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