The Dermatology Life Quality Index (DLQI) as the Primary Outcome in Randomised Clinical Trials: A systematic review.

BACKGROUND: Primary endpoint measures in clinical trials are typically measures of disease severity, with patient reported outcome measures (PROMs) relegated as secondary endpoints. However validation of some PROMs may be more rigorous than that of disease severity measures, arguing for a primary role for PROMs. OBJECTIVES: This study reports on 24 peer reviewed journal articles that used the Dermatology Life Quality Index (DLQI) as primary outcome, derived from a systematic review of randomised controlled trials (RCTs) utlising DLQI covering all diseases and interventions. MATERIALS AND METHOD: The study protocol was prospectively published on the PROSPERO database, and the study followed PRISMA guidelines. Searches were made with Medline, Cochrane library, EMBASE, Web of Science, SCOPUS, CINAHL(EBSCO) and PsycINFO databases and records combined into an Endnote database. Records were filtered for duplicates and selected by study inclusion/exclusion criteria. Full text articles were sourced and data was extracted by two reviewers into a bespoke REDCap database, with a third reviewer adjudicating differences. The Jadad scoring method was used to determine risk of bias. RESULTS: Of the 3,220 publications retrieved from online searching, 457 articles met eligibility criteria and included 198,587 patients. DLQI scores were primary outcomes in 24 (5.3%) of these studies comprising 15 different diseases and 3,436 patients. Most study interventions (17/24 studies, 68%) were systemic drugs with biologics (liraglutide, alefacept, secukinumab, ustekinumab, adalimumab) accounting for five out of 25 pharmacological interventions (20%). Topical treaments comprised 32% (8 studies) whereas non-pharmacological interventions (8) were 24% of the total interventions (33). Three studies used non-traditional medicines. Eight studies were multicentred (33.3%), with trials conducted in at least 14 different countries, and four (16.7%) were conducted in multiple countries. The Jadad risk of bias scale showed that bias was uncertain or low, as 87.5% of studies had Jadad scores of ≥3. CONCLUSIONS: This study provides evidence for use of the DLQI as primary outcome in clinical trials to inform researchers' and clinicians' decisions for its further use.

A systematic review of 454 randomized controlled trials using the Dermatology Life Quality Index: experience in 69 diseases and 43 countries.

BACKGROUND: Over 29 years of clinical application, the Dermatology Life Quality Index (DLQI) has remained the most used patient-reported outcome (PRO) in dermatology due to its robustness, simplicity and ease of use. OBJECTIVES: To generate further evidence of the DLQI's utility in randomized controlled trials (RCTs) and to cover all diseases and interventions. METHODS: The methodology followed PRISMA guidelines and included seven bibliographical databases, searching articles published from 1 January 1994 until 16 November 2021. Articles were reviewed independently by two assessors, and an adjudicator resolved any opinion differences. RESULTS: Of 3220 screened publications, 454 articles meeting the eligibility criteria for inclusion, describing research on 198 190 patients, were analysed. DLQI scores were primary endpoints in 24 (5.3%) of studies. Most studies were of psoriasis (54.1%), although 69 different diseases were studied. Most study drugs were systemic (85.1%), with biologics comprising 55.9% of all pharmacological interventions. Topical treatments comprised 17.0% of total pharmacological interventions. Nonpharmacological interventions, mainly laser therapy and ultraviolet radiation treatment, comprised 12.2% of the total number of interventions. The majority of studies (63.7%) were multicentric, with trials conducted in at least 42 different countries; 40.2% were conducted in multiple countries. The minimal clinically importance difference (MCID) was reported in the analysis of 15.0% of studies, but only 1.3% considered full score meaning banding of the DLQI. Forty-seven (10.4%) of the studies investigated statistical correlation of the DLQI with clinical severity assessment or other PRO/quality of life tools; and 61-86% of studies had within-group scores differences greater than the MCID in 'active treatment arms'. The Jadad risk-of-bias scale showed that bias was generally low, as 91.8% of the studies had Jadad scores of ≥ 3; only 0.4% of studies showed a high risk of bias from randomization. Thirteen per cent had a high risk of bias from blinding and 10.1% had a high risk of bias from unknown outcomes of all participants in the studies. In 18.5% of the studies the authors declared that they followed an intention-to-treat protocol; imputation for missing DLQI data was used in 34.4% of studies. CONCLUSIONS: This systematic review provides a wealth of evidence of the use of the DLQI in clinical trials to inform researchers' and -clinicians' decisions for its further use. Recommendations are also made for improving the reporting of data from future RCTs using the DLQI.

