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Expanding patient-reported outcomes (PRO) assessment integrated into routine clinical care of patients with HIV to new PROMIS domains: identifying patient priorities, developing cross-walks with legacy instruments, and evaluating predictive validity
Investigator (PI): Crane, Heidi
Performing Organization (PO): (Current): University of Washington, Fred Hutchinson Center for AIDS Research / (206) 744-3620
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2018
Record Source/Award ID: PCORI/ME-1403-14081
Funding: Total Award Amount: $734,471
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: This exciting proposal continues our longstanding work to integrate patient-reported outcomes (PRO) data into routine clinical care to optimize patient care and PCOR. Of great relevance to this proposal, we lead a PRO Measurement Information System (PROMIS) U01 focused on PROs in routine clinical care for patients living with HIV (PLWH). Objectives: Our aims are to identify PROMIS domains of highest priority to PLWH (aim 1), co-calibrate legacy scales with PROMIS for high-priority domains (aim 2), and determine content validity and integrate the highest priority domains into routine clinical care for PLWH (aim 3). Methods: Study population and sample size: We will perform interviews and focus groups for at least 200 PLWH (aims 1 and 3) in English and Spanish at Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) sites in Seattle, Boston, Birmingham, San Francisco, and San Diego, and collect PRO data from at least 9000 clinical assessments from PLWH (aims 2 and 3). Engagement plan: Patients are colleagues for all of our work. Patients will provide important feedback at every stage, from identifying domains to emphasize (aim 1) to formulating, implementing, and refining dissemination plans. We have recruited three patient co-investigators. We will continue collaborations with community advisory boards from three different clinics. Analytic methods: All methods will adhere to PROMIS standards we helped develop. Aim 1 will involve standard analyses of survey data and qualitative assessment of themes. For aim 2 we will co-administer PROMIS short forms and legacy scales. We will use confirmatory factor analyses (CFA) to assess dimensionality and determine whether PROMIS parameters are appropriate for PLWH, and item response theory (IRT) to co-calibrate and evaluate measurement properties, with methods we have published. For aim 3 we will perform and analyze individual and focus groups interviews to evaluate completeness of PROMIS item banks, usefulness of PROMIS short forms and computerized adaptive testing items for the specific context of clinical care of PLWH, and item comprehensibility. If indicated, we will develop candidate new items using PROMIS methods. We will administer existing PROMIS items, new candidate items, and legacy scales to PLWH, and analyze these data with CFA and IRT. We will capitalize on CNICS's diverse population to evaluate items for differential item functioning (DIF), emphasizing DIF impact using the approach and analytic framework we developed. We will evaluate predictive validity using CNICS's extensive clinical data. Patient outcomes: We will enhance patient care and PCOR by improving understanding of PROMIS 2 domains of highest priority to patients. Anticipated impact: Much more needs to be known about the use of PROMIS 2 scales in clinical care. This project will enhance our understanding of how to optimize PRO collection in clinical care to improve care and optimize PCOR.
MeSH Terms:
  • Community Health Services /organization & administration
  • Delivery of Health Care /*organization & administration
  • Focus Groups
  • HIV Infections /*rehabilitation
  • /therapy
  • Humans
  • Language
  • Multicenter Studies as Topic
  • * Outcome Assessment, Health Care
  • Patient Participation
  • Patient-Centered Care /*organization & administration
  • Predictive Value of Tests
  • Program Development
  • United States
Country: United States
State: Washington
Zip Code: 98104
UI: 20152322
Project Status: Completed
Record History: ('2017: Project extended to 2017. Project extended, 7/7/15.',) ('2018: Project extended to 2018.',)