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DOI: 10.1055/a-1630-6895
Das Treatment Exit Options for Uveitis (TOFU) Register: Einbindung von Patienten in die Evidenzgenerierung
The Treatment Exit Options for Uveitis (TOFU) Registry: Involving Patients in the Generation of Evidence![](https://www.thieme-connect.de/media/gesu/2021S01/lookinside/thumbnails/2021-03-1382_10.1055-a-1630-6895-1.jpg)
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.
Publikationsverlauf
Artikel online veröffentlicht:
03. November 2021
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Literatur
- 1 Acharya NR, Tham VM, Esterberg E. et al Incidence and prevalence of uveitis: results from the Pacific Ocular Inflammation Study. JAMA ophthalmology 2013; 131: 1405-1412
- 2 Mercanti A, Parolini B, Bonora A. et al Epidemiology of endogenous uveitis in north-eastern Italy. Analysis of 655 new cases. Acta Ophthalmologica 2001; 79: 64-68
- 3 Darrel RW, Wagener HP, Henry P, Kurland LT, Leonard T. Epidemiology of uveitis: incidence and prevalence in a small urban community. Archives of ophthalmology 1962; 68: 502-514
- 4 Thorne JE, Suhler E, Skup M. et al Prevalence of noninfectious uveitis in the United States: a claims-based analysis. JAMA ophthalmology 2016; 134: 1237-1245
- 5 Rothova A, Suttorp-van Schulten MS, Treffers WF. et al Causes and frequency of blindness in patients with intraocular inflammatory disease. British Journal of Ophthalmology 1996; 80: 332-336
- 6 Jalil A, Yin K, Coyle L. et al Vision-related quality of life and employment status in patients with uveitis of working age: a prospective study. Ocular immunology and inflammation 2012; 20: 262-265
- 7 Frick KD, Drye LT, Kempen JH. et al Associations among visual acuity and vision- and health-related quality of life among patients in the multicenter uveitis steroid treatment trial. Investigative ophthalmology & visual science 2012; 53: 1169-1176
- 8 Berufsverband der Augenärzte (BVA) und Deutsche Ophthalmologische Gesellschaft (DOG). Leitlinie Nr. 24b Nichtinfektiöse Uveitis posterior. Online: http://www.augeninfo.de/leit/leit.php
- 9 Joseph A, Raj D, Dua HS. et al Infliximab in the treatment of refractory posterior uveitis. Ophthalmology 2003; 110: 1449-1453
- 10 Samson CM, Waheed N, Baltatzis S. et al Methotrexate therapy for chronic noninfectious uveitis: analysis of a case series of 160 patients. Ophthalmology 2001; 108: 1134-1139
- 11 Doycheva D, Zierhut M, Blumenstock G. et al Long-term results of therapy with mycophenolate mofetil in chronic non-infectious uveitis. Graefe's Archive for Clinical and Experimental Ophthalmology 2011; 249: 1235
- 12 Abásolo L, Rosales Z, Díaz-Valle D. et al Immunosuppressive drug discontinuation in noninfectious uveitis from real-life clinical practice: a survival analysis. American journal of ophthalmology 2016; 169: 1-8
- 13 Joshi L, Talat L, Yaganti S. et al Outcomes of changing immunosuppressive therapy after treatment failure in patients with noninfectious uveitis. Ophthalmology 2014; 121: 1119-1124
- 14 Niemeyer KM, Gonzales JA, Rathinam SR. et al Quality-of-Life Outcomes From a Randomized Clinical Trial Comparing Antimetabolites for Intermediate, Posterior, and Panuveitis. American journal of ophthalmology 2017; 179: 10-17
- 15 Venkataraman A, Rathinam SR. A pre- and post-treatment evaluation of vision-related quality of life in uveitis. Indian journal of ophthalmology 2008; 56: 307-312
- 16 Multicenter Uveitis Steroid Treatment (MUST) Trial Follow-up Study Research Group. Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study. Ophthalmology 2015; 122: 1976-1986
- 17 Gui W, Dombrow M, Marcus I. et al Quality of Life in Patients with Noninfectious Uveitis Treated with or without Systemic Anti-inflammatory Therapy. Ocular immunology and inflammation 2015; 23: 135-143
- 18 Kaleemunnisha S, Sudharshan S, Biswas J. Quality of life in non-infectious uveitis patients on immunosuppressive therapy. Middle East African journal of ophthalmology 2014; 21: 225
- 19 Li JQ, Heinz C, Dell J. et al. Treatment Exit Options for Non-infectious Uveitis (TOFU): Study Protocol for a Prospective Clinical Registry Ophthalmic Epidemiology. 2021
- 20 Standardization of Uveitis Nomenclature Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. American journal of ophthalmology 2005; 140: 509-516
- 21 General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. The Journal of the American College of Dentists 2014; 81: 14
- 22 European League Against Rheumatism. EULAR outcome measures library. Online: http://oml.eular.org/
- 23 Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmaco Economics 1993; 4: 353-365
- 24 Li J, Heinz C, Finger RP. Registerstudien in der Ophthalmologie. Ophthalmologe 2018; 115: 826-831
- 25 Jaffe GJ, Dick AD. Brézin AP et al Adalimumab in patients with active noninfectious uveitis. New England Journal of Medicine. 2016 375. 932-943
- 26 Calvert M, Blazeby J, Altman DG. et al Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013; 309: 814-822
- 27 Stausberg J, Maier B, Bestehorn K. et al Memorandum Register für die Versorgungsforschung: Update 2019. Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) 2020; 82: e39-e66
- 28 Gjertsen J-E, Vinje T, Lie SA. et al Patient satisfaction, pain, and quality of life 4 months after displaced femoral neck fractures: a comparison of 663 fractures treated with internal fixation and 906 with bipolar hemiarthroplasty reported to the Norwegian Hip Fracture Register. Acta Orthopaedica 2008; 79: 594-601
- 29 Braithwaite T, Calvert M, Gray A. et al The use of patient-reported outcome research in modern ophthalmology: impact on clinical trials and routine clinical practice. Patient Related Outcome Measures 2019; 10: 9-24
- 30 Prem Senthil M, Khadka J, Pesudovs K. Assessment of patient-reported outcomes in retinal diseases: a systematic review. Survey of Ophthalmology 2017; 62: 546-582
- 31 Denniston AK, Holland GN, Kidess A. et al Heterogeneity of primary outcome measures used in clinical trials of treatments for intermediate, posterior, and panuveitis. Orphanet J Rare Dis 2015; 10: 97
- 32 Tallouzi MO, Mathers JM, Moore DJ. et al COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis. Trials 2017; 18: 1-9
- 33 Gossec L, Dougados M, Dixon W. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open 2015; 1: e000019