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query-laysum | 1924 | [
{
"role": "user",
"content": "Abstract: Background\nThe impact of lymphadenectomy extent on the survival of patients with primary resectable gastric carcinoma is debated.\nObjectives\nWe aimed to systematically review and meta-analyze the evidence on the impact of the three main types of progressively more extended lymph node dissection (that is, D1, D2 and D3 lymphadenectomy) on the clinical outcome of patients with primary resectable carcinoma of the stomach. The primary objective was to assess the impact of lymphadenectomy extent on survival (overall survival [OS], disease specific survival [DSS] and disease free survival [DFS]). The secondary aim was to assess the impact of lymphadenectomy on post-operative mortality.\nSearch methods\nWe searched CENTRAL, MEDLINE and EMBASE until 2001, including references from relevant articles and conference proceedings. We also contacted known researchers in the field. For the updated review, CENTRAL, MEDLINE and EMBASE were searched from 2001 to February 2015.\nSelection criteria\nWe considered randomized controlled trials (RCTs) comparing the three main types of lymph node dissection (i.e., D1, D2 and D3 lymphadenectomy) in patients with primary non-metastatic resectable carcinoma of the stomach.\nData collection and analysis\nTwo authors independently extracted data from the included studies. Hazard ratios (HR) and relative risks (RR) along with their 95% confidence intervals (CI) were used to measure differences in survival and mortality rates between trial arms, respectively. Potential sources of between-study heterogeneity were investigated by means of subgroup and sensitivity analyses. The same two authors independently assessed the risk of bias of eligible studies according to the standards of the Cochrane Collaboration and the quality of the overall evidence based on the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria.\nMain results\nEight RCTs (enrolling 2515 patients) met the inclusion criteria. Three RCTs (all performed in Asian countries) compared D3 with D2 lymphadenectomy: data suggested no significant difference in OS between these two types of lymph node dissection (HR 0.99, 95% CI 0.81 to 1.21), with no significant difference in postoperative mortality (RR 1.67, 95% CI 0.41 to 6.73). Data for DFS were available only from one trial and for no trial were DSS data available. Five RCTs (n = 3 European; n = 2 Asian) compared D2 to D1 lymphadenectomy: OS (n = 5; HR 0.91, 95% CI 0.71 to 1.17) and DFS (n=3; HR 0.95, 95% CI 0.84 to 1.07) findings suggested no significant difference between these two types of lymph node dissection. In contrast, D2 lymphadenectomy was associated with a significantly better DSS compared to D1 lymphadenectomy (HR 0.81, 95% CI 0.71 to 0.92), the quality of the body of evidence being moderate; however, D2 lymphadenectomy was also associated with a higher postoperative mortality rate (RR 2.02, 95% CI 1.34 to 3.04).\nAuthors' conclusions\nD2 lymphadenectomy can improve DSS in patients with resectable carcinoma of the stomach, although the increased incidence of postoperative mortality reduces its therapeutic benefit.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Gastric carcinoma is a leading cause of cancer death worldwide. For patients affected with this disease, the main therapy is surgery, which consists of gastric resection along with the removal of lymph nodes surrounding the stomach (a procedure called lymphadenectomy). Three types of progressively more extended lymphadenectomies exist (called D1, D2 and D3); their therapeutic benefit is debated."
}
]
|
query-laysum | 1925 | [
{
"role": "user",
"content": "Abstract: Background\nIn arterial line cannulation in children and adolescents, traditional methods of locating the artery include palpation and Doppler auditory assistance. It is unclear whether ultrasound guidance is superior to these methods. This is an update of a review originally published in 2016.\nObjectives\nTo evaluate the benefits and harms of ultrasound guidance compared with traditional techniques (palpation, Doppler auditory assistance) for assisting arterial line placement at all potential sites in children and adolescents.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and Web of Science from inception to 30 October 2022. We also searched four trials registers for ongoing trials, and we checked the reference lists of included studies and relevant reviews for other potentially eligible trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing ultrasound guidance versus other techniques (palpation or Doppler auditory assistance) to guide arterial line cannulation in children and adolescents (aged under 18 years). We planned to include quasi-RCTs and cluster-RCTs. For RCTs with both adult and paediatric populations, we planned to include only the paediatric population data.\nData collection and analysis\nTwo review authors independently assessed the risk of bias of included trials and extracted data. We used standard Cochrane meta-analytical procedures, and we applied the GRADE method to assess the certainty of evidence.\nMain results\nWe included nine RCTs reporting 748 arterial cannulations in children and adolescents (under 18 years of age) undergoing different surgical procedures. Eight RCTs compared ultrasound with palpation, and one compared ultrasound with Doppler auditory assistance. Five studies reported the incidence of haematomas. Seven involved radial artery cannulation and two involved femoral artery cannulation.\nThe people performing arterial cannulation were physicians with different levels of experience. The risk of bias varied across studies, with some studies lacking details of allocation concealment. It was not possible to blind practitioners in any case; this adds a performance bias that is inherent to the type of intervention studied in our review.\nCompared to traditional methods, ultrasound guidance probably causes a large increase in first-attempt success rates (risk ratio (RR) 2.01, 95% confidence interval (CI) 1.64 to 2.46; 8 RCTs, 708 participants; moderate-certainty evidence) and probably causes a large reduction in the risk of complications such as haematoma formation (RR 0.26, 95% CI 0.14 to 0.47; 5 RCTs, 420 participants; moderate-certainty evidence). No studies reported data about ischaemic damage. Ultrasound guidance probably improves success rates within two attempts (RR 1.78, 95% CI 1.25 to 2.51; 2 RCTs, 134 participants; moderate-certainty evidence) and overall rate of successful cannulation (RR 1.32, 95% CI 1.10 to 1.59; 6 RCTs, 374 participants; moderate-certainty evidence). In addition, ultrasound guidance probably reduces the number of attempts to successful cannulation (mean difference (MD) −0.99 attempts, 95% CI −1.15 to −0.83; 5 RCTs, 368 participants; moderate-certainty evidence) and duration of the cannulation procedure (MD −98.77 seconds, 95% CI −150.02 to −47.52, 5 RCTs, 402 participants; moderate-certainty evidence).\nMore studies are needed to confirm whether the improvement in first-attempt success rates is more pronounced in neonates and younger children compared to older children and adolescents.\nAuthors' conclusions\nWe identified moderate-certainty evidence that ultrasound guidance for arterial cannulation compared with palpation or Doppler auditory assistance improves first-attempt success rate, second-attempt success rate and overall success rate. We also found moderate-certainty evidence that ultrasound guidance reduces the incidence of complications, the number of attempts to successful cannulation and the duration of the cannulation procedure.\n\nGiven the provided abstract, please respond to the following query: \"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 only moderate because it was impossible to mask the doctors performing the cannulation (they knew which children had ultrasound-assisted cannulation), and because the studies included few children and reported few events."
}
]
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query-laysum | 1926 | [
{
"role": "user",
"content": "Abstract: Background\nSleep bruxism is an oral activity characterized by involuntary teeth grinding or clenching during sleep. Several forms of treatment have been proposed for this disorder, including behavioural, dental and pharmacological strategies.\nObjectives\nTo evaluate the effectiveness and safety of pharmacological therapy for the treatment of sleep bruxism compared with other drugs, no treatment or placebo.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8, 2014), MEDLINE (1966 to August 2014), EMBASE (1980 to August 2013) and LILACS (1982 to August 2014). We identified additional reports from the reference lists of retrieved reports and from reviews on treatment of sleep bruxism. We applied no language restrictions.\nSelection criteria\nWe selected randomized controlled trials (RCTs) or quasi-RCTs that compared drugs with other drugs, no treatment or placebo in people with sleep bruxism.\nData collection and analysis\nReview authors carried out data extraction and quality assessment of the included trials independently and in duplicate. We discussed discrepancies until we reached consensus. We consulted a third review author in cases of persistent disagreement. We contacted authors of primary studies when necessary.\nMain results\nWe identified 18 potentially relevant RCTs, but only seven met the inclusion criteria. All studies had a small number of participants, ranging from seven to 16 people per study and had a cross-over design. Three studies were of low risk of bias, while four were of uncertain risk. Amitriptyline (three studies), bromocriptine (one study), clonidine (one study), propranolol (one study), levodopa (Prolopa®) (one study) and tryptophan (one study) were compared with placebo. Studies evaluating bromocriptine, clonidine, propranolol and levodopa reported our primary outcome of indices of bruxism motor activity.\nResults were imprecise and consistent with benefit, no difference or harm. These were the specific findings for each of the drugs according to specific outcomes: 1. Amitriptyline versus placebo for masseteric electromyography (EMG) activity per minute: standardized mean difference (SMD) -0.28 (95% confidence interval (CI) -0.91 to 0.34; P value = 0.37), 2. bromocriptine versus placebo for bruxism episodes per hour: mean difference (MD) 0.60 (95% CI -2.93 to 4.13), bruxism bursts per hour: MD -2.00 (95% CI -53.47 to 49.47), bruxism bursts per episode: MD 0.50 (95% CI -1.85 to 2.85) or number of episodes with grinding noise: MD 2.40 (95% CI -24.00 to 28.80), 3. clonidine versus placebo for number of bruxism episodes per hour: MD -2.41 (95% CI -4.84 to 0.02), 4. propranolol versus placebo for the number of bruxism episodes per hour: MD 1.16 (95% CI -1.89 to 4.21), 5. L-tryptophan versus placebo for masseteric EMG activity per second: SMD 0.08 (95% CI -0.90 to 1.06) and 6. levodopa versus placebo for bruxism episodes per hour of sleep: MD -1.47 (95% CI -3.64 to 0.70), for bruxism bursts per episode: MD 0.06 (95% CI -2.47 to 2.59).\nWe combined several secondary outcomes (sleep duration, masseteric EMG activity per minute and pain intensity) in a meta-analysis for comparison of amitriptyline with placebo. The results for most comparisons were uncertain because of statistical imprecision. One study reported that clonidine reduced rapid eye movement (REM) sleep stage and increased the second stage of sleep. However, results for other sleep-related outcomes with clonidine were uncertain. Adverse effects were frequent in people who took amitriptyline (5/10 had drowsiness, difficulty awakening in the morning, insomnia or xerostomia compared with 0/10 in the placebo group), as well as in people who received propranolol (7/16 had moderate-to-severe xerostomia compare with 2/16 in the placebo group). Clonidine was associated with prolonged morning hypotension in three of 16 participants. The use of preventive medication avoided any adverse effects in people treated with levodopa and bromocriptine.\nAuthors' conclusions\nThere was insufficient evidence on the effectiveness of pharmacotherapy for the treatment of sleep bruxism. This systematic review points to the need for more, well-designed, RCTs with larger sample sizes and adequate methods of allocation, outcome assessment and duration of follow-up. Ideally, parallel RCTs should be used in future studies to avoid the bias associated with cross-over studies. There is a need to standardize the outcomes of RCTs on treatments for sleep bruxism.\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": "There are several signs and symptoms of sleep bruxism, such as abnormal tooth wear, fractured teeth, jaw muscle discomfort, joint pain or tenderness, and headaches. Treatments include odontological devices such as occlusal splints, psychotherapy and medications (pharmacotherapy). Pharmacological treatments include drugs such as benzodiazepines, anticonvulsants, beta-blockers, dopamine agents, antidepressants, muscle relaxants and others. However, little is known about the effectiveness, safety and long-term follow-up of medications for sleep bruxism."
}
]
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query-laysum | 1927 | [
{
"role": "user",
"content": "Abstract: Background\nPsoriasis is a chronic skin disease that may develop at any age. Estimates for the United States and Europe suggest that psoriasis accounts for 4% of skin diseases in children. In most cases, the condition is mild and can be treated with creams. However, a small percentage of children have moderate to severe disease that requires drugs, such as ciclosporin or methotrexate, and some will require injections with newer biological agents, such as anti-TNF (tumour necrosis factor) drugs. Anti-TNF drugs (among them etanercept, infliximab, and adalimumab) are designed to reduce inflammation in the body caused by tumour necrosis factor. Evidence for the safety and efficacy of these biological agents in paediatric psoriasis is lacking.\nObjectives\nTo assess the efficacy and safety of anti-TNF agents for the treatment of paediatric psoriasis.\nSearch methods\nWe searched the following databases up to July 2015: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 6), MEDLINE (from 1946), Embase (from 1974), and LILACS (from 1982). We also searched 13 trials registers and checked the reference lists of included studies and key review articles for further references to relevant randomised controlled trials (RCTs). We handsearched conference proceedings and attempted to contact trial authors and relevant pharmaceutical manufacturers. We searched the US Food and Drug Administration's and European Medicines Agency's adverse effects databases.\nSelection criteria\nAll relevant RCTs that evaluated the efficacy and safety of anti-TNF agents for the treatment of chronic plaque psoriasis in individuals less than 18 years of age.\nData collection and analysis\nTwo review authors independently checked titles and abstracts and performed data extraction and 'Risk of bias' assessment of the included studies. One review author entered data into Review Manager (RevMan), and a second review author checked the data. We also attempted to obtain unclear data from the trial authors where possible.\nOur primary outcomes were investigator-assessed number of participants achieving a 75% improvement in Psoriasis Area and Severity Index-75 (PASI 75) compared to baseline, improvement in quality of life using an instrument such as Children's Dermatology Life Quality Index (CDLQI), and adverse effects. Our secondary outcomes included the proportion of participants achieving PASI 50 and the Physician's Global Assessment (PGA).\nMain results\nWe included one study with 211 participants (median age 13 years), in which etanercept (dosage ranged from 0.8 to 50 mg per kilogram of body weight) was compared to placebo. Follow-up was over a 48-week period.\nAt week 12, 57% versus 11% who received etanercept or placebo, respectively, achieved the PASI 75 (risk ratio 4.95, 95% confidence interval (CI) 2.83 to 8.65; high-quality evidence). Absolute risk reduction and the number needed to treat to obtain a benefit with etanercept was 45% (95% CI 33.95 to 56.40) and 2 (95% CI 1.77 to 2.95), respectively.\nThe percentage improvement from baseline of the CDLQI scores at week 12 was better in the etanercept group than the placebo group (52.3% versus 17.5%, respectively (P = 0.0001)). Analysis between the groups showed an effect size that was clinically important (mean difference 2.30, 95% CI 0.85 to 3.75; high-quality evidence). However, means, medians, and minimal important difference results and results of the Pediatric Quality of Life Inventory, Stein Impact on Family Scale, and Harter Self-Perception Profile for Children scores must be interpreted with caution, as they were not prespecified outcomes.\nThree serious adverse events were reported, but they were resolved without sequelae. Deaths or other events such as malignant tumours, opportunistic infections, tuberculosis, or demyelination were not reported in the included study.\nAlso, 13% of participants in the placebo group and 53% in the etanercept group had a PGA of clear or almost clear (risk ratio 3.96, 95% CI 2.36 to 6.66; high-quality evidence) at week 12.\nAuthors' conclusions\nThis review found only one RCT evaluating the use of this type of biological therapy. Although the risk of publication bias was high, as we included only one industry-sponsored RCT, the risk of allocation, selection, performance, attrition, and selective reporting biases for all outcomes (except for CDLQI) was low, and no short-term serious adverse events were found.\nWe can conclude, based on this single included study, that etanercept seems to be efficacious and safe (at least in the short term) for the treatment of paediatric psoriasis. However, as the GRADE approach refers not to individual studies but to a body of evidence, we shall wait for the results of the ongoing studies in a future update of this review. In addition, future studies should evaluate quality-of-life endpoints established a priori and standardise primary outcome measures such as PASI 75, and should include the PGA as a secondary endpoint. Also, collating and reporting adverse events uniformly is required to better evaluate safety.\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": "Psoriasis is a long-term skin disease that may develop at any age. Estimates for the United States and Europe suggest that psoriasis accounts for 4% of skin diseases in children. In most cases, the condition is mild and can be treated with creams. However, a small percentage of children have moderate to severe disease that requires drugs, such as ciclosporin or methotrexate, and some will require injections with newer biological agents, such as anti-TNF (tumour necrosis factor) drugs. Anti-TNF drugs (among them etanercept, infliximab, and adalimumab) are designed to reduce inflammation in the body caused by tumour necrosis factor."
}
]
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query-laysum | 1928 | [
{
"role": "user",
"content": "Abstract: Background\nThalassaemia is an autosomal recessive blood disorder, caused by mutations in globin genes or their regulatory regions, resulting in a reduced rate of synthesis of one of the globin chains that make up haemoglobin. In β-thalassaemia there is an underproduction of β-globin chains combined with excess of free α-globin chains. The excess free α-globin chains precipitate in red blood cells, leading to their increased destruction (haemolysis) and ineffective erythropoiesis. The conventional treatment is based on the correction of haemoglobin through regular red blood cell transfusions and treating the iron overload that develops subsequently with iron chelation therapy. Although, early detection and initiations of such supportive treatment has improved the quality of life for people with transfusion-dependent thalassaemia, allogeneic hematopoietic stem cell transplantation is the only widely available therapy with a curative potential. Gene therapy for β-thalassaemia has recently received conditional authorisation for marketing in Europe, and may soon become widely available as another alternative therapy with curative potential for people with transfusion-dependent thalassaemia. This is an update of a previously published Cochrane Review.\nObjectives\nTo evaluate the effectiveness and safety of different types of hematopoietic stem cell transplantation, in people with transfusion-dependent β-thalassaemia.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries.\nDate of the most recent search: 07 April 2021.\nSelection criteria\nRandomised controlled trials and quasi-randomised controlled trials comparing hematopoietic stem cell transplantation with each other or with standard therapy (regular transfusion and chelation regimen).\nData collection and analysis\nTwo review authors independently screened trials and had planned to extract data and assess risk of bias using standard Cochrane methodologies and assess the quality using GRADE approach, but no trials were identified for inclusion in the current review.\nMain results\nNo relevant trials were retrieved after a comprehensive search of the literature.\nAuthors' conclusions\nWe were unable to identify any randomised controlled trials or quasi-randomised controlled trials on the effectiveness and safety of different types of hematopoietic stem cell transplantation in people with transfusion-dependent β-thalassaemia. The absence of high-level evidence for the effectiveness of these interventions emphasises the need for well-designed, adequately-powered, randomised controlled clinical trials.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is current to: 07 April 2021."
}
]
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query-laysum | 1929 | [
{
"role": "user",
"content": "Abstract: Background\nUnilateral cerebral palsy (CP) is a condition that affects muscle control and function on one side of the body. Children with unilateral CP experience difficulties using their hands together secondary to disturbances that occur in the developing fetal or infant brain. Often, the more affected limb is disregarded. Constraint-induced movement therapy (CIMT) aims to increase use of the more affected upper limb and improve bimanual performance. CIMT is based on two principles: restraining the use of the less affected limb (for example, using a splint, mitt or sling) and intensive therapeutic practice of the more affected limb.\nObjectives\nTo evaluate the effect of constraint-induced movement therapy (CIMT) in the treatment of the more affected upper limb in children with unilateral CP.\nSearch methods\nIn March 2018 we searched CENTRAL, MEDLINE, Embase, CINAHL, PEDro, OTseeker, five other databases and three trials registers. We also ran citation searches, checked reference lists, contacted experts, handsearched key journals and searched using Google Scholar.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-RCTs or clinically controlled trials implemented with children with unilateral CP, aged between 0 and 19 years, where CIMT was compared with a different form of CIMT, or a low dose, high-dose or dose-matched alternative form of upper-limb intervention such as bimanual intervention. Primarily, outcomes were bimanual performance, unimanual capacity and manual ability. Secondary outcomes included measures of self-care, body function, participation and quality of life.\nData collection and analysis\nTwo review authors independently screened titles and abstracts to eliminate ineligible studies. Five review authors were paired to extract data and assess risk of bias in each included study. GRADE assessments were undertaken by two review authors.\nMain results\nWe included 36 trials (1264 participants), published between 2004 and 2018. Sample sizes ranged from 11 to 105 (mean 35). Mean age was 5.96 years (standard deviation (SD) 1.82), range three months to 19.8 years; 53% male and 47% participants had left hemiplegia. Fifty-seven outcome measures were used across studies. Average length of CIMT programs was four weeks (range one to 10 weeks). Frequency of sessions ranged from twice weekly to seven days per week. Duration of intervention sessions ranged from 0.5 to eight hours per day. The mean total number of hours of CIMT provided was 137 hours (range 20 to 504 hours). The most common constraint devices were a mitt/glove or a sling (11 studies each).\nWe judged the risk of bias as moderate to high across the studies.\nKey results: Primary outcomes at primary endpoint (immediately after intervention)\nCIMT versus low-dose comparison (e.g. occupational therapy)\nWe found low-quality evidence that CIMT was more effective than a low-dose comparison for improving bimanual performance (mean difference (MD) 5.44 Assisting Hand Assessment (AHA) units, 95% confidence interval (CI) 2.37 to 8.51).\nCIMT was more effective than a low-dose comparison for improving unimanual capacity (Quality of upper extremity skills test (QUEST) - Dissociated movement MD 5.95, 95% CI 2.02 to 9.87; Grasps; MD 7.57, 95% CI 2.10 to 13.05; Weight bearing MD 5.92, 95% CI 2.21 to 9.6; Protective extension MD 12.54, 95% CI 8.60 to 16.47). Three studies reported adverse events, including frustration, constraint refusal and reversible skin irritations from casting.\nCIMT versus high-dose comparison (e.g. individualised occupational therapy, bimanual therapy)\nWhen compared with a high-dose comparison, CIMT was not more effective for improving bimanual performance (MD −0.39 AHA Units, 95% CI −3.14 to 2.36). There was no evidence that CIMT was more effective than a high-dose comparison for improving unimanual capacity in a single study using QUEST (Dissociated movement MD 0.49, 95% CI −10.71 to 11.69; Grasp MD −0.20, 95% CI −11.84 to 11.44). Two studies reported that some children experienced frustration participating in CIMT.\nCIMT versus dose-matched comparison (e.g. Hand Arm Bimanual Intensive Therapy, bimanual therapy, occupational therapy)\nThere was no evidence of differences in bimanual performance between groups receiving CIMT or a dose-matched comparison (MD 0.80 AHA units, 95% CI −0.78 to 2.38).\nThere was no evidence that CIMT was more effective than a dose-matched comparison for improving unimanual capacity (Box and Blocks Test MD 1.11, 95% CI −0.06 to 2.28; Melbourne Assessment MD 1.48, 95% CI −0.49 to 3.44; QUEST Dissociated movement MD 6.51, 95% CI −0.74 to 13.76; Grasp, MD 6.63, 95% CI −2.38 to 15.65; Weightbearing MD −2.31, 95% CI −8.02 to 3.40) except for the Protective extension domain (MD 6.86, 95% CI 0.14 to 13.58).\nThere was no evidence of differences in manual ability between groups receiving CIMT or a dose-matched comparison (ABILHAND-Kids MD 0.74, 95% CI 0.31 to 1.18). From 15 studies, two children did not tolerate CIMT and three experienced difficulty.\nAuthors' conclusions\nThe quality of evidence for all conclusions was low to very low. For children with unilateral CP, there was some evidence that CIMT resulted in improved bimanual performance and unimanual capacity when compared to a low-dose comparison, but not when compared to a high-dose or dose-matched comparison. Based on the evidence available, CIMT appears to be safe for children with CP.\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 includes studies published up to March 2018."
}
]
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query-laysum | 1930 | [
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a neurological disorder affecting both children and adults. Epileptic seizures are the result of excessive and abnormal cortical cell electrical activity in the brain. In response to criticism that epilepsy care for children has little impact on long-term outcomes, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies.\nThis is an updated version of a Cochrane Review previously published in 2018.\nObjectives\nTo assess the effects of any specialised or dedicated intervention for epilepsy versus usual care in children and adolescents with epilepsy and their families.\nSearch methods\nWe searched the following databases on 14 January 2020: the Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 13 January 2020), PsycINFO (1887 to 14 January 2020), CINAHL Plus (1937 to 14 January 2020), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Register of Studies (CRS Web) includes the Cochrane Epilepsy Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted experts in the field seeking information on unpublished and ongoing studies and checked the websites of epilepsy organisations and the reference lists of included studies.\nSelection criteria\nWe included randomised controlled trials recruiting children and adolescents with epilepsy.\nData collection and analysis\nTwo review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 1. Seizure frequency and severity; 2. Appropriateness and volume of medication prescribed (including evidence of drug toxicity); 3. Participants' reported knowledge of information and advice received from professionals; 4. Participants' reports of health and quality of life; 5. Objective measures of general health status; 6. Objective measures of social or psychological functioning (including the number of days spent on sick leave/absence from school or work, and employment status); and 7. Costs of care or treatment. The results of the data extraction and quality assessment for each study were presented in structured tables and as a narrative summary. All summary statistics were extracted for each outcome.\nMain results\nWe included nine studies of eight interventions in the review, reporting on seven distinct self-management programmes for educating or counselling children with epilepsy and their parents, and one new model of care. Based largely on self-reported outcomes, each programme showed some benefits for the well-being of children with epilepsy; however, all of the included studies had methodological flaws. No single programme was evaluated with different study samples, and in no instance was the same outcome measured and reported in the same way across studies, precluding any possible meta-analysis, even if the interventions were considered sufficiently similar to include in meta-analysis.\nWe chose the outcomes for which data might be important for decisions about the interventions as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions. We found moderate certainty evidence that one of the educational interventions reduced seizure frequency. There was low certainty evidence that two other educational interventions reduced seizure severity, seizure control, and seizure cure rates. The evidence for all other outcomes (drug adherence, knowledge, self-efficacy and self-perception of epilepsy on quality of life) was mixed.\nAuthors' conclusions\nWhilst each of the programmes evaluated in this review showed some benefit to children with epilepsy, their impact was extremely variable. No programme showed benefits across the full range of outcomes, and all studies had methodological problems. There is currently insufficient evidence in favour of any single programme. Further evidence from randomised controlled trials using validated measures and considering clinical meaningfulness as well as statistical significance of results is required.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was poor because all of the included studies had problems in how they were run."
}
]
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query-laysum | 1931 | [
{
"role": "user",
"content": "Abstract: Background\nHypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review.\nObjectives\nTo investigate efficacy and tolerability of nebulised hypertonic saline treatment in people with cystic fibrosis (CF) compared to placebo or other treatments that enhance mucociliary clearance.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases.\nMost recent search: 25 April 2022.\nSelection criteria\nWe included randomised and quasi-randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity).\nData collection and analysis\nTwo authors independently reviewed all identified trials and data, and assessed trial quality. We assessed the certainty of the evidence using GRADE. For cross-over trials we stipulated a one-week washout period. We planned to use results from a paired analysis in the review, but this was only possible in one trial. For other cross-over trials, we chose to treat the trials as if they were parallel.\nMain results\nWe included 24 trials (1318 participants, aged one month to 56 years); we excluded 29 trials, two trials are ongoing and six are awaiting classification. We judged 15 of the 24 included trials to have a high risk of bias due to participants' ability to discern the taste of the solutions.\nHypertonic saline 3% to 7% versus placebo (stable disease)\nWe are uncertain whether the regular use of nebulised hypertonic saline in stable lung disease leads to an improvement in forced expiratory volume in one second (FEV1) % predicted at four weeks, (mean difference (MD) 3.30%, 95% confidence interval (CI) 0.71 to 5.89; 4 trials, 246 participants; very low-certainty evidence). In preschool children we found no difference in lung clearance index (LCI) at four weeks, but a small improvement after 48 weeks of treatment with hypertonic saline compared to isotonic saline (MD -0.60, 95% CI -1.00 to -0.19; 2 trials, 192 participants). We are also uncertain whether hypertonic saline made a difference to mucociliary clearance, pulmonary exacerbations or adverse events compared to placebo.\nHypertonic saline versus control (acute exacerbation)\nTwo trials compared hypertonic saline to control, but only one provided data. There may be little or no difference in lung function measured by FEV1 % predicted after hypertonic saline compared to isotonic saline (MD 5.10%, 95% CI -14.67 to 24.87; 1 trial, 130 participants). Neither trial reported any deaths or measures of sputum clearance. There were no serious adverse events.\nHypertonic saline versus rhDNase\nThree trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two trials (61 participants) provided data for inclusion in the review. We are uncertain whether there was an effect of hypertonic saline on FEV1 % predicted after three weeks (MD 1.60%, 95% CI -7.96 to 11.16; 1 trial, 14 participants; very low-certainty evidence). At three months, rhDNase may lead to a greater increase in FEV1 % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease (MD 8.00%, 95% CI 2.00 to 14.00; low-certainty evidence). We are uncertain whether adverse events differed between the two treatments. No deaths were reported.\nHypertonic saline versus amiloride\nOne trial (12 participants) compared hypertonic saline to amiloride but did not report on most of our outcomes. The trial found that there was no difference between treatments in measures of sputum clearance (very low-certainty evidence).\nHypertonic saline compared with sodium-2-mercaptoethane sulphonate (Mistabron®)\nOne trial (29 participants) compared hypertonic saline to sodium-2-mercaptoethane sulphonate. The trial did not measure our primary outcomes. There was no difference between treatments in any measures of sputum clearance, courses of antibiotics or adverse events (very low-certainty evidence).\nHypertonic saline versus mannitol\nOne trial (12 participants) compared hypertonic saline to mannitol, but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low-certainty evidence).\nHypertonic saline versus xylitol\nTwo trials compared hypertonic saline to xylitol, but we are uncertain whether there is any difference in FEV1 % predicted or median time to exacerbation between groups (very low-certainty evidence). No other outcomes were reported in the review.\nHypertonic saline 7% versus hypertonic saline 3%\nWe are uncertain whether there was an improvement in FEV1 % predicted after treatment with 7% hypertonic saline compared with 3% (very low-certainty evidence).\nAuthors' conclusions\nWe are very uncertain if regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (three trials; very low-certainty evidence); there was no difference seen at 48 weeks (one trial; low-certainty evidence). Hypertonic saline improved LCI modestly in children under the age of six years.\nEvidence from one small cross-over trial in children indicates that rhDNase may lead to better lung function than hypertonic saline at three months; qualifying this, we highlight that while the study did demonstrate that the improvement in FEV1 was greater with daily rhDNase, there were no differences seen in any of the secondary outcomes.\nHypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the certainty of the evidence ranged from very low to low at best, according to the GRADE criteria.\nThe role of hypertonic saline in conjunction with cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy now needs to be considered, and future research needs to focus on this aspect.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
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query-laysum | 1932 | [
{
"role": "user",
"content": "Abstract: Background\nAccording to the Global Burden of Disease Study 2015, lower respiratory tract infection is the leading cause of infectious disease death, and the fifth most common cause of death overall. Vitamin C has a role in modulating resistance to infectious agents, therefore vitamin C supplementation may be important in preventing and treating pneumonia.\nObjectives\nTo assess the impact of vitamin C supplementation to prevent and treat pneumonia in children and adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PubMed, CINAHL, LILACS, Web of Science, and two trials registers to 4 March 2020. We also checked references to identify additional studies. We did not apply any publication status or language filters.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs (studies using allocation methods that are not random, e.g. date of birth, medical record number) assessing the role of vitamin C supplementation in the prevention and treatment of pneumonia in children and adults compared to control or placebo.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included five studies in the review and identified two ongoing studies. The five included studies involved a total of 2655 participants; two studies were RCTs and three were quasi-RCTs. The included studies were conducted in one high-income country (USA) and three lower-middle-income countries (Bangladesh and Pakistan). Three studies were conducted in hospital inpatient settings, one in school, and one in a military training centre. Three studies included children under five years of age, one study included school-aged children, and one study included adult participants. Two studies assessed the effect of vitamin C supplementation for pneumonia prevention; and three studies assessed the effect of vitamin C supplementation as an adjunct to pneumonia treatment. For pneumonia prevention, the included studies provided supplementation in doses of 1 g daily for 14 weeks, 2 g daily for 8 weeks, and 2 g daily for 14 weeks. For pneumonia treatment, the included studies provided vitamin C supplementation in doses of 125 mg daily and 200 mg daily until the symptoms resolved or discharge, as an adjunct to the pneumonia treatment. Overall, the included studies were judged to be at either high or unclear risk of bias for random sequence generation, allocation concealment, and blinding; and the evidence certainty was very low.\nTwo studies assessed the effect of vitamin C supplementation for pneumonia prevention; we judged the certainty of the evidence as very low. We are uncertain about the effect of vitamin C supplementation on pneumonia incidence and adverse events (urticaria). None of the included studies reported other primary outcomes (pneumonia prevalence and mortality) or any of the secondary outcomes.\nThree studies assessed the effect of vitamin C supplementation as an adjunct to pneumonia treatment; we judged the certainty of the evidence as very low. We are uncertain of the effect of vitamin C supplementation on duration of illness and hospitalisation. None of the included studies reported other primary or secondary outcomes.\nAuthors' conclusions\nDue to the small number of included studies and very low certainty of the existing evidence, we are uncertain of the effect of vitamin C supplementation for the prevention and treatment of pneumonia. Further good-quality studies are required to assess the role of vitamin C supplementation in the prevention and treatment of pneumonia.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We assessed the rate of pneumonia (incidence), how common pneumonia is (prevalence), numbers of deaths from pneumonia (mortality), and unintended and harmful outcomes (adverse effects) associated with vitamin C for preventing pneumonia. Only one study (674 participants) reported incidence, and one study reported one adverse effect (hives) associated with vitamin C for preventing pneumonia. No study reported on prevalence or mortality. Evidence was insufficient to determine the effect of vitamin C for preventing pneumonia.\nWe also assessed how long people were ill (duration of illness), how many people were cured, mortality, and adverse effects associated with the use of vitamin C as a treatment for pneumonia. Only one study reported duration of illness. No studies reported cure rates or adverse effects. Evidence was insufficient to determine the effect of vitamin C for treating pneumonia."
}
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query-laysum | 1933 | [
{
"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: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Review authors working with Cochrane Oral Health searched for studies up to 16 January 2019. We identified 35 studies (3929 adult participants). Participants knew that they were in an experiment, which might have affected their teeth cleaning or eating behaviour. Some studies had other problems that might make their findings less reliable, such as people dropping out of the study or not using the assigned device.\nStudies evaluated the following devices plus toothbrushing compared to toothbrushing only: floss (15 studies), interdental brushes (2 studies), wooden cleaning sticks (2 studies), rubber/elastomeric cleaning sticks (2 studies) and oral irrigators (5 studies). Four devices were compared with floss: interdental brushes (9 studies), wooden cleaning sticks (3 studies), rubber/elastomeric cleaning sticks (9 studies), oral irrigators (2 studies). Three studies compared rubber/elastomeric cleaning sticks with interdental brushes.\nNo studies evaluated decay, and few evaluated severe gum disease. Outcomes were measured at short (one month to six weeks) and medium term (three and six months)."
}
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query-laysum | 1934 | [
{
"role": "user",
"content": "Abstract: Background\nMyelodysplastic syndrome (MDS) is one of the most frequent haematologic malignancies of the elderly population and characterised by progenitor cell dysplasia with ineffective haematopoiesis and a high rate of transformation to acute myeloid leukaemia (AML). Thrombocytopenia represents a common problem for patients with MDS. ranging from mild to serious bleeding events and death. To manage thrombocytopenia, the current standard treatment includes platelet transfusion, unfortunately leading to a range of side effects. Thrombopoietin (TPO) mimetics represent an alternative treatment option for MDS patients with thrombocytopenia. However, it remains unclear, whether TPO mimetics influence the increase of blast cells and therefore to premature progression to AML.\nObjectives\nTo evaluate the efficacy and safety of thrombopoietin (TPO) mimetics for patients with MDS.\nSearch methods\nWe searched for randomised controlled trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (January 2000 to August 2017), trials registries (ISRCTN, EU clinical trials register and clinicaltrials.gov) and conference proceedings. We did not apply any language restrictions. Two review authors independently screened search results, disagreements were solved by discussion.\nSelection criteria\nWe included randomised controlled trials comparing TPO mimetics with placebo, no further treatment or another TPO mimetic in patients with MDS of all risk groups, without gender, age or ethnicity restrictions. Additional chemotherapeutic treatment had to be equal in both arms.\nData collection and analysis\nTwo review authors independently extracted data and assessed the quality of trials, disagreements were resolved by discussion. Risk ratio (RR) was used to analyse mortality during study, transformation to AML, incidence of bleeding events, transfusion requirement, all adverse events, adverse events >= grade 3, serious adverse events and platelet response. Overall survival (OS) and progression-free survival (PFS) have been extracted as hazard ratios, but could not be pooled as results were reported in heterogenous ways. Health-related quality of life and duration of thrombocytopenia would have been analysed as standardised mean differences, but no trial reported these outcomes.\nMain results\nWe did not identify any trial comparing one TPO mimetic versus another. We analysed six eligible trials involving 746 adult patients. All trials were reported as randomised and double-blind trials including male and female patients. Two trials compared TPO mimetics (romiplostim or eltrombopag) with placebo, one trial evaluated eltrombopag in addition to the hypomethylating agent azacitidine, two trials analysed romiplostim additionally to a hypomethylating agent (azacitidine or decitabine) and one trial evaluated romiplostim in addition to the immunomodulatory drug lenalidomide. There are more data on romiplostim (four included, completed, full-text trials) than on eltrombopag (two trials included: one full-text publication, one abstract publication). Due to small sample sizes and imbalances in baseline characteristics in three trials and premature termination of two studies, we judged the potential risk of bias of all included trials as high.\nDue to heterogenous reporting, we were not able to pool data for OS. Instead of that, we analysed mortality during study. There is little or no evidence for a difference in mortality during study for thrombopoietin mimetics compared to placebo (RR 0.97, 95% confidence interval (CI) 0.73 to 1.27, N = 6 trials, 746 patients, low-quality evidence). It is unclear whether the use of TPO mimetics induces an acceleration of transformation to AML (RR 1.02, 95% CI 0.59 to 1.77, N = 5 trials, 372 patients, very low-quality evidence).Thrombopoietin mimetics probably improve the incidence of all bleeding events (RR 0.92, 95% CI 0.86 to 0.99, N = 5 trials, 390 patients, moderate-quality evidence). This means that in the study population, 713 out of 1000 in the placebo arm will have a bleeding event, compared to 656 of 1000 (95% CI 613 to 699) in the TPO mimetics arm. There is little or no evidence for a difference that TPO mimetics significantly diminish the rate of transfusion requirement (RR 0.83, 95% CI 0.66 to 1.05, N = 4 trials, 358 patients, low-quality evidence). No studies were found that looked at quality of life or duration of thrombocytopenia.\nThere is no evidence that patients given TPO mimetics suffer more all adverse events (RR 1.01, 95% CI 0.96 to 1.07, N = 5 trials, 390 patients, moderate-quality evidence). There is uncertainty whether the number of serious adverse events decrease under therapy with TPO mimetics (RR 0.89, 95% CI 0.54 to 1.46, N = 4 trials, 356 patients, very low-quality evidence).\nWe identified one ongoing study and one study marked as completed (March 2015), but without publication of results for MDS patients (only results reported for AML and MDS patients together). Both studies evaluate MDS patients receiving eltrombopag in comparison to placebo.\nAuthors' conclusions\nNo trial evaluated one TPO mimetic versus another.\nSix trials including adult patients analysed one TPO mimetic versus placebo, sometimes combined with standard therapy in both arms. Given the uncertainty of the quality of evidence, meta-analyses show that there is little or no evidence for a difference in mortality during study and premature progress to AML. However, these assumptions have to be further explored. Treatment with TPO mimetics resulted in a lower number of MDS patients suffering from bleeding events.There is no evidence for a difference between study groups regarding transfusion requirement. Enlarged sample sizes and a longer follow-up of future trials should improve the estimate of safety and efficacy of TPO mimetics, moreover health-related quality of life should be evaluated. As two ongoing studies currently investigate eltrombopag (one already completed, but without published results), we are awaiting results for this drug.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "With this review we aimed to take a closer look at TPO mimetics in the treatment of MDS patients. We intended to focus on changes of overall survival, mortality during study, transformation to AML, incidence of bleeding events, transfusion requirement, health-related quality of life, all adverse events, and serious adverse events to explore the effect of TPO mimetics."
}
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query-laysum | 1935 | [
{
"role": "user",
"content": "Abstract: Background\nPain in Guillain-Barré syndrome (GBS) is common, yet it is often under recognised and poorly managed. In recent years, a variety of pharmacological treatment options have been investigated in clinical trials for people with GBS-associated pain. This is an updated version of the original Cochrane review published in Issue 10, 2013.\nObjectives\nTo assess the efficacy and safety of pharmacological treatments for various pain symptoms associated with GBS, during both the acute and convalescent (three months or more after onset) phases of GBS.\nSearch methods\nOn 3 November 2014, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL, MEDLINE and EMBASE. In addition, we searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs in participants with confirmed GBS, with pain assessment as either the primary or secondary outcome. For cross-over trials, an adequate washout period between phases was required for inclusion.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of identified records, selected studies for inclusion, extracted eligible data, cross-checked the data for accuracy and assessed the risk of bias of each study.\nMain results\nThree short-term RCTs, which enrolled 277 randomised participants with acute phase GBS, were included. Risk of bias in the included studies was generally unclear due to insufficient information. None of the included studies reported the primary outcome selected for this review, which was number of patients with self reported pain relief of 50% or greater. One small study investigated seven-day regimens of gabapentin versus placebo. Pain was rated on a scale from 0 (no pain) to 10 (maximum pain). Amongst the 18 participants, significantly lower mean pain scores were found at the endpoint (day 7) in the gabapentin phase compared to the endpoint of the placebo phase (mean difference -3.61, 95% CI -4.12 to -3.10) (very low quality evidence). For adverse events, no significant differences were found in the incidence of nausea (risk ratio (RR) 0.50, 95% CI 0.05 to 5.04) or constipation (RR 0.14, 95% CI 0.01 to 2.54). A second study enrolling 36 participants compared gabapentin, carbamazepine and placebo, all administered over seven days. Participants in the gabapentin group had significantly lower median pain scores on all treatment days in comparison to the placebo and carbamazepine groups (P < 0.05). There were no statistically significant differences in the median pain scores between the carbamazepine and placebo groups from day 1 to day 3, but from day 4 until the end of the study significantly lower median pain scores were noted in the carbamazepine group (P < 0.05) (very low quality evidence). There were no adverse effects of gabapentin or carbamazepine reported, other than sedation. One large RCT (223 participants, all also treated with intravenous immunoglobulin), compared a five-day course of methylprednisolone with placebo and found no statistically significant differences in number of participants developing pain (RR 0.89, 95% CI 0.68 to 1.16), number of participants with decreased pain (RR 0.95, 95% CI 0.63 to 1.42) or number of participants with increased pain (RR 0.85, 95% CI 0.52 to 1.41) (low quality evidence). The study did not report whether there were any adverse events.\nAuthors' conclusions\nSince the last version of this review we found no new studies. While management of pain in GBS is essential and pharmacotherapy is widely accepted as being an important component of treatment, this review does not provide sufficient evidence to support the use of any pharmacological intervention in people with pain in GBS. Although reductions in pain severity were found when comparing gabapentin and carbamazepine with placebo, the evidence was limited and its quality very low. Larger, well-designed RCTs are required to further investigate the efficacy and safety of potential interventions for patients with pain in GBS. Additionally, interventions for pain in the convalescent phase of GBS should be investigated.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Two medicines, gabapentin and carbamazepine, reduced pain severity compared to placebo (inactive) treatment and they had few side effects. One study found that people taking gabapentin had less pain, sleepiness or need for additional pain killers than those given carbamazepine. However, these studies were small and the treatment period was short. One trial, with 223 participants, found that methylprednisolone, which is a steroid medicine, did not affect the numbers of people who developed pain or change the numbers with more pain or less pain compared with placebo. This study did not report whether there were any side effects.\nThis review does not provide enough evidence to say whether or not treatments for pain in people with GBS work. Although both gabapentin and carbamazepine reduced the severity of pain compared to placebo, and few side effects were reported, the studies were small and the quality of the evidence was very low. Much larger, well-designed studies are needed to confirm that drug treatments are safe and effective for people with pain in the period soon after onset of GBS. Long-term studies of pain treatments at the stage when people with GBS are recovering should also be conducted and these should include assessment of effects of pain treatments on quality of life.\nThis review was first published in 2013 and an updated search in 2014 revealed no additional studies. The evidence is current to November 2014."
}
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query-laysum | 1936 | [
{
"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: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies of all currently used treatments taken by mouth or injected to treat SJS, TEN, or SJS/TEN overlap. We were interested in studies that compared one of these treatments against another, or against supportive treatment alone to determine whether one worked better than the other."
}
]
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query-laysum | 1937 | [
{
"role": "user",
"content": "Abstract: Background\nTriple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer associated with shorter survival and a higher likelihood of the cancer returning. In early TNBC, platinum-based chemotherapy has been shown to improve pathological complete response (pCR); however, its effect on long-term survival outcomes has not been fully elucidated and recommendations to include platinum chemotherapy are not consistent in international guidelines.\nObjectives\nTo evaluate the benefits and harms of platinum-based chemotherapy as adjuvant and neoadjuvant treatment in people with early triple-negative breast cancer.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 4 April 2022.\nSelection criteria\nWe included randomised controlled trials examining neoadjuvant or adjuvant platinum chemotherapy for early TNBC.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were disease-free survival (DFS) and overall survival (OS). Our secondary outcomes were pCR, treatment adherence, grade III or IV toxicity related to chemotherapy, and quality of life. Prespecified subgroups included BRCA mutation status, homologous recombination deficiency (HRD) status, frequency of chemotherapy, type of platinum agent used, and the presence or absence of anthracycline chemotherapy. We assessed risk of bias using Cochrane's RoB 1 tool and certainty of evidence using the GRADE approach.\nMain results\nFrom 3972 records, we included 20 published studies involving 21 treatment comparisons, and 25 ongoing studies. For most domains, risk of bias was low across studies. There were 16 neoadjuvant chemotherapy studies (one of which combined neoadjuvant and adjuvant therapy) and four adjuvant chemotherapy trials. Most studies used carboplatin (17 studies) followed by cisplatin (two), and lobaplatin (one). Eight studies had an anthracycline-free intervention arm, five of which had a carboplatin-taxane intervention compared to an anthracycline-taxane control.\nAll studies reporting DFS and OS used carboplatin. Inclusion of platinum chemotherapy improved DFS in neoadjuvant and adjuvant settings (neoadjuvant: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.53 to 0.75; 7 studies, 8 treatment comparisons, 1966 participants; high-certainty evidence; adjuvant: HR 0.69, 95% CI 0.54 to 0.88; 4 studies, 1256 participants; high-certainty evidence). Platinum chemotherapy in the regimen improved OS (neoadjuvant: HR 0.69, 95% CI 0.55 to 0.86; 7 studies, 8 treatment comparisons, 1973 participants; high-certainty evidence; adjuvant: 0.70, 95% CI 0.50 to 0.96; 4 studies, 1256 participants; high-certainty evidence). Median follow-up for survival outcomes ranged from 36 to 97.6 months.\nOur analysis confirmed platinum chemotherapy increased pCR rates (risk ratio (RR) 1.44, 95% CI 1.31 to 1.59; 15 studies, 16 treatment comparisons, 3083 participants; high-certainty evidence). Subgroup analyses showed no evidence of differences in DFS according to BRCA mutation status, HRD status, lymph node status, or whether the intervention arm contained anthracycline chemotherapy or not.\nPlatinum chemotherapy was associated with reduced dose intensity, with participants more likely to require chemotherapy delays (RR 2.23, 95% CI 1.70 to 2.94; 4 studies, 5 treatment comparisons, 1053 participants; moderate-certainty evidence), dose reductions (RR 1.77, 95% CI 1.56 to 2.02; 7 studies, 8 treatment comparisons, 2055 participants; moderate-certainty evidence) and early cessation of treatment (RR 1.20, 95% CI 1.04 to 1.38; 16 studies, 17 treatment comparisons, 4178 participants; moderate-certainty evidence). Increased haematological toxicity occurred in the platinum group who were more likely to experience grade III/IV neutropenia (RR 1.53, 95% CI 1.43 to 1.63; 19 studies, 20 treatment comparisons, 4849 participants; moderate-certainty evidence), anaemia (RR 8.20, 95% CI 5.66 to 11.89; 18 studies, 19 treatment comparisons, 4757 participants; moderate-certainty evidence) and thrombocytopenia (RR 7.59, 95% CI 5.10 to 11.29; 18 studies, 19 treatment comparisons, 4731 participants; moderate-certainty evidence). There was no evidence of a difference between chemotherapy groups in febrile neutropenia (RR 1.16, 95% CI 0.89 to 1.49; 11 studies, 3771 participants; moderate-certainty evidence). Renal impairment was very rare (0.4%, 2 events in 463 participants; note 3 studies reported 0 events in both arms; 4 studies; high-certainty evidence). Treatment-related death was very rare (0.2%, 7 events in 3176 participants and similar across treatment groups; RR 0.58, 95% 0.14 to 2.33; 10 studies, 11 treatment comparisons; note 8 studies reported treatment-related deaths but recorded 0 events in both groups. Thus, the RR and CIs were calculated from 3 studies rather than 11; 3176 participants; high-certainty evidence). Five studies collected quality of life data but did not report them.\nAuthors' conclusions\nPlatinum-based chemotherapy using carboplatin in the adjuvant or neoadjuvant setting improves long-term outcomes of DFS and OS in early TNBC, with no evidence of differences by subgroup. This was at the cost of more frequent chemotherapy delays and dose reductions, and greater haematological toxicity, though serious adverse events including neuropathy, febrile neutropenia or treatment-related death were not increased.\nThese findings support the use of platinum-based chemotherapy for people with early TNBC. The optimal dose and regimen are not defined by this analysis, but there is a suggestion that similar relative benefits result from the addition of carboplatin to either anthracycline-free regimens or those containing anthracycline agents.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This evidence is up-to-date to April 2022."
}
]
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query-laysum | 1938 | [
{
"role": "user",
"content": "Abstract: Background\nHandwashing is important to reduce the spread and transmission of infectious disease. Ash, the residue from stoves and fires, is a material used for cleaning hands in settings where soap is not widely available.\nObjectives\nTo assess the benefits and harms of hand cleaning with ash compared with hand cleaning using soap or other materials for reducing the spread of viral and bacterial infections.\nSearch methods\nOn 26 March 2020 we searched CENTRAL, MEDLINE, Embase, WHO Global Index Medicus, and the WHO International Clinical Trials Registry Platform.\nSelection criteria\nWe included all types of studies, in any population, that examined hand cleaning with ash compared to hand cleaning with any other material.\nData collection and analysis\nTwo review authors independently screened titles and full texts, and one review author extracted outcome data and assessed risk of bias, which another review author double-checked. We used the ROBINS-I tool for observational studies, we used RoB 2.0 for three interventional studies, and we used GRADE to assess the certainty of the evidence. We planned to synthesise data with random-effects meta-analyses. Our prespecified outcome measures were overall mortality, number of cases of infections (as defined in the individual studies), severity of infectious disease, harms (as reported in the individual studies), and adherence.\nMain results\nWe included 14 studies described in 19 records using eight different study designs, but only one randomised trial. The studies were primarily conducted in rural settings in low- and lower-middle-income countries. Six studies reported outcome data relevant to our review.\nA retrospective case-control study and a cohort study assessed diarrhoea in children under the age of five years and self-reported reproductive tract symptoms in women, respectively. It was very uncertain whether the rate of hospital contacts for moderate-to-severe diarrhoea in children differed between households that cleaned hands using ash compared with households cleaning hands using soap (RR 0.97, 95% CI 0.84 to 1.11; very low-certainty evidence). Similarly, it was very uncertain whether the rate of women experiencing symptoms of reproductive tract infection differed between women cleaning hands with ash compared with cleaning hands using soap (RR 0.48, 95% CI 0.12 to 1.86; very low-certainty evidence) or when compared with handwashing with water only or not washing hands (RR 0.50, 95% CI 0.13 to 1.96; very low-certainty evidence).\nFour studies reported on bacteriological counts after hand wash. We rated all four studies at high risk of bias, and we did not synthesise data due to methodological heterogeneity and unclear outcome reporting.\nAuthors' conclusions\nBased on the available evidence, the benefits and harms of hand cleaning with ash compared with soap or other materials for reducing the spread of viral or bacterial infections are uncertain.\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 whether people who use ash for hand cleaning are more or less likely to catch infectious diseases than people who use soap, water, mud or soil, or who do not clean their hands. We also wanted to know whether using ash causes unwanted effects, like sore hands or a rash."
