditions from child-centred to adult-oriented health care systems’. In order to develop appropriate services for adolescents, evidence of what works and what factors act as barriers and facilitators of effective interventions is needed.\nObjectives\nTo evaluate the effectiveness of interventions designed to improve the transition of care for adolescents from paediatric to adult health services.\nSearch methods\nWe searched The Cochrane Central Register of Controlled Trials 2015, Issue 1, (including the Cochrane Effective Practice and Organisation of Care Group Specialised Register), MEDLINE, EMBASE, PsycINFO, and Web of Knowledge to 19 June 2015. We also searched reference lists of included studies and relevant reviews, and contacted experts and study authors for additional studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs), controlled before- and after-studies (CBAs), and interrupted time-series studies (ITSs) that evaluated the effectiveness of any intervention (care model or clinical pathway), that aimed to improve the transition of care for adolescents from paediatric to adult health services. We considered adolescents with any chronic condition that required ongoing clinical care, who were leaving paediatric services and going on to receive services in adult healthcare units, and their families. Participating providers included all health professionals responsible for the care of young people.\nData collection and analysis\nTwo review authors independently extracted data from included papers, assessed the risk of bias of each study, and assessed the certainty of the evidence for the main comparisons using GRADE. Discrepancies were resolved by discussion. Authors were contacted for missing data. We reported the findings of the studies as pre- and post-intervention means and calculated the unadjusted absolute change from baseline with 95% confidence intervals (CI).\nMain results\nWe included four RCTs (N = 238 participants) that explored: a two-day workshop-based transition preparation training for adolescents with spina bifida; a nurse-led, one-on-one, teaching session with the additional support of a ‘health passport’ for adolescents with heart disease; a web- and SMS-based educational intervention for adolescents with a range of different conditions; and a structured comprehensive transition programme with a transition co-ordinator for adolescents with type 1 diabetes.\nOne study evaluating a one-on-one nurse-led intervention, and one evaluating a technology-based intervention suggested that these interventions may lead to slight improvements in transitional readiness and chronic disease self-management measured at six- to eight-month follow-ups (low certainty evidence). Results with the TRAQ self-management tool were: MD 0.20; 95% CI -0.16 to 0.56 and MD 0.43; 95% CI; -0.09 to 0.95; with the TRAQ self-advocacy tool: MD 0.37; 95% CI -0.06 to 0.80; and with the PAM tool were: MD 10; 95% CI 2.96 to 17.04. In contrast, transition-preparation training delivered via a two-day workshop for patients with spina bifida may lead to little or no difference in measures of self-care practice and general health behaviours when measured using the DSCPI-90©.\nTwo studies evaluated the use of health services. One study evaluated a technology-based intervention and another a comprehensive transition programme; these interventions may lead to slightly more young people taking positive steps to initiate contact with health professionals themselves (Relative risk (RR): 4.87; 95% CI 0.24 to 98.12 and RR 1.50; 95% CI 0.32 to 6.94, respectively; low certainty evidence.\nYoung people’s knowledge of their disease may slightly improve with a nurse-led, one-on-one intervention to prepare young people for transition to an adult congenital heart programme (MD 14; 95% CI 2.67 to 25.33; one study; low certainty evidence).\nDisease-specific outcome measures were reported in two studies, both of which led to little or no difference in outcomes (low certainty evidence). One study found little or no difference between intervention and control groups. A second study found that follow-up HbA1c in young people with type 1 diabetes mellitus increased by 1.2% for each percentage increase in baseline HbA1c, independent of treatment group (1.2%; 95% CI 0.4 to 1.9; P = 0.01).\nTransition interventions may lead to little or no difference in well-being or quality of life as measured with the PARS III or PedsQ (two studies; low certainty evidence). Both the technology-based intervention and the two-day workshop for young people with spina bifida found little or no difference between intervention and control groups (MD 1.29; 95% CI -4.49 to 7.07). One study did not report the data.\nFour telephone support calls from a transition co-ordinator may lead to little or no difference in rates of transfer from paediatric to adult diabetes services (one study; low certainty evidence). At 12-month follow-up, there was little or no difference between groups of young people receiving usual care or a telephone support (RR 0.80; 95% CI 0.59 to 1.08)). They may slightly reduce the risk of disease-related hospital admissions at 12-month follow-up (RR 0.29; 95% CI 0.03 to 2.40).\nAuthors' conclusions\nThe available evidence (four small studies; N = 238), covers a limited range of interventions developed to facilitate transition in a limited number of clinical conditions, with only four to 12 months follow-up. These follow-up periods may not be long enough for any changes to become apparent as transition is a lengthy process. There was evidence of improvement in patients' knowledge of their condition in one study, and improvements in self-efficacy and confidence in another, but since few studies were eligible for this review, and the overall certainty of the body of this evidence is low, no firm conclusions can be drawn about the effectiveness of the evaluated interventions. Further research is very likely to have an important impact on our confidence in the intervention effect and likely could change our conclusions. There is considerable scope for the rigorous evaluation of other models of transitional care, reporting on clinical outcomes with longer term follow-up.\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": "Three of the transitional-care programmes found that the intervention may slightly improve transitional readiness in young people, enabling them to better self-manage and adjust to using adult health services. One transitional-care programme that evaluated a two-day workshop for young people with spina bifida found little or no difference in measures of transitional readiness. Transitional-care programmes may slightly improve a young persons knowledge of their condition and their own appropriate use of health services. Transitional-care programmes led to little or no difference in health status, quality of life or well-being, or rates of transfer from child to adult health services."
}
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query-laysum | 1437 | [
{
"role": "user",
"content": "Abstract: Background\nViral load (VL) testing in people living with HIV (PLHIV) helps to monitor antiretroviral therapy (ART). VL is still largely tested using central laboratory-based platforms, which have long test turnaround times and involve sophisticated equipment. VL tests with point-of-care (POC) platforms capable of being used near the patient are potentially easy to use, give quick results, are cost-effective, and could replace central or reference VL testing platforms.\nObjectives\nTo estimate the diagnostic accuracy of POC tests to detect high viral load levels in PLHIV attending healthcare facilities.\nSearch methods\nWe searched eight electronic databases using standard, extensive Cochrane search methods, and did not use any language, document type, or publication status limitations. We also searched the reference lists of included studies and relevant systematic reviews, and consulted an expert in the field from the World Health Organization (WHO) HIV Department for potentially relevant studies. The latest search was 23 November 2020.\nSelection criteria\nWe included any primary study that compared the results of a VL test with a POC platform to that of a central laboratory-based reference test to detect high viral load in PLHIV on HIV/AIDS care or follow-up. We included all forms of POC tests for VL as defined by study authors, regardless of the healthcare facility in which the test was conducted. We excluded diagnostic case-control studies with healthy controls and studies that did not provide sufficient data to create the 2 × 2 tables to calculate sensitivity and specificity. We did not limit our study inclusion to age, gender, or geographical setting.\nData collection and analysis\nTwo review authors independently screened the titles, abstracts, and full texts of the search results to identify eligible articles. They also independently extracted data using a standardized data extraction form and conducted risk of bias assessment using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Using participants as the unit of analysis, we fitted simplified univariable models for sensitivity and specificity separately, employing a random-effects model to estimate the summary sensitivity and specificity at the current and commonly reported World Health Organization (WHO) threshold (≥ 1000 copies/mL). The bivariate models did not converge to give a model estimate.\nMain results\nWe identified 18 studies (24 evaluations, 10,034 participants) defining high viral loads at main thresholds ≥ 1000 copies/mL (n = 20), ≥ 5000 copies/mL (n = 1), and ≥ 40 copies/mL (n = 3). All evaluations were done on samples from PLHIV retrieved from routine HIV/AIDS care centres or health facilities. For clinical applicability, we included 14 studies (20 evaluations, 8659 participants) assessing high viral load at the clinical threshold of ≥ 1000 copies/mL in the meta-analyses. Of these, sub-Saharan Africa, Europe, and Asia contributed 16, three, and one evaluation respectively. All included participants were on ART in only nine evaluations; in the other 11 evaluations the proportion of participants on ART was either partial or not clearly stated. Thirteen evaluations included adults only (n = 13), five mixed populations of adults and children, whilst in the remaining two the age of included populations was not clearly stated. The majority of evaluations included commercially available tests (n = 18). Ten evaluations were POC VL tests conducted near the patient in a peripheral or onsite laboratory, whilst the other 10 were evaluations of POC VL tests in a central or reference laboratory setting. The test types evaluated as POC VL tests included Xpert HIV-1 Viral Load test (n = 8), SAMBA HIV-1 Semi-Q Test (n = 9), Alere Q NAT prototype assay for HIV-1 (n = 2) and m-PIMA HIV-1/2 Viral Load test (n = 1). The majority of evaluations (n = 17) used plasma samples, whilst the rest (n = 3) utilized whole blood samples.\nPooled sensitivity (95% confidence interval (CI)) of POC VL at a threshold of ≥ 1000 copies/mL was 96.6% (94.8 to 97.8) (20 evaluations, 2522 participants), and pooled specificity (95% CI) was 95.7% (90.8 to 98.0) (20 evaluations, 6137 participants). Median prevalence for high viral load (≥ 1000 copies/mL) (n = 20) was 33.4% (range 6.9% to 88.5%).\nLimitations\nThe risk of bias was mostly assessed as unclear across the four domains due to incomplete reporting.\nAuthors' conclusions\nWe found POC VL to have high sensitivity and high specificity for the diagnosis of high HIV viral load in PLHIV attending healthcare facilities at a clinical threshold of ≥ 1000 copies/mL.\n\nGiven the provided abstract, please respond to the following query: \"What are the implications of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "In theory, for a population of 1000 PLHIV where 100 have high virus levels, 136 people would receive a positive result with the molecular POC test; of these, 39 will not have high viral levels (false-positive result) and would be incorrectly identified as not responding to ART treatment, possibly leading to unnecessary testing or further treatment; and 864 would receive a negative test result with the molecular POC test; of these, three will actually have high virus levels (false-negative result) and would be missed whilst failing ART treatment."
}
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query-laysum | 1438 | [
{
"role": "user",
"content": "Abstract: Background\nAcne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear.\nObjectives\nTo assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne.\nSearch methods\nWe searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers.\nSelection criteria\nClinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life.\nMain results\nWe included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA.\nThe vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years.\nWe assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias.\nWe grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events.\nAzelaic acid\nIn terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence).\nLow-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence).\nIn terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of azelaic acid versus tretinoin, but individual application site reactions were reported, such as scaling.\nSalicylic acid\nFor PGA, there may be little or no difference between salicylic acid and tretinoin (RR 1.00, 95% CI 0.92 to 1.09; 1 study, 46 participants; low-quality evidence); we are not certain whether there is a difference between salicylic acid and pyruvic acid (1 study, 86 participants; very low-quality evidence); and PGA was not measured in the comparison of salicylic acid versus benzoyl peroxide.\nThere may be no difference between groups in withdrawals when comparing salicylic acid and pyruvic acid (RR 0.89, 95% CI 0.53 to 1.50; 1 study, 86 participants); when salicylic acid was compared to tretinoin, neither group had withdrawals (both based on low-quality evidence (2 studies, 74 participants)). We are uncertain whether there is a difference in withdrawals between salicylic acid and benzoyl peroxide (1 study, 41 participants; very low-quality evidence).\nFor total minor adverse events, we are uncertain if there is any difference between salicylic acid and benzoyl peroxide (1 study, 41 participants) or tretinoin (2 studies, 74 participants) (both very low-quality evidence). This outcome was not reported for salicylic acid versus pyruvic acid, but individual application site reactions were reported, such as scaling and redness.\nNicotinamide\nFour studies evaluated nicotinamide against clindamycin or erythromycin, but none measured PGA. Low-quality evidence showed there may be no difference in withdrawals between nicotinamide and clindamycin (RR 1.12, 95% CI 0.49 to 2.60; 3 studies, 216 participants) or erythromycin (RR 1.40, 95% CI 0.46 to 4.22; 1 study, 158 participants), or in total minor adverse events between nicotinamide and clindamycin (RR 1.20, 95% CI 0.73 to 1.99; 3 studies, 216 participants; low-quality evidence). Total minor adverse events were not reported in the nicotinamide versus erythromycin comparison.\nAlpha-hydroxy (fruit) acid\nThere may be no difference in PGA when comparing glycolic acid peel to salicylic-mandelic acid peel (RR 1.06, 95% CI 0.88 to 1.26; 1 study, 40 participants; low-quality evidence), and we are uncertain if there is a difference in total minor adverse events due to very low-quality evidence (1 study, 44 participants). Neither group had withdrawals (2 studies, 84 participants; low-quality evidence).\nAuthors' conclusions\nCompared to benzoyl peroxide, azelaic acid probably leads to a worse treatment response, measured using PGA. When compared to tretinoin, azelaic acid probably makes little or no difference to treatment response. For other comparisons and outcomes the quality of evidence was low or very low.\nRisk of bias and imprecision limit our confidence in the evidence. We encourage the comparison of more methodologically robust head-to-head trials against commonly used active drugs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Cochrane Review aimed to assess the effects of six topical treatments (azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid (organic acids found in food, sometimes known as fruit acid) on people with acne when compared with an inactive substance (placebo), no treatment, or other topical treatments. The evidence is current to May 2019."
}
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query-laysum | 1439 | [
{
"role": "user",
"content": "Abstract: Background\nRestless legs syndrome (RLS) is a common disease affecting about 5% to 15% of the population. Symptoms of RLS can be severe in a minority of and can have a major impact on sleep, mostly sleep initiation, and quality of life. Benzodiazepines are drugs that can induce and maintain sleep and, hence, intuitively are thought to be beneficial to people with RLS. Altough benzodiazepines, particularly clonazepam, are used to treat RLS symptoms, a systematic review done by the American Academy of Sleep Medicine stated that benzodiazepines should not be used as a first-line treatment, although could be used as a coadjuvant therapy.\nObjectives\nTo evaluate the efficacy and safety of benzodiazepine compared to placebo or other treatment for idiopathic RLS, including unconfounded trials comparing benzodiazepines versus open control.\nSearch methods\nIn March 2016 we searched CENTRAL, MEDLINE, Embase and LILACS We checked the references of each study and contacted study authors to identify any additional studies. We considered studies published in any language.\nSelection criteria\nRandomised clinical trials of benzodiazepine treatment in idiopathic RLS.\nData collection and analysis\nWe did not perform data collection and analysis, since we did not include any studies,\nMain results\nWe did not identify any studies that met the inclusion criteria of the review. Two cross-over studies are awaiting classification because the cross-over trials did not give data at the end of the first cross-over period.\nAuthors' conclusions\nThe effectiveness of benzodiazepines for RLS treatment is currently unknown.\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": "Restless legs syndrome (RLS) is a common and distressing disease affecting 5% to 15% of the population. Many physicians are still unaware of the disease and do not recognize its symptoms. This disease can affect sleep significantly, impairing quality of life. There is a need for safe and effective treatment for RLS. Current treatments include dopamine agonists, anticonvulsants, and opioids."
}
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query-laysum | 1440 | [
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"role": "user",
"content": "Abstract: Background\nChinese herbal medicines have been used for a long time to treat osteoporosis. The evidence of their benefits and harms needs to be systematically reviewed.\nObjectives\nTo assess the beneficial and harmful effects of Chinese herbal medicines as a general experimental intervention for treating primary osteoporosis by comparing herbal treatments with placebo, no intervention and conventional medicine.\nSearch methods\nWe searched the following electronic databases to January 2013: the Specialised Register of the Cochrane Complementary Medicine Field, CENTRAL, MEDLINE, EMBASE, LILACS, JICST-E, AMED, Chinese Biomedical Database and CINAHL.\nSelection criteria\nRandomised controlled trials of Chinese herbal medicines compared with placebo, no intervention or conventional medicine were included.\nData collection and analysis\nTwo authors extracted data and assessed risk of bias independently. Disagreement was resolved by discussion.\nMain results\nOne hundred and eight randomised trials involving 10,655 participants were included. Ninety-nine different Chinese herbal medicines were tested and compared with placebo (three trials), no intervention (five trials) or conventional medicine (61 trials), or Chinese herbal medicines plus western medicine were compared with western medicine (47 trials). The risk of bias across all studies was unclear for most domains primarily due to inadequate reporting of study design. Although we rated the risk of selective reporting for all studies as unclear, only a few studies contributed numerical data to the key outcomes.\nSeven trials reported fracture incidence, but they were small in sample size, suffered from various biases and tested different Chinese herbal medicines. These trials compared Kanggusong capsules versus placebo, Kanggusong granule versus Caltrate or ipriflavone plus Caltrate, Yigu capsule plus calcium versus placebo plus calcium, Xianlinggubao capsule plus Caltrate versus placebo plus Caltrate, Bushen Zhuanggu granules plus Caltrate versus placebo granules plus Caltrate, Kanggusong soup plus Caltrate versus Caltrate, Zhuangguqiangjin tablets and Shujinbogu tablets plus calcitonin ampoule versus calcitonin ampoule. The results were inconsistent.\nOne trial showed that Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol had a better effect on quality of life score (scale 0 to 100, higher is better) than calcium carbonate tablets and alfacalcidol (mean difference (MD) 5.30; 95% confidence interval (CI) 3.67 to 6.93).\nCompared with placebo in three separate trials, Chinese herbal medicines (Migu decoction, Bushen Yigu soft extract, Kanggusong capsules) showed a statistically significant increase in bone mineral density (BMD) (e.g. Kanggusong capsules, MD 0.06 g/cm3; 95% CI 0.02 to 0.10). Compared with no intervention in five trials, only two showed that Chinese herbal medicines had a statistically significant effect on increase in BMD (e.g. Shigu yin, MD 0.08 g/cm3; 95% CI 0.03 to 0.13). Compared with conventional medicine in 61 trials, 23 showed that Chinese herbal medicines had a statistically significant effect on increase in BMD. In 48 trials evaluating Chinese herbal medicines plus western medication against western medication, 26 showed better effects of the combination therapy on increase in BMD.\nNo trial reported death or serious adverse events of Chinese herbal medicines, while some trials reported minor adverse effects such as nausea, diarrhoea, etc.\nAuthors' conclusions\nCurrent findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Key results: what happens to people with osteoporosis who take Chinese herbal medicines?\". 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 | 1441 | [
{
"role": "user",
"content": "Abstract: Background\nFrey's syndrome is characterised by transient flushing and sometimes facial sweating in the area of the auriculotemporal nerve. It most commonly occurs after parotidectomy, but other causes may include submandibular gland surgery, mandibular condylar fracture, obstetric (forceps) trauma, sympathectomy and metabolic disease. Although the pathophysiology of Frey's syndrome remains controversial, the generally accepted hypothesis is that it occurs as the result of injury to the auriculotemporal nerve.\nThere is currently no clear evidence to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome, therefore the prevention of this symptom during surgery is important. The main method used for prevention is the interposition of a graft between the skin flap and the parotid bed during surgery. Biomaterials, allograft or autograft can be used for this purpose.\nObjectives\nTo evaluate the effects and safety of biomaterial, allograft or autograft interposition for the prevention of Frey's syndrome in patients undergoing parotidectomy, and to identify its effect on prevention and delayed occurrence.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Cochrane Register of Controlled Trials (CENTRAL; 2019, Issue 2); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 5 February 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs) in patients with parotid disease (including tumours, inflammation, trauma etc.) undergoing parotidectomy with a minimal follow-up period of six months. We planned to include trials with interventions including biomaterial, allograft or autograft interposition alone or in combination with other surgical techniques. We included trials that compared any graft interposition and no graft interposition, or different graft interpositions.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcome measures were incidence rate of Frey's syndrome assessed clinically (Minor's starch-iodine test) and other complications (postoperative infection, subjective painful or restricted cervical movement, scar spread, rejection of the graft, complications related to the donor site such as accessory nerve injury and haematoma). Our secondary outcome measures were incidence rate of Frey's syndrome assessed by participants (by questionnaire) and sweating area assessed by Minor's starch-iodine test. We used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included three RCTs (124 participants), two of which we assessed as at high risk of bias and one at unclear risk of bias. All studies were hospital-based and recruited participants undergoing superficial parotidectomy. Most participants were diagnosed with benign lesions of the parotid gland. Participants were followed up for more than six months. The studies evaluated the two comparisons shown below:\nSternocleidomastoid muscle flap versus no flap\nTwo studies assessed this comparison. Both assessed the effects of the sternocleidomastoid muscle flap procedure on the incidence rate of Frey's syndrome assessed clinically but neither showed a significant difference between groups (risk ratio (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.23; 24 participants and RR 1.23, 95% CI 0.88 to 1.73; 36 participants; very low-certainty evidence). We did not pool the data due to the high heterogeneity (I² = 87%).\nOne study found that the sternocleidomastoid muscle flap may result in little or no difference in other complications including haematoma (RR 2.18, 95% CI 0.09 to 50.16; 36 participants; low-certainty evidence), subjective painful or restricted cervical movement (RR 0.54, 95% CI 0.14 to 2.05; 36 participants; low-certainty evidence) and scar spread in the cervical region (RR 0.71, 95% CI 0.05 to 10.54; 36 participants; low-certainty evidence). Both studies reported the incidence rate of Frey's syndrome assessed by participants, with one reporting no events in either group and the other finding no evidence of a difference (RR 0.63, 95% CI 0.32 to 1.26; 36 participants; low-certainty evidence).\nAcellular dermal matrix versus no graft\nOnly one study assessed this comparison. Use of an acellular dermal matrix graft may result in little or no difference to the incidence rate of Frey's syndrome (assessed clinically) in comparison with the no graft group, but the evidence is very uncertain (RR 0.08, 95% CI 0.00 to 1.25; 30 participants; very low-certainty evidence).\nAcellular dermal matrix may slightly increase the wound infection rate compared with control (RR 17.00, 95% CI 1.02 to 282.67; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence of seromas or sialoceles (RR 2.33, 95% CI 0.66 to 8.23; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence rate of Frey's syndrome (assessed by participants) in comparison with the no graft group (RR 0.33, 95% CI 0.04 to 3.04; 64 participants; low-certainty evidence).\nAuthors' conclusions\nThe evidence for the effectiveness of graft interposition in preventing Frey's syndrome is of low or very low certainty. The use of acellular dermal matrix may be associated with an increase in the wound infection rate, and little or no difference in the incidence of seromas or sialoceles. Further studies are needed to draw reliable conclusions.\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": "The clinical symptoms of Frey's syndrome include sweating and flushing of the cheek when eating and chewing. It results from abnormal regrowth of damaged autonomic nerve fibres of the parotid glands, for example during surgery for parotid gland tumours. It is unclear whether placing a graft between the skin flap and the parotid bed during surgery can prevent this syndrome. Various types of grafts can be used, including biomaterial or skin, muscle or other tissue from the patient. These grafts may possibly hinder the abnormal connections of the nerves controlling the sweat glands and parotid glands when the cut nerves are re-linking after surgery."
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query-laysum | 1442 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with schizophrenia often experience symptoms which fail to fully respond to antipsychotic medication. Transcranial magnetic stimulation (TMS) has been proposed as a new treatment for people with schizophrenia, especially those who experience persistent auditory hallucinations.\nObjectives\nTo estimate the effects of TMS alone, compared with sham TMS or with 'standard management' and any other comparison interventions in reducing psychotic symptoms associated with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (June 2006, June 2008, April 2013). This register is compiled by methodical searches of MEDLINE, EMBASE, BIOSIS, CINAHL, Dissertation abstracts, LILACS, PSYNDEX, PsycINFO, RUSSMED, and Sociofile, and is supplemented with handsearching of relevant journals and numerous conference proceedings.\nSelection criteria\nWe included all randomised controlled trials recruiting at least five participants and comparing TMS with sham TMS or any other treatment for people with schizophrenia.\nData collection and analysis\nWe extracted data independently. For dichotomous data we calculated relative risks (RRs) and their 95% confidence intervals (CIs). For continuous data, we calculated mean differences (MD) and 95% CI. We used a fixed-effect model. We assessed overall quality of the evidence using the GRADE approach.\nMain results\nWe included 41 studies with 1473 participants in the review. We found significant differences in favour of temporoparietal TMS compared to sham TMS for global state measured on the CGI scale (7 RCTs, n = 224, MD -0.5, 95% CI -0.76 to -0.23, very low-quality evidence) and positive symptoms measured on the PANSS scale (5 RCTs, n = 127, MD -6.09, 95% CI -10.95 to -1.22, very low-quality evidence). Participants experienced significantly more headaches in the temporoparietal TMS group (10 RCTs, n = 392, RR 2.65, 95% CI 1.56 to 4.50, very low-quality evidence). However, no more participants left the study early from the TMS group than from the sham group (very low-quality evidence). Cognitive state was assessed using 39 different measures, and all were equivocal (very low-quality evidence).\nWe included only two trials which compared temporoparietal TMS with standard treatment. In both trials the participants received first- and second-generation antipsychotic medication in both treatment groups, therefore TMS was used an adjunctive therapy to medication. We found no significant differences in the number of participants that showed clinical improvement in global state (1 RCT, n = 100, RR 1.19, 95% CI 0.91 to 1.57) or left the study early (2 RCTs, n = 140, RR 0.33, 95% CI 0.08 to 1.46) (both very low-quality evidence). No studies reported on global state score, mental state, cognitive state and adverse effects.\nFor prefrontal TMS compared to sham TMS, global state was measured on three different scales, all of which presented equivocal results (very low quality evidence). We could not pool data for mental state on the PANSS scale due to high heterogeneity. Cognitive state was assessed using 19 different measures, with 15/19 being equivocal (very low-quality evidence). Prefrontal TMS caused more headaches (6 RCTs, n = 164, RR 2.77, 95% CI 1.22 to 6.26, very low-quality evidence) but there was no difference in the number of participants leaving the study early (very low-quality evidence). No studies reported data for clinical improvement.\nWe found a significant difference in favour of prefrontal theta burst stimulation TMS compared to sham TMS for mental state on the PANNS scale (3 RCTs, n = 108, MD -5.71, 95% CI -9.32 to -2.10, very low evidence). We found no difference for clinical improvement, cognitive state, number of headaches, and leaving the study early (very low-quality evidence).\nNone of the included studies reported satisfaction with care.\nAuthors' conclusions\nBased on this review, there is insufficient evidence to support or refute the use of TMS to treat symptoms of schizophrenia. Although some evidence suggests that TMS, and in particular temporoparietal TMS, may improve certain symptoms (such as auditory hallucinations and positive symptoms of schizophrenia) compared to sham TMS, the results were not robust enough to be unequivocal across the assessment measures used. There was insufficient evidence to suggest any added benefit with TMS used as an adjunctive therapy to antipsychotic medication.\nThe overall quality of evidence was graded as very low due to risk of bias, and this was accompanied by an imprecision in estimates due to the relatively small number of participants in the studies. Thus, consideration is required in improving the quality of trial processes, as well as the quality of reporting of ongoing and future TMS trials, so as to facilitate accurate future judgements in assessing risk of bias. Differences in TMS techniques in relation to stimulation intensity, stimulation length, brain areas stimulated and variations in the design of sham TMS all contributed to the heterogeneity of study findings and limited the interpretation and applicability of the results. In addition, the trials assessed their outcomes with a variety of scales, and usable data were limited. Therefore, to better evaluate the treatment effects of TMS in people with schizophrenia, we favour the use of standardised treatment protocols and outcome measures.\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": "Transcranial magnetic stimulation is a relatively new and sophisticated device-based therapy. TMS involves the skilful application of a strong magnetic field close to the surface of the scalp. The TMS device delivers strong and very brief magnetic pulses that stimulate the brain and its network of neurons. TMS is a relatively painless and non-invasive technique that stimulates parts of the brain (the cerebral cortex). Brain activity has been shown to differ in people with schizophrenia compared to other people.\nPeople with schizophrenia often experience symptoms, such as hearing voices or seeing things (hallucinations), which fail to fully respond to medication. TMS has been proposed as a new treatment for people with schizophrenia, especially those who experience persistent auditory hallucinations. Antipsychotic medication also often has debilitating side effects, such as weight gain, apathy or lack or drive, and shaking. TMS could be an alternative treatment for people who do not cope well with standard medication."
}
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query-laysum | 1443 | [
{
"role": "user",
"content": "Abstract: Background\nProstaglandins are naturally occurring lipids that are synthesised from arachidonic acid. Multiple studies have evaluated the benefits of prostaglandins in reducing ischaemia reperfusion injury after liver transplantation. New studies have been published since the previous review, and hence it was important to update the evidence for this intervention.\nObjectives\nTo evaluate the benefits and harms of prostaglandins in adults undergoing liver transplantation compared with placebo or standard care.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 27 December 2022.\nSelection criteria\nWe included randomised clinical trials evaluating prostaglandins initiated in the perioperative period compared with placebo or standard care for adults undergoing liver transplantation. We included trials irrespective of reported outcomes.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. all-cause mortality, 2. serious adverse events, and 3. health-related quality of life. Our secondary outcomes were 4. liver retransplantation, 5. early allograft dysfunction, 6. primary non-function of the allograft, 7. acute kidney failure, 8. length of hospital stay, and 9. adverse events considered non-serious. We used GRADE to assess certainty of evidence.\nMain results\nWe included 11 randomised clinical trials with 771 adult liver transplant recipients (mean age 47.31 years, male 61.48%), of whom 378 people were randomised to receive prostaglandins and 393 people were randomised to either placebo (272 participants) or standard care (121 participants). All trials were published between 1993 and 2016. Ten trials were conducted in high- and upper-middle-income countries.\nProstaglandins may reduce all-cause mortality up to one month (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.61 to 1.23; risk difference (RD) 21 fewer per 1000, 95% CI 63 fewer to 36 more; 11 trials, 771 participants; low-certainty evidence). Prostaglandins may result in little to no difference in serious adverse events (RR 0.92, 95% CI 0.60 to 1.40; RD 81 fewer per 1000, 95% CI 148 fewer to 18 more; 6 trials, 568 participants; low-certainty evidence). None of the included trials reported health-related quality of life. Prostaglandins may result in little to no difference in liver retransplantation (RR 0.98, 95% CI 0.49 to 1.96; RD 1 fewer per 1000, 95% CI 33 fewer to 62 more; 6 trials, 468 participants; low-certainty evidence); early allograft dysfunction (RR 0.62, 95% CI 0.33 to 1.18; RD 137 fewer per 1000, 95% CI 241 fewer to 47 more; 1 trial, 99 participants; low-certainty evidence); primary non-function of the allograft (RR 0.58, 95% CI 0.26 to 1.32; RD 23 fewer per 1000, 95% CI 40 fewer to 16 more; 7 trials, 624 participants; low-certainty evidence); and length of hospital stay (mean difference (MD) −1.15 days, 95% CI −5.44 to 3.14; 4 trials, 369 participants; low-certainty evidence). Prostaglandins may result in a large reduction in the development of acute kidney failure requiring dialysis (RR 0.42, 95% CI 0.24 to 0.73; RD 100 fewer per 1000, 95% CI 132 fewer to 49 fewer; 5 trials, 477 participants; low-certainty evidence). The evidence is very uncertain about the effect of prostaglandins on adverse events considered non-serious (RR 1.19, 95% CI 0.42 to 3.36; RD 225 fewer per 1000, 95% CI 294 fewer to 65 fewer; 4 trials, 329 participants; very low-certainty evidence).\nTwo trials reported receiving funding; one of these was with vested interests.\nWe found one registered ongoing trial.\nAuthors' conclusions\nEleven trials evaluated prostaglandins in adult liver transplanted recipients. Based on low-certainty evidence, prostaglandins may reduce all-cause mortality up to one month; may cause little to no difference in serious adverse events, liver retransplantation, early allograft dysfunction, primary non-function of the allograft, and length of hospital stay; and may have a large reduction in the development of acute kidney injury requiring dialysis. We do not know the effect of prostaglandins on adverse events considered non-serious. We lack adequately powered, high-quality trials evaluating the effects of prostaglandins for people undergoing liver transplantation.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Death from any cause\nProstaglandins may reduce death from any cause (11 studies, 771 people). In 1000 people, we may expect that 21 fewer people would die with prostaglandins compared with standard care or placebo.\nDid people get better with prostaglandins?\n– Prostaglandins may result in little to no difference in need for retransplantation (6 studies, 468 participants).\n– Prostaglandins may result in little to no difference in initial poor function of the liver (1 study, 99 participants).\n– Prostaglandins may result in little to no difference in initial non-function of the liver (7 studies, 624 participants).\n– Prostaglandins may result in a large reduction in the development of acute kidney injury needing dialysis (5 studies, 477 participants).\nDid people get worse with prostaglandins?\nWe did not find any information to suggest that prostaglandins cause harm.\nQuality of life\nNone of the studies reported quality of life.\nUnwanted effects\nWe found no information to suggest that prostaglandins cause harm."
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query-laysum | 1444 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis affecting the knee is common and represents a continuum of disease from early cartilage thinning to full-thickness cartilage loss, bony erosion, and deformity. Many studies do not stratify their results based on the severity of the disease at baseline or recruitment.\nObjectives\nTo assess the benefits and harms of surgical intervention for the management of symptomatic mild to moderate knee osteoarthritis defined as knee pain and radiographic evidence of non-end stage osteoarthritis (Kellgren-Lawrence grade 1, 2, 3 or equivalent on MRI/arthroscopy). Outcomes of interest included pain, function, radiographic progression, quality of life, short-term serious adverse events, re-operation rates and withdrawals due to adverse events.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase up to May 2018. We also conducted searches of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for ongoing trials. Authors of trials were contacted if some but not all their participants appeared to fit our inclusion criteria.\nSelection criteria\nWe included randomised controlled trials that compared surgery to non-surgical interventions (including sham and placebo control groups, exercise or physiotherapy, and analgesic or other medication), injectable therapies, and trials that compared one type of surgical intervention to another surgical intervention in people with symptomatic mild to moderate knee osteoarthritis.\nData collection and analysis\nTwo review authors independently selected trials and extracted data using standardised forms. We analysed the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\nA total of five studies involving 566 participants were identified as eligible for this review. Single studies compared arthroscopic partial meniscectomy to physical therapy (320 participants), arthroscopic surgery (debridement ± synovectomy ± chondroplasty) to closed needle joint lavage with saline (32 participants) and high tibial osteotomy surgery to knee joint distraction surgery (62 participants). Two studies (152 participants) compared arthroscopic surgery (washout ± debridement; debridement) to a hyaluronic acid injection. Only one study was at low risk of selection bias, and due to the difficulty of blinding participants to their treatment, all studies were at risk of performance and detection bias.\nReporting of results in this summary has been restricted to the primary comparison: surgical intervention versus non-surgical intervention.\nA single study, included 320 participants with symptoms consistent with meniscal tear. All subjects had the meniscal tear confirmed on knee MRI and radiographic evidence of mild to moderate osteoarthritis (osteophytes, cartilage defect or joint space narrowing). Patients with severe osteoarthritis (KL grade 4) were excluded. The study compared arthroscopic partial meniscectomy and physical therapy to physical therapy alone (a six-week individualised progressive home exercise program). This study was at low risk of selection bias and outcome reporting biases, but was susceptible to performance and detection biases. A high rate of cross-over (30.2%) occurred from the physical therapy group to the arthroscopic group.\nLow-quality evidence suggests there may be little difference in pain and function at 12 months follow-up in people who have arthroscopic partial meniscectomy and those who have physical therapy. Evidence was downgraded to low quality due to risk of bias and imprecision.\nMean pain was 19.3 points on a 0 to 100 point KOOS pain scale with physical therapy at 12 months follow-up and was 0.2 points better with surgery (95% confidence interval (CI) 4.05 better to 3.65 points worse with surgery, an absolute improvement of 0.2% (95% CI 4% better to 4% worse) and relative improvement 0.4% (95% CI 9% better to 8% worse) (low quality evidence). Mean function was 14.5 on a 0 to 100 point KOOS function scale with physical therapy at 12 months follow-up and 0.8 points better with surgery (95% CI 4.3 better to 2.7 worse); 0.8% absolute improvement (95% CI 4% better to 3% worse) and 2.1% relative improvement (95% CI 11% better to 7% worse) (low quality evidence).\nRadiographic structural osteoarthritis progression and quality of life outcomes were not reported.\nDue to very low quality evidence, we are uncertain if surgery is associated with an increased risk of serious adverse events, incidence of total knee replacement or withdrawal rates. Evidence was downgraded twice due to very low event rates, and once for risk of bias.\nAt 12 months, the surgery group had a total of three serious adverse events including fatal pulmonary embolism, myocardial infarction and hypoxaemia. The physical therapy alone group had two serious adverse events including sudden death and stroke (Peto OR 1.58, 95% CI 0.27 to 9.21); 1% more events with surgery (95% CI 2% less to 3% more) and 58% relative change (95% CI 73% less to 821% more). One participant in each group withdrew due to adverse events.\nTwo of 164 participants (1.2%) in the physical therapy group and three of 156 in the surgery group underwent conversion to total knee replacement within 12 months (Peto OR 1.76, 95% CI 0.43 to 7.13); 1% more events with surgery (95% CI 2% less to 5% more); 76% relative change (95% CI 57% less to 613% more).\nAuthors' conclusions\nThe review found no placebo-or sham-controlled trials of surgery in participants with symptomatic mild to moderate knee osteoarthritis. There was low quality evidence that there may be no evidence of a difference between arthroscopic partial meniscectomy surgery and a home exercise program for the treatment of this condition. Similarly, low-quality evidence from a few small trials indicates there may not be any benefit of arthroscopic surgery over other non-surgical treatments including saline irrigation and hyaluronic acid injection, or one type of surgery over another. We are uncertain of the risk of adverse events or of progressing to total knee replacement due to very small event rates. Thus, there is uncertainty around the current evidence to support or oppose the use of surgery in mild to moderate knee osteoarthritis. As no benefit has been demonstrated from the low quality trials included in this review, it is possible that future higher quality trials for these surgical interventions may not contradict these results.\n\nGiven the provided abstract, please respond to the following query: \"Funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "One study was supported by grant 9040 from the Robert Wood Johnson Foundation, by the NIH (NIAMS) and by the Percy Surgical Research Trust of Lutheran General Hospital. One study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. One study was funded by ZonMw (The Netherlands Organisation for Health Research and Development). Two studies did not report any funding source."
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query-laysum | 1445 | [
{
"role": "user",
"content": "Abstract: Background\nNonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently prescribed drugs for the treatment of sciatica. A previous Cochrane review on the efficacy of NSAIDs summarised findings for acute and chronic low back pain (LBP) and sciatica. This is an update of the original review (2008) focusing on people suffering from sciatica.\nObjectives\nTo determine the efficacy of NSAIDs in pain reduction, overall improvement, and reported side effects in people with sciatica.\nSearch methods\nWe performed electronic searches up to 24 June 2015 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PubMed, and two trials registers. We searched reference lists of included studies and relevant reviews on the topics for additional trials.\nSelection criteria\nWe included randomised controlled trials (double-blind, single-blind, and open-label) that assessed the efficacy of NSAIDs in sciatica. We included all trials that compared NSAIDs to placebo, to other NSAIDs, or to other medication. Additional interventions were allowed if there was a clear contrast for the treatment with NSAIDs in the trial.\nData collection and analysis\nThree review authors independently assessed the risk of bias and extracted the data. Where feasible we calculated pooled results using Review Manager 5.3. We reported pain relief outcomes using mean difference (MD) with 95% confidence intervals (95% CI). We used risk ratios (RR) with 95% CI to report global improvement of treatment, adverse effects, and additional medication. We performed a meta-analysis if possible. We assessed level of evidence using the GRADE approach. We used standard methodological procedures recommended by The Cochrane Collaboration.\nMain results\nWe included 10 trials reported in 9 publications (N = 1651). Only one trial out of 10 was assessed at low risk of bias. Five trials used the currently recommended daily dose for the drug, and two trials used lower daily doses available over the counter. Three trials investigated NSAIDs no longer approved for human use. The follow-up duration was short in all studies but one.\nThree trials (n = 918) compared the effects of NSAIDs to those of placebo on pain reduction. The pooled mean difference showed comparable pain reduction (visual analogue scale, 0 to 100) in the NSAIDs and placebo groups (MD -4.56, 95% CI -11.11 to 1.99). Heterogeneity was high (I2 = 82%), and the quality of the evidence was very low. When we excluded one trial with a short follow-up of eight hours, the mean difference further decreased (MD -0.09, 95% CI -9.89 to 9.71). Three trials (n = 753) compared NSAIDs to placebo regarding global improvement. We found low-quality evidence that NSAIDs are more effective than placebo with a risk ratio of 1.14 (95% CI 1.03 to 1.27). One trial (n = 214) studied the effect of NSAIDs on disability, finding very low-quality evidence that NSAIDs are no more effective than placebo on disability. Four trials (n = 967) comparing NSAIDs to placebo reported adverse effects, with low-quality evidence that the risk for adverse effects is higher in the NSAID group than in the placebo group (RR 1.40, 95% CI 1.02 to 1.93). The adverse effects reported in this review are consistent with those previously reported in the literature.\nAuthors' conclusions\nThis updated systematic review including 10 trials evaluating the efficacy of NSAIDs versus placebo or other drugs in people with sciatica reports low- to very low-level evidence using the GRADE criteria. The efficacy of NSAIDs for pain reduction was not significant. NSAIDs showed a better global improvement compared to placebo. These findings must be interpreted with caution, as the level of evidence according to the GRADE classification was very low for the outcome pain reduction and low for global improvement due to small study samples, inconsistent results, imprecision, and a high risk of bias in the included trials. While the trials included in the analysis were not powered to detect potential rare side effects, we found an increased risk for side effects in the short-term NSAIDs use. As NSAIDs are frequently prescribed, the risk-benefit ratio of prescribing the drug needs to be considered.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "NSAIDs are no more effective in reducing pain in sciatica than placebo or other drugs. NSAIDs are more effective in overall improvement compared to placebo or other drugs, but this finding should be interpreted with caution as the methodological quality of included trials is low. There is an increased risk of side effects when using NSAIDs compared to placebo. In light of the potentially serious adverse effects associated with NSAIDs, and as this drug is frequently prescribed, high-quality trials in different patient populations are warranted to address the short- and long-term benefits and long-term risks of NSAIDs."
}
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query-laysum | 1446 | [
{
"role": "user",
"content": "Abstract: Background\nDental caries (tooth decay) and periodontal diseases (gingivitis and periodontitis) affect the majority of people worldwide, and treatment costs place a significant burden on health services. Decay and gum disease can cause pain, eating and speaking difficulties, low self-esteem, and even tooth loss and the need for surgery. As dental plaque is the primary cause, self-administered daily mechanical disruption and removal of plaque is important for oral health. Toothbrushing can remove supragingival plaque on the facial and lingual/palatal surfaces, but special devices (such as floss, brushes, sticks, and irrigators) are often recommended to reach into the interdental area.\nObjectives\nTo evaluate the effectiveness of interdental cleaning devices used at home, in addition to toothbrushing, compared with toothbrushing alone, for preventing and controlling periodontal diseases, caries, and plaque. A secondary objective was to compare different interdental cleaning devices with each other.\nSearch methods\nCochrane Oral Health’s Information Specialist searched: Cochrane Oral Health’s Trials Register (to 16 January 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2018, Issue 12), MEDLINE Ovid (1946 to 16 January 2019), Embase Ovid (1980 to 16 January 2019) and CINAHL EBSCO (1937 to 16 January 2019). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication.\nSelection criteria\nRandomised controlled trials (RCTs) that compared toothbrushing and a home-use interdental cleaning device versus toothbrushing alone or with another device (minimum duration four weeks).\nData collection and analysis\nAt least two review authors independently screened searches, selected studies, extracted data, assessed studies' risk of bias, and assessed evidence certainty as high, moderate, low or very low, according to GRADE. We extracted indices measured on interproximal surfaces, where possible. We conducted random-effects meta-analyses, using mean differences (MDs) or standardised mean differences (SMDs).\nMain results\nWe included 35 RCTs (3929 randomised adult participants). Studies were at high risk of performance bias as blinding of participants was not possible. Only two studies were otherwise at low risk of bias. Many participants had a low level of baseline gingival inflammation.\nStudies evaluated the following devices plus toothbrushing versus toothbrushing: floss (15 trials), interdental brushes (2 trials), wooden cleaning sticks (2 trials), rubber/elastomeric cleaning sticks (2 trials), oral irrigators (5 trials). Four devices were compared with floss: interdental brushes (9 trials), wooden cleaning sticks (3 trials), rubber/elastomeric cleaning sticks (9 trials) and oral irrigators (2 trials). Another comparison was rubber/elastomeric cleaning sticks versus interdental brushes (3 trials).\nNo trials assessed interproximal caries, and most did not assess periodontitis. Gingivitis was measured by indices (most commonly, Löe-Silness, 0 to 3 scale) and by proportion of bleeding sites. Plaque was measured by indices, most often Quigley-Hein (0 to 5).\nPrimary objective: comparisons against toothbrushing alone\nLow-certainty evidence suggested that flossing, in addition to toothbrushing, may reduce gingivitis (measured by gingival index (GI)) at one month (SMD -0.58, 95% confidence interval (CI) -1.12 to -0.04; 8 trials, 585 participants), three months or six months. The results for proportion of bleeding sites and plaque were inconsistent (very low-certainty evidence).\nVery low-certainty evidence suggested that using an interdental brush, plus toothbrushing, may reduce gingivitis (measured by GI) at one month (MD -0.53, 95% CI -0.83 to -0.23; 1 trial, 62 participants), though there was no clear difference in bleeding sites (MD -0.05, 95% CI -0.13 to 0.03; 1 trial, 31 participants). Low-certainty evidence suggested interdental brushes may reduce plaque more than toothbrushing alone (SMD -1.07, 95% CI -1.51 to -0.63; 2 trials, 93 participants).\nVery low-certainty evidence suggested that using wooden cleaning sticks, plus toothbrushing, may reduce bleeding sites at three months (MD -0.25, 95% CI -0.37 to -0.13; 1 trial, 24 participants), but not plaque (MD -0.03, 95% CI -0.13 to 0.07).\nVery low-certainty evidence suggested that using rubber/elastomeric interdental cleaning sticks, plus toothbrushing, may reduce plaque at one month (MD -0.22, 95% CI -0.41 to -0.03), but this was not found for gingivitis (GI MD -0.01, 95% CI -0.19 to 0.21; 1 trial, 12 participants; bleeding MD 0.07, 95% CI -0.15 to 0.01; 1 trial, 30 participants).\nVery-low certainty evidence suggested oral irrigators may reduce gingivitis measured by GI at one month (SMD -0.48, 95% CI -0.89 to -0.06; 4 trials, 380 participants), but not at three or six months. Low-certainty evidence suggested that oral irrigators did not reduce bleeding sites at one month (MD -0.00, 95% CI -0.07 to 0.06; 2 trials, 126 participants) or three months, or plaque at one month (SMD -0.16, 95% CI -0.41 to 0.10; 3 trials, 235 participants), three months or six months, more than toothbrushing alone.\nSecondary objective: comparisons between devices\nLow-certainty evidence suggested interdental brushes may reduce gingivitis more than floss at one and three months, but did not show a difference for periodontitis measured by probing pocket depth. Evidence for plaque was inconsistent.\nLow- to very low-certainty evidence suggested oral irrigation may reduce gingivitis at one month compared to flossing, but very low-certainty evidence did not suggest a difference between devices for plaque.\nVery low-certainty evidence for interdental brushes or flossing versus interdental cleaning sticks did not demonstrate superiority of either intervention.\nAdverse events\nStudies that measured adverse events found no severe events caused by devices, and no evidence of differences between study groups in minor effects such as gingival irritation.\nAuthors' conclusions\nUsing floss or interdental brushes in addition to toothbrushing may reduce gingivitis or plaque, or both, more than toothbrushing alone. Interdental brushes may be more effective than floss. Available evidence for tooth cleaning sticks and oral irrigators is limited and inconsistent. Outcomes were mostly measured in the short term and participants in most studies had a low level of baseline gingival inflammation. Overall, the evidence was low to very low-certainty, and the effect sizes observed may not be clinically important. Future trials should report participant periodontal status according to the new periodontal diseases classification, and last long enough to measure interproximal caries and periodontitis.\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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"role": "assistant",
"content": "The evidence is low to very low-certainty. The effects observed may not be clinically important. Studies measured outcomes mostly in the short term and many participants had a low level of gum disease at the beginning of the studies."
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query-laysum | 1447 | [
{
"role": "user",
"content": "Abstract: Background\nFatigue is a common and disabling symptom in people with a primary brain tumour (PBT). The effectiveness of interventions for treating clinically significant levels of fatigue in this population is unclear. This is an updated version of the original Cochrane Review published in Issue 4, 2016.\nObjectives\nTo assess the effectiveness and safety of pharmacological and non-pharmacological interventions for adults with PBT and clinically significant (or high levels) of fatigue.\nSearch methods\nFor this updated review, we searched CENTRAL, MEDLINE and Embase, and checked the reference lists of included studies in April 2022. We also searched relevant conference proceedings, and ClinicalTrials.gov for ongoing trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated any pharmacological or non-pharmacological intervention in adults with PBT and fatigue, where fatigue was the primary outcome measure. We restricted inclusion specifically to studies that enrolled only participants with clinically significant levels of fatigue to improve the clinical utility of the findings.\nData collection and analysis\nTwo review authors (JD, DC) independently evaluated search results for the updated search. Two review authors (JD, SYK) extracted data from selected studies, and carried out a risk of bias assessment. We extracted data on fatigue, mood, cognition, quality of life and adverse events outcomes.\nMain results\nThe original review identified one study and this update identified a further two for inclusion. One study investigated the use of modafinil, one study the use of armodafinil and one study the use of dexamfetamine. We identified three ongoing studies.\nIn the original review, the single eligible trial compared modafinil to placebo for 37 participants with a high- or low-grade PBT. One new study compared two doses of armodafinil (150 mg and 250 mg) to placebo for 297 people with a high-grade glioma. The second new study compared dexamfetamine sulfate to placebo for 46 participants with a low- or high-grade PBT. The evidence was uncertain for both modafinil and dexamfetamine regarding fatigue outcome measures, compared to controls, at study endpoint. Two trials did not reach the planned recruitment target and therefore may not, in practice, have been adequately powered to detect a difference. These trials were at a low risk of bias across most areas. There was an unclear risk of bias related to the use of mean imputation for one study because the investigators did not analyse the impact of imputation on the results and information regarding baseline characteristics and randomisation were not clear. The certainty of the evidence measured using GRADE was very low across all three studies.\nThere was one identified study awaiting classification once data are available, which investigated the feasibility of 'health coaching' for people with a PBT experiencing fatigue. There were three ongoing studies that may be eligible for an update of this review, all investigating a non-pharmacological intervention for fatigue in people with PBT.\nAuthors' conclusions\nThere is currently insufficient evidence to draw reliable and generalisable conclusions regarding potential effectiveness or harm of any pharmacological or non-pharmacological treatments for fatigue in people with PBT. More research is needed on how best to treat people with brain tumours with high fatigue.\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 is current to April 2022."
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query-laysum | 1448 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a Cochrane Review first published in 2001.\nHernias are protrusions of all or part of an organ through the body wall that normally contains it. Groin hernias include inguinal (96%) and femoral (4%) hernias, and are often symptomatic with discomfort. They are extremely common, with an estimated lifetime risk in men of 27%. Occasionally they may present as emergencies with complications such as bowel incarceration, obstruction and strangulation. The definitive treatment of all hernias is surgical repair, inguinal hernia repair being one of the most common surgical procedures performed. Mesh (hernioplasty) and the traditional non-mesh repairs (herniorrhaphy) are commonly used, with an increasing preference towards mesh repairs in high-income countries.\nObjectives\nTo evaluate the benefits and harms of different inguinal and femoral hernia repair techniques in adults, specifically comparing closure with mesh versus without mesh. Outcomes include hernia recurrence, complications (including neurovascular or visceral injury, haematoma, seroma, testicular injury, infection, postoperative pain), mortality, duration of operation, postoperative hospital stay and time to return to activities of daily living.\nSearch methods\nWe searched the following databases on 9 May 2018: Cochrane Colorectal Cancer Group Specialized Register, Cochrane Central Register of Controlled Trials (Issue 1), Ovid MEDLINE (from 1950), Ovid Embase (from 1974) and Web of Science (from 1900). Furthermore, we checked the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials. We applied no language or publication restrictions. We also searched the reference lists of included trials and review articles.\nSelection criteria\nWe included randomised controlled trials of mesh compared to non-mesh inguinal or femoral hernia repairs in adults over the age of 18 years.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Where available, we collected information on adverse effects. We presented dichotomous data as risk ratios, and where possible we calculated the number needed to treat for an additional beneficial outcome (NNTB). We presented continuous data as mean difference. Analysis of missing data was based on intention-to-treat principles, and we assessed heterogeneity using an evaluation of clinical and methodological diversity, Chi2 test and I2 statistic. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included 25 studies (6293 participants) in this review. All included studies specified inguinal hernias, and two studies reported that femoral hernias were included.\nMesh repair probably reduces the risk of hernia recurrence compared to non-mesh repair (21 studies, 5575 participants; RR 0.46, 95% CI 0.26 to 0.80, I2 = 44%, moderate-quality evidence). In absolute numbers, one hernia recurrence was prevented for every 46 mesh repairs compared with non-mesh repairs. Twenty-four studies (6293 participants) assessed a wide range of complications with varying follow-up times. Neurovascular and visceral injuries were more common in non-mesh repair groups (RR 0.61, 95% CI 0.49 to 0.76, I2 = 0%, NNTB = 22, high-quality evidence). Wound infection was found slightly more commonly in the mesh group (20 studies, 4540 participants; RR 1.29, 95% CI 0.89 to 1.86, I2 = 0%, NNTB = 200, low-quality evidence). Mesh repair reduced the risk of haematoma compared to non-mesh repair (15 studies, 3773 participants; RR 0.88, 95% CI 0.68 to 1.13, I2 = 0%, NNTB = 143, low-quality evidence). Seromas probably occur more frequently with mesh repair than with non-mesh repair (14 studies, 2640 participants; RR 1.63, 95% CI 1.03 to 2.59, I2 = 0%, NNTB = 72, moderate-quality evidence), as does wound swelling (two studies, 388 participants; RR 4.56, 95% CI 1.02 to 20.48, I2 = 33%, NNTB = 72, moderate-quality evidence). The comparative effect on wound dehiscence is uncertain due to wide confidence intervals (two studies, 329 participants; RR 0.55, 95% CI 0.12 to 2.48, I2 = 37% NNTB = 77, low-quality evidence). Testicular complications showed nearly equivocal results; they probably occurred slightly more often in the mesh group however the confidence interval around the effect was wide (14 studies, 3741 participants; RR 1.06, 95% CI 0.63 to 1.76, I2 = 0%, NNTB = 2000, low-quality evidence). Mesh reduced the risk of postoperative urinary retention compared to non-mesh (eight studies, 1539 participants; RR 0.53, 95% CI 0.38 to 0.73, I2 = 56%, NNTB = 16, moderate-quality evidence).\nPostoperative and chronic pain could not be compared due to variations in measurement methods and follow-up time (low-quality evidence).\nNo deaths occurred during the follow-up periods reported in the seven studies (2546 participants) reporting this outcome (high-quality evidence).\nThe average operating time was longer for non-mesh repairs by a mean of 4 minutes 22 seconds, despite wide variation across the studies regarding size and direction of effect, thus this result is uncertain (20 studies, 4148 participants; 95% CI -6.85 to -1.60, I2= 97%, very low-quality evidence). Hospital stay may be shorter with mesh repair, by 0.6 days (12 studies, 2966 participants; 95% CI -0.86 to -0.34, I2 = 98%, low-quality evidence), and participants undergoing mesh repairs may return to normal activities of daily living a mean of 2.87 days sooner than those with non-mesh repair (10 studies, 3183 participants; 95% CI -4.42 to -1.32, I2 = 96%, low-quality evidence), although the results of both these outcomes are also limited by wide variation in the size and direction of effect across the studies.\nAuthors' conclusions\nMesh and non-mesh repairs are effective surgical approaches in treating hernias, each demonstrating benefits in different areas. Compared to non-mesh repairs, mesh repairs probably reduce the rate of hernia recurrence, and reduce visceral or neurovascular injuries, making mesh repair a common repair approach. Mesh repairs may result in a reduced length of hospital stay and time to return to activities of daily living, but these results are uncertain due to variation in the results of the studies. Non-mesh repair is less likely to cause seroma formation and has been favoured in low-income countries due to low cost and reduced availability of mesh materials. Risk of bias in the included studies was low to moderate and generally handled well by study authors, with attention to details of allocation, blinding, attrition and reporting.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched a number of databases for studies; this search was last updated on 9 May 2018."
}
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query-laysum | 1449 | [
{
"role": "user",
"content": "Abstract: Background\nConventionally used soybean oil-based lipid emulsion (S-LE) have high polyunsaturated fatty acid (PUFA) content and phytosterols that may contribute to adverse effects in preterm infants. The newer lipid emulsions (LE) from different lipid sources are currently available for use in preterm infants.\nObjectives\nTo compare the safety and efficacy of all LE for parenteral nutrition (PN) in preterm infants (less than 37 weeks' gestation) including preterm infants with surgical conditions or parenteral nutrition-associated liver disease (PNALD)/cholestasis using direct comparisons and pair-wise meta-analyses.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE (1946 to 18 June 2018), Embase (1974 to 18 July 2018), CINAHL (1982 to 18 June 2018), MIDRIS (1971 to 31 May 2018), conference proceedings, trial registries (ClinicalTrials.gov and WHO's Trials Registry and Platform), and reference lists of retrieved articles.\nSelection criteria\nRandomised or quasi-randomised controlled studies in preterm infants with or without surgical conditions or PNALD within the first six months of life.\nData collection and analysis\nData collection and analysis conformed to the methods of Cochrane Neonatal. We used the GRADE approach to assess the quality of evidence for important outcomes in addition to reporting statistical significance of results.\nMain results\nWe included 29 studies (n = 2037) in this review. LE were classified in three broad groups: 1. all fish oil-containing LE including pure fish oil-LE (F-LE) and multisource LE (e.g. medium-chain triglycerides (MCT)-olive-fish-soybean oil-LE (MOFS-LE), MCT-fish-soybean oil-LE (MFS-LE) and olive-fish-soybean oil-LE (OFS-LE); 2. conventional S-LE; 3. alternative-LE (e.g. MCT-soybean oil-LE (MS-LE), olive-soybean oil-LE and borage oil-based LE).\nWe considered the following broad comparisons: fish oil LE versus non-fish oil LE; fish oil LE versus another fish oil LE; alternative-LE versus S-LE; alternative-LE versus another alternative-LE in preterm infants less than 37 weeks' gestation, preterm infants with surgical conditions and preterm infants with PNALD/cholestasis. Separate subgroup comparisons of each LE preparation were included within these broader groups.\nMost studies in preterm infants used PN for mean duration of four weeks or less and for longer duration in infants with cholestasis or surgical conditions.\nWe defined the primary outcome of PNALD/cholestasis as conjugated bilirubin (Cbil) 2 mg/dL or greater and resolution of PNALD/cholestasis as Cbil less than 2 mg/dL. There was heterogeneity in definitions used by the included studies with Cbil cut-offs ranging from 17.1 μmol/L (1 mg/dL) up to 50 μmol/L (about 3 mg/dL).\nIn preterm infants, meta-analysis found no evidence of a difference in the incidence of PNALD/cholestasis (Cbil cut-off: 2 mg/dl) between fish oil-LEs and all non-fish oil LEs (typical risk ratio (RR) 0.61, 95% confidence interval (CI) 0.24 to 1.56; typical risk difference (RD) –0.03, 95% CI –0.08 to 0.02; 4 studies; n = 328; low-quality evidence).\nWe also considered an outcome allowing for any definition of PNALD (different Cbil cutoffs). In the meta-analysis for PNALD/cholestasis, using any definition and restricted to low or unclear risk of bias studies, there was no evidence of a difference between fish oil LE and all non-fish oil LE for incidence of cholestasis (typical RR 0.80, 95% CI 0.53 to 1.21; typical RD –0.02, 95% CI –0.05 to 0.02; 10 studies; n = 1024; low-quality evidence). There was no evidence of difference in subgroup meta-analyses of individual LE types in any comparison.\nIn preterm infants with surgical conditions or cholestasis, there was only one small study each reporting no evidence of a difference in incidence or resolution of cholestasis respectively with use of a pure F-LE versus S-LE (using a Cbil cut-off of 2 mg/dL).\nIn preterm infants with PNALD/cholestasis (using any definition), the meta-analysis showed significantly less cholestasis with the use of fish oil-LE compared to S-LE (typical RR 0.54, 95% CI 0.32 to 0.91; typical RD –0.39, 95% CI –0.65 to –0.12; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 9; 2 studies; n = 40; very low-quality evidence). However, this outcome had a very low number of participants from two small studies with methodological differences, one of which was terminated early, increasing the uncertainty about effect estimates.\nThere were no differences between LE types in pair-wise meta-analyses for growth in preterm infants. There was paucity of studies in preterm infants with surgical conditions or cholestasis to perform meta-analyses for growth and most other outcomes.\nIn the secondary outcomes for preterm infants, there was no difference between fish-oil LE and non-fish oil LE in meta-analysis for severe retinopathy of prematurity (ROP) (stage 3 or greater, or requiring surgery: typical RR 0.80, 95% CI 0.55 to 1.16; typical RD –0.03, 95% CI –0.07 to 0.02; 7 studies; n = 731; very low-quality evidence). There were no differences in the LE types in pair-wise meta-analyses for death, bronchopulmonary dysplasia (BPD), ventilation duration, patent ductus arteriosus, sepsis, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, jaundice, hyperglycaemia, hypertriglyceridaemia, intrahepatocellular lipid content and conjugated bilirubin levels in any comparison.\nIn surgical infants, one study (n = 19) reported no differences in death, sepsis rates, Cbil and neurodevelopmental outcomes with pure F-LE versus S-LE.\nIn infants with cholestasis, there were no evidence of differences in death or sepsis in meta-analyses between fish oil-LE and S-LE; (2 studies; n = 40; very low-quality evidence).\nAuthors' conclusions\nIn the current review, we did not find any particular LE with or without fish oil to be better than another LE in preterm infants for prevention of PNALD/cholestasis, growth, mortality, ROP, BPD and other neonatal outcomes.\nIn preterm infants with surgical conditions or cholestasis, there is currently insufficient evidence from randomised studies to determine with any certainty if fish oil LEs offer advantage in prevention or resolution of cholestasis or in any other clinical outcome.\nFurther research, with larger well-designed trials, is warranted to evaluate the ideal composition of LE in preterm infants and the role of fish oil-containing and other LEs in the prevention and resolution of PNALD, ROP and other 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": "which lipid (fat) emulsions (LE) have the best outcomes in preterm infants with and without liver disease and surgical conditions?"
}
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query-laysum | 1450 | [
{
"role": "user",
"content": "Abstract: Background\nEnuresis (bedwetting) affects up to 20% of five year-olds and 2% of adults. Although spontaneous remission often occurs, the social, emotional and psychological costs can be great. Tricyclics have been used to treat enuresis since the 1960s.\nObjectives\nTo assess the effects of tricyclic and related drugs compared with other interventions for treating children with enuresis.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Trials Register (containing trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings), on 30 November 2015, and reference lists of relevant articles.\nSelection criteria\nWe included all randomised and quasi-randomised trials comparing a tricyclic or related drug with another intervention for treating enuresis. We also included combination therapies that included tricyclics. We excluded trials for treating daytime wetting.\nData collection and analysis\nTwo review authors independently assessed the quality of the eligible trials, and extracted data. We settled differences by discussion with a third review author.\nMain results\nSixty-four trials met the inclusion criteria, involving 4071 children. The quality of many trials was poor, with comparisons addressed by single studies. Minor adverse effects were common, and reported in 30 trials. These included dizziness, headache, mood changes, gastrointestinal discomforts and neutropenia. More serious side-effects can occur but were not reported. Seven trials reported no adverse effects.\nTricyclics are more effective than placebo, particularly for short-term outcomes. Compared to placebo, imipramine resulted in one fewer wet nights per week (mean difference (MD) -0.95, 95% confidence interval (CI) -1.40 to -0.50; 4 trials, 347 children), with fewer failing to achieve 14 consecutive dry nights (78% versus 95% for placebo, RR 0.74, 95% CI 0.61 to 0.90; 12 trials, 831 children). Amitriptyline and desipramine were more effective than placebo, but nortriptyline and mianserin showed no difference. Most tricyclics did not have a sustained effect after ceasing treatment, with 96% wetting at follow-up for imipramine versus 97% for placebo.\nImipramine combined with oxybutynin is also more effective than placebo, with 33% failing to achieve 14 consecutive dry nights at the end of treatment versus 78% for placebo (RR 0.43, 95% CI 0.23 to 0.78; 1 trial, 47 children) and 45% wetting at follow-up versus 79% for placebo (RR 0.58, 95% CI 0.34 to 0.99; 1 trial, 36 children).\nThere was insufficient evidence to judge the effect between different doses of tricyclics, and between different tricyclics. Treatment outcomes between tricyclic and desmopressin were similar, but were mixed when tricyclic was compared with an anticholinergic. However, when imipramine was compared with desmopressin plus oxybutynin (1 trial, 45 children), the combination therapy was more effective, with one fewer wet nights per week (MD 1.07, 95% CI 0.06 to 2.08) and 36% failing to achieve 14 consecutive dry nights versus 87% for imipramine (RR 2.39, 95% CI 1.35 to 4.25). Tricyclics were also more effective or showed no difference in response when compared to other drugs which are no longer used for enuresis.\nTricyclics were less effective than alarms. Although there was no difference in the number of wet nights, 67% failed to achieve 14 consecutive dry nights for imipramine versus only 17% for alarms (RR 4.00, 95% CI 1.06 to 15.08; 1 trial, 24 children). Alarm therapy also had a more sustained effect after ceasing treatment with 100% on imipramine versus 58% on alarms wetting at follow-up (RR 1.67, 95% CI 1.03 to 2.69; 1 trial, 24 children).\nImipramine was more effective than simple behavioural therapies during treatment, with one fewer wet nights per week compared with star chart plus placebo (MD -0.80, 95% CI -1.33 to -0.27; 1 trial, 250 children). At follow-up 40% were wet with imipramine versus 80% with fluids and avoiding punishment (RR 0.50, 95% CI 0.28 to 0.89; 1 trial, 40 children). However, imipramine was less effective than complex behavioural therapies, with 61% failing to achieve 14 consecutive dry nights for imipramine versus 33% for the three-step programme (RR 1.83, 95% CI 1.08 to 3.12; 1 trial, 72 children) and 16% for the three-step programme combined with motivational therapy and computer-led education (RR 3.91, 95% CI 2.30 to 6.66; 1 trial, 132 children) at the end of treatment, with similar results at follow-up.\nTricyclics were more effective than restricted diet, with 99% failing to achieve 14 consecutive dry nights versus 84% for imipramine (RR 0.84, 95% CI 0.75 to 0.93; 1 trial, 147 children).There was insufficient evidence to judge the effect of tricyclics compared to the other miscellaneous interventions studied.\nAt the end of treatment there were about two fewer wet nights for imipramine plus oxybutynin compared with imipramine monotherapy (MD -2.10, 95% CI -2.99 to -1.21; 1 trial, 63 children) and 48% on imipramine plus oxybutynin failed to achieve 14 consecutive dry nights compared with 74% on imipramine monotherapy (RR 0.68, 95% CI 0.50 to 0.92; 2 trials, 101 children). At follow-up, 45% on imipramine plus oxybutynin were wetting versus 83% on imipramine monotherapy (RR 0.55, 95% CI 0.32 to 0.92; 1 trial, 36 children).\nWhen imipramine combined with desmopressin was compared with imipramine monotherapy, there was no difference in outcomes. However, when imipramine plus desmopressin was compared with desmopressin monotherapy, the combination was more effective, with 15% not achieving 14 consecutive dry nights at the end of treatment for imipramine plus desmopressin versus 40% for desmopressin monotherapy (RR 0.38, 95% CI 0.17 to 0.83; 1 trial, 86 children). Tricyclics combined with alarm therapy were not more effective than alarm monotherapy, alarm combined with desmopressin or alarm combined with nortriptyline. The addition of a tricyclic to other behavioural therapies did not alter treatment response.\nAuthors' conclusions\nThere was evidence that tricyclics are effective at reducing the number of wet nights during treatment, but do not have a sustained effect after treatment stops, with most children relapsing. In contrast, there was evidence that alarm therapy has better short- and long-term outcomes. There was some evidence that tricyclics combined with anticholinergics may be more effective that tricyclic monotherapy.\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": "Bedwetting (nocturnal enuresis or enuresis) is the involuntary loss of urine during sleep without being caused by a physical disorder. It can result in social, emotional and psychological problems and lower quality of life. It affects around 15% to 20% of five-year-olds, and can persist in up to 2% of adults. Many different types of drugs have been used to treat bedwetting, both as a single treatment and in combination with other treatments. Tricyclics are antidepressants, which have been used for treating bedwetting since the 1960s. They probably work by their antispasmodic effect on the bladder. This review examines 64 trials of tricyclic drugs, involving 4071 children."
}
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query-laysum | 1451 | [
{
"role": "user",
"content": "Abstract: Background\nKeratoconus is a degenerative condition of the cornea that profoundly affects vision and vision-specific quality of life. The axial cornea thins and protrudes, resulting in irregularity and, eventually, scarring of the cornea. There are multiple options available for treating keratoconus. Intrastromal corneal ring segments are small, crescent-shaped plastic rings that are placed in the deep, peripheral corneal stroma in order to flatten the cornea. They are made of polymethylmethacrylate (PMMA). The procedure does not involve corneal tissue nor does it invade the central optical zone. Intrastromal corneal ring segments are approved for use when contact lenses or spectacles are no longer adequate.\nObjectives\nTo evaluate the effectiveness and safety of intrastromal corneal ring segments as a treatment for keratoconus.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2018, Issue 1); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not implement any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 25 January 2018.\nSelection criteria\nTwo review authors independently assessed records from the electronic searches to identify randomized controlled trials (RCTs). Disagreements were resolved by discussion.\nData collection and analysis\nWe planned for two authors to independently review full-text reports, using standard methodological procedures expected by Cochrane.\nMain results\nWe found no RCTs comparing intrastromal corneal ring segments with spectacles or contact lenses.\nAuthors' conclusions\nIn the absence of eligible RCTs to review, no conclusions can be drawn.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The review authors searched for studies that have been up to 25 January 2018."
}
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query-laysum | 1452 | [
{
"role": "user",
"content": "Abstract: Background\nAntipsychotic (neuroleptic) medication is used extensively to treat people with serious mental illnesses. However, it is associated with a wide range of adverse effects, including movement disorders. Because of this, many people treated with antipsychotic medication also receive anticholinergic drugs in order to reduce some of the associated movement side-effects. However, there is also a suggestion from animal experiments that the chronic administration of anticholinergics could cause tardive dyskinesia.\nObjectives\nTo determine whether the use or the withdrawal of anticholinergic drugs (benzhexol, benztropine, biperiden, orphenadrine, procyclidine, scopolamine, or trihexylphenidyl) are clinically effective for the treatment of people with both antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illnesses.\nSearch methods\nWe retrieved 712 references from searching the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (16 July 2015 and 26 April 2017). We also inspected references of all identified studies for further trials and contacted authors of trials for additional information.\nSelection criteria\nWe included reports identified in the search if they were controlled trials dealing with people with antipsychotic-induced tardive dyskinesia and schizophrenia or other chronic mental illness who had been randomly allocated to (a) anticholinergic medication versus placebo (or no intervention), (b) anticholinergic medication versus any other intervention for the treatment of tardive dyskinesia, or (c) withdrawal of anticholinergic medication versus continuation of anticholinergic medication.\nData collection and analysis\nWe independently extracted data from included trials and we estimated risk ratios (RR) with 95% confidence intervals (CIs). We assumed that people who left early had no improvement. We assessed risk of bias and created a 'Summary of findings' table using GRADE.\nMain results\nThe previous version of this review included no trials. We identified two trials that could be included from the 2015 and 2017 searches. They randomised 30 in- and outpatients with schizophrenia in the USA and Germany. Overall, the risk of bias was unclear, mainly due to poor reporting: allocation concealment was not described; generation of the sequence was not explicit; studies were not clearly blinded; and outcome data were not fully reported.\nFindings were sparse. One study reported on the primary outcomes and found that significantly more participants allocated to procyclidine (anticholinergic) had not improved to a clinically important extent compared with those allocated to isocarboxazid (MAO-inhibitor) after 40 weeks' treatment (1 RCT, n = 20; RR 4.20, 95% CI 1.40 to 12.58; very low quality evidence); that there was no evidence of a difference in the incidence of any adverse effects (1 RCT, n = 20; RR 0.33, 95% CI 0.02 to 7.32; very low quality evidence); or acceptability of treatment (measured by participants leaving the study early) (1 RCT, n = 20; RR 0.33, 95% CI 0.02 to 7.32; very low quality evidence). The other trial compared anticholinergic withdrawal with anticholinergic continuation and found no evidence of a difference in the incidence of acceptability of treatment (measured by participants leaving the study early) (1 RCT, n = 10; RR 2.14, 95% CI 0.11 to 42.52; very low quality evidence).\nNo trials reported on social confidence, social inclusion, social networks, or personalised quality of life — outcomes designated important to patients. No studies comparing either i. anticholinergics with placebo or no treatment, or ii. studies of anticholinergic withdrawal, were found that reported on the primary outcome 'no clinically important improvement in TD symptoms and adverse events'.\nAuthors' conclusions\nBased on currently available evidence, no confident statement can be made about the effectiveness of anticholinergics to treat people with antipsychotic-induced tardive dyskinesia. The same applies for the withdrawal of such medications. Whether the withdrawal of anticholinergics may benefit people with antipsychotic-induced TD should be evaluated in a parallel-group, placebo-controlled randomised trial, with adequate sample size and at least 6 weeks of follow-up.\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": ".\nThere were sparse findings from two small and poorly reported trials. It is uncertain whether giving anticholinergic drugs is helpful in the treatment of tardive dyskinesia for people who are taking antipsychotic medication. It is also uncertain whether the withdrawal of anticholinergic medication improves the symptoms of tardive dyskinesia."
}
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query-laysum | 1454 | [
{
"role": "user",
"content": "Abstract: Background\nPeople with heart failure report various symptoms and show a trajectory of periodic exacerbations and recoveries, where each exacerbation event may lead to death. Current clinical practice guidelines indicate the importance of discussing future care strategies with people with heart failure. Advance care planning (ACP) is the process of discussing an individual's future care plan according to their values and preferences, and involves the person with heart failure, their family members or surrogate decision-makers, and healthcare providers. Although it is shown that ACP may improve discussion about end-of-life care and documentation of an individual's preferences, the effects of ACP for people with heart failure are uncertain.\nObjectives\nTo assess the effects of advance care planning (ACP) in people with heart failure compared to usual care strategies that do not have any components promoting ACP.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, Social Work Abstracts, and two clinical trials registers in October 2019. We checked the reference lists of included studies. There were no restrictions on language or publication status.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared ACP with usual care in people with heart failure. Trials could have parallel group, cluster-randomised, or cross-over designs. We included interventions that implemented ACP, such as discussing and considering values, wishes, life goals, and preferences for future medical care. The study participants comprised adults (18 years of age or older) with heart failure.\nData collection and analysis\nTwo review authors independently extracted outcome data from the included studies, and assessed their risk of bias. We contacted trial authors when we needed to obtain missing information.\nMain results\nWe included nine RCTs (1242 participants and 426 surrogate decision-makers) in this review. The meta-analysis included seven studies (876 participants). Participants' mean ages ranged from 62 to 82 years, and 53% to 100% of the studies' participants were men. All included studies took place in the US or the UK.\nOnly one study reported concordance between participants' preferences and end-of-life care, and it enrolled people with heart failure or renal disease. Owing to one study with small sample size, the effects of ACP on concordance between participants' preferences and end-of-life care were uncertain (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.91 to 1.55; participants = 110; studies = 1; very low-quality evidence). It corresponded to an assumed risk of 625 per 1000 participants receiving usual care and a corresponding risk of 744 per 1000 (95% CI 569 to 969) for ACP. There was no evidence of a difference in quality of life between groups (standardised mean difference (SMD) 0.06, 95% CI –0.26 to 0.38; participants = 156; studies = 3; low-quality evidence). However, one study, which was not included in the meta-analysis, showed that the quality of life score improved by 14.86 points in the ACP group compared with 11.80 points in the usual care group.\nCompletion of documentation by medical staff regarding discussions with participants about ACP processes may have increased (RR 1.68. 95% CI 1.23 to 2.29; participants = 92; studies = 2; low-quality evidence). This corresponded to an assumed risk of 489 per 1000 participants with usual care and a corresponding risk of 822 per 1000 (95% CI 602 to 1000) for ACP. One study, which was not included in the meta-analysis, also showed that ACP helped to improve documentation of the ACP process (hazard ratio (HR) 2.87, 95% CI 1.09 to 7.59; participants = 232).\nThree studies reported that implementation of ACP led to an improvement of participants' depression (SMD –0.58, 95% CI –0.82 to –0.34; participants = 278; studies = 3; low-quality evidence). We were uncertain about the effects of ACP on the quality of communication when compared to the usual care group (MD –0.40, 95% CI –1.61 to 0.81; participants = 9; studies = 1; very low-quality evidence). We also noted an increase in all-cause mortality in the ACP group (RR 1.32, 95% CI 1.04 to 1.67; participants = 795; studies = 5).\nThe studies did not report participants' satisfaction with care/treatment and caregivers' satisfaction with care/treatment.\nAuthors' conclusions\nACP may help to increase documentation by medical staff regarding discussions with participants about ACP processes, and may improve an individual's depression. However, the quality of the evidence about these outcomes was low. The quality of the evidence for each outcome was low to very low due to the small number of studies and participants included in this review. Additionally, the follow-up periods and types of ACP intervention were varied. Therefore, further studies are needed to explore the effects of ACP that consider these differences carefully.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In October 2019, we searched for studies assessing the effects of ACP in people with heart failure. We included studies that delivered ACP, which included different methods such as discussion and consideration of individuals' values and preferences on future care and medical treatment compared to usual care strategies."
}
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query-laysum | 1455 | [
{
"role": "user",
"content": "Abstract: Background\nPremenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings, bloating, breast tenderness and sleep disturbances. About 3% to 10% of women who experience these symptoms may also meet criteria for premenstrual dysphoric disorder (PMDD). PMS symptoms recur during the luteal phase of the menstrual cycle and reduce by the end of menstruation. PMS results from ovulation and may be due to ovarian steroid interactions relating to neurotransmitter dysfunction. Premenstrual disorders have a devastating effect on women, their families and their work.\nSeveral treatment options have been suggested for PMS, including pharmacological and surgical interventions. The treatments thought to be most effective tend to fall into one of two categories: suppressing ovulation or correcting a speculated neuroendocrine anomaly.\nTransdermal oestradiol by patch, gel or implant effectively stops ovulation and the cyclical hormonal changes which produce the cyclical symptoms. These preparations are normally used for hormone therapy and contain lower doses of oestrogen than found in oral contraceptive pills. A shortened seven-day course of a progestogen is required each month for endometrial protection but can reproduce premenstrual syndrome-type symptoms in these women.\nObjectives\nTo determine the effectiveness and safety of non-contraceptive oestrogen-containing preparations in the management of PMS.\nSearch methods\nOn 14 March 2016, we searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register; Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; PsycINFO; CINAHL; ClinicalTrials.gov; metaRegister of Controlled trials (mRCT); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal. In addition, we checked the reference lists of articles retrieved.\nSelection criteria\nWe included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of premenstrual syndrome in women of reproductive age with PMS diagnosed by at least two prospective cycles without current psychiatric disorder.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data on premenstrual symptoms and adverse effects and entered data into Review Manager 5 software. Where possible, intention-to-treat or modified intention-to-treat analysis was used. Studies were pooled using a fixed-effect model, analysing cross-over trials as parallel trials. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated for premenstrual symptom scores. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes. The overall quality of the evidence was assessed using the GRADE working group methods.\nMain results\nThe search resulted in 524 potentially relevant articles. Five eligible randomized controlled trials (RCTs) were identified (305 women). Trials using oral tablets, transdermal patches and implants were identified. No trial used gels.\nOne small cross-over trial (11 women, effective sample size 22 women considering cross-over trials) compared oral luteal-phase oestrogen versus placebo. Data were very low quality and unsuitable for analysis, but study authors reported that the intervention was ineffective and might aggravate the symptoms of PMS. They also reported that there were no adverse events.\nThree studies compared continuous oestrogen with progestogen versus placebo (with or without progestogen). These trials were of reasonable quality, although with a high risk of attrition bias and an unclear risk of bias due to potential carry-over effects in two cross-over trials. Continuous oestrogen had a small to moderate positive effect on global symptom scores (SMD −0.34, 95% CI −0.59 to −0.10, P = 0.005, 3 RCTs, 158 women, effective sample size 267 women, I² = 63%, very low quality evidence). The evidence was too imprecise to determine if the groups differed in withdrawal rates due to adverse effects (RR 0.64, 95% CI 0.26 to 1.58, P = 0.33, 3 RCTs, 196 women, effective sample size 284 women, I² = 0%, very low quality evidence). Similarly, the evidence was very imprecise in measures of specific adverse events, with large uncertainties around the true value of the relative risk. None of the studies reported on long-term risks such as endometrial cancer or breast cancer.\nOne study compared patch dosage (100 vs 200 µg oestrogen, with progestogen in both arms) and had a high risk of performance bias, detection bias and attrition bias. The study did not find evidence that dosage affects global symptoms but there was much uncertainty around the effect estimate (SMD −1.55, 95% CI −8.88 to 5.78, P = 0.68, 1 RCT, 98 women, very low quality evidence). The evidence on rates of withdrawal for adverse events was too imprecise to draw any conclusions (RR 0.70, 95% CI 0.34 to 1.46, P = 0.34, 1 RCT, 107 women, low-quality evidence). However, it appeared that the 100 µg dose might be associated with a lower overall risk of adverse events attributed to oestrogen (RR 0.51, 95% Cl 0.26 to 0.99, P = 0.05, 1 RCT, 107 women, very low quality evidence) with a large uncertainty around the effect estimate.\nThe overall quality of the evidence for all comparisons was very low, mainly due to risk of bias (specifically attrition), imprecision, and statistical and clinical heterogeneity.\nAuthors' conclusions\nWe found very low quality evidence to support the effectiveness of continuous oestrogen (transdermal patches or subcutaneous implants) plus progestogen, with a small to moderate effect size. We found very low quality evidence from a study based on 11 women to suggest that luteal-phase oral unopposed oestrogen is probably ineffective and possibly detrimental for controlling the symptoms of PMS. A comparison between 200 µg and 100 µg doses of continuous oestrogen was inconclusive with regard to effectiveness, but suggested that the lower dose was less likely to cause side effects. Uncertainty remains regarding safety, as the identified studies were too small to provide definite answers. Moreover, no included trial addressed adverse effects that might occur beyond the typical trial duration of 2-8 months. This suggests the choice of oestrogen dose and mode of administration could be based on an individual woman’s preference and modified according to the effectiveness and tolerability of the chosen regimen.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The overall quality of the evidence for all comparisons was graded as very low, mainly due to risk of bias in the included studies, imprecision (due to small sample sizes) and differences between the studies."
}
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query-laysum | 1456 | [
{
"role": "user",
"content": "Abstract: Background\nNumerous medications are available for the acute treatment of migraine in adults, and some have now been approved for use in children and adolescents in the ambulatory setting. A systematic review of acute treatment of migraine medication trials in children and adolescents will help clinicians make evidence-informed management choices.\nObjectives\nTo assess the effects of pharmacological interventions by any route of administration versus placebo for migraine in children and adolescents 17 years of age or less. For the purposes of this review, children were defined as under 12 years of age and adolescents 12 to 17 years of age.\nSearch methods\nWe searched seven bibliographic databases and four clinical trial registers as well as gray literature for studies through February 2016.\nSelection criteria\nWe included prospective randomized controlled clinical trials of children and adolescents with migraine, comparing acute symptom relieving migraine medications with placebo in the ambulatory setting.\nData collection and analysis\nTwo reviewers screened titles and abstracts and reviewed the full text of potentially eligible studies. Two independent reviewers extracted data for studies meeting inclusion criteria. We calculated the risk ratios (RRs) and number needed to treat for an additional beneficial outcome (NNTB) for dichotomous data. We calculated the risk difference (RD) and number needed to treat for an additional harmful outcome (NNTH) for proportions of adverse events. The percentage of pain-free patients at two hours was the primary efficacy outcome measure. We used adverse events to evaluate safety and tolerability. Secondary outcome measures included headache relief, use of rescue medication, headache recurrence, presence of nausea, and presence of vomiting. We assessed the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) and created 'Summary of findings' tables.\nMain results\nWe identified a total of 27 randomized controlled trials (RCTs) of migraine symptom-relieving medications, in which 9158 children and adolescents were enrolled and 7630 (range of mean age between 8.2 and 14.7 years) received medication. Twenty-four studies focused on drugs in the triptan class, including almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, sumatriptan + naproxen sodium, and zolmitriptan. Other medications studied included paracetamol (acetaminophen), ibuprofen, and dihydroergotamine (DHE). More than half of the studies evaluated sumatriptan. All but one study reported adverse event data. Most studies presented a low or unclear risk of bias, and the overall quality of evidence, according to GRADE criteria, was low to moderate, downgraded mostly due to imprecision and inconsistency. Ibuprofen was more effective than placebo for producing pain freedom at two hours in two small studies that included 162 children (RR 1.87, 95% confidence interval (CI) 1.15 to 3.04) with low quality evidence (due to imprecision). Paracetamol was not superior to placebo in one small study of 80 children. Triptans as a class of medication were superior to placebo in producing pain freedom in 3 studies involving 273 children (RR 1.67, 95% CI 1.06 to 2.62, NNTB 13) (moderate quality evidence) and 21 studies involving 7026 adolescents (RR 1.32, 95% CI 1.19 to 1.47, NNTB 6) (moderate quality evidence). There was no significant difference in the effect sizes between studies involving children versus adolescents. Triptans were associated with an increased risk of minor (non-serious) adverse events in adolescents (RD 0.13, 95% CI 0.08 to 0.18, NNTH 8), but studies did not report any serious adverse events. The risk of minor adverse events was not significant in children (RD 0.06, 95% CI − 0.04 to 0.17, NNTH 17). Sumatriptan plus naproxen sodium was superior to placebo in one study involving 490 adolescents (RR 3.25, 95% CI 1.78 to 5.94, NNTB 6) (moderate quality evidence). Oral dihydroergotamine was not superior to placebo in one small study involving 13 children.\nAuthors' conclusions\nLow quality evidence from two small trials shows that ibuprofen appears to improve pain freedom for the acute treatment of children with migraine. We have only limited information on adverse events associated with ibuprofen in the trials included in this review. Triptans as a class are also effective at providing pain freedom in children and adolescents but are associated with higher rates of minor adverse events. Sumatriptan plus naproxen sodium is also effective in treating adolescents with migraine.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In our review, we looked at 27 randomized controlled trials of drugs compared to placebo to find out which treatments were effective at providing pain freedom two hours after treatment. We also wanted to know what side effects might be caused by the treatments. A total of 7630 children received medication in the studies. The evidence is current to February 2016. Each study had between 13 and 888 participants. Their average age was 12.9 years and ranged from 8.2 to 14.7 years. Nineteen of the studies were funded by the drug manufacturer."
}
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query-laysum | 1457 | [
{
"role": "user",
"content": "Abstract: Background\nAcute limb ischaemia usually is caused by a blood clot blocking an artery or a bypass graft. Severe acute ischaemia will lead to irreversible damage to muscles and nerves if blood flow is not restored in a few hours. Once irreversible damage occurs, amputation will be necessary and the condition can be life-threatening. Infusion of clot-busting drugs (thrombolysis) is a useful tool in the management of acute limb ischaemia. Fibrinolytic drugs are used to disperse blood clots (thrombi) to clear arterial occlusion and restore blood flow. Thrombolysis is less invasive than surgery. A variety of techniques are used to deliver fibrinolytic agents. This is an update of a review first published in 2004.\nObjectives\nTo compare the effects of infusion techniques during peripheral arterial thrombolysis for treatment of patients with acute limb ischaemia.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 20 October 2020. We undertook reference checking to identify additional studies.\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing infusion techniques for fibrinolytic agents in the treatment of acute limb ischaemia.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials using the Cochrane 'Risk of bias' tool. We evaluated certainty of evidence using GRADE. For dichotomous outcomes, we calculated the odds ratio (OR) with the corresponding 95% confidence interval (CI). We were not able to carry out meta-analyses due to clinical heterogeneity, so we have reported the results and performed the comparisons narratively. The main outcomes of interest were amputation-free survival or limb salvage, amputation, mortality, vessel patency, duration of thrombolysis, and complications such as cerebrovascular accident and major and minor bleeding.\nMain results\nNine studies with a total of 671 participants are included in this update. Trials covered a variety of infusion techniques, dosage regimens, and adjunctive agents. We grouped trials according to types of techniques assessed (e.g. intravenous and intra-arterial delivery of the agent, 'high-' and 'low-dose' regimens of the agent, continuous infusion and 'forced infusion' of the agent, use of adjunctive antiplatelet agents). We assessed the certainty of evidence as very low to low due to the limited power of individual studies to deliver clinically relevant results, small and heterogeneous study populations, use of different inclusion criteria by each study in terms of severity and duration of ischaemia, considerably different outcome measures between trials, and use of different fibrinolytic agents. This heterogeneity prevented pooling of data in meta-analyses.\nNo regimen has been shown to confer benefit in terms of amputation-free survival (at 30 days), amputation, or death. For vessel patency, complete success was more likely with intra-arterial (IA) than with intravenous (IV) infusion (odds ratio (OR) 13.22, 95% confidence interval (CI) 2.79 to 62.67; 1 study, 40 participants; low-certainty evidence); radiological failure may be more likely with IV infusion (OR 0.02, 95% CI 0.00 to 0.38; 1 study, 40 participants; low-certainty evidence). Due to the small numbers involved in each arm and design differences between arms, it is not possible to conclude whether any technique offered any advantage over another. None of the treatment strategies clearly affected complications such as cerebrovascular accident or major bleeding requiring surgery or blood transfusion. Minor bleeding complications were more frequent in systemic (intravenous) therapy compared to intra-arterial infusion (OR 0.03, 95% CI 0.00 to 0.56; 1 study, 40 participants), and in high-dose compared to low-dose therapy (OR 0.11, 95% CI 0.01 to 0.96; 1 study, 63 participants).\nLimited evidence from individual trials appears to indicate that high-dose and forced-infusion regimens reduce the duration of thrombolysis. In one trial, the median duration of infusion was 4 hours (range 0.25 to 46) for the high-dose group and 20 hours (range 2 to 46) for the low-dose group. In a second trial, treatment using pulse spray was continued for a median of 120 minutes (range 40 to 310) compared with low-dose infusion for a median of 25 hours (range 2 to 60). In a third trial, the median duration of therapy was reduced with pulse spray at 195 minutes (range 90 to 1260 minutes) compared to continuous infusion at 1390 minutes (range 300 to 2400 minutes). However, none of the studies individually showed improvement in limb salvage at 30 days nor benefit for the amputation rate related to the technique of drug delivery. Similarly, no studies reported a clear difference in occurrence of cerebrovascular accident or major bleeding. Although 'high-dose' and 'forced-infusion' techniques achieved vessel patency in less time than 'low-dose' infusion, more minor bleeding complications may be associated (OR 0.11, 95% CI 0.01 to 0.96; 1 study, 72 participants; and OR 0.48, 95% CI 0.17 to 1.32; 1 study, 121 participants, respectively). Use of adjunctive platelet glycoprotein IIb/IIIa antagonists did not improve outcomes, and results were limited by inclusion of participants with non-limb-threatening ischaemia.\nAuthors' conclusions\nThere is insufficient evidence to show that any thrombolytic regimen provides a benefit over any other in terms of amputation-free survival, amputation, or 30-day mortality. The rate of CVA or major bleeding requiring surgery or blood transfusion did not clearly differ between regimens but may occur more frequently in high dose and IV regimens. This evidence was limited and of very low certainty. Minor bleeding may be more common with high-dose and IV regimens.\nIn this context, thrombolysis may be an acceptable therapy for patients with marginally threatened limbs (Rutherford grade IIa) compared with surgery. Caution is advised for patients who do not have limb-threatening ischaemia (Rutherford grade I) because of risks of major haemorrhage, cerebrovascular accident, and death from thrombolysis.\n\nGiven the provided abstract, please respond to the following query: \"How up-to date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Evidence in this Cochrane Review is current to 20 October 2020."