Perceived Stigmatization among Dermatological Outpatients Compared with Controls: An Observational Multicentre Study in 17 European Countries.

Perceived stigmatization places a large psychosocial burden on patients with some skin conditions. Little is known about the experience of stigmatization across a wide range of skin diseases. This observational cross-sectional study aimed to quantify perceived stigmatization and identify its predictors among patients with a broad spectrum of skin diseases across 17 European countries. Self-report questionnaires assessing perceived stigmatization and its potential predictors were completed by 5,487 dermatology outpatients and 2,808 skin-healthy controls. Dermatological diagnosis, severity, and comorbidity were clinician-assessed. Patients experienced higher levels of perceived stigmatization than controls (p < 0.001, d = 0.26); patients with psoriasis, atopic dermatitis, alopecia, and bullous disorders were particularly affected. Multivariate regression analyses showed that perceived stigmatization was related to sociodemographic (lower age, male sex, being single), general health-related (higher body mass index, lower overall health), disease-related (higher clinician-assessed disease severity, presence of itch, longer disease duration), and psychological (greater distress, presence of suicidal ideation, greater body dysmorphic concerns, lower appearance satisfaction) variables. To conclude, perceived stigmatization is common in patients with skin diseases. Factors have been identified that will help clinicians and policymakers to target vulnerable patient groups, offer adequate patient management, and to ultimately develop evidence-based interventions.

Quality of life measurement in vitiligo. Position statement of the European Academy of Dermatology and Venereology Task Force on Quality of Life and Patient Oriented Outcomes with external experts.

Members of the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life (QoL) and Patient Oriented Outcomes reviewed the instruments available for health-related (HR) QoL assessment in vitiligo and together with external vitiligo experts (including representatives of the EADV Vitiligo Task Force) have made practical recommendations concerning the assessment of QoL in vitiligo patients. The Dermatology Life Quality Index (DLQI) was the most frequently used HRQoL instrument, making comparison of results between different countries possible. Several vitiligo-specific instruments were identified. The vitiligo Impact Scale (VIS) is an extensively validated vitiligo-specific HRQoL instrument with proposed minimal important change and clinical interpretation for VIS-22 scores. VIS-22 was developed for use in India, where there are some specific cultural beliefs concerning vitiligo. The EADV Task Force on QoL and Patient Oriented Outcomes recommends use of the DLQI and the Children's Dermatology Life Quality Index (CDLQI) as dermatology-specific instruments in vitiligo. There is a strong need for a valid (including cross-cultural validation) vitiligo-specific instrument that can be either a new instrument or the improvement of existing instruments. This validation must include the proof of responsiveness.

Translation and validation of the Polish language version of the Teenagers Quality of Life questionnaire (T-QoL).

Introduction: Skin diseases affect patients at any age, but as each period in life is different, tools used to assess quality of life impairment should be adjusted according to the particular age group. Adolescence is a unique time, when young individuals go through many changes, making them especially vulnerable to stress. Aim: Translation and validation of a Polish language version of the Teenagers Quality of Life questionnaire (T-QoL) questionnaire. Material and methods: T-QoL was translated following international guidelines. A group of 34 dermatological patients, aged 12-19 years old, with various skin diseases were given the T-QoL as well as the CDLQI or DLQI to complete. They were also asked to complete the T-QoL questionnaire for the second time after 3-5 days. Statistical analysis of the results was performed. Results: The Polish version of T-QoL is internally consistent (Cronbach α 0.893 for the whole questionnaire). Moreover, it presents very good convergent validity (ICC = 0.864). No statistically significant differences between each question were noticed between the first and second time of completing the form. T-QoL scores correlated significantly with DLQI (p = 0.008, r = 0.636) and CDLQI (p < 0.001, r = 0.777) scores. Conclusions: The Polish version of the T-QoL questionnaire is a reliable instrument with adequate convergent validity, consistency and reproducibility. It can be successfully used to measure quality of life impairment among teenagers.

