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The patient-reported outcomes measurement information systems (PROMIS®) physical function and its derivative measures in adults: a systematic review of content validity

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Abstract

Purpose

This study aims to systematically review and critically appraise the content validity of the adult versions of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) item bank and its derivative measures in any adult population.

Methods

MEDLINE and EMBASE were searched in October 2021 for studies on measurement properties of PROMIS-PF measures in an adult population. Studies were included if the study described the development of a PROMIS-PF measure or investigated its relevance, comprehensiveness, or comprehensibility. Assessment of the methodological quality of eligible studies, rating of results, and summarizing evidence was performed following the COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) methodology for assessing content validity. A modified GRADE approach was used to determine the level of evidence.

Results

Three development studies and eight studies on the content validity of one or more of the PROMIS-PF measures were identified. The methodological quality of most studies was rated doubtful. There was low to high level evidence for sufficient relevance, comprehensiveness, and comprehensibility of most PROMIS-PF measures for healthy seniors and various disease populations. We found low to moderate level evidence for insufficient relevance of PROMIS-PF measures for patients with conditions that affected only one body part, and insufficient comprehensibility of the PROMIS-PF measures for minority elderly.

Conclusion

Most PROMIS-PF measures demonstrate sufficient content validity in healthy seniors and various disease populations. However, the quality of this evidence is generally low to moderate, due to limitations in the methodological quality of the studies.

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  • 18 June 2022

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References

  1. Smith, T. O., Mansfield, M., Hawker, G. A., Hunter, D. J., March, L. M., Boers, M., Shea, B. J., Christensen, R., Guillemin, F., Terwee, C. B., Williamson, P. R., Roos, E. M., Loeser, R. F., Schnitzer, T. J., Kloppenburg, M., Neogi, T., Ladel, C. H., Kalsi, G., Kaiser, U., … Conaghan, P. G. (2019). Uptake of the OMERACT-OARSI hip and knee osteoarthritis core outcome set: Review of randomized controlled trials from 1997 to 2017. Journal of Rheumatology, 46(8), 976–980. https://doi.org/10.3899/jrheum.181066

    Article  PubMed  Google Scholar 

  2. Ramsey, I., Eckert, M., Hutchinson, A. D., Marker, J., & Corsini, N. (2020). Core outcome sets in cancer and their approaches to identifying and selecting patient-reported outcome measures: A systematic review. J Patient Rep Outcomes, 4(1), 77. https://doi.org/10.1186/s41687-020-00244-3

    Article  PubMed  PubMed Central  Google Scholar 

  3. Lange, T., Rataj, E., Kopkow, C., Lützner, J., Günther, K. P., & Schmitt, J. (2017). Outcome assessment in total knee arthroplasty: A systematic review and critical appraisal. Journal of Arthroplasty, 32(2), 653-665.e651. https://doi.org/10.1016/j.arth.2016.09.014

    Article  PubMed  Google Scholar 

  4. Ciani, O., Salcher-Konrad, M., Meregaglia, M., Smith, K., Gorst, S. L., Dodd, S., Williamson, P. R., & Fattore, G. (2021). Patient-reported outcome measures in core outcome sets targeted overlapping domains but through different instruments. Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2021.03.003

    Article  PubMed  Google Scholar 

  5. Terwee, C., Zuidgeest, M., Vonkeman, H., Cella, D., Haverman, L., & Roorda, L. (2020). Common patient-reported outcomes across ichom standard sets - the potential contribution of PROMIS. OSF Preprints. https://doi.org/10.31219/osf.io/fbw2j

    Article  Google Scholar 

  6. Horn, M. E., Reinke, E. K., Couce, L. J., Reeve, B. B., Ledbetter, L., & George, S. Z. (2020). Reporting and utilization of patient-reported outcomes measurement information System® (PROMIS®) measures in orthopedic research and practice: A systematic review. Journal of Orthopaedic Surgery and Research, 15(1), 553. https://doi.org/10.1186/s13018-020-02068-9

    Article  PubMed  PubMed Central  Google Scholar 

  7. Calvert, M., Kyte, D., Price, G., Valderas, J. M., & Hjollund, N. H. (2019). Maximising the impact of patient reported outcome assessment for patients and society. BMJ, 364, k5267. https://doi.org/10.1136/bmj.k5267

