International comparability of reference unit costs of education services: when harmonizing methodology is not enough (PECUNIA project).

BACKGROUND: Health problems can lead to costs in the education sector. However, these costs are rarely incorporated in health economic evaluations due to the lack of reference unit costs (RUCs), cost per unit of service, of education services and of validated methods to obtain them. In this study, a standardized unit cost calculation tool developed in the PECUNIA project, the PECUNIA RUC Template for services, was applied to calculate the RUCs of selected education services in five European countries. METHODS: The RUCs of special education services and of educational therapy were calculated using the information collected via an exploratory gray literature search and contact with service providers. RESULTS: The RUCs of special education services ranged from €55 to €189 per school day. The RUCs of educational therapy ranged from €6 to €25 per contact and from €5 to €35 per day. Variation was observed in the type of input data and measurement unit, among other. DISCUSSION: The tool helped reduce variability in the RUCs related to costing methodology and gain insights into other aspects that contribute to the variability (e.g. data availability). Further research and efforts to generate high quality input data are required to reduce the variability of the RUCs.

Magnitude of terminological bias in international health services research: a disambiguation analysis in mental health.

AIMS: Health services research (HSR) is affected by a widespread problem related to service terminology including non-commensurability (using different units of analysis for comparisons) and terminological unclarity due to ambiguity and vagueness of terms. The aim of this study was to identify the magnitude of the terminological bias in health and social services research and health economics by applying an international classification system. METHODS: This study, that was part of the PECUNIA project, followed an ontoterminology approach (disambiguation of technical and scientific terms using a taxonomy and a glossary of terms). A listing of 56 types of health and social services relevant for mental health was compiled from a systematic review of the literature and feedback provided by 29 experts in six European countries. The disambiguation of terms was performed using an ontology-based classification of services (Description and Evaluation of Services and DirectoriEs - DESDE), and its glossary of terms. The analysis focused on the commensurability and the clarity of definitions according to the reference classification system. Interrater reliability was analysed using κ. RESULTS: The disambiguation revealed that only 13 terms (23%) of the 56 services selected were accurate. Six terms (11%) were confusing as they did not correspond to services as defined in the reference classification system (non-commensurability bias), 27 (48%) did not include a clear definition of the target population for which the service was intended, and the definition of types of services was unclear in 59% of the terms: 15 were ambiguous and 11 vague. The κ analyses were significant for agreements in unit of analysis and assignment of DESDE codes and very high in definition of target population. CONCLUSIONS: Service terminology is a source of systematic bias in health service research, and certainly in mental healthcare. The magnitude of the problem is substantial. This finding has major implications for the international comparability of resource use in health economics, quality and equality research. The approach presented in this paper contributes to minimise differentiation between services by taking into account key features such as target population, care setting, main activities and type and number of professionals among others. This approach also contributes to support financial incentives for effective health promotion and disease prevention. A detailed analysis of services in terms of cost measurement for economic evaluations reveals the necessity and usefulness of defining services using a coding system and taxonomical criteria rather than by 'text-based descriptions'.

Normative data and socio-demographic determinants of the dermatology life quality index in a large online sample of the Hungarian population.

INTRODUCTION: Population norms are available for several generic health-related quality of life questionnaires, but rarely for disease- or specialty-specific questionnaires. The aim of our study was to calculate population norms for the Dermatology Life Quality Index (DLQI) score.. AREAS COVERED: We conducted an online self-completed questionnaire survey on a large sample of the general Hungarian adult population. Respondents' socio-demographic characteristics and dermatology-related quality of life aspects were recorded. A total of 2,001 participants completed the questionnaire, with the average age of 48.2 (SD = 16.6) years, half of the respondents in our sample (n = 981) reported long-standing health problems. The average DLQI score was 1.9 (SD = 4.0) with women having a higher average (2.0, SD = 3.9) than men (1.8, SD = 4.0; p = <0.001). The DLQI score differed among age-groups with younger people having relatively higher DLQI averages. When the multivariate linear regression model was applied, it showed that young age, lower income and unemployment status were associated with higher DLQI scores, while controlling for the existence of skin disease (p < 0.05). EXPERT OPINION: This study established DLQI population norms among the general population, which may provide a reference point in health-policy and financing decision-making.

A comparative study on the measurement properties of Dermatology Life Quality Index (DLQI), DLQI-Relevant and Skindex-16.

