Methodological aspects of outcomes research

European Spine Journal

Volumn 15, Issue SUPPL. 1, 2006, Pages

  Hiebert, Rudi ^a   Nordin, Margareta ^a  

^a NYU HOSPITAL FOR JOINT DISEASES   (United States)

Author keywords

Literature review; Research methods; Spine; Tutorial

Indexed keywords

CASE CONTROL STUDY; CLINICAL PRACTICE; COHORT ANALYSIS; COMPARATIVE STUDY; EVALUATION; FOLLOW UP; HYPOTHESIS; INFORMATION; METHODOLOGY; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZATION; REVIEW; RISK; STATISTICAL ANALYSIS;

BACK PAIN; COHORT STUDIES; CROSS-SECTIONAL STUDIES; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; REVIEW LITERATURE; STATISTICS;

EID: 31944439373     PISSN: 09406719     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00586-005-1057-5     Document Type: Review

References (56)

1. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders. Available at: http://www.nptf.ualberta.ca/. Accessed November 1, 2005
2. Summary minutes. Orthopaedic and Rehabilitation Devices Advisory Panel, United States Food and Drug Administration. Yaszemski MJ, Chairperson. Gaithersburg, MD, June 2-3 2004
3. Abenhaim L, Rossignol M, Valat JP, Nordin M, Avouac B, Blotman F, Charlot J, Dreiser RL, Legrand E, Rozenberg S, Vautravers P (2000) The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain. Spine 25(4 Suppl):1S-33S
4. Bang H, Ni L, Davis CE (2004) Assessment of blinding in clinical trials. Control Clin Trials 25(2):143-156
5. Beaton DE, Boers M, Wells GA (2002) Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol 14(2):109-114
6. Bereczki D, Gesztelyi G (2000) A Hungarian example for hand searching specialized national healthcare journals of small countries for controlled trials: is it worth the trouble?. Health Libr Rev 17(3):144-147
7. Bigos SJ, Bowyer O, Braen G (1994) Acute low back problems in adults, clinical practice guideline, No. 14. vol AHCPR Pub 95-0642. U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, Rockville, MD
8. Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD (2005) A prospective, randomized, multicenter Food and Drug Administration Investigational Device Exemptions study of lumbar total disc replacement with the Charité artificial disc versus lumbar fusion: Part I: evaluation of clinical outcomes. Spine 30(14):1565-1575; discussion E1387-1591
9. Bombardier C (2000) Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 25(24):3100-3103
10. Box GEP, Hunter WG, Hunter JS (1978) Statistics for experimenters. Wiley, New York, NY
11. Breslow NE, Day NE (1987) Statistical methods in cancer research: the design and analysis of cohort studies, vol 2. International agency for research on cancer, Lyon, France
12. Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O (2003) Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine 28(17):1913-1921
13. Buttner-Janz K, Schellnack K, Zippel H (1989) Biomechanics of the SB Charité lumbar intervertebral disc endoprosthesis. Int Orthop 13(3):173-176
14. Carey TS (1999) Randomized controlled trials in surgery: an essential component of scientific progress. Spine 24(23):2553-2555
15. Carragee EJ (2005) Clinical practice. Persistent low back pain. N Engl J Med 352(18):1891-1898
16. Chalmers CC, Smith H, Blackburn B, Silverman B, Schroeder B, Reiter D, Ambroz A (1981) A method for assessing the quality of randomized clinical trial. Control Clin Trials 2:31-49
17. Cinotti G, David T, Postacchini F (1996) Results of disc prosthesis after a minimum follow-up period of 2 years. Spine 21(8):995-1000
18. Coyle YM (2000) Developing theoretical constructs for outcomes research. Am J Med Sci 319(4):245-249
19. David T (1993) Lumbar disc prosthesis. Eur Spine J 1:254-259
20. Delamarter RB, Bae HW, Pradhan BB (2005) Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial. Orthop Clin North Am 36(3):301-313
21. Deyo RA, Nachemson A, Mirza SK (2004) Spinal-fusion surgery - the case for restraint. N Engl J Med 350(7):722-726
22. Donovan JL, Blake DR (1992) Patient non-compliance: deviance or reasoned decision-making? Soc Sci Med 34(5):507-513
23. Enker P, Steffee A, McMillin C, Keppler L, Biscup R, Miller S (1993) Artificial disc replacement. Preliminary report with a 3-year minimum follow-up. Spine 18(8):1061-1070
24. Errico TJ, Gatchel RJ, Schofferman J, Benzel EC, Faciszewski T, Eskay-Auerbach M, Wang JC (2004) A fair and balanced view of spine fusion surgery. Spine J 4(5 Suppl):S129-138
25. Fairbank JC, Pynsent PB (2000) The oswestry disability index. Spine 25(22):2940-2953
26. Fleiss JL (1981) Statistical methods for rates and proportions, 2nd edn. Wiley, New York
27. Fleiss JL (1986) The design and analysis of clinical experiments. Wiley, New York
28. Fritzell P, Hagg O, Wessberg P, Nordwall A (2001) 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 26(23):2521-2532
