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The Aesthetic Surgery Education and Research Foundation

Development of Genital Surgery Patient-Reported Outcome Measure Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Gemma Sharp, PhD

Grant Award: ASERF Interim Grant

Amount Awarded: $8,500

Project Name: Personalized Facelift: Development of Genital Surgery Patient-Reported Outcome Measure

Project Summary:  Adult women aged 18 and over in the USA and Australia who have ever undergone an aesthetic genital procedure of any type will be invited to participate in the proposed study through the private clinics of my collaborators (Dr Christine Hamori and Dr Jayson Oates). I will endeavour to include a broad spectrum of procedure types as well as patient demographic features in the sample. I would aim to involve approximately 50 women in the study.
In the first phase of the study, I will interview women via video conference or over the phone obtaining verbal consent at the start of the each interview. The interviews will take a semi-structured approach and involve an in-depth exploration of the personal experiences of patients with aesthetic genital surgery thus providing the areas/topics which are most important for them. The results from the interviews will allow the development of a conceptual framework of patient satisfaction and quality of life in aesthetic genital surgery. Briefly, I will undertake a qualitative analysis of all interview transcripts to identify common themes across the interviews. I will consult with my collaborators regularly to discuss and reach consensus on the themes identified and the content of the conceptual framework. I will also examine the literature and discuss with my collaborators/other medical professionals to determine whether any other important domains need to be added to the conceptual framework.  An exhaustive list of potential items will be generated for each domain within the conceptual framework. It is likely that there will be some domains which will be specific to the surgery type (e.g., hymenoplasty patients are likely to nominate different topics than vaginoplasty patients). This list will form a draft version of the PROM.

I will then invite the same women who participated in the first semi-structured interviews to review the draft PROM in a cognitive or "think aloud" interview. This will involve the participant going through the draft with me asking questions aimed at soliciting her interpretation of the item and the thought process around selecting a response. The data from these interviews will allow me to determine whether participants have understood the item and whether the response options are suitable. The draft PROM will be revised as needed on the basis of the feedback from the "think aloud" interviews and in discussion with my collaborators. After revision, the PROM will be field-tested with pre- and post-genital surgery patients (aged 18 and over) from Dr Hamori and Dr Oates' clinics. I will also invite other clinics in the USA and Australia to become involved at this stage to increase participant numbers. The PROM will be developed into an online survey using the platform, Qualtrics, and a weblink to the survey disseminated to patients via email. I would aim for 1,000 patients to complete the survey. Using Qualtrics, I will be able to accurately measure completion times. I will also offer space at the end of the online survey for patients to add feedback on acceptability of the measure. Psychometric statistical analyses will be performed on the data collected and the final PROM will be developed based on these results. Depending on the time taken to reach the required number of participants for the interviews as well as the field testing of the measure, this project may take longer than 12 months. Please note that my ethics application for this project, ensuring the safety of the research method and participants, is currently being assessed by the Monash University Human Research Ethics Committee (see attached receipt of submission). We expect to receive full approval from this committee in July 2018 and will submit this official notification to ASERF as soon as it is received


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