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 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 fundingEuropean 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

7th EU Framework Programme: PAIN-OUT

Registry Research 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

Similar to aims of PAIN OUT

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)

Study epidemiology of pain (incidence/prevalence) General (n = 4280) vs. Orthopaedic (n=4997) surgery in 11 medical centers How can registries be a base for research in the field of pain ?

1561 patients registered in the QUIPS database between – as 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 Cultural differences

* (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, 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 (see also abstract booklet) EU clinical and research partners