Journal: BMC Medical Research Methodology

Article Title: The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade ®

doi: 10.1186/s12874-024-02428-7

Figure Lengend Snippet: Empirical equipoise, covariate balance, empirical calibration validity diagnostics and representativeness for IBD primary analysis Key: Amb EMR = IQVIA Ambulatory Electronic Medical Records; ASMD = absolute standardized mean difference; CCAE = Merative™ MarketScan ® Commercial Database; CI = Confidence Interval; Clinformatics ® = Optum ® De-Identified Clinformatics ® Data Mart Database; EASE = expected absolute systematic error; HR = Hazard ratio; IBD = irritable bowel diseases (Crohn’s disease or ulcerative colitis); IBD comparator = golimumab, certolizumab pegol, ustekinumab, or vedolizumab; Optum ® EHR = Optum ® De-Identified Electronic Health Record; Pharmetrics = IQVIA Adjudicated Health Plan Claims Data; Remicade ® (m) = Remicade ® exposure; Target covariate prevalence = prevalence of baseline covariates in the initial Remicade ® exposure cohort before study design restrictions were applied; Analytic covariate prevalence = prevalence of baseline covariates in Remicade ® exposure cohort after study design restrictions were applied (i.e., PS matching)

Article Snippet: The EHR databases included Optum ® de-identified Electronic Health Record Dataset (Optum ® EHR) and IQVIA Ambulatory EMR (Amb EMR).

Techniques:

Journal: BMC Medical Research Methodology

Article Title: The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade ®

doi: 10.1186/s12874-024-02428-7

Figure Lengend Snippet: Attrition diagrams for inflammatory bowel diseases (IBD); patient attrition counts and proportions after sequential design choices applied Key: Amb EMR = IQVIA Ambulatory Electronic Medical Records; ASMD = absolute standardized mean difference; CCAE = Merative™ MarketScan ® Commercial Database; CI = Confidence Interval; Clinformatics ® = Optum ® De-Identified Clinformatics ® Data Mart Database; EASE = expected absolute systematic error; HR = Hazard ratio; Optum ® EHR = Optum ® De-Identified Electronic Health Record; Pharmetrics = IQVIA Adjudicated Health Plan Claims Data; RA = rheumatoid arthritis; RA comparator = certolizumab pegol or tocilizumab; Remicade ® (m) = Remicade ® exposure with concurrent methotrexate; Target covariate prevalence = prevalence of baseline covariates in the initial Remicade ® exposure cohort before study design restrictions were applied; Analytic covariate prevalence = prevalence of baseline covariates in Remicade ® exposure cohort after study design restrictions were applied (i.e., PS matching)

Article Snippet: The EHR databases included Optum ® de-identified Electronic Health Record Dataset (Optum ® EHR) and IQVIA Ambulatory EMR (Amb EMR).

Techniques:

Journal: BMC Medical Research Methodology

Article Title: The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade ®

doi: 10.1186/s12874-024-02428-7

Figure Lengend Snippet: Empirical equipoise, covariate balance, empirical calibration validity diagnostics and representativeness for RA primary analysis Key – Target: patients with inflammatory bowel diseases newly exposed to Remicade ® , Comparator: patients with inflammatory bowel diseases newly exposed to [golimumab, certolizumab pegol, ustekinumab, or vedolizumab], CCAE: Merative™ MarketScan ® Commercial Database, Optum ® EHR = Optum ® De-Identified Electronic Health Record; Pharmetrics = IQVIA Adjudicated Health Plan Claims Data

Article Snippet: The EHR databases included Optum ® de-identified Electronic Health Record Dataset (Optum ® EHR) and IQVIA Ambulatory EMR (Amb EMR).

Techniques:

Journal: BMC Medical Research Methodology

Article Title: The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade ®

doi: 10.1186/s12874-024-02428-7

Figure Lengend Snippet: Risk of non-infectious uveitis (NIU) among patients with inflammatory bowel diseases (IBD) Key – PS: propensity score, OT: on-treatment, ITT: intention-to-treat, T: Remicade ® new users with IBD, C: golimumab, certolizumab pegol, ustekinumab, or vedolizumab new users with IBD, IR: incidence rate, PYs: person-years, CCAE: Merative™ MarketScan ® Commercial Database, Optum ® EHR: Optum ® De-Identified Electronic Health Record, Pharmetrics: IQVIA Adjudicated Health Plan Claims Data

Article Snippet: The EHR databases included Optum ® de-identified Electronic Health Record Dataset (Optum ® EHR) and IQVIA Ambulatory EMR (Amb EMR).

Techniques: