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Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their ...

Worldwide trends in volume and quality of published protocols of randomized controlled trials

Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological ...

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps

Background The COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further ...

The use of anti stretch marks’ products by women in pregnancy: a descriptive, cross-sectional survey

Background Stretch marks (Striae gravidarum) are a cutaneous change occurring commonly during pregnancy. A variety of products are available and promoted as ways to prevent or reduce their development, but it is not clear what products are used most commonly. The objective of this study was to identify topical products used during pregnancy to prevent or reduce the development of ...

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Maarten Boers 0 Peter Tugwell Mike Clarke Paula R. Williamson Caroline B. Terwee 0 0 Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial

Background The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue ...

Impact of non-pharmacological interventions on prevention and treatment of delirium in critically ill patients: protocol for a systematic review of quantitative and qualitative research

Background Critically ill patients have an increased risk of developing delirium during their intensive care stay. To date, pharmacological interventions have not been shown to be effective for delirium management but non-pharmacological interventions have shown some promise. The aim of this systematic review is to identify effective non-pharmacological interventions for reducing ...

Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial

Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the ...

Do Cochrane summaries help student midwives understand the findings of Cochrane systematic reviews: the BRIEF randomised trial

0 2 Toby Lasserson 1 Elaine Beller Margaret Carroll Vanora Hundley Judith Sunderland Declan Devane Jane Noyes Susan Key Sarah Norris Janine Wyn-Davies Mike Clarke 0 School of Nursing and Midwifery ... practice; OSCEs: objective structured clinical examinations; OR: odds ratio; RD: risk difference; 95 % CI: 95 % confidence interval. Competing interests Fiona Alderdice, Mike Clarke, Toby Lasserson, Declan

Core outcome sets and systematic reviews

Systematic reviews seek to bring together research evidence to answer the question for the review. The reviewers usually wish to compare, contrast and, if appropriate, combine the findings of the existing research studies. However, these intentions are often thwarted by inconsistencies in the outcomes that were measured and reported in the individual studies. This, in turn, makes ...

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey

Background A COS represents an agreed minimum set of outcomes that should be measured and reported in all trials of a specific condition. The COMET (Core Outcome Measures in Effectiveness Trials) initiative aims to collate and stimulate the development and application of COS, by including data on relevant studies within a publically available internet-based resource. In recent ...

Improving the organisation of maternal health service delivery and optimising childbirth by increasing vaginal birth after caesarean section through enhanced women-centred care (OptiBIRTH trial): study protocol for a randomised controlled trial (ISRCTN10612254)

Background The proportion of pregnant women who have a caesarean section shows a wide variation across Europe, and concern exists that these proportions are increasing. Much of the increase in caesarean sections in recent years is due to a cascade effect in which a woman who has had one caesarean section is much more likely to have one again if she has another baby. In some places, ...

COMET V meeting summary

care research community. Mike Clarke (COMET) brought all of this together by highlighting the resources that are available through COMET to assist in the development and evaluation of COS. The ensuing ... define global standard sets of outcome measures that really matter to patients for the most relevant medical conditions. Mike Clarke (COMET Management Group) closed the first day with a presentation about

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)

Mike Clarke Maria Lohan Queen's University Belfast, Northern Ireland, UK Background Recruitment to school-based randomised trials is challenging; even more so when the focus of the study is a sensitive