Body dysmorphia in common skin diseases: results of an observational, cross-sectional multicentre study among dermatological outpatients in 17 European countries.

BACKGROUND: Body dysmorphic disorder (BDD) is a common psychiatric disorder associated with high costs for healthcare systems as patients may repeatedly ask for different, often not effective, interventions. BDD symptoms are more prevalent in patients with dermatological conditions than in the general population, but there are no large sample studies comparing the prevalence of BDD symptoms between patients with dermatological conditions and healthy skin controls. OBJECTIVES: To compare the prevalence of BDD symptoms between patients with different dermatological conditions and healthy skin controls and to describe sociodemographic, physical and psychological factors associated with BDD symptoms to identify patients who may have a particularly high chance of having this condition. METHODS: This observational, cross-sectional, comparative multicentre study included 8295 participants: 5487 consecutive patients with different skin diseases (56% female) recruited among dermatological outpatients at 22 clinics in 17 European countries, and 2808 healthy skin controls (66% female). BDD symptoms were assessed by the Dysmorphic Concern Questionnaire. Sociodemographic data and information on psychological factors and physical conditions were collected. Each patient was given a dermatological diagnosis according to ICD-10 by a dermatologist. The study was registered with number DRKS00012745. RESULTS: The average participation rate of invited dermatological patients was 82.4% across all centres. BDD symptoms were five times more prevalent in patients with dermatological conditions than in healthy skin controls (10.5% vs. 2.1%). Patients with hyperhidrosis, alopecia and vitiligo had a more than 11-fold increased chance (adjusted Odds Ratio (OR) > 11) of having BDD symptoms compared with healthy skin controls, and patients with atopic dermatitis, psoriasis, acne, hidradenitis suppurativa, prurigo and bullous diseases had a more than sixfold increased chance (adjusted OR > 6) of having BDD symptoms. Using a logistic regression model, BDD symptoms were significantly related to lower age, female sex, higher psychological stress and feelings of stigmatization. CONCLUSIONS: Clinical BDD symptoms are significantly associated with common dermatological diseases. As such symptoms are associated with higher levels of psychological distress and multiple unhelpful consultations, general practitioners and dermatologists should consider BDD and refer patients when identified to an appropriate service for BDD screening and management.

Validation of the German version of the Family Reported Outcome Measure (FROM-16) to assess the impact of disease on the partner or family member.

BACKGROUND: The Family Reported Outcome Measure (FROM-16) assesses the impact of a patient's chronic illness on the quality of life (QoL) of the patient's partner or family members. The aim of the study was to translate, explore the structure of and validate the FROM-16. METHODS: The questionnaire was translated from English into German (forward, backward, four independent translators). Six interviews with family members were conducted to confirm the questionnaire for linguistic, conceptual, semantic and experiential equivalence and its practicability. The final German translation was tested for internal consistency, reproducibility and test validity. Criterion validity was tested by correlating the scores of the FROM-16 and the Global Health Scale (GHS). Principal component analysis, factor analysis, and confirmatory factor analysis was used to assess the questionnaire's structure and its domains. Reliability and reproducibility were tested computing the intraclass correlation coefficient (ICC) using one sample t-test for testing the hypothesis that the difference between the scores was not different from zero. RESULTS: Overall, 83 family members (61% female, median age: 61 years) completed the questionnaire at two different times (mean interval: 22 days). Internal consistency was good for the FROM-16 scores (Cronbach's α for total score = 0.86). In those with stable GHS, the ICC for the total score was 0.87 and the difference was not different from zero (p = 0.262) indicating reproducible results. A bi-factor model with a general factor including all items, and two sub-factors comprising the items from the original 2-factor construct had the best fit. CONCLUSIONS: The German FROM-16 has good reliability, test validity and practicability. It can be considered as an appropriate and generic tool to measure QoL of a patient's partner or family member. Due to the presence of several cross-loadings we do not recommend the reporting of the scores of the two domains proposed for the original version of FROM-16 when using the German version. Thus, in reporting the results emphasis should be put on the total score. TRIAL REGISTRATION: Retrospectively registered: DRKS00021070.

