Introduction: Prospective longitudinal outcomes registries are at the center of evidence-driven healthcare reform. Obtaining real-world outcomes data at 12-months can be costly and challenging. We analyze whether 3-month outcome measurements suffice to identify effective versus non-effective care for degenerative lumbar surgery

Methods: 3,073 patients undergoing elective spine surgery for degenerative lumbar disease were entered into a prospective multi-center registry(N2QOD). Baseline, 3-, 12-months follow-up ODI was recorded. Previously published values of minimal clinically important difference(MCID) for ODI-12.8 and substantial clinical benefit(SCB) for ODI-18.8 was utilized. Concordance rate of achieving MCID and SCB for ODI at 3-and 12-months was computed. The absolute difference between 12-and 3-month ODI scores was compared with the absolute differences between 12-month ODI and a multivariable proportional odds logistic regression model-predicted 12-month ODI that took into account the patients’ baseline characteristics

Results: 3,073 patients undergoing elective spine surgery for degenerative lumbar disease were entered into a prospective multi-center registry(N2QOD). Baseline, 3-, 12-months follow-up ODI was recorded. Previously published values of minimal clinically important difference(MCID) for ODI-12.8 and substantial clinical benefit(SCB) for ODI-18.8 was utilized. Concordance rate of achieving MCID and SCB for ODI at 3-and 12-months was computed. The absolute difference between 12-and 3-month ODI scores was compared with the absolute differences between 12-month ODI and a multivariable proportional odds logistic regression model-predicted 12-month ODI.

Conclusions: The 3-month ODI scores do not accurately estimate the 12-month ODI scores at the individual patient level regardless of the diagnosis and treatment. There is a greater uncertainty in predicting 12-month outcomes when the 3-month outcome is negative. Many patients failing to benefit from surgery by 3-months do so by 12-months, and many report loss of benefit. Prospective longitudinal registries need to span at least 12-months to determine effectiveness of spine care for over 20% of the patients

Patient Care: This analysis highlights the importance of tracking the patient-reported outcomes out to 12-months to understand the current trajectory of the spine outcomes, in the registry efforts.

Learning Objectives: By the end of the session the participants should be able to: 1) Described the importance of tracking the patient-reported outcomes out to 12-months after surgery, 2) the cross-over rates from achieving clinically meaningful benefit to losing the benefit and vise-a-versa was approximately 20%, which suggests the need for longer follow-up to track the accurate outcomes.

References: 1) Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY: 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 8:968-974, 2008 2) Glassman SD, Copay AG, Berven SH, Polly DW, Subach BR, Carreon LY: Defining substantial clinical benefit following lumbar spine arthrodesis. J Bone Joint Surg Am 90:1839-1847, 2008 3) Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG: Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377-381, 2009 4) Asher AL, Speroff T, Dittus RS, Parker SL, Davies JM, Selden N, et al: The National Neurosurgery Quality and Outcomes Database (N2QOD): A Collaborative North American Outcomes Registry to Advance Value-Based Spine Care. Spine (Phila Pa 1976) 39:S106-116, 2014 5) Asher AL, Devin CJ, Mroz T, Fehlings M, Parker SL, McGirt MJ: Clinical registries and evidence-based care pathways: raising the bar for meaningful measurement and delivery of value-based care. Spine (Phila Pa 1976) 39:S136-138, 2014