29. Fu WK (2000) Re: randomized controlled trials in surgery: an essential component of scientific progress (Spine 1999; 24:2553-2555). Spine 25(15):2002-2004
30. Gibson JN, Grant IC, Waddell G (1999) The cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine 24(17):1820-1832
31. Gibson JN, Waddell G (2005) Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev (2):CD001352
32. Griffith SL, Shelokov AP, Buttner-Janz K, LeMaire JP, Zeegers WS (1994) A multicenter retrospective study of the clinical results of the link SB Charité intervertebral prosthesis. The initial European experience. Spine 19(16):1842-1849
33. Guzman J, Esmail R, Karjalainen K, Malmivaara A, Irvin E, Bombardier C (2001) Multidisciplinary rehabilitation for chronic low back pain: systematic review. BMJ 322(7301):1511-1516
34. Haynes RB, McKibbon KA, Fitzgerald D, Guyatt GH, Walker CJ, Sackett DL (1986) How to keep up with the medical literature: IV. Using the literature to solve clinical problems. Ann Intern Med 105(4):636-640
35. Hildebrandt J, Ursin H, Mannion AF, Airaksinen O, Brox JI, Cedraschi C, Klaber-Moffett J, Kovacs F, Reis S, Staal B, Zanoli G, Broos L, Jensen I, Krismer M, Leboeuf-Yde C, Niebling W, Vlaeyen JW (2005) European guidelines for the management of chronic non-specific low back pain. European Co-Operation in the field of Scientific and Technical Research (COST). Available at: http:// www.backpaineurope.org/web/files/ WG2_Guidelines.pdf. Accessed August 25, 2005
36. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17(1):1-12
37. Juni P, Altman DG, Egger M (2001) Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 323(7303):42-46
38. Meinert CL, Tonascia S (1986) Clinical trials: design, conduct, and analysis, vol 8. Oxford University Press, New York, NY
39. Miller FG, Brody H (2003) A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 33(3):19-28
40. Moher D, Schulz KF, Altman DG (2003) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Clin Oral Investig 7(1):2-7
41. Nachemson AL, Jonsson E (eds) (2000) Neck and back pain: the scientific evidence of causes, diagnosis, and treatment. Williams & Wilkins, Lippincott
42. Ostelo RW, de Vet HC, Waddell G, Kerckhoffs MR, Leffers P, van Tulder M (2003) Rehabilitation following first-time lumbar disc surgery: a systematic review within the framework of the cochrane collaboration. Spine 28(3):209-218
43. Park SY, Moon SH, Park MS, Oh KS, Lee HM (2005) The effects of ketorolac injected via patient controlled analgesia postoperatively on spinal fusion. Yonsei Med J 46(2):245-251
44. Roland M, Fairbank J (2000) The Roland-Morris disability questionnaire and the oswestry disability questionnaire. Spine 25(24):3115-3124
45. Schlesselman JJ (1982) Case control studies: design, conduct, analysis, 1st edn. Oxford University Press, New York, NY
46. Schulz K (2001) Assessing allocation concealment and blinding in randomized controlled trials: why bother? Evid Based Nurs 4(1):4
47. Sott A, Harrison D (2000) Increasing age does not affect good outcome after lumbar disc replacement. Int Orthop 24:50-53
48. Spitzer WO, LeBlanc FE, DuPuis M (1987) Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine 12(7 Suppl):S1-59
49. Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E (1995) Scientific monograph of the Quebec Task Force on whiplash-associated disorders: redefining "whiplash" and its management. Spine 20(8 Suppl):1S-73S
50. Taylor SJ, Taylor AE, Foy MA, Fogg AJ (1999) Responsiveness of common outcome measures for patients with low back pain. Spine 24(17):1805-1812
51. van Tulder M, Furlan A, Bombardier C, Bouter L (2003) Updated method guidelines for systematic reviews in the cochrane collaboration back review group. Spine 28(12):1290-1299
52. van Tulder MW, Becker A, Bekkering T, Breen A, Gil del Real MT, Hutchinson A, Koes BW, Laerum E, Malmivaara A, Nachemson AL, Niehus W, Roux E, Rozenberg S (2005) European guidelines for the management of acute nonspecific low back pain in primary care. European Co-Operation in the field of Scientific and Technical Research (COST). Available at: http:// www.backpaineurope.org/web/ files/ WG1_Guidelines.pdf. Accessed August 25, 2005
53. Vogt MT, Hanscom B, Lauerman WC, Kang JD (2002) Influence of smoking on the health status of spinal patients: the national spine network database. Spine 27(3):313-319
54. Waddell G, McIntosh A, Hutchinson A, Feder G, Lewis M (1999) Low back pain evidence review. Royal College of General Practitioners, London
55. Walters S, Campbell M, Paisley S (2001) Methods for determining sample sizes for studies involving health-related quality of life measures: a tutorial. Health Serv Outcomes Res Methodol 2:83-99
56. Zeegers WS, Bohnen LM, Laaper M, Verhaegen MJ (1999) Artificial disc replacement with the modular type SB Charité III: 2-year results in 50 prospectively studied patients. Eur Spine J 8(3):210-217