BACKGROUND: Dermatology Life Quality Index (DLQI) and Skindex-16 are among the most commonly used dermatology-specific health-related quality-of-life (HRQoL) instruments. DLQI has two common scoring methods, the original and the DLQI-Relevant (DLQI-R) modification. Head-to-head comparisons of the measurement properties of the DLQI, DLQI-R and Skindex-16 are currently lacking. OBJECTIVES: We aim to compare the measurement properties of the DLQI, DLQI-R and Skindex-16. METHODS: We analysed data from 618 patients with self-reported physician-diagnosed dermatological conditions from a cross-sectional survey carried out in Hungary in early 2020. DLQI, DLQI-R and Skindex-16 were compared in terms of ceiling and floor effects, informativity, convergent validity and known-group validity. RESULTS: Mean DLQI, DLQI-R and Skindex-16 total scores were 3·76 ± 5·03, 4·11 ± 5·34 and 29·36 ± 26·62, respectively. Among patients with a DLQI/DLQI-R total score of zero, 64% reported problems on Skindex-16. Overall, 23-38% of patients with 'not relevant' responses on DLQI items 3 (shopping/home/gardening), 7 (working/studying), 8 (interpersonal problems) and 9 (sexual difficulties) reported problems on their corresponding Skindex-16 items. Average relative informativity (Shannon's evenness index) was the highest for Skindex-16 (0·85), followed by DLQI-R (0·66) and DLQI (0·54). DLQI, DLQI-R and Skindex-16 demonstrated similar convergent validity. DLQI was able to better discriminate between known groups of patients based on overall skin-related HRQoL impairment, whereas DLQI-R and Skindex-16 performed better with respect to self-perceived health status. CONCLUSIONS: Skindex-16 seems to be more sensitive than DLQI/DLQI-R in capturing mild impairment in HRQoL. Our findings help to provide a fuller understanding of the difference between DLQI, DLQI-R and Skindex-16 and support the informed choice of instrument for clinical and research purposes.

Disease burden of patients with pemphigus from a societal perspective.

Introduction: Cost-of-illness studies are widely used for healthcare decision-making; however, no such study is available in pemphigus from the societal perspective. The purpose of this analysis was to estimate annual cost-of-illness per patient with pemphigus from a societal perspective. Areas covered: Between 2014 and 2017, a multicenter, cross-sectional study was carried out. Consecutive pemphigus patients aged ≥18 years were recruited at all four university dermatology departments in Hungary. Direct and indirect costs were calculated, including costs for treatments, outpatient visits, hospital admissions, informal care, travel costs and productivity loss. Generalized linear model was used to analyze predictors of costs. Atotal of 109 patients with pemphigus enrolled with amean age of 57.1 (SD 14.8) years. Total cost per pemphigus patient was €3,995 (SD €7,526) peryear, with productivity loss (58%) and informal care (19%) accounting for the majority. Annual means of 189 and 41 working hours were lost due to absence from work and reduced productivity, respectively. Younger age and pemphigus vulgaris were associated with higher costs (p < 0.05). Expert opinion: This is the first cost-of-illness study applying the societal perspective in pemphigus. Our results indicate a substantial economic burden on society, mainly driven by productivity loss and informal care.

Subjective expectations regarding longevity and future health: a cross-sectional survey among patients with Crohn's disease.

AIM: The aim was to explore the subjective health expectations (sHE) of patients with Crohn's disease (CD) for both the near future and the elderly. METHOD: A cross-sectional survey was performed in four gastroenterology centres in Hungary. Consecutive outpatients with CD with age ≥ 18 were recruited. Socio-demographic and disease characteristics were recorded and the Crohn's Disease Activity Index (CDAI), Perianal Disease Activity Index, Patients' Global Assessment (PGA) and current pain visual analogue scale (VAS) were assessed. Subjective life expectancy (sLE) was explored and compared to statistical life expectancy. Current health and sHE for 1 year ahead and for ages 60/70/80/90 were assessed using the descriptive system of the EQ-5D-3L. RESULTS: In all, 206 patients (54.9% men) with a mean age of 34.7 (SD 10.5 years) and disease duration of 10.5 (SD 6.3) years were studied. The CDAI score was 110.5 (SD 77.0) and 66% were treated by biologic drugs. Mean current EQ-5D-3L score was 0.80 (SD 0.17) and patients expected a 0.05 (SD 0.15) improvement within a year (P < 0.05). For ages 60/70/80/90, a mean EQ-5D-3L score of 0.59, 0.38, 0.10 and -0.12 respectively was provisioned. Age, current health status, sLE, PGA and pain VAS showed significant correlation with both 1-year and older age sHE (P < 0.05). Long-term sHE and sLE were negatively affected by the presence of extraintestinal manifestations but not by previous CD-related surgery. CONCLUSION: Patients with CD expect severe deterioration in health in later life. Given that unrealistic sHE may affect patients' current quality of life and health behaviour, we encourage physicians to explore and consider CD patients' sHE in clinical care.

Validity of EQ-5D-5L, Skindex-16, DLQI and DLQI-R in patients with hidradenitis suppurativa.

BACKGROUND: Numerous generic, skin- and disease-specific health-related quality of life (HRQoL) measures are available for patients with hidradenitis suppurativa (HS). Yet, robust psychometric evidence is lacking in many aspects of these outcome measures. OBJECTIVES: We sought to determine convergent and known-groups validity of multiple generic and skin-specific HRQoL measures and to identify predictors of impaired HRQoL in patients with HS. METHODS: Between 2017 and 2019, a multicentre cross-sectional study was carried out involving 200 consecutive HS patients. HRQoL outcomes included the EQ-5D-5L, EQ visual analogue scale (EQ VAS), Skindex-16, Dermatology Life Quality Index (DLQI) and DLQI-Relevant (DLQI-R). Disease severity was graded by HS-Physician's Global Assessment (HS-PGA) scale and the Modified Sartorius scale (MSS). RESULTS: Overall, 77%, 56%, 51%, 46% and 28% reported problems in the pain/discomfort, usual activities, anxiety/depression, mobility and self-care dimensions of EQ-5D-5L. Mean ± SD EQ VAS, DLQI and DLQI-R scores were 64.29 ± 22.68, 11.75 ± 8.11 and 12.19 ± 8.33, respectively. Skindex-16 responses indicated that the emotional burden of HS (64.55 ± 29.28) far exceeded those of functioning (49.40 ± 34.70) and physical symptoms (46.74 ± 29.36). EQ-5D-5L, EQ VAS, DLQI, DLQI-R and Skindex-16 total scores had moderate or strong correlations with each other (range: |0.487| to |0.993|), weak or moderate correlations with HS-PGA (|0.350| to |0.433|) and weak correlations with MSS (|0.324| to |0.389|). DLQI-R slightly outperformed DLQI both in terms of convergent and known-groups validity. Being female, lower education level, more severe disease and genital involvement were associated with worse HRQoL (P < 0.05). CONCLUSION: This study provides high-quality evidence that among skin-specific outcomes, the DLQI, DLQI-R and Skindex-16, and among generic instruments, the EQ-5D-5L are suitable to be used in HS patients. In future research, we recommend the use of existing well-validated HRQoL tools instead of developing new measures for each study. The development of composite measures that combine physician- and patient-reported outcomes is not supported by evidence in HS. [Correction added on 25 July 2020, after first online publication: in the Abstract section, the ± signs were missing and have been added to this version.].

DLQI-R scoring improves the discriminatory power of the Dermatology Life Quality Index in patients with psoriasis, pemphigus and morphea.

BACKGROUND: The Dermatology Life Quality Index (DLQI) rates 'not relevant' responses (NRRs) as the item on the questionnaire having no impact on the patients' lives at all. The DLQI-Relevant (DLQI-R) is a recently developed scoring that adjusts the total score of the questionnaire for the number of NRRs indicated by a patient. OBJECTIVES: To compare the discriminatory power of the original and DLQI-R scoring approaches in terms of absolute and relative informativity. METHODS: Cross-sectional data from 637 patients with morphea, pemphigus and psoriasis were used for the analyses. To assess absolute and relative informativity, Shannon's index and Shannon's evenness index were calculated for the 10 items on the questionnaire and for DLQI and DLQI-R total scores. RESULTS: Mean DLQI and DLQI-R scores of patients were 6·13 vs. 6·91. In the subset of patients with NRRs (n = 261, 41%), absolute informativity was higher with the DLQI-R scoring for all eight items with NRR options in all three conditions. The DLQI-R exhibited a better relative informativity in 8, 8 and 6 items in pemphigus, morphea and psoriasis, respectively. The DLQI-R led to an improvement in average item-level informativity in all DLQI score bands up to 20 points. Regarding total scores, the DLQI-R produced both a higher absolute and relative informativity in all three conditions. CONCLUSIONS: In patients with morphea, pemphigus and psoriasis, DLQI-R scoring improves the discriminatory power of the questionnaire by benefiting from the additional information in NRRs. DLQI-R scoring may be useful both in clinical practice and research. A scoring chart has been developed to aid physicians with scoring. What's already known about this topic? The original scoring of the Dermatology Life Quality Index (DLQI) rates 'not relevant' responses as the item of the questionnaire having no impact on the patients' lives at all. DLQI-Relevant (DLQI-R) is a new scoring developed in 2018 that adjusts the total score of the questionnaire for the number of 'not relevant' responses indicated by patients. The discriminatory power of the DLQI-R compared with the DLQI has not yet been investigated. What does this study add? In patients with psoriasis, pemphigus and morphea, DLQI-R scoring improves the discriminatory power of the questionnaire by benefiting from the additional information in 'not relevant' responses. What are the clinical implications of this work? DLQI-R scoring may help to more accurately quantify patients' health-related quality of life both in clinical practice and research. A scoring chart has been developed to aid physicians with scoring.

