Registry-based randomized clinical trials’ indications, methods, health outcomes and reporting: A scoping review protocol (original) (raw)
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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 re...
Defining the Features of Registry Based Randomised Controlled Trials (rRCT): A Systematic Review
2020
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 indep...
Journal of Clinical Epidemiology, 2016
Registry-based randomized controlled trials are defined as pragmatic trials that use registries as a platform for case records, data collection, randomization, and follow-up. Recently, the application of registry-based randomized controlled trials has attracted increasing attention in health research to address comparative effectiveness research questions in real-world settings, mainly due to their low cost, enhanced generalizability of findings, rapid consecutive enrollment, and the potential completeness of follow-up for the reference population, when compared with conventional randomized effectiveness trials. However several challenges of registry-based randomized controlled trials have to be taken into consideration, including registry data quality, ethical issues, and methodological challenges. In this article, we summarize the advantages, challenges, and areas for future research related to registry-based randomized controlled trials.
Registry randomised trials: a methodological perspective
BMJ Open, 2023
Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.
BMC Medical Research Methodology
Background: While conducting systemic reviews, searching for ongoing or unpublished trials is critical to address publication bias. As of April 2019, records of ongoing or unpublished randomized and/or quasi-randomized controlled trials registered in the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov are available in the Cochrane Central Register of Controlled Trials (CENTRAL). These records registered in CENTRAL include studies published since the inception of ICTRP and ClinicalTrials.gov. Whether systematic reviewers can search CENTRAL to identify ongoing or unpublished trials instead of ICTRP and ClinicalTrials.gov is unknown. Methods: This was a cross-sectional study. A consecutive sample of ongoing or unpublished studies published from June 1, 2019 to December 27, 2019 was selected from the Cochrane Reviews. The sensitivity and the number needed to read (NNR) were assessed from among the studies selected from CENT RAL instead of ICTRP and ClinicalTrials.gov and also assessed the characteristics of studies not identified by searching CENTRAL. Results: In total, 247 records from 50 Cochrane reviews were included; of these, 200 were identified by searching CENTRAL, whereas the remaining 47 records were not. The sensitivity of searching CENTRAL was 0.81 (95% confidence interval [CI]: 0.76, 0.85). The NNR was 115 (95% CI: 101, 133). The 47 unidentified studies were registered through ClinicalTrials.gov or ICTRP. Sixteen unidentified studies were not indexed in CENTRAL. Conclusions: For systematic reviewers, searching CENTRAL could not substitute for searching ClinicalTrials.gov and/ or ICTRP. Systematic reviewers should not only search CENTRAL but also ICTRP and ClinicalTrials.gov to identify unpublished trials.
BMJ Open, 2018
IntroductionRandomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.Methods and analysisIn separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, elec...
2021
Supplemental material, sj-pdf-1-cjk-10.1177_20543581211041182 for MyTEMP: Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial by Stephanie N. Dixon, Jessica M. Sontrop, Ahmed Al-Jaishi, Lauren Killin, Christopher W. McIntyre, Sierra Anderson, Amit Bagga, Derek Benjamin, Peter Blake, P. J. Devereaux, Eduard Iliescu, Arsh Jain, Charmaine E. Lok, Gihad Nesrallah, Matthew J. Oliver, Sanjay Pandeya, Manish M. Sood, Paul Tam, Ron Wald, Michael Walsh, Merrick Zwarenstein and Amit X. Garg in Canadian Journal of Kidney Health and Disease
Objectives: The use of trial registry records and randomized controlled trial (RCT) study protocols can assist systematic reviewers in evaluating and, possibly, minimizing publication and selective reporting biases. This study examined current guidance on the use of registry records and RCT study protocols from key systematic review organizations, institutes, and collaborations. Study Design and Setting: Handbooks, guidelines, and standard documents from key systematic review organizations and the EQUATOR network database were identified. Textual excerpts providing guidance on the use of trial registry records, RCT protocols, and ongoing/unpublished studies were extracted independently by two reviewers and coded into a systematic review framework. Results: Eleven documents published in English between 2009 and 2016 were included. Guidance for using RCT protocols and trial registry records was provided for 7 of 16 framework categories, and guidance for using unpublished and ongoing studies was available for 8 of 16 categories. Conclusion: This study identified gaps and ambiguities in language in guidance on the use of RCT protocols and trial registry records. To encourage and assist reviewers to use trial registry records and RCT study protocols in systematic reviews, current guidance should be expanded and clarified.