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Quality of Life Research

, Volume 24, Issue 10, pp 2333–2344 | Cite as

Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients

  • Roxanne E. Jensen
  • Arnold L. Potosky
  • Bryce B. Reeve
  • Elizabeth Hahn
  • David Cella
  • James Fries
  • Ashley Wilder Smith
  • Theresa H. M. Keegan
  • Xiao-Cheng Wu
  • Lisa Paddock
  • Carol M. Moinpour
Article

Abstract

Purpose

To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample.

Methods

Cancer patients 6–13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race–ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status.

Results

PROMIS physical function short forms showed high internal consistency (Cronbach’s α = 0.92–0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r ≥ 0.68), and discriminant validity (unrelated domains all r ≤ 0.3) across survey short forms, age, and race–ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms.

Conclusions

This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race–ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.

Keywords

Patient-reported outcomes Oncology Validation studies Physical function 

Notes

Acknowledgments

PROMIS II was funded by cooperative agreements with a Statistical Center (Northwestern University, PI: David Cella, PhD, 1U54AR057951), a Technology Center (Northwestern University, PI: Richard C. Gershon, PhD, 1U54AR057943), a Network Center (American Institutes for Research, PI: Susan (San) D. Keller, PhD, 1U54AR057926), and thirteen Primary Research Sites which may include more than one institution (State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD, and Arthur A. Stone, PhD, 1U01AR057948; University of Washington, Seattle, PIs: Heidi M. Crane, MD, MPH; Paul K. Crane, MD, MPH; and Donald L. Patrick, PhD, 1U01AR057954; University of Washington, Seattle, PIs: Dagmar Amtmann, PhD, and Karon Cook, PhD, 1U01AR052171; University of North Carolina, Chapel Hill, PI: Darren A. DeWalt, MD, MPH, 2U01AR052181; Children’s Hospital of Philadelphia, PI: Christopher B. Forrest, MD, PhD, 1U01AR057956; Stanford University, PI: James F. Fries, MD, 2U01AR052158; Boston University, PIs: Stephen M. Haley, PhD and David Scott Tulsky, PhD (University of Michigan, Ann Arbor), 1U01AR057929; University of California, Los Angeles, PIs: Dinesh Khanna, MD and Brennan Spiegel, MD, MSHS, 1U01AR057936; University of Pittsburgh, PI: Paul A. Pilkonis, PhD, 2U01AR052155; Georgetown University, PIs: Arnold L. Potosky, PhD and Carol. M. Moinpour, PhD (Fred Hutchinson Cancer Research Center, Seattle),U01AR057971; Children’s Hospital Medical Center, Cincinnati, PI: Esi M. Morgan DeWitt, MD, MSCE, 17 1U01AR057940; University of Maryland, Baltimore, PI: Lisa M. Shulman, MD, 1U01AR057967; and Duke University, PI: Kevin P. Weinfurt, PhD, 2U01AR052186). NIH Science Officers on this project have included Deborah Ader, PhD; Vanessa Ameen, MD; Susan Czajkowski, PhD; Basil Eldadah, MD, PhD; Lawrence Fine, MD, DrPH; Lawrence Fox, MD, PhD; Lynne Haverkos, MD, MPH; Thomas Hilton, PhD; Laura Lee Johnson, PhD; Michael Kozak, PhD; Peter Lyster, PhD; Donald Mattison, MD; Claudia Moy, PhD; Louis Quatrano, PhD; Bryce B. Reeve, PhD; William Riley, PhD; Ashley Wilder Smith, PhD, MPH; Susana Serrate-Sztein,MD; Ellen Werner, PhD; and James Witter, MD, PhD. This project was supported by the following: U01AR057971 (PIs: Potosky, Moinpour), National Cancer Institute supplement P30CA051008, NCI P30CA051008, UL1TR000101 (previously UL1RR031975) from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through the Clinical and Translational Science Awards Program (CTSA).

Conflict of interest

The authors have no conflicts of interest to disclose.

