PMID- 31569175 OWN - NLM STAT- MEDLINE DCOM- 20200828 LR - 20200828 IS - 2380-0194 (Electronic) IS - 2380-0186 (Linking) VI - 32 IP - 9 DP - 2019 Nov TI - Minimal Clinically Important Difference and Substantial Clinical Benefit Using PROMIS CAT in Cervical Spine Surgery. PG - 392-397 LID - 10.1097/BSD.0000000000000895 [doi] AB - STUDY DESIGN: This was a prospective cohort study. OBJECTIVE: The objective of this study was to establish minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) in cervical spine pathology. SUMMARY OF BACKGROUND DATA: PROMIS enables improved psychometric properties with reduced questionnaire burden through computer adaptive testing. Despite studies showing good correlation with "legacy" outcome measures, literature on the clinical significance of changes in PROMIS scores is scarce. MATERIALS AND METHODS: Adult patients undergoing cervical spine surgery at a single institution between 2016 and 2018 were prospectively enrolled. Patients completed questionnaires [Short Form-36 (SF-36), Neck Disability Index (NDI), Visual Analogue Scale Arm/Neck, and PROMIS Pain Interference (PI) and Physical Function (PF)] preoperatively and at 6 months postoperatively. MCID was calculated using distribution-based and SCB using anchor-based methods. The SF-36 Health Transition Item was utilized as an anchor with the cutoff values chosen using receiver operating characteristic curve analysis. RESULTS: There were 139 patients meeting inclusion criteria, with a mean age of 56.4 years and diagnoses of myelopathy (n=36), radiculopathy (n=48) and myeloradiculopathy (n=49). There were significant improvements in PROMIS PF, PROMIS PI, NDI, and SF-36 preoperatively to postoperatively (P<0.001). The test-retest reliability of all tests was excellent (intraclass correlation coefficients=0.87-0.94). PROMIS, SF-36, and NDI were all correlated with the anchor question (|r|=0.34-0.48, P<0.001). MCIDs were 8.5 (NDI), 11.1 (SF-36 Physical Component Score), 9.7 (SF-36 Mental Component Score), 4.9 (PROMIS PI), and 4.5 (PROMIS PF). SCB was 13.0 (NDI), 24.0 (SF-36 Physical Component Score), 11.8 (SF-36 Mental Component Score), 6.9 (PROMIS PI), and 6.8 (PROMIS PF). MCIDs were greater than standard error of measurement for all measures. CONCLUSIONS: We report MCID of 4.9 (PI) and 4.5 (PF) and SCB of 6.9 (PI) and 6.8 (PF). These data support the use of PROMIS computer adaptive tests in cervical spine patients and provide important reference as PROMIS reporting becomes more widespread in the literature. FAU - Steinhaus, Michael E AU - Steinhaus ME AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Iyer, Sravisht AU - Iyer S AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Lovecchio, Francis AU - Lovecchio F AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Khechen, Benjamin AU - Khechen B AD - Spine Service, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL. FAU - Stein, Daniel AU - Stein D AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Ross, Thomas AU - Ross T AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Yang, Jingyan AU - Yang J AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. AD - Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY. FAU - Singh, Kern AU - Singh K AD - Spine Service, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL. FAU - Albert, Todd J AU - Albert TJ AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Lebl, Darren AU - Lebl D AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Huang, Russel AU - Huang R AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Sandhu, Harvinder AU - Sandhu H AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Rawlins, Bernard AU - Rawlins B AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Schwab, Frank AU - Schwab F AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Lafage, Virginie AU - Lafage V AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. FAU - Kim, Han Jo AU - Kim HJ AD - Spine Service, Department of Orthopaedic Surgery, Hospital for Special Surgery, New York, NY. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Spine Surg JT - Clinical spine surgery JID - 101675083 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Cervical Vertebrae/*surgery MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - *Patient Reported Outcome Measures MH - Prospective Studies MH - Radiculopathy/diagnosis/*surgery MH - Spinal Cord Diseases/diagnosis/*surgery MH - Surveys and Questionnaires MH - Young Adult EDAT- 2019/10/01 06:00 MHDA- 2020/08/29 06:00 CRDT- 2019/10/01 06:00 PHST- 2019/10/01 06:00 [pubmed] PHST- 2020/08/29 06:00 [medline] PHST- 2019/10/01 06:00 [entrez] AID - 10.1097/BSD.0000000000000895 [doi] PST - ppublish SO - Clin Spine Surg. 2019 Nov;32(9):392-397. doi: 10.1097/BSD.0000000000000895.