The International Endometriosis Evaluation Program (IEEP Study) – A Systematic Study for Physicians, Researchers and Patients

Abstract

Introduction: Endometriosis is a heterogeneous disease characterized by a range of different presentations. It is usually diagnosed when patients present with pain and/or infertility, but it has also been diagnosed in asymptomatic patients. Because of the different diagnostic approaches and diverse therapies, time to diagnosis can vary considerably and the definitive diagnosis may be delayed, with some cases not being diagnosed for several years. Endometriosis patients have many unmet needs. A systematic registration and follow-up of endometriosis patients could be useful to obtain an insight into the course of the disease. The validation of biomarkers could contribute to the development of diagnostic and predictive tests which could help select patients for surgical assessment earlier and offer better predictions about patients who might benefit from medical, surgical or other interventions. The aim is also to obtain a better understanding of the etiology, pathogenesis and progression of the disease. Material and Methods: To do this, an online multicenter documentation system was introduced to facilitate the establishment of a prospective multicenter case-control study, the IEEP (International Endometriosis Evaluation Program) study. We report here on the first 696 patients with endometriosis included in the program between June 2013 and June 2015. Results: A documentation system was created, and the structure and course of the study were mapped out with regard to data collection and the collection of biomaterials. Conclusion: The documentation system permits the history and clinical data of patients with endometriosis to be recorded. The IEEP combines this information with biomaterials and uses it for scientific studies. The recorded data can also be used to evaluate clinical quality control measures such as the certification parameters used by the EEL (European Endometriosis League) to assess certified endometriosis centers.

Zusammenfassung

Einleitung: Das Erkrankungsbild der Endometriose ist sehr heterogen. Die Diagnosestellung erfolgt häufig im Zusammenhang mit Schmerzen und/oder Sterilität. Es können aber auch keine Beschwerden vorhanden sein. Dies führt dazu, dass die Zeit bis zur definitiven Diagnose aufgrund verschiedener Diagnostik- und Behandlungsansätze unterschiedlich lang sein kann und die Diagnose teilweise hierdurch verzögert wird. Die Validierung von Biomarkern könnte zur Entwicklung eines diagnostischen und prädiktiven Tests beitragen, um besser beurteilen zu können, ob und von welcher Therapie eine Patientin profitiert. Material und Methoden: Um diese Fragestellungen zu beantworten, wurde multizentrisch ein onlinebasiertes Dokumentationssystem eingeführt, das zur Implementierung einer prospektiven multizentrischen Fall-Kontroll-Studie, der IEEP (International Endometriosis Evaluation Program)-Studie, beiträgt. Im Zeitraum von Juni 2013 bis Juni 2015 wurden die anamnestischen und klinischen Daten von 696 Patientinnen erfasst. Ergebnisse: Durch die Implementierung konnten der Ablauf und die Strukturierung der Studie, insbesondere die Datenerhebung und die Biomaterialsammlung, etabliert werden. Schlussfolgerung: In dem Dokumentationssystem ist es möglich, anamnestische und klinische Daten von Patientinnen mit Endometriose so zu dokumentieren, um sowohl in Kombination mit Biomaterialien wissenschaftliche Fragestellungen im Rahmen der IEEP-Studie zu beantworten, als auch Daten zu Zertifizierungszwecken zu erheben.

Key words

endometriosis - biomarker - epidemiology - diagnostics - case control study

Schlüsselwörter

Endometriose - Biomarker - Epidemiologie - Diagnostik - Fallkontrollstudie

^* These two authors have contributed equally to this paper.

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