Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach.
BACKGROUND
The assessment of patient-relevant treatment benefit gains importance in treatment evaluation. The 'Patient Benefit Index' (PBI) is a validated instrument for the assessment of such benefits in patients with skin diseases. Patients rate the importance of specific treatment needs before treatment and benefits achieved after treatment. To date, no specific instrument for chronic hand eczema (CHE) has been published.


OBJECTIVE
Development and validation of a specific PBI for treatment evaluation in patients with CHE.


METHODS
Items reflecting disease burden and treatment needs were collected in 20 patients with CHE. Relevant items were selected by an expert panel of dermatologists, psychologists, and patients. The resulting 'Patient Benefit Index for chronic hand eczema' (PBI-HE) was validated in an open label treatment study with alitretinoin in n = 249 patients.


RESULTS
Cronbach's alpha was 0.93. High convergent validity was demonstrated for clinical improvement and treatment success (Spearman r = 0.60-0.78, P < 0.001); 84.3% of patients reached a PBI >or= 1, indicating more than minimum patient-relevant benefit of alitretinoin. Feasibility was high, with a rate of missing data < 1%.


CONCLUSIONS
The PBI-HE is a feasible, reliable, and valid instrument for the assessment of patient-relevant treatment benefits in CHE.
Blome
Christine
C
CVderm - German Center for Health Services Research in Dermatology, University Clinics of Hamburg, Hamburg, Germany. c.blome@uke.uni-hamburg.de
Maares
Jürgen
J
Diepgen
Thomas
T
Jeffrustenbach
Stephan
S
Augustin
Matthias
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D017281:Cost of Illness; D004485:Eczema / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006229:Hand Dermatoses / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020380:Needs Assessment; D017063:Outcome Assessment, Health Care / Q000379:methods*; D017060:Patient Satisfaction; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires