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

1. 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

2. Disclosure Statement of conflict of interest in the context of the subject of this presentation Within 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 …………………… …………………………….. ……………………

3. Medical Registries “.. 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 • Trauma registries - since 1920s • Cancer registries - since 1960s

4. RCTs Registries • 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 • Mirrors daily practice • Large number of cases • Infomation on rare cases, complications & adverse effects • Uncontrolled confounders • No randomisation • Causality? + + - -

5. 7th EU Framework Programme:PAIN-OUT

6. Data from clinical sites internationally Registry Research Quality improvement Clinicians, researchers, epidemiologists, hospital administrators, policy makers Feedback/Benchmarking, Clinical Decision Support,Knowledge Library

7. 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

8. PAIN OUT & QUIPS: The International Acute Pain Registry 200 sites and >250,000 datasets

9. 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)

10. 1561 patients registered in the QUIPS database between 1.2009 –1.2011 as undergoing LapC 20% of patients were treated according to all the recommendations Variation of care (e.g. adherence to guidelines)

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

12. Cultural differences

13. Cultural differences • Non praying: n=3948 • Praying: n=855

14. Cultural differences * (p=0.001)

15. 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

16. EU clinical and research partners Prof N Rawal, Dr R Backstrom, Prof Funk, Sweden Prof R Langford, Dr K Ullrich, Dr R Taylor UK Prof M Puig, Spain Dr D Fletcher, France Prof C Konrad, Switzerland Prof T Volk, Prof E Pogatzki-Zahn, Dr A Kopf, Germany Dr L Fodor, Romania Dr S Brill, Israel Dr Leykin, Italy Dr C Engel, Germany I Buchholtz, Germany www.pain-out.eu (see also abstract booklet)