Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice

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  • 1 Department of Neurosurgery, Penn State Hershey Medical Center, Hershey, Pennsylvania;
  • 2 Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee;
  • 3 OM1, Inc., Boston, Massachusetts;
  • 4 Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts;
  • 5 Tufts University School of Medicine, Boston, Massachusetts;
  • 6 Department of Orthopaedic Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee;
  • 7 Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota;
  • 8 Spine IQ, Oskaloosa, Iowa;
  • 9 Medtronic/Mazor Robotics, Caesarea, Israel;
  • 10 Department of Neurosurgery, Henry Ford Medical Group, Detroit, Michigan;
  • 11 Arthritis Foundation, Atlanta, Georgia;
  • 12 Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, New York;
  • 13 American Academy of Orthopaedic Surgeons, Washington, DC;
  • 14 Department of Neurosurgery, University of Kansas Hospital, Kansas City, Kansas;
  • 15 Division of Extramural Research, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland; and
  • 16 Harvard Medical School, Boston, Massachusetts
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OBJECTIVE

The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice.

METHODS

Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality’s Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process.

RESULTS

The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization.

CONCLUSIONS

This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

ABBREVIATIONS AHRQ = Agency for Healthcare Research and Quality; CMS = Centers for Medicare and Medicaid Services; DLS = degenerative lumbar spondylolisthesis; EHR = electronic health record; NRS = numeric rating scale; ODI = Oswestry Disability Index; OMF = Outcome Measures Framework; PHQ-4 = Patient Health Questionnaire-4; PRO = patient-reported outcome; PROMIS = Patient-Reported Outcomes Measurement Information System.

Supplementary Materials

    • Appendix A (PDF 437 KB)

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Contributor Notes

Correspondence Richard E. Gliklich: OM1, Inc., Boston, MA. rgliklich@om1.com.

INCLUDE WHEN CITING Published online March 19, 2021; DOI: 10.3171/2020.9.SPINE20437.

Disclosures Dr. Devin reports being a consultant for Stryker and Wright Medical and having direct stock ownership in Balanced Back. Dr. Gliklich and Ms. Leavy are employees and stockholders of OM1, Inc., which has received funding from the Agency for Healthcare Research and Quality (AHRQ) for this work. Dr. Archer reports being a consultant for NeuroPoint Alliance, Inc., and receiving financial support directly to her institution from NeuroPoint Alliance. Dr. Goertz reports being an employee of the Spine Institute for Quality. Dr. Dinstein reports being an employee of Medtronic PLC. Dr. Lavelle reports being a consultant for 4-Web; having direct stock ownership in 4-Web, Prosydian, and Cardan Robotics; having nonfinancial relationships including grants paid to institution outside submitted work by DePuy Spine, Empirical Spine, K2M, Spinal Kinetics, and Vertebral Technologies; and participation in advisory boards for Innovasis and Prosydian.

  • 1

    Parker SL, Wong CC, Gates MJ, . The relative impact of lumbar spondylosis on quality of life in the United States: a population health perspective. Spine J. 2012;12(9):S85.

    • Search Google Scholar
    • Export Citation
  • 2

    Hoy D, March L, Brooks P, . The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968974.

    • Search Google Scholar
    • Export Citation
  • 3

    Dieleman JL, Baral R, Birger M, . US spending on personal health care and public health, 1996-2013. JAMA. 2016;316(24):26272646.

  • 4

    Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. 3rd ed. AHRQ Publication No. 13(14)-EHC111. Agency for Healthcare Research and Quality; 2014.

    • Search Google Scholar
    • Export Citation
  • 5

    Gliklich RE, Leavy MB, Karl J, . A framework for creating standardized outcome measures for patient registries. J Comp Eff Res. 2014;3(5):473480.

    • Search Google Scholar
    • Export Citation
  • 6

    Calkins H, Gliklich RE, Leavy MB, . Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice: endorsed by the Heart Rhythm Society Board of Trustees. Heart Rhythm. 2019;16(1):e3e16.

    • Search Google Scholar
    • Export Citation
  • 7

    Jarvik JG, Comstock BA, Bresnahan BW, . Study protocol: the Back Pain Outcomes using Longitudinal Data (BOLD) registry. BMC Musculoskelet Disord. 2012;13:64.

    • Search Google Scholar
    • Export Citation
  • 8

    Clement RC, Welander A, Stowell C, . A proposed set of metrics for standardized outcome reporting in the management of low back pain. Acta Orthop. 2015;86(5):523533.

    • Search Google Scholar
    • Export Citation
  • 9

    Reid DBC, Shah KN, Ruddell JH, . Effect of narcotic prescription limiting legislation on opioid utilization following lumbar spine surgery. Spine J. 2019;19(4):717725.

    • Search Google Scholar
    • Export Citation
  • 10

    PROMIS Numeric Rating Scale v1.0—Pain Intensity 1a 05Oct2017. HealthMeasures. Accessed November 4, 2020. http://www.healthmeasures.net/index.php?option=com_instruments&view=measure&id=896&Itemid=992

    • Search Google Scholar
    • Export Citation
  • 11

    Tishelman JC, Vasquez-Montes D, Jevotovsky DS, . Patient-Reported Outcomes Measurement Information System instruments: outperforming traditional quality of life measures in patients with back and neck pain. J Neurosurg Spine. 2019;30(4):545550.

    • Search Google Scholar
    • Export Citation
  • 12

    Proceedings of the 4th Annual PROMIS® Health Organization Conference: Global Advances in Methodology and Clinical Science: Dublin, Ireland. 28-29 October 2018. J Patient Rep Outcomes. 2018;2 (1)(suppl 1):53.

    • Search Google Scholar
    • Export Citation
  • 13

    Kim EJ, Chotai S, Archer KR, . Need for two-year patient-reported outcomes score for lumbar spine surgery is procedure-specific: analysis from a prospective longitudinal spine registry. Spine (Phila Pa 1976). 2017;42(17):13311338.

    • Search Google Scholar
    • Export Citation
  • 14

    Soroceanu A, Ching A, Abdu W, McGuire K. Relationship between preoperative expectations, satisfaction, and functional outcomes in patients undergoing lumbar and cervical spine surgery: a multicenter study. Spine (Phila Pa 1976). 2012;37(2):E103E108.

    • Search Google Scholar
    • Export Citation
  • 15

    Kalakoti P, Sciubba DM, Pugely AJ, . Impact of psychiatric comorbidities on short-term outcomes following intervention for lumbar degenerative disc disease. Spine (Phila Pa 1976). 2018;43(19):13631371.

    • Search Google Scholar
    • Export Citation
  • 16

    Chiarotto A, Boers M, Deyo RA, . Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018;159(3):481495.

    • Search Google Scholar
    • Export Citation
  • 17

    Deyo RA, Dworkin SF, Amtmann D, . Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015;95(2):e1e18.

    • Search Google Scholar
    • Export Citation

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