Total shoulder outcomes: is PROMIS of value?

PROMIS Global-10 Performs Poorly Relative to Legacy Shoulder Instruments in Patients undergoing Total Shoulder Arthroplasty for Glenohumeral Arthritis.

The PROMIS Global-10 is a 10-item questionnaire that assesses general health related quality of life.

These authors conducted a retrospective cohort study of 170 patients who underwent TSA for shoulder arthritis and completed preoperative and 1-year postoperative surveys. The physical (PROMIS-P) and mental (PROMIS-M) components of PROMIS Global-10 were compared to legacy patient reported outcome measures (PROMs) including the American Shoulder and Elbow Surgeons (ASES) score, the Single Assessment Numeric Evaluation (SANE), and the Shoulder Activity Scale (SAS). 

All legacy PROMs and PROMIS-P were significantly higher at 1-year follow-up compared to preoperative level (p<.0001), whereas PROMIS-M did not change. 

Preoperatively, both PROMIS components were poorly correlated with all legacy PROMs.

Postoperatively, PROMIS-M was poorly correlated with all legacy PROMs  whereas PROMIS-P had fair correlation with ASES and poor correlation witH SANE and SAS. 

The effect sizes for SANE and ASES were high, whereas the effect size for SAS was moderate, and the effect sizes for the PROMIS measures were small. 

ASES was the most responsive measure and PROMIS-M was the least responsive.

Performance of PROMIS Global-10 compared with legacy instruments in patients with shoulder arthritis 

The authors concluded that the PROMIS Global-10 physical scores show excellent correlation with the EQ-5D. However, the PROMIS Global-10 cannot replace actual EQ-5D scores for cost-effectiveness assessment in this population because of the large variance in agreement between actual and PROMIS Global-10–estimated EQ- 5D scores. PROMIS Global-10 physical scores showed good correlation with the ASES score but poor correlation with other gold-standard patient-reported outcome instruments, suggesting that it is an inappropriate instrument for outcome measurement in populations with shoulder arthritis. 

These studies point out out some of the shortcomings of PROMIS, but there are others. Use of PROMIS requires the patient to have access to and be comfortable using a computer interface, such as an iPad

While patient user support and access to such an interface may be facilitated in the surgeon's office, these resources are unlikely to available at the patient's home. The actual cost and patient compliance with PROMIS have not been studied. 

The concern is that the use of the PROMIS system results in a selection bias by creating an accessibility and technology threshold for inclusion.

On the other hand, the use of a simple and short paper form (see below) that can be mailed in or sent via email greatly facilitates the tracking of the patient's progress and minimizes the risk of loss to followup.

Here's another PROMIS study:

Correlation of PROMIS Physical Function Upper Extremity Computer Adaptive Test with American Shoulder and Elbow Surgeons shoulder assessment form and Simple Shoulder Test in patients with shoulder arthritis 

The purpose of this study was to evaluate the Patient-Reported Outcomes Measurement Informative System Physical Function Upper Extremity Computer Adaptive Test (PROMIS PFUE CAT) measurement tool against the already validated American Shoulder and Elbow Surgeons (ASES) shoulder assessment form and the Simple Shoulder Test (SST) in patients with shoulder arthritis.

Fifty-two patients with the primary diagnosis of shoulder arthritis were asked to fill out the ASES, SST, and PROMIS PFUE CAT.

The PROMIS PFUE CAT showed a strong-moderate correlation with the SST (r = 0.64; P < .001) and a moderate correlation with the ASES (r = 0.57; P < .001). The average times to complete the SST, ASES, and PROMIS PFUE CAT were determined to be 96.9 ± 25.1 seconds, 160.6 ± 51.5 seconds, and 62.6 ± 22.8 seconds, respectively.

These authors suggest that computerized adaptive technology be used to decrease the burden placed on patients by currently accepted patient-reported outcome measurement tools.

The burden of the PROMIS approach is that the patient needs to have access to and use a computer uploaded with the necessary software. The cost of implementing this system is not mentioned in this paper. In contrast, the SST can be completed anywhere and requires only a pencil or a pen.

The scatter plot from this article also brings up another issue with the PROMIS: four patients who indicated that they could perform none of the 12 functions of the SST, still had PROMIS scores in the same range as three patients what could perform eight of these functions. Thus, the PROMIS was unable to discriminate between a non-functioning shoulder and a reasonably functional one.

At this point the promise of PROMIS does not seem compelling. 

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