References

  1. 1.
    Ness, K. K., Wall, M. M., Oakes, J. M., Robison, L. L., & Gurney, J. G. (2006). Physical performance limitations and participation restrictions among cancer survivors: a population-based study. Annals of Epidemiology, 16(3), 197–205.CrossRefPubMedGoogle Scholar
  2. 2.
    Courneya, K. S., & Friedenreich, C. M. (2007). Physical activity and cancer control. Seminars in Oncology Nursing, 23(4), 242–252.CrossRefPubMedGoogle Scholar
  3. 3.
    Stafford, R. S., & Cyr, P. L. (1997). The impact of cancer on the physical function of the elderly and their utilization of health care. Cancer, 80(10), 1973–1980.CrossRefPubMedGoogle Scholar
  4. 4.
    Izano, M., Satariano, W. A., Hiatt, R. A., & Braithwaite, D. (2013). The impact of functional limitations on long-term outcomes among African-American and white women with breast cancer: a cohort study. BMJ Open, 3(10), e003232.PubMedCentralCrossRefPubMedGoogle Scholar
  5. 5.
    Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., et al. (1993). The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579.PubMedGoogle Scholar
  6. 6.
    Ware, J. E, Jr, & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care, 30(6), 473–483.CrossRefPubMedGoogle Scholar
  7. 7.
    Cella, D., Yount, S., Rothrock, N., Gershon, R., Cook, K., Reeve, B., et al. (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 Suppl 1), S3–S11.PubMedCentralCrossRefPubMedGoogle Scholar
  8. 8.
    DeWalt, D. A., Rothrock, N., Yount, S., & Stone, A. A. (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45(5 Suppl 1), S12–S21.PubMedCentralCrossRefPubMedGoogle Scholar
  9. 9.
    Reeve, B. B., Hays, R. D., Bjorner, J. B., Cook, K. F., Crane, P. K., Teresi, J. A., et al. (2007). Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Medical Care, 45(5 Suppl 1), S22–S31.CrossRefPubMedGoogle Scholar
  10. 10.
    Schag, C. C., Heinrich, R. L., & Ganz, P. A. (1984). Karnofsky performance status revisited: Reliability, validity, and guidelines. Journal of Clinical Oncology, 2(3), 187–193.PubMedGoogle Scholar
  11. 11.
    Peus, D., Newcomb, N., & Hofer, S. (2013). Appraisal of the Karnofsky performance status and proposal of a simple algorithmic system for its evaluation. BMC Medical Informatics and Decision Making, 13(1), 72.PubMedCentralCrossRefPubMedGoogle Scholar
  12. 12.
    Fries, J., Rose, M., & Krishnan, E. (2011). The PROMIS of better outcome assessment: responsiveness, floor and ceiling effects, and Internet administration. Journal of Rheumatology, 38(8), 1759–1764.CrossRefPubMedGoogle Scholar
  13. 13.
    Stucki, G., Stucki, S., Bruhlmann, P., & Michel, B. A. (1995). Ceiling effects of the Health Assessment Questionnaire and its modified version in some ambulatory rheumatoid arthritis patients. Annals of the Rheumatic Diseases, 54(6), 461–465.PubMedCentralCrossRefPubMedGoogle Scholar
  14. 14.
    Bruce, B., Fries, J. F., Ambrosini, D., Lingala, B., Gandek, B., Rose, M., & Ware, J. E, Jr. (2009). Better assessment of physical function: Item improvement is neglected but essential. Arthritis Research & Therapy, 11(6), R191.CrossRefGoogle Scholar
  15. 15.
    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.CrossRefPubMedGoogle Scholar
  16. 16.
    Liu, H., Cella, D., Gershon, R., Shen, J., Morales, L. S., Riley, W., & Hays, R. D. (2010). Representativeness of the Patient-Reported Outcomes Measurement Information System Internet panel. Journal of Clinical Epidemiology, 63(11), 1169–1178.PubMedCentralCrossRefPubMedGoogle Scholar
  17. 17.
    Hambleton, R. K., Swaminathan, H., & Rogers, H. J. (1991). Fundamentals of item response theory. Newbury Park, CA: Sage.Google Scholar
  18. 18.
    Eremenco, S. L., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & The Health Professions, 28(2), 212–232.CrossRefGoogle Scholar
  19. 19.
    U.S. Census Bureau, U.S. Department of Commerce, & Economics and Statistics Administration. Overview of Race and Hispanic Origin. (2010). 2010 Census briefs. Issued March 2011. http://www.census.gov/prod/cen2010/briefs/c2010br-02.pdf. Accessed July 2, 2014
  20. 20.
