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Strong instrumental variables biased propensity scores in comparative effectiveness research: a case study in oncology

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      Abstract

      Objective

      Some medications require specific medical procedures in the weeks before their start. Such procedures may meet the definition of instrumental variables (IVs). We examined how they may influence treatment effect estimation in propensity score (PS)-adjusted comparative studies, and how to remedy.

      Study Design and Setting

      Different covariate assessment periods (CAP) did and did not include the month preceding treatment start were used to compute PS in the French claims database (SNDS), and 1:1 match patients with metastatic castration resistant prostate cancer initiating abiraterone acetate or docetaxel. The 36-month survival was assessed.

      Results

      Among 1 213 docetaxel and 2 442 abiraterone initiators, the PS distribution resulting from the CAP [-12; 0 months] distinctly separated populations (c=0.93; 273 matched-pairs). The CAP [-12;-1 months] identified 765 pairs (c=0.81). Strong docetaxel treatment predictors during the month before treatment start were implantable delivery systems (1% vs. 59%), which fulfilled IV conditions. The 36-month survival was not meaningfully different under the [-12;0 months] CAP but differed by 10% points (38% vs. 28%) after excluding month -1.

      Conclusion

      In setting of highly predictive pre-treatment procedures, excluding the immediate pre-exposure time from the CAP will reduce the risk of including potential IVs in PS models and may reduce bias.

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