}
]
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query-laysum | 1939 | [
{
"role": "user",
"content": "Abstract: Background\nThyroid nodules (TN) are common in the adult population. Some physicians use suppressive levothyroxine (LT4) therapy to achieve a reduction in the number and volume of TN. In addition, minimally invasive treatments, such as percutaneous ethanol injection (PEI) sclerotherapy, laser photocoagulation (LP), and microwave (MW), radiofrequency (RF) and high-intensity focused ultrasound (HIFU) ablation, have been proposed, especially for pressure symptoms and cosmetic complaints, as an alternative to surgery. However, the risk to benefit ratio of all treatments for benign TN is currently unknown.\nObjectives\nTo assess the effects of LT4 or minimally invasive therapies (PEI, LP, and RF/HIFU/MW ablation) on benign TN.\nSearch methods\nWe identified studies from computerised searches of The Cochrane Library, MEDLINE, EMBASE and LILACS (all performed up to April 2014). We also searched trial registers, examined reference lists of included randomised controlled trials (RCTs) and systematic reviews, and contacted study authors.\nSelection criteria\nWe included studies if they were RCTs of LT4, PEI, LP, RF, HIFU or MW therapy in participants with an established diagnosis of benign TN. We excluded trials investigating the prevention of recurrence of thyroid disease after surgery, irradiation or treatment with radioiodine.\nData collection and analysis\nTwo review authors independently extracted data, assessed studies for risk of bias and evaluated overall study quality utilising the GRADE instrument. We assessed the statistical heterogeneity of included studies by visually inspecting forest plots and quantifying the diversity using the I² statistic. We synthesised data using random-effects model meta-analysis or descriptive analysis, as appropriate.\nMain results\nThirty-one studies randomised 2952 outpatients to investigate the effects of different therapies on benign TN. Studies on LT4, PEI, LP and RF ablation therapy randomised 2083, 607, 192 and 70 participants, respectively. We found no RCTs of HIFU or MW ablation therapy in benign TN. The duration of treatment varied according to the applied therapies: up to five years for LT4 and one to three PEI ablations, one to three LP sessions and one or two RF sessions. Median follow-up was 12 months for LT4 and six months for minimally invasive therapies. Evidence was of low-to-moderate quality, and risk of performance and detection bias for subjective outcomes was high in most trials.\nNo study evaluated all-cause mortality or health-related quality of life. Only one LT4 study provided some data on the development of thyroid cancer, reporting no abnormal cytological findings. One LP study provided limited information on costs of treatment.\nLT4 compared with no treatment or placebo was associated with a nodule volume reduction of 50% or more in 16% compared with 10% of participants after 6 to 24 months of follow-up (risk ratio (RR) 1.57 (95% confidence interval (CI) 1.04 to 2.38); P = 0.03; 958 participants; 10 studies; moderate-quality evidence). Pressure symptoms or cosmetic complaints were not investigated in LT4 studies. LT4 therapy was generally well tolerated: three studies provided quantitative data on signs and symptoms of hyperthyroidism, which were observed in 25% of LT4-treated versus 7% of placebo-treated participants at 12 to 18 months of follow-up (269 participants; 3 trials; low-quality evidence).\nPEI compared with cyst aspiration only was associated with a nodule volume reduction of 50% or more in 83% compared with 44% of participants after 1 to 24 months of follow-up (RR 1.83 (95% CI 1.32 to 2.54); P = 0.0003; 105 participants; 3 studies; low-quality evidence). Improvements in neck compression symptoms after 6 to 12 months of follow-up were seen in 78% of participants receiving PEI versus 38% of those in comparator groups. No reliable summary effect estimate could be established, RR ranged from 1.0 to 3.06 in favour of PEI (370 participants; 3 trials; low-quality evidence). In all trials, participants experienced periprocedural cervical tenderness and light-to-moderate pain usually lasting from minutes to several hours. As a result of the PEI procedure, 26% of participants reported slight-to-moderate pain compared with 12% of those receiving cyst aspiration only (RR 1.78 (95% CI 0.62 to 5.12); P = 0.28; 104 participants; 3 studies; low-quality evidence).\nOne study comparing LP with LT4 showed a nodule volume reduction of 50% or more in favour of LP after 12 months of follow-up in 33% of LP participants versus 0% of LT4 participants, respectively (62 participants; 1 trial; low-quality evidence). A total of 82% of LP-treated versus 0% of untreated participants showed improvements in pressure symptoms after 6 to 12 months of follow-up (RR 26.65 (95% CI 5.47 to 129.72); P < 0.0001; 92 participants; 3 trials; low-quality evidence). Around 20% of LP-treated participants reported light-to-moderate cervical pain lasting 48 hours or more (97 participants; 3 trials; low-quality evidence).\nOne trial with 40 participants, comparing RF with no treatment, resulted in a mean nodule volume reduction of 76% in the RF group compared with 0% of those in the no-treatment group at six months of follow-up (low-quality evidence). These RF-treated participants had fewer pressure symptoms and cosmetic complaints after 12 months of follow-up compared with untreated participants (a 2.8 decrease versus a 1.1 increase on a six-point scale, respectively, with higher values indicating more severe symptoms; low-quality evidence). All participants complained of pain and discomfort during RF, which disappeared when the energy was reduced or turned off (low-quality evidence).\nAuthors' conclusions\nNo study evaluated all-cause mortality, health-related quality of life or provided systematic data on the development of thyroid cancer. Longest follow-up was five years and median follow-up was 12 months. Nodule volume reductions were achieved by PEI, LP and RF, and to a lesser extent, by LT4. However, the clinical relevance of this outcome measure is doubtful. PEI, LP and RF led to improvements in pressure symptoms and cosmetic complaints. Adverse events such as light-to-moderate periprocedural pain were seen after PEI, LP and RF. Future studies should focus on patient-important outcome measures, especially health-related quality of life, and compare minimally invasive procedures with surgery. RCTs with follow-up periods of several years and good-quality observational studies are needed to provide evidence on the development of thyroid cancer, all-cause mortality and long-term 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": "Nodules (lumps) within the thyroid gland are common and usually benign. They are more frequent in women, the elderly and in iodine-deficient areas. Thyroid nodules are often observed as an incidental finding in the course of ultrasonography of the thyroid, nodules of more than 1 cm in size are usually detected by palpation of the thyroid gland during a physical examination. Thyroid nodules may occur as a single nodule or as multiple nodules and may contain fluid (cyst). About 5 in 100 palpable thyroid nodules have a risk of becoming malignant (thyroid cancer). Thyroid nodules are often treated with thyroid hormones in order to reduce the size of the nodule. If thyroid nodules cause problems such as pressure symptoms or cosmetic complaints, surgery may be performed. Other therapies try to destroy the thyroid nodule by means of minimally invasive procedures (techniques which are less invasive than open surgery) and are usually performed on an outpatient basis."
}
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query-laysum | 1940 | [
{
"role": "user",
"content": "Abstract: Background\nHepatic encephalopathy is a common complication of cirrhosis and has high associated morbidity and mortality. The condition is classified as overt if it is clinically apparent or minimal if only evident though psychometric testing. The exact pathogenesis of this syndrome is unknown although ammonia is thought to play a key role. L-ornithine L-aspartate has ammonia-lowering properties and may, therefore, benefit people with cirrhosis and hepatic encephalopathy.\nObjectives\nTo evaluate the beneficial and harmful effects of L-ornithine L-aspartate versus placebo, no intervention, or other active interventions in people with cirrhosis and hepatic encephalopathy.\nSearch methods\nWe undertook electronic searches of The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS and Science Citation Index Expanded to December 2017 and manual searches of meetings and conference proceedings; checks of bibliographies; and corresponded with investigators and pharmaceutical companies.\nSelection criteria\nWe included randomised clinical trials, irrespective of publication status, language, or blinding. We included participants with cirrhosis who had minimal or overt hepatic encephalopathy or who were at risk for developing hepatic encephalopathy. We compared: L-ornithine L-aspartate versus placebo or no intervention; and L-ornithine L-aspartate versus other active agents such as non-absorbable disaccharides, antibiotics, probiotics, or branched-chain amino acids.\nData collection and analysis\nTwo review authors, working independently, retrieved data from published reports and correspondence with investigators and pharmaceutical companies. The primary outcomes were mortality, hepatic encephalopathy, and serious adverse events. We undertook meta-analyses and presented the results as risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI). We assessed bias control using the Cochrane Hepato-Biliary Group domains; we evaluated the risk of publication bias and other small trial effects in regression analyses; conducted subgroup and sensitivity analyses; and performed Trial Sequential Analyses. We determined the quality of the evidence using GRADE.\nMain results\nWe identified 36 randomised clinical trials, involving at least 2377 registered participants, which fulfilled our inclusion criteria including 10 unpublished randomised clinical trials. However, we were only able to access outcome data from 29 trials involving 1891 participants. Five of the included trials assessed prevention, while 31 trials assessed treatment. Five trials were at low risk of bias in the overall assessment of mortality; one trial was at low risk of bias in the assessment of the remaining outcomes.\nL-ornithine L-aspartate had a beneficial effect on mortality compared with placebo or no intervention when including all trials (RR 0.42, 95% CI 0.24 to 0.72; I2 = 0%; 19 trials; 1489 participants; very low quality evidence), but not when the analysis was restricted to the trials at low risk of bias (RR 0.47, 95% CI 0.06 to 3.58; 4 trials; 244 participants). It had a beneficial effect on hepatic encephalopathy compared with placebo or no intervention when including all trials (RR 0.70, 95% CI 0.59 to 0.83; 22 trials; 1375 participants; I2 = 62%; very low quality evidence), but not in the one trial at low risk of bias (RR 0.96, 95% CI 0.85 to 1.07; 63 participants). The analysis of serious adverse events showed a potential benefit of L-ornithine L-aspartate when including all randomised clinical trials (RR 0.63, 95% CI 0.45 to 0.90; 1 trial; 1489 participants; I2 = 0%; very low quality evidence), but not in the one trial at low risk of bias for this outcome (RR 0.83, 95% CI 0.15 to 4.65; 63 participants). The Trial Sequential Analyses of mortality, hepatic encephalopathy, and serious adverse events found insufficient evidence to support or refute beneficial effects. Subgroup analyses showed no difference in outcomes in the trials evaluating evaluating the prevention or treatment of either overt or minimal hepatic encephalopathy or trials evaluating oral versus intravenous administration We were unable to undertake a meta-analysis of the three trials involving 288 participants evaluating health-related quality of life. Overall, we found no difference between L-ornithine L-aspartate and placebo or no intervention in non-serious adverse events (RR 1.15, 95% CI 0.75 to 1.77; 14 trials; 1076 participants; I2 = 40%). In comparison with lactulose, L-ornithine L-aspartate had no effect on mortality (RR 0.68, 95% CI 0.11 to 4.17; 4 trials; 175 participants; I2 = 0%); hepatic encephalopathy (RR 1.13, 95% CI 0.81 to 1.57); serious adverse events (RR 0.69, 95% CI 0.22 to 2.11); or non-serious adverse events (RR 0.05, 95% CI 0.01 to 0.18). In comparison with probiotics, L-ornithine L-aspartate had no effect on mortality (RR 1.01, 95% CI 0.11 to 9.51); serious adverse events (RR 1.07, 95% CI 0.23 to 4.88); or changes in blood ammonia concentrations from baseline (RR -2.30 95% CI -6.08 to 1.48), but it had a possible beneficial effect on hepatic encephalopathy (RR 0.71, 95% CI 0.56 to 0.90). Finally, in comparison with rifaximin, L-ornithine L-aspartate had no effect on mortality (RR 0.33, 95% CI 0.04 to 3.03; 2 trials; 105 participants); hepatic encephalopathy (RR 1.06, 95% CI 0.57 to 1.96); serious adverse events (RR 0.32, 95% CI 0.01 to 7.42), or non-serious adverse events (RR 0.32, 95% CI 0.01 to 7.42).\nAuthors' conclusions\nThe results of this review suggest a possible beneficial effect of L-ornithine L-aspartate on mortality, hepatic encephalopathy, and serious adverse events in comparisons with placebo or no-intervention, but, because the quality of the evidence is very low, we are very uncertain about these findings. There was very low quality evidence of a possible beneficial effect of L-ornithine L-aspartate on hepatic encephalopathy, when compared with probiotics, but no other benefits were demonstrated in comparison with other active agents. Additional access to data from completed, but unpublished trials, and new randomised placebo-controlled, double-blind clinical trials are needed.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Six of the 36 randomised clinical trials we included received no funding or any other support from pharmaceutical companies. Seventeen trials received financial support from pharmaceutical companies and a further three received L-ornithine L-aspartate or inactive placebo free of charge; there was no information on funding in the remaining 10 trials."
}
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query-laysum | 1941 | [
{
"role": "user",
"content": "Abstract: Background\nAlthough the benefits of vision screening seem intuitive, the value of such programmes in junior and senior schools has been questioned. In addition there exists a lack of clarity regarding the optimum age for screening and frequency at which to carry out screening.\nObjectives\nTo evaluate the effectiveness of vision screening programmes carried out in schools to reduce the prevalence of correctable visual acuity deficits due to refractive error in school-age children.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 4); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 3 May 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs), including cluster-randomised trials, that compared vision screening with no vision screening, or compared interventions to improve uptake of spectacles or efficiency of vision screening.\nData collection and analysis\nTwo review authors independently screened search results and extracted data. Our pre-specified primary outcome was uncorrected, or suboptimally corrected, visual acuity deficit due to refractive error six months after screening. Pre-specified secondary outcomes included visual acuity deficit due to refractive error more than six months after screening, visual acuity deficit due to causes other than refractive error, spectacle wearing, quality of life, costs, and adverse effects. We graded the certainty of the evidence using GRADE.\nMain results\nWe identified seven relevant studies. Five of these studies were conducted in China with one study in India and one in Tanzania. A total of 9858 children aged between 10 and 18 years were randomised in these studies, 8240 of whom (84%) were followed up between one and eight months after screening. Overall we judged the studies to be at low risk of bias. None of these studies compared vision screening for correctable visual acuity deficits with not screening.\nTwo studies compared vision screening with the provision of free spectacles versus vision screening with no provision of free spectacles (prescription only). These studies provide high-certainty evidence that vision screening with provision of free spectacles results in a higher proportion of children wearing spectacles than if vision screening is accompanied by provision of a prescription only (risk ratio (RR) 1.60, 95% confidence interval (CI) 1.34 to 1.90; 1092 participants). The studies suggest that if approximately 250 per 1000 children given vision screening plus prescription only are wearing spectacles at follow-up (three to six months) then 400 per 1000 (335 to 475) children would be wearing spectacles after vision screening and provision of free spectacles. Low-certainty evidence suggested better educational attainment in children in the free spectacles group (adjusted difference 0.11 in standardised mathematics score, 95% CI 0.01 to 0.21, 1 study, 2289 participants). Costs were reported in one study in Tanzania in 2008 and indicated a relatively low cost of screening and spectacle provision (low-certainty evidence). There was no evidence of any important effect of provision of free spectacles on uncorrected visual acuity (mean difference -0.02 logMAR (95% CI adjusted for clustering -0.04 to 0.01) between the groups at follow-up (moderate-certainty evidence). Other pre-specified outcomes of this review were not reported.\nTwo studies explored the effect of an educational intervention in addition to vision screening on spectacle wear. There was moderate-certainty evidence of little apparent effect of the education interventions investigated in these studies in addition to vision screening, compared to vision screening alone for spectacle wearing (RR 1.11, 95% CI 0.95 to 1.31, 1 study, 3177 participants) or related outcome spectacle purchase (odds ratio (OR) 0.84, 95% CI 0.55 to 1.31, 1 study, 4448 participants). Other pre-specified outcomes of this review were not reported.\nThree studies compared vision screening with ready-made spectacles versus vision screening with custom-made spectacles. These studies provide moderate-certainty evidence of no clinically meaningful differences between the two types of spectacles. In one study, mean logMAR acuity in better and worse eye was similar between groups: mean difference (MD) better eye 0.03 logMAR, 95% CI 0.01 to 0.05; 414 participants; MD worse eye 0.06 logMAR, 95% CI 0.04 to 0.08; 414 participants). There was high-certainty evidence of no important difference in spectacle wearing (RR 0.98, 95% CI 0.91 to 1.05; 1203 participants) between the two groups and moderate-certainty evidence of no important difference in quality of life between the two groups (the mean quality-of-life score measured using the National Eye Institute Refractive Error Quality of Life scale 42 was 1.42 better (1.04 worse to 3.90 better) in children with ready-made spectacles (1 study of 188 participants). Although none of the studies reported on costs directly, ready-made spectacles are cheaper and may represent considerable cost-savings for vision screening programmes in lower income settings. There was low-certainty evidence of no important difference in adverse effects between the two groups. Adverse effects were reported in one study and were similar between groups. These included blurred vision, distorted vision, headache, disorientation, dizziness, eyestrain and nausea.\nAuthors' conclusions\nVision screening plus provision of free spectacles improves the number of children who have and wear the spectacles they need compared with providing a prescription only. This may lead to better educational outcomes. Health education interventions, as currently devised and tested, do not appear to improve spectacle wearing in children. In lower-income settings, ready-made spectacles may provide a useful alternative to expensive custom-made spectacles.\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": "Vision screening and provision of free spectacles improves the number of children who have and wear the spectacles they need. In lower-income settings, ready-made spectacles may provide a useful alternative to expensive custom-made spectacles."
}
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query-laysum | 1942 | [
{
"role": "user",
"content": "Abstract: Background\nChildhood constipation is a common problem with substantial health, economic and emotional burdens. Existing therapeutic options, mainly pharmacological, are not consistently effective, and some are associated with adverse effects after prolonged use. Transcutaneous electrical stimulation (TES), a non-pharmacological approach, is postulated to facilitate bowel movement by modulating the nerves of the large bowel via the application of electrical current transmitted through the abdominal wall.\nObjectives\nOur main objective was to evaluate the effectiveness and safety of TES when employed to improve bowel function and constipation-related symptoms in children with constipation.\nSearch methods\nWe searched MEDLINE (PubMed) (1950 to July 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 7, 2015), EMBASE (1980 to July 2015), the Cochrane IBD Group Specialized Register, trial registries and conference proceedings to identify applicable studies .\nSelection criteria\nRandomized controlled trials that assessed any type of TES, administered at home or in a clinical setting, compared to no treatment, a sham TES, other forms of nerve stimulation or any other pharmaceutical or non-pharmaceutical measures used to treat constipation in children were considered for inclusion.\nData collection and analysis\nTwo authors independently assessed studies for inclusion, extracted data and assessed risk of bias of the included studies. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for categorical outcomes data and the mean difference (MD) and corresponding 95% CI for continuous outcomes. We evaluated the overall quality of the evidence supporting the outcomes assessed in this review using the GRADE criteria.\nMain results\nOne study from Australia including 46 children aged 8 to 18 years was eligible for inclusion. There were multiple reports identified, including one unpublished report, that focused on different outcomes of the same study. The study had unclear risk of selection bias, high risks of performance, detection and attrition biases, and low risks of reporting biases.\nWe are very uncertain about the effects of TES on bowel movements, colonic transit, soiling symptoms and quality of life due to high risk of bias, indirectness and imprecision. For our outcomes of interest the 95% CI of most analysis results include potential benefit and no effect. There is insufficient evidence to determine the effect of TES on bowel movements and colonic transit. The study reported that 16/21 children in the TES group and 15/21 in the sham group had > 3 complete spontaneous bowel movements (CSBM) per week (RR 1.07, 95% CI 0.74 to 1.53; very low-quality evidence). Ten out of 14 children in the TES group had improved colonic transit compared to 1/7 in the sham group (RR 5.00, 95% CI 0.79 to 31.63; very low-quality evidence). Mean colonic transit rate, measured as the position of the geometric centre of the radioactive substance ingested along the intestinal tract, was higher in children who received TES compared to sham (MD 1.05, 95% CI 0.36 to 1.74; one study, 30 participants; very low-quality evidence). The radiological assessment of colonic transit outcomes means that these results might not translate to important improvement in clinical symptoms or increased bowel movements. There is insufficient evidence to determine the effect of TES on symptoms and quality of life (QoL) outcomes. Nine out of 13 children in the TES group had improved soiling-related symptoms compared to 4/12 sham participants (RR 2.08, 95% CI 0.86 to 5.00; very low-quality evidence). Four out of 8 TES participants reported an improvement in QoL compared to 1/8 sham participants (RR 4.00, 95% CI 0.56 to 28.40; very low-quality evidence). The effects of TES on self-perceived (MD 5.00, 95% CI -1.21 to 11.21; one study, 33 participants; very low-quality evidence) or parent-perceived QoL (MD -0.20, 95% CI -7.57 to 7.17, one study, 33 participants; very low-quality evidence) are uncertain. No adverse effects were reported in the included study.\nAuthors' conclusions\nThe results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the efficacy and safety of TES in children with chronic constipation can be drawn. Further randomized controlled trials assessing TES for the management of childhood constipation should be conducted. Future trials should include clear documentation of methodologies, especially measures to evaluate the effectiveness of blinding, and incorporate patient-important outcomes such as the number of patients with improved CSBM, improved clinical symptoms and quality of life.\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": "Childhood constipation is a common problem with substantial health, economic and emotional burdens. Currently, most treatment options include the use of laxatives with diet modification. None of the common medications used are found to be consistently effective, and there are concerns regarding side effects and dependence, especially following long-term use of laxatives. TES is a newer, non-pharmacological mode of treatment that involves placing the electrodes on the belly of affected children, which generates small electrical wave forms (interferential current) across the belly wall in a dose that is well below a level that may cause concern, aiming to stimulate the bowel to improve bowel motion."
}
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query-laysum | 1944 | [
{
"role": "user",
"content": "Abstract: Background\nClomiphene citrate (CC) is generally considered first-line treatment in women with anovulation due to polycystic ovary syndrome (PCOS). Ovulation induction with follicle-stimulating hormone (FSH; gonadotrophins) is second-line treatment for women who do not ovulate or conceive while taking CC. Metformin may increase the effectiveness of ovulation induction with gonadotrophins and may promote safety by preventing multiple pregnancy.\nObjectives\nTo determine the effectiveness and safety of metformin co-treatment during ovulation induction with gonadotrophins with respect to rates of live birth and multiple pregnancy in women with PCOS.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility (CGF) Group specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO and the Cumulative Index to Nursing and Allied Health Literature (CINAH) on 8 June 2016, and the reference lists of included and other relevant studies. We searched ongoing trials registries in the World Health Organization (WHO) portal and on clinicaltrials.gov on 4 September 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) reporting data on comparison of clinical outcomes in women with PCOS undergoing ovulation induction with gonadotrophins plus metformin versus gonadotrophins alone or gonadotrophins plus placebo.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth rate and multiple pregnancy rate. Secondary outcomes were ovulation rate, clinical pregnancy rate, ovarian hyperstimulation syndrome (OHSS) rate, miscarriage rate, cycle cancellation rate and adverse effects.\nMain results\nWe included five RCTs (with 264 women) comparing gonadotrophins plus metformin versus gonadotrophins. The gonadotrophin used was recombinant FSH in four studies and highly purified FSH in one study. Evidence was of low quality: The main limitations were serious risk of bias due to poor reporting of study methods and blinding of participants and outcome assessors.\nLive birth\nMetformin plus FSH was associated with a higher cumulative live birth rate when compared with FSH (odds ratio (OR) 2.31, 95% confidence interval (CI) 1.23 to 4.34; two RCTs, n = 180; I2 = 0%; low-quality evidence). This suggests that if the chance of live birth after FSH is assumed to be 27%, then the chance after addition of metformin would be between 32% and 60%.\nOther pregnancy outcomes\nMetformin use was associated with a higher ongoing pregnancy rate (OR 2.46, 95% CI 1.36 to 4.46; four RCTs, n = 232; I2 = 0%; low-quality evidence) and a higher clinical pregnancy rate (OR 2.51, 95% CI 1.46 to 4.31; five RCTs, n = 264; I2 = 0%; low-quality evidence).\nMultiple pregnancy\nResults showed no evidence of a difference in multiple pregnancy rates between metformin plus FSH and FSH (OR 0.55, 95% CI 0.15 to 1.95; four RCTs, n = 232; I2 = 0%; low-quality evidence) and no evidence of a difference in rates of miscarriage or OHSS.\nOther adverse effects\nEvidence was inadequate as the result of limited available data on adverse events after metformin compared with after no metformin (OR 1.78, 95% CI 0.39 to 8.09; two RCTs, n = 91; I2 = 0%; very low-quality evidence).\nAuthors' conclusions\nPreliminary evidence suggests that metformin may increase the live birth rate among women undergoing ovulation induction with gonadotrophins. At this moment, evidence is insufficient to show an effect of metformin on multiple pregnancy rates and adverse events. Additional trials are necessary before we can provide further conclusions that may affect clinical 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": "Women with polycystic ovary syndrome (PCOS) have reduced pregnancy chances caused by absence of or reduction in ovulation requiring medical treatment. About 80% of women will ovulate on clomiphene citrate, and 50% will become pregnant. Remaining women may take gonadotrophins - hormones that act on the ovaries to stimulate ovulation. The association between insulin resistance and anovulation has led to the hypothesis that addition of metformin might increase the effectiveness of ovulation induction."
}
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query-laysum | 1945 | [
{
"role": "user",
"content": "Abstract: Background\nPain is a common feature of childhood and adolescence around the world, and for many young people, that pain is chronic. The World Health Organization guidelines for pharmacological treatments for children's persisting pain acknowledge that pain in children is a major public health concern of high significance in most parts of the world. While in the past, pain was largely dismissed and was frequently left untreated, views on children's pain have changed over time, and relief of pain is now seen as important.\nWe designed a suite of seven reviews on chronic non-cancer pain and cancer pain (looking at antidepressants, antiepileptic drugs, non-steroidal anti-inflammatory drugs, opioids, and paracetamol as priority areas) in order to review the evidence for children's pain utilising pharmacological interventions in children and adolescents.\nAs the leading cause of morbidity in children and adolescents in the world today, chronic disease (and its associated pain) is a major health concern. Chronic pain (lasting three months or longer) can arise in the paediatric population in a variety of pathophysiological classifications: nociceptive, neuropathic, idiopathic, visceral, nerve damage pain, chronic musculoskeletal pain, and chronic abdominal pain, and other unknown reasons.\nOpioids are used worldwide for the treatment of pain. They bind to opioid receptors in the central nervous system (mu, kappa, delta, and sigma) and can be agonists, antagonists, mixed agonist-antagonists, or partial agonists. Opioids are generally available in healthcare settings across most high-income countries, but access may be restricted in low- and middle-income countries. For example, opioids currently available in the UK include: buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol. Opioids are used in varying doses (generally based on body weight for paediatric patients) by means of parenteral, transmucosal, transdermal, or oral administration (immediate release or modified release). To achieve adequate pain relief in children using opioids, with an acceptable grade of adverse effects, the recommended method is a lower dose gradually titrated to effect in the child.\nObjectives\nTo assess the analgesic efficacy and adverse events of opioids used to treat chronic non-cancer pain in children and adolescents aged between birth and 17 years, in any setting.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library, MEDLINE via Ovid, and Embase via Ovid from inception to 6 September 2016. We also searched the reference lists of retrieved studies and reviews, and searched online clinical trial registries.\nSelection criteria\nRandomised controlled trials, with or without blinding, of any dose and any route, treating chronic non-cancer pain in children and adolescents, comparing opioids with placebo or an active comparator.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility. We planned to use dichotomous data to calculate risk ratio and number needed to treat, using standard methods. We planned to assess GRADE (Grading of Recommendations Assessment, Development and Evaluation) and planned to create a 'Summary of findings' table.\nMain results\nNo studies were eligible for inclusion in this review.\nThere is no evidence to support or refute the use of opioids for treating chronic non-cancer pain in children and adolescents.\nAuthors' conclusions\nWe are unable to comment about efficacy or harm from the use of opioids to treat chronic non-cancer pain in children and adolescents.\nWe know from adult randomised controlled trials that some opioids, such as morphine and codeine, can be effective in certain chronic pain conditions.\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": "Children can experience chronic or recurrent pain related to genetic conditions, damaged nerves, chronic musculoskeletal pain, and chronic abdominal pain, as well as for other unknown reasons. Chronic pain is pain that lasts three months or longer and is commonly accompanied by changes in lifestyle and functional abilities, as well as by signs and symptoms of depression and anxiety.\nOpioids are used worldwide for the treatment of pain. Opioids are generally available in healthcare settings across most high-income countries, but access may be restricted in low- and middle-income countries. For example, opioids currently available in the UK include: buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol. Opioids are used in varying doses and are commonly administered via injection or oral tablets."
}
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query-laysum | 1946 | [
{
"role": "user",
"content": "Abstract: Background\nHigh altitude illness (HAI) is a term used to describe a group of cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres ( ˜ 8200 feet ). Acute hypoxia, acute mountain sickness (AMS), high altitude cerebral oedema (HACE) and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude. In this review, the first in a series of three about preventive strategies for HAI, we assess the effectiveness of six of the most recommended classes of pharmacological interventions.\nObjectives\nTo assess the clinical effectiveness and adverse events of commonly-used pharmacological interventions for preventing acute HAI.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), Embase (OVID), LILACS and trial registries in January 2017. We adapted the MEDLINE strategy for searching the other databases. We used a combination of thesaurus-based and free-text terms to search.\nSelection criteria\nWe included randomized-controlled and cross-over trials conducted in any setting where commonly-used classes of drugs were used to prevent acute HAI.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane.\nMain results\nWe included 64 studies (78 references) and 4547 participants in this review, and classified 12 additional studies as ongoing. A further 12 studies await classification, as we were unable to obtain the full texts. Most of the studies were conducted in high altitude mountain areas, while the rest used low pressure (hypobaric) chambers to simulate altitude exposure. Twenty-four trials provided the intervention between three and five days prior to the ascent, and 23 trials, between one and two days beforehand. Most of the included studies reached a final altitude of between 4001 and 5000 metres above sea level. Risks of bias were unclear for several domains, and a considerable number of studies did not report adverse events of the evaluated interventions. We found 26 comparisons, 15 of them comparing commonly-used drugs versus placebo. We report results for the three most important comparisons:\nAcetazolamide versus placebo (28 parallel studies; 2345 participants)\nThe risk of AMS was reduced with acetazolamide (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.56; I2 = 0%; 16 studies; 2301 participants; moderate quality of evidence). No events of HAPE were reported and only one event of HACE (RR 0.32, 95% CI 0.01 to 7.48; 6 parallel studies; 1126 participants; moderate quality of evidence). Few studies reported side effects for this comparison, and they showed an increase in the risk of paraesthesia with the intake of acetazolamide (RR 5.53, 95% CI 2.81 to 10.88, I2 = 60%; 5 studies, 789 participants; low quality of evidence).\nBudenoside versus placebo (2 parallel studies; 132 participants)\nData on budenoside showed a reduction in the incidence of AMS compared with placebo (RR 0.37, 95% CI 0.23 to 0.61; I2 = 0%; 2 studies, 132 participants; low quality of evidence). Studies included did not report events of HAPE or HACE, and they did not find side effects (low quality of evidence).\nDexamethasone versus placebo (7 parallel studies; 205 participants)\nFor dexamethasone, the data did not show benefits at any dosage (RR 0.60, 95% CI 0.36 to 1.00; I2 = 39%; 4 trials, 176 participants; low quality of evidence). Included studies did not report events of HAPE or HACE, and we rated the evidence about adverse events as of very low quality.\nAuthors' conclusions\nOur assessment of the most commonly-used pharmacological interventions suggests that acetazolamide is an effective pharmacological agent to prevent acute HAI in dosages of 250 to 750 mg/day. This information is based on evidence of moderate quality. Acetazolamide is associated with an increased risk of paraesthesia, although there are few reports about other adverse events from the available evidence. The clinical benefits and harms of other pharmacological interventions such as ibuprofen, budenoside and dexamethasone are unclear. Large multicentre studies are needed for most of the pharmacological agents evaluated in this review, to evaluate their effectiveness and safety.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We rated the quality of the evidence as moderate to very low. Several studies had quality shortcomings, including their use of small numbers of participants and a lack of reporting of important outcomes such as side effects. For most of the drugs covered by the studies, additional research is required to clarify their effectiveness and safety."
}
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query-laysum | 1947 | [
{
"role": "user",
"content": "Abstract: Background\nTuberculous meningitis (TBM) is the main form of tuberculosis that affects the central nervous system and is associated with high rates of death and disability. Most international guidelines recommend longer antituberculous treatment (ATT) regimens for TBM than for pulmonary tuberculosis disease to prevent relapse. However, longer regimens are associated with poor adherence, which could contribute to increased relapse, development of drug resistance, and increased costs to patients and healthcare systems.\nObjectives\nTo compare the effects of short-course (six months) regimens versus prolonged-course regimens for people with tuberculous meningitis (TBM).\nSearch methods\nWe searched the following databases up to 31 March 2016: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; EMBASE; LILACS; INDMED; and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists and contacted researchers in the field.\nSelection criteria\nWe included randomized controlled trials (RCTs) and prospective cohort studies of adults and children with TBM treated with antituberculous regimens that included rifampicin for six months or longer than six months. The primary outcome was relapse, and included studies required a minimum of six months follow-up after completion of treatment.\nData collection and analysis\nTwo review authors (SJ and HR) independently assessed the literature search results for eligibility, and performed data extraction and 'Risk of bias' assessments of the included studies. We contacted study authors for additional information when necessary. Most data came from single arm cohort studies without a direct comparison so we pooled the findings for each group of cohorts and presented them separately using a complete-case analysis. When a study reported more than one cohort, the cohorts were analysed separately. We assessed the quality of the evidence narratively, as using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was inappropriate with no direct comparisons between short- and prolonged-course regimens.\nMain results\nFour RCTs, 13 prospective cohort studies, and one unpublished ongoing cohort study met our inclusion criteria, and included a total of 2098 participants with TBM. None of the included RCTs directly compared six months versus longer regimens, so we analysed all data as individual cohorts to obtain relapse rates in each set of cohorts.\nWe included 20 cohorts reported in 18 studies. One of these was reported separately, leaving 19 cohorts in the main analysis. We included seven cohorts of participants treated for six months with a total of 458 participants. Three studies were conducted in Thailand, two in South Africa, and one each in Ecuador and Papua New Guinea between the 1980s and 2009. We included 12 cohorts of participants treated for longer than six months (ranging from eight to 16 months), with a total of 1423 participants. Four studies were conducted in India, three in Thailand and one each in China, South Africa, Romania, Turkey, and Vietnam, between the late 1970s and 2011. The unpublished ongoing cohort study is conducted in India and included 217 participants.\nThe proportion of participants classified as having stage III disease (severe) was higher in the cohorts treated for six months (33.2% versus 16.9%), but the proportion with known concurrent HIV was higher in the cohorts treated for longer (0/458 versus 122/1423). Although there were variations in the treatment regimens, most cohorts received isoniazid, rifampicin, and pyrazinamide during the intensive phase.\nInvestigators achieved follow-up beyond 18 months after completing treatment in three out of the seven cohorts treated for six months, and five out of the 12 cohorts treated for eight to 16 months. All studies had potential sources of bias in their estimation of the relapse rate, and comparisons between the cohorts could be confounded.\nRelapse was an uncommon event across both groups of cohorts (3/369 (0.8%) with six months treatment versus 7/915 (0.8%) with longer), with only one death attributed to relapse in each group.\nOverall, the proportion of participants who died was higher in the cohorts treated for longer than six months (447/1423 (31.4%) versus 58/458 (12.7%)). However, most deaths occurred during the first six months in both treatment cohorts, which suggested that the difference in death rate was not directly related to duration of ATT but was due to confounding. Clinical cure was higher in the group of cohorts treated for six months (408/458 (89.1%) versus longer than six months (984/1336 (73.7%)), consistent with the observations for deaths.\nFew participants defaulted from treatment with six months treatment (4/370 (1.1%)) versus longer treatment (8/355 (2.3%)), and adherence was not well reported.\nAuthors' conclusions\nIn all cohorts most deaths occurred in the first six months; and relapse was uncommon in all participants irrespective of the regimen. Further inferences are probably inappropriate given this is observational data and confounding is likely. These data are almost all from participants who are HIV-negative, and thus the inferences will not apply to the efficacy and safety of the six months regimens in HIV-positive people. Well-designed RCTs, or large prospective cohort studies, comparing six months with longer treatment regimens with long follow-up periods established at initiation of ATT are needed to resolve the uncertainty regarding the safety and efficacy of six months regimens for TBM.\n\nGiven the provided abstract, please respond to the following query: \"What the evidence shows\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Cochrane review assessed the effects of six-month regimens for treating people with TBM compared with longer regimens. Cochrane researchers examined the available evidence up to 31 March 2016 and they included 18 studies. None of the included studies directly compared people with TBM treated for six months with people with TBM treated for longer. Two of the included studies analysed two groups of participants treated for six months and longer than six months. Therefore, the review authors included information from seven groups of people treated for six months (458 people), 12 groups of people treated for longer than 6 months (1423 people), and one ongoing study of 217 people which was analysed separately due to methodological concerns. Although the treatment regimens in the included studies varied, most participants received standard first-line antituberculous drugs, and were followed up for more than a year after the end of treatment. The studies included adults and children with TBM, but few participants were HIV-positive.\nRelapse was an uncommon event across both groups of studies, with only one death attributed to relapse in each group. Most deaths occurred during the first six months of treatment in both groups of studies, which showed that treatment duration did not have a direct impact on the risk of death in these studies. There was a higher death rate in participants treated for longer than six months, and this probably reflects the differences between the participants in the two groups of studies. Few participants defaulted from treatment, and adherence was not clearly documented.\nThey found no evidence of high relapse rates in people treated for six months, and relapse was uncommon in all patients irrespective of regimen. There may be differences between the participants treated for six months and longer than six months that could have led to bias (confounding factors), so further research would help determine if shorter regimens are safe. Most of the data were in patients without HIV, and so these inferences do not apply to patients who are HIV-positive."
}
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query-laysum | 1948 | [
{
"role": "user",
"content": "Abstract: Background\nSevere coronavirus disease 2019 (COVID-19) can cause thrombotic events that lead to severe complications or death. Antiplatelet agents, such as acetylsalicylic acid, have been shown to effectively reduce thrombotic events in other diseases: they could influence the course of COVID-19 in general.\nObjectives\nTo assess the efficacy and safety of antiplatelets given with standard care compared to no treatment or standard care (with/without placebo) for adults with COVID-19.\nSearch methods\nWe searched the Cochrane COVID-19 Study Register (which comprises MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO ICTRP, medRxiv, CENTRAL), Web of Science, WHO COVID-19 Global literature on coronavirus disease and the Epistemonikos COVID-19 L*OVE Platform to identify completed and ongoing studies without language restrictions to December 2022.\nSelection criteria\nWe followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating antiplatelet agents for the treatment of COVID-19 in adults with COVID-19, irrespective of disease severity, gender or ethnicity.\nData collection and analysis\nWe followed standard Cochrane methodology.\nTo assess bias in included studies, we used the Cochrane risk of bias tool (RoB 2) for RCTs. We rated the certainty of evidence using the GRADE approach for the outcomes.\nMain results\nAntiplatelets plus standard care versus standard care (with/without placebo)\nAdults with a confirmed diagnosis of moderate to severe COVID-19\nWe included four studies (17,541 participants) that recruited hospitalised people with a confirmed diagnosis of moderate to severe COVID-19. A total of 8964 participants were analysed in the antiplatelet arm (either with cyclooxygenase inhibitors or P2Y12 inhibitors) and 8577 participants in the control arm. Most people were older than 50 years and had comorbidities such as hypertension, lung disease or diabetes. The studies were conducted in high- to lower middle-income countries prior to wide-scale vaccination programmes.\nAntiplatelets compared to standard care:\n– probably result in little to no difference in 28-day mortality (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.85 to 1.05; 3 studies, 17,249 participants; moderate-certainty evidence). In absolute terms, this means that for every 177 deaths per 1000 people not receiving antiplatelets, there were 168 deaths per 1000 people who did receive the intervention (95% CI 151 to 186 per 1000 people);\n– probably result in little to no difference in worsening (new need for invasive mechanical ventilation or death up to day 28) (RR 0.95, 95% CI 0.90 to 1.01; 2 studies, 15,266 participants; moderate-certainty evidence);\n– probably result in little to no difference in improvement (participants discharged alive up to day 28) (RR 1.00, 95% CI 0.96 to 1.04; 2 studies, 15,454 participants; moderate-certainty evidence);\n– probably result in a slight reduction of thrombotic events at longest follow-up (RR 0.90, 95% CI 0.80 to 1.02; 4 studies, 17,518 participants; moderate-certainty evidence);\n– may result in a slight increase in serious adverse events at longest follow-up (Peto odds ratio (OR) 1.57, 95% CI 0.48 to 5.14; 1 study, 1815 participants; low-certainty evidence), but non-serious adverse events during study treatment were not reported;\n– probably increase the occurrence of major bleeding events at longest follow-up (Peto OR 1.68, 95% CI 1.29 to 2.19; 4 studies, 17,527 participants; moderate-certainty evidence).\nAdults with a confirmed diagnosis of asymptomatic SARS-CoV-2 infection or mild COVID-19\nWe included two RCTs allocating participants, of whom 4209 had confirmed mild COVID-19 and were not hospitalised. A total of 2109 participants were analysed in the antiplatelet arm (treated with acetylsalicylic acid) and 2100 participants in the control arm. No study included people with asymptomatic SARS-CoV-2 infection.\nAntiplatelets compared to standard care:\n– may result in little to no difference in all-cause mortality at day 45 (Peto OR 1.00, 95% CI 0.45 to 2.22; 2 studies, 4209 participants; low-certainty evidence);\n– may slightly decrease the incidence of new thrombotic events up to day 45 (Peto OR 0.37, 95% CI 0.09 to 1.46; 2 studies, 4209 participants; low-certainty evidence);\n– may make little or no difference to the incidence of serious adverse events up to day 45 (Peto OR 1.00, 95% CI 0.60 to 1.64; 1 study, 3881 participants; low-certainty evidence), but non-serious adverse events were not reported.\nThe evidence is very uncertain about the effect of antiplatelets on the following outcomes (compared to standard care plus placebo):\n– admission to hospital or death up to day 45 (Peto OR 0.79, 95% CI 0.57 to 1.10; 2 studies, 4209 participants; very low-certainty evidence);\n– major bleeding events up to longest follow-up (no event occurred in 328 participants; very low-certainty evidence).\nQuality of life and adverse events during study treatment were not reported.\nAuthors' conclusions\nIn people with confirmed or suspected COVID-19 and moderate to severe disease, we found moderate-certainty evidence that antiplatelets probably result in little to no difference in 28-day mortality, clinical worsening or improvement, but probably result in a slight reduction in thrombotic events. They probably increase the occurrence of major bleeding events. Low-certainty evidence suggests that antiplatelets may result in a slight increase in serious adverse events.\nIn people with confirmed COVID-19 and mild symptoms, we found low-certainty evidence that antiplatelets may result in little to no difference in 45-day mortality and serious adverse events, and may slightly reduce thrombotic events. The effects on the combined outcome admission to hospital or death up to day 45 and major bleeding events are very uncertain. Quality of life was not reported.\nIncluded studies were conducted in high- to lower middle-income settings using antiplatelets prior to vaccination roll-outs.\nWe identified a lack of evidence concerning quality of life assessments, adverse events and people with asymptomatic infection. The 14 ongoing and three completed, unpublished RCTs that we identified in trial registries address similar settings and research questions as in the current body of evidence. We expect to incorporate the findings of these studies in future versions of this review.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "Antiplatelets are a group of different medicines that can prevent potentially fatal clot formation in the blood vessels ('thrombotic events'). For hospitalised patients with COVID-19, they probably slightly reduce thrombotic events but probably do not affect deaths, clinical worsening or improvement in COVID-19 compared with placebo or standard care.\nHowever, antiplatelets may result in a slight increase in serious unwanted effects ('adverse events') and probably increase major bleeding.\nSimilarly, in non-hospitalised people, antiplatelets slightly decrease thrombotic events. They may result in little to no difference in deaths or serious unwanted effects, however the evidence on admission to hospital or death and major bleeding events is very uncertain.\nThere are 14 further studies that have not completed yet, and the results of three other completed studies are not yet available."
}
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query-laysum | 1949 | [
{
"role": "user",
"content": "Abstract: Background\nStroke is the third leading cause of disability worldwide. Physical activity is important for secondary stroke prevention and for promoting functional recovery. However, people with stroke are more inactive than healthy age-matched controls. Therefore, interventions to increase activity after stroke are vital to reduce stroke-related disability.\nObjectives\nTo summarise the available evidence regarding the effectiveness of commercially available, wearable activity monitors and smartphone applications for increasing physical activity levels in people with stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, SPORTDiscus, and the following clinical trial registers: WHO International Clinical Trials Registry Platform, Clinical Trials, EU Clinical Trial Register, ISRCTN Registry, Australian and New Zealand Clinical Trial Registry, and Stroke Trials Registry to 3 March 2018. We also searched reference lists, Web of Science forward tracking, and Google Scholar, and contacted trial authors to obtain further data if required. We did not restrict the search on language or publication status.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and randomised cross-over trials that included use of activity monitors versus no intervention, another type of intervention, or other activity monitor. Participants were aged 18 years or older with a diagnosis of stroke, in hospital or living in the community. Primary outcome measures were steps per day and time in moderate-to-vigorous intensity activity. Secondary outcomes were sedentary time, time spent in light intensity physical activity, walking duration, fatigue, mood, quality of life, community participation and adverse events. We excluded upper limb monitors that only measured upper limb activity.\nData collection and analysis\nWe followed standard Cochrane methodology to analyse and interpret the data. At least two authors independently screened titles and abstracts for inclusion. We resolved disagreements by consulting a third review author. We extracted the following data from included studies into a standardised template: type of study, participant population, study setting, intervention and co-interventions, time-frame, and outcomes. We graded levels of bias as high, low, or unclear, and assessed the quality of evidence for each outcome using the GRADE approach.\nMain results\nWe retrieved 28,098 references, from which we identified 29 potential articles. Four RCTs (in 11 reports) met the inclusion criteria.The sample sizes ranged from 27 to 135 (total 245 participants). Time poststroke varied from less than one week (n = 1), to one to three months (n = 2), or a median of 51 months (n = 1). Stroke severity ranged from a median of one to six on the National Institutes of Health Stroke Scale (NIHSS). Three studies were conducted in inpatient rehabilitation, and one was in a university laboratory. All studies compared use of activity monitor plus another intervention (e.g. a walking retraining programme or an inpatient rehabilitation programme) versus the other intervention alone. Three studies reported on the primary outcome of daily step counts.\nThere was no clear effect for the use of activity monitors in conjunction with other interventions on step count in a community setting (mean difference (MD) -1930 steps, 95% confidence interval (CI) -4410 to 550; 1 RCT, 27 participants; very low-quality evidence), or in an inpatient rehabilitation setting (MD 1400 steps, 95% CI -40 to 2840; 2 RCTs, 83 participants; very low-quality evidence). No studies reported the primary outcome moderate-to-vigorous physical activity, but one did report time spent in moderate and vigorous intensity activity separately: this study reported that an activity monitor in addition to usual inpatient rehabilitation increased the time spent on moderate intensity physical activity by 4.4 minutes per day (95% CI 0.28 to 8.52; 1 RCT, 48 participants; low-quality evidence) compared with usual rehabilitation alone, but there was no clear effect for the use of an activity monitor plus usual rehabilitation for increasing time spent in vigorous intensity physical activity compared to usual rehabilitation (MD 2.6 minutes per day, 95% CI -0.8 to 6; 1 RCT, 48 participants; low-quality evidence). The overall risk of bias was low, apart from high-risk for blinding of participants and study personnel. None of the included studies reported any information relating to adverse effects.\nAuthors' conclusions\nOnly four small RCTs with 274 participants (three in inpatient rehabilitation and one in the community) have examined the efficacy of activity monitors for increasing physical activity after stroke. Although these studies showed activity monitors could be incorporated into practice, there is currently not enough evidence to support the use of activity monitors to increase physical activity after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that the use of wearable activity monitors to provide feedback on physical activity did not increase physical activity levels in people with stroke. No conclusions could be drawn regarding the influence of stroke severity, walking ability, stroke survivor age, or time poststroke on the outcomes. The four included studies were conducted in different settings, and used different outcome measures, which limited the ability to combine data. No study reported whether the use of physical activity monitors was harmful. More research is needed to determine if they are effective."
}
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query-laysum | 1950 | [
{
"role": "user",
"content": "Abstract: Background\nTraumatic wounds (wounds caused by injury) range from abrasions and minor skin incisions or tears, to wounds with extensive tissue damage or loss as well as damage to bone and internal organs. Two key types of traumatic wounds considered in this review are those that damage soft tissue only and those that involve a broken bone, that is, open fractures. In some cases these wounds are left open and negative pressure wound therapy (NPWT) is used as a treatment. This medical device involves the application of a wound dressing through which negative pressure is applied and tissue fluid drawn away from the area. The treatment aims to support wound management, to prepare wounds for further surgery, to reduce the risk of infection and potentially to reduce time to healing (with or without surgical intervention). There are no systematic reviews assessing the effectiveness of NPWT for traumatic wounds.\nObjectives\nTo assess the effects of NPWT for treating open traumatic wounds in people managed in any care setting.\nSearch methods\nIn June 2018 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nPublished and unpublished randomised controlled trials that used NPWT for open traumatic wounds involving either open fractures or soft tissue wounds. Wound healing, wound infection and adverse events were our primary outcomes.\nData collection and analysis\nTwo review authors independently selected eligible studies, extracted data, carried out a 'Risk of bias' assessment and rated the certainty of the evidence. Data were presented and analysed separately for open fracture wounds and other open traumatic wounds (not involving a broken bone).\nMain results\nSeven RCTs (1377 participants recruited) met the inclusion criteria of this review. Study sample sizes ranged from 40 to 586 participants. One study had three arms, which were all included in the review. Six studies compared NPWT at 125 mmHg with standard care: one of these studies did not report any relevant outcome data. One further study compared NPWT at 75 mmHg with standard care and NPWT 125mmHg with NPWT 75 mmHg.\nOpen fracture wounds (four studies all comparing NPWT 125 mmHg with standard care)\nOne study (460 participants) comparing NPWT 125 mmHg with standard care reported the proportions of wounds healed in each arm. At six weeks there was no clear difference between groups in the number of participants with a healed, open fracture wound: risk ratio (RR) 1.01 (95% confidence interval (CI) 0.81 to 1.27); moderate-certainty evidence, downgraded for imprecision.\nWe pooled data on wound infection from four studies (596 participants). Follow-up varied between studies but was approximately 30 days. On average, it is uncertain whether NPWT at 125 mmHg reduces the risk of wound infection compared with standard care (RR 0.48, 95% CI 0.20 to 1.13; I2 = 56%); very low-certainty evidence downgraded for risk of bias, inconsistency and imprecision.\nData from one study shows that there is probably no clear difference in health-related quality of life between participants treated with NPWT 125 mmHg and those treated with standard wound care (EQ-5D utility scores mean difference (MD) -0.01, 95% CI -0.08 to 0.06; 364 participants, moderate-certainty evidence; physical component summary score of the short-form 12 instrument MD -0.50, 95% CI -4.08 to 3.08; 329 participants; low-certainty evidence downgraded for imprecision).\nModerate-certainty evidence from one trial (460 participants) suggests that NPWT is unlikely to be a cost-effective treatment for open fractures in the UK. On average, NPWT was more costly and conferred few additional quality-adjusted life years (QALYs) when compared with standard care. The incremental cost-effectiveness ratio was GBP 267,910 and NPWT was shown to be unlikely to be cost effective at a range of cost-per-QALYs thresholds. We downgraded the certainty of the evidence for imprecision.\nOther open traumatic wounds (two studies, one comparing NPWT 125 mmHg with standard care and a three-arm study comparing NPWT 125 mmHg, NPWT 75 mmHg and standard care)\nPooled data from two studies (509 participants) suggests no clear difference in risk of wound infection between open traumatic wounds treated with NPWT at 125 mmHg or standard care (RR 0.61, 95% CI 0.31 to 1.18); low-certainty evidence downgraded for risk of bias and imprecision.\nOne trial with 463 participants compared NPWT at 75 mmHg with standard care and with NPWT at 125 mmHg. Data on wound infection were reported for each comparison. It is uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and standard care (RR 0.44, 95% CI 0.17 to 1.10; 463 participants) and uncertain if there is a difference in risk of wound infection between NPWT 75 mmHg and 125 mmHg (RR 1.04, 95% CI 0.31 to 3.51; 251 participants. We downgraded the certainty of the evidence for risk of bias and imprecision.\nAuthors' conclusions\nThere is moderate-certainty evidence for no clear difference between NPWT and standard care on the proportion of wounds healed at six weeks for open fracture wounds. There is moderate-certainty evidence that NPWT is not a cost-effective treatment for open fracture wounds. Moderate-certainty evidence means that the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. It is uncertain whether there is a difference in risk of wound infection, adverse events, time to closure or coverage surgery, pain or health-related quality of life between NPWT and standard care for any type of open traumatic wound.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We cannot be certain whether NPWT is effective for treating traumatic wounds. We are moderately confident that there is no clear difference in healing rates in open fracture wounds treated with NPWT compared with standard care. We are very uncertain whether people treated with NPWT experience fewer wound infections compared with those treated with standard care. There is moderate-certainty evidence that NPWT is not a cost-effective treatment for open fracture wounds."
}
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query-laysum | 1951 | [
{
"role": "user",
"content": "Abstract: Background\nRheumatoid arthritis is a systemic auto-immune disorder that causes widespread and persistent inflammation of the synovial lining of joints and tendon sheaths. Presently, there is no cure for rheumatoid arthritis and treatment focuses on managing symptoms such as pain, stiffness and mobility, with the aim of achieving stable remission and improving mobility. Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID) used for treatment of people with rheumatoid arthritis.\nObjectives\nTo assess the benefits and harms of celecoxib in people with rheumatoid arthritis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trials registers (ClinicalTrials.gov and the World Health Organization trials portal) to May 18, 2017. We also searched the reference and citation lists of included studies.\nSelection criteria\nWe included prospective randomized controlled trials (RCTs) that compared oral celecoxib (200 mg and 400 mg daily) versus no intervention, placebo or a traditional NSAID (tNSAID) in people with confirmed rheumatoid arthritis, of any age and either sex. We excluded studies with fewer than 50 participants in each arm or had durations of fewer than four weeks treatment.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nWe included eight RCTs with durations of 4 to 24 weeks, published between 1998 and 2014 that involved a total of 3988 adults (mean age = 54 years), most of whom were women (73%). Participants had rheumatoid arthritis for an average of 9.2 years. All studies were assessed at high or unclear risk of bias in at least one domain. Overall, evidence was assessed as moderate-to-low quality. Five studies were funded by pharmaceutical companies.\nCelecoxib versus placebo\nWe included two studies (N = 873) in which participants received 200 mg daily or 400 mg daily or placebo. Participants who received celecoxib showed significant clinical improvement compared with those receiving placebo (15% absolute improvement; 95% CI 7% to 25%; RR 1.53, 95% CI 1.25 to 1.86; number needed to treat to benefit (NNTB) = 7, 95% CI 5 to 13; 2 studies, 873 participants; moderate to low quality evidence).\nParticipants who received celecoxib reported less pain than placebo-treated people (11% absolute improvement; 95% CI 8% to 14%; NNTB = 4, 95% CI 3 to 6; 1 study, 706 participants) but results were inconclusive for improvement in physical function (MD -0.10, 95% CI 0.29 to 0.10; 1 study, 706 participants).\nIn the celecoxib group, 15/293 participants developed ulcers, compared with 4/99 in the placebo group (Peto OR 1.26, 95% CI 0.44 to 3.63; 1 study, 392 participants; low quality evidence). Nine (of 475) participants in the celecoxib group developed short-term serious adverse events, compared with five (of 231) in the placebo group (Peto OR 0.87 (0.28 to 2.69; 1 study, 706 participants; low quality evidence).\nThere were fewer withdrawals among people who received celecoxib (163/475) compared with placebo (130/231) (22% absolute change; 95% CI 16% to 27%; RR 0.61, 95% CI 0.52 to 0.72; 1 study, 706 participants).\nCardiovascular events (myocardial infarction, stroke) were not reported. However, regulatory agencies warn of increased cardiovascular event risk associated with celecoxib.\nCelecoxib versus tNSAIDs\nSeven studies (N = 2930) compared celecoxib and tNSAIDs (amtolmetin guacyl, diclofenac, ibuprofen, meloxicam, nabumetone, naproxen, pelubiprofen); one study included comparisons of both placebo and tNSAIDs (N = 1149).\nThere was a small improvement, which may not be clinically significant, in numbers of participants achieving ACR20 criteria response in the celecoxib group compared to tNSAIDs (4% absolute improvement; 95% CI 0% less improvement to 8% more improvement; RR 1.10, 95% CI 0.99 to 1.23; 4 studies, 1981 participants). There was a lack of evidence of difference between participants in the celecoxib and tNSAID groups in terms of pain or physical function. Results were assessed at moderate-to-low quality evidence (downgraded due to risk of bias and inconsistency).\nPeople who received celecoxib had a lower incidence of gastroduodenal ulcers ≥ 3 mm (34/870) compared with those who received tNSAIDs (116/698). This corresponded to 12% absolute change (95% CI 11% to 13%; RR 0.22, 95% CI 0.15 to 0.32; 5 studies, 1568 participants; moderate quality evidence). There were 7% fewer withdrawals among people who received celecoxib (95% CI 4% to 9%; RR 0.73, 95% CI 0.62 to 0.86; 6 studies, 2639 participants).\nResults were inconclusive for short-term serious adverse events and cardiovascular events (low quality evidence). There were 17/918 serious adverse events in people taking celecoxib compared to 42/1236 among people who received placebo (Peto OR 0.71; 95% CI 0.39 to 1.28; 5 studies, 2154 participants). Cardiovascular events were reported in both celecoxib and placebo groups in one study (149 participants).\nAuthors' conclusions\nCelecoxib may improve clinical symptoms, alleviate pain and contribute to little or no difference in physical function compared with placebo. Celecoxib was associated with fewer numbers of participant withdrawals. Results for incidence of gastroduodenal ulcers (≥ 3 mm) and short-term serious adverse events were uncertain; however, there were few reported events for either.\nCelecoxib may slightly improve clinical symptoms compared with tNSAIDs. Results for reduced pain and improved physical function were uncertain. Particpants taking celecoxib had lower incidence of gastroduodenal ulcers (≥ 3 mm) and there were fewer withdrawals from trials. Results for cardiovascular events and short-term serious adverse events were also uncertain.\nUncertainty about the rate of cardiovascular events between celecoxib and tNSAIDs could be due to risk of bias; another factor is that these were small, short-term trials. It has been reported previously that both celecoxib and tNSAIDs increase cardiovascular event rates. Our confidence in results about harms is therefore low. Larger head-to-head clinical trials comparing celecoxib to other tNSAIDs is needed to better inform clinical practice.\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": "When compared with placebo, of every 100 people who received celecoxib, 15 had symptom improvement after 4 to 12 weeks. People who took celecoxib rated their pain 11 points lower (on a scale of 0 to 100) after 12 weeks.\nResults were inconclusive about improvements in physical function and numbers of people who developed gastroduodenal ulcers over 3 mm diameter when we compared celecoxib and placebo. Evidence was also inconclusive about harms that appear shortly after use of the drugs. None of the studies that compared celecoxib and placebo reported heart attacks or strokes.\nResults about improvement in pain and physical function were inconclusive when celecoxib was compared with tNSAIDs. A small improvement was found in relation to a scoring system (ACR20) used by doctors to assess people with rheumatoid arthritis. Of every 100 people who took celecoxib: 13 fewer developed gastroduodenal ulcers over 3 mm diameter; and 7 fewer withdrew from studies compared with people receiving tNSAIDs.\nCelecoxib may improve rheumatoid arthritis symptoms and alleviate pain more than placebo, but probably provides little or no difference in physical function improvement."
