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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.

Background Over 29 years of clinical application, the Dermatology Life Quality Index (DLQI) has remained the most used PRO in dermatology due to its robustness, simplicity and ease of use. Objectives This systematic review aimed to generate further evidence of its utility in randomised controlled trials and is the first to cover all diseases and interventions. Methods The methodology followed PRISMA guidelines and included seven bibliographic databases, searching articles published from January 1 1994 until November 16, 2021. Articles were reviewed independently by two assessors, and an adjudicator resolved any opinion differences. Results Of 3220 screened publications, 457 articles meeting eligibility criteria for inclusion, describing research on 198,587 patients, were analysed. DLQI scores were primary endpoints in 24 (5.3%) of studies. Most studies were of psoriasis (53.2%), although 68 different diseases were studied. Most study drugs were systemic (84.3%), with biologics 55.9% of all pharmacological interventions. Topical treatments comprised 17.1% of total pharmacological interventions. Non-pharmacological interventions were 13.8% of the total interventions, mainly laser therapy and UV treatment. 63.6% of studies were multicentre, with trials conducted in at least 42 different countries, and 41.7% were conducted in multiple countries. Minimal importance difference (MID) was reported in analysis of 15.1% of studies, but only 1.3% considered full score meaning banding of DLQI. 61 (13.4%) of studies investigated statistical correlation of DLQI with clinical severity assessment or other PRO/QoL tools. 62% to 86% of studies had within group scores differences greater than the MID in “active treatment arms”. The JADAD risk of bias scale showed that bias was generally low, as 91.4% of studies had JADAD scores of ≥3; only 0.44% of studies showed high risk from randomisation, 13.8% high risk from blinding and 10.4% high risk from unknown outcome of all participants in the studies. 18.3% of studies declared that they followed an intention-to treat (ITT) protocol, and imputation for missing DLQI data was used in 34.1% of studies. Conclusions This systematic review provides a wealth of evidence for use of the DLQI in clinical trials to inform researchers’ and clinicians’ decision for its further use. Recommendations are also made for improving the reporting of data from future RCT trials using DLQI.

The European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on Quality of Life (QoL) and Patient-Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa (ARHS) do not recommend the use of any generic instrument as a single method of Health Related (HR) QoL assessment in rosacea, except when comparing quimp (quality of life impairment) in rosacea patients with that in other non-dermatologic skin diseases and/or healthy controls. The EADV TFs on QoL and Patient-Oriented Outcomes and ARHS recommend the use of the dermatology-specific HRQoL instrument the Dermatology Life Quality Index (DLQI) and the rosacea-specific HRQoL instrument RosaQoL in rosacea patients. The DLQI minimal clinically important difference may be used as a marker of clinical efficacy of the treatment and DLQI score banding of 0 or 1 corresponding to no effect on patients' HRQoL could be an important treatment goal. This information may be added to consensuses and guidelines for rosacea.

ObjectiveTo 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 settingA 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.ParticipantsFamily members/partners (aged ≥18 years) of patients with different health conditions.InterventionFamily members/partners of patients completed the FROM-16 questionnaire and a Global Question (GQ).Main outcome measureVarious 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.ResultsA 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).ConclusionThe 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.

ObjectivesThe 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).DesignA patient-partner, multinational, subject-initiated, cross-sectional online survey.SettingInternational survey using ME/CFS charities, support groups and social media.ParticipantsParticipants 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.InterventionsEuroQoL-5 Dimension (EQ-5D-3L), completed by people with ME/CFS, and Family Reported Outcome Measure (FROM-16) questionnaire, completed by family members.ResultsThe 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 (pConclusionsTo 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.