}
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query-laysum | 1458 | [
{
"role": "user",
"content": "Abstract: Background\nThe perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.\nObjectives\nWe aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.\nSearch methods\nOn 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.\nSelection criteria\nWe included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women’ subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding.\nEstrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI −0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence).\nWe are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI −1.52 to 1.68; 1 study, 104 women; very low-quality evidence).\nWe are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence).\nWe are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD −1.00, 95% CI −2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.24, 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence).\nWe are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence).\nThe observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.\nAuthors' conclusions\nHormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our confidence in the evidence is moderate to very low due to variation in the results. This was probably because studies used different drugs and doses, and different questionnaires for assessment."
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query-laysum | 1459 | [
{
"role": "user",
"content": "Abstract: Background\nIt has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for treating people with severe COVID-19.\nObjectives\nTo update the evidence on the effectiveness and safety of IL-6 blocking agents compared to standard care alone or to a placebo for people with COVID-19.\nSearch methods\nWe searched the World Health Organization (WHO) International Clinical Trials Registry Platform, the Living OVerview of Evidence (L·OVE) platform, and the Cochrane COVID-19 Study Register to identify studies on 7 June 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) evaluating IL-6 blocking agents compared to standard care alone or to placebo for people with COVID-19, regardless of disease severity.\nData collection and analysis\nPairs of researchers independently conducted study selection, extracted data and assessed risk of bias. We assessed the certainty of evidence using the GRADE approach for all critical and important outcomes. In this update we amended our protocol to update the methods used for grading evidence by establishing minimal important differences for the critical outcomes.\nMain results\nThis update includes 22 additional trials, for a total of 32 trials including 12,160 randomized participants all hospitalized for COVID-19 disease. We identified a further 17 registered RCTs evaluating IL-6 blocking agents without results available as of 7 June 2022.\nThe mean age range varied from 56 to 75 years; 66.2% (8051/12,160) of enrolled participants were men. One-third (11/32) of included trials were placebo-controlled. Twenty-two were published in peer-reviewed journals, three were reported as preprints, two trials had results posted only on registries, and results from five trials were retrieved from another meta-analysis. Eight were funded by pharmaceutical companies.\nTwenty-six included studies were multicenter trials; four were multinational and 22 took place in single countries. Recruitment of participants occurred between February 2020 and June 2021, with a mean enrollment duration of 21 weeks (range 1 to 54 weeks). Nineteen trials (60%) had a follow-up of 60 days or more. Disease severity ranged from mild to critical disease. The proportion of participants who were intubated at study inclusion also varied from 5% to 95%. Only six trials reported vaccination status; there were no vaccinated participants included in these trials, and 17 trials were conducted before vaccination was rolled out.\nWe assessed a total of six treatments, each compared to placebo or standard care. Twenty trials assessed tocilizumab, nine assessed sarilumab, and two assessed clazakizumab. Only one trial was included for each of the other IL-6 blocking agents (siltuximab, olokizumab, and levilimab). Two trials assessed more than one treatment.\nEfficacy and safety of tocilizumab and sarilumab compared to standard care or placebo for treating COVID-19\nAt day (D) 28, tocilizumab and sarilumab probably result in little or no increase in clinical improvement (tocilizumab: risk ratio (RR) 1.05, 95% confidence interval (CI) 1.00 to 1.11; 15 RCTs, 6116 participants; moderate-certainty evidence; sarilumab: RR 0.99, 95% CI 0.94 to 1.05; 7 RCTs, 2425 participants; moderate-certainty evidence). For clinical improvement at ≥ D60, the certainty of evidence is very low for both tocilizumab (RR 1.10, 95% CI 0.81 to 1.48; 1 RCT, 97 participants; very low-certainty evidence) and sarilumab (RR 1.22, 95% CI 0.91 to 1.63; 2 RCTs, 239 participants; very low-certainty evidence).\nThe effect of tocilizumab on the proportion of participants with a WHO Clinical Progression Score (WHO-CPS) of level 7 or above remains uncertain at D28 (RR 0.90, 95% CI 0.72 to 1.12; 13 RCTs, 2117 participants; low-certainty evidence) and that for sarilumab very uncertain (RR 1.10, 95% CI 0.90 to 1.33; 5 RCTs, 886 participants; very low-certainty evidence).\nTocilizumab reduces all cause-mortality at D28 compared to standard care/placebo (RR 0.88, 95% CI 0.81 to 0.94; 18 RCTs, 7428 participants; high-certainty evidence). The evidence about the effect of sarilumab on this outcome is very uncertain (RR 1.06, 95% CI 0.86 to 1.30; 9 RCTs, 3305 participants; very low-certainty evidence).\nThe evidence is uncertain for all cause-mortality at ≥ D60 for tocilizumab (RR 0.91, 95% CI 0.80 to 1.04; 9 RCTs, 2775 participants; low-certainty evidence) and very uncertain for sarilumab (RR 0.95, 95% CI 0.84 to 1.07; 6 RCTs, 3379 participants; very low-certainty evidence).\nTocilizumab probably results in little to no difference in the risk of adverse events (RR 1.03, 95% CI 0.95 to 1.12; 9 RCTs, 1811 participants; moderate-certainty evidence). The evidence about adverse events for sarilumab is uncertain (RR 1.12, 95% CI 0.97 to 1.28; 4 RCT, 860 participants; low-certainty evidence).\nThe evidence about serious adverse events is very uncertain for tocilizumab (RR 0.93, 95% CI 0.81 to 1.07; 16 RCTs; 2974 participants; very low-certainty evidence) and uncertain for sarilumab (RR 1.09, 95% CI 0.97 to 1.21; 6 RCTs; 2936 participants; low-certainty evidence).\nEfficacy and safety of clazakizumab, olokizumab, siltuximab and levilimab compared to standard care or placebo for treating COVID-19\nThe evidence about the effects of clazakizumab, olokizumab, siltuximab, and levilimab comes from only one or two studies for each blocking agent, and is uncertain or very uncertain.\nAuthors' conclusions\nIn hospitalized people with COVID-19, results show a beneficial effect of tocilizumab on all-cause mortality in the short term and probably little or no difference in the risk of adverse events compared to standard care alone or placebo. Nevertheless, both tocilizumab and sarilumab probably result in little or no increase in clinical improvement at D28.\nEvidence for an effect of sarilumab and the other IL-6 blocking agents on critical outcomes is uncertain or very uncertain. Most of the trials included in our review were done before the waves of different variants of concern and before vaccination was rolled out on a large scale.\nAn additional 17 RCTs of IL-6 blocking agents are currently registered with no results yet reported. The number of pending studies and the number of participants planned is low. Consequently, we will not publish further updates of this review.\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 32 studies in 12,160 people with COVID-19. The average age of people was 56 to 75 years, and 66% of the participants were men. The studies took place at hospitals in different countries around the world. Eight studies were funded by pharmaceutical companies.\nThe medicines most tested were tocilizumab and sarilumab.\nWe found 17 additional registered studies of IL-6-blocking medicines to treat COVID-19; these studies have no published results. Ten of these studies have either been completed or are still in progress. Seven were terminated."
}
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query-laysum | 1460 | [
{
"role": "user",
"content": "Abstract: Background\nOtitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. When persistent, it may lead to behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and mechanical treatment. Autoinflation is a self-administered technique, which aims to ventilate the middle ear and encourage middle ear fluid clearance by providing a positive pressure of air in the nose and nasopharynx (using a nasal balloon or other handheld device). This positive pressure (sometimes combined with simultaneous swallow) encourages opening of the Eustachian tube and may help ventilate the middle ear.\nObjectives\nTo assess the efficacy (benefits and harms) of autoinflation for the treatment of otitis media with effusion in children.\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 20 January 2023.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared autoinflation with either watchful waiting (no treatment), non-surgical treatment or ventilation tubes.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) OME-specific quality of life and 3) pain and distress. Secondary outcomes were: 1) persistence of OME, 2) other adverse effects (including eardrum perforation), 3) compliance or adherence to treatment, 4) receptive language skills, 5) speech development, 6) cognitive development, 7) psychosocial skills, 8) listening skills, 9) generic health-related quality of life, 10) parental stress, 11) vestibular function and 12) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for each outcome.\nAlthough we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.\nMain results\nWe identified 11 completed studies that met our inclusion criteria (1036 participants). The majority of studies included children aged between 3 and 11 years. Most were carried out in Europe or North America, and they were conducted in both hospital and community settings. All compared autoinflation (using a variety of different methods and devices) to no treatment. Most studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks. The outcomes were predominantly assessed just after the treatment phase had been completed. Here we report the effects at the longest follow-up for our main outcome measures.\nReturn to normal hearing\nThe evidence was very uncertain regarding the effect of autoinflation on the return to normal hearing. The longest duration of follow-up was 11 weeks. At this time point, the risk ratio was 2.67 in favour of autoinflation (95% confidence interval (CI) 1.73 to 4.12; 85% versus 32%; number needed to treat to benefit (NNTB) 2; 1 study, 94 participants), but the certainty of the evidence was very low.\nDisease-specific quality of life\nAutoinflation may result in a moderate improvement in quality of life (related to otitis media) after short-term follow-up. One study assessed quality of life using the Otitis Media Questionnaire-14 (OMQ-14) at three months of follow-up. Results were reported as the number of standard deviations above or below zero difference, with a range from -3 (better) to +3 (worse). The mean difference was -0.42 lower (better) for those who received autoinflation (95% CI -0.62 to -0.22; 1 study, 247 participants; low-certainty evidence; the authors report a change of 0.3 as clinically meaningful).\nPain and distress caused by the procedure\nAutoinflation may result in an increased risk of ear pain, but the evidence was very uncertain. One study assessed this outcome, and identified a risk ratio of 3.50 for otalgia in those who received autoinflation, although the overall occurrence of pain was low (95% CI 0.74 to 16.59; 4.4% versus 1.3%; number needed to treat to harm (NNTH) 32; 1 study, 320 participants; very low-certainty evidence).\nPersistence of OME\nThe evidence suggests that autoinflation may slightly reduce the persistence of OME at three months. Four studies were included, and the risk ratio for persistence of OME was 0.88 for those receiving autoinflation (95% CI 0.80 to 0.97; 4 studies, 483 participants; absolute reduction of 89 people per 1000 with persistent OME; NNTB 12; low-certainty evidence).\nAuthors' conclusions\nAll the evidence we identified was of low or very low certainty, meaning that we have little confidence in the estimated effects. However, the data suggest that autoinflation may have a beneficial effect on OME-specific quality of life and persistence of OME in the short term, but the effect is uncertain for return to normal hearing and adverse effects. The potential benefits should be weighed against the inconvenience of regularly carrying out autoinflation, and the possible risk of ear pain.\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 is up-to-date to January 2023."
}
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query-laysum | 1461 | [
{
"role": "user",
"content": "Abstract: Background\nLaparoscopy is a common procedure used to diagnose and treat various gynaecological conditions. Shoulder-tip pain (STP) as a result of the laparoscopy occurs in up to 80% of women, with potential for significant morbidity, delayed discharge and readmission. Interventions at the time of gynaecological laparoscopy have been developed in an attempt to reduce the incidence and severity of STP.\nObjectives\nTo determine the effectiveness and safety of methods for reducing the incidence and severity of shoulder-tip pain (STP) following gynaecological laparoscopy.\nSearch methods\nWe searched the following databases: Cochrane Gynaecology and Fertility (CGF) Specialised Register, the Cochrane Central Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO and CINAHL from inception to 8 August 2018. We also searched the reference lists of relevant articles and registers of ongoing trials.\nSelection criteria\nRandomised controlled trials (RCTs) of interventions used during or immediately after gynaecological laparoscopy to reduce the incidence or severity of STP.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes: incidence or severity of STP and adverse events of the interventions; secondary outcomes: analgesia usage, delay in discharge, readmission rates, quality-of-life scores and healthcare costs.\nMain results\nWe included 32 studies (3284 women). Laparoscopic procedures in these studies varied from diagnostic procedures to complex operations. The quality of the evidence ranged from very low to moderate. The main limitations were risk of bias, imprecision and inconsistency.\nSpecific technique versus \"standard\" technique for releasing the pneumoperitoneum\nUse of a specific technique of releasing the pneumoperitoneum (pulmonary recruitment manoeuvre, extended assisted ventilation or actively aspirating intra-abdominal gas) reduced the severity of STP at 24 hours (standardised mean difference (SMD) -0.66, 95% confidence interval (CI) -0.82 to -0.50; 5 RCTs; 670 participants; I2 = 0%, low-quality evidence) and reduced analgesia usage (SMD -0.53, 95% CI -0.70 to -0.35; 4 RCTs; 570 participants; I2 = 91%, low-quality evidence). There appeared to be little or no difference in the incidence of STP at 24 hours (odds ratio (OR) 0.87, 95% CI 0.41 to 1.82; 1 RCT; 118 participants; low-quality evidence).\nNo adverse events occurred in the only study assessing this outcome.\nFluid instillation versus no fluid instillation\nFluid instillation is probably associated with a reduction in STP incidence (OR 0.38, 95% CI 0.22 to 0.66; 2 RCTs; 220 participants; I2 = 0%, moderate-quality evidence) and severity (mean difference (MD) (0 to 10 visual analogue scale (VAS) scale) -2.27, 95% CI -3.06 to -1.48; 2 RCTs; 220 participants; I2 = 29%, moderate-quality evidence) at 24 hours, and may reduce analgesia usage (MD -12.02, 95% CI -23.97 to -0.06; 2 RCTs; 205 participants, low-quality evidence).\nNo study measured adverse events.\nIntraperitoneal drain versus no intraperitoneal drain\nUsing an intraperitoneal drain may reduce the incidence of STP at 24 hours (OR 0.30, 95% CI 0.20 to 0.46; 3 RCTs; 417 participants; I2 = 90%, low-quality evidence) and may reduce analgesia use within 48 hours post-operatively (SMD -1.84, 95% CI -2.14 to -1.54; 2 RCTs; 253 participants; I2 = 90%). We are uncertain whether it reduces the severity of STP at 24 hours, as the evidence was very low quality (MD (0 to 10 VAS scale) -1.85, 95% CI -2.15 to -1.55; 3 RCTs; 320 participants; I2 = 70%).\nNo study measured adverse events.\nSubdiaphragmatic intraperitoneal local anaesthetic versus control (no fluid instillation, normal saline or Ringer’s lactate)\nThere is probably little or no difference between the groups in incidence of STP (OR 0.72, 95% CI 0.42 to 1.23; 4 RCTs; 336 participants; I2 = 0%; moderate-quality evidence) and there may be no difference in STP severity (MD -1.13, 95% CI -2.52 to 0.26; 1 RCT; 50 participants; low-quality evidence), both measured at 24 hours. However, the intervention may reduce post-operative analgesia use (SMD-0.57, 95% CI -0.94 to -0.21; 2 RCTs; 129 participants; I2 = 51%, low-quality evidence).\nNo adverse events occurred in any study.\nLocal anaesthetic into peritoneal cavity (not subdiaphragmatic) versus normal saline\nLocal anaesthetic into the peritoneal cavity may reduce the incidence of STP at 4 to 8 hours post-operatively (OR 0.23, 95% CI 0.06 to 0.93; 2 RCTs; 157 participants; I2 = 56%; low-quality evidence). Our other outcomes of interest were not assessed.\nWarmed, or warmed and humidified CO2 versus unwarmed and unhumidified CO2\nThere may be no difference between these interventions in incidence of STP at 24 to 48 hours (OR 0.81 95% CI 0.45 to 1.49; 2 RCTs; 194 participants; I2 = 12%; low-quality evidence) or in analgesia usage within 48 hours (MD -4.97 mg morphine, 95% CI -11.25 to 1.31; 1 RCT; 95 participants; low-quality evidence); there is probably little or no difference in STP severity at 24 hours (MD (0 to 10 VAS scale) 0.11, 95% CI -0.75 to 0.97; 2 RCTs; 157 participants; I2 = 50%; moderate-quality evidence).\nNo study measured adverse events.\nGasless laparoscopy versus CO2 insufflation\nGasless laparoscopy may be associated with increased severity of STP within 72 hours post-operatively when compared with standard treatment (MD 3.8 (0 to 30 VAS scale), 95% CI 0.76 to 6.84; 1 RCT; 54 participants, low-quality evidence), and there may be no difference in the risk of adverse events (OR 2.56, 95% CI 0.25 to 26.28; 1 RCT; 54 participants; low-quality evidence).\nNo study measured the incidence of STP.\nAuthors' conclusions\nThere is low to moderate-quality evidence that the following interventions are associated with a reduction in the incidence or severity, or both, of STP, or a reduction in analgesia requirements for women undergoing gynaecological laparoscopy: a specific technique for releasing the pneumoperitoneum; intraperitoneal fluid instillation; an intraperitoneal drain; and local anaesthetic applied to the peritoneal cavity (not subdiaphragmatic).\nThere is low to moderate-quality evidence that subdiaphragmatic intraperitoneal local anaesthetic and warmed and humidified insufflating gas may not make a difference to the incidence or severity of STP.\nThere is low-quality evidence that gasless laparoscopy may increase the severity of STP, compared with standard treatment.\nFew studies reported data on adverse events. Some potentially useful interventions have not been studied by RCTs of gynaecological laparoscopy.\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": "Cochrane authors wanted to find out how effective different methods (interventions) are in reducing the amount and severity of shoulder pain following gynaecological keyhole surgery."
}
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query-laysum | 1462 | [
{
"role": "user",
"content": "Abstract: Background\nDiarrhoea is a major cause of death and disease, especially among young children in low-income countries. In these settings, many infectious agents associated with diarrhoea are spread through water contaminated with faeces.\nIn remote and low-income settings, source-based water quality improvement includes providing protected groundwater (springs, wells, and bore holes), or harvested rainwater as an alternative to surface sources (rivers and lakes). Point-of-use water quality improvement interventions include boiling, chlorination, flocculation, filtration, or solar disinfection, mainly conducted at home.\nObjectives\nTo assess the effectiveness of interventions to improve water quality for preventing diarrhoea.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register (11 November 2014), CENTRAL (the Cochrane Library, 7 November 2014), MEDLINE (1966 to 10 November 2014), EMBASE (1974 to 10 November 2014), and LILACS (1982 to 7 November 2014). We also handsearched relevant conference proceedings, contacted researchers and organizations working in the field, and checked references from identified studies through 11 November 2014.\nSelection criteria\nRandomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies (CBA) comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We used meta-analyses to estimate pooled measures of effect, where appropriate, and investigated potential sources of heterogeneity using subgroup analyses. We assessed the quality of evidence using the GRADE approach.\nMain results\nForty-five cluster-RCTs, two quasi-RCTs, and eight CBA studies, including over 84,000 participants, met the inclusion criteria. Most included studies were conducted in low- or middle-income countries (LMICs) (50 studies) with unimproved water sources (30 studies) and unimproved or unclear sanitation (34 studies). The primary outcome in most studies was self-reported diarrhoea, which is at high risk of bias due to the lack of blinding in over 80% of the included studies.\nSource-based water quality improvements\nThere is currently insufficient evidence to know if source-based improvements such as protected wells, communal tap stands, or chlorination/filtration of community sources consistently reduce diarrhoea (one cluster-RCT, five CBA studies, very low quality evidence). We found no studies evaluating reliable piped-in water supplies delivered to households.\nPoint-of-use water quality interventions\nOn average, distributing water disinfection products for use at the household level may reduce diarrhoea by around one quarter (Home chlorination products: RR 0.77, 95% CI 0.65 to 0.91; 14 trials, 30,746 participants, low quality evidence; flocculation and disinfection sachets: RR 0.69, 95% CI 0.58 to 0.82, four trials, 11,788 participants, moderate quality evidence). However, there was substantial heterogeneity in the size of the effect estimates between individual studies.\nPoint-of-use filtration systems probably reduce diarrhoea by around a half (RR 0.48, 95% CI 0.38 to 0.59, 18 trials, 15,582 participants, moderate quality evidence). Important reductions in diarrhoea episodes were shown with ceramic filters, biosand systems and LifeStraw® filters; (Ceramic: RR 0.39, 95% CI 0.28 to 0.53; eight trials, 5763 participants, moderate quality evidence; Biosand: RR 0.47, 95% CI 0.39 to 0.57; four trials, 5504 participants, moderate quality evidence; LifeStraw®: RR 0.69, 95% CI 0.51 to 0.93; three trials, 3259 participants, low quality evidence). Plumbed in filters have only been evaluated in high-income settings (RR 0.81, 95% CI 0.71 to 0.94, three trials, 1056 participants, fixed effects model).\nIn low-income settings, solar water disinfection (SODIS) by distribution of plastic bottles with instructions to leave filled bottles in direct sunlight for at least six hours before drinking probably reduces diarrhoea by around a third (RR 0.62, 95% CI 0.42 to 0.94; four trials, 3460 participants, moderate quality evidence).\nIn subgroup analyses, larger effects were seen in trials with higher adherence, and trials that provided a safe storage container. In most cases, the reduction in diarrhoea shown in the studies was evident in settings with improved and unimproved water sources and sanitation.\nAuthors' conclusions\nInterventions that address the microbial contamination of water at the point-of-use may be important interim measures to improve drinking water quality until homes can be reached with safe, reliable, piped-in water connections. The average estimates of effect for each individual point-of-use intervention generally show important effects. Comparisons between these estimates do not provide evidence of superiority of one intervention over another, as such comparisons are confounded by the study setting, design, and population.\nFurther studies assessing the effects of household connections and chlorination at the point of delivery will help improve our knowledge base. As evidence suggests effectiveness improves with adherence, studies assessing programmatic approaches to optimising coverage and long-term utilization of these interventions among vulnerable populations could also help strategies to improve health outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What causes diarrhoea and what water quality interventions might prevent diarrhoea?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Diarrhoea is a major cause of death and disease, especially among young children in low-income countries where the most common causes are faecally contaminated water and food, or poor hygiene practices.\nIn remote and low-income settings, source-based water quality improvement may include providing protected groundwater (springs, wells, and bore holes) or harvested rainwater as an alternative to surface sources (rivers and lakes). Alternatively water may be treated at the point-of-use in people's homes by boiling, chlorination, flocculation, filtration, or solar disinfection. These point-of-use interventions have the potential to overcome both contaminated sources and recontamination of safe water in the home."
}
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query-laysum | 1463 | [
{
"role": "user",
"content": "Abstract: Background\nGliomas are the most common primary brain tumour. They are graded using the WHO classification system, with Grade II-IV astrocytomas, oligodendrogliomas and oligoastrocytomas. Low-grade gliomas (LGGs) are WHO Grade II infiltrative brain tumours that typically appear solid and non-enhancing on magnetic resonance imaging (MRI) scans. People with LGG often have little or no neurologic deficit, so may opt for a watch-and-wait-approach over surgical resection, radiotherapy or both, as surgery can result in early neurologic disability. Occasionally, high-grade gliomas (HGGs, WHO Grade III and IV) may have the same MRI appearance as LGGs. Taking a watch-and-wait approach could be detrimental for the patient if the tumour progresses quickly. Advanced imaging techniques are increasingly used in clinical practice to predict the grade of the tumour and to aid clinical decision of when to intervene surgically. One such advanced imaging technique is magnetic resonance (MR) perfusion, which detects abnormal haemodynamic changes related to increased angiogenesis and vascular permeability, or \"leakiness\" that occur with aggressive tumour histology. These are reflected by changes in cerebral blood volume (CBV) expressed as rCBV (ratio of tumoural CBV to normal appearing white matter CBV) and permeability, measured by Ktrans.\nObjectives\nTo determine the diagnostic test accuracy of MR perfusion for identifying patients with primary solid and non-enhancing LGGs (WHO Grade II) at first presentation in children and adults. In performing the quantitative analysis for this review, patients with LGGs were considered disease positive while patients with HGGs were considered disease negative.\nTo determine what clinical features and methodological features affect the accuracy of MR perfusion.\nSearch methods\nOur search strategy used two concepts: (1) glioma and the various histologies of interest, and (2) MR perfusion. We used structured search strategies appropriate for each database searched, which included: MEDLINE (Ovid SP), Embase (Ovid SP), and Web of Science Core Collection (Science Citation Index Expanded and Conference Proceedings Citation Index). The most recent search for this review was run on 9 November 2016.\nWe also identified 'grey literature' from online records of conference proceedings from the American College of Radiology, European Society of Radiology, American Society of Neuroradiology and European Society of Neuroradiology in the last 20 years.\nSelection criteria\nThe titles and abstracts from the search results were screened to obtain full-text articles for inclusion or exclusion. We contacted authors to clarify or obtain missing/unpublished data.\nWe included cross-sectional studies that performed dynamic susceptibility (DSC) or dynamic contrast-enhanced (DCE) MR perfusion or both of untreated LGGs and HGGs, and where rCBV and/or Ktrans values were reported. We selected participants with solid and non-enhancing gliomas who underwent MR perfusion within two months prior to histological confirmation. We excluded studies on participants who received radiation or chemotherapy before MR perfusion, or those without histologic confirmation.\nData collection and analysis\nTwo review authors extracted information on study characteristics and data, and assessed the methodological quality using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We present a summary of the study characteristics and QUADAS-2 results, and rate studies as good quality when they have low risk of bias in the domains of reference standard of tissue diagnosis and flow and timing between MR perfusion and tissue diagnosis.\nIn the quantitative analysis, LGGs were considered disease positive, while HGGs were disease negative. The sensitivity refers to the proportion of LGGs detected by MR perfusion, and specificity as the proportion of detected HGGs. We constructed two-by-two tables with true positives and false negatives as the number of correctly and incorrectly diagnosed LGG, respectively, while true negatives and false positives are the number of correctly and incorrectly diagnosed HGG, respectively.\nMeta-analysis was performed on studies with two-by-two tables, with further sensitivity analysis using good quality studies. Limited data precluded regression analysis to explore heterogeneity but subgroup analysis was performed on tumour histology groups.\nMain results\nSeven studies with small sample sizes (4 to 48) met our inclusion criteria. These were mostly conducted in university hospitals and mostly recruited adult patients. All studies performed DSC MR perfusion and described heterogeneous acquisition and post-processing methods. Only one study performed DCE MR perfusion, precluding quantitative analysis.\nUsing patient-level data allowed selection of individual participants relevant to the review, with generally low risks of bias for the participant selection, reference standard and flow and timing domains. Most studies did not use a pre-specified threshold, which was considered a significant source of bias, however this did not affect quantitative analysis as we adopted a common rCBV threshold of 1.75 for the review. Concerns regarding applicability were low.\nFrom published and unpublished data, 115 participants were selected and included in the meta-analysis. Average rCBV (range) of 83 LGGs and 32 HGGs were 1.29 (0.01 to 5.10) and 1.89 (0.30 to 6.51), respectively. Using the widely accepted rCBV threshold of <1.75 to differentiate LGG from HGG, the summary sensitivity/specificity estimates were 0.83 (95% CI 0.66 to 0.93)/0.48 (95% CI 0.09 to 0.90). Sensitivity analysis using five good quality studies yielded sensitivity/specificity of 0.80 (95% CI 0.61 to 0.91)/0.67 (95% CI 0.07 to 0.98). Subgroup analysis for tumour histology showed sensitivity/specificity of 0.92 (95% CI 0.55 to 0.99)/0.42 (95% CI 0.02 to 0.95) in astrocytomas (6 studies, 55 participants) and 0.77 (95% CI 0.46 to 0.93)/0.53 (95% CI 0.14 to 0.88) in oligodendrogliomas+oligoastrocytomas (6 studies, 56 participants). Data were too sparse to investigate any differences across subgroups.\nAuthors' conclusions\nThe limited available evidence precludes reliable estimation of the performance of DSC MR perfusion-derived rCBV for the identification of grade in untreated solid and non-enhancing LGG from that of HGG. Pooled data yielded a wide range of estimates for both sensitivity (range 66% to 93% for detection of LGGs) and specificity (range 9% to 90% for detection of HGGs). Other clinical and methodological features affecting accuracy of the technique could not be determined from the limited data. A larger sample size of both LGG and HGG, preferably using a standardised scanning approach and with an updated reference standard incorporating molecular profiles, is required for a definite conclusion.\n\nGiven the provided abstract, please respond to the following query: \"Why is differentiation of low-grade and high-grade gliomas important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low-grade gliomas (LGGs) are slow growing brain tumours that have a typical appearance on standard MRI. Patients with LGGs who have few or no symptoms may prefer to delay treatment until such time they experience progression of their symptoms or appearance of the tumour on MRI; this is called the watch-and-wait approach. However occasionally, high-grade gliomas (HGGs), which are aggressive and require early treatment, can mimic the appearance of LGGs. It is only by examining tissues obtained by surgery - either through sampling (biopsy) or removal of tumour (resection) - can LGG and HGG be definitively differentiated. But a patient with few or no symptoms may want to avoid risking early neurologic disability resulting from surgery. Thus an accurate noninvasive method to differentiate gliomas can aid patients' decision making whether to opt for a watch-and-wait approach or undergo early treatment."
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query-laysum | 1464 | [
{
"role": "user",
"content": "Abstract: Background\nMacular hole (MH) is a full-thickness defect in the central portion of the retina that causes loss of central vision. According to the usual definition, a large MH has a diameter greater than 400 µm at the narrowest point. For closure of MH, there is evidence that pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling achieves better anatomical outcomes than standard PPV. PPV with ILM peeling is currently the standard of care for MH management; however, the failure rate of this technique is higher for large MHs than for smaller MHs. Some studies have shown that the inverted ILM flap technique is superior to conventional ILM peeling for the management of large MHs.\nObjectives\nTo evaluate the clinical effectiveness and safety of pars plana vitrectomy with the inverted internal limiting membrane flap technique versus pars plana vitrectomy with conventional internal limiting membrane peeling for treating large macular holes, including idiopathic, traumatic, and myopic macular holes.\nSearch methods\nThe Cochrane Eyes and Vision Information Specialist searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registries on 12 December 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) that evaluated PPV with ILM peeling versus PPV with inverted ILM flap for treatment of large MHs (with a basal diameter greater than 400 µm at the narrowest point measured by optical coherence tomography) of any type (idiopathic, traumatic, or myopic).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and assessed the certainty of the body of evidence using GRADE.\nMain results\nWe included four RCTs (285 eyes of 275 participants; range per study 24 to 91 eyes). Most participants were women (63%), and of older age (range of means 59.4 to 66 years). Three RCTs were single-center trials, and the same surgeon performed all surgeries in two RCTs (the third single-center RCT did not report the number of surgeons). One RCT was a multicenter trial (three sites), and four surgeons performed all surgeries. Two RCTs took place in India, one in Poland, and one in Mexico. Maximum follow-up ranged from three months (2 RCTs) to 12 months (1 RCT). No RCTs reported conflicts of interest or disclosed financial support. All four RCTs enrolled people with large idiopathic MHs and compared conventional PPV with ILM peeling versus PPV with inverted ILM flap techniques. Variations in technique across the four RCTs were minimal. There was some heterogeneity in interventions: in two RCTs, all participants underwent combined cataract-PPV surgery, whereas in one RCT, some participants underwent cataract surgery after PPV (the fourth RCT did not mention cataract surgery). The critical outcomes for this review were mean best-corrected visual acuity (BCVA) and MH closure rates. All four RCTs provided data for meta-analyses of both critical outcomes. We assessed the risk of bias for both outcomes using the Cochrane risk of bias tool (RoB 2); there were some concerns for risk of bias associated with lack of masking of outcome assessors and selective reporting of outcomes in all RCTs.\nAll RCTs reported postoperative BCVA values; only one RCT reported the change in BCVA from baseline. Based on evidence from the four RCTs, it is unclear if the inverted ILM flap technique compared with ILM peeling reduces (improves) postoperative BCVA measured on a logarithm of the minimum angle of resolution (logMAR) chart at one month (mean difference [MD] −0.08 logMAR, 95% confidence interval [CI] −0.20 to 0.05; P = 0.23, I2 = 65%; 4 studies, 254 eyes; very low-certainty evidence), but it may improve BCVA at three months or more (MD −0.17 logMAR, 95% CI −0.23 to −0.10; P < 0.001, I2 = 0%; 4 studies, 276 eyes; low-certainty evidence). PPV with an inverted ILM flap compared to PPV with ILM peeling probably increases the proportion of eyes achieving MH closure (risk ratio [RR] 1.10, 95% CI 1.02 to 1.18; P = 0.01, I2 = 0%; 4 studies, 276 eyes; moderate-certainty evidence) and type 1 MH closure (RR 1.31, 95% CI 1.03 to 1.66; P = 0.03, I² = 69%; 4 studies, 276 eyes; moderate-certainty evidence). One study reported that none of the 38 participants experienced postoperative retinal detachment.\nAuthors' conclusions\nWe found low-certainty evidence from four small RCTs that PPV with the inverted ILM flap technique is superior to PPV with ILM peeling with respect to BCVA gains at three or more months after surgery. We also found moderate-certainty evidence that the inverted ILM flap technique achieves more overall and type 1 MH closures. There is a need for high-quality multicenter RCTs to ascertain whether the inverted ILM flap technique is superior to ILM peeling with regard to anatomical and functional outcomes. Investigators should use the standard logMAR charts when measuring BCVA to facilitate comparison across trials.\n\nGiven the provided abstract, please respond to the following query: \"What is pars plana vitrectomy?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Vitrectomy is removal of the vitreous humor (the gel that naturally fills the eye). It is a crucial step to be able to access the retina. The pars plana is part of the eye that does not touch critical internal eye structures such as the retina. In pars plana vitrectomy (PPV), the eye surgeon inserts the surgical instruments through the pars plana to avoid damaging the retina or adjacent eye structures."
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query-laysum | 1465 | [
{
"role": "user",
"content": "Abstract: Background\nMultiple myeloma is a bone marrow-based hematological malignancy accounting for approximately two per cent of cancers. First-line treatment for transplant-ineligible individuals consists of multiple drug combinations of bortezomib (V), lenalidomide (R), or thalidomide (T). However, access to these medicines is restricted in many countries worldwide.\nObjectives\nTo assess and compare the effectiveness and safety of multiple drug combinations of V, R, and T for adults with newly diagnosed transplant-ineligible multiple myeloma and to inform an application for the inclusion of these medicines into the World Health Organization's (WHO) list of essential medicines.\nSearch methods\nWe searched CENTRAL and MEDLINE, conference proceedings and study registries on 14 February 2019 for randomised controlled trials (RCTs) comparing multiple drug combinations of V, R and T for adults with newly diagnosed transplant-ineligible multiple myeloma.\nSelection criteria\nWe included RCTs comparing combination therapies of V, R, and T, plus melphalan and prednisone (MP) or dexamethasone (D) for first-line treatment of adults with transplant-ineligible multiple myeloma. We excluded trials including adults with relapsed or refractory disease, trials comparing drug therapies to other types of therapy and trials including second-generation novel agents.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias of included trials. As effect measures we used hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) and risk ratios (RRs) for adverse events. An HR or RR < 1 indicates an advantage for the intervention compared to the main comparator MP. Where available, we extracted quality of life (QoL) data (scores of standardised questionnaires). Results quoted are from network meta-analysis (NMA) unless stated.\nMain results\nWe included 25 studies (148 references) comprising 11,403 participants and 21 treatment regimens. Treatments were differentiated between restricted treatment duration (treatment with a pre-specified amount of cycles) and continuous therapy (treatment administered until disease progression, the person becomes intolerant to the drug, or treatment given for a prolonged period). Continuous therapies are indicated with a \"c\". Risk of bias was generally high across studies due to the open-label study design.\nOverall survival (OS)\nEvidence suggests that treatment with RD (HR 0.63 (95% confidence interval (CI) 0.40 to 0.99), median OS 55.2 months (35.2 to 87.0)); TMP (HR 0.75 (95% CI 0.58 to 0.97), median OS: 46.4 months (35.9 to 60.0)); and VRDc (HR 0.49 (95% CI 0.26 to 0.92), median OS 71.0 months (37.8 to 133.8)) probably increases survival compared to median reported OS of 34.8 months with MP (moderate certainty). Treatment with VMP may result in a large increase in OS, compared to MP (HR 0.70 (95% CI 0.45 to 1.07), median OS 49.7 months (32.5 to 77.3)), low certainty).\nProgression-free survival (PFS)\nTreatment withRD (HR 0.65 (95% CI0.44 to 0.96), median PFS: 24.9 months (16.9 to 36.8)); TMP (HR 0.63 (95% CI 0.50 to 0.78), median PFS:25.7 months (20.8 to 32.4)); VMP (HR 0.56 (95% CI 0.35 to 0.90), median PFS: 28.9 months (18.0 to 46.3)); and VRDc (HR 0.34 (95% CI 0.20 to 0.58), median PFS: 47.6 months (27.9 to 81.0)) may result in a large increase in PFS (low certainty) compared to MP (median reported PFS: 16.2 months).\nAdverse events\nThe risk of polyneuropathies may be lower with RD compared to treatment with MP (RR 0.57 (95% CI 0.16 to 1.99), risk for RD: 0.5% (0.1 to 1.8), mean reported risk for MP: 0.9% (10 of 1074 patients affected), low certainty). However, the CIs are also compatible with no difference or an increase in neuropathies. Treatment with TMP (RR 4.44 (95% CI1.77 to 11.11), risk: 4.0% (1.6 to 10.0)) and VMP (RR 88.22 (95% CI 5.36 to 1451.11), risk: 79.4% (4.8 to 1306.0)) probably results in a large increase in polyneuropathies compared to MP (moderate certainty). No study reported the amount of participants with grade ≥ 3 polyneuropathies for treatment with VRDc.\nVMP probably increases the proportion of participants with serious adverse events (SAEs) compared to MP (RR 1.28 (95% CI 1.06 to 1.54), risk for VMP: 46.2% (38.3 to 55.6), mean risk for MP: 36.1% (177 of 490 patients affected), moderate certainty). RD, TMP, and VRDc were not connected to MP in the network and the risk of SAEs could not be compared.\nTreatment with RD (RR 4.18 (95% CI 2.13 to 8.20), NMA-risk: 38.5% (19.6 to 75.4)); and TMP (RR 4.10 (95% CI 2.40 to 7.01), risk: 37.7% (22.1 to 64.5)) results in a large increase of withdrawals from the trial due to adverse events (high certainty) compared to MP (mean reported risk: 9.2% (77 of 837 patients withdrew)). The risk is probably slightly increased with VMP (RR 1.06 (95% CI 0.63 to 1.81), risk: 9.75% (5.8 to 16.7), moderate certainty), while it is much increased with VRDc (RR 8.92 (95% CI 3.82 to 20.84), risk: 82.1% (35.1 to 191.7), high certainty) compared to MP.\nQuality of life\nQoL was reported in four studies for seven different treatment regimens (MP, MPc, RD, RMP, RMPc, TMP, TMPc) and was measured with four different tools. Assessment and reporting differed between studies and could not be meta-analysed. However, all studies reported an improvement of QoL after initiation of anti-myeloma treatment for all assessed treatment regimens.\nAuthors' conclusions\nBased on our four pre-selected comparisons of interest, continuous treatment with VRD had the largest survival benefit compared with MP, while RD and TMP also probably considerably increase survival. However, treatment combinations of V, R, and T also substantially increase the incidence of AEs, and lead to a higher risk of treatment discontinuation. Their effectiveness and safety profiles may best be analysed in further randomised head-to-head trials. Further trials should focus on consistent reporting of safety outcomes and should use a standardised instrument to evaluate QoL to ensure comparability of treatment-combinations.\n\nGiven the provided abstract, please respond to the following query: \"RD\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "RD,TMP, andVRDcleads to a much higher proportion of people stopping treatment because of AEs than MP (high certainty). The risk of stopping treatment withRDis 38.5%; withTMP37.7%, withVRDc82.1%. Treatment withVMPprobably increases the risk of stopping treatment because of AEs compared to MP (9.75%, moderate certainty).\nQuality of life\nQuality of life (QoL) was reported in four studies for seven different treatments and was measured with four different tools. Assessment and reporting differed between studies and could not be meta-analysed. However, all studies reported an improvement in QoL after anti-myeloma treatment was started for all assessed treatments."
}
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query-laysum | 1466 | [
{
"role": "user",
"content": "Abstract: Background\nMalabsorption of fat and protein contributes to poor nutritional status in people with cystic fibrosis. Impaired pancreatic function may also result in increased gastric acidity, leading in turn to heartburn, peptic ulcers and the impairment of oral pancreatic enzyme replacement therapy. The administration of gastric acid-reducing agents has been used as an adjunct to pancreatic enzyme therapy to improve absorption of fat and gastro-intestinal symptoms in people with cystic fibrosis. It is important to establish the evidence regarding potential benefits of drugs that reduce gastric acidity in people with cystic fibrosis. This is an update of a previously published review.\nObjectives\nTo assess the effect of drug therapies for reducing gastric acidity for: nutritional status; symptoms associated with increased gastric acidity; fat absorption; lung function; quality of life and survival; and to determine if any adverse effects are associated with their use.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic and non-electronic database searches, handsearches of relevant journals, abstract books and conference proceedings. Both authors double checked the reference lists of the searches\nMost recent search of the Group's Trials Register: 26 April 2021.\nOn the 26 April 2021 further searches were conducted on the clinicaltrials.gov register to identify any ongoing trials that may be of relevance. The WHO ICTRP database was last searched in 2020 and is not currently available for searching due to the Covid-19 pandemic.\nSelection criteria\nAll randomised and quasi-randomised trials involving agents that reduce gastric acidity compared to placebo or a comparator treatment.\nData collection and analysis\nBoth authors independently selected trials, assessed trial quality and extracted data.\nMain results\nThe searches identified 40 trials; 17 of these, with 273 participants, were suitable for inclusion, but the number of trials assessing each of the different agents was small. Seven trials were limited to children and four trials enrolled only adults. Meta-analysis was not performed, 14 trials were of a cross-over design and we did not have the appropriate information to conduct comprehensive meta-analyses. All the trials were run in single centres and duration ranged from five days to six months. The included trials were generally not reported adequately enough to allow judgements on risk of bias.\nHowever, one trial found that drug therapies that reduce gastric acidity improved gastro-intestinal symptoms such as abdominal pain; seven trials reported significant improvement in measures of fat malabsorption; and two trials reported no significant improvement in nutritional status. Only one trial reported measures of respiratory function and one trial reported an adverse effect with prostaglandin E2 analogue misoprostol. No trials have been identified assessing the effectiveness of these agents in improving quality of life, the complications of increased gastric acidity, or survival.\nAuthors' conclusions\nTrials have shown limited evidence that agents that reduce gastric acidity are associated with improvement in gastro-intestinal symptoms and fat absorption. Currently, there is insufficient evidence to indicate whether there is an improvement in nutritional status, lung function, quality of life, or survival. Furthermore, due to the unclear risks of bias in the included trials, we are unable to make firm conclusions based on the evidence reported therein. We therefore recommend that large, multicentre, randomised controlled clinical trials are undertaken to evaluate these interventions.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence for using drugs to reduce stomach acid in people with cystic fibrosis."
