Procedures
One-on-one interviews were conducted via phone by trained research assistants who were matched in gender to the patient. Interviews were digitally recorded and professionally transcribed; additionally, detailed field notes were taken during and immediately after the interviews. Each interview was roughly 30-60 minutes long and had three parts. The first part consisted of qualitative interviews about patient preferences for discussing SD, and these results will be published separately. The second part consisted of Think-Aloud methods and the third part consisted of cognitive interviewing. Per best practice recommendations, prior to completing Think-Aloud procedures using the SexFS Brief, participants received an introduction to the exercise and participated in a practice Think-Aloud exercise with questions derived from an unrelated PROMIS measure with similar formatting.31 Specifically, patients were asked to state the question number and to verbalize all thoughts as they answered each question. This practice procedure served to familiarize participants with the Think-Aloud method and to allow them to clarify any misunderstandings about the task. In both the practice and SexFS Brief rounds, participants were not interrupted; occasional reminders to verbalize their thoughts were used when needed, as well concurrent and spontaneous verbal probing to explore any verbal or non-verbal behavior such as hesitations or uncertainty (i.e. pauses, or vocalizations such as sighs or “Ummm”). At the conclusion of the SexFS Brief, patients were advised not to submit their responses to the questions in order to provide further confidentiality, as collecting survey responses was not the purpose of this study.
Following the Think-Aloud task, additional cognitive interviewing was performed. Probes were both semi-structured and reactive. In accordance with evidence-based cognitive interviewing for survey evaluation, probes addressed each PRO item and included general questions such as “Was that easy or hard to answer?”, or “I noticed that you hesitated. Tell me about that”.32,34 Focused probes evaluated response process validity according to Tourangeau’s 4-stage cognitive model for answering questions (understanding, retrieval, judgement, and response).35 In addition, comprehensive participant impressions of the content validity of the SexFS Brief were evaluated with questions such as “What do you think about this questionnaire?”, “Were there any questions that didn’t feel relevant to you?”, and “Was there anything not included that you thought it should have asked?”.34 Finally, probes evaluated participant overall impressions of acceptability and usefulness with questions such as “How was completing that survey for you?”.