Oral communication, CS22 / C108

Official XXIst International Pigment Cell Conference website - 21-24 Sept 2011, Bordeaux - France | updated: September 04 2011

Systematic review of outcome measurements for the treatment of vitiligo

SPEAKER V. Eleftheriadou #whois submiter ?
AUTHOR(s) V. Eleftheriadou, K. Thomas, J. Batchelor, J. Ravenscroft, M. Whitton

BACKGROUND: Vitiligo is a chronic depigmentation disorder affecting around 0.5% of the world population. Despite previous attempts, there is still a lack of consensus as to the definition, methods of assessment and outcome measurements of this disorder. The updated Cochrane systematic review concluded that the majority of studies differ greatly in the ways in which vitiligo is measured. The pre-specified outcomes were based mainly on empirical evidence and specialist consensus, therefore more research is needed to address the definition of effectiveness and success of interventions from clinicians’ and patients’ perspective. OBJECTIVES: The objective of this review is to describe the heterogeneity in outcome measurements currently used in randomised controlled trials for vitiligo. METHODS: A systematic review of outcome measures used in randomised controlled trials published in English and included in the updated Cochrane systematic review was performed. Two independent researchers extracted outcomes data from eligible randomised controlled trials. RESULT: Fifty four randomised controlled trials were evaluated. Three were excluded as published English translations were not available. Only 22% (12/54) of trials had clearly stated primary outcome measures. Repigmentation was reported as an outcome in 98% (53/54) of trials and was measured using a great variety of scales including grades (e.g. 0-4), categories (e.g. poor to excellent, partial to complete), percentage of repigmentation, quartiles (e.g. 0-24, 25-50, 51-74, 75-100) percentage grades (e.g. 0-40, 40-60, 60-100, 0-30, 31-50, 51-75, 75-100), reduction of surface areas in %, mean difference in lesion size in mm. The definition of excellent repigmentation (or the top grade repigmentation) varied from trial to trial and included values from 50% to 100% repigmentation of vitiliginous lesions. Repigmentation was assessed mainly by clinicians. Only 1% (2/54) of trials included patients as assessors. Pattern of repigmentation was reported in 4% (7/54) of trials. Colour match of newly regimented vitiliginous lesions was assessed in 2% (4/54) of trials. Patients’ opinions on colour match were only included in one of them. Three percent (6/54) of trials assessed quality of life of patients. Five percent (9/54) measured cessation of spreading of the disease; only 1.5% (3/54) clearly stated the scale used. Only 2% (4/54) of studies reported patients’ opinions regarding treatment efficacy and degree of satisfaction including cosmetic acceptability of the results. Other outcomes such as side effects, cumulative dose, mean number of sessions to reach repigmentation, blood parameters were reported. CONCLUSION: The importance of incorporating patients’ and clinicians’ views into clinical research is now being increasingly recognised. We believe that more emphasis should be placed on patients’ views with regard to assessing outcome measurements in future vitiligo trials and that consensus should be reached as to the most informative ways of reporting percentage of repigmentation.



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Université de Bordeaux 2 & Conseil Régional Aquitaine