Development of a Disease-Specific Version of the EQ-5D-5L for Use in Patients Suffering from Psoriasis: Lessons Learned from a Feasibility Study in the UK

AbstractObjectivesThe EuroQol five-dimensional (EQ-5D) questionnaire is a generic measure widely used for the assessment of health status. Research has suggested that it may be insensitive to the burdens associated with particular conditions. This study was designed to explore the feasibility of developing and valuing a disease-specific “bolt-on” version of the EQ-5D questionnaire for use in psoriasis.MethodsA series of steps were undertaken to develop, test, and evaluate dimensions for a psoriasis-specific version of the EQ-5D questionnaire (hereafter referred to as the EQ-PSO questionnaire). Candidate dimensions were explored through a review of published literature, in-depth qualitative interviews with patients, and consultation with a clinical expert. A psychometric validation exercise was then undertaken to establish how well dimensions functioned. Two dimensions were selected for inclusion in a draft measure alongside the existing EQ-5D questionnaire dimensions: “skin irritation” and “self-confidence.” Last, a time trade-off valuation exercise was conducted with 300 members of the UK general public to derive utilities for health states described by the measure.ResultsThe psychometric analyses indicated that the two new candidate dimensions captured additional variance over and above the existing five dimensions. Data from the valuation exercise were analyzed by using different models. A collapsed random effects model was put forward as a parsimonious and accurate approach. Based on this model, estimated utilities ranged from 0.98 ± 0.02 for state “1111111” to 0.03 ± 0.29 for state “5555555.”ConclusionsThis study has developed the EQ-PSO questionnaire to support future psoriasis research and has informed the development of future bolt-on versions of the EQ-5D questionnaire

Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

BACKGROUND: The Millennium Declaration in 2000 brought special global attention to HIV, tuberculosis, and malaria through the formulation of Millennium Development Goal (MDG) 6. The Global Burden of Disease 2013 study provides a consistent and comprehensive approach to disease estimation for between 1990 and 2013, and an opportunity to assess whether accelerated progress has occured since the Millennium Declaration. METHODS: To estimate incidence and mortality for HIV, we used the UNAIDS Spectrum model appropriately modified based on a systematic review of available studies of mortality with and without antiretroviral therapy (ART). For concentrated epidemics, we calibrated Spectrum models to fit vital registration data corrected for misclassification of HIV deaths. In generalised epidemics, we minimised a loss function to select epidemic curves most consistent with prevalence data and demographic data for all-cause mortality. We analysed counterfactual scenarios for HIV to assess years of life saved through prevention of mother-to-child transmission (PMTCT) and ART. For tuberculosis, we analysed vital registration and verbal autopsy data to estimate mortality using cause of death ensemble modelling. We analysed data for corrected case-notifications, expert opinions on the case-detection rate, prevalence surveys, and estimated cause-specific mortality using Bayesian meta-regression to generate consistent trends in all parameters. We analysed malaria mortality and incidence using an updated cause of death database, a systematic analysis of verbal autopsy validation studies for malaria, and recent studies (2010-13) of incidence, drug resistance, and coverage of insecticide-treated bednets. FINDINGS: Globally in 2013, there were 1·8 million new HIV infections (95% uncertainty interval 1·7 million to 2·1 million), 29·2 million prevalent HIV cases (28·1 to 31·7), and 1·3 million HIV deaths (1·3 to 1·5). At the peak of the epidemic in 2005, HIV caused 1·7 million deaths (1·6 million to 1·9 million). Concentrated epidemics in Latin America and eastern Europe are substantially smaller than previously estimated. Through interventions including PMTCT and ART, 19·1 million life-years (16·6 million to 21·5 million) have been saved, 70·3% (65·4 to 76·1) in developing countries. From 2000 to 2011, the ratio of development assistance for health for HIV to years of life saved through intervention was US$4498 in developing countries. Including in HIV-positive individuals, all-form tuberculosis incidence was 7·5 million (7·4 million to 7·7 million), prevalence was 11·9 million (11·6 million to 12·2 million), and number of deaths was 1·4 million (1·3 million to 1·5 million) in 2013. In the same year and in only individuals who were HIV-negative, all-form tuberculosis incidence was 7·1 million (6·9 million to 7·3 million), prevalence was 11·2 million (10·8 million to 11·6 million), and number of deaths was 1·3 million (1·2 million to 1·4 million). Annualised rates of change (ARC) for incidence, prevalence, and death became negative after 2000. Tuberculosis in HIV-negative individuals disproportionately occurs in men and boys (versus women and girls); 64·0% of cases (63·6 to 64·3) and 64·7% of deaths (60·8 to 70·3). Globally, malaria cases and deaths grew rapidly from 1990 reaching a peak of 232 million cases (143 million to 387 million) in 2003 and 1·2 million deaths (1·1 million to 1·4 million) in 2004. Since 2004, child deaths from malaria in sub-Saharan Africa have decreased by 31·5% (15·7 to 44·1). Outside of Africa, malaria mortality has been steadily decreasing since 1990. INTERPRETATION: Our estimates of the number of people living with HIV are 18·7% smaller than UNAIDS's estimates in 2012. The number of people living with malaria is larger than estimated by WHO. The number of people living with HIV, tuberculosis, or malaria have all decreased since 2000. At the global level, upward trends for malaria and HIV deaths have been reversed and declines in tuberculosis deaths have accelerated. 101 countries (74 of which are developing) still have increasing HIV incidence. Substantial progress since the Millennium Declaration is an encouraging sign of the effect of global action. FUNDING: Bill & Melinda Gates Foundation