Major life changing decision profile: Creation of the Polish language version.

Chronic diseases have long-term consequences and can affect individuals' life course. The aim of this study was to create the Polish language version of a questionnaire estimating the impact of the disease on important life decisions-the major life changing decision profile (MLCDP). The translation of the MLCDP followed international guidelines. The created Polish language version of the questionnaire was administered to 32 nephrology and dermatology ward inpatients. To assess its properties, statistical analysis of the results obtained was conducted. The Polish language version of the MLCDP demonstrated very good internal consistency with a Cronbach α coefficient of 0.84. The questionnaire presented excellent test-retest reliability, established with a coefficient ICC of 0.97. The Polish language version of MLCDP has shown high internal consistency and reproducibility, and can be used effectively to assess the cumulative impact of the disease by indicating the number of major life decisions affected by chronic disease.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Major Impact on Lives of Both Patients and Family Members.

Background and objectives: To explore the impacts that Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) has on the patient and their family members using the WHOQOL-BREF (Abbreviated World Health Organisation Quality of Life questionnaire) and FROM-16 (Family Reported Outcome Measure-16) quality of life assessments. Materials and Methods: A quantitative research study using postal questionnaires was conducted. A total of 39 adult volunteers expressed an interest in participating in the study: 24 returned appropriately completed questionnaires. Patients with ME/CFS completed the WHOQOL-BREF and up to four of their family members completed the FROM-16 questionnaire. Results: ME/CFS negatively affects the quality of life of the patient (median scores WHOQOL-BREF: Physical health = 19, Psychological = 44, Social relationships = 37.5, Environment = 56, n = 24) and their family members' quality of life (FROM-16: Emotional = 9.5, Personal and social = 11.5, Overall = 20.5, n = 42). There was a significant correlation between the patient's reported quality of life scores and their family members' mean FROM-16 total scores. Conclusions: This study identifies the major impact that having an adult family member with ME/CFS has on the lives of partners and of other family members. Quality of life of ME/CFS patients was reduced most by physical health compared to the other domains. Quality of life of family members was particularly impacted by worry, family activities, frustration and sadness. This highlights the importance of measuring the impact on the lives of family members using tools such as the FROM-16 in the ME/CFS clinical encounter and ensuring appropriate support is widely available to family members.

Counting the Burden: Atopic Dermatitis and Health-related Quality of Life.

Atopic dermatitis is the most prevalent chronic inflammatory skin condition globally. The burden of atopic dermatitis on children and adults is extensive and there is also significant impact on the lives of patient caregivers and family members. It is important to be able to measure this impact to inform clinical decisions and to plan appropriate patient and carer support. The current impact of atopic dermatitis on children and adults can be measured using several different quality of life questionnaires: the most frequently used are the Dermatology Quality of Life (DLQI), Children's Dermatology Quality of Life and Infants Dermatology Quality of Life. The impact on partners and family can be measured using several atopic dermatitis specific questionnaires or the Family DLQI or the generic Family Reported Outcome Measure, FROM-16.

Family Reported Outcome Measure - 16 (FROM-16): Creation, Reliability and Reproducibility of the Polish Language Version.

