Background: Growing recognition of the value of routine, systematic collection of patient-reported data in care has led to the development and use of self-report assessments, referred to as patient-reported outcomes (PROs). PROs assess conditions and behaviors that might otherwise be overlooked or that are difficult and time-consuming for clinicians to assess in brief clinical encounters.

Objectives: We had 3 aims for this study:

1. Aim 1. Identify PRO domains of highest priority to people living with HIV (PLWH).

2. Aim 2. Cocalibrate legacy instruments with PROMIS® instruments.

3. Aim 3. Examine content validity and integrate clinically relevant domains into routine clinical care for PLWH.

Methods:

1. Study population and sample size: We conducted interviews and focus groups on patient PRO domain priorities as well as concept elicitation and cognitive interviews for key domains among PLWH (aims 1 and 3) in English and Spanish at Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) sites across the United States and collected PRO data from clinical assessments from PLWH (aims 2 and 3).

2. Analytic methods: Aim 1 involved standard analyses of survey data and qualitative assessment of themes to identify and set priorities for key PRO domains for PLWH and for important subgroups such as transgender individuals. For aim 2 we coadministered PROMIS short forms and legacy instruments. We used item response theory to cocalibrate PROMIS and legacy instruments and to evaluate the measurement properties of PROMIS instruments. This is important because it facilitates seamless patient-centered outcomes research before and after changes in PROs at an individual clinic. For aim 3 we conducted and analyzed data from interviews and focus groups to evaluate the completeness of existing item banks and instruments and to identify additions needed for clinical care of PLWH. We then implemented clinically relevant PRO domains into clinical care at HIV clinics in CNICS.

Results:

1. Aim 1. PLWH and clinicians showed high discordance in rank order priorities (P < .001). In particular, PLWH ranked domains related to social context (HIV stigma, social support) as high priorities, whereas clinicians were more likely to prioritize substance and tobacco use. Women and Hispanic patients ranked social support more highly than other groups. Interviews with 68 patients revealed concern that negative social context adversely affects other health domains, including depression and self-medicating behavior.

2. Aim 2. We completed data collection for depression, alcohol, global functioning, intimate partner violence, and social support instrument cocalibration (n > 500 PLWH for each domain). For example, 2497 PLWH completed both legacy and PROMIS Alcohol Use measures as part of the same assessment.

3. Aim 3. We conducted concept elicitation interviews focused on social support with 32 patients who identified needs in terms of emotional support, feelings of belonging or inclusion, and practical support. In focus groups, 23 patients ranked candidate items representing these subdomains. We assessed high-priority social support items in cognitive interviews with 30 patients and reworded the items for comprehensibility, resulting in a well-understood measure comprising 8 items. Cognitive interviews with 44 patients for intimate partner violence yielded well-understood items that measured feeling controlled or trapped, being made to feel afraid of harm, being pressured or forced to engage in sexual activity, and experiencing nonsexual physical harm. The resulting 4-item brief instrument has been integrated into routine clinical care at CNICS sites across the United States and used as a basis for clinic-based interventions to reduce intimate partner violence.

Limitations: Our results are from busy HIV specialty clinics in academic settings. Their geographical diversity is a strength, but our findings might not be generalizable to other clinical settings.

Conclusions: Priorities in HIV clinical care vary substantially between patients and clinicians, and by patient gender, race, and level of engagement in care. We identified social support and intimate partner violence as key clinically relevant domains of care for measure development.