Validation of PROMIS Physical Function in MIS TLIF: 2-Year Follow-up

Spine (Phila Pa 1976). 2020 Nov 15;45(22):E1516-E1522. doi: 10.1097/BRS.0000000000003635.

Abstract

Study design: Retrospective cohort.

Objective: We evaluate the correlation of the Patient-Reported Outcomes Measurement Information System for physical function (PROMIS-PF) with legacy patient-reported outcome measures (PROMs) in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) up to 2 years postoperatively.

Summary of background data: PROMIS-PF has not been validated past 6 months following MIS TLIF.

Methods: A surgical registry was retrospectively reviewed for eligible MIS TLIFs between May 2015 and September 2017. Inclusion criteria were primary, one- or two-level MIS TLIFs for degenerative spinal pathology. Patients without preoperative or 2-year follow up PROMIS-PF surveys were excluded. Demographic, perioperative, and PROMs including Visual Analog Scale (VAS) back, VAS leg, Oswestry Disability Index (ODI), 12-Item Short Form (SF-12) physical component summary (PCS) scores, and PROMIS-PF at preoperative and postoperative timepoint (e.g., 6 weeks, 12 weeks, 6 months, 1 year, and 2 years). A paired t test evaluated PROM improvement from baseline. The relationship of PROMIS-PF with VAS back, VAS leg, SF-12 PCS, and ODI was evaluated with a Pearson correlation coefficient.

Results: The 68-subject cohort was 41.2% female, with an average age of 52.9 years; 44.1% were obese, and the majority underwent one-level fusions (95.6%). Pain (VAS back, VAS leg) and disability metrics (ODI) demonstrated significant improvement at all timepoints following MIS TLIF when compared to baseline (all P < 0.001). Physical function (SF-12 PCS, PROMIS-PF) demonstrated significant postoperative improvement at 12 weeks, 6 months, 1 year, and 2 years (all P < 0.001). All evaluated timepoints, with the exception of preoperative VAS back scores, revealed strong PROMIS-PF correlations with VAS back, VAS leg, ODI, and SF-12 PCS.

Conclusion: PROMIS-PF demonstrated a strong correlation with pain (VAS back, VAS leg), disability (ODI) and physical function (SF-12) at all postoperative follow-ups through 2 years. Our study provides longitudinal evidence for utilizing PROMIS-PF as a valid physical function measure among patients undergoing MIS TLIF.

Level of evidence: 4.

Publication types

  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Back Pain / epidemiology
  • Back Pain / surgery
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Lumbar Vertebrae / surgery*
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures / trends
  • Obesity / epidemiology
  • Obesity / surgery
  • Pain Measurement / methods
  • Pain Measurement / standards*
  • Patient Reported Outcome Measures*
  • Retrospective Studies
  • Spinal Fusion / trends*
  • Surveys and Questionnaires / standards*