Paper II: thematic framework analysis of registry-based randomized controlled trials provided insights for designing trial ready registries

TY - JOUR

T1 - Paper II

T2 - thematic framework analysis of registry-based randomized controlled trials provided insights for designing trial ready registries

AU - Krause, Karolin R.

AU - Tay, Joanne

AU - Douglas, William A.

AU - Sammy, Adrian

AU - Baba, Ami

AU - Goren, Katherine

AU - Thombs, Brett D.

AU - Howie, Alison H.

AU - Oskoui, Maryam

AU - Frøbert, Ole

AU - Trakadis, Yannis

AU - Little, Julian

AU - Potter, Beth K.

AU - Butcher, Nancy J.

AU - Offringa, Martin

N1 - Publisher Copyright: © 2023 Elsevier Inc.

PY - 2023/7

Y1 - 2023/7

N2 - Objectives: Registry-based randomized controlled trials (RRCTs) are increasingly used, promising to address challenges associated with traditional randomized controlled trials. We identified strengths and limitations reported in planned and completed RRCTs to inform future RRCTs. Study Design and Setting: We conducted an environmental scan of literature discussing conceptual or methodological strengths and limitations of using registries for trial design and conduct (n = 12), followed by an analysis of RRCT protocols (n = 13) and reports (n = 77) identified from a scoping review. Using framework analysis, we developed and refined a conceptual framework of RRCT-specific strengths and limitations. We mapped and interpreted strengths and limitations discussed by authors of RRCT articles using framework codes and quantified the frequencies at which these were mentioned. Results: Our conceptual framework identified six main RRCT strengths and four main RRCT limitations. Considering implications for RRCT conduct and design, we formulated ten recommendations for registry designers, administrators, and trialists planning future RRCTs. Conclusion: Consideration and application of empirically underpinned recommendations for future registry design and trial conduct may help trialists utilize registries and RRCTs to their full potential.

AB - Objectives: Registry-based randomized controlled trials (RRCTs) are increasingly used, promising to address challenges associated with traditional randomized controlled trials. We identified strengths and limitations reported in planned and completed RRCTs to inform future RRCTs. Study Design and Setting: We conducted an environmental scan of literature discussing conceptual or methodological strengths and limitations of using registries for trial design and conduct (n = 12), followed by an analysis of RRCT protocols (n = 13) and reports (n = 77) identified from a scoping review. Using framework analysis, we developed and refined a conceptual framework of RRCT-specific strengths and limitations. We mapped and interpreted strengths and limitations discussed by authors of RRCT articles using framework codes and quantified the frequencies at which these were mentioned. Results: Our conceptual framework identified six main RRCT strengths and four main RRCT limitations. Considering implications for RRCT conduct and design, we formulated ten recommendations for registry designers, administrators, and trialists planning future RRCTs. Conclusion: Consideration and application of empirically underpinned recommendations for future registry design and trial conduct may help trialists utilize registries and RRCTs to their full potential.

KW - Best practice

KW - Randomized controlled trials

KW - Registries

KW - Registry-based randomized controlled trials

KW - RRCTs

KW - Strengths and limitations

UR - http://www.scopus.com/inward/record.url?scp=85160254956&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2023.04.015

DO - 10.1016/j.jclinepi.2023.04.015

M3 - Review

C2 - 37146660

AN - SCOPUS:85160254956

SN - 0895-4356

VL - 159

SP - 330

EP - 343

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -