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When describing harms and benefits to potential trial participants, participant information leaflets are inadequate
BackgroundProviding informed consent for trials requires providing trial participants with comprehensive information about the trial, including...
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Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols
BackgroundRetaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure...
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Associations between Participant Characteristics and Participant Feedback about an Unsupervised Online Cognitive Assessment in a Research Registry
BackgroundThis study aims to understand whether and how participant characteristics (age, gender, education, ethnocultural identity) are related to...
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The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials
BackgroundA failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to...
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Does refining an intervention based on participant feedback increase acceptability? An experimental approach
BackgroundParticipant feedback is an important consideration for increasing intervention acceptability, yet whether incorporating such feedback...
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Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study
BackgroundThe use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple...
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Social Marketing Perspective on Participant Recruitment in Informatics-Based Intervention Studies
Effective recruitment strategies are pivotal for informatics-based intervention trials success, particularly for people living with HIV (PLWH), where...
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Centring participant experience: a realist evaluation of a menstruator-friendly facility design project in a refugee settlement, Lebanon
IntroductionMenstrual health in humanitarian contexts is a neglected topic. Its taboo nature presents difficulties for participants in menstrual...
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Identifying relapse predictors in individual participant data with decision trees
BackgroundDepression is a highly common and recurrent condition. Predicting who is at most risk of relapse or recurrence can inform clinical...
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Integrating participant feedback and concerns to improve community and individual level chemical exposure assessment reports
BackgroundAs exposure assessment has shifted towards community-engaged research there has been an increasing trend towards reporting results to...
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Influence of Participant Perceptions of Adherence-Related Interactions with Study/Study Team on Drug Levels: HPTN069 Analysis of Self-Reported Adherence Experiences While on Study
Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how...
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Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool
BackgroundPatient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and...
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Psychological and Behavioural Within-participant Predictors of Adherence to Oral HIV Pre-Exposure Prophylaxis (PrEP)
Oral PrEP’s effectiveness relies on adequate adherence during periods of substantial HIV risk. Since most PrEP users will miss doses, understanding...
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Comparing body composition between the sweet-liking phenotypes: experimental data, systematic review and individual participant data meta-analysis
BackgroundLegislation aimed at reducing sugar intake assumes that sweet-liking drives overconsumption. However, evidence that a greater liking for...
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Participant characteristics in the prevention of gestational diabetes as evidence for precision medicine: a systematic review and meta-analysis
BackgroundPrecision prevention involves using the unique characteristics of a particular group to determine their responses to preventive...
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Long-term participant retention and engagement patterns in an app and wearable-based multinational remote digital depression study
Recent growth in digital technologies has enabled the recruitment and monitoring of large and diverse populations in remote health studies. However,...
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A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)
BackgroundDecentralised clinical trials (DCTs) are clinical trials where all or most trial activities occur in or near participants’ homes instead of...
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Laparoscopic versus open gastrectomy for nonmetastatic T4a gastric cancer: a meta-analysis of reconstructed individual participant data from propensity score-matched studies
BackgroundThe applicability of laparoscopy to nonmetastatic T4a patients with gastric cancer remains unclear due to the lack of high-quality...
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Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion
Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical...
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Overlap** research efforts in a global pandemic: a rapid systematic review of COVID-19-related individual participant data meta-analyses
BackgroundIndividual participant data meta-analyses (IPD-MAs), which involve harmonising and analysing participant-level data from related studies,...
