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Mathias Tiedemann Svendsen,1–3 Klaus Ejner Andersen,1–3 Flemming Andersen,1,3 Jakob Hansen,4 Anton Pottegård,5 Helle Johannessen6 1Department of Dermatology and Allergy Centre, Odense University Hospital, 2Centre for Innovative Medical Technology, Institute of Clinical Research, University of Southern Denmark, Odense C, 3Dermatological Investigations Scandinavia, University of Southern Denmark, Odense C, 4Leo Pharma, Ballerup, 5Clinical Pharmacology, Department of Public Health, University of Southern Denmark, 6Research Unit of User Perspectives, Department of Public Health, University of Southern Denmark, Odense C, Denmark Abstract: Nonadherence to topical treatment of psoriasis is a common cause of treatment failure. This focus group study was conducted to obtain the patients’ own experiences and explanations regarding medical adherence. The participants consisted of eight primary adherent patients with moderate psoriasis treated with corticosteroid or corticosteroid–calcipotriol combinations, purposefully sampled by age and sex at a dermatology outpatient clinic. Secondary medical adherence was supported by accessibility of the prescribing physician, the prescriber taking time to listen, having a more manageable disease, using a nonstaining product, and establishing routines around treatment at home. Secondary medical adherence was affected negatively by changes in daily routines, if the treatment influenced the patient’s sexual life, having too little time in the consultation room, lack of confidence in the prescriber, diverging information from health care personnel, experiencing side effects, having fear of side effects, impractical formulations of topical products, and impatience regarding time before an effect of the treatment was observed. From this study, the recommendations for the prescribing doctor to improve medical adherence are, the doctor needs to take time to listen to the patient, prescribe a topical product that is easy to apply and less greasy, inform the patients about benefits from treatments, and explain the rationale behind the treatment plan. Keywords: psoriasis, adherence, corticosteroids, calcipotriol, focus groups

Background: Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier to treatment success. Psoriasis patients require support, in order to improve their long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by dermatology nurses can reduce the severity of psoriasis, improve the use of topical drugs, and is cost-effective compared to standard procedure., Methods: The intervention consists of improved support delivered to patients by three experienced dermatology nurses, who will support patients on a regular basis by consultations with a focus on providing reminder systems, accountability, reinforcement, and building trust in the treatment. Each patient will be supported by the same dermatology nurse throughout the entire study period. The effect will be compared with standard procedure. The intervention will be tested in a randomized controlled trial during a 48-week period. A group of patients with moderate-to-severe psoriasis (psoriasis affecting ≥ 4% of the total body surface area) and 18-85 years of age who are prescribed topical treatment will be randomized to a non-intervention (n ≈ 57) or intervention group (n ≈ 57). Participants in both arms will be prescribed topical preparations containing corticosteroid and/or calcipotriol. The primary outcome will be a change in the severity of psoriasis, measured as reduction in the Lattice-System Physician's Global Assessment. Secondary outcomes will include changes in health-related quality of life (measured by disease specific and generic questionnaires), primary adherence (i.e., proportion of filled prescriptions), and secondary adherence by objective measure (rate of topical drug consumption (obtained by weighing medication packages) compared to estimated recommended consumption). A health economic evaluation is planned to run alongside the trial. Participants' total health costs will be estimated on the basis of health costs reported to the national health registries and costs spent on the intervention, after which a cost-utility and cost-effectiveness analysis will be carried out., Discussion: If the intervention can reduce the severity of psoriasis in a significant manner and is economically favorable compared to standard treatment, there is potential for implementing the intervention in dermatology clinics., Trial Registration: Clinicaltrials.gov NCT04220554 . Registered on January 7, 2020. Study results, either positive, negative, or inconclusive, will be published on www.clinicaltrials.gov . Trial registration no. with the Danish Regional Committee on Health Research Ethics, registration no. 72613., (© 2021. The Author(s).)