}
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query-laysum | 1952 | [
{
"role": "user",
"content": "Abstract: Background\nInfective endocarditis is a microbial infection of the endocardial surface of the heart. Antibiotics are the cornerstone of treatment, but due to the differences in presentation, populations affected, and the wide variety of micro-organisms that can be responsible, their use is not standardised. This is an update of a review previously published in 2016.\nObjectives\nTo assess the existing evidence about the clinical benefits and harms of different antibiotics regimens used to treat people with infective endocarditis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase Classic and Embase, LILACS, CINAHL, and the Conference Proceedings Citation Index - Science on 6 January 2020. We also searched three trials registers and handsearched the reference lists of included papers. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) assessing the effects of antibiotic regimens for treating definitive infective endocarditis diagnosed according to modified Duke's criteria. We considered all-cause mortality, cure rates, and adverse events as the primary outcomes. We excluded people with possible infective endocarditis and pregnant women.\nData collection and analysis\nTwo review authors independently performed study selection, 'Risk of bias' assessment, and data extraction in duplicate. We constructed 'Summary of findings' tables and used GRADE methodology to assess the quality of the evidence. We described the included studies narratively.\nMain results\nSix small RCTs involving 1143 allocated/632 analysed participants met the inclusion criteria of this first update. The included trials had a high risk of bias. Three trials were sponsored by drug companies. Due to heterogeneity in outcome definitions and different antibiotics used data could not be pooled.\nThe included trials compared miscellaneous antibiotic schedules having uncertain effects for all of the prespecified outcomes in this review. Evidence was either low or very low quality due to high risk of bias and very low number of events and small sample size.\nThe results for all-cause mortality were as follows: one trial compared quinolone (levofloxacin) plus standard treatment (antistaphylococcal penicillin (cloxacillin or dicloxacillin), aminoglycoside (tobramycin or netilmicin), and rifampicin) versus standard treatment alone and reported 8/31 (26%) with levofloxacin plus standard treatment versus 9/39 (23%) with standard treatment alone; risk ratio (RR) 1.12, 95% confidence interval (CI) 0.49 to 2.56. One trial compared fosfomycin plus imipenem 3/4 (75%) versus vancomycin 0/4 (0%) (RR 7.00, 95% CI 0.47 to 103.27), and one trial compared partial oral treatment 7/201 (3.5%) versus conventional intravenous treatment 13/199 (6.53%) (RR 0.53, 95% CI 0.22 to 1.31).\nThe results for rates of cure with or without surgery were as follows: one trial compared daptomycin versus low-dose gentamicin plus an antistaphylococcal penicillin (nafcillin, oxacillin, or flucloxacillin) or vancomycin and reported 9/28 (32.1%) with daptomycin versus 9/25 (36%) with low-dose gentamicin plus antistaphylococcal penicillin or vancomycin; RR 0.89, 95% CI 0.42 to 1.89. One trial compared glycopeptide (vancomycin or teicoplanin) plus gentamicin with cloxacillin plus gentamicin (13/23 (56%) versus 11/11 (100%); RR 0.59, 95% CI 0.40 to 0.85). One trial compared ceftriaxone plus gentamicin versus ceftriaxone alone (15/34 (44%) versus 21/33 (64%); RR 0.69, 95% CI 0.44 to 1.10), and one trial compared fosfomycin plus imipenem versus vancomycin (1/4 (25%) versus 2/4 (50%); RR 0.50, 95% CI 0.07 to 3.55).\nThe included trials reported adverse events, the need for cardiac surgical interventions, and rates of uncontrolled infection, congestive heart failure, relapse of endocarditis, and septic emboli, and found no conclusive differences between groups (very low-quality evidence). No trials assessed quality of life.\nAuthors' conclusions\nThis first update confirms the findings of the original version of the review. Limited and low to very low-quality evidence suggests that the comparative effects of different antibiotic regimens in terms of cure rates or other relevant clinical outcomes are uncertain. The conclusions of this updated Cochrane Review were based on few RCTs with a high risk of bias. Accordingly, current evidence does not support or reject any regimen of antibiotic therapy for the treatment of infective endocarditis.\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": "Infective endocarditis is an infection of the inner lining of the heart. It is a serious infection that is frequently fatal, and cardiac surgery is often required. Antibiotics are medicines that treat infections and are the cornerstone of treatment for infective endocarditis. Treatment of patients with infective endocarditis is nosocomial (in-hospital). Despite this, there are surprising differences between guidelines in their recommendations for antibiotic therapy. Furthermore, due to the dose and length of time that antibiotics must be given for, the antibiotics can have serious side effects, such as kidney and ear damage, and cause allergic reactions."
}
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query-laysum | 1953 | [
{
"role": "user",
"content": "Abstract: Background\nEmotional and behavioural problems in children are common. Research suggests that parenting has an important role to play in helping children to become well-adjusted, and that the first few months and years are especially important. Parenting programmes may have a role to play in improving the emotional and behavioural adjustment of infants and toddlers, and this review examined their effectiveness with parents and carers of young children.\nObjectives\n1. To establish whether group-based parenting programmes are effective in improving the emotional and behavioural adjustment of young children (maximum mean age of three years and 11 months); and\n2. To assess whether parenting programmes are effective in the primary prevention of emotional and behavioural problems.\nSearch methods\nIn July 2015 we searched CENTRAL (the Cochrane Library), Ovid MEDLINE, Embase (Ovid), and 10 other databases. We also searched two trial registers and handsearched reference lists of included studies and relevant systematic reviews.\nSelection criteria\nTwo reviewers independently assessed the records retrieved by the search. We included randomised controlled trials (RCTs) and quasi-RCTs of group-based parenting programmes that had used at least one standardised instrument to measure emotional and behavioural adjustment in children.\nData collection and analysis\nOne reviewer extracted data and a second reviewer checked the extracted data. We presented the results for each outcome in each study as standardised mean differences (SMDs) with 95% confidence intervals (CIs). Where appropriate, we combined the results in a meta-analysis using a random-effects model. We used the GRADE (Grades of Recommendations, Assessment, Development, and Evaluation) approach to assess the overall quality of the body of evidence for each outcome.\nMain results\nWe identified 22 RCTs and two quasi-RCTs evaluating the effectiveness of group-based parenting programmes in improving the emotional and behavioural adjustment of children aged up to three years and 11 months (maximum mean age three years 11 months).\nThe total number of participants in the studies were 3161 parents and their young children. Eight studies were conducted in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru. All of the included studies were of behavioural, cognitive-behavioural or videotape modelling parenting programmes.\nWe judged 50% (or more) of the included studies to be at low risk for selection bias, detection bias (observer-reported outcomes), attrition bias, selective reporting bias, and other bias. As it is not possible to blind participants and personnel to the type of intervention in these trials, we judged all studies to have high risk of performance bias. Also, there was a high risk of detection bias in the 20 studies that included parent-reported outcomes.\nThe results provide evidence that group-based parenting programmes reduce overall emotional and behavioural problems (SMD -0.81, 95% CI -1.37 to -0.25; 5 studies, 280 participants, low quality evidence) based on total parent-reported data assessed at postintervention. This result was not, however, maintained when two quasi-RCTs were removed as part of a sensitivity analysis (SMD -0.67, 95% CI -1.43 to 0.09; 3 studies, 221 participants). The results of data from subscales show evidence of reduced total externalising problems (SMD -0.23, 95% CI -0.46 to -0.01; 8 studies, 989 participants, moderate quality evidence). Single study results show very low quality evidence of reductions in externalising problems hyperactivity-inattention subscale (SMD -1.34; 95% CI -2.37 to -0.31; 19 participants), low quality evidence of no effect on total internalising problems (SMD 0.34; 95% CI -0.12 to 0.81; 73 participants), and very low quality evidence of an increase in social skills (SMD 3.59; 95% CI 2.42 to 4.76; 32 participants), based on parent-reported data assessed at postintervention. Results for secondary outcomes, which were also measured using subscales, show an impact on parent-child interaction in terms of reduced negative behaviour (SMD -0.22, 95% CI -0.39 to -0.06; 7 studies, 941 participants, moderate quality evidence), and improved positive behaviour (SMD 0.48, 95% CI 0.17 to 0.79; 4 studies, 173 participants, moderate quality evidence) as rated by independent observers postintervention. No further meta-analyses were possible. Results of subgroup analyses show no evidence for treatment duration (seven weeks or less versus more than eight weeks) and inconclusive evidence for prevention versus treatment interventions.\nAuthors' conclusions\nThe findings of this review, which relate to the broad group of universal and at-risk (targeted) children and parents, provide tentative support for the use of group-based parenting programmes to improve the overall emotional and behavioural adjustment of children with a maximum mean age of three years and 11 months, in the short-term. There is, however, a need for more research regarding the role that these programmes might play in the primary prevention of both emotional and behavioural problems, and their long-term effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We searched the scientific literature for all randomised controlled trials (RCTs) and quasi-RCTs published up to July 2015. RCTs are studies in which people are randomly allocated to treatment groups. Quasi-RCTs are studies in which people receive treatment based on methods that are not strictly random such as date of birth, or their hospital record number, and the results of quasi-RCTs are generally considered less trustworthy than those of RCTs.\nWe found 24 trials (22 RCTs and two quasi-RCTs) to include in our review. These studies included, in total, information from 3161 parents and their young children. Eight studies had been carried out in the USA, five in the UK, four in Canada, five in Australia, one in Mexico, and one in Peru.\nAll of the studies looked at behavioural, cognitive-behavioural or videotape modelling parenting programmes. Behavioural programmes are aimed at helping parents develop methods that will reduce bad behaviour, usually with the use of techniques such as praise or rewards. It also aims to help parents set limits that make sense. Cognitive-behavioral skills allow parents think about behaviour patterns and focus on solutions. Programmes can use a variety of techniques; for example, videotape modelling programmes enable parents to learn by watching videotaped films of other parents implementing some of the techniques described above."
}
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query-laysum | 1954 | [
{
"role": "user",
"content": "Abstract: Background\nSymptoms of autism spectrum disorder (ASD) have been associated, in part, with the dysfunction of N-methyl-D-aspartate (NMDA) glutamate receptors at excitatory synapses and glutamate abnormalities. Medications related to glutamatergic neurotransmission, such as D-cycloserine - which is a partial agonist of the NMDA glutamate receptor - are potential treatment options for the core features of ASD. However, the potential effect of D-cycloserine on the social and communication skills deficits of individuals with ASD has not been thoroughly explored and no systematic reviews of the evidence have been conducted.\nObjectives\nTo assess the efficacy and adverse effects of D-cycloserine compared with placebo for social and communication skills in individuals with ASD.\nSearch methods\nIn November 2020, we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers. We also searched the reference lists of relevant publications and contacted the authors of the included study, Minshawi 2016, to identify any additional studies. In addition, we contacted pharmaceutical companies, searched manufacturers' websites and sources of reports of adverse events.\nSelection criteria\nAll randomised controlled trials (RCTs) of any duration and dose of D-cycloserine, with or without adjunct treatment, compared to placebo in individuals with ASD.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted relevant data, assessed the risk of bias, graded the certainty of the evidence using the GRADE approach, and analysed and evaluated the data. We provide a narrative report of the findings as only one study is included in this review.\nMain results\nWe included a single RCT (Minshawi 2016) funded by the United States Department of Defense. It was conducted at two sites in the USA: Indiana University School of Medicine and Cincinnati Children's Hospital Medical Centre. In the included study, 67 children with ASD aged between 5 and 11 years were randomised to receive either 10 weeks (10 doses) of (50 mg) D-cycloserine plus social skills training, or placebo plus social skills training. Randomisation was carried out 1:1 between D-cycloserine and placebo arms, and outcome measures were recorded at one-week post-treatment. The 'risk of bias' assessment for the included study was low for five domains and unclear for two domains.\nThe study (67 participants) reported low certainty evidence of little to no difference between the two groups for all outcomes measured at one week post-treatment: social interaction impairment (mean difference (MD) 3.61 (assessed with the Social Responsiveness Scale), 95% confidence interval (CI) -5.60 to 12.82); social communication impairment (MD -1.08 (measured using the inappropriate speech subscale of the Aberrant Behavior Checklist (ABC)), 95% CI -2.34 to 0.18); restricted, repetitive, stereotyped patterns of behaviour (MD 0.12 (measured by the ABC stereotypy subscale), 95% CI -1.71 to 1.95); serious adverse events (risk ratio (RR) 1.11, 95% CI 0.94 to 1.31); non-core symptoms of ASD (RR 0.97 (measured by the Clinical Global Impression-Improvement scale), 95% CI 0.49 to 1.93); and tolerability of D-cycloserine (RR 0.32 (assessed by the number of dropouts), 95% CI 0.01 to 7.68).\nAuthors' conclusions\nWe are unable to conclude with certainty whether D-cycloserine is effective for individuals with ASD. This review included low certainty data from only one study with methodological issues and imprecision. The added value of this review compared to the included study is we assessed the risk of bias and evaluated the certainty of evidence using the GRADE approach. Moreover, if we find new trials in future updates of this review, we could potentially pool the data, which may either strengthen or decrease the evidence for our findings.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Autism spectrum disorder (ASD) is a relatively common disorder involving the abnormal development of the brain. It often leads to repetitive behaviours, restrictive activities, limited interests, reduced social functioning and language skills. There are no effective treatments for these features of ASD but recent research suggests that D-cycloserine might improve social and communication skills in people with ASD. D-cycloserine is a type of medicine used to treat tuberculosis (a contagious infection that usually affects the lungs) and schizophrenia (a serious mental disorder of thought, emotion and behaviour). We wanted to know whether D-cycloserine, alone or in combination with other treatment, was better or worse than placebo (dummy pill) at improving social and communication skills in individuals with ASD. We also wanted to know if there were any harmful side effects from using this medication."
}
]
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query-laysum | 1955 | [
{
"role": "user",
"content": "Abstract: Background\nEpithelial ovarian cancer is the sixth most common cancer worldwide: 295,414 new cases were diagnosed in 2018, with 184,799 deaths. The lack of an effective screening strategy has led to the majority of women being diagnosed at an advanced stage. For these women, intravenous carboplatin combined with paclitaxel for six cycles is widely accepted as the standard first-line treatment for epithelial ovarian cancer, in combination with debulking surgery. However, there is conflicting evidence regarding the optimal dosing schedule of paclitaxel when combined with carboplatin in this setting.\nObjectives\nTo compare the efficacy and tolerability of intravenous weekly paclitaxel with that of tri-weekly paclitaxel, in combination with intravenous carboplatin, as first-line treatment for epithelial ovarian cancer (defined as epithelial ovarian, primary peritoneal and fallopian tube cancer).\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase databases for relevant studies up to 15 November 2021, using keywords and MeSH terms. We additionally handsearched conference libraries, online clinical trial databases and screened through lists of retrieved references.\nSelection criteria\nWe Included randomised controlled trials (RCTs) comparing weekly paclitaxel in combination with carboplatin versus tri-weekly paclitaxel in combination with carboplatin, for treatment of newly-diagnosed epithelial ovarian cancer.\nData collection and analysis\nWe used the hazard ratio (HR) to estimate the primary efficacy outcomes progression-free (PFS) and overall survival (OS). We used the risk ratio (RR) to estimate the primary toxicity outcome of severe neutropenia and secondary outcomes of quality of life (QoL) and treatment-related adverse events. Two review authors independently selected studies, extracted data, and assessed risk of bias, using standard Cochrane methodological procedures. We included individual participant data (IPD) from one of the included studies, ICON-8, provided by the study team. We analysed data using a random-effects model in Review Manager 5.4 software. Additionally, we reconstructed IPD for PFS and OS data from published Kaplan-Meier curves from all studies and subsequently pooled these to analyse the two primary efficacy outcomes.\nMain results\nFrom 2469 records, we identified four eligible RCTs with data for 3699 participants. All eligible studies were included in the main meta-analysis and reported on PFS and OS.\nThere was likely a slight improvement in PFS when paclitaxel was dosed weekly compared to tri-weekly (HR 0.89, 95% confidence interval (CI) 0.81 to 0.98; 4 studies, 3699 participants; moderate-certainty evidence). We found little to no improvement in OS when paclitaxel was dosed weekly compared to tri-weekly (HR 0.92, 95% CI 0.79 to 1.06; 4 studies, 3699 participants; high-certainty evidence). There was likely little to no difference in high-grade (grade 3 or 4) neutropenia when paclitaxel was dosed weekly compared to tri-weekly (RR 1.11, 95% CI 0.86 to 1.43; 4 studies, 3639 participants; moderate-certainty evidence). However, weekly paclitaxel increased high-grade (grade 3 or 4) anaemia when compared to tri-weekly dosing (RR 1.57, 95% CI 1.12 to 2.20; 4 studies, 3639 participants; high-certainty evidence). There may be little to no difference in high-grade neuropathy when paclitaxel was dosed weekly compared to tri-weekly (RR 1.12, 95% CI 0.64 to 1.94; 4 studies, 3639 participants; low-certainty evidence). The overall risk of detection bias and performance bias was low for OS, but was unclear for other outcomes, as treatments were not blinded. The risk of bias in other domains was low or unclear.\nWe note that OS data were immature for three of the included studies (GOG-0262, ICON-8 and MITO-7).\nAuthors' conclusions\nWeekly paclitaxel combined with carboplatin for first-line treatment of epithelial ovarian cancer likely improves PFS slightly (moderate-certainty evidence) but not OS (high-certainty evidence), compared to tri-weekly paclitaxel combined with carboplatin. However, this was associated with increased risk for high-grade anaemia, treatment discontinuation, dose delays and dose omissions (high- to low-certainty evidence). Our findings may not apply to women receiving bevacizumab in first-line therapy, those receiving treatment in the neo-adjuvant setting, or those with rare subtypes of clear cell or mucinous ovarian cancer.\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": "Ovarian cancer is the sixth most common cancer worldwide. Treatment consists of a combination of surgery and chemotherapy (most commonly including paclitaxel and carboplatin), with the aim to reduce or delay the return of the cancer (known as progression-free survival (PFS)), and improve chances for cancer survival (known as overall survival (OS)). Several clinical trials (studies) have investigated whether the dosing schedule (timing) of paclitaxel affects these outcomes. However, the results from reported studies are conflicting."
}
]
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query-laysum | 1956 | [
{
"role": "user",
"content": "Abstract: Background\nLong-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICSs) are inhaled medications used to manage chronic obstructive pulmonary disease (COPD). When two classes of medications are required, a LAMA plus an ICS (LABA+ICS) were previously recommended within a single inhaler as the first-line treatment for managing stable COPD in people in high-risk categories. However, updated international guidance recommends a LAMA plus a LABA (LAMA+LABA). This systematic review is an update of a Cochrane Review first published in 2017.\nObjectives\nTo compare the benefits and harms of LAMA+LABA versus LABA+ICS for treatment of people with stable COPD.\nSearch methods\nWe performed an electronic search of the Cochrane Airways Group Specialised Register, ClinicalTrials.gov, and the World Health Organization Clinical Trials Search Portal, followed by handsearches. Two review authors screened the selected articles. The most recent search was run on 10 September 2022.\nSelection criteria\nWe included parallel or cross-over randomised controlled trials of at least one month's duration, comparing LAMA+LABA and LABA+ICS for stable COPD. We included studies conducted in an outpatient setting and irrespective of blinding.\nData collection and analysis\nTwo review authors independently extracted data and evaluated risk of bias. We resolved any discrepancies through discussion. We analysed dichotomous data as odds ratios (ORs), and continuous data as mean differences (MDs), with 95% confidence intervals (CIs) using Review Manager 5. Primary outcomes were: participants with one or more exacerbations of COPD; serious adverse events; quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score change from baseline; and trough forced expiratory volume in one second (FEV1). We used the GRADE framework to rate our certainty of the evidence in each meta-analysis as high, moderate, low or very low.\nMain results\nThis review updates the first version of the review, published in 2017, and increases the number of included studies from 11 to 19 (22,354 participants). The median number of participants per study was 700. In each study, between 54% and 91% (median 70%) of participants were males. Study participants had an average age of 64 years and percentage predicted FEV1 of 51.5% (medians of study means). Included studies had a generally low risk of selection, performance, detection, attrition, and reporting biases. All but two studies were sponsored by pharmaceutical companies, which had varying levels of involvement in study design, conduct, and data analysis.\nPrimary outcomes\nThe odds of having an exacerbation were similar for LAMA+LABA compared with LABA+ICS (OR 0.91, 95% CI 0.78 to 1.06; I2 = 61%; 13 studies, 20,960 participants; moderate-certainty evidence). The odds of having a serious adverse event were also similar (OR 1.02, 95% CI 0.91 to 1.15; I2 = 20%; 18 studies, 23,183 participants; high-certainty evidence). Participants receiving LAMA+LABA had a similar improvement in quality of life, as measured by the SGRQ, to those receiving LABA+ICS (MD -0.57, 95% CI -1.36 to 0.21; I2 = 78%; 9 studies, 14,437 participants; moderate-certainty evidence) but showed a greater improvement in trough FEV1 (MD 0.07, 95% CI 0.05 to 0.08; I2 = 73%; 12 studies, 14,681 participants; moderate-certainty evidence).\nSecondary outcomes\nLAMA+LABA decreased the odds of pneumonia compared with LABA+ICS from 5% to 3% (OR 0.61, 95% CI 0.52 to 0.72; I2 = 0%; 14 studies, 21,829 participants; high-certainty evidence) but increased the odds of all-cause death from 1% to 1.4% (OR 1.35, 95% CI 1.05 to 1.75; I2 = 0%; 15 studies, 21,510 participants; moderate-certainty evidence). The odds of achieving a minimal clinically important difference of four or more points on the SGRQ were similar between LAMA+LABA and LABA+ICS (OR 1.06, 95% CI 0.90 to 1.25; I2 = 77%; 4 studies, 13,614 participants; moderate-certainty evidence).\nAuthors' conclusions\nCombination LAMA+LABA therapy probably holds similar benefits to LABA+ICS for exacerbations and quality of life, as measured by the St George's Respiratory Questionnaire, for people with moderate to severe COPD, but offers a larger improvement in FEV1 and a slightly lower risk of pneumonia. There is little to no difference between LAMA+LABA and LAMA+ICS in the odds of having a serious adverse event. Whilst all-cause death may be lower with LABA+ICS, there was a very small number of events in the analysis, translating to a low absolute risk. Findings are based on moderate- to high-certainty evidence from heterogeneous trials with an observation period of less than one year. This review should be updated again in a few years.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up to date to 10 September 2022. The results from future or ongoing trials evaluating newly developed medicines are awaited. This review should be updated again in a few years."
}
]
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query-laysum | 1957 | [
{
"role": "user",
"content": "Abstract: Background\nObstructive sleep apnoea (OSA) is a common sleep disorder characterised by partial or complete upper airway occlusion during sleep, leading to intermittent cessation (apnoea) or reduction (hypopnoea) of airflow and dips in arterial oxygen saturation during sleep. Many patients with recognised and unrecognised OSA receive hypnotics, sedatives and opiates/opioids to treat conditions including pain, anxiety and difficulty sleeping. Concerns have been expressed that administration of these drugs to people with co-existing OSA may worsen OSA.\nObjectives\nTo investigate whether administration of sedative and hypnotic drugs exacerbates the severity of OSA (as measured by the apnoea-hypopnoea index (AHI) or the 4% oxygen desaturation index (ODI)) in people with known OSA.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register (CAGR) of trials. The search was current as of March 2015.\nSelection criteria\nRandomised, placebo-controlled trials including adult participants with confirmed OSA, where participants were randomly assigned to use opiates or opioids, sedatives, hypnotics or placebo. We included participants already using continuous positive airway pressure (CPAP) or a mandibular advancement device.\nData collection and analysis\nWe used standard methodological procedures as recommended by The Cochrane Collaboration.\nMain results\nFourteen studies examining the effects of 10 drugs and including a total of 293 participants contributed to this review. Trials were small, with only two trials, which used sodium oxybate, recruiting more than 40 participants, and all but three trials were of only one to three nights in duration. Most participants had mild to moderate OSA with a mean AHI of 11 to 25 events/h, and only two trials recruited patients with severe OSA. Two trials investigating the effects of ramelteon, a treatment option for insomnia, recruited adults over 60 years of age with OSA and concomitant insomnia.\nThe drugs studied in this review included remifentanil (infusion) 0.75 mcg/kg/h, eszopiclone 3 mg, zolpidem 10 and 20 mg, brotizolam 0.25 mg, flurazepam 30 mg, nitrazepam 10 mg to 15 mg, temazepam 10 mg, triazolam 0.25 mg, ramelteon 8 mg and 16 mg and sodium oxybate 4.5 g and 9 g. We were unable to pool most of the data, with the exception of data for eszopiclone and ramelteon.\nNone of the drugs in this review produced a significant increase in AHI or ODI. Two trials have shown a beneficial effect on OSA. One study showed that a single administration of eszopiclone 3 mg significantly decreased AHI compared with placebo (24 ± 4 vs 31 ± 5; P value < 0.05), and a second study of sodium oxybate 4.5 g showed a significant decrease in AHI compared with placebo (mean difference (MD) -7.41, 95% confidence interval (CI) -14.17 to -0.65; N = 48).\nOnly four trials reported outcome data on ODI. No significant increase, in comparison with placebo, was shown with eszopiclone (21 (22 to 37) vs 28.0 (15 to 36); P value = NS), zolpidem (0.81 ± 0.29 vs 1.46 ± 0.53; P value = NS), flurazepam (18.6 ± 19 vs 19.6 ± 15.9; P value = NS) and temazepam (6.53 ± 9.4 vs 6.56 ± 8.3; P value = 0.98).\nA significant decrease in minimum nocturnal peripheral capillary oxygen saturation (SpO2) was observed with zolpidem 20 mg (76.8 vs 85.2; P value = 0.002), flurazepam 30 mg (81.7 vs 85.2; P value = 0.002), remifentanil infusion (MD -7.00, 95% CI -11.95 to -2.05) and triazolam 0.25 mg in both rapid eye movement (REM) and non-REM (NREM) sleep (MD -14.00, 95% CI -21.84 to -6.16; MD -10.20, 95% CI -16.08 to -4.32, respectively.\nOne study investigated the effect of an opiate (remifentanil) on patients with moderate OSA. Remifentanil infusion did not significantly change AHI (MD 10.00, 95% CI -9.83 to 29.83); however it did significantly decrease the number of obstructive apnoeas (MD -9.00, 95% CI -17.40 to -0.60) and significantly increased the number of central apnoeas (MD 16.00, 95% CI -2.21 to 34.21). Similarly, although without significant effect on obstructive apnoeas, central apnoeas were increased in the sodium oxybate 9 g treatment group (MD 7.3 (18); P value = 0.005) in a cross-over trial.\nDrugs studied in this review were generally well tolerated, apart from adverse events reported in 19 study participants prescribed remifentanil (n = 1), eszopiclone (n = 6), sodium oxybate (n = 9) or ramelteon (n = 3).\nAuthors' conclusions\nThe findings of this review show that currently no evidence suggests that the pharmacological compounds assessed have a deleterious effect on the severity of OSA as measured by change in AHI or ODI. Significant clinical and statistical decreases in minimum overnight SpO2 were observed with remifentanil, zolpidem 20 mg and triazolam 0.25 mg. Eszopiclone 3 mg and sodium oxybate 4.5 g showed a beneficial effect on the severity of OSA with a reduction in AHI and may merit further assessment as a potential therapeutic option for a subgroup of patients with OSA. Only one trial assessed the effect of an opioid (remifentanil); some studies included CPAP treatment, whilst in a significant number of participants, previous treatment with CPAP was not stated and thus a residual treatment effect of CPAP could not be excluded. Most studies were small and of short duration, with indiscernible methodological quality.Caution is therefore required when such agents are prescribed for patients with OSA, especially outside the severity of the OSA cohorts and the corresponding dose of compounds given in the particular studies. Larger, longer trials involving patients across a broader spectrum of OSA severity are needed to clarify these results.\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 set out to look at evidence derived from randomised placebo-controlled trials to identify the risks of these drugs for patients with known OSA."
}
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query-laysum | 1958 | [
{
"role": "user",
"content": "Abstract: Background\nAbstracts of presentations at scientific meetings are usually available only in conference proceedings. If subsequent full publication of results reported in these abstracts is based on the magnitude or direction of the results, publication bias may result. Publication bias creates problems for those conducting systematic reviews or relying on the published literature for evidence about health and social care.\nObjectives\nTo systematically review reports of studies that have examined the proportion of meeting abstracts and other summaries that are subsequently published in full, the time between meeting presentation and full publication, and factors associated with full publication.\nSearch methods\nWe searched MEDLINE, Embase, the Cochrane Library, Science Citation Index, reference lists, and author files. The most recent search was done in February 2016 for this substantial update to our earlier Cochrane Methodology Review (published in 2007).\nSelection criteria\nWe included reports of methodology research that examined the proportion of biomedical results initially presented as abstracts or in summary form that were subsequently published. Searches for full publications had to be at least two years after meeting presentation.\nData collection and analysis\nTwo review authors extracted data and assessed risk of bias. We calculated the proportion of abstracts published in full using a random-effects model. Dichotomous variables were analyzed using risk ratio (RR), with multivariable models taking into account various characteristics of the reports. We assessed time to publication using Kaplan-Meier survival analyses.\nMain results\nCombining data from 425 reports (307,028 abstracts) resulted in an overall full publication proportion of 37.3% (95% confidence interval (CI), 35.3% to 39.3%) with varying lengths of follow-up. This is significantly lower than that found in our 2007 review (44.5%. 95% CI, 43.9% to 45.1%). Using a survival analyses to estimate the proportion of abstracts that would be published in full by 10 years produced proportions of 46.4% for all studies; 68.7% for randomized and controlled trials and 44.9% for other studies. Three hundred and fifty-three reports were at high risk of bias on one or more items, but only 32 reports were considered at high risk of bias overall.\nForty-five reports (15,783 abstracts) with 'positive' results (defined as any 'significant' result) showed an association with full publication (RR = 1.31; 95% CI 1.23 to 1.40), as did 'positive' results defined as a result favoring the experimental treatment (RR =1.17; 95% CI 1.07 to 1.28) in 34 reports (8794 abstracts). Results emanating from randomized or controlled trials showed the same pattern for both definitions (RR = 1.21; 95% CI 1.10 to 1.32 (15 reports and 2616 abstracts) and RR = 1.17; 95% CI, 1.04 to 1.32 (13 reports and 2307 abstracts), respectively.\nOther factors associated with full publication include oral presentation (RR = 1.46; 95% CI 1.40 to 1.52; studied in 143 reports with 115,910 abstracts); acceptance for meeting presentation (RR = 1.65; 95% CI 1.48 to 1.85; 22 reports with 22,319 abstracts); randomized trial design (RR = 1.51; 95% CI 1.36 to 1.67; 47 reports with 28,928 abstracts); and basic research (RR = 0.78; 95% CI 0.74 to 0.82; 92 reports with 97,372 abstracts). Abstracts originating at an academic setting were associated with full publication (RR = 1.60; 95% CI 1.34 to 1.92; 34 reports with 16,913 abstracts), as were those considered to be of higher quality (RR = 1.46; 95% CI 1.23 to 1.73; 12 reports with 3364 abstracts), or having high impact (RR = 1.60; 95% CI 1.41 to 1.82; 11 reports with 6982 abstracts). Sensitivity analyses excluding reports that were abstracts themselves or classified as having a high risk of bias did not change these findings in any important way.\nIn considering the reports of the methodology research that we included in this review, we found that reports published in English or from a native English-speaking country found significantly higher proportions of studies published in full, but that there was no association with year of report publication. The findings correspond to a proportion of abstracts published in full of 31.9% for all reports, 40.5% for reports in English, 42.9% for reports from native English-speaking countries, and 52.2% for both these covariates combined.\nAuthors' conclusions\nMore than half of results from abstracts, and almost a third of randomized trial results initially presented as abstracts fail to be published in full and this problem does not appear to be decreasing over time. Publication bias is present in that 'positive' results were more frequently published than 'not positive' results. Reports of methodology research written in English showed that a higher proportion of abstracts had been published in full, as did those from native English-speaking countries, suggesting that studies from non-native English-speaking countries may be underrepresented in the scientific literature. After the considerable work involved in adding in the more than 300 additional studies found by the February 2016 searches, we chose not to update the search again because additional searches are unlikely to change these overall conclusions in any important way.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have confidence in our findings. We considered five criteria to constitute a risk of bias in the included reports, including methods to identify and match full publications to abstracts, and methods to determine whether a factor was associated with full publication. Overall, 7.5% (32/425) of the reports were scored as having an overall high risk of bias, 83.1% (353/425) had at least one criterion at high risk of bias, and 6.1% (26/425) had all criteria at low risk of bias."
}
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query-laysum | 1959 | [
{
"role": "user",
"content": "Abstract: Background\nSecuring the endotracheal tube is a common procedure in the neonatal intensive care unit. Adequate fixation of the tube is essential to ensure effective ventilation of the infant whilst minimising potential complications secondary to the intervention. Methods used to secure the endotracheal tube often vary between units and sometimes even between healthcare providers in the same nursery.\nObjectives\nTo compare the different methods of securing the endotracheal tube in the ventilated neonate and their effects on the risk of accidental extubation and other potential complications that can result from an unstable endotracheal tube.\nSearch methods\nA literature search of MEDLINE (from 1966 to June 2013), CINAHL (from 1982 to June 2013) and CENTRAL in The Cochrane Library was conducted to identify relevant trials to be analysed.\nSelection criteria\nAll randomised and quasi-randomised controlled trials of infants who were intubated for mechanical ventilation in a neonatal intensive care nursery where methods of stabilising the endotracheal tube were being compared.\nData collection and analysis\nData were collected from individual studies to determine the methods being compared, the methodology of the trial, and whether there were areas of bias that could significantly affect the results of the studies. In particular, studies were assessed for blinding of randomisation and allocation, blinding of the intervention, completeness of follow up, blinding of outcome assessments and selective reporting.\nMain results\nFive randomised controlled trials were identified and included for review. Accidental extubation was the most common outcome measured (five studies). None of the studies reported on the need for re-intubation or the rate of tube malposition, however one study did report on endotracheal tube slippage. A variety of other adverse effects were reported including mortality, incidence of perioral skin trauma and tube re-taping. All five studies were of poor methodological quality, small size, contained significant risks of bias and compared methods of securing the endotracheal tube that were too dissimilar for the data to be collated or included in a meta-analysis. We have not reported these further.\nAuthors' conclusions\nThis review highlighted the need for further well designed and completed studies to be conducted for this common neonatal procedure. Evidence is lacking to determine the most effective and safe method to stabilise the endotracheal tube in the ventilated neonate.\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 was low. Limitations in design and implementation were evident to different degrees in all five studies. None of the studies indicated whether allocation was concealed. Due to the nature of the intervention the studies were unable to be blinded, however none of the studies indicated whether data were collected in a blinded fashion therefore conferring risks of bias. One study had a large group of neonates that were excluded from the analysis and publication bias. Conclusive results from well designed and conducted trials could help to optimise current practice."
}
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query-laysum | 1960 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovary syndrome (PCOS) is characterised by infrequent or absent ovulation, and high levels of androgens and insulin (hyperinsulinaemia). Hyperinsulinaemia occurs secondary to insulin resistance and is associated with increased risk of cardiovascular disease and diabetes mellitus. Insulin-sensitising agents such as metformin may be effective in treating PCOS-related anovulation.\nObjectives\nTo evaluate the effectiveness and safety of insulin-sensitising drugs in improving reproductive and metabolic outcomes for women with PCOS undergoing ovulation induction.\nSearch methods\nWe searched the following databases from inception to January 2017: Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL. We searched registers of ongoing trials and reference lists from relevant studies.\nSelection criteria\nWe included randomised controlled trials of insulin-sensitising drugs compared with placebo, no treatment, or an ovulation-induction agent for women with oligo and anovulatory PCOS.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility and bias. Primary outcomes were live birth rate and gastrointestinal adverse effects. Secondary outcomes included other pregnancy outcomes, menstrual frequency and metabolic effects. We combined data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I2 statistic and reported quality of the evidence for primary outcomes using GRADE methodology.\nMain results\nWe assessed the interventions metformin, clomiphene citrate, metformin plus clomiphene citrate, D-chiro-inositol, rosiglitazone and pioglitazone. We compared these with each other, placebo or no treatment. We included 48 studies (4451 women), 42 of which investigated metformin (4024 women). Evidence quality ranged from very low to moderate. Limitations were risk of bias (poor reporting of methodology and incomplete outcome data), imprecision and inconsistency.\nMetformin versus placebo or no treatment\nThe evidence suggests that metformin may improve live birth rates compared with placebo (OR 1.59, 95% CI 1.00 to 2.51, 4 studies, 435 women, I2 = 0%, low-quality evidence). The metformin group experienced more gastrointestinal side effects (OR 4.76, 95% CI 3.06 to 7.41, 7 studies, 670 women, I2 = 61%, moderate-quality evidence) but had higher rates of clinical pregnancy (OR 1.93, 95% CI 1.42 to 2.64, 9 studies, 1027 women, I2 = 43%, moderate-quality evidence), ovulation (OR 2.55, 95% CI 1.81 to 3.59, 14 studies, 701 women, I2 = 58%, moderate-quality evidence) and menstrual frequency (OR 1.72, 95% CI 1.14 to 2.61, 7 studies, 427 women, I2 = 54%, low-quality evidence). There was no clear evidence of a difference in miscarriage rates (OR 1.08, 95% CI 0.50 to 2.35, 4 studies, 748 women, I2 = 0%, low-quality evidence).\nMetformin plus clomiphene citrate versus clomiphene citrate alone\nThere was no conclusive evidence of a difference between the groups in live birth rates (OR 1.21, 95% CI 0.92 to 1.59, 9 studies, 1079 women, I2 = 20%, low-quality evidence), but gastrointestinal side effects were more common with combined therapy (OR 3.97, 95% CI 2.59 to 6.08, 3 studies, 591 women, I2 = 47%, moderate-quality evidence). However, the combined therapy group had higher rates of clinical pregnancy (OR 1.59, 95% CI 1.27 to 1.99, 16 studies, 1529 women, I2 = 33%, moderate-quality evidence) and ovulation (OR 1.57, 95% CI 1.28 to 1.92, 21 studies, 1624 women, I2 = 64%, moderate-quality evidence). There was a statistically significant difference in miscarriage rate per woman, with higher rates in the combined therapy group (OR 1.59, 95% CI 1.03 to 2.46, 9 studies, 1096 women, I2 = 0%, low-quality evidence) but this is of uncertain clinical significance due to low-quality evidence, and no clear difference between groups when we analysed miscarriage per pregnancy (OR 1.30, 95% CI 0.80 to 2.12, 8 studies; 400 pregnancies, I2 = 0%, low-quality evidence).\nMetformin versus clomiphene citrate\nWhen all studies were combined, findings for live birth were inconclusive and inconsistent (OR 0.71, 95% CI 0.49 to 1.01, 5 studies, 741 women, I2 = 86%, very low-quality evidence). In subgroup analysis by obesity status, obese women had a lower birth rate in the metformin group (OR 0.30, 95% CI 0.17 to 0.52, 2 studies, 500 women, I2 = 0%, very low-quality evidence), while data from the non-obese group showed a possible benefit from metformin, with high heterogeneity (OR 1.71, 95% CI 1.00 to 2.94, 3 studies, 241 women, I2 = 78%, very low-quality evidence). Similarly, among obese women taking metformin there were lower rates of clinical pregnancy (OR 0.34, 95% CI 0.21 to 0.55, 2 studies, 500 women, I2 = 0%, very low-quality evidence) and ovulation (OR 0.29, 95% CI 0.20 to 0.43 2 studies, 500 women, I2 = 0%, low-quality evidence) while among non-obese women, the metformin group had more pregnancies (OR 1.56, 95% CI 1.05 to 2.33, 5 studies, 490 women, I2 = 41%, very low-quality evidence) and no clear difference in ovulation rates (OR 0.81, 95% CI 0.51 to 1.28, 4 studies, 312 women, low-quality evidence, I2=0%). There was no clear evidence of a difference in miscarriage rates (overall: OR 0.92, 95% CI 0.50 to 1.67, 5 studies, 741 women, I2 = 52%, very low-quality evidence).\nD-chiro-inositol (2 studies), rosiglitazone (1 study) or pioglitazone (1 study) versus placebo or no treatment\nWe were unable to draw conclusions regarding other insulin-sensitising drugs as no studies reported primary outcomes.\nAuthors' conclusions\nOur updated review suggests that metformin alone may be beneficial over placebo for live birth, although the evidence quality was low. When metformin was compared with clomiphene citrate, data for live birth were inconclusive, and our findings were limited by lack of evidence. Results differed by body mass index (BMI), emphasising the importance of stratifying results by BMI. An improvement in clinical pregnancy and ovulation suggests that clomiphene citrate remains preferable to metformin for ovulation induction in obese women with PCOS.\nAn improved clinical pregnancy and ovulation rate with metformin and clomiphene citrate versus clomiphene citrate alone suggests that combined therapy may be useful although we do not know whether this translates into increased live births. Women taking metformin alone or with combined therapy should be advised that there is no evidence of increased miscarriages, but gastrointestinal side effects are more likely.\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": "Our updated review showed that metformin may be beneficial in improving the chances of having a live birth compared with either no treatment or placebo. It is not clear from the available evidence whether metformin or clomiphene citrate is superior for live birth rate, although pregnancy and ovulation rates are improved with clomiphene citrate, and women taking clomiphene citrate have fewer side effects. However, it is possible that a woman's body mass index may affect which treatment she should take for the greatest benefit, although further research is required to establish this. Metformin did not appear to increase the risk of miscarriage.\nThe limited improvement in metabolic outcomes with metformin treatment highlights the importance of weight loss and lifestyle adjustment, particularly in overweight women with PCOS."
}
]
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query-laysum | 1961 | [
{
"role": "user",
"content": "Abstract: Background\nThis review represents one in a family of three reviews focusing on the effectiveness of interventions in reducing drug use and criminal activity for offenders.\nObjectives\nTo assess the effectiveness of interventions for female drug-using offenders in reducing criminal activity, or drug use, or both.\nSearch methods\nWe searched 12 electronic bibliographic databases up to February 2019.\nSelection criteria\nWe included randomised controlled trials (RCTs).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 13 trials with 2560 participants. Interventions were delivered in prison (7/13 studies, 53%) and community (6/13 studies, 47%) settings. The rating of bias was affected by the lack of clear reporting by authors, and we rated many items as 'unclear'.\nIn two studies (190 participants) collaborative case management in comparison to treatment as usual did not reduce drug use (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.20 to 2.12; 1 study, 77 participants; low-certainty evidence), reincarceration at nine months (RR 0.71, 95% CI 0.32 to 1.57; 1 study, 77 participants; low-certainty evidence), and number of subsequent arrests at 12 months (RR 1.11, 95% CI 0.83 to 1.49; 1 study, 113 participants; low-certainty evidence).\nOne study (36 participants) comparing buprenorphine to placebo showed no significant reduction in self-reported drug use at end of treatment (RR 0.57, 95% CI 0.27 to 1.20) and three months (RR 0.58, 95% CI 0.25 to 1.35); very low-certainty evidence. No adverse events were reported.\nOne study (38 participants) comparing interpersonal psychotherapy to a psychoeducational intervention did not find reduction in drug use at three months (RR 0.67, 95% CI 0.30 to 1.50; low-certainty evidence).\nOne study (31 participants) comparing acceptance and commitment therapy (ACT) to a waiting list showed no significant reduction in self-reported drug use using the Addiction Severity Index (mean difference (MD) -0.04, 95% CI -0.37 to 0.29) and abstinence from drug use at six months (RR 2.89, 95% CI 0.73 to 11.43); low-certainty evidence.\nOne study (314 participants) comparing cognitive behavioural skills to a therapeutic community programme and aftercare showed no significant reduction in self-reported drug use (RR 0.86, 95% CI 0.58 to 1.27), re-arrest for any type of crime (RR 0.73, 95% CI 0.52 to 1.03); criminal activity (RR 0.80, 95% CI 0.63 to 1.03), or drug-related crime (RR 0.95, 95% CI 0.68 to 1.32). A significant reduction for arrested (not for parole) violations at six months follow-up was significantly in favour of cognitive behavioural skills (RR 0.43, 95% CI 0.25 to 0.77; very low-certainty evidence). A second study with 115 participants comparing cognitive behavioural skills to an alternative substance abuse treatment showed no significant reduction in reincarceration at 12 months (RR 0.70, 95% CI 0.43 to 1.12; low certainty-evidence.\nOne study (44 participants) comparing cognitive behavioural skills and standard therapy versus treatment as usual showed no significant reduction in Addiction Severity Index (ASI) drug score at three months (MD 0.02, 95% CI -0.05 to 0.09) and six months (MD -0.02, 95% CI -0.09 to 0.05), and incarceration at three months (RR 0.46, 95% CI 0.04 to 4.68) and six months (RR 0.51, 95% CI 0.20 to 1.27); very low-certainty evidence.\nOne study (171 participants) comparing a single computerised intervention versus case management showed no significant reduction in the number of days not using drugs at three months (MD -0.89, 95% CI -4.83 to 3.05; low certainty-evidence).\nOne study (116 participants) comparing dialectic behavioural therapy and case management (DBT-CM) versus a health promotion intervention showed no significant reduction at six months follow-up in positive drug testing (RR 0.67, 95% CI 0.43 to 1.03), number of people not using marijuana (RR 1.23, 95% CI 0.95 to 1.59), crack (RR 1.00, 95% CI 0.87 to 1.14), cocaine (RR 1.02, 95% CI 0.93 to 1.12), heroin (RR 1.05, 95% CI 0.98 to 1.13), methamphetamine (RR 1.02, 95% CI 0.87 to 1.20), and self-reported drug use for any drug (RR 1.20, 95% CI 0.92 to 1.56); very low-certainty evidence.\nOne study (211 participants) comparing a therapeutic community programme versus work release showed no significant reduction in marijuana use at six months (RR 1.03, 95% CI 0.19 to 5.65), nor 18 months (RR 1.00, 95% CI 0.07 to 14.45), heroin use at six months (RR 1.59, 95% CI 0.49 to 5.14), nor 18 months (RR 1.92, 95% CI 0.24 to 15.37), crack use at six months (RR 2.07, 95% CI 0.41 to 10.41), nor 18 months (RR 1.64, 95% CI 0.19 to 14.06), cocaine use at six months (RR 1.09, 95% CI 0.79 to 1.50), nor 18 months (RR 0.93, 95% CI 0.64 to 1.35). It also showed no significant reduction in incarceration for drug offences at 18 months (RR 1.45, 95% CI 0.87 to 2.42); with overall very low- to low-certainty evidence.\nOne study (511 participants) comparing intensive discharge planning and case management versus prison only showed no significant reduction in use of marijuana (RR 0.79, 95% CI 0.53 to 1.16), hard drugs (RR 1.12, 95% CI 0.88 to 1.43), crack cocaine (RR 1.08, 95% CI 0.75 to 1.54), nor positive hair testing for marijuana (RR 0.75, 95% CI 0.55 to 1.03); it found a significant reduction in arrests (RR 0.19, 95% CI 0.04 to 0.87), but no significant reduction in drug charges (RR 1.07, 95% CI 0.75 to 1.53) nor incarceration (RR 1.09, 95% CI 0.86 to 1.39); moderate-certainty evidence.\nOne narrative study summary (211 participants) comparing buprenorphine pre- and post-release from prison showed no significant reduction in drug use at 12 months post-release; low certainty-evidence. No adverse effects were reported.\nAuthors' conclusions\nThe studies showed a high degree of heterogeneity for types of comparisons, outcome measures and small samples. Descriptions of treatment modalities are required. On one outcome of arrest (no parole violations), we identified a significant reduction when cognitive behavioural therapy (CBT) was compared to a therapeutic community programme. But for all other outcomes, none of the interventions were effective. Larger trials are required to increase the precision of confidence about the certainty of evidence.\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": "February 2019."
}
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query-laysum | 1962 | [
{
"role": "user",
"content": "Abstract: Background\nMotor control exercise (MCE) is used by healthcare professionals worldwide as a common treatment for low back pain (LBP). However, the effectiveness of this intervention for acute LBP remains unclear.\nObjectives\nTo evaluate the effectiveness of MCE for patients with acute non-specific LBP.\nSearch methods\nWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), four other databases and two trial registers from their inception to April 2015, tracked citations and searched reference lists. We placed no limitations on language nor on publication status.\nSelection criteria\nWe included only randomised controlled trials (RCTs) examining the effectiveness of MCE for patients with acute non-specific LBP. We considered trials comparing MCE versus no treatment, versus another type of treatment or added as a supplement to other interventions. Primary outcomes were pain intensity and disability. Secondary outcomes were function, quality of life and recurrence.\nData collection and analysis\nTwo review authors screened for potentially eligible studies, assessed risk of bias and extracted data. A third independent review author resolved disagreements. We examined MCE in the following comparisons: (1) MCE versus spinal manipulative therapy; (2) MCE versus other exercises; and (3) MCE as a supplement to medical management. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the quality of evidence. For missing or unclear information, we contacted study authors. We considered the following follow-up intervals: short term (less than three months after randomisation); intermediate term (at least three months but within 12 months after randomisation); and long term (12 months or longer after randomisation).\nMain results\nWe included three trials in this review (n = 197 participants). Study sample sizes ranged from 33 to 123 participants. Low-quality evidence indicates no clinically important differences between MCE and spinal manipulative therapy for pain at short term and for disability at short term and long term. Low-quality evidence also suggests no clinically important differences between MCE and other forms of exercise for pain at short or intermediate term and for disability at intermediate term or long term follow-up. Moderate-quality evidence shows no clinically important differences between MCE and other forms of exercise for disability at short term follow-up. Finally, very low-quality evidence indicates that addition of MCE to medical management does not provide clinically important improvement for pain or disability at short term follow-up. For recurrence at one year, very low-quality evidence suggests that MCE and medical management decrease the risk of recurrence by 64% compared with medical management alone.\nAuthors' conclusions\nWe identified only three small trials that also evaluated different comparisons; therefore, no firm conclusions can be drawn on the effectiveness of MCE for acute LBP. Evidence of very low to moderate quality indicates that MCE showed no benefit over spinal manipulative therapy, other forms of exercise or medical treatment in decreasing pain and disability among patients with acute and subacute low back pain. Whether MCE can prevent recurrences of LBP remains uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Evidence is current to April 2015."
}
]
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query-laysum | 1963 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin D deficiency is often reported in people with chronic liver diseases. Improving vitamin D status could therefore be beneficial for people with chronic liver diseases.\nObjectives\nTo assess the beneficial and harmful effects of vitamin D supplementation in adults with chronic liver diseases.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We scanned bibliographies of relevant publications and enquired experts and pharmaceutical companies as to additional trials. All searches were up to November 2020.\nSelection criteria\nRandomised clinical trials that compared vitamin D at any dose, duration, and route of administration versus placebo or no intervention in adults with chronic liver diseases. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)), or an active form of vitamin D (1α-hydroxyvitamin D (alfacalcidol), 25-hydroxyvitamin D (calcidiol), or 1,25-dihydroxyvitamin D (calcitriol)).\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of evidence.\nMain results\nWe included 27 randomised clinical trials with 1979 adult participants. This review update added 12 trials with 945 participants. We assessed all trials at high risk of bias. All trials had a parallel-group design. Eleven trials were conducted in high-income countries and 16 trials in middle-income countries. Ten trials included participants with chronic hepatitis C, five trials participants with liver cirrhosis, 11 trials participants with non-alcoholic fatty liver disease, and one trial liver transplant recipients. All of the included trials reported the baseline vitamin D status of participants. Participants in nine trials had baseline serum 25-hydroxyvitamin D levels at or above vitamin D adequacy (20 ng/mL), whilst participants in the remaining 18 trials were vitamin D insufficient (less than 20 ng/mL). Twenty-four trials administered vitamin D orally, two trials intramuscularly, and one trial intramuscularly and orally. In all 27 trials, the mean duration of vitamin D supplementation was 6 months, and the mean follow-up of participants from randomisation was 7 months. Twenty trials (1592 participants; 44% women; mean age 48 years) tested vitamin D3 (cholecalciferol); three trials (156 participants; 28% women; mean age 54 years) tested vitamin D2; four trials (291 participants; 60% women; mean age 52 years) tested 1,25-dihydroxyvitamin D; and one trial (18 participants; 0% women; mean age 52 years) tested 25-hydroxyvitamin D. One trial did not report the form of vitamin D. Twelve trials used a placebo, whilst the other 15 trials used no intervention in the control group. Fourteen trials appeared to be free of vested interest. Eleven trials did not provide any information on clinical trial support or sponsorship. Two trials were funded by industry.\nWe are very uncertain regarding the effect of vitamin D versus placebo or no intervention on all-cause mortality (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.51 to 1.45; 27 trials; 1979 participants). The mean follow-up was 7 months (range 1 to 18 months). We are very uncertain regarding the effect of vitamin D versus placebo or no intervention on liver-related mortality (RR 1.62, 95% CI 0.08 to 34.66; 1 trial; 18 participants) (follow-up: 12 months); serious adverse events such as hypercalcaemia (RR 5.00, 95% CI 0.25 to 100.8; 1 trial; 76 participants); myocardial infarction (RR 0.75, 95% CI 0.08 to 6.81; 2 trials; 86 participants); thyroiditis (RR 0.33, 95% CI 0.01 to 7.91; 1 trial; 68 participants); circular haemorrhoidal prolapse (RR 3.00, 95% CI 0.14 to 65.9; 1 trial; 20 participants); bronchopneumonia (RR 0.33, 95% CI 0.02 to 7.32; 1 trial 20 participants); and non-serious adverse events. The certainty of evidence for all outcomes is very low.\nWe found no data on liver-related morbidity such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, ascites, or liver cancer. There were also no data on health-related quality of life.\nThe evidence is also very uncertain regarding the effect of vitamin D versus placebo or no intervention on rapid, early, and sustained virological response in people with chronic hepatitis C.\nAuthors' conclusions\nGiven the high risk of bias and insufficient power of the included trials and the very low certainty of the available evidence, vitamin D supplementation versus placebo or no intervention may increase or reduce all-cause mortality, liver-related mortality, serious adverse events, or non-serious adverse events in adults with chronic liver diseases. There is a lack of data on liver-related morbidity and health-related quality of life. Further evidence on clinically important outcomes analysed in this review is needed.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We judged all trials to be at high risk of bias (that is an underestimation or overestimation of the true intervention effect). The certainty of evidence is very low."
}
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query-laysum | 1964 | [
{
"role": "user",
"content": "Abstract: Background\nChronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss.\nAural toileting is a term describing a number of processes for manually cleaning the ear. Techniques used may include dry mopping (with cotton wool or tissue paper), suction clearance (typically under a microscope) or irrigation (using manual or automated syringing). Dry mopping may be effective in removing mucopurulent discharge. Compared to irrigation or microsuction it is less effective in removing epithelial debris or thick pus. Aural toileting can be used alone or in addition to other treatments for CSOM, such as antibiotics or topical antiseptics.\nObjectives\nTo assess the effects of aural toilet procedures for people with CSOM.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 March 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) with at least a one-week follow-up involving people (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks.\nWe included any aural toileting method as the intervention, at any frequency and for any duration. The comparisons were aural toileting compared with a) placebo or no intervention, and b) any other aural toileting method. We analysed trials in which background treatments were used in both arms (e.g. topical antiseptics or topical antibiotics) separately.\nData collection and analysis\nWe used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome.\nOur primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes were hearing, serious complications, and the adverse events of ear bleeding and dizziness/vertigo/balance problems.\nMain results\nWe included three studies with a total of 431 participants (465 ears), reporting on two comparisons. Two studies included only children with CSOM in the community (351 participants) and the other study (80 participants) included children and adults with chronic ear discharge for at least six weeks. None of the included studies reported the outcomes of health-related quality of life, ear pain or the adverse event of ear bleeding.\nDaily aural toileting (dry mopping) versus no treatment\nTwo studies (351 children; 370 ears) compared daily dry mopping with no treatment. Neither study presented results for resolution of ear discharge at between one and up to two weeks or between two to four weeks. For resolution of ear discharge after four weeks, one study reported the results per person. We are very uncertain whether there is a difference at 16 weeks (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.60 to 1.72; 1 study; 217 participants) because the certainty of the evidence is very low.\nNo results were reported for the adverse events of dizziness, vertigo or balance problems. Only one study reported serious complications, but it was not clear which group these patients were from, or whether the complications occurred pre- or post-treatment. One study reported hearing, but the results were presented by treatment outcome rather than by treatment group so it is not possible to determine whether there is a difference between the two groups.\nDaily aural toileting versus single aural toileting on top of topical ciprofloxacin\nOne study (80 participants; 95 ears) compared daily aural toileting (suction) with administration of topical antibiotic (ciprofloxacin) ear drops in a clinic, to a single aural toileting (suction) episode followed by daily self-administered topical antibiotic drops, in participants of all ages. We are unsure whether there is a difference in resolution of ear discharge at between one and up to two weeks (RR 1.09, 95% CI 0.91 to 1.30; 1 study; 80 participants) because the certainty of the evidence is very low. There were no results reported for resolution of ear discharge at between two to four weeks. The results for resolution of ear discharge after four weeks were presented by ear, not person, and could not be adjusted to by person. One patient in the group with single aural toileting and self administration of topical antibiotic ear drops reported the adverse event of dizziness, which the authors attributed to the use of cold topical ciprofloxacin. It is very uncertain whether there is a difference between the groups (RR 0.33, 95% CI 0.01 to 7.95; 1 study; 80 participants, very low-certainty). No results were reported for the other adverse events of vertigo or balance problems, or for serious complications. The authors only reported qualitatively that there was no difference between the two groups in hearing results (very low-certainty).\nAuthors' conclusions\nWe are very uncertain whether or not treatment with aural toileting is effective in resolving ear discharge in people with CSOM, due to a lack of data and the poor quality of the available evidence. We also remain uncertain about other outcomes, including adverse events, as these were not well reported. Similarly, we are very uncertain whether daily suction clearance, followed by antibiotic ear drops administered at a clinic, is better than a single episode of suction clearance followed by self-administration of topical antibiotic ear drops.\n\nGiven the provided abstract, please respond to the following query: \"Why this is important\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic suppurative otitis media (CSOM), also known as chronic otitis media (COM), is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent ear discharge – pus that leaks out from a hole in the eardrum – and hearing loss.\nDifferent approaches can be used to clean the affected ears and remove discharge. These include:\n- using cotton wool or tissue paper (dry mopping);\n- sucking up material blocking the ear with a small device (usually done under a microscope); or\n- washing out the ear (irrigation).\nTo find out how effective ear cleaning is in people with CSOM, and whether it causes unwanted effects, we reviewed the evidence from research studies. In particular, we wanted to know whether ear cleaning stopped ear discharge, and whether it affected health-related quality of life, or hearing. We also wanted to know if it caused pain, discomfort or irritation in the ear, unwanted effects such as dizziness or ear bleeding, or any serious complications."
}
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query-laysum | 1965 | [
{
"role": "user",
"content": "Abstract: Background\nIntrauterine insemination (IUI), combined with ovarian stimulation (OS), has been demonstrated to be an effective treatment for infertile couples. Several agents for ovarian stimulation, combined with IUI, have been proposed, but it is still not clear which agents for stimulation are the most effective. This is an update of the review, first published in 2007.\nObjectives\nTo assess the effects of agents for ovarian stimulation for intrauterine insemination in infertile ovulatory women.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trial registers from their inception to November 2020. We performed reference checking and contacted study authors and experts in the field to identify additional studies.\nSelection criteria\nWe included truly randomised controlled trials (RCTs) that compared different agents for ovarian stimulation combined with IUI for infertile ovulatory women concerning couples with unexplained infertility. mild male factor infertility and minimal to mild endometriosis.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane.\nMain results\nIn this updated review, we have included a total of 82 studies, involving 12,614 women. Due to the multitude of comparisons between different agents for ovarian stimulation, we highlight the seven most often reported here.\nGonadotropins versus anti-oestrogens (13 studies)\nFor live birth, the results of five studies were pooled and showed a probable improvement in the cumulative live birth rate for gonadotropins compared to anti-oestrogens (odds ratio (OR) 1.37, 95% confidence interval (CI) 1.05 to 1.79; I2 = 30%; 5 studies, 1924 participants; moderate-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is assumed to be 22.8%, the chance following gonadotropins would be between 23.7% and 34.6%. The pooled effect of seven studies revealed that we are uncertain whether gonadotropins lead to a higher multiple pregnancy rate compared with anti-oestrogens (OR 1.58, 95% CI 0.60 to 4.17; I2 = 58%; 7 studies, 2139 participants; low-certainty evidence).\nAromatase inhibitors versus anti-oestrogens (8 studies)\nOne study reported live birth rates for this comparison. We are uncertain whether aromatase inhibitors improve live birth rate compared with anti-oestrogens (OR 0.75, CI 95% 0.51 to 1.11; 1 study, 599 participants; low-certainty evidence). This suggests that if the chance of live birth following anti-oestrogens is 23.4%, the chance following aromatase inhibitors would be between 13.5% and 25.3%. The results of pooling four studies revealed that we are uncertain whether aromatase inhibitors compared with anti-oestrogens lead to a higher multiple pregnancy rate (OR 1.28, CI 95% 0.61 to 2.68; I2 = 0%; 4 studies, 1000 participants; low-certainty evidence).\nGonadotropins with GnRH (gonadotropin-releasing hormone) agonist versus gonadotropins alone (4 studies)\nNo data were available for live birth. The pooled effect of two studies revealed that we are uncertain whether gonadotropins with GnRH agonist lead to a higher multiple pregnancy rate compared to gonadotropins alone (OR 2.53, 95% CI 0.82 to 7.86; I2 = 0; 2 studies, 264 participants; very low-certainty evidence).\nGonadotropins with GnRH antagonist versus gonadotropins alone (14 studies)\nThree studies reported live birth rate per couple, and we are uncertain whether gonadotropins with GnRH antagonist improve live birth rate compared to gonadotropins (OR 1.5, 95% CI 0.52 to 4.39; I2 = 81%; 3 studies, 419 participants; very low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 25.7%, the chance following gonadotropins combined with GnRH antagonist would be between 15.2% and 60.3%. We are also uncertain whether gonadotropins combined with GnRH antagonist lead to a higher multiple pregnancy rate compared with gonadotropins alone (OR 1.30, 95% CI 0.74 to 2.28; I2 = 0%; 10 studies, 2095 participants; moderate-certainty evidence).\nGonadotropins with anti-oestrogens versus gonadotropins alone (2 studies)\nNeither of the studies reported data for live birth rate. We are uncertain whether gonadotropins combined with anti-oestrogens lead to a higher multiple pregnancy rate compared with gonadotropins alone, based on one study (OR 3.03, 95% CI 0.12 to 75.1; 1 study, 230 participants; low-certainty evidence).\nAromatase inhibitors versus gonadotropins (6 studies)\nTwo studies revealed that aromatase inhibitors may decrease live birth rate compared with gonadotropins (OR 0.49, 95% CI 0.34 to 0.71; I2=0%; 2 studies, 651 participants; low-certainty evidence). This suggests that if the chance of a live birth following gonadotropins alone is 31.9%, the chance of live birth following aromatase inhibitors would be between 13.7% and 25%. We are uncertain whether aromatase inhibitors compared with gonadotropins lead to a higher multiple pregnancy rate (OR 0.69, 95% CI 0.06 to 8.17; I2=77%; 3 studies, 731 participants; very low-certainty evidence).\nAromatase inhibitors with gonadotropins versus anti-oestrogens with gonadotropins (8 studies)\nWe are uncertain whether aromatase inhibitors combined with gonadotropins improve live birth rate compared with anti-oestrogens plus gonadotropins (OR 0.99, 95% CI 0.3 8 to 2.54; I2 = 69%; 3 studies, 708 participants; very low-certainty evidence). This suggests that if the chance of a live birth following anti-oestrogens plus gonadotropins is 13.8%, the chance following aromatase inhibitors plus gonadotropins would be between 5.7% and 28.9%. We are uncertain of the effect of aromatase inhibitors combined with gonadotropins compared to anti-oestrogens combined with gonadotropins on multiple pregnancy rate (OR 1.31, 95% CI 0.39 to 4.37; I2 = 0%; 5 studies, 901 participants; low-certainty evidence).\nAuthors' conclusions\nBased on the available results, gonadotropins probably improve cumulative live birth rate compared with anti-oestrogens (moderate-certainty evidence). Gonadotropins may also improve cumulative live birth rate when compared with aromatase inhibitors (low-certainty evidence). From the available data, there is no convincing evidence that aromatase inhibitors lead to higher live birth rates compared to anti-oestrogens. None of the agents compared lead to significantly higher multiple pregnancy rates. Based on low-certainty evidence, there does not seem to be a role for different combined therapies, nor for adding GnRH agonists or GnRH antagonists in IUI programs.\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": "- ‘Fertility medicines’ are the range of hormones and medicines used to help women get pregnant. This review shows that, in a comparison of two widely-used fertility medicines – gonadotropins and anti-oestrogens – gonadotropins probably increase the number of live births.\n- We have little to no confidence in the evidence comparing the effectiveness of other fertility medicines, both for live birth and multiple pregnancy (expecting more than one baby) rates.\n- To improve the evidence, future studies of intrauterine insemination (where sperm is placed directly in the womb) should compare fertility medicines with a placebo (dummy drug). More studies comparing anti-oestrogens with aromatase inhibitors (another widely-used fertility drug) are also needed."
}
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query-laysum | 1966 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Risedronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts. This is an update of a Cochrane Review that was originally published in 2003.\nObjectives\nWe assessed the benefits and harms of risedronate in the primary and secondary prevention of osteoporotic fractures for postmenopausal women at lower and higher risk for fractures, respectively.\nSearch methods\nWith broader and updated strategies, we searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE and Embase. A grey literature search, including the online databases ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and drug approval agencies, as well as bibliography checks of relevant systematic reviews was also performed. Eligible trials published between 1966 to 24 March 2021 were identified.\nSelection criteria\nWe included randomised controlled trials that assessed the benefits and harms of risedronate in the prevention of fractures for postmenopausal women. Participants must have received at least one year of risedronate, placebo or other anti-osteoporotic drugs, with or without concurrent calcium/vitamin D. Major outcomes were clinical vertebral, non-vertebral, hip and wrist fractures, withdrawals due to adverse events, and serious adverse events. In the interest of clinical relevance and applicability, we classified a study as secondary prevention if its population fulfilled more than one of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, low bone mineral density (BMD)T score ≤ -2.5, and age ≥ 75 years old. If none of these criteria was met, the study was considered to be primary prevention.\nData collection and analysis\nWe used standard methodology expected by Cochrane. We pooled the relative risk (RR) of fractures using a fixed-effect model based on the expectation that the clinical and methodological characteristics of the respective primary and secondary prevention studies would be homogeneous, and the experience from the previous review suggesting that there would be a small number of studies. The base case included the data available for the longest treatment period in each placebo-controlled trial and a >15% relative change was considered clinically important. The main findings of the review were presented in summary of findings tables, using the GRADE approach.\nIn addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs.\nMain results\nForty-three trials fulfilled the eligibility criteria, among which 33 studies (27,348 participants) reported data that could be extracted and quantitatively synthesized. We had concerns about particular domains of risk of bias in each trial. Selection bias was the most frequent concern, with only 24% of the studies describing appropriate methods for both sequence generation and allocation concealment. Fifty per cent and 39% of the studies reporting benefit and harm outcomes, respectively, were subject to high risk. None of the studies included in the quantitative syntheses were judged to be at low risk of bias in all seven domains. The results described below pertain to the comparisons for daily risedronate 5 mg versus placebo which reported major outcomes. Other comparisons are described in the full text.\nFor primary prevention, low- to very low-certainty evidence was collected from four studies (one to two years in length) including 989 postmenopausal women at lower risk of fractures. Risedronate 5 mg/day may make little or no difference to wrist fractures [RR 0.48 ( 95% CI 0.03 to 7.50; two studies, 243 participants); absolute risk reduction (ARR) 0.6% fewer (95% CI 1% fewer to 7% more)] and withdrawals due to adverse events [RR 0.67 (95% CI 0.38 to 1.18; three studies, 748 participants); ARR 2% fewer (95% CI 5% fewer to 1% more)], based on low-certainty evidence. However, its preventive effects on non-vertebral fractures and serious adverse events are not known due to the very low-certainty evidence. There were zero clinical vertebral and hip fractures reported therefore the effects of risedronate for these outcomes are not estimable.\nFor secondary prevention, nine studies (one to three years in length) including 14,354 postmenopausal women at higher risk of fractures provided evidence. Risedronate 5 mg/day probably prevents non-vertebral fractures [RR 0.80 (95% CI 0.72 to 0.90; six studies, 12,173 participants); RRR 20% (95% CI 10% to 28%) and ARR 2% fewer (95% CI 1% fewer to 3% fewer), moderate certainty], and may reduce hip fractures [RR 0.73 (95% CI 0.56 to 0.94); RRR 27% (95% CI 6% to 44%) and ARR 1% fewer (95% CI 0.2% fewer to 1% fewer), low certainty]. Both of these effects are probably clinically important. However, risedronate's effects are not known for wrist fractures [RR 0.64 (95% CI 0.33 to 1.24); three studies,1746 participants); ARR 1% fewer (95% CI 2% fewer to 1% more), very-low certainty] and not estimable for clinical vertebral fractures due to zero events reported (low certainty). Risedronate results in little to no difference in withdrawals due to adverse events [RR 0.98 (95% CI 0.90 to 1.07; eight studies, 9529 participants); ARR 0.3% fewer (95% CI 2% fewer to 1% more); 16.9% in risedronate versus 17.2% in control, high certainty] and probably results in little to no difference in serious adverse events [RR 1.00 (95% CI 0.94 to 1.07; six studies, 9435 participants); ARR 0% fewer (95% CI 2% fewer to 2% more; 29.2% in both groups, moderate certainty).\nAuthors' conclusions\nThis update recaps the key findings from our previous review that, for secondary prevention, risedronate 5 mg/day probably prevents non-vertebral fracture, and may reduce the risk of hip fractures. We are uncertain on whether risedronate 5mg/day reduces clinical vertebral and wrist fractures. Compared to placebo, risedronate probably does not increase the risk of serious adverse events.\nFor primary prevention, the benefit and harms of risedronate were supported by limited evidence with high uncertainty.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to postmenopausal women at lower risk for fractures who take risedronate or placebo\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- for spine fractures suggested by clinical signs and symptoms and hip fractures, it was not possible to calculate the effect because none of these fractures were reported in any of the studies;\n- compared to placebo, there is not enough information to tell if risedronate prevents fractures in wrist and bones other than in the spine."
}
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query-laysum | 1967 | [
{
"role": "user",
"content": "Abstract: Background\nHepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that, compared with placebo, terlipressin may reduce mortality and improve renal function in people with hepatorenal syndrome, but we need current evidence from systematic reviews on the benefits and harms of terlipressin versus other vasoactive drugs.\nObjectives\nTo evaluate the beneficial and harmful effects of terlipressin versus other vasoactive drugs for people with hepatorenal syndrome.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and Science Citation Index Expanded; conducted manual searches of references in relevant literature; and wrote to experts and pharmaceutical companies (date of last search November 2016).\nSelection criteria\nRandomised clinical trials comparing terlipressin versus any other type of vasoactive drugs for hepatorenal syndrome. We allowed albumin and other cointerventions if provided equally in the comparison groups.\nData collection and analysis\nThree authors independently extracted data. The primary outcomes were mortality, hepatorenal syndrome (persistent hepatorenal syndrome despite treatment), and serious adverse events. We conducted meta-analyses and present the results as risk ratios (RR) with 95% confidence intervals (CI). We performed sensitivity, subgroup, and Trial Sequential Analyses and evaluated bias control based on the Cochrane Hepato-Biliary Group domains.\nMain results\nWe included 10 randomised clinical trials with 474 participants. The trials compared terlipressin versus noradrenaline (seven trials), octreotide (one trial), midodrine and octreotide (one trial), or dopamine (one trial). All participants in both groups received albumin as cointervention. We classified two trials at low risk of bias and eight trials at high risk of bias in the assessment of mortality and all trials at high risk of bias for remaining outcomes. In five trials, investigators specifically stated that they did not receive funding from for-profit organisations. We had no information about the funding source from the remaining five trials.\nTerlipressin was not superior or inferior compared with other vasoactive drugs in regard to mortality when including the two trials with a low risk of bias (RR 0.92, 95% CI 0.63 to 1.36; 94 participants, very low quality evidence) or when including all 10 trials (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). One meta-analysis including nine trials suggested a beneficial effect of terlipressin on hepatorenal syndrome (RR 0.79, 95% CI 0.63 to 0.99; 394 participants; I² = 26%; very low quality evidence). Due to the high mortality of hepatorenal syndrome, the registration of other serious adverse events is uncertain, but comparing terlipressin and other vasoactive drugs we found no significant difference (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). Several trials did not report systematically of adverse events, but terlipressin seemed to increase the risks of diarrhoea or abdominal pain, or both (RR 3.50, 95% CI 1.19 to 10.27; 221 participants; 5 trials, I² = 0%). However, Trial Sequential Analyses found insufficient evidence to support or refute any differences between interventions for all outcomes. Considering reversal of hepatorenal syndrome, subgroup analyses on the type of other vasoactive drugs found that terlipressin was superior compared with midodrine and octreotide (RR 0.47, 95% CI 0.30 to 0.72) or octreotide alone (RR 0.56, 95% CI 0.33 to 0.96), but each subgroup only included one small trial. None of the remaining subgroup or sensitivity analyses found differences between terlipressin and other vasoactive drugs. We downgraded the evidence to very low quality because of the high risk of bias, imprecision, and the results of the Trial Sequential Analyses.\nAuthors' conclusions\nThis review found insufficient evidence to support or refute beneficial or harmful effects of terlipressin and albumin versus other vasoactive drugs and albumin. Additional research is needed to evaluate if clinically meaningful differences exist between interventions.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In five trials, investigators specifically stated that they did not receive funding from organisations that could profit from the trial results. We did not have information about the funding source from the remaining five trials."
}
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query-laysum | 1968 | [
{
"role": "user",
"content": "Abstract: Background\nPostoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Antiemetic drugs are only partially effective in preventing PONV. An alternative approach is to stimulate the PC6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004, updated in 2009 and now in 2015.\nObjectives\nTo determine the effectiveness and safety of PC6 acupoint stimulation with or without antiemetic drug versus sham or antiemetic drug for the prevention of PONV in people undergoing surgery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library, Issue 12, 2014), MEDLINE (January 2008 to December 2014), EMBASE (January 2008 to December 2014), ISI Web of Science (January 2008 to December 2014), World Health Organization Clinical Trials Registry, ClinicalTrials.gov, and reference lists of articles to identify additional studies. We applied no language restrictions.\nSelection criteria\nAll randomized trials of techniques that stimulated the PC6 acupoint compared with sham treatment or drug therapy, or combined PC6 acupoint and drug therapy compared to drug therapy, for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous electrical acupoint stimulation, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, acu-stimulation device, and acupressure in people undergoing surgery. Primary outcomes were the incidences of nausea and vomiting after surgery. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects.\nData collection and analysis\nTwo review authors independently extracted the data and assessed the risk of bias domains for each trial. We used a random-effects model and reported risk ratio (RR) with associated 95% confidence interval (95% CI). We used trial sequential analyses to help provide information on when we had reached firm evidence in cumulative meta-analyses of the primary outcomes, based on a 30% risk ratio reduction in PONV.\nMain results\nWe included 59 trials involving 7667 participants. We rated two trials at low risk of bias in all domains (selection, attrition, reporting, blinding and other). We rated 25 trials at high risk in one or more risk-of-bias domains. Compared with sham treatment, PC6 acupoint stimulation significantly reduced the incidence of nausea (RR 0.68, 95% CI 0.60 to 0.77; 40 trials, 4742 participants), vomiting (RR 0.60, 95% CI 0.51 to 0.71; 45 trials, 5147 participants) and the need for rescue antiemetics (RR 0.64, 95% CI 0.55 to 0.73; 39 trials, 4622 participants). As heterogeneity among trials was substantial and there were study limitations, we rated the quality of evidence as low. Using trial sequential analysis, the required information size and boundary for benefit were reached for both primary outcomes.\nPC6 acupoint stimulation was compared with six different types of antiemetic drugs (metoclopramide, cyclizine, prochlorperazine, droperidol. ondansetron and dexamethasone). There was no difference between PC6 acupoint stimulation and antiemetic drugs in the incidence of nausea (RR 0.91, 95% CI 0.75 to 1.10; 14 trials, 1332 participants), vomiting (RR 0.93, 95% CI 0.74 to 1.17; 19 trials, 1708 participants), or the need for rescue antiemetics (RR 0.87, 95% CI 0.65 to 1.16; 9 trials, 895 participants). We rated the quality of evidence as moderate, due to the study limitations. Using trial sequential analyses, the futility boundary was crossed before the required information size was surpassed for both primary outcomes.\nCompared to antiemetic drugs, the combination of PC6 acupoint stimulation and antiemetic therapy reduced the incidence of vomiting (RR 0.56, 95% CI 0.35 to 0.91; 9 trials, 687 participants) but not nausea (RR 0.79, 95% CI 0.55 to 1.13; 8 trials, 642 participants). We rated the quality of evidence as very low, due to substantial heterogeneity among trials, study limitations and imprecision. Using trial sequential analysis, none of the boundaries for benefit, harm or futility were crossed for PONV. The need for rescue antiemetic was lower in the combination PC6 acupoint stimulation and antiemetic group than the antiemetic group (RR 0.61, 95% CI 0.44 to 0.86; 5 trials, 419 participants).\nThe side effects associated with PC6 acupoint stimulation were minor, transient and self-limiting (e.g. skin irritation, blistering, redness and pain) in 14 trials. Publication bias was not apparent in the contour-enhanced funnel plots.\nAuthors' conclusions\nThere is low-quality evidence supporting the use of PC6 acupoint stimulation over sham. Compared to the last update in 2009, no further sham comparison trials are needed. We found that there is moderate-quality evidence showing no difference between PC6 acupoint stimulation and antiemetic drugs to prevent PONV. Further PC6 acupoint stimulation versus antiemetic trials are futile in showing a significant difference, which is a new finding in this update. There is inconclusive evidence supporting the use of a combined strategy of PC6 acupoint stimulation and antiemetic drug over drug prophylaxis, and further high-quality trials 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": "We found 59 relevant studies, conducted between 1986 and 2015, involving 7667 participants undergoing elective surgery. Seven of the trials were conducted in 727 children. The PC6 acupoint stimulation varied from invasive techniques, such as traditional acupuncture needles, to noninvasive techniques, such as acupressure wristbands. PC6 acupoint stimulation was compared with six different types of antiemetic drugs (metoclopramide, cyclizine, prochlorperazine, droperidol. ondansetron and dexamethasone)."
}
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query-laysum | 1969 | [
{
"role": "user",
"content": "Abstract: Background\nCongenital cataracts are lens opacities in one or both eyes of babies or children present at birth. These may cause a reduction in vision severe enough to require surgery. Cataracts are proportionally the most treatable cause of visual loss in childhood, and are a particular problem in low-income countries, where early intervention may not be possible. Paediatric cataracts provide different challenges to those in adults. Intense inflammation, amblyopia (vision is obstructed by cataract from birth which prevents normal development of the visual system), posterior capsule opacification and uncertainty about the final trajectory of ocular growth parameters can affect results of treatment. Two options currently considered for children under 2 years of age with bilateral congenital cataracts are: (i) intraocular lens (IOL) implantation; or (ii) leaving a child with primary aphakia (no lens in the eye), necessitating the need for contact lenses or aphakic glasses. Other important considerations regarding surgery include the prevention of visual axis opacification (VAO), glaucoma and the route used to perform lensectomy.\nObjectives\nTo assess the effectiveness of infant cataract surgery or lensectomy to no surgery for bilateral congenital cataracts in children aged 2 years and under.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 1); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 25 January 2022.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared infant cataract surgery or lensectomy to no surgery, in children with bilateral congenital cataracts aged 2 years and younger. This update (of a review published in 2001 and updated in 2006) does not include children over 2 years of age because they have a wider variety of aetiologies, and are therefore managed differently, and have contrasting outcomes.\nData collection and analysis\nWe used standard methods expected by Cochrane. Two review authors extracted data independently. We assessed the risk of bias of included studies using RoB 1 and assessed the certainty of the evidence using GRADE.\nMain results\nWe identified three RCTs that met our inclusion criteria with each trial comparing a different aspect of surgical intervention for this condition. The trials included a total of 79 participants under 2 years of age, were conducted in India and follow-up ranged from 1 to 5 years. Study participants and outcome assessors were not masked in these trials.\nOne study (60 children) compared primary IOL implantation with primary aphakia. The results from this study suggest that there may be little or no difference in visual acuity at 5 years comparing children with pseudophakia (mean logMAR 0.50) and aphakia (mean logMAR 0.59) (mean difference (MD) -0.09 logMAR, 95% confidence intervals (CIs) -0.24 to 0.06; 54 participants; very low-certainty evidence), but the evidence is very uncertain. The evidence is very uncertain as to the effect of IOL implantation compared with aphakia on visual axis opacification (VAO) (risk ratio (RR) 1.29, 95% CI 0.23 to 7.13; 54 participants; very low-certainty evidence). The trial investigators did not report on the cases of amblyopia. There was little evidence of a difference betwen the two groups in cases of glaucoma at 5 years follow-up (RR 0.86, 95% CI 0.24 to 3.10; 54 participants; very low-certainty evidence). Cases of retinal detachment and reoperation rates were not reported. The impact of IOL implantation on adverse effects is very uncertain because of the sparse data available: of the children who were pseudophakic, 1/29 needed a trabeculectomy and 8/29 developed posterior synechiae. In comparison, no trabeculectomies were needed in the aphakic group and 2/25 children had posterior synechiae (54 participants; very low-certainty evidence).\nThe second study (14 eyes of 7 children under 2 years of age) compared posterior optic capture of IOL without vitrectomy versus endocapsular implantations with anterior vitrectomy (commonly called 'in-the-bag surgery'). The authors did not report on visual acuity, amblyopia, glaucoma and reoperation rate. They had no cases of VAO in either group. The evidence is very uncertain as to the effect of in-the-bag implantation in children aged under 1 year. There was a higher incidence of inflammatory sequelae: 4/7 in-the-bag implantation eyes and 1/7 in optic capture eyes (P = 0.04, 7 participants; very low-certainty evidence). We graded the certainty of evidence as low or very low for imprecision in all outcomes because their statistical analysis reported that a sample size of 13 was needed in each group to achieve a power of 80%, whereas their subset of children under the age of 1 year had only 7 eyes in each group.\nThe third study (24 eyes of 12 children) compared a transcorneal versus pars plana route using a 25-gauge transconjunctival sutureless vitrectomy system. The evidence is very uncertain as to the effect of the route chosen on the incidence of VAO, with no cases reported at 1 year follow-up in either group. The investigators did not report on visual acuity, amblyopia, glaucoma, retinal detachment and reoperation rate. The pars plana route had the adverse effects of posterior capsule rupture in 2/12 eyes, and 1/12 eyes needing sutures. Conversely, 1/12 eyes operated on by the transcorneal route needed sutures. We graded the outcomes with very low-certainty because of the small sample size and the absence of a priori sample size calculation.\nAuthors' conclusions\nThere is no high level evidence for the effectiveness of one type of surgery for bilateral congenital cataracts over another, or whether surgery itself is better than primary aphakia. Further RCTs are required to inform modern practice about concerns, including the timing of surgery, age at which surgery should be undertaken, age for implantation of an IOL and development of complications, such as reoperations, glaucoma and retinal detachment. Standardising the methods used to measure visual function, along with objective monitoring of compliance with the use of aphakic glasses/contact lenses would greatly improve the quality of study data and enable more reliable interpretation of outcomes.\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 which surgical approach improves vision the most, or causes the fewest complications, or both, in children aged 2 years and under."
}
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query-laysum | 1970 | [
{
"role": "user",
"content": "Abstract: Background\nSince the early 2010s, there has been a push to enhance the capacity to effectively treat wasting in children through community-based service delivery models and thus reduce morbidity and mortality.\nObjectives\nTo assess the effectiveness of identification and treatment of moderate and severe wasting in children aged five years or under by lay health workers working in the community compared with health providers working in health facilities.\nSearch methods\nWe searched MEDLINE, CENTRAL, two other databases, and two ongoing trials registers to 24 September 2021. We also screened the reference lists of related systematic reviews and all included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and non-randomised studies in children aged five years or under with moderate wasting (defined as weight-for-height Z-score (WHZ) below −2 but no lower than ≥ −3, or mid-upper-arm circumference (MUAC) below 125 mm but no lower than 115 mm, and no nutritional oedema) or severe wasting (WHZ below −3 or MUAC below 115 mm or nutritional oedema).\nEligible interventions were:\n• identification by lay health workers (LHWs) of children with wasting (intervention 1);\n• identification by LHWs of children with wasting and medical complications needing referral (intervention 2); and\n• identification by LHWs of children with wasting without medical complications needing referral (intervention 3).\nEligible comparators were:\n• identification and treatment of wasting by health professionals such as nurses or doctors (at health facilities); and\n• identification and treatment of wasting by health facility-based teams, including health professionals and LHWs.\nData collection and analysis\nTwo review authors independently screened trials, extracted data and assessed risk of bias using the Cochrane risk of bias tool (RoB 2) and Cochrane Effective Practice and Organisation of Care (EPOC) guidelines. We used a random-effects model to meta-analyse data, producing risk ratios (RRs) for dichotomous outcomes in trials with individual allocation, adjusted RRs for dichotomous outcomes in trials with cluster allocation (using the generic inverse variance method in Review Manager 5), and mean differences (MDs) for continuous outcomes. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included two RCTs and five non-RCTs. Six studies were from African countries, and one was from Pakistan. Six studies included children with severe wasting, and one included children with moderate wasting. All studies offered home-based ready-to-use therapeutic food treatment and monitoring. Children received antibiotics in three studies, vitamins or micronutrients in three studies, and deworming treatment in two studies. In three studies, the comparison arm involved LHWs screening children for malnutrition and referring them to health facilities for diagnosis and treatment.\nAll the non-randomised studies had a high overall risk of bias.\nInterventions 1 and 2\nIdentification and referral for treatment by LHWs, compared with treatment by health professionals following self-referral, may result in little or no difference in the percentage of children who recover from moderate or severe wasting (MD 1.00%, 95% confidence interval (CI) −2.53 to 4.53; 1 RCT, 29,475 households; low certainty).\nIntervention 3\nCompared with treatment by health professionals following identification by LHWs, identification and treatment of severe wasting in children by LHWs:\n• may slightly reduce improvement from severe wasting (RR 0.93, 95% CI 0.86 to 0.99; 1 RCT, 789 participants; low certainty);\n• may slightly increase non-response to treatment (RR 1.44, 95% CI 1.04 to 2.01; 1 RCT, 789 participants; low certainty);\n• may result in little or no difference in the number of children with WHZ above −2 on discharge (RR 0.94, 95% CI 0.28 to 3.18; 1 RCT, 789 participants; low certainty);\n• probably results in little or no difference in the number of children with WHZ between −3 and −2 on discharge (RR 1.09, 95% CI 0.87 to 1.36; 1 RCT, 789 participants; moderate certainty);\n• probably results in little or no difference in the number of children with WHZ below −3 (severe wasting) on discharge (RR 1.23, 95% CI 0.75 to 2.04; 1 RCT, 789 participants; moderate certainty);\n• probably results in little or no difference in the number of children with MUAC equal to or greater than 115 mm on discharge (RR 0.99, 95% CI 0.93 to 1.06; 1 RCT, 789 participants; moderate certainty);\n• results in little or no difference in weight gain per day (mean weight gain 0.50 g/kg/day higher, 95% CI 1.74 lower to 2.74 higher; 1 RCT, 571 participants; high certainty);\n• probably has little or no effect on relapse of severe wasting (RR 1.03, 95% CI 0.69 to 1.54; 1 RCT, 649 participants; moderate certainty);\n• may have little or no effect on mortality among children with severe wasting (RR 0.46, 95% CI 0.04 to 5.98; 1 RCT, 829 participants; low certainty);\n• probably has little or no effect on the transfer of children with severe wasting to inpatient care (RR 3.71, 95% CI 0.36 to 38.23; 1 RCT, 829 participants; moderate certainty); and\n• probably has little or no effect on the default of children with severe wasting (RR 1.48, 95% CI 0.65 to 3.40; 1 RCT, 829 participants; moderate certainty).\nThe evidence was very uncertain for total MUAC gain, MUAC gain per day, total weight gain, treatment coverage, and transfer to another LHW site or health facility.\nNo studies examined sustained recovery, deterioration to severe wasting, appropriate identification of children with wasting or oedema, appropriate referral of children with moderate or severe wasting, adherence, or adverse effects and other harms.\nAuthors' conclusions\nIdentification and treatment of severe wasting in children who do not require inpatient care by LHWs, compared with treatment by health professionals, may lead to similar or slightly poorer outcomes. We found only two RCTs, and the evidence from non-randomised studies was of very low certainty for all outcomes due to serious risks of bias and imprecision. No studies included children aged under 6 months. Future studies must address these methodological issues.\n\nGiven the provided abstract, please respond to the following query: \"What is wasting?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Childhood wasting refers to children being too thin for their height. Wasting happens when the child does not have enough food or enough healthy food, or because of disease. Children suffering from wasting are more often sick, can have developmental problems, and are more likely to die, particularly when the wasting is severe. Millions of children suffer from wasting, and most of them live in poor countries.\nThe best solution to this problem is to stop wasting occurring in the first place. When this is not possible, it is important to identify and treat children with wasting as soon as possible. However, treatment can take weeks or months, and it may be difficult or expensive for families to access care. As a result, many children are not getting the help they need."
}
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query-laysum | 1971 | [
{
"role": "user",
"content": "Abstract: Background\nExercise training is commonly recommended for individuals with fibromyalgia. This review is one of a series of reviews about exercise training for people with fibromyalgia that will replace the \"Exercise for treating fibromyalgia syndrome\" review first published in 2002.\nObjectives\n• To evaluate the benefits and harms of aerobic exercise training for adults with fibromyalgia\n• To assess the following specific comparisons\n० Aerobic versus control conditions (eg, treatment as usual, wait list control, physical activity as usual)\n० Aerobic versus aerobic interventions (eg, running vs brisk walking)\n० Aerobic versus non-exercise interventions (eg, medications, education)\n\nWe did not assess specific comparisons involving aerobic exercise versus other exercise interventions (eg, resistance exercise, aquatic exercise, flexibility exercise, mixed exercise). Other systematic reviews have examined or will examine these comparisons (Bidonde 2014; Busch 2013).\nSearch methods\nWe searched the Cochrane Library, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Physiotherapy Evidence Database (PEDro), Thesis and Dissertation Abstracts, the Allied and Complementary Medicine Database (AMED), the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and the ClinicalTrials.gov registry up to June 2016, unrestricted by language, and we reviewed the reference lists of retrieved trials to identify potentially relevant trials.\nSelection criteria\nWe included randomized controlled trials (RCTs) in adults with a diagnosis of fibromyalgia that compared aerobic training interventions (dynamic physical activity that increases breathing and heart rate to submaximal levels for a prolonged period) versus no exercise or another intervention. Major outcomes were health-related quality of life (HRQL), pain intensity, stiffness, fatigue, physical function, withdrawals, and adverse events.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, performed a risk of bias assessment, and assessed the quality of the body of evidence for major outcomes using the GRADE approach. We used a 15% threshold for calculation of clinically relevant differences between groups.\nMain results\nWe included 13 RCTs (839 people). Studies were at risk of selection, performance, and detection bias (owing to lack of blinding for self-reported outcomes) and had low risk of attrition and reporting bias. We prioritized the findings when aerobic exercise was compared with no exercise control and present them fully here.\nEight trials (with 456 participants) provided low-quality evidence for pain intensity, fatigue, stiffness, and physical function; and moderate-quality evidence for withdrawals and HRQL at completion of the intervention (6 to 24 weeks). With the exception of withdrawals and adverse events, major outcome measures were self-reported and were expressed on a 0 to 100 scale (lower values are best, negative mean differences (MDs)/standardized mean differences (SMDs) indicate improvement). Effects for aerobic exercise versus control were as follows: HRQL: mean 56.08; five studies; N = 372; MD -7.89, 95% CI -13.23 to -2.55; absolute improvement of 8% (3% to 13%) and relative improvement of 15% (5% to 24%); pain intensity: mean 65.31; six studies; N = 351; MD -11.06, 95% CI -18.34 to -3.77; absolute improvement of 11% (95% CI 4% to 18%) and relative improvement of 18% (7% to 30%); stiffness: mean 69; one study; N = 143; MD -7.96, 95% CI -14.95 to -0.97; absolute difference in improvement of 8% (1% to 15%) and relative change in improvement of 11.4% (21.4% to 1.4%); physical function: mean 38.32; three studies; N = 246; MD -10.16, 95% CI -15.39 to -4.94; absolute change in improvement of 10% (15% to 5%) and relative change in improvement of 21.9% (33% to 11%); and fatigue: mean 68; three studies; N = 286; MD -6.48, 95% CI -14.33 to 1.38; absolute change in improvement of 6% (12% improvement to 0.3% worse) and relative change in improvement of 8% (16% improvement to 0.4% worse). Pooled analysis resulted in a risk ratio (RR) of moderate quality for withdrawals (17 per 100 and 20 per 100 in control and intervention groups, respectively; eight studies; N = 456; RR 1.25, 95%CI 0.89 to 1.77; absolute change of 5% more withdrawals with exercise (3% fewer to 12% more).\nThree trials provided low-quality evidence on long-term effects (24 to 208 weeks post intervention) and reported that benefits for pain and function persisted but did not for HRQL or fatigue. Withdrawals were similar, and investigators did not assess stiffness and adverse events.\nWe are uncertain about the effects of one aerobic intervention versus another, as the evidence was of low to very low quality and was derived from single trials only, precluding meta-analyses. Similarly, we are uncertain of the effects of aerobic exercise over active controls (ie, education, three studies; stress management training, one study; medication, one study) owing to evidence of low to very low quality provided by single trials. Most studies did not measure adverse events; thus we are uncertain about the risk of adverse events associated with aerobic exercise.\nAuthors' conclusions\nWhen compared with control, moderate-quality evidence indicates that aerobic exercise probably improves HRQL and all-cause withdrawal, and low-quality evidence suggests that aerobic exercise may slightly decrease pain intensity, may slightly improve physical function, and may lead to little difference in fatigue and stiffness. Three of the reported outcomes reached clinical significance (HRQL, physical function, and pain). Long-term effects of aerobic exercise may include little or no difference in pain, physical function, and all-cause withdrawal, and we are uncertain about long-term effects on remaining outcomes. We downgraded the evidence owing to the small number of included trials and participants across trials, and because of issues related to unclear and high risks of bias (performance, selection, and detection biases). Aerobic exercise appears to be well tolerated (similar withdrawal rates across groups), although evidence on adverse events is scarce, so we are uncertain about its safety.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies until June 2016, and found 13 studies (839 individuals). Most studies (61.5%) included only female participants. Average age of participants was 41 years (minimum 32 to maximum 56 years). According to the inclusion/exclusion criteria, most participants were not doing exercises before starting the study.\nAerobic interventions were compared with controls (wait list, treatment as usual, daily activities as usual) over six to 24 weeks. On average, exercise sessions were provided two to three times per week for 35 minutes each session. Exercises involved walking, cycling, running, and doing low-impact aerobics and aquacise. Participants exercised at different intensities, starting light and increasing as the study progressed. All programs were supervised."
}
]
|
query-laysum | 1972 | [
{
"role": "user",
"content": "Abstract: Background\nDifferent first-line drug classes for patients with hypertension are often assumed to have similar effectiveness with respect to reducing mortality and morbidity outcomes, and lowering blood pressure. First-line low-dose thiazide diuretics have been previously shown to have the best mortality and morbidity evidence when compared with placebo or no treatment. Head-to-head comparisons of thiazides with other blood pressure-lowering drug classes would demonstrate whether there are important differences.\nObjectives\nTo compare the effects of first-line diuretic drugs with other individual first-line classes of antihypertensive drugs on mortality, morbidity, and withdrawals due to adverse effects in patients with hypertension. Secondary objectives included assessments of the need for added drugs, drug switching, and blood pressure-lowering.\nSearch methods\nCochrane Hypertension's Information Specialist searched the Cochrane Hypertension Specialized Register, CENTRAL, MEDLINE, Embase, and trials registers to March 2021. We also checked references and contacted study authors to identify additional studies. A top-up search of the Specialized Register was carried out in June 2022.\nSelection criteria\nRandomized active comparator trials of at least one year's duration were included. Trials had a clearly defined intervention arm of a first-line diuretic (thiazide, thiazide-like, or loop diuretic) compared to another first-line drug class: beta-blockers, calcium channel blockers, alpha adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, direct renin inhibitors, or other antihypertensive drug classes. Studies had to include clearly defined mortality and morbidity outcomes (serious adverse events, total cardiovascular events, stroke, coronary heart disease (CHD), congestive heart failure, and withdrawals due to adverse effects).\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 20 trials with 26 comparator arms randomizing over 90,000 participants. The findings are relevant to first-line use of drug classes in older male and female hypertensive patients (aged 50 to 75) with multiple co-morbidities, including type 2 diabetes. First-line thiazide and thiazide-like diuretics were compared with beta-blockers (six trials), calcium channel blockers (eight trials), ACE inhibitors (five trials), and alpha-adrenergic blockers (three trials); other comparators included angiotensin II receptor blockers, aliskiren (a direct renin inhibitor), and clonidine (a centrally acting drug). Only three studies reported data for total serious adverse events: two studies compared diuretics with calcium channel blockers and one with a direct renin inhibitor.\nCompared to first-line beta-blockers, first-line thiazides probably result in little to no difference in total mortality (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.84 to 1.10; 5 trials, 18,241 participants; moderate-certainty), probably reduce total cardiovascular events (5.4% versus 4.8%; RR 0.88, 95% CI 0.78 to 1.00; 4 trials, 18,135 participants; absolute risk reduction (ARR) 0.6%, moderate-certainty), may result in little to no difference in stroke (RR 0.85, 95% CI 0.66 to 1.09; 4 trials, 18,135 participants; low-certainty), CHD (RR 0.91, 95% CI 0.78 to 1.07; 4 trials, 18,135 participants; low-certainty), or heart failure (RR 0.69, 95% CI 0.40 to 1.19; 1 trial, 6569 participants; low-certainty), and probably reduce withdrawals due to adverse effects (10.1% versus 7.9%; RR 0.78, 95% CI 0.71 to 0.85; 5 trials, 18,501 participants; ARR 2.2%; moderate-certainty).\nCompared to first-line calcium channel blockers, first-line thiazides probably result in little to no difference in total mortality (RR 1.02, 95% CI 0.96 to 1.08; 7 trials, 35,417 participants; moderate-certainty), may result in little to no difference in serious adverse events (RR 1.09, 95% CI 0.97 to 1.24; 2 trials, 7204 participants; low-certainty), probably reduce total cardiovascular events (14.3% versus 13.3%; RR 0.93, 95% CI 0.89 to 0.98; 6 trials, 35,217 participants; ARR 1.0%; moderate-certainty), probably result in little to no difference in stroke (RR 1.06, 95% CI 0.95 to 1.18; 6 trials, 35,217 participants; moderate-certainty) or CHD (RR 1.00, 95% CI 0.93 to 1.08; 6 trials, 35,217 participants; moderate-certainty), probably reduce heart failure (4.4% versus 3.2%; RR 0.74, 95% CI 0.66 to 0.82; 6 trials, 35,217 participants; ARR 1.2%; moderate-certainty), and may reduce withdrawals due to adverse effects (7.6% versus 6.2%; RR 0.81, 95% CI 0.75 to 0.88; 7 trials, 33,908 participants; ARR 1.4%; low-certainty).\nCompared to first-line ACE inhibitors, first-line thiazides probably result in little to no difference in total mortality (RR 1.00, 95% CI 0.95 to 1.07; 3 trials, 30,961 participants; moderate-certainty), may result in little to no difference in total cardiovascular events (RR 0.97, 95% CI 0.92 to 1.02; 3 trials, 30,900 participants; low-certainty), probably reduce stroke slightly (4.7% versus 4.1%; RR 0.89, 95% CI 0.80 to 0.99; 3 trials, 30,900 participants; ARR 0.6%; moderate-certainty), probably result in little to no difference in CHD (RR 1.03, 95% CI 0.96 to 1.12; 3 trials, 30,900 participants; moderate-certainty) or heart failure (RR 0.94, 95% CI 0.84 to 1.04; 2 trials, 30,392 participants; moderate-certainty), and probably reduce withdrawals due to adverse effects (3.9% versus 2.9%; RR 0.73, 95% CI 0.64 to 0.84; 3 trials, 25,254 participants; ARR 1.0%; moderate-certainty).\nCompared to first-line alpha-blockers, first-line thiazides probably result in little to no difference in total mortality (RR 0.98, 95% CI 0.88 to 1.09; 1 trial, 24,316 participants; moderate-certainty), probably reduce total cardiovascular events (12.1% versus 9.0%; RR 0.74, 95% CI 0.69 to 0.80; 2 trials, 24,396 participants; ARR 3.1%; moderate-certainty) and stroke (2.7% versus 2.3%; RR 0.86, 95% CI 0.73 to 1.01; 2 trials, 24,396 participants; ARR 0.4%; moderate-certainty), may result in little to no difference in CHD (RR 0.98, 95% CI 0.86 to 1.11; 2 trials, 24,396 participants; low-certainty), probably reduce heart failure (5.4% versus 2.8%; RR 0.51, 95% CI 0.45 to 0.58; 1 trial, 24,316 participants; ARR 2.6%; moderate-certainty), and may reduce withdrawals due to adverse effects (1.3% versus 0.9%; RR 0.70, 95% CI 0.54 to 0.89; 3 trials, 24,772 participants; ARR 0.4%; low-certainty).\nFor the other drug classes, data were insufficient. No antihypertensive drug class demonstrated any clinically important advantages over first-line thiazides.\nAuthors' conclusions\nWhen used as first-line agents for the treatment of hypertension, thiazides and thiazide-like drugs likely do not change total mortality and likely decrease some morbidity outcomes such as cardiovascular events and withdrawals due to adverse effects, when compared to beta-blockers, calcium channel blockers, ACE inhibitors, and alpha-blockers.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to March 2021."
}
]
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query-laysum | 1973 | [
{
"role": "user",
"content": "Abstract: Background\nPrimary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not associated with other systemic or ocular abnormalities. PCG results in considerable morbidity even in high-income countries.\nObjectives\nTo compare the effectiveness and safety of different surgical techniques for PCG.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue 4); Ovid MEDLINE; Embase.com; PubMed; metaRegister of Controlled Trials (mRCT) (last searched 23 June 2014); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 27 April 2020.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs comparing different surgical interventions in children under five years of age with PCG.\nData collection and analysis\nWe used standard Cochrane methodology.\nMain results\nWe included 16 trials (13 RCTs and three quasi-RCTs) with 587 eyes in 446 children. Eleven (69%) trials were conducted in Egypt and the Middle East, three in India, and two in the USA. All included trials involved children younger than five years of age, with follow-up ranging from six to 80 months.\nThe interventions compared varied across trials. Three trials (on 68 children) compared combined trabeculotomy and trabeculectomy (CTT) with trabeculotomy. Meta-analysis of these trials suggests there may be little to no evidence of a difference between groups in mean IOP (mean difference (MD) 0.27 mmHg, 95% confidence interval (CI) −0.74 to 1.29; 88 eyes; 2 studies) and surgical success (risk ratio (RR) 1.01, 95% CI 0.90 to 1.14; 102 eyes; 3 studies) at one year postoperatively. We assessed the certainty of evidence as very low for these outcomes, downgrading for risk of bias (-1) and imprecision (-2). Hyphema was the most common adverse outcome in both groups (no meta-analysis due to considerable heterogeneity; I2 = 83%).\nTwo trials (on 39 children) compared viscotrabeculotomy to conventional trabeculotomy. Meta-analysis of 42 eyes suggests there is no evidence of between groups difference in mean IOP (MD −1.64, 95% CI −5.94 to 2.66) and surgical success (RR 1.11, 95% CI 0.70 to 1.78) at six months postoperatively. We assessed the certainty of evidence as very low, downgrading for risk of bias and imprecision due to small sample size. Hyphema was the most common adverse outcome (38% in viscotrabeculotomy and 28% in conventional trabeculotomy), with no evidence of difference difference (RR 1.33, 95% CI 0.63 to 2.83).\nTwo trials (on 95 children) compared microcatheter-assisted 360-degree circumferential trabeculotomy to conventional trabeculotomy. Meta-analysis of two trials suggests that mean IOP may be lower in the microcatheter group at six months (MD −2.44, 95% CI −3.69 to −1.19; 100 eyes) and at 12 months (MD −1.77, 95% CI −2.92 to −0.63; 99 eyes); and surgical success was more likely to be achieved in the microcatheter group compared to the conventional trabeculotomy group (RR 1.59, 95% CI 1.14 to 2.21; 60 eyes; 1 trial at 6 months; RR 1.54, 95% CI 1.20 to 1.97; 99 eyes; 2 trials at 12 months). We assessed the certainty of evidence for these outcomes as moderate due to small sample size. Hyphema was the most common adverse outcome (40% in the microcatheter group and 17% in the conventional trabeculotomy group), with greater likelihood of occurring in the microcatheter group (RR 2.25, 95% CI 1.25 to 4.04); the evidence was of moderate certainty due to small sample size (−1).\nOf the nine remaining trials, no two trials compared the same two surgical interventions: one trial compared CTT versus CTT with sclerectomy; three trials compared various suturing techniques and adjuvant use including mitomycin C, collagen implant in CTT; one trial compared CTT versus Ahmed valve implant in previously failed surgeries; one trial compared CTT with trabeculectomy; one trial compared trabeculotomy to goniotomy; and two trials compared different types of goniotomy. No trials reported quality of life or economic data.\nMany of the included trials had limitations in study design, implementation, and reporting, therefore the reliability and applicability of the evidence remains unclear.\nAuthors' conclusions\nThe evidence suggests that there may be little to no evidence of difference between CTT and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. A 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy. Considering the rarity of the disease, future research would benefit from a multicenter, possibly international trial, involving parents of children with PCG and with a follow-up of at least one year.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 16 studies with a total of 446 children with PCG. The children were followed for between six and 80 months after surgery. Eleven studies were conducted in Egypt and the Middle East, three in India, and two in the USA.\nTrabeculectomy plus trabeculotomy versus trabeculectomy alone\nThree studies (on 68 children) compared trabeculectomy combined with trabeculotomy, against trabeculectomy alone. The studies were poorly conducted and small, and results were inconsistent across the studies (very low-certainty evidence). So, we cannot tell from these studies which surgical approach is more successful or causes fewer unwanted effects.\nViscotrabeculotomy versus conventional trabeculotomy\nTwo studies (on 39 children) compared viscotrabeculotomy (a type of trabeculotomy that uses a thick liquid to create an opening in the eye’s drainage system) with conventional trabeculotomy. The studies were poorly conducted and small (very low-certainty evidence), so we cannot tell from these studies which surgical approach is more successful or causes fewer unwanted effects.\nTrabeculotomy (microcatheter assisted, 360-degree) versus conventional trabeculotomy\nTwo studies (on 95 children) compared another type of trabeculotomy (microcatheter-assisted 360-degree trabeculotomy)—where an opening is made all around the eye with the help of a very small, hollow tube—against conventional trabeculotomy. The evidence was of moderate certainty, because the studies were well conducted, but small. The evidence suggests that microcatheter-assisted 360-degree trabeculotomy probably reduces eye pressure slightly one year after surgery. Children given this treatment are probably more likely to have normal eye pressure (under 21 mmHg) one year after surgery than those who have conventional trabeculotomy. However, the evidence suggests that they are probably more likely to also experience hyphema, a side effect in which blood collects at the front of the eye, partially or completely blocking vision.\nOther surgical procedures\nNone of the remaining nine trials investigated the same surgical procedures. This means that for many surgical procedures for PCG, such as trabeculectomy on its own or goniotomy, there is too little evidence to determine whether one method is better or causes more unwanted effects than others."
