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

Sara Lodi; Andrew Phillips; Jens Lundgren; Roger Logan; Shweta Sharma; Stephen R Cole; Abdel Babiker; Matthew Law; Haitao Chu; Dana Byrne; Andrzej Horban; Jonathan A C Sterne; Kholoud Porter; Caroline Sabin; Dominique Costagliola; Sophie Abgrall; John Gill; Giota Touloumi; Antonio G Pacheco; Ard van Sighem; Peter Reiss; Heiner C Bucher; Alexandra Montoliu Giménez; Inmaculada Jarrin; Linda Wittkop; Laurence Meyer; Santiago Perez-Hoyos; Amy Justice; James D Neaton; Miguel A Hernán; INSIGHT START Study Group and the HIV-CAUSAL Collaboration

doi:10.1093/aje/kwz100

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

Sara Lodi^*, Andrew Phillips, Jens Lundgren, Roger Logan, Shweta Sharma, Stephen R Cole, Abdel Babiker, Matthew Law, Haitao Chu, Dana Byrne, Andrzej Horban, Jonathan A C Sterne, Kholoud Porter, Caroline Sabin, Dominique Costagliola, Sophie Abgrall, John Gill, Giota Touloumi, Antonio G Pacheco, Ard van SighemPeter Reiss, Heiner C Bucher, Alexandra Montoliu Giménez, Inmaculada Jarrin, Linda Wittkop, Laurence Meyer, Santiago Perez-Hoyos, Amy Justice, James D Neaton, Miguel A Hernán, INSIGHT START Study Group and the HIV-CAUSAL Collaboration

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

20 Citationer (Scopus)

Abstract

Effect estimates from randomized trials and observational studies might not be directly comparable because of differences in study design, other than randomization, and in data analysis. We propose a 3-step procedure to facilitate meaningful comparisons of effect estimates from randomized trials and observational studies: 1) harmonization of the study protocols (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 for the human immunodeficiency virus from the Strategic Timing of Antiretroviral Therapy (START) randomized trial and the observational HIV-CAUSAL Collaboration.

Originalsprog	Engelsk
Tidsskrift	American Journal of Epidemiology
ISSN	0002-9262
DOI	https://doi.org/10.1093/aje/kwz100
Status	Udgivet - 1 aug. 2019

FN’s Verdensmål

Dette resultat bidrager til følgende verdensmål

Adgang til dokumentet

10.1093/aje/kwz100

Citationsformater

Lodi, S., Phillips, A., Lundgren, J., Logan, R., Sharma, S., Cole, S. R., Babiker, A., Law, M., Chu, H., Byrne, D., Horban, A., Sterne, J. A. C., Porter, K., Sabin, C., Costagliola, D., Abgrall, S., Gill, J., Touloumi, G., Pacheco, A. G., ... INSIGHT START Study Group and the HIV-CAUSAL Collaboration (2019). Effect estimates in randomized trials and observational studies: comparing apples with apples. American Journal of Epidemiology. https://doi.org/10.1093/aje/kwz100

Lodi, S, Phillips, A, Lundgren, J, Logan, R, Sharma, S, Cole, SR, Babiker, A, Law, M, Chu, H, Byrne, D, Horban, A, Sterne, JAC, Porter, K, Sabin, C, Costagliola, D, Abgrall, S, Gill, J, Touloumi, G, Pacheco, AG, van Sighem, A, Reiss, P, Bucher, HC, Montoliu Giménez, A, Jarrin, I, Wittkop, L, Meyer, L, Perez-Hoyos, S, Justice, A, Neaton, JD, Hernán, MA & INSIGHT START Study Group and the HIV-CAUSAL Collaboration 2019, 'Effect estimates in randomized trials and observational studies: comparing apples with apples', American Journal of Epidemiology. https://doi.org/10.1093/aje/kwz100

