Spine Tango International Spine Registry

T. Zweig Hirslanden SALEM-SPITAL dasRückenzentrum, Bern, Schweiz 2 EUROSPINE, the Spine Society of Europe 3 ISPM, Institut für Sozial- und Präventiv Medizin (ass.) 1

Overview Background epidemiology surgeons level History from the roots to modern registry architecture Spine Tango  The international Spine Registry (SwissSpine) Results publications 1 example

? Where is the position of  registries in spine surgery

Archie Cochrane

1909‐1988

“As opposed to a controlled  research setting (RCT), a vast  variety of factors influence  the treatment efficiency such  as screening, diagnosis, place  of treatment, length of stay,  rehabilitation, and optimum  use of personnel and  materials (Registries). “

“Effectiveness and Efficiency: Random Reflections on Health Services”, 1972

Brief Anatomy of Research Clinical / epidemiological  studies

Observation

Intervention

“natural experiments” 

“initiated experiments” 

Descriptive - case series - cross-sectional

Analytic ‐ case control  ‐ cohort (Registry)

Descriptive ‐ case series

Analytic ‐randomized  trial (RCT)

Codmans demand "We believe it is the duty of every hospital to establish a  follow‐up system, so that as far as possible the result of  every case will be available at all times for investigation by  members of the staff, the trustees, or administration, or by  other authorized investigators or statisticians." Ernest A. Codman 1909‐1988

Swiss history – Orthopaedic Titans MEM‐CED, Maurice E. Müller Center for Education and Documtion IEFO – IEFM ‐ ISPM

left: Maurice E. Müller 1918‐2009 (Ordinarius: 1963‐80 Insel) right: Sir John Charnley (GB) 1911‐1982 Friedman DP, Rubin JC Sullivan KJ (2017) Toward an  Information for Global Health Improvment (IMIA  Yearbook of medical Informatics 2017 Demning/Shewhart (1930)

1960 ties Hip registry

2005 – 2017 Spine Tango

Know the outcome !

A Study in Hospital Efficiency. 337 patients discharged between 1911 and 1916, EA Codman

Distributed Server Concept

Growth Curve

January 2018

Generated daily for the hompage by ISPM/SRDL

Form counts Spine Tango Forms 102'184; 17%

70'007; 12%

413'842; 71%

Surgery

Follow‐up

PROMS

Status Q3 2017; “All PROMS” includes COMI Back, COMI Neck, ODI, NDI, EQ‐5D, SF‐12, SF‐36. 

Form counts 300'000

250'000

No. Forms

200'000

150'000 All PROMS Follow‐Up 100'000

Surgery

50'000

0

Status Q3 2017; “All PROMS” includes COMI Back, COMI Neck, ODI, NDI, EQ‐5D, SF‐12, SF‐36. 

Form counts Module

Surgery

Follow‐Up

All PROMS

Australia Austria Belgium Germany Italy Poland Switzerland United Kingdom PanAmerican International Total

2,093 1,522 4,725 18,040 1,480 840 35,362 22,185 9,445 6,492 102,184

2,992 48 3,434 11,808 110 99 37,760 8,191 3,906 1,659 70,007

14,429 31,355 12,920 44,818 1,139 3,514 172,743 80,413 21,877 30,634 413,842

Status Q3 2017; “All PROMS” includes COMI Back, COMI Neck, ODI, NDI, EQ‐5D, SF‐12, SF‐36. 

SwissSpine Setup

SFOPH HTA Report

designs, administers evaluates

assigns

certifies

Members SSS

SSS

Patients

owner, responsible

University Bern IEFO

mandates

Industry

Mediator (law firm)

SWISSspine Registry

technical data, financing, sales

SwissSpine

Worldwide first mandatory national registry for cost intensive procedures under scrutiny (2007‐2017)

