Defining Patient-relevant Thresholds and Change Scores for the HOOS JR and KOOS JR Anchored on the Patient-acceptable Symptom State Question.

Abstract

When evaluating the results of clinical research studies, readers need to know that patients perceive effect sizes, not p values. Knowing the minimum clinically important difference (MCID) and the patient-acceptable symptom state (PASS) threshold for patient-reported outcome measures helps us to ascertain whether our interventions result in improvements that are large enough for patients to care about, and whether our treatments alleviate patient symptoms sufficiently. Prior studies have developed the MCID and PASS threshold for the Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) anchored on satisfaction with surgery, but to our knowledge, neither the MCID nor the PASS thresholds for these instruments anchored on a single-item PASS question have been described. (1) What are the MCID (defined here as the HOOS/KOOS JR change score associated with achieving PASS) and PASS threshold for the HOOS JR and KOOS JR anchored on patient responses to the single-item PASS instrument? (2) How do patient demographic factors such as age, gender, and BMI correlate with MCID and PASS thresholds using the single-item PASS instrument? Between July 2020 and September 2021, a total of 10,970 patients underwent one primary unilateral THA or TKA and completed at least one of the three surveys (preoperative HOOS or KOOS JR, 1-year postoperative HOOS or KOOS JR, and 1-year postoperative single-item anchor) at one large, academic medical center. Of those, only patients with data for all three surveys were eligible, leaving 13% (1465 total; 783 THAs and 682 TKAs) for analysis. Despite this low percentage, the overall sample size was large, and there was little difference between completers and noncompleters in terms of demographics or baseline patient-reported outcome measure scores. Patients undergoing bilateral total joint arthroplasty or revision total joint arthroplasty and those without all three surveys at 1 year of follow-up were excluded. A receiver operating characteristic curve analysis, leveraging a 1-year, single-item PASS (that is, "Do you consider that your current state is satisfactory?" with possible answers of "yes" or "no") as the anchor was then used to establish the MCID and PASS thresholds among the 783 included patients who underwent primary unilateral THA and 682 patients who underwent primary unilateral TKA. We also explored the associations of age at the time of surgery (younger than 65 years or 65 years and older), gender (men or women), BMI (< 30 or ≥ 30 kg/m 2 ), and baseline Patient-Reported Outcome Measure Information System-10 physical and mental component scores (< 50 or ≥ 50) for each of the MCID and PASS thresholds through stratified analyses. For the HOOS JR, the MCID associated with the PASS was 23 (95% CI 18 to 31), with an area under the receiver operating characteristic curve of 0.75, and the PASS threshold was 81 (95% CI 77 to 85), with an area under the receiver operating characteristic curve of 0.81. For the KOOS JR, the MCID was 16 (95% CI 14 to 18), with an area under the receiver operating characteristic curve of 0.75, and the PASS threshold was 71 (95% CI 66 to 73) with an area under the receiver operating characteristic curve of 0.84. Stratified analyses indicated higher change scores and PASS threshold for younger men undergoing THA and higher PASS thresholds for older women undergoing TKA. Here, we demonstrated the utility of a single patient-centered anchor question, raising the question as to whether simply collecting a postoperative PASS is an easier way to measure success than collecting preoperative and postoperative patient-reported outcome measures and then calculating MCIDs and the substantial clinical benefit. Level III, therapeutic study.