Quality of care in an IVF programme from a patient's perspective: development of a validated instrument.

STUDY QUESTION: Is it possible to develop a trustworthy instrument to evaluate the patient's perspective on fertility care and to document fully all methodological steps, including validation? SUMMARY ANSWER: A validated instrument has been developed for both women and men undergoing assisted reproduction to monitor the quality of care on a regular basis, similar to live birth rates and other effectiveness data. WHAT IS KNOWN ALREADY?: Within fertility care, several instruments have been developed, but many have significant methodological problems and few have been validated. Most instruments focus exclusively on women and no questionnaires have been directed at women and men separately. STUDY DESIGN, SIZE AND DURATION: The questionnaire specific to IVF treatments (QPP-IVF) is based on the theoretical foundation of the validated general instrument, quality of care from patients perspective (QPP), for both women and men. The QPP-IVF was developed and validated by quantitative methods. A two-centre study ran between September 2011 and May 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: In all, 655 women and men participated. The measurements consisted of two kinds of evaluations: the rating of perceived reality of care and the rating of the subjective importance of various aspects of treatment. The questionnaire consisted of 43 items for women and 42 items for men. An exploratory factor analysis was performed for women for all items of subjective importance. Eigenvalue, explained variance and factor loading are given for each factor. Internal consistency of subscales was assessed by Cronbach's alpha, item discriminant validity and percentage scaling success. For external validity, a correlation with fertility quality of life (FertiQoL) was performed and for reliability, a test-retest analysis was carried out. Sensitivity analyses were performed by known-group analyses. All significance tests were two sided and conducted at the 5% significance level. MAIN RESULTS AND THE ROLE OF CHANCE: The QPP-IVF instrument, divided into four dimensions, seemed a valid and reliable way of measuring the quality of care from a patient's perspective, for both women and men. The item-scaling test confirmed 10 underlying factors, with scaling success in all subscales and Cronbach's alpha >0.70 for women in almost all subscales. It was somewhat lower for men but still acceptable. The external validity was acceptable, with significant correlation between QPP-IVF and FertiQoL. The test-retest analysis confirmed that QPP-IVF was a stable instrument, with intra-class correlation coefficients from 0.74 to 0.89 for women. Sensitivity analyses indicated a sensitive instrument. LIMITATIONS, REASON FOR CAUTION: The response rate to the questionnaire was 67.5%. Although considered acceptable in questionnaire studies, this response level might introduce a certain risk of selection bias. The questionnaire was developed and validated only in Sweden. WIDER IMPLICATIONS OF THE FINDINGS: The QPP-IVF may be of use for purposes of quality improvement and national comparisons. Future studies should focus on establishing the QPP-IVF as a valuable instrument for measuring the quality of care outside Sweden.