George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell
{"title":"Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.","authors":"George A Wells, Shu-Ching Hsieh, Joan Peterson, Carine Zheng, Shannon E Kelly, Beverley Shea, Peter Tugwell","doi":"10.1002/14651858.CD001155.pub3","DOIUrl":"10.1002/14651858.CD001155.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Osteoporosis is an abnormal reduction in bone mass and bone deterioration, leading to increased fracture risk. Alendronate belongs to the bisphosphonate class of drugs, which inhibit bone resorption by interfering with the activity of osteoclasts (bone cells that break down bone tissue). This is an update of a Cochrane review first published in 2008.</p><p><strong>Objectives: </strong>To assess the benefits and harms of alendronate in the primary and secondary prevention of osteoporotic fractures in postmenopausal women at lower and higher risk of fracture, respectively.</p><p><strong>Search methods: </strong>We searched Evidence-Based Medicine Reviews (which includes CENTRAL), MEDLINE, Embase, two trial registers, drug approval agency websites, and the bibliographies of relevant systematic reviews to identify the studies included in this review. The latest search date was 01 February 2023. We imposed no restrictions on language, date, form of publication, or reported outcomes.</p><p><strong>Eligibility criteria: </strong>We included only randomized controlled trials that assessed the effects of alendronate on postmenopausal women. Targeted participants must have received at least one year of alendronate. We classified a study as secondary prevention if its population met one or more of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, a low bone mineral density T-score (-2.5 or lower), and 75 years old or older. If a study population met none of those criteria, we classified it as a primary prevention study.</p><p><strong>Outcomes: </strong>Our major outcomes were clinical vertebral, non-vertebral, hip, and wrist fractures, withdrawals due to adverse events, and serious adverse events.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias 1 tool.</p><p><strong>Synthesis methods: </strong>We used standard methodological procedures expected by Cochrane. Based on the previous review experience, in which the clinical and methodological characteristics in the primary and secondary prevention studies were homogeneous, we used a fixed-effect model for meta-analysis and estimated effects using the risk ratio (RR) for dichotomous outcomes. Our base case analyses included all eligible placebo-controlled studies with usable data. We selected the data available for the longest treatment period. We consider a relative change exceeding 15% as clinically important.</p><p><strong>Included studies: </strong>We included 119 studies, of which 102 studies provided data for quantitative synthesis. Of these, we classified 34 studies (15,188 participants) as primary prevention and 68 studies (29,577 participants) as secondary prevention. We had concerns about risks of bias in most studies. Selection bias was the most frequently overlooked domain, with only 20 studies (19%) describing appropriate methods for both sequence generation and allocation concealment. Eight studie","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD001155"},"PeriodicalIF":8.8,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11770842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle
{"title":"Intravenous antibiotics for pulmonary exacerbations in people with cystic fibrosis.","authors":"Matthew N Hurley, Sherie Smith, Patrick Flume, Nikki Jahnke, Andrew P Prayle","doi":"10.1002/14651858.CD009730.pub3","DOIUrl":"10.1002/14651858.CD009730.pub3","url":null,"abstract":"<p><strong>Background: </strong>Cystic fibrosis is a multisystem disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. Intravenous (IV) antibiotics are commonly used in the treatment of acute deteriorations in symptoms (pulmonary exacerbations); however, recently the assumption that exacerbations are due to increases in bacterial burden has been questioned. This is an update of a previously published review.</p><p><strong>Objectives: </strong>To establish whether IV antibiotics for the treatment of pulmonary exacerbations in people with cystic fibrosis improve short-term and long-term clinical outcomes.</p><p><strong>Search methods: </strong>We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews and ongoing trials registers. Date of last search of Cochrane Trials Register: 19 June 2024.