}
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query-laysum | 1974 | [
{
"role": "user",
"content": "Abstract: Background\nInsecticide-treated nets (ITNs) and indoor residual spraying (IRS) are used to prevent malaria transmission. Both interventions use insecticides to kill mosquitoes that bite and rest indoors. Adding IRS to ITNs may improve malaria control simply because two interventions can be better than one. Furthermore, IRS may improve malaria control where ITNs are failing due to insecticide resistance. Pyrethroid insecticides are the predominant class of insecticide used for ITNs, as they are more safe than other insecticide classes when in prolonged contact with human skin. While many mosquito populations have developed some resistance to pyrethroid insecticides, a wider range of insecticides can be used for IRS. This review is an update of the previous Cochrane 2019 edition.\nObjectives\nTo summarize the effect on malaria of additionally implementing IRS, using non-pyrethroid-like or pyrethroid-like insecticides, in communities currently using ITNs.\nSearch methods\nWe searched the Cochrane Infectious Diseases Group Specialized Register; CENTRAL; MEDLINE; and five other databases for records from 1 January 2000 to 8 November 2021, on the basis that ITN programmes did not begin to be implemented as policy before the year 2000.\nSelection criteria\nWe included cluster-randomized controlled trials (cRCTs), interrupted time series (ITS), or controlled before-after studies (CBAs) comparing IRS plus ITNs with ITNs alone. We included studies with at least 50% ITN ownership (defined as the proportion of households owning one or more ITN) in both study arms.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility, analyzed risk of bias, and extracted data. We used risk ratio (RR) and 95% confidence intervals (CI). We stratified by type of insecticide, 'pyrethroid-like' and 'non-pyrethroid-like'; the latter could improve malaria control better than adding IRS insecticides that have the same way of working as the insecticide on ITNs ('pyrethroid-like'). We used subgroup analysis of ITN usage in the studies to explore heterogeneity. We assessed the certainty of evidence using the GRADE approach.\nMain results\nEight cRCTs (10 comparisons), one CBA, and one ITS study, all conducted since 2008 in sub-Saharan Africa, met our inclusion criteria. The primary vectors in all sites were mosquitoes belonging to the Anopheles gambiae s.l. complex species; five studies in Benin, Mozambique, Ghana, Sudan, and Tanzania also reported the vector Anopheles funestus. Five cRCTs and both quasi-experimental design studies used insecticides with targets different to pyrethroids (two used bendiocarb, three used pirimiphos-methyl, and one used propoxur. Each of these studies were conducted in areas where the vectors were described as resistant or highly resistant to pyrethroids. Two cRCTs used dichloro-diphenyl-trichlorethane (DDT), an insecticide with the same target as pyrethroids. The remaining cRCT used both types of insecticide (pyrethroid deltamethrin in the first year, switching to bendiocarb for the second year).\nIndoor residual spraying using 'non-pyrethroid-like' insecticides\nSix studies were included (four cRCTs, one CBA, and one ITS). Our main analysis for prevalence excluded a study at high risk of bias due to repeated sampling of the same population. This risk did not apply to other outcomes. Overall, the addition of IRS reduced malaria parasite prevalence (RR 0.61, 95% CI 0.42 to 0.88; 4 cRCTs, 16,394 participants; high-certainty evidence). IRS may also reduce malaria incidence on average (rate ratio 0.86, 95% CI 0.61 to 1.23; 4 cRCTs, 323,631 child-years; low-certainty evidence) but the effect was absent in two studies. Subgroup analyses did not explain the qualitative heterogeneity between studies. One cRCT reported no effect on malaria incidence or parasite prevalence in the first year, when a pyrethroid-like insecticide was used for IRS, but showed an effect on both outcomes in the second year, when a non-pyrethroid-like IRS was used.\nThe addition of IRS may also reduce anaemia prevalence (RR 0.71, 95% CI 0.38 to 1.31; 3 cRCTs, 4288 participants; low-certainty evidence). Four cRCTs reported the impact of IRS on entomological inoculation rate (EIR), with variable results; overall, we do not know if IRS had any effect on the EIR in communities using ITNs (very low-certainty evidence). Studies also reported the adult mosquito density and the sporozoite rate, but we could not summarize or pool these entomological outcomes due to differences in the reported data. Three studies measured the prevalence of pyrethroid resistance before and after IRS being introduced: there was no difference detected, but these data are limited.\nIndoor residual spraying using 'pyrethroid-like' insecticides\nAdding IRS using a pyrethroid-like insecticide did not appear to markedly alter malaria incidence (rate ratio 1.07, 95% CI 0.80 to 1.43; 2 cRCTs, 15,717 child-years; moderate-certainty evidence), parasite prevalence (RR 1.11, 95% CI 0.86 to 1.44; 3 cRCTs, 10,820 participants; moderate-certainty evidence), or anaemia prevalence (RR 1.12, 95% CI 0.89 to 1.40; 1 cRCT, 4186 participants; low-certainty evidence). Data on EIR were limited so no conclusion was made (very low-certainty evidence).\nAuthors' conclusions\nin communities using ITNs, the addition of IRS with 'non-pyrethroid-like' insecticides was associated with reduced malaria prevalence. Malaria incidence may also be reduced on average, but there was unexplained qualitative heterogeneity, and the effect may therefore not be observed in all settings.\nWhen using 'pyrethroid-like' insecticides, there was no detectable additional benefit of IRS in communities using ITNs.\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": "We searched for studies that evaluated the impact on malaria transmission when IRS, using a World Health Organization (WHO)-recommended dosage, was implemented in communities that were using either ready-treated ITN products or standard nets treated with insecticide at a WHO-recommended dose. We considered effects on both human health outcomes and on mosquito populations."
}
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query-laysum | 1975 | [
{
"role": "user",
"content": "Abstract: Background\nVilanterol (VI) is a long-acting beta2-agonist (LABA) that binds to the beta2-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy.\nFluticasone furoate (FF) is an inhaled corticosteroid (ICS), and ICS therapy is recommended by the BTS asthma guidelines. ICSs, the mainstay of asthma treatment, lead to a reduction in both airway inflammation and airway hyper-responsiveness. Regular use leads to improvement in symptoms and lung function. ICSs are currently recommended as 'preventer' therapy for patients who use a 'reliever' medication (e.g. short-acting beta2 agonist (SABA), salbutamol) three or more times per week. Most of the commonly used ICS treatments are twice-daily medications, although two once-daily products are currently licensed (ciclesonide and mometasone).\nAt the present time, only one once-daily ICS/LABA combination (FF/VI) is available, and several other combination inhalers are recommended for twice-daily administration.\nObjectives\nTo compare effects of VI and FF in combination versus placebo, or versus other ICSs and/or LABAs, on acute exacerbations and on health-related quality of life (HRQoL) in adults and children with chronic asthma.\nSearch methods\nWe searched the Cochrane Airways Group Register of trials, clinical trial registries, manufacturers' websites and reference lists of included studies up to June 2016.\nSelection criteria\nWe included randomised controlled trials (RCTs) of adults and children with a diagnosis of asthma. Included studies compared VI and FF combined versus placebo, or versus other ICSs and/or LABAs. Our primary outcomes were health-related quality of life, severe asthma exacerbation, as defined by hospital admissions or treatment with a course of oral corticosteroids, and serious adverse events.\nData collection and analysis\nTwo review authors independently extracted data and analysed outcomes using a fixed-effect model. We used standard Cochrane methods.\nMain results\nWe identified 14 studies that met our inclusion criteria, with a total of 6641 randomised participants, of whom 5638 completed the study. All studies lasted between two and 78 weeks and showed good methodological quality overall.\nWe included 10 comparisons in this review, seven for which the dose of VI and FF was 100/25 mcg (VI/FF 100/25 mcg vs placebo; VI/FF 100/25 mcg vs same dose of FF; VI/FF 100/25 mcg vs same dose of VI; VI/FF 100/25 mcg vs fluticasone propionate (FP) 500 mcg twice-daily; VI/FF 100/25 mcg vs fluticasone propionate/salmeterol (FP/SAL) 250/50 mcg twice-daily; VI/FF 100/25 mcg vs FP/SAL 250/25 mcg twice-daily; FF/VI 100/25 vs FP/SAL500/50) and three for which the dose of VI and FF was 200/25 mcg (VI/FF 200/25 mcg vs placebo; VI/FF 200/25 mcg vs FP 500 mcg; VI/FF 200/25 mcg vs same dose of FF).\nWe found very few opportunities to combine results from the 14 included studies in meta-analyses. We tabulated the data for our pre-specified primary outcomes. In particular, we found insufficient information to assess whether once-daily VI/FF was better or worse than twice-daily FP/SAL in terms of efficacy or safety.\nOnly one of the 14 studies looked at health-related quality of life when comparing VI and FF 100/25 mcg versus placebo and identified a significant advantage of VI/FF 100/25 mcg (mean difference (MD) 0.30, 95% confidence interval (CI) 0.14 to 0.46; 329 participants); we recognised this as moderate-quality evidence. Only two studies compared VI/FF 100/25 mcg versus placebo with respect to exacerbations; both studies reported no exacerbations in either treatment arm. Five studies (VI/FF 100/25 mcg vs placebo) sought information on serious adverse events; all five studies reported no serious adverse events in the VI/FF 100/25 mcg or placebo arms. We found no comparison relevant to our primary outcomes for VI/FF at a higher dose (200/25 mcg) versus placebo.\nThe small number of studies contributing to each comparison precludes the opportunity to draw robust conclusions for clinical practice. These studies were not of sufficient duration to allow conclusions about long-term side effects.\nAuthors' conclusions\nSome evidence suggests clear advantages for VI/FF, in combination, compared with placebo, particularly for forced expiratory volume in one second (FEV1) and peak expiratory flow; however, the variety of questions addressed in the included studies did not allow review authors to draw firm conclusions. Information was insufficient for assessment of whether once-daily VI/FF was better or worse than twice-daily FP/SAL in terms of efficacy or safety. It is clear that more research is required to reduce the uncertainties that surround interpretation of these studies. It will be necessary for these findings to be replicated in other work before more robust conclusions are revealed. Only five of the 13 included studies provided data on health-related quality of life, and only six recorded asthma exacerbations. Only one study focused on paediatric patients, so no conclusions can be drawn for the paediatric population. More research is needed, particularly in the primary outcome areas selected for this review, so that we can draw firmer conclusions in the next update of this review.\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": "Overall, the evidence presented in this review is taken from well-designed studies at low risk of bias in terms of decisions on who received which treatment, blinding and how to report outcomes for participants who did not finish the study. However, because we were not able to combine results for many of our outcomes of interest, or because the outcome was rare, we judged the quality of the evidence overall to be low to moderate."
}
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query-laysum | 1976 | [
{
"role": "user",
"content": "Abstract: Background\n'Keratinocyte cancer' is now the preferred term for the most commonly identified skin cancers basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), which were previously commonly categorised as non-melanoma skin cancers (NMSC). Keratinocyte cancer (KC) represents about 95% of malignant skin tumours. Lifestyle changes have led to increased exposure to the sun, which has, in turn, led to a significant increase of new cases of KC, with a worldwide annual incidence of between 3% and 8%. The successful use of preventive measures could mean a significant reduction in the resources used by health systems, compared with the high cost of the treatment of these conditions. At present, there is no information about the quality of the evidence for the use of these sun protection strategies with an assessment of their benefits and risks.\nObjectives\nTo assess the effects of sun protection strategies (i.e. sunscreen and barrier methods) for preventing keratinocyte cancer (that is, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) of the skin) in the general population.\nSearch methods\nWe searched the following databases up to May 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registries and the bibliographies of included studies for further references to relevant trials.\nSelection criteria\nWe included randomised controlled clinical trials (RCTs) of preventive strategies for keratinocyte cancer, such as physical barriers and sunscreens, in the general population (children and adults), which may provide information about benefits and adverse events related to the use of solar protection measures. We did not include trials focused on educational strategies to prevent KC or preventive strategies in high-risk groups. Our prespecified primary outcomes were BCC or cSCC confirmed clinically or by histopathology at any follow-up and adverse events.\nData collection and analysis\nTwo review authors independently selected studies for eligibility using Early Review Organizing Software (EROS). Similarly, two review authors independently used predesigned data collection forms to extract information from the original study reports about the participants, methods of randomisation, blinding, comparisons of interest, number of participants originally randomised by arm, follow-up losses, and outcomes, and they assessed the risk of bias. We resolved any disagreement by consulting a third author and contacted trial investigators of identified trials to obtain additional information. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included one RCT (factorial design) that randomised 1621 participants.\nThis study compared the daily application of sunscreen compared with discretionary use of sunscreen, with or without beta-carotene administration, in the general population. The study was undertaken in Australia; 55.2% of participants had fair skin, and they were monitored for 4.5 years for new cases of BCC or cSCC assessed by histopathology. We found this study to be at low risk of bias for domains such as allocation, blinding, and incomplete outcome data. However, we found multiple unclear risks related to other biases, including an unclear assessment of possible interactions between the effects of the different interventions evaluated (that is, sunscreen and beta-carotene). We found no difference in terms of the number of participants developing BCC (n = 1621; risk ratio (RR) 1.03, 95% confidence interval (CI) 0.74 to 1.43) or cSCC (n = 1621; RR 0.88, 95% CI 0.50 to 1.54) when comparing daily application of sunscreen with discretionary use, even when analyses were restricted to groups without beta-carotene supplementation. This evidence was of low quality, which means that there is some certainty that future studies may alter our confidence in this evidence.\nWe reported adverse events in a narrative way and included skin irritation or contact allergy.\nWe identified no studies that evaluated other sun protection measures, such as the use of sun-protective clothing, sunglasses, or hats, or seeking the shade when outdoors.\nAuthors' conclusions\nIn this review, we assessed the effect of solar protection in preventing the occurrence of new cases of keratinocyte cancer. We only found one study that was suitable for inclusion. This was a study of sunscreens, so we were unable to assess any other forms of sun protection. The study addressed our prespecified primary outcomes, but not most of our secondary outcomes. We were unable to demonstrate from the available evidence whether sunscreen was effective for the prevention of basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).\nOur certainty in the evidence was low because there was a lack of histopathological confirmation of BCC or cSCC in a significant percentage of cases. Amongst other sources of bias, it was not clear whether the study authors had assessed any interaction effects between the sunscreen and beta-carotene interventions. We think that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.\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": "This review included studies identified up to May 2016."
}
]
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query-laysum | 1977 | [
{
"role": "user",
"content": "Abstract: Background\nNon-absorbable disaccharides (lactulose and lactitol) are recommended as first-line treatment for hepatic encephalopathy. The previous (second) version of this review included 10 randomised clinical trials (RCTs) evaluating non-absorbable disaccharides versus placebo/no intervention and eight RCTs evaluating lactulose versus lactitol for people with cirrhosis and hepatic encephalopathy. The review found no evidence to either support or refute the use of the non-absorbable disaccharides and no differences between lactulose versus lactitol.\nObjectives\nTo assess the beneficial and harmful effects of i) non-absorbable disaccharides versus placebo/no intervention and ii) lactulose versus lactitol in people with cirrhosis and hepatic encephalopathy.\nSearch methods\nWe carried out electronic searches of the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 10), MEDLINE, EMBASE, and Science Citation Index Expanded to 19 October 2015; manual searches of meetings and conference proceedings; checks of bibliographies; and correspondence with investigators and pharmaceutical companies.\nSelection criteria\nWe included RCTs, irrespective of publication status, language, or blinding.\nData collection and analysis\nTwo review authors, working independently, retrieved data from published reports and correspondence with investigators. The primary outcomes were mortality, hepatic encephalopathy, and serious adverse events. We presented the results of meta-analyses as risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI). We assessed the quality of the evidence using 'Grading of Recommendations Assessment Development and Evaluation' (GRADE) and bias control using the Cochrane Hepato-Biliary Group domains. Our analyses included regression analyses of publication bias and other small study effects, Trial Sequential Analyses to detect type 1 and type 2 errors, and subgroup and sensitivity analyses.\nMain results\nWe included 38 RCTs with a total of 1828 participants. Eight RCTs had a low risk of bias in the assessment of mortality. All trials had a high risk of bias in the assessment of the remaining outcomes. Random-effects meta-analysis showed a beneficial effect of non-absorbable disaccharides versus placebo/no intervention on mortality when including all RCTs with extractable data (RR 0.59, 95% CI 0.40 to 0.87; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence) and in the eight RCTs with a low risk of bias (RR 0.63, 95% CI 0.41 to 0.97; 705 participants). The Trial Sequential Analysis with the relative risk reduction (RRR) reduced to 30% confirmed the findings when including all RCTs, but not when including only RCTs with a low risk of bias or when we reduced the RRR to 22%. Compared with placebo/no intervention, the non-absorbable disaccharides were associated with beneficial effects on hepatic encephalopathy (RR 0.58, 95% CI 0.50 to 0.69; 1415 participants; 22 RCTs; I2 = 32%; moderate quality evidence). Additional analyses showed that non-absorbable disaccharides can help to reduce serious adverse events associated with the underlying liver disease including liver failure, hepatorenal syndrome, and variceal bleeding (RR 0.47, 95% CI 0.36 to 0.60; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence). We confirmed the results in Trial Sequential Analysis. Tests for subgroup differences showed no statistical differences between RCTs evaluating prevention, overt, or minimal hepatic encephalopathy. The evaluation of secondary outcomes showed a potential beneficial effect of the non-absorbable disaccharides on quality of life, but we were not able to include the data in an overall meta-analysis (very low quality evidence). Non-absorbable disaccharides were associated with non-serious (mainly gastrointestinal) adverse events (very low quality evidence). None of the RCTs comparing lactulose versus lactitol evaluated quality of life. The review found no differences between lactulose and lactitol for the remaining outcomes (very low quality evidence).\nAuthors' conclusions\nThis review includes a large number of RCTs evaluating the prevention or treatment of hepatic encephalopathy. The analyses found evidence that non-absorbable disaccharides may be associated with a beneficial effect on clinically relevant outcomes compared with placebo/no intervention.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Seven RCTs received financial support and 11 RCTs received lactitol or inactive placebo free of charge from a pharmaceutical company."
}
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query-laysum | 1978 | [
{
"role": "user",
"content": "Abstract: Background\nApnea of prematurity is a common problem in preterm infants that may have significant consequences on their development. Methylxanthines (aminophylline, theophylline, and caffeine) are effective in the treatment of apnea of prematurity. Doxapram is used as a respiratory stimulant in cases refractory to the methylxanthine treatment.\nObjectives\nTo evaluate the benefits and harms of doxapram administration on the incidence of apnea and other short-term and longer-term clinical outcomes in preterm infants.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was March 2023.\nSelection criteria\nWe included randomized controlled trials (RCTs) assessing the role of doxapram in prevention and treatment of apnea of prematurity and prevention of reintubation in preterm infants (less than 37 weeks' gestation). We included studies comparing doxapram with either placebo or methylxanthines as a control group, or when doxapram was used as an adjunct to methylxanthines and compared to methylxanthines alone as a control group. We included studies of doxapram at any dose and route.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were clinical apnea, need for positive pressure ventilation after initiation of treatment, failed apnea reduction after two to seven days, and failed extubation (defined as unable to wean from invasive intermittent positive pressure ventilation [IPPV] and extubate or reintubation for IPPV within one week). We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included eight RCTs enrolling 248 infants. Seven studies (214 participants) provided data for meta-analysis. Five studied doxapram for treatment of apnea in preterm infants. Three studied doxapram to prevent reintubation in preterm infants. None studied doxapram in preventing apnea in preterm infants. All studies administered doxapram intravenously as continuous infusions. Two studies used doxapram as an adjunct to aminophylline compared to aminophylline alone and one study as an adjunct to caffeine compared to caffeine alone.\nWhen used to treat apnea, compared to no treatment, doxapram may result in a slight reduction in failed apnea reduction (risk ratio [RR] 0.45, 95% confidence interval [CI] 0.20 to 1.05; 1 study, 21 participants; low-certainty evidence). The evidence is very uncertain about the effect of doxapram on need for positive pressure ventilation after initiation of treatment (RR 0.31, 95% CI 0.01 to 6.74; 1 study, 21 participants; very low-certainty evidence). Doxapram may result in little to no difference in side effects causing cessation of therapy (0 events in both groups; risk difference [RD] 0.00, 95% CI −0.17 to 0.17; 1 study, 21 participants; low-certainty evidence). Compared to alternative treatment, the evidence is very uncertain about the effect of doxapram on failed apnea reduction (RR 1.35, 95% CI 0.53 to 3.45; 4 studies, 84 participants; very low-certainty evidence). The evidence is very uncertain about the effect of doxapram on need for positive pressure ventilation after initiation of treatment (RR 2.40, 95% CI 0.11 to 51.32; 2 studies, 37 participants; very-low certainty evidence; note 1 study recorded 0 events in both groups. Thus, the RR and CIs were calculated from 1 study rather than 2). Doxapram may result in little to no difference in side effects causing cessation of therapy (0 events in all groups; RD 0.00, 95% CI −0.15 to 0.15; 37 participants; 2 studies; low-certainty evidence). As adjunct therapy to methylxanthine, the evidence is very uncertain about the effect of doxapram on failed apnea reduction after two to seven days (RR 0.08, 95% CI 0.01 to 1.17; 1 study, 10 participants; very low-certainty evidence). No studies reported on clinical apnea, chronic lung disease at 36 weeks' postmenstrual age (PMA), death at any time during initial hospitalization, long-term neurodevelopmental outcomes in the three comparisons, and need for positive pressure ventilation and side effects when used as adjunct therapy to methylxanthine.\nIn studies to prevent reintubation, when compared to alternative treatment, the evidence is very uncertain about the effect of doxapram on failed extubation (RR 0.43, 95% CI 0.10 to 1.83; 1 study, 25 participants; very low-certainty evidence). As adjunct therapy to methylxanthine, doxapram may result in a slight reduction in 'clinical apnea' after initiation of treatment (RR 0.36, 95% CI 0.13 to 0.98; 1 study, 56 participants; low-certainty evidence). Doxapram may result in little to no difference in failed extubation (RR 0.92, 95% CI 0.52 to 1.62; 1 study, 56 participants; low-certainty evidence). The evidence is very uncertain about the effect of doxapram on side effects causing cessation of therapy (RR 6.42, 95% CI 0.80 to 51.26; 2 studies, 85 participants; very low-certainty evidence). No studies reported need for positive pressure ventilation, chronic lung disease at 36 weeks' PMA, long-term neurodevelopmental outcomes in the three comparisons; failed extubation when compared to no treatment; and clinical apnea, death at any time during initial hospitalization, and side effects when compared to no treatment or alternative treatment.\nWe identified two ongoing studies, one conducted in Germany and one in multiple centers in the Netherlands and Belgium.\nAuthors' conclusions\nIn treating apnea of prematurity, doxapram may slightly reduce failure in apnea reduction when compared to no treatment and there may be little to no difference in side effects against both no treatment and alternative treatment. The evidence is very uncertain about the need for positive pressure ventilation when compared to no treatment or alternative treatment and about failed apnea reduction when used as alternative or adjunct therapy to methylxanthine. For use to prevent reintubation, doxapram may reduce apnea episodes when administered in adjunct to methylxanthine, but with little to no difference in failed extubation. The evidence is very uncertain about doxapram's effect on death when used as adjunct therapy to methylxanthine and about failed extubation when used as alternative or adjunct therapy to methylxanthine.\nThere is a knowledge gap about the use of doxapram as a therapy to prevent apnea. More studies are needed to clarify the role of doxapram in the treatment of apnea of prematurity, addressing concerns about long-term outcomes. The ongoing studies may provide useful data.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We have little confidence in the evidence because not all the studies provided data about everything of interest. Available data are on few infants with a very low number of events of interest."
}
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query-laysum | 1979 | [
{
"role": "user",
"content": "Abstract: Background\nEndovascular aortic aneurysm repair (EVAR) is used to treat aorto-iliac and isolated iliac aneurysms in selected patients, and prospective studies have shown advantages compared with open surgical repair, mainly in the first years of follow-up. Although this technique produces good results, anatomic issues (such as common iliac artery ectasia or an aneurysm that involves the iliac bifurcation) can make EVAR more complex and challenging and can lead to an inadequate distal seal zone for the stent-graft. Inadequate distal fixation in the common iliac arteries can lead to a type Ib endoleak. To avoid this complication, one of the most commonly used techniques is unilateral or bilateral internal iliac artery occlusion and extension of the iliac limb stent-graft to the external iliac arteries with or without embolisation of the internal iliac artery. However, this occlusion is not without harm and is associated with ischaemic complications in the pelvic territory such as buttock claudication, sexual dysfunction, ischaemic colitis, gluteal necrosis, and spinal cord injury.\nNew endovascular devices and alternative techniques such as iliac branch devices and the sandwich technique have been described to maintain pelvic perfusion and decrease complications, achieving revascularisation of the internal iliac arteries in patients not suitable for an adequate seal zone in the common iliac arteries. These approaches may also preserve the quality of life of treated individuals and may decrease other serious complications including spinal cord ischaemia, ischaemic colitis, and gluteal necrosis, thereby decreasing the morbidity and mortality of EVAR.\nObjectives\nTo assess the effects of internal iliac artery revascularisation versus internal iliac artery occlusion during endovascular repair of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation.\nSearch methods\nThe Cochrane Vascular Information Specialists searched the Cochrane Vascular Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE; Embase; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 28 August 2019. The review authors searched Latin American Caribbean Health Sciences Literature (LILACS) and the Indice Bibliográfico Español de Ciencias de la Salud (IBECS) on 28 August 2019 and contacted specialists in the field and manufacturers to identify relevant studies.\nSelection criteria\nWe planned to include all randomised controlled trials (RCTs) that compared internal iliac artery revascularisation with internal iliac artery occlusion for patients undergoing endovascular treatment of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation.\nData collection and analysis\nTwo review authors independently assessed identified studies for potential inclusion in the review. We used standard methodological procedures in accordance with the Cochrane Handbook for Systematic Review of Interventions.\nMain results\nWe identified no RCTs that met the inclusion criteria.\nAuthors' conclusions\nWe found no RCTs that compared internal iliac artery revascularisation versus internal iliac artery occlusion for endovascular treatment of aorto-iliac aneurysms and isolated iliac aneurysms involving the iliac bifurcation. High-quality studies that evaluate the best strategy for managing endovascular repair of aorto-iliac aneurysms with inadequate distal seal zones in the common iliac artery are needed.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no RCTs that compared internal iliac artery revascularisation versus internal iliac artery occlusion for endovascular treatment of aorto-iliac aneurysms. High-quality studies that evaluate the best strategy for managing the endovascular repair of aorto-iliac aneurysms with inadequate distal seal zones in the common iliac artery are needed."
}
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query-laysum | 1980 | [
{
"role": "user",
"content": "Abstract: Background\nWhen compared to the general population, persons with an intellectual disability have lower life expectancy, higher morbidity, and more difficulty finding and obtaining healthcare. Organisational interventions are used to reconfigure the structure or delivery of healthcare services. This is the first update of the original review.\nObjectives\nTo assess the effects of organisational interventions of healthcare services for the mental and physical health problems of persons with an intellectual disability.\nSearch methods\nFor this update we searched CENTRAL, MEDLINE, EMBASE, CINAHL and other databases, from April 2006 to 4 September 2015. We checked reference lists of included studies and consulted experts in the field.\nSelection criteria\nRandomised controlled trials of organisational interventions of healthcare services aimed at improving care of mental and physical health problems of adult persons with an intellectual disability.\nData collection and analysis\nWe employed standard methodological procedures as outlined in the Cochrane Handbook of Systematic Reviews of Interventions, in addition to specific guidance from the Cochrane Effective Practice and Organisation of Care (EPOC) Group.\nMain results\nWe identified one new trial from the updated searches.\nSeven trials (347 participants) met the selection criteria. The interventions varied but had common components: interventions that increased the intensity and frequency of service delivery (4 trials, 200 participants), community-based specialist behaviour therapy (1 trial, 63 participants), and outreach treatment (1 trial, 50 participants). Another trial compared two active arms (traditional counselling and integrated intervention for bereavement, 34 participants).\nThe included studies investigated interventions dealing with the mental health problems of persons with an intellectual disability; none focused on physical health problems. Four studies assessed the effect of organisational interventions on behavioural problems for persons with an intellectual disability, three assessed care giver burden, and three assessed the costs associated with the interventions. None of the included studies reported data on the effect of organisational interventions on adverse events. Most studies were assessed as having low risk of bias.\nIt is uncertain whether interventions that increase the frequency and intensity of delivery or outreach treatment decrease behavioural problems for persons with an intellectual disability (two and one trials respectively, very low certainty evidence). Behavioural problems were slightly decreased by community-based specialist behavioural therapy (one trial, low certainty evidence). Increasing the frequency and intensity of service delivery probably makes little or no difference to care giver burden (MD 0.03, 95% CI -3.48 to 3.54, two trials, moderate certainty evidence). It is uncertain whether outreach treatment makes any difference for care giver burden (one trial, very low certainty evidence). There was very limited evidence regarding costs, with low to very low certainty evidence for the different interventions.\nAuthors' conclusions\nThere is very limited evidence on the organisation of healthcare services for persons with an intellectual disability. There are currently no well-designed studies focusing on organising the health services of persons with an intellectual disability and concurrent physical problems. There are very few studies of organisational interventions targeting mental health needs and the results of those that were found need corroboration. There is an urgent need for high-quality health services research to identify optimal health services for persons with an intellectual disability and concurrent physical problem.\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 conducted a review of the literature to assess the effects of different ways to organise services. This is the first update of a previously published review."
}
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query-laysum | 1981 | [
{
"role": "user",
"content": "Abstract: Background\nUnilateral ureteric-pelvic junction obstruction (UPJO) is the most common cause of obstructive uropathy and may lead to renal impairment and loss of renal function. The current diagnostic approach with renal imaging cannot reliably determine which newborns and infants less than two years of age have a significant obstruction and are at risk for permanent kidney damage. There is therefore no consensus on optimal therapeutic management of unilateral UPJO.\nObjectives\nTo assess the effects of surgical versus non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2016), MEDLINE/Ovid, and EMBASE/Ovid databases from their inception to 13 June 2016. We searched the reference lists of potentially relevant studies without using any language restriction. We also searched the following trial registers for relevant registered studies: www.clinicaltrials.gov/; ISRCTN registry (controlled-trials.com/); www.trialscentral.org/; apps.who.int/trialsearch/; www.drks.de/; and www.anzctr.org.au/trialSearch.aspx.\nSelection criteria\nWe selected randomised and quasi-randomised controlled trials comparing surgical with non-surgical interventions for the treatment of unilateral UPJO.\nData collection and analysis\nTwo review authors independently assessed study eligibility and risk of bias of included studies and extracted data. In case of disagreements we consulted a third review author. The data reported in the two included studies did not allow us to perform a meta-analysis.\nMain results\nWe found only two studies at high risk of bias that were eligible for inclusion in this review. The total sample size, including both trials, was small (n = 107 participants less than six months of age from the UK and USA), and not all prespecified outcome measures were assessed. Reported measures only accounted for the short-term follow-ups. The mean split renal function was not statistically different between the surgical and non-surgical group at the six-month or one-year time point (very low-quality evidence). The surgical group showed a significantly less obstructed drainage pattern and a lower urinary tract dilatation than the non-surgical group (very low-quality evidence). Transfer from the non-surgical group to the surgical group was reported for about one out of five participants. Split renal function after secondary surgical intervention was reported with variable results, but most of the participants reverted to pre-deteriorated values. The studies either provided no or insufficient data on the following outcome measures: postoperative complications, UPJO-associated clinical symptoms, costs of interventions, radiation exposure, quality of life, and adverse effects.\nAuthors' conclusions\nWe found limited evidence assessing the benefits and harms of surgical compared to non-surgical treatment options for newborns and infants less than two years of age with unilateral UPJO. The majority of participants in the non-surgical treatment group did not experience any significant deterioration of split renal function, and only about 20% of them underwent secondary surgical intervention, with minor risk of permanent deteriorated split renal function. The study follow-up period was too short to assess the long-term effects on split renal function in both treatment groups. We need further randomised controlled trials with sufficient statistical power and an adequate follow-up period to determine the optimal therapy for newborns and infants less than two years of age with unilateral UPJO.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies up to 13 June 2016 and found two trials that compared groups of newborns and infants less than two years of age, including a total of 107 children who had surgery or no surgery and were followed for up to five years. Based on very low-quality evidence, we found that short-term kidney function (after six and 12 months) was similar in the two groups. Very low-quality evidence also showed that after surgery, the pelvis of the kidney was smaller and urine seemed to flow better from the kidney down the ureter. However, due to the methods and size and of the studies, we are very uncertain about these results. There was insufficient evidence to determine whether one group of participants did better longer term, had fewer complications, or had better quality of life."
}
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query-laysum | 1983 | [
{
"role": "user",
"content": "Abstract: Background\nInflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial.\nObjectives\nThe primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials.\nSelection criteria\nRandomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nWe included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study).\nAll studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used.\nIn one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9).\nIn one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36).\nThere were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk.\nThe reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events.\nTime to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies.\nAn analysis of all intravenous iron preparations to all oral iron preparations showed that intravenous administration may lead to more responders (368/554 versus 205/373, RR 1.17, 95% CI 1.05 to 1.31, NNTB = 11, low-certainty due to risk of bias and inconsistency). Withdrawals due to adverse events may be greater in oral iron preparations vs intravenous (15/554 versus 31/373, RR 0.39, 95% CI 0.20 to 0.74, low-certainty due to risk of bias, inconsistency and imprecision).\nAuthors' conclusions\nIntravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo.\nWe are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11.\nWhilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery.\nOther outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes.\nGiven the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Iron delivered via a vein as ferric carboxymaltose probably improves anaemia in more people that iron sucrose via a vein, although both groups of people improved. Oral iron as ferric maltol may improve more patients than dummy treatment. No conclusions can be drawn on other treatments due to lack of evidence and quality issues with the studies that were found. Further research is needed, particularly to investigate whether iron delivered through a vein is better than iron delivered orally and also how much treating anaemia in people with IBD makes a difference in terms of the symptoms they may experience."
}
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query-laysum | 1984 | [
{
"role": "user",
"content": "Abstract: Background\nSelf-harm (SH; intentional self-poisoning or self-injury) is common, often repeated, and associated with suicide. This is an update of a broader Cochrane review first published in 1998, previously updated in 1999, and now split into three separate reviews. This review focuses on psychosocial interventions in adults who engage in self-harm.\nObjectives\nTo assess the effects of specific psychosocial treatments versus treatment as usual, enhanced usual care or other forms of psychological therapy, in adults following SH.\nSearch methods\nThe Cochrane Depression, Anxiety and Neurosis Group (CCDAN) trials coordinator searched the CCDAN Clinical Trials Register (to 29 April 2015). This register includes relevant randomised controlled trials (RCTs) from: the Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date).\nSelection criteria\nWe included RCTs comparing psychosocial treatments with treatment as usual (TAU), enhanced usual care (EUC) or alternative treatments in adults with a recent (within six months) episode of SH resulting in presentation to clinical services.\nData collection and analysis\nWe used Cochrane's standard methodological procedures.\nMain results\nWe included 55 trials, with a total of 17,699 participants. Eighteen trials investigated cognitive-behavioural-based psychotherapy (CBT-based psychotherapy; comprising cognitive-behavioural, problem-solving therapy or both). Nine investigated interventions for multiple repetition of SH/probable personality disorder, comprising emotion-regulation group-based psychotherapy, mentalisation, and dialectical behaviour therapy (DBT). Four investigated case management, and 11 examined remote contact interventions (postcards, emergency cards, telephone contact). Most other interventions were evaluated in only single small trials of moderate to very low quality.\nThere was a significant treatment effect for CBT-based psychotherapy compared to TAU at final follow-up in terms of fewer participants repeating SH (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55 to 0.88; number of studies k = 17; N = 2665; GRADE: low quality evidence), but with no reduction in frequency of SH (mean difference (MD) -0.21, 95% CI -0.68 to 0.26; k = 6; N = 594; GRADE: low quality).\nFor interventions typically delivered to individuals with a history of multiple episodes of SH/probable personality disorder, group-based emotion-regulation psychotherapy and mentalisation were associated with significantly reduced repetition when compared to TAU: group-based emotion-regulation psychotherapy (OR 0.34, 95% CI 0.13 to 0.88; k = 2; N = 83; GRADE: low quality), mentalisation (OR 0.35, 95% CI 0.17 to 0.73; k = 1; N = 134; GRADE: moderate quality). Compared with TAU, dialectical behaviour therapy (DBT) showed a significant reduction in frequency of SH at final follow-up (MD -18.82, 95% CI -36.68 to -0.95; k = 3; N = 292; GRADE: low quality) but not in the proportion of individuals repeating SH (OR 0.57, 95% CI 0.21 to 1.59, k = 3; N = 247; GRADE: low quality). Compared with an alternative form of psychological therapy, DBT-oriented therapy was also associated with a significant treatment effect for repetition of SH at final follow-up (OR 0.05, 95% CI 0.00 to 0.49; k = 1; N = 24; GRADE: low quality). However, neither DBT vs 'treatment by expert' (OR 1.18, 95% CI 0.35 to 3.95; k = 1; N = 97; GRADE: very low quality) nor prolonged exposure DBT vs standard exposure DBT (OR 0.67, 95% CI 0.08 to 5.68; k = 1; N =18; GRADE: low quality) were associated with a significant reduction in repetition of SH.\nCase management was not associated with a significant reduction in repetition of SH at post intervention compared to either TAU or enhanced usual care (OR 0.78, 95% CI 0.47 to 1.30; k = 4; N = 1608; GRADE: moderate quality). Continuity of care by the same therapist vs a different therapist was also not associated with a significant treatment effect for repetition (OR 0.28, 95% CI 0.07 to 1.10; k = 1; N = 136; GRADE: very low quality). None of the following remote contact interventions were associated with fewer participants repeating SH compared with TAU: adherence enhancement (OR 0.57, 95% CI 0.32 to 1.02; k = 1; N = 391; GRADE: low quality), mixed multimodal interventions (comprising psychological therapy and remote contact-based interventions) (OR 0.98, 95% CI 0.68 to 1.43; k = 1 study; N = 684; GRADE: low quality), including a culturally adapted form of this intervention (OR 0.83, 95% CI 0.44 to 1.55; k = 1; N = 167; GRADE: low quality), postcards (OR 0.87, 95% CI 0.62 to 1.23; k = 4; N = 3277; GRADE: very low quality), emergency cards (OR 0.82, 95% CI 0.31 to 2.14; k = 2; N = 1039; GRADE: low quality), general practitioner's letter (OR 1.15, 95% CI 0.93 to 1.44; k = 1; N = 1932; GRADE: moderate quality), telephone contact (OR 0.74, 95% CI 0.42 to 1.32; k = 3; N = 840; GRADE: very low quality), and mobile telephone-based psychological therapy (OR not estimable due to zero cell counts; GRADE: low quality).\nNone of the following mixed interventions were associated with reduced repetition of SH compared to either alternative forms of psychological therapy: interpersonal problem-solving skills training, behaviour therapy, home-based problem-solving therapy, long-term psychotherapy; or to TAU: provision of information and support, treatment for alcohol misuse, intensive inpatient and community treatment, general hospital admission, or intensive outpatient treatment.\nWe had only limited evidence on whether the intervention had different effects in men and women. Data on adverse effects, other than planned outcomes relating to suicidal behaviour, were not reported.\nAuthors' conclusions\nCBT-based psychological therapy can result in fewer individuals repeating SH; however, the quality of this evidence, assessed using GRADE criteria, ranged between moderate and low. Dialectical behaviour therapy for people with multiple episodes of SH/probable personality disorder may lead to a reduction in frequency of SH, but this finding is based on low quality evidence. Case management and remote contact interventions did not appear to have any benefits in terms of reducing repetition of SH. Other therapeutic approaches were mostly evaluated in single trials of moderate to very low quality such that the evidence relating to these interventions is inconclusive.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Clinicians working with people who engage in SH, policy makers, people who themselves have engaged in SH or may be at risk of doing so, and their families and relatives."
}
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query-laysum | 1985 | [
{
"role": "user",
"content": "Abstract: Background\nPain management is a high priority for patients with rheumatoid arthritis (RA). Antidepressants are sometimes used as adjuvant agents to enhance pain relief, help with sleep and reduce depression. Such antidepressants include tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), selective serotonin noradrenaline reuptake inhibitors (SNRIs) and norepinephrine reuptake inhibitors (NRIs). However, the prescription of antidepressants in this population remains controversial because of conflicting scientific evidence.\nObjectives\nThe aim of this review was to determine the efficacy and safety of antidepressants in pain management in patients with RA.\nSearch methods\nWe performed a computer assisted search of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, 4th quarter); MEDLINE (1950 to November Week 1, 2010); EMBASE (2010 Week 44); and PsycINFO (1806 to November Week 2, 2010). We also searched the 2008-2009 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) abstracts and performed a handsearch of reference lists of articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) which compared an antidepressant therapy to another therapy (active or placebo, including non-pharmacological therapies) in adult patients with RA who had at least one clinically relevant outcome measure. Outcomes of interest were pain, adverse effects, function, sleep, depression and quality of life.\nData collection and analysis\nTwo blinded review authors independently extracted data and assessed the risk of bias in the trials. We conducted meta-analyses to examine the efficacy of antidepressants on pain, depression and function, as well as their safety.\nMain results\nWe included eight RCTs (652 participants) in this review. All trials evaluated TCAs and two trials evaluated a SSRI as a comparator. Seven of the eight trials had high risk of bias. There was insufficient data for a number needed to treat for an additional beneficial outcome (NNTB) to be calculated for the primary outcome measure of pain. The qualitative analyses found no evidence of an effect of antidepressants on pain intensity or depression in the short-term (less than one week), and conflicting evidence of a medium- (one to six weeks) or long-term (more than six weeks) benefit. There were significantly more minor adverse events in patients receiving TCAs compared with those receiving a placebo (risk ratio (RR) 2.27, 95% confidence interval (CI) 1.17 to 4.42), but there was no significant increase in withdrawals due to an adverse event (RR 1.09, 95% CI 0.49 to 2.42).\nAuthors' conclusions\nThere is currently insufficient evidence to support the routine prescription of antidepressants as analgesics in patients with RA as no reliable conclusions about their efficacy can be drawn from eight placebo RCTs. The use of these agents may be associated with adverse events which are generally mild and do not lead to cessation of treatment. More high quality trials are needed in this area.\n\nGiven the provided abstract, please respond to the following query: \"Best estimate of what happens to people with RA who take antidepressants\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Total adverse events:\n27 more people out of 100 experienced an adverse event after up to 12 weeks of receiving an antidepressant (absolute difference 27%);\n59 out of 100 people who took antidepressants suffered an adverse event; and\n32 out of 100 people who took a placebo suffered an adverse event."
}
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query-laysum | 1986 | [
{
"role": "user",
"content": "Abstract: Background\nInvasive fungal infections are important causes of morbidity and mortality among critically ill patients. Early institution of antifungal therapy is pivotal for mortality reduction. Starting a targeted antifungal therapy after culture positivity and fungi identification requires a long time. Therefore, alternative strategies (globally defined as 'untargeted antifungal treatments') for antifungal therapy institution in patients without proven microbiological evidence of fungal infections have been discussed by international guidelines. This review was originally published in 2006 and updated in 2016. This updated review provides additional evidence for the clinician dealing with suspicion of fungal infection in critically ill, non-neutropenic patients, taking into account recent findings in this field.\nObjectives\nTo assess the effects of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) compared to placebo or no antifungal or any other antifungal drug (either systemic or nonabsorbable) in non-neutropenic, critically ill adults and children. We assessed effectiveness in terms of total (all-cause) mortality and incidence of proven invasive fungal infections as primary outcomes.\nSearch methods\nWe searched the following databases to February 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), and EMBASE (OVID). We also searched reference lists of identified studies and major reviews, abstracts of conference proceedings, scientific meetings and clinical trials registries. We contacted experts in the field, study authors and pharmaceutical companies as part of the search strategy.\nSelection criteria\nWe included randomized controlled trials (RCTs) (irrespective of language or publication status) comparing the use of untargeted treatment with any antifungal drug (either systemic or nonabsorbable) to placebo, no antifungal, or another antifungal agent in non-neutropenic critically ill participants.\nData collection and analysis\nThree authors independently applied selection criteria, extracted data and assessed the risk of bias. We resolved any discrepancies by discussion. We synthesized data using the random-effects model and expressed the results as risk ratios (RR) with 95% confidence intervals. We assessed overall evidence quality using the GRADE approach.\nMain results\nWe included 22 studies (total of 2761 participants). Of those 22 studies, 12 were included in the original published review and 10 were newly identified. Eleven trials compared the use of fluconazole to placebo or no antifungal treatment. Three trials compared ketoconazole versus placebo. One trial compared anidulafungin with placebo. One trial compared caspofungin to placebo. Two trials compared micafungin to placebo. One trial compared amphotericin B to placebo. Two trials compared nystatin to placebo and one trial compared the effect of clotrimazole, ketoconazole, nystatin and no treatment. We found two new ongoing studies and four new studies awaiting classification. The RCTs included participants of both genders with wide age range, severity of critical illness and clinical characteristics. Funding sources from pharmaceutical companies were reported in 11 trials and one trial reported funding from a government agency. Most of the studies had an overall unclear risk of bias for key domains of this review (random sequence generation, allocation concealment, incomplete outcome data). Two studies had a high risk of bias for key domains. Regarding the other domains (blinding of participants and personnel, outcome assessment, selective reporting, other bias), most of the studies had a low or unclear risk but four studies had a high risk of bias.\nThere was moderate grade evidence that untargeted antifungal treatment did not significantly reduce or increase total (all-cause) mortality (RR 0.93, 95% CI 0.79 to 1.09, P value = 0.36; participants = 2374; studies = 19). With regard to the outcome of proven invasive fungal infection, there was low grade evidence that untargeted antifungal treatment significantly reduced the risk (RR 0.57, 95% CI 0.39 to 0.83, P value = 0.0001; participants = 2024; studies = 17). The risk of fungal colonization was significantly reduced (RR 0.71, 95% CI 0.52 to 0.97, P value = 0.03; participants = 1030; studies = 12) but the quality of evidence was low. There was no difference in the risk of developing superficial fungal infection (RR 0.69, 95% CI 0.37 to 1.29, P value = 0.24; participants = 662; studies = 5; low grade of evidence) or in adverse events requiring cessation of treatment between the untargeted treatment group and the other group (RR 0.89, 95% CI 0.62 to 1.27, P value = 0.51; participants = 1691; studies = 11; low quality of evidence). The quality of evidence for the outcome of total (all-cause) mortality was moderate due to limitations in study design. The quality of evidence for the outcome of invasive fungal infection, superficial fungal infection, fungal colonization and adverse events requiring cessation of therapy was low due to limitations in study design, non-optimal total population size, risk of publication bias, and heterogeneity across studies.\nAuthors' conclusions\nThere is moderate quality evidence that the use of untargeted antifungal treatment is not associated with a significant reduction in total (all-cause) mortality among critically ill, non-neutropenic adults and children compared to no antifungal treatment or placebo. The untargeted antifungal treatment may be associated with a reduction of invasive fungal infections but the quality of evidence is low, and both the heterogeneity and risk of publication bias is high.\nFurther high-quality RCTs are needed to improve the strength of the evidence, especially for more recent and less studied drugs (e.g. echinocandins). Future trials should adopt standardized definitions for microbiological outcomes (e.g. invasive fungal infection, colonization) to reduce heterogeneity. Emergence of resistance to antifungal drugs should be considered as outcome in studies investigating the effects of untargeted antifungal treatment to balance risks and benefit.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is moderate quality evidence that the use of antifungal treatment given before definitive diagnosis of fungal infection is not associated with a significant reduction in mortality from all causes among critically ill adults and children with a normal number of neutrophils in the blood. This type of antifungal treatment may be associated with a reduction of invasive fungal infections but the quality of evidence on this point is low.\nFurther studies with high-quality design are needed to improve the evidence."
}
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query-laysum | 1987 | [
{
"role": "user",
"content": "Abstract: Background\nVitamin C supplementation may help reduce the risk of pregnancy complications such as pre-eclampsia, intrauterine growth restriction and maternal anaemia. There is a need to evaluate the efficacy and safety of vitamin C supplementation in pregnancy.\nObjectives\nTo evaluate the effects of vitamin C supplementation, alone or in combination with other separate supplements on pregnancy outcomes, adverse events, side effects and use of health resources.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies.\nSelection criteria\nAll randomised or quasi-randomised controlled trials evaluating vitamin C supplementation in pregnant women. Interventions using a multivitamin supplement containing vitamin C or where the primary supplement was iron were excluded.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.\nMain results\nTwenty-nine trials involving 24,300 women are included in this review. Overall, 11 trials were judged to be of low risk of bias, eight were high risk of bias and for 10 trials it was unclear. No clear differences were seen between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%; moderate quality evidence), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%), perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,105 participants; seven studies; I² = 35%), birthweight (mean difference (MD) 26.88 g, 95% CI -18.81 to 72.58; 17,326 participants; 13 studies; I² = 69%), intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%; high quality evidence), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%; high quality evidence), preterm PROM (prelabour rupture of membranes) (average RR 0.98, 95% CI 0.70 to 1.36; 16,825 participants; 10 studies; I² = 70%; low quality evidence), term PROM (average RR 1.26, 95% CI 0.62 to 2.56; 2674 participants; three studies; I² = 87%), and clinical pre-eclampsia (average RR 0.92, 95% CI 0.80 to 1.05; 21,956 participants; 16 studies; I² = 41%; high quality evidence).\nWomen supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control were at decreased risk of having a placental abruption (RR 0.64, 95% CI 0.44 to 0.92; 15,755 participants; eight studies; I² = 0%; high quality evidence) and had a small increase in gestational age at birth (MD 0.31, 95% CI 0.01 to 0.61; 14,062 participants; nine studies; I² = 65%), however they were also more likely to self-report abdominal pain (RR 1.66, 95% CI 1.16 to 2.37; 1877 participants; one study). In the subgroup analyses based on the type of supplement, vitamin C supplementation alone was associated with a reduced risk of preterm PROM (average RR 0.66, 95% CI 0.48 to 0.91; 1282 participants; five studies; I² = 0%) and term PROM (average RR 0.55, 95% CI 0.32 to 0.94; 170 participants; one study). Conversely, the risk of term PROM was increased when supplementation included vitamin C and vitamin E (average RR 1.73, 95% CI 1.34 to 2.23; 3060 participants; two studies; I² = 0%). There were no differences in the effects of vitamin C on other outcomes in the subgroup analyses examining the type of supplement. There were no differing patterns in other subgroups of women based on underlying risk of pregnancy complications, timing of commencement of supplementation or dietary intake of vitamin C prior to trial entry. The GRADE quality of the evidence was high for intrauterine growth restriction, preterm birth, and placental abruption, moderate for stillbirth and clinical pre-eclampsia, low for preterm PROM.\nAuthors' conclusions\nThe data do not support routine vitamin C supplementation alone or in combination with other supplements for the prevention of fetal or neonatal death, poor fetal growth, preterm birth or pre-eclampsia. Further research is required to elucidate the possible role of vitamin C in the prevention of placental abruption and prelabour rupture of membranes. There was no convincing evidence that vitamin C supplementation alone or in combination with other supplements results in other important benefits or harms.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review included data from 29 trials involving over 24,000 pregnant women from 17 different countries. Four trials did not contribute data to the review. The overall risk of bias of the trials was low to unclear, and the evidence was moderate to high quality. The most common daily dosage of vitamin C was 1000 mg, which was used in 15 studies. The findings indicated that routine supplementation with vitamin C during pregnancy, either alone or in combination with other supplements (mainly vitamin E) did not improve outcomes for women and their babies. There was a 36% relative reduction in the placenta coming away early from the uterine wall (placental abruption) in women given vitamin C supplements (eight studies, over 15,700 women); this was rated as high-quality evidence. However, it was unclear whether this finding was due to vitamin C or another agent, as most trials gave women vitamin C combined with vitamin E. In the studies that gave women vitamin C only, there was a reduction in prelabour rupture of the membranes (PROM) occurring either preterm or at term. However, there was an increased risk of term PROM in the studies that gave women vitamin C and vitamin E. Therefore, further research is required to examine the role of vitamin C in reducing placental abruption and the development of PROM. The review found in one study only an increased risk of abdominal pain with vitamin C indicating there may be harms associated with vitamin C supplements in pregnancy."
}
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query-laysum | 1988 | [
{
"role": "user",
"content": "Abstract: Background\nPsoriasis is a chronic skin disease that affects approximately two per cent of the general population. Plaque psoriasis is the most common form: it usually appears as raised, red patches of inflamed skin, covered with silvery white scales. The patches often occur in a symmetrical pattern. Guttate psoriasis is a particular form of psoriasis with widespread, small erythematosquamous lesions. Streptococcal infection is suspected to be a triggering factor for the onset of guttate psoriasis, and flare-up of chronic plaque psoriasis. The previous Cochrane Review on this topic was published in 2000; it required an update because antistreptococcal treatment continues to be used to treat psoriasis, especially for the acute form of guttate psoriasis.\nObjectives\nTo assess the effects of antistreptococcal interventions for guttate and chronic plaque psoriasis.\nSearch methods\nWe searched Cochrane Skin Specialised Register, Cochrane Register of Studies Online, CENTRAL, MEDLINE, Embase, LILACS, and five trials registers (January 2019). We checked the reference lists of included and excluded studies and searched conference proceedings from the American Academy of Dermatology, Society for Investigative Dermatology, and European Academy of Dermatology and Venereology.\nSelection criteria\nWe considered randomised controlled trials (RCTs) assessing antistreptococcal interventions (tonsillectomy or systemic antibiotic treatment) in people with clinically diagnosed acute guttate and chronic plaque psoriasis compared with placebo, no intervention, or each other.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcome measures were: 1) time-to-resolution; achieving clear or almost clear skin (Physician Global Assessment (PGA) 0 or 1 or Psoriasis Area and Severity Index (PASI) 90 or 100); 2) proportion of participants with adverse effects and severe adverse effects. Secondary outcomes were: 1) proportion of participants achieving clear or almost clear skin; 2) proportion of participants achieving PASI 75 or PGA 1 to 2; 3) risk of having at least one relapse at long-term follow-up. Short-term assessment was defined as within eight weeks of the start of treatment; long-term was at least one year after the start of treatment.\nMain results\nWe included five trials (162 randomised participants); three were conducted in a hospital dermatology department. One study declared funding by a pharmaceutical company. Participants' ages ranged from 12 to 77 years; only two participants were younger than 15 years. Mean PASI score at baseline varied from 5.7 (i.e. mild) to 23 (i.e. severe) in four studies. Twenty-three of 162 participants had streptococcus-positive throat swab culture. We did not perform a meta-analysis due to heterogeneity of participants' characteristics and interventions.\nNone of the trials measured our efficacy primary outcome, time-to-resolution, or the secondary outcome, risk of having at least one relapse at long-term follow-up.\nWe rated the quality of the results as very low-quality evidence, due to high risk of bias (absence of blinding of participants and caregivers, and high risk of outcome reporting bias) and imprecision (single study data with a low number of events). Hence, we are very uncertain about the results presented.\nGuttate psoriasis\nOne three-armed trial (N = 43) assessed penicillin (50,000 international units (IU)/kg/day in three doses) versus erythromycin (250 mg four times per day) versus no treatment (treatment for 14 days, with six-week follow-up from start of treatment). Adverse events and the proportion of participants achieving clear or almost clear skin were not measured.\nOne trial (N = 20) assessed penicillin (1.6 MU (million units) intramuscularly once a day) versus no treatment (six weeks of treatment, with eight-week follow-up from start of treatment). At six-week (short-term) follow-up, no adverse events were observed in either group, and there was no statistically significant difference between the two groups in the proportion of participants with clear or almost clear skin (risk ratio (RR) 2.00, 95% confidence interval (CI) 0.68 to 5.85).\nOne trial (N = 20) assessed rifampicin (300 mg twice daily) versus placebo (14-day treatment duration; six-week follow-up from start of treatment); none of the review outcomes were measured.\nThese trials did not measure the proportion of participants achieving PASI 75 or PGA 1 to 2.\nChronic plaque psoriasis\nOne trial (N = 50) assessed long-term azithromycin treatment (500 mg daily dose) versus vitamin C. Adverse events were reported in the azithromycin group (10 out of 30 had nausea and mild abdominal upset), but not in the vitamin C group. The proportion of participants who achieved clear or almost clear skin was not measured. In the azithromycin group, 18/30 versus 0/20 participants in the vitamin C group reached PASI 75 at the end of 48 weeks of treatment (RR 25.06, 95% CI 1.60 to 393.59).\nOne trial (N = 29) assessed tonsillectomy versus no treatment, with 24-month follow-up after surgery. One participant in the tonsillectomy group had minor bleeding. At eight-week follow-up, 1/15 in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 90; and 3/15 participants in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 75 (RR 6.56, 95% CI 0.37 to 116.7).\nAuthors' conclusions\nWe found only five trials (N = 162), which assessed the effects of five comparisons (systemic antibiotic treatment (penicillin, azithromycin) or tonsillectomy). Two comparisons (erythromycin compared to no treatment, and rifampicin compared to placebo) did not measure any of the outcomes of interest. There was very low-quality evidence for the outcomes that were measured, Therefore, we are uncertain of both the efficacy and safety of antistreptococcal interventions for guttate and chronic plaque psoriasis.\nThe included trials were at unclear or high risk of bias and involved only a small number of unrepresentative participants, with limited measurement of our outcomes of interest. The studies did not allow investigation into the influence of Streptococcal infection, and a key intervention (amoxicillin) was not assessed.\nFurther trials assessing the efficacy and tolerance of penicillin V or amoxicillin are needed in children and young adults with guttate psoriasis.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Chronic plaque psoriasis is a long-term condition that causes patches of red, flaky skin, covered with scales (called plaques); it is the most frequent form of psoriasis, and is more common in adults.\nGuttate psoriasis is characterised by smaller lesions, and is more common in children and young people. Some studies have suggested that guttate psoriasis occurs in less than 30% of people with psoriasis.\nThe cause of psoriasis is unknown, but Streptococcal infection may trigger guttate psoriasis or flare-ups of chronic plaque psoriasis.\nTonsillectomy may prevent or reduce the severity of throat infections, and limit the Streptococcus reservoir. Antibiotics work by destroying the bacteria that appear to trigger psoriasis."