    Article  PubMed  Google Scholar 

  8. Atkinson, T. M., Stover, A. M., Storfer, D. F., Saracino, R. M., D’Agostino, T. A., Pergolizzi, D., Matsoukas, K., Li, Y., & Basch, E. (2017). Patient-reported physical function measures in cancer clinical trials. Epidemiologic reviews, 39(1), 59–70. https://doi.org/10.1093/epirev/mxx008

    Article  PubMed  PubMed Central  Google Scholar 

  9. Oude Voshaar, M. A. H., Vonkeman, H. E., Courvoisier, D., Finckh, A., Gossec, L., Leung, Y. Y., Michaud, K., Pinheiro, G., Soriano, E., Wulfraat, N., Zink, A., & van de Laar, M. (2019). Towards standardized patient reported physical function outcome reporting: Linking ten commonly used questionnaires to a common metric. Quality of Life Research, 28(1), 187–197. https://doi.org/10.1007/s11136-018-2007-0

    Article  CAS  PubMed  Google Scholar 

  10. Bruce, B., Fries, J. F., Ambrosini, D., Lingala, B., Gandek, B., Rose, M., & Ware, J. E. (2009). Better assessment of physical function: item improvement is neglected but essential. Arthritis Research & Therapy, 11(6), R191. https://doi.org/10.1186/ar2890

    Article  Google Scholar 

  11. Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., Ader, D., Fries, J. F., Bruce, B., & Rose, M. (2007). The patient-reported outcomes measurement information system (PROMIS): Progress of an NIH roadmap cooperative group during its first two years. Medical Care, 45(5), S3–S11. https://doi.org/10.1097/01.mlr.0000258615.42478.55

    Article  PubMed  PubMed Central  Google Scholar 

  12. Fries, J. F., Lingala, B., Siemons, L., Glas, C. A., Cella, D., Hussain, Y. N., Bruce, B., & Krishnan, E. (2014). Extending the floor and the ceiling for assessment of physical function. Arthritis & Rhematology, 66(5), 1378–1387. https://doi.org/10.1002/art.38342

    Article  Google Scholar 

  13. Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., Amtmann, D., Bode, R., Buysse, D., Choi, S., Cook, K., Devellis, R., DeWalt, D., Fries, J. F., Gershon, R., Hahn, E. A., Lai, J. S., Pilkonis, P., Revicki, D., … Hays, R. (2010). The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology, 63(11), 1179–1194. https://doi.org/10.1016/j.jclinepi.2010.04.011

    Article  PubMed  PubMed Central  Google Scholar 

  14. Ayala, RJd. (2009). The theory and practice of item response theory. The Guilford Press.

    Google Scholar 

  15. Rose, M., Bjorner, J. B., Gandek, B., Bruce, B., Fries, J. F., & Ware, J. E., Jr. (2014). The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. Journal of clinical epidemiology., 467(5), 516–526.

    Article  Google Scholar 

  16. Rose, M., Bjorner, J. B., Becker, J., Fries, J. F., & Ware, J. E. (2008). Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). Journal of Clinical Epidemiology, 61(1), 17–33. https://doi.org/10.1016/j.jclinepi.2006.06.025

    Article  CAS  PubMed  Google Scholar 

  17. Sireci, S. G. (1998). The construct of content validity. Social Indicators Research, 45(1), 83–117. https://doi.org/10.1023/A:1006985528729

    Article  Google Scholar 

  18. Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1–eliciting concepts for a new PRO instrument. Value Health, 14(8), 967–977. https://doi.org/10.1016/j.jval.2011.06.014

    Article  PubMed  Google Scholar 

  19. Magasi, S., Ryan, G., Revicki, D., Lenderking, W., Hays, R. D., Brod, M., Snyder, C., Boers, M., & Cella, D. (2012). Content validity of patient-reported outcome measures: Perspectives from a PROMIS meeting. Quality of Life Research, 21(5), 739–746. https://doi.org/10.1007/s11136-011-9990-8

    Article  PubMed  Google Scholar 

  20. Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J., Stratford, P. W., Knol, D. L., Bouter, L. M., & de Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of Clinical Epidemiology, 63(7), 737–745. https://doi.org/10.1016/j.jclinepi.2010.02.006