</p><p><strong>Selection criteria: </strong>Randomised controlled trials and the first treatment cycle of cross-over studies comparing IV antibiotics (given alone or in an antibiotic combination) with placebo, or inhaled or oral antibiotics for people with cystic fibrosis experiencing a pulmonary exacerbation. Studies comparing different IV antibiotic regimens were also eligible.</p><p><strong>Data collection and analysis: </strong>We assessed studies for eligibility and risk of bias, and extracted data. Using GRADE, we assessed the certainty of the evidence for the outcomes lung function % predicted (forced expiratory volume in one second (FEV<sub>1</sub>) and forced vital capacity (FVC)), time to next exacerbation and quality of life.</p><p><strong>Main results: </strong>We included 45 studies involving 2810 participants. The included studies were mostly small, and inadequately reported, many of which were quite old. The certainty of the evidence was mostly low. Combined intravenous antibiotics versus placebo Data reported for absolute change in % predicted FEV<sub>1</sub> and FVC suggested a possible improvement in favour of IV antibiotics, but the evidence is very uncertain (1 study, 12 participants; very low-certainty evidence). The study did not measure time to next exacerbation or quality of life. Intravenous versus nebulised antibiotics Five studies (122 participants) reported FEV<sub>1</sub>, with analysable data only from one study (16 participants). We found no difference between groups (moderate-certainty evidence). Three studies (91 participants) reported on FVC, with analysable data from only one study (54 participants). We are very uncertain on the effect of nebulised antibiotics (very low-certainty evidence). In one study, the 16 participants on nebulised plus IV antibiotics had a lower mean number of days to next exacerbation than those on combined IV antibiotics (low-certainty evidence), but we found ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD009730"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke
{"title":"Lurasidone versus typical antipsychotics for schizophrenia.","authors":"Dawid Storman, Magdalena Koperny, Krzysztof Styczeñ, Wojciech Datka, Rafal R Jaeschke","doi":"10.1002/14651858.CD012429.pub2","DOIUrl":"10.1002/14651858.CD012429.pub2","url":null,"abstract":"<p><strong>Background: </strong>Antipsychotic drugs are the mainstay of treatment for schizophrenia. Even though several novel second-generation antipsychotics (i.e. lurasidone, iloperidone and cariprazine) have been approved in recent years, typical antipsychotics (e.g. chlorpromazine, haloperidol, and fluphenazine) remain a crucial therapeutic option for the condition around the world. Little is known about the relative risk-to-benefit ratio of the 'latest' second-generation antipsychotics compared to the typical agents of 'established stature'.</p><p><strong>Objectives: </strong>To systematically review the efficacy and safety of lurasidone versus typical antipsychotics for adults with schizophrenia or schizophrenia-related disorders.</p><p><strong>Search methods: </strong>We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials on 5 June 2019. We also ran an update search in CENTRAL, MEDLINE, Embase, and three additional databases as well as two trial registers and the US Food and Drug Administration database on 1 April 2024.</p><p><strong>Selection criteria: </strong>We searched for randomized controlled trials (RCTs) comparing lurasidonewith typical antipsychotic drugs (such as chlorpromazine, fluphenazine, haloperidol, loxapine, mesoridazine, molindone, perphenazine, thioridazine, thiothixene, zuclopenthixol) for adults with schizophrenia. No additional search restrictions were applied.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, trial methods, and funding sources. Two review authors independently extracted data and assessed the risk of bias. We assessed the certainty of evidence with GRADE for these key outcomes: change in mental state, death by suicide or natural cause, quality of life, total serious adverse events and severe adverse events (as defined by study authors).