Abstract
A conceptual model was developed of the impact of ovarian stimulation on women's functioning and wellbeing. A patient-reported outcome (PRO) measure was generated based on this model. Qualitative measures used comprised a discussion guide and coding system devised according to the Food and Drug Administration guidelines for developing PRO measures. Data were gathered through telephone and face-to-face interviews and focus groups. A total of 47 women across nine fertility healthcare providers in France, UK and USA were included in the analysis. The mean age of patients was 35 years (range 24-44). Based on data collected and prior postulated domains, a conceptual model of the impact of ovarian stimulation was developed. Three major (psychological, interference in daily life, logistics) and one minor (side effects) domain were identified. Short-term consequences included problems with psychological health and productivity. Longer term consequences included depression and poor self-image. Factors that modified the impact of ovarian stimulation were also identified. This is the first model providing insight into the impact of ovarian stimulation on women's functioning and wellbeing. Once validated, it can be applied in quantitative research to improve understanding of the impact of ovarian stimulation, and assist in developing more patient-centred approaches to treatment.
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