Patient-assigned health utility values for controlled and uncontrolled pemphigus vulgaris and foliaceus.

BACKGROUND: The assessment of health-related quality of life (HRQoL) in patients with pemphigus is now of increasing interest due to the availability of highly effective new therapies. Preference-based HRQoL values or health utilities required for medical and financial decision-making are not yet available directly from pemphigus patients. OBJECTIVE: To obtain health utility values for current health and hypothetical health states from the perspective of pemphigus patients. METHODS: A cross-sectional questionnaire survey was carried out with pemphigus patients. Disease severity was rated by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS). Patients were asked to evaluate their current health as well as three common hypothetical pemphigus health states [uncontrolled pemphigus vulgaris (PV), uncontrolled pemphigus foliaceus (PF) and controlled PV/PF] by using composite time trade-off (cTTO). Multiple regression was applied to explore determinants of utility values. RESULTS: Responses of 108 patients (64.8% women, mean age 57.4 years) were analysed. Mean ABSIS score was 11.6. The mean utility values for the hypothetical uncontrolled PV, uncontrolled PF and controlled PV/PF health states were 0.41, 0.52 and 0.66 with cTTO. The mean cTTO scores for current health were higher compared with the hypothetical health states (0.76; P < 0.001). Patients with higher ABSIS, worse pain intensity scores and those having a caregiver reported lower utility values for current health (P < 0.05). CONCLUSIONS: In pemphigus, HRQoL impairment expressed in utility values seems to be considerable, especially in comparison with other chronic dermatological conditions (e.g. psoriasis, atopic eczema, chronic hand eczema). These health utilities inform physicians, policymakers and funders about the overall extent of health loss in pemphigus and provide evidence to guide medical decisions and cost-effectiveness analyses of treatment strategies. Future research is needed to evaluate the caregiver burden in pemphigus.

Validity of the EQ-5D in patients with pemphigus vulgaris and pemphigus foliaceus.

BACKGROUND: No studies to date have employed the EuroQoL EQ-5D questionnaire to assess health-related quality of life (HRQoL) in patients with pemphigus. OBJECTIVES: To evaluate the HRQoL of patients with pemphigus by the EQ-5D and to analyse the convergent and known-groups validity of the EQ-5D in this patient population. METHODS: Between 2014 and 2017, a multicentre cross-sectional study was carried out. Outcome measures included the five-level EQ-5D (EQ-5D-5L), Dermatology Life Quality Index (DLQI), Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and an average pain intensity visual analogue scale (VAS) for the past 3 months. RESULTS: In total, 109 consecutive patients with pemphigus participated in the study (mean age 57 years; 64% women). Among the EQ-5D dimensions, the most problems were reported regarding pain/discomfort (50%), mobility (43%) and anxiety/depression (43%). No significant difference was found in mean EQ-5D index scores between patients with pemphigus vulgaris and those with pemphigus foliaceus (0·81 vs. 0·86, P = 0·14). The mean EQ-5D index scores of patients with limited, moderate, significant and extreme pemphigus were 0·88, 0·82, 0·72 and 0·67, respectively (P = 0·001). The number of comorbidities was associated with greater impairment in EQ-5D index scores (P < 0·001). DLQI (rs = -0·62, P < 0·001) and the average pain intensity VAS (rs = -0·59, P < 0·001) more strongly correlated with the EQ-5D index scores than did ABSIS (rs = -0·40, P < 0·001). CONCLUSIONS: This is the first study employing the EQ-5D questionnaire in pemphigus. The EQ-5D is a valid measure of HRQoL in patients with pemphigus that can be useful both in clinical practice and in economic evaluations to assess the health gains associated with new effective treatments.