</p><p><strong>Main results: </strong>We included two studies with a total of 308 individuals diagnosed with schizophrenia (220 men and 85 women). A total of 223 participants received lurasidone (20, 40, or 80 mg/day), and 82 received haloperidol (up to 10 mg/day) or perphenazine (up to 32 mg/day); three people did not receive any study medication. Both studies were performed in the US. The duration of the follow-up was four to six weeks. Death by suicide/natural causes and quality of life were not reported by the two included studies. The evidence is very uncertain about the effects of lurasidone on change in mental state: the Brief Psychiatric Rating Scale (BPRS) (MD 3.74, 95% CI 0.57 to 6.90; 1 RCT, 281 participants; very low-certainty evidence); and the Positive and Negative Syndrome Scale (PANSS) (MD 6.68, 95% CI 2.45 to 10.91; 1 RCT, 281 participants; very low-certainty evidence). The evidence is also very uncertain about the effects of lurasidone on total serious adverse events (","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD012429"},"PeriodicalIF":8.8,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Natasha Clarke, Emily Pechey, Ian Shemilt, Mark Pilling, Nia W Roberts, Theresa M Marteau, Susan A Jebb, Gareth J Hollands
{"title":"Calorie (energy) labelling for changing selection and consumption of food or alcohol.","authors":"Natasha Clarke, Emily Pechey, Ian Shemilt, Mark Pilling, Nia W Roberts, Theresa M Marteau, Susan A Jebb, Gareth J Hollands","doi":"10.1002/14651858.CD014845.pub2","DOIUrl":"10.1002/14651858.CD014845.pub2","url":null,"abstract":"<p><strong>Background: </strong>Overconsumption of food and consumption of any amount of alcohol increases the risk of non-communicable diseases. Calorie (energy) labelling is advocated as a means to reduce energy intake from food and alcoholic drinks. However, there is continued uncertainty about these potential impacts, with a 2018 Cochrane review identifying only a small body of low-certainty evidence. This review updates and extends the 2018 Cochrane review to provide a timely reassessment of evidence for the effects of calorie labelling on people's selection and consumption of food or alcoholic drinks.</p><p><strong>Objectives: </strong>- To estimate the effect of calorie labelling for food (including non-alcoholic drinks) and alcoholic drinks on selection (with or without purchasing) and consumption. - To assess possible modifiers - label type, setting, and socioeconomic status - of the effect of calorie labelling on selection (with or without purchasing) and consumption of food and alcohol.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PsycINFO, five other published or grey literature databases, trial registries, and key websites, followed by backwards and forwards citation searches. Using a semi-automated workflow, we searched for and selected records and corresponding reports of eligible studies, with these searches current to 2 August 2021. Updated searches were conducted in September 2023 but their results are not fully integrated into this version of the review.</p><p><strong>Selection criteria: </strong>Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs with between-subjects (parallel group) or within-subjects (cross-over) designs, interrupted time series studies, or controlled before-after studies comparing calorie labelling with no calorie labelling, applied to food (including non-alcoholic drinks) or alcoholic drinks. Eligible studies also needed to objectively measure participants' selection (with or without purchasing) or consumption, in real-world, naturalistic laboratory, or laboratory settings.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion and extracted study data. We applied the Cochrane RoB 2 tool and ROBINS-I to assess risk of bias in included studies. Where possible, we used (random-effects) meta-analyses to estimate summary effect sizes as standardised mean differences (SMDs) with 95% confidence intervals (CIs), and subgroup analyses to investigate potential effect modifiers, including study, intervention, and participant characteristics. We synthesised data from other studies in a narrative summary. We rated the certainty of evidence using GRADE.</p><p><strong>Main results: </strong>We included 25 studies (23 food, 2 alcohol and food), comprising 18 RCTs, one quasi-RCT, two interrupted time series studies, and four controlled before-after studies. Most studies were conducted in real-world field sett","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD014845"},"PeriodicalIF":8.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11738108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Idnan Yunas, Ioannis D Gallos, Adam J Devall, Marcelina Podesek, John Allotey, Yemisi Takwoingi, Arri Coomarasamy