}
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query-laysum | 1467 | [
{
"role": "user",
"content": "Abstract: Background\nVestibular migraine is a form of migraine where one of the main features is recurrent attacks of vertigo. These episodes are often associated with other features of migraine, including headache and sensitivity to light or sound. The unpredictable and severe attacks of vertigo can lead to a considerable reduction in quality of life. The condition is estimated to affect just under 1% of the population, although many people remain undiagnosed. A number of pharmacological interventions have been used, or proposed to be used, at the time of a vestibular migraine attack to help reduce the severity or resolve the symptoms. These are predominantly based on treatments that are in use for headache migraine, with the belief that the underlying pathophysiology of these conditions is similar.\nObjectives\nTo assess the benefits and harms of pharmacological interventions used to relieve acute attacks of vestibular migraine.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 September 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable vestibular migraine comparing triptans, ergot alkaloids, dopamine antagonists, antihistamines, 5-HT3 receptor antagonists, gepants (CGRP receptor antagonists), magnesium, paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) with either placebo or no treatment.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) improvement in headache, 6) improvement in other migrainous symptoms and 7) other adverse effects. We considered outcomes reported at three time points: < 2 hours, 2 to 12 hours, > 12 to 72 hours. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included two RCTs with a total of 133 participants, both of which compared the use of triptans to placebo for an acute attack of vestibular migraine. One study was a parallel-group RCT (of 114 participants, 75% female). This compared the use of 10 mg rizatriptan to placebo. The second study was a smaller, cross-over RCT (of 19 participants, 70% female). This compared the use of 2.5 mg zolmitriptan to placebo.\nTriptans may result in little or no difference in the proportion of people whose vertigo improves at up to two hours after taking the medication. However, the evidence was very uncertain (risk ratio 0.84, 95% confidence interval 0.66 to 1.07; 2 studies; based on 262 attacks of vestibular migraine treated in 124 participants; very low-certainty evidence). We did not identify any evidence on the change in vertigo using a continuous scale. Only one of the studies assessed serious adverse events. No events were noted in either group, but as the sample size was small we cannot be sure if there are risks associated with taking triptans for this condition (0/75 receiving triptans, 0/39 receiving placebo; 1 study; 114 participants; very low-certainty evidence).\nAuthors' conclusions\nThe evidence for interventions used to treat acute attacks of vestibular migraine is very sparse. We identified only two studies, both of which assessed the use of triptans. We rated all the evidence as very low-certainty, meaning that we have little confidence in the effect estimates and cannot be sure if triptans have any effect on the symptoms of vestibular migraine. Although we identified sparse information on potential harms of treatment in this review, the use of triptans for other conditions (such as headache migraine) is known to be associated with some adverse effects.\nWe did not identify any placebo-controlled randomised trials for other interventions that may be used for this condition. Further research is needed to identify whether any interventions help to improve the symptoms of vestibular migraine attacks and to determine if there are side effects associated with their use.\n\nGiven the provided abstract, please respond to the following query: \"How is vestibular migraine treated?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Key approaches to treatment include trying to prevent attacks from starting (preventative treatment), as well as treatments to relieve the symptoms of an attack. There are no widely recommended treatments to manage the symptoms of a vestibular migraine attack. People are sometimes advised to take medicines used to treat headache migraine. The assumption is that these medicines may also work for vestibular migraine."
}
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query-laysum | 1468 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the review last published in 2011. It focuses on early postoperative enteral nutrition after lower gastrointestinal surgery. Traditional management consisted of 'nil by mouth', where patients receive fluids followed by solids after bowel function has returned. Although several trials have reported lower incidence of infectious complications and faster wound healing upon early feeding, other trials have shown no effect. The immediate advantage of energy intake (carbohydrates, protein or fat) could enhance recovery with fewer complications, and this warrants a systematic evaluation.\nObjectives\nTo evaluate whether early commencement of postoperative enteral nutrition (within 24 hours), oral intake and any kind of tube feeding (gastric, duodenal or jejunal), compared with traditional management (delayed nutritional supply) is associated with a shorter length of hospital stay (LoS), fewer complications, mortality and adverse events in patients undergoing lower gastrointestinal surgery (distal to the ligament of Treitz).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library 2017, issue 10), Ovid MEDLINE (1950 to 15 November 2017), Ovid Embase (1974 to 15 November 2017). We also searched for ongoing trials in ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (15 November 2017). We handsearched reference lists of identified studies and previous systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCT) comparing early commencement of enteral nutrition (within 24 hours) with no feeding in adult participants undergoing lower gastrointestinal surgery.\nData collection and analysis\nTwo review authors independently assessed study quality using the Cochrane 'Risk of bias' tool tailored to this review and extracted data. Data analyses were conducted according to the Cochrane recommendations.\n\nWe rated the quality of evidence according to GRADE.\n\nPrimary outcomes were LoS and postoperative complications (wound infections, intraabdominal abscesses, anastomotic dehiscence, pneumonia).\n\nSecondary outcomes were: mortality, adverse events (nausea, vomiting), and quality of life (QoL).\n\nLoS was estimated using mean difference (MD (presented as mean +/- SD). For other outcomes we estimated the common risk ratio (RR) and calculated the associated 95% confidence intervals. For analysis, we used an inverse-variance random-effects model for the primary outcome (LoS) and Mantel-Haenszel random-effects models for the secondary outcomes. We also performed Trial Sequential Analyses (TSA).\nMain results\nWe identified 17 RCTs with 1437 participants undergoing lower gastrointestinal surgery. Most studies were at high or unclear risk of bias in two or more domains. Six studies were judged as having low risk of selection bias for random sequence generation and insufficient details were provided for judgement on allocation concealment in all 17 studies. With regards to performance and deception bias; 14 studies reported no attempt to blind participants and blinding of personnel was not discussed either. Only one study was judged as low risk of bias for blinding of outcome assessor. With regards to incomplete outcome data, three studies were judged to be at high risk because they had more than 10% difference in missing data between groups. For selective reporting, nine studies were judged as unclear as protocols were not provided and eight studies had issues with either missing data or incomplete reporting of results.\nLOS was reported in 16 studies (1346 participants). The mean LoS ranged from four days to 16 days in the early feeding groups and from 6.6 days to 23.5 days in the control groups. Mean difference (MD) in LoS was 1.95 (95% CI, -2.99 to -0.91, P < 0.001) days shorter in the early feeding group. However, there was substantial heterogeneity between included studies (I2 = 81, %, Chi2 = 78.98, P < 0.00001), thus the overall quality of evidence for LoS is low. These results were confirmed by the TSA showing that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit.\n\nWe found no differences in the incidence of postoperative complications: wound infection (12 studies, 1181 participants, RR 0.99, 95%CI 0.64 to 1.52, very low-quality evidence), intraabdominal abscesses (6 studies, 554 participants, RR 1.00, 95%CI 0.26 to 3.80, low-quality evidence), anastomotic leakage/dehiscence (13 studies, 1232 participants, RR 0.78, 95%CI 0.38 to 1.61, low-quality evidence; number needed to treat for an additional beneficial outcome (NNTB) = 100), and pneumonia (10 studies, 954 participants, RR 0.88, 95%CI 0.32 to 2.42, low-quality evidence; NNTB = 333).\nMortality was reported in 12 studies (1179 participants), and showed no between-group differences (RR = 0.56, 95%CI, 0.21 to 1.52, P = 0.26, I2 = 0%, Chi2 = 3.08, P = 0.96, low-quality evidence). The most commonly reported cause of death was anastomotic leakage, sepsis and acute myocardial infarction.\nSeven studies (613 participants) reported vomiting (RR 1.23, 95%CI, 0.96 to 1.58, P = 0.10, I2 = 0%, Chi2 = 4.98, P = 0.55, low-quality evidence; number needed to treat for an additional harmful outcome (NNTH) = 19), and two studies (118 participants) reported nausea (RR 0.95, 0.71 to 1.26, low-quality evidence). Four studies reported combined nausea and vomiting (RR 0.94, 95%CI 0.51 to 1.74, very low-quality evidence). One study reported QoL assessment; the scores did not differ between groups at 30 days after discharge on either QoL scale EORTC QLQ-C30 or EORTC QlQ-OV28 (very low-quality evidence).\nAuthors' conclusions\nThis review suggests that early enteral feeding may lead to a reduced postoperative LoS, however cautious interpretation must be taken due to substantial heterogeneity and low-quality evidence. For all other outcomes (postoperative complications, mortality, adverse events, and QoL) the findings are inconclusive, and further trials are justified to enhance the understanding of early feeding for these. In this updated review, only a few additional studies have been included, and these were small and of poor quality.\n\nTo improve the evidence, future trials should address quality issues and focus on clearly defining and measuring postoperative complications to allow for better comparison between studies. However due to the introduction of fast track protocols which already include an early feeding component, future trials may be challenging. A more feasible trial may be to investigate the effect of differing postoperative energy intake regimens on relevant outcomes.\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 evidence that patients who received nutrition within the first 24 hours after their surgery were able to leave hospital almost two days sooner than those patients who were not given any nutrition until their bowel activity returned. However, the quality of the evidence is low and therefore early feeding after surgery may not lead to patients leaving hospital sooner. They may also have a reduced risk of dying. However, we found weak evidence that patients who were given nutrition within the first day after their operation were more at risk of vomiting. There were no differences in complication rates (such as wound infection or pneumonia) between patients who were fed early and those that were not."
}
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query-laysum | 1469 | [
{
"role": "user",
"content": "Abstract: Background\nMajor depressive disorder (MDD) is highly debilitating, difficult to treat, has a high rate of recurrence, and negatively impacts the individual and society as a whole. One potential treatment for MDD is n-3 polyunsaturated fatty acids (n-3PUFAs), also known as omega-3 oils, naturally found in fatty fish, some other seafood, and some nuts and seeds. Various lines of evidence suggest a role for n-3PUFAs in MDD, but the evidence is far from conclusive. Reviews and meta-analyses clearly demonstrate heterogeneity between studies. Investigations of heterogeneity suggest different effects of n-3PUFAs, depending on the severity of depressive symptoms, where no effects of n-3PUFAs are found in studies of individuals with mild depressive symptomology, but possible benefit may be suggested in studies of individuals with more severe depressive symptomology. Hence it is important to establish their effectiveness in treating MDD. This review updates and incorporates an earlier review with the same research objective (Appleton 2015).\nObjectives\nTo assess the effects of n-3 polyunsaturated fatty acids (also known as omega-3 fatty acids) versus a comparator (e.g. placebo, antidepressant treatment, standard care, no treatment, wait-list control) for major depressive disorder (MDD) in adults.\nSearch methods\nWe searched the Cochrane Central Register of Controlled trials (CENTRAL), Ovid MEDLINE, Embase and PsycINFO together with trial registries and grey literature sources (to 9 January 2021). We checked reference lists and contacted authors of included studies for additional information when necessary.\nSelection criteria\nWe included studies in the review if they: used a randomised controlled trial design; provided n-3PUFAs as an intervention; used a comparator; measured depressive symptomology as an outcome; and were conducted in adults with MDD. Primary outcomes were depressive symptomology (continuous data collected using a validated rating scale) and adverse events. Secondary outcomes were depressive symptomology (dichotomous data on remission and response), quality of life, and non-completion of studies.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. We assessed the certainty of the evidence using GRADE criteria.\nMain results\nThe review includes 35 relevant studies: 34 studies involving a total of 1924 participants investigated the impact of n-3PUFA supplementation compared to placebo, and one study involving 40 participants investigated the impact of n-3PUFA supplementation compared to antidepressant treatment.\nFor the placebo comparison, n-3PUFA supplementation resulted in a small to modest benefit for depressive symptomology, compared to placebo: standardised mean difference (SMD) (random-effects model) −0.40 (95% confidence interval (CI) −0.64 to −0.16; 33 studies, 1848 participants; very low-certainty evidence), but this effect is unlikely to be clinically meaningful. An SMD of 0.40 represents a difference between groups in scores on the HDRS (17-item) of approximately 2.5 points (95% CI 1.0 to 4.0), where the minimal clinically important change score on this scale is 3.0 points. The confidence intervals include both a possible clinically important effect and a possible negligible effect, and there is considerable heterogeneity between studies. Sensitivity analyses, funnel plot inspection and comparison of our results with those of large well-conducted trials also suggest that this effect estimate may be biased towards a positive finding for n-3PUFAs. Although the numbers of individuals experiencing adverse events were similar in intervention and placebo groups (odds ratio (OR) 1.27, 95% CI 0.99 to 1.64; 24 studies, 1503 participants; very low-certainty evidence), the confidence intervals include a small decrease to a modest increase in adverse events with n-3PUFAs. There was no evidence for a difference between n-3PUFA and placebo groups in remission rates (OR 1.13, 95% CI 0.74 to 1.72; 8 studies, 609 participants, low-certainty evidence), response rates (OR 1.20, 95% CI 0.80 to 1.79; 17 studies, 794 participants; low-certainty evidence), quality of life (SMD −0.38 (95% CI −0.82 to 0.06), 12 studies, 476 participants, very low-certainty evidence), or trial non-completion (OR 0.92, 95% CI 0.70 to 1.22; 29 studies, 1777 participants, very low-certainty evidence). The evidence on which these results are based was also very limited, highly heterogeneous, and potentially biased.\nOnly one study, involving 40 participants, was available for the antidepressant comparison. This study found no differences between treatment with n-3PUFAs and treatment with antidepressants in depressive symptomology (mean difference (MD) −0.70, 95% CI −5.88 to 4.48), rates of response to treatment (OR 1.23, 95% CI 0.35 to 4.31), or trial non-completion (OR 1.00, 95% CI 0.21 to 4.71). Confidence intervals are however very wide in all analyses, and do not rule out important beneficial or detrimental effects of n-3PUFAs compared to antidepressants. Adverse events were not reported in a manner suitable for analysis, and rates of depression remission and quality of life were not reported.\nAuthors' conclusions\nAt present, we do not have sufficient high-certainty evidence to determine the effects of n-3PUFAs as a treatment for MDD. Our primary analyses may suggest a small-to-modest, non-clinically beneficial effect of n-3PUFAs on depressive symptomology compared to placebo; however the estimate is imprecise, and we judged the certainty of the evidence on which this result is based to be low to very low. Our data may also suggest similar rates of adverse events and trial non-completion in n-3PUFA and placebo groups, but again our estimates are very imprecise. Effects of n-3PUFAs compared to antidepressants are very imprecise and uncertain. More complete evidence is required for both the potential positive and negative effects of n-3PUFAs for MDD.\n\nGiven the provided abstract, please respond to the following query: \"What questions does this review aim to answer?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do n-3PUFAs, compared to an alternative, have an effect on depressive symptoms, negative side effects, rates of recovery, quality of life, and rates of study non-completion, in individuals with MDD?"
}
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query-laysum | 1470 | [
{
"role": "user",
"content": "Abstract: Background\nSurgical training has traditionally been one of apprenticeship, where the surgical trainee learns to perform surgery under the supervision of a trained surgeon. This is time consuming, costly, and of variable effectiveness. Training using a box model physical simulator - either a video box or a mirrored box - is an option to supplement standard training. However, the impact of this modality on trainees with no prior laparoscopic experience is unknown.\nObjectives\nTo compare the benefits and harms of box model training versus no training, another box model, animal model, or cadaveric model training for surgical trainees with no prior laparoscopic experience.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to May 2013.\nSelection criteria\nWe included all randomised clinical trials comparing box model trainers versus no training in surgical trainees with no prior laparoscopic experience. We also included trials comparing different methods of box model training.\nData collection and analysis\nTwo authors independently identified trials and collected data. We analysed the data with both the fixed-effect and the random-effects models using Review Manager for analysis. For each outcome, we calculated the standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat analysis whenever possible.\nMain results\nTwenty-five trials contributed data to the quantitative synthesis in this review. All but one trial were at high risk of bias. Overall, 16 trials (464 participants) provided data for meta-analysis of box training (248 participants) versus no supplementary training (216 participants). All the 16 trials in this comparison used video trainers. Overall, 14 trials (382 participants) provided data for quantitative comparison of different methods of box training. There were no trials comparing box model training versus animal model or cadaveric model training.\nBox model training versus no training: The meta-analysis showed that the time taken for task completion was significantly shorter in the box trainer group than the control group (8 trials; 249 participants; SMD -0.48 seconds; 95% CI -0.74 to -0.22). Compared with the control group, the box trainer group also had lower error score (3 trials; 69 participants; SMD -0.69; 95% CI -1.21 to -0.17), better accuracy score (3 trials; 73 participants; SMD 0.67; 95% CI 0.18 to 1.17), and better composite performance scores (SMD 0.65; 95% CI 0.42 to 0.88). Three trials reported movement distance but could not be meta-analysed as they were not in a format for meta-analysis. There was significantly lower movement distance in the box model training compared with no training in one trial, and there were no significant differences in the movement distance between the two groups in the other two trials. None of the remaining secondary outcomes such as mortality and morbidity were reported in the trials when animal models were used for assessment of training, error in movements, and trainee satisfaction.\nDifferent methods of box training: One trial (36 participants) found significantly shorter time taken to complete the task when box training was performed using a simple cardboard box trainer compared with the standard pelvic trainer (SMD -3.79 seconds; 95% CI -4.92 to -2.65). There was no significant difference in the time taken to complete the task in the remaining three comparisons (reverse alignment versus forward alignment box training; box trainer suturing versus box trainer drills; and single incision versus multiport box model training). There were no significant differences in the error score between the two groups in any of the comparisons (box trainer suturing versus box trainer drills; single incision versus multiport box model training; Z-maze box training versus U-maze box training). The only trial that reported accuracy score found significantly higher accuracy score with Z-maze box training than U-maze box training (1 trial; 16 participants; SMD 1.55; 95% CI 0.39 to 2.71). One trial (36 participants) found significantly higher composite score with simple cardboard box trainer compared with conventional pelvic trainer (SMD 0.87; 95% CI 0.19 to 1.56). Another trial (22 participants) found significantly higher composite score with reverse alignment compared with forward alignment box training (SMD 1.82; 95% CI 0.79 to 2.84). There were no significant differences in the composite score between the intervention and control groups in any of the remaining comparisons. None of the secondary outcomes were adequately reported in the trials.\nAuthors' conclusions\nThe results of this review are threatened by both risks of systematic errors (bias) and risks of random errors (play of chance). Laparoscopic box model training appears to improve technical skills compared with no training in trainees with no previous laparoscopic experience. The impacts of this decreased time on patients and healthcare funders in terms of improved outcomes or decreased costs are unknown. There appears to be no significant differences in the improvement of technical skills between different methods of box model training. Further well-designed trials of low risk of bias and random errors are necessary. Such trials should assess the impacts of box model training on surgical skills in both the short and long term, as well as clinical outcomes when the trainee becomes competent to operate on patients.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All but one of the trials were of high risk of bias (defects in study design that can lead to arriving at incorrect conclusions with overestimation of benefits and underestimation of harms). Furthermore, our results are prone to risks of random errors. Overall, the quality of evidence was very low."
}
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query-laysum | 1471 | [
{
"role": "user",
"content": "Abstract: Background\nThe long chain polyunsaturated fatty acids (LCPUFA) docosahexaenoic acid (DHA) and arachidonic acid (AA) are considered essential for maturation of the developing brain, retina and other organs in newborn infants. Standard infant milk formulae are not supplemented with LCPUFA; they contain only alpha-linolenic acid and linoleic acid, from which formula-fed infants must synthesise their own DHA and AA, respectively. Over the past few years, some manufacturers have added LCPUFA to formula milk and have marketed these products as providing an advantage for the overall development of full-term infants.\nObjectives\nTo assess whether supplementation of formula milk with LCPUFA is both safe and beneficial for full-term infants, while focusing on effects on visual function, neurodevelopment and physical growth.\nSearch methods\nTwo review authors independently searched the Cochrane Central Register of Controlled Trials (CENTRAL; December 2016), MEDLINE (Ovid, 1966 to December 2016), Embase (Ovid, 1980 to December 2016), the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1980 to December 2016) and abstracts of the Pediatric Academic Societies (2000 to 2016). We applied no language restrictions.\nSelection criteria\nWe reviewed all randomised controlled trials (RCTs) evaluating effects of LCPUFA supplemented versus non-supplemented formula milk on visual function, neurodevelopment and physical growth. We did not include trials reporting only biochemical outcomes.\nData collection and analysis\nTwo review authors extracted data independently. We assessed risk of bias of included studies using the guidelines of the Cochrane Neonatal Review Group. When appropriate, we conducted meta-analysis to determine a pooled estimate of effect.\nMain results\nWe identified 31 RCTs and included 15 of these in the review (N = 1889).\nNine studies assessed visual acuity, six of which used visual evoked potentials (VEP), two Teller cards and one both. Four studies reported beneficial effects, and the remaining five did not. Meta-analysis of three RCTs showed significant benefit for sweep VEP acuity at 12 months (log of the minimum angle of resolution (logMAR)) (mean difference (MD) -0.15, 95% confidence interval (CI) -0.17 to -0.13; I2 = 0; three trials; N = 244), but meta-analysis of three other RCTs showed no benefit for visual acuity measured with Teller cards at 12 months (cycles/degree) (MD -0.01, 95% CI -0.12 to 0.11; I2 = 0; three trials; N = 256). GRADE analysis for the outcome of visual acuity indicated that the overall quality of evidence was low.\nEleven studies measured neurodevelopmental outcomes at or before two years. Nine studies used Bayley Scales of Infant Development, version II (BSID-II), and only two of these studies reported beneficial effects. Meta-analysis revealed no significant differences between LCPUFA and placebo groups in BSID Mental Developmental Index (MDI) scores at 18 months (MD 0.06, 95% CI -2.01 to 2.14; I2 = 75%; four trials; N = 661) and no significant differences in BSID Psychomotor Development Index (PDI) scores at 18 months (MD 0.69, 95% CI -0.78 to 2.16; I2 = 61%; four trials; N = 661). Results showed no significant differences between the two groups in BSID-II scores at one year and two years of age. One study reported better novelty preference measured by the Fagan Infant Test at nine months. Another study reported better problem solving at 10 months. One study used the Brunet and Lezine test to assess the developmental quotient and found no beneficial effects. Follow-up of some infants in different studies at three, six and nine years of age revealed no beneficial effects of supplementation. GRADE analysis of these outcomes indicated that the overall quality of evidence was low.\nThirteen studies measured physical growth; none found beneficial or harmful effects of supplementation. Meta-analysis of five RCTs showed that the supplemented group had lower weight (z scores) at one year of age (MD -0.23, 95% CI -0.40 to -0.06; I2 = 83%; N = 521) and that the two groups showed no significant differences with respect to length and head circumference (z scores). Meta-analysis at 18 months and at two years revealed no significant differences between the two groups with respect to weight (kg), length (cm) and head circumference (cm). GRADE analysis of these outcomes indicated that the overall quality of evidence was low.\nAuthors' conclusions\nMost of the included RCTs reported no beneficial effects or harms of LCPUFA supplementation on neurodevelopmental outcomes of formula-fed full-term infants and no consistent beneficial effects on visual acuity. Routine supplementation of full-term infant milk formula with LCPUFA cannot be recommended at this time.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does feeding full-term babies with formula milk enriched with long chain polyunsaturated fatty acids (LCPUFA) result in improved vision and overall neurodevelopment compared with feeding formula milk not enriched with LCPUFA?"
}
]
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query-laysum | 1472 | [
{
"role": "user",
"content": "Abstract: Background\nScabies, caused by Sarcoptes scabiei variety hominis or the human itch mite, is a common parasitic infection. While anyone can become infected, it causes significant morbidity in immunocompromised hosts and it spreads easily between human hosts where there is overcrowding or poor sanitation. The most common symptom reported is itch which is worse at night. As the symptoms are attributed to an allergic reaction to the mite, symptoms usually develop between four to six weeks after primary infection. Therefore, people may be infected for some time prior to developing symptoms. During this time, while asymptomatic, they may spread infection to others they are in close contact with. Consequently, it is usually recommended that when an index case is being treated, others who have been in close contact with the index case should also be provided with treatment.\nObjectives\nTo assess the effects of prophylactic interventions for contacts of people with scabies to prevent infestation in the contacts.\nSearch methods\nWe searched electronic databases (Cochrane Occupational Safety and Health Review Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (Ovid), Pubmed, EMBASE, LILACS, CINAHL, OpenGrey and WHO ICTRP) up to November 2013.\nSelection criteria\nRandomised controlled trials (RCTs) or cluster RCTs which compared prophylactic interventions which were given to contacts of index cases with scabies infestation. Interventions could be compared to each other, or to placebo or to no treatment. Both drug treatments and non-drug treatments were acceptable.\nData collection and analysis\nTwo authors intended to extract dichotomous data (developed infection or did not develop infection) for the effects of interventions and report this as risk ratios with 95% confidence intervals. We intended to report any adverse outcomes similarly.\nMain results\nWe did not include any trials in this review. Out of 29 potentially-relevant studies, we excluded 16 RCTs as the data for the contacts were either not reported or were reported only in combination with the outcomes for the index cases. We excluded a further 11 studies as they were not RCTs. We also excluded one study as not all subjects were examined at baseline and follow-up, and another as it was a case study.\nAuthors' conclusions\nThe effects of providing prophylactic treatments for contacts of people with scabies to prevent infestation are unknown. We need well-designed RCTs of the use of prophylactic measures to prevent the transmission of scabies conducted with people who had the opportunity for prolonged skin contact with an index case, such as family members, healthcare workers or residential care personnel, within the previous six weeks.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently no evidence to say if treating or advising people who have been in contact with scabies-infected people is effective in preventing the spread of scabies infection. We need researchers to conduct studies with people who may have been in skin contact with a person who has been diagnosed with a scabies infection within the previous six weeks. Half of these people should be given preventive treatment and the other half something else. Who gets what should be determined by chance so that the two groups are truly similar in every respect except the treatment they receive."
}
]
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query-laysum | 1473 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculous meningitis is a serious form of tuberculosis (TB) that affects the meninges that cover a person's brain and spinal cord. It is associated with high death rates and with disability in people who survive. Corticosteroids have been used as an adjunct to antituberculous drugs to treat people with tuberculous meningitis, but their role has been controversial.\nObjectives\nTo evaluate the effects of corticosteroids as an adjunct to antituberculous treatment on death and severe disability in people with tuberculous meningitis.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register up to the 18 March 2016; CENTRAL; MEDLINE; EMBASE; LILACS; and Current Controlled Trials. We also contacted researchers and organizations working in the field, and checked reference lists.\nSelection criteria\nRandomized controlled trials that compared corticosteroid plus antituberculous treatment with antituberculous treatment alone in people with clinically diagnosed tuberculous meningitis and included death or disability as outcome measures.\nData collection and analysis\nWe independently assessed search results and methodological quality, and extracted data from the included trials. We analysed the data using risk ratios (RR) with 95% confidence intervals (CIs) and used a fixed-effect model. We performed an intention-to-treat analysis, where we included all participants randomized to treatment in the denominator. This analysis assumes that all participants who were lost to follow-up have good outcomes. We carried out a sensitivity analysis to explore the impact of the missing data.\nMain results\nNine trials that included 1337 participants (with 469 deaths) met the inclusion criteria.\nAt follow-up from three to 18 months, steroids reduce deaths by almost one quarter (RR 0.75, 95% CI 0.65 to 0.87; nine trials, 1337 participants, high quality evidence). Disabling neurological deficit is not common in survivors, and steroids may have little or no effect on this outcome (RR 0.92, 95% CI 0.71 to 1.20; eight trials, 1314 participants, low quality evidence). There was no difference between groups in the incidence of adverse events, which included gastrointestinal bleeding, invasive bacterial infections, hyperglycaemia, and liver dysfunction.\nOne trial followed up participants for five years. The effect on death was no longer apparent at this time-point (RR 0.93, 95% CI 0.78 to 1.12; one trial, 545 participants, moderate quality evidence); and there was no difference in disabling neurological deficit detected (RR 0.91, 95% CI 0.49 to 1.69; one trial, 545 participants, low quality evidence).\nOne trial included human immunodeficiency virus (HIV)-positive people. The stratified analysis by HIV status in this trial showed no heterogeneity, with point estimates for death (RR 0.90, 95% CI 0.67 to 1.20; one trial, 98 participants) and disability (RR 1.23, 95% CI 0.08 to 19.07; one trial, 98 participants) similar to HIV-negative participants in the same trial.\nAuthors' conclusions\nCorticosteroids reduce mortality from tuberculous meningitis, at least in the short term.\nCorticosteroids may have no effect on the number of people who survive tuberculous meningitis with disabling neurological deficit, but this outcome is less common than death, and the CI for the relative effect includes possible harm. However, this small possible harm is unlikely to be quantitatively important when compared to the reduction in mortality.\nThe number of HIV-positive people included in the review is small, so we are not sure if the benefits in terms of reduced mortality are preserved in this group of patients.\n\nGiven the provided abstract, please respond to the following query: \"What is tuberculous meningitis and how might corticosteroids work?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Tuberculous meningitis is a serious form of tuberculosis that affects the meninges that cover the brain and spinal cord, causing headache, coma and death. The clinical outcome is often poor even when people with tuberculous meningitis are treated with antituberculous drugs.\nCorticosteroids are commonly used in addition to antituberculous drugs for treating people with the condition. These drugs help reduce inflammation of the surface of the brain and associated blood vessels, and are thought to decrease pressure inside the brain, and thus reduce the risk of death. Some clinicians are concerned that corticosteroids may improve survival, but result in more severely disabled survivors."
}
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query-laysum | 1474 | [
{
"role": "user",
"content": "Abstract: Background\nSurgery is a common treatment modality for stress urinary incontinence (SUI), usually offered to women for whom conservative treatments have failed. Midurethral tapes have superseded colposuspension because cure rates are comparable and recovery time is reduced. However, some women will not be cured after midurethral tape surgery. Currently, there is no consensus on how to manage the condition in these women.\nThis is an update of a Cochrane Review first published in 2013.\nObjectives\nTo assess the effects of interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women; and to summarise the principal findings of economic evaluations of these interventions.\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 9 November 2018). We also searched the reference lists of relevant articles.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials in women who had recurrent stress urinary incontinence after previous minimally invasive midurethral tape surgery. We included conservative, pharmacological and surgical treatments.\nData collection and analysis\nTwo review authors checked the abstracts of identified studies to confirm their eligibility. We obtained full-text reports of relevant studies and contacted study authors directly for additional information where necessary. We extracted outcome data onto a standard proforma and processed them according to the guidance in the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe included one study in this review. This study was later reported in an originally unplanned secondary analysis of 46 women who underwent transobturator tape for recurrent SUI after one or more previous failed operations. We were unable to use the data, as they were not presented according to the nature of the first operation.\nWe excluded 12 studies, five because they were not randomised controlled trials (RCTs) and four because previous incontinence surgery was not performed using midurethral tape. We considered a further three to be ineligible because neither the trial report nor personal communication with the trialists could confirm whether any of the participants had previously undergone surgery with tape.\nWe had also planned to develop a brief economic commentary summarising the principal findings of relevant economic evaluations but supplementary systematic searches did not identify any such studies.\nAuthors' conclusions\nThere were insufficient data to assess the effects of any of the different management strategies for recurrent or persistent stress incontinence after failed midurethral tape surgery. No published papers have reported exclusively on women whose first operation was a midurethral tape. Evidence from further RCTs and economic evaluations is required to address uncertainties about the effects and costs of these treatments.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current up to 9 November 2018."
}
]
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query-laysum | 1475 | [
{
"role": "user",
"content": "Abstract: Background\nAlcohol use in young people is a risk factor for a range of short- and long-term harms and is a cause of concern for health services, policy-makers, youth workers, teachers, and parents.\nObjectives\nTo assess the effectiveness of universal, selective, and indicated family-based prevention programmes in preventing alcohol use or problem drinking in school-aged children (up to 18 years of age).\nSpecifically, on these outcomes, the review aimed:\n• to assess the effectiveness of universal family-based prevention programmes for all children up to 18 years (‘universal interventions’);\n• to assess the effectiveness of selective family-based prevention programmes for children up to 18 years at elevated risk of alcohol use or problem drinking (‘selective interventions’); and\n• to assess the effectiveness of indicated family-based prevention programmes for children up to 18 years who are currently consuming alcohol, or who have initiated use or regular use (‘indicated interventions’).\nSearch methods\nWe identified relevant evidence from the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library, MEDLINE (Ovid 1966 to June 2018), Embase (1988 to June 2018), Education Resource Information Center (ERIC; EBSCOhost; 1966 to June 2018), PsycINFO (Ovid 1806 to June 2018), and Google Scholar. We also searched clinical trial registers and handsearched references of topic-related systematic reviews and the included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster RCTs (C-RCTs) involving the parents of school-aged children who were part of the general population with no known risk factors (universal interventions), were at elevated risk of alcohol use or problem drinking (selective interventions), or were already consuming alcohol (indicated interventions). Psychosocial or educational interventions involving parents with or without involvement of children were compared with no intervention, or with alternate (e.g. child only) interventions, allowing experimental isolation of parent components.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 46 studies (39,822 participants), with 27 classified as universal, 12 as selective, and seven as indicated. We performed meta-analyses according to outcome, including studies reporting on the prevalence, frequency, or volume of alcohol use. The overall quality of evidence was low or very low, and there was high, unexplained heterogeneity.\nUpon comparing any family intervention to no intervention/standard care, we found no intervention effect on the prevalence (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) -0.08 to 0.08; studies = 12; participants = 7490; I² = 57%; low-quality evidence) or frequency (SMD -0.31, 95% CI -0.83 to 0.21; studies = 8; participants = 1835; I² = 96%; very low-quality evidence) of alcohol use in comparison with no intervention/standard care. The effect of any parent/family interventions on alcohol consumption volume compared with no intervention/standard care was very small (SMD -0.14, 95% CI -0.27 to 0.00; studies = 5; participants = 1825; I² = 42%; low-quality evidence).\nWhen comparing parent/family and adolescent interventions versus interventions with young people alone, we found no difference in alcohol use prevalence (SMD -0.39, 95% CI -0.91 to 0.14; studies = 4; participants = 5640; I² = 99%; very low-quality evidence) or frequency (SMD -0.16, 95% CI -0.42 to 0.09; studies = 4; participants = 915; I² = 73%; very low-quality evidence). For this comparison, no trials reporting on the volume of alcohol use could be pooled in meta-analysis.\nIn general, the results remained consistent in separate subgroup analyses of universal, selective, and indicated interventions. No adverse effects were reported.\nAuthors' conclusions\nThe results of this review indicate that there are no clear benefits of family-based programmes for alcohol use among young people. Patterns differ slightly across outcomes, but overall, the variation, heterogeneity, and number of analyses performed preclude any conclusions about intervention effects. Additional independent studies are required to strengthen the evidence and clarify the marginal effects observed.\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": "Overall, we found no evidence for the effectiveness of family-based interventions on the prevalence, frequency, or volume of alcohol use among young people. Some analyses focusing on specific subgroups of studies (e.g. including only universal interventions, targeting ethnic minority groups) showed small intervention effects, but considering variation in results, variation between studies, and overall low quality of the evidence, we are uncertain whether these interventions have a positive effect on young people's alcohol consumption. Some studies reported positive intervention effects on secondary outcomes (parental supply of alcohol, family involvement, alcohol misuse, and alcohol dependence) but with small numbers; these studies could not be pooled, so the evidence is insufficient. No adverse effects were reported."
}
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query-laysum | 1476 | [
{
"role": "user",
"content": "Abstract: Background\nThe use of anaesthetics in the elderly surgical population (more than 60 years of age) is increasing. Postoperative delirium, an acute condition characterized by reduced awareness of the environment and a disturbance in attention, typically occurs between 24 and 72 hours after surgery and can affect up to 60% of elderly surgical patients. Postoperative cognitive dysfunction (POCD) is a new-onset of cognitive impairment which may persist for weeks or months after surgery.\nTraditionally, surgical anaesthesia has been maintained with inhalational agents. End-tidal concentrations require adjustment to balance the risks of accidental awareness and excessive dosing in elderly people. As an alternative, propofol-based total intravenous anaesthesia (TIVA) offers a more rapid recovery and reduces postoperative nausea and vomiting. Using TIVA with a target controlled infusion (TCI) allows plasma and effect-site concentrations to be calculated using an algorithm based on age, gender, weight and height of the patient.\nTIVA is a viable alternative to inhalational maintenance agents for surgical anaesthesia in elderly people. However, in terms of postoperative cognitive outcomes, the optimal technique is unknown.\nObjectives\nTo compare maintenance of general anaesthesia for elderly people undergoing non-cardiac surgery using propofol-based TIVA or inhalational anaesthesia on postoperative cognitive function, mortality, risk of hypotension, length of stay in the postanaesthesia care unit (PACU), and hospital stay.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11), MEDLINE (1946 to November 2017), Embase (1974 to November 2017), PsycINFO (1887 to November 2017). We searched clinical trials registers for ongoing studies, and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included randomized controlled trials (RCTs) with participants over 60 years of age scheduled for non-cardiac surgery under general anaesthesia. We planned to also include quasi-randomized trials. We compared maintenance of anaesthesia with propofol-based TIVA versus inhalational maintenance of anaesthesia.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data, assessed risk of bias, and synthesized findings.\nMain results\nWe included 28 RCTs with 4507 randomized participants undergoing different types of surgery (predominantly cardiovascular, laparoscopic, abdominal, orthopaedic and ophthalmic procedures). We found no quasi-randomized trials. Four studies are awaiting classification because we had insufficient information to assess eligibility.\nAll studies compared maintenance with propofol-based TIVA versus inhalational maintenance of anaesthesia. Six studies were multi-arm and included additional TIVA groups, additional inhalational maintenance or both. Inhalational maintenance agents included sevoflurane (19 studies), isoflurane (eight studies), and desflurane (three studies), and was not specified in one study (reported as an abstract). Some studies also reported use of epidural analgesia/anaesthesia, fentanyl and remifentanil.\nWe found insufficient reporting of randomization methods in many studies and all studies were at high risk of performance bias because it was not feasible to blind anaesthetists to study groups. Thirteen studies described blinding of outcome assessors. Three studies had a high of risk of attrition bias, and we noted differences in the use of analgesics between groups in six studies, and differences in baseline characteristics in five studies. Few studies reported clinical trials registration, which prevented assessment of risk of selective reporting bias.\nWe found no evidence of a difference in incidences of postoperative delirium according to type of anaesthetic maintenance agents (odds ratio (OR) 0.59, 95% confidence interval (CI) 0.15 to 2.26; 321 participants; five studies; very low-certainty evidence); we noted during sensitivity analysis that using different time points in one study may influence direction of this result. Thirteen studies (3215 participants) reported POCD, and of these, six studies reported data that could not be pooled; we noted no difference in scores of POCD in four of these and in one study, data were at a time point incomparable to other studies. We excluded one large study from meta-analysis because study investigators had used non-standard anaesthetic management and this study was not methodologically comparable to other studies. We combined data for seven studies and found low-certainty evidence that TIVA may reduce POCD (OR 0.52, 95% CI 0.31 to 0.87; 869 participants).\nWe found no evidence of a difference in mortality at 30 days (OR 1.21, 95% CI 0.33 to 4.45; 271 participants; three studies; very low-certainty evidence). Twelve studies reported intraoperative hypotension. We did not perform meta-analysis for 11 studies for this outcome. We noted visual inconsistencies in these data, which may be explained by possible variation in clinical management and medication used to manage hypotension in each study (downgraded to low-certainty evidence); one study reported data in a format that could not be combined and we noted little or no difference between groups in intraoperative hypotension for this study. Eight studies reported length of stay in the PACU, and we did not perform meta-analysis for seven studies. We noted visual inconsistencies in these data, which may be explained by possible differences in definition of time points for this outcome (downgraded to very low-certainty evidence); data were unclearly reported in one study. We found no evidence of a difference in length of hospital stay according to type of anaesthetic maintenance agent (mean difference (MD) 0 days, 95% CI -1.32 to 1.32; 175 participants; four studies; very low-certainty evidence).\nWe used the GRADE approach to downgrade the certainty of the evidence for each outcome. Reasons for downgrading included: study limitations, because some included studies insufficiently reported randomization methods, had high attrition bias, or high risk of selective reporting bias; imprecision, because we found few studies; inconsistency, because we noted heterogeneity across studies.\nAuthors' conclusions\nWe are uncertain whether maintenance with propofol-based TIVA or with inhalational agents affect incidences of postoperative delirium, mortality, or length of hospital stay because certainty of the evidence was very low. We found low-certainty evidence that maintenance with propofol-based TIVA may reduce POCD. We were unable to perform meta-analysis for intraoperative hypotension or length of stay in the PACU because of heterogeneity between studies. We identified 11 ongoing studies from clinical trials register searches; inclusion of these studies in future review updates may provide more certainty for the review outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Anaesthesia during surgery in elderly people (more than 60 years of age) is increasing.\nTraditionally, general anaesthesia is maintained with an inhaled drug (a vapour which the patient breathes in) which needs to be adjusted to ensure that the patient remains unconscious during surgery without receiving too much anaesthetic. An alternative method is to use propofol which is injected into a vein throughout the anaesthetic procedure; this is called total intravenous anaesthesia (TIVA).\nElderly people are more likely to experience confusion or problems with thinking following surgery, which can occur up to several days postoperatively. These cognitive problems can last for weeks or months, and can affect the patients' ability to plan, focus, remember, or undertake activities of daily living. We looked at two types of postoperative confusion: delirium (a problem with awareness and attention which is often temporary) and cognitive dysfunction (a persistent problem with brain function).\nTIVA with propofol may be a good alternative to inhaled drugs, and it is known that patients who have TIVA experience less nausea and vomiting, and wake up more quickly after anaesthesia. However, it is unknown which is the better anaesthetic technique in terms of postoperative cognitive outcomes."
}
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query-laysum | 1477 | [
{
"role": "user",
"content": "Abstract: Background\nUpper endoscopy is the definitive treatment for upper gastrointestinal haemorrhage (UGIH). However, up to 13% of people who undergo upper endoscopy will have incomplete visualisation of the gastric mucosa at presentation. Erythromycin acts as a motilin receptor agonist in the upper gastrointestinal (GI) tract and increases gastric emptying, which may lead to better quality of visualisation and improved treatment effectiveness. However, there is uncertainty about the benefits and harms of erythromycin in UGIH.\nObjectives\nTo evaluate the benefits and harms of erythromycin before endoscopy in adults with acute upper gastrointestinal haemorrhage, compared with any other treatment or no treatment/placebo.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 15 October 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) that investigated erythromycin before endoscopy compared to any other treatment or no treatment/placebo before endoscopy in adults with acute UGIH.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. UGIH-related mortality and 2. serious adverse events. Our secondary outcomes were 1. all-cause mortality, 2. visualisation of gastric mucosa, 3. non-serious adverse events, 4. rebleeding, 5. blood transfusion, and 5. rescue invasive intervention. We used GRADE criteria to assess the certainty of the evidence for each outcome.\nMain results\nWe included 11 RCTs with 878 participants. The mean age ranged from 53.13 years to 64.5 years, and most participants were men (72.3%). One RCT included only non-variceal haemorrhage, one included only variceal haemorrhage, and eight included both aetiologies. We defined short-term outcomes as those occurring within one week of initial endoscopy.\nErythromycin versus placebo\nThree RCTs (255 participants) compared erythromycin with placebo. There were no UGIH-related deaths. The evidence is very uncertain about the short-term effects of erythromycin compared with placebo on serious adverse events (risk difference (RD) −0.01, 95% confidence interval (CI) −0.04 to 0.02; 3 studies, 255 participants; very low certainty), all-cause mortality (RD 0.00, 95% CI −0.03 to 0.03; 3 studies, 255 participants; very low certainty), non-serious adverse events (RD 0.01, 95% CI −0.03 to 0.05; 3 studies, 255 participants; very low certainty), and rebleeding (risk ratio (RR) 0.63, 95% CI 0.13 to 2.90; 2 studies, 195 participants; very low certainty). Erythromycin may improve gastric mucosa visualisation (mean difference (MD) 3.63 points on 16-point ordinal scale, 95% CI 2.20 to 5.05; higher MD means better visualisation; 2 studies, 195 participants; low certainty). Erythromycin may also result in a slight reduction in blood transfusion (MD −0.44 standard units of blood, 95% CI −0.86 to −0.01; 3 studies, 255 participants; low certainty).\nErythromycin plus nasogastric tube lavage versus no intervention/placebo plus nasogastric tube lavage\nSix RCTs (408 participants) compared erythromycin plus nasogastric tube lavage with no intervention/placebo plus nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin plus nasogastric tube lavage compared with no intervention/placebo plus nasogastric tube lavage on all-cause mortality (RD −0.02, 95% CI −0.08 to 0.03; 3 studies, 238 participants; very low certainty), visualisation of the gastric mucosa (standardised mean difference (SMD) 0.48 points on 10-point ordinal scale, 95% CI 0.10 to 0.85; higher SMD means better visualisation; 3 studies, 170 participants; very low certainty), non-serious adverse events (RD 0.00, 95% CI −0.05 to 0.05; 6 studies, 408 participants; very low certainty), rebleeding (RR 1.13, 95% CI 0.63 to 2.02; 1 study, 169 participants; very low certainty), and blood transfusion (MD −1.85 standard units of blood, 95% CI −4.34 to 0.64; 3 studies, 180 participants; very low certainty).\nErythromycin versus nasogastric tube lavage\nFour RCTs (287 participants) compared erythromycin with nasogastric tube lavage. There were no UGIH-related deaths and no serious adverse events. The evidence is very uncertain about the short-term effects of erythromycin compared with nasogastric tube lavage on all-cause mortality (RD 0.02, 95% CI −0.05 to 0.08; 3 studies, 213 participants; very low certainty), visualisation of the gastric mucosa (RR 1.19, 95% CI 0.79 to 1.79; 2 studies, 198 participants; very low certainty), non-serious adverse events (RD −0.10, 95% CI −0.34 to 0.13; 3 studies, 213 participants; very low certainty), rebleeding (RR 0.77, 95% CI 0.40 to 1.49; 1 study, 169 participants; very low certainty), and blood transfusion (median 2 standard units of blood, interquartile range 0 to 4 in both groups; 1 study, 169 participants; very low certainty).\nErythromycin plus nasogastric tube lavage versus metoclopramide plus nasogastric tube lavage\nOne RCT (30 participants) compared erythromycin plus nasogastric tube lavage with metoclopramide plus nasogastric tube lavage. The evidence is very uncertain about the effects of erythromycin plus nasogastric tube lavage on all the reported outcomes (serious adverse events, visualisation of gastric mucosa, non-serious adverse events, and blood transfusion).\nAuthors' conclusions\nWe are unsure if erythromycin before endoscopy in people with UGIH has any clinical benefits or harms. However, erythromycin compared with placebo may improve gastric mucosa visualisation and result in a slight reduction in blood transfusion.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We wanted to know if erythromycin was better than placebo (any dummy treatment) or other medicines to improve the following outcomes.\n• Death caused by upper gastrointestinal bleeding\n• Serious unwanted events\n• Death by any cause\n• Mild unwanted events\n• Ease of viewing the stomach during endoscopy\n• Rebleeding\n• Need for blood transfusion\n• Need for rescue procedure (such as surgery)"
}
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query-laysum | 1478 | [
{
"role": "user",
"content": "Abstract: Background\nBasilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the central nervous system (CNS). Cerebrospinal fluid (CSF) leakage has been associated with a greater risk of contracting meningitis. Antibiotics are often given prophylactically, although their role in preventing bacterial meningitis has not been established.\nObjectives\nTo evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with basilar skull fractures.\nSearch methods\nWe searched CENTRAL (2014, Issue 5), MEDLINE (1966 to June week 1, 2014), EMBASE (1974 to June 2014) and LILACS (1982 to June 2014). We also performed an electronic search of meeting proceedings from the American Association of Neurological Surgeons (1997 to September 2005) and handsearched the abstracts of meeting proceedings of the European Association of Neurosurgical Societies (1995, 1999 and 2003).\nSelection criteria\nRandomised controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention. We also identified non-RCTs to perform a separate meta-analysis in order to compare results.\nData collection and analysis\nThree review authors independently screened and selected trials, assessed risk of bias and extracted data. We sought clarification with trial authors when needed. We pooled risk ratios (RRs) for dichotomous data with their 95% confidence intervals (CIs) using a random-effects model. We assessed the overall quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.\nMain results\nIn this update we did not identify any new trials for inclusion. We included five RCTs with 208 participants in the review and meta-analysis. We also identified 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with basilar skull fractures. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. When we evaluated the five included RCTs, there were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality and need for surgical correction in patients with CSF leakage. There were no reported adverse effects of antibiotic administration, although one of the five RCTs reported an induced change in the posterior nasopharyngeal flora towards potentially more pathogenic organisms resistant to the antibiotic regimen used in prophylaxis. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2168 patients), which produced results consistent with the randomised data from the included studies.\nUsing the GRADE approach, we assessed the quality of trials as moderate.\nAuthors' conclusions\nCurrently available evidence from RCTs does not support prophylactic antibiotic use in patients with basilar skull fractures, whether there is evidence of CSF leakage or not. Until more research is available, the effectiveness of antibiotics in patients with basilar skull fractures cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review examined five randomised controlled trials, comprising a total of 208 participants with basilar skull fracture, which compared those who received preventive antibiotic therapy with those who did not receive antibiotics, to establish how many participants developed meningitis. The evidence is current to June 2014."
