Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction

Elizabeth J Scott, Robert Westermann, Nathalie A Glass, Carolyn Hettrich, Brian R Wolf, Matthew J Bollier, Elizabeth J Scott, Robert Westermann, Nathalie A Glass, Carolyn Hettrich, Brian R Wolf, Matthew J Bollier

Abstract

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains.

Purpose: To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction.

Study design: Cohort study (diagnosis); Level of evidence, 2.

Methods: Initially, 157 patients completed the PROMIS PF CAT, Short Form-36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol-5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models.

Results: At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF (r = 0.75-0.80, P < .01), KOOS-ADL (r = 0.63-0.70, P < .01), and KOOS-sport (r = 0.32-0.69, P < .01); excellent-good correlation with the EQ-5D (r = 0.60-0.71, P < .01); and good correlation with the KOOS-QOL (r = 0.52-0.58, P < .01). As expected, there were poor correlations with the MARS (r = 0.00-0.24, P < .01) and SF-36 GH (r = 0.16-0.34, P < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments (r = 0.42-0.72, P < .01), including the MARS (r = 0.42, P < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different.

Conclusion: The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction.

Keywords: ACL; PROMIS; arthroscopic surgery; knee; outcomes.

Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: R.W. receives educational support from Smith & Nephew and has received hospitality payments from Smith & Nephew. C.H. receives research support from Tornier and Zimmer Biomet, is a past consultant for Pacira Pharmaceuticals, and has received hospitality payments from Tornier and Arthrex. B.R.W. is a paid consultant for ConMed Linvatec, receives research support from OREF, receives educational support from Wardlow Enterprises, receives financial or material support from Arthrex and Smith & Nephew, is a speaker/presenter for Linvatec, and has received hospitality payments from Linvatec. M.J.B. receives financial or material support from Arthrex, has received hospitality payments from Arthrex and DePuy Orthopaedics, and is a paid speaker/presenter for Arthrex.

Figures

Figure 1.
Figure 1.
Flowchart of patient selection and analysis. Of the original 157 patients enrolled, 139 patients with a 6-month follow-up were able to be included; of these, 111 completed 2-year testing. PROMIS, patient-reported outcomes measurement information system.

References

    1. Anthony CA, Glass NA, Hancock K, Bollier M, Wolf BR, Hettrich CM. Performance of PROMIS instruments in patients with shoulder instability. Am J Sports Med. 2017;45(2):449–453.
    1. Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati Knee Rating System in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999;27(4):402–416.
    1. Beaton DE, Schemitsch E. Measures of health-related quality of life and physical function. Clin Orthop Relat Res. 2003;(413):90–105.
    1. Brodke DS, Goz V, Voss MW, Lawrence BD, Spiker WR, Hung M. PROMIS PF CAT outperforms the ODI and SF-36 physical function domain in spine patients. Spine (Phila Pa 1976). 2017;42(12):921–929.
    1. Carr AJ. Evidence-based orthopaedic surgery: what type of research will best improve clinical practice? J Bone Joint Surg Br. 2005;87(12):1593–1594.
    1. Cella D, Gershon R, Lai JS, Choi S. The future of outcomes measurement: item banking, tailored short-forms, and computerized adaptive assessment. Qual Life Res. 2007;16(suppl 1):133–141.
    1. Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap Cooperative Group during its first two years. Med Care. 2007;45(5)(Suppl 1):S3–S11.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed Hillsdale, New Jersey: Erlbaum Associates; 1988.
    1. Collins JE, Katz JN, Donnell-Fink LA, Martin SD, Losina E. Cumulative incidence of ACL reconstruction after ACL injury in adults: role of age, sex, and race. Am J Sports Med. 2013;41(3):544–549.
    1. Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res. 2011;2(4):137–144.
    1. Fries JF, Cella D, Rose M, Krishnan E, Bruce B. Progress in assessing physical function in arthritis: PROMIS short forms and computerized adaptive testing. J Rheumatol. 2009;36(9):2061–2066.
    1. Hancock KJ, Glass N, Anthony CA, et al. Performance of PROMIS for healthy patients undergoing meniscal surgery. J Bone Joint Surg Am. 2017;99(11):954–958.
    1. Hung M, Stuart AR, Higgins TF, Saltzman CL, Kubiak EN. Computerized adaptive testing using the PROMIS physical function item bank reduces test burden with less ceiling effects compared with the short musculoskeletal function assessment in orthopaedic trauma patients. J Orthop Trauma. 2014;28(8):439–443.
    1. Kim CY, Wiznia DH, Averbukh L, et al. PROMIS computer adaptive tests compared with time to brake in patients with complex lower extremity trauma. J Orthop Trauma. 2016;30(11):592–596.
    1. Kvist J. Rehabilitation following anterior cruciate ligament injury: current recommendations for sports participation. Sports Med. 2004;34(4):269–280.
    1. Letchford R, Sparkes V, van Deursen RW. Assessing participation in the ACL injured population: selecting a patient reported outcome measure on the basis of measurement properties. Knee. 2015;22(3):262–269.
    1. Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007;35(10):1756–1769.
    1. Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982;10(3):150–154.
    1. Marx RG, Jones EC, Allen AA, et al. Reliability, validity, and responsiveness of four knee outcome scales for athletic patients. J Bone Joint Surg Am. 2001;83(10):1459–1469.
    1. Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001;29(2):213–218.
    1. Na SE, Ha CW, Lee CH. A new high-flexion knee scoring system to eliminate the ceiling effect. Clin Orthop Relat Res. 2012;470(2):584–593.
    1. Patel AA, Donegan D, Albert T. The 36-item Short Form. J Am Acad Orthop Surg. 2007;15(2):126–134.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–343.
    1. Revicki DA, Cella DF. Health status assessment for the twenty-first century: item response theory, item banking and computer adaptive testing. Qual Life Res. 1997;6(6):595–600.
    1. Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.
    1. Shoukri MM, Pause CA. Statistical Methods for Health Sciences. 2nd ed Boca Raton, Florida: CRC Press; 1999.
    1. Smith TO, Postle K, Penny F, McNamara I, Mann CJ. Is reconstruction the best management strategy for anterior cruciate ligament rupture? A systematic review and meta-analysis comparing anterior cruciate ligament reconstruction versus non-operative treatment. Knee. 2014;21(2):462–470.
    1. Spindler KP, Wright RW. Clinical practice: anterior cruciate ligament tear. N Engl J Med. 2008;359(20):2135–2142.
    1. Terwee CB, Bot SD, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34–42.
    1. van de Graaf VA, Wolterbeek N, Scholtes VA, Mutsaerts EL, Poolman RW. Reliability and validity of the IKDC, KOOS, and WOMAC for patients with meniscal injuries. Am J Sports Med. 2014;42(6):1408–1416.
    1. van Meer BL, Meuffels DE, Vissers MM, et al. Knee injury and Osteoarthritis Outcome Score or International Knee Documentation Committee Subjective Knee Form: which questionnaire is most useful to monitor patients with an anterior cruciate ligament rupture in the short term? Arthroscopy. 2013;29(4):701–715.
    1. Wang D, Jones MH, Khair MM, Miniaci A. Patient-reported outcome measures for the knee. J Knee Surg. 2010;23(3):137–151.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36), I: conceptual framework and item selection. Med Care. 1992;30(6):473–483.
    1. Wright RW. Knee injury outcomes measures. J Am Acad Orthop Surg. 2009;17(1):31–39.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit