Assessing the Collective Population Representativeness of Related Type 2 Diabetes Trials by Combining Public Data from ClinicalTrials.gov and NHANES.
Randomized controlled trials generate high-quality medical evidence. However, the use of unjustified inclusion/exclusion criteria may compromise the external validity of a study. We have introduced a method to assess the population representativeness of related clinical trials using electronic health record (EHR) data. As EHR data may not perfectly represent the real-world patient population, in this work, we further validated the method and its results using the National Health and Nutrition Examination Survey (NHANES) data. We visualized and quantified the differences in the distributions of age, HbA1c, and BMI among the target population of Type 2 diabetes trials, diabetics in NHANES databases, and a convenience sample of patients enrolled in selected Type 2 diabetes trials. The results are consistent with the previous study.
Department of Biomedical Informatics, Columbia University, New York, NY, USA.
Zhe
Z
He
Department of Biostatistics, Columbia University, New York, NY, USA.
Shuang
S
Wang
Department of Biomedical Informatics, Columbia University, New York, NY, USA.
Elhaam
E
Borhanian
Department of Biomedical Informatics, Columbia University, New York, NY, USA.
Chunhua
C
Weng
D000368:Aged; D016208:Databases, Factual / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology* / Q000628:therapy*; D004035:Diet Therapy / Q000706:statistics & numerical data; D057286:Electronic Health Records / Q000145:classification / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008498:Medical Record Linkage / Q000379:methods*; D008875:Middle Aged; D009749:Nutrition Surveys; D011159:Population Surveillance / Q000379:methods*; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic / Q000145:classification / Q000706:statistics & numerical data*; D013812:Therapeutics; D014481:United States / Q000453:epidemiology