}
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query-laysum | 1989 | [
{
"role": "user",
"content": "Abstract: Background\nHeavy menstrual bleeding is one of the most common reasons for referral of premenopausal women to a gynaecologist. Although medical therapy is generally first line, many women eventually will require further treatment. Endometrial ablation by hysteroscopic and more recent \"second-generation\" devices such as balloon, radiofrequency or microwave ablation offers a day-case surgical alternative to hysterectomy. Complete endometrial destruction is one of the main determinants of treatment success. Surgery is most effective if undertaken when endometrial thickness is less than four millimeters. One option is to perform the surgery in the immediate postmenstrual phase, which is not always practical. The other option is to use hormonal agents that induce endometrial thinning pre-operatively. The most commonly evaluated agents are goserelin (a gonadotrophin-releasing hormone analogue, or GnRHa) and danazol. Other GnRH analogues and progestogens have also been studied, although fewer data are available. It has been suggested that these agents will reduce operating time, improve the intrauterine operating environment and reduce absorption of fluid used for intraoperative uterine cavity distension. They may also improve long-term outcomes, including menstrual loss and dysmenorrhoea.\nObjectives\nTo investigate the effectiveness and safety of pre-operative endometrial thinning agents (GnRH agonists, danazol, estrogen-progestins and progestogens) versus another agent or placebo when given before endometrial destruction in premenopausal women with heavy menstrual bleeding.\nSearch methods\nThe following electronic databases were searched to April 2013 for published and unpublished randomised controlled trials that met the inclusion criteria: the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of controlled trials, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO.\nOther electronic sources of trials included trial registers for ongoing and registered trials; citation indexes; conference abstracts in the Web of Knowledge; the LILACS database for trials from the Portuguese- and Spanish-speaking world; PubMed; and the OpenSIGLE database and Google for grey literature.\nAll searches were performed in consultation with the MDSG Trials Search Co-ordinator.\nSelection criteria\nRandomised controlled trials (RCTs) were included if they compared the effects of these agents with one other, or with placebo or no treatment, on relevant intraoperative and postoperative treatment outcomes. Selection of trials was carried out independently by two review authors.\nData collection and analysis\nTwo review authors independently assessed studies for risk of bias and extracted data on surgical outcomes, effectiveness outcomes, proportion of women requiring further surgical therapy during follow-up, endometrial outcome measures, acceptability of use outcomes and quality of life. Data were analysed on an intention-to-treat basis. Dichotomous data were combined for meta-analysis with RevMan software using the Mantel-Haenszel method to estimate pooled risk ratios (RRs). Continuous data were combined for meta-analysis with RevMan software using an inverse variance method to estimate the pooled mean difference (MD) with 95% confidence interval (CI). The overall quality of evidence for the main findings was assessed with the use of GRADE working group methods.\nMain results\nTwenty studies with 1969 women were included in this review. These studies compared GnRHa, danazol and progestogens versus placebo or no treatment; GnRHa versus danazol, progestogens, GnRH antagonists or dilatation & curettage; and danazol versus progestogens. Four studies performed more than one comparison.\nWhen compared with no treatment, GnRHa used before hysteroscopic resection were associated with a higher rate of postoperative amenorrhoea at 12 months (RR 1.6, 95% CI 1.2 to 2.0, 7 RCTs, 605 women, moderate heterogeneity; I2 = 40%) and at 24 months (RR 1.62, 95% CI 1.04 to 2.52, 2 RCTs, 357 women, no heterogeneity; I2 = 0%), a slightly shorter duration of surgery (-3.5 minutes, 95% CI -4.7 to -2.3, 5 RCTs, 156 women, substantial heterogeneity; I2 = 72%) and greater ease of surgery (RR 0.32, 95% CI 0.22 to 0.46, 2 RCTs, 415 women, low heterogeneity; I2 = 4%). Postoperative dysmenorrhoea was reduced (RR 0.59, 95% CI 0.40 to 0.87, 2 RCTs, 133 women, no heterogeneity; I2 = 0%). The use of GnRHa had no effect on intraoperative complication rates (RR 1.47, 95% CI 0.35 to 6.06, 5 RCTs, 592 women, no heterogeneity; I2 = 0%), and participant satisfaction with this surgery was high irrespective of the use of pre-operative endometrial thinning agents (RR 0.99, 95% CI 0.93 to 1.05, 6 RCTs, 599 women, low heterogeneity; I2 = 11%). GnRHa produced more consistent endometrial atrophy than was produced by danazol (RR 1.84, 95% CI 1.23 to 2.75, 2 RCTs, 142 women, no heterogeneity; I2 = 0%). For other intraoperative and postoperative outcomes, any differences were minimal, and no benefits of GnRHa pretreatment were noted in studies in which women underwent second-generation ablation techniques. Both GnRHa and danazol produced side effects in a significant proportion of women, although few studies reported these in detail. Few randomised data were available to allow assessment of the effectiveness of progestogens as endometrial thinning agents. When reported, the long-term effects of endometrial thinning agents on benefits such as postoperative amenorrhoea were reduced with time.\nThe main study weaknesses were that most participants received no follow-up beyond 24 months and that the studies used a small sample size. Heterogeneity for outcomes reported ranged from none to substantial. More than half the trials had no blinding of participants or outcome assessment. Most of the trials were determined to have uncertain selection and reporting bias, as they did not report allocation concealment and evidence of selective reporting was noted. The quality of reporting of adverse events was generally poor, but, when described in the studies, they included menopausal symptoms such as hot flushes, vaginal dryness, hirsutism, decreased libido and voice changes, as well as other side effects such as headache and weight gain.\nAuthors' conclusions\nLow-quality evidence suggests that endometrial thinning with GnRHa and danazol before hysteroscopic surgery improves operating conditions and short-term postoperative outcomes. GnRHa produced slightly more consistent endometrial thinning than was produced by danazol, although both achieved satisfactory results. The effect of these agents on longer-term postoperative outcomes was reduced with time. No benefits of GnRHa pretreatment were apparent with second-generation ablation techniques. Also, side effects were more common when these agents were used.\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": "GnRH analogues and danazol used before hysteroscopic surgery improve both operating conditions for the surgeon and short-term bleeding symptoms for women (up to 24 months after surgery). GnRH analogues thin the lining of the womb better and more consistently than danazol, although both agents produce satisfactory results. Adverse effects were more common in women taking GnRH analogues or danazol compared with no treatment, and this was especially true with danazol. Adverse effects included menopausal symptoms such as hot flushes, vaginal dryness, hirsutism, decreased libido and voice changes, as well as other side effects such as headache and weight gain. The use of medications to thin the lining of the womb before surgery does not appear to improve heavy menstrual bleeding in the long term (i.e. longer than 24 months). However, only a few small studies followed up with women for longer than 24 months. Also, medications given to thin the womb lining do not provide additional benefit when used with the newer second-generation endometrial destruction techniques, which are being performed increasingly in hospitals."
}
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query-laysum | 1990 | [
{
"role": "user",
"content": "Abstract: Background\nThe diagnostic challenges associated with the COVID-19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS-CoV-2 infection. Serology tests to detect the presence of antibodies to SARS-CoV-2 enable detection of past infection and may detect cases of SARS-CoV-2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS-CoV-2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS-CoV-2 epidemiology.\nObjectives\nTo assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS-CoV-2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS-CoV-2. Sources of heterogeneity investigated included: timing of test, test method, SARS-CoV-2 antigen used, test brand, and reference standard for non-SARS-CoV-2 cases.\nSearch methods\nThe COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre) ‘COVID-19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID-19 evidence’. We did not apply language restrictions.\nSelection criteria\nWe included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT-PCR test. Small studies with fewer than 25 SARS-CoV-2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction tests (RT-PCR), clinical diagnostic criteria, and pre-pandemic samples).\nData collection and analysis\nWe use standard screening procedures with three reviewers. Quality assessment (using the QUADAS-2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta-analysis, we fitted univariate random-effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and summarised results for tests that were evaluated in 200 or more samples and that met a modification of UK Medicines and Healthcare products Regulatory Agency (MHRA) target performance criteria.\nMain results\nWe included 178 separate studies (described in 177 study reports, with 45 as pre-prints) providing 527 test evaluations. The studies included 64,688 samples including 25,724 from people with confirmed SARS-CoV-2; most compared the accuracy of two or more assays (102/178, 57%). Participants with confirmed SARS-CoV-2 infection were most commonly hospital inpatients (78/178, 44%), and pre-pandemic samples were used by 45% (81/178) to estimate specificity. Over two-thirds of studies recruited participants based on known SARS-CoV-2 infection status (123/178, 69%). All studies were conducted prior to the introduction of SARS-CoV-2 vaccines and present data for naturally acquired antibody responses. Seventy-nine percent (141/178) of studies reported sensitivity by week after symptom onset and 66% (117/178) for convalescent phase infection. Studies evaluated enzyme-linked immunosorbent assays (ELISA) (165/527; 31%), chemiluminescent assays (CLIA) (167/527; 32%) or lateral flow assays (LFA) (188/527; 36%).\nRisk of bias was high because of participant selection (172, 97%); application and interpretation of the index test (35, 20%); weaknesses in the reference standard (38, 21%); and issues related to participant flow and timing (148, 82%). We judged that there were high concerns about the applicability of the evidence related to participants in 170 (96%) studies, and about the applicability of the reference standard in 162 (91%) studies.\nAverage sensitivities for current SARS-CoV-2 infection increased by week after onset for all target antibodies. Average sensitivity for the combination of either IgG or IgM was 41.1% in week one (95% CI 38.1 to 44.2; 103 evaluations; 3881 samples, 1593 cases), 74.9% in week two (95% CI 72.4 to 77.3; 96 evaluations, 3948 samples, 2904 cases) and 88.0% by week three after onset of symptoms (95% CI 86.3 to 89.5; 103 evaluations, 2929 samples, 2571 cases). Average sensitivity during the convalescent phase of infection (up to a maximum of 100 days since onset of symptoms, where reported) was 89.8% for IgG (95% CI 88.5 to 90.9; 253 evaluations, 16,846 samples, 14,183 cases), 92.9% for IgG or IgM combined (95% CI 91.0 to 94.4; 108 evaluations, 3571 samples, 3206 cases) and 94.3% for total antibodies (95% CI 92.8 to 95.5; 58 evaluations, 7063 samples, 6652 cases). Average sensitivities for IgM alone followed a similar pattern but were of a lower test accuracy in every time slot.\nAverage specificities were consistently high and precise, particularly for pre-pandemic samples which provide the least biased estimates of specificity (ranging from 98.6% for IgM to 99.8% for total antibodies).\nSubgroup analyses suggested small differences in sensitivity and specificity by test technology however heterogeneity in study results, timing of sample collection, and smaller sample numbers in some groups made comparisons difficult. For IgG, CLIAs were the most sensitive (convalescent-phase infection) and specific (pre-pandemic samples) compared to both ELISAs and LFAs (P < 0.001 for differences across test methods). The antigen(s) used (whether from the Spike-protein or nucleocapsid) appeared to have some effect on average sensitivity in the first weeks after onset but there was no clear evidence of an effect during convalescent-phase infection.\nInvestigations of test performance by brand showed considerable variation in sensitivity between tests, and in results between studies evaluating the same test. For tests that were evaluated in 200 or more samples, the lower bound of the 95% CI for sensitivity was 90% or more for only a small number of tests (IgG, n = 5; IgG or IgM, n = 1; total antibodies, n = 4). More test brands met the MHRA minimum criteria for specificity of 98% or above (IgG, n = 16; IgG or IgM, n = 5; total antibodies, n = 7). Seven assays met the specified criteria for both sensitivity and specificity.\nIn a low-prevalence (2%) setting, where antibody testing is used to diagnose COVID-19 in people with symptoms but who have had a negative PCR test, we would anticipate that 1 (1 to 2) case would be missed and 8 (5 to 15) would be falsely positive in 1000 people undergoing IgG or IgM testing in week three after onset of SARS-CoV-2 infection.\nIn a seroprevalence survey, where prevalence of prior infection is 50%, we would anticipate that 51 (46 to 58) cases would be missed and 6 (5 to 7) would be falsely positive in 1000 people having IgG tests during the convalescent phase (21 to 100 days post-symptom onset or post-positive PCR) of SARS-CoV-2 infection.\nAuthors' conclusions\nSome antibody tests could be a useful diagnostic tool for those in whom molecular- or antigen-based tests have failed to detect the SARS-CoV-2 virus, including in those with ongoing symptoms of acute infection (from week three onwards) or those presenting with post-acute sequelae of COVID-19. However, antibody tests have an increasing likelihood of detecting an immune response to infection as time since onset of infection progresses and have demonstrated adequate performance for detection of prior infection for sero-epidemiological purposes. The applicability of results for detection of vaccination-induced antibodies is uncertain.\n\nGiven the provided abstract, please respond to the following query: \"Who do the results of this review apply to?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A high percentage of participants were in hospital with COVID-19, so were likely to have more severe disease than people with COVID-19 who were not hospitalised. Only a small number of studies assessed these tests in people with no symptoms. The results of the review may therefore be more applicable to those with severe disease than people with mild symptoms.\nStudies frequently did not report whether participants had symptoms at the time samples were taken for testing making it difficult to fully separate test results for early-phase infection as opposed to later-phase infections.\nThe studies in our review assessed several test methods across a global population, therefore it is likely that test results would be similar in most areas of the world."
}
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query-laysum | 1991 | [
{
"role": "user",
"content": "Abstract: Background\nAttention deficit hyperactivity disorder (ADHD) is a prevalent neurobiological condition, characterised by behavioral and cognitive symptoms such as inattention, impulsivity and/or excessive activity. The syndrome is commonly accompanied by psychiatric comorbidities and is associated with educational and occupational underachievement.\nAlthough psychostimulant medications are the mainstay of treatment for ADHD, not all adults respond optimally to, or can tolerate, these medicines. Thus, alternative non-stimulant treatment approaches for ADHD have been explored. One of these alternatives is bupropion, an aminoketone antidepressant and non-competitive antagonism of nicotinic acetylcholine receptors. Bupropion is registered for the treatment of depression and smoking cessation, but is also used off-label to treat ADHD.\nObjectives\nTo assess the effects and safety of bupropion for the treatment of adults with ADHD.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and seven other databases in February 2017. We also searched three trials registers and three online theses portals. In addition, we checked references of included studies and contacted study authors to identify potentially relevant studies that were missed by our search.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that evaluated the effects (including adverse effects) of bupropion compared to placebo in adults with ADHD.\nData collection and analysis\nTwo review authors (WV, GB) independently screened records and extracted data using a data extraction sheet that we tested in a pilot study. We extracted all relevant data on study characteristics and results. We assessed risks of bias using the Cochrane 'Risk of bias' tool, and assessed the overall quality of evidence using the GRADE approach. We used a fixed-effect model to pool the results across studies.\nMain results\nWe included six studies with a total of 438 participants. Five studies were conducted in the USA, and one in Iran. All studies evaluated a long-acting version of bupropion, with the dosage ranging from 150 mg up to 450 mg daily. Study intervention length varied from six to 10 weeks. Four studies explicitly excluded participants with psychiatric comorbidity and one study included only participants with opioid dependency. Four studies were funded by industry, but the impact of this on study results is unknown. Two studies were publicly funded and in one of these studies, the lead author was a consultant for several pharmaceutical companies and also received investigator-driven funding from two companies, however none of these companies manufacture bupropion. We judged none of the studies to be free of bias because for most risk of bias domains the study reports failed to provide sufficient details. Using the GRADE approach, we rated the overall quality of evidence as low. We downgraded the quality of the evidence because of serious risk of bias and serious imprecision due to small sample sizes.\nWe found low-quality evidence that bupropion decreased the severity of ADHD symptoms (standardised mean difference -0.50, 95% confidence interval (CI) -0.86 to -0.15, 3 studies, 129 participants), and increased the proportion of participants achieving clinical improvement (risk ratio (RR) 1.50, 95% CI 1.13 to 1.99, 4 studies, 315 participants), and reporting an improvement on the Clinical Global Impression - Improvement scale (RR 1.78, 95% CI 1.27 to 2.50, 5 studies, 337 participants). There was low-quality evidence that the proportion of participants who withdrew due to any adverse effect was similar in the bupropion and placebo groups (RR 1.20, 95% CI 0.35 to 4.10, 3 studies, 253 participants). The results were very similar when using a random-effects model and when we analysed only studies that excluded participants with a psychiatric comorbidity.\nAuthors' conclusions\nThe findings of this review, which compared bupropion to placebo for adult ADHD, indicate a possible benefit of bupropion. We found low-quality evidence that bupropion decreased the severity of ADHD symptoms and moderately increased the proportion of participants achieving a significant clinical improvement in ADHD symptoms. Furthermore, we found low-quality evidence that the tolerability of bupropion is similar to that of placebo. In the pharmacological treatment of adults with ADHD, extended- or sustained-release bupropion may be an alternative to stimulants. The low-quality evidence indicates uncertainty with respect to the pooled effect estimates. Further research is very likely to change these estimates. More research is needed to reach more definite conclusions as well as clarifying the optimal target population for this medicine. Treatment response remains to be reported in a DSM5-diagnosed population. There is also a lack of knowledge on long-term outcomes.\n\nGiven the provided abstract, please respond to the following query: \"Study funding sources\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Four studies were funded by industry and two studies were publicly funded. In one of the publicly-funded studies, the lead author was paid by industry (although not by the manufacturers of buproprion) for research activities."
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query-laysum | 1992 | [
{
"role": "user",
"content": "Abstract: Background\nBronchodilators are a central component for treating exacerbations of chronic obstructive pulmonary disease (COPD) all over the world. Clinicians often use nebulisers as a mode of delivery, especially in the acute setting, and many patients seem to benefit from them. However, evidence supporting this choice from systematic analysis is sparse, and available data are frequently biased by the inclusion of asthma patients. Therefore, there is little or no formal guidance regarding the mode of delivery, which has led to a wide variation in practice between and within countries and even among doctors in the same hospital. We assessed the available randomised controlled trials (RCTs) to help guide practice in a more uniform way.\nObjectives\nTo compare the effects of nebulisers versus pressurised metered dose inhalers (pMDI) plus spacer or dry powder inhalers (DPI) in bronchodilator therapy for exacerbations of COPD.\nSearch methods\nWe searched the Cochrane Airways Group Trial Register and reference lists of articles up to 1 July 2016.\nSelection criteria\nRCTs of both parallel and cross-over designs. We included RCTs during COPD exacerbations, whether measured during hospitalisation or in an outpatient setting. We excluded RCTs involving mechanically ventilated patients due to the different condition of both patients and airways in this setting.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and assessed the risk of bias. We report results with 95% confidence intervals (CIs).\nMain results\nThis review includes eight studies with a total of 250 participants comparing nebuliser versus pMDI plus spacer treatment. We identified no studies comparing DPI with nebulisers. We found two studies assessing the primary outcome of 'change in forced expiratory volume in one second (FEV1) one hour after dosing'. We could not pool these studies, but both showed a non-significant difference in favour of the nebuliser group, with similar frequencies of serious adverse events. For the secondary outcome, 'change in FEV1 closest to one hour after dosing': we found a significant difference of 83 ml (95% CI 10 to 156, P = 0.03) in favour of nebuliser treatment. For the secondary outcome of adverse events, we found a non-significant odds ratio of 1.65 (95% CI 0.42 to 6.48) in favour of the pMDI plus spacer group.\nAuthors' conclusions\nThere is a lack of evidence in favour of one mode of delivery over another for bronchodilators during exacerbations of COPD. We found no difference between nebulisers versus pMDI plus spacer regarding the primary outcomes of FEV1 at one hour and safety. For the secondary outcome 'change in FEV1 closest to one hour after dosing' during an exacerbation of COPD, we found a greater improvement in FEV1 when treating with nebulisers than with pMDI plus spacers.\nA limited amount of data are available (eight studies involving 250 participants). These studies were difficult to pool, of low quality and did not provide enough evidence to favour one mode of delivery over another. No data of sufficient quality have been published comparing nebulisers versus DPIs in this setting. More studies are required to assess the optimal mode of delivery during exacerbations of COPD.\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": "Someone experiencing a lung attack suffers from shortness of breath because the airways are narrowed. Bronchodilators are a type of drug that helps to open these airways, but the best way to deliver them to the body is unknown. We searched for the best delivery device during lung attacks, focusing on whether there is a difference between wet nebulisers, which allow people to breathe in medicine as a mist using a mask or mouthpiece, compared with inhalers."
}
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query-laysum | 1993 | [
{
"role": "user",
"content": "Abstract: Background\nThe insertion of central venous catheters (CVCs) may be associated with peri- and post-procedural bleeding. People who require a central line often have disorders of coagulation as a result of their underlying illness, co-morbidities or the effects of treatment. Clinical practice in some institutions is to mitigate the risk of bleeding in these patients by prophylactically transfusing fresh frozen plasma (FFP) in order to correct clotting factor deficiencies prior to central line insertion. However, FFP transfusion is not without risk, and it remains unclear whether this intervention is associated with reduced rates of bleeding or other clinically-meaningful outcomes.\nObjectives\nTo assess the effect of different prophylactic plasma transfusion regimens prior to central line insertion in people with abnormal coagulation.\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 3), PubMed (e-publications only), Ovid MEDLINE (from 1946), Ovid Embase (from 1974), the Transfusion Evidence Library (from 1950) and ongoing trial databases to 1 March 2016.\nSelection criteria\nWe included RCTs involving transfusions of plasma to prevent bleeding in people of any age with abnormal coagulation requiring insertion of a central venous catheter, published in English.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe identified four trials eligible for inclusion, of which three are ongoing. We did not exclude any studies because they were not published in English.\nThe included study randomised 81 adults in intensive care whose INR (International Normalised Ratio) was greater than or equal to 1.5 to no FFP or to a single dose of 12 mL/kg FFP prior to undergoing central venous catheterisation (58 participants) or other invasive procedure (23 participants). It is the subgroup of 58 adults undergoing CVC insertion that were included in this review, the study authors provided unpublished data for this review's outcomes.\nThe quality of the evidence was low or very low across different outcomes according to the GRADE methodology. The included study was at high risk of bias due to lack of blinding of participants and personnel and imbalance in the number of participants who had liver disease between study arms.\nThere was insufficient evidence to determine a difference in major procedure-related bleeding within 24 hours (one RCT; 58 participants; no events in either study arm, very low-quality evidence). We are very uncertain whether FFP reduces minor procedure-related bleeding within 24 hours of the study (one RCT; 58 participants, RR 0.67, 95% CI 0.12 to 3.70, very low-quality evidence).\nNo studies were found that looked at: all-cause mortality; the proportion of participants receiving plasma or red cell transfusions; serious adverse reactions (transfusion or line-related complications); number of days in hospital; change in INR; or quality of life.\nThe three ongoing studies are still recruiting participants (expected recruitment: up to 355 participants in total). and are due to be completed by February 2018.\nAuthors' conclusions\nThere is only very limited evidence from one RCT to inform the decision whether or not to administer prophylactic plasma prior to central venous catheterisation for people with abnormal coagulation. It is not possible from the current RCT evidence to recommend whether or not prophylactic plasma transfusion is beneficial or harmful in this situation. The three ongoing RCTs will not be able to answer this review’s questions, because they are small studies and do not address all of the comparisons included in this review (355 participants in total). To detect an increase in the proportion of participants who had major bleeding from 1 in 100 to 2 in 100 would require a study containing at least 4634 participants (80% power, 5% significance).\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence is very low because this review includes only one small study."
}
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query-laysum | 1994 | [
{
"role": "user",
"content": "Abstract: Background\nNausea and vomiting are distressing symptoms which are experienced commonly during caesarean section under regional anaesthesia and in the postoperative period.\nObjectives\nTo assess the efficacy of pharmacological and non-pharmacological interventions versus placebo or no intervention given prophylactically to prevent nausea and vomiting in women undergoing regional anaesthesia for caesarean section.\nSearch methods\nFor this update, we searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (16 April 2020), and reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of studies and conference abstracts, and excluded quasi-RCTs and cross-over studies.\nData collection and analysis\nReview authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Our primary outcomes are intraoperative and postoperative nausea and vomiting. Data entry was checked. Two review authors independently assessed the certainty of the evidence using the GRADE approach.\nMain results\nEighty-four studies (involving 10,990 women) met our inclusion criteria. Sixty-nine studies, involving 8928 women, contributed data. Most studies involved women undergoing elective caesarean section. Many studies were small with unclear risk of bias and sometimes few events. The overall certainty of the evidence assessed using GRADE was moderate to very low.\n5-HT3 antagonists: We found intraoperative nausea may be reduced by 5-HT3 antagonists (average risk ratio (aRR) 0.55, 95% confidence interval (CI) 0.42 to 0.71, 12 studies, 1419 women, low-certainty evidence). There may be a reduction in intraoperative vomiting but the evidence is very uncertain (aRR 0.46, 95% CI 0.29 to 0.73, 11 studies, 1414 women, very low-certainty evidence). There is probably a reduction in postoperative nausea (aRR 0.40, 95% CI 0.30 to 0.54, 10 studies, 1340 women, moderate-certainty evidence), and these drugs may show a reduction in postoperative vomiting (aRR 0.47, 95% CI 0.31 to 0.69, 10 studies, 1450 women, low-certainty evidence).\nDopamine antagonists: We found dopamine antagonists may reduce intraoperative nausea but the evidence is very uncertain (aRR 0.38, 95% CI 0.27 to 0.52, 15 studies, 1180 women, very low-certainty evidence). Dopamine antagonists may reduce intraoperative vomiting (aRR 0.41, 95% CI 0.28 to 0.60, 12 studies, 942 women, low-certainty evidence) and postoperative nausea (aRR 0.61, 95% CI 0.48 to 0.79, 7 studies, 601 women, low-certainty evidence). We are uncertain if dopamine antagonists reduce postoperative vomiting (aRR 0.63, 95% CI 0.44 to 0.92, 9 studies, 860 women, very low-certainty evidence).\nCorticosteroids (steroids): We are uncertain if intraoperative nausea is reduced by corticosteroids (aRR 0.56, 95% CI 0.37 to 0.83, 6 studies, 609 women, very low-certainty evidence) similarly for intraoperative vomiting (aRR 0.52, 95% CI 0.31 to 0.87, 6 studies, 609 women, very low-certainty evidence). Corticosteroids probably reduce postoperative nausea (aRR 0.59, 95% CI 0.49 to 0.73, 6 studies, 733 women, moderate-certainty evidence), and may reduce postoperative vomiting (aRR 0.68, 95% CI 0.49 to 0.95, 7 studies, 793 women, low-certainty evidence).\nAntihistamines: Antihistamines may have little to no effect on intraoperative nausea (RR 0.99, 95% CI 0.47 to 2.11, 1 study, 149 women, very low-certainty evidence) or intraoperative vomiting (no events in the one study of 149 women). Antihistamines may reduce postoperative nausea (aRR 0.44, 95% CI 0.30 to 0.64, 4 studies, 514 women, low-certainty evidence), however, we are uncertain whether antihistamines reduce postoperative vomiting (average RR 0.48, 95% CI 0.29 to 0.81, 3 studies, 333 women, very low-certainty evidence).\nAnticholinergics: Anticholinergics may reduce intraoperative nausea (aRR 0.67, 95% CI 0.51 to 0.87, 4 studies, 453 women, low-certainty evidence) but may have little to no effect on intraoperative vomiting (aRR 0.79, 95% CI 0.40 to 1.54, 4 studies; 453 women, very low-certainty evidence). No studies looked at anticholinergics in postoperative nausea, but they may reduce postoperative vomiting (aRR 0.55, 95% CI 0.41 to 0.74, 1 study, 161 women, low-certainty evidence).\nSedatives: We found that sedatives probably reduce intraoperative nausea (aRR 0.65, 95% CI 0.51 to 0.82, 8 studies, 593 women, moderate-certainty evidence) and intraoperative vomiting (aRR 0.35, 95% CI 0.24 to 0.52, 8 studies, 593 women, moderate-certainty evidence). However, we are uncertain whether sedatives reduce postoperative nausea (aRR 0.25, 95% CI 0.09 to 0.71, 2 studies, 145 women, very low-certainty evidence) and they may reduce postoperative vomiting (aRR 0.09, 95% CI 0.03 to 0.28, 2 studies, 145 women, low-certainty evidence).\nOpioid antagonists: There were no studies assessing intraoperative nausea or vomiting. Opioid antagonists may result in little or no difference to the number of women having postoperative nausea (aRR 0.75, 95% CI 0.39 to 1.45, 1 study, 120 women, low-certainty evidence) or postoperative vomiting (aRR 1.25, 95% CI 0.35 to 4.43, 1 study, 120 women, low-certainty evidence).\nAcupressure: It is uncertain whether acupressure/acupuncture reduces intraoperative nausea (aRR 0.55, 95% CI 0.41 to 0.74, 9 studies, 1221 women, very low-certainty evidence). Acupressure may reduce intraoperative vomiting (aRR 0.52, 95% CI 0.33 to 0.80, 9 studies, 1221 women, low-certainty evidence) but it is uncertain whether it reduces postoperative nausea (aRR 0.46, 95% CI 0.27 to 0.75, 7 studies, 1069 women, very low-certainty evidence) or postoperative vomiting (aRR 0.52, 95% CI 0.34 to 0.79, 7 studies, 1069 women, very low-certainty evidence).\nGinger: It is uncertain whether ginger makes any difference to the number of women having intraoperative nausea (aRR 0.66, 95% CI 0.36 to 1.21, 2 studies, 331 women, very low-certainty evidence), intraoperative vomiting (aRR 0.62, 95% CI 0.38 to 1.00, 2 studies, 331 women, very low-certainty evidence), postoperative nausea (aRR 0.63, 95% CI 0.22 to 1.77, 1 study, 92 women, very low-certainty evidence) and postoperative vomiting (aRR 0.20, 95% CI 0.02 to 1.65, 1 study, 92 women, very low-certainty evidence).\nFew studies assessed our secondary outcomes including adverse effects or women's views.\nAuthors' conclusions\nThis review indicates that 5-HT3 antagonists, dopamine antagonists, corticosteroids, sedatives and acupressure probably or possibly have efficacy in reducing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. However the certainty of evidence varied widely and was generally low. Future research is needed to assess side effects of treatment, women's views and to compare the efficacy of combinations of different medications.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out from randomised controlled trials how effective drugs and other treatments are for reducing nausea and vomiting during and after caesarean section with epidural or spinal anaesthesia, when compared with an inactive control. We searched for all relevant studies to answer our review question (April 2020)."
}
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query-laysum | 1995 | [
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) End TB Strategy stresses universal access to drug susceptibility testing (DST). DST determines whether Mycobacterium tuberculosis bacteria are susceptible or resistant to drugs. Xpert MTB/XDR is a rapid nucleic acid amplification test for detection of tuberculosis and drug resistance in one test suitable for use in peripheral and intermediate level laboratories. In specimens where tuberculosis is detected by Xpert MTB/XDR, Xpert MTB/XDR can also detect resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.\nObjectives\nTo assess the diagnostic accuracy of Xpert MTB/XDR for pulmonary tuberculosis in people with presumptive pulmonary tuberculosis (having signs and symptoms suggestive of tuberculosis, including cough, fever, weight loss, night sweats).\nTo assess the diagnostic accuracy of Xpert MTB/XDR for resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin in people with tuberculosis detected by Xpert MTB/XDR, irrespective of rifampicin resistance (whether or not rifampicin resistance status was known) and with known rifampicin resistance.\nSearch methods\nWe searched multiple databases to 23 September 2021. We limited searches to 2015 onwards as Xpert MTB/XDR was launched in 2020.\nSelection criteria\nDiagnostic accuracy studies using sputum in adults with presumptive or confirmed pulmonary tuberculosis. Reference standards were culture (pulmonary tuberculosis detection); phenotypic DST (pDST), genotypic DST (gDST),composite (pDST and gDST) (drug resistance detection).\nData collection and analysis\nTwo review authors independently reviewed reports for eligibility and extracted data using a standardized form. For multicentre studies, we anticipated variability in the type and frequency of mutations associated with resistance to a given drug at the different centres and considered each centre as an independent study cohort for quality assessment and analysis. We assessed methodological quality with QUADAS-2, judging risk of bias separately for each target condition and reference standard. For pulmonary tuberculosis detection, owing to heterogeneity in participant characteristics and observed specificity estimates, we reported a range of sensitivity and specificity estimates and did not perform a meta-analysis. For drug resistance detection, we performed meta-analyses by reference standard using bivariate random-effects models. Using GRADE, we assessed certainty of evidence of Xpert MTB/XDR accuracy for detection of resistance to isoniazid and fluoroquinolones in people irrespective of rifampicin resistance and to ethionamide and amikacin in people with known rifampicin resistance, reflecting real-world situations. We used pDST, except for ethionamide resistance where we considered gDST a better reference standard.\nMain results\nWe included two multicentre studies from high multidrug-resistant/rifampicin-resistant tuberculosis burden countries, reporting on six independent study cohorts, involving 1228 participants for pulmonary tuberculosis detection and 1141 participants for drug resistance detection. The proportion of participants with rifampicin resistance in the two studies was 47.9% and 80.9%. For tuberculosis detection, we judged high risk of bias for patient selection owing to selective recruitment. For ethionamide resistance detection, we judged high risk of bias for the reference standard, both pDST and gDST, though we considered gDST a better reference standard.\nPulmonary tuberculosis detection\n- Xpert MTB/XDR sensitivity range, 98.3% (96.1 to 99.5) to 98.9% (96.2 to 99.9) and specificity range, 22.5% (14.3 to 32.6) to 100.0% (86.3 to 100.0); median prevalence of pulmonary tuberculosis 91.3%, (interquartile range, 89.3% to 91.8%), (2 studies; 1 study reported on 2 cohorts, 1228 participants; very low-certainty evidence, sensitivity and specificity).\nDrug resistance detection\nPeople irrespective of rifampicin resistance\n- Isoniazid resistance: Xpert MTB/XDR summary sensitivity and specificity (95% confidence interval (CI)) were 94.2% (87.5 to 97.4) and 98.5% (92.6 to 99.7) against pDST, (6 cohorts, 1083 participants, moderate-certainty evidence, sensitivity and specificity).\n- Fluoroquinolone resistance: Xpert MTB/XDR summary sensitivity and specificity were 93.2% (88.1 to 96.2) and 98.0% (90.8 to 99.6) against pDST, (6 cohorts, 1021 participants; high-certainty evidence, sensitivity; moderate-certainty evidence, specificity).\nPeople with known rifampicin resistance\n- Ethionamide resistance: Xpert MTB/XDR summary sensitivity and specificity were 98.0% (74.2 to 99.9) and 99.7% (83.5 to 100.0) against gDST, (4 cohorts, 434 participants; very low-certainty evidence, sensitivity and specificity).\n- Amikacin resistance: Xpert MTB/XDR summary sensitivity and specificity were 86.1% (75.0 to 92.7) and 98.9% (93.0 to 99.8) against pDST, (4 cohorts, 490 participants; low-certainty evidence, sensitivity; high-certainty evidence, specificity).\nOf 1000 people with pulmonary tuberculosis, detected as tuberculosis by Xpert MTB/XDR:\n- where 50 have isoniazid resistance, 61 would have an Xpert MTB/XDR result indicating isoniazid resistance: of these, 14/61 (23%) would not have isoniazid resistance (FP); 939 (of 1000 people) would have a result indicating the absence of isoniazid resistance: of these, 3/939 (0%) would have isoniazid resistance (FN).\n- where 50 have fluoroquinolone resistance, 66 would have an Xpert MTB/XDR result indicating fluoroquinolone resistance: of these, 19/66 (29%) would not have fluoroquinolone resistance (FP); 934 would have a result indicating the absence of fluoroquinolone resistance: of these, 3/934 (0%) would have fluoroquinolone resistance (FN).\n- where 300 have ethionamide resistance, 296 would have an Xpert MTB/XDR result indicating ethionamide resistance: of these, 2/296 (1%) would not have ethionamide resistance (FP); 704 would have a result indicating the absence of ethionamide resistance: of these, 6/704 (1%) would have ethionamide resistance (FN).\n- where 135 have amikacin resistance, 126 would have an Xpert MTB/XDR result indicating amikacin resistance: of these, 10/126 (8%) would not have amikacin resistance (FP); 874 would have a result indicating the absence of amikacin resistance: of these, 19/874 (2%) would have amikacin resistance (FN).\nAuthors' conclusions\nReview findings suggest that, in people determined by Xpert MTB/XDR to be tuberculosis-positive, Xpert MTB/XDR provides accurate results for detection of isoniazid and fluoroquinolone resistance and can assist with selection of an optimised treatment regimen. Given that Xpert MTB/XDR targets a limited number of resistance variants in specific genes, the test may perform differently in different settings. Findings in this review should be interpreted with caution. Sensitivity for detection of ethionamide resistance was based only on Xpert MTB/XDR detection of mutations in the inhA promoter region, a known limitation. High risk of bias limits our confidence in Xpert MTB/XDR accuracy for pulmonary tuberculosis.\nXpert MTB/XDR's impact will depend on its ability to detect tuberculosis (required for DST), prevalence of resistance to a given drug, health care infrastructure, and access to other tests.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are the results of the studies in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For pulmonary tuberculosis detection, we did not consider the results reliable because around 90% of the participants had Xpert-detected pulmonary tuberculosis to begin with due to the way people were chosen to participate in the studies. For drug resistance detection, we were confident in the results, except for results for ethionamide resistance detection, where the reference standards were not ideal."
}
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query-laysum | 1996 | [
{
"role": "user",
"content": "Abstract: Background\nDental caries (tooth decay) is a common disease that is preventable by reducing the dietary intake of free sugars and using topical sodium fluoride products. An antibacterial agent known as chlorhexidine may also help prevent caries. A number of over-the-counter and professionally administered chlorhexidine-based preparations are available in a variety of formulations and in a range of strengths. Although previous reviews have concluded that some formulations of chlorhexidine may be effective in inhibiting the progression of established caries in children, there is currently a lack of evidence to either claim or refute a benefit for its use in preventing dental caries.\nObjectives\nTo assess the effects of chlorhexidine-containing oral products (toothpastes, mouthrinses, varnishes, gels, gums and sprays) on the prevention of dental caries in children and adolescents.\nSearch methods\nWe searched the Cochrane Oral Health Group Trials Register (25 February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 12), MEDLINE via OVID (1946 to 25 February 2015), EMBASE via OVID (1980 to 25 February 2015) and CINAHL via EBSCO (1937 to 25 February 2015). We handsearched several journals placed no language restrictions on our search. After duplicate citations were removed, the electronic searches retrieved 1075 references to studies.\nSelection criteria\nWe included parallel-group, randomised controlled trials (RCTs) that compared the caries preventive effects of chlorhexidine gels, toothpastes, varnishes, mouthrinses, chewing gums or sprays with each other, placebo or no intervention in children and adolescents. We excluded trials with combined interventions of chlorhexidine and fluoride or comparisons between chlorhexidine and fluoride interventions.\nData collection and analysis\nTwo review authors independently extracted trial data and assessed risk of bias. We resolved disagreements by consensus. We contacted trial authors for clarification or additional study details when necessary. The number of included studies that were suitable for meta-analysis was limited due to the clinical diversity of the included studies with respect to age, composition of intervention, and variation in outcome measures and follow-up. Where we were unable to conduct meta-analysis, we elected to present a narrative synthesis of the results.\nMain results\nWe included eight RCTs that evaluated the effects of chlorhexidine varnishes (1%, 10% or 40% concentration) and chlorhexidine gel (0.12%) on the primary or permanent teeth, or both, of children from birth to 15 years of age at the start of the study. The studies randomised a total of 2876 participants, of whom 2276 (79%) were evaluated. We assessed six studies as being at high risk of bias overall and two studies as being at unclear risk of bias overall. Follow-up assessment ranged from 6 to 36 months.\nSix trials compared chlorhexidine varnish with placebo or no treatment. It was possible to pool the data from two trials in the permanent dentition (one study using 10% chlorhexidine and the other, 40%). This led to an increase in the DMFS increment in the varnish group of 0.53 (95% confidence interval (CI) -0.47 to 1.53; two trials, 690 participants; very low quality evidence). Only one trial (10% concentration chlorhexidine varnish) provided usable data for elevated mutans streptococci levels > 4 with RR 0.93 (95% CI 0.80 to 1.07, 496 participants; very low quality evidence). One trial measured adverse effects (for example, ulcers or tooth staining) and reported that there were none; another trial reported that no side effects of the treatment were noted. No trials reported on pain, quality of life, patient satisfaction or costs.\nTwo trials compared chlorhexidine gel (0.12% concentration) with no treatment in the primary dentition. The presence of new caries gave rise to a 95% confidence interval that was compatible with either an increase or a decrease in caries incidence (RR 1.00, 95% CI 0.36 to 2.77; 487 participants; very low quality evidence). Similarly, data for the effects of chlorhexidine gel on the prevalence of mutans streptococci were inconclusive (RR 1.26, 95% CI 0.95 to 1.66; two trials, 490 participants; very low quality evidence). Both trials measured adverse effects and did not observe any. Neither of these trials reported on the other secondary outcomes such as measures of pain, quality of life, patient satisfaction or direct and indirect costs of interventions.\nAuthors' conclusions\nWe found little evidence from the eight trials on varnishes and gels included in this review to either support or refute the assertion that chlorhexidine is more effective than placebo or no treatment in the prevention of caries or the reduction of mutans streptococci levels in children and adolescents. There were no trials on other products containing chlorhexidine such as sprays, toothpastes, chewing gums or mouthrinses. Further high quality research is required, in particular evaluating the effects on both the primary and permanent dentition and using other chlorhexidine-containing oral products.\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": "Due to the lack of suitable studies and concerns about possible bias in the included studies, the evidence is very low quality. As a result, we are not able to conclude whether or not chlorhexidine is effective in preventing tooth decay in children or adolescents, when compared to placebo (an inactive substitute for chlorhexidine) or no treatment. Future research on the use of chlorhexidine to prevent tooth decay is needed and should consider both primary and permanent teeth and should assess other chlorhexidine-containing products that can be used at home, such as toothpastes or mouthrinses."
}
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query-laysum | 1997 | [
{
"role": "user",
"content": "Abstract: Background\nAcceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area.\nObjectives\nTo assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing.\nSearch methods\nIn October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies.\nSelection criteria\nAll variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models.\nMain results\nWe included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty.\nParenting interventions\nEvidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm.\nPsychological interventions\nPsychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills.\nAuthors' conclusions\nThere is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.\n\nGiven the provided abstract, please respond to the following query: \"What are the limitations of the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are not confident in the results from a lot of the studies because many people dropped out during the study, so there was a lot of missing data and there were not enough large, well-designed studies to be certain about the results. There is limited evidence of important benefits available so far in this emerging field."
}
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query-laysum | 1998 | [
{
"role": "user",
"content": "Abstract: Background\nMedications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage. The majority of miscarriages occur in the first trimester. The aim of cervical ripening is to reduce the possibility of injury to the uterus and cervix and improve the surgical ease of the procedure. Cervical ripening agents can have adverse effects and it is uncertain as to whether these risks outweigh the benefits of their use.\nObjectives\nTo systematically review the benefits and harms of using cervical ripening agents prior to surgical evacuation of non-viable pregnancy prior to 14 weeks' gestation.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015) and reference lists of retrieved papers.\nSelection criteria\nRandomised controlled trials (published in full-text form, or as abstracts only), which assessed the use of pharmacological or mechanical agents to ripen the cervix in women undergoing dilation and curettage or vacuum aspiration for non-viable pregnancy at less than 14 weeks' gestation were eligible for inclusion. Cluster-randomised controlled trials and trials using a cross-over design were not eligible for inclusion.\nUnpublished randomised controlled trials and quasi-randomised trials would have been eligible for inclusion but none were identified.\nData collection and analysis\nTwo review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data were checked for accuracy.\nMain results\nWe included nine trials with 469 women. A diverse set of medications and regimens were studied in these trials, making the comparisons available for meta-analysis limited. The comparisons draw data from six trials with 383 participants. All trials were relatively small and had several aspects of unclear risk of bias with few of this review's outcomes reported. Due to this, no data from three trials were able to be used despite them meeting inclusion criteria.\nWe carried out four comparisons: isosorbide mononitrate or dinitrate compared with misoprostol; misoprostol compared with placebo; chemical dilation (use of medications) compared with mechanical dilation; and any cervical preparation compared with placebo.\nNone of the included studies reported data on the review's primary outcome: cervical or uterine injury (perforation, laceration, creation of a false passage).\nNo clear difference was shown between isosorbide compounds and misoprostol for the outcome need for manual cervical dilation (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.10 to 5.64; three trials, 150 women; Tau² = 2.11; I² = 69%), however the data were heterogenous. In terms of adverse effects, misoprostol was associated with more vomiting (RR 0.11, 95% CI 0.01 to 0.85; two trials, 120 women), however there were no clear differences between isosorbide compounds and misoprostol in relation to other reported adverse effects (headache, nausea or hypotension). The dosing regimens differed in terms of dose, number of administrations and route of administration in the different trials. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators in a single trial (65 women) that measured difficulty in cervical dilation, excessive bleeding and adverse effects.\nMisoprostol was shown to be more effective than placebo for cervical ripening (reduced need for manual cervical dilation) (RR 0.14, 95% CI 0.08 to 0.26; one trial, 120 women), and surgical time was reduced when misoprostol was used (mean difference (MD) -3.15, 95% CI -3.59 to -2.70; one trial, 120 women). However, compared to placebo, misoprostol, was associated with more abdominal pain (RR 29.00, 95% CI 1.77 to 475.35; one trial, 120 women), although no clear differences in the risk of other adverse effects (nausea, vomiting, headache or fever) were observed between groups.\nThere was no clear differences between chemical dilation and mechanical dilators for the outcomes: difficulty in cervical dilation, excessive bleeding or adverse effects.\nCompared with placebo, any cervical preparation reduced the need for manual cervical dilatation (average RR 0.25, 95% CI 0.07 to 0.89; two trials, 168 women; Tau² = 0.67; I² = 81%), and reduced surgical time (MD -2.55, 95% CI -3.67 to -1.43, two trials, 168 women; Tau² = 0.63; I² = 96%).\nNone of the included trials reported on the review's other secondary outcomes, including: injury to bladder or bowel, miscarriage/preterm birth in a subsequent pregnancy, analgesia use after administration of ripening agent but before surgery, or analgesia use after surgery.\nAuthors' conclusions\nThis review found no evidence to evaluate cervical ripening prior to first trimester surgical evacuation for miscarriage for reducing the rate of cervical or uterine injury, however, this may be because these outcomes are very rare. Cervical preparation was shown to reduce the need for manual cervical dilatation compared with placebo.\nMisoprostol and isosorbide mononitrate and dinitrate were similarly effective in ripening the cervix, however there was more vomiting with misoprostol. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators.\nThe nine studies included in this review were small and the methodological quality of the trials was mixed, and for the most part, not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Consequently, large, high-quality trials are required to determine whether the benefits of this treatment outweigh the risks. Further research should be powered to assess the rate of cervical and uterine injury between interventions. Future research should also guide clinicians in deciding whether the benefits of reduced manual cervical dilatation outweigh the risks of adverse effects associated with these agents (nausea, vomiting, headache, fever, diarrhoea and pain). Women's satisfaction and outcomes of future pregnancies should also be assessed.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A large number of gynaecologists are already using cervical ripening techniques before surgical evacuation of the uterus for miscarriages. It is important to assess whether this is an effective and safe practice."
}
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query-laysum | 1999 | [
{
"role": "user",
"content": "Abstract: Background\nSmoking cessation is the most important treatment for smokers with chronic obstructive pulmonary disease (COPD), but little is known about the effectiveness of different smoking cessation interventions for this particular group of smokers.\nObjectives\nTo evaluate the effectiveness of behavioural or pharmacological smoking cessation interventions, or both, in smokers with COPD.\nSearch methods\nWe searched all records in the Cochrane Airways Group Specialised Register of Trials. In addition to this electronic search, we searched clinical trial registries for planned, ongoing, and unpublished trials. We searched all databases from their inception. We checked the reference lists of all included studies and of other systematic reviews in relevant topic areas. We searched for errata or retractions from eligible trials on PubMed. We conducted our most recent search in March 2016.\nSelection criteria\nWe included randomised controlled trials assessing the effectiveness of any behavioural or pharmacological treatment, or both, in smokers with COPD reporting at least six months of follow-up abstinence rates.\nData collection and analysis\nTwo review authors independently extracted the data and performed the methodological quality assessment for each study. We resolved any disagreements by consensus.\nMain results\nWe included 16 studies (involving 13,123 participants) in this systematic review, two of which were of high quality. These two studies showed that nicotine sublingual tablet and varenicline increased the quit rate over placebo (risk ratio (RR) 2.60 (95% confidence interval (CI) 1.29 to 5.24) and RR 3.34 (95% CI 1.88 to 5.92)). Pooled results of two studies also showed a positive effect of bupropion compared with placebo (RR 2.03 (95% CI 1.26 to 3.28)). When pooling these four studies, we found high-quality evidence for the effectiveness of pharmacotherapy plus high-intensity behavioural treatment compared with placebo plus high-intensity behavioural treatment (RR 2.53 (95% CI 1.83 to 3.50)). Furthermore, we found some evidence that high-intensity behavioural treatment increased abstinence rates when compared with usual care (RR 25.38 (95% CI 8.03 to 80.22)) or low-intensity behavioural treatment (RR 2.18 (95% CI 1.05 to 4.49)). Finally, the results showed effectiveness of various combinations of psychosocial and pharmacological interventions.\nAuthors' conclusions\nWe found high-quality evidence in a meta-analysis including four (1,540 participants) of the 16 included studies that a combination of behavioural treatment and pharmacotherapy is effective in helping smokers with COPD to quit smoking. Furthermore, we conclude that there is no convincing evidence for preferring any particular form of behavioural or pharmacological treatment.\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 find out the best way to help people with chronic obstructive pulmonary disease (COPD) to stop smoking."
}
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query-laysum | 2000 | [
{
"role": "user",
"content": "Abstract: Background\nPulmonary hypertension is a condition of complex aetiology that culminates in right heart failure and early death. Soluble guanylate cyclase (sGC) stimulators are a promising class of agents that have recently gained approval for use.\nObjectives\nTo evaluate the efficacy of sGC stimulators in pulmonary hypertension.\nSearch methods\nWe searched CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE, EMBASE and the reference lists of articles. Searches are current as of 12 February 2016.\nSelection criteria\nWe selected randomised controlled trials (RCTs) involving participants with pulmonary hypertension of all ages, severities and durations of treatment.\nData collection and analysis\nAW, MS and RW independently selected studies, assessed evidence quality and extracted data. This process was overseen by RT and SG. All included studies were sponsored by the drug manufacturer.\nMain results\nFive trials involving 962 participants are included in this review. All trials were of relatively short duration (< 16 weeks). Due to the heterogenous aetiology of pulmonary hypertension in participants, results are best considered according to each pulmonary hypertension subtype.\nPooled analysis shows a mean difference (MD) increase in six-minute walking distance (6MWD) of 30.13 metres (95% CI 5.29 to 54.96; participants = 659; studies = 3). On subgroup analysis, for pulmonary arterial hypertension (PAH) there was no effect noted (6MWD; MD 11.91 metres, 95% CI −44.92 to 68.75; participants = 398; studies = 2), and in chronic thromboembolic pulmonary hypertension (CTEPH) sGC stimulators improved 6MWD by an MD of 45 metres (95% CI 23.87 to 66.13; participants = 261; studies = 1). Data for left heart disease-associated PH was not available for pooling. Importantly, when participants receiving phosphodiesterase inhibitors were excluded, sGC stimulators increased 6MWD by a MD of 36 metres in PAH. The second primary outcome, mortality, showed no change on pooled analysis against placebo (Peto odds ratio (OR) 0.57, 95% CI 0.18 to 1.80).\nPooled secondary outcomes include an increase in World Health Organization (WHO) functional class (OR 1.53, 95% CI 0.87 to 2.72; participants = 858; studies = 4), no effect on clinical worsening (OR 0.45, 95% CI 0.17 to 1.14; participants = 842; studies = 3), and a reduction in mean pulmonary artery pressure (MD −2.77 mmHg, 95% CI −4.96 to −0.58; participants = 744; studies = 5). There was no significant difference in serious adverse events on pooled analysis (OR 1.12, 95% CI 0.66 to 1.90; participants = 818; studies = 5) or when analysed at PAH (MD −3.50, 95% CI −5.54 to −1.46; participants = 344; studies = 1), left heart disease associated subgroups (OR 1.56, 95% CI 0.78 to 3.13; participants = 159; studies = 2) or CTEPH subgroups (OR 1.29, 95% CI 0.65 to 2.56; participants = 261; studies = 1).\nIt is important to consider the results for PAH in the context of a person who is not also receiving a phosphodiesterase-V inhibitor, a contra-indication to sGC stimulator use. It should also be noted that CTEPH results are applicable to inoperable or recurrent CTEPH only.\nEvidence was rated according to the GRADE scoring system. One outcome was considered high quality, two were moderate, and eight were of low or very low quality, meaning that for many of the outcomes the true effect could differ substantially from our estimate. There were only minor concerns regarding the risk of bias in these trials, all being RCTs largely following the original protocol. Most trials employed an intention-to-treat analysis.\nAuthors' conclusions\nsGC stimulators improve pulmonary artery pressures in people with PAH (who are treatment naive or receiving a prostanoid or endothelin antagonist) or those with recurrent or inoperable CTEPH. In these settings this can be achieved without notable complication. However, sGC stimulators should not be taken by people also receiving phosphodiestase-V inhibitors or nitrates due to the risks of hypotension, and there is currently no evidence supporting their use in pulmonary hypertension associated with left heart disease. There is no evidence supporting their use in children. These conclusions are based on data with limitations, including unavailable data from two of the 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": "This evidence is current to February 2016. Males and females of all ages diagnosed with PH were included in this review. We selected only randomised clinical trials. All trials used a comparison to no treatment. Trial durations ranged from 12 to 16 weeks. This review involves five trials on 962 participants. All included studies were sponsored by the maker of the drug."
