Performance and responsiveness to change of PROMIS UE in patients undergoing total shoulder arthroplasty

Abstract

The Patient‐Reported Outcomes Measurement Information System Upper Extremity Computer Adaptive Test (PROMIS UE CAT) is a newer patient‐reported outcome measure for upper extremity physical function. To date, no longitudinal study exists assessing PROMIS UE CAT responsiveness in patients undergoing shoulder arthroplasty. The purpose of this prospective longitudinal study is to report PROMIS UE CAT responsiveness to change and correlation to legacy instruments in patients undergoing total shoulder arthroplasty (TSA). Ninety‐six patients (97 shoulders) undergoing TSA completed the PROMIS UE, Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) preoperatively and postoperatively at 6 weeks, 12 weeks, and after 6 months. Spearman's correlation coefficients (r) were calculated between PROMIS UE and other scores at each time‐point. Responsiveness to change was assessed using the effect size (Cohen's d) and standardized response mean compared with the preoperative time‐point. Floor and ceiling effects were also assessed. PROMIS UE CAT demonstrated positive responsiveness at all time‐points after TSA. It demonstrated excellent correlation (range: 0.68–0.84) with ASES, SST, and OSS at all postoperative time‐points, but the correlation was weaker (r < 0.6, except OSS) preoperatively. Only OSS and SST showed ceiling effects at the 6–12‐month time‐point (16.8% and 18.2%, respectively). PROMIS UE CAT responsiveness to change and strength of correlation with legacy instruments improves with time elapsed after TSA. Further quantification of meaningful responsiveness to change will require estimation of the minimal clinically important difference and substantial clinical benefit for PROMIS UE CAT.

Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs

“…While the difference in the MCID and SCB values for PROMIS instruments may not be as drastic as in other non‐PROMIS PROMs, a similar trend of the SCB estimations being a slightly greater value was shown in our study as well [14, 20, 22, 34]. This in part is due to the PROMIS scoring system itself; as the average score is set at 50 in reference to the general United States population, smaller score differences represent a greater change in one’s perceived condition [5, 20, 22, 41]. Utilizing the optimal cutoff point value as determined by Youden’s index, a modestly greater score difference was seen in those who achieved the SCB versus MCID for each of the PROMIS instruments.…”

“…Since the development and introduction of the Patient‐Reported Outcomes Measurement Information System (PROMIS) by the National Institute of Health, there has been an extensive investigation to determine its validity in all fields of clinical medicine. PROMIS utilizes a combination of item response theory and computer adaptive testing (CAT) to assess a patient's condition in as few of questions as possible limiting question redundancy and administrative burden, while its adoption as a single scoring system would allow for an easier comparison of studies and the ability to directly compare research study outcomes [3, 12, 18, 29, 36, 41, 43, 47, 50]. Moreover, PROMIS Upper Extremity CAT Version 2.0 (UE) and PROMIS Pain instruments have shown strong correlations with legacy outcome measures across the many facets of shoulder pathology [3, 7, 9, 10, 12, 17, 18, 23, 29, 36, 39–41, 44, 47].…”

“…PROMIS utilizes a combination of item response theory and computer adaptive testing (CAT) to assess a patient's condition in as few of questions as possible limiting question redundancy and administrative burden, while its adoption as a single scoring system would allow for an easier comparison of studies and the ability to directly compare research study outcomes [3, 12, 18, 29, 36, 41, 43, 47, 50]. Moreover, PROMIS Upper Extremity CAT Version 2.0 (UE) and PROMIS Pain instruments have shown strong correlations with legacy outcome measures across the many facets of shoulder pathology [3, 7, 9, 10, 12, 17, 18, 23, 29, 36, 39–41, 44, 47]. While these cross‐sectional and longitudinal studies have shown that PROMIS is valid for measuring patient outcomes, the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for many of the common procedures to treat shoulder conditions are not currently known.…”

Analysis of factors associated with patient-reported outcome (PRO) score completion rate one year after shoulder surgeries

“… 10 , 25 Regarding TSA, the high response rates in these patients was mirrored in a study by Pines et al which established excellent responsiveness and correlation of P-UE to legacy outcome measures, finding 84.4% (81/96) follow-up in TSA patients at 12 months. 38 …”

“…ASES has demonstrated good correlation to PROMIS scores for various upper extremity procedures and pathologies. 5 , 24 , 27 , 38 , 51 , 53 …”