Skin disease can affect the quality of life (QoL) of teenagers in a variety of different ways, some being unique to this age group.To develop and validate a dermatology-specific QoL instrument for adolescents with skin diseases.Qualitative semistructured interviews were conducted with adolescents with skin disease to gain in-depth understanding of how skin diseases affect their QoL. A prototype instrument based on the themes identified from content analysis of interviews was tested in several stages, using classical test theory and item response theory models to develop this new tool and conduct its psychometric evaluation.Thirty-three QoL issues were identified from semistructured interviews with 50 adolescents. A questionnaire based on items derived from content analysis of interviews was subjected to Rasch analysis: factor analysis identified three domains, therefore not supporting the validity of T-QoL as a unidimensional measure. Psychometric evaluation of the final 18-item questionnaire was carried out in a cohort of 203 adolescents. Convergent validity was demonstrated by significant correlation with Skindex-Teen and Dermatology Life Quality Index (DLQI) or Children's DLQI. The T-QoL showed excellent internal consistency reliability: Cronbach's α = 0·89 for total scale score and 0·85, 0·60 and 0·74, respectively, for domains 1, 2 and 3. Test-retest reliability was high in stable volunteers. T-QoL showed sensitivity to change in two subgroups of patients who indicated change in their self-assessed disease severity.Built on rich qualitative data from patients, the T-QoL is a simple and valid tool to quantify the impact of skin disease on adolescents' QoL; it could be used as an outcome measure in both clinical practice and clinical research.

Psoriasis is a chronic, immune-mediated disorder with cutaneous and systemic manifestations and substantial negative effects on patient quality of life. Psoriasis has a strong, albeit polygenic, genetic basis. Whereas approximately half of the accountable genetic effect of psoriasis maps to the major histocompatibility complex,70 other loci have been identified, many of which implicate nuclear factor-κB, interferon signalling and the IL-23-IL-23 receptor axis. Psoriasis pathophysiology is characterized by abnormal keratinocyte proliferation and immune cell infiltration in the dermis and epidermis involving the innate and adaptive immune systems, with important roles for dendritic cells and T cells, among other cells. Frequent comorbidities are rheumatological and cardiovascular in nature, in particular, psoriatic arthritis. Current treatments for psoriasis include topical agents, photo-based therapies, traditional systemic drugs and biologic agents. Treatments can be used in combination or as monotherapy. Biologic therapies that target specific disease mediators have become a mainstay in the treatment of moderate-to-severe disease, whereas advances in the treatment of mild-to-moderate disease have been limited.

Acne is a common chronic disease that typically requires prolonged treatment. Several small studies conducted over the past few years suggest that adherence to acne medications is often poor. In addition, data regarding the factors that positively or negatively impact adherence in patients with acne are sparse. This study utilized a simple, validated questionnaire (ECOB, Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux) to assess the risk of poor adherence in a large worldwide cohort of acne patients (n = 3339) from three major geographic regions [the Americas (n = 952), Europe (n = 1196), and Asia (n = 1191). In addition, information about patient and treatment characteristics was collected to identify factors that correlated with adherence. Overall, there was a poor adherence rate of 50% in this study; this varied by region, with significantly worse adherence in Europe versus Asia and America (poor adherence rates of 58%, 48%, and 43%, respectively, P < 0.0001). To provide insight into factors that affect medication-taking behavior in acne, adherence was analyzed by the type of treatment (a combination of topical and systemic, topical only, oral isotretinoin). Among patients taking a combination of both systemic and topical therapy, 60% (n = 944) of patients had poor adherence to at least one treatment as defined in the study protocol. In this group, there was a higher proportion of patients who had poor adherence to systemic treatment versus topical treatment (54% vs. 44%, respectively). Among patients treated with topical therapy only, poor adherence occurred in 40% (n = 356) of cases. A total of 46% (n = 325) of patients using oral isotretinoin therapy had poor adherence. Multivariate analysis showed that poor adherence was independently correlated with young age (most strongly with

SUMMARY A combination of alkali treatment and proteinase K digestion was used to solubilize nail samples from patients with onychomycosis treated orally with terbinafine. The samples were extracted and the levels of terbinafine and its metabolite measured by high-pressure liquid chromatography. The results showed a relatively rapid penetration of terbinafine into normal nail plate, suggesting that diffusion via the nail plate is the primary route of entry into this tissue. The levels of terbinafine achieved in nail samples exceeded the range of MICs for dermatophytes at the earliest time point (4 weeks) tested in 50% of patients and remained stable, without accumulation, during periods of treatment of up to 3 months.

The main areas of importance in the selection of acne therapy include efficacy, tolerability, acceptance and potential compliance. Adapalene has been shown to be highly effective, with clinical advantages as compared to tretinoin. Of importance is the superiority of adapalene in onset of effect, which can have a positive impact on overall patient compliance and ultimate efficacy. Adapalene has also been shown to be highly acceptable and tolerable, which also contributes to patient compliance. ( J Dermatol Treat (2000) 11 (Suppl 2): S9-S12)

The Dermatitis Family Impact (DFI) questionnaire is a disease-specific measure to assess the impact of atopic eczema on the quality of life (QoL) of the parents and family members of affected children. We set out to review the published literature and to collate data on the clinical and psychometric aspects of the DFI questionnaire from its development in 1998-2012, in order to create a single source of reference for users of the DFI. A literature search was performed of publications, including abstracts, describing the use of the DFI between 1998 and 2012. In total, we identified 53 publications (37 full articles and 16 abstracts) describing the use of the DFI in 50 studies. Only one study demonstrated test-retest reliability (r = 0 . 95). Three studies demonstrated internal consistency, with Cronbach α ranging from 0.85 to 0.90. Fifteen studies showed sensitivity to change of DFI scores, with significant differences between baseline and the end of the study. Twenty-six studies correlated the DFI to other objective and subjective instruments to demonstrate its construct (convergent) validity. Seventeen validated translations of the DFI have been used in 16 different countries (including two multinational studies). Nine clinical studies have assessed the effectiveness of five different topical drugs and one probiotic supplement. Two studies have assessed the effectiveness of care by dermatology nurses and dermatologists. The use of the DFI has revealed the major impact of atopic eczema on the QoL of families of affected children. The strengths of the DFI include wide international experience of its use, defined test-retest reliability, good internal consistency, sensitivity to change, and good construct (convergent) validity. Areas requiring further research include creation of validated score descriptors, assessment of minimum important clinical difference and testing of dimensionality, factor structure and differential item functioning.

Chronic diseases can severely impair patients' quality of life but little information is available about the long-term impact of chronic diseases. The chronic nature of disease may decrease patients' psychosocial well-being, may change their attitude towards life goals and influence major life-changing decisions (MLCDs). Understanding of the impact on MLCDs is largely missing from health outcomes research. It is potentially important in the assessment of the overall burden and cumulative impact of chronic disease. This chapter reviews the concepts of life events, life transition, life goals concepts and what constitutes a long-term impact, essential background to this area. We also describe the relationship of the concept of MLCD with the concept of cumulative life course impairment. Chronic disease has long-term impact on patients' lives, particularly by influencing MLCDs related to career, job, relationships, education, having children and early retirement. We describe qualitative research carried out in Cardiff that has sought to give more detailed insight into what decisions constitute MLCDs, in patients both from dermatology and from several general medical disciplines. We have also proposed the MLCD Profile to measure the number of MLCDs that an individual patient may have experienced as being influenced by chronic disease. Adding the domain of MLCDs to how we think about the burden of disease experienced by an individual, could broaden understanding of the true extent of disease impact.

