Validity, responsiveness and minimal important change of the EQ-5D-5L in patients after rotator cuff repair, shoulder arthroplasty or thumb carpometacarpal arthroplasty

Methods

In this prospective study, all patients completed the EQ-5D-5L before surgery and 6 months and 1 year after surgery. In addition, RCR patients completed the Oxford Shoulder Score (OSS), TSA patients completed the Shoulder Pain and Disability Index (SPADI) and CMC I patients completed the brief Michigan Hand Outcomes Questionnaire (brief MHQ) at each designated time point. Construct validity (Pearson’s correlation coefficient, r), responsiveness (effect size), minimal important difference (MID), minimal important change (MIC), and floor and ceiling effects of the EQ-5D-5L were determined. To test discriminative ability, EQ-5D-5L utility indices of patients who were in a patient acceptable symptom state (PASS) or not at follow-up were compared using the Mann–Whitney U test.

Results

We included 153 RCR, 150 TSA, and 151 CMC I patients. The EQ-5D-5L utility index correlated with the OSS (r = 0.73), SPADI (r = − 0.65) and brief MHQ (r = 0.61). The effect sizes were 1.3 (RCR and CMC I group) and 1.1 (TSA). The MID and MIC ranged from 0.027 to 0.209. Ceiling effects were found. The EQ-5D-5L utility index differed significantly between patients being in a PASS versus patients who were not in a PASS.

Conclusion

The EQ-5D-5L utility index shows good construct validity, responsiveness and discriminative ability in patients after arthroscopic RCR, TSA and CMC I arthroplasty and is suitable to quantify quality of life.

Clinical trial registration: This auxiliary analysis is part of a primary study that was originally registered at ClinicalTrials.gov (NCT01954433) on October 1, 2013.