Is a New Patient Reported Outcomes Measure Valid after 2 Years?

Because it’s a new measure, there’s precious little data regarding the long-term efficacy of the Patient-Reported Outcomes Measurement Information Systems for lumbar decompression surgeries.

A study from Rush University Medical Center in Chicago set out to rectify that and their work, “Two-Year Postoperative Validation of Patient-Reported Outcomes Measurement Information System Physical Function After Lumbar Decompression,” was published in the September 1, 2021 edition of the Journal of the American Academy of Orthopaedic Surgeons.

Co-author Kern Singh, M.D., co-director of the Minimally Invasive Spine Institute at Rush and founder and president of the Minimally Invasive Spine Study Group explained the genesis of the study to OTW, “In the current climate of healthcare and spine surgery, it is increasingly incumbent upon surgeons to demonstrate value to patients. As such there is renewed focus on patient-reported outcome measures (PROMs) to assess patient perceptions of progress across variety of quality-of-life domains following surgery.”

“Many ‘legacy’ PROM questionnaires such as Oswestry Disability Index (ODI) and 12-Item Short form (SF-12 PCS) have demonstrated reliability and validity in evaluating patient progress in disability and physical function; however, have fallen short with regards to precision and length of time to fill out.”

“To address these issues, the Patient-Reported Outcomes Measurement Information System instrument was developed by the National Institute of Health. The instrument uses computer adaptive testing customized questions to increase both efficiency, standardization, and accuracy of patient perception of postoperative improvement.”

“Prior research has validated this study for short term intervals postoperatively in lumbar decompression patients, but our study was the first to validate across multiple PROMs up to a 2-year time point. This was the right time to conduct this study as it can provide value-oriented spine surgeons increased confidence in utilizing PROMIS-PF for evaluation of longitudinal; physical function improvement following lumbar decompression surgery.”

The study group enrolled 92 patients, most of whom were nonsmokers (87.0%) and had a mean Charlson Comorbidity Index of 1.82. A total of 25.0% of patients were diagnosed with hypertension and 63.0% of patients had a spinal diagnosis of herniated nucleus pulposus. Patients lacking a diagnosis of herniated nucleus pulposus primarily had spinal stenosis secondary to generalized degenerative changes. The majority of the lumbar decompressions were performed at one level (58.7%)—mean surgical time was 54.5 minutes, mean estimated blood loss was 31.0 mL, and mean hospital length of stay was 8.3 hours.

Dr. Singh told OTW, “Our study provides a robust correlation analysis that demonstrated that PROMIS-PF, a marker of physical function, has both a strong and noticeable correlation with both ODI and SF-12 PCS at preoperative timepoint but also through the 2-year timepoint. Collectively, our findings help establish validity of PROMIS-PF as an effective PROM to evaluate postoperative improvement in physical function.”

“By establishing a validity of PROMIS PF as an effective PROM to evaluate postoperative improvement in physical function in lumbar decompression patients, our study adds to robust literature in validation studies that have been conducted in both cervical spine and lumbar fusion patients. Collectively, our findings help establish validity of PROMIS-PF as an effective PROM to evaluate-term postoperative improvement in physical function following lumbar decompression. In totality when considered with prior studies, this may increase confidence in transitioning from legacy PROMs toward the PROMIS questionnaire, which may reduce questionnaire burden and time to completion for patients and potentially increase sensitivity to diseases at different postoperative timepoints.”