Patients' Perspectives on the Impact of Genital Psoriasis: A Qualitative Study

Contains fulltext : 181645.pdf (publisher's version ) (Open Access

The experience of itch in children with psoriasis: A qualitative exploration of the Itch Numeric Rating Scale

Background/Objectives Psoriasis is a chronic, immune‐mediated dermatologic disorder with a prevalence among children estimated at 0.1%–0.45%, and a median age of onset at approximately 7–10 years. Pediatric psoriasis is known to have negative impacts on health‐related quality of life. Among the most bothersome symptoms, itch has been measured using the Itch Numeric Rating Scale (NRS). This study explored the symptom and impacts of itch with pediatric psoriasis patients and evaluated the content validity of the Itch NRS in children. Methods Semi‐structured qualitative interviews were conducted among a sample of pediatric patients diagnosed with plaque psoriasis. Results Concept elicitation interviews were completed with 22 children (ages 7–17 years). When asked about most frequent symptoms, 61% reported itching (n = 14) and 65% reported flaking (n = 15). The majority reported itching as bothersome; about half described impacts on their regular activities. Cognitive interviews were completed with 25 children (ages 8–17 years). Most reported that independently completing the Itch NRS would be easy, and all described the meaning of the response options similar to the intended value. Overall, the Itch NRS was received favorably, with comments that the scale was easy or relevant to their experience with psoriasis. Conclusions This qualitative study supports the content validity of the Itch NRS for use in a pediatric psoriasis population aged 8–17. Given the established importance of itch to pediatric psoriasis patients, future research exploring the impact of itch on the lives of pediatric psoriasis patients may provide a valuable contribution to the field

Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort

PURPOSE: Alopecia areata (AA) is a common disorder of patchy hair loss which carries a substantial psychological burden for patients. The current understanding of AA prevalence, disease course and burden is limited, and further research is needed to improve patient care. This prospective cohort of AA patients within the Danish Skin Cohort was established to provide data that can serve as a tool in future studies of for example, AA epidemiology and disease burden. PARTICIPANTS: A total of 1494 patients with dermatologist-verified AA were included in the cohort. Patients were invited and included through electronic or phone-based questionnaires. Information regarding demographics, biometrics, lifestyle factors, skin type, AA onset and development, health-related quality of life and self-reported severity assessment was collected. FINDINGS TO DATE: The mean (SD) age of AA onset was 32.7 (17.6) years. The mean body mass index and history of cigarette smoking was comparable with the general population. The majority (92.5%) of participants were Caucasian. In total, 72.4% of patients received their diagnosis by a physician within a year after onset of symptoms, and 66.9% reported to still have symptoms of AA within the past year. A total of 12% reported to have a first-degree family member with AA. In total, 31.4% of patients were missing all or nearly all hairs on their scalp, 32.2% had no or barely no eyelashes and 36.2% had no or barely no eyebrow hairs. Overall, most patients (55.7%) did not experience irritated eyes, but 30% reported slight eye irritation and 47.2% reported no damage to finger nails or toenails. FUTURE PLANS: Observational studies regarding comorbidities, psychosocial burden of AA and efficacy of pharmacological interventions will be carried out and additional data will be linked from nationwide registries of routinely collected data. Furthermore, follow-up survey data will be added for longitudinal analyses

