Accuracy of Cardiovascular Trial Outcome Ascertainment and Treatment Effect Estimates from Routine Health Data: A Systematic Review and Meta-Analysis.

Humans Myocardial Infarction Reproducibility of Results Retrospective Studies Stroke / diagnosis
cardiovascular disease incidence myocardial infarction peripheral arterial disease

Journal

Circulation. Cardiovascular quality and outcomes
ISSN: 1941-7705
Titre abrégé: Circ Cardiovasc Qual Outcomes
Pays: United States
ID NLM: 101489148

Informations de publication

Date de publication:
05 2021
Historique:
pubmed: 18 5 2021
medline: 16 10 2021
entrez: 17 5 2021
Statut: ppublish

Résumé

Registry-based randomized controlled trials allow for outcome ascertainment using routine health data (RHD). While this method provides a potential solution to the rising cost and complexity of clinical trials, comparative analyses of outcome ascertainment by clinical end point committee (CEC) adjudication compared with RHD sources are sparse. Among cardiovascular trials, we set out to systematically compare the incidence of cardiovascular events and estimated randomized treatment effects ascertained from RHD versus traditional clinical evaluation and adjudication. We searched MEDLINE (1976 to August 2020) for studies where outcome ascertainment was performed by both RHD and CEC adjudication to compare the incidence of cardiovascular events and treatment effects. We derived ratios of hazard ratios to compare treatment effects from RHD and CEC adjudication. We pooled ratios of hazard ratios using an inverse variance random-effects meta-analysis. Nine studies (1988-2020; 32 156 patients) involving 10 randomized control trials compared outcome ascertainment with RHD and CEC in patients with or at risk of cardiovascular disease. There was a high degree of agreement and interrater reliability between CEC and RHD outcome determination for all-cause mortality (agreement percentage: 98.4%-100% and κ: 0.95-1.0) and cardiovascular mortality (agreement percentage: 97.8%-99.9% and κ: 0.66-0.99). For myocardial infarction, the κ values ranged from 0.67-0.98, and for stroke the values ranged from 0.52-0.89. In contrast, the κ value for peripheral artery disease was low (κ: 0.27). There was little difference in the randomized treatment effect derived from CEC and RHD ascertainment of events based on the ratios of hazard ratio, with pooled ratios of hazard ratios ranging from 0.93 (95% CI, 0.63-1.39) for cardiovascular mortality to 1.27 (95% CI, 0.67-2.41) for stroke. Clinical outcome ascertainment using retrospectively acquired RHD displayed high levels of agreement with CEC adjudication for identifying all-cause mortality and cardiovascular outcomes. Importantly, cardiovascular treatment effects in randomized control trials determined from RHD and CEC resulted in similar point estimates. Overall, our review supports the use of RHD as a potential alternative source for clinical outcome ascertainment in cardiovascular trials. Validation studies with prospectively planned linkage are warranted.