Publications 2017 (n=8, total 46 peer reviewed) Becker H‐J, Nauer S, Porchet F, Kleinstück FS, Haschtmann D, Fekete TF, et al. A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal  Stenosis Outcome Study  (LSOS). Eur Spine J. 2017;26(2):441 Borcek AO, Bulduk EB, Civi S, Emmez H, Kaymaz M. Spine Tango in Turkish: Development  of a Local Registry System. Turk Neurosurg. 2017;27(2):237 Gabel CP, Cuesta‐Vargas A, Qian M, Vengust R, Berlemann U, Aghayev E, et al. The Oswestry Disability Index, confirmatory factor analysis in a sample of 35,263 verifies a  one‐factor structure but practicality issues remain. Eur Spine J. 2017;26(8):2007 Herren C, Sobottke R, Mannion AF, Zweig T, Munting E, Otten P, et al. Incidental durotomy in decompression for lumbar spinal  stenosis: incidence, risk factors and effect on outcomes in the Spine Tango registry. Eur Spine J. 2017;  Sobottke R, Herren C, Siewe J, Mannion AF, Roder C, Aghayev E. Predictors of improvement in quality of life and pain relief in  lumbar spinal stenosis relative to patient age: a study based on the Spine Tango registry. Eur Spine J. 2017;26(2):462 Virdee JS, Nadig A, Anagnostopoulos G, George KJ. Comparison of perioperative and 12 month lifestyle outcomes in minimally invasive transforaminal lumbar interbody fusion versus conventional lumbar fusion. Br J Neurosurg. 2017;31(2):167 Zarghooni K, Beyer F, Papadaki J, Boese CK, Siewe J, Schiffer G, et al. [Quality of Life and Functional Outcome after Microsurgical Decompression in Lumbar Spinal Stenosis: a Register Study]. Z Orthop Unfall. 2017  Aug;155(4):429 Zweig T, Enke J, Mannion AF, Sobottke R, Melloh M, Freeman BJC, et al. Is the duration of pre‐operative conservative treatment associated with the clinical outcome following surgical decompression for lumbar spinal stenosis? A study based on the Spine Tango  Registry. Eur Spine J. 2017;26(2):488–500. 

Is the duration of pre‐operative conservative treatment  associated with the clinical outcome following surgical  decompression for lumbar spinal stenosis? ** Thomas Zweig1, 2; Anne F. Mannion3; Rolf Sobottke6; Markus Melloh5; Brian J. C. Freeman4;  Emin Aghayev2; Spine Tango Contributors  1

– The Spine Center Bern, 3025 Bern, Switzerland – Swiss Center of Excellence in Medical Registries (Swiss RDL), Institute for Social and Preventive Medicine, University of Bern 3 – Spine Center, Department of Teaching, Research and Development, Schulthess Klinik, 8008 Zurich, Switzerland 4 – Department of Spinal Surgery, Discipline of Orthopaedics and Trauma, School of Medicine, University of Adelaide, Australia 5 – Center for Health Sciences, School of Health Professions, Zurich University of Applied Sciences, 8401 Winterthur, Switzerland 6 ‐ Centre for Orthopaedic and Trauma Surgery, Medical Center StädteRegion Aachen, 52146 Würselen, Germany 2

ESJ 12/2016 (MS Number: ESJO‐D‐16‐00236R1)

Background LSS is the most common and fastest increasing reason for  lumbar spinal surgery 1 in the population older than 65 y ‐ surgical decompression is a well accepted indication. • • • • • • • • • •

Aalto et al. Athiviraham et al. Deyo et al. Gibson et al. Jakola et al. Katz et al. Kleinstück et al. Pao et al. Sigmundsson et al. Sobottke et al. 1. Sobottke R, Herren C, Siewe J, Mannion AF, Roder C, Aghayev E  (2015) Predictors of improvement in quality of life and pain relief in  lumbar spinal stenosis relative to patient age: a study based on the Spine Tango registry. Eur Spine J. doi: 10.1007/s00586‐015‐4078‐8

Question out of daily practice “Is my surgical outocome changed by the duration of conservative therapy?

Hypothesis Does the duration of conservative therapy is associated with the outcome of surgical decompression of LSS (legpain,  backpain, QoL).

Amundsen et. al:  kein Unterschied initiale Operation oder späterer Zeitpunkt (Grossteil: 12 Wochen erfolglose Therapie)

Material and Methods  • •

•

• •

Prospecitve consecutive mulitcenter registry data (Spine Tango) inclusion: – LSS – > 20 y – Lumbar und Lumbosakral – 1 to 5 seg, – No revisions – Only decompressions (no implants) – ASA know – Complete data Exclusion – Additional pathology – Instrumentation, Fusion Patienten: Sample: n= 3, 478 aus 32 Institutionen, 9 Countries (AT, B, D, I, P, CH UK, USA) Statistik: Propensity score basierte und gewichtete multivariate Regressionsanalyse mit “inverse probability of treatment weighting (IPTW)”

Grouping ‐ duration of conserv. Therapy prior surgery

4 Gruppen

duration 1) Non 2)  12 mo total

N 497 965a 758 1258b 3,478

Leg pain

No sig. Diff (p = 0.22)

QoL

No sig diff. (p=0.54)

Back pain

Post hoc Analyse Keine signifikanten Unterschiede Gruppe wenn Gruppe 4 als Referenz

No

12

Pre

5.7

6.0

5.7

5.9

Post

3.4

3.5

3.6

3.6

Diff

2.3

2.5

2.1

2.2

Conclusions •

The duration of conservative therapie prior surgery is not associated with the ultimate outcome of LSS-decompression with regards to: Leg pain QoL Surgical complications General complications

•

This interpretation is not to be justified with these findings: Every patient with LSS can have conservative therapy > 12 month.

•

This study shows that the decision finding for the „right“ point of time seams to work between patients and surgeons.

Thank you