Factors associated with treatment satisfaction in patients with hidradenitis suppurativa: results from the Global VOICE project.

BACKGROUND: Nearly half of patients with hidradenitis suppurativa (HS) report dissatisfaction with their treatment. However, factors related to treatment satisfaction have not been explored. OBJECTIVES: To measure associations between treatment satisfaction and clinical and treatment-related characteristics among patients with HS. METHODS: Treatment satisfaction was evaluated utilizing data from a cross-sectional global survey of patients with HS recruited from 27 institutions, mainly HS referral centres, in 14 different countries from October 2017 to July 2018. The primary outcome was patients' self-reported overall satisfaction with their current treatments for HS, rated on a five-point scale from 'very dissatisfied' to 'very satisfied'. RESULTS: The final analysis cohort comprised 1418 patients with HS, most of whom were European (55%, 780 of 1418) or North American (38%, 542 of 1418), and female (85%, 1210 of 1418). Overall, 45% (640 of 1418) of participants were either dissatisfied or very dissatisfied with their current medical treatment. In adjusted analysis, patients primarily treated by a dermatologist for HS had 1·99 [95% confidence interval (CI) 1·62-2·44, P < 0·001] times the odds of being satisfied with current treatment than participants not primarily treated by a dermatologist. Treatment with biologics was associated with higher satisfaction [odds ratio (OR) 2·36, 95% CI 1·74-3·19, P < 0·001] relative to treatment with nonbiologic systemic medications. Factors associated with lower treatment satisfaction included smoking (OR 0·78, 95% CI 0·62-0·99; active vs. never), depression (OR 0·69, 95% CI 0·54-0·87), increasing number of comorbidities (OR 0·88 per comorbidity, 95% CI 0·81-0·96) and increasing flare frequency. CONCLUSIONS: There are several factors that appear to positively influence satisfaction with treatment among patients with HS, including treatment by a dermatologist and treatment with a biologic medication. Factors that appear to lower treatment satisfaction include active smoking, depression, accumulation of comorbid conditions and increasing flare frequency. Awareness of these factors may support partnered decision making with the goal of improving treatment outcomes. What is already known about this topic? Nearly half of patients with hidradenitis suppurativa report dissatisfaction with their treatments. What does this study add? Satisfaction with treatment is increased by receiving care from a dermatologist and treatment with biologics. Satisfaction with treatment is decreased by tobacco smoking, accumulation of comorbid conditions including depression, and higher flare frequency. What are the clinical implications of this work? Awareness of the identified factors associated with poor treatment satisfaction may support partnered decision making and improve treatment outcomes.

Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project.

BACKGROUND: A needs assessment for patients with hidradenitis suppurativa (HS) will support advancements in multidisciplinary care, treatment, research, advocacy, and philanthropy. OBJECTIVE: To evaluate unmet needs from the perspective of HS patients. METHODS: Prospective multinational survey of patients between October 2017 and July 2018. RESULTS: Before receiving a formal HS diagnosis, 63.7% (n = 827) of patients visited a physician ≥5 times. Mean delay in diagnosis was 10.2 ± 8.9 years. Patients experienced flare daily, weekly, or monthly in 23.0%, 29.8%, and 31.1%, respectively. Most (61.4% [n = 798]) rated recent HS-related pain as moderate or higher, and 4.5% described recent pain to be the worst possible. Access to dermatology was rated as difficult by 37.0% (n = 481). Patients reported visiting the emergency department and hospital ≥5 times for symptoms in 18.3% and 12.5%, respectively. An extreme impact on life was reported by 43.3% (n = 563), and 14.5% were disabled due to disease. Patients reported a high frequency of comorbidities, most commonly mood disorders. Patients were dissatisfied with medical or procedural treatments in 45.9% and 34.6%, respectively. LIMITATIONS: Data were self-reported. Patients with more severe disease may have been selected. CONCLUSION: HS patients have identified several critical unmet needs that will require stakeholder collaboration to meaningfully address.

Development of HiSQOL: A Hidradenitis Suppurativa-Specific Quality of Life Instrument.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic and painful skin disease. In addition, HS lesions may be associated with pus and odour, potentially leading to significant stigma and, consequently, greatly affected quality of life (QOL). QOL is a multidimensional construct, which can be measured in various ways. However, generic or dermatologic QOL measures may not capture changes in QOL particularly affected in HS. Accordingly, patients and experts included in the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) agreed that future clinical HS trials should measure HS-specific QOL. OBJECTIVES: To develop an HS-specific QOL instrument (HiSQOL, Hidradenitis Suppurativa Quality of life). METHOD: The initial phases of the questionnaire development, described in this study, included item generation by patient interviews, development of a pilot questionnaire, questionnaire refinement, and pilot testing. RESULTS: For item generation, 21 patients were interviewed individually or in focus groups. Analysis of the interviews identified 105 candidate items and, next, a pilot questionnaire was developed. Finally, item reduction and two rounds of pilot testing resulted in a