Proposal of a new scoring formula for the Dermatology Life Quality Index in psoriasis.

BACKGROUND: 'Not relevant' responses (NRRs) on the Dermatology Life Quality Index (DLQI) may occur in up to 40% of patients with psoriasis. As these responses are scored as the item of the questionnaire having no impact on the patients' lives at all, it is more difficult for these patients to fulfil the DLQI > 10 criterion required by clinical guidelines to become candidates for systemic treatment including biologics. OBJECTIVES: We propose a new scoring system for the DLQI that corrects for the bias in the NRR option and test its construct validity in a sample of patients with psoriasis. METHODS: Data from 242 patients (104 of whom marked at least one NRR) from two earlier cross-sectional surveys were reanalysed. For each patient, the DLQI score was calculated in two ways: (i) according to the original scoring and (ii) by applying a new scoring formula (DLQI-R) that adjusts the total score for the number of NRRs. The construct validity of the DLQI-R was tested against the Psoriasis Area and Severity Index (PASI) and EQ-5D-3L. RESULTS: The mean DLQI and DLQI-R scores were 9·99 ± 7·52 and 11·0 ± 8·02, respectively. The DLQI-R allowed eight more patients (3·3%) to achieve the 'PASI > 10 and DLQI > 10' threshold. The results were robust when limiting the maximum number of NRRs allowed to two or three. Compared with the DLQI, DLQI-R correlated slightly better with PASI (rs = 0·59 vs. 0·57) and EQ-5D-3L index scores (rs = -0·58 vs. -0·54). CONCLUSIONS: The DLQI-R seems to be a valid scoring system for avoiding the bias in the NRR option and can help to improve patients' access to biologics.

Association between quality of life and clinical characteristics in patients with morphea.

BACKGROUND: Morphea can lead to considerable cosmetic or functional impairment; nevertheless, health-related quality of life (HRQoL) is rarely documented in adult morphea patients. OBJECTIVE: To investigate the impact of morphea on HRQoL and to identify determinants of impaired HRQoL. METHODS: A cross-sectional study has been carried out among adult morphea patients. HRQoL was evaluated by the Dermatology Life Quality Index (DLQI). The modified Localised Scleroderma Skin Severity Index (mLoSSI) and the Localised Scleroderma Damage Index (LoSDI) were applied to evaluate disease activity and damage, respectively. Physician Global Assessment of Activity and Damage (PGA-A, PGA-D) were also completed. Determinants of HRQoL were analysed by multiple regression. RESULTS: A total of 101 patients (84% females) entered the study, with a mean age of 56.8 ± 14.8 years. Median mLoSSI, LoSDI, PGA-A and PGA-D scores were 8, 5, 9 and 9 points, respectively. Patients with generalised localised (51%) and plaque-type morphea (45%) had median total DLQI scores of 4 and 1, respectively. Embarrassment (53%), itchy or painful skin (46%), and clothing issues (43%) were the most commonly reported problems in the DLQI. Female gender, generalised morphea, higher disease activity (PGA-A score) and involvement of hands and/or feet were significant predictors of impaired HRQoL (p < 0.05). CONCLUSION: This study represents the largest sample of adult morphea patients surveyed about their HRQoL in Europe. The frequent occurrence of embarrassment warrants an increased attention to improve patients' mental health. Care must be taken in case of involvement of functionally sensitive areas, as these cases might require more intensive treatment.

A detailed analysis of 'not relevant' responses on the DLQI in psoriasis: potential biases in treatment decisions.

