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?”.