Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS).

Introduction: Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

Evaluation of validity, reliability and ability to detect change for the Hand Eczema Severity Index (HECSI) and evaluation of HECSI-75 and HECSI-90 as within-patient responder definitions.

Background: The Hand Eczema Severity Index (HECSI) is a Clinician-Reported Outcome measure of the severity of hand eczema (HE).

Objectives: This study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI-75 and HECSI-90 as responder definitions.

Methods: Analyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double-blind, vehicle-controlled trial of delgocitinib cream, pooled across treatment groups.

Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity.

The Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE) is a novel Clinician-Reported Outcome measure that allows investigators to assess cross-sectional CHE global disease severity using clinical characteristics of erythema, scaling, lichenification/hyperkeratosis, vesiculation, oedema, and fissures as guidelines for overall severity assessment. This study aimed to evaluate the psychometric properties of the IGA-CHE for use as an outcome measure in CHE clinical trials and clinical practice. Psychometric analyses were performed using data from a sample of 280 patients with moderate to severe CHE from a phase 3 trial of delgocitinib cream, pooled across treatment groups.

The management of Chronic Hand Eczema: A retrospective patient record review.

Background: Chronic Hand Eczema (CHE) is a heterogeneous fluctuating inflammatory disease that represents a significant burden. Effective treatment options for moderate to severe CHE are limited.

Objectives: To assess how patients with moderate to severe CHE are treated in clinical practice.

Matching-Adjusted Indirect Comparison of Long-Term Efficacy and Safety Outcomes for Calcipotriol Plus Betamethasone Dipropionate Foam Versus Halobetasol Proprionate Plus Tazarotene Lotion in the Treatment of Plaque Psoriasis.

Introduction: To date, there have been no head-to-head clinical studies comparing calcipotriol 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam and halobetasol propionate 0.

Matching-adjusted indirect comparison of efficacy outcomes in trials of calcipotriol plus betamethasone dipropionate foam and cream formulations for the treatment of plaque psoriasis.

Background And Objectives: Once-daily, fixed-combination calcipotriol 50 μg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream.

Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial.

Background: Psoriasis contributes to unemployment, work impairment, missed workdays and substantial indirect costs due to lost productivity. Combination Cal/BD foam is the only topical that is approved for long-term maintenance treatment of plaque psoriasis for 52 weeks. This is the first known investigation of the effect of topical psoriasis therapy on productivity.

Quality of life and patient-perceived symptoms in patients with psoriasis undergoing proactive or reactive management with the fixed-dose combination Cal/BD foam: A post-hoc analysis of PSO-LONG.

Background: Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key to clinical decision-making.

Objectives: This post hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.

Clinical, patient and estimated cost benefits of proactive management versus reactive management with calcipotriol/betamethasone dipropionate foam for the treatment of plaque psoriasis in Finland.

Background: Proactive management of plaque psoriasis with twice-weekly topical calcipotriol/betamethasone dipropionate (Cal/BD) foam has a demonstrated clinical benefit in preventing disease relapse compared to reactive management, where Cal/BD foam is only given as rescue therapy once-daily for four weeks after relapse. The impact of proactive management with Cal/BD foam on a wider range of clinical responses is not yet known, nor is its potential cost-effectiveness in the healthcare system of Finland.

Methods: This study involved a post-hoc analysis exploring the clinical and patient-reported benefits of proactive versus reactive management with Cal/BD foam observed in the PSO-LONG trial (NCT02899962).

The Effect on BSA of Proactive Management versus Reactive Management of Psoriasis With Fixed-Dose Cal/BD Foam in the PSO-LONG Study.

Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed.

Characteristics of non-response in the Danish Health Interview Surveys, 1987-1994.

Background: The types and quantity of non-response in surveys influence the extent to which the results may be generalized. This study analysed trends in non-response in the Danish Health Interview Surveys from 1987 to 1994 and used the National Patient Registry to assess whether non-response biased the estimated population prevalence of morbidity when solely based on responders.

Methods: The data were for the 23,096 adults sampled for the Danish Health Interview Surveys in 1987, 1991 and 1994.

Use of hormone replacement therapy among Danish nurses at increased risk of osteoporosis.

Observational studies and recent randomized trials have shown that postmenopausal hormone replacement therapy (HRT) may reduce the risk of osteoporotic fractures by about 30 to 40%. In this study we used a log linear graphical model to determine whether women with a known increased risk of osteoporosis were more likely to use HRT than other women and to examine whether women at increased risk modified this risk through their lifestyle. Cox regression analysis was used to analyze if women at risk of osteoporosis used HRT longer than women not at risk.

Do age and social relations moderate the relationship between self-rated health and mortality among adult Danes?

It is well established that self-rated health (SRH) predicts mortality even after controlling for a wide range of factors. We explored the extent to which age and social relations (structural and functional) influenced the relationship between SRH and mortality (after 13 years follow-up) in a representative sample of adult Danes (N=6693). After controlling for socioeconomic status, illness, and lifestyle variables, we found that age moderated the SRH-mortality relationship such that it was present for respondents under 55 but absent for respondents over 56.

Lifestyle factors and choice of hormone replacement therapy among Danish nurses.

Background: Studies have found that women who use hormone replacement therapy (HRT) are healthier or report better health than non-users. This study examines the association between lifestyle factors, self-reported health and the use of HRT in Danish female nurses above the age of 50 years.

Methods: Postal questionnaires were used for data collection.

Risk of endophthalmitis after cataract extraction: results from the International Cataract Surgery Outcomes study.

Aim: To estimate risk of infectious endophthalmitis after cataract extraction in Denmark and to compare results with the risk of this complication in the USA.

Methods: In the national Danish administrative hospital register, 19,426 patients were identified who underwent first eye cataract surgery from 1985 to 1987 and who were 50 years of age or older. Of these, 61 patients had postoperative endophthalmitis.

Risk of retinal detachment following cataract extraction: results from the International Cataract Surgery Outcomes Study.

Aims: To estimate the risk of retinal detachment (RD) following cataract extraction in Denmark, and to compare the risk with that following cataract extraction in the USA, and with that in a sample of Danish patients who did not have ocular surgery.

Methods: A sample was created from the administrative Danish Hospital Register and included 19,252 patients who underwent first eye cataract surgery between 1985 and 1987, and who were 50 years of age or older. The patients were then followed for 4-6 years using the register data.