Quality of Life Research

, Volume 25, Issue 2, pp 293–302 | Cite as

Content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) items in the context of HIV clinical care

  • Todd C. Edwards
  • Rob J. Fredericksen
  • Heidi M. Crane
  • Paul K. Crane
  • Mari M. Kitahata
  • William C. Mathews
  • Kenneth H. Mayer
  • Leo S. Morales
  • Michael J. Mugavero
  • Rosa Solorio
  • Frances M. Yang
  • Donald L. Patrick



To assess content validity and patient and provider prioritization of Patient-Reported Outcomes Measurement Information System (PROMIS) depression, anxiety, fatigue, and alcohol use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed.


We conducted concept elicitation interviews (n = 161), item pool matching, prioritization focus groups (n = 227 participants), and cognitive interviews (n = 48) with English-speaking (~75 %) and Spanish-speaking (~25 %) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3–8 members each.


Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing.


PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care.


HIV Clinical practice Patient-centered outcomes PROMIS 



We would like to thank our study participants who so generously shared their time and insights with us, and also our PROMIS Network colleagues, Paul Pilkonis and Kevin Weinfurt, for their valuable advice and guidance. We would also like to acknowledge our research coordinators, data managers, and interviewers who were instrumental in carrying out the study: Joel Aguirre, Erika Austin, Nelly Ayala, Scott Batey, Tyler Brown, Anna Church, Paul Crawford, Lydia Dant, Gina Denoble, Chris Grasso, Niko Lazarakis, Edgar Paez, and Melonie Walcott. We would especially like to thank our past project manager, Anne Skalicky, who was instrumental in commencing and carrying out this research.


This research was funded by a cooperative agreement awarded to the University of Washington (Principal Investigators: D Patrick, H Crane, P Crane) from the National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (Grant #U01 AR 057954). Support was also provided by the National Institute of Allergy and Infectious Diseases (NIAID) University of Washington Center for AIDS Research (Grant #P30 AI027757) and CNICS (R24 AI067039) and National Institute of Alcohol Abuse and Alcoholism (NIAAA) (ARCH Grants U01 AA020802, U01 AA020793, and U24 AA020801).

Compliance with ethical standards

Conflict of interest

None of the authors have conflicts of interest to report associated with this study.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.


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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Todd C. Edwards
    • 1
  • Rob J. Fredericksen
    • 2
  • Heidi M. Crane
    • 2
  • Paul K. Crane
    • 2
  • Mari M. Kitahata
    • 2
  • William C. Mathews
    • 3
  • Kenneth H. Mayer
    • 4
  • Leo S. Morales
    • 1
  • Michael J. Mugavero
    • 5
  • Rosa Solorio
    • 1
  • Frances M. Yang
    • 6
  • Donald L. Patrick
    • 1
  1. 1.Department of Health Services, School of Public HealthUniversity of WashingtonSeattleUSA
  2. 2.Harborview Madison Clinic, School of MedicineUniversity of WashingtonSeattleUSA
  3. 3.Owen ClinicUniversity of California – San DiegoSan DiegoUSA
  4. 4.The Fenway Institute, School of Public HealthHarvard UniversityBostonUSA
  5. 5.1917 ClinicUniversity of Alabama – BirminghamBirminghamUSA
  6. 6.Georgia Regents UniversityAugustaUSA

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