3.4. Study Design and Procedures

The described work was conducted in multiple steps. All steps were completed in serial order for the depression, anxiety, fatigue, and alcohol use items.

A semistructured protocol was developed for each scale (Spanish versions). The protocol consisted primarily of cognitive probing and paraphrasing.

For all PROMIS items, testing consisted of administering the scale items and subsequently asking individuals for the meaning of selected words or expressions. When participants did not understand a question, the intended meaning of the question was explained. Participants were also asked to suggest alternative wording or phrasing to improve the clarity of questions that were difficult to understand.

Table 1 describes the study sample. To ensure broad representation of Latino persons living with HIV across severity levels for each domain, we defined severity levels for each domain as assessed by the clinical assessment and then selected Latinos living with HIV for each severity level to test for comprehension of PROMIS items (Table 2).

Severity of disease found among participants in the first round of cognitive interviews.

Prior to the cognitive interview, participants completed a domain-specific item set (e.g., only the depression items) through paper and pencil administration. We followed this with the cognitive interview, wherein we asked open-ended questions regarding response categories, time frame, item interpretation, and domain content.

A trained RA reviewed each item stem and its response with the participant. The RA began by using the standardized question (see Table 3) for each item. The RA recorded the participant's interpretation of the item and opinion on preferences in an Excel spreadsheet. We also asked participants about the extent to which each item contained information they considered most important to communicate with their provider regarding their experiences, whether the questions included all the issues they deemed important for their provider to know regarding their experience with depression/anxiety/fatigue/alcohol use, and what was missing from each list of items.

The cognitive interview guide for participants.

The cognitive interviews evaluated participants' comprehension of the translated item. Each PROMIS English item was taken through three main steps necessary to meet FACIT methodology requirements [5]. The interviewers first took the participants through the think-aloud process and then performed the respondent debriefing. In the respondent debriefing, participants reviewed the problem areas and identified common themes and possible solutions.

Cognitive interviews were conducted with 56 Latinos living with HIV for the first round of this project, then with 28 for the second round, and then with five for the third round. Each participant was tested with PROMIS items from one domain, using one set of instructions, and one response scale.

For the first round of item testing, we tested 195 PROMIS items. This was followed by a second round of cognitive interviews on 54 items, and a third round on 21 items. All interviews were audio-recorded.