}
]
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query-laysum | 1479 | [
{
"role": "user",
"content": "Abstract: Background\nThere is a common perception that smoking generally helps people to manage stress, and may be a form of 'self-medication' in people with mental health conditions. However, there are biologically plausible reasons why smoking may worsen mental health through neuroadaptations arising from chronic smoking, leading to frequent nicotine withdrawal symptoms (e.g. anxiety, depression, irritability), in which case smoking cessation may help to improve rather than worsen mental health.\nObjectives\nTo examine the association between tobacco smoking cessation and change in mental health.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group's Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and the trial registries clinicaltrials.gov and the International Clinical Trials Registry Platform, from 14 April 2012 to 07 January 2020. These were updated searches of a previously-conducted non-Cochrane review where searches were conducted from database inception to 13 April 2012.\nSelection criteria\nWe included controlled before-after studies, including randomised controlled trials (RCTs) analysed by smoking status at follow-up, and longitudinal cohort studies. In order to be eligible for inclusion studies had to recruit adults who smoked tobacco, and assess whether they quit or continued smoking during the study. They also had to measure a mental health outcome at baseline and at least six weeks later.\nData collection and analysis\nWe followed standard Cochrane methods for screening and data extraction. Our primary outcomes were change in depression symptoms, anxiety symptoms or mixed anxiety and depression symptoms between baseline and follow-up. Secondary outcomes included change in symptoms of stress, psychological quality of life, positive affect, and social impact or social quality of life, as well as new incidence of depression, anxiety, or mixed anxiety and depression disorders.\nWe assessed the risk of bias for the primary outcomes using a modified ROBINS-I tool. For change in mental health outcomes, we calculated the pooled standardised mean difference (SMD) and 95% confidence interval (95% CI) for the difference in change in mental health from baseline to follow-up between those who had quit smoking and those who had continued to smoke. For the incidence of psychological disorders, we calculated odds ratios (ORs) and 95% CIs. For all meta-analyses we used a generic inverse variance random-effects model and quantified statistical heterogeneity using I2. We conducted subgroup analyses to investigate any differences in associations between sub-populations, i.e. unselected people with mental illness, people with physical chronic diseases.\nWe assessed the certainty of evidence for our primary outcomes (depression, anxiety, and mixed depression and anxiety) and our secondary social impact outcome using the eight GRADE considerations relevant to non-randomised studies (risk of bias, inconsistency, imprecision, indirectness, publication bias, magnitude of the effect, the influence of all plausible residual confounding, the presence of a dose-response gradient).\nMain results\nWe included 102 studies representing over 169,500 participants. Sixty-two of these were identified in the updated search for this review and 40 were included in the original version of the review. Sixty-three studies provided data on change in mental health, 10 were included in meta-analyses of incidence of mental health disorders, and 31 were synthesised narratively.\nFor all primary outcomes, smoking cessation was associated with an improvement in mental health symptoms compared with continuing to smoke: anxiety symptoms (SMD −0.28, 95% CI −0.43 to −0.13; 15 studies, 3141 participants; I2 = 69%; low-certainty evidence); depression symptoms: (SMD −0.30, 95% CI −0.39 to −0.21; 34 studies, 7156 participants; I2 = 69%' very low-certainty evidence); mixed anxiety and depression symptoms (SMD −0.31, 95% CI −0.40 to −0.22; 8 studies, 2829 participants; I2 = 0%; moderate certainty evidence). These findings were robust to preplanned sensitivity analyses, and subgroup analysis generally did not produce evidence of differences in the effect size among subpopulations or based on methodological characteristics. All studies were deemed to be at serious risk of bias due to possible time-varying confounding, and three studies measuring depression symptoms were judged to be at critical risk of bias overall. There was also some evidence of funnel plot asymmetry. For these reasons, we rated our certainty in the estimates for anxiety as low, for depression as very low, and for mixed anxiety and depression as moderate.\nFor the secondary outcomes, smoking cessation was associated with an improvement in symptoms of stress (SMD −0.19, 95% CI −0.34 to −0.04; 4 studies, 1792 participants; I2 = 50%), positive affect (SMD 0.22, 95% CI 0.11 to 0.33; 13 studies, 4880 participants; I2 = 75%), and psychological quality of life (SMD 0.11, 95% CI 0.06 to 0.16; 19 studies, 18,034 participants; I2 = 42%). There was also evidence that smoking cessation was not associated with a reduction in social quality of life, with the confidence interval incorporating the possibility of a small improvement (SMD 0.03, 95% CI 0.00 to 0.06; 9 studies, 14,673 participants; I2 = 0%). The incidence of new mixed anxiety and depression was lower in people who stopped smoking compared with those who continued (OR 0.76, 95% CI 0.66 to 0.86; 3 studies, 8685 participants; I2 = 57%), as was the incidence of anxiety disorder (OR 0.61, 95% CI 0.34 to 1.12; 2 studies, 2293 participants; I2 = 46%). We deemed it inappropriate to present a pooled estimate for the incidence of new cases of clinical depression, as there was high statistical heterogeneity (I2 = 87%).\nAuthors' conclusions\nTaken together, these data provide evidence that mental health does not worsen as a result of quitting smoking, and very low- to moderate-certainty evidence that smoking cessation is associated with small to moderate improvements in mental health. These improvements are seen in both unselected samples and in subpopulations, including people diagnosed with mental health conditions. Additional studies that use more advanced methods to overcome time-varying confounding would strengthen the evidence in this area.\n\nGiven the provided abstract, please respond to the following query: \"Smoking and mental health\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Some health providers and people who smoke believe that smoking helps reduce stress and other mental health symptoms, like depression and anxiety. They worry that stopping smoking may make mental health symptoms worse. However, studies have shown that smoking may have a negative impact on people's mental health, and stopping smoking could reduce anxiety and depression."
}
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query-laysum | 1480 | [
{
"role": "user",
"content": "Abstract: Background\nStandard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving drugs), with or without additional endovascular techniques), could reduce the long-term complications of post-thrombotic syndrome (PTS) including pain, swelling, skin discolouration, or venous ulceration in the affected leg. This is the fourth update of a Cochrane Review first published in 2004.\nObjectives\nTo assess the effects of thrombolytic clot removal strategies and anticoagulation compared to anticoagulation alone for the management of people with acute deep vein thrombosis (DVT) of the lower limb.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 21 April 2020. We also checked the references of relevant articles to identify additional studies.\nSelection criteria\nWe considered randomised controlled trials (RCTs) examining thrombolysis (with or without adjunctive clot removal strategies) and anticoagulation versus anticoagulation alone for acute DVT.\nData collection and analysis\nWe used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials with the Cochrane 'Risk of bias' tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we calculated the risk ratio (RR) with the corresponding 95% confidence interval (CI). We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. The primary outcomes of interest were clot lysis, bleeding and post thrombotic syndrome.\nMain results\nTwo new studies were added for this update. Therefore, the review now includes a total of 19 RCTs, with 1943 participants. These studies differed with respect to the thrombolytic agent, the doses of the agent and the techniques used to deliver the agent. Systemic, loco-regional and catheter-directed thrombolysis (CDT) strategies were all included. For this update, CDT interventions also included those involving pharmacomechanical thrombolysis. Three of the 19 included studies reported one or more domain at high risk of bias. We combined the results as any (all) thrombolysis interventions compared to standard anticoagulation.\nComplete clot lysis occurred more frequently in the thrombolysis group at early follow-up (RR 4.75; 95% CI 1.83 to 12.33; 592 participants; eight studies) and at intermediate follow-up (RR 2.42; 95% CI 1.42 to 4.12; 654 participants; seven studies; moderate-certainty evidence). Two studies reported on clot lysis at late follow-up with no clear benefit from thrombolysis seen at this time point (RR 3.25, 95% CI 0.17 to 62.63; two studies). No differences between strategies (e.g. systemic, loco-regional and CDT) were detected by subgroup analysis at any of these time points (tests for subgroup differences: P = 0.41, P = 0.37 and P = 0.06 respectively).\nThose receiving thrombolysis had increased bleeding complications (6.7% versus 2.2%) (RR 2.45, 95% CI 1.58 to 3.78; 1943 participants, 19 studies; moderate-certainty evidence). No differences between strategies were detected by subgroup analysis (P = 0.25).\nUp to five years after treatment, slightly fewer cases of PTS occurred in those receiving thrombolysis; 50% compared with 53% in the standard anticoagulation (RR 0.78, 95% CI 0.66 to 0.93; 1393 participants, six studies; moderate-certainty evidence). This was still observed at late follow-up (beyond five years) in two studies (RR 0.56, 95% CI 0.43 to 0.73; 211 participants; moderate-certainty evidence).\nWe used subgroup analysis to investigate if the level of DVT (iliofemoral, femoropopliteal or non-specified) had an effect on the incidence of PTS. No benefit of thrombolysis was seen for either iliofemoral or femoropopliteal DVT (six studies; test for subgroup differences: P = 0.29). Systemic thrombolysis and CDT had similar levels of effectiveness. Studies of CDT included four trials in femoral and iliofemoral DVT, and results from these are consistent with those from trials of systemic thrombolysis in DVT at other levels of occlusion.\nAuthors' conclusions\nComplete clot lysis occurred more frequently after thrombolysis (with or without additional clot removal strategies) and PTS incidence was slightly reduced. Bleeding complications also increased with thrombolysis, but this risk has decreased over time with the use of stricter exclusion criteria of studies. Evidence suggests that systemic administration of thrombolytics and CDT have similar effectiveness. Using GRADE, we judged the evidence to be of moderate-certainty, due to many trials having small numbers of participants or events, or both. Future studies are needed to investigate treatment regimes in terms of agent, dose and adjunctive clot removal methods; prioritising patient-important outcomes, including PTS and quality of life, to aid clinical decision making.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "First, we searched the medical literature for randomised controlled trials (RCTs), clinical studies where people are randomly put into one of two or more treatment groups. This type of study provides the most robust evidence about the effects of a treatment. We then compared the results, and summarised the evidence from all the studies. Finally, we assessed how certain the evidence was. To do this, we considered factors such as the way studies were conducted, study sizes, and consistency of findings across studies. Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty."
}
]
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query-laysum | 1481 | [
{
"role": "user",
"content": "Abstract: Background\nLate-onset sepsis is associated with increased rates of mortality and morbidity in newborn infants, in addition to poorer long-term developmental outcomes and increased length of stay and hospital costs. Central line-associated blood stream infection (CLABSI) is the most common cause of late-onset sepsis in hospitalised infants, and prevention of CLABSI is a key objective in neonatal care. Increased frequency of CLABSI around the time of removal of central venous catheters (CVCs) has been reported, and use of antibiotics at the time of removal may reduce the incidence and impact of late-onset sepsis in vulnerable newborn infants.\nObjectives\nTo determine the efficacy and safety of giving antibiotics at the time of removal of a central venous catheter (CVC) for reduction of morbidity and mortality in newborn infants, in particular effects on late-onset sepsis.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group without language restriction to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 3), MEDLINE via PubMed (1966 to 6 April 2017), Embase (1980 to 6 April 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 6 April 2017). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised, quasi-randomised, and cluster-randomised trials considering use of any antibiotic or combination of antibiotics at the time of CVC removal in newborn infants compared with placebo, no antibiotics, or another antibiotic or combination of antibiotics.\nData collection and analysis\nWe extracted data using standard methods of the Cochrane Neonatal Review Group. Two review authors independently selected, assessed the quality of, and extracted data from the included study.\nMain results\nOnly one randomised controlled trial was eligible for inclusion in this analysis. Forty-four of a total of 88 infants received two doses of cephazolin at the time of removal of CVC compared with no antibiotics at the time of removal of CVC in the control group. No infant in the intervention group developed late-onset sepsis after CVC removal compared with five of 44 (11%) in the control group (risk ratio (RR) 0.09, 95% confidence interval (CI) 0.01 to 1.60). Cephazolin given at the time of removal of CVC did not statistically significantly alter late-onset sepsis rates and led to no significant differences in any of the prespecified outcomes. Review authors judged the study to be of low quality because of high risk of bias and imprecision.\nAuthors' conclusions\nRandomised controlled trials have provided inadequate evidence for assessment of the efficacy or safety of antibiotics given at the time of CVC removal. The single identified trial was underpowered to address this question. Future research should be directed towards targeting use of antibiotics upon removal of CVC for those at greatest risk of complications from CVC removal-related CLABSI. Researchers should include safety data such as impact upon antibiotic use and resistance patterns. This investigation would best occur as part of a bundle of quality improvement care interventions provided by neonatal networks.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Does giving antibiotics at the time of removal of a central line reduce death and other serious complications in newborn infants?"
}
]
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query-laysum | 1482 | [
{
"role": "user",
"content": "Abstract: Background\nShort (or small) saphenous vein (SSV) varices occur as a result of an incompetent sapheno-popliteal junction, where the SSV joins the popliteal vein, resulting in reflux in the SSV; they account for about 15% of varicose veins. Untreated varicose veins may sometimes lead to ulceration of the leg, which is difficult to manage. Traditionally, treatment was restricted to surgery or conservative management. Since the 1990s, however, a number of minimally invasive techniques have been developed; these do not normally require a general anaesthetic, are day-case procedures with a quicker return to normal activities and avoid the risk of wound infection which may occur following surgery. Nerve injury remains a risk with thermal ablation, but in cases where it does occur, the injury tends to be transient.\nObjectives\nTo compare the effectiveness of endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and ultrasound-guided foam sclerotherapy (UGFS) versus conventional surgery in the treatment of SSV varices.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Specialised Register (last searched 17 March 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2). We searched clinical trials databases for details of ongoing or unpublished studies.\nSelection criteria\nWe considered all randomised controlled trials (RCTs) comparing EVLA, endovenous RFA or UGFS with conventional surgery in the treatment of SSV varices for inclusion.\nData collection and analysis\nWe independently reviewed, assessed and selected trials that met the inclusion criteria; any disagreements were resolved by discussion. We extracted data and used the Cochrane's tool for assessing risk of bias. When the data permitted, we performed either fixed-effect meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs) or random-effects meta-analyses where there was moderate to significant heterogeneity.\nMain results\nWe identified three RCTs, all of which compared EVLA with surgery; one also compared UGFS with surgery. There were no trials comparing RFA with surgery. The EVLA versus surgery comparison included 311 participants: 185 received EVLA and 126 received surgery. In the UGFS comparison, each treatment group contained 21 people. For several outcomes in the EVLA comparison, only a single study provided relevant data; as a result, the current review is limited in its ability to demonstrate meaningful results for some planned outcomes. The quality of evidence according to GRADE was moderate to low for the outcome measures in the EVLA versus surgery comparison, but low for the UGFS versus surgery comparison. Reasons for downgrading in the EVLA versus surgery comparison were risk of bias (for some outcomes, the outcome assessors were not blinded; and in one study the EVLA-surgery allocation of 2:1 did not appear to be prespecified); imprecision (data were only available from a single small study and the CIs were relatively wide); indirectness (one trial reported results at six months rather than one year and was inadequately powered for SSV varices-only analysis). Reasons for downgrading in the UGFS versus surgery comparison were imprecision (only one trial offered UGFS and several participants were missing from the analysis) and a limitation in design (the study was inadequately powered for SSV participants alone).\nFor the EVLA versus surgery comparison, recanalisation or persistence of reflux at six weeks occurred less frequently in the EVLA group than in the surgery group (OR 0.07, 95% CI 0.02 to 0.22; I2 = 51%; 289 participants, 3 studies, moderate-quality evidence). Recurrence of reflux at one year was also less frequent in the EVLA group than in the surgery group (OR 0.24, 95% CI 0.07 to 0.77; I2 = 0%; 119 participants, 2 studies, low-quality evidence). For the outcome clinical evidence of recurrence (i.e. presence of new visible varicose veins) at one year, there was no difference between the two treatment groups (OR 0.54, 95% CI 0.17 to 1.75; 99 participants, 1 study, low-quality evidence). Four participants each in the EVLA and surgery groups required reintervention due to technical failure (99 participants, 1 study, moderate-quality evidence). There was no difference between the two treatment groups for disease-specific quality of life (QoL) (Aberdeen Varicose Veins Questionnaire) either at six weeks (mean difference (MD) 0.15, 95% CI -1.65 to 1.95; I2 = 0%; 265 participants, 2 studies, moderate-quality evidence), or at one year (MD -1.08, 95% CI -3.39 to 1.23; 99 participants, 1 study, low-quality evidence). Main complications reported at six weeks were sural nerve injury, wound infection and deep venous thrombosis (DVT) (one DVT case in each treatment group; EVLA: 1/161, 0.6%; surgery 1/104, 1%; 265 participants, 2 studies, moderate-quality evidence).\nFor the UGFS versus surgery comparison, there were insufficient data to detect clear differences between the two treatment groups for the two outcomes recanalisation or persistence of reflux at six weeks (OR 0.34, 95% CI 0.06 to 2.10; 33 participants, 1 study, low-quality evidence), and recurrence of reflux at one year (OR 1.19, 95% CI 0.29 to 4.92; 31 participants, 1 study, low-quality evidence). No other outcomes could be reported for this comparison because the study data were not stratified according to saphenous vein.\nAuthors' conclusions\nModerate- to low-quality evidence exists to suggest that recanalisation or persistence of reflux at six weeks and recurrence of reflux at one year are less frequent when EVLA is performed, compared with conventional surgery. For the UGFS versus conventional surgery comparison, the quality of evidence is assessed to be low; consequently, the effectiveness of UGFS compared with conventional surgery in the treatment of SSV varices is uncertain. Further RCTs for all comparisons are required with longer follow-up (at least five years). In addition, measurement of outcomes such as recurrence of reflux, time taken to return to work, duration of procedure, pain, etc., and choice of time points during follow-up should be standardised such that future trials evaluating newer technologies can be compared efficiently.\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": "For the EVLA comparison, the quality of evidence was moderate for recanalisation or persistence of reflux, QoL and complications, all at six weeks, and retreatment due to technical failure, but low for recurrence of reflux, QoL and clinical evidence of recurrence after one year. The quality of evidence was downgraded due to imprecision (small number of trials with few participants) and bias (outcome assessors aware of treatment allocation in some studies and one study recruited insufficient participants with SSV). For the UGFS comparison, evidence was low quality because one study (with few participants with SSV) offered UGFS and several participants were missing from the analysis.\nThe main difficulty with this review was lack of data: we found a small number of trials and two trials had substantial amounts of unavailable data. Further well-designed studies are needed."
}
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query-laysum | 1483 | [
{
"role": "user",
"content": "Abstract: Background\nIntracranial artery stenosis (ICAS) is an arterial narrowing in the brain that can cause stroke. Endovascular therapy (ET) and conventional medical treatment (CMT) may prevent recurrent ischaemic stroke caused by ICAS. However, there is no consensus on the best treatment for people with ICAS.\nObjectives\nTo evaluate the safety and efficacy of endovascular therapy plus conventional medical treatment compared with conventional medical treatment alone for the management of symptomatic intracranial artery stenosis.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, four other databases, and three trials registries on 16 August 2022. We contacted study authors and researchers when we required additional information.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing ET plus CMT with CMT alone for the treatment of symptomatic ICAS. ET modalities included angioplasty alone, balloon-mounted stent, and angioplasty followed by placement of a self-expanding stent. CMT included antiplatelet therapy in addition to control of risk factors such as hypertension, hyperlipidaemia, and diabetes.\nData collection and analysis\nTwo review authors independently screened the records to select eligible RCTs, then extracted data from them. We resolved any disagreements through discussion, reaching consensus decisions among the full team. We assessed risk of bias and applied the GRADE approach to assess the certainty of the evidence. The primary outcome was death by any cause or non-fatal stroke of any type within three months of randomisation. Secondary outcomes included all-cause death or non-fatal stroke of any type occurring more than three months after randomisation, ipsilateral stroke, transient ischaemic attack, ischaemic stroke, haemorrhagic stroke, death, restenosis, dependency, and health-related quality of life.\nMain results\nWe included four RCTs with 989 participants who had symptomatic ICAS, with an age range of 18 to 85 years. We identified two ongoing RTCs. All trials had high risk of performance bias, as it was impossible to blind participants and personnel to the intervention. Three trials were terminated early. One trial was at high risk of attrition bias because of substantial loss to follow-up after one year and a high proportion of participants transferring from ET to CMT. The certainty of evidence ranged from low to moderate; we downgraded for imprecision.\nCompared to CMT alone, ET plus CMT probably increases the risk of short-term death or stroke (risk ratio (RR) 2.93, 95% confidence interval (CI) 1.81 to 4.75; 4 RCTs, 989 participants; moderate certainty), short-term ipsilateral stroke (RR 3.26, 95% CI 1.94 to 5.48; 4 RCTs, 989 participants; moderate certainty), short-term ischaemic stroke (RR 2.24, 95% CI 1.30 to 3.87; 4 RCTs, 989 participants; moderate certainty), and long-term death or stroke (RR 1.49, 95% CI 1.12 to 1.99; 4 RCTs, 970 participants; moderate certainty). Compared to CMT alone, ET plus CMT may increase the risk of short-term haemorrhagic stroke (RR 13.49, 95% CI 2.59 to 70.15; 4 RCTs, 989 participants; low certainty), short-term death (RR 5.43, 95% CI 1.21 to 24.40; 4 RCTs, 989 participants; low certainty), and long-term haemorrhagic stroke (RR 7.81, 95% CI 1.43 to 42.59; 3 RCTs, 879 participants; low certainty). It is unclear if ET plus CMT compared with CMT alone has an effect on the risk of short-term transient ischaemic attack (RR 0.79, 95% CI 0.30 to 2.07; 3 RCTs, 344 participants; moderate certainty), long-term transient ischaemic attack (RR 1.05, 95% CI 0.50 to 2.19; 3 RCTs, 335 participants; moderate certainty), long-term ipsilateral stroke (RR 1.78, 95% CI 1.00 to 3.17; 4 RCTs, 970 participants; moderate certainty), long-term ischaemic stroke (RR 1.56, 95% CI 0.77 to 3.16; 4 RCTs, 970 participants; moderate certainty), long-term death (RR 1.61, 95% CI 0.77 to 3.38; 4 RCTs, 951 participants; moderate certainty), and long-term dependency (RR 1.51, 95% CI 0.93 to 2.45; 4 RCTs, 947 participants; moderate certainty). No subgroup analyses significantly modified the effect of ET plus CMT versus CMT alone. The trials included no data on restenosis or health-related quality of life.\nAuthors' conclusions\nThis review provides moderate-certainty evidence that ET plus CMT compared with CMT alone increases the risk of short-term stroke and death in people with recent symptomatic severe ICAS. This effect was still apparent at long-term follow-up but appeared to be due to the early risks of ET; therefore, there may be no clear difference between the interventions in terms of their effects on long-term stroke and death. The impact of delayed ET intervention (more than three weeks after a qualifying event) warrants further study.\n\nGiven the provided abstract, please respond to the following query: \"What is intracranial artery stenosis?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Intracranial artery stenosis (ICAS) is the narrowing of the blood vessels in the brain caused by buildup of plaque (fatty deposits). It is a common cause of stroke worldwide. When this condition causes stroke symptoms, it is known as symptomatic ICAS."
}
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query-laysum | 1484 | [
{
"role": "user",
"content": "Abstract: Background\nOral mucositis is a side effect of chemotherapy, head and neck radiotherapy, and targeted therapy, affecting over 75% of high-risk patients. Ulceration can lead to severe pain and difficulty with eating and drinking, which may necessitate opioid analgesics, hospitalisation and supplemental nutrition. These complications may disrupt cancer therapy, which may reduce survival. There is also a risk of death from sepsis if pathogens enter the ulcers of immunocompromised patients. Ulcerative oral mucositis can be costly to healthcare systems, yet there are few preventive interventions proven to be beneficial. Cytokines and growth factors may help the regeneration of cells lining of the mouth, thus preventing or reducing oral mucositis and its negative effects.\nObjectives\nTo assess the effects of cytokines and growth factors for preventing oral mucositis in patients with cancer who are receiving treatment.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (searched 10 May 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched 10 May 2017); MEDLINE Ovid (1946 to 10 May 2017); Embase Ovid (7 December 2015 to 10 May 2017); CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 10 May 2017); and CANCERLIT PubMed (1950 to 10 May 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials.\nSelection criteria\nWe included parallel-design randomised controlled trials (RCTs) assessing the effects of cytokines and growth factors in patients with cancer receiving treatment.\nData collection and analysis\nTwo review authors independently screened the results of electronic searches, extracted data and assessed risk of bias. For dichotomous outcomes, we reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, we reported mean differences (MD) and 95% CIs. We pooled similar studies in random-effects meta-analyses. We reported adverse effects in a narrative format.\nMain results\nWe included 35 RCTs analysing 3102 participants. Thirteen studies were at low risk of bias, 12 studies were at unclear risk of bias, and 10 studies were at high risk of bias.\nOur main findings were regarding keratinocyte growth factor (KGF) and are summarised as follows.\nThere might be a reduction in the risk of moderate to severe oral mucositis in adults receiving bone marrow/stem cell transplantation after conditioning therapy for haematological cancers (RR 0.89, 95% CI 0.80 to 0.99; 6 studies; 852 participants; low-quality evidence). We would need to treat 11 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 6 to 112). There might be a reduction in the risk of severe oral mucositis in this population, but there is also some possibility of an increase in risk (RR 0.85, 95% CI 0.65 to 1.11; 6 studies; 852 participants; low-quality evidence). We would need to treat 10 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 5 to prevent the outcome to 14 to cause the outcome).\nThere is probably a reduction in the risk of moderate to severe oral mucositis in adults receiving radiotherapy to the head and neck with cisplatin or fluorouracil (RR 0.91, 95% CI 0.83 to 1.00; 3 studies; 471 participants; moderate-quality evidence). We would need to treat 12 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 7 to infinity). It is very likely that there is a reduction in the risk of severe oral mucositis in this population (RR 0.79, 95% CI 0.69 to 0.90; 3 studies; 471 participants; high-quality evidence). We would need to treat 7 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 5 to 15).\nIt is likely that there is a reduction in the risk of moderate to severe oral mucositis in adults receiving chemotherapy alone for mixed solid and haematological cancers (RR 0.56, 95% CI 0.45 to 0.70; 4 studies; 344 participants; moderate-quality evidence). We would need to treat 4 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 3 to 6). There might be a reduction in the risk of severe oral mucositis in this population (RR 0.30, 95% CI 0.14 to 0.65; 3 studies; 263 participants; low -quality evidence). We would need to treat 10 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 8 to 19).\nDue to the low volume of evidence, single-study comparisons and insufficient sample sizes, we found no compelling evidence of a benefit for any other cytokines or growth factors and there was no evidence on children. There did not appear to be any serious adverse effects of any of the interventions assessed in this review.\nAuthors' conclusions\nWe are confident that KGF is beneficial in the prevention of oral mucositis in adults who are receiving: a) radiotherapy to the head and neck with cisplatin or fluorouracil; or b) chemotherapy alone for mixed solid and haematological cancers. We are less confident about a benefit for KGF in adults receiving bone marrow/stem cell transplant after conditioning therapy for haematological cancers because of multiple factors involved in that population, such as whether or not they received total body irradiation (TBI) and whether the transplant was autologous (the patients' own cells) or allogeneic (cells from a donor). KGF appears to be a relatively safe intervention.\nDue to limited research, we are not confident that there are any beneficial effects of other cytokines and growth factors. There is currently insufficient evidence to draw any conclusions about the use of cytokines and growth factors in children.\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": "Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 10 May 2017. It includes 35 studies (published between 1993 and 2017) with 3102 participants, all patients being treated for cancer, aged from 1 to 87 years old. Review authors included studies comparing cytokines and growth factors for the prevention of oral mucositis. The studies were carried out all over the world and often featured multiple sites, although most took place in high-income countries."
}
]
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query-laysum | 1485 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a serious brain disorder characterized by recurrent unprovoked seizures. Approximately two-thirds of seizures can be controlled with antiepileptic medications (Kwan 2000). For some of the others, surgery can completely eliminate or significantly reduce the occurrence of disabling seizures. Localization of epileptogenic areas for resective surgery is far from perfect, and new tools are being investigated to more accurately localize the epileptogenic zone (the zone of the brain where the seizures begin) and improve the likelihood of freedom from postsurgical seizures. Recordings of pathological high-frequency oscillations (HFOs) may be one such tool.\nObjectives\nTo assess the ability of HFOs to improve the outcomes of epilepsy surgery by helping to identify more accurately the epileptogenic areas of the brain.\nSearch methods\nFor the latest update, we searched the Cochrane Epilepsy Group Specialized Register (25 July 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 25 July 2016), MEDLINE (Ovid, 1946 to 25 July 2016), CINAHL Plus (EBSCOhost, 25 July 2016), Web of Science (Thomson Reuters, 25 July 2016), ClinicalTrials.gov (25 July 2016), and the World Health Organization International Clinical Trials Registry Platform ICTRP (25 July 2016).\nSelection criteria\nWe included studies that provided information on the outcomes of epilepsy surgery for at least six months and which used high-frequency oscillations in making decisions about epilepsy surgery.\nData collection and analysis\nThe primary outcome of the review was the Engel Class Outcome System (class I = no disabling seizures, II = rare disabling seizures, III = worthwhile improvement, IV = no worthwhile improvement). Secondary outcomes were responder rate, International League Against Epilepsy (ILAE) epilepsy surgery outcome, frequency of adverse events from any source and quality of life outcomes. We intended to analyse outcomes via an aggregated data fixed-effect model meta-analysis.\nMain results\nTwo studies representing 11 participants met the inclusion criteria. Both studies were small non-randomised trials, with no control group and no blinding. The quality of evidence for all outcomes was very low. The combination of these two studies resulted in 11 participants who prospectively used ictal HFOs for epilepsy surgery decision making. Results of the postsurgical seizure freedom Engel class I to IV outcome were determined over a period of 12 to 38 months (average 23.4 months) and indicated that six participants had an Engel class I outcome (seizure freedom), two had class II (rare disabling seizures), three had class III (worthwhile improvement). No adverse effects were reported. Neither study compared surgical results guided by HFOs versus surgical results guided without HFOs.\nAuthors' conclusions\nNo reliable conclusions can be drawn regarding the efficacy of using HFOs in epilepsy surgery decision making at present.\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": "No reliable conclusions can be drawn from the limited evidence that exists at present."
}
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query-laysum | 1486 | [
{
"role": "user",
"content": "Abstract: Background\nMany women, and other females, with epithelial ovarian cancer (EOC) develop resistance to conventional chemotherapy drugs. Drugs that inhibit angiogenesis (development of new blood vessels), essential for tumour growth, control cancer growth by denying blood supply to tumour nodules.\nObjectives\nTo compare the effectiveness and toxicities of angiogenesis inhibitors for treatment of epithelial ovarian cancer (EOC).\nSearch methods\nWe identified randomised controlled trials (RCTs) by searching CENTRAL, MEDLINE and Embase (from 1990 to 30 September 2022). We searched clinical trials registers and contacted investigators of completed and ongoing trials for further information.\nSelection criteria\nRCTs comparing angiogenesis inhibitors with standard chemotherapy, other types of anti-cancer treatment, other angiogenesis inhibitors with or without other treatments, or placebo/no treatment in a maintenance setting, in women with EOC.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our outcomes were overall survival (OS), progression-free survival (PFS), quality of life (QoL), adverse events (grade 3 and above) and hypertension (grade 2 and above).\nMain results\nWe identified 50 studies (14,836 participants) for inclusion (including five studies from the previous version of this review): 13 solely in females with newly-diagnosed EOC and 37 in females with recurrent EOC (nine studies in platinum-sensitive EOC; 19 in platinum-resistant EOC; nine with studies with mixed or unclear platinum sensitivity). The main results are presented below.\nNewly-diagnosed EOC\nBevacizumab, a monoclonal antibody that binds vascular endothelial growth factor (VEGF), given with chemotherapy and continued as maintenance, likely results in little to no difference in OS compared to chemotherapy alone (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.88 to 1.07; 2 studies, 2776 participants; moderate-certainty evidence). Evidence is very uncertain for PFS (HR 0.82, 95% CI 0.64 to 1.05; 2 studies, 2746 participants; very low-certainty evidence), although the combination results in a slight reduction in global QoL (mean difference (MD) -6.4, 95% CI -8.86 to -3.94; 1 study, 890 participants; high-certainty evidence). The combination likely increases any adverse event (grade ≥ 3) (risk ratio (RR) 1.16, 95% CI 1.07 to 1.26; 1 study, 1485 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 2) (RR 4.27, 95% CI 3.25 to 5.60; 2 studies, 2707 participants; low-certainty evidence).\nTyrosine kinase inhibitors (TKIs) to block VEGF receptors (VEGF-R), given with chemotherapy and continued as maintenance, likely result in little to no difference in OS (HR 0.99, 95% CI 0.84 to 1.17; 2 studies, 1451 participants; moderate-certainty evidence) and likely increase PFS slightly (HR 0.88, 95% CI 0.77 to 1.00; 2 studies, 2466 participants; moderate-certainty evidence). The combination likely reduces QoL slightly (MD -1.86, 95% CI -3.46 to -0.26; 1 study, 1340 participants; moderate-certainty evidence), but it increases any adverse event (grade ≥ 3) slightly (RR 1.31, 95% CI 1.11 to 1.55; 1 study, 188 participants; moderate-certainty evidence) and may result in a large increase in hypertension (grade ≥ 3) (RR 6.49, 95% CI 2.02 to 20.87; 1 study, 1352 participants; low-certainty evidence).\nRecurrent EOC (platinum-sensitive)\nModerate-certainty evidence from three studies (with 1564 participants) indicates that bevacizumab with chemotherapy, and continued as maintenance, likely results in little to no difference in OS (HR 0.90, 95% CI 0.79 to 1.02), but likely improves PFS (HR 0.56, 95% CI 0.50 to 0.63) compared to chemotherapy alone. The combination may result in little to no difference in QoL (MD 0.8, 95% CI -2.11 to 3.71; 1 study, 486 participants; low-certainty evidence), but it increases the rate of any adverse event (grade ≥ 3) slightly (RR 1.11, 1.07 to 1.16; 3 studies, 1538 participants; high-certainty evidence). Hypertension (grade ≥ 3) was more common in arms with bevacizumab (RR 5.82, 95% CI 3.84 to 8.83; 3 studies, 1538 participants).\nTKIs with chemotherapy may result in little to no difference in OS (HR 0.86, 95% CI 0.67 to 1.11; 1 study, 282 participants; low-certainty evidence), likely increase PFS (HR 0.56, 95% CI 0.44 to 0.72; 1 study, 282 participants; moderate-certainty evidence), and may have little to no effect on QoL (MD 6.1, 95% CI -0.96 to 13.16; 1 study, 146 participants; low-certainty evidence). Hypertension (grade ≥ 3) was more common with TKIs (RR 3.32, 95% CI 1.21 to 9.10).\nRecurrent EOC (platinum-resistant)\nBevacizumab with chemotherapy and continued as maintenance increases OS (HR 0.73, 95% CI 0.61 to 0.88; 5 studies, 778 participants; high-certainty evidence) and likely results in a large increase in PFS (HR 0.49, 95% CI 0.42 to 0.58; 5 studies, 778 participants; moderate-certainty evidence). The combination may result in a large increase in hypertension (grade ≥ 2) (RR 3.11, 95% CI 1.83 to 5.27; 2 studies, 436 participants; low-certainty evidence). The rate of bowel fistula/perforation (grade ≥ 2) may be slightly higher with bevacizumab (RR 6.89, 95% CI 0.86 to 55.09; 2 studies, 436 participants).\nEvidence from eight studies suggest TKIs with chemotherapy likely result in little to no difference in OS (HR 0.85, 95% CI 0.68 to 1.08; 940 participants; moderate-certainty evidence), with low-certainty evidence that it may increase PFS (HR 0.70, 95% CI 0.55 to 0.89; 940 participants), and may result in little to no meaningful difference in QoL (MD ranged from -0.19 at 6 weeks to -3.40 at 4 months). The combination increases any adverse event (grade ≥ 3) slightly (RR 1.23, 95% CI 1.02 to 1.49; 3 studies, 402 participants; high-certainty evidence). The effect on bowel fistula/perforation rates is uncertain (RR 2.74, 95% CI 0.77 to 9.75; 5 studies, 557 participants; very low-certainty evidence).\nAuthors' conclusions\nBevacizumab likely improves both OS and PFS in platinum-resistant relapsed EOC. In platinum-sensitive relapsed disease, bevacizumab and TKIs probably improve PFS, but may or may not improve OS. The results for TKIs in platinum-resistant relapsed EOC are similar. The effects on OS or PFS in newly-diagnosed EOC are less certain, with a decrease in QoL and increase in adverse events. Overall adverse events and QoL data were more variably reported than were PFS data.\nThere appears to be a role for anti-angiogenesis treatment, but given the additional treatment burden and economic costs of maintenance treatments, benefits and risks of anti-angiogenesis treatments should be carefully considered.\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 treatments that prevent new blood vessel formation (angiogenesis) improve outcomes for women with epithelial ovarian cancer (EOC).\nOvarian cancer is the eighth most common cancer in women (and other females) worldwide, with an annual mortality rate of 4.2 per 100,000 women. EOC originates from the surface layers of ovaries or fallopian tubes and represents 90% of all ovarian cancers.\nTreatment of EOC involves surgery to remove cancer deposits and platinum-based chemotherapy (medicines that kill fast-growing cells). However, despite good initial response, many with advanced disease eventually require further treatment.\nCancers need new blood vessels to supply oxygen and nutrients for growth; inhibiting angiogenesis may slow or stop cancer growth. Angiogenesis can be blocked either by smothering the angiogenesis hormone (called VEGF) with a monoclonal antibody (an antibody that recognises a single target) or by interfering with cell responses to VEGF binding with its receptor (VEGF-R), by inhibiting enzymes (tyrosine kinases (TK)) associated with VEGF-R (tyrosine kinase inhibitor (TKI))."
}
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query-laysum | 1487 | [
{
"role": "user",
"content": "Abstract: Background\nNon-tubal ectopic pregnancy is the implantation of an embryo at a site lying outside the uterine cavity or fallopian tubes. Sites include a caesarean scar, the cornua uteri, the ovary, the cervix, and the abdomen. There has been an increasing trend in the occurrence of these rare conditions, especially caesarean scar pregnancy (CSP).\nObjectives\nTo evaluate the clinical effectiveness and safety of surgery, medical treatment, and expectant management of non-tubal ectopic pregnancy in terms of fertility outcomes and complications.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization (WHO) search portal and nine other databases to 12 December 2019. We handsearched reference lists of articles retrieved and contacted experts in the field to obtain additional data.\nSelection criteria\nWe included randomized controlled trials (RCTs) published in all languages that examined the effects and safety of surgery, medical treatment, and expectant management of non-tubal ectopic pregnancy.\nData collection and analysis\nWe used Cochrane standard methodological procedures. Primary outcomes were treatment success and complications.\nMain results\nWe included five RCTs with 303 women, all reporting Caesarean scar pregnancy. Two compared uterine arterial embolization (UAE) or uterine arterial chemoembolization (UACE) plus methotrexate (MTX) versus systemic MTX and subsequent dilation and suction curettage; one compared UACE plus MTX versus ultrasonography-guided local MTX injection; and two compared suction curettage under hysteroscopy versus suction curettage under ultrasonography after UAE/UACE.\nThe quality of evidence ranged from moderate to very low. The main limitations were imprecision (small sample sizes and very wide confidence intervals (CI) for most analyses), multiple comparisons with a small number of trials, and insufficient data available to assess heterogeneity.\nUAE/UACE versus systemic MTX prior to suction curettage\nTwo studies reported this comparison. One compared UAE with systemic MTX and one compared UACE plus MTX versus systemic MTX, in both cases followed by a suction curettage.\nWe are uncertain whether UAE/UACE improved success rates after initial treatment (UAE: risk ratio (RR) 1.00, 95% CI 0.90 to 1.12; 1 RCT, 72 women; low-quality evidence; UACE: RR 0.87, 95% CI 0.54 to 1.38; 1 RCT, 28 women; low-quality evidence).\nWe are uncertain whether UAE/UACE reduced rates of complications (UAE: RR 0.47, 95% CI 0.13 to 1.75; 1 RCT, 72 women; low-quality evidence; UACE: RR 0.62, 95% CI 0.26 to 1.48; 1 RCT, 28 women; low-quality evidence).\nWe are uncertain whether UAE/UACE reduced adverse effects (UAE: RR 1.58, 95% CI 0.41 to 6.11; 1 RCT, 72 women; low-quality evidence; UACE: RR 1.16, 95% CI 0.32 to 4.24; 1 RCT, 28 women; low-quality evidence), and it was not obvious that the types of events had similar values to participants (e.g. fever versus vomiting).\nBlood loss was lower in UAE/UACE groups than systemic MTX groups (UAE: mean difference (MD) –378.70 mL, 95% CI –401.43 to –355.97; 1 RCT, 72 women; moderate-quality evidence; UACE: MD –879.00 mL, 95% CI –1135.23 to -622.77; 1 RCT, 28 women; moderate-quality evidence).\nData were not available on time to normalize β-human chorionic gonadotropin (β-hCG).\nUACE plus MTX versus ultrasonography-guided local MTX injection\nWe are uncertain whether UACE improved success rates after initial treatment (RR 0.95, 95% CI 0.56 to 1.60; 1 RCT, 45 women; very low-quality evidence).\nAdverse effects: the study reported the same number of failed treatments in each arm (RR 0.88, 95% CI 0.40 to 1.92; 1 RCT, 45 women).\nWe are uncertain whether UACE shortened the time to normalize β-hCG (MD 1.50 days, 95% CI –3.16 to 6.16; 1 RCT, 45 women; very low-quality evidence).\nData were not available for complications.\nSuction curettage under hysteroscopy versus under ultrasonography after UAE/UACE.\nTwo studies reported this comparison. One compared suction curettage under hysteroscopy versus under ultrasonography after UAE, and one compared these interventions after UACE.\nWe are uncertain whether suction curettage under hysteroscopy improved success rates after initial treatment (UAE: RR 0.91, 95% CI 0.81 to 1.03; 1 RCT, 66 women; very low-quality evidence; UACE: RR 1.02, 95% CI 0.96 to 1.09; 1 RCT, 92 women; low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy reduced rates of complications (UAE: RR 4.00, 95% CI 0.47 to 33.91; 1 RCT, 66 women; very low-quality evidence; UACE: RR 0.18, 95% CI 0.01 to 3.72; 1 RCT, 92 women; low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy reduced adverse effects (UAE: RR 3.09, 95% CI 0.12 to 78.70; 1 RCT, 66 women; very low-quality evidence; UACE: not estimable; 1 RCT, 92 women; very low-quality evidence).\nWe are uncertain whether suction curettage under hysteroscopy shortened the time to normalize β-hCG (UAE: MD 4.03 days, 95% CI –1.79 to 9.85; 1 RCT, 66 women; very low-quality evidence; UACE: MD 0.84 days, 95% CI –1.90 to 3.58; 1 RCT, 92 women; low-quality evidence).\nNon-tubal ectopic pregnancy other than CSP\nNo studies reported on non-tubal ectopic pregnancies in locations other than on a caesarean scar.\nAuthors' conclusions\nFor Caesarean scar pregnancies (CSP) it is uncertain whether there is a difference in success rates, complications, or adverse events between UAE/UACE and administration of systemic MTX before suction curettage (low-quality evidence). Blood loss was lower if suction curettage is conducted after UAE/UACE than after administration of systemic MTX (moderate-quality evidence). It is uncertain whether there is a difference in treatment success rates, complications, adverse effects or time to normalize β-hCG between suction curettage under hysteroscopy and under ultrasonography (very low-quality evidence). There are no studies of non-tubal ectopic pregnancy other than CSP and RCTs for these types of pregnancy are unlikely.\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": "Non-tubal ectopic pregnancy is the implantation of an embryo outside the womb (uterus) or fallopian tubes (which connect the uterus to the ovaries). Sites include a caesarean scar formed as the healing of an incision in the uterus after caesarean section, the cornua uteri (where the uterus and fallopian tubes meet), the ovary, the cervix, and the abdomen. There has been an increase in the occurrence of these rare conditions, especially caesarean scar pregnancy (CSP). Ectopic pregnancy makes up 80% of maternal deaths that occur in the first trimester, of which non-tubal ectopic pregnancy deaths account for a higher rate than tubal pregnancy deaths. Early diagnosis and effective treatment are essential to reduce the immediate and delayed side effects, and to avoid significant maternal illness and death. Treatments include surgery (e.g. uterine arterial embolization (UAE; a tube delivers small particles that block the blood supply to the uterus), uterine arterial chemoembolization (UACE; a tube delivers small particles that block the blood supply to the uterus and chemotherapy), dilation and suction curettage (to remove the products of the pregnancy)); medical treatment (e.g. a medicine called methotrexate); or expectant management (wait to see if a miscarriage occurs naturally)."
}
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query-laysum | 1488 | [
{
"role": "user",
"content": "Abstract: Background\nThe ideal quantity of dietary protein for formula-fed low birth weight infants is still a matter of debate. Protein intake must be sufficient to achieve normal growth without leading to negative effects such as acidosis, uremia, and elevated levels of circulating amino acids.\nObjectives\nTo determine whether higher (≥ 3.0 g/kg/d) versus lower (< 3.0 g/kg/d) protein intake during the initial hospital stay of formula-fed preterm infants or low birth weight infants (< 2.5 kilograms) results in improved growth and neurodevelopmental outcomes without evidence of short- or long-term morbidity.\nSpecific objectives were to examine the following comparisons of interventions and to conduct subgroup analyses if possible.\n1. Low protein intake if the amount was less than 3.0 g/kg/d.\n2. High protein intake if the amount was equal to or greater than 3.0 g/kg/d but less than 4.0 g/kg/d.\n3. Very high protein intake if the amount was equal to or greater than 4.0 g/kg/d.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8), in the Cochrane Library (August 2, 2019); OVID MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, and Ovid MEDLINE(R) (to August 2, 2019); MEDLINE via PubMed (to August 2, 2019) for the previous year; and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (to August 2, 2019). We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-randomized trials.\nSelection criteria\nWe included RCTs contrasting levels of formula protein intake as low (< 3.0 g/kg/d), high (≥ 3.0 g/kg/d but < 4.0 g/kg/d), or very high (≥ 4.0 g/kg/d) in formula-fed hospitalized neonates weighing less than 2.5 kilograms. We excluded studies if infants received partial parenteral nutrition during the study period, or if infants were fed formula as a supplement to human milk.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and the GRADE approach to assess the certainty of evidence.\nMain results\nWe identified six eligible trials that enrolled 218 infants through searches updated to August 2, 2019. Five studies compared low (< 3 g/kg/d) versus high (3.0 to 4.0 g/kg/d) protein intake using formulas that kept other nutrients constant. The trials were small (n = 139), and almost all had methodological limitations; the most frequent uncertainty was about attrition. Low-certainty evidence suggests improved weight gain (mean difference [MD] 2.36 g/kg/d, 95% confidence interval [CI] 1.31 to 3.40) and higher nitrogen accretion in infants receiving formula with higher protein content (3.0 to 4.0 g/kg/d) versus lower protein content (< 3 g/kg/d), while other nutrients were kept constant. No significant differences were seen in rates of necrotizing enterocolitis, sepsis, or diarrhea. We are uncertain whether high versus low protein intake affects head growth (MD 0.37 cm/week, 95% CI 0.16 to 0.58; n = 18) and length gain (MD 0.16 cm/week, 95% CI -0.02 to 0.34; n = 48), but sample sizes were small for these comparisons.\nOne study compared high (3.0 to 4.0 g/kg/d) versus very high (≥ 4 g/kg/d) protein intake (average intakes were 3.6 and 4.1 g/kg/d) during and after an initial hospital stay (n = 77). Moderate-certainty evidence shows no significant differences in weight gain or length gain to discharge, term, and 12 weeks corrected age from very high protein intake (4.1 versus 3.6 g/kg/d). Three of the 24 infants receiving very high protein intake developed uremia.\nAuthors' conclusions\nHigher protein intake (≥ 3.0 g/kg/d but < 4.0 g/kg/d) from formula accelerates weight gain. However, limited information is available regarding the impact of higher formula protein intake on long-term outcomes such as neurodevelopment. Research is needed to investigate the safety and effectiveness of protein intake ≥ 4.0 g/kg/d.\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 six eligible trials that enrolled a total of 218 infants through searches updated to August 2, 2019."
}
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query-laysum | 1489 | [
{
"role": "user",
"content": "Abstract: Background\nMedical abortion became an alternative method of pregnancy termination following the development of prostaglandins and antiprogesterone in the 1970s and 1980s. Recently, synthesis inhibitors of oestrogen (such as letrozole) have also been used to enhance efficacy. The most widely researched drugs are prostaglandins (such as misoprostol, which has a strong uterotonic effect), mifepristone, mifepristone with prostaglandins, and letrozole with prostaglandins. More evidence is needed to identify the best dosage, regimen, and route of administration to optimise patient outcomes. This is an update of a review last published in 2011.\nObjectives\nTo compare the effectiveness and side effects of different medical methods for first trimester abortion.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Global Health, and LILACs on 28 February 2021. We also searched Clinicaltrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform, and reference lists of retrieved papers.\nSelection criteria\nWe considered randomised controlled trials (RCTs) that compared different medical methods for abortion before the 12th week of gestation. The primary outcome is failure to achieve complete abortion. Secondary outcomes are mortality, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the method.\nData collection and analysis\nTwo review authors independently selected and evaluated studies for inclusion, and assessed the risk of bias. We processed data using Review Manager 5 software. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 99 studies in the review (58 from the original review and 41 new studies).\n1. Combined regimen mifepristone/prostaglandin\nMifepristone dose: high-dose (600 mg) compared to low-dose (200 mg) mifepristone probably has similar effectiveness in achieving complete abortion (RR 1.07, 95% CI 0.87 to 1.33; I2 = 0%; 4 RCTs, 3494 women; moderate-certainty evidence).\nProstaglandin dose: 800 µg misoprostol probably reduces abortion failure compared to 400 µg (RR 0.63, 95% CI 0.51 to 0.78; I2= 0%; 3 RCTs, 4424 women; moderate-certainty evidence).\nProstaglandin timing: misoprostol administered on day one probably achieves more success on complete abortion than on day three (RR 1.94, 95% CI 1.05 to 3.58; 1489 women; 1 RCT; moderate-certainty evidence).\nAdministration strategy: there may be no difference in failure of complete abortion with self-administration at home compared with hospital administration (RR 1.63, 95% CI 0.68 to 3.94; I2 = 84%; 2263 women; 4 RCTs; low-certainty evidence), but failure may be higher when administered by nurses in hospital compared to by doctors in hospital (RR 2.69, 95% CI 1.39 to 5.22; I2 = 66%; 3 RCTs, 3056 women; low-certainty evidence).\nAdministration route: oral misoprostol probably leads to more failures than the vaginal route (RR 2.38, 95% CI 1.46 to 3.87; I2 = 39%; 3 RCTs, 1704 women; moderate-certainty evidence) and may be associated with more frequent side effects such as nausea (RR 1.14, 95% CI 1.03 to 1.26; I2 = 0%; 2 RCTs, 1380 women; low-certainty evidence) and diarrhoea (RR 1.80 95% CI 1.49 to 2.17; I2 = 0%; 2 RCTs, 1379 women). Compared with the vaginal route, complete abortion failure is probably lower with sublingual (RR 0.68, 95% CI 0.22 to 2.11; I2 = 59%; 2 RCTs, 3229 women; moderate-certainty evidence) and may be lower with buccal administration (RR 0.71, 95% CI 0.34 to 1.46; I2 = 0%; 2 RCTs, 479 women; low-certainty evidence), but sublingual or buccal routes may lead to more side effects. Women may experience more vomiting with sublingual compared to buccal administration (RR 1.33, 95% CI 1.01 to 1.77; low-certainty evidence).\n2. Mifepristone alone versus combined regimen\nThe efficacy of mifepristone alone in achieving complete abortion compared to combined mifepristone/prostaglandin up to 12 weeks is unclear (RR of failure 3.25, 95% CI 0.81 to 13.09; I2 = 83%; 3 RCTs, 273 women; very low-certainty evidence).\n3. Prostaglandin alone versus combined regimen\nNineteen studies compared prostaglandin alone to a combined regimen (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate). Compared to any of the combination regimens, misoprostol alone may increase the risk for failure to achieve complete abortion (RR of failure 2.39, 95% CI 1.89 to 3.02; I2 = 64%; 18 RCTs, 3471 women; low-certainty evidence), and with more diarrhoea.\n4. Prostaglandin alone (route of administration)\nOral misoprostol alone may lead to more failures in complete abortion than the vaginal route (RR 3.68, 95% CI 1.56 to 8.71, 2 RCTs, 216 women; low-certainty evidence). Failure to achieve complete abortion may be slightly reduced with sublingual compared with vaginal (RR 0.69, 95% CI 0.37 to 1.28; I2 = 87%; 5 RCTs, 2705 women; low-certainty evidence) and oral administration (RR 0.58, 95% CI 0.11 to 2.99; I2 = 66%; 2 RCTs, 173 women). Failure to achieve complete abortion may be similar or slightly higher with sublingual administration compared to buccal administration (RR 1.11, 95% CI 0.71 to 1.74; 1 study, 401 women).\nAuthors' conclusions\nSafe and effective medical abortion methods are available. Combined regimens (prostaglandin combined with mifepristone, letrozole, estradiol valerate, tamoxifen, or methotrexate) may be more effective than single agents (prostaglandin alone or mifepristone alone). In the combined regimen, the dose of mifepristone can probably be lowered to 200 mg without significantly decreasing effectiveness. Vaginal misoprostol is probably more effective than oral administration, and may have fewer side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all studies were conducted in settings with good access to emergency services, which may limit the generalisability of these results.\n\nGiven the provided abstract, please respond to the following query: \"What is medical abortion?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Medical abortion uses one or more medicines alone or in combination to end a pregnancy. The most common medicines are the hormones prostaglandin and mifepristone. Other medicines include methotrexate (a kind of chemotherapy), and letrozole, which slows the production of the hormone oestrogen. These medicines work by softening the cervix (neck of the womb) and causing the uterus (womb) to contract. They may be swallowed (taken orally), put under the tongue or in the cheek, or put in the vagina. They can be given by a nurse or a doctor in hospital, or taken by women at home.\nMedical abortion methods may cause unwanted effects such as heavy bleeding, pain, nausea, vomiting and diarrhoea, Failed abortion is an infrequent but important complication of medical abortion. Medical methods for early abortion are already widely available in some countries, and new medicines are being developed."
}
]
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query-laysum | 1490 | [
{
"role": "user",
"content": "Abstract: Background\nMultinodular goitre is common in women. Treatments for non-toxic multinodular goitre include surgery, levothyroxine suppressive therapy, and radioiodine. Radioiodine therapy is the only non-surgical alternative for non-toxic multinodular goitre. However, a high amount of radioiodine is needed to enable the thyroid nodules to adequately take up the radioiodine, because the multinodular goitre takes up a low amount of iodine. Recombinant human thyrotropin (rhTSH) has been used to increase radioiodine uptake and reduce thyroid volume of the multinodular goitre. Whether the improved reduction of the goitre resulting from rhTSH-stimulated radioiodine therapy is beneficial to the person remains controversial.\nObjectives\nTo assess the effects of recombinant human thyrotropin-aided radioiodine treatment for non-toxic multinodular goitre.\nSearch methods\nWe searched the CENTRAL, MEDLINE, Scopus as well as ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 18 December 2020.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) comparing the effects of rhTSH-aided radioiodine treatment compared with radioiodine alone for non-toxic multinodular goitre, with at least 12 months of follow-up.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance. Screening for inclusion, data extraction, and risk of bias assessment were carried out by one review author and checked by a second. Our main outcomes were health-related quality of life (QoL), hypothyroidism, adverse events, thyroid volume, all-cause mortality, and costs. We used a random-effects model to perform meta-analyses, and calculated risk ratios (RRs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We evaluated the certainty of the evidence using the GRADE approach.\nMain results\nWe included six RCTs. A total of 197 participants were allocated to rhTSh-aided radioiodine therapy, and 124 participants were allocated to radioiodine. A single dose of radioiodine was administered 24 hours after the intramuscular injection of a single dose of rhTSH. The duration of follow-up ranged between 12 and 36 months.\nLow-certainty evidence from one study, with 85 participants, showed uncertain effects for QoL for either intervention. RhTSH-aided radioiodine increased hypothyroidism compared with radioiodine alone (64/197 participants (32.5%) in the rhTSH-aided radioiodine group versus 15/124 participants (12.1%) in the radioiodine alone group; RR 2.53, 95% CI 1.52 to 4.20; 6 studies, 321 participants; moderate-certainty evidence in favour of radioiodine alone). A total of 118/197 participants (59.9%) in the rhTSH-aided radioiodine group compared with 60/124 participants (48.4%) in the radioiodine alone group experienced adverse events (random-effects RR 1.24, 95% CI 0.94 to 1.63; 6 studies, 321 participants; fixed-effect RR 1.23, 95% CI 1.02 to 1.49 in favour of radioiodine only; low-certainty evidence).\nRhTSH-aided radioiodine reduced thyroid volume with a MD of 11.9% (95% CI 4.4 to 19.4; 6 studies, 268 participants; moderate-certainty evidence). One study with 28 participants reported one death in the radioiodine alone group (very-low certainty evidence). No study reported on costs.\nAuthors' conclusions\nRhTSH-aided radioiodine treatment for non-toxic multinodular goitre, compared to radioiodine alone, probably increased the risk of hypothyroidism but probably led to a greater reduction in thyroid volume. Data on QoL and costs were sparse or missing.\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": "Goitre is an enlargement of the thyroid gland that can be classified as simple, diffuse goitre or multinodular goitre. Nodules (lumps) within the thyroid gland are common and usually benign. They are more frequent in women, the elderly, and in people who live in iodine-deficient areas. Thyroid nodules may occur as a single nodule or as multiple nodules (multinodular). Multinodular goitre can be 'toxic' (producing too much thyroid hormone), or non-toxic (normal thyroid function). Treatments for non-toxic multinodular goitre include surgery, thyroid hormone suppressive therapy, and radioiodine therapy. Usually, higher amounts of radioiodine are needed to enable an appropriate radioiodine uptake in the thyroid nodules. Genetically engineered recombinant human thyroid-stimulating hormone (rhTSH) has been used to increase radioiodine uptake.\nWe wanted to find out whether rhTSH-aided radioiodine treatment is better for people with non-toxic multinodular goitre compared with radioiodine treatment alone. The outcomes we were specifically interested in were health-related quality of life, underactive thyroid (hypothyroidism), side effects, reduction in thyroid volume, death from any cause, and costs."
}
]
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query-laysum | 1491 | [
{
"role": "user",
"content": "Abstract: Background\nThis review update has been managed by both the Childhood Cancer and Cochrane Gynaecological, Neuro-oncology and Orphan Cancer Groups.\nThe use of anthracycline chemotherapy is limited by the occurrence of cardiotoxicity. To prevent this cardiotoxicity, different anthracycline dosage schedules have been studied.\nObjectives\nTo determine the occurrence of cardiotoxicity with the use of different anthracycline dosage schedules (that is peak doses and infusion durations) in people with cancer.\nSearch methods\nWe searched the databases of the Cochrane Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 11, 2015), MEDLINE (1966 to December 2015), and EMBASE (1980 to December 2015). We also searched reference lists of relevant articles, conference proceedings, experts in the field, and ongoing trials databases.\nSelection criteria\nRandomised controlled trials (RCTs) in which different anthracycline dosage schedules were compared in people with cancer (children and adults).\nData collection and analysis\nTwo review authors independently performed the study selection, the 'Risk of bias' assessment, and data extraction. We performed analyses according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nWe identified 11 studies: 7 evaluated different infusion durations (803 participants), and 4 evaluated different peak doses (5280 participants). Seven studies were RCTs addressing different anthracycline infusion durations; we identified long-term follow-up data for one of the trials in this update. The meta-analysis showed a statistically significant lower rate of clinical heart failure with an infusion duration of six hours or longer as compared to a shorter infusion duration (risk ratio (RR) 0.27; 95% confidence interval 0.09 to 0.81; 5 studies; 557 participants). The majority of participants included in these studies were adults with different solid tumours. For different anthracycline peak doses, we identified two RCTs addressing a doxorubicin peak dose of less than 60 mg/m2 versus 60 mg/m2 or more, one RCT addressing a liposomal doxorubicin peak dose of 25 mg/m2 versus 50 mg/m2, and one RCT addressing an epirubicin peak dose of 83 mg/m2 versus 110 mg/m2. A significant difference in the occurrence of clinical heart failure was identified in none of the studies. The participants included in these studies were adults with different solid tumours. High or unclear 'Risk of bias' issues were present in all studies.\nAuthors' conclusions\nAn anthracycline infusion duration of six hours or longer reduces the risk of clinical heart failure, and it seems to reduce the risk of subclinical cardiac damage. Since there is only a small amount of data for children and data obtained in adults cannot be extrapolated to children, different anthracycline infusion durations should be evaluated further in children.\nWe identified no significant difference in the occurrence of clinical heart failure in participants treated with a doxorubicin peak dose of less than 60 mg/m2 or 60 mg/m2 or more. Only one RCT was available for the other identified peak doses, so we can make no definitive conclusions about the occurrence of cardiotoxicity. More high-quality research is needed, both in children and adults and in leukaemias and solid tumours.\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": "Anthracyclines are one of the most effective treatments for various types of cancer. Unfortunately, there is a risk of heart damage depending on the total dose a patient has received. In an effort to prevent heart damage, different anthracycline dosage schedules such as different infusion durations or different individual peak doses (the maximal dose received in one week) are being used."
}
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query-laysum | 1492 | [
{
"role": "user",
"content": "Abstract: Background\nAlcohol is consumed by over 2 billion people worldwide. It is a common substance of abuse and its use can lead to more than 200 disorders including hypertension. Alcohol has both acute and chronic effects on blood pressure. This review aimed to quantify the acute effects of different doses of alcohol over time on blood pressure and heart rate in an adult population.\nObjectives\nPrimary objective\nTo determine short-term dose-related effects of alcohol versus placebo on systolic blood pressure and diastolic blood pressure in healthy and hypertensive adults over 18 years of age.\nSecondary objective\nTo determine short-term dose-related effects of alcohol versus placebo on heart rate in healthy and hypertensive adults over 18 years of age.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2019: the Cochrane Hypertension Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 2), in the Cochrane Library; MEDLINE (from 1946); Embase (from 1974); the World Health Organization International Clinical Trials Registry Platform; and ClinicalTrials.gov. We also contacted authors of relevant articles regarding further published and unpublished work. These searches had no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing effects of a single dose of alcohol versus placebo on blood pressure (BP) or heart rate (HR) in adults (≥ 18 years of age).\nData collection and analysis\nTwo review authors (ST and CT) independently extracted data and assessed the quality of included studies. We also contacted trial authors for missing or unclear information. Mean difference (MD) from placebo with 95% confidence interval (CI) was the outcome measure, and a fixed-effect model was used to combine effect sizes across studies.\nMain results\nWe included 32 RCTs involving 767 participants. Most of the study participants were male (N = 642) and were healthy. The mean age of participants was 33 years, and mean body weight was 78 kilograms.\nLow-dose alcohol (< 14 g) within six hours (2 RCTs, N = 28) did not affect BP but did increase HR by 5.1 bpm (95% CI 1.9 to 8.2) (moderate-certainty evidence).\nMedium-dose alcohol (14 to 28 g) within six hours (10 RCTs, N = 149) decreased systolic blood pressure (SBP) by 5.6 mmHg (95% CI -8.3 to -3.0) and diastolic blood pressure (DBP) by 4.0 mmHg (95% CI -6.0 to -2.0) and increased HR by 4.6 bpm (95% CI 3.1 to 6.1) (moderate-certainty evidence for all).\nMedium-dose alcohol within 7 to 12 hours (4 RCTs, N = 54) did not affect BP or HR.\nMedium-dose alcohol > 13 hours after consumption (4 RCTs, N = 66) did not affect BP or HR.\nHigh-dose alcohol (> 30 g) within six hours (16 RCTs, N = 418) decreased SBP by 3.5 mmHg (95% CI -6.0 to -1.0), decreased DBP by 1.9 mmHg (95% CI-3.9 to 0.04), and increased HR by 5.8 bpm (95% CI 4.0 to 7.5). The certainty of evidence was moderate for SBP and HR, and was low for DBP.\nHigh-dose alcohol within 7 to 12 hours of consumption (3 RCTs, N = 54) decreased SBP by 3.7 mmHg (95% CI -7.0 to -0.5) and DBP by 1.7 mmHg (95% CI –4.6 to 1.8) and increased HR by 6.2 bpm (95% CI 3.0 to 9.3). The certainty of evidence was moderate for SBP and HR, and low for DBP.\nHigh-dose alcohol ≥ 13 hours after consumption (4 RCTs, N = 154) increased SBP by 3.7 mmHg (95% CI 2.3 to 5.1), DBP by 2.4 mmHg (95% CI 0.2 to 4.5), and HR by 2.7 bpm (95% CI 0.8 to 4.6) (moderate-certainty evidence for all).\nAuthors' conclusions\nHigh-dose alcohol has a biphasic effect on BP; it decreases BP up to 12 hours after consumption and increases BP > 13 hours after consumption. High-dose alcohol increases HR at all times up to 24 hours. Findings of this review are relevant mainly to healthy males, as only small numbers of women were included in the included trials.\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 32 randomised controlled trials involving 767 participants published up to March 2019. Although these trials included adults from 18 to 96 years of age with various health conditions, most study participants were young healthy males. The source of funding was not reported for a majority of the studies."
}
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query-laysum | 1493 | [
{
"role": "user",
"content": "Abstract: Background\nGroup A streptococcus (GAS) accounts for 20% to 40% of cases of pharyngitis in children; the remaining cases are caused by viruses. Compared with throat culture, rapid antigen detection tests (RADTs) offer diagnosis at the point of care (within five to 10 minutes).\nObjectives\nTo determine the diagnostic accuracy of RADTs for diagnosing GAS in children with pharyngitis. To assess the relative diagnostic accuracy of the two major types of RADTs (enzyme immunoassays (EIA) and optical immunoassays (OIA)) by indirect and direct comparison.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, Web of Science, CDSR, DARE, MEDION and TRIP (January 1980 to July 2015). We also conducted related citations tracking via PubMed, handsearched reference lists of included studies and relevant review articles, and screened all articles citing included studies via Google Scholar.\nSelection criteria\nWe included studies that compared RADT for GAS pharyngitis with throat culture on a blood agar plate in a microbiology laboratory in children seen in ambulatory care.\nData collection and analysis\nTwo review authors independently screened titles and abstracts for relevance, assessed full texts for inclusion, and carried out data extraction and quality assessment using the QUADAS-2 tool. We used bivariate meta-analysis to estimate summary sensitivity and specificity, and to investigate heterogeneity across studies. We compared the accuracy of EIA and OIA tests using indirect and direct evidence.\nMain results\nWe included 98 unique studies in the review (116 test evaluations; 101,121 participants). The overall methodological quality of included studies was poor, mainly because many studies were at high risk of bias regarding patient selection and the reference standard used (in 73% and 43% of test evaluations, respectively). In studies in which all participants underwent both RADT and throat culture (105 test evaluations; 58,244 participants; median prevalence of participants with GAS was 29.5%), RADT had a summary sensitivity of 85.6%; 95% confidence interval (CI) 83.3 to 87.6 and a summary specificity of 95.4%; 95% CI 94.5 to 96.2. There was substantial heterogeneity in sensitivity across studies; specificity was more stable. There was no evidence of a trade-off between sensitivity and specificity. Heterogeneity in accuracy was not explained by study-level characteristics such as whether an enrichment broth was used before plating, mean age and clinical severity of participants, and GAS prevalence. The sensitivity of EIA and OIA tests was comparable (summary sensitivity 85.4% versus 86.2%). Sensitivity analyses showed that summary estimates of sensitivity and specificity were stable in low risk of bias studies.\nAuthors' conclusions\nIn a population of 1000 children with a GAS prevalence of 30%, 43 patients with GAS will be missed. Whether or not RADT can be used as a stand-alone test to rule out GAS will depend mainly on the epidemiological context. The sensitivity of EIA and OIA tests seems comparable. RADT specificity is sufficiently high to ensure against unnecessary use of antibiotics. Based on these results, we would expect that amongst 100 children with strep throat, 86 would be correctly detected with the rapid test while 14 would be missed and not receive antibiotic treatment.\n\nGiven the provided abstract, please respond to the following query: \"Background and aims\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sore throat is very common in children. It can be caused by viruses or bacteria. The bacterium most frequently identified during sore throat in children is group A streptococcus ('strep throat'). Amongst children with sore throat, antibiotic treatment is only useful in those with strep throat.\nSimple, rapid tests for the diagnosis of strep throat have been available since the 1980s. Physicians can do a rapid test at the point of care by swabbing the throat. Based on the result of the rapid test, they can then decide if antibiotics are needed.\nWe reviewed the evidence about the performance of rapid tests for correctly detecting strep throat in children seen in Outpatient departments with a main complaint of sore throat."
}
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query-laysum | 1494 | [
{
"role": "user",
"content": "Abstract: Background\nFatigue is a prevalent and burdensome symptom for patients with incurable cancer receiving cancer treatment with palliative intent and is associated with reduced quality of life. Psychosocial interventions seem promising for management of fatigue among cancer patients.\nObjectives\nTo assess the effects of psychosocial interventions for fatigue in adult patients with incurable cancer receiving cancer treatment with palliative intent.\nSearch methods\nWe searched the following databases: CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and seven clinical trial registries; we also searched the reference lists of articles. The date of our most recent search was 29 November 2016.\nSelection criteria\nWe included randomised controlled trials that compared psychosocial interventions in adults aged 18 years or over undergoing cancer treatment with palliative intent for incurable cancer versus usual care or other controls. Psychosocial interventions were defined as various kinds of interventions provided to influence or change cognitions, emotions, behaviours, social interactions, or a combination of these. Psychosocial interventions of interest to this review had to involve at least two interactions between the patient and the care provider in which the care provider gave the patient personal feedback concerning changes sought by these interventions. We included trials that reported fatigue as an outcome of interest.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data, including information on adverse events. We assessed the quality of evidence using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and created a 'Summary of findings’ table.\nMain results\nWe identified 14 studies (16 reports) that met inclusion criteria for this review and involved 3077 randomised participants in total. Most of these studies included a mixed sample of participants; we obtained data for the subset of interest for this review (diagnosis of incurable cancer and receiving cancer treatment) from the study investigators of 12 studies, for which we included 535 participants in the subset meta-analysis for fatigue post intervention. Researchers investigated a broad range of psychosocial interventions with different intervention aims and durations. We identified sources of potential bias, including lack of description of methods of blinding and allocation concealment and inclusion of small study populations.\nFindings from our meta-analysis do not support the effectiveness of psychosocial interventions for reducing fatigue post intervention (standardised mean difference (SMD) -0.25, 95% confidence interval (CI) -0.50 to 0.00; not significant; 535 participants, 12 studies; very low-quality evidence). First follow-up findings on fatigue suggested benefit for participants assigned to the psychosocial intervention compared with control (SMD -0.66, 95% CI -1.00 to -0.32; 147 participants, four studies; very low-quality evidence), which was not sustained at second follow-up (SMD -0.41, 95% CI -1.12 to 0.30; not significant; very low-quality evidence).\nResults for our secondary outcomes revealed very low-quality evidence for the efficacy of psychosocial interventions in improving physical functioning post intervention (SMD 0.32, 95% CI 0.01 to 0.63; 307 participants, seven studies). These findings were not sustained at first follow-up (SMD 0.37, 95% CI -0.20 to 0.94; not significant; 122 participants, two studies; very low-quality evidence). Findings do not support the effectiveness of psychosocial interventions for improving social functioning (mean difference (MD) 4.16, 95% CI -11.20 to 19.53; not significant; 141 participants, four studies), role functioning (MD 3.49, 95% CI -12.78 to 19.76; not significant; 143 participants, four studies), emotional functioning (SMD -0.11, 95% CI -0.56 to 0.35; not significant; 115 participants, three studies), or cognitive functioning (MD -2.23, 95% CI -12.52 to 8.06; not significant; 86 participants, two studies) post intervention. Only three studies evaluated adverse events. These studies found no difference between the number of adverse events among participants in the intervention versus control group.\nUsing GRADE, we considered the overall quality of evidence for our primary and secondary outcomes to be very low. Therefore, we have very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of effect. Limitations in study quality and imprecision due to sparse data resulted in downgrading of the quality of data. Additionally, most studies were at high risk of bias owing to their small sample size for the subset of patients with incurable cancer (fewer than 50 participants per arm), leading to uncertainty about effect estimates.\nAuthors' conclusions\nWe found little evidence around the benefits of psychosocial interventions provided to reduce fatigue in adult patients with incurable cancer receiving cancer treatment with palliative intent. Additional studies with larger samples are required to assess whether psychosocial interventions are beneficial for addressing fatigue in patients with incurable cancer.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors found no support for the effectiveness of psychological therapies in reducing tiredness when assessed directly following the intervention. Very low-quality evidence suggests that psychological therapies may improve physical functioning directly after the intervention and may improve tiredness at first follow-up. Evidence shows no support for the effectiveness of psychosocial therapies in improving other domains of functioning. Limited evaluation of potential harm suggests no differences in side effects between patients receiving psychological therapy and those given usual care. Limited good quality evidence allows no conclusions on the use of psychological therapies in people with incurable cancer. Larger, high-quality trials are needed to find out whether psychological therapies help reduce tiredness for people with incurable cancer during cancer treatment."
}
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query-laysum | 1495 | [
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis is the most common, life-threatening, recessively inherited disease of Caucasian populations. It is a multisystem disorder caused by a mutation in the gene encoding the cystic fibrosis transmembrane conductance regulator protein which is important in producing sweat, digestive juices and mucus.The impaired or absent function of this protein results in the production of viscous mucus within the lungs and an environment that is susceptible to chronic airway obstruction and pulmonary colonization by a range of pathogenic bacteria. Morbidity and mortality of cystic fibrosis is related to chronic pulmonary sepsis and its complications by these bacteria.\nInfluenza can worsen the course of the disease in cystic fibrosis by increasing the risk of pneumonia and secondary respiratory complications. Antiviral agents form an important part of influenza management and include the neuraminidase inhibitors zanamivir and oseltamivir. These inhibitors can limit the infection and prevent the spread of the virus.\nObjectives\nTo assess the effects of neuraminidase inhibitors for the treatment of influenza infection in people with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.\nMost recent search: 02 November 2015.\nSelection criteria\nRandomised controlled trials and quasi-randomised controlled trials comparing neuraminidase inhibitors with placebo or other antiviral drugs.\nData collection and analysis\nTwo review authors had planned to independently screen studies, extract data and assess risk of bias using standard Cochrane methodologies. No studies were identified for inclusion.\nMain results\nNo relevant studies were retrieved after a comprehensive search of the literature.\nAuthors' conclusions\nWe were unable to identify any randomised controlled studies or quasi-randomised controlled studies on the efficacy of neuraminidase inhibitors for the treatment of influenza infection in people with cystic fibrosis. The absence of high level evidence for the effectiveness of these interventions emphasises the need for well-designed, adequately powered, randomised controlled clinical studies.\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 did not find any studies looking at the use of neuraminidase inhibitors for influenza in people with cystic fibrosis."
}
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query-laysum | 1496 | [
{
"role": "user",
"content": "Abstract: Background\nNearsightedness (myopia) causes blurry vision when one is looking at distant objects. Interventions to slow the progression of myopia in children include multifocal spectacles, contact lenses, and pharmaceutical agents.\nObjectives\nTo assess the effects of interventions, including spectacles, contact lenses, and pharmaceutical agents in slowing myopia progression in children.\nSearch methods\nWe searched CENTRAL; Ovid MEDLINE; Embase.com; PubMed; the LILACS Database; and two trial registrations up to February 2018. A top up search was done in February 2019.\nSelection criteria\nWe included randomized controlled trials (RCTs). We excluded studies when most participants were older than 18 years at baseline. We also excluded studies when participants had less than -0.25 diopters (D) spherical equivalent myopia.\nData collection and analysis\nWe followed standard Cochrane methods.\nMain results\nWe included 41 studies (6772 participants). Twenty-one studies contributed data to at least one meta-analysis. Interventions included spectacles, contact lenses, pharmaceutical agents, and combination treatments. Most studies were conducted in Asia or in the United States. Except one, all studies included children 18 years or younger. Many studies were at high risk of performance and attrition bias.\nSpectacle lenses: undercorrection of myopia increased myopia progression slightly in two studies; children whose vision was undercorrected progressed on average -0.15 D (95% confidence interval [CI] -0.29 to 0.00; n = 142; low-certainty evidence) more than those wearing fully corrected single vision lenses (SVLs). In one study, axial length increased 0.05 mm (95% CI -0.01 to 0.11) more in the undercorrected group than in the fully corrected group (n = 94; low-certainty evidence). Multifocal lenses (bifocal spectacles or progressive addition lenses) yielded small effect in slowing myopia progression; children wearing multifocal lenses progressed on average 0.14 D (95% CI 0.08 to 0.21; n = 1463; moderate-certainty evidence) less than children wearing SVLs. In four studies, axial elongation was less for multifocal lens wearers than for SVL wearers (-0.06 mm, 95% CI -0.09 to -0.04; n = 896; moderate-certainty evidence). Three studies evaluating different peripheral plus spectacle lenses versus SVLs reported inconsistent results for refractive error and axial length outcomes (n = 597; low-certainty evidence).\nContact lenses: there may be little or no difference between vision of children wearing bifocal soft contact lenses (SCLs) and children wearing single vision SCLs (mean difference (MD) 0.20D, 95% CI -0.06 to 0.47; n = 300; low-certainty evidence). Axial elongation was less for bifocal SCL wearers than for single vision SCL wearers (MD -0.11 mm, 95% CI -0.14 to -0.08; n = 300; low-certainty evidence). Two studies investigating rigid gas permeable contact lenses (RGPCLs) showed inconsistent results in myopia progression; these two studies also found no evidence of difference in axial elongation (MD 0.02mm, 95% CI -0.05 to 0.10; n = 415; very low-certainty evidence). Orthokeratology contact lenses were more effective than SVLs in slowing axial elongation (MD -0.28 mm, 95% CI -0.38 to -0.19; n = 106; moderate-certainty evidence). Two studies comparing spherical aberration SCLs with single vision SCLs reported no difference in myopia progression nor in axial length (n = 209; low-certainty evidence).\nPharmaceutical agents: at one year, children receiving atropine eye drops (3 studies; n = 629), pirenzepine gel (2 studies; n = 326), or cyclopentolate eye drops (1 study; n = 64) showed significantly less myopic progression compared with children receiving placebo: MD 1.00 D (95% CI 0.93 to 1.07), 0.31 D (95% CI 0.17 to 0.44), and 0.34 (95% CI 0.08 to 0.60), respectively (moderate-certainty evidence). Axial elongation was less for children treated with atropine (MD -0.35 mm, 95% CI -0.38 to -0.31; n = 502) and pirenzepine (MD -0.13 mm, 95% CI -0.14 to -0.12; n = 326) than for those treated with placebo (moderate-certainty evidence) in two studies. Another study showed favorable results for three different doses of atropine eye drops compared with tropicamide eye drops (MD 0.78 D, 95% CI 0.49 to 1.07 for 0.1% atropine; MD 0.81 D, 95% CI 0.57 to 1.05 for 0.25% atropine; and MD 1.01 D, 95% CI 0.74 to 1.28 for 0.5% atropine; n = 196; low-certainty evidence) but did not report axial length. Systemic 7-methylxanthine had little to no effect on myopic progression (MD 0.07 D, 95% CI -0.09 to 0.24) nor on axial elongation (MD -0.03 mm, 95% CI -0.10 to 0.03) compared with placebo in one study (n = 77; moderate-certainty evidence). One study did not find slowed myopia progression when comparing timolol eye drops with no drops (MD -0.05 D, 95% CI -0.21 to 0.11; n = 95; low-certainty evidence).\nCombinations of interventions: two studies found that children treated with atropine plus multifocal spectacles progressed 0.78 D (95% CI 0.54 to 1.02) less than children treated with placebo plus SVLs (n = 191; moderate-certainty evidence). One study reported -0.37 mm (95% CI -0.47 to -0.27) axial elongation for atropine and multifocal spectacles when compared with placebo plus SVLs (n = 127; moderate-certainty evidence). Compared with children treated with cyclopentolate plus SVLs, those treated with atropine plus multifocal spectacles progressed 0.36 D less (95% CI 0.11 to 0.61; n = 64; moderate-certainty evidence). Bifocal spectacles showed small or negligible effect compared with SVLs plus timolol drops in one study (MD 0.19 D, 95% CI 0.06 to 0.32; n = 97; moderate-certainty evidence). One study comparing tropicamide plus bifocal spectacles versus SVLs reported no statistically significant differences between groups without quantitative results.\nNo serious adverse events were reported across all interventions. Participants receiving antimuscarinic topical medications were more likely to experience accommodation difficulties (Risk Ratio [RR] 9.05, 95% CI 4.09 to 20.01) and papillae and follicles (RR 3.22, 95% CI 2.11 to 4.90) than participants receiving placebo (n=387; moderate-certainty evidence).\nAuthors' conclusions\nAntimuscarinic topical medication is effective in slowing myopia progression in children. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit. Orthokeratology contact lenses, although not intended to modify refractive error, were more effective than SVLs in slowing axial elongation. We found only low or very low-certainty evidence to support RGPCLs and sperical aberration SCLs.\n\nGiven the provided abstract, please respond to the following query: \"Key message\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Eye drop medication, such as atropine, probably slows myopia progression in children. Children taking these eye drops may have blurred near vision, sensitivity to light, and some itching and discomfort. Multifocal lenses, either spectacles or contact lenses, may also confer a small benefit."
}
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query-laysum | 1497 | [
{
"role": "user",
"content": "Abstract: Background\nMobile health (mHealth), refers to healthcare practices supported by mobile devices, such as mobile phones and tablets. Within primary care, health workers often use mobile devices to register clients, track their health, and make decisions about care, as well as to communicate with clients and other health workers. An understanding of how health workers relate to, and experience mHealth, can help in its implementation.\nObjectives\nTo synthesise qualitative research evidence on health workers' perceptions and experiences of using mHealth technologies to deliver primary healthcare services, and to develop hypotheses about why some technologies are more effective than others.\nSearch methods\nWe searched MEDLINE, Embase, CINAHL, Science Citation Index and Social Sciences Citation Index in January 2018. We searched Global Health in December 2015. We screened the reference lists of included studies and key references and searched seven sources for grey literature (16 February to 5 March 2018). We re-ran the search strategies in February 2020. We screened these records and any studies that we identified as potentially relevant are awaiting classification.\nSelection criteria\nWe included studies that used qualitative data collection and analysis methods. We included studies of mHealth programmes that were part of primary healthcare services. These services could be implemented in public or private primary healthcare facilities, community and workplace, or the homes of clients. We included all categories of health workers, as well as those persons who supported the delivery and management of the mHealth programmes. We excluded participants identified as technical staff who developed and maintained the mHealth technology, without otherwise being involved in the programme delivery. We included studies conducted in any country.\nData collection and analysis\nWe assessed abstracts, titles and full-text papers according to the inclusion criteria. We found 53 studies that met the inclusion criteria and sampled 43 of these for our analysis. For the 43 sampled studies, we extracted information, such as country, health worker category, and the mHealth technology. We used a thematic analysis process. We used GRADE-CERQual to assess our confidence in the findings.\nMain results\nMost of the 43 included sample studies were from low- or middle-income countries. In many of the studies, the mobile devices had decision support software loaded onto them, which showed the steps the health workers had to follow when they provided health care. Other uses included in-person and/or text message communication, and recording clients' health information. Almost half of the studies looked at health workers' use of mobile devices for mother, child, and newborn health.\nWe have moderate or high confidence in the following findings.\nmHealth changed how health workers worked with each other : health workers appreciated being more connected to colleagues, and thought that this improved co-ordination and quality of care. However, some described problems when senior colleagues did not respond or responded in anger. Some preferred face-to-face connection with colleagues. Some believed that mHealth improved their reporting, while others compared it to \"big brother watching\".\nmHealth changed how health workers delivered care : health workers appreciated how mHealth let them take on new tasks, work flexibly, and reach clients in difficult-to-reach areas. They appreciated mHealth when it improved feedback, speed and workflow, but not when it was slow or time consuming. Some health workers found decision support software useful; others thought it threatened their clinical skills. Most health workers saw mHealth as better than paper, but some preferred paper. Some health workers saw mHealth as creating more work.\nmHealth led to new forms of engagement and relationships with clients and communities : health workers felt that communicating with clients by mobile phone improved care and their relationships with clients, but felt that some clients needed face-to-face contact. Health workers were aware of the importance of protecting confidential client information when using mobile devices. Some health workers did not mind being contacted by clients outside working hours, while others wanted boundaries. Health workers described how some community members trusted health workers that used mHealth while others were sceptical. Health workers pointed to problems when clients needed to own their own phones.\nHealth workers' use and perceptions of mHealth could be influenced by factors tied to costs, the health worker, the technology, the health system and society, poor network access, and poor access to electricity : some health workers did not mind covering extra costs. Others complained that phone credit was not delivered on time. Health workers who were accustomed to using mobile phones were sometimes more positive towards mHealth. Others with less experience, were sometimes embarrassed about making mistakes in front of clients or worried about job security. Health workers wanted training, technical support, user-friendly devices, and systems that were integrated into existing electronic health systems. The main challenges health workers experienced were poor network connections, access to electricity, and the cost of recharging phones. Other problems included damaged phones. Factors outside the health system also influenced how health workers experienced mHealth, including language, gender, and poverty issues. Health workers felt that their commitment to clients helped them cope with these challenges.\nAuthors' conclusions\nOur findings propose a nuanced view about mHealth programmes. The complexities of healthcare delivery and human interactions defy simplistic conclusions on how health workers will perceive and experience their use of mHealth. Perceptions reflect the interplay between the technology, contexts, and human attributes. Detailed descriptions of the programme, implementation processes and contexts, alongside effectiveness studies, will help to unravel this interplay to formulate hypotheses regarding the effectiveness of mHealth.\n\nGiven the provided abstract, please respond to the following query: \"Health workers' use and perceptions of mHealth could be influenced by factors tied to costs, the health worker, the technology, the health system and society, poor network access, and poor access to electricity\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "some health workers did not mind covering extra costs. Others complained that phone credit was not delivered on time. Health workers who were accustomed to using mobile phones were sometimes more positive towards mHealth. Others with less experience, were sometimes embarrassed about making mistakes in front of clients or worried about job security. Health workers wanted training, technical support, user-friendly devices, and systems that were integrated into existing electronic health systems. The main challenges health workers experienced were poor network connections, access to electricity, and the cost of recharging phones. Other problems included damaged phones. Factors outside the health system also influenced how health workers experienced mHealth, including language, gender, and poverty issues. Health workers felt that their commitment to clients helped them cope with these challenges."
