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.

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.

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.

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'.

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.

Correlating the Dermatology Life Quality Index with psychiatric measures: A systematic review.

Skin conditions may have a major impact on the psychologic well-being of patients, ranging from depression to anxiety. The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life tool in dermatology, though it has yet to be correlated with psychiatric measures used in clinical therapeutic trials. We conducted a systematic review to determine whether there is any correlation between the DLQI and psychiatric measure scores, potentially allowing the DLQI to be used as a surrogate measure for depression or psychiatric screening. Six databases were searched using the following keywords: "DLQI," "Dermatology Life Quality Index," "Psych*," "depression," "anxiety," "stress," and "trial*." All randomized trials where full DLQI and psychiatric scores were provided were included. PRISMA guidelines were followed. In all, 462 records were screened, but only seven met inclusion criteria. Hospital Anxiety and Depression Scale (HADS) was the most commonly used psychiatric measure; the "depression" component score changes correlated strongly with the DLQI (r = 0.715). There needs to be guidance on psychiatric measurement and reporting in clinical trials. Although the DLQI correlated well with the "depression" domain of the HADS scale, interviews and screening for depression are still vital for full assessment of patient psychologic well-being.

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.