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SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses

SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of “coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orth... Full description

Journal Title: European spine journal 2009-03-20, Vol.18 (6), p.851-861
Main Author: Schluessmann, E
Other Authors: Diel, P , Aghayev, E , Zweig, T , Moulin, P , Röder, C
Format: Electronic Article Electronic Article
Language: English
Subjects:
Adolescent
Adult
Aged
Analgesics
Analysis
Arthroplasty - instrumentation
Arthroplasty - methods
Arthroplasty - statistics & numerical data
Backache
Care and treatment
Comorbidity
Data Collection - methods
Disabled persons
Diskectomy - instrumentation
Diskectomy - methods
Diskectomy - statistics & numerical data
Erratum
Female
Health Policy - trends
Health technology assessment
Humans
Implants, Artificial
Intervertebral Disc Displacement - pathology
Intervertebral Disc Displacement - surgery
Low Back Pain - etiology
Low Back Pain - physiopathology
Low Back Pain - surgery
Lumbar Vertebrae - pathology
Lumbar Vertebrae - surgery
Male
Medicine
Medicine & Public Health
Middle Aged
Neurosurgery
Original
Original Article
Orthopedic surgery
Outcome
Outcome Assessment (Health Care) - methods
Outcome Assessment (Health Care) - trends
Pain
Pain Measurement - methods
Postoperative Complications - epidemiology
Prospective Studies
Prostheses and Implants - adverse effects
Prostheses and Implants - statistics & numerical data
Prosthesis
Quality Assurance, Health Care - methods
Quality Assurance, Health Care - trends
Registries - standards
Registry
Reoperation - statistics & numerical data
Surgical Orthopedics
Surveys and Questionnaires
SWISSspine
Switzerland
Technology Assessment, Biomedical - methods
Technology Assessment, Biomedical - trends
Total disc arthroplasty
Young Adult
Publisher: Berlin/Heidelberg: Springer-Verlag
ID: ISSN: 0940-6719
Link: https://www.ncbi.nlm.nih.gov/pubmed/19301042
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2899652
title: SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses
format: Article
creator:
  • Schluessmann, E
  • Diel, P
  • Aghayev, E
  • Zweig, T
  • Moulin, P
  • Röder, C
subjects:
  • Adolescent
  • Adult
  • Aged
  • Analgesics
  • Analysis
  • Arthroplasty - instrumentation
  • Arthroplasty - methods
  • Arthroplasty - statistics & numerical data
  • Backache
  • Care and treatment
  • Comorbidity
  • Data Collection - methods
  • Disabled persons
  • Diskectomy - instrumentation
  • Diskectomy - methods
  • Diskectomy - statistics & numerical data
  • Erratum
  • Female
  • Health Policy - trends
  • Health technology assessment
  • Humans
  • Implants, Artificial
  • Intervertebral Disc Displacement - pathology
  • Intervertebral Disc Displacement - surgery
  • Low Back Pain - etiology
  • Low Back Pain - physiopathology
  • Low Back Pain - surgery
  • Lumbar Vertebrae - pathology
  • Lumbar Vertebrae - surgery
  • Male
  • Medicine
  • Medicine & Public Health
  • Middle Aged
  • Neurosurgery
  • Original
  • Original Article
  • Orthopedic surgery
  • Outcome
  • Outcome Assessment (Health Care) - methods
  • Outcome Assessment (Health Care) - trends
  • Pain
  • Pain Measurement - methods
  • Postoperative Complications - epidemiology
  • Prospective Studies
  • Prostheses and Implants - adverse effects
  • Prostheses and Implants - statistics & numerical data
  • Prosthesis
  • Quality Assurance, Health Care - methods
  • Quality Assurance, Health Care - trends
  • Registries - standards
  • Registry
  • Reoperation - statistics & numerical data
  • Surgical Orthopedics
  • Surveys and Questionnaires
  • SWISSspine
  • Switzerland
  • Technology Assessment, Biomedical - methods
  • Technology Assessment, Biomedical - trends
  • Total disc arthroplasty
  • Young Adult
ispartof: European spine journal, 2009-03-20, Vol.18 (6), p.851-861
description: SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of “coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3–29.4 points preop to 1-year postop, p  
language: eng
source:
identifier: ISSN: 0940-6719
fulltext: no_fulltext
issn:
  • 0940-6719
  • 1432-0932
url: Link