    Article  PubMed  Google Scholar 

  21. PROMIS Physical Function Scoring Manual.

  22. Terwee, C. B., Jansma, E. P., Riphagen, I. I., & de Vet, H. C. (2009). Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Quality of Life Research, 18(8), 1115–1123. https://doi.org/10.1007/s11136-009-9528-5

    Article  PubMed  PubMed Central  Google Scholar 

  23. Terwee, C. B., Prinsen, C. A. C., Chiarotto, A., Westerman, M. J., Patrick, D. L., Alonso, J., Bouter, L. M., de Vet, H. C. W., & Mokkink, L. B. (2018). COSMIN methodology for evaluating the content validity of patient-reported outcome measures: A Delphi study. Quality of Life Research, 27(5), 1159–1170. https://doi.org/10.1007/s11136-018-1829-0

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Terwee, C. B., Mokkink, L. B., Knol, D. L., Ostelo, R. W., Bouter, L. M., & de Vet, H. C. (2012). Rating the methodological quality in systematic reviews of studies on measurement properties: A scoring system for the COSMIN checklist. Quality of Life Research, 21(4), 651–657. https://doi.org/10.1007/s11136-011-9960-1

    Article  PubMed  Google Scholar 

  25. DeWalt, D. A., Rothrock, N., Yount, S., & Stone, A. A. (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45(5), S12–S21. https://doi.org/10.1097/01.mlr.0000254567.79743.e2

    Article  PubMed  PubMed Central  Google Scholar 

  26. Smit, E. B., Bouwstra, H., van der Wouden, J. C., Hertogh, C., Wattel, E. M., Roorda, L. D., & Terwee, C. B. (2020). Development of a Patient-Reported Outcomes Measurement Information System (PROMIS®) short form for measuring physical function in geriatric rehabilitation patients. Quality of Life Research, 29(9), 2563–2572. https://doi.org/10.1007/s11136-020-02506-5

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Ow, Y. L., Thumboo, J., Cella, D., Cheung, Y. B., Yong Fong, K., & Wee, H. L. (2011). Domains of health-related quality of life important and relevant to multiethnic English-speaking Asian systemic lupus erythematosus patients: A focus group study. Arthritis Care Res (Hoboken), 63(6), 899–908. https://doi.org/10.1002/acr.20462

    Article  Google Scholar 

  28. Lynch, A. D., Dodds, N. E., Yu, L., Pilkonis, P. A., & Irrgang, J. J. (2016). Individuals with knee impairments identify items in need of clarification in the Patient Reported Outcomes Measurement Information System (PROMIS(R)) pain interference and physical function item banks - a qualitative study. Health and Quality of Life Outcomes, 14, 77. https://doi.org/10.1186/s12955-016-0478-7

    Article  PubMed  PubMed Central  Google Scholar 

  29. Gelhorn, H. L., Tong, S., McQuarrie, K., Vernon, C., Hanlon, J., MacLaine, G., Lenderking, W., Ye, X., Speck, R. M., Lackman, R. D., Bukata, S. V., Healey, J. H., Keedy, V. L., Anthony, S. P., Wagner, A. J., Von Hoff, D. D., Singh, A. S., Becerra, C. R., Hsu, H. H., … Tap, W. D. (2016). Patient-reported Symptoms of Tenosynovial Giant Cell Tumors. Clinical Therapeutics, 38(4), 778–793. https://doi.org/10.1016/j.clinthera.2016.03.008

    Article  PubMed  PubMed Central  Google Scholar 

  30. Gelhorn, H. L., Ye, X., Speck, R. M., Tong, S., Healey, J. H., Bukata, S. V., Lackman, R. D., Murray, L., Maclaine, G., Lenderking, W. R., Hsu, H. H., Lin, P. S., & Tap, W. D. (2019). The measurement of physical functioning among patients with Tenosynovial Giant Cell Tumor (TGCT) using the Patient-Reported Outcomes Measurement Information System (PROMIS). J Patient Rep Outcomes, 3(1), 6. https://doi.org/10.1186/s41687-019-0099-0

