Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials-Reference-Cited by-同舟云学术

Outcome Assessment by Central Adjudicators Versus Site Investigators in Stroke Trials

Published:2019-08 Issue:8 Volume:50 Page:2187-2196
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

Godolphin Peter J.¹²,Bath Philip M.²,Algra Ale³⁴,Berge Eivind⁵,Brown Martin M.⁶,Chalmers John⁷,Duley Lelia¹,Eliasziw Misha⁸,Gregson John⁹,Greving Jacoba P.⁴,Hankey Graeme J.¹⁰,Hosomi Naohisa¹¹,Johnston S. Claiborne¹²,Patsko Emily¹³,Ranta Annamarei¹⁴,Sandset Per Morten¹⁵,Serena Joaquín¹⁶,Weimar Christian¹⁷,Montgomery Alan A.¹,Knipp S.C.,Giugliano R.P.,Bonati L.H.,Nagai Y.,Matsumoto M.,Barnett H.J.M.,Fox A.J.,Farrant M.,Easton J.D.,Elm J.J.,Neal B.,Arima H.,Dávalos A.,Amarenco P.,Evans S.,Sprigg N.,Dineen R.,Eikelboom J.W.,Chen C.

Affiliation:

1. From the Nottingham Clinical Trials Unit (P.J.G., L.D., A.A.M.), University of Nottingham, United Kingdom

2. Stroke Trials Unit, Division of Clinical Neuroscience (P.J.G., P.M.B.), University of Nottingham, United Kingdom

3. Department of Neurology and Neurosurgery (A.A.), University Medical Center Utrecht, Utrecht University, the Netherlands

4. Julius Center for Health Sciences and Primary Care (A.A., J.P.G.), University Medical Center Utrecht, Utrecht University, the Netherlands

5. Department of Internal Medicine (E.B.), Oslo University Hospital, Norway

6. Stroke Research Group, UCL Institute of Neurology, UCL, London, United Kingdom (M.M.B.)

7. The George Institute for Global Health, University of NSW, Sydney, Australia (J.C.)

8. Department of Public Health and Community Medicine, Tufts University, Boston, MA (M.E.)

9. Department of Medical Statistics, LSHTM, London, United Kingdom (J.G.)

10. Medical School, The University of Western Australia, Perth (G.J.H.)

11. Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Japan (N.H.)

12. Dell Medical School, The University of Texas at Austin (S.C.J.)

13. Diabetes Research Centre, University of Leicester, United Kingdom (E.P.)

14. University of Otago, Wellington, New Zealand (A.R.)

15. Department of Haematology (P.M.S.), Oslo University Hospital, Norway

16. Department of Neurology, Stroke Unit, Hospital Josep Trueta, IDIBGI, Girona, Spain (J.S.)

17. Universitätsklinikum Essen, Klinik für Neurologie, Essen, Germany (C.W.).

Abstract

Background and Purpose— In randomized stroke trials, central adjudication of a trial’s primary outcome is regularly implemented. However, recent evidence questions the importance of central adjudication in randomized trials. The aim of this review was to compare outcomes assessed by central adjudicators with outcomes assessed by site investigators. Methods— We included randomized stroke trials where the primary outcome had undergone an assessment by site investigators and central adjudicators. We searched MEDLINE, EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science, PsycINFO, and Google Scholar for eligible studies. We extracted information about the adjudication process as well as the treatment effect for the primary outcome, assessed both by central adjudicators and by site investigators. We calculated the ratio of these treatment effects so that a ratio of these treatment effects >1 indicated that central adjudication resulted in a more beneficial treatment effect than assessment by the site investigator. A random-effects meta-analysis model was fitted to estimate a pooled effect. Results— Fifteen trials, comprising 69 560 participants, were included. The primary outcomes included were stroke (8/15, 53%), a composite event including stroke (6/15, 40%) and functional outcome after stroke measured on the modified Rankin Scale (1/15, 7%). The majority of site investigators were blind to treatment allocation (9/15, 60%). On average, there was no difference in treatment effect estimates based on data from central adjudicators and site investigators (pooled ratio of these treatment effects=1.02; 95% CI, [0.95–1.09]). Conclusions— We found no evidence that central adjudication of the primary outcome in stroke trials had any impact on trial conclusions. This suggests that potential advantages of central adjudication may not outweigh cost and time disadvantages in stroke studies if the primary purpose of adjudication is to ensure validity of trial findings.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

Reference44 articles.

1. Effects of the Endpoint Adjudication Process on the Results of a Randomised Controlled Trial: The ADVANCE Trial

2. A comparison of approaches for adjudicating outcomes in clinical trials

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