@article{2893f9e08b264ff7a3a3c947e00ef23a,

title = "Effect estimates in randomized trials and observational studies: comparing apples with apples",

abstract = "Effect estimates from randomized trials and observational studies might not be directly comparable because of differences in study design, other than randomization, and in data analysis. We propose a 3-step procedure to facilitate meaningful comparisons of effect estimates from randomized trials and observational studies: 1) harmonization of the study protocols (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 for the human immunodeficiency virus from the Strategic Timing of Antiretroviral Therapy (START) randomized trial and the observational HIV-CAUSAL Collaboration.",

author = "Sara Lodi and Andrew Phillips and Jens Lundgren and Roger Logan and Shweta Sharma and Cole, {Stephen R} and Abdel Babiker and Matthew Law and Haitao Chu and Dana Byrne and Andrzej Horban and Sterne, {Jonathan A C} and Kholoud Porter and Caroline Sabin and Dominique Costagliola and Sophie Abgrall and John Gill and Giota Touloumi and Pacheco, {Antonio G} and {van Sighem}, Ard and Peter Reiss and Bucher, {Heiner C} and {Montoliu Gim{\'e}nez}, Alexandra and Inmaculada Jarrin and Linda Wittkop and Laurence Meyer and Santiago Perez-Hoyos and Amy Justice and Neaton, {James D} and Hern{\'a}n, {Miguel A} and {INSIGHT START Study Group and the HIV-CAUSAL Collaboration}",

year = "2019",

month = aug,

day = "1",

doi = "10.1093/aje/kwz100",

language = "English",

journal = "American Journal of Epidemiology",

issn = "0002-9262",

publisher = "Oxford University Press",

}

TY - JOUR

T1 - Effect estimates in randomized trials and observational studies

T2 - comparing apples with apples

AU - Lodi, Sara

AU - Phillips, Andrew

AU - Lundgren, Jens

AU - Logan, Roger

AU - Sharma, Shweta

AU - Cole, Stephen R

AU - Babiker, Abdel

AU - Law, Matthew

AU - Chu, Haitao

AU - Byrne, Dana

AU - Horban, Andrzej

AU - Sterne, Jonathan A C

AU - Porter, Kholoud

AU - Sabin, Caroline

AU - Costagliola, Dominique

AU - Abgrall, Sophie

AU - Gill, John

AU - Touloumi, Giota

AU - Pacheco, Antonio G

AU - van Sighem, Ard

AU - Reiss, Peter

AU - Bucher, Heiner C

AU - Montoliu Giménez, Alexandra

AU - Jarrin, Inmaculada

AU - Wittkop, Linda

AU - Meyer, Laurence

AU - Perez-Hoyos, Santiago

AU - Justice, Amy

AU - Neaton, James D

AU - Hernán, Miguel A

AU - INSIGHT START Study Group and the HIV-CAUSAL Collaboration

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Effect estimates from randomized trials and observational studies might not be directly comparable because of differences in study design, other than randomization, and in data analysis. We propose a 3-step procedure to facilitate meaningful comparisons of effect estimates from randomized trials and observational studies: 1) harmonization of the study protocols (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 for the human immunodeficiency virus from the Strategic Timing of Antiretroviral Therapy (START) randomized trial and the observational HIV-CAUSAL Collaboration.

AB - Effect estimates from randomized trials and observational studies might not be directly comparable because of differences in study design, other than randomization, and in data analysis. We propose a 3-step procedure to facilitate meaningful comparisons of effect estimates from randomized trials and observational studies: 1) harmonization of the study protocols (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 for the human immunodeficiency virus from the Strategic Timing of Antiretroviral Therapy (START) randomized trial and the observational HIV-CAUSAL Collaboration.

U2 - 10.1093/aje/kwz100

DO - 10.1093/aje/kwz100

M3 - Journal article

C2 - 31063192

SN - 0002-9262

JO - American Journal of Epidemiology

JF - American Journal of Epidemiology

ER -

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

Abstract

FN’s Verdensmål

Adgang til dokumentet

Fingeraftryk

Citationsformater