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titleSWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses
creatorSchluessmann, E ; Diel, P ; Aghayev, E ; Zweig, T ; Moulin, P ; Röder, C
creatorcontribSchluessmann, E ; Diel, P ; Aghayev, E ; Zweig, T ; Moulin, P ; Röder, C ; SWISSspine Registry Group ; On behalf of School of the SWISSspine Registry Group
descriptionSWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of “coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3–29.4 points preop to 1-year postop, p  < 0.0001) leg pain VAS (55.5–19.1 points preop to 1-year postop, p  < 0.001), improvement of quality of life (EQ-5D, 0.32–0.73 points preop to 1-year postop, p  < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS “threshold value” of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.
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subjectAdolescent ; Adult ; Aged ; Analgesics ; Analysis ; Arthroplasty - instrumentation ; Arthroplasty - methods ; Arthroplasty - statistics & numerical data ; Backache ; Care and treatment ; Comorbidity ; Data Collection - methods ; Disabled persons ; Diskectomy - instrumentation ; Diskectomy - methods ; Diskectomy - statistics & numerical data ; Erratum ; Female ; Health Policy - trends ; Health technology assessment ; Humans ; Implants, Artificial ; Intervertebral Disc Displacement - pathology ; Intervertebral Disc Displacement - surgery ; Low Back Pain - etiology ; Low Back Pain - physiopathology ; Low Back Pain - surgery ; Lumbar Vertebrae - pathology ; Lumbar Vertebrae - surgery ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neurosurgery ; Original ; Original Article ; Orthopedic surgery ; Outcome ; Outcome Assessment (Health Care) - methods ; Outcome Assessment (Health Care) - trends ; Pain ; Pain Measurement - methods ; Postoperative Complications - epidemiology ; Prospective Studies ; Prostheses and Implants - adverse effects ; Prostheses and Implants - statistics & numerical data ; Prosthesis ; Quality Assurance, Health Care - methods ; Quality Assurance, Health Care - trends ; Registries - standards ; Registry ; Reoperation - statistics & numerical data ; Surgical Orthopedics ; Surveys and Questionnaires ; SWISSspine ; Switzerland ; Technology Assessment, Biomedical - methods ; Technology Assessment, Biomedical - trends ; Total disc arthroplasty ; Young Adult
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0SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses
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descriptionSWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of “coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3–29.4 points preop to 1-year postop, p  < 0.0001) leg pain VAS (55.5–19.1 points preop to 1-year postop, p  < 0.001), improvement of quality of life (EQ-5D, 0.32–0.73 points preop to 1-year postop, p  < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS “threshold value” of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.
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3Analgesics
4Analysis
5Arthroplasty - instrumentation
6Arthroplasty - methods
7Arthroplasty - statistics & numerical data
8Backache
9Care and treatment
10Comorbidity
11Data Collection - methods
12Disabled persons
13Diskectomy - instrumentation
14Diskectomy - methods
15Diskectomy - statistics & numerical data
16Erratum
17Female
18Health Policy - trends
19Health technology assessment
20Humans
21Implants, Artificial
22Intervertebral Disc Displacement - pathology
23Intervertebral Disc Displacement - surgery
24Low Back Pain - etiology
25Low Back Pain - physiopathology
26Low Back Pain - surgery
27Lumbar Vertebrae - pathology
28Lumbar Vertebrae - surgery
29Male
30Medicine
31Medicine & Public Health
32Middle Aged
33Neurosurgery
34Original
35Original Article
36Orthopedic surgery
37Outcome
38Outcome Assessment (Health Care) - methods
39Outcome Assessment (Health Care) - trends
40Pain
41Pain Measurement - methods
42Postoperative Complications - epidemiology
43Prospective Studies
44Prostheses and Implants - adverse effects
45Prostheses and Implants - statistics & numerical data
46Prosthesis
47Quality Assurance, Health Care - methods
48Quality Assurance, Health Care - trends
49Registries - standards
50Registry
51Reoperation - statistics & numerical data
52Surgical Orthopedics
53Surveys and Questionnaires
54SWISSspine
55Switzerland
56Technology Assessment, Biomedical - methods
57Technology Assessment, Biomedical - trends
58Total disc arthroplasty
59Young Adult
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authorSchluessmann, E ; Diel, P ; Aghayev, E ; Zweig, T ; Moulin, P ; Röder, C
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43Prospective Studies
44Prostheses and Implants - adverse effects
45Prostheses and Implants - statistics & numerical data
46Prosthesis
47Quality Assurance, Health Care - methods
48Quality Assurance, Health Care - trends
49Registries - standards
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51Reoperation - statistics & numerical data
52Surgical Orthopedics
53Surveys and Questionnaires
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56Technology Assessment, Biomedical - methods
57Technology Assessment, Biomedical - trends
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abstractSWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of “coverage with evidence development”. It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3–29.4 points preop to 1-year postop, p  < 0.0001) leg pain VAS (55.5–19.1 points preop to 1-year postop, p  < 0.001), improvement of quality of life (EQ-5D, 0.32–0.73 points preop to 1-year postop, p  < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS “threshold value” of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.
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pubSpringer-Verlag
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doi10.1007/s00586-009-0934-8
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