{"title":"Tests for diagnosis of postpartum haemorrhage at vaginal birth.","authors":"Idnan Yunas, Ioannis D Gallos, Adam J Devall, Marcelina Podesek, John Allotey, Yemisi Takwoingi, Arri Coomarasamy","doi":"10.1002/14651858.CD016134","DOIUrl":"10.1002/14651858.CD016134","url":null,"abstract":"<p><strong>Background: </strong>Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. Accurate diagnosis of PPH can prevent adverse outcomes by enabling early treatment.</p><p><strong>Objectives: </strong>What is the accuracy of methods (index tests) for diagnosing primary PPH (blood loss ≥ 500 mL in the first 24 hours after birth) and severe primary PPH (blood loss ≥ 1000 mL in the first 24 hours after birth) (target conditions) in women giving birth vaginally (participants) compared to weighed blood loss measurement or other objective measurements of blood loss (reference standards)?</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Web of Science Core Collection, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform to 24 May 2024.</p><p><strong>Selection criteria: </strong>We included women who gave birth vaginally in any setting. Study types included diagnostic cohort studies and cross-sectional studies that reported 2 x 2 data (number of true positive, false positive, false negative, and true negative results) or where the 2 x 2 data could be derived from test accuracy estimates. Eligible index tests included: visual estimation; calibrated blood collection devices; approach with calibrated drape and observations; blood loss estimation using the SAPHE (Signalling a Postpartum Hemorrhage Emergency) Mat; blood loss field image analysis and other technologies; uterine atony assessment; clinical variables (e.g. heart rate, blood pressure, shock index); early warning charts; haemoglobin levels; and predelivery fibrinogen levels. Eligible reference standards included objective methods such as: gravimetric blood loss measurement, which involves weighing collected blood, as well as weighing blood-soaked pads, gauze and sheets, and subtracting their dry weight; calibrated devices to measure blood volume (volumetric blood loss measurement); the alkaline-haematin method of blood loss estimation; and blood extracted using machine-extraction and measured spectrometrically as oxyhaemoglobin.</p><p><strong>Data collection and analysis: </strong>At least two review authors, working independently, undertook study screening, selection, data extraction, assessment of risk of bias, and assessment of the certainty of the evidence. We resolved any differences through consensus or with input from another author. We generated 2 x 2 tables of the true positives, true negatives, false positives, and false negatives to calculate the sensitivity, specificity, and 95% confidence intervals for each index test. We presented sensitivity and specificity estimates from studies in forest plots. Where possible, we conducted meta-analyses for each index test and reference standard combination for each target condition. We examined heterogeneity by visual inspection of the forest plots.</p><p><strong>Main results: </strong>Our review included 18 studies with a total of 291,040","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD016134"},"PeriodicalIF":8.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Edward R Bader, Mazen M Allam, Thomas Gw Harris, Neena Suchdev, Yoon Kong Loke, Raphae Barlas
{"title":"Thrombolysis for aneurysmal subarachnoid haemorrhage.","authors":"Edward R Bader, Mazen M Allam, Thomas Gw Harris, Neena Suchdev, Yoon Kong Loke, Raphae Barlas","doi":"10.1002/14651858.CD013748.pub2","DOIUrl":"10.1002/14651858.CD013748.pub2","url":null,"abstract":"<p><strong>Background: </strong>Aneurysmal subarachnoid haemorrhage continues to cause a significant burden of morbidity and mortality despite advances in care. Trials investigating local administration of thrombolytics have reported promising results.</p><p><strong>Objectives: </strong>- To assess the effect of thrombolysis on improving functional outcome and case fatality following aneurysmal subarachnoid haemorrhage - To determine the effect of thrombolysis on the risk of cerebral artery vasospasm, delayed cerebral ischaemia, and hydrocephalus following subarachnoid haemorrhage - To determine the risk of complications of local thrombolysis in aneurysmal subarachnoid haemorrhage SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (last searched 9 March 2023), MEDLINE Ovid (1946 to 9 March 2023), and Embase Ovid (1974 to 9 March 2023). We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We performed forward and reverse citation tracking of included studies using Google Scholar.