Objectives: The main objectives of this article are to systematically review the recent literature on patient safety in relation to the use of eHealth and to investigate how the Danish authorities supervise private eHealth clinics with regard to patient safety., Methods: Original studies reporting the association between patient safety and the use of eHealth as a means of communication between patients and healthcare providers were included. Four literature databases were searched for English-language articles reporting results from cohort studies and clinical trials, published from 2015 until March 2021. Moreover, registered private eHealth clinics in Denmark were evaluated with reference to a recent national audit of patient safety issues in eHealth., Results: The literature search retrieved four intervention studies. The studies did not identify any particular patient safety risks associated with the use of eHealth. Many different authorized healthcare providers (preferably, doctors) apply eHealth in various contexts. eHealth is being used as the only form of contact between the healthcare provider and the patient, as a supplement to patient visitations in an outpatient clinic, or as a tool for communicating between two or more healthcare providers. The regulation of eHealth involves patient safety issues but also has interfaces to marketing, IT systems, and infrastructure. Supervision of eHealth includes the organization of clinics, handling patient charts, prescription medicine, patient legal rights, and patient transition. However, there are many interfaces in the division of responsibilities among the various governmental players., Conclusion: eHealth is being used increasingly and in many settings, although recently published intervention studies investigating patient safety issues by the use of eHealth are limited. A structured and continuous governmental control and regulation of patient safety in relation to the use of eHealth is warranted., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.T.S. and K.E.A. have received grants from LEO Pharma to conduct clinical trials testing interventions using eHealth patient-support solutions (ClinicalTrials.gov NCT04220554 and NCT02858713). In addition, M.T.S. was responsible for designing indicators and safety benchmark measures for eHealth for the Danish Patient Safety Authority and conducted the first national regulatory supervision of private eHealth providers. All of the data reported are publicly available. S.N.T. declares no conflicts of interest. No private companies or governmental regulatory institutions have been involved in the ideas behind or the writing of this article. All authors take full responsibility for the content of this article., (© The Author(s) 2021.)

Objectives: Examining whether specific population groups who are not working and those who have an employment have the same health literacy level. Methods: Data were retrieved from a nationally representative cross-sectional study of the Danish population conducted with the health literacy questionnaire (HLS-EU-Q16) in 2016 and 2017. Socio-demographic characteristics were drawn from national registers. Odds ratio for the association between employment status and health literacy was estimated from logistic regression models, adjusted for socio-demographic characteristics. Probability weights were used to adjust for differences in responses. Results: Logistic regression analyses showed that receiving unemployment benefits, social assistance, employment and support allowance, retirement pension and sickness benefit were significantly associated with having inadequate health literacy compared to being employed in any industry. The highest odds ratio for inadequate health literacy was present for receiving unemployment benefit OR = 1.78 (95% CI: 1.23-2.56). Conclusion: Population groups not working and receiving economic public support have higher odds of inadequate health literacy competencies compared to those active in the labor force, considering age and socioeconomic factors. The result contributes to understanding health disparities in connection to occupational situation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Svendsen, Damgaard, Bak, Bøggild, Torp-Pedersen, Svendsen and Berg-Beckhoff.)