Chronic diseases not only have a direct influence on patients' quality of life, but can also affect the life of family members. The aim of this study was to create the Polish language version of a questionnaire estimating impact of disease on quality of family life: the Family Reported Outcome Measure - 16 (FROM-16). A standard forward and backward translation procedure was used to convert the original English version of FROM-16 into the Polish language. Creation of the Polish version was performed in a group of 30 patients' family members. The Polish language version of FROM-16 showed very good internal consistency reliability, the Cronbach α coefficient was 0.89. Reproducibility level was established with an intraclass correlation coefficient of 0.98. The Polish language version of FROM-16 can potentially be used as a tool to assess quality of life of patients' family members.

Exploring the EQ-5D Dimension of Pain/Discomfort in Dermatology Outpatients from a Multicentre Study in 13 European Countries.

Pain and discomfort are important symptoms in dermatology. The aim of this cross-sectional, multicentre study was to describe the prevalence of pain/discomfort and its associations in patients with several dermatological conditions across 13 European countries. The outcome was the prevalence of pain/discomfort according to a question of the EQ-5D questionnaire. Data collected from November 2011 to February 2013 were complete for 3,509 consecutive outpatients. Moderate or extreme pain/discomfort was reported by 55.5% of patients and 31.5% of controls with no skin conditions. The highest proportions were reported by patients with hidradenitis suppurativa (92.9%), leg ulcer (81.4%), prurigo (80%) and lichen planus (75.6%). Pain/discomfort was associated with older age, low educational level, clinical severity, flare on scalp or hands, itch, depression, anxiety, low quality of life, and thoughts of suicide. It is important to enquire specifically about pain/discomfort during clinical consultations and to address it when planning a patient's care.

Psychosocial Aspects of Adult Acne: Data from 13 European Countries.

The link between acne and psychiatric morbidities has been demonstrated in many studies; however, large scale studies aiming to reveal the psychosocial impact of acne are rare. The aim of this study was to assess the psychological burden of adult acne patients. This analysis was based on a multicenter study including 213 acne patients and 213 controls from 13 European countries. The Hospital Anxiety and Depression Scale (HADS), Dermatology Life Quality Index, and EuroQol 5 dimensions 3 levels scores of the patients with acne were analyzed. Patients with acne (n = 213) had higher HADS scores for anxiety (mean ± standard deviation 6.70 ± 3.84) and depression (3.91 ± 3.43) than the controls (p < 0.001 for both). For patients with acne, 40.6% reported that they were very concerned about their skin disease, 12.3% had suicidal ideation, and, among those, 10 (4%) patients implied that acne was the cause of their suicidal thoughts. After adjusting for other variables, patients who had suicidal ideation (p = 0.007, and adjusted odds ratio 3.32 [95% confidence interval (CI): 1.39-7.93]) and stressful life events (p < 0.001, and adjusted OR 5.85 [95% CI: 2.65-12.86]) had a greater chance of fulfilling the HADS criteria for anxiety. This study highlights the need for a psychotherapeutic approach in order to recognize the concerns of acne patients and optimize their treatment.

Occurrence, Chronicity and Intensity of Itch in a Clinical Consecutive Sample of Patients with Skin Diseases: A Multi-centre Study in 13 European Countries.

Itch is an unpleasant symptom, affecting many dermatological patients. Studies investigating the occurrence and intensity of itch in dermatological patients often focus on a single skin disease and omit a control group with healthy skin. The aim of this multi-centre study was to assess the occurrence, chronicity and intensity (visual analogue scale 0-10) of itch in patients with different skin diseases and healthy-skin controls. Out of 3,530 dermatological patients, 54.3% reported itch (mean ± standard deviation itch intensity 5.5 ± 2.5), while out of 1,094 healthy-skin controls 8% had itch (3.6 ± 2.3). Chronic itch was reported by 36.9% of the patients and 4.7% of the healthy-skin controls. Itch was most frequent (occurrence rates higher than 80%) in patients with unclassified pruritus, prurigo and related conditions, atopic dermatitis and hand eczema. However, many patients with psychodermatological conditions and naevi also reported itch (occurrence rates higher than 19%).

