TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries

Louise A A Gerbens, Aaron E Boyce, Dmitri Wall, Sebastien Barbarot, Richard J de Booij, Mette Deleuran, Maritza A Middelkamp-Hup, Amanda Roberts, Christian Vestergaard, Stephan Weidinger, Christian J Apfelbacher, Alan D Irvine, Jochen Schmitt, Paula R Williamson, Phyllis I Spuls, Carsten Flohr, Louise A A Gerbens, Aaron E Boyce, Dmitri Wall, Sebastien Barbarot, Richard J de Booij, Mette Deleuran, Maritza A Middelkamp-Hup, Amanda Roberts, Christian Vestergaard, Stephan Weidinger, Christian J Apfelbacher, Alan D Irvine, Jochen Schmitt, Paula R Williamson, Phyllis I Spuls, Carsten Flohr

Abstract

Background: Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies.

Methods/design: Participants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group.

Discussion: Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders.

Trial registration: Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.

Keywords: Atopic dermatitis; Atopic eczema; Consensus methods; Core set; Daily practice data; Delphi; Disease registries; Immunomodulatory therapies; Interoperability; Patient registries.

Figures

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Fig. 1
The TREatment of ATopic eczema (TREAT) Delphi exercise

References

    1. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109–22. doi: 10.1016/S0140-6736(15)00149-X.
    1. Silverberg JI. Health care utilization, patient costs, and access to care in US adults with eczema: a population-based study. JAMA Dermatol. 2015;151(7):743–52. doi: 10.1001/jamadermatol.2014.5432.
    1. McAleer MA, Flohr C, Irvine AD. Management of difficult and severe eczema in childhood. BMJ. 2012;345:e4770. doi: 10.1136/bmj.e4770.
    1. European Medicines Agency. Questions and answers on Sandimmun, Sandimmun Neoral and associated names (ciclosporin, 10, 25, 50 and 100 mg capsules, 100 mg/ml oral solution and 50 mg/ml concentrate for solution for infusion). 2013. . Accessed 1 Jan 2017.
    1. Roekevisch E, Spuls PI, Kuester D, et al. Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: a systematic review. J Allergy Clin Immunol. 2014;133(2):429–38. doi: 10.1016/j.jaci.2013.07.049.
    1. Garritsen FM, Roekevisch E, van der Schaft J, et al. Ten years experience with oral immunosuppressive treatment in adult patients with atopic dermatitis in two academic centres. J Eur Acad Dermatol Venereol. 2015;29(10):1905–12. doi: 10.1111/jdv.13064.
    1. van der Schaft J, Politiek K, van den Reek JM, et al. Drug survival for ciclosporin A in a long-term daily practice cohort of adult patients with atopic dermatitis. Br J Dermatol. 2015;172(6):1621–7. doi: 10.1111/bjd.13730.
    1. Politiek K, van der Schaft J, Coenraads PJ, et al. Drug survival for methotrexate in a daily practice cohort of adult patients with severe atopic dermatitis. Br J Dermatol. 2016;174(1):201–3. doi: 10.1111/bjd.13961.
    1. Ring J, Alomar A, Bieber T, et al. Guidelines for treatment of atopic eczema (atopic dermatitis) Part II. J Eur Acad Dermatol Venereol. 2012;26(9):1176–93. doi: 10.1111/j.1468-3083.2012.04636.x.
    1. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71(2):327–49. doi: 10.1016/j.jaad.2014.03.030.
    1. Proudfoot LE, Powell AM, Ayis S, et al. The European TREatment of severe Atopic eczema in children Taskforce (TREAT) survey. Br J Dermatol. 2013;169(4):901–9. doi: 10.1111/bjd.12505.
    1. PAtient REgistries iNiTiative (PARENT). Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. . Accessed 1 Jan 2017.
    1. Ormerod AD, Augustin M, Baker C, et al. Challenges for synthesising data in a network of registries for systemic psoriasis therapies. Dermatology. 2012;224(3):236–43. doi: 10.1159/000338572.
    1. Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393. doi: 10.1371/journal.pmed.1000393.
    1. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ. 1995;311(7001):376–80. doi: 10.1136/bmj.311.7001.376.
    1. Williamson P, Altman D, Blazeby J, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132. doi: 10.1186/1745-6215-13-132.
    1. Keeney S, Hasson F, McKenna HP. A critical review of the Delphi technique as a research methodology for nursing. Int J Nurs Stud. 2001;38(2):195–200. doi: 10.1016/S0020-7489(00)00044-4.
    1. Harman NL, Bruce IA, Kirkham JJ, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514. doi: 10.1371/journal.pone.0129514.
    1. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395–400. doi: 10.1016/j.jclinepi.2010.09.012.
    1. Cantrill JA, Sibbald B, Buetow S. The Delphi and nominal group techniques in health services research. Int J Pharm Pract. 1996;4(2):67–74. doi: 10.1111/j.2042-7174.1996.tb00844.x.
    1. Harman NL, Bruce IA, Callery P, et al. MOMENT—Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70. doi: 10.1186/1745-6215-14-70.
    1. Schmitt J, Spuls P, Boers M, et al. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting. Allergy. 2012;67(9):1111–7. doi: 10.1111/j.1398-9995.2012.02874.x.
    1. Chalmers JR, Schmitt J, Apfelbacher C, et al. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME) Br J Dermatol. 2014;171(6):1318–25. doi: 10.1111/bjd.13237.
    1. Boers M, Kirwan JR, Tugwell P, et al. The OMERACT Handbook. 2015. . Accessed 1 Jan 2017.
    1. Green B, Jones M, Hughes D, et al. Applying the Delphi technique in a study of GPs’ information requirements. Health Soc Care Community. 1999;7(3):198–205. doi: 10.1046/j.1365-2524.1999.00176.x.

Source: PubMed

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