BACKGROUND: Dermatology Life Quality Index (DLQI) is the most common health-related quality of life measure in dermatology that is widely used in treatment guidelines for psoriasis. Eight of the 10 questions of the DLQI offer a 'not relevant' response (NRR) option that is scored as the item had no impact on patients' life at all. OBJECTIVE: To explore the occurrence of NRRs on the DLQI in psoriasis patients and to examine the effect of several socio-demographic and clinical factors on giving NRRs. METHODS: Data were obtained from two cross-sectional surveys among psoriasis patients at two academic dermatology clinics in Hungary. Health-related quality of life was measured by employing DLQI and EQ-5D-3L, while disease severity was graded by Psoriasis Area and Severity Index (PASI). Multivariate logistic regression was applied to determine the predictors of providing NRRs. RESULTS: Mean age of the 428 patients was 49 years, and 65% were males. Mean PASI, DLQI and EQ-5D-3L index scores were 8.4 ± 9.5, 6.8 ± 7.4 and 0.74 ± 0.28, respectively. Overall, 38.8% of the patients had at least one NRR: 19.6% (one), 11.5% (two), 5.1% (three) and 2.6% (more than three). Most NRRs occurred in sport, sexual difficulties and working/studying items of the DLQI (28.4%, 16.4% and 14.0%, respectively). Female gender (OR 1.65; 95% CI 1.04-2.61), older age (OR 1.05; 95% CI 1.03-1.07) and higher PASI score (OR 1.03; 95% CI 1.01-1.06) were associated with providing more NRRs, whereas highly educated patients (OR 0.34; 95% CI 0.16-0.72) and those with a full-time job (OR 0.47; 95% CI 0.29-0.77) less frequently tended to tick NRRs. CONCLUSION: The high rate of psoriasis patients with NRRs, especially among women, less educated and elderly patients, indicates a content validity problem of the measure. A reconsideration of the use of the DLQI for medical and financial decision-making in psoriasis patients is suggested.

Expression of G protein-coupled oestrogen receptor in melanoma and in pregnancy-associated melanoma.

BACKGROUND: The hormone sensitivity of melanoma and the role of 'classical' oestrogen receptor (ER) α and ß in tumour progression have been intensively studied with rather contradictory results. The presence of 'non-classical' G protein-coupled oestrogen receptor (GPER) has not been investigated on human melanoma tissues. OBJECTIVE: To analyse the expression of GPER, ERα and ERß in pregnancy-associated (PAM) and in non-pregnancy-associated (NPAM) melanomas in correlation with traditional prognostic markers and disease-free survival (DFS). METHODS: Receptor protein levels were tested using immunohistochemistry in 81 formalin-fixed paraffin-embedded melanoma tissues. PAMs (n = 38) were compared with age- and Breslow thickness-matched cases (n = 43) including non-pregnant women (NPAM-W) (n = 22) and men (NPAM-M) (n = 21). The association between receptor expression and DFS was analysed by uni- and multivariate Cox proportional hazards regression. RESULTS: G protein-coupled oestrogen receptor was detected both in PAMs and NPAMs. In 39 of the 41 (95.1%) GPER-positive melanomas, GPER and ERß were co-expressed. GPER/ERß-positive melanomas were significantly more common in PAM compared to NPAM (P = 0.0001) with no significant difference between genders (P = 0.4383). In PAMs, the distribution of GPER and ERß was similar (78.4% vs. 81.6%; P = 0.8504), while in NPAM, ERß was the representative ER (60.5% vs. 27.9%; P = 0.0010) without gender difference (59.1% vs. 61.9%). GPER-/ERß-positive melanomas were associated with lower Breslow thickness, lower mitotic rate and higher presence of peritumoral lymphocyte infiltration (PLI) compared to GPER-/ERß-negative cases (P = 0.0156, P = 0.0036 and P = 0.0001) predicting a better DFS (HR = 0.785, 95% CI 0.582-1.058). Despite the significantly higher frequency of GPER and ERß expression in PAM, no significant difference was found in DFS between PAM and NPAM. All but one case failed to show ERα expression. CONCLUSIONS: The presence of GPER and its simultaneous expression with ERß can serve as a new prognostic indicator in a significant subpopulation of melanoma patients.

Valuation of pemphigus vulgaris and pemphigus foliaceus health states: a convenience sample experiment.

