GIST 2.0: A scalable multi-trait metric for quantifying population representativeness of individual clinical studies.
The design of randomized controlled clinical studies can greatly benefit from iterative assessments of population representativeness of eligibility criteria. We propose a multi-trait metric - GIST 2.0 that can compute the a priori generalizability based on the population representativeness of a clinical study by explicitly modeling the dependencies among all eligibility criteria. We evaluate this metric on twenty clinical studies of two diseases and analyze how a study's eligibility criteria affect its generalizability (collectively and individually). We statistically analyze the effects of trial setting, trait selection and trait summarizing technique on GIST 2.0. Finally we provide theoretical as well as empirical validations for the expected properties of GIST 2.0.
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States. Electronic address: as5050@cumc.columbia.edu.
Anando
A
Sen
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States. Electronic address: sc4025@cumc.columbia.edu.
Shreya
S
Chakrabarti
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States; Department of Medicine, New York University, New York NY 10016, United States. Electronic address: ag3304@cumc.columbia.edu.
Andrew
A
Goldstein
Department of Biostatistics, Columbia University, New York, NY 10032, United States. Electronic address: sw2206@cumc.columbia.edu.
Shuang
S
Wang
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States; Janssen Research and Development, Titusville, NJ 08560, United States. Electronic address: ryan@ohdsi.org.
Patrick B
PB
Ryan
Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States. Electronic address: cw2384@cumc.columbia.edu.
Chunhua
C
Weng
D035843:Biomedical Research; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012984:Software
Clinical trials; Eligibility criteria; Generalizability; Population representativeness; Trait dependencies