The Relationship Between Patient-Reported Severity of Hair Loss and Health-Related Quality of Life and Treatment Patterns Among Patients with Alopecia Areata

IntroductionAlopecia areata (AA) is an autoimmune disease characterized by hair loss. Patients with AA experience a range of social and emotional impacts, and the lack of effective treatments and multiple affected locations can deepen the burden of illness. The objective of the current study was to assess health-related quality of life (HRQL) among patients with AA, and to evaluate the relationship between patient-reported AA severity, HRQL and treatment patterns.MethodsA web survey was completed by participants recruited through the National Alopecia Areata Foundation. The survey included questions on disease characteristics, burden and impact (evaluated by the Skindex-16 for AA and items on work/school and sexual relationships), healthcare utilization and treatment experience. Analyses were conducted for the overall sample and by key subgroups, including AA severity and disease duration.ResultsA total of 1327 participants with AA completed the survey. The mean age was 39.7 [standard deviation (SD) 12.3] years and 58.4% were female. On average, participants had experienced signs and symptoms of AA for 11.5 years (SD 12.5) and were diagnosed by a healthcare provider (HCP) 10.5 (SD 12.2) years ago. Participants reported a range of severity of current scalp hair loss, including 0% (2.6%), 1-20% (39.8%), 21-49% (26.2%), 50-94% (10.2%) and 95-100% (21.3%). Participants reporting 95-100% of scalp hair missing were less likely to be currently seeing an HCP and to currently be on treatments for AA. There was a non-linear relationship between HRQL and current AA severity. Participants with 1-20% to 50-94% of current scalp hair missing reported higher symptom, functioning and emotional impacts due to AA than participants with 0% missing scalp hair and/or 95-100% missing scalp hair. Similar findings were observed for current eyebrow and eyelash severity, except for emotional impacts.ConclusionSeverity of AA plays an important role in understanding the burden of illness and healthcare patterns of people living with AA

A qualitative interview study to explore adolescents' experience of alopecia areata and the content validity of sign/symptom patient-reported outcome measures.

BackgroundThe content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents.ObjectivesTo explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample.MethodsSemi-structured, 90-min, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥ 50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis.ResultsEleven adolescents (aged 12-17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1).ConclusionsThe Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA

The dermatologic intimacy scale: quantitatively measuring the impact of skin disease on intimacy

Introduction: Patient-reported outcome measures are increasingly utilized in dermatology to assess the impact of skin disease on quality of life. Despite recognition of the influence of skin disease on intimate relationships, an instrument to assess intimacy has not been developed. The objective of this study was to create the dermatologic intimacy scale (DIS) and administer the prototype to a patient population. Methods: A group of healthcare providers at the University of California San Francisco created the DIS prototype. A total of 1676 psoriasis patients of an online community were invited to complete a cross-sectional survey including demographic information, DIS, body surface area (BSA) and anatomical involvement. Results: A total of 1109 patients completed the survey in its entirety. Patients with moderate-to-severe psoriasis (BSA ≥3%) had a higher DIS score overall and for each individual question than patients with mild disease (BSA < 3%; p < .001). Patients with genitalia, nails, face, neck and scalp involvement had higher scores compared to patients without involvement (p < .001). Conclusions: Patients with more extensive disease and specific anatomical involvement experience a greater impact on intimacy. Interpretation is limited by patient response rate, as patients with or without intimacy issues may be more or less likely to respond. Further analysis is necessary for validation and interpretation