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

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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.

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  1. Jensen, R. E., Rothrock, N. E., DeWitt, E. M., et al. (2015). The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care. Medical Care, 53, 153–159.

    Article  PubMed  Google Scholar 

  2. Kozak, M. S., Mugavero, M. J., Ye, J., et al. (2012). Patient reported outcomes in routine care: Advancing data capture for HIV cohort research. Clinical Infectious Diseases, 54, 141–147.

    Article  PubMed Central  PubMed  Google Scholar 

  3. Snyder, C. F., Aaronson, N. K., Choucair, A. K., et al. (2012). Implementing patient-reported outcomes assessment in clinical practice: A review of the options and considerations. Quality of Life Research, 21, 1305–1314.

    Article  PubMed  Google Scholar 

  4. Haroutiunian, S., Donaldson, G., Yu, J., & Lipman, A. G. (2012). Development and validation of shortened, restructured Treatment Outcomes in Pain Survey instrument (the S-TOPS) for assessment of individual pain patients’ health-related quality of life. Pain, 153, 1593–1601.

    Article  PubMed  Google Scholar 

  5. Brubaker, L., Khullar, V., Piault, E., et al. (2011). Goal attainment scaling in patients with lower urinary tract symptoms: Development and pilot testing of the Self-Assessment Goal Achievement (SAGA) questionnaire. International Urogynecology Journal, 22, 937–946.

    Article  PubMed  Google Scholar 

  6. Mannion, A. F., Caporaso, F., Pulkovski, N., & Sprott, H. (2010). Goal attainment scaling as a measure of treatment success after physiotherapy for chronic low back pain. Rheumatology, 49, 1734–1738.

    Article  PubMed  Google Scholar 

  7. Lohr, K. N., & Zebrack, B. J. (2009). Using patient-reported outcomes in clinical practice: Challenges and opportunities. Quality of Life Research, 18, 99–107.

    Article  PubMed  Google Scholar 

  8. Donaldson, G. (2008). Patient-reported outcomes and the mandate of measurement. Quality of Life Research, 17, 1303–1313.

    Article  PubMed  Google Scholar 

  9. Fredericksen, R., Edwards, T. C., Crawford, P. et al. (in press) Patient and provider priorities for self-reported domains of clinical care. AIDS Care.

  10. Magasi, S., Ryan, G., Revicki, D., et al. (2012). Content validity of patient-reported outcome measures: Perspectives from a PROMIS meeting. Quality of Life Research, 21, 739–746.

    Article  PubMed  Google Scholar 

  11. Fredericksen, R. J., Crane, P. K., Tufano, J., et al. (2012). Integrating a web-based patient assessment into primary care for HIV-infected adults. Journal of AIDS and HIV Research, 4, 47–55.

    Article  PubMed Central  PubMed  Google Scholar 

  12. Lawrence, S. T., Willig, J. H., Crane, H. M., et al. (2010). Routine, self-administered, touch-screen, computer-based suicidal ideation assessment linked to automated response team notification in an HIV primary care setting. Clinical Infectious Diseases, 50, 1165–1173.

    Article  PubMed Central  PubMed  Google Scholar 

  13. Bradley, K. A., Bush, K. R., Epler, A. J., et al. (2003). Two brief alcohol-screening tests From the Alcohol Use Disorders Identification Test (AUDIT): Validation in a female Veterans Affairs patient population. Archives of Internal Medicine, 163, 821–829.

    Article  PubMed  Google Scholar 

  14. Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16, 606–613.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  15. Justice, A. C., Holmes, W., Gifford, A. L., et al. (2001). Development and validation of a self-completed HIV symptom index. Journal of Clinical Epidemiology, 54(Suppl 1), S77–S90.

    Article  PubMed  Google Scholar 

  16. Spitzer, R. L., Kroenke, K., & Williams, J. B. (1999). Validation and utility of a self-report version of PRIME-MD: The PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA, 282, 1737–1744.

    Article  CAS  PubMed  Google Scholar 

  17. Bush, K., Kivlahan, D. R., McDonell, M. B., Fihn, S. D., & Bradley, K. A. (1998). The AUDIT alcohol consumption questions (AUDIT-C): An effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Archives of Internal Medicine, 158, 1789–1795.

    Article  CAS  PubMed  Google Scholar 

  18. DeWalt, D. A., Rothrock, N., Yount, S., & Stone, A. A. (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45, S12–S21.

    Article  PubMed Central  PubMed  Google Scholar 

  19. Brislin, R. W. (1986). Chapter 5: The wording and translation of research instruments. In W. J. Lonner & J. W. Berry (Eds.), Field methods in cross-cultural research (pp. 137–164). London: Sage Publications.

  20. Eremenco, S. L., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation and the Health Professions, 28, 212–232.

    Article  PubMed  Google Scholar 

  21. Fowler, F. J. (1993). Survey research methods. Newbury Park, CA: Sage.

    Google Scholar 

  22. Jabine, T. B. (1984). Cognitive aspects of survey methodology: Building a bridge between disciplines. Report of the Advanced Research Seminar on Cognitive Aspects of Survey Methodology. National Academies.

  23. Willis, G. B. (1999). Cognitive interviewing: A “how to” guide. Research Triangle Park, NC: Research Triangle Institute.

  24. Harley, C., Takeuchi, E., Taylor, S., et al. (2012). A mixed methods approach to adapting health-related quality of life measures for use in routine oncology clinical practice. Quality of Life Research, 21, 389–403.

    Article  PubMed  Google Scholar 

  25. Snyder, C. F., Jensen, R. E., Geller, G., Carducci, M. A., & Wu, A. W. (2010). Relevant content for a patient-reported outcomes questionnaire for use in oncology clinical practice: Putting doctors and patients on the same page. Quality of Life Research, 19, 1045–1055.

    Article  PubMed  Google Scholar 

  26. Greenhalgh, J. (2009). The applications of PROs in clinical practice: What are they, do they work, and why? Quality of Life Research, 18, 115–123.

    Article  PubMed  Google Scholar 

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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).

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Correspondence to Todd C. Edwards.

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

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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.

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

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Edwards, T.C., Fredericksen, R.J., Crane, H.M. et al. Content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) items in the context of HIV clinical care. Qual Life Res 25, 293–302 (2016).

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