Background Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. Methods We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. Conclusion Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

Background Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of new therapies. Despite this, nephrology trials, especially of patients with end stage renal disease (ESRD) are much fewer in number than other specialties. Recruitment difficulties are cited as a particular challenge. Using registries to conduct RCTs is a reasonably new practice but is appealing as it combines the benefits of observational studies and clinical trials. There is limited literature on patient motivators, barriers, and consent to these registries. The purpose of our study is to establish this. MethodsWe conducted a cross-sectional questionnaire-based study. A questionnaire consisting of closed and open-ended questions was collected at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Results 87 patients completed the questionnaire. Motivators for participation included personal and altruistic benefits. Barriers/concerns include time requirements, risks (incl. data safety) and side effects along with impacts on current treatment. Though a total of 29.8% of patients ‘strongly agree/agree’ to having concerns regarding their data storage in a registry, 79.3% of patients were ‘very likely/likely’ to consent to participate in the registry. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. ConclusionImproving patients understanding of clinical trials, emphasising personal and altruistic benefits, and addressing patient’s concerns regarding time and risks of involvement, may improve their likelihood to participate in a registry for RCTs and more broadly speaking, RCTs.

Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures such as case report completion, randomisation and follow up data. While the practice of utilising registries to support the conduct of randomised trials is increasing, the reporting of how a registry is used within a trial can vary, causing difficulty in identifying registry based randomised trials and interpreting their exact definition. Methods: The databases PubMed, Embase, Cinahl Plus, Scopus and the Cochrane Central Register of Controlled Trials will be searched using a combination of subject headings, MeSH and free text terms. Search terms will be adapted accordingly for each database, with English language articles included and no other filters applied. Also, grey literature and reference lists will be searched, contacting trial authors for clarification when necessary. Two independent reviewers will complete study screening, selection and quality assessment. A preliminary synthesis will be conducted tabulating the relevant evidence into separate data extraction tables. A narrative synthesis approach will be adopted based on the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews.Results: The present study will synthesise existing registry based randomised trial literature and define their key features.Conclusions: It is essential that trialists and researchers can review published trials and endeavour to duplicate trial designs. There is a lack of consensus in terms of the reporting of registry based randomised trials, making replication of this emerging trial design difficult. This review will clearly summarise and define the key features of these randomised trials, to allow researchers understand and reproduce the novel registry based randomised controlled trial methodology. Systematic Review Registration: PROPSERO CRD42020192419

Background: Registry-based Randomized 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, randomization and the collection of outcome data. While the practice of utilising registries to support the conduct of randomized 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 their advantages and challenges. 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 47862 titles were screened and 24 rRCTs were included. Eleven rRCTs (45.8%) used more than one registry to facilitate trial conduct. Six rRCTs (25%) randomized participants via a specific randomization 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, less participant burden and ability to conduct multiple trials from the same registry. Challenges are: data collection/management, quality assurance issues and the timing of informed consent. Conclusion: 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. Systematic Review Registration: PROPSERO CRD42020192419

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