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials comparing subarachnoid thrombolysis via any route of administration into any anatomical site continuous with the subarachnoid space versus placebo, sham thrombolysis, or standard treatment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion in the review. We extracted study data and used version 2 of the Cochrane risk-of-bias tool for randomised trials to assess the risk of bias in the studies. We resolved any disagreement through discussion with a third author. Our primary outcome was poor functional outcome. Secondary outcomes were case fatality, haemorrhagic complications, cerebral artery vasospasm, delayed cerebral ischaemia, cerebral infarction, and hydrocephalus. We performed meta-analyses for each outcome and performed sensitivity analysis excluding studies at high risk of bias. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs). We performed further sensitivity analysis by including all intervention groups from studies reporting more than one intervention group. For each outcome, we used the GRADE criteria to determine the certainty of the evidence.</p><p><strong>Main results: </strong>We included eight studies from six countries in this review. The studies had a total of 410 participants, of whom 205 received thrombolysis. We identified three ongoing trials. We assessed one trial as having a high risk of bias for all outcomes; we assessed the remainder as having a low risk of bias or some concerns. Thrombolysis likely results in a reduction in poor functional outcome when compared to placebo or standard care (29.4% versus 39.7%, RR 0.73, 95% CI 0.56 to 0.94; 8 studies, 408 participants; moderate-certainty evidence). Thrombolysis likely results in little to no difference in case fatality (12.8% versus 17.7%, RR ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD013748"},"PeriodicalIF":8.8,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740285/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Gottlieb, Daniel J Kim, Gary D Peksa, Jennifer Westrick, Amy Marks
{"title":"Transtracheal ultrasound for identifying endotracheal intubation in adults.","authors":"Michael Gottlieb, Daniel J Kim, Gary D Peksa, Jennifer Westrick, Amy Marks","doi":"10.1002/14651858.CD015936","DOIUrl":"10.1002/14651858.CD015936","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the diagnostic accuracy of transtracheal ultrasound for detecting endotracheal intubation in adult patients. Secondary objectives Secondary objectives include assessing the diagnostic accuracy of transtracheal ultrasound amongst the following subgroups: setting (e.g. prehospital, emergency department, intensive care unit, operating room) operator specialty (e.g. emergency medicine, non-emergency medicine) operator experience (e.g. attending physician, resident physician, non-physician) ultrasound technique (e.g. static, dynamic) ultrasound transducer (e.g. curvilinear, linear).</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD015936"},"PeriodicalIF":8.8,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11737020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elza van Duijnhoven, Niels Fj Waterval, Fieke Sophia Koopman, Alberto Esquenazi, Frans Nollet, Merel-Anne Brehm
{"title":"Ankle-foot orthoses for improving walking in adults with calf muscle weakness due to neuromuscular disorders.","authors":"Elza van Duijnhoven, Niels Fj Waterval, Fieke Sophia Koopman, Alberto Esquenazi, Frans Nollet, Merel-Anne Brehm","doi":"10.1002/14651858.CD014871.pub2","DOIUrl":"10.1002/14651858.CD014871.pub2","url":null,"abstract":"<p><strong>Background: </strong>Calf muscle weakness is a common symptom in slowly progressive neuromuscular disorders that lead to walking problems like instability and increased walking effort. The mainstay of treatment to improve walking in this population is the provision of ankle-foot-orthoses (AFOs). Since we are not aware of an up-to-date and complete overview of the effects of AFOs used for calf muscle weakness in slowly progressive neuromuscular disorders, we reviewed the evidence for the effectiveness of AFOs to improve walking in this patient group, in order to support clinical decision-making.</p><p><strong>Objectives: </strong>To review the evidence for the effects of ankle-foot orthoses (AFOs) for improving walking in adults with calf muscle weakness due to slowly progressive neuromuscular disorders.</p><p><strong>Search methods: </strong>On 10 February 2023, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, ClinicalTrials.gov, and WHO ICTRP.</p><p><strong>Selection criteria: </strong>We looked for randomised controlled trials (RCTs), including randomised cross-over studies and quasi-RCTs, and non-randomised studies (NRSs) that examined the effects of AFO interventions compared with shoes-only walking in adults with calf muscle weakness due to neuromuscular disorders.</p><p><strong>Data collection and analysis: </strong>We used the methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We summarised findings for the primary outcome (objectively measured walking effort, assessed as walking energy cost) and secondary outcomes (perceived walking effort, physical mobility, gait parameters, AFO use, satisfaction with the AFO, and adverse events). We grouped results according to the type of AFO material and synthesised them in meta-analysis where possible. We used the GRADE approach to rate the certainty of the evidence.</p><p><strong>Main results: </strong>We included four randomised cross-over studies and six NRSs with 186 participants in total (the smallest study had 8 participants and the largest had 37). All studies were designed as self-controlled studies and examined the effects of custom-made and/or prefabricated AFOs. The AFOs were made of carbon (5 studies), polypropylene (5 studies), silicone (1 study), metal (1 study), elastic materials (2 studies), or leather combined with other materials (1 study). Outcome measures with AFOs were assessed during a single session (in some studies, people already used the study AFO in daily life), when the AFO was delivered, or at three-week or three-month follow-up. We judged one study to be at moderate risk of bias, and nine studies to be at high or serious risk of bias, primarily due to bias arising from period and carryover effects, selection bias, the inability to blind participants and assessors, missing data, and selective reporting. We found that carbon AFOs may reduce walking energy cost (mean differen","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD014871"},"PeriodicalIF":8.8,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11737026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christa Rohwer, Anke C Rohwer, Catherine Cluver, Katharine Ker, G Justus Hofmeyr
{"title":"Tranexamic acid for preventing postpartum haemorrhage after vaginal birth.","authors":"Christa Rohwer, Anke C Rohwer, Catherine Cluver, Katharine Ker, G Justus Hofmeyr","doi":"10.1002/14651858.CD007872.pub4","DOIUrl":"10.1002/14651858.CD007872.pub4","url":null,"abstract":"<p><strong>Rationale: </strong>Postpartum haemorrhage (PPH) is common and potentially life-threatening. The antifibrinolytic drug tranexamic acid (TXA) is thought to be effective for treating PPH. There is growing interest in whether TXA is effective for preventing PPH after vaginal birth. In randomised controlled trials (RCTs), TXA has been associated with increased risk of seizures and unexplained increased mortality when given more than three hours after traumatic bleeding. Reliable evidence on the effects, cost-effectiveness and safety of prophylactic TXA is required before considering widespread use. This review updates one published in 2015.</p><p><strong>Objectives: </strong>To assess the effects of TXA for preventing PPH compared to placebo or no treatment (with or without uterotonic co-treatment) in women following vaginal birth.</p><p><strong>Search methods: </strong>We searched MEDLINE, Embase, CENTRAL, and WHO ICTRP (to 6 September 2024). We also searched reference lists of retrieved studies.</p><p><strong>Eligibility criteria: </strong>We included RCTs evaluating TXA alone or in addition to standard care (uterotonics) for preventing PPH following vaginal birth. For this update, we required trials to be prospectively registered (before participant recruitment), and we applied a trustworthiness checklist.</p><p><strong>Outcomes: </strong>Critical outcomes were blood loss ≥ 500 mL and blood loss ≥ 1000 mL. Important outcomes included maternal death, severe morbidity, blood transfusion, receipt of additional surgical interventions to control PPH, thromboembolic events, receipt of additional uterotonics, hysterectomy, and maternal satisfaction.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tool (RoB 1) to assess the risk of bias in the studies.</p><p><strong>Synthesis methods: </strong>Two review authors independently selected trials, extracted data, assessed risk of bias, and assessed trial trustworthiness. We used random-effects meta-analysis to combine data. We assessed the certainty of the evidence using GRADE.</p><p><strong>Included studies: </strong>We included three RCTs with 18,974 participants in total. The trials were conducted in both high- and low-resource settings and involved participants at both low and high risk of PPH. The trials compared intravenous TXA (1 g) and standard care versus placebo (saline) and standard care. After applying our trustworthiness checklist, we did not include any of the 12 trials in the previous version of this review.</p><p><strong>Synthesis of results: </strong>Prophylactic tranexamic acid in addition to standard care compared to placebo in addition to standard care TXA results in little to no difference in blood loss ≥ 500 mL (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.81 to 1.06; 2 studies, 18,897 participants; 5 fewer per 1000, 95% CI 15 fewer to 5 more; high-certainty evidence). TXA likely results in little to no difference in blood loss ≥ 1000 mL (RR 0.86,","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD007872"},"PeriodicalIF":8.8,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robin Wm Vernooij, Mini Michael, Julia Mt Colombijn, Daniel S Owers, Angela C Webster, Giovanni Fm Strippoli, Elisabeth M Hodson
{"title":"Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients.","authors":"Robin Wm Vernooij, Mini Michael, Julia Mt Colombijn, Daniel S Owers, Angela C Webster, Giovanni Fm Strippoli, Elisabeth M Hodson","doi":"10.1002/14651858.CD005133.pub4","DOIUrl":"10.1002/14651858.CD005133.pub4","url":null,"abstract":"<p><strong>Background: </strong>Cytomegalovirus (CMV) is a significant cause of morbidity and death in solid organ transplant recipients. Pre-emptive treatment of patients with CMV viraemia using antiviral agents has been suggested as an alternative to routine prophylaxis to prevent CMV disease. This is an update of a Cochrane review first published in 2006 and updated in 2013.</p><p><strong>Objectives: </strong>To determine the benefits and harms of pre-emptive treatment of CMV viraemia to prevent CMV disease and death (any cause) and the indirect effects of CMV infection (acute rejection, graft loss, opportunistic infections) in solid organ transplant recipients.</p><p><strong>Search methods: </strong>The Cochrane Kidney and Transplant Register of Studies was searched up to 17 December 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) and quasi-RCTs comparing pre-emptive treatment with placebo, no specific treatment, or antiviral prophylaxis in solid organ transplant recipients.</p><p><strong>Data collection and analysis: </strong>Two authors independently assessed the eligibility of the identified studies, assessed the risk of bias, and extracted all data. Results were expressed as risk ratio (RR) and 95% confidence intervals (CI) for dichotomous outcomes. Statistical analyses were performed using a random-effects model. The certainty of evidence was assessed per outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.</p><p><strong>Main results: </strong>In this update, we have included seven new studies, bringing the total number of included studies to 22 (1883 participants). Of these, seven investigated pre-emptive treatment versus placebo or standard care, 12 looked at pre-emptive treatment versus antiviral prophylaxis, one study investigated oral versus intravenous pre-emptive treatment, one investigated pre-emptive valganciclovir versus pre-emptive ganciclovir, and one investigated letermovir 40 mg twice/day versus 80 mg once/day. Studies were conducted in Australia, Brazil, the Czech Republic, Germany, Italy, Japan, Norway, Spain, South Korea, and the USA. Organ transplant recipients included kidney, liver, heart, lung, and kidney-pancreas. Thirteen studies were single-centre studies, six were multicentre, and three were unknown. The number of participants ranged from 12 to 296. Overall, selection bias was unclear (55%); performance, detection and attrition bias were high (91%, 63% and 95%, respectively), and reporting bias was low (55%). Compared with placebo or standard care, pre-emptive treatment probably reduces the risk of CMV disease (7 studies, 315 participants: RR 0.29, 95% CI 0.11 to 0.80","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD005133"},"PeriodicalIF":8.8,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11729901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142977799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}