Validation of the controlled ovarian stimulation impact measure (COSI): assessing the patient perspective

BACKGROUND Controlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners. COS also requires concerted efforts by the patients in administering medication and general compliance to treatment protocols. Little is known about the impacts on patients that may be specific to this important first step in treatment. The absence of a conceptually sound and well-validated measure assessing patient experience and functioning during ovarian stimulation has been an obstacle to understanding the impacts of ovarian stimulation on women pursuing IVF. To address this gap, the Controlled Ovarian Stimulation Impact Measure (COSI) was developed based upon accepted methods for designing patient reported outcome (PRO) measures. The purpose of this study was to psychometrically validate the COSI. METHODS 267 patients from three countries (Ireland, United Kingdom, United States) were administered the COSI. Psychometric validation was conducted according to an a priori statistical analysis plan. RESULTS The final 28-item COSI was found to have robust scale structure with four domains: Interference in Daily Life (Work and Home), Injection Burden, Psychological Health and Compliance Worry. Internal consistency of all domains was adequate (between 0.80 to 0.87) as was test-retest reliability (between 0.72-0.87). All a-priori hypotheses for convergent and known-groups validity tests were met. CONCLUSIONS There is a measurable impact of COS on patient functioning and well-being. The COSI is a well-developed and validated PRO measure of this impact. Future work should include examination of responsiveness and confirmation of concepts in non-western countries.