}
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query-laysum | 1498 | [
{
"role": "user",
"content": "Abstract: Background\nDental caries is a highly prevalent chronic disease which affects the majority of people. It has been postulated that the consumption of xylitol could help to prevent caries. The evidence on the effects of xylitol products is not clear and therefore it is important to summarise the available evidence to determine its effectiveness and safety.\nObjectives\nTo assess the effects of different xylitol-containing products for the prevention of dental caries in children and adults.\nSearch methods\nWe searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 14 August 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2014, Issue 7), MEDLINE via OVID (1946 to 14 August 2014), EMBASE via OVID (1980 to 14 August 2014), CINAHL via EBSCO (1980 to 14 August 2014), Web of Science Conference Proceedings (1990 to 14 August 2014), Proquest Dissertations and Theses (1861 to 14 August 2014). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials assessing the effects of xylitol products on dental caries in children and adults.\nData collection and analysis\nTwo review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias of the included studies. We attempted to contact study authors for missing data or clarification where feasible. For continuous outcomes, we used means and standard deviations to obtain the mean difference and 95% confidence interval (CI). We used the continuous data to calculate prevented fractions (PF) and 95% CIs to summarise the percentage reduction in caries. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs. As there were less than four studies included in the meta-analysis, we used a fixed-effect model. We planned to use a random-effects model in the event that there were four or more studies in a meta-analysis.\nMain results\nWe included 10 studies that analysed a total of 5903 participants. One study was assessed as being at low risk of bias, two were assessed as being at unclear risk of bias, with the remaining seven being at high risk of bias.\nThe main finding of the review was that, over 2.5 to 3 years of use, a fluoride toothpaste containing 10% xylitol may reduce caries by 13% when compared to a fluoride-only toothpaste (PF -0.13, 95% CI -0.18 to -0.08, 4216 children analysed, low-quality evidence).\nThe remaining evidence on children, from small single studies with risk of bias issues and great uncertainty associated with the effect estimates, was insufficient to determine a benefit from xylitol products. One study reported that xylitol syrup (8 g per day) reduced caries by 58% (95% CI 33% to 83%, 94 infants analysed, low quality evidence) when compared to a low-dose xylitol syrup (2.67 g per day) consumed for 1 year.\nThe following results had 95% CIs that were compatible with both a reduction and an increase in caries associated with xylitol: xylitol lozenges versus no treatment in children (very low quality body of evidence); xylitol sucking tablets versus no treatment in infants (very low quality body of evidence); xylitol tablets versus control (sorbitol) tablets in infants (very low quality body of evidence); xylitol wipes versus control wipes in infants (low quality body of evidence).\nThere was only one study investigating the effects of xylitol lozenges, when compared to control lozenges, in adults (low quality body of evidence). The effect estimate had a 95% CI that was compatible with both a reduction and an increase in caries associated with xylitol.\nFour studies reported that there were no adverse effects from any of the interventions. Two studies reported similar rates of adverse effects between study arms. The remaining studies either mentioned adverse effects but did not report any usable data, or did not mention them at all. Adverse effects include sores in the mouth, cramps, bloating, constipation, flatulence, and loose stool or diarrhoea.\nAuthors' conclusions\nWe found some low quality evidence to suggest that fluoride toothpaste containing xylitol may be more effective than fluoride-only toothpaste for preventing caries in the permanent teeth of children, and that there are no associated adverse-effects from such toothpastes. The effect estimate should be interpreted with caution due to high risk of bias and the fact that it results from two studies that were carried out by the same authors in the same population. The remaining evidence we found is of low to very low quality and is insufficient to determine whether any other xylitol-containing products can prevent caries in infants, older children, or adults.\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": "Authors from the Cochrane Oral Health Group carried out this review of existing studies and the evidence is current up to 14 August 2014. It includes 10 studies published from 1991 to 2014 in which 7969 participants were randomised (5903 of whom were included in the analyses) to receive xylitol products or a placebo (a substitute without xylitol) or no treatment, and the amount of tooth decay was compared. One study included adults, the others included children aged from 1 month to 13 years. The products tested were the kind that are held in the mouth and sucked (lozenges, sucking tablets and sweets) or slowly released through a dummy/pacifier, as well as toothpastes, syrups, and wipes."
}
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query-laysum | 1499 | [
{
"role": "user",
"content": "Abstract: Background\nA detailed summary and meta-analysis of the dose-related effect of pravastatin on lipids is not available.\nObjectives\nPrimary objective\nTo assess the pharmacology of pravastatin by characterizing the dose-related effect and variability of the effect of pravastatin on the surrogate marker: low-density lipoprotein (LDL cholesterol). The effect of pravastatin on morbidity and mortality is not the objective of this systematic review.\nSecondary objectives\n• To assess the dose-related effect and variability of effect of pravastatin on the following surrogate markers: total cholesterol; high-density lipoprotein (HDL cholesterol); and triglycerides. \n• To assess the effect of pravastatin on withdrawals due to adverse effects.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to September 2021: CENTRAL (2021, Issue 8), Ovid MEDLINE, Ovid Embase, Bireme LILACS, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.\nSelection criteria\nRandomized placebo-controlled trials evaluating the dose response of different fixed doses of pravastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of cardiovascular disease.\nData collection and analysis\nTwo review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered lipid data from placebo-controlled trials into Review Manager 5 as continuous data and withdrawal due to adverse effects (WDAEs) data as dichotomous data. We searched for WDAEs information from all trials. We assessed all trials using Cochrane's risk of bias tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases.\nMain results\nSixty-four RCTs evaluated the dose-related efficacy of pravastatin in 9771 participants. The participants were of any age, with and without evidence of cardiovascular disease, and pravastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over the doses of 5 mg to 160 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol, and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of pravastatin on blood HDL cholesterol. Pravastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 21.7% to 31.9%, total cholesterol by 16.1% to 23.3%,and triglycerides by 5.8% to 20.0%. The certainty of evidence for these effects was judged to be moderate to high. For every two-fold dose increase there was a 3.4% (95% confidence interval (CI) 2.2 to 4.6) decrease in blood LDL cholesterol. This represented a dose-response slope that was less than the other studied statins: atorvastatin, rosuvastatin, fluvastatin, pitavastatin and cerivastatin. From other systematic reviews we conducted on statins for its effect to reduce LDL cholesterol, pravastatin is similar to fluvastatin, but has a decreased effect compared to atorvastatin, rosuvastatin, pitavastatin and cerivastatin. The effect of pravastatin compared to placebo on WADES has a risk ratio (RR) of 0.81 (95% CI 0.63 to 1.03). The certainty of evidence was judged to be very low.\nAuthors' conclusions\nPravastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. This review did not provide a good estimate of the incidence of harms associated with pravastatin because of the lack of reporting of adverse effects in 48.4% of the randomized placebo-controlled trials.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "People taking 5 mg to 160 mg of pravastatin per day lowered their low-density lipoprotein cholesterol by 18.3% to 35.3%.\nThe difference in unwanted effects between pravastatin and placebo was uncertain in these short-term studies."
}
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query-laysum | 1500 | [
{
"role": "user",
"content": "Abstract: Background\nUrgent-start peritoneal dialysis (PD), defined as initiation of PD within two weeks of catheter insertion, has been emerging as an alternative mode of dialysis initiation for patients with chronic kidney disease (CKD) requiring urgent dialysis without established permanent dialysis access. Recently, several small studies have reported comparable patient outcomes between urgent-start and conventional-start PD.\nObjectives\nTo examine the benefits and harms of urgent-start PD compared with conventional-start PD in adults and children with CKD requiring long-term kidney replacement therapy.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 25 May 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.\nFor non-randomised controlled trials, MEDLINE (OVID) (1946 to 27 June 2019), EMBASE (OVID) (1980 to 27 June 2019), Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov (up to 27 June 2019) were searched.\nSelection criteria\nAll randomised controlled trials (RCTs) and non-RCTs comparing the outcomes of urgent-start PD (within 2 weeks of catheter insertion) and conventional-start PD ( ≥ 2 weeks of catheter insertion) treatment in children and adults CKD patients requiring long-term dialysis were included. Studies without a control group were excluded.\nData collection and analysis\nData were extracted and quality of studies were examined by two independent authors. The authors contacted investigators for additional information. Summary estimates of effect were examined using random-effects model and results were presented as risk ratios (RR) with 95% confidence intervals (CI) as appropriate for the data. The certainty of evidence for individual outcome was assessed using the GRADE approach.\nMain results\nA total of 16 studies (2953 participants) were included in this review, which included one multicentre RCT (122 participants) and 15 non-RCTs (2831 participants): 13 cohort studies (2671 participants) and 2 case-control studies (160 participants). The review included unadjusted data for analyses due to paucity of studies reporting adjusted data.\nIn low certainty evidence, urgent-start PD may increase dialysate leak (1 RCT, 122 participants: RR 3.90, 95% CI 1.56 to 9.78) compared with conventional-start PD which translated into an absolute number of 210 more leaks per 1000 (95% CI 40 to 635).\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases catheter blockage (4 cohort studies, 1214 participants: RR 1.33, 95% CI 0.40 to 4.43; 2 case-control studies, 160 participants: RR 1.89, 95% CI 0.58 to 6.13), catheter malposition (6 cohort studies, 1353 participants: RR 1.63, 95% CI 0.80 to 3.32; 1 case-control study, 104 participants: RR 3.00, 95% CI 0.64 to 13.96), and PD dialysate flow problems (3 cohort studies, 937 participants: RR 1.44, 95% CI 0.34 to 6.14) compared to conventional-start PD.\nIn very low certainty evidence, it is uncertain whether urgent-start PD increases exit-site infection (2 cohort studies, 337 participants: RR 1.43, 95% CI 0.24 to 8.61; 1 case-control study, 104 participants RR 1.20, 95% CI 0.41 to 3.50), exit-site bleeding (1 RCT, 122 participants: RR 0.70, 95% CI 0.03 to 16.81; 1 cohort study, 27 participants: RR 1.58, 95% CI 0.07 to 35.32), peritonitis (7 cohort studies, 1497 participants: RR 1.00, 95% CI 0.68 to 1.46; 2 case-control studies, 160 participants: RR 1.09, 95% CI 0.12 to 9.51), catheter readjustment (2 cohort studies, 739 participants: RR 1.27, 95% CI 0.40 to 4.02), or reduces technique survival (1 RCT, 122 participants: RR 1.09, 95% CI 1.00 to 1.20; 8 cohort studies, 1668 participants: RR 0.90, 95% CI 0.76 to 1.07; 2 case-control studies, 160 participants: RR 0.92, 95% CI 0.79 to 1.06).\nIn very low certainty evidence, it is uncertain whether urgent-start PD compared with conventional-start PD increased death (any cause) (1 RCT, 122 participants: RR 1.49, 95% CI 0.87 to 2.53; 7 cohort studies, 1509 participants: RR 1.89, 95% CI 1.07 to 3.3; 1 case-control study, 104 participants: RR 0.90, 95% CI 0.27 to 3.02; very low certainty evidence). None of the included studies reported on tunnel tract infection.\nAuthors' conclusions\nIn patients with CKD who require dialysis urgently without ready-to-use dialysis access in place, urgent-start PD may increase the risk of dialysate leak and has uncertain effects on catheter blockage, malposition or readjustment, PD dialysate flow problems, infectious complications, exit-site bleeding, technique survival, and patient survival compared with conventional-start PD.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Peritoneal dialysis is a form of kidney replacement therapy in which the lining of the abdomen is used as a filter for dialysis. The dialysis fluid is introduced via a tube which is placed into the abdomen, called a peritoneal dialysis catheter. Traditionally, dialysis is delayed for two weeks after catheter placement, in order to allow proper wound healing. However, some studies reported that patients with chronic kidney disease who urgently need to start dialysis within two weeks of catheter insertion (urgent- start peritoneal dialysis) experienced comparable outcomes to others who commenced dialysis more than two weeks after catheter insertion (conventional-start peritoneal dialysis)."
}
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query-laysum | 1501 | [
{
"role": "user",
"content": "Abstract: Background\nAcross the developed world, an estimated 150,000 to 300,000 people are treated annually with pelvic radiotherapy and 80% will develop gastrointestinal (GI) symptoms during treatment. Acute GI symptoms are associated with a greater risk of chronic, often debilitating, GI symptoms. Up to one-third of patients are malnourished before pelvic radiotherapy and up to four-fifths of patients lose weight during treatment. Malnutrition is linked to a higher risk of GI toxicity, which can lead to breaks in radiotherapy and early cessation of chemotherapy, thus compromising the efficacy of the primary cancer treatment.\nObjectives\nTo assess the effects of nutritional interventions for reducing GI toxicity in adults undergoing radical pelvic radiotherapy.\nSearch methods\nWe searched the Cochrane Gynaecological Cancer Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2012, MEDLINE and EMBASE to May 2012. We handsearched the citation lists of included studies and previous systematic reviews identified to identify further relevant trials.\nSelection criteria\nWe included studies if they were randomised controlled trials (RCTs) or non-randomised studies with concurrent comparison groups including quasi-randomised trials, cluster RCTs, non-randomised trials, prospective and retrospective cohort studies, and case series of 30 or more patients. We only included studies if they assessed the effect of a nutritional intervention in adults aged 18 years or over undergoing radical pelvic radiotherapy as part of anticancer treatment for a primary pelvic malignancy. We excluded patients with stomas and a previous history of inflammatory bowel disease. Nutritional support interventions could be provided at any stage before or during pelvic radiotherapy and included dietary counselling; dietary modification of fibre, lactose or fat; supplementary foods or drinks or fortified foods; standard oral nutrition supplements including polymeric-, peptide- or amino acid-based supplements and those where novel substrates have been added; enteral tube feeds; or parenteral nutrition (partial or total). We excluded probiotics, prebiotics and synbiotics.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data. We contacted study authors to obtain missing data. We assessed bias for each of the included studies using the bias assessment tables in the Cochrane software Review Manager5. We performed meta-analysis, when indicated, using the Mantel-Haenszel fixed-effect method or inverse variance fixed-effect method displayed with heterogeneity. We undertook meta-analyses on trials evaluating dietary modification against standard treatment for diarrhoea at the end of radiotherapy and for change in weight from baseline to end of radiotherapy.\nMain results\nThe searches identified 7558 titles, and we excluded 7513 during title and abstract searches. We reviewed 45 papers in full, and excluded 39. We identified four studies on handsearching of the references, which, along with the six eligible papers from the database search, led to 10 studies being included. Four studies, three of which were RCTs and one prospective study, investigated the effect of elemental diet on GI symptoms; one RCT investigated the effect of dietary modification and elemental diet; and five RCTs investigated dietary modification. Studies were varied in terms of risk of bias. Data were dichotomised for presence and absence of diarrhoea at the end of radiotherapy for four trials evaluating dietary modification comprising modified fat, lactose, fibre or combinations of these dietary changes. A reduction in diarrhoea was demonstrated with nutritional intervention (risk ratio (RR) 0.66; 95% confidence interval (CI) 0.51 to 0.87, four studies, 413 participants, moderate quality of evidence) with low heterogeneity (Chi2 = 3.50, I2 = 14%). Two trials evaluating dietary modification on weight change (comparing baseline and end of radiotherapy) showed no difference between intervention or control (mean difference (MD) -0.57 kg; 95% CI -1.22 to 0.09) with low heterogeneity (Chi2 = 1.41, I2 = 29%). Generally adverse effects were poorly reported in included studies. Elemental diet in particular was poorly tolerated. GI symptoms or toxicity > 6 months after radiotherapy was not reported in included studies\nAuthors' conclusions\nThere have been benefits demonstrated with dietary modification during pelvic radiotherapy to reduce diarrhoea. Those diets included single interventions or combinations of modified fat, lactose-restriction, fat-restriction and fibre supplementation. We were unable to meta-analyse elemental diet, as data were not available. We considered some of the studies to be at high risk of bias. There have been recent advances in novel, more targeted radiotherapy techniques, such that the findings of older studies need to be interpreted with caution. In addition, there were problems with compliance and palatability with some of the interventions, particularly elemental diet, which limits its usefulness in 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": "Searches of all relevant sources of medical information identified 7558 articles, and, after initial screening of all these articles, we selected 45 as being suitable for this review. On reading the summaries of these 45 trials, 10 were suitable to be included in this review. We included trials that looked at the effects of a nutritional intervention in adults aged 18 years or over having radical pelvic radiotherapy as part of anticancer treatment for a primary pelvic cancer. We excluded patients with stomas and a previous history of inflammatory bowel disease."
}
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query-laysum | 1502 | [
{
"role": "user",
"content": "Abstract: Background\nPatent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Cyclooxygenase inhibitors (COX-I) may prevent PDA-related complications. Controversy exists on which COX-I drug is the most effective and has the best safety profile in preterm infants.\nObjectives\nTo compare the effectiveness and safety of prophylactic COX-I drugs and 'no COXI prophylaxis' in preterm infants using a Bayesian network meta-analysis (NMA).\nSearch methods\nSearches of Cochrane CENTRAL via Wiley, OVID MEDLINE and Embase via Elsevier were conducted on 9 December 2021. We conducted independent searches of clinical trial registries and conference abstracts; and scanned the reference lists of included trials and related systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) that enrolled preterm or low birth weight infants within the first 72 hours of birth without a prior clinical or echocardiographic diagnosis of PDA and compared prophylactic administration of indomethacin or ibuprofen or acetaminophen versus each other, placebo or no treatment.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. We used the GRADE NMA approach to assess the certainty of evidence derived from the NMA for the following outcomes: severe intraventricular haemorrhage (IVH), mortality, surgical or interventional PDA closure, necrotizing enterocolitis (NEC), gastrointestinal perforation, chronic lung disease (CLD) and cerebral palsy (CP).\nMain results\nWe included 28 RCTs (3999 preterm infants). Nineteen RCTs (n = 2877) compared prophylactic indomethacin versus placebo/no treatment, 7 RCTs (n = 914) compared prophylactic ibuprofen versus placebo/no treatment and 2 RCTs (n = 208) compared prophylactic acetaminophen versus placebo/no treatment. Nine RCTs were judged to have high risk of bias in one or more domains.We identified two ongoing trials on prophylactic acetaminophen.\nBayesian random-effects NMA demonstrated that prophylactic indomethacin probably led to a small reduction in severe IVH (network RR 0.66, 95% Credible Intervals [CrI] 0.49 to 0.87; absolute risk difference [ARD] 43 fewer [95% CrI, 65 fewer to 16 fewer] per 1000; median rank 2, 95% CrI 1-3; moderate-certainty), a moderate reduction in mortality (network RR 0.85, 95% CrI 0.64 to 1.1; ARD 24 fewer [95% CrI, 58 fewer to 16 more] per 1000; median rank 2, 95% CrI 1-4; moderate-certainty) and surgical PDA closure (network RR 0.40, 95% CrI 0.14 to 0.66; ARD 52 fewer [95% CrI, 75 fewer to 30 fewer] per 1000; median rank 2, 95% CrI 1-2; moderate-certainty) compared to placebo. Prophylactic indomethacin resulted in trivial difference in NEC (network RR 0.76, 95% CrI 0.35 to 1.2; ARD 16 fewer [95% CrI, 42 fewer to 13 more] per 1000; median rank 2, 95% CrI 1-3; high-certainty), gastrointestinal perforation (network RR 0.92, 95% CrI 0.11 to 3.9; ARD 4 fewer [95% CrI, 42 fewer to 137 more] per 1000; median rank 1, 95% CrI 1-3; moderate-certainty) or CP (network RR 0.97, 95% CrI 0.44 to 2.1; ARD 3 fewer [95% CrI, 62 fewer to 121 more] per 1000; median rank 2, 95% CrI 1-3; low-certainty) and may result in a small increase in CLD (network RR 1.10, 95% CrI 0.93 to 1.3; ARD 36 more [95% CrI, 25 fewer to 108 more] per 1000; median rank 3, 95% CrI 1-3; low-certainty).\nProphylactic ibuprofen probably led to a small reduction in severe IVH (network RR 0.69, 95% CrI 0.41 to 1.14; ARD 39 fewer [95% CrI, 75 fewer to 18 more] per 1000; median rank 2, 95% CrI 1-4; moderate-certainty) and moderate reduction in surgical PDA closure (network RR 0.24, 95% CrI 0.06 to 0.64; ARD 66 fewer [95% CrI, from 82 fewer to 31 fewer] per 1000; median rank 1, 95% CrI 1-2; moderate-certainty) compared to placebo. Prophylactic ibuprofen may result in moderate reduction in mortality (network RR 0.83, 95% CrI 0.57 to 1.2; ARD 27 fewer [95% CrI, from 69 fewer to 32 more] per 1000; median rank 2, 95% CrI 1-4; low-certainty) and leads to trivial difference in NEC (network RR 0.73, 95% CrI 0.31 to 1.4; ARD 18 fewer [95% CrI, from 45 fewer to 26 more] per 1000; median rank 1, 95% CrI 1-3; high-certainty), or CLD (network RR 1.00, 95% CrI 0.83 to 1.3; ARD 0 fewer [95% CrI, from 61 fewer to 108 more] per 1000; median rank 2, 95% CrI 1-3; low-certainty). The evidence is very uncertain on effect of ibuprofen on gastrointestinal perforation (network RR 2.6, 95% CrI 0.42 to 20.0; ARD 76 more [95% CrI, from 27 fewer to 897 more] per 1000; median rank 3, 95% CrI 1-3; very low-certainty).\nThe evidence is very uncertain on the effect of prophylactic acetaminophen on severe IVH (network RR 1.17, 95% CrI 0.04 to 55.2; ARD 22 more [95% CrI, from 122 fewer to 1000 more] per 1000; median rank 4, 95% CrI 1-4; very low-certainty), mortality (network RR 0.49, 95% CrI 0.16 to 1.4; ARD 82 fewer [95% CrI, from 135 fewer to 64 more] per 1000; median rank 1, 95% CrI 1-4; very low-certainty), or CP (network RR 0.36, 95% CrI 0.01 to 6.3; ARD 70 fewer [95% CrI, from 109 fewer to 583 more] per 1000; median rank 1, 95% CrI 1-3; very low-certainty).\nIn summary, based on ranking statistics, both indomethacin and ibuprofen were equally effective (median ranks 2 respectively) in reducing severe IVH and mortality. Ibuprofen (median rank 1) was more effective than indomethacin in reducing surgical PDA ligation (median rank 2). However, no statistically-significant differences were observed between the COX-I drugs for any of the relevant outcomes.\nAuthors' conclusions\nProphylactic indomethacin probably results in a small reduction in severe IVH and moderate reduction in mortality and surgical PDA closure (moderate-certainty), may result in a small increase in CLD (low-certainty) and results in trivial differences in NEC (high-certainty), gastrointestinal perforation (moderate-certainty) and cerebral palsy (low-certainty). Prophylactic ibuprofen probably results in a small reduction in severe IVH and moderate reduction in surgical PDA closure (moderate-certainty), may result in a moderate reduction in mortality (low-certainty) and trivial differences in CLD (low-certainty) and NEC (high-certainty). The evidence is very uncertain about the effect of acetaminophen on any of the clinically-relevant outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched scientific databases for randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) in preterm babies (born at less than 37 weeks into pregnancy) or low-birthweight (weighing less than 2500 grams) infants where COX-I drugs were given without the prior knowledge of the presence of a PDA, within the first 72 hours after birth. The included studies compared administration of indomethacin or ibuprofen or acetaminophen versus each other, placebo or no treatment."
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query-laysum | 1503 | [
{
"role": "user",
"content": "Abstract: Background\nEpidemiological evidence has suggested a link between use of beta₂-agonists and increased asthma mortality. Much debate has surrounded possible causal links for this association, and whether regular (daily) long-acting beta₂-agonists (LABAs) are safe, particularly when used in combination with inhaled corticosteroids (ICSs). This is an update of a Cochrane Review that now includes data from two large trials including 11,679 adults and 6208 children; both were mandated by the US Food and Drug Administration (FDA).\nObjectives\nTo assess risks of mortality and non-fatal serious adverse events (SAEs) in trials that randomised participants with chronic asthma to regular salmeterol and ICS versus the same dose of ICS.\nSearch methods\nWe identified randomised trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trials registers for unpublished trial data. We also checked FDA submissions in relation to salmeterol. The date of the most recent search was 10 October 2018.\nSelection criteria\nWe included parallel-design randomised trials involving adults, children, or both with asthma of any severity who were randomised to treatment with regular salmeterol and ICS (in separate or combined inhalers) versus the same dose of ICS of at least 12 weeks in duration.\nData collection and analysis\nWe conducted the review according to standard procedures expected by Cochrane. We obtained unpublished data on mortality and SAEs from the sponsors, from ClinicalTrials.gov, and from FDA submissions. We assessed our confidence in the evidence according to current GRADE recommendations.\nMain results\nWe have included in this review 41 studies (27,951 participants) in adults and adolescents, along with eight studies (8453 participants) in children. We judged that the overall risk of bias was low for all-cause events, and we obtained data on SAEs from all study authors. All except 542 adults (and none of the children) were given salmeterol and fluticasone in the same (combination) inhaler.\nDeaths\nEleven of a total of 14,233 adults taking regular salmeterol and ICS died, as did 13 of 13,718 taking regular ICS at the same dose. The pooled Peto odds ratio (OR) was 0.80 (95% confidence interval (CI) 0.36 to 1.78; participants = 27,951; studies = 41; I² = 0%; moderate-certainty evidence). In other words, for every 1000 adults treated for 25 weeks, one death occurred among those on ICS alone, and the corresponding risk among those taking salmeterol and ICS was also one death (95% CI 0 to 2 deaths).\nNo children died, and no adults or children died of asthma, so we remain uncertain about mortality in children and about asthma mortality in any age group.\nNon-fatal serious adverse events\nA total of 332 adults receiving regular salmeterol with ICS experienced a non-fatal SAE of any cause, compared to 282 adults receiving regular ICS. The pooled Peto OR was 1.14 (95% CI 0.97 to 1.33; participants = 27,951; studies = 41; I² = 0%; moderate-certainty evidence). For every 1000 adults treated for 25 weeks, 21 adults on ICS alone had an SAE, and the corresponding risk for those on salmeterol and ICS was 23 adults (95% CI 20 to 27).\nSixty-five of 4229 children given regular salmeterol with ICS suffered an SAE of any cause, compared to 62 of 4224 children given regular ICS. The pooled Peto OR was 1.04 (95% CI 0.73 to 1.48; participants = 8453; studies = 8; I² = 0%; moderate-certainty evidence). For every 1000 children treated for 23 weeks, 15 children on ICS alone had an SAE, and the corresponding risk for those on salmeterol and ICS was 15 children (95% CI 11 to 22).\nAsthma-related serious adverse events\nEighty and 67 adults in each group, respectively, experienced an asthma-related non-fatal SAE. The pooled Peto OR was 1.15 (95% CI 0.83 to 1.59; participants = 27,951; studies = 41; I² = 0%; low-certainty evidence). For every 1000 adults treated for 25 weeks, five receiving ICS alone had an asthma-related SAE, and the corresponding risk among those on salmeterol and ICS was six adults (95% CI 4 to 8).\nTwenty-nine children taking salmeterol and ICS and 23 children taking ICS alone reported asthma-related events. The pooled Peto OR was 1.25 (95% CI 0.72 to 2.16; participants = 8453; studies = 8; I² = 0%; moderate-certainty evidence). For every 1000 children treated for 23 weeks, five receiving an ICS alone had an asthma-related SAE, and the corresponding risk among those receiving salmeterol and ICS was seven children (95% CI 4 to 12).\nAuthors' conclusions\nWe did not find a difference in the risk of death or serious adverse events in either adults or children. However, trial authors reported no asthma deaths among 27,951 adults or 8453 children randomised to regular salmeterol and ICS or ICS alone over an average of six months. Therefore, the risk of dying from asthma on either treatment was very low, but we remain uncertain about whether the risk of dying from asthma is altered by adding salmeterol to ICS.\nInclusion of new trials has increased the precision of the estimates for non-fatal SAEs of any cause. We can now say that the worst-case estimate is that at least 152 adults and 139 children must be treated with combination salmeterol and ICS for six months for one additional person to be admitted to the hospital (compared to treatment with ICS alone). These possible risks still have to be weighed against the benefits experienced by people who take combination treatment.\nHowever more than 90% of prescribed treatment was taken in the new trials, so the effects observed may be different from those seen with salmeterol in combination with ICS in daily practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Another Cochrane Review found that using regular salmeterol without regular ICS for adults with asthma led to an increase in serious adverse events (death or admission to hospital). We wanted to find out if more adverse (harmful) effects occur when people take regular salmeterol in addition to ICS. We looked only at adverse effects - deaths, being admitted to hospital and life-threatening effects. We did not look at the benefits of taking salmeterol for other outcomes. We updated this review in 2018 because of new evidence from large randomised trials of salmeterol in combination with ICS, in 11,679 adults and 6208 children with asthma."
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query-laysum | 1504 | [
{
"role": "user",
"content": "Abstract: Background\nUncertainty exists about the optimal point at which multi-component fortifier should be added to human milk for promoting growth in preterm infants. The most common practice is to start fortification when the infant’s daily enteral feed volume reaches 100 mL/kg body weight. Another approach is to commence fortification earlier, in some cases as early as the first enteral feed. Early fortification of human milk could increase nutrient intake and growth rates but may increase the risk of feed intolerance and necrotising enterocolitis (NEC).\nObjectives\nTo assess effects on growth and safety of early fortification of human milk versus late fortification in preterm infants\nTo assess whether effects vary based upon gestational age (≤ 27 weeks; 28 to 31 weeks; ≥ 32 weeks), birth weight (< 1000 g; 1000 to 1499 g; ≥ 1500 g), small or appropriate for gestational age, or type of fortifier (bovine milk-based human milk fortifier (HMF); human milk-based HMF; formula powder)\nSearch methods\nWe used the standard strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8); OVID MEDLINE (R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions (R) (1946 to 15 August 2019); MEDLINE via PubMed (1 August 2018 to 15 August 2019) for the previous year; and the Cumulative Index to Nursing and Allied Health Literatue (CINAHL) (1981 to 15 August 2019). We searched clinical trials databases and reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials that compared early versus late fortification of human milk in preterm infants. We defined early fortification as fortification started at < 100 mL/kg/d enteral feed volume or < 7 days postnatal age, and late fortification as fortification started at ≥ 100 mL/kg/d feeds or ≥ 7 days postnatal age.\nData collection and analysis\nBoth review authors assessed trial eligibility and risk of bias and independently extracted data. We analysed treatment effects in individual trials, and we reported risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with respective 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included two trials with a total of 237 infants. All participants were very low birth weight infants (birth weight < 1500 g). Early fortification was started at 20 mL/kg/d enteral feeds in one study and 40 mL/kg/d in the other study. Late fortification was started at 100 mL/kg/d feeds in both studies. One study used bovine milk-based fortifier, and the other used human milk-based fortifier.\nMeta-analysis showed that early fortification may have little or no effect on growth outcomes including time to regain birth weight (MD -0.06 days, 95% CI -1.32 to 1.20 days), linear growth (MD 0.10 cm/week, 95% CI -0.03 to 0.22 cm/week), or head growth (MD -0.01 cm/week, 95% CI -0.07 to 0.06 cm/week) during the initial hospitalisation period. Early fortification may have little or no effect on the risk of NEC (MD -0.01, 95% CI -0.07 to 0.06). The certainty of evidence was low for these outcomes due to risk of bias (lack of blinding) and imprecision (small sample size).\nEarly fortification may have little or no effect on incidence of surgical NEC, time to reach full enteral feeds, extrauterine growth restriction at discharge, proportion of infants with feed interruption episodes, duration of total parenteral nutrition (TPN), duration of central venous line usage, or incidence of invasive infection, all-cause mortality, and duration of hospital stay. The certainty of evidence was low for these outcomes due to risk of bias (lack of blinding) and imprecision (small sample size).\nWe did not have data for other outcomes such as subsequent weight gain after birth weight is regained, parenteral nutrition-associated liver disease, postdischarge growth, and neurodevelopmental outcomes.\nAuthors' conclusions\nAvailable evidence is insufficient to support or refute early fortification of human milk in preterm infants. Further large trials would be needed to provide data of sufficient quality and precision to inform policy and practice.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Uncertainty exists about the optimal point at which HMF should be added to human milk for promoting growth in preterm infants. The most common practice is to start HMF when the infant’s daily feed volume reaches 100 mL/kg body weight. Another approach is to commence HMF earlier, in some cases as early as the first feed. Adding HMF early could increase nutrient intake and growth rates but may increase the risk of feed intolerance and necrotising enterocolitis."
}
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query-laysum | 1505 | [
{
"role": "user",
"content": "Abstract: Background\nA perianal abscess is a collection of pus under the skin, around the anus. It usually occurs due to an infection of an anal gland. In the UK, the annual incidence is 40 per 100,000 of the adult population, and the standard treatment is admission to hospital for incision and drainage under general anaesthetic. Following drainage of the pus, an internal dressing (pack) is placed into the cavity to stop bleeding. Common practice is for community nursing teams to change the pack regularly until the cavity heals. Some practitioners in the USA and Australia make a small stab incision under local anaesthetic and place a catheter into the cavity which drains into an external dressing. It is removed when it stops draining. Elsewhere in the USA, simple drainage is performed in an outpatient setting under local anaesthetic.\nObjectives\nTo assess the effects of internal dressings in healing wound cavities resulting from drainage of perianal abscesses.\nSearch methods\nIn May 2016 we searched: The Cochrane Wounds 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 Plus. We also searched clinical trial registries to identify ongoing and unpublished studies, and searched reference lists of relevant reports to identify additional studies. We did not restrict studies with respect to language, date of publication, or study setting.\nSelection criteria\nPublished or unpublished randomised controlled trials (RCTs) comparing any type of internal dressing (packing) used in the post-operative management of perianal abscess cavities with alternative treatments or different types of internal dressing.\nData collection and analysis\nTwo review authors independently performed study selection, risk of bias assessment, and data extraction.\nMain results\nWe included two studies, with a total of 64 randomised participants (50 and 14 participants) aged 18 years or over, with a perianal abscess. In both studies, participants were enrolled on the first post-operative day and randomised to continued packing by community district nursing teams or to no packing. Participants in the non-packing group managed their own wounds in the community and used absorbant dressings to cover the area. Fortnightly follow-up was undertaken until the cavity closed and the skin re-epithelialised, which constituted healing. For non-attenders, telephone follow-up was conducted.\nBoth studies were at high risk of bias due to risk of attrition, performance and detection bias.\nIt was not possible to pool the two studies for the outcome of time to healing. It is unclear whether continued post-operative packing of the cavity of perianal abscesses affects time to complete healing. One study reported a mean time to wound healing of 26.8 days (95% confidence interval (CI) 22.7 to 30.7) in the packing group and 19.5 days (95% CI 13.6 to 25.4) in the non-packing group (it was not clear if all participants healed). We re-analysed the data and found no clear difference in the time to healing (7.30 days longer in the packing group, 95% CI -2.24 to 16.84; 14 participants). This was assessed as very low quality evidence (downgraded three levels for very serious imprecision and serious risk of bias). The second study reported a median time to complete wound healing of 24.5 days (range 10 to 150 days) in the packing group and 21 days (range 8 to 90 days) in the non-packed group. There was insufficient information to be able to recreate the analysis and the original analysis was inappropriate (did not account for censoring). This second study also provided very low quality evidence (downgraded four levels for serious risk of bias, serious indirectness and very serious imprecision).\nThere was very low quality evidence (downgraded for risk of bias, indirectness and imprecision) of no difference in wound pain scores at the initial dressing change. Both studies also reported patients' retrospective judgement of wound pain over the preceding two weeks (visual analogue scale, VAS) as lower for the non-packed group (2; both studies) compared with the packed group (0; both studies); (very low quality evidence) but we have been unable to reproduce these analyses as no variance data were published.\nThere was no clear evidence of a difference in the number of post-operative fistulae detected between the packed and non-packed groups (risk ratio (RR) 2.31, 95% CIs 0.56 to 9.45, I2 = 0%) (very low quality evidence downgraded three levels for very serious imprecision and serious risk of bias).\nThere was no clear evidence of a difference in the number of abscess recurrences between the packed and non-packed groups over the variable follow-up periods (RR 0.72, 95% CI 0.22 to 2.37, I2 = 0%) (very low quality evidence downgraded three levels for serious risk of bias and very serious imprecision).\nNo study reported participant health-related quality of life/health status, incontinence rates, time to return to work or normal function, resource use in terms of number of dressing changes or visits to a nurse, or change in wound size.\nAuthors' conclusions\nIt is unclear whether using internal dressings (packing) for the healing of perianal abscess cavities influences time to healing, wound pain, development of fistulae, abscess recurrence or other outcomes. Despite this absence of evidence, the practice of packing abscess cavities is commonplace. Given the lack of high quality evidence, decisions to pack may be based on local practices or patient preferences. Further clinical research is needed to assess the effects and patient experience of packing.\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": "After extensive searching to find relevant studies, we found only two randomised controlled trials (RCTs) that were eligible for this review (RCTs provide more robust results than other trial types). The studies were small with a total of 64 participants randomised, all over 18 years of age, with a perianal abscess. In the studies, participants received either packing by community nursing teams or no packing. Participants in the non-packing group managed their own wounds by using absorbant dressings to cover the area with no internal dressing. Participants were seen fortnightly until the cavity had healed.\nIt is not clear whether time to complete wound healing is affected by packing of cavity (and what evidence exists is very low quality). There was very low quality evidence that packing made no difference to wound pain at the first dressing change. There was very low quality evidence that on judging the wound pain over the preceding two weeks, participants in the packing group had experienced more pain that those in the non-packing group.\nIt is not clear whether packing or not affects the number of post-operative fistulae or abscess recurrences.\nWe did not find any RCTs that compared participant health-related quality of life/health status, incontinence rates, time to return to work or normal function, resource use in terms of number of dressing changes or visits to a nurse, or change in wound size.\nThere is no high quality evidence for the use of packing for healing perianal abscess cavities.\nAssessed as up to date to 17th May 2016."
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query-laysum | 1506 | [
{
"role": "user",
"content": "Abstract: Background\nSevere bleeding and coagulopathy are serious clinical conditions that are associated with high mortality. Thromboelastography (TEG) and thromboelastometry (ROTEM) are increasingly used to guide transfusion strategy but their roles remain disputed. This review was first published in 2011 and updated in January 2016.\nObjectives\nWe assessed the benefits and harms of thromboelastography (TEG)-guided or thromboelastometry (ROTEM)-guided transfusion in adults and children with bleeding. We looked at various outcomes, such as overall mortality and bleeding events, conducted subgroup and sensitivity analyses, examined the role of bias, and applied trial sequential analyses (TSAs) to examine the amount of evidence gathered so far.\nSearch methods\nIn this updated review we identified randomized controlled trials (RCTs) from the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 1); MEDLINE; Embase; Science Citation Index Expanded; International Web of Science; CINAHL; LILACS; and the Chinese Biomedical Literature Database (up to 5 January 2016). We contacted trial authors, authors of previous reviews, and manufacturers in the field. The original search was run in October 2010.\nSelection criteria\nWe included all RCTs, irrespective of blinding or language, that compared transfusion guided by TEG or ROTEM to transfusion guided by clinical judgement, guided by standard laboratory tests, or a combination. We also included interventional algorithms including both TEG or ROTEM in combination with standard laboratory tests or other devices. The primary analysis included trials on TEG or ROTEM versus any comparator.\nData collection and analysis\nTwo review authors independently abstracted data; we resolved any disagreements by discussion. We presented pooled estimates of the intervention effects on dichotomous outcomes as risk ratio (RR) with 95% confidence intervals (CIs). Due to skewed data, meta-analysis was not provided for continuous outcome data. Our primary outcome measure was all-cause mortality. We performed subgroup and sensitivity analyses to assess the effect based on the presence of coagulopathy of a TEG- or ROTEM-guided algorithm, and in adults and children on various clinical and physiological outcomes. We assessed the risk of bias through assessment of trial methodological components and the risk of random error through TSA.\nMain results\nWe included eight new studies (617 participants) in this updated review. In total we included 17 studies (1493 participants). A total of 15 trials provided data for the meta-analyses. We judged only two trials as low risk of bias. The majority of studies included participants undergoing cardiac surgery.\nWe found six ongoing trials but were unable to retrieve any data from them. Compared with transfusion guided by any method, TEG or ROTEM seemed to reduce overall mortality (7.4% versus 3.9%; risk ratio (RR) 0.52, 95% CI 0.28 to 0.95; I2 = 0%, 8 studies, 717 participants, low quality of evidence) but only eight trials provided data on mortality, and two were zero event trials. Our analyses demonstrated a statistically significant effect of TEG or ROTEM compared to any comparison on the proportion of participants transfused with pooled red blood cells (PRBCs) (RR 0.86, 95% CI 0.79 to 0.94; I2 = 0%, 10 studies, 832 participants, low quality of evidence), fresh frozen plasma (FFP) (RR 0.57, 95% CI 0.33 to 0.96; I2 = 86%, 8 studies, 761 participants, low quality of evidence), platelets (RR 0.73, 95% CI 0.60 to 0.88; I2 = 0%, 10 studies, 832 participants, low quality of evidence), and overall haemostatic transfusion with FFP or platelets (low quality of evidence). Meta-analyses also showed fewer participants with dialysis-dependent renal failure.\nWe found no difference in the proportion needing surgical reinterventions (RR 0.75, 95% CI 0.50 to 1.10; I2 = 0%, 9 studies, 887 participants, low quality of evidence) and excessive bleeding events or massive transfusion (RR 0.38, 95% CI 0.38 to 1.77; I2 = 34%, 2 studies, 280 participants, low quality of evidence). The planned subgroup analyses failed to show any significant differences.\nWe graded the quality of evidence as low based on the high risk of bias in the studies, large heterogeneity, low number of events, imprecision, and indirectness. TSA indicates that only 54% of required information size has been reached so far in regards to mortality, while there may be evidence of benefit for transfusion outcomes. Overall, evaluated outcomes were consistent with a benefit in favour of a TEG- or ROTEM-guided transfusion in bleeding patients.\nAuthors' conclusions\nThere is growing evidence that application of TEG- or ROTEM-guided transfusion strategies may reduce the need for blood products, and improve morbidity in patients with bleeding. However, these results are primarily based on trials of elective cardiac surgery involving cardiopulmonary bypass, and the level of evidence remains low. Further evaluation of TEG- or ROTEM-guided transfusion in acute settings and other patient categories in low risk of bias studies is needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The ability to make a sufficient blood clot is crucial in participants with bleeding. Clotting can be measured by various tests. TEG and ROTEM tests have the advantage of showing the total clotting capacity. These tests are performed at the bedside, and generally provide a rapid and useful result, guiding clinicians towards a more goal-directed transfusion management."
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query-laysum | 1507 | [
{
"role": "user",
"content": "Abstract: Background\nNicotine replacement therapy (NRT) aims to replace nicotine from cigarettes. This helps to reduce cravings and withdrawal symptoms, and ease the transition from cigarette smoking to complete abstinence. Although there is high-certainty evidence that NRT is effective for achieving long-term smoking abstinence, it is unclear whether different forms, doses, durations of treatment or timing of use impacts its effects.\nObjectives\nTo determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group trials register for papers mentioning NRT in the title, abstract or keywords, most recently in April 2022.\nSelection criteria\nWe included randomised trials in people motivated to quit, comparing one type of NRT use with another. We excluded studies that did not assess cessation as an outcome, with follow-up of fewer than six months, and with additional intervention components not matched between arms. Separate reviews cover studies comparing NRT to control, or to other pharmacotherapies.\nData collection and analysis\nWe followed standard Cochrane methods. We measured smoking abstinence after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs) and study withdrawals due to treatment.\nMain results\nWe identified 68 completed studies with 43,327 participants, five of which are new to this update. Most completed studies recruited adults either from the community or from healthcare clinics. We judged 28 of the 68 studies to be at high risk of bias. Restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results for any comparisons apart from the preloading comparison, which tested the effect of using NRT prior to quit day whilst still smoking.\nThere is high-certainty evidence that combination NRT (fast-acting form plus patch) results in higher long-term quit rates than single form (risk ratio (RR) 1.27, 95% confidence interval (CI) 1.17 to 1.37; I2 = 12%; 16 studies, 12,169 participants). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg patches are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29; I2 = 38%; 5 studies, 1655 participants), and that 21 mg patches are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08; 1 study, 537 participants). Moderate-certainty evidence, again limited by imprecision, also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41; I2 = 0%; 3 studies, 3446 participants).\nNine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward. There was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44; I2 = 0%; 9 studies, 4395 participants).\nHigh-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05; I2 = 0%; 8 studies, 3319 participants).\nWe found no clear evidence of an effect of duration of nicotine patch use (low-certainty evidence); duration of combination NRT use (low- and very low-certainty evidence); or fast-acting NRT type (very low-certainty evidence).\nCardiac AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no clear evidence of an effect on these outcomes, and rates were low overall. More withdrawals due to treatment were reported in people using nasal spray compared to patches in one study (RR 3.47, 95% CI 1.15 to 10.46; 1 study, 922 participants; very low-certainty evidence) and in people using 42/44 mg patches in comparison to 21/22 mg patches across two studies (RR 4.99, 95% CI 1.60 to 15.50; I2 = 0%; 2 studies, 544 participants; low-certainty evidence).\nAuthors' conclusions\nThere is high-certainty evidence that using combination NRT versus single-form NRT and 4 mg versus 2 mg nicotine gum can result in an increase in the chances of successfully stopping smoking. Due to imprecision, evidence was of moderate certainty for patch dose comparisons. There is some indication that the lower-dose nicotine patches and gum may be less effective than higher-dose products. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT before quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is limited. New studies should ensure that AEs, SAEs and withdrawals due to treatment are reported.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is high-certainty evidence that:\n- combination NRT works better than a single form of NRT; and \n- there is no difference in effect between different types of NRT (such as gum or patch).\nThis means that future research is very unlikely to change our conclusions. This is because the evidence is based on many participants and on well-conducted studies.\nHowever, the certainty of the evidence was moderate, low or very low for all the other questions we considered. This means that our findings may change as new research is carried out. In most cases, this is because there were not enough studies, there were problems with the design of studies that do exist, and/or these studies were too small.\nIn terms of the safety of different ways of using NRT, we rated the evidence for this outcome to be of low or very low certainty because many studies did not report on safety. Large studies covered in a separate review show high-certainty evidence that NRT is safe to use for quitting smoking."