The Role of Therapy in Impairing Quality of Life in Dermatological Patients: A Multinational Study.

Skin disease and its therapy affect health-related quality of life (HRQoL). The aim of this study was to measure the burden caused by dermatological therapy in 3,846 patients from 13 European countries. Adult outpatients completed questionnaires, including the Dermatology Life Quality Index (DLQI), which has a therapy impact question. Therapy issues were reported by a majority of patients with atopic dermatitis (63.4%), psoriasis (60.7%), prurigo (54.4%), hidradenitis suppurativa (54.3%) and blistering conditions (53%). The largest reduction in HRQoL attributable to therapy, as a percentage of total DLQI, adjusted for confounders, was seen in blistering conditions (10.7%), allergic/drug reactions (10.2%), psoriasis (9.9%), vasculitis/immunological ulcers (8.8%), atopic dermatitis (8.7%), and venous leg ulcers (8.5%). In skin cancer, although it had less impact on HRQoL, the reduction due to therapy was 6.8%. Treatment for skin disease contributes considerably to reducing HRQoL: the burden of dermatological treatment should be considered when planning therapy and designing new dermatological therapies.

The psychosocial burden of hand eczema: Data from a European dermatological multicentre study.

BACKGROUND: The essential physical role, visibility and social importance of the hands place a major psychological burden on patients with hand eczema. OBJECTIVES: The aim of this study was to identify the psychological, social and clinical characteristics of patients with hand eczema, in particular the prevalences of depression, anxiety, suicidal ideation, and comorbidities. MATERIALS AND METHODS: Data on patients with hand eczema were analysed from a large European multicentre study conducted with dermatology outpatients from 13 countries. Groups of patients and controls were compared to analyse the psychological burden of hand eczema. RESULTS: Female patients with hand eczema had higher Hospital Anxiety and Depression Scale (HADS) scores for anxiety (n = 86, median = 7.0) than controls (n = 900, median = 5.0, P = .02), and for depression (median = 4.0) than controls (3.0, P < .001). Patients with high suicidal ideation, with low socioeconomic status and who were widowed or divorced were more likely to fulfil the HADS criteria for anxiety [odds ratio (OR) > 1, P = .038, P < .001, and P < .001, respectively]. The median Dermatology Life Quality Index score was 7.0 (n = 68). DISCUSSION: This study identifies a specific psychological burden experienced by hand eczema patients, highlighting the need for focused psychosocial interventions. Physicians in particular should be aware of the need to identify anxiety and depression in female patients.

How to Train to Discharge a Dermatology Outpatient: A Review.

BACKGROUND/AIMS: The decision to discharge is a critical and common outpatient consultation event. However, little guidance exists over how discharge decision-making can be taught. We aimed to provide educational recommendations concerning outpatient discharge decision-making. METHODS: Recommendations were drawn from prior interviews with 40 consultant dermatologists and 56 dermatology outpatients, and from the "traffic light" design discharge information checklist, developed using the Delphi technique. RESULTS: The key strategies to follow to appropriately manage the outpatient discharge process are: to warn patients in advance, to understand patients' agendas, to allow extra time for the discharge process, to prepare patients to self-manage, to provide a "safety net" and provide the GP with a clear management plan. Aspects to be considered include patient mobility, presence of carer, type of employment, diagnostic certainty, and use of the checklist or guidelines. Key training aspects include teaching structured thought processes when discharging, discharging according to context, developing communication and negotiation skills, avoiding decision biases and encouraging good interprofessional collaboration. Training should include the consideration of the possibility of discharge at each consultation. Novel training strategies have been developed on how to appropriately manage the outpatient discharge process, including involving and informing patients. These strategies focus on safe decision-making, being patient-centred and organizing an efficient health care service framework. CONCLUSION: Structured outpatient discharge training for dermatologists is now possible, based on information from detailed doctor- and patient-based qualitative studies.