Brown, T.

Chiou, C.F.

Deal, L.

Fehnel, S.

Katz, E.

Martin, S.

Olanrewaju, O.

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PSS17
SICKNESS ABSENCES DUE TO CHRONIC HAND ECZEMA (CHE) IN PATIENTS
TREATED WITH ORAL ALITRETINOIN UNDER DAILY PRACTICE CONDITIONS:
RESULTS OF THE TOCCATA OBSERVATIONAL STUDY COMPRISING 522
WORKERS
Diepgen TL1, Kuessner D2
1Dept. of Social Medicine, Occupational and Environmental Dermatology, University Heidelberg,
Heidelberg, Germany, 2Basilea Pharmaceutica International Ltd., Basel, Switzerland
OBJECTIVES:CHE can lead to considerable sickness absences, but quantitative data
regarding CHE-related productivity changes under different treatments are scarce.
TheGermanobservational studyTOCCATA, collected effectiveness and tolerability
data of oral alitretinoin in daily practice and concomitantly documented informa-
tion regarding CHE-related productivity loss, the main subject of this analysis.
METHODS: A total of 680 adult CHE patients treated with oral alitretinoin for up to
24 weeks, according to the approved prescribing information, were included. Sick-
ness absence days due to CHE were documented at baseline (over the last 12
months prior to the study and when ongoing at inclusion) and at each monthly
follow-up visit (4 weeks retrospectively). This analysis focuses on the proportion of
patients with sick leave and days off work due to CHE and correlation of changes in
disease severity. RESULTS: 219 (42%) of all 522 patients in employment had sick
leaves in the last 12 months (mean: 35 days), 80 (15.4%) patients were on sick leave
at inclusion, and this proportion gradually decreased to 7.1% at observation end. In
line with this observation, the 80 patients had an average 17.6 consecutive days off
work (last 4 weeks at inclusion), however, only 7.6 days off during the four weeks
before end of observation. The highest reduction in CHE-related sickness absence
was observed between the visits 4 to 12 weeks, which was associated with the
clinical CHE improvements seen during this period.CONCLUSIONS:This is the first
report of beneficial changes in disease-related sickness absences in CHE patients
associated with successful oral alitretinoin treatment. At end of study, the number
of patientswith sickness absences due to CHEhaddecreased by approximately 50%
compared to baseline. This observation certainly merits further exploration in dif-
ferent health care settings potentially confirming economic benefits for patients,
their employers and the society at large.
SENSORY SYSTEMS DISORDERS – Patient-Reported Outcomes & Patient
Preference Studies
PSS18
COMPARISON OF A 24-HOUR AND 7-DAY VERSION OF A PATIENT REPORTED
OUTCOME MEASURE FOR PSORIASIS SYMPTOM SEVERITY
Bushnell DM1, Martin ML2, McCarrier KP2, Chiou CF3, Ortmeier B4
1Health Research Associates, Inc., Mountlake Terrace, WA, USA, 2Health Research Associates,
Inc., Seattle, WA, USA, 3Janssen Global Services, Companies of Johnson & Johnson, Raritan, NJ,
USA, 4Amgen, Inc., Thousand Oaks, CA, USA
OBJECTIVES: Research about the limitations of cognitive processes in memory
suggest retrospective recall may be less accurate than recall within the past 24
hours. Daily diaries, however, are often more burdensome for study subjects and
are more expensive to administer than weekly retrospective instruments. We
sought to evaluate a 24-hour recall version (24-hour PSI) and a 7-day retrospective
version (7-day PSI) of the Psoriasis Symptom Inventory (PSI) to test the equivalence
of symptom severity assessed with the two versions.METHODS: Using a prospec-
tive, observational design, adult patients receiving usual care for their plaque pso-
riasis (Psoriasis Area and Severity Index [PASI]10) were recruited from clinics and
randomized. Subjects completed the 24-hour PSI for 7 days and completed the
7-day PSI on the seventh day. Comparison of average daily diary scores and 7-day
retrospective scores were made with Pearson’s correlation coefficients and simple
bivariate comparisons (t-test). Potential exposure effects of daily PSI administra-