BACKGROUND: Health-related quality of life (HRQoL) in pemphigus has been widely investigated; nevertheless, utility values for economic evaluations are still lacking. OBJECTIVES: To estimate health utilities for hypothetical pemphigus vulgaris (PV) and pemphigus foliaceus (PF) health states in a general population sample. METHODS: Three health states (uncontrolled PV, uncontrolled PF and controlled pemphigus) were developed based on a systematic literature review of HRQoL studies in pemphigus. Utilities were obtained from a convenience sample of 108 adults using a visual analogue scale (VAS) and 10-year time trade-off (TTO). Lead-time TTO was applied for health states regarded as worse than dead with a lead time to disease time ratio of 1 : 1. RESULTS: The mean VAS utility scores for PV, PF and controlled pemphigus were 0·25 ± 0·15, 0·37 ± 0·17 and 0·63 ± 0·16, respectively. Corresponding TTO utilities were as follows: 0·34 ± 0·38, 0·51 ± 0·32 and 0·75 ± 0·31. Overall, 14% and 6% judged PV and PF as being worse than dead. For both VAS and TTO values, significant differences were observed between all health states (P < 0·001). VAS utilities were rated significantly lower compared with TTO in each health state (P < 0·001). CONCLUSIONS: This is the first study that reports health utility values for PV and PF. Successful treatment of pemphigus might result in significant utility gain (0·24-0·41). These empirical findings with respect to three health states in pemphigus may serve as anchor points for further utility studies and cost-effectiveness analyses.

Alopecia areata and health-related quality of life: a systematic review and meta-analysis.

BACKGROUND: No systematic review has yet evaluated the available evidence on health-related quality of life (HRQOL) in alopecia areata (AA). OBJECTIVES: To conduct a systematic review and meta-analysis of HRQOL studies among patients diagnosed with AA. METHODS: A systematic search was performed for papers published between 1946 and 15 December 2014 in Medline, Embase, Web of Science, CINAHL, PsycINFO and the Cochrane Library. Random-effects meta-analyses were conducted to pool data. RESULTS: Twenty-one studies were included, representing a total of 2530 adult patients with AA. Of the 14 different HRQOL measures used in the studies, Dermatology Life Quality Index (DLQI; n = 8) and SF-36 (n = 7) were the most common. Three AA-specific HRQOL instruments were identified: Alopecia Areata Quality of Life Index, Alopecia Areata Quality of Life and Alopecia Areata Symptom Impact Scale. The mean pooled DLQI score of patients with AA was 6·3 (95% confidence interval 5·6-7·1). Comparing age- and sex-matched controls, the meta-analysis of SF-36 studies revealed significantly reduced HRQOL across the role-emotional, mental health and vitality domains (P < 0·001). Wearing a wig had a positive impact, while scalp involvement, anxiety and depression had a negative impact on HRQOL. Conflicting results were found regarding the association between HRQOL and age, sex, marital status and disease duration. CONCLUSIONS: Patients with AA experience significant impairment in HRQOL, especially in the area of mental health. Several generic and dermatology-specific HRQOL instruments have been used, but no validation studies have confirmed their applicability in AA. The newly developed AA-specific measures seem very promising; however, a more extensive assessment of validity and reliability is needed.

Use of biologics for psoriasis in Central and Eastern European countries.

OBJECTIVES: To evaluate the use of biological agents for the treatment of psoriasis and to explore country-specific differences within six Central and Eastern European (CEE) countries, namely Bulgaria, Croatia, the Czech Republic, Hungary, Poland and Romania. METHODS: A literature overview on the epidemiology and disease burden of psoriasis in CEE was conducted. The number of patients treated with biologics was obtained from patient registries, ministries of health, national professional societies and health insurance funds. Biological treatment rates were estimated by two different methods: (i) as a proportion of all psoriasis patients of a country (assuming a common prevalence of psoriasis 2%) and (ii) per 100,000 population. Moreover, we provide a detailed comparison of drug coverage policies and guidelines regulating the treatment with biologics in psoriasis. RESULTS: On average 0.25% of all psoriasis patients, or five psoriasis patients out of 100,000 inhabitants are treated with biologics embedding a 14.6-fold difference between the six countries. Bulgaria, Croatia and Poland lag behind the other three countries in the use of biologics. The significant differences among CEE countries cannot be explained by variations in prices of biologics, cost-effectiveness or budget impact of biologics. It seems that the time since coverage decision, the fewer number of covered biologics, the more restrictive criteria to be eligible for covered treatment in terms of baseline Psoriasis Area and Severity Index and Dermatology Life Quality Index scores, and the maximum duration of treatment allowed are responsible for the majority of the differences. CONCLUSIONS: There exists a disconnect between the European psoriasis treatment guidelines and the various CEE country-specific biologic coverage eligibilities. The cost of biologic therapy for psoriasis is not solely and directly responsible for the different use rates amongst the CEE countries. Psoriasis may not be perceived by all payers as a serious disease that can be successfully treated in a cost-effective manner.