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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., Methods: We used Web of Science to identify all publication types citing PRECIS-2, published between May 2015 and July 2023. Citations were eligible if they contained 'substantive' suggestions, comments, or criticism of the PRECIS-2 tool. We defined 'substantive' as comments explicitly referencing at least one PRECIS-2 domain or a concept directly linked to an existing or newly proposed domain. Two reviewers independently extracted comments, suggestions, and criticisms, noting their implications for the update. These were discussed among authors to achieve consensus on the interpretation of each comment and its implications for PRECIS-3., Results: The search yielded 885 publications, and after full-text review, 89 articles met the inclusion criteria. Comments pertained to new domains, changes in existing domains, or were relevant across several or all domains. Proposed new domains included assessment of the comparator arm and a domain to describe blinding. There were concerns about scoring eligibility and recruitment domains for cluster trials. Suggested areas for improvement across domains included the need for more scoring guidance for explanatory design choices., Discussion: Published comments recognise PRECIS-2's success in aiding trialists with pragmatic or explanatory design choices. Enhancing its implementation and widespread use will involve adding new domains, refining domain definitions, and addressing overall tool issues. This citation review offers valuable user feedback, pivotal for shaping the upcoming version of the PRECIS tool, PRECIS-3., Competing Interests: Declaration of competing interest All authors declare no conflict of interest. Dr Kirsty Loudon developed the PRECIS-2 tool as part of a DPhil., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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., Study Design and Setting: We reviewed trial documentation for 407 randomized controlled trials published in the UK National Institute of Health Research library from 2016 to 2021. We extracted data on the recording (if it was recorded and the categories used) and reporting (if the categories remained the same as those obtained, or not) of ethnicity for each trial along with demographics. In the analysis we categorized the manner of recording and reporting of ethnicity in the trials according to UK Census ethnicity categories., Results: Ethnicity was recorded in 67.3% (n = 274) of trials. The location in the trial report where ethnicity was recorded was available for 42% (n = 116) of trials. The details on how ethnicity was collected (predefined categories or self-defined) was available for 54/274 (20%) of trials and details on the specifics of the categories recorded was available for 44 (16%) trials. Of the 44, 6 of those did not go on to report on ethnicity in the trial report. Of the remaining 38, only 13 reported ethnicity exactly as it had been recorded. Taken as a whole from the 407 trial reports examined 9.3% (38/407) of trials demonstrated exactly how they both recorded, and reported, ethnicity. Authors made reference to whom results were relevant in terms of ethnicity in 80/407 (19.7%)., Conclusion: Ethnicity is underrecorded and underreported in clinical trials. This is a threat to the generalizability of the findings and needs to be improved., Competing Interests: Declaration of competing interest The authors declare no conflicts of interests., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

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. This provided us with a reading age. We also assessed the compatibility of the lay summaries with the Plain English UK Guidelines and the National Adult Literacy Agency Guidelines, Ireland., Results: No lay summary met the recommended reading age for health care information of 11-12 years. None of them were considered "easy" to read, in fact over 85% were considered "difficult" to read., Conclusion: The lay summary is a key document for disseminating trial results to a broad population who may not necessarily have the medical or technical jargon to read a trial report. Its importance cannot be overstated. Assessing readability in conjunction with plain language guidelines is relatively easy and therefore an immediate change to practice is feasible. However, since specific skills are required to write lay summaries that meet the required standards, it is important that the need for such expertise is recognized and supported by research funders., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate how trialists record and report their recruitment strategies and the recruiter details in trial protocols, registries, and publications., Study Design and Setting: A retrospective study of ovarian cancer (OC) trials between 2010 and 2021. We reviewed 154 trial publications, 30 protocols, 105 registry entries, and 26 trial websites associated with 88 phase III OC trials., Results: None of the 88 trials reviewed published a recruitment strategy or made reference to an available recruitment strategy for the trial. Only 31% (n = 28) made reference to the recruiter but this was reported only in the protocol so we have no evidence these named recruiters performed the task. None of the trials reviewed which closed early or extended recruitment timelines due to slow accrual, reported measures taken to improve recruitment rates before stoppages or changes took place. There were disparities in the reported target recruitment numbers between the protocol, the publication, and the registry., Conclusion: Recruitment strategies exist, and we are sure most trial centers use recruitment strategies, but they need to be recorded and reported, as part of the supplementary material if not the main publication, so we can evaluate their effectiveness., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Under-served groups are populations unrepresented or disengaged from medical research or services despite a disproportionately high healthcare burden. Under-served groups may be directly (age, pregnancy as examples) or indirectly excluded (provision of written information in one language only as an example) from trial enrollment by strict eligibility exclusions. The purpose of our study was to assess eligibility criteria in published phase III breast cancer clinical trials to determine whether they excluded underserved groups either directly or indirectly., Study Design and Setting: Medline was searched for phase III randomized controlled trials evaluating interventional drugs for breast cancer in high-impact journals published between January 1st, 2010 and December 31st, 2020. A total of 5133 eligible trials were returned, and 40 were selected, by simple randomization, for inclusion., Results: All 40 trials had multiple exclusions that affected the recruitment of underserved groups. Clinical or scientific rationale for the recorded inclusion and exclusion criteria was underreported in 39 of 40 trials., Conclusion: Clinical trial eligibility criteria exclude underserved groups from breast cancer trials. Trialists should provide a justification for each eligibility criterion, and funders, reviewers, ethics committees, and others should demand one. Without this, underserved groups will remain just that: underserved., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: The standard low-phosphorus diet restricts pulses, nuts, and whole grains and other high phosphorus foods to control hyperphosphatemia. We conducted a randomized controlled trial to evaluate the effectiveness, safety, and tolerability of the modified diet, which introduced some pulses and nuts, increased the use of whole grains, increased focus on the avoidance of phosphate additives, and introduced the prescription of low-biological-value protein such as bread., Methods: We conducted a multicenter, pragmatic, parallel-arm, open-label, randomized controlled trial of modified versus standard diet in 74 adults on hemodialysis with hyperphosphatemia over 1 month. Biochemistry was assessed using monthly laboratory tests. Dietary intake was assessed using a 2-day record of weighed intake of food, and tolerability was assessed using a patient questionnaire., Results: There was no significant difference in the change in serum phosphate between the standard and modified diets. Although total dietary phosphorus intake was similar, phytate-bound phosphorus, found in pulses, nuts, and whole grains, was significantly higher in the modified diet ( P  < 0.001). Dietary fiber intake was also significantly higher ( P  < 0.003), as was the percentage of patients reporting an increase in bowel movements while following the modified diet ( P  = 0.008). There was no significant difference in the change in serum potassium or in reported protein intake between the 2 diets. Both diets were similarly well tolerated., Conclusion: The modified low phosphorus diet was well tolerated and was associated with similar phosphate and potassium control but with a wider food choice and greater fiber intake than the standard diet., (© 2020 International Society of Nephrology. Published by Elsevier Inc.)

Introduction: In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools., Methods: Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists. This review included academic and commercial instruments that met the Organisation for Economic Co-operation and Development (OECD) classification of RBM tools., Results: Ninety-one potential RBM tools were identified and 24 were eligible for inclusion. These tools were published between 2000 and 2015. Eight tools were paper based or electronic questionnaires and 16 operated as Service as a System (SaaS). Risk associated with the investigational medicinal product (IMP), phase of the clinical trial and study population were examined by all tools and suitable mitigation guidance through on-site and centralised monitoring was provided., Conclusion: RBM tools for clinical trials are relatively new, their features and use varies widely and they continue to evolve. This makes it difficult to identify the "best" RBM technique or tool. For example, equivalence testing is required to determine if RBM strategies directed by paper based and SaaS based RBM tools are comparable. Such research could be embedded within multi-centre clinical trials and conducted as a SWAT (Study within a Trial)., (Copyright © 2016 Elsevier Inc. All rights reserved.)