Seminars in Spine Surgery
Volume 21, Issue 4 , Pages 202-209 , December 2009

The Importance of Study Design in the Spine Literature

  • Adam M. Pearson, MD, MS

      Affiliations

    • Department of Orthopaedics, Dartmouth Hitchcock Medical Center and Dartmouth Medical School, Lebanon, NH
    • Corresponding Author InformationAddress reprint requests to Adam M. Pearson, MD, MS, 1 Medical Center Drive, Lebanon, NH 03755
    • ,
  • Tor D. Tosteson, ScD

      Affiliations

    • Department of Community and Family Medicine, Dartmouth Hitchcock Medical Center and Dartmouth Medical School, Lebanon, NH
    • ,
  • James N. Weinstein, DO, MS

      Affiliations

    • Department of Orthopaedics, Dartmouth Hitchcock Medical Center and Dartmouth Medical School, Lebanon, NH

References 

  1. Schafer J, O'Connor D, Feinglass S, et al. Medicare Evidence Development and Coverage Advisory Committee: meeting on lumbar fusion surgery for treatment of chronic back pain from degenerative disc disease. Spine. 2007;32:2403–2404
  2. Weinstein JN, Lurie JD, Olson PR, et al. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine. 2006;31:2707–2714
  3. Fritzell P, Hagg O, Wessberg P, et al. Volvo award winner in clinical studies: lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine. 2001;26:2521–2532discussion:32-34
  4. Fairbank J, Frost H, Wilson-MacDonald J, et al. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ. 2005;330:1233
  5. Brox JI, Sorensen R, Friis A, et al. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine. 2003;28:1913–1921
  6. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperative treatment for lumbar disk herniation (The Spine Patient Outcomes Research Trial (SPORT) observational cohort). JAMA. 2006;296:2451–2459
  7. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disc herniation (The Spine Patient Outcomes Research Trial (SPORT): a randomized trial). JAMA. 2006;296:2441–2445
  8. Cummings SR, Browner WS, Hulley SB. Conceiving the research question. In: Designing Clinical Research. (ed 2). Philadelphia, PA: Lippincott Williams and Wilkins; 2001;p. 17–23
  9. Atlas SJ, Deyo RA, Keller RB, et al. The Maine Lumbar Spine Study, Part II (1-year outcomes of surgical and nonsurgical management of sciatica). Spine. 1996;21:1777–1786
  10. Weber H. Lumbar disc herniation (A controlled, prospective study with ten years of observation). Spine. 1983;8:131–140
  11. Hulley SB, Newman TB, Cummings SR. Choosing the study subjects: specification, sampling, and recruitment. In: Designing Clinical Research. (ed 2). Philadelphia, PA: Lippincott Williams and Wilkins; 2001;p. 25–35
  12. Weinstein JN, Deyo RA. Clinical research: issues in data collection. Spine. 2000;25:3104–3109
  13. Birkmeyer NJ, Weinstein JN, Tosteson AN, et al. Design of the spine patient outcomes research trial (SPORT). Spine. 2002;27:1361–1372
  14. Kocher MS, Zurakowski D. Clinical epidemiology and biostatistics: a primer for orthopaedic surgeons. J Bone Joint Surg Am. 2004;86-A:607–620
  15. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders (Introduction). Spine. 2000;25:3097–3099
  16. Ware JE, Sherbourne CD. The MOS 36-Item short-form health survey (SF-36) (I. Conceptual framework and item selection). Med Care. 1992;30:473–483
  17. Bergner M, Bobbitt RA, Carter WB, et al. The sickness impact profile: development and final revision of a health status measure. Med Care. 1981;19:787–805
  18. Fairbank JC, Couper J, Davies JB, et al. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66:271–273
  19. Roland M, Morris R. A study of the natural history of back pain (Part I: development of a reliable and sensitive measure of disability in low-back pain). Spine. 1983;8:141–144
  20. Lurie J. A review of generic health status measures in patients with low back pain. Spine. 2000;25:3125–3129
  21. Zanoli G, Stromqvist B, Padua R, et al. Lessons learned searching for a HRQoL instrument to assess the results of treatment in persons with lumbar disorders. Spine. 2000;25:3178–3185
  22. Kopec JA. Measuring functional outcomes in persons with back pain: a review of back-specific questionnaires. Spine. 2000;25:3110–3114
  23. Atlas SJ, Deyo RA, Patrick DL, et al. The Quebec Task Force classification for spinal disorders and the severity, treatment, and outcomes of sciatica and lumbar spinal stenosis. Spine. 1996;21:2885–2892
  24. Blood EA, Tosteson TD. A practical introduction to biostatistics in the spine literature. Semin Spine Sur. 2009;21:210–215
  25. Deyo RA, Battie M, Beurskens AJ, et al. Outcome measures for low back pain research (A proposal for standardized use). Spine. 1998;23:2003–2013
  26. Ware JE. SF-36 health survey update. Spine. 2000;25:3130–3139
  27. Roland M, Fairbank J. The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine. 2000;25:3115–3124
  28. Newman TB, Browner WS, Hulley SB. Enhancing causal inference in observational studies. In: Designing Clinical Research. (ed 2). Philadelphia, PA: Lippincott Williams and Wilkins; 2001;p. 125–137
  29. Flum DR. Interpreting surgical trials with subjective outcomes: avoiding UnSPORTsmanlike conduct. JAMA. 2006;296:2483–2485
  30. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342:1878–1886
  31. Newman TB, Browner WS, Cummings SR, et al. Designing an observational study: cross-sectional and case-control studies. In: Designing Clinical Research. (ed 2). Philadelphia, PA: Lippincott Williams and Wilkins; 2001;p. 107–123
  32. Brighton B, Bhandari M, Tornetta P, et al. Hierarchy of evidence: from case reports to randomized controlled trials. Clin Orthop Relat Res. 2003;19–24
  33. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342:1887–1892

PII: S1040-7383(09)00066-5

doi: 10.1053/j.semss.2009.08.002

Seminars in Spine Surgery
Volume 21, Issue 4 , Pages 202-209 , December 2009

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