Sections du résumé

BACKGROUND
Registry-based randomized controlled trials allow for outcome ascertainment using routine health data (RHD). While this method provides a potential solution to the rising cost and complexity of clinical trials, comparative analyses of outcome ascertainment by clinical end point committee (CEC) adjudication compared with RHD sources are sparse. Among cardiovascular trials, we set out to systematically compare the incidence of cardiovascular events and estimated randomized treatment effects ascertained from RHD versus traditional clinical evaluation and adjudication.
METHODS
We searched MEDLINE (1976 to August 2020) for studies where outcome ascertainment was performed by both RHD and CEC adjudication to compare the incidence of cardiovascular events and treatment effects. We derived ratios of hazard ratios to compare treatment effects from RHD and CEC adjudication. We pooled ratios of hazard ratios using an inverse variance random-effects meta-analysis.
RESULTS
Nine studies (1988-2020; 32 156 patients) involving 10 randomized control trials compared outcome ascertainment with RHD and CEC in patients with or at risk of cardiovascular disease. There was a high degree of agreement and interrater reliability between CEC and RHD outcome determination for all-cause mortality (agreement percentage: 98.4%-100% and κ: 0.95-1.0) and cardiovascular mortality (agreement percentage: 97.8%-99.9% and κ: 0.66-0.99). For myocardial infarction, the κ values ranged from 0.67-0.98, and for stroke the values ranged from 0.52-0.89. In contrast, the κ value for peripheral artery disease was low (κ: 0.27). There was little difference in the randomized treatment effect derived from CEC and RHD ascertainment of events based on the ratios of hazard ratio, with pooled ratios of hazard ratios ranging from 0.93 (95% CI, 0.63-1.39) for cardiovascular mortality to 1.27 (95% CI, 0.67-2.41) for stroke.
CONCLUSIONS
Clinical outcome ascertainment using retrospectively acquired RHD displayed high levels of agreement with CEC adjudication for identifying all-cause mortality and cardiovascular outcomes. Importantly, cardiovascular treatment effects in randomized control trials determined from RHD and CEC resulted in similar point estimates. Overall, our review supports the use of RHD as a potential alternative source for clinical outcome ascertainment in cardiovascular trials. Validation studies with prospectively planned linkage are warranted.

Identifiants

DOI: 10.1161/CIRCOUTCOMES.120.007903 PMID: 33993728
pubmed: 33993728
doi: 10.1161/CIRCOUTCOMES.120.007903
doi:

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

e007903

Subventions

Organisme : CIHR
ID : MYG 151211
Pays : Canada

Auteurs

Craig Rodrigues (C)

Women's College Research Institute, Toronto, Canada (C.R., S.P., E.L., J.A.U.).
School of Medicine, Queen's University, Kingston, Canada (C.R.).

Ayodele Odutayo (A)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.

Sagar Patel (S)

Women's College Research Institute, Toronto, Canada (C.R., S.P., E.L., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.

Arnav Agarwal (A)

Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.

Bruno Roza da Costa (BR)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Institute of Health Policy, Management, and Evaluation (B.R.d.C., P.J., J.A.U.), University of Toronto, Toronto, Canada.
Institute of Primary Health Care (BIHAM), University of Bern, Switzerland (B.R.d.C.).

Ethan Lin (E)

Women's College Research Institute, Toronto, Canada (C.R., S.P., E.L., J.A.U.).
Faculty of Medicine, University of Ottawa, Canada (E.L.).

Robert W Yeh (RW)

Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).

Peter Jüni (P)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.
Institute of Health Policy, Management, and Evaluation (B.R.d.C., P.J., J.A.U.), University of Toronto, Toronto, Canada.

Shaun G Goodman (SG)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.

Michael E Farkouh (ME)

Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto, Canada (M.E.F., J.A.U.).

Jacob A Udell (JA)

Women's College Research Institute, Toronto, Canada (C.R., S.P., E.L., J.A.U.).
Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada (A.O., B.R.d.C., P.J., S.G.G., M.E.F., J.A.U.).
Department of Medicine, Faculty of Medicine (A.O., S.P., A.A., P.J., S.G.G., M.E.F., J.A.U.), University of Toronto, Toronto, Canada.
Institute of Health Policy, Management, and Evaluation (B.R.d.C., P.J., J.A.U.), University of Toronto, Toronto, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto, Canada (M.E.F., J.A.U.).
ICES, Toronto, Canada (J.A.U.).
Cardiovascular Division, Department of Medicine, Women's College Hospital, Toronto, Canada (J.A.U.).

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Accuracy of Cardiovascular Trial Outcome...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Nécrose › Infarctus › Infarctus du myocarde › Accuracy of Cardiovascular Trial Outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › Accuracy of Cardiovascular Trial Outcome...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études rétrospectives › Accuracy of Cardiovascular Trial Outcome...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Accident vasculaire cérébral › Accuracy of Cardiovascular Trial Outcome...