Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis

Objective To investigate the effect of the CONSORT for Abstracts guidelines, and different editorial policies used by five leading general medical journals to implement the guidelines, on the reporting quality of abstracts of randomised trials

Compression stockings for preventing deep vein thrombosis (DVT) in airline passengers

Background Air travel might increase the risk of deep vein thrombosis (DVT). It has been suggested that wearing compression stockings might reduce this risk. This is an update of the review first published in 2006. Objectives To assess the effects of wearing compression stockings versus not wearing them for preventing DVT in people travelling on flights lasting at least four hours. Search methods The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 April 2020. We also checked the bibliographies of relevant studies and reviews identified by the search to check for any additional trials. Selection criteria Randomised trials of compression stockings versus no stockings in passengers on flights lasting at least four hours. Trials in which passengers wore a stocking on one leg but not the other, or those comparing stockings and another intervention were also eligible. Data collection and analysis Two review authors independently selected trials for inclusion and extracted data. We sought additional information from trialists where necessary. Main results One new study that fulfilled the inclusion criteria was identified for this update. Twelve randomised trials (n = 2918) were included in this review: ten (n = 2833) compared wearing graduated compression stockings on both legs versus not wearing them; one trial (n = 50) compared wearing graduated compression tights versus not wearing them; and one trial (n = 35) compared wearing a graduated compression stocking on one leg for the outbound flight and on the other leg on the return flight. Eight trials included people judged to be at low or medium risk of developing DVT (n = 1598) and two included high‐risk participants (n = 1273). All flights had a duration of more than five hours. Fifty of 2637 participants with follow‐up data available in the trials of wearing compression stockings on both legs had a symptomless DVT; three wore stockings, 47 did not (odds ratio (OR) 0.10, 95% confidence interval (CI) 0.04 to 0.25, P Authors' conclusions There is high‐certainty evidence that airline passengers similar to those in this review can expect a substantial reduction in the incidence of symptomless DVT and low‐certainty evidence that leg oedema is reduced if they wear compression stockings. The certainty of the evidence was limited by the way that oedema was measured. There is moderate‐certainty evidence that superficial vein thrombosis may be reduced if passengers wear compression stockings. We cannot assess the effect of wearing stockings on death, pulmonary embolism or symptomatic DVT because no such events occurred in these trials. Randomised trials to assess these outcomes would need to include a very large number of people

The Moses–Littenberg meta-analytical method generates systematic differences in test accuracy compared to hierarchical meta-analytical models

AbstractObjectiveTo compare meta-analyses of diagnostic test accuracy using the Moses–Littenberg summary receiver operating characteristic (SROC) approach with those of the hierarchical SROC (HSROC) model.Study Design and SettingTwenty-six data sets from existing test accuracy systematic reviews were reanalyzed with the Moses–Littenberg model, using equal weighting (“E-ML”) and weighting by the inverse variance of the log DOR (“W-ML”), and with the HSROC model. The diagnostic odds ratios (DORs) were estimated and covariates added to both models to estimate relative DORs (RDORs) between subgroups. Models were compared by calculating the ratio of DORs, the ratio of RDORs, and P-values for detecting asymmetry and effects of covariates on DOR.ResultsCompared to the HSROC model, the Moses–Littenberg model DOR estimates were a median of 22% (“E-ML”) and 47% (“W-ML”) lower at Q*, and 7% and 42% lower at the central point in the data. Instances of the ML models giving estimates higher than the HSROC model also occurred. Investigations of heterogeneity also differed; the Moses–Littenberg models on average estimating smaller differences in RDOR.ConclusionsMoses–Littenberg meta-analyses can generate lower estimates of test accuracy, and smaller differences in accuracy, compared to mathematically superior hierarchical models. This has implications for the usefulness of meta-analyses using this approach. We recommend meta-analysis of diagnostic test accuracy studies to be conducted using available hierarchical model–based approaches

Publication bias in clinical trials

This is the protocol for a review and there is no abstract. The objectives are as follows: To summarise evidence of publication bias for trials of health care interventions.Output Type: Protoco

Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: A study protocol

Introduction. Musculoskeletal deformities and gait deviations are common features in ambulatory cerebral palsy (CP). Deformity correction through lower limb orthopaedic surgery is the standard form of care aimed at improving or preserving motor function. Current research on CP care does not always take into account individual patients’ expectations and needs. There is a wide range of outcome domains and outcome measures used to assess outcome from treatment. This can lead to reporting bias and make it difficult to compare and contrast studies. A core outcome set (COS) would enhance the efficiency, relevance and overall quality of CP orthopaedic surgery research. The aim of this study is to establish a standardised COS for use in evaluating lower limb orthopaedic surgery for ambulatory children and young people with CP. Methods/analysis. A set of outcomes domains and outcome measures will be developed as follows: (1) a qualitative evidence synthesis to identify relevant outcomes from children and young people and family perspective; (2) a scoping review to identify relevant outcomes and outcome measures; (3) qualitative research to explore the experience of key stakeholders; (4) prioritisation of outcome domains will be achieved through a two-round Delphi process with key stakeholders; (5) a final COS will be developed at a consensus meeting with representation from key stakeholder groups. Ethics and dissemination. Ethical approval for this study was granted in the UK by the Oxfordshire Research Ethics Committee B (REC reference 19/SC/0357). Informed consent will be obtained from participants taking part in the qualitative research and Delphi process. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the project COS results. Trial registration number COMET registration: 1236. PROSPERO registration number CRD42018089538

Update on the endorsement of CONSORT by high impact factor journals: a survey of journal

The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. This research aims to provide an update on the endorsement of CONSORT by high impact medical journals.We performed a cross-sectional examination of the onlin

The acute management of trauma hemorrhage: a systematic review of randomized controlled trials

INTRODUCTION: Worldwide, trauma is a leading cause of death and disability. Haemorrhage is responsible for up to 40% of trauma deaths. Recent strategies to improve mortality rates have focused on optimal methods of early hemorrhage control and correction of coagulopathy. We undertook a systematic review of randomized controlled trials (RCT) which evaluated trauma patients with hemorrhagic shock within the first 24 hours of injury and appraised how the interventions affected three outcomes: bleeding and/or transfusion requirements; correction of trauma induced coagulopathy and mortality. METHODS: Comprehensive searches were performed of MEDLINE, EMBASE, CENTRAL (The Cochrane Library Issue 7, 2010), Current Controlled Trials, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) and the National Health Service Blood and Transplant Systematic Review Initiative (NHSBT SRI) RCT Handsearch Database. RESULTS: A total of 35 RCTs were identified which evaluated a wide range of clinical interventions in trauma hemorrhage. Many of the included studies were of low methodological quality and participant numbers were small. Bleeding outcomes were reported in 32 studies; 7 reported significantly reduced transfusion use following a variety of clinical interventions, but this was not accompanied by improved survival. Minimal information was found on traumatic coagulopathy across the identified RCTs. Overall survival was improved in only three RCTs: two small studies and a large study evaluating the use of tranexamic acid. CONCLUSIONS: Despite 35 RCTs there has been little improvement in outcomes over the last few decades. No clear correlation has been demonstrated between transfusion requirements and mortality. The global trauma community should consider a coordinated and strategic approach to conduct well designed studies with pragmatic endpoints

The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed

Objectives To examine the reporting characteristics and methodological details of randomised trials indexed in PubMed in 2000 and 2006 and assess whether the quality of reporting has improved after publication of the Consolidated Standards of Reporting Trials (CONSORT) Statement in 2001

A decision tool for updating Cochrane reviews

This report describes the development and validation of an updating tool to help assess the need and likely benefits of updating a Cochrane review. The report is presented in five sections. Section 1 describes the background and rationale for the updating tool, including information about when and how to update. Section 2 describes the development of the updating tool and the resulting decision tree and checklist. Section 3 presents the results of the in-house and ongoing formal pilot of the tool, while Sections 4 and 5 provide information about the dissemination of the tool and our key conclusions. This project was funded by the Cochrane Opportunities Fund in 2007

Patients’ and parents’ views about lower limb orthopaedic surgery for ambulant children and young people with cerebral palsy: A qualitative evidence synthesis

Purpose. The article identifies the aspects of health and outcomes that are considered important from the perspective of ambulatory children with cerebral palsy (CP) and their parents regarding lower limb orthopaedic surgery and explores how they experience surgical interventions. Methods. Four databases (Embase, MEDLINE (Ovid), CINAHL and PsycINFO) were searched from inception to 11 April 2020. Studies were included if they: 1) they involved children or young adults diagnosed with ambulant CP or their family, 2) participants had experience with lower limb orthopaedic surgery and 3) studies employed qualitative research methods. The Critical Appraisal Skills Programme was used to appraise identified studies. The ‘Best-fit framework’ synthesis approach was used by applying the International Classification of Functioning-Children and Youth (ICF–CY) linking rules and thematic synthesis. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results. Six studies were included. Four themes were generated which were linked to the ICF–CY framework: Body function and structure, Activity and participation, Environmental factors, Personal factors, as well as non-ICF–CY themes including Emotional well-being and Goal setting. Important surgical outcomes identified were pain, fatigue, movement-related function, mobility, walking ability, community life, emotional well-being, and adequate provision of public and health services. Conclusion. These findings are important for understanding patient-centred outcomes in lower limb ortho-paedics surgery and providing focus for future interventional studies aimed at improving outcomes of importance to children with CP. These findings highlight the importance of long-term support to help people negotiate the challenge of surgical regimes and to achieve good outcomes after orthopaedic surgery. The outcomes identified will contribute to the development of a core outcome set in this field