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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 ...

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 ...

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 ...

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 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 ...

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 ...

Core outcome sets and trial registries

Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research ...

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

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 ...

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

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 ...

Collating the knowledge base for core outcome set development: developing and appraising the search strategy for a systematic review

Background The COMET (Core Outcome Measures in Effectiveness Trials) Initiative is developing a publicly accessible online resource to collate the knowledge base for core outcome set development (COS) and the applied work from different health conditions. Ensuring that the database is as comprehensive as possible and keeping it up to date are key to its value for users. This ...

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 ...

Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews

Background A core outcome set (COS) can address problems of outcome heterogeneity and outcome reporting bias in trials and systematic reviews, including Cochrane reviews, helping to reduce waste. One of the aims of the international Core Outcome Measures in Effectiveness Trials (COMET) Initiative is to link the development and use of COS with the outcomes specified and reported in ...

SWAT-1: The effectiveness of a ‘site visit’ intervention on recruitment rates in a multi-centre randomised trial

Background Recruitment rates in multi-centre randomised trials often fall below target recruitment rates, causing problems for study outcomes. The Studies Within A Trial (SWAT) Programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council Network of Hubs in the United Kingdom and others, is developing methods for ...