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Systematic Review of Diagnostic Criteria Used in Atopic Dermatitis Randomized Controlled Trials

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Abstract

Background

Numerous diagnostic criteria for atopic dermatitis are used in clinical trials, which may limit comparison of results.

Objective

We sought to determine the most commonly used atopic dermatitis diagnostic criteria in randomized controlled trials internationally.

Methods

We performed a systematic review of randomized controlled trials with a pharmacological intervention from 2007 to 2016. Cochrane Library, EMBASE, GREAT, LILACS, MEDLINE, and Scopus were searched. Two authors independently performed the study selection and data extraction.

Results

Two hundred and twelve randomized controlled trials met inclusion/exclusion criteria. Overall, ten different diagnostic criteria were used. The Hanifin and Rajka criteria were most commonly used (41.0%), followed by the UK refinement of the Hanifin and Rajka criteria (9.0%), Japanese Dermatological Association criteria (4.2%), and American Academy of Dermatology criteria (3.8%). No diagnostic criteria were specified in 37.3% of randomized controlled trials. The Hanifin and Rajka criteria were the most commonly used atopic dermatitis diagnostic criteria in clinical trials of topical and systemic interventions, across all years between 2007 and 2016, in pediatric and adult populations, in most countries and regions internationally.

Conclusions

The results highlight the lack of uniformity and documentation of atopic dermatitis diagnostic criteria in randomized controlled trials for atopic dermatitis. We recommend harmonizing the diagnostic criteria for atopic dermatitis in future randomized controlled trials.

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References

  1. Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI, Group IPTS. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009;24(6):1251.e23–1258.e23.

    Google Scholar 

  2. Garg N, Silverberg JI. Epidemiology of childhood atopic dermatitis. Clin Dermatol. 2015;33(3):281–8.

    Article  PubMed  Google Scholar 

  3. Silverberg JI, Garg NK, Paller AS, Fishbein AB, Zee PC. Sleep disturbances in adults with eczema are associated with impaired overall health: a US population-based study. J Investig Dermatol. 2015;135(1):56–66.

    Article  CAS  PubMed  Google Scholar 

  4. Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013;132(5):1132–8.

    Article  PubMed  Google Scholar 

  5. Bieber T. Atopic dermatitis 2.0: from the clinical phenotype to the molecular taxonomy and stratified medicine. Allergy. 2012;67(12):1475–82.

    CAS  PubMed  Google Scholar 

  6. Silverberg JI. Racial and ethnic disparities in atopic dermatitis. Curr Dermatol Rep. 2015;4(1):44–8.

    Article  Google Scholar 

  7. Noda S, Suarez-Farinas M, Ungar B, et al. The Asian atopic dermatitis phenotype combines features of atopic dermatitis and psoriasis with increased TH17 polarization. J Allergy Clin Immunol. 2015;136(5):1254–64.

    Article  CAS  PubMed  Google Scholar 

  8. Hanifin J, Rajka G. Diagnostic features of atopic eczema. Acta Dermato-Venereol. 1980;92:44–7.

    Google Scholar 

  9. Siegfried EC, Hebert AA. Diagnosis of atopic dermatitis: mimics, overlaps, and complications. J Clin Med. 2015;4(5):884–917.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Andersen RM, Thyssen JP, Maibach HI. Qualitative vs. quantitative atopic dermatitis criteria: in historical and present perspectives. J Eur Acad Dermatol Venereol. 2016;30(4):604–18.

    Article  CAS  PubMed  Google Scholar 

  11. Brenninkmeijer EE, Schram ME, Leeflang MM, Bos JD, Spuls PI. Diagnostic criteria for atopic dermatitis: a systematic review. Br J Dermatol. 2008;158(4):754–65.

    Article  CAS  PubMed  Google Scholar 

  12. De D, Kanwar AJ, Handa S. Comparative efficacy of Hanifin and Rajka’s criteria and the UK working party’s diagnostic criteria in diagnosis of atopic dermatitis in a hospital setting in North India. J Eur Acad Dermatol Venereol. 2006;20(7):853–9.

    CAS  PubMed  Google Scholar 

  13. Johnke H, Vach W, Norberg LA, Bindslev-Jensen C, Host A, Andersen KE. A comparison between criteria for diagnosing atopic eczema in infants. Br J Dermatol. 2005;153(2):352–8.

    Article  CAS  PubMed  Google Scholar 

  14. Roguedas AM, Machet L, Fontes V, Lorette G. Atopic dermatitis: which are the diagnostic criteria used in medical literature? Ann Dermatol Venereol. 2004;131(2):161–4.

    Article  PubMed  Google Scholar 

  15. Bos JD, Van Leent EJ, Sillevis Smitt JH. The millennium criteria for the diagnosis of atopic dermatitis. Exp Dermatol. 1998;7(4):132–8.

    Article  CAS  PubMed  Google Scholar 

  16. Diepgen TL, Sauerbrei W, Fartasch M. Development and validation of diagnostic scores for atopic dermatitis incorporating criteria of data quality and practical usefulness. J Clin Epidemiol. 1996;49(9):1031–8.

    Article  CAS  PubMed  Google Scholar 

  17. Asher MI, Keil U, Anderson HR, et al. International Study of Asthma and Allergies in Childhood (ISAAC): rationale and methods. Eur Respir J. 1995;8(3):483–91.

