Abstract
In the discussion about the rationale for spine registries, two basic questions have to be answered. The first one deals with the value of orthopaedic registries per se, considering them as observational studies and comparing the evidence they generate with that of randomised controlled trials. The second question asks if the need for registries in spine surgery is similar to that in the arthroplasty sector. The widely held view that randomised controlled trials are the ‘gold standard’ for evaluation and that observational methods have little or no value ignores the limitations of randomised trials. They may prove unnecessary, inappropriate, impossible, or inadequate. In addition, the external validity and hence the ability to make generalisations about the results of randomised trials is often low. Therefore, the false conflict between those who advocate randomised trials in all situations and those who believe observational data provide sufficient evidence needs to be replaced with mutual recognition of their complementary roles. The fact that many surgical techniques or technologies were introduced into the field of spine surgery without randomised trials or prospective cohort comparisons makes obvious an even increased need for spine registries compared to joint arthroplasty. An essential methodological prerequisite for a registry is a common terminology for reporting results and a sophisticated technology that networks all participants so that one central data pool is created and accessed. Recognising this need, the Spine Society of Europe has researched and developed Spine Tango, the first European spine registry, which can be accessed under www.eurospine.org.
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References
Aebi M, Grob D (2004) SSE Spine Tango: a European Spine Registry promoted by the Spine Society of Europe (SSE). Eur Spine J 13:661–662
Agency for Health Care Research and Quality (07.06.2005). Healthcare cost and utilization project, HCUPnet. http://www.ahrq.gov/data/hcup (Accessed September 21, 2005)
Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. BMJ 312:1215–1218
Black NA, Johnston A (1990) Volume and outcome in hospital care: evidence, explanations and implications. Health Serv Manage Res 3:108–114
Bourne RB (1999) The planning and implementation of the Canadian Joint Replacement Registry. Bull Hosp Jt Dis 58:128–132
Chalmers I (1986) Minimising harm and maximising benefit during innovation in health care: controlled or uncontrolled experimentation? Birth 13:155–164
Cochrane A (1989) Archie Cochrane in his own words. Control Clin Trials 10:428–433
Cochrane collaboration. www.cochrane.org (Accessed September 21, 2005)
CONSORT group—strength in science, sound ethics. www.consort-statement.org (Accessed September 21, 2005)
Deyo RA, Nachemson AN, Mirza SK (2004) Spinal fusion surgery—the case for restraint. N Engl J Med 350:722–726
Dixon J, Glennerster H (1995) What do we know about fundholding in general practice? BMJ 311:727–730
Dorey F, Grigoris P, Amstutz H (1994) Making do without randomised trials. J Bone Joint Surg Br 76-B:1–3
Fouyas IP, Statham PFX, Sandercock PAG (2002) Cochrane review on the role of surgery in cervical spondylotic radiculopathy. Spine 27:736–747
Fowler FJ, Wennberg JE, Timothy RP, Barry MJ, Mulley AG, Hanley D (1988) Symptom status and quality of life following prostatectomy. JAMA 259:3018–3022
Gibson J, Waddell G (2005) Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev 18(2):CD001352
Gibson J, Grant IC, Waddell G (1999) The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine 24:1820–1832
Graves SE, Davidson D, Ingerson L, Ryan P, Griffith EC, McDermott BF, McElroy HJ, Pratt NL (2004) The Australian Orthopaedic Association National Joint Replacement Registry. Med J Aust 180:S31–S34
Havelin LI (1999) The Norwegian Joint Registry. Bull Hosp Jt Dis 58:139–147
Hlatky MA, Califf RM, Harrell FE, Lee KL, Mark DB, Pryor D (1988) Comparison of predictions based on observational data with the results of randomised controlled trials of coronary artery bypass surgery. J Am Coll Cardiol 11:237–245
Katz JN (1995) Lumbar spinal fusion: surgical rates, costs, and complications. Spine 20:78S–83S
Lang I, Willert HG (2001) Experiences with the German Endoprosthesis Register. Z Arztl Fortbild Qualitatssich 95:203–208
Lilford R, Jackson J (1995) Equipoise and the ethics of randomization. J R Soc Med 88:552–559
Linder L (1995) Boneloc—the Christiansen experience revisited. Acta Orthop Scand 66:205–206
Mendenhall Associates, Inc (2002) Spinal industry update. Orthop Netw News 13:7–8
No authors listed (1992) Cross design synthesis: a new strategy for studying medical outcomes? Lancet 340:944–946
Rahme H, Jacobsen MB, Salomonsson B (2001) The Swedish Elbow Arthroplasty Register and the Swedish Shoulder Arthroplasty Register: two new Swedish arthroplasty registers. Acta Orthop Scand 72:107–112
Rothwell AG (1999) Development of the New Zealand Joint Register. Bull Hosp Jt Dis 58:148–160
Rothwell PM (2005) External validity of randomized controlled trials: ‘To whom do the results of his trial apply’. Lancet 365:82–93
Röder C, EL-Kerdi A, Eggli S, Aebi M (2004) A centralized total joint replacement registry using web-based technologies. J Bone Joint Surg Am 86-A:2077–2080
Röder C, EL-Kerdi A, Grob D, Aebi M (2002) A European Spine Register. Eur Spine J 11:303–307
Schulz KF (1995) Subverting randomization in controlled trials. JAMA 274:1456–1458
Stiller CA (1994) Centralised treatment, entry to trials, and survival. Br J Cancer 70:352–362
Stromqvist B, Jonsson B, Fritzell P, Hagg O, Larsson BE, Lind B (2001) The Swedish National Register for lumbar spine surgery: Swedish Society for Spinal Surgery. Acta Orthop Scand 72:99–106
Thanner J, Freij-Larsson C, Kärrholm J, Malchau H, Wesslen B (1995) Evaluation of Boneloc. Acta Orthop Scand 66:207–214
Ward LC, Fielding JWL, Dunn JA, Kelly KA (1992) The selection of cases for randomised trials: a registry of concurrent trial and non-trial participants. Br J Cancer 66:943–950
Wasson JH, Reda DJ, Bruskewitz RC, Elinson J, Keller AM, Henderson WG (1995) A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. N Engl J Med 332:75–79
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Röder, C., Müller, U. & Aebi, M. The rationale for a spine registry. Eur Spine J 15 (Suppl 1), S52–S56 (2006). https://doi.org/10.1007/s00586-005-1050-z
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DOI: https://doi.org/10.1007/s00586-005-1050-z