دورية أكاديمية
أعرض في EDS

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.

التفاصيل البيبلوغرافية
العنوان: 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.
المؤلفون: Murphy E; Health Research Board-Trials Methodology Research Network (HRB-TMRN), Galway, Ireland. ellen.murphy@ucc.ie.; Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility University College Cork, Cork, Ireland. ellen.murphy@ucc.ie., Gillies K; Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Shiely F; Health Research Board-Trials Methodology Research Network (HRB-TMRN), Galway, Ireland.; Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility University College Cork, Cork, Ireland.; School of Public Health, University College Cork, Cork, Ireland.
المصدر: Trials [Trials] 2024 Jun 10; Vol. 25 (1), pp. 372. Date of Electronic Publication: 2024 Jun 10.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Pamphlets* , Randomized Controlled Trials as Topic*/methods, Humans ; Adult ; Communication ; Patient Selection ; Research Subjects/psychology ; Patient Education as Topic/methods ; Clinical Trial Protocols as Topic ; Health Knowledge, Attitudes, Practice ; United Kingdom ; Research Design ; Patient Dropouts
مستخلص: 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.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol.
Methods: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.
Results: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).
Conclusion: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.
(© 2024. The Author(s).)
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معلومات مُعتمدة: HRB-TMRN-2021-001 Health Research Board - Trials Methodology Research Network
فهرسة مساهمة: Keywords: Communication; Informed consent; Participant information leaflet; Patient information leaflet; Reporting; Retention; Retention strategy
تواريخ الأحداث: Date Created: 20240610 Date Completed: 20240611 Latest Revision: 20240613
رمز التحديث: 20240613
مُعرف محوري في PubMed: PMC11163762
DOI: 10.1186/s13063-024-08194-7
PMID: 38858790
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-024-08194-7