Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials-Reference-Cited by-同舟云学术

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Published:2023-09-27 Issue:9 Volume:6 Page:e2336023
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Hansford Harrison J.¹²,Cashin Aidan G.¹²,Jones Matthew D.¹²,Swanson Sonja A.³⁴⁵,Islam Nazrul⁶⁷,Douglas Susan R. G.¹,Rizzo Rodrigo R. N.¹²,Devonshire Jack J.²,Williams Sam A.²,Dahabreh Issa J.⁴⁵⁸,Dickerman Barbra A.⁴⁵,Egger Matthias⁹¹⁰¹¹,Garcia-Albeniz Xabier⁵¹²,Golub Robert M.¹³,Lodi Sara⁴¹⁴,Moreno-Betancur Margarita¹⁵¹⁶,Pearson Sallie-Anne¹⁷,Schneeweiss Sebastian¹⁸,Sterne Jonathan A. C.¹⁹²⁰²¹,Sharp Melissa K.²²,Stuart Elizabeth A.²³,Hernán Miguel A.⁴⁵⁸,Lee Hopin²⁴²⁵,McAuley James H.¹²

Affiliation:

1. School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia

2. Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia

3. Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania

4. CAUSALab, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

5. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

6. Oxford Population Health, Big Data Institute, University of Oxford, Oxford, United Kingdom

7. Faculty of Medicine, University of Southampton, Southampton, United Kingdom

8. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts

9. Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland

10. Centre for Infectious Disease Epidemiology and Research, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

11. Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom

12. RTI Health Solutions, Barcelona, Spain

13. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois

14. Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts

15. Clinical Epidemiology & Biostatistics Unit, Murdoch Children’s Research Institute, Royal Children’s Hospital, Parkville, Victoria, Australia

16. Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia

17. School of Population Health, Faculty of Medicine and Health, UNSW Sydney, New South Wales, Australia

18. Division of Pharmacoepidemiology, Department of Medicine, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts

19. Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom

20. NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom

21. Health Data Research UK South-West, Bristol, United Kingdom

22. Department of Public Health and Epidemiology, RCSI University of Medicine and Health Sciences, Dublin, Ireland

23. Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

24. University of Exeter Medical School, Exeter, United Kingdom

25. EMEA Methods & Evidence Generation, IQVIA, London, United Kingdom

Abstract

ImportanceObservational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.ObjectiveTo assess the reporting of observational studies that explicitly aimed to emulate a target trial.Evidence ReviewWe searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.FindingsA total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.Conclusions and RelevanceIn this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2809945/hansford_2023_oi_231035_1697125109.98255.pdf

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