}
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query-laysum | 2001 | [
{
"role": "user",
"content": "Abstract: Background\nOsteoarthritis is a chronic disease characterized by joint pain, tenderness, and limitation of movement. At present, no cure is available. Thus only treatment of the person's symptoms and treatment to prevent further development of the disease are possible. Clinical trials indicate that aquatic exercise may have advantages for people with osteoarthritis. This is an update of a published Cochrane review.\nObjectives\nTo evaluate the effects of aquatic exercise for people with knee or hip osteoarthritis, or both, compared to no intervention.\nSearch methods\nWe searched the following databases up to 28 April 2015: the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library Issue 1, 2014), MEDLINE (from 1949), EMBASE (from 1980), CINAHL (from 1982), PEDro (Physiotherapy Evidence Database), and Web of Science (from 1945). There was no language restriction.\nSelection criteria\nRandomized controlled clinical trials of aquatic exercise compared to a control group (e.g. usual care, education, social attention, telephone call, waiting list for surgery) of participants with knee or hip osteoarthritis.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data and assessed risk of bias of the included trials. We analysed the pooled results using standardized mean difference (SMD) values.\nMain results\nNine new trials met the inclusion criteria and we excluded two earlier included trials. Thus the number of participants increased from 800 to 1190 and the number of included trials increased from six to 13. Most participants were female (75%), with an average age of 68 years and a body mass index (BMI) of 29.4. Osteoarthritis duration was 6.7 years, with a great variation of the included participants. The mean aquatic exercise duration was 12 weeks. We found 12 trials at low to unclear risk of bias for all domains except blinding of participants and personnel. They showed that aquatic exercise caused a small short term improvement compared to control in pain (SMD −0.31, 95% CI −0.47 to −0.15; 12 trials, 1076 participants) and disability (SMD −0.32, 95% CI −0.47 to −0.17; 12 trials, 1059 participants). Ten trials showed a small effect on quality of life (QoL) (SMD −0.25, 95% CI −0.49 to −0.01; 10 trials, 971 participants). These effects on pain and disability correspond to a five point lower (95% CI three to eight points lower) score on mean pain and mean disability compared to the control group (scale 0 to 100), and a seven point higher (95% CI 0 to 13 points higher) score on mean QoL compared with control group (scale 0 to 100). No included trials performed a radiographic evaluation. No serious adverse events were reported in the included trials with relation to aquatic exercise.\nAuthors' conclusions\nThere is moderate quality evidence that aquatic exercise may have small, short-term, and clinically relevant effects on patient-reported pain, disability, and QoL in people with knee and hip OA. The conclusions of this review update does not change those of the previous published version of this Cochrane review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of life [higher score is better]\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People who completed an aquatic exercise programme rated their quality of life as seven points higher (0 to 13 points higher) on a 0 to 100 scale at the end of aquatic exercise compared with people who did not receive aquatic exercise (13% absolute improvement)\nPeople who completed an exercise program rated their quality of life to be 57 points on a scale of 0 to 100\nPeople in the control group rated their quality of life to be 50 points on a scale of 0 to 100"
}
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query-laysum | 2002 | [
{
"role": "user",
"content": "Abstract: Background\nHip fractures are a major healthcare problem, presenting a considerable challenge and burden to individuals and healthcare systems. The number of hip fractures globally is rising rapidly. The majority of intracapsular hip fractures are treated surgically.\nObjectives\nTo assess the relative effects (benefits and harms) of all surgical treatments used in the management of intracapsular hip fractures in older adults, using a network meta-analysis of randomised trials, and to generate a hierarchy of interventions according to their outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Web of Science, and five other databases in July 2020. We also searched clinical trials databases, conference proceedings, reference lists of retrieved articles and conducted backward-citation searches.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing different treatments for fragility intracapsular hip fractures in older adults. We included total hip arthroplasties (THAs), hemiarthroplasties (HAs), internal fixation, and non-operative treatments. We excluded studies of people with hip fracture with specific pathologies other than osteoporosis or resulting from high-energy trauma.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion. One review author completed data extraction which was checked by a second review author. We collected data for three outcomes at different time points: mortality and health-related quality of life (HRQoL) - both reported within 4 months, at 12 months, and after 24 months of surgery, and unplanned return to theatre (at end of study follow-up).\nWe performed a network meta-analysis (NMA) with Stata software, using frequentist methods, and calculated the differences between treatments using risk ratios (RRs) and standardised mean differences (SMDs) and their corresponding 95% confidence intervals (CIs). We also performed direct comparisons using the same codes.\nMain results\nWe included 119 studies (102 RCTS, 17 quasi-RCTs) with 17,653 participants with 17,669 intracapsular fractures in the review; 83% of fractures were displaced. The mean participant age ranged from 60 to 87 years and 73% were women.\nAfter discussion with clinical experts, we selected 12 nodes that represented the best balance between clinical plausibility and efficiency of the networks: cemented modern unipolar HA, dynamic fixed angle plate, uncemented first-generation bipolar HA, uncemented modern bipolar HA, cemented modern bipolar HA, uncemented first-generation unipolar HA, uncemented modern unipolar HA, THA with single articulation, dual-mobility THA, pins, screws, and non-operative treatment. Seventy-five studies (with 11,855 participants) with data for at least two of these treatments contributed to the NMA.\nWe selected cemented modern unipolar HA as a reference treatment against which other treatments were compared. This was a common treatment in the networks, providing a clinically appropriate comparison. In order to provide a concise summary of the results, we report only network estimates when there was evidence of difference between treatments.\nWe downgraded the certainty of the evidence for serious and very serious risks of bias and when estimates included possible transitivity, particularly for internal fixation which included more undisplaced fractures. We also downgraded for incoherence, or inconsistency in indirect estimates, although this affected few estimates. Most estimates included the possibility of benefits and harms, and we downgraded the evidence for these treatments for imprecision.\nWe found that cemented modern unipolar HA, dynamic fixed angle plate and pins seemed to have the greatest likelihood of reducing mortality at 12 months. Overall, 23.5% of participants who received the reference treatment died within 12 months of surgery. Uncemented modern bipolar HA had higher mortality than the reference treatment (RR 1.37, 95% CI 1.02 to 1.85; derived only from indirect evidence; low-certainty evidence), and THA with single articulation also had higher mortality (network estimate RR 1.62, 95% CI 1.13 to 2.32; derived from direct evidence from 2 studies with 225 participants, and indirect evidence; very low-certainty evidence). In the remaining treatments, the certainty of the evidence ranged from low to very low, and we noted no evidence of any differences in mortality at 12 months.\nWe found that THA (single articulation), cemented modern bipolar HA and uncemented modern bipolar HA seemed to have the greatest likelihood of improving HRQoL at 12 months. This network was comparatively sparse compared to other outcomes and the certainty of the evidence of differences between treatments was very low. We noted no evidence of any differences in HRQoL at 12 months, although estimates were imprecise.\nWe found that arthroplasty treatments seemed to have a greater likelihood of reducing unplanned return to theatre than internal fixation and non-operative treatment. We estimated that 4.3% of participants who received the reference treatment returned to theatre during the study follow-up. Compared to this treatment, we found low-certainty evidence that more participants returned to theatre if they were treated with a dynamic fixed angle plate (network estimate RR 4.63, 95% CI 2.94 to 7.30; from direct evidence from 1 study with 190 participants, and indirect evidence). We found very low-certainty evidence that more participants returned to theatre when treated with pins (RR 4.16, 95% CI 2.53 to 6.84; only from indirect evidence), screws (network estimate RR 5.04, 95% CI 3.25 to 7.82; from direct evidence from 2 studies with 278 participants, and indirect evidence), and non-operative treatment (RR 5.41, 95% CI 1.80 to 16.26; only from indirect evidence). There was very low-certainty evidence of a tendency for an increased risk of unplanned return to theatre for all of the arthroplasty treatments, and in particular for THA, compared with cemented modern unipolar HA, with little evidence to suggest the size of this difference varied strongly between the arthroplasty treatments.\nAuthors' conclusions\nThere was considerable variability in the ranking of each treatment such that there was no one outstanding, or subset of outstanding, superior treatments. However, cemented modern arthroplasties tended to more often yield better outcomes than alternative treatments and may be a more successful approach than internal fixation. There is no evidence of a difference between THA (single articulation) and cemented modern unipolar HA in the outcomes measured in this review. THA may be an appropriate treatment for a subset of people with intracapsular fracture but we have not explored this further.\n\nGiven the provided abstract, please respond to the following query: \"What are the treatments?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "- Replacing the broken hip with an artificial one. This can be done using a hemiarthroplasty (HA), which replaces only the ball part of the joint, and can be unipolar (a single artificial joint) or bipolar which has an additional joint within the HA. A total hip arthroplasty (THA) replaces all of the hip joint, including the socket, and usually has just one artifical joint between the ball and the socket (single articulation) or sometimes two (dual-mobility). All types of artificial joints can be fixed in place with or without bone cement.\n- Using metal implants to fix the broken parts of the bones. Pins or screws may be inserted through the two parts of broken bone, or the surgeon may use a 'fixed angle plate' which sits on the outer edge of the broken bone and is attached to the bone with screws or pins.\n- Treatment without an operation, usually requiring a period of rest in bed whilst the leg is held in position using traction with weights."
}
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query-laysum | 2003 | [
{
"role": "user",
"content": "Abstract: Background\nBone marrow failure disorders include a heterogenous group of disorders, of which myelodysplastic syndrome (MDS), forms the largest subgroup. MDS is predominantly a disease of the elderly, with many elderly people managed conservatively with regular allogeneic red blood cell (RBC) transfusions to treat their anaemia. However, RBC transfusions are not without risk. Despite regular transfusions playing a central role in treating such patients, the optimal RBC transfusion strategy (restrictive versus liberal) is currently unclear.\nObjectives\nTo assess the efficacy and safety of a restrictive versus liberal red blood cell transfusion strategy for patients with myelodysplasia, acquired aplastic anaemia, and other inherited bone marrow failure disorders.\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 4), Ovid MEDLINE (from 1946), Ovid EMBASE (from 1974), EBSCO CINAHL (from 1937), the Transfusion Evidence Library (from 1980) and ongoing trial databases to 26th May 2015.\nSelection criteria\nRCTs including patients with long-term bone marrow failure disorders that require allogeneic blood transfusion, who are not being actively treated with a haematopoietic stem cell transplant, or intensive chemotherapy.\nData collection and analysis\nWe used standard Cochrane review methodology. One author initially screened all references, and excluded any that were clearly irrelevant or duplicates. Two authors then independently screened all abstracts of articles, identified by the review search strategy, for relevancy. Two authors independently assessed the full text of all potentially relevant articles for eligibility, completed the data extraction and assessed the studies for risk of bias using The Cochrane Collaboration’s ’Risk of bias’ tool.\nMain results\nWe included one trial (13 participants) and identified three ongoing trials that assess RBC transfusion strategies in people with MDS.\nThe quality of the evidence was very low across different outcomes according to GRADE methodology.\nThe one included study randomised participants to a restrictive [haemoglobin (Hb) transfusion trigger < 72 g/L, 8 participants] or liberal [Hb trigger < 96 g/L, 5 participants] transfusion policy. There was insufficient evidence to determine a difference in all-cause mortality (1 RCT; 13 participants; RR 0.13, 95% CI 0.01 to 2.32; very low quality evidence). There was insufficient evidence to determine a difference in the number of red blood cell transfusions (1 RCT; 13 participants; 1.8 units per patient per month in the liberal group, compared to 0.8 in the restrictive arm, no standard deviation was reported; very low quality evidence). There were no anaemia-related complications reported (cardiac failure) and no reported effect on activity levels (no statistics provided). The study did not report: mortality due to bleeding/infection/transfusion reactions or iron overload, quality of life, frequency and length of hospital admissions, serious infections (requiring admission to hospital), or serious bleeding (e.g. WHO/CTCAE grade 3 (or equivalent) or above).\nAuthors' conclusions\nThis review indicates that there is currently a lack of evidence for the recommendation of a particular transfusion strategy for bone marrow failure patients undergoing supportive treatment only. The one RCT included in this review was only published as an abstract and contained only 13 participants. Further randomised trials with robust methodology are required to develop the optimal transfusion strategy for such patients, particularly as the incidence of the main group of bone marrow failure disorders, MDS, rises with an ageing population.\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 evidence for the findings was of very low quality. This was because very small numbers of participants were included in the study. Only 13 patients were recruited to the trial rather than the planned 200 participants due to problems with recruitment."
}
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query-laysum | 2004 | [
{
"role": "user",
"content": "Abstract: Background\nAcute postoperative pain is still an issue in patients undergoing abdominal surgery. Postoperative pain and side effects of analgesic treatment, in particular those of opioids, need to be minimized. Opioid-sparing analgesics, possibly including dexmedetomidine, seem a promising avenue by which to improve postoperative outcomes.\nObjectives\nOur primary aim was to determine the analgesic efficacy and opioid-sparing effect of perioperative dexmedetomidine for acute pain after abdominal surgery in adults.\nSecondary aims were to establish effects of dexmedetomidine on postoperative nausea and vomiting (PONV), gastrointestinal function and mobilization, together with the side effect profile of dexmedetomidine.\nSearch methods\nWe searched the following databases: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Institute for Scientific Information (ISI), Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL), and reference lists of articles to May 2014. We searched the Science Citation Index, ClinicalTrials.gov and Current Controlled Trials, and we contacted pharmaceutical companies to identify unpublished and ongoing studies. We applied no language restrictions. We reran the search in May 2015 and found nine studies of interest. We will deal with the studies of interest when we update the review.\nSelection criteria\nWe included randomized, controlled trials of perioperative dexmedetomidine versus placebo or other drug during abdominal surgery in adults. Trials included one of the following outcomes: amount of 'rescue' opioid, postoperative pain, time to 'rescue' analgesia, participants requiring 'rescue' analgesia, postoperative sedation, PONV, time to first passage of flatus and stool or time to first out-of-bed mobilization.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts for eligibility. We retrieved full trial reports if necessary, and we extracted relevant data from the included studies using a data collection form and assessed risk of bias. We resolved disagreements by discussion with the third review author. We sought additional information of relevance for risk of bias assessment or extraction of data by contacting study authors or, if necessary, co-authors from present or former studies.\nMain results\nOur systematic review included seven studies with a total of 492 participants. We included 422 participants in our analysis. Thirteen studies are awaiting classification. For the comparison dexmedetomidine versus placebo (six studies, 402 participants), most studies found a reduction in 'rescue' opioid consumption in the first 24 hours after surgery, together with in general no clinically important differences in postoperative pain (visual analogue scale (VAS) 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain) in the first 24 hours after surgery - except for one study (80 participants) with a reduction in VAS pain at two hours after surgery in favour of dexmedetomidine, with a mean difference of -30.00 mm (95% confidence interval (CI) -38.25 to -21.75). As the result of substantial heterogeneity, pooling of data in statistical meta-analyses was not appropriate. The quality of evidence was very low for our primary outcomes because of imprecision of results and risk of bias. Regarding our secondary aims, evidence was too scant in general to allow robust conclusions, or the estimates too imprecise or of poor methodological quality. Regarding adverse effects, low quality data (one study, 80 participants) suggest that the proportion of participants with hypotension requiring intervention was slightly higher in the high-dose dexmedetomidine group with a risk ratio of 2.50 (95% CI 0.94 to 6.66), but lower doses of dexmedetomidine led to no differences compared with control. Evidence for the comparison dexmedetomidine versus fentanyl was insufficient to permit robust conclusions (one study, 20 participants).\nAuthors' conclusions\nDexmedetomidine, when administered perioperatively for acute pain after abdominal surgery in adults, seemed to have some opioid-sparing effect together with in general no important differences in postoperative pain when compared with placebo. However the quality of the evidence was very low as the result of imprecision, methodological limitations and substantial heterogeneity among the seven included studies. The clinical importance for patients is uncertain, in as much as the influence of dexmedetomidine on patient-important outcomes such as gastrointestinal function, mobilization and adverse effects could not be satisfactorily determined. All included studies were relatively small, and publication bias could not be ruled out. Applicability of evidence was limited to middle-aged participants who were relatively free of co-morbidity and were undergoing elective abdominal surgery. A potential bias was a considerable quantity of unobtainable data from studies with mixed surgery. To detect and investigate patient-important outcomes, larger studies with longer periods of follow-up are needed.\n\nGiven the provided abstract, please respond to the following query: \"Key results and quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most of the studies that compared dexmedetomidine with no treatment found that dexmedetomidine reduced the need for opioids for treating pain for 24 hours after surgery. During the same period, no important differences in pain were noted, except one study (80 participants) showed a reduction in intensity of pain at two hours after surgery with dexmedetomidine. The quality of the evidence was very low because the results were not similar across studies, and because some studies were poorly conducted. The influence of dexmedetomidine on postoperative nausea and vomiting could not be determined because results were not similar across studies. No conclusion could be made for bowel function and mobilization and side effects such as postoperative sedation, as data were insufficient. One study with 80 participants reported a higher rate of low blood pressure ('low' meaning that medication was required) for participants receiving a high dose of dexmedetomidine compared with no treatment, but for lower doses of dexmedetomidine, they noted no differences compared with no treatment.\nFor the comparison dexmedetomidine versus fentanyl, data were insufficient to allow conclusions (only one small study)."
}
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query-laysum | 2005 | [
{
"role": "user",
"content": "Abstract: Background\nNeonates born through meconium-stained amniotic fluid (MSAF) are at risk of developing meconium aspiration syndrome (MAS). Neonates who are non-vigorous due to intrapartum asphyxia are at higher risk of developing MAS. Clearance of meconium from the airways below the vocal cords by tracheal suction before initiating other steps of resuscitation may reduce the risk of development of MAS. However, conducting tracheal suction may not only be ineffective, it may also delay effective resuscitation, thus prolonging and worsening the hypoxic-ischaemic insult.\nObjectives\nTo evaluate the efficacy of tracheal suctioning at birth in preventing meconium aspiration syndrome and other complications among non-vigorous neonates born through meconium-stained amniotic fluid.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 11) in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) (1946 to 25 November 2020) for randomised controlled trials (RCTs) and quasi-randomised trials. We also searched clinical trials databases and the reference lists of retrieved articles for RCTs and quasi-randomised trials (up to November 2020).\nSelection criteria\nWe included studies enrolling non-vigorous neonates born through MSAF, if the intervention being tested included tracheal suction at the time of birth with an intent to clear the trachea of meconium before regular breathing efforts began. Tracheal suction could be performed with an endotracheal tube or a wide-gauge suction catheter. Neonates in the control group should have been resuscitated at birth with no effort made to clear the trachea of meconium.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data, consulting with a third review author about any disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies. Our primary outcomes were: MAS; all-cause neonatal mortality; and incidence of hypoxic-ischaemic encephalopathy (HIE). Secondary outcomes included: need for mechanical ventilation; incidence of pulmonary air leaks; culture-positive sepsis; and persistent pulmonary hypertension. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included four studies (enrolling 581 neonates) in the review. All four studies were conducted in tertiary care hospitals in India. Three of the four studies included neonates born at and beyond term gestation, whereas one included neonates born at and beyond 34 weeks of gestation. Due to the nature of the intervention, it was not possible to blind the healthcare personnel conducting the intervention.\nTracheal suction compared to no suction in non-vigorous neonates born through MSAF\nIn non-vigorous infants, no differences were noted in the risks of MAS (RR 1.00, 95% CI 0.80 to 1.25; RD 0.00, 95% CI -0.07 to 0.08; 4 studies, 581 neonates) or all-cause neonatal mortality (RR 1.24, 95% CI 0.76 to 2.02; RD 0.02, 95% CI -0.03 to 0.07; 4 studies, 575 neonates) with or without tracheal suctioning. No differences were reported in the risk of any severity HIE (RR 1.05, 95% CI 0.68 to 1.63; 1 study, 175 neonates) or moderate to severe HIE (RR 0.68, 95% CI 0.43 to 1.09; 1 study, 152 neonates) among non-vigorous neonates born through MSAF. We are also uncertain as to the effect of tracheal suction on other outcomes such as incidence of mechanical ventilation (RR 0.99, 95% CI 0.68 to 1.44; RD 0.00, 95% CI -0.06 to 0.06; 4 studies, 581 neonates), pulmonary air leaks (RR 1.22, 95% CI 0.38 to 3.93; RD 0.00, 95% CI -0.02 to 0.03; 3 studies, 449 neonates), persistent pulmonary hypertension (RR 1.29, 95% CI 0.60 to 2.77; RD 0.02, 95% CI -0.03 to 0.06; 3 studies, 406 neonates) and culture-positive sepsis (RR 1.32, 95% CI 0.48 to 3.57; RD 0.01, 95% CI -0.03 to 0.05; 3 studies, 406 neonates). All reported outcomes were judged as providing very low certainty evidence.\nAuthors' conclusions\nWe are uncertain about the effect of tracheal suction on the incidence of MAS and its complications among non-vigorous neonates born through MSAF. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the review question.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "There was very low certainty evidence from the four studies included in this review. Firstly, in most of the studies, the healthcare workers who provided the clinical care or decided the presence of outcomes were aware of the study group assignment of the babies, thus increasing the risk of bias. Secondly, due to the small size of the studies and the low incidences of the outcomes, we had low confidence in ruling out clinically important benefits or harms when tracheal suction was performed. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the research question."
}
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query-laysum | 2006 | [
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovary syndrome (PCOS) is characterised by infrequent or absent ovulation, and high levels of androgens and insulin (hyperinsulinaemia). Hyperinsulinaemia occurs secondary to insulin resistance and is associated with an increased biochemical risk profile for cardiovascular disease and an increased prevalence of diabetes mellitus. Insulin-sensitising agents such as metformin may be effective in treating PCOS-related anovulation. This is an update of Morley 2017 and only includes studies on metformin.\nObjectives\nTo evaluate the effectiveness and safety of metformin in combination with or in comparison to clomiphene citrate (CC), letrozole and laparoscopic ovarian drilling (LOD) in improving reproductive outcomes and associated gastrointestinal side effects for women with PCOS undergoing ovulation induction.\nSearch methods\nWe searched the following databases from inception to December 2018: Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL. We searched registers of ongoing trials and reference lists from relevant studies.\nSelection criteria\nWe included randomised controlled trials of metformin compared with placebo, no treatment, or in combination with or compared with CC, letrozole and LOD for women with PCOS subfertility.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility and bias. Primary outcomes were live birth rate and gastrointestinal adverse effects. Secondary outcomes included other pregnancy outcomes and ovulation. We combined data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I2 statistic and reported quality of the evidence for primary outcomes and reproductive outcomes using GRADE methodology.\nMain results\nWe included 41 studies (4552 women). Evidence quality ranged from very low to moderate based on GRADE assessment. Limitations were risk of bias (poor reporting of methodology and incomplete outcome data), imprecision and inconsistency.\nMetformin versus placebo or no treatment\nThe evidence suggests that metformin may improve live birth rates compared with placebo (OR 1.59, 95% CI 1.00 to 2.51; I2 = 0%; 4 studies, 435 women; low-quality evidence). For a live birth rate of 19% following placebo, the live birth rate following metformin would be between 19% and 37%. The metformin group probably experiences more gastrointestinal side effects (OR 4.00, 95% CI 2.63 to 6.09; I2 = 39%; 7 studies, 713 women; moderate-quality evidence). With placebo, the risk of gastrointestinal side effects is 10% whereas with metformin this risk is between 22% and 40%. There are probably higher rates of clinical pregnancy (OR 1.98, 95% CI 1.47 to 2.65; I2 = 30%; 11 studies, 1213 women; moderate-quality evidence). There may be higher rates of ovulation with metformin (OR 2.64, 95% CI 1.85 to 3.75; I2 = 61%; 13 studies, 684 women; low-quality evidence). We are uncertain about the effect on miscarriage rates (OR 1.08, 95% CI 0.50 to 2.35; I2 = 0%; 4 studies, 748 women; low-quality evidence).\nMetformin plus CC versus CC alone\nWe are uncertain if metformin plus CC improves live birth rates compared to CC alone (OR 1.27, 95% CI 0.98 to 1.65; I2 = 28%; 10 studies, 1219 women; low-quality evidence), but gastrointestinal side effects are probably more common with combined therapy (OR 4.26, 95% CI 2.83 to 6.40; I2 = 8%; 6 studies, 852 women; moderate quality evidence). The live birth rate with CC alone is 24%, which may change to between 23% to 34% with combined therapy. With CC alone, the risk of gastrointestinal side effects is 9%, which increases to between 21% to 37% with combined therapy. The combined therapy group probably has higher rates of clinical pregnancy (OR 1.62, 95% CI 1.32 to 1.99; I2 = 31%; 19 studies, 1790 women; moderate-quality evidence). The combined group may have higher rates of ovulation (OR 1.65, 95% CI 1.35 to 2.03; I2 = 63%;21 studies, 1568 women; low-quality evidence). There was no clear evidence of an effect on miscarriage (OR 1.35, 95% CI 0.91 to 2.00; I2 = 0%; 10 studies, 1206 women; low-quality evidence).\nMetformin versus CC\nWhen all studies were combined, findings for live birth were inconclusive and inconsistent (OR 0.71, 95% CI 0.49 to 1.01; I2 = 86%; 5 studies, 741 women; very low-quality evidence). In subgroup analysis by obesity status, obese women had a lower birth rate in the metformin group (OR 0.30, 95% CI 0.17 to 0.52; 2 studies, 500 women), while the non-obese group showed a possible benefit from metformin, with high heterogeneity (OR 1.71, 95% CI 1.00 to 2.94; I2 = 78%, 3 studies, 241 women; very low-quality evidence). However, due to the very low quality of the evidence we cannot draw any conclusions. Among obese women taking metformin there may be lower rates of clinical pregnancy (OR 0.34, 95% CI 0.21 to 0.55; I2 = 0%; 2 studies, 500 women; low-quality evidence) and ovulation (OR 0.29, 95% CI 0.20 to 0.43; I2 = 0%; 2 studies, 500 women; low-quality evidence) while among non-obese women, the metformin group may have more pregnancies (OR 1.56, 95% CI 1.06 to 2.29; I2 = 26%; 6 studies, 530 women; low-quality evidence) and no clear difference in ovulation rates (OR 0.80, 95% CI 0.52 to 1.25; I2 = 0%; 5 studies, 352 women; low-quality evidence). We are uncertain whether there is a difference in miscarriage rates between the groups (overall: OR 0.92, 95% CI 0.51 to 1.66; I2 = 36%; 6 studies, 781 women; low-quality evidence) and no studies reported gastrointestinal side effects.\nAuthors' conclusions\nOur updated review suggests that metformin may be beneficial over placebo for live birth however, more women probably experience gastrointestinal side effects. We are uncertain if metformin plus CC improves live birth rates compared to CC alone, but gastrointestinal side effects are probably increased with combined therapy. When metformin was compared with CC, data for live birth were inconclusive, and the findings were limited by lack of evidence. Results differed by body mass index (BMI), emphasising the importance of stratifying results by BMI. No studies reported gastrointestinal side effects in this comparison. Due to the low quality of the evidence, we are uncertain of the effect of metformin on miscarriage in all three comparisons.\n\nGiven the provided abstract, please respond to the following query: \"Metformin plus CC versus CC alone\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We are uncertain if metformin plus CC improves live birth rate compared to CC alone, but gastrointestinal side effects are probably more common. The live birth rate with CC alone is 24% which may change to between 23% to 34% with metformin and CC combined. With CC alone, the risk of gastrointestinal side effects is 9%, which increases to between 21% to 37% with metformin and CC combined. However, pregnancy rate is probably improved with metformin and CC. Ovulation rates may be improved with metformin and CC. There was no clear evidence of an effect on miscarriage."
}
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query-laysum | 2007 | [
{
"role": "user",
"content": "Abstract: Background\nChronic pain is common in adults, and often has a detrimental impact upon physical ability, well-being, and quality of life. Previous reviews have shown that certain antidepressants may be effective in reducing pain with some benefit in improving patients’ global impression of change for certain chronic pain conditions. However, there has not been a network meta-analysis (NMA) examining all antidepressants across all chronic pain conditions.\nObjectives\nTo assess the comparative efficacy and safety of antidepressants for adults with chronic pain (except headache).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, AMED and PsycINFO databases, and clinical trials registries, for randomised controlled trials (RCTs) of antidepressants for chronic pain conditions in January 2022.\nSelection criteria\nWe included RCTs that examined antidepressants for chronic pain against any comparator. If the comparator was placebo, another medication, another antidepressant, or the same antidepressant at different doses, then we required the study to be double-blind. We included RCTs with active comparators that were unable to be double-blinded (e.g. psychotherapy) but rated them as high risk of bias. We excluded RCTs where the follow-up was less than two weeks and those with fewer than 10 participants in each arm.\nData collection and analysis\nTwo review authors separately screened, data extracted, and judged risk of bias. We synthesised the data using Bayesian NMA and pairwise meta-analyses for each outcome and ranked the antidepressants in terms of their effectiveness using the surface under the cumulative ranking curve (SUCRA). We primarily used Confidence in Meta-Analysis (CINeMA) and Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) to assess the certainty of the evidence. Where it was not possible to use CINeMA and ROB-MEN due to the complexity of the networks, we used GRADE to assess the certainty of the evidence.\nOur primary outcomes were substantial (50%) pain relief, pain intensity, mood, and adverse events. Our secondary outcomes were moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change (PGIC), serious adverse events, and withdrawal.\nMain results\nThis review and NMA included 176 studies with a total of 28,664 participants. The majority of studies were placebo-controlled (83), and parallel−armed (141). The most common pain conditions examined were fibromyalgia (59 studies); neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of RCTs was 10 weeks. Seven studies provided no useable data and were omitted from the NMA. The majority of studies measured short-term outcomes only and excluded people with low mood and other mental health conditions.\nAcross efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. In duloxetine studies, standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that of duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.\nPrimary efficacy outcomes\nDuloxetine standard dose (60 mg) showed a small to moderate effect for substantial pain relief (odds ratio (OR) 1.91, 95% confidence interval (CI) 1.69 to 2.17; 16 studies, 4490 participants; moderate-certainty evidence) and continuous pain intensity (standardised mean difference (SMD) −0.31, 95% CI −0.39 to −0.24; 18 studies, 4959 participants; moderate-certainty evidence). For pain intensity, milnacipran standard dose (100 mg) also showed a small effect (SMD −0.22, 95% CI −0.39 to 0.06; 4 studies, 1866 participants; moderate-certainty evidence). Mirtazapine (30 mg) had a moderate effect on mood (SMD −0.5, 95% CI −0.78 to −0.22; 1 study, 406 participants; low-certainty evidence), while duloxetine showed a small effect (SMD −0.16, 95% CI −0.22 to −0.1; 26 studies, 7952 participants; moderate-certainty evidence); however it is important to note that most studies excluded participants with mental health conditions, and so average anxiety and depression scores tended to be in the 'normal' or 'subclinical' ranges at baseline already.\nSecondary efficacy outcomes\nAcross all secondary efficacy outcomes (moderate pain relief, physical function, sleep, quality of life, and PGIC), duloxetine and milnacipran were the highest-ranked antidepressants with moderate-certainty evidence, although effects were small. For both duloxetine and milnacipran, standard doses were as efficacious as high doses.\nSafety\nThere was very low-certainty evidence for all safety outcomes (adverse events, serious adverse events, and withdrawal) across all antidepressants. We cannot draw any reliable conclusions from the NMAs for these outcomes.\nAuthors' conclusions\nOur review and NMAs show that despite studies investigating 25 different antidepressants, the only antidepressant we are certain about for the treatment of chronic pain is duloxetine. Duloxetine was moderately efficacious across all outcomes at standard dose. There is also promising evidence for milnacipran, although further high-quality research is needed to be confident in these conclusions. Evidence for all other antidepressants was low certainty. As RCTs excluded people with low mood, we were unable to establish the effects of antidepressants for people with chronic pain and depression. There is currently no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up to date to January 2022."
}
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query-laysum | 2008 | [
{
"role": "user",
"content": "Abstract: Background\nMost women undergoing assisted reproduction treatment will reach the stage of embryo transfer (ET), but the proportion of embryos that can be successfully implanted after ET has remained small since the mid-1990s. Human chorionic gonadotropin (hCG) is a hormone that is synthesised and released by the syncytiotrophoblast and has a fundamental role in embryo implantation and the early stages of pregnancy. Intrauterine administration of hCG via ET catheter during a mock procedure around the time of ET is a novel approach that has been suggested to improve the outcomes of assisted reproduction.\nObjectives\nTo investigate whether intrauterine (intracavity) administration of hCG (IC-hCG) around the time of ET improves clinical outcomes in subfertile women undergoing assisted reproduction.\nSearch methods\nWe performed searches on 9 January 2018 using Cochrane methods.\nSelection criteria\nWe looked for randomised controlled trials (RCTs) evaluating IC-hCG around the time of ET, irrespective of language and country of origin.\nData collection and analysis\nTwo review authors independently selected studies, assessed risk of bias, extracted data from studies, and attempted to contact study authors when data were missing. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods. Primary outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy rate and complications.\nMain results\nSeventeen RCTs investigated the effects of IC-hCG administration for 4751 subfertile women undergoing assisted reproduction. IC-hCG was administered in variable doses at different times before the ET. hCG was obtained from the urine of pregnant women or from cell cultures using recombinant DNA technology.\nMost studies (12/17) were at high risk of bias in at least one of the seven domains assessed. Common problems were unclear reporting of study methods and lack of blinding. The main limitations for evidence quality were high risk of bias and serious imprecision.\nFor analyses of live birth and clinical pregnancy, there was considerable heterogeneity (I² > 75%) and therefore we present subgroups for dosage and stage of ET. Exploration for sources of heterogeneity revealed two key prespecified variables as important determinants: stage of ET (cleavage vs blastocyst stage) and dose of IC-hCG (< 500 international units (IU) vs ≥ 500 IU). We performed meta-analyses within subgroups defined by stage of embryo and dose of IC-hCG.\nLive birth rates among women having cleavage-stage ET with an IC-hCG dose < 500 IU compared to women having cleavage-stage ET without IC-hCG showed no benefit of the intervention and would be consistent with no substantive difference or disadvantage of indeterminate magnitude (risk ratio (RR) 0.76, 95% confidence interval (CI) 0.58 to 1.01; one RCT; 280 participants; I² = 0%; very low-quality evidence). In a clinic with a live birth rate of 49% per cycle, use of IC-hCG < 500 IU would be associated with a live birth rate ranging from 28% to 50%.\nResults show an increase in live birth rate in the subgroup of women undergoing cleavage-stage ET with an IC-hCG dose ≥ 500 IU compared to women having cleavage-stage ET without IC-hCG (RR 1.57, 95% CI 1.32 to 1.87; three RCTs; 914 participants; I² = 0%; moderate-quality evidence). At a clinic with a live birth rate of 27% per cycle, use of IC-hCG ≥ 500 IU would be associated with a live birth rate ranging from 36% to 51%.\nResults show no substantive differences in live birth among women having blastocyst-stage ET with an IC-hCG dose ≥ 500 IU compared to women having blastocyst-stage ET without IC-hCG (RR 0.92, 95% CI 0.80 to 1.04; two RCTs; 1666 participants; I² = 0%; moderate-quality evidence). At a clinic with a live birth rate of 36% per cycle, use of IC-hCG ≥ 500 IU would be associated with a live birth rate ranging from 29% to 38%.\nEvidence for clinical pregnancy among women having cleavage-stage ET with an IC-hCG dose < 500 IU showed no benefit of the intervention and would be consistent with no substantive difference or disadvantage of indeterminate magnitude (RR 0.88, 95% CI 0.70 to 1.10; one RCT; 280 participants; I² = 0%; very low-quality evidence).\nResults show an increase in clinical pregnancy rate in the subgroup of women having cleavage-stage ET with an IC-hCG dose ≥ 500 IU compared to women having cleavage-stage ET without IC-hCG (RR 1.49, 95% CI 1.32 to 1.68; 12 RCTs; 2186 participants; I² = 18%; moderate-quality evidence).\nResults show no substantive differences in clinical pregnancy among women having blastocyst-stage ET with an IC-hCG dose ≥ 500 IU (RR 0.99, 95% CI 0.85 to 1.15; four RCTs; 2091 participants; I² = 42%; moderate-quality evidence) compared to women having blastocyst-stage ET with no IC-hCG.\nNo RCTs investigated blastocyst-stage ET with an IC-hCG dose < 500 IU.\nWe are uncertain whether miscarriage was influenced by intrauterine hCG administration (RR 1.04, 95% CI 0.81 to 1.35; 11 RCTs; 3927 participants; I² = 0%; very low-quality evidence).\nReported complications were ectopic pregnancy (four RCTs; 1073 participants; four events overall), heterotopic pregnancy (one RCT; 495 participants; one event), intrauterine death (three RCTs; 1078 participants; 22 events), and triplets (one RCT; 48 participants; three events). Events were few, and very low-quality evidence was insufficient to permit conclusions to be drawn.\nAuthors' conclusions\nThere is moderate quality evidence that women undergoing cleavage-stage transfer using an IC-hCG dose ≥ 500 IU have an improved live birth rate. There is insufficient evidence for IC-hCG treatment for blastocyst transfer. There should be further trials with live birth as the primary outcome to identify the groups of women who would benefit the most from this intervention. There was no evidence that miscarriage was reduced following IC-hCG administration, irrespective of embryo stage at transfer or dose of IC-hCG. Events were too few to allow conclusions to be drawn with regard to other complications.\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": "Live birth rates in women having day three ET with human chorionic gonadotropin administered into the uterus (IC-hCG) at a dose < 500 IU compared to women having day three ET without pregnancy hormone showed no benefit of the intervention and would be consistent with no substantive difference or disadvantage of indeterminate magnitude (very low-quality evidence: one study; 280 women). In a clinic with a live birth rate of 49% per cycle following day three ET, use of a pregnancy hormone dose < 500 IU would be associated with a live birth rate varying from 28% to 50%.\nLive birth rate was increased in a subgroup of women having day three ET with a pregnancy hormone dose of 500 IU or greater compared to women having day three ET without pregnancy hormone (moderate-quality evidence: three studies; 914 women). At a clinic with a live birth rate of 27% per cycle, use of a pregnancy hormone dose of 500 IU or greater would be associated with a live birth rate varying from 36% to 51%.\nTrial results show no substantive differences in live birth among women having day five ET with a pregnancy hormone dose of 500 IU or greater compared to women having day five ET without pregnancy hormone (moderate-quality evidence: two studies; 1666 women). At a clinic with a live birth rate of 36% per cycle, use of a pregnancy hormone dose of 500 IU or greater would be associated with a live birth rate varying from 29% to 38%.\nWe are uncertain whether administration of pregnancy hormone into the womb at any dose or time affected miscarriage (very low-quality evidence: 11 studies; 3927 women).\nEvidence for clinical pregnancy among women having day three ET with a pregnancy hormone dose < 500 IU showed no benefit of the intervention and would be consistent with no substantive difference or disadvantage of indeterminate magnitude (very low-quality evidence: one study; 280 women).\nThe clinical pregnancy rate was increased in the subgroup of women having day three ET with a pregnancy hormone dose of 500 IU or greater compared to women having day three ET without pregnancy hormone (moderate-quality evidence: 12 studies; 2186 women).\nTrial results show no substantive difference in clinical pregnancy among women having day five ET with a pregnancy hormone dose of 500 IU or greater compared to women having day five ET with no pregnancy hormone (moderate-quality evidence: four studies; 2091 women).\nNo randomised controlled trials (RCTs) investigated day five ET with a pregnancy hormone dose < 500 IU.\nOther complications reported in the included studies were ectopic pregnancy (where the embryo develops outside the womb), heterotopic pregnancy (where embryos develop inside and outside the womb), foetal death, and triplets. Events were few, and insufficient evidence of very low quality does not permit us to determine whether there were differences between groups.\nThere should be further trials with live birth as the primary outcome to identify the groups of women who would benefit the most from this intervention."
}
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query-laysum | 2009 | [
{
"role": "user",
"content": "Abstract: Background\nEndodontic treatment involves removal of the dental pulp and its replacement by a root canal filling. Restoration of root filled teeth can be challenging due to structural differences between vital and non-vital root-filled teeth. Direct restoration involves placement of a restorative material e.g. amalgam or composite, directly into the tooth. Indirect restorations consist of cast metal or ceramic (porcelain) crowns. The choice of restoration depends on the amount of remaining tooth, and may influence durability and cost. The decision to use a post and core in addition to the crown is clinician driven. The comparative clinical performance of crowns or conventional fillings used to restore root-filled teeth is unknown. This review updates the original, which was published in 2012.\nObjectives\nTo assess the effects of restoration of endodontically treated teeth (with or without post and core) by crowns versus conventional filling materials.\nSearch methods\nWe searched the following databases: the Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE via OVID, EMBASE via OVID, CINAHL via EBSCO, LILACS via BIREME. We also searched the reference lists of articles and ongoing trials registries.There were no restrictions regarding language or date of publication. The search is up-to-date as of 26 March 2015.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-randomised controlled trials in participants with permanent teeth that have undergone endodontic treatment. Single full coverage crowns compared with any type of filling materials for direct restoration or indirect partial restorations (e.g. inlays and onlays). Comparisons considered the type of post and core used (cast or prefabricated post), if any.\nData collection and analysis\nTwo review authors independently extracted data from the included trial and assessed its risk of bias. We carried out data analysis using the 'treatment as allocated' patient population, expressing estimates of intervention effect for dichotomous data as risk ratios, with 95% confidence intervals (CI).\nMain results\nWe included one trial, which was judged to be at high risk of performance, detection and attrition bias. The 117 participants with a root-filled, premolar tooth restored with a carbon fibre post, were randomised to either a full coverage metal-ceramic crown or direct adhesive composite restoration. None experienced a catastrophic failure (i.e. when the restoration cannot be repaired), although only 104 teeth were included in the final, three-year assessment. There was no clear difference between the crown and composite group and the composite only group for non-catastrophic failures of the restoration (1/54 versus 3/53; RR 0.33; 95% CI 0.04 to 3.05) or failures of the post (2/54 versus 1/53; RR 1.96; 95% CI 0.18 to 21.01) at three years. The quality of the evidence for these outcomes is very low. There was no evidence available for any of our secondary outcomes: patient satisfaction and quality of life, incidence or recurrence of caries, periodontal health status, and costs.\nAuthors' conclusions\nThere is insufficient evidence to assess the effects of crowns compared to conventional fillings for the restoration of root-filled teeth. Until more evidence becomes available, clinicians should continue to base decisions about how to restore root-filled teeth on their own clinical experience, whilst taking into consideration the individual circumstances and preferences of their patients.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review (an update of the original published in 2012) has been conducted to assess whether there is a difference in the effects of restoration of root-filled teeth (with or without post and core) by indirect restorations (commonly crowns, inlays, or onlays) compared to conventional filling materials placed directly into the tooth."
}
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query-laysum | 2010 | [
{
"role": "user",
"content": "Abstract: Background\nA deficiency in vitamin K has been associated with increased calcium deposition and coronary artery calcification, which may lead to cardiovascular disease.\nObjectives\nTo determine the effectiveness of vitamin K supplementation as a single nutrient supplement for the primary prevention of cardiovascular disease.\nSearch methods\nWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 8 of 12, 2014); MEDLINE (Ovid, 1946 to September week 2 2014); EMBASE Classic + EMBASE (Ovid, 1947 to September 18 2014); Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index, Science (CPCI-S) (both 1990 to 17 September 2014) on Web of Science (Thomson Reuters); Database of Abstracts of Reviews of Effects (DARE); Health Technology Assessment Database and Health Economics Evaluations Database (Issue 3 of 4, 2014). We searched trial registers and reference lists of reviews for further studies. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials of vitamin K supplementation as a single nutrient supplement, lasting at least three months, and involving healthy adults or adults at high risk of cardiovascular disease. The comparison group was no intervention or placebo. The outcomes of interest were cardiovascular disease clinical events and cardiovascular disease risk factors.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, abstracted the data and assessed the risk of bias.\nMain results\nWe included only one small trial (60 participants randomised) which overall was judged to be at low risk of bias. The study examined two doses of menaquinone (vitamin K2) over 3 months in healthy participants aged 40 to 65 years. The primary focus of the trial was to examine the effects of menaquinone (subtype MK7) on different matrix Gla proteins (MGP - vitamin K dependent proteins in the vessel wall) at different doses, but the authors also reported blood pressure and lipid levels. The trial did not report on our primary outcomes (cardiovascular disease clinical events) as it was small, short term and conducted in healthy participants.\nIn terms of cardiovascular disease risk factors, no effects were seen for vitamin K2 on blood pressure or lipid levels, although the trial was small and findings are limited. The trial did not report any of our other secondary outcomes.\nAuthors' conclusions\nThe very limited results of this review highlight the lack of evidence currently available to determine the effectiveness of vitamin K supplementation for the primary prevention of cardiovascular disease, and demonstrate the need for further high quality trials in this area.\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 only trial identified for this review was judged to be at low risk of bias (so there was less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers). However the evidence is limited to one small trial and no firm conclusions can be reached at this time."
}
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query-laysum | 2011 | [
{
"role": "user",
"content": "Abstract: Background\nPeripheral artery disease (PAD) is associated with a high clinical and socioeconomic burden. Treatments to alleviate the symptoms of PAD and decrease the risks of amputation and death are a high societal priority. A number of growth factors have shown a potential to stimulate angiogenesis. Growth factors delivered directly (as recombinant proteins), or indirectly (e.g. by viral vectors or DNA plasmids encoding these factors), have emerged as a promising strategy to treat patients with PAD.\nObjectives\nTo assess the effects of growth factors that promote angiogenesis for treating people with PAD of the lower extremities.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Specialised Register (June 2016) and CENTRAL (2016, Issue 5). We searched trial registries for details of ongoing or unpublished studies. We also checked the reference lists of relevant publications and, if necessary, tried to contact the trialists for details of the studies.\nSelection criteria\nWe included randomised controlled trials comparing growth factors (delivered directly or indirectly) with no intervention, placebo or any other intervention not based on the growth factor's action in patients with PAD of the lower extremities. The primary outcomes were limb amputation, death and adverse events. The secondary outcomes comprised walking ability, haemodynamic measures, ulceration and rest pain.\nData collection and analysis\nTwo review authors independently selected trials and assessed the risk of bias. We used outcomes of the studies at low risk of bias for the main analysis and of all studies in the sensitivity analyses. We calculated odds ratios (OR) for dichotomous outcomes and mean differences for continuous outcomes with 95% confidence intervals (CI). We evaluated statistical heterogeneity using the I2 statistic and Cochrane's Q test. We conducted meta-analysis for the overall effect and for each growth factor as a subgroup analysis using OR in a fixed-effect model. We evaluated the robustness of the results in a sensitivity analysis using risk ratio (RR) and/or a random-effects model. We also assessed the quality of the evidence for each outcome.\nMain results\nWe included 20 trials in the review and used 14 studies (on approximately 1400 participants) with published results in the analyses. Six published studies compared fibroblast growth factors (FGF), four studies hepatocyte growth factors (HGF) and another four studies vascular endothelial growth factors (VEGF), versus placebo or no therapy. Six of these studies exclusively or mainly investigated participants with intermittent claudication and eight studies exclusively participants with critical limb ischaemia. Follow-up generally ranged from three months to one year. Two small studies provided some data at 2 years and one of them also at 10 years.\nThe direction and size of effects for growth factors on major limb amputations (OR 0.99, 95% CI 0.71 to 1.38; 10 studies, N = 1075) and death (OR 0.99, 95% CI 0.69 to 1.41; 12 studies, N = 1371) at up to two years are uncertain. The quality of the evidence is low due to risk of bias and imprecision (at one year, moderate-quality evidence due to imprecision). However, growth factors may decrease the rate of any limb amputations (OR 0.56, 95% CI 0.31 to 0.99; 6 studies, N = 415). The quality of the evidence is low due to risk of bias and selective reporting.\nThe direction and size of effects for growth factors on serious adverse events (OR 1.09, 95% CI 0.79 to 1.50; 13 studies, N = 1411) and on any adverse events (OR 1.10, 95% CI 0.73 to 1.64; 4 studies, N = 709) at up to two years are also uncertain. The quality of the evidence is low due to risk of bias and imprecision (for serious adverse events at one year, moderate-quality evidence due to imprecision).\nGrowth factors may improve haemodynamic measures (low-quality evidence), ulceration (very low-quality evidence) and rest pain (very low-quality evidence) up to one year, but they have little or no effect on walking ability (low-quality evidence). We did not identify any relevant differences in effects between growth factors (FGF, HGF and VEGF).\nAuthors' conclusions\nThe results of this review do not support the use of therapy with the growth factors FGF, HGF or VEGF in people with PAD of the lower extremities to prevent death or major limb amputation or to improve walking ability. However, the use of these growth factors may improve haemodynamic measures and decrease the rate of any limb amputations (probably due to preventing minor amputations) with an uncertain effect on adverse events; an improvement of ulceration and rest pain is very uncertain. New trials at low risk of bias are needed to generate evidence with more certainty.\n\nGiven the provided abstract, please respond to the following query: \"Key results and implications\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "We identified 20 studies and analysed the results of 14 published studies involving approximately 1400 patients and assessing three types of growth factors (evidence current to June 2016).\nOur review shows that the effects of growth factors on the most important clinical parameters comprising limb amputations above the ankle, death and adverse events are uncertain (low-quality evidence up to two years, although moderate-quality evidence for one year). However, the rate of all limb amputations may decrease (low-quality evidence). In addition, growth factors may improve parameters of blood flow (low-quality evidence), ulceration (very low-quality evidence) and rest pain (very low-quality evidence) at up to one year, but have little or no effect on walking ability (low-quality evidence). We downgraded the quality of evidence mostly due to low statistical power and poor study quality. We did not identify any relevant differences in effects between growth factors.\nThis review does not support growth factor therapy in people with reduced blood supply to the legs to prevent limb amputations above the ankle or death or to improve walking ability. However, using growth factors may improve parameters of blood flow and prevent limb amputations below the ankle with an uncertain effect on adverse events; an improvement of ulceration and rest pain is very uncertain. New high-quality studies are needed to generate evidence with more certainty."
}
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query-laysum | 2012 | [
{
"role": "user",
"content": "Abstract: Background\nFamilial hypercholesterolemia is one of the most common inherited metabolic diseases and is an autosomal dominant disorder meaning heterozygotes, or carriers, are affected. Those who are homozygous have severe disease. The average worldwide prevalence of heterozygous familial hypercholesterolemia is at least 1 in 500, although recent genetic epidemiological data from Denmark and next generation sequencing data suggest the frequency may be closer to 1 in 250. Diagnosis of familial hypercholesterolemia in children is based on elevated total cholesterol and low-density lipoprotein cholesterol levels or DNA-based analysis, or both. Coronary atherosclerosis has been detected in men with heterozygous familial hypercholesterolemia as young as 17 years old and in women with heterozygous familial hypercholesterolemia at 25 years old. Since the clinical complications of atherosclerosis occur prematurely, especially in men, lifelong treatment, started in childhood, is needed to reduce the risk of cardiovascular disease. In children with the disease, diet was the cornerstone of treatment but the addition of lipid-lowering medications has resulted in a significant improvement in treatment. Anion exchange resins, such as cholestyramine and colestipol, were found to be effective, but they are poorly tolerated. Since the 1990s studies carried out on children aged 6 to 17 years with heterozygous familial hypercholesterolemia have demonstrated significant reductions in their serum total and low-density lipoprotein cholesterol levels. While statins seem to be safe and well-tolerated in children, their long-term safety in this age group is not firmly established. This is an update of a previously published version of this Cochane Review.\nObjectives\nTo assess the effectiveness and safety of statins in children with heterozygous familial hypercholesterolemia.\nSearch methods\nRelevant studies were identified from the Group's Inborn Errors and Metabolism Trials Register and Medline.\nDate of most recent search: 04 November 2019.\nSelection criteria\nRandomized and controlled clinical studies including participants up to 18 years old, comparing a statin to placebo or to diet alone.\nData collection and analysis\nTwo authors independently assessed studies for inclusion and extracted data.\nMain results\nWe found 26 potentially eligible studies, of which we included nine randomized placebo-controlled studies (1177 participants). In general, the intervention and follow-up time was short (median 24 weeks; range from six weeks to two years). Statins reduced the mean low-density lipoprotein cholesterol concentration at all time points (high-quality evidence). There may be little or no difference in liver function (serum aspartate and alanine aminotransferase, as well as creatinine kinase concentrations) between treated and placebo groups at any time point (low-quality evidence). There may be little or no difference in myopathy (as measured in change in creatinine levels) (low-quality evidence) or clinical adverse events (moderate-quality evidence) with statins compared to placebo. One study on simvastatin showed that this may slightly improve flow-mediated dilatation of the brachial artery (low-quality evidence), and on pravastatin for two years may have induced a regression in carotid intima media thickness (low-quality evidence).\nNo studies reported rhabdomyolysis (degeneration of skeletal muscle tissue) or death due to rhabdomyolysis, quality of life or compliance to study medication.\nAuthors' conclusions\nStatin treatment is an effective lipid-lowering therapy in children with familial hypercholesterolemia. Few or no safety issues were identified. Statin treatment seems to be safe in the short term, but long-term safety remains unknown. Children treated with statins should be carefully monitored and followed up by their pediatricians and their care transferred to an adult lipidologist once they reach 18 years of age. Large long-term randomized controlled trials are needed to establish the long-term safety issues of statins.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence for the effectiveness and safety of statins in children with inherited high blood cholesterol."
}
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query-laysum | 2013 | [
{
"role": "user",
"content": "Abstract: Background\nLiver transplantation is an established treatment option for end-stage liver failure. To date, no consensus has been reached on the use of immunosuppressive T-cell specific antibody induction compared with corticosteroid induction of immunosuppression after liver transplantation.\nObjectives\nTo assess the benefits and harms of T-cell specific antibody induction versus corticosteroid induction for prevention of acute rejection in liver transplant recipients.\nSearch methods\nWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 30 September 2013 together with reference checking, citation searching, contact with trial authors and pharmaceutical companies to identify additional trials.\nSelection criteria\nWe included all randomised clinical trials assessing immunosuppression with T-cell specific antibody induction versus corticosteroid induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy.\nData collection and analysis\nWe used RevMan for statistical analysis of dichotomous data with risk ratio (RR) and of continuous data with mean difference (MD), both with 95% confidence intervals (CIs). We assessed risk of systematic errors (bias) using bias risk domains with definitions. We used trial sequential analysis to control for random errors (play of chance).\nMain results\nWe included 10 randomised trials with a total of 1589 liver transplant recipients, which studied the use of T-cell specific antibody induction versus corticosteroid induction. All trials were with high risk of bias. We compared any kind of T-cell specific antibody induction versus corticosteroid induction in 10 trials with 1589 participants, including interleukin-2 receptor antagonist induction versus corticosteroid induction in nine trials with 1470 participants, and polyclonal T-cell specific antibody induction versus corticosteroid induction in one trial with 119 participants.\nOur analyses showed no significant differences regarding mortality (RR 1.01, 95% CI 0.72 to 1.43), graft loss (RR 1.12, 95% CI 0.82 to 1.53) and acute rejection (RR 0.84, 95% CI 0.70 to 1.00), infection (RR 0.96, 95% CI 0.85 to 1.09), hepatitis C virus recurrence (RR 0.89, 95% CI 0.79 to 1.00), malignancy (RR 0.59, 95% CI 0.13 to 2.73), and post-transplantation lymphoproliferative disorder (RR 1.00, 95% CI 0.07 to 15.38) when any kind of T-cell specific antibody induction was compared with corticosteroid induction (all low-quality evidence). Cytomegalovirus infection was less frequent in patients receiving any kind of T-cell specific antibody induction compared with corticosteroid induction (RR 0.50, 95% CI 0.33 to 0.75; low-quality evidence). This was also observed when interleukin-2 receptor antagonist induction was compared with corticosteroid induction (RR 0.55, 95% CI 0.37 to 0.83; low-quality evidence), and when polyclonal T-cell specific antibody induction was compared with corticosteroid induction (RR 0.21, 95% CI 0.06 to 0.70; low-quality evidence). However, when trial sequential analysis regarding cytomegalovirus infection was applied, the required information size was not reached. Furthermore, diabetes mellitus occurred less frequently when T-cell specific antibody induction was compared with corticosteroid induction (RR 0.45, 95% CI 0.34 to 0.60; low-quality evidence), when interleukin-2 receptor antagonist induction was compared with corticosteroid induction (RR 0.45, 95% CI 0.35 to 0.61; low-quality evidence), and when polyclonal T-cell specific antibody induction was compared with corticosteroid induction (RR 0.12, 95% CI 0.02 to 0.95; low-quality evidence). When trial sequential analysis was applied, the trial sequential monitoring boundary for benefit was crossed. We found no subgroup differences for type of interleukin-2 receptor antagonist (basiliximab versus daclizumab). Four trials reported on adverse events. However, no differences between trial groups were noted. Limited data were available for meta-analysis on drug-specific adverse events such as haematological adverse events for antithymocyte globulin. No data were available on quality of life.\nAuthors' conclusions\nBecause of the low quality of the evidence, the effects of T-cell antibody induction remain uncertain. T-cell specific antibody induction seems to reduce diabetes mellitus and may reduce cytomegalovirus infection when compared with corticosteroid induction. No other clear benefits or harms were associated with the use of T-cell specific antibody induction compared with corticosteroid induction. For some analyses, the number of trials investigating the use of T-cell specific antibody induction after liver transplantation is small, and the numbers of participants and outcomes in these randomised trials are limited. Furthermore, the included trials are heterogeneous in nature and have applied different types of T-cell specific antibody induction therapy. All trials were at high risk of bias. Hence, additional randomised clinical trials are needed to assess the benefits and harms of T-cell specific antibody induction compared with corticosteroid induction for liver transplant recipients. Such trials ought to be conducted with low risks of systematic error and of random error.\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": "Historically, corticosteroids have been the backbone of immunosuppression after liver transplantation, and corticosteroids are typically started immediately before or during transplantation. However, the use of corticosteroids is associated with several complications such as infection, hepatitis C virus recurrence, diabetes mellitus, hypertension, obesity, osteoporosis, fracture, and reduced quality of life. Hence, corticosteroid avoidance and corticosteroid reduction regimens for liver transplant recipients have been developed.\nAntibodies against T-cells are also used to induce immunosuppression after liver transplantation. This T-cell specific antibody induction therapy is intended to reduce rejection of the transplanted liver and is given within the first two weeks after transplantation. Furthermore, these antibodies may allow for delayed introduction of calcineurin inhibitors to protect kidney function.\nDifferent types of T-cell specific antibody induction therapy have been used for liver transplant recipients: interleukin-2 receptor antagonists (BT563, daclizumab, or basiliximab), monoclonal antibodies specific for the CD3 receptor (muromonab-CD3) or the CD52 surface protein (alemtuzumab), and polyclonal antibodies (rabbit or horse antithymocyte globulin (ATG) or antilymphocyte globulin (ALG)). A novel approach has been to replace corticosteroids with T-cell specific antibody induction as part of a corticosteroid reduction or avoidance regimen. The benefits and harms of this T-cell specific antibody induction therapy remain unclear."
}
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query-laysum | 2014 | [
{
"role": "user",
"content": "Abstract: Background\nAcetylcholinesterase inhibitors, such as neostigmine, have traditionally been used for reversal of non-depolarizing neuromuscular blocking agents. However, these drugs have significant limitations, such as indirect mechanisms of reversal, limited and unpredictable efficacy, and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety, reduced incidence of residual block on recovery, and more efficient use of healthcare resources.\nObjectives\nThe main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents in adults.\nSearch methods\nWe searched the following databases on 2 May 2016: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (WebSPIRS Ovid SP), Embase (WebSPIRS Ovid SP), and the clinical trials registries www.controlled-trials.com, clinicaltrials.gov, and www.centerwatch.com. We re-ran the search on 10 May 2017.\nSelection criteria\nWe included randomized controlled trials (RCTs) irrespective of publication status, date of publication, blinding status, outcomes published, or language. We included adults, classified as American Society of Anesthesiologists (ASA) I to IV, who received non-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration.\nData collection and analysis\nTwo review authors independently screened titles and abstracts to identify trials for eligibility, examined articles for eligibility, abstracted data, assessed the articles, and excluded obviously irrelevant reports. We resolved disagreements by discussion between review authors and further disagreements through consultation with the last review author. We assessed risk of bias in 10 methodological domains using the Cochrane risk of bias tool and examined risk of random error through trial sequential analysis. We used the principles of the GRADE approach to prepare an overall assessment of the quality of evidence. For our primary outcomes (recovery times to train-of-four ratio (TOFR) > 0.9), we presented data as mean differences (MDs) with 95 % confidence intervals (CIs), and for our secondary outcomes (risk of adverse events and risk of serious adverse events), we calculated risk ratios (RRs) with CIs.\nMain results\nWe included 41 studies (4206 participants) in this updated review, 38 of which were new studies. Twelve trials were eligible for meta-analysis of primary outcomes (n = 949), 28 trials were eligible for meta-analysis of secondary outcomes (n = 2298), and 10 trials (n = 1647) were ineligible for meta-analysis.\nWe compared sugammadex 2 mg/kg and neostigmine 0.05 mg/kg for reversal of rocuronium-induced moderate neuromuscular blockade (NMB). Sugammadex 2 mg/kg was 10.22 minutes (6.6 times) faster then neostigmine 0.05 mg/kg (1.96 vs 12.87 minutes) in reversing NMB from the second twitch (T2) to TOFR > 0.9 (MD 10.22 minutes, 95% CI 8.48 to 11.96; I2 = 84%; 10 studies, n = 835; GRADE: moderate quality).\nWe compared sugammadex 4 mg/kg and neostigmine 0.07 mg/kg for reversal of rocuronium-induced deep NMB. Sugammadex 4 mg/kg was 45.78 minutes (16.8 times) faster then neostigmine 0.07 mg/kg (2.9 vs 48.8 minutes) in reversing NMB from post-tetanic count (PTC) 1 to 5 to TOFR > 0.9 (MD 45.78 minutes, 95% CI 39.41 to 52.15; I2 = 0%; two studies, n = 114; GRADE: low quality).\nFor our secondary outcomes, we compared sugammadex, any dose, and neostigmine, any dose, looking at risk of adverse and serious adverse events. We found significantly fewer composite adverse events in the sugammadex group compared with the neostigmine group (RR 0.60, 95% CI 0.49 to 0.74; I2 = 40%; 28 studies, n = 2298; GRADE: moderate quality). Risk of adverse events was 28% in the neostigmine group and 16% in the sugammadex group, resulting in a number needed to treat for an additional beneficial outcome (NNTB) of 8. When looking at specific adverse events, we noted significantly less risk of bradycardia (RR 0.16, 95% CI 0.07 to 0.34; I2= 0%; 11 studies, n = 1218; NNTB 14; GRADE: moderate quality), postoperative nausea and vomiting (PONV) (RR 0.52, 95% CI 0.28 to 0.97; I2 = 0%; six studies, n = 389; NNTB 16; GRADE: low quality) and overall signs of postoperative residual paralysis (RR 0.40, 95% CI 0.28 to 0.57; I2 = 0%; 15 studies, n = 1474; NNTB 13; GRADE: moderate quality) in the sugammadex group when compared with the neostigmine group. Finally, we found no significant differences between sugammadex and neostigmine regarding risk of serious adverse events (RR 0.54, 95% CI 0.13 to 2.25; I2= 0%; 10 studies, n = 959; GRADE: low quality).\nApplication of trial sequential analysis (TSA) indicates superiority of sugammadex for outcomes such as recovery time from T2 to TOFR > 0.9, adverse events, and overall signs of postoperative residual paralysis.\nAuthors' conclusions\nReview results suggest that in comparison with neostigmine, sugammadex can more rapidly reverse rocuronium-induced neuromuscular block regardless of the depth of the block. Sugammadex 2 mg/kg is 10.22 minutes (˜ 6.6 times) faster in reversing moderate neuromuscular blockade (T2) than neostigmine 0.05 mg/kg (GRADE: moderate quality), and sugammadex 4 mg/kg is 45.78 minutes (˜ 16.8 times) faster in reversing deep neuromuscular blockade (PTC 1 to 5) than neostigmine 0.07 mg/kg (GRADE: low quality). With an NNTB of 8 to avoid an adverse event, sugammadex appears to have a better safety profile than neostigmine. Patients receiving sugammadex had 40% fewer adverse events compared with those given neostigmine. Specifically, risks of bradycardia (RR 0.16, NNTB 14; GRADE: moderate quality), PONV (RR 0.52, NNTB 16; GRADE: low quality), and overall signs of postoperative residual paralysis (RR 0.40, NNTB 13; GRADE: moderate quality) were reduced. Both sugammadex and neostigmine were associated with serious adverse events in less than 1% of patients, and data showed no differences in risk of serious adverse events between groups (RR 0.54; GRADE: low quality).\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sugammadex is more efficient and safer than neostigmine for reversing moderate and deep induced paralysis."
}
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query-laysum | 2015 | [
{
"role": "user",
"content": "Abstract: Background\nAllergic rhinitis is a common condition affecting both adults and children. Patients experience symptoms of nasal obstruction, rhinorrhoea, sneezing and nasal itching, which may affect their quality of life.\nNasal irrigation with saline (salty water), also known as nasal douching, washing or lavage, is a procedure that rinses the nasal cavity with isotonic or hypertonic saline solutions. It can be performed with low positive pressure from a spray, pump or squirt bottle, with a nebuliser or with gravity-based pressure in which the person instils saline into one nostril and allows it to drain out of the other. Saline solutions are available over the counter and can be used alone or as an adjunct to other therapies.\nObjectives\nTo evaluate the effects of nasal saline irrigation in people with allergic rhinitis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL; 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 23 November 2017.\nSelection criteria\nRandomised controlled trials (RCTs) comparing nasal saline irrigation, delivered by any means and with any volume, tonicity and alkalinity, with (a) no nasal saline irrigation or (b) other pharmacological treatments in adults and children with allergic rhinitis. We included studies comparing nasal saline versus no saline, where all participants also received pharmacological treatment (intranasal corticosteroids or oral antihistamines).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Primary outcomes were patient-reported disease severity and a common adverse effect - epistaxis. Secondary outcomes were disease-specific health-related quality of life (HRQL), individual symptom scores, general HRQL, the adverse effects of local irritation or discomfort, ear symptoms (pain or pressure) and nasal endoscopy scores. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.\nMain results\nWe included 14 studies (747 participants). The studies included children (seven studies, 499 participants) and adults (seven studies, 248 participants). No studies reported outcomes beyond three months follow-up. Saline volumes ranged from 'very low' to 'high' volume. Where stated, studies used either hypertonic or isotonic saline solution.\nNasal saline versus no saline treatment\nAll seven studies (112 adults; 332 children) evaluating this comparison used different scoring systems for patient-reported disease severity, so we pooled the data using the standardised mean difference (SMD). Saline irrigation may improve patient-reported disease severity compared with no saline at up to four weeks (SMD -1.32, 95% confidence interval (CI) -1.84 to -0.81; 407 participants; 6 studies; low quality) and between four weeks and three months (SMD -1.44, 95% CI -2.39 to -0.48; 167 participants; 5 studies; low quality). Although the evidence was low quality the SMD values at both time points are considered large effect sizes. Subgroup analysis showed the improvement in both adults and children. Subgroup analyses for volume and tonicity were inconclusive due to heterogeneity.\nTwo studies reported methods for recording adverse effects and five studies mentioned them. Two studies (240 children) reported no adverse effects (epistaxis or local discomfort) in either group and three only reported no adverse effects in the saline group.\nOne study (48 children) reported disease-specific HRQL using a modified RCQ-36 scale. It was uncertain whether there was a difference between the groups at any of the specified time points (very low quality). No other secondary outcomes were reported.\nNasal saline versus no saline with adjuvant use of intranasal steroids or oral antihistamines\nThree studies (40 adults; 79 children) compared saline with intranasal steroids versus intranasal steroids alone; one study (14 adults) compared saline with oral antihistamines versus oral antihistamines alone. It is uncertain if there is a difference in patient-reported disease severity at up to four weeks (SMD -0.60, 95% CI -1.34 to 0.15; 32 participants; 2 studies; very low quality) or from four weeks to three months (SMD -0.32, 95% CI -0.85 to 0.21; 58 participants; 2 studies; very low quality). Although none of the studies reported methods for recording adverse effects, three mentioned them: one study (40 adults; adjuvant intranasal steroids) reported no adverse effects (epistaxis or local discomfort) in either group; the other two only reported no adverse effects in the saline group.\nIt is uncertain if saline irrigation in addition to pharmacological treatment improved disease-specific HRQL at four weeks to three months, compared with pharmacological treatment alone (SMD -1.26, 95% CI -2.47 to -0.05; 54 participants; 2 studies; very low quality). No other secondary outcomes were reported.\nNasal saline versus intranasal steroids\nIt is uncertain if there was a difference in patient-reported disease severity between nasal saline and intranasal steroids at up to four weeks (MD 1.06, 95% CI -1.65 to 3.77; 14 participants; 1 study), or between four weeks and three months (SMD 1.26, 95% CI -0.92 to 3.43; 97 participants; 3 studies), or indisease-specific HRQL between four weeks and three months (SMD 0.01, 95% CI -0.73 to 0.75; 83 participants; 2 studies). Only one study reported methods for recording adverse effects although three studies mentioned them. One (21 participants) reported two withdrawals due to adverse effects but did not describe these or state which group. Three studies reported no adverse effects (epistaxis or local discomfort) with saline, although one study reported that 27% of participants experienced local discomfort with steroid use. No other secondary outcomes were reported.\nAuthors' conclusions\nSaline irrigation may reduce patient-reported disease severity compared with no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects. No data were available for any outcomes beyond three months. The overall quality of evidence was low or very low. The included studies were generally small and used a range of different outcome measures to report disease severity scores, with unclear validation. This review did not include direct comparisons of saline types (e.g. different volume, tonicity).\nSince saline irrigation could provide a cheap, safe and acceptable alternative to intranasal steroids and antihistamines further high-quality, adequately powered research in this area is warranted.\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": "Allergic rhinitis is inflammation (swelling and/or irritation) of the inside of the nose caused by allergies. It is common in both children and adults. Allergic rhinitis can be intermittent (fewer than four days per week, or four weeks per year) or persistent (more than four days per week, or four weeks per year). The allergy can be caused by many different things but common allergens (things causing allergy) are: grass or tree pollen, mould, dust mites or animal dander (tiny flakes of skin). People with allergic rhinitis experience symptoms (nasal obstruction, runny nose, nasal itching and sneezing) that may affect their quality of life.\nNasal saline irrigation (also known as nasal douche, wash or lavage) is a procedure that rinses the nasal cavity with saline (salt water) solutions. How saline works is not fully understood but it is probably through making the mucus (snot) thinner, making it easier to remove and also removing some of the allergens from the nose that cause irritation. Nasal saline irrigation can be performed with sprays, pumps or squirt bottles. Saline solutions can be isotonic (the same concentration of salt that is found in the body - 0.9% NaCl) or hypertonic (more salty than found in the body - more than 0.9% NaCl). Although saline irrigation is thought to be safe there have been reports of epistaxis (nosebleeds) and irritation or discomfort in the nose and ears. This therapy is available without prescription and can be used alone or as an add-on to other pharmacological treatment for allergic rhinitis, such as intranasal (in the nose) steroids and oral antihistamines)."
}
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query-laysum | 2016 | [
{
"role": "user",
"content": "Abstract: Background\nInfective endocarditis is a microbial infection of the endocardial surface of the heart. Antibiotics are the cornerstone of treatment, but due to the differences in presentation, populations affected, and the wide variety of micro-organisms that can be responsible, their use is not standardised. This is an update of a review previously published in 2016.\nObjectives\nTo assess the existing evidence about the clinical benefits and harms of different antibiotics regimens used to treat people with infective endocarditis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase Classic and Embase, LILACS, CINAHL, and the Conference Proceedings Citation Index - Science on 6 January 2020. We also searched three trials registers and handsearched the reference lists of included papers. We applied no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) assessing the effects of antibiotic regimens for treating definitive infective endocarditis diagnosed according to modified Duke's criteria. We considered all-cause mortality, cure rates, and adverse events as the primary outcomes. We excluded people with possible infective endocarditis and pregnant women.\nData collection and analysis\nTwo review authors independently performed study selection, 'Risk of bias' assessment, and data extraction in duplicate. We constructed 'Summary of findings' tables and used GRADE methodology to assess the quality of the evidence. We described the included studies narratively.\nMain results\nSix small RCTs involving 1143 allocated/632 analysed participants met the inclusion criteria of this first update. The included trials had a high risk of bias. Three trials were sponsored by drug companies. Due to heterogeneity in outcome definitions and different antibiotics used data could not be pooled.\nThe included trials compared miscellaneous antibiotic schedules having uncertain effects for all of the prespecified outcomes in this review. Evidence was either low or very low quality due to high risk of bias and very low number of events and small sample size.\nThe results for all-cause mortality were as follows: one trial compared quinolone (levofloxacin) plus standard treatment (antistaphylococcal penicillin (cloxacillin or dicloxacillin), aminoglycoside (tobramycin or netilmicin), and rifampicin) versus standard treatment alone and reported 8/31 (26%) with levofloxacin plus standard treatment versus 9/39 (23%) with standard treatment alone; risk ratio (RR) 1.12, 95% confidence interval (CI) 0.49 to 2.56. One trial compared fosfomycin plus imipenem 3/4 (75%) versus vancomycin 0/4 (0%) (RR 7.00, 95% CI 0.47 to 103.27), and one trial compared partial oral treatment 7/201 (3.5%) versus conventional intravenous treatment 13/199 (6.53%) (RR 0.53, 95% CI 0.22 to 1.31).\nThe results for rates of cure with or without surgery were as follows: one trial compared daptomycin versus low-dose gentamicin plus an antistaphylococcal penicillin (nafcillin, oxacillin, or flucloxacillin) or vancomycin and reported 9/28 (32.1%) with daptomycin versus 9/25 (36%) with low-dose gentamicin plus antistaphylococcal penicillin or vancomycin; RR 0.89, 95% CI 0.42 to 1.89. One trial compared glycopeptide (vancomycin or teicoplanin) plus gentamicin with cloxacillin plus gentamicin (13/23 (56%) versus 11/11 (100%); RR 0.59, 95% CI 0.40 to 0.85). One trial compared ceftriaxone plus gentamicin versus ceftriaxone alone (15/34 (44%) versus 21/33 (64%); RR 0.69, 95% CI 0.44 to 1.10), and one trial compared fosfomycin plus imipenem versus vancomycin (1/4 (25%) versus 2/4 (50%); RR 0.50, 95% CI 0.07 to 3.55).\nThe included trials reported adverse events, the need for cardiac surgical interventions, and rates of uncontrolled infection, congestive heart failure, relapse of endocarditis, and septic emboli, and found no conclusive differences between groups (very low-quality evidence). No trials assessed quality of life.\nAuthors' conclusions\nThis first update confirms the findings of the original version of the review. Limited and low to very low-quality evidence suggests that the comparative effects of different antibiotic regimens in terms of cure rates or other relevant clinical outcomes are uncertain. The conclusions of this updated Cochrane Review were based on few RCTs with a high risk of bias. Accordingly, current evidence does not support or reject any regimen of antibiotic therapy for the treatment of infective endocarditis.\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 aimed to assess the existing evidence about the clinical benefits and harms of different antibiotics regimens used to treat people with infective endocarditis."
}
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query-laysum | 2017 | [
{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide – containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo.\nAuthors' conclusions\nWe identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof.\nVery few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.\n\nGiven the provided abstract, please respond to the following query: \"Why is this question important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with COVID-19 develop a mild to moderate respiratory illness, and some may have no symptoms (asymptomatic infection). Others experience severe symptoms and need specialist treatment and intensive care.\nCOVID-19 spreads from person to person primarily through droplets that are produced when an infected person coughs, sneezes or talks. A person can also become infected by touching a surface or object that has viral droplets on it, and then touching their own mouth or nose.\nAdministering antimicrobial mouthwash (to rinse the mouth) or nasal spray (sprayed into the nose) to people with COVID-19 might help them fight the infection and prevent them from infecting the healthcare workers who treat them. Antimicrobial mouthwash and nasal spray are liquids that kill or stop the growth of micro-organisms such as viruses or bacteria.\nAs with any medical treatment, antimicrobial mouthwash and nasal spray have potential risks as well as benefits. It is possible that using mouthwash or nasal spray could cause a variety of unwanted (adverse) effects, including irritation, allergic reactions or loss of smell. It may also remove micro-organisms from the mouth or nose that are useful for protecting the body against infection."
}
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query-laysum | 2018 | [
{
"role": "user",
"content": "Abstract: Background\nPatellar (knee cap) dislocation occurs when the patella disengages completely from the trochlear (femoral) groove. It affects up to 42/100,000 people, and is most prevalent in those aged 20 to 30 years old. It is uncertain whether surgical or non-surgical treatment is the best approach. This is important as recurrent dislocation occurs in up to 40% of people who experience a first time (primary) dislocation. This can reduce quality of life and as a result people have to modify their lifestyle. This review is needed to determine whether surgical or non-surgical treatment should be offered to people after patellar dislocation.\nObjectives\nTo assess the effects (benefits and harms) of surgical versus non-surgical interventions for treating people with primary or recurrent patellar dislocation.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, AMED, CINAHL, Physiotherapy Evidence Database and trial registries in December 2021. We contacted corresponding authors to identify additional studies.\nSelection criteria\nWe included randomised and quasi-randomised controlled clinical trials evaluating surgical versus non-surgical interventions for treating primary or recurrent lateral patellar dislocation in adults or children.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were recurrent patellar dislocation, and patient-rated knee and physical function scores. Our secondary outcomes were health-related quality of life, return to former activities, knee pain during activity or at rest, adverse events, patient-reported satisfaction, patient-reported knee instability symptoms and subsequent requirement for knee surgery. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included 10 studies (eight randomised controlled trials (RCTs) and two quasi-RCTs) of 519 participants with patellar dislocation. The mean ages in the individual studies ranged from 13.0 to 27.2 years. Four studies included children, mainly adolescents, as well as adults; two only recruited children. Study follow-up ranged from one to 14 years.\nWe are unsure of the evidence for all outcomes in this review because we judged the certainty of the evidence to be very low. We downgraded each outcome by three levels. Reasons included imprecision (when fewer than 100 events were reported or the confidence interval (CI) indicated appreciable benefits as well as harms), risk of bias (when studies were at high risk of performance, detection and attrition bias), and inconsistency (in the event that pooled analysis included high levels of statistical heterogeneity).\nWe are uncertain whether surgery lowers the risk of recurrent dislocation following primary patellar dislocation compared with non-surgical management at two to nine year follow-up. Based on an illustrative risk of recurrent dislocation in 348 people per 1000 in the non-surgical group, we found that 157 fewer people per 1000 (95% CI 209 fewer to 87 fewer) had recurrent dislocation between two and nine years after surgery (8 studies, 438 participants).\nWe are uncertain whether surgery improves patient-rated knee and function scores. Studies measured this outcome using different scales (the Tegner activity scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm, Kujala Patellofemoral Disorders score and Hughston visual analogue scale). The most frequently reported score was the Kujala Patellofemoral Disorders score. This indicated people in the surgical group had a mean score of 5.73 points higher at two to nine year follow-up (95% CI 2.91 lower to 14.37 higher; 7 studies, 401 participants). On this 100-point scale, higher scores indicate better function, and a change score of 10 points is considered to be clinically meaningful; therefore, this CI includes a possible meaningful improvement.\nWe are uncertain whether surgery increases the risk of adverse events. Based on an assumed risk of overall incidence of complications during the first two years in 277 people out of 1000 in the non-surgical group, 335 more people per 1000 (95% CI 75 fewer to 723 more) had an adverse event in the surgery group (2 studies, 144 participants).\nThree studies (176 participants) assessed participant satisfaction at two to nine year follow-up, reporting little difference between groups. Based on an assumed risk of 763 per 1000 non-surgical participants reporting excellent or good outcomes, seven more participants per 1000 (95% CI 199 fewer to 237 more) reported excellent or good satisfaction.\nFour studies (256 participants) assessed recurrent patellar subluxation at two to nine year follow-up. Based on an assumed risk of patellar subluxation in 292 out of 1000 in the non-surgical group, 73 fewer people per 1000 (95% CI 146 fewer to 35 more) had patellar subluxation as a result of surgery.\nSlightly more people had subsequent surgery in the non-surgical group. Pooled two to nine year follow-up data from three trials (195 participants) indicated that, based on an assumed risk of subsequent surgery in 215 people per 1000 in the non-surgical group, 118 fewer people per 1000 (95% CI 200 fewer to 372 more) had subsequent surgery after primary surgery.\nAuthors' conclusions\nWe are uncertain whether surgery improves outcome compared to non-surgical management as the certainty of the evidence was very low. No sufficiently powered trial has examined people with recurrent patellar dislocation. Adequately powered, multicentre, randomised trials are needed. To inform the design and conduct of these trials, expert consensus should be achieved on the minimal description of both surgical and non-surgical interventions, and the pathological variations that may be relevant to both choice of these interventions.\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 10 relevant studies (519 adults and children). Studies randomly allocated people to receive surgery or a non-surgical treatment. In nine studies, people were treated for a first-time dislocation, one study treated people after repeated knee cap dislocations. People ranged from 13 to 27 years of age, with six studies including children. People in the studies were monitored from one to nine years after their injury."
}
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query-laysum | 2019 | [
{
"role": "user",
"content": "Abstract: Background\nSystemic androgen deprivation therapy (ADT), also referred to as hormone therapy, has long been the primary treatment for metastatic prostate cancer. Additional agents have been reserved for the castrate-resistant disease stage when ADT start becoming less effective. Abiraterone is an agent with an established role in that disease stage, which has only recently been evaluated in the hormone-sensitive setting.\nObjectives\nTo assess the effects of early abiraterone acetate, in combination with systemic ADT, for newly diagnosed metastatic hormone-sensitive prostate cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, six other databases, two trials registries, grey literature, and conference proceedings, up to 15 May 2020. We applied no restrictions on publication language or status.\nSelection criteria\nWe included randomized trials, in which men diagnosed with hormone-sensitive prostate cancer were administered abiraterone acetate and prednisolone with ADT or ADT alone.\nData collection and analysis\nTwo review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses\nusing a random-effects model. We rated the quality of evidence according to the GRADE approach.\nMain results\nThe search identified two randomized controlled trials (RCT), with 2201 men, who were assigned to receive either abiraterone acetate 1000 mg once daily and low dose prednisone (5mg) in addition to ADT, or ADT alone. In the LATITUDE trial, the median age and range of men in the intervention group was 68 (38 to 89) years, and 67 (33 to 92) years in the control group. Nearly all of the men in this study (97.6%) had prostate cancer with a Gleason score of at least 8 (ISUP grade group 4).\nPrimary outcomes\nThe addition of abiraterone acetate to ADT reduces the probability of death from any cause compared to ADT alone (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.56 to 0.73; 2 RCTs, 2201 men; high certainty of evidence); this corresponds to 163 fewer deaths per 1000 men with hormone-sensitive metastatic prostate cancer (210 fewer to 115 fewer) at five years.\nAbiraterone acetate in addition to ADT probably results in little to no difference in quality of life compared to ADT alone, measured with the Functional Assessment of Cancer Therapy-prostate total score (FACT-P; range 0 to 156; higher values indicates better quality of life), at 12 months (mean difference [MD] 2.90 points, 95% CI 0.11 to 5.60; 1 RCT, 838 men; moderate certainty of evidence).\nSecondary outcomes\nAbiraterone plus ADT increases the risk of grades III to V adverse events compared to ADT alone (risk ratio [RR] 1.34, 95% CI 1.22 to 1.47; 1 RCT, 1199 men; high certainty of evidence); this corresponds to 162 more grade III to V events per 1000 men with hormone-sensitive metastatic prostate cancer (105 more to 224 more) at a median follow-up of 30 months.\nAbiraterone acetate in addition to ADT probably reduces the probability of death due to prostate cancer compared to ADT alone (HR 0.58, 95% CI 0.50 to 0.68; 2 RCTs, 2201 men; moderate certainty of evidence). This corresponds to 120 fewer death from prostate cancer per 1000 men with hormone-sensitive metastatic prostate cancer (95% CI 145 fewer to 90 fewer) after a median follow-up of 30 months.\nThe addition of abiraterone acetate to ADT probably decreases the probability of disease progression compared to ADT alone (HR 0.35, 95%CI 0.26 to 0.49; 2 RCTs, 2097 men; moderate certainty of evidence). This corresponds to 369 fewer incidences of disease progression per 1000 men with hormone-sensitive metastatic prostate cancer (456 fewer to 256 fewer) after a median follow-up of 30 months.\nThe addition of abiraterone acetate to ADT probably increases the risk of discontinuing treatment due to adverse events compared to ADT alone (RR 1.50, 95% CI 1.17 to 1.92; 1 RCT, 1199 men; moderate certainty of evidence). This corresponds to 51 more men (95% CI 17 more to 93 more) discontinuing treatment because of adverse events per 1000 men treated with abiraterone acetate and ADT compared to ADT alone after a median follow-up of 30 months.\nAuthors' conclusions\nThe addition of abiraterone acetate to androgen deprivation therapy improves overall survival but probably not quality of life. It probably also extends disease-specific survival, and delays disease progression compared to androgen deprivation therapy alone. However, the risk of grades III to V adverse events is increased, and probably, so is the risk of discontinuing treatment due to adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this review was to find out what the effect of adding abiraterone was, in men with prostate cancer, who were receiving and still responding to hormone therapy."
}
]
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query-laysum | 2020 | [
{
"role": "user",
"content": "Abstract: Background\nMidazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular.\nObjectives\nTo determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions.\nSelection criteria\nRandomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics.\nData collection and analysis\nTwo authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison.\nMain results\nWe included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions.\nIntravenous midazolam versus diazepam (14 trials; 1069 participants)\nThere was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence).\nIntravenous midazolam versus placebo (5 trials; 493 participants)\nOne trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence).\nOral midazolam versus chloral hydrate (4 trials; 268 participants)\nMidazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence).\nOral midazolam versus placebo (3 trials; 176 participants)\nMidazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05).\nIntranasal midazolam versus placebo (2 trials; 149 participants)\nMidazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence).\nAuthors' conclusions\nWe found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up-to-date to January 2016. We included 30 trials involving 2319 participants. We looked at trials that compared midazolam with no active treatment ('dummy' treatment/placebo) or a different medication for sedation before a procedure. The trials involved children and adults having procedures to diagnose medical problems rather than procedures for treatment of a disease. We disregarded trials where people received a general anaesthetic or other medications for sedation or pain relief in addition to midazolam during their procedure."
}
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query-laysum | 2021 | [
{
"role": "user",
"content": "Abstract: Background\nThis is an updated merged review of two originally separate Cochrane reviews: one on robot-assisted surgery (RAS) for benign gynaecological disease, the other on RAS for gynaecological cancer. RAS is a relatively new innovation in laparoscopic surgery that enables the surgeon to conduct the operation from a computer console, situated away from the surgical table. RAS is already widely used in the United States for hysterectomy and has been shown to be feasible for other gynaecological procedures. However, the clinical effectiveness and safety of RAS compared with conventional laparoscopic surgery (CLS) have not been clearly established and require independent review.\nObjectives\nTo assess the effectiveness and safety of RAS in the treatment of women with benign and malignant gynaecological disease.\nSearch methods\nFor this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, and EMBASE via Ovid, on 8 January 2018. We searched www.ClinicalTrials.gov. on 16 January 2018.\nSelection criteria\nRandomised controlled trials (RCTs) comparing RAS versus CLS or open surgery in women requiring surgery for gynaecological disease.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion and risk of bias, and extracted study data and entered them into an Excel spreadsheet. We examined different procedures in separate comparisons and for hysterectomy subgrouped data according to type of disease (non-malignant versus malignant). When more than one study contributed data, we pooled data using random-effects methods in RevMan 5.3.\nMain results\nWe included 12 RCTs involving 1016 women. Studies were at moderate to high overall risk of bias, and we downgraded evidence mainly due to concerns about risk of bias in the studies contributing data and imprecision of effect estimates. Procedures performed were hysterectomy (eight studies) and sacrocolpopexy (three studies). In addition, one trial examined surgical treatment for endometriosis, which included resection or hysterectomy. Among studies of women undergoing hysterectomy procedures, two studies involved malignant disease (endometrial cancer); the rest involved non-malignant disease.\n• RAS versus CLS (hysterectomy)\nLow-certainty evidence suggests there might be little or no difference in any complication rates between RAS and CLS (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.54 to 1.59; participants = 585; studies = 6; I² = 51%), intraoperative complication rates (RR 1.05, 95% CI 0.31 to 3.56; participants = 487; studies = 5; I² = 28%), postoperative complications (RR 0.82, 95% CI 0.42 to 1.59; participants = 533; studies = 5; I2 = 51%), and blood transfusions (RR 2.49, 95% CI 0.75 to 8.23; participants = 346; studies = 4; I2 = 0%)). There was no statistical difference between malignant and non-malignant disease subgroups with regard to complication rates. Survival outcomes for women with malignant disease were not reported.\nMean total operating time was longer on average in the RAS arm than in the CLS arm (mean difference (MD) 41.18 minutes, 95% CI -6.17 to 88.53; participants = 148; studies = 2; I² = 80%; very low-certainty evidence), and the mean length of hospital stay was slightly shorter with RAS than with CLS (MD -0.30 days, 95% CI -0.53 to -0.07; participants = 192; studies = 2; I² = 0%; very low-certainty evidence).\n• RAS versus CLS (sacrocolpopexy)\nVery low-certainty evidence suggests little or no difference in rates of any complications between women undergoing sacrocolpopexy by RAS or CLS (RR 0.95, 95% CI 0.21 to 4.24; participants = 186; studies = 3; I² = 78%), nor in intraoperative complications (RR 0.82, 95% CI 0.09 to 7.59; participants = 108; studies = 2; I² = 47%). Low-certainty evidence on postoperative complications suggests these might be higher with RAS (RR 3.54, 95% CI 1.31 to 9.56; studies = 1; participants = 68). Researchers did not report blood transfusions and deaths up to 30 days.\nLow-certainty evidence suggests that RAS might be associated with increased operating time (MD 40.53 min, 95% CI 12.06 to 68.99; participants = 186; studies = 3; I² = 73%). Very low-certainty evidence suggests little or no difference between the two techniques in terms of duration of stay (MD 0.26 days, 95% CI -0.15 to 0.67; participants = 108; studies = 2; I² = 0%).\n• RAS versus open abdominal surgery (hysterectomy)\nTwo studies of 20 and 96 participants with non-malignant disease and malignant disease, respectively, compared RAS with open surgery. For most outcomes only one study contributed data, with most evidence assessed as very low-certainty. Low-certainty evidence from the study among women with endometrial cancer suggests that lymph node yields may be lower with RAS (MD -8.00, 95% CI -14.97 to -1.03), operating time may be longer (233 minutes (range 166 to 320 minutes) compared with 187 minutes (range 109 to 300), hospital stays may be shorter (mean of 2 days [1 to 5] versus 5 days [4 to 9]; P<0.001), and overall costs may be less (MD -1568.00 US dollars, 95% CI -3100.75 to -35.25) than open surgery. Survival outcomes were not reported.\n• RAS versus CLS for endometriosis\nA single study with data for 73 women was included in this comparison; women with endometriosis underwent procedures ranging from relatively minor endometrial resection through hysterectomy; many of the women included in this study had undergone previous surgery for their condition. For most outcomes, event rates were low, and the sample size was insufficient to detect potential differences between groups.\nAuthors' conclusions\nEvidence on the effectiveness and safety of RAS compared with CLS for non-malignant disease (hysterectomy and sacrocolpopexy) is of low certainty but suggests that surgical complication rates might be comparable. Evidence on the effectiveness and safety of RAS compared with CLS or open surgery for malignant disease is more uncertain, particularly because survival data are lacking. RAS is an operator-dependent expensive technology; therefore evaluating the safety of this technology independently will present challenges.\n\nGiven the provided abstract, please respond to the following query: \"How we conducted the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified studies by searching databases and writing to researchers of registered trials. Two review authors independently assessed studies and collected the data from each study. We included only randomised controlled trials. We pooled data from similar individual studies in the analyses, and we examined different types of operations separately (hysterectomy, sacrocolpopexy, or surgery for endometriosis)."
}
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query-laysum | 2022 | [
{
"role": "user",
"content": "Abstract: Background\nThe reading skills of 16% of children fall below the mean range for their age, and 5% of children have significant and severe reading problems. Phonics training is one of the most common reading treatments used with poor readers, particularly children.\nObjectives\nTo measure the effect of phonics training and explore the impact of various factors, such as training duration and training group size, that might moderate the effect of phonics training on literacy-related skills in English-speaking poor readers.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 12 other databases, and three trials registers up to May 2018. We also searched reference lists of included studies and contacted experts in the field to identify additional studies.\nSelection criteria\nWe included studies that used randomisation, quasi-randomisation, or minimisation to allocate participants to a phonics intervention group (phonics training only or phonics training plus one other literacy-related skill) or a control group (no training or non-literacy training). Participants were English-speaking poor readers with word reading one standard deviation below the appropriate level for their age (children, adolescents, and adults) or one grade or year below the appropriate level (children only), for no known reason. Participants had no known comorbid developmental disorder, or physical, neurological, or emotional problem.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included 14 studies with 923 participants in this review. Studies took place in Australia, Canada, the UK, and the USA. Six of the 14 included studies were funded by government agencies and one was funded by a university grant. The rest were funded by charitable foundations or trusts. Each study compared phonics training alone, or in conjunction with one other reading-related skill, to either no training (i.e. treatment as usual) or alterative training (e.g. maths). Participants were English-speaking children or adolescents, of low and middle socioeconomic status, whose reading was one year, one grade, or one standard deviation below the level expected for their age or grade for no known reason. Phonics training varied between studies in intensity (up to four hours per week), duration (up to seven months), training group size (individual and small groups), and delivery (human and computer). We measured the effect of phonics training on seven primary outcomes (mixed/regular word reading accuracy, non-word reading accuracy, irregular word reading accuracy, mixed/regular word reading fluency, non-word reading fluency, reading comprehension, and spelling). We judged all studies to be at low risk of bias for most risk criteria, and used the GRADE approach to assess the quality of the evidence.\nThere was low-quality evidence that phonics training may have improved poor readers' accuracy for reading real and novel words that follow the letter-sound rules (standardised mean difference (SMD) 0.51, 95% confidence interval (CI) 0.13 to 0.90; 11 studies, 701 participants), and their accuracy for reading words that did not follow these rules (SMD 0.67, 95% CI 0.26 to 1.07; 10 studies, 682 participants). There was moderate-quality evidence that phonics training probably improved English-speaking poor readers' fluency for reading words that followed the letter-sounds rules (SMD 0.45, 95% CI 0.19 to 0.72; 4 studies, 224 participants), and non-word reading fluency (SMD 0.39, 95% CI 0.10 to 0.68; 3 studies, 188 participants), as well as their accuracy for reading words that did not follow these rules (SMD 0.84, 95% CI 0.30 to 1.39; 4 studies, 294 participants). In addition, there was low-quality evidence that phonics training may have improved poor readers' spelling (SMD 0.47, 95% CI –0.07 to 1.01; 3 studies, 158 participants), but only slightly improve their reading comprehension (SMD 0.28, 95% CI –0.07 to 0.62; 5 studies, 343 participants).\nAuthors' conclusions\nPhonics training appears to be effective for improving literacy-related skills, particularly reading fluency of words and non-words, and accuracy of reading irregular words. More studies are needed to improve the precision of outcomes, including word and non-word reading accuracy, reading comprehension, spelling, letter-sound knowledge, and phonological output. More data are also needed to determine if phonics training in English-speaking poor readers is moderated by factors such as training type, intensity, duration, group size, or administrator.\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 phonics training improve literacy-related skills in English-speaking poor readers."
}
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query-laysum | 2023 | [
{
"role": "user",
"content": "Abstract: Background\nNitric oxide (NO) has multiple effects that may be beneficial in acute stroke, including lowering blood pressure, and promoting reperfusion and cytoprotection. Some forms of nitric oxide synthase inhibition (NOS-I) may also be beneficial. However, high concentrations of NO are likely to be toxic to brain tissue. This is an update of a Cochrane review first published in 1998, and last updated in 2002.\nObjectives\nTo assess the safety and efficacy of NO donors, L-arginine, and NOS-I in people with acute stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (last searched 6 February 2017), MEDLINE (1966 to June 2016), Embase (1980 to June 2016), ISI Science Citation Indexes (1981 to June 2016), Stroke Trials Registry (searched June 2016), International Standard Randomised Controlled Trial Number (ISRCTN) (searched June 2016), Clinical Trials registry (searched June 2016), and International Clinical Trials Registry Platform (ICTRP) (searched June 2016). Previously, we had contacted drug companies and researchers in the field.\nSelection criteria\nRandomised controlled trials comparing nitric oxide donors, L-arginine, or NOS-I versus placebo or open control in people within one week of onset of confirmed stroke.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data. The review authors cross-checked data and resolved issues through discussion. We obtained published and unpublished data, as available. Data were reported as mean difference (MD) or odds ratio (OR) with 95% confidence intervals (CI).\nMain results\nWe included five completed trials, involving 4197 participants; all tested transdermal glyceryl trinitrate (GTN), an NO donor. The assessed risk of bias was low across the included studies; one study was double-blind, one open-label and three were single-blind. All included studies had blinded outcome assessment. Overall, GTN did not improve the primary outcome of death or dependency at the end of trial (modified Rankin Scale (mRS) > 2, OR 0.97, 95% CI 0.86 to 1.10, 4195 participants, high-quality evidence). GTN did not improve secondary outcomes, including death (OR 0.78, 95% CI 0.40 to 1.50) and quality of life (MD -0.01, 95% CI -0.17 to 0.15) at the end of trial overall (high-quality evidence). Systolic/diastolic blood pressure (BP) was lower in people treated with GTN (MD -7.2 mmHg (95% CI -8.6 to -5.9) and MD -3.3 (95% CI -4.2 to -2.5) respectively) and heart rate was higher (MD 2.0 beats per minute (95% CI 1.1 to 2.9)). Headache was more common in those randomised to GTN (OR 2.37, 95% CI 1.55 to 3.62). We did not find any trials assessing other nitrates, L-arginine, or NOS-I.\nAuthors' conclusions\nThere is currently insufficient evidence to recommend the use of NO donors, L-arginine or NOS-I in acute stroke, and only one drug (GTN) has been assessed. In people with acute stroke, GTN reduces blood pressure, increases heart rate and headache, but does not alter clinical outcome (all based on high-quality evidence).\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review is up-to-date as of September 2016. We included five trials involving 4197 people; all trials assessed glyceryl trinitrate, a drug that is given as a skin patch and which releases nitric oxide. One study was international, whilst the remainder were studies performed at single centres. Not all trials contributed data to all outcomes. We used both unpublished and published information, where available. We did not find any trials assessing other nitrate drugs, L-arginine, or nitric oxide synthase inhibitors."
}
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query-laysum | 2024 | [
{
"role": "user",
"content": "Abstract: Background\nPrevious research has shown that the prophylactic use of uterotonic agents in the third stage of labour reduces postpartum blood loss and moderate to severe postpartum haemorrhage (PPH). PPH is defined as a blood loss of 500 mL or more within 24 hours after birth. This is one of a series of systematic reviews assessing the effects of prophylactic use of uterotonic drugs; in this review prophylactic ergot alkaloids as a whole, and different regimens of administration of ergot alkaloids, are compared with no uterotonic agents. This is an update of a Cochrane Review which was first published in 2007 and last updated in 2011.\nObjectives\nTo determine the effectiveness and safety of prophylactic use of ergot alkaloids in the third stage of labour by any route (intravenous (IV), intramuscular (IM), or oral) compared with no uterotonic agents, for the prevention of PPH.\nSearch methods\nFor this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (19 September 2017); we also searched reference lists of retrieved studies.\nSelection criteria\nWe included all randomised controlled trials or cluster-randomised trials comparing prophylactic ergot alkaloids by any route (IV, IM, or oral) with no uterotonic agents in the third stage of labour among women giving birth vaginally.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, extracted data and checked them for accuracy; they also assessed the risk of bias in included studies. Two review authors assessed the quality of the evidence using the GRADE approach.\nMain results\nThere were eight included studies: three studies had a low risk of bias and five studies had high risk of bias. The studies compared ergot alkaloids with no uterotonic agents, with a total of 2031 women in the ergot alkaloids group and 1978 women in the placebo or no treatment group. Seven studies used the IV/IM route of administration and one study used the oral route.\nErgot alkaloids (any route of administration) versus no uterotonic agents\nUse of ergot alkaloids in the third stage of labour decreased mean blood loss (mean difference (MD) -80.52 mL, 95% confidence interval (CI) -96.39 to -64.65 mL; women = 2718; studies = 3; moderate-quality evidence); decreased PPH of at least 500 mL (average risk ratio (RR) 0.52, 95% CI 0.28 to 0.94; women = 3708; studies = 5; I2 = 83%; low-quality evidence); increased maternal haemoglobin concentration (g/dL) at 24 to 48 hours postpartum (MD 0.50 g/dL, 95% CI 0.38 to 0.62; women = 1429; studies = 1; moderate-quality evidence); and decreased the use of therapeutic uterotonics (average RR 0.37, 95% CI 0.15 to 0.90; women = 2698; studies = 3; I2 = 89%; low-quality evidence). There were no clear differences between groups in severe PPH of at least 1000 mL (average RR 0.32, 95% CI 0.04 to 2.59; women = 1718; studies = 2; I2 = 74%; very low-quality evidence). The risk of retained placenta or manual removal of the placenta, or both, were inconsistent with high heterogeneity. Ergot alkaloids increased the risk of elevated blood pressure (average RR 2.60, 95% CI 1.03 to 6.57: women = 2559; studies = 3; low-quality evidence) and pain after birth requiring analgesia (RR 2.53, 95% CI 1.34 to 4.78: women = 1429; studies = 1; moderate-quality evidence) but there were no differences between groups in vomiting, nausea, headache or eclamptic fit.\nResults for IV/IM ergot alkaloids versus no uterotonic agents were similar to those for the main comparison of ergot alkaloids administered by any route, since most of the studies (seven of eight) used the IV/IM route. Only one small study (289 women) compared oral ergometrine with placebo and it showed no benefit of ergometrine over placebo. No maternal adverse effects were reported.\nNone of the studies reported on any of our prespecified neonatal outcomes\nAuthors' conclusions\nProphylactic IM or IV injections of ergot alkaloids may be effective in reducing blood loss, reducing PPH (estimated blood loss of at least 500 mL), and increasing maternal haemoglobin. Ergot alkaloids may also decrease the use of therapeutic uterotonics, but adverse effects may include elevated blood pressure and pain after birth requiring analgesia. There were no differences between groups in terms of other adverse effects (vomiting, nausea, headache or eclamptic fit). There is a lack of evidence on the effects of ergot alkaloids on severe PPH, and retained or manual removal of placenta. There is also a lack of evidence on the oral route of administration of ergot alkaloids.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for evidence in September 2017 and included eight trials involving 4009 women receiving ergometrine by mouth (orally), into the muscle (intramuscularly (IM)) or into the vein (intravenously (IV)). Of eight trials, seven included studies were analysed in this updated review.\nThe evidence from the trials analysed suggests that ergot alkaloids may decrease mean blood loss, increase maternal haemoglobin levels in the blood, and may decrease both blood loss of at least 500 mL (PPH) and the use of therapeutic uterotonics. It is uncertain whether ergot alkaloids have any effect on numbers of women experiencing high blood loss of at least 1000 mL (severe PPH). The evidence also suggested that they may increase adverse effects such as increased blood pressure and pain after birth. They may make little or no difference between groups in terms of other adverse effects (vomiting, nausea, headache or eclamptic fit) and results were inconsistent on the risk of retained or manual removal of placenta. Most of the evidence came from trials that administered ergot alkaloids using the IM or IV route. There was only one small trial that looked at the use of oral ergot alkaloids and results were inconclusive. There were limited numbers of included studies and results between studies were not always consistent or precise. Overall quality of evidence across critical and important outcomes ranged from very low to moderate."
}
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query-laysum | 2025 | [
{
"role": "user",
"content": "Abstract: Background\nThe first-line treatment in donor sperm treatment consists of inseminations that can be done by intrauterine insemination (IUI) or by intracervical insemination (ICI).\nObjectives\nTo compare the effectiveness and safety of intrauterine insemination (IUI) and intracervical insemination (ICI) in women who start donor sperm treatment.\nSearch methods\nWe searched the Cochrane Gynaecology and Fertility Group Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL in October 2016, checked references of relevant studies, and contacted study authors and experts in the field to identify additional studies. We searched PubMed, Google Scholar, the Grey literature, and five trials registers on 15 December 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs) reporting on IUI versus ICI in natural cycles or with ovarian stimulation, and RCTs comparing different cointerventions in IUI and ICI. We included cross-over studies if pre-cross-over data were available.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. We collected data on primary outcomes of live birth and multiple pregnancy rates, and on secondary outcomes of clinical pregnancy, miscarriage, and cancellation rates.\nMain results\nWe included six RCTs (708 women analysed) on ICI and IUI in donor sperm treatment. Two studies compared IUI and ICI in natural cycles, two studies compared IUI and ICI in gonadotrophin-stimulated cycles, and two studies compared timing of IUI and ICI. There was very low-quality evidence; the main limitations were risk of bias due to poor reporting of study methods, and serious imprecision.\nIUI versus ICI in natural cycles\nThere was insufficient evidence to determine whether there was any clear difference in live birth rate between IUI and ICI in natural cycles (odds ratio (OR) 3.24, 95% confidence interval (CI) 0.12 to 87.13; 1 RCT, 26 women; very low-quality evidence). There was only one live birth in this study (in the IUI group). IUI resulted in higher clinical pregnancy rates (OR 6.18, 95% CI 1.91 to 20.03; 2 RCTs, 76 women; I² = 48%; very low-quality evidence).\nNo multiple pregnancies or miscarriages occurred in this study.\nIUI versus ICI in gonadotrophin-stimulated cycles\nThere was insufficient evidence to determine whether there was any clear difference in live birth rate between IUI and ICI in gonadotrophin-stimulated cycles (OR 2.55, 95% CI 0.72 to 8.96; 1 RCT, 43 women; very low-quality evidence). This suggested that if the chance of a live birth following ICI in gonadotrophin-stimulated cycles was assumed to be 30%, the chance following IUI in gonadotrophin-stimulated cycles would be between 24% and 80%. IUI may result in higher clinical pregnancy rates than ICI (OR 2.83, 95% CI 1.38 to 5.78; 2 RCTs, 131 women; I² = 0%; very low-quality evidence). IUI may be associated with higher multiple pregnancy rates than ICI (OR 2.77, 95% CI 1.00 to 7.69; 2 RCTs, 131 women; I² = 0%; very low-quality evidence). This suggested that if the risk of multiple pregnancy following ICI in gonadotrophin-stimulated cycles was assumed to be 10%, the risk following IUI would be between 10% and 46%.\nWe found insufficient evidence to determine whether there was any clear difference between the groups in miscarriage rates in gonadotrophin-stimulated cycles (OR 1.97, 95% CI 0.43 to 9.04; 2 RCTs, overall 67 pregnancies; I² = 50%; very low-quality evidence).\nTiming of IUI and ICI\nWe found no studies that reported on live birth rates.\nWe found a higher clinical pregnancy rate when IUI was timed one day after a rise in blood levels of luteinising hormone (LH) compared to IUI two days after a rise in blood levels of LH (OR 2.00, 95% CI 1.14 to 3.53; 1 RCT, 351 women; low-quality evidence). We found insufficient evidence to determine whether there was any clear difference in clinical pregnancy rates between ICI timed after a rise in urinary levels of LH versus a rise in basal temperature plus cervical mucus scores (OR 1.31, 95% CI 0.42 to 4.11; 1 RCT, 56 women; very low-quality evidence).\nNeither of these studies reported multiple pregnancy or miscarriage rates as outcomes.\nAuthors' conclusions\nThere was insufficient evidence to determine whether there was a clear difference in live birth rates between IUI and ICI in natural or gonadotrophin-stimulated cycles in women who started with donor sperm treatment. There was insufficient evidence available for the effect of timing of IUI or ICI on live birth rates. Very low-quality data suggested that in gonadotrophin-stimulated cycles, IUI may be associated with a higher clinical pregnancy rate than ICI, but also with a higher risk of multiple pregnancy rate. We concluded that the current evidence was too limited to choose between IUI or ICI, in natural cycles or with ovarian stimulation, in donor sperm treatment.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
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{
"role": "assistant",
"content": "There was insufficient evidence to determine whether there was any clear difference between IUI and ICI in live birth rates, in either natural cycles or in gonadotrophin-stimulated cycles. As there was only one live birth in the small study using natural cycles, we could not make any meaningful comparison between the groups. The evidence on gonadotrophin-stimulated cycles suggested that if the live birth rate following ICI was assumed to be 30%, the chance of live birth rate following IUI in gonadotrophin-stimulated cycles would be between 24% and 80%. For IUI and ICI in natural cycles, no multiple pregnancies were reported. In gonadotrophin-stimulated cycles, IUI was associated with higher multiple pregnancy rates than ICI. The evidence suggested that if the risk of multiple pregnancy following ICI in gonadotrophin-stimulated cycles was assumed to be 10%, the risk of multiple pregnancy following IUI would be between 10% and 46%.\nWe concluded that the evidence was too limited to encourage or discourage either IUI or ICI, in natural cycles or with ovarian stimulation in donor sperm treatment."
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