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Effect estimates in randomized trials and observational studies: comparing apples with apples

Lodi, S; Phillips, A; Lundgren, J; Logan, R; Sharma, S; Cole, SR; Babiker, A; ... INSIGHT START Study Group and the HIV-CAUSAL Collaboration, ; + view all (2019) Effect estimates in randomized trials and observational studies: comparing apples with apples. American Journal Of Epidemiology , 188 (8) pp. 1569-1577. 10.1093/aje/kwz100. Green open access

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Abstract

Effect estimates from randomized trials and observational studies may not be directly comparable because of differences in study design, other than randomization, and in data analysis. We propose a three-step procedure to facilitate meaningful comparisons of effect estimates from randomized trials and observational studies: 1) harmonization of the study protocol (eligibility criteria, treatment strategies, outcome, start and end of follow-up, causal contrast) so that the studies target the same causal effect, 2) harmonization of the data analysis to estimate the causal effect, and 3) sensitivity analyses to investigate the impact of discrepancies that could not be accounted for in the harmonization process. To illustrate our approach, we compared estimates of the effect of immediate with deferred initiation of antiretroviral therapy in individuals positive to the human immunodeficiency virus from the START randomized trial and the observational HIV-CAUSAL Collaboration.

Type: Article
Title: Effect estimates in randomized trials and observational studies: comparing apples with apples
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/aje/kwz100
Publisher version: https://doi.org/10.1093/aje/kwz100
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: causal inference; per-protocol; target trial; antiretroviral initiation;
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/10073793
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