In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators’ use of core outcome sets in randomised controlled trials

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

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Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective

International Wound Journal ◽

10.1111/iwj.12950 ◽

2018 ◽

Vol 15 (6) ◽

pp. 929-942 ◽

Cited By ~ 6

Author(s):

Victoria Team ◽

Lyndal Bugeja ◽

Carolina D Weller

Keyword(s):

Randomised Controlled Trials ◽

Barriers And Facilitators ◽

Controlled Trials ◽

Participant Recruitment ◽

Randomised Controlled

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Systematic review of clinical outcome reporting in randomised controlled trials of burn care

BMJ Open ◽

10.1136/bmjopen-2018-025135 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025135 ◽

Cited By ~ 4

Author(s):

Amber E Young ◽

Anna Davies ◽

Sophie Bland ◽

Sara Brookes ◽

Jane M Blazeby

Keyword(s):

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Free Text ◽

Core Outcome ◽

Care Research ◽

Burn Care ◽

Outcome Reporting ◽

Outcome Set ◽

Randomised Controlled

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.

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Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

ERJ Open Research ◽

10.1183/23120541.00072-2019 ◽

2019 ◽

Vol 5 (2) ◽

pp. 00072-2019 ◽

Cited By ~ 6

Author(s):

Alexander G. Mathioudakis ◽

Mia Moberg ◽

Julie Janner ◽

Pablo Alonso-Coello ◽

Jørgen Vestbo

Keyword(s):

Outcome Measures ◽

Systematic Reviews ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Significant Heterogeneity ◽

Core Outcome ◽

Copd Exacerbations ◽

Outcome Set ◽

Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

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A systematic review of the outcomes reported in Cardiac arrest randomised controlled trials: The need for a core outcome set

Resuscitation ◽

10.1016/j.resuscitation.2013.08.129 ◽

2013 ◽

Vol 84 ◽

pp. S50

Author(s):

Laura Whitehead ◽

Gavin Perkins ◽

Andrew Clarey ◽

Kirstie Haywood

Keyword(s):

Systematic Review ◽

Cardiac Arrest ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Core Outcome ◽

Outcome Set ◽

Randomised Controlled

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Outcomes in randomised controlled trials of multifocal lenses in cataract surgery: the case for development of a core outcome set

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315410 ◽

2020 ◽

Vol 104 (10) ◽

pp. 1345-1349

Author(s):

Jennifer R Evans ◽

Samantha R de Silva ◽

Mohammed Ziaei ◽

Varo Kirthi ◽

Martin D Leyland

Keyword(s):

Cataract Surgery ◽

Outcome Measures ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Intraocular Lenses ◽

Controlled Trials ◽

Core Outcome ◽

Outcome Set ◽

Patient Reported ◽

Randomised Controlled

Background/aimsTo describe and summarise the outcomes reported in randomised controlled trials of multifocal versus monofocal intraocular lenses in cataract surgery.MethodsWe identified all randomised controlled trials of multifocal versus monofocal lenses in a Cochrane review (last search date June 2016). We extracted and summarised data on all outcomes reported using the framework of domain, measurement, metric and method of aggregation.ResultsAll studies collected data on distance and near visual acuity but there was considerable variation in the measures used and whether these outcomes were unaided or best corrected. Most studies reported final value measurements, rather than change from baseline. Approximately half of the studies reported data as a continuous measure only, one-third reported both continuous and categorical measures and a minority reported categorical measures only. There was little consensus as to cut-points. Although a majority of studies included one or more patient-reported outcome measures, none of the studies reported patient involvement in the choice of outcomes.ConclusionThe collection and analysis of data on outcome measures in studies of multifocal intraocular lenses in cataract surgery are complicated. As a result, there is considerable heterogeneity in collection and reporting in the medical literature. This makes it difficult to synthesise such data to provide robust estimates of effect and is a potential source of research waste. Investigators in this field must produce a core outcome set that is informed by patients’ views and we propose an initial set of outcomes on which these could be based.

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Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

Trials ◽

10.1186/1745-6215-16-s2-p53 ◽

2015 ◽

Vol 16 (S2) ◽

Author(s):

Katie Gillies ◽

Cynthia Fraser ◽

Vikki Entwistle ◽

Shaun Treweek ◽

Paula Williamson ◽

...

Keyword(s):

Informed Consent ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Core Outcome ◽

Outcome Set ◽

Randomised Controlled

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Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

10.21203/rs.2.12497/v1 ◽

2019 ◽

Author(s):

Amanda Jane Blatch-Jones ◽

Jacqueline Nuttall ◽

Abby Bull ◽

Louise Worswick ◽

Mark Mullee ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Qualitative Interviews ◽

Human Interaction ◽

Digital Tools ◽

Controlled Trials ◽

Digital Tool ◽

Recruitment And Retention ◽

Research Participants ◽

Stakeholder Groups ◽

Randomised Controlled

Abstract Background Recruitment and retention of participants in Randomised Controlled Trials (RCTs) is a key determinant of success, but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful. Methods A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach. Results Responses from 24 CTUs (46%) identified that database-screening tools were the most widely used digital tool for recruitment, with the most frequent reported success criteria being saving General Practitioner time and reaching more patients. Fewer retention tools were used, with Short Message Service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: ‘security and transparency’, ‘inclusivity and engagement’, ‘human interaction’, ‘obstacles and risks’ and ‘potential benefits’. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants. Conclusions Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

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