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.

Meaning of Family Reported Outcome Measure (FROM-16) severity score bands: a cross-sectional online study in the UK.

OBJECTIVE: To assign clinical meanings to the Family Reported Outcome Measure (FROM-16) scores through the development of score bands using the anchor-based approach. DESIGN AND SETTING: A cross-sectional online study recruited participants through UK-based patient support groups, research support platforms (HealthWise Wales, Autism Research Centre-Cambridge University database, Join Dementia Research) and through social service departments in Wales. PARTICIPANTS: Family members/partners (aged ≥18 years) of patients with different health conditions. INTERVENTION: Family members/partners of patients completed the FROM-16 questionnaire and a Global Question (GQ). MAIN OUTCOME MEASURE: Various FROM-16 band sets were devised as a result of mapping of mean, median and mode of the GQ scores to FROM-16 total score, and receiver operating characteristic-area under the curve cut-off values. The band set with the best agreement with GQ based on weighted kappa was selected. RESULTS: A total of 4413 family members/partners (male=1533, 34.7%; female=2858, 64.8%; Prefer not to say=16, 0.4%; other=6, 0.14%) of people with a health condition (male=1994, 45.2%; female=2400, 54.4%; Prefer not to say=12, 0.3%; other=7, 0.16%) completed the online survey: mean FROM-16 score=15.02 (range 0-32, SD=8.08), mean GQ score=2.32 (range 0-4, SD=1.08). The proposed FROM-16 score bandings are: 0-1=no effect on the quality of life of family member; 2-8=small effect on family member; 9-16=moderate effect on family member; 17-25=very large effect on family member; 26-32=extremely large effect on family member (weighted kappa=0.60). CONCLUSION: The FROM-16 score descriptor bands provide new information to clinicians about interpreting scores and score changes, allowing better-informed treatment decisions for patients and their families. The score banding of FROM-16, along with a short administration time, demonstrates its potential to support holistic clinical practice.

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.

Impact of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) on the quality of life of people with ME/CFS and their partners and family members: an online cross-sectional survey.

OBJECTIVES: The aim of this study was to assess the impact of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) on the quality of life (QoL) of people with ME/CFS and their relative or partner (family member). DESIGN: A patient-partner, multinational, subject-initiated, cross-sectional online survey. SETTING: International survey using ME/CFS charities, support groups and social media. PARTICIPANTS: Participants were self-selected with recruitment via social media. Inclusion criteria were aged 18 years or over and reported diagnosis of ME/CFS by health professional. 1418 people with ME/CFS and their 1418 family members from 30 countries participated in the survey. Participants with ME/CFS had a mean age of 45.8 years (range 18-81) and were predominantly women (1214 (85.6%) of 1418). Family members had a mean age of 51.9 years (range 18-87) and were predominantly men (women: 504 (35.5%) of 1418). 991 (70%) family members were partners of the people with ME/CFS. INTERVENTIONS: EuroQoL-5 Dimension (EQ-5D-3L), completed by people with ME/CFS, and Family Reported Outcome Measure (FROM-16) questionnaire, completed by family members. RESULTS: The mean overall health status on a Visual Analogue Scale for people with ME/CFS was 33.8 (0=worst, 100=best). People with ME/CFS were most affected by ability to perform usual activities, pain, mobility, self-care and least impacted by anxiety. For family members, the overall mean FROM-16 score was 17.9 (0=no impact, 32=worst impact), demonstrating a major impact on QoL. Impact on QoL was significantly correlated between the person with ME/CFS and their family member (p<0.0001). Family members were most impacted emotionally by worry, frustration and sadness and personally by family activities, holidays, sex life and finances. CONCLUSIONS: To the best of our knowledge, this is the largest study on the impact of the QoL of persons with ME/CFS and their family members. While open participation surveys are limited by selection bias, this research has revealed a significant worldwide burden of ME/CFS on the QoL of people with ME/CFS and their family members.

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.

Quality of Life in Hidradenitis Suppurativa: An Update.