    Article  PubMed  PubMed Central  Google Scholar 

  31. Oude Voshaar, M. A., Ten Klooster, P. M., Glas, C. A., Vonkeman, H. E., Taal, E., Krishnan, E., Bernelot Moens, H. J., Boers, M., Terwee, C. B., van Riel, P. L., & van de Laar, M. A. (2015). Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures. Rheumatology (Oxford), 54(12), 2221–2229. https://doi.org/10.1093/rheumatology/kev265

    Article  Google Scholar 

  32. Liegl, G., Rose, M., Correia, H., Fischer, H. F., Kanlidere, S., Mierke, A., Obbarius, A., & Nolte, S. (2018). An initial psychometric evaluation of the German PROMIS v12 Physical Function item bank in patients with a wide range of health conditions. Clinical Rehabilitation, 32(1), 84–93. https://doi.org/10.1177/0269215517714297

    Article  PubMed  Google Scholar 

  33. Schnohr, C. W., Rasmussen, C. L., Langberg, H., & Bjorner, J. B. (2017). Danish translation of a physical function item bank from the Patient-Reported Outcome Measurement Information System (PROMIS). Pilot Feasibility Stud, 3, 29. https://doi.org/10.1186/s40814-017-0146-7

    Article  PubMed  PubMed Central  Google Scholar 

  34. Krohe, M., Tang, D. H., Klooster, B., Revicki, D., Galipeau, N., & Cella, D. (2019). Content validity of the National Comprehensive Cancer Network - Functional Assessment of Cancer Therapy - Breast Cancer Symptom Index (NFBSI-16) and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form with advanced breast cancer patients. Health and Quality of Life Outcomes, 17(1), 92. https://doi.org/10.1186/s12955-019-1162-5

    Article  PubMed  PubMed Central  Google Scholar 

  35. Paz, S. H., Jones, L., Calderon, J. L., & Hays, R. D. (2017). Readability and Comprehension of the Geriatric Depression Scale and PROMIS((R)) Physical Function Items in Older African Americans and Latinos. Patient, 10(1), 117–131. https://doi.org/10.1007/s40271-016-0191-y

    Article  PubMed  PubMed Central  Google Scholar 

  36. England, R. W., Bailey, C. R., Anatchkova, M. D., Skalicky, A. M., Meissner, M. H., Rosenblatt, M., Gelhorn, H. L., & Weiss, C. R. (2020). Qualitative study of patients with venous malformations: Symptom experiences and content validity of patient-reported outcome measures. Quality of Life Research, 29(6), 1707–1719. https://doi.org/10.1007/s11136-020-02435-3

    Article  PubMed  Google Scholar 

  37. Terwee, C. B., Roorda, L. D., de Vet, H. C., Dekker, J., Westhovens, R., van Leeuwen, J., Cella, D., Correia, H., Arnold, B., Perez, B., & Boers, M. (2014). Dutch-Flemish translation of 17 item banks from the patient-reported outcomes measurement information system (PROMIS). Quality of Life Research, 23(6), 1733–1741. https://doi.org/10.1007/s11136-013-0611-6

    Article  CAS  PubMed  Google Scholar 

  38. Horn, M. K., Liu, K., Mathias, S. D., Colwell, H. H., Li, T., Mahadevia, P., & Pierson, R. F. (2021). Evaluating the content validity, clarity, and relevance of two patient-reported outcomes for use with adults with EGFR-mutated NSCLC. JTO clinical and research reports, 2(8), 100198. https://doi.org/10.1016/j.jtocrr.2021.100198

    Article  PubMed  PubMed Central  Google Scholar 

  39. Kim, Y., Yoon, J., Kim, N., Lee, M., Kang, D., Park, H. Y., Oh, D., Sung, K. S., Suh, G. Y., Ahn, J. S., & Cho, J. (2021). Patient-reported outcomes measurement information system: Translation and linguistic validation of six profile domains for Korean adults. Journal of Korean Medical Science, 36(33), e212. https://doi.org/10.3346/jkms.2021.36.e212

    Article  PubMed  PubMed Central  Google Scholar 

  40. Perez, J. L., Mosher, Z. A., Watson, S. L., Sheppard, E. D., Brabston, E. W., McGwin, G., Jr., & Ponce, B. A. (2017). Readability of orthopaedic patient-reported outcome measures: Is there a fundamental failure to communicate? Clinical Orthopaedics and Related Research, 475(8), 1936–1947. https://doi.org/10.1007/s11999-017-5339-0