    Assessment Center. Instruments available for use in Assessment Center. (2014). Retrieved August 14, 2014, from http://www.assessmentcenter.net/documents/instrumentLibrary.pdf
  21. 21.
    Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric Theory (3rd ed.). New York: McGraw-Hill.Google Scholar
  22. 22.
    Peterman, A. H., Fitchett, G., Brady, M. J., Hernandez, L., & Cella, D. (2002). Measuring spiritual well-being in people with cancer: The functional assessment of chronic illness therapy–Spiritual Well-being Scale (FACIT-Sp). Annals of Behavioral Medicine, 24(1), 49–58.CrossRefPubMedGoogle Scholar
  23. 23.
    Ware, J. E., Jr., Davies-Avery, A., & Stewart, A. L. (1978). The measurement and meaning of patient satisfaction. Health & Medical Care Services Review, 1(1), 3–15.Google Scholar
  24. 24.
    Marin, G., Sabogal, F., Marin, B. V., Otero-Sabogal, R., & Perez-Stable, E. J. (1987). Development of a short acculturation scale for Hispanics. Hispanic Journal of Behavioral Sciences, 9(2), 183–205. doi: 10.1177/07399863870092005.CrossRefGoogle Scholar
  25. 25.
    Oken, M. M., Creech, R. H., Tormey, D. C., Horton, J., Davis, T. E., McFadden, E. T., & Carbone, P. P. (1982). Toxicity and response criteria of the Eastern Cooperative Oncology Group. American Journal of Clinical Oncology, 5(6), 649–655.CrossRefPubMedGoogle Scholar
  26. 26.
    Nunnally, J. (1978). Psychometric theory. New York: McGraw-Hill.Google Scholar
  27. 27.
    Yost, K. J., Eton, D. T., Garcia, S. F., & Cella, D. (2011). Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. Journal of Clinical Epidemiology, 64(5), 507–516.PubMedCentralCrossRefPubMedGoogle Scholar
  28. 28.
    Fries, J. F., Krishnan, E., Rose, M., Lingala, B., & Bruce, B. (2011). Improved responsiveness and reduced sample size requirements of PROMIS physical function scales with item response theory. Arthritis Research & Therapy, 13(5), R147.CrossRefGoogle Scholar
  29. 29.
    Hung, M., Baumhauer, J. F., Latt, L. D., Saltzman, C. L., SooHoo, N. F., Hunt, K. J., … Ankle Outcomes Research N. (2013). Validation of PROMIS (R) Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research. Clinical Orthopaedics and Related Research, 471(11), 3466–3474.PubMedCentralCrossRefPubMedGoogle Scholar
  30. 30.
    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, 67(5), 516–526.PubMedCentralCrossRefPubMedGoogle Scholar
  31. 31.
    Bruce, B., Fries, J., Lingala, B., Hussain, Y. N., & Krishnan, E. (2013). Development and assessment of floor and ceiling items for the PROMIS physical function item bank. Arthritis Research & Therapy, 15(5), R144.CrossRefGoogle Scholar
  32. 32.
    Fries, J. F., Lingala, B., Siemons, L., Glas, C. A., Cella, D., Hussain, Y. N., … Krishnan, E. (2014). Extending the floor and the ceiling for assessment of physical function. Arthritis & Rheumatology, 66(5), 1378–1387.CrossRefGoogle Scholar
  33. 33.
    PROMIS (Patient-Reported Outcomes Measurement Information System). PROMIS Adult Profile Instruments. (2014). http://www.assessmentcenter.net/documents/PROMIS%20Profile%20Scoring%20Manual.pdf. Accessed July 2, 2014
  34. 34.
    Arora, N. K., Reeve, B. B., Hays, R. D., Clauser, S. B., & Oakley-Girvan, I. (2011). Assessment of quality of cancer-related follow-up care from the cancer survivor’s perspective. Journal of Clinical Oncology, 29(10), 1280–1289.PubMedCentralCrossRefPubMedGoogle Scholar
  35. 35.
    Catalano, P. J., Ayanian, J. Z., Weeks, J. C., Kahn, K. L., Landrum, M. B., Zaslavsky, A. M., … Cancer Care Outcomes Research Surveillance, C. (2013). Representativeness of participants in the cancer care outcomes research and surveillance consortium relative to the surveillance, epidemiology, and end results program. Medical Care, 51(2), e9–15.PubMedCentralCrossRefPubMedGoogle Scholar
  36. 36.
    Harlan, L. C., Lynch, C. F., Keegan, T. H., Hamilton, A. S., Wu, X. C., Kato, I., West, M. M., Cress, R. D., Schwartz, S. M., Smith, A. W., Deapen, D., Stringer, S. M., Potosky, A. L., & Group, A. H. S. C. (2011). Recruitment and follow-up of adolescent and young adult cancer survivors: The AYA HOPE Study. Journal of Cancer Survivorship, 5(3), 305–314.Google Scholar
