To investigate the responsiveness of the following non-disease specific PROMs; 4-item pain intensity measure (P4), Patient Specific Functional Scale2.0 (PSFS2.0), Satisfaction and Recovery Index (SRI), and physical (PCS) and mental component summary (MCS) scores of the SF-12v2® Health Survey Acute in patients with musculoskeletal disorders and to estimate their MCIDs.
Data of outpatients receiving musculoskeletal physical therapy were collected through surveys of multi-center cohorts (Tokyo, and Chiba). The participants completed the first survey before their first physical therapy session and the second survey after the third to seventh sessions. The responsiveness was assessed by investigating the area under the receiver operating characteristic curve (AUC) and by investigating prior-hypotheses with correlations between change scores. In the former method, the AUCs of the measures were calculated for discriminating improved cases (i.e., 11-point Global Rating of Change Scale [GRCS]≥2) and non-improved cases (i.e., GRCS2). In the latter method, 12 hypotheses for each of the P4, PSFS2.0, SRI, and SF-12 PCS and MCS scores, were tested using Pearson’s correlation coefficient for normally distributed data and Spearman’s rank correlation coefficient for non-normally distributed data, respectively, tested by the Shapiro-Wilk test. The MCID scores were estimated with GRCS using the predictive modelling method.
The data of 100 participants were analyzed. The PSFS2.0 satisfied both acceptable responsiveness criteria, the P4 and SRI satisfied moderate responsiveness criterion of the construct approach only, and the PCS and MCS satisfied both poor responsiveness criteria. The MCIDs were 1.64, 2.92, 6.16, 4.49, and 1.67 for the P4, PSFS2.0, SRI, and PCS and MCS scores, respectively.
The PSFS2.0 has acceptable responsiveness and could be used to determine treatment effect in clinical practice, and the P4 and SRI could also be used in some cases.
The minimum important changes of the P4, PSFS2.0, SRI, and PCS and MCS were identified. The PSFS2.0 met the criteria for acceptability responsiveness for the two methods. The PSFS2.0 is recommended for detecting functional changes in clinical practice, and a difference of 3 points or more can be used as a criterion for determining clinical effectiveness. The SF-12 would not be suitable for identifying treatment effects. This study was conducted in the Japanese population, and it may not be possible to generalize the findings to the populations of other nations.
Patient Reported Outcome Measures
Minimal Clinically Important Difference
