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AbstractBackgroundHistorically, peer reviewing has focused on the importance of research questions/hypotheses, appropriateness of research methods, risk of bias, and quality of writing. Until recently, the issues related to trustworthiness—including but not limited to plagiarism and fraud—have been largely neglected because of lack of awareness and lack of adequate tools/training. We set out to identify all relevant papers that have tackled the issue of trustworthiness assessment to identify key domains that have been suggested as an integral part of any such assessment.MethodsWe searched the literature for publications of tools, checklists, or methods used or proposed for the assessment of trustworthiness of randomized trials. Data items (questions) were extracted from the included publications and transcribed on Excel including the assessment domain. Both authors then independently recategorised each data item in five domains (governance, plausibility, plagiarism, reporting, and statistics).ResultsFrom the 41 publications we extracted a total of 284 questions and framed 77 summary questions grouped in five domains: governance (13 questions), plausibility (17 questions), plagiarism (4 questions), reporting (29 questions), and statistics (14 questions).ConclusionThe proposed menu of domains and questions should encourage peer reviewers, editors, systematic reviewers and developers of guidelines to engage in a more formal trustworthiness assessment. Methodologists should aim to identify the domains and questions that should be considered mandatory, those that are optional depending on the resources available, and those that could be discarded because of lack of discriminatory power.

AbstractBackgroundThere is increasing concern that a significant proportion of randomized controlled trials (RCTs) included in Cochrane reviews may not be trustworthy. Applying the Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool (CPC‐TST) has already had a clinically important effect on several reviews published by the Cochrane Pregnancy and Childbirth Group.ObjectivesWe wanted to assess the impact of removing untrustworthy RCTs from already‐published Cochrane reviews on a defined clinical area (antenatal and postnatal nutritional interventions).MethodsWe applied the tool to 18 Cochrane reviews (374 RCTs). The tool had four domains: (i) is the research governance trustworthy; (ii) are the baseline characteristics trustworthy; (iii) is the study feasible; (iv) are the results plausible? When additional information was needed, authors were contacted using a standard template. At least two attempts were made to contact the authors. At the end of the evaluation process each study was classified as: (i) included (YES to all questions); (ii) excluded (retracted study); or (iii) awaiting classification (any NO to the questions).ResultsNinety‐three out of 374 included studies (25%) were reclassified as "excluded" or "awaiting classification." The number of included RCTs was reduced in 14 out of 18 reviews. Six reviews (33%) were judged to require updating because of important differences in the Summary of Findings tables (direction and size of effects and/or GRADE ratings), conclusions, implication for practice, and/or implication for research.ConclusionsFormal assessment of trustworthiness, and inclusion only of studies that satisfy prespecified criteria for trustworthiness, affect conclusions in a relatively large number of Cochrane reviews, with potentially important clinical implications for practice and research.

BACKGROUND: The setting in which induction of labour takes place (home or inpatient) is likely to have implications for safety, women's experiences and costs. Home induction may be started at home with the subsequent active phase of labour happening either at home or in a healthcare facility (hospital, birth centre, midwifery‐led unit). More commonly, home induction starts in a healthcare facility, then the woman goes home to await the start of labour. Inpatient induction takes place in a healthcare facility where the woman stays while awaiting the start of labour. OBJECTIVES: To assess the effects on neonatal and maternal outcomes of third trimester home induction of labour compared with inpatient induction using the same method of induction. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (31 January 2020)), and reference lists of retrieved studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) in which home and inpatient settings for induction have been compared. We included conference abstracts but excluded quasi‐randomised trials and cross‐over studies. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study reports for inclusion. Two review authors carried out data extraction and assessment of risk of bias independently. GRADE assessments were checked by a third review author. MAIN RESULTS: We included seven RCTs, six of which provided data on 1610 women and their babies. Studies were undertaken between 1998 and 2015, and all were in high‐ or upper‐middle income countries. Most women were induced for post dates. Three studies reported government funding, one reported no funding and three did not report on their funding source. Most GRADE assessments gave very low‐certainty evidence, downgrading mostly for high risk of bias and serious imprecision. 1. Home compared to inpatient induction with vaginal ...

Pregnancy and Childbirth presents the best evidence for the care of pregnant women to doctors, midwives, students and parents. The logical sequence of chapters and the index give quick access to the abstracts of over four hundred Cochrane systematic reviews. The book serves both as a stand-alone reference, and as a companion to locating full reviews on the Cochrane Library. The Cochrane Library is published by John Wiley on behalf of The Cochrane Collaboration. www.thecochranelibrary.com

OBJECTIVES: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013–15. DATA DESCRIPTION: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.

Objectives: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15. Data description: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.