Spine Tango, utility and results from real life. Emin Aghayev Institute for Social and Preventive Medicine University of Bern

Transcription

1 Spine Tango, utility and results from real life Emin Aghayev Institute for Social and Preventive Medicine University of Bern

2 Table of content What is Spine Tango History and key figures Why do we need a registry What data are collected What for can we use the data (evidence level, examples) Prerequisites for a successful registry Take home messages

3 Spine Tango Registry Spine Tango is an international registry that documents the effectiveness and safety of spine care, treatment techniques and technologies. Two main objectives: 1) the tracking of diseases and outcomes over time by aggregating and analysing patient data, quality management, and research, 2) the generation of a (collective) evidence base for prevention, treatment effectiveness, patient safety, and best practices.

4 History 2000 the idea 2002 the first case report form 2004 web based plattform for international use May the first widerly distributed form version (the so called 2005 form) form version 2007 first benchmarking reports for every participating hospital form version form version

5 History Growth rates of the various Spine Tango modules Switzerland International Germany Austria Great Britain Panamerica Italy Australia Poland Belgium 0 till Years

6 Key numbers Launched in: 2004 Data: Surgeries ca Follow up ca patient reported COMI ca Sponsor: EUROSPINE (society) Countries: 17 Centres: ca. 65 (18 in CH) Intention: multiple (implant database, clinical data, research, PROMs etc.) Scientific output: 53 peer reviewed papers (1 outstanding paper award)

7 Rational for a spine registry high demands but limited recourses increasing health care costs growing number of spinal implants various innovations multiple treatment options heterogeneous patient population aging society often missing consensus surgeon preferences reimbursement denials regional difference EVIDENCE

8 Swiss Federal Office of Statistics Swiss Health Atlas Vertebroplasty 2013 Kyphoplasty 2013

9 Biblical but topical? Pater, dimitte illis: non enim sciunt quid faciunt. Father forgive them, for they do not know what they are doing. Crucifixión. Antonio Saura 1963

10 Content Physician based Surgery form Follow up form Conservative form Patient based Core Outcome Index Measures (COMI) back surgery neck surgery back conservative neck conservative Oswestry EQ 5D NDI

11 Content

12 Content (conservative form)

13 Evidence level and type of research

14 Evidence level Registry data

15 In the contect of Health Technology Assessment Investigational cascade Efficacy Effectiveness Cost-efficiency Controlled trials Observational research Economic Analyses Efficacy Safety Can it work? Ideal clinical situations Patient outcomes Does it work? Normal clinical setting Costs and outcomes Real life

16 Benefits of a spine registry (or how can it help to improve treatment outcomes?) EVIDENCE >50 Publikationen broad research focus: health services, outcome research, and comparative effectiveness research research infrastructure > Fälle aus 65 Spitäler Benchmarkingberichte quality assurance on various levels and internal activity reports continuous education early warning / safety guard trend analyses real life snapshot for political decisions shared decision making (outcome prediction) standardization of spine care

17 Trend analyses (Swiss data)

18 Type of research: Registry supplements the evidence from RCTs

19 Registry supplements the evidence from RCTS (Staub et al.) Degenerative Bandscheibenerkrankung: Bandscheibenprothesen (BP) oder Fusion? Coric 2011 Kelly 2011 Marzluff 2010 McAfee 2010 Pettine 2010 Heller 2009 Mummaneni 2007 Nabhan 2007 Porchet 2004

20 Registry supplements the evidence from RCTS (Staub et al.) 987 pats 1) Typical RCT pats N=739 (75.2%) Age 60 years no spondylosis no facet joint degeneration no spondylolisthesis no trauma no C7/Th1 1:1 matching TDA:AIF 2) Atypical RCT patients N=248 (24.8%) Age >60 years or spondylosis or facet joint degeneration or spondylolisthesis or trauma or C7/Th1 multivariate analysis TDA:AIF 3) Patients with an additional FU>2 yrs N=149 (15.1%) multivariate analysis TDA:AIF (on patient age, sex, segment, ASA status, duration of conservative therapy, deg. dic disease, disc herniation, baseline neck and arm pain and COMI score and follow up interval)

21 Type of research: Comparative effectiveness research Comparing Laminotomy, Hemilaminectomy, Laminectomy, and Laminectomy with instrumented Fusion Munting et al. ESJ Feb;24(2): Despite better patient outcomes after laminectomy in combination with instrumented fusion, caution is advised due to higher rates of surgical and general complications and consequent required measures.»

22 Prognostic model: Schulthess Clinic) By courtesy of Mannion AF and team

23 Type of research: Causal relationship Comparing the pre operative duration of conservative treatment with regard to the outcome following surgical decompression for lumbar spinal stenosis Zweig et al. ESJ. 2017; in press The duration of pre operative conservative treatment was not associated with the ultimate outcome of decompression surgery.»

24 Take home messages Registry is an important and partially unique study design and tool for quality assurance and generation of collective evidence in the daily life. The need for cost effective, multi sourced, and widely shareable data collection has never been greater in spine care. The interest in registries is constantly growing, and rightly so.