tion in the days preceding the 7-day retrospective assessment were examined in
sensitivity analyses. RESULTS: Among the 139 subjects, mean age and PASI scores
were 51.2 and 17.6, respectively. There was high agreement between results from
the daily 24-hour PSI and the 7-day PSI assessments. With the exception of Flaking
(0.08, p0.02), no significant mean differences were found in the remaining seven
PSI symptoms (Itching, Redness, Scaling, Burning, Stinging, Cracking, and Pain) between
the 24-hour PSI (7-day average) and the 7-day PSI. Correlations between the two PSI
versions ranged from 0.86 (scaling) to 0.92 (pain). Completion of the daily assess-
ment did not influence responses on the 7-day PSI.CONCLUSIONS:Overall findings
show that the two PSI versions yield equivalent results. Both the 24-hour PSI and
7-day PSI would provide comprehensive capture of symptoms in psoriasis studies
and clinical trials.
PSS19
VALIDATION OF THE PAEDIATRIC HEARING IMPAIRMENT CAREGIVER
EXPERIENCE (PHICE) INSTRUMENT
Lim HYL1, Xiang L2, Li R1, Wong N1, Yuen CPK3
1National University Health System, Singapore, 2National University of Singapore, Singapore,
3The Hong Kong Institute of Education, Tai Po, New Territories, Hong Kong
OBJECTIVES: To validate and shorten the Paediatric Hearing Impairment Caregiver
Experience (PHICE) instrument. METHODS: A total of 125 caregivers of hearing
impaired children attending the otolaryngology, audiology, and aural rehabilita-
tion at a local clinic were administered the 68 item questionnaire. Exploratory
factor analysis was conducted. A 5 factor structure was adopted and items with
high cross-loadings were dropped. The 5 factor structure was then analysed using
confirmatory factor analysis. Cronbach’s  was computed to assess internal
consistency. RESULTS: A 5 factor structure corresponding to the factors: Adapta-
tion to hearing loss, Childcare support, Healthcare, Education and Policywas
adopted. Confirmatory factor analysis suggest a good model fit (RMSEA  0.067,
RMR 0.329, SRMR 0.0752, NFI 0.830, CFI 0.949). This model fit is assessed to
be superior than the original 8 factor structure. Cronbach’s were high (0.75) for
each subscale. 3 questions that were deemed important from a clinical point of
view butwas removedwould continue to be a part of the instrument but will not be
used in the computation of the subscale scores. CONCLUSIONS: The 68 item ques-
tionnaire has been reduced to 39 items. A new 5 factor structure is proposed that
better explains the underlying items. Three items was added back despite being
dropped due to their important clinical value.
PSS20
COMPARATIVE STUDY OF THE PERFORMANCES OF GENERIC AND DISEASE-
SPECIFIC MEASURES IN CATARACT PATIENTS
Suh JK, Doctor J
USC School of Pharmacy, Los Angeles, CA, USA
OBJECTIVES: To evaluate the overall performances of generic and disease-specific
measures.METHODS:One disease-specific and five genericmeasureswere admin-
istered in cataract patients at baseline, 1- and 6-month. The disease-specific mea-
sure was the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
and the genericmeasures included the Short Form-6D (SF-6D), EuroQol-5D (EQ-5D),
Self-Administered Quality of Well-being Scale (QWB-SA), and two versions of the
Health Utilities Index (HUI2 and HUI3). The global rating of change, in a 5-point
rating scale, was applied as an anchor and the score change between baseline and
6-month was calculated accordingly. Two definitions for responders who experi-
enced a minimally important difference were used: patients whose global ratings
were “somewhat better” or above (Model 1) and patients rated as “somewhat bet-
ter” or above, or “somewhat worse” or below (Model 2). In Model 2, for the patients
who reported “somewhat worse” or below, the sign of the score changes were
reversed. In Experiment 1 the performance of the generic measure was compared
against the VFQ-25 based on Model 1. In Experiment2 the impact of using different
classifications for the responderswas examined by comparing the performances of
Model 1 and Model 2 for each measure. The performances of the measures were
compared based on the areas under the receiver operating characteristics curves.
RESULTS: A total of 223 cataract patients were included. In Experiment 1, only the
EQ-5D showed significantly lower performance than the VFQ-25 (p0.0001) and
there were no differences between the VFQ-25 and the other generic measures. In
Experiment 2, the performances between Model 1 and 2 were not significant in all
the measures. CONCLUSIONS: In this cataract population, we found that the ge-
nericmeasureswere as sensitive as the disease-specificmeasure inmost cases and
the performance of themeasure did not depend on the different definitions for the
responder.
PSS21
ASSESSING PRURITUS AMONG PATIENTS WITH ATOPIC DERMATITIS:
TARGETED LITERATURE AND INSTRUMENT REVIEW
Brown T1, Olanrewaju O1, Deal L2, Katz E3, Chiou CF3, Martin S1, Fehnel S1
1RTI Health Solutions, Research Triangle Park, NC, USA, 2eResearch Technology Inc, Philadelphia,
PA, USA, 3Janssen Global Services, LLC, West Hills, CA, USA
OBJECTIVES: Pruritus is a key criterion in the diagnosis of atopic dermatitis (AD)
and has been associated with lower levels of health-related quality of life in both
pediatric and adult patients. The objective of this studywas to identify information
and instruments relevant to the measurement of pruritus in adolescent and adult
AD patients. METHODS: A PubMed search was conducted to identify relevant lit-
erature and existing PROmeasures (items, subscales, and instruments) designed to
assess the severity, frequency, and/or impact of AD-related pruritus. Articles were
limited to studies conducted in humans, published since 2000, and in English.
Search terms included atopic dermatitis, itch, and pruritus. In addition to using
sources identified during the literature review, a search of published PRO instru-
ment sources (e.g., Patient-Reported Outcome & Quality of Life Instruments Data-
base [PROQOLID]) and the RTI-HS internal PRO instrument repository was con-
ducted. Identified PRO instruments were evaluated based on the criteria described
in the Food and Drug Administration’s 2009 guidance on PROs for product label
claims. RESULTS: Literature review results confirmed pruritus is a central feature
of AD and affects both daytime functioning and nighttime sleep in many AD pa-
tients. In addition, the effective treatment of pruritus represents an unmet need
among patients with AD. Nine PRO instruments measuring AD-related pruritus
were identified and evaluated. Only one of these measures had been developed
exclusively in patients with AD, and none of these measures were developed or
evaluated with the scientific rigor outlined in the FDA’s PRO guidance.
CONCLUSIONS: The results of this targeted review indicate the need for new treat-
ments that improve pruritus among patientswith AD. In addition, to communicate
this treatment benefit, the development of a newAD-related pruritus instrument is
warranted in order tomore accurately describe the effect of therapy on this impor-
tant disease symptom.
PSS22
A COMPREHENSIVE HEALTH IMPACT ASSESSMENT AND DETERMINANTS OF
QUALITY OF LIFE, HEALTH AND PSYCHOLOGICAL STATUS IN ACNE PATIENTS
Pagliarello C, di Pietro C, Tabolli S
IDI IRCCS, Rome, Italy
OBJECTIVES: . Measurement of acne impact on QoL, health and psychological sta-
tus. To analyse the relationship between socio-demographic variables, disease se-
verity and mental status on QoL of acne sufferers. METHODS: . Acne cases were
selected from a survey conducted in 2010. The Short-Form 12-Item Health Survey
and the Skindex-29 were used to assess health status and QoL. The 12-Items Gen-
eral HealthQuestionnairewas used to identify individuals at risk for non-psychotic
A253V A L U E I N H E A L T H 1 5 ( 2 0 1 2 ) A 1 – A 2 5 6


PSS21 Assessing Pruritus Among Patients with Atopic Dermatitis: Targeted Literature and Instrument Review 

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PSS21 Assessing Pruritus Among Patients with Atopic Dermatitis: Targeted Literature and Instrument Review

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