The Patient-Reported Outcomes Measurement Information System (PROMIS) assessing physical function and pain interference with computer adaptive tests offers a streamlined, effective approach for measuring self-reported outcomes in patients with chronic low back pain, according to a study in Spine.
Traditional measures of functional disability such as the Oswestry Disability Index are considered the standard for quantifying disability and health-related quality of life in patients with chronic low back pain. However, these measures do not account for domains of health considered important to these individuals. As such, PROMIS was developed to provide clinicians and researchers with precise, valid, and responsive patient reported outcome measures for different domains of health. In this study, researchers aimed to confirm validity of PROMIS physical function and pain interference computer adaptive tests.
A total of 217 patients with chronic low back pain (mean age, 53.8±12.8 years) who completed a 3-month Interdisciplinary Pain Program between August 2016 and December 2018 were enrolled in this study. The 3-month program was conducted by physical therapists, pain psychologists, and spine specialists who were focused on helping patients manage their chronic low back pain with nonopioid therapies. Prior to and upon completion of the program, patients completed patient-reported outcome measures on several different PROMIS scales, including scales that assessed anxiety, fatigue, physical function, social role satisfaction, pain interference, and sleep disturbance.
At baseline and at 3 months, the Modified Low Back Pain Disability Index (MDQ) and the Patient Health Questionnaire-9 were completed. The 10-item PROIMS Global Health (GH), which produces the Global Physical Health (GPH) and Global Mental Health (GMH) scores, were also completed and assessed.
Study investigators observed convergent validity as demonstrated by significant correlations between baseline pairwise patient-reported outcome measure comparisons (P <.01). At graduation of the 3-month program, there were significant improvements in all patient-reported outcome measures. The largest improvements were observed for PROMIS social role satisfaction (mean change, -7.4 points; effect size, 0.73; 95% CI, 0.55-0.91), pain interference (mean change, -6.2 points; effect size, 0.81; 95% CI, 0.63-0.99), and depression (mean change, -5.8 points; effect size, 0.61; 95% CI, 0.44-0.77).
There was also a significant improvement in the MDQ from baseline to 3 months (46.4±16.1 to 34.7±19.0, respectively; mean change, -11.9 points; effect size, 0.81; 95% CI, 0.67–0.94). More than half of patients achieved minimal clinically important differences MCIDs for MDQ (54.6%), PROMIS social role satisfaction (54.0%), and pain interference (52.2%).
Limitations of the study include the lack of data assessment in program “noncompleters” and the lack of direct comparators for the fatigue, sleep disturbance, social role satisfaction, anxiety, and depression domains.
The researchers suggest that “patient-entered data collection can be streamlined through the use of PROMIS computer-adaptive tests which offer advantages over legacy measures such as the Oswestry Disability Index.”
Lapin B, Davin S, Stilphen M, Benzel E, Katzan IL. Validation of PROMIS CATs and PROMIS global health in an interdisciplinary pain program for patients with chronic low back pain. Spine (Phila Pa 1976). 2020;45(4):E227-E235