  37. 37.
    Paz, S. H., Spritzer, K. L., Morales, L. S., & Hays, R. D. (2013). Age-related Differential Item Functioning for the Patient-Reported Outcomes Information System (PROMIS(R)) Physical Functioning Items. Prim Health Care, 3(131).Google Scholar
  38. 38.
    McCabe, R. M., Grutsch, J. F., Nutakki, S. B., Braun, D. P., & Markman, M. (2014). Can quality of life assessments differentiate heterogeneous cancer patients? PLoS One, 9(6), e99445.Google Scholar
  39. 39.
    Reeve, B. B., Potosky, A. L., Smith, A. W., Han, P. K., Hays, R. D., Davis, W. W., et al. (2009). Impact of cancer on health-related quality of life of older Americans. Journal of the National Cancer Institute, 101(12), 860–868.Google Scholar
  40. 40.
    Rosenfeld, B., Roth, A. J., Gandhi, S., & Penson, D. (2004). Differences in health-related quality of life of prostate cancer patients based on stage of cancer. Psycho-Oncology, 13(11), 800–807.Google Scholar
  41. 41.
    Ganz, P. A., Rowland, J. H., Meyerowitz, B. E., & Desmond, K. A. (1998). Impact of different adjuvant therapy strategies on quality of life in breast cancer survivors. Recent Results in Cancer Research, 152, 396–411.Google Scholar
  42. 42.
    Hile, E. S., Fitzgerald, G. K., & Studenski, S. A. (2010). Persistent mobility disability after neurotoxic chemotherapy. Physical Therapy, 90(11), 1649–1657.Google Scholar
  43. 43.
    Smith, A. M., Villareal, M., Bernstein, D. I., & Swikert, D. J. (2012). Asthma in the elderly: Risk factors and impact on physical function. Annals of Allergy, Asthma & Immunology, 108(5), 305–310.Google Scholar
  44. 44.
    Eisner, M. D., Blanc, P. D., Yelin, E. H., Sidney, S., Katz, P. P., Ackerson, L., et al. (2008). COPD as a systemic disease: Impact on physical functional limitations. American Journal of Medicine, 121(9), 789–796.Google Scholar
  45. 45.
    Dominick, K. L., Ahern, F. M., Gold, C. H., & Heller, D. A. (2004). Health-related quality of life among older adults with arthritis. Health and Quality of Life Outcomes, 2, 5.Google Scholar
  46. 46.
    Silver, J. K., Baima, J., & Mayer, R. S. (2013). Impairment-driven cancer rehabilitation: An essential component of quality care and survivorship. CA: A Cancer Journal for Clinicians, 63(5), 295–317.Google Scholar
  47. 47.
    Fortin, M., Bravo, G., Hudon, C., Lapointe, L., Almirall, J., Dubois, M. F., & Vanasse, A. (2006). Relationship between multimorbidity and health-related quality of life of patients in primary care. Quality of Life Research, 15(1), 83–91.Google Scholar
  48. 48.
    Speck, R. M., Courneya, K. S., Masse, L. C., Duval, S., & Schmitz, K. H. (2010). An update of controlled physical activity trials in cancer survivors: A systematic review and meta-analysis. Journal of Cancer Survivorship, 4(2), 87–100.Google Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Roxanne E. Jensen
    • 1
  • Arnold L. Potosky
    • 1
  • Bryce B. Reeve
    • 2
    • 3
  • Elizabeth Hahn
    • 4
  • David Cella
    • 4
  • James Fries
    • 5
  • Ashley Wilder Smith
    • 6
  • Theresa H. M. Keegan
    • 7
    • 8
  • Xiao-Cheng Wu
    • 9
  • Lisa Paddock
    • 10
  • Carol M. Moinpour
    • 11
  1. 1.Cancer Prevention and Control Program, Lombardi Comprehensive Cancer CenterGeorgetown UniversityWashingtonUSA
  2. 2.Lineberger Comprehensive Cancer CenterUniversity of North CarolinaChapel HillUSA
  3. 3.Department of Health Policy and ManagementUniversity of North CarolinaChapel HillUSA
  4. 4.Northwestern University Feinberg School of MedicineChicagoUSA
  5. 5.Stanford UniversityPalo AltoUSA
  6. 6.Division of Cancer Control and Population SciencesNational Cancer InstituteRockvilleUSA
  7. 7.Cancer Prevention Institute of CaliforniaFremontUSA
  8. 8.Department of Health Research and PolicyStanford University School of MedicineStanfordUSA
  9. 9.Louisiana State University Health Sciences Center School of Public HealthNew OrleansUSA
  10. 10.Rutgers Cancer Institute of New JerseyNew BrunswickUSA
  11. 11.Public Health Sciences DivisionFred Hutchinson Cancer Research CenterSeattleUSA

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