Development and validation of the FertiMed questionnaire assessing patients' experiences with hormonal fertility medication.

Study Question: Can a valid and reliable questionnaire be developed to assess patients' experiences with all of the characteristics of hormonal fertility medication valued by them?

Summary Answer: The FertiMed questionnaire is a valid and reliable tool that assesses patients' experiences with all medication characteristics valued by them and that can be used for all hormonal fertility medications, irrespective of their route of administration.

What Is Known Already: Hormonal fertility medications cause emotional strain and differ in their dosage regime and route of administration, although they often have comparable effectiveness. Medication experiences of former patients would be informative for medication choices. A recent literature review showed that there is no trustworthy tool to compare patients' experiences of medications with differing routes of administration, regarding all medication characteristics which patients value.

Study Design, Size, Duration: The items of the new FertiMed questionnaire were generated by literature review and 23 patient interviews. In 2013, 411 IVF-patients were asked to retrospectively complete the FertiMed questionnaire to assess 1 out of the 8 different medications used for ovarian stimulation, induction of pituitary quiescence, ovulation triggering or luteal support.

Participants/materials, Setting, Methods: In total, 276 patients (on average 35 per medication) from 2 university fertility clinics (Belgium, the Netherlands) completed the FertiMed questionnaire (67% response rate). The FertiMed questionnaire questioned whether items were valued by patients and whether these items were experienced while using the assessed medication. Hence, the final outcome 'Experiences with Valued Aspects Scores' (EVAS) combined importance and experience ratings. The content and face validity, reliability, feasibility and discriminative potential of the FertiMed questionnaire were tested and changes were made accordingly.

Main Results And The Role Of Chance: Patient interviews defined 51 items relevant to seven medication characteristics previously proved to be important to patients. Item analysis deleted 10 items. The combined results from the reliability and content validity analysis identified 10 characteristics instead of 7. The final FertiMed questionnaire was valid (Adapted Goodness of Fit Index = 0.95) and all but one characteristic ('ease of use: disturbance') could be assessed reliably (Cronbach's α > 0.60). The EVAS per characteristic differed between the medications inducing pituitary quiescence (P = 0.001).

Limitations, Reason For Caution: As all eight medications prescribed in the recruiting clinics were questioned, sample sizes per medication were rather small for presenting EVAS per medication and for testing the discriminative potential of the FertiMed questionnaire.

Wider Implication Of The Findings: The FertiMed questionnaire can be used for all hormonal fertility medications to assess in a valid and reliable way whether patients experience what they value regarding 10 medication characteristics (e.g. side effects and ease of use). Future randomized controlled trials (RCT) comparing medications could include the FertiMed questionnaire as a Patient Reported Experience Measure (PREM). Insights from these RCTs could be used to develop evidence-based decision aids aiming to facilitate shared physician-patient medication choices.

Study Funding/competing Interests: Funding was received from the University of Leuven and Amsterdam University Medical Centre. E.A.F.D. holds a postdoctoral fellowship of the Research Foundation of Flanders. T.D. was appointed Vice-President and Head Global Medical Affairs Fertility at Merck (Darmstadt, Germany) on 1 October 2015. The reported project was initiated and finished before this date. The other authors had no conflicts of interest to declare.