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

التفاصيل البيبلوغرافية
العنوان: Registry-based randomised controlled trials: conduct, advantages and challenges-a systematic review.
المؤلفون: Shiely F; Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, 4th Floor Western Gateway Building, Western Road, Cork, Ireland. f.shiely@ucc.ie.; School of Public Health, University College Cork, 4th Floor Western Gateway Building, Western Road, Cork, Ireland. f.shiely@ucc.ie., O Shea N; Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, 4th Floor Western Gateway Building, Western Road, Cork, Ireland.; Health Research Board, Trials Methodology Research Network, University College Cork, Cork, Ireland., Murphy E; Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, 4th Floor Western Gateway Building, Western Road, Cork, Ireland.; Health Research Board, Trials Methodology Research Network, University College Cork, Cork, Ireland., Eustace J; Department of Renal Medicine, Cork University Hospital, Cork, Ireland.
المصدر: Trials [Trials] 2024 Jun 11; Vol. 25 (1), pp. 375. Date of Electronic Publication: 2024 Jun 11.
نوع المنشور: Journal Article; Systematic Review
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: Randomized Controlled Trials as Topic*/standards , Randomized Controlled Trials as Topic*/methods , Registries*, Humans ; Patient Selection ; Pragmatic Clinical Trials as Topic/methods ; Research Design
مستخلص: 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.
Methods: A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two reviewers. A risk of bias for each study was completed. A narrative synthesis was conducted.
Results: A total 47,862 titles were screened and 24 rRCTs were included. Eleven rRCTs (45.8%) used more than one registry to facilitate trial conduct. Six rRCTs (25%) randomised participants via a specific randomisation module embedded within a registry. Recruitment ranged between 209 to 106,000 participants. Advantages of rRCTs are recruitment efficiency, shorter trial times, cost effectiveness, outcome data completeness, smaller carbon footprint, lower participant burden and the ability to conduct multiple trials from the same registry. Challenges are data collection/management, quality assurance issues and the timing of informed consent.
Conclusions: Optimising the design of rRCTs is dependent on the capabilities of the registry. New registries should be designed and existing registries reviewed to enable the conduct of rRCTs. At all times, data management and quality assurance of all registry data should be given key consideration. We suggest the inclusion of the term 'registry-based' in the title of all rRCT manuscripts and a clear simple breakdown of the registry-based conduct of the trial in the abstract to facilitate indexing in the major databases.
(© 2024. The Author(s).)
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معلومات مُعتمدة: HRB-TMRN-2017-001. Ireland HRBI_ Health Research Board
فهرسة مساهمة: Keywords: Registry-based randomised controlled trials; Trials methodology
تواريخ الأحداث: Date Created: 20240611 Date Completed: 20240612 Latest Revision: 20240614
رمز التحديث: 20240614
مُعرف محوري في PubMed: PMC11165819
DOI: 10.1186/s13063-024-08209-3
PMID: 38863017
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-024-08209-3