    Article  PubMed  PubMed Central  Google Scholar 

  41. Chiarotto, A., Ostelo, R. W., Boers, M., & Terwee, C. B. (2018). A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain. Journal of Clinical Epidemiology, 95, 73–93. https://doi.org/10.1016/j.jclinepi.2017.11.005

    Article  PubMed  Google Scholar 

  42. Abma, I. L., Butje, B. J. D., Ten Klooster, P. M., & van der Wees, P. J. (2021). Measurement properties of the Dutch-Flemish patient-reported outcomes measurement information system (PROMIS) physical function item bank and instruments: A systematic review. Health and Quality of Life Outcomes, 19(1), 62. https://doi.org/10.1186/s12955-020-01647-y

    Article  PubMed  PubMed Central  Google Scholar 

  43. World Health O. (2001). International classification of functioning, disability and health: ICF. World Health Organization.

    Google Scholar 

  44. Zheng, Y., Chang, C. H., & Chang, H. H. (2013). Content-balancing strategy in bifactor computerized adaptive patient-reported outcome measurement. Quality of Life Research, 22(3), 491–499. https://doi.org/10.1007/s11136-012-0179-6

    Article  PubMed  Google Scholar 

  45. Cook, K. F., Choi, S. W., & Johnson, K. L. (2010). Amtmann D (2010) Developing brief fatigue short forms calibrated to a common mathematical metric: Is content-balancing important? Patient related Outcome Measures, 1, 65–71. https://doi.org/10.2147/prom.S7585

    Article  PubMed Central  Google Scholar 

  46. Hays, R. D., Spritzer, K. L., Amtmann, D., Lai, J. S., Dewitt, E. M., Rothrock, N., Dewalt, D. A., Riley, W. T., Fries, J. F., & Krishnan, E. (2013). Upper-extremity and mobility subdomains from the Patient-Reported Outcomes Measurement Information System (PROMIS) adult physical functioning item bank. Archives of Physical Medicine and Rehabilitation, 94(11), 2291–2296. https://doi.org/10.1016/j.apmr.2013.05.014

    Article  PubMed  Google Scholar 

  47. Kaat, A. J., Buckenmaier, C. T., 3rd., Cook, K. F., Rothrock, N. E., Schalet, B. D., Gershon, R. C., & Vrahas, M. S. (2019). The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS). Journal of Patient-Reported Outcomes, 3(1), 69. https://doi.org/10.1186/s41687-019-0158-6

    Article  PubMed  PubMed Central  Google Scholar 

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Funding

This study was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (Quality Medical Specialists Foundation, Grant Number: 53070331). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. CT is president of the PROMIS Health Organisation (PHO).

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Authors and Affiliations

  1. Department of Neurology, OLVG, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands

    V. J. Zonjee, M. J. de Mooij, S. M. van Schaik & R. M. Van den Berg-Vos

  2. IQ Healthcare, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands

    I. L. Abma

  3. Department of Neurology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands

    R. M. Van den Berg-Vos

  4. Amsterdam Rehabilitation Research Center | Reade, Amsterdam, The Netherlands

    L. D. Roorda

  5. Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, The Netherlands

    C. B. Terwee

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  1. V. J. Zonjee
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Correspondence to V. J. Zonjee.

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Conflict of interest

VZ, IA, MdM, SvS, and RvdB declare no conflicts of interest. CT and LR are leaders of the Dutch-Flemish PROMIS National Center. CT is one of the developers of the COSMIN methodology. CT and LR are co-authors on three of the included papers of this review but were not involved in the rating of the methodology and results of these papers. The content of this study does not necessarily represent the official view of the PHO or the Dutch-Flemish PROMIS National Center.

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Zonjee, V.J., Abma, I.L., de Mooij, M.J. et al. The patient-reported outcomes measurement information systems (PROMIS®) physical function and its derivative measures in adults: a systematic review of content validity. Qual Life Res 31, 3317–3330 (2022). https://doi.org/10.1007/s11136-022-03151-w

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