Das Treatment Exit Options for Uveitis (TOFU) Register: Einbindung von Patienten in die Evidenzgenerierung

Zusammenfassung

Uveitis ist eine seltenere entzündliche Augenerkrankung, die zu schwerer Sehbehinderung und Blindheit führen kann und besonders Menschen im berufstätigen Alter betrifft. Besonders schwere Verläufe, die meist einer immunmodulierenden Therapie (IMT) bedürfen, treten bei einer Uveitis auf, die die hinteren Teile des Auges oder das ganze Auge betreffen und nicht infektiöser Ursache sind. Für diese Formen der Erkrankung gibt es nur wenig gute Evidenz zum langfristigen Management der Erkrankung und insbesondere zur Beendigung oder Reduktion einer IMT. Das Treatment exit Options For non-infectious Uveitis (TOFU) Register der Sektion Uveitis der Deutschen Ophthalmologischen Gesellschaft (DOG) hat das Ziel, Krankheitsverläufe von Patienten mit nicht-infektiöser nicht-anteriorer Uveitis zu dokumentieren und Empfehlungen zur Beendigung einer IMT zu erarbeiten. Ein wesentlicher Aspekt des TOFU-Registers ist die aktive Einbeziehung von Patienten in die Erfassung Patienten-berichteter Endpunkte über ein Patientenmodul (Patient Reported Outcomes, PROs). Neben seh- und gesundheitsbezogener Lebensqualität werden auch Fragebögen zur Therapieadhärenz, Produktivität und Auswirkungen der Therapien eingesetzt. Die eingesetzten Fragebögen wurden in dieser Kombination in einer Pilotstudie mit Patienten getestet und es hat sich gezeigt, dass die wesentlichen Patienten-relevanten Aspekte der Erkrankung und deren Auswirkungen auf den Alltag erfasst werden. Das Patientenmodul, wie das Register selbst, nutzt zur Dokumentation die electronic data capture (EDC)-Software REDCap (Version 9, Vanderbilt University, USA). Durch die Einbindung von Patienten in sowohl die Konzeption des Registers als auch die fortlaufende Datensammlung wird sichergestellt, dass Patienten-relevante Evidenz für z. B. die Erstellung von Leitlinien und Behandlungsempfehlungen generiert wird.

Abstract

Uveitis comprises a group of rare diseases characterised by intraocular inflammation which may cause vision impairment and blindness and mostly affects people of working age. Non-infectious uveitis involving the posterior pole or the entire eye is often treated with different immunomodulating or disease-modifying anti-rheumatic drugs (DMARDs). However, the evidence on long-term management strategies and reduction/termination of treatment is limited. To help develop treatment exit strategies for patients with quiescent uveitis on long-term DMARD treatment, the Treatment Exit Options for Non-infectious Uveitis registry was initiated by the German ophthalmological society. A key aspect of the registry is active participation of patients (patient-reported outcomes, PROs). In a pilot study involving members of patient organizations, a combination of questionnaires covering vision- and general health-related quality of life, adherence to treatment, productivity and effects of treatment were evaluated. As the pilot study showed coverage of relevant patient-related aspects of the disease and its effect on daily life, the evaluated questionnaires were implemented in the registry’s patient module. The registry including the patient module uses the electronic data capture (EDC) software REDCap (Version 9, Vanderbilt University, USA). By involving patients in both conceptualization and ongoing data collection, the TOFU registry emphasizes the patients’ perspectives, and the inclusion of patient-relevant evidence for such as the development of guidelines and treatment recommendations is ensured.

Schlüsselwörter

Uveitis - Register - Versorgungsforschung - Augenheilkunde - Patienteneinbindung

Key words

uveitis - registry - healthcare research - ophthalmology - patient involvement

Publication History

Article published online:
03 November 2021

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