    Article  CAS  PubMed  Google Scholar 

  18. Williams HC, Burney PG, Hay RJ, et al. The U.K. Working Party’s diagnostic criteria for atopic dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994;131(3):383–96.

    Article  CAS  PubMed  Google Scholar 

  19. Schultz Larsen F, Hanifin JM. Secular change in the occurrence of atopic dermatitis. Acta Derm Venereol Suppl (Stockh). 1992;176:7–12.

    CAS  Google Scholar 

  20. Kang KF, Tian RM. Criteria for atopic dermatitis in a Chinese population. Acta Derm Venereol Suppl (Stockh). 1989;144:26–7.

    CAS  Google Scholar 

  21. Tagami H. Japanese Dermatological Association criteria for the diagnosis of atopic dermatitis. J Dermatol. 2002;29(6):398.

    Article  Google Scholar 

  22. Schultz Larsen F, Diepgen T, Svensson A. Clinical criteria in diagnosing atopic dermatitis: the Lillehammer criteria 1994. Acta Derm Venereol Suppl (Stockh). 1996;96:115–9.

    Google Scholar 

  23. Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, et al. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004;113(5):832–6.

    Article  CAS  PubMed  Google Scholar 

  24. Nankervis H, Pynn EV, Boyle RJ, et al. House dust mite reduction and avoidance measures for treating eczema. Cochrane Database Syst Rev. 2015;1:CD008426.

    PubMed  Google Scholar 

  25. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6(7):e1000100.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Gu H, Chen XS, Chen K, et al. Evaluation of diagnostic criteria for atopic dermatitis: validity of the criteria of Williams et al in a hospital-based setting. Br J Dermatol. 2001;145(3):428–33.

    Article  CAS  PubMed  Google Scholar 

  27. Hanifin JM, Cooper KD, Ho VC, et al. Guidelines of care for atopic dermatitis, developed in accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association “Administrative Regulations for Evidence-Based Clinical Practice Guidelines”. J Am Acad Dermatol. 2004;50(3):391–404.

    Article  PubMed  Google Scholar 

  28. Schmitt J, Apfelbacher C, Spuls PI, et al. The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology. J Investig Dermatol. 2015;135(1):24–30.

    Article  CAS  PubMed  Google Scholar 

  29. Schmitt J, Williams H. Harmonising Outcome Measures for Eczema (HOME). Report from the First International Consensus Meeting (HOME 1), 24 July 2010, Munich, Germany. Br J Dermatol. 2010;163(6):1166–8.

    Article  CAS  PubMed  Google Scholar 

  30. Flohr C. Atopic dermatitis diagnostic criteria and outcome measures for clinical trials: still a mess. J Investig Dermatol. 2011;131(3):557–9.

    Article  CAS  PubMed  Google Scholar 

  31. Bhattacharya T, Silverberg JI. Efficacy of systemic treatments for atopic dermatitis in racial and ethnic minorities in the United States. JAMA Dermatol. 2014;150(11):1232–4.

    Article  PubMed  Google Scholar 

  32. Henderson MD, Abboud J, Cogan CM, et al. Skin-of-color epidemiology: a report of the most common skin conditions by race. Pediatr Dermatol. 2012;29(5):584–9.

    Article  PubMed  Google Scholar 

  33. Bai Y, Yang D, Wang Y. Clinical study on treatment of acute eczema by Shuangfujin. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2007;27(1):72–5.

    PubMed  Google Scholar 

  34. Wu Q, Chen L. Clinical observation of adult chronic eczema treated with clearing heat 25 Wei Wan combined triamcinolone acetonide. Clin J Med Off. 2008;36:267–8.

    Google Scholar 

  35. Park Y, Kim H, Kim K, et al. Report from ADRG: a study on the diagnostic criteria of Korean atopic dermatitis. Korean J Dermatol. 2006;44(6):659–63.

    Google Scholar 

  36. Seymour JL, Keswick BH, Hanifin JM, Jordan WP, Milligan MC. Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis. J Am Acad Dermatol. 1987;17(6):988–97.

    Article  CAS  PubMed  Google Scholar 

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Acknowledgements

The authors thank Yufan Yan, BS, Northwestern University Feinberg School of Medicine for providing assistance with translation services.

Author information

Authors and Affiliations

Authors

Contributions

JIS had full access to all the data in the study and takes responsibility for the integrity of the data and accuracy of the data analysis. Study concept and design: JIS. Acquisition of data: PPV, RC. Analysis and interpretation of data: JIS, PPV, RC. Drafting of the manuscript: JIS, PPV, RC. Critical revision of the manuscript for important intellectual content: JIS, PPV, RC. Statistical analysis: PPV, JIS. Obtained funding: JIS.

Corresponding author

Correspondence to Jonathan I. Silverberg.

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Funding

This publication was made possible with support from the Agency for Healthcare Research and Quality, Grant No. K12 HS023011, and the Dermatology Foundation.

Conflict of interest

Jonathan I. Silverberg, Paras P. Vakharia, and Rishi Chopra have no conflicts of interest directly relevant to the contents of this study.

Ethics approval

This study was exempt from institutional review board approval.

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Vakharia, P.P., Chopra, R. & Silverberg, J.I. Systematic Review of Diagnostic Criteria Used in Atopic Dermatitis Randomized Controlled Trials. Am J Clin Dermatol 19, 15–22 (2018). https://doi.org/10.1007/s40257-017-0299-4

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