Registries as a base for pan-European health services research in the field of pain

Winfried Meissner, M.D.

Ruth Zaslansky, D.Sc.

Dept. of Anaesthesia & Intensive Care University Hospital Jena, Jena, Germany

Disclosure Statement of conflict of interest in the context of the subject of this presentationWithin the past 12 months, I or my spouse/partner have had following financial interest/arrangement(s) or affiliation(s)

below.

Affiliation/Financial Relationship Company

•Support for travel European Commission•Honoraria for lectures ……………………•Honoraria for advisory board activities ……………………•Participation in clinical trials ……………………•Research funding European Commission•Financial shares and options ……………………•…………………………….. ……………………

“.. a system that uses observational methods

with a common formation of variables to evaluate a population defined by a

particular disease or condition and that serves

scientists, clinicians or policy-makers.”

Registries for Evaluating Patient Oucomes:

A User‘s Guilde 2007

Medical Registries

Trauma registries - since 1920s Cancer registries - since 1960s

RCTs Registries

• Mirrors daily practice

• Large number of cases

• Infomation on rare cases, complications & adverse effects

• Uncontrolled confounders

• No randomisation

• Causality?

• Highly selected population

• All variables well controlled

• Asses efficacy of treatments under ideal conditions

• Findings don‘t generalize well to everyday practice

• Underpowered to detect complications, rare situations & adverse events

+ +

- -

Task Force “International Pain Registry”

Ruth Zaslansky, DSc Israel / GermanyC. Richard Chapman, PhD USADaniel Carr, MD USAJane Ballantyne, MB, BS, FRCA USALouis Brasseur, MD FranceM. Soledad Cepeda, MD, Phd ColumbiaPongparadee Chaudakshetrin, MD ThailandPamela Macintyre, MB, BS, FANZCA AustraliaVincent Chan, MD CanadaArthur Lipman, PharmD USANarinder Rawal, MD PhD SwedenPhilip J. Wiffen, BPharm, MRPharm EnglandWinfried Meissner, MD Germany

7th EU Framework Programme:PAIN-OUT

RegistryResearch

Clinicians, researchers, epidemiologists, hospital administrators,

policy makers

Feedback/Benchmarking, Clinical Decision Support,

Knowledge Library

Data from clinical sites internationally

Quality improvement

Project tools:

Patient reported OUTCOMES

Validated questionnaire

Uniform variables for all patients

Questionnaire in 18 languages + Clinical data

Patients assessed on the first day after surgery

PAIN OUT & QUIPS: The International Acute Pain Registry

200 sites and >250,000 datasets

Registries as a base for research in the field of pain

Registries can be used to study• Epidemiology of pain (incidence/prevalence)• Variation of care (adherence to guidelines etc.)• Areas of under-, overtreatment• Long-time outcome (e.g., persistent postoperative pain, QoL)• Cultural/ethnic differences• Cost/benefit or risk/benefit ratio• Effectiveness of interventions

Registries can be used for• Hypothesis generating• Detecting risks / complications (e.g., pharmacovigilance)

1561 patients registered in the QUIPS database

between 1.2009 –1.2011as undergoing LapC

20% of patients were treated

according to all the recommendations

Variation of care (e.g. adherence to guidelines)

Study long-term outcomes (e.g., persistent postoperative pain)

Cultural differences

• Non praying: n=3948

• Praying: n=855

0

10

20

30

40

50

60

70

80

90

100

Prayer [%]

Cultural differences

0123456789

10

Worst pain Satisfaction

PrayersNon-prayers

* (p=0.001)

Cultural differences

PAIN OUT

• Established an international platform for research in pain

• Created a web-based, user-friendly system for feedback and benchmarking of patient-reported outcomes

• Created a large & constantly growing database which will permit:

- powerful data analysis

- hypothesis generating

• Complement Randomized Controlled Studies

Prof N Rawal, Dr R Backstrom, Prof Funk, SwedenProf R Langford, Dr K Ullrich, Dr R Taylor UK Prof M Puig, Spain Dr D Fletcher, France Prof C Konrad, SwitzerlandProf T Volk, Prof E Pogatzki-Zahn, Dr A Kopf, GermanyDr L Fodor, RomaniaDr S Brill, IsraelDr Leykin, ItalyDr C Engel, GermanyI Buchholtz, Germany

www.pain-out.eu (see also abstract booklet)

EU clinical and research partners