Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema

Current Opinion in Allergy and Clinical Immunology

Volumn 15, Issue 3, 2015, Pages 227-233

  Chalmers, Joanne ^a   Deckert, Stefanie ^b   Schmitt, Jochen ^a,b  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

Author keywords

atopic eczema; clinical trial; core outcome set; outcome domain; outcome measurement instrument

Indexed keywords

ATOPIC DERMATITIS; ECZEMA AREA AND SEVERITY INDEX; HUMAN; IMMUNOTHERAPY; METHODOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SKIN DISEASE ASSESSMENT; CLINICAL TRIAL (TOPIC); DERMATITIS, ATOPIC; PATHOLOGY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

CLINICAL TRIALS AS TOPIC; DERMATITIS, ATOPIC; HUMANS; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84957438308     PISSN: 15284050     EISSN: 14736322     Source Type: Journal    
DOI: 10.1097/ACI.0000000000000158     Document Type: Review

References (43)

1. Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med 2005; 352:2314-2324.
2. Schmitt J, Schmitt NM, Kirch W, Meurer M. Outpatient care and medical treatment of children and adults with atopic eczema. J Dtsch Dermatol Ges 2009; 7:345-351.
3. Bieber T. Atopic dermatitis. N Engl J Med 2008; 358:1483-1494.
4. Smaldone A, Honig JC, Byrne MW. Sleepless in America: inadequate sleep and relationships to health and well being of our nation's children. Pediatrics 2007; 119 (Suppl 1):S29-S37.
5. Metz M, Wahn U, Gieler U, et al. Chronic pruritus associated with derma-tologic disease in infancy and childhood: update from an interdisciplinary group of dermatologists and pediatricians. Pediatr Allergy Immunol 2013; 24:527-539.
6. Bender BG, Ballard R, Canono B, et al. Disease severity, scratching, and sleep quality in patients with atopic dermatitis. J Am Acad Dermatol 2008; 58:415-420.
7. Carroll CL, Balkrishnan R, Feldman SR, et al. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol 2005; 22:192-199.
8. Schmitt J, Chen CM, Apfelbacher C, et al. Infant eczema, infant sleeping problems, and mental health at 10 years of age: the prospective birth cohort study LISAplus. Allergy 2011; 66:404-411.
9. Schmitt J, Romanos M, Pfennig A, et al. Psychiatric comorbidity in adult eczema. Br J Dermatol 2009; 161:878-883.
10. Buske-Kirschbaum A, Schmitt J, Plessow F, et al. Psychoendocrine and psychoneuroimmunological mechanisms in the comorbidity of atopic eczema and attention deficit/hyperactivity disorder. Psychoneuroendocrinology 2013; 38:12-23.
11. Horii KA, Simon SD, Liu DY, Sharma V. Atopic dermatitis in children in the United States, 1997-2004: visit trends, patient and provider characteristics, and prescribing patterns. Pediatrics 2007; 120:e527-e534.
12. Jenner N, Campbell J, Marks R. Morbidity and cost of atopic eczema in Australia. Australas J Dermatol 2004; 45:16-22.
13. Schmitt J, Apfelbacher CJ, Flohr C. Eczema. BMJ Clin Evid 2011; 5:1716.
14. 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; 133:429-438.
15. Charman C, Chambers C, Williams H. Measuring atopic dermatitis severity in randomized controlled clinical trials: what exactly are we measuring? J Invest Dermatol 2003; 120:932-941.
16. Schmitt J, Schakel K, Schmitt N, Meurer M. Systemic treatment of severe atopic eczema: a systematic review. Acta Derm Venereol 2007; 87:100-111.
17. Kirkham JJ, Gargon E, Clarke M, Williamson PR. Can a core outcome set improve the quality of systematic reviews? A survey of the Co-ordinating Editors of Cochrane Review Groups. Trials 2013; 14:21.
18. Schmitt J, Langan SM, Williams HC. What are the best outcome measurements for atopic eczema? A systematic review. J Allergy Clin Immunol 2007;120:1389-1398.
19. Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiper-spective delphi consensus process. J Invest Dermatol 2011; 131:623-630.
20. Schmitt J, Williams HC. Harmonising Outcome Measures for Eczema (HOME). Report from the first international consensus meeting (HOME 1), 24 July 2010, Munich, Germany. Br J Dermatol 2010; 163:1166-1168.
21. 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 Invest Dermatol 2015; 135:24-30.
22. 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; 67:1111-1117.
23. 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; 171:1318-1325.
24. Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology 1993; 186:23-31.
25. Tofte SJ, Graeber M, Cherill R, Omoto M, et al. Eczema area and severity index (EASI): a new tool to evaluate atopic dermatitis. J Eur Acad Dermatol Venereol 1998; 11 (Suppl 2):S197.
26. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ 1995; 311:376-380.
27. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs 2000; 32:1008-1015.
28. Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials 2012; 13:103.
29. Taylor WJ. Preliminary identification of core domains for outcome studies in psoriatic arthritis using Delphi methods. Ann Rheum Dis 2005; 64 (Suppl 2):ii110-ii112.
30. Dionne CE, Dunn KM, Croft PR, et al. A consensus approach toward the standardization of back pain definitions for use in prevalence studies. Spine (Phila Pa 1976) 2008; 33:95-103.
31. Gazi H, Pope JE, Clements P, et al. Outcome measurements in scleroderma: results from a delphi exercise. J Rheumatol 2007; 34:501-509.
32. Tugwell P, Boers M. OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. J Rheumatol 1993; 20:528-530.
33. Boers M, Brooks P, Strand CV, Tugwell P. The OMERACT filter for outcome measures in rheumatology. J Rheumatol 1998; 25:198-199.
34. Tugwell P, Boers M, Brooks P, et al. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007; 8:38.
35. Sinha I, Jones L, Smyth RL, Williamson PR. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med 2008; 5:e96.
36. Mokkink LB, Terwee CB, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010; 63:737-745.
37. Charman CR, Venn AJ, Williams H. Measuring atopic eczema severity visually: which variables are most important to patients? Arch Dermatol 2005; 141:1146-1151.
38. Schmitt J, Langan S, Deckert S, et al. Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation. J Allergy Clin Immunol 2013; 13:1337-1347.
39. Kunz B, Oranje AP, Labreze L, et al. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997; 195:10-19.
40. Idzerda L, Rader T, Tugwell P, Boers M. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets. J Rheumatol 2014; 41:986-993.
41. Boers M, Kirwan JR, Tugwell P. The OMERACT Handbook. 2014; http://www.omeract.org/pdf/OMERACT-Handbook.pdf. [Accessed 15 January 2015]
42. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials 2012; 13:132.
43. Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol 2014; 134:800-807.