Use of participant data and biological samples is insufficiently described in participant information leaflets.

Background: With greater availability of participant data and biobank repositories following clinical trial completion, adequately describing future data and biological sample reuse plans to trial participants is increasingly important. We evaluated how trial teams currently describe current and future use of participant data and biological samples in participant information leaflets (PILs).

Methods: Retrospective qualitative analysis of 240 PILs (182 clinical trials) in Ireland and the UK.

Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials.

Background: It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials.

Effective interventions to increase representation of under-served groups in randomised trials in UK and Ireland: a scoping literature review.

Background: Participants in clinical trials often do not reflect the populations that could benefit from the treatments being investigated. There are known barriers to trial participation for under-served groups, but limited evidence on strategies to alleviate these barriers to improve representation. This scoping review aimed to identify effective interventions and design features that improve the representation `of under-served groups in trials, focusing on the UK and Ireland.

Comments, suggestions, and criticisms of the Pragmatic Explanatory Continuum Indicator Summary-2 design tool: a citation analysis.

Introduction: The pragmatic explanatory continuum indicator summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions, and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, which is PRECIS-3.

Enhancing Men's Awareness of Testicular Diseases (E-MAT) using virtual reality: A randomised pilot feasibility study and mixed method process evaluation.

Introduction: Testicular cancer is among the most common malignancies in men under the age of 50 years. Most testicular symptoms are linked to benign diseases. Men's awareness of testicular diseases and testicular self-examination behaviours are suboptimal.

Trial participants' self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck.

Background: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.

Methods: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK.

Codesign and Launch of 'On the Ball': An Inclusive Community-Based 'Testicular Awareness' Campaign.

Introduction: Increased awareness of testicular diseases can lead to early diagnosis. Evidence suggests that men's awareness of testicular diseases is low, with many expressing their willingness to delay help-seeking for symptoms of concern. The risk of testicular diseases is higher in gender and sexual minority groups.

Registry-based randomised controlled trials: conduct, advantages and challenges-a systematic review.

Background: Registry-based randomised controlled trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large-scale registries to facilitate key clinical trial procedures including recruitment, randomisation and the collection of outcome data. Whilst the practice of utilising registries to support the conduct of randomised trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data, and to discuss the advantages and challenges of rRCTs.

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.

Background: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.

Factors influencing smartwatch use and comfort with health data sharing: a sequential mixed-method study protocol.

Introduction: Smartwatches have become ubiquitous for tracking health metrics. These data sets hold substantial potential for enhancing healthcare and public health initiatives; it may be used to track chronic health conditions, detect previously undiagnosed health conditions and better understand public health trends. By first understanding the factors influencing one's continuous use of the device, it will be advantageous to assess factors that may influence a person's willingness to share their individual data sets.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

Background: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).

Analysis of core outcome set reporting in coronary intervention trials.

Background: This paper will focus on outcome reporting within percutaneous coronary intervention (PCI) trials. A core outcome set (COS) is a standardised set of outcomes that are recommended to be reported in every clinical trial. Using a COS can help to ensure that all relevant outcomes are consistently reported across clinical trials.

Investigating the characteristics of health-related data collection tools used in randomised controlled trials in low-income and middle-income countries: protocol for a systematic review.

Introduction: Health-related data collection tools, including digital ones, have become more prevalent across clinical studies in the last number of years. However, using digital data collection tools in low-income and middle-income countries presents unique challenges. In this review, we aim to provide an overview of the data collection tools currently being used in randomised controlled trials (RCTs) conducted in low-resource settings and evaluate the tools based on the characteristics outlined in the modified Mobile Survey Tool framework.

How, and why, science and health researchers read scientific (IMRAD) papers.

Objectives: The purpose of our study was to determine the order in which science and health researchers read scientific papers, their reasons for doing so and the perceived difficulty and perceived importance of each section.

Study Design And Setting: An online survey open to science and health academics and researchers distributed via existing research networks, X (formerly Twitter), and LinkedIn.

Results: Almost 90% of respondents self-declared to be experienced in reading research papers.

How do trial teams plan for retention during the design stage of the trial? A scoping review.

Background: Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require "plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols" be included in trial protocols. It is unknown how often protocols report this retention information.

Determining clinical perspectives and strategies for improving enrollment of minoritized communities in prostate cancer clinical trials.

Background: Black men and other minoritized populations have represented 4-5% or less of participants in most practice-informing clinical trials. This study sought to assess the knowledge, attitudes, and practices of clinicians around equity and inclusion in prostate cancer clinical trial initiatives in the United States.

Methods: An anonymous, web-based questionnaire was administered via REDCap (Research Electronic Data Capture) with questions focused on inclusivity of minoritized populations with respect to race and ethnicity in prostate cancer clinical trials research.

Promoting 'testicular awareness': Co-design of an inclusive campaign using the World Café Methodology.

Introduction: Testicular cancer is the most common cancer in men aged 15-44 years in many countries. Most men with testicular cancer present with a lump. Testicular symptoms are more likely to occur secondary to benign diseases like epididymo-orchitis, a common sexually transmitted infection.

Underrecording and underreporting of participant ethnicity in clinical trials is persistent and is a threat to inclusivity and generalizability.

Objectives: People from ethnic minority groups are underserved by randomized trials, and poor representation of these groups reduces generalizability of results. There is no guidance on which ethnicity categories are appropriate for use in trials and thus inconsistency exists. The purpose of this study is to establish, in a large sample of trials, if participant ethnicity is recorded, how it is obtained (categories used), and if its reporting varies from its recording.

Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design.

Background: Clinical research nurses are a key part of the clinical trial team but typically get involved later in the trial, usually during recruitment. The purpose of our study was to establish if CRNs who read the trial protocol can predict the performance of the trial.

Methods: We randomly selected 18 trial protocols with three statuses, terminated, withdrawn, and completed, from ClinicalTrials.

Trial lay summaries were not fit for purpose.

Background And Objectives: To establish if trial lay summaries are suitable for lay readers.

Methods: A random sample of 60 randomized controlled trial (RCT) reports (15%) from the National Institute for Health and Care Research (NIHR) Journals Library, UK, were selected from 407 available ones. We extracted the lay summary and determined the readability using the previously validated Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simplified Measure of Gobbledegook (SMOG), Gunning Fog (GF), Coleman-Liau Index (CLI), and Automated Readability Index (ARI) readability scales.

Patient and Public Involvement (PPI) in outcome selection in breast cancer and nephrology trials.

We recently reported that according to patients and healthcare professionals in breast cancer and nephrology trials, teams conducting the trials got their choice of primary outcome wrong (72% of the time) more often than they got it right (28% of the time). A Patient and Public Involvement (PPI) representative, co-author of this letter, asked (on Twitter) whether PPI contributors had been involved in the design of the original trials and by extension the outcome selection. The purpose of this study was to answer this question.