}
]
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query-laysum | 1508 | [
{
"role": "user",
"content": "Abstract: Background\nIdiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased.\nObjectives\nTo evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature.\nSelection criteria\nRandomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized.\nThere was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) -2.10, 95% confidence interval (CI) -7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years).\nResults of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow-up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow-up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20).\nThere is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow-up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow-up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention-to-treat (ITT) analysis).\nThere was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow-up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression.\nOnly one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10).\nAuthors' conclusions\nDue to the important clinical differences among the studies, it was not possible to perform a meta-analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise-based' trials, prospective controlled cohort studies, prospective studies conducted according to pre-defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any results on pulmonary disorders and disability. Quality of life was not affected during brace treatment (very low quality evidence); quality of life, back pain, and psychological and cosmetic issues did not change in the long term (very low quality evidence). Rigid bracing seems effective in 20° to 40° curves (low quality evidence), elastic bracing in 15° to 30° curves (low quality evidence), and very rigid bracing in high degree curves above 45° (very low quality evidence); rigid was more successful than an elastic bracing (low quality evidence), and a pad pressure control system did not increase results (very low quality evidence). No specific harms were reported.\nPrimary outcomes such as pulmonary disorders, disability, back pain, psychological and cosmetic issues, and quality of life should be better evaluated in the future. Side effects, as well as the usefulness of exercises and other adjunctive treatments to bracing should be studied too."
}
]
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query-laysum | 1509 | [
{
"role": "user",
"content": "Abstract: Background\nColorectal resection through a midline laparotomy is a commonly performed surgical procedure to treat various bowel conditions. The typical postoperative hospital stay after this operation is 6 to 10 days. The main factors hindering early recovery and discharge are thought to include postoperative pain and delayed return of bowel function.\nContinuous infusion of a local anaesthetic into tissues surrounding the surgical incision via a multi-lumen indwelling wound catheter placed by the surgeon prior to wound closure may reduce postoperative pain, opioid consumption, the time to return of bowel function, and the length of hospital stay.\nObjectives\nTo evaluate the efficacy and adverse events of continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults.\nSearch methods\nWe searched the CENTRAL, MEDLINE and Embase databases to January 2019 to identify trials relevant to this review. We also searched reference lists of relevant trials and reviews for eligible trials. Additionally, we searched two clinical trials registers for ongoing trials.\nSelection criteria\nWe considered randomised controlled trials (including non-standard designs) or quasi-randomised controlled trials comparing continuous wound infusion of a local anaesthetic versus a placebo or a sham after midline laparotomy for colorectal resection in adults. We did not compare continuous local anaesthetic wound infusion to other techniques, such as transverse abdominis plane block or thoracic epidural analgesia. We allowed non-randomised analgesic co-interventions carried out equally in the intervention and control groups.\nData collection and analysis\nTwo review authors independently identified trials for inclusion and assessed their quality using the Cochrane 'Risk of bias' tool. We extracted data using standardised forms, including pain at rest and on movement (10-point scale), opioid consumption via a patient-controlled analgesia (PCA) system (mg morphine equivalent), postoperative opioid-related adverse events, the time to rescue analgesia, the time to first flatus and to first bowel movement, the time to ambulation, the length of hospital stay, serious postoperative adverse events, and patient satisfaction. We quantitatively synthesised the data by meta-analysis. We summarised and graded the certainty of the evidence for critical outcomes using the GRADEpro tool and created a 'Summary of findings' table.\nMain results\nThis review included six randomised controlled trials that enrolled a total of 564 adults undergoing elective midline laparotomy for colorectal resection comparing continuous wound infusion of a local anaesthetic to a normal saline placebo. Due to 23 post-randomisation exclusions, a total of 541 participants contributed data to the analysis of at least one outcome (local anaesthetic 268; control 273). Most participants were aged 55 to 65 years, with normal body mass index and low to moderate anaesthetic risk (American Society of Anesthesiologists class I-III). Random sequence generation, allocation concealment, and blinding were appropriately carried out in most trials. However, we had to downgrade the certainty of the evidence for most outcomes due to serious study limitations (risk of bias), inconsistency, indirectness, imprecision and reporting bias.\nPrimary outcomes\nOn postoperative day 1, pain at rest (mean difference (MD) −0.59 (from 3.1), 95% confidence interval (CI) −1.12 to −0.07; 5 studies, 511 participants; high-certainty evidence), pain on movement (MD −1.1 (from 6.1), 95% CI −2.3 to −0.01; 3 studies, 407 participants; low-certainty evidence) and opioid consumption via PCA (MD −12 mg (from 41 mg), 95% CI −20 to −4; 6 studies, 528 participants; moderate-certainty evidence) were reduced in the local anaesthetic group compared to the control group.\nSecondary outcomes\nThere was a reduction in the time to first bowel movement (MD −0.67 from 4.4 days, 95% CI −1.17 to −0.17; 4 studies, 197 participants; moderate-certainty evidence) and the length of hospital stay (MD −1.2 from 7.4 days, 95% CI −2.0 to −0.3; 4 studies, 456 participants; high-certainty evidence) in the local anaesthetic group compared to the control group.\nThere was no evidence of a difference in any serious postoperative adverse events until hospital discharge (RR 1.04, 95% CI 0.68 to 1.58; 6 studies, 541 participants; low-certainty evidence) between the two study groups.\nAuthors' conclusions\nAfter elective midline laparotomy for colorectal resection, continuous wound infusion of a local anaesthetic compared to a normal saline placebo reduces postoperative pain at rest and the length of hospital stay, on the basis of high-certainty evidence. This means we are very confident that the effect estimates for these outcomes lie close to the true effects. There is moderate-certainty evidence to indicate that the intervention probably reduces opioid consumption via PCA and the time to first bowel movement. This means we are moderately confident that effect estimates for these outcomes are likely to be close to the true effects, but there is a possibility that they are substantially different. The intervention may reduce postoperative pain on movement, however, this conclusion is based on low-certainty evidence. This means our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. There is low-certainty evidence to indicate that the intervention may have little or no effect on the rates of any serious postoperative adverse events until hospital discharge. High-quality randomised controlled trials to evaluate the intervention with a focus on important clinical and patient-centred outcomes are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with bowel disease can be treated with surgery to remove a part of the bowel (colorectal resection). A long vertical cut in the abdomen (midline laparotomy) is often required. Recovery after this type of surgery can be slow and painful. Continuous injection of a local anaesthetic (numbing a specific area of the body, e.g. around the wound) may reduce pain after this type of surgery. The local anaesthetic may also reduce the amount of morphine-like pain killers required and side effects related to these medications. This could mean a shorter recovery time for the patient and earlier discharge from the hospital."
}
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query-laysum | 1510 | [
{
"role": "user",
"content": "Abstract: Background\nThere remains uncertainty about the optimum timing of antiretroviral therapy (ART) initiation in HIV-positive people with cryptococcal meningitis. This uncertainty is the result of conflicting data on the mortality risk and occurrence of immune reconstitution inflammatory syndrome (IRIS) when ART is initiated less than four weeks after cryptococcal meningitis treatment is commenced.\nObjectives\nTo compare the outcomes of early initiation of ART (less than four weeks after starting antifungal treatment) versus delayed initiation of ART (four weeks or more after starting antifungal treatment) in HIV-positive people with concurrent cryptococcal meningitis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase for trials published between 1 January 1980 and 7 August 2017. We additionally searched international trial registries, including ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP), and conference abstracts from the International AIDS Society (IAS) and the Conference on Retroviruses and Opportunistic Infections (CROI) for ongoing or unpublished studies between 2015 and 2017. We reviewed reference lists of included studies to identify additional studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) that compared early versus delayed ART initiation in HIV-positive people with cryptococcal meningitis. Children, adults, and adolescents from any setting were eligible for inclusion.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria and extracted data. We presented dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CIs). We presented time-to-death data as hazard ratios with 95% CIs. We assessed the certainty of the evidence using the GRADE approach.\nMain results\nFour trials including 294 adult participants met the inclusion criteria of this review. Participants were predominantly from low- and middle-income countries. Two trials treated cryptococcal meningitis with amphotericin B and fluconazole; a third trial used fluconazole monotherapy; and the fourth trial did not specify the antifungal used.\nEarly ART initiation may increase all-cause mortality compared to delayed ART initiation (RR 1.42, 95% CI 1.02 to 1.97; 294 participants, 4 trials; low-certainty evidence). Early ART initiation may reduce relapse of cryptococcal meningitis compared to delayed ART initiation (RR 0.27, 95% CI 0.07 to 1.04; 205 participants, 2 trials, low-certainty evidence). We are uncertain whether early ART initiation increases or reduces cryptococcal IRIS events compared to delayed ART initiation (RR 3.56, 95% CI 0.51 to 25.02; 205 participants, 2 trials; I2 = 54%; very low-certainty evidence). We are uncertain if early ART initiation increases or reduces virological suppression at six months compared to delayed ART initiation (RR 0.93, 95% CI 0.72 to 1.22; 205 participants, 2 trials; I2 statistic = 0%; very low-certainty evidence).\nWe were unable to pool results related to rate of fungal clearance for the two trials that reported this outcome; individual trial results indicated that there was no difference in cerebrospinal fluid fungal clearance between trial arms. Similarly, we were unable to pool results on adverse events for the trials reporting on this outcome; individual trial results indicated no difference in the occurrence of grade 3 to 5 adverse events between trial arms.\nThree of the four included trials had an overall low or unclear risk of bias related to the primary outcome of all-cause mortality. However, we assessed one trial as at high risk of bias due to selective outcome reporting and other bias. This, in addition to the few clinical events and imprecision of effect estimates, led to downgrading of the evidence to low or very low certainty.\nAuthors' conclusions\nThe results of this review are relevant to HIV-positive adults with cryptococcal meningitis in low- and middle-income countries. These data suggest a higher risk of mortality among people who initiate ART within four weeks of cryptococcal meningitis diagnosis. However, it is unclear if this higher mortality risk is related to cryptococcal meningitis-IRIS.\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": "Cryptococcal meningitis is a fungal infection of the brain and the membranes covering the brain that occurs most frequently in people with weakened immune systems, such as people who are HIV-positive. Some studies have shown that HIV-positive people who start ART soon after initiating cryptococcal meningitis treatment (within four weeks) may deteriorate and die more frequently than those who delay treatment for a longer period (more than four weeks). This higher risk of death in the early ART group has been attributed to the occurrence of a condition called immune reconstitution inflammatory syndrome (IRIS). When ART is initiated, HIV-positive people with underlying infections such as cryptococcal meningitis may paradoxically develop a deterioration in their condition as their body's immune system attacks the fungus, resulting in worsening symptoms and sometimes death. It has been proposed that IRIS is the cause of more deaths in early ART initiators than in delayed ART initiators. Despite adequate treatment of cryptococcal meningitis with antifungal drugs, a relapse of the disease may occur in some HIV-positive people with cryptococcal meningitis. To date there have been few trials investigating the effect of ART on mortality, frequency of IRIS, or relapse."
}
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query-laysum | 1512 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the Cochrane Review previously published in 2013. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.\nWorldwide, phenytoin is a commonly used antiepileptic drug. It is important to know how newer drugs, such as oxcarbazepine, compare with commonly used standard treatments.\nObjectives\nTo review the time to treatment failure, remission and first seizure with oxcarbazepine compared to phenytoin, when used as monotherapy in people with focal onset seizures or generalised tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nWe searched the following databases on 20 August 2018: the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid, 1946 to 20 August 2018), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We handsearched relevant journals and contacted pharmaceutical companies, original trial investigators and experts in the field.\nSelection criteria\nWe included randomised controlled trials comparing monotherapy with either oxcarbazepine or phenytoin in children or adults with focal onset seizures or generalised onset tonic-clonic seizures.\nData collection and analysis\nThis was an individual participant data (IPD) review. Our primary outcome was time to treatment failure and our secondary outcomes were time to first seizure post-randomisation, time to six-month and 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs) with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nIndividual participant data were available for 480 out of a total of 517 participants (93%), from two out of three included trials. For remission outcomes, a HR of less than one indicated an advantage for phenytoin; and for first seizure and treatment failure outcomes, a HR of less than one indicated an advantage for oxcarbazepine.\nThe results for time to treatment failure for any reason related to treatment showed a potential advantage of oxcarbazepine over phenytoin, but this was not statistically significant (pooled HR adjusted for epilepsy type: 0.78 95% CI 0.53 to 1.14, 476 participants, two trials, moderate-quality evidence). Our analysis showed that treatment failure due to adverse events occurred later on with oxcarbazepine than phenytoin (pooled HR for all participants: 0.22 (95% CI 0.10 to 0.51, 480 participants, two trials, high-quality evidence). Our analysis of time to treatment failure due to lack of efficacy showed no clear difference between the drugs (pooled HR for all participants: 1.17 (95% CI 0.31 to 4.35), 480 participants, two trials, moderate-quality evidence).\nWe found no clear or statistically significant differences between drugs for any of the secondary outcomes of the review: time to first seizure post-randomisation (pooled HR adjusted for epilepsy type: 0.97 95% CI 0.75 to 1.26, 468 participants, two trials, moderate-quality evidence); time to 12-month remission (pooled HR adjusted for epilepsy type 1.04 95% CI 0.77 to 1.41, 468 participants, two trials, moderate-quality evidence) and time to six-month remission (pooled HR adjusted for epilepsy type: 1.06 95% CI 0.82 to 1.36, 468 participants, two trials, moderate-quality evidence).\nThe most common adverse events reported in more than 10% of participants on either drug were somnolence (28% of total participants, with similar rates for both drugs), headache (15% of total participants, with similar rates for both drugs), dizziness (14.5% of total participants, reported by slightly more participants on phenytoin (18%) than oxcarbazepine (11%)) and gum hyperplasia (reported by substantially more participants on phenytoin (18%) than oxcarbazepine (2%)).\nThe results of this review are applicable mainly to individuals with focal onset seizures; 70% of included individuals experienced seizures of this type at baseline. The two studies included in IPD meta-analysis were generally of good methodological quality but the design of the studies may have biased the results for the secondary outcomes (time to first seizure post-randomisation, time to six-month and 12-month remission) as seizure recurrence data were not collected following treatment failure or withdrawal from the study. In addition, misclassification of epilepsy type may have impacted on results, particularly for individuals with generalised onset seizures.\nAuthors' conclusions\nHigh-quality evidence provided by this review indicates that treatment failure due to adverse events occurs significantly later with oxcarbazepine than phenytoin. For individuals with focal onset seizures, moderate-quality evidence suggests that oxcarbazepine may be superior to phenytoin in terms of treatment failure for any reason, seizure recurrence and seizure remission. Therefore, oxcarbazepine may be a preferable alternative treatment than phenytoin, particularly for individuals with focal onset seizures. The evidence in this review which relates to individuals with generalised onset seizures is of low quality and does not inform current treatment policy.\nWe recommend that future trials should be designed to the highest quality possible with regards to choice of population, classification of seizure type, duration of follow-up (including continued follow-up after failure or withdrawal of randomised treatment), choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The two studies included in analysis were well designed but no information about seizures was recorded after people stopped taking their trial medication, which may have impacted on the results of the study.\nMost people (70%) included in the studies within this review had focal onset seizures, so the results are mainly relevant to people with this epilepsy type. Also up to 30% of the people in the trials used in our results may have been wrongly classified as having generalised seizures, which may have impacted on the results.\nFor these reasons, we judged the quality of the evidence provided by this review to be of moderate quality for people with focal onset seizures, and low quality for people with generalised onset seizures."
}
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query-laysum | 1513 | [
{
"role": "user",
"content": "Abstract: Background\nNon-infectious uveitis describes a heterogenous group of ocular disorders characterised by intraocular inflammation in the absence of infection. Uveitis is a leading cause of visual loss, most commonly due to uveitic macular oedema (UMO). Treatment is aimed at reducing disease activity by suppression of the intraocular inflammatory response. In the case of macular oedema, the aim is to restore macular architecture as quickly as possible, in order to prevent irreversible photoreceptor damage in this area. Acute exacerbations are typically managed with corticosteroids, which may be administered topically, locally or systemically. Whilst these are often rapidly effective in achieving disease control, long-term use is associated with significant local and systemic side effects, and 'steroid sparing agents' are typically used to achieve prolonged control in severe or recalcitrant disease. Anti-tumour necrosis factor (TNF) drugs block a critical cytokine in the inflammatory signalling process, and have emerged as effective steroid-sparing immunomodulatory agents in a wide range of non-ocular conditions. There is mechanistic data to suggest that they may provide a more targeted approach to disease control in UMO than other agents, but to date, these agents have predominantly been used 'off label' as the majority are not licensed for ocular use. This review aims to summarise the available literature reporting the use of anti-TNF therapy in UMO, thus developing the evidence-base on which to make future treatment decisions and develop clinical guidelines in this area.\nObjectives\nTo assess the efficacy of anti-TNF therapy in treatment of UMO.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 2), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; LILACS; Web of Science Conference Proceedings Citation Index- Science (CPCI-S); System for Information on Grey Literature in Europe (OpenGrey); the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 29 March 2018.\nSelection criteria\nWe planned to include all relevant randomised controlled trials assessing the use of anti-TNF agents in treatment of UMO. No limits were applied to participant age, gender or ethnicity. The primary comparisons of this review were: anti-TNF versus no treatment or placebo; anti-TNF versus another pharmacological agent; comparison of different anti-TNF drugs; comparison of different doses and routes of administration of the same anti-TNF drug. The primary outcome measure that we assessed for this review was best-corrected visual acuity (BCVA) in the treated eye. Secondary outcome measures were anatomical macular change, clinical estimation of vitreous haze and health-related quality of life.\nData collection and analysis\nTwo review authors independently screened titles and abstracts retrieved through the database searches. We retrieved full-text reports of studies categorised as 'unsure' or 'include' after we had reviewed the abstracts. Two review authors independently reviewed each full-text report for eligibility. We resolved discrepancies through discussion.\nMain results\nWe identified no completed or ongoing trial that was eligible for this Cochrane Review.\nAuthors' conclusions\nOur review did not identify any evidence from randomised controlled trials for or against the role of anti-TNF agents in the management of UMO. Although there are a number of high-quality randomised controlled trials that demonstrate the efficacy of anti-TNF agents in preventing recurrence of inflammation in uveitis, the reported study outcomes do not include changes in UMO. As a result, there were insufficient data to conclude whether there was a significant treatment effect specifically for UMO. Future trials should be designed to include quantitative measures of UMO as primary study outcomes, for example by reporting the presence or absence of UMO, or by measuring central macular thickness for study participants. Furthermore, whilst UMO is an important complication of uveitis, we acknowledge that uveitis is associated with many significant structural and functional complications. It is not possible to determine treatment efficacy based on a single outcome measure. We recommend that future reviews of therapeutic interventions in uveitis should use composite measures of treatment response comprising a range of potential complications of disease.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane Review authors searched for studies that had been published up to 29 March 2018."
}
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query-laysum | 1514 | [
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not achieve satisfactory improvements in their mental state, particularly the symptom of hearing voices (hallucinations), with medical treatment.\nObjectives\nTo examine the effects of Avatar Therapy for people with schizophrenia or related disorders.\nSearch methods\nIn December 2016, November 2018 and April 2019, the Cochrane Schizophrenia Group's Study-Based Register of Trials (including registries of clinical trials) was searched, review authors checked references of all identified relevant reports to identify more studies and contacted authors of trials for additional information.\nSelection criteria\nAll randomised clinical trials focusing on Avatar Therapy for people with schizophrenia or related disorders.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and 95% confidence intervals (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and 95% CIs. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. Our main outcomes of interest were clinically important change in; mental state, insight, global state, quality of life and functioning as well as adverse effects and leaving the study early.\nMain results\nWe found 14 potentially relevant references for three studies (participants = 195) comparing Avatar Therapy with two other interventions; treatment as usual or supportive counselling. Both Avatar Therapy and supportive counselling were given in addition (add-on) to the participants' normal care. All of the studies had high risk of bias across one or more domains for methodology and, for other risks of bias, authors from one of the studies were involved in the development of the avatar systems on trial and in another trial, authors had patents on the avatar system pending.\n1. Avatar Therapy compared with treatment as usual\nWhen Avatar Therapy was compared with treatment as usual average endpoint Positive and Negative Syndrome Scale – Positive (PANSS-P) scores were not different between treatment groups (MD –1.93, 95% CI –5.10 to 1.24; studies = 1, participants = 19; very low-certainty evidence). A measure of insight (Revised Beliefs about Voices Questionnaire; BAVQ-R) showed an effect in favour of Avatar Therapy (MD –5.97, 95% CI –10.98 to –0.96; studies = 1, participants = 19; very low-certainty evidence). No one was rehospitalised in either group in the short term (risk difference (RD) 0.00, 95% CI –0.20 to 0.20; studies = 1, participants = 19; low-certainty evidence). Numbers leaving the study early from each group were not clearly different – although more did leave from the Avatar Therapy group (6/14 versus 0/12; RR 11.27, 95% CI 0.70 to 181.41; studies = 1, participants = 26; low-certainty evidence). There was no clear difference in anxiety between treatment groups (RR 5.54, 95% CI 0.34 to 89.80; studies = 1, participants = 19; low-certainty evidence). For quality of life, average Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF) scores favoured Avatar Therapy (MD 9.99, 95% CI 3.89 to 16.09; studies = 1, participants = 19; very low-certainty evidence). No study reported data for functioning.\n2. Avatar Therapy compared with supportive counselling\nWhen Avatar Therapy was compared with supportive counselling (all short-term), general mental state (Psychotic Symptom Rating Scale (PSYRATS)) scores favoured the Avatar Therapy group (MD –4.74, 95% CI –8.01 to –1.47; studies = 1, participants = 124; low-certainty evidence). For insight (BAVQ-R), there was a small effect in favour of Avatar Therapy (MD –8.39, 95% CI –14.31 to –2.47; studies = 1, participants = 124; low-certainty evidence). Around 20% of each group left the study early (risk ratio (RR) 1.06, 95% CI 0.59 to 1.89; studies = 1, participants = 150; moderate-certainty evidence). Analysis of quality of life scores (Manchester Short Assessment of Quality of Life (MANSA)) showed no clear difference between groups (MD 2.69, 95% CI –1.48 to 6.86; studies = 1, participants = 120; low-certainty evidence). No data were available for rehospitalisation rates, adverse events or functioning.\nAuthors' conclusions\nOur analyses of available data shows few, if any, consistent effects of Avatar Therapy for people living with schizophrenia who experience auditory hallucinations. Where there are effects, or suggestions of effects, we are uncertain because of their risk of bias and their unclear clinical meaning. The theory behind Avatar Therapy is compelling but the practice needs testing in large, long, well-designed, well-reported randomised trials undertaken with help from – but not under the direction of – Avatar Therapy pioneers.\n\nGiven the provided abstract, please respond to the following query: \"Searches\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane Schizophrenia's Information Specialist searched through the Cochrane Schizophrenia Group's database for randomised trials (clinical studies where people are randomly put into one of two or more treatment groups) of people with schizophrenia receiving either Avatar Therapy or treatment as usual. We found 14 reports from four studies.\nThe evidence is current to April 2020."
}
]
|
query-laysum | 1515 | [
{
"role": "user",
"content": "Abstract: Background\nChronic obstructive pulmonary disease (COPD) is associated with dyspnoea, cough or sputum production (or both) and affects quality of life and functional status. More efficient approaches to alternative management that may include patients themselves managing their condition need further exploration in order to reduce the impact on both patients and healthcare services. Digital interventions may potentially impact on health behaviours and encourage patient engagement.\nObjectives\nTo assess benefits and harms of digital interventions for managing COPD and apply Behaviour Change Technique (BCT) taxonomy to describe and explore intervention content.\nSearch methods\nWe identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register (date of last search 28 April 2020). We found other trials at web-based clinical trials registers.\nSelection criteria\nWe included RCTs comparing digital technology interventions with or without routine supported self-management to usual care, or control treatment for self-management. Multi-component interventions (of which one component was digital self-management) compared with usual care, standard care or control treatment were included.\nData collection and analysis\nWe used standard Cochrane methods. Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias. Discrepancies were resolved with a third review author. We assessed certainty of the evidence using the GRADE approach. Primary outcomes were impact on health behaviours, self-efficacy, exacerbations and quality of life, including the St George's Respiratory Questionnaire (SGRQ). The minimally important difference (MID) for the SGRQ is 4 points. Two review authors independently applied BCT taxonomy to identify mechanisms in the digital interventions that influence behaviours.\nMain results\nFourteen studies were included in the meta-analyses (1518 participants) ranging from 13 to 52 weeks duration. Participants had mild to very severe COPD. Risk of bias was high due to lack of blinding. GRADE ratings were low to very low certainty due to lack of blinding and imprecision. Common BCT clusters identified as behaviour change mechanisms in interventions were goals and planning, feedback and monitoring, social support, shaping knowledge and antecedents.\nDigital technology intervention with or without routine supported self-management\nInterventions included mobile phone (three studies), smartphone applications (one study), and web or Internet-based (five studies).\nEvidence is very uncertain about effects on impact on health behaviours as measured by six-minute walk distance (6MWD) at 13 weeks (mean difference (MD) 26.20, 95% confidence interval (CI) -21.70 to 74.10; participants = 122; studies = 2) or 23 to 26 weeks (MD 14.31, 95% CI -19.41 to 48.03; participants = 164; studies = 3). There may be improvement in 6MWD at 52 weeks (MD 54.33 95% CI -35.47 to 144.12; participants = 204; studies = 2) but studies were varied (very low certainty).\nThere may be no difference in self-efficacy on managing Chronic Disease Scale (SEMCD) or pulmonary rehabilitation adapted index of self-efficacy tool (PRAISE). Evidence is very uncertain.\nQuality of life may be slightly improved on the chronic respiratory disease questionnaire (CRQ) at 13 weeks (MD 0.45, 95% CI 0.01 to 0.90; participants = 123; studies = 2; low certainty), but is not clinically important (MID 0.5). There may be little or no difference at 23 or 52 weeks (low to very low certainty). There may be a clinical improvement on SGRQ total at 52 weeks (MD -26.57, 95% CI -34.09 to -19.05; participants = 120; studies = 1; low certainty). Evidence for COPD assessment test (CAT) and Clinical COPD Questionnaire (CCQ) is very uncertain.\nThere may be little or no difference in dyspnoea symptoms (CRQ dyspnoea) at 13, 23 weeks or 52 weeks (low to very low certainty evidence) or mean number of exacerbations at 26 weeks (low-certainty evidence).\nThere was no evidence for the number of people experiencing adverse events.\nMulti-component interventions\nDigital components included mobile phone (one study), and web or internet-based (four studies).\nEvidence is very uncertain about effects on impact on health behaviour (6MWD) at 13 weeks (MD 99.60, 95% CI -15.23 to 214.43; participants = 20; studies = 1).\nNo evidence was found for self-efficacy. Four studies reported effects on quality of life (SGRQ and CCQ scales). The evidence is very uncertain.\nThere may be no difference in the number of people experiencing exacerbations or mean days to first exacerbation at 52 weeks with a multi-component intervention compared to standard care.\nEvidence is very uncertain about effects on the number of people experiencing adverse events at 52 weeks.\nAuthors' conclusions\nThere is insufficient evidence to demonstrate a clear benefit or harm of digital technology interventions with or without supported self-management, or multi-component interventions compared to usual care in improving the 6MWD or self-efficacy. We found there may be some short-term improvement in quality of life with digital interventions, but there is no evidence about whether the effect is sustained long term. Dyspnoea symptoms may improve over a longer duration of digital intervention use. The evidence for multi-component interventions is very uncertain and as there is little or no evidence for adverse events, we cannot determine the benefit or harm of these interventions. The evidence base is predominantly of very low certainty with concerns around high risk of bias due to lack of blinding. Given that variation of interventions and blinding is likely to be a concern, future, larger studies are needed taking these limitations in consideration. Future studies are needed to determine whether the small improvements observed in this review can be applied to the general COPD population.\nA clear understanding of behaviour change through the BCT classification is important to gauge uptake of digital interventions and health outcomes in people with varying severity of COPD. Currently there is no guidance for interpreting BCT components of a digital intervention for changes to health outcomes. We could not interpret the BCT findings to the health outcomes we were investigating due to limited evidence that was of very low certainty. In future research, standardised approaches need to be considered when designing protocols to investigate effectiveness of digital interventions by including a standardised approach to BCT classification in addition to validated behavioural outcome measures that may reflect changes in behaviour.\n\nGiven the provided abstract, please respond to the following query: \"Why did we do this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out if digital interventions were helpful for people with COPD in terms of managing their condition, and if these interventions played a part in changing their behaviour towards self-management. Additionally, we wanted to understand the behaviour change techniques incorporated in different digital interventions."
}
]
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query-laysum | 1516 | [
{
"role": "user",
"content": "Abstract: Background\nLiver transplantation is the only chance of cure for people with end-stage liver disease and some people with advanced liver cancers or acute liver failure. The increasing prevalence of these conditions drives demand and necessitates the increasing use of donated livers which have traditionally been considered suboptimal. Several novel machine perfusion preservation technologies have been developed, which attempt to ameliorate some of the deleterious effects of ischaemia reperfusion injury. Machine perfusion technology aims to improve organ quality, thereby improving outcomes in recipients of suboptimal livers when compared to traditional static cold storage (SCS; ice box).\nObjectives\nTo evaluate the effects of different methods of machine perfusion (including hypothermic oxygenated machine perfusion (HOPE), normothermic machine perfusion (NMP), controlled oxygenated rewarming, and normothermic regional perfusion) versus each other or versus static cold storage (SCS) in people undergoing liver transplantation.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 10 January 2023.\nSelection criteria\nWe included randomised clinical trials which compared different methods of machine perfusion, either with each other or with SCS. Studies comparing HOPE via both hepatic artery and portal vein, or via portal vein only, were grouped. The protocol detailed that we also planned to include quasi-randomised studies to assess treatment harms.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. overall participant survival, 2. quality of life, and 3. serious adverse events. Secondary outcomes were 4. graft survival, 5. ischaemic biliary complications, 6. primary non-function of the graft, 7. early allograft function, 8. non-serious adverse events, 9. transplant utilisation, and 10. transaminase release during the first week post-transplant. We assessed bias using Cochrane's RoB 2 tool and used GRADE to assess certainty of evidence.\nMain results\nWe included seven randomised trials (1024 transplant recipients from 1301 randomised/included livers). All trials were parallel two-group trials; four compared HOPE versus SCS, and three compared NMP versus SCS. No trials used normothermic regional perfusion.\nWhen compared with SCS, it was uncertain whether overall participant survival was improved with either HOPE (hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.42 to 1.98; P = 0.81, I2 = 0%; 4 trials, 482 recipients; low-certainty evidence due to imprecision because of low number of events) or NMP (HR 1.08, 95% CI 0.31 to 3.80; P = 0.90; 1 trial, 222 recipients; very low-certainty evidence due to imprecision and risk of bias).\nNo trials reported quality of life.\nWhen compared with SCS alone, HOPE was associated with improvement in the following clinically relevant outcomes: graft survival (HR 0.45, 95% CI 0.23 to 0.87; P = 0.02, I2 = 0%; 4 trials, 482 recipients; high-certainty evidence), serious adverse events in extended criteria DBD liver transplants (OR 0.45, 95% CI 0.22 to 0.91; P = 0.03, I2 = 0%; 2 trials, 156 participants; moderate-certainty evidence) and clinically significant ischaemic cholangiopathy in recipients of DCD livers (OR 0.31, 95% CI 0.11 to 0.92; P = 0.03; 1 trial, 156 recipients; high-certainty evidence). In contrast, NMP was not associated with improvement in any of these clinically relevant outcomes. NMP was associated with improved utilisation compared with SCS (one trial found a 50% lower rate of organ discard; P = 0.008), but the reasons underlying this effect are unknown.\nWe identified 11 ongoing studies investigating machine perfusion technologies.\nAuthors' conclusions\nIn situations where the decision has been made to transplant a liver donated after circulatory death or donated following brain death, end-ischaemic HOPE will provide superior clinically relevant outcomes compared with SCS alone. Specifically, graft survival is improved (high-certainty evidence), serious adverse events are reduced (moderate-certainty evidence), and in donors after circulatory death, clinically relevant ischaemic biliary complications are reduced (high-certainty evidence). There is no good evidence that NMP has the same benefits over SCS in terms of these clinically relevant outcomes. NMP does appear to improve utilisation of grafts that would otherwise be discarded with SCS; however, the reasons for this, and whether this effect is specific to NMP, is not clear. Further studies into NMP viability criteria and utilisation, as well as head-to-head trials with other perfusion technologies are needed.\nIn the setting of donation following circulatory death transplantation, further trials are needed to assess the effect of these ex situ machine perfusion methods against, or in combination with, normothermic regional perfusion.\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 know which of these techniques is the best for improving the quality of donated livers."
}
]
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query-laysum | 1517 | [
{
"role": "user",
"content": "Abstract: Background\nThis systematic review update summarizes the current evidence on the use of natalizumab for induction of remission in Crohn's disease (CD).\nObjectives\nTo determine the efficacy and safety of natalizumab for induction of remission in CD.\nSearch methods\nWe searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Trials Register, and clinicaltrials.gov from inception to 10 May 2018.\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing natalizumab to a placebo or control therapy for induction of remission in CD.\nData collection and analysis\nTwo authors independently screened studies, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was failure to enter clinical remission. Secondary outcomes included clinical response, mean change in Crohn's Disease Activity Index (CDAI), adverse events (AEs), withdrawal due to AEs and serious AEs. For dichotomous outcomes, we calculated the risk ratio (RR) and 95% confidence interval (95% CI). For continuous outcomes we calculated the mean difference (MD) and 95% CI. Data were pooled for meta-analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). We used GRADE to assess the overall quality of the evidence.\nMain results\nA total of five RCTs (1771 participants) were included. Four studies (1692 participants) compared one, two or three infusions of natalizumab (300 mg or 3 mg/kg or 6mg/kg) to placebo. One study (79 participants) compared three infusions of natalizumab (300 mg) and infliximab (5 mg/kg) to infliximab and placebo. Four studies were rated as low risk of bias. One study was rated as unclear risk of bias for selective reporting.\nOne, two and three infusions of natalizumab were superior to placebo for induction of remission and clinical response. Infusions were administered at weeks zero, four and eight. After one infusion, 76% (849/1117) of natalizumab participants failed to enter remission at 4 weeks compared to 83% (411/494) of placebo participants (RR 0.91, 95% CI 0.86 to 0.96, 3 studies, GRADE high quality). At 4 weeks, the RR for clinical response was 0.78 (95% CI 0.66 to 0.92, 3 studies, 1611 participants, GRADE moderate quality). After two infusions, after 8 weeks, 66% (693/1049) of natalizumab participants failed to enter remission compared to 77% (382/494) of placebo participants (RR 0.85, 95% CI 0.76 to 0.95; 3 studies, GRADE moderate quality). At 8 weeks, the RR for clinical response was 0.73 (95% CI 0.58 to 0.91, 3 studies, 1543 participants, GRADE low quality). After three infusions, at 12 weeks, 61% (596/983) of natalizumab participants failed to enter remission compared to 73% (313/431) of placebo participants (RR 0.85, 95% CI 0.78 to 0.92, 2 studies, GRADE high quality). At 12 weeks, the RR for clinical response was 0.76 (95% CI 0.67 to 0.86, 2 studies, 1414 participants, GRADE high quality). One study (507 participants) reported on change in CADI from baseline. Natalizumab participants had a larger drop in mean CDAI scores than placebo participants at 4, 8 and 12 weeks.\nThe rates of AEs, withdrawals due to AEs and serious AEs were similar across groups at 4, 8 and 12 weeks. After one infusion, 74% (50/68) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 0.91, 95% CI 0.75 to 1.09, GRADE moderate quality). Withdrawal due to an AE occurred in 1% (1/68) of natalizumab participants and 3% of placebo participants (RR 0.46, 95% CI 0.04 to 4.98, GRADE low quality). SAEs occurred in 10% (7/68) of natalizumab participants compared to 11% (7/63) of placebo participants (RR 0.93, 95% CI 0.34 to 2.49, GRADE low quality). After two infusions, 86% (57/66) of natalizumab participants experienced an AE compared to 81% (51/63) of placebo participants (RR 1.07, 95% CI 0.92 to 1.24, GRADE moderate quality). Withdrawal due to an AE occurred in 3% (2/66) natalizumab participants compared to 3% (2/63) placebo participants (RR 0.95, 95% CI 0.14 to 6.57, GRADE low quality). SAEs occurred in 9% (6/66) of natalizumab participants and 11% (7/63) of placebo participants (RR 0.82, 95% CI 0.29 to 2.30, GRADE low quality). After three infusions, 86% (848/984) of natalizumab participants experienced an AE compared to 83% (359/431) placebo participants (RR 1.03, 95% CI 0.98 to 1.08, GRADE high quality). Withdrawals due to AEs occurred in 8% (82/984) of natalizumab participants compared to 10% (45/431) of placebo participants (RR 0.86, 95% CI 0.59 to 1.26, GRADE moderate quality). SAEs occurred in 7% (65/983) of natalizumab participants and 8% (36/431) of placebo participants (RR 0.76. 95% CI 0.37 to 1.56, GRADE low quality). Adverse events included headache, nausea, nasopharyngitis, abdominal pain, fatigue, vomiting, and exacerbation of CD.\nThe study comparing combination therapy with natalizumab and infliximab to infliximab and placebo demonstrated similar remission rates at 10 weeks. Sixty-four per cent (33/52) of participants assigned to natalizumab and infliximab failed to achieve remission compared to 70% (19/27) assigned to placebo and infliximab (RR 0.90, 95% CI 0.65 to 1.24, GRADE moderate quality). The rates of AEs (moderate quality evidence), withdrawals due to AEs (low quality evidence) and serious AEs (low quality evidence) were similar across groups at 10 weeks. Adverse events included headache, exacerbation of CD, nausea, and nasopharyngitis.\nNatalizumab is associated with the development of progressive multifocal leukoencephalopathy (PML) resulting in some patient deaths. There are currently no tests which can reliably predict those at risk of developing PML.\nAuthors' conclusions\nHigh quality data suggest that natalizumab is effective for induction of clinical remission and response in some patients with moderately to severely active CD. However, none of the included studies had the power to detect rare but serious adverse events such as PML. Due to the association with PML, and the availability of alternative agents that are not associated with PML, natalizumab is not likely to be used in patients who fail currently available medical therapy. The use of natalizumab in select patients (e.g. patients allergic to different biologics) needs to be carefully considered against the potential risk of developing PML. Futher studies of natalizumab are not likely to be done.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We performed a comprehensive literature review and identified five randomized controlled trials (an experiment in which participants are randomly assigned to receive two or more interventions and the results are compared) that involved a total of 1771 participants. Four studies (1692 participants) compared one, two or three intravenous infusions of natalizumab (300 mg or 3 mg/kg or 6mg/kg) to placebo (a sham infusion - an infusion that was identical in appearance to natalizumab but did not contain any active medicine). These studies followed participants for 12 weeks. One study (79 participants) compared three intravenous infusions of natalizumab (300 mg) and infliximab (5 mg/kg) to infliximab and placebo. The participants in this study were unable to achieve remission despite treatment with the biologic drug infliximab. This study followed participants for 10 weeks. All of the studies were high quality."
}
]
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query-laysum | 1518 | [
{
"role": "user",
"content": "Abstract: Background\nPatent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Cyclooxygenase inhibitors (COX-I) may prevent PDA-related complications. Controversy exists on which COX-I drug is the most effective and has the best safety profile in preterm infants.\nObjectives\nTo compare the effectiveness and safety of prophylactic COX-I drugs and 'no COXI prophylaxis' in preterm infants using a Bayesian network meta-analysis (NMA).\nSearch methods\nSearches of Cochrane CENTRAL via Wiley, OVID MEDLINE and Embase via Elsevier were conducted on 9 December 2021. We conducted independent searches of clinical trial registries and conference abstracts; and scanned the reference lists of included trials and related systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) that enrolled preterm or low birth weight infants within the first 72 hours of birth without a prior clinical or echocardiographic diagnosis of PDA and compared prophylactic administration of indomethacin or ibuprofen or acetaminophen versus each other, placebo or no treatment.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. We used the GRADE NMA approach to assess the certainty of evidence derived from the NMA for the following outcomes: severe intraventricular haemorrhage (IVH), mortality, surgical or interventional PDA closure, necrotizing enterocolitis (NEC), gastrointestinal perforation, chronic lung disease (CLD) and cerebral palsy (CP).\nMain results\nWe included 28 RCTs (3999 preterm infants). Nineteen RCTs (n = 2877) compared prophylactic indomethacin versus placebo/no treatment, 7 RCTs (n = 914) compared prophylactic ibuprofen versus placebo/no treatment and 2 RCTs (n = 208) compared prophylactic acetaminophen versus placebo/no treatment. Nine RCTs were judged to have high risk of bias in one or more domains.We identified two ongoing trials on prophylactic acetaminophen.\nBayesian random-effects NMA demonstrated that prophylactic indomethacin probably led to a small reduction in severe IVH (network RR 0.66, 95% Credible Intervals [CrI] 0.49 to 0.87; absolute risk difference [ARD] 43 fewer [95% CrI, 65 fewer to 16 fewer] per 1000; median rank 2, 95% CrI 1-3; moderate-certainty), a moderate reduction in mortality (network RR 0.85, 95% CrI 0.64 to 1.1; ARD 24 fewer [95% CrI, 58 fewer to 16 more] per 1000; median rank 2, 95% CrI 1-4; moderate-certainty) and surgical PDA closure (network RR 0.40, 95% CrI 0.14 to 0.66; ARD 52 fewer [95% CrI, 75 fewer to 30 fewer] per 1000; median rank 2, 95% CrI 1-2; moderate-certainty) compared to placebo. Prophylactic indomethacin resulted in trivial difference in NEC (network RR 0.76, 95% CrI 0.35 to 1.2; ARD 16 fewer [95% CrI, 42 fewer to 13 more] per 1000; median rank 2, 95% CrI 1-3; high-certainty), gastrointestinal perforation (network RR 0.92, 95% CrI 0.11 to 3.9; ARD 4 fewer [95% CrI, 42 fewer to 137 more] per 1000; median rank 1, 95% CrI 1-3; moderate-certainty) or CP (network RR 0.97, 95% CrI 0.44 to 2.1; ARD 3 fewer [95% CrI, 62 fewer to 121 more] per 1000; median rank 2, 95% CrI 1-3; low-certainty) and may result in a small increase in CLD (network RR 1.10, 95% CrI 0.93 to 1.3; ARD 36 more [95% CrI, 25 fewer to 108 more] per 1000; median rank 3, 95% CrI 1-3; low-certainty).\nProphylactic ibuprofen probably led to a small reduction in severe IVH (network RR 0.69, 95% CrI 0.41 to 1.14; ARD 39 fewer [95% CrI, 75 fewer to 18 more] per 1000; median rank 2, 95% CrI 1-4; moderate-certainty) and moderate reduction in surgical PDA closure (network RR 0.24, 95% CrI 0.06 to 0.64; ARD 66 fewer [95% CrI, from 82 fewer to 31 fewer] per 1000; median rank 1, 95% CrI 1-2; moderate-certainty) compared to placebo. Prophylactic ibuprofen may result in moderate reduction in mortality (network RR 0.83, 95% CrI 0.57 to 1.2; ARD 27 fewer [95% CrI, from 69 fewer to 32 more] per 1000; median rank 2, 95% CrI 1-4; low-certainty) and leads to trivial difference in NEC (network RR 0.73, 95% CrI 0.31 to 1.4; ARD 18 fewer [95% CrI, from 45 fewer to 26 more] per 1000; median rank 1, 95% CrI 1-3; high-certainty), or CLD (network RR 1.00, 95% CrI 0.83 to 1.3; ARD 0 fewer [95% CrI, from 61 fewer to 108 more] per 1000; median rank 2, 95% CrI 1-3; low-certainty). The evidence is very uncertain on effect of ibuprofen on gastrointestinal perforation (network RR 2.6, 95% CrI 0.42 to 20.0; ARD 76 more [95% CrI, from 27 fewer to 897 more] per 1000; median rank 3, 95% CrI 1-3; very low-certainty).\nThe evidence is very uncertain on the effect of prophylactic acetaminophen on severe IVH (network RR 1.17, 95% CrI 0.04 to 55.2; ARD 22 more [95% CrI, from 122 fewer to 1000 more] per 1000; median rank 4, 95% CrI 1-4; very low-certainty), mortality (network RR 0.49, 95% CrI 0.16 to 1.4; ARD 82 fewer [95% CrI, from 135 fewer to 64 more] per 1000; median rank 1, 95% CrI 1-4; very low-certainty), or CP (network RR 0.36, 95% CrI 0.01 to 6.3; ARD 70 fewer [95% CrI, from 109 fewer to 583 more] per 1000; median rank 1, 95% CrI 1-3; very low-certainty).\nIn summary, based on ranking statistics, both indomethacin and ibuprofen were equally effective (median ranks 2 respectively) in reducing severe IVH and mortality. Ibuprofen (median rank 1) was more effective than indomethacin in reducing surgical PDA ligation (median rank 2). However, no statistically-significant differences were observed between the COX-I drugs for any of the relevant outcomes.\nAuthors' conclusions\nProphylactic indomethacin probably results in a small reduction in severe IVH and moderate reduction in mortality and surgical PDA closure (moderate-certainty), may result in a small increase in CLD (low-certainty) and results in trivial differences in NEC (high-certainty), gastrointestinal perforation (moderate-certainty) and cerebral palsy (low-certainty). Prophylactic ibuprofen probably results in a small reduction in severe IVH and moderate reduction in surgical PDA closure (moderate-certainty), may result in a moderate reduction in mortality (low-certainty) and trivial differences in CLD (low-certainty) and NEC (high-certainty). The evidence is very uncertain about the effect of acetaminophen on any of the clinically-relevant outcomes.\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": "According to GRADE (a method to score the certainty of the trials supporting each outcome), the certainty of the evidence varied from very low to high but was moderate for the most important outcomes of severe brain bleeding and death."
}
]
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