Cherry angiomas (Campbell de Morgan spots) are common acquired red skin papules composed of dilated capillary loops, usually of unknown aetiology. Extragenital lichen sclerosus (LS) presents as porcelain-white scaly atrophic lesions with or without genital involvement. We report two cases of segmental multiple cherry angiomas in association with extragenital LS. Two unrelated women, aged 46 and 66 years, presented with extragenital LS affecting their axillae and lower abdomen. During the examination, both patients were noted to have several hundred red skin papules in a segmental distribution, affecting the left thigh and flank of one woman, and the right abdomen and back of the other. Clinically and histologically, the papules were consistent with cherry angiomas. The striking segmental distribution of multiple cherry angiomas may be due to genetic mosaicism; however, segmental Fabry disease was excluded by sequence analysis of the α-galactosidase A gene. Any causal link between cherry angiomas and LS remains uncertain.

Congenital erythropoietic porphyria (CEP) is an autosomal recessive photomutilating porphyria with onset usually in childhood, where haematological complications determine prognosis. Due to its extreme rarity and clinical heterogeneity, management decisions in CEP are often difficult.To develop a management algorithm for patients with CEP based on data from carefully characterized historical cases.A single investigator collated data related to treatments and their outcomes in 29 patients with CEP from the U.K., France, Germany and Switzerland.Six children were treated with bone marrow transplantation (BMT); five have remained symptomatically cured up to 11.5 years post-transplantation. Treatments such as oral charcoal, splenectomy and chronic hypertransfusion were either of no benefit or were associated with complications and negative impact on health-related quality of life. Lack of consistent genotype-phenotype correlation meant that this could not be used to predict disease prognosis. The main poor prognostic factors were early age of disease onset and severity of haematological manifestations.A management algorithm is proposed where every patient, irrespective of disease severity at presentation, should receive a comprehensive, multidisciplinary clinical assessment and should then be reviewed at intervals based on their predicted prognosis, and the rate of onset of complications. A BMT should be considered in those with progressive, symptomatic haemolytic anaemia and/or thrombocytopenia. Uroporphyrinogen III synthase genotypes associated with poor prognosis would additionally justify consideration for a BMT. Rigorous photoprotection of the skin and eyes from visible light is essential in all patients.

In order to plan optimum drug regimens for the treatment of onychomycosis with terbinafine, it is necessary to have information concerning the pharmacokinetics of terbinafine in the nail plate. A group of 24 patients with mycology culture-positive onychomycosis took 125, 250 or 500 mg terbinafine once daily for 16 weeks in a double-blind parallel-group study. Distal nail clippings, proximal nail samples and blood samples were taken at frequent intervals during therapy and during a follow-up of up to 36 weeks. Of the 24 patients, 17 completed the study. There was an apparent dose response with regard to concentration of terbinafine and its main metabolite demethylterbinafine in the distal and proximal part of affected nails as well as in plasma. The length of time during which terbinafine could be detected after stopping treatment increased with increasing dosage. The results suggest that short-term therapy with the higher dosage regimens is likely to have a higher efficacy rate.

Clinical decision making in dermatology is a complex process and might be influenced by a wide range of nonclinical factors.The aim of this study was to explore the role of nonclinical influences, beyond diagnosis and severity, on clinical decision making in dermatology.Semi-structured qualitative interviews were conducted with 46 clinicians working in departments of dermatology of nine different hospitals in Wales. Interviews were audio-recorded and later transcribed and their contents analysed.Nonclinical factors influencing patient management decisions in dermatology that were identified related to patients, clinicians and practice characteristics. Patient-related factors included place of residence, socioeconomic circumstances, education and intelligence, ethnicity, age, treatment adherence, expectations from treatment, quality of life, concerns and worries, difficult patients, and family members or friends. Clinician-related factors included time constraints in clinic, clinicians' personal circumstances, relationship with colleagues, and relationship with pharmaceutical companies. Practice-related factors included working in private practice, cost of treatment to the National Health Service (NHS), prescribing bureaucracy, and availability of treatment service in the work place. There was a difference between the consultants' views and those of the other clinicians over the impact of pharmaceutical companies on clinicians' prescribing and the awareness of treatment costs to the NHS. Most of the factors identified could potentially influence the clinicians' decision-making process subconsciously. Some clinicians highlighted that these factors are untaught in the medical curriculum, and are usually ignored in clinical guidelines, and therefore represent a challenge to the practice of evidence-based medicine.This study has described one aspect of the reality of medical decision making beyond the conventional evidence-based guidelines approach. Proper understanding of nonclinical influences on decision making is of paramount importance for the best patient-centred treatment outcomes.