Aims: The usefulness of mortality statistics relies on the validity of death certificate diagnosis. However, diagnosing the causal sequence of conditions leading to death is not simple. We examined diagnostic support for fatal acute myocardial infarction (AMI) and investigated its association with regional variation., Methods and Results: From Danish nationwide registers, we identified the study population (N = 3,244,051) of whom 36,669 individuals were recorded with AMI as the underlying cause-of-death between 2002 and 2015. We included clinical diagnoses, procedures, and claimed prescriptions related to atherosclerotic disease to evaluate the level of diagnostic support for fatal AMI in three diagnostic groups (Definite; Plausible; Uncertain). Adjusted mortality rates, rate ratios, and odds ratios were estimated for each AMI category, stratified by hospital region using multivariable regression models. More than one-third (N = 12,827, 35%) of deaths reported as fatal AMI had uncertain diagnostic support. The largest regional variation in AMI mortality rate ratios, varying from 1.16 (95%CI:1.02;1.31) to 1.62 (95%CI:1.43;1.83), was found among cases with uncertain diagnostic supportive data. Substantial inter-regional differences in the degree to which death occurs outside hospital [OR: 1.01 (95%CI:0.92;1.12) - 1.49 (95%CI:1.36;1.63)] and general practitioners determining the cause-of-death at home were present. Minor regional differences [OR: 0.96 (95%CI:0.85;1.07) - 1.16 (95%CI:1.04;1.29)] in in-hospital AMI mortality were observed., Conclusion: There is significant regional variation associated with recording AMI as a cause-of-death. This variation is predominately based on death certificate diagnoses without diagnostic supportive evidence. Studies of fatal AMI should include a stratification on supportive evidence of the diagnosis., Competing Interests: MTS reports grants from the Danish Heart Foundation and the Maria Pedersen and Jensine Heiberg Foundation, during the conduct of the study. STM reports grants from Trygfonden, the Laerdal Foundation, the Danish Heart Foundation outside the submitted work. CTP reports grants from Bayer and Novo Nordisk outside the submitted work. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Health literacy concerns the ability of citizens to meet the complex demands of health in modern society. Data on the distribution of health literacy in general populations and how health literacy impacts health behavior and general health remains scarce. The present study aims to investigate the prevalence of health literacy levels and associations of health literacy with socioeconomic position, health risk behavior, and health status at a population level., Methods: A nationwide cross-sectional survey linked to administrative registry data was applied to a randomly selected sample of 15,728 Danish individuals aged ≥25 years. By the short form HLS-EU-Q16 health literacy was measured for the domains of healthcare, disease prevention, and health promotion. Adjusted multinomial logistic regression analyses were used to estimate associations of health literacy with demographic and socioeconomic characteristics, health risk behavior (physical activity, smoking, alcohol consumption, body weight), and health status (sickness benefits, self-assessed health)., Results: Overall, 9007 (57.3%) individuals responded to the survey. Nearly 4 in 10 respondents faced difficulties in accessing, understanding, appraising, and applying health information. Notably, 8.18% presented with inadequate health literacy and 30.94% with problematic health literacy. Adjusted for potential confounders, regression analyses showed that males, younger individuals, immigrants, individuals with basic education or income below the national average, and individuals receiving social benefits had substantially higher odds of inadequate health literacy. Among health behavior factors (smoking, high alcohol consumption, and inactivity), only physical behavior [sedentary: OR: 2.31 (95% CI: 1.81; 2.95)] was associated with inadequate health literacy in the adjusted models. The long-term health risk indicator body-weight showed that individuals with obesity [OR: 1.78 (95% CI: 1.39; 2.28)] had significantly higher odds of lower health literacy scores. Poor self-assessed health [OR: 4.03 (95% CI: 3.26; 5.00)] and payments of sickness absence compensation benefits [OR: 1.74 (95% CI: 1.35; 2.23)] were associated with lower health literacy scores., Conclusions: Despite a relatively highly educated population, the prevalence of inadequate health literacy is high. Inadequate health literacy is strongly associated with a low socioeconomic position, poor health status, inactivity, and overweight, but to a lesser extent with health behavior factors such as smoking and high alcohol consumption.

Background: Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence., Methods/design: Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT)., Participants: 134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata)., Intervention: A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient's rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period. Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician's Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI)., Discussion: This trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could easily be implemented as a standard routine of care in the clinic., Trial Registration: NCT02858713 , registered on August 3, 2016. EudraCT number 2016-002143-42.

Background: The diuretic hydrochlorothiazide is amongst the most frequently prescribed drugs in the United States and Western Europe, but there is suggestive evidence that hydrochlorothiazide use increases the risk of lip cancer., Objectives: To study the association between use of hydrochlorothiazide and squamous cell carcinoma of the lip., Methods: We conducted a case-control study using Danish nationwide registry data. From the Cancer Registry (2004-2012), we identified 633 case patients with squamous cell carcinoma (SCC) of the lip and matched them to 63 067 population controls using a risk-set sampling strategy. Hydrochlorothiazide use (1995-2012) was obtained from the Prescription Registry and defined according to cumulative use. Applying conditional logistic regression, we calculated odds ratios (ORs) for SCC lip cancer associated with hydrochlorothiazide use, adjusting for predefined potential confounders obtained from demographic, prescription and patient registries., Results: Ever-use of hydrochlorothiazide was associated with an adjusted OR for SCC lip cancer of 2.1 (95% confidence interval (CI): 1.7-2.6), increasing to 3.9 (95%CI: 3.0-4.9) for high use (≥25 000 mg). There was a clear dose-response effect (P < 0.001), with the highest cumulative dose category of hydrochlorothiazide (≥100 000 mg) presenting an OR of 7.7 (95%CI: 5.7-10.5). No association with lip cancer was seen with use of other diuretics or nondiuretic antihypertensives. Assuming causality, we estimated that 11% of the SCC lip cancer cases could be attributed to hydrochlorothiazide use., Conclusions: Hydrochlorothiazide use is strongly associated with an increased risk of lip cancer., (© 2017 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)