Abstract

Abstract Introduction Patient-reported outcome measures that were initially designed for research studies including heterosexual, partnered, educated cisgender women may have limited applicability for clinical use among Sexual and Gender Minority (SGM) patients and patients without a partner. Objective We aimed to conduct cognitive interviews with both SGM persons and heterosexual women to determine readability, comprehension, and applicability of questionnaire items to assess sexual function in populations with diverse sexual practices, focusing on items from the Female Sexual Function Index (FSFI), and to establish content validity of a modified measure. Methods We conducted four rounds of cognitive interviews with 52 participants (28 SGM, 24 heterosexual) who provided feedback on their comprehension and wording of FSFI questionnaire items and response scales. Participants made recommendations for changes to the questionnaire, which was iteratively revised between interview rounds. Two independent coders analyzed the transcripts using structural coding based on five predefined codes (i.e., satisfaction with item, specificity/language change needed, missing/suggested item, patient definitions of concepts, and confusion with item). Results After four rounds of cognitive interviews and revisions to the questionnaire, participants found the final version of the questionnaire acceptable and understandable, thereby reaching thematic saturation and establishing content validity of the modified FSFI. Modifications included: replacing all instances of “sexual stimulation” and “intercourse” with “sexual activity (alone or with a partner)”; broadening the definition of “vaginal penetration” beyond penile-vaginal penetration; adding skip logic to include the option “no sexual activity”. Participants identified missing concepts important to their sexual health, such as including the use of external lubricant. Heterosexual participants found the questionnaire initially refined by SGM participants to be acceptable, and offered targeted feedback including clarifying the clinical relevance of certain domains (e.g., questions about “emotional closeness”), clarifying terminology (e.g., sexually aroused (turned on) and naturally lubricated (wet)) and re-ordering domains (e.g., “pain should be asked about earlier”). Conclusions Feedback from direct interviews supports modifying FSFI items and further psychometric testing. This and other similar questionnaires need to be adapted to the broader clinical practice population such that all persons’ experiences are accurately reflected and assessed, ultimately assuring that sexual health needs can be met more inclusively. Further research in racially and educationally diverse populations is needed. Disclosure No

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