Background In 2006 a U.K. government White Paper recommended making NHS care in England more accessible by shifting services from secondary care into community settings. There is a shortage of contemporary activity data for U.K. dermatology units to allow benchmarking for service development. This study will not only provide useful comparative data for the future in Wales, but will also serve to highlight the impact of changes made in England. Objective To provide an overview of 1 week's dermatology outpatient activity for the whole of Wales. Methods All dermatology units in Wales collected data for 1 week in early 2007. The case mix, appropriateness of referral, requirement for surgery or second-line therapies and follow-up requirements were all determined. Results A total of 2142 patients were seen. Of new patients, 21% had skin cancer. Seventeen per cent of skin cancers had no diagnosis suggested by the general practitioner (GP) and 10% of basal cell carcinomas, 33% of squamous cell carcinomas and 17% of malignant melanomas were inappropriately diagnosed. In all, 26% of new patients had benign lesions, and this group caused the greatest diagnostic difficulty for GPs. Seventy-one per cent of these patients were diagnosed, reassured and discharged at their first visit without the need for biopsy or surgery. Thirty-seven per cent of new patients required surgery, of which 21% required complex intervention. Twenty-six per cent of follow-up patients were receiving second-line therapies. The new to follow-up ratio varied considerably according to diagnosis, the mean ratio being 1 : 0.21 for benign lesions through to 1 : 5.53 for psoriasis. This highlights the inappropriate nature of a 'one fits all' ratio. The majority of follow-up patients in secondary care required this level of input for monitoring of cancer, complex second-line therapies or surgery. Conclusions This study provides evidence to support logical planning of dermatological services and to assess the impact of proposed changes on different healthcare systems in the U.K.

There is little information concerning how much health-related quality-of-life (HRQoL) information is elicited in dermatology outpatient consultations.To observe and record ad hoc HRQoL discussion in inflammatory skin disease consultations, to systematically measure the patient's HRQoL and to measure patient satisfaction with dermatology care.Clinic consultations of patients with inflammatory skin conditions attending a secondary care clinic were observed by a single researcher (CP). Data were collected on the 10 subject areas of the Dermatology Life Quality Index (DLQI) and on sleep, burden, frustration and depression. Patients were sent the DLQI and Medical Interview Satisfaction Scale (MISS)-21 questionnaires after the consultation.In total, 100 consultations were observed (psoriasis n = 50, eczema n = 17, acne n = 13 and others n = 20). In 26% (n = 26), there was no mention of HRQoL issues. In 59% (n = 44), HRQoL discussions were initiated by the clinician. In only 26% (n = 19) of consultations wereor = 3 items on the observer's checklist raised. In all, 57 evaluable DLQI and MISS-21 questionnaires were returned. The mean +/- SD DLQI score was 7.2 +/- 7.0 (n = 18) for patients with whom there was no HRQoL discussion and 10.8 +/- 6.7 (n = 39, P = 0.038) for those with whom HRQoL was discussed. The mean +/- SD MISS-21 score was 108.8 +/- 16.5 (n = 18) for the patients with whom there was no HRQoL discussion and 111.3 +/- 13.6 (n = 39, P = 0.42) for those with whom HRQoL was discussed. The mean +/- SD patient expectation score was 5.5 +/- 1.0 (median 5, range 3-7). There was a positive correlation between the patient expectation and MISS-21 scores (r(s) = 0.815, P0.0001).Despite little extent or depth to HRQoL discussion, HRQoL issues were raised in the majority of inflammatory skin disease consultations. The consultations usually met the patients' expectations and most patients were satisfied.