Knowledge on hidradenitis suppurativa/acne inversa (HS) is rapidly increasing. HS has a profound impact on patients and their family life. Several factors, such as comorbidities, unemployment and HS severity, make this impact even more severe. The most widely used instrument to measure this impact is the dermatology-specific DLQI. We also identified six HS-specific health-related quality of life (HRQoL) instruments. Of them, HIDRAdisk, HSIA, HiSQOL and HSQoL-24 are better validated but there is still lack of experience of its use. Several treatment methods showed positive effect on patients' HRQoL. Surgery remains a method with a substantial positive effect on HRQoL. Several studies confirming a positive effect of adalimumab on the HRQoL of patients with HS were published during the last three years. Data on the influence of several other biologics on HRQoL of HS patients are controversial or based on studies with a small number of patients.

Measuring the impact of COVID-19 on the quality of life of the survivors, partners and family members: a cross-sectional international online survey.

OBJECTIVE: This study aimed to measure the impact of COVID-19 on the quality of life (QoL) of survivors and their partners and family members. DESIGN AND SETTING: A prospective cross-sectional global online survey using social media. PARTICIPANTS: Patients with COVID-19 and partners or family members (age ≥18 years). INTERVENTION: Online survey from June to August 2020. MAIN OUTCOME MEASURE: The EuroQol group five dimensions three level (EQ-5D-3L) to measure the QoL of survivors of COVID-19, and the Family Reported Outcome Measure (FROM-16) to assess the impact on their partner/family member's QoL. RESULTS: The survey was completed by 735 COVID-19 survivors (mean age=48 years; females=563) at a mean of 12.8 weeks after diagnosis and by 571 partners and 164 family members (n=735; mean age=47 years; females=246) from Europe (50.6%), North America (38.5%) and rest of the world (10.9%). The EQ-5D mean score for COVID-19 survivors was 8.65 (SD=1.9, median=9; range=6-14). 81.1% (596/735) reported pain and discomfort, 79.5% (584/735) problems with usual activities, 68.7% (505/735) anxiety and depression and 56.2% (413/735) problems with mobility. Hospitalised survivors (20.1%, n=148) and survivors with existing health conditions (30.9%, n=227) reported significantly more problems with mobility and usual activities (p<0.05), with hospitalised also experiencing more impact on self-care (p≤0.001). Among 735 partners and family members, the mean FROM-16 score (maximum score=highest impact =32) was 15 (median=15, range=0-32). 93.6% (688/735) reported being worried, 81.7% (601/735) frustrated, 78.4% (676/735) sad, 83.3% (612/735) reported impact on their family activities, 68.9% (507/735) on sleep and 68.1% (500/735) on their sex life. CONCLUSION: COVID-19 survivors reported a major persisting impact on their physical and psychosocial health. The lives of their partners and other family members were also severely affected. There is a need for a holistic support system sensitive to the needs of COVID-19 survivors and their family members who experience a major 'secondary burden'.

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.

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.

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.

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.

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.

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.

Itch and Mental Health in Dermatological Patients across Europe: A Cross-Sectional Study in 13 Countries.

Itch is a highly prevalent and multidimensional symptom. We aimed to analyze the association between itch and mental health in dermatological patients. This multicenter study is observational and cross-sectional and was conducted in dermatological clinics across 13 European countries. A total of 3,530 patients and 1,094 healthy controls were included. Patients were examined clinically. Outcome measures were itch (presence, chronicity, and intensity), the Hospital Anxiety and Depression Scale, EQ-5D visual analogue scale, sociodemographics, suicidal ideation, and stress (negative life events and economic difficulties). Ethical approval was obtained. Results showed significant association between the presence of itch in patients and clinical depression (odds ratio, 1.53; 95% confidence interval, 1.15-2.02), suicidal ideation (odds ratio, 1.27; 95% confidence interval, 1.01-1.60), and economic difficulties (odds ratio, 1.24; 95% confidence interval, 1.10-1.50). The mean score of reported generic health status assessed by the EQ-5D visual analogue scale was 65.9 (standard deviation = 20.1) in patients with itch, compared with 74.7 (standard deviation = 18.0) in patients without itch (P < 0.001) and 74.9 (standard deviation = 15.7) in controls with itch compared with 82.9 (standard deviation = 15.6) in controls without itch (P < 0.001). Itch contributes substantially to the psychological disease burden in dermatological patients, and the management of patients should include access to multidisciplinary care.