Defining a Minimum Clinically Important Difference in Patient-Reported Outcome Measures in Lumbar Tubular Microdecompression Patients

Overview

Journal Int J Spine Surg

Date 2020 Sep 28

PMID 32986575

Citations 3

Authors

Trent A VanHorn

Ziyad O Knio

Tadhg J OGara

Affiliations

Soon will be listed here.

Abstract

Background: Patient-reported outcome measures (PROMs) are critical tools used in the assessment and reporting of surgical outcomes. However, significant differences in PROM scores have not been shown to consistently correlate with clinical improvement from the physician or patient perspective. Defining a minimum clinically important difference (MCID) for PROMs offers interpretation of surgical outcomes with an emphasis on patient-centered feedback. The goal of this study was to define a MCID for the following PROMs in lumbar tubular microdecompression (LTMD) patients: the EuroQol-Five Dimensions (EQ-5D) index, Oswestry Disability Index (ODI), leg pain visual analog scale (VAS), and low back pain VAS.

Methods: This study examined 235 index LTMD patients with PROMs collected at preoperative evaluation and 1-year follow-up. Using an anchor-based approach with patient satisfaction index, a receiver operating characteristic analysis was performed to define a MCID in the EQ-5D index, ODI, leg pain VAS, and low back pain VAS.

Results: The patients had a mean age of 65.18 ± 12.81 years, and 47.7% were male. The MCID values for the EQ-5D, ODI, leg pain VAS, and low back pain VAS are 0.219, 15.0-16.5, 0.5, and 2.5-3.5, respectively.

Conclusions: This study helps define a MCID for the EQ-5D index in LTMD patients. Given its ease of administration and economic relevance, further characterization of the EQ-5D index may warrant its use as a potential alternative or adjunct to the routinely collected PROMs following spine surgery.

Level Of Evidence: 3.

Citing Articles

A Comparison of Analgesic Efficacy of Triamcinolone vs Magnesium Sulfate as Adjuvants in Caudal Block in Patients with Low Back Pain: A Double-Blind Randomized Controlled Trial.

Dadkhah P, Hashemi M, Taheri M, Alizadeh Ojoor A, Jaffari M, Jaffari A Anesth Pain Med. 2024; 14(2):e145718.

PMID: 39411375 PMC: 11473997. DOI: 10.5812/aapm-145718.

Values derived from patient reported outcomes in spine surgery: a systematic review of the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state.

Issa T, Lee Y, Henry T, Trenchfield D, Schroeder G, Vaccaro A Eur Spine J. 2023; 32(10):3333-3351.

PMID: 37642774 DOI: 10.1007/s00586-023-07896-x.

Low-dose mesenchymal stem cell therapy for discogenic pain: safety and efficacy results from a 1-year feasibility study.

Bates D, Vivian D, Freitag J, Wickham J, Mitchell B, Verrills P Future Sci OA. 2022; 8(5):FSO794.

PMID: 35662742 PMC: 9136638. DOI: 10.2144/fsoa-2021-0155.

References

Mehra A, Baker D, Disney S, Pynsent P . Oswestry Disability Index scoring made easy. Ann R Coll Surg Engl. 2008; 90(6):497-9. PMC: 2647244. DOI: 10.1308/003588408X300984. View

Coretti S, Ruggeri M, McNamee P . The minimum clinically important difference for EQ-5D index: a critical review. Expert Rev Pharmacoecon Outcomes Res. 2014; 14(2):221-33. DOI: 10.1586/14737167.2014.894462. View

Jaeschke R, Singer J, Guyatt G . Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989; 10(4):407-15. DOI: 10.1016/0197-2456(89)90005-6. View

Fairbank J, Pynsent P . The Oswestry Disability Index. Spine (Phila Pa 1976). 2000; 25(22):2940-52; discussion 2952. DOI: 10.1097/00007632-200011150-00017. View

Shaw J, Johnson J, Coons S . US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005; 43(3):203-20. DOI: 10.1097/00005650-200503000-00003. View

Robin X, Turck N, Hainard A, Tiberti N, Lisacek F, Sanchez J . pROC: an open-source package for R and S+ to analyze and compare ROC curves. BMC Bioinformatics. 2011; 12:77. PMC: 3068975. DOI: 10.1186/1471-2105-12-77. View

Johnsen L, Hellum C, Nygaard O, Storheim K, Brox J, Rossvoll I . Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013; 14:148. PMC: 3648434. DOI: 10.1186/1471-2474-14-148. View

. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990; 16(3):199-208. DOI: 10.1016/0168-8510(90)90421-9. View

Unal I . Defining an Optimal Cut-Point Value in ROC Analysis: An Alternative Approach. Comput Math Methods Med. 2017; 2017:3762651. PMC: 5470053. DOI: 10.1155/2017/3762651. View

10.

Chung A, Copay A, Olmscheid N, Campbell D, Walker J, Chutkan N . Minimum Clinically Important Difference: Current Trends in the Spine Literature. Spine (Phila Pa 1976). 2016; 42(14):1096-1105. DOI: 10.1097/BRS.0000000000001990. View

11.

Hung M, Saltzman C, Kendall R, Bounsanga J, Voss M, Lawrence B . What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions?. Clin Orthop Relat Res. 2018; 476(10):2027-2036. PMC: 6259866. DOI: 10.1097/CORR.0000000000000419. View

12.

Mueller B, Carreon L, Glassman S . Comparison of the EuroQOL-5D with the Oswestry Disability Index, back and leg pain scores in patients with degenerative lumbar spine pathology. Spine (Phila Pa 1976). 2012; 38(9):757-61. DOI: 10.1097/BRS.0b013e31827ab803. View

13.

Weinstein J, Tosteson T, Lurie J, Tosteson A, Blood E, Hanscom B . Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008; 358(8):794-810. PMC: 2576513. DOI: 10.1056/NEJMoa0707136. View

14.

Copay A, Glassman S, Subach B, Berven S, Schuler T, Carreon L . Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008; 8(6):968-74. DOI: 10.1016/j.spinee.2007.11.006. View

15.

Roland M, Morris R . A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976). 1983; 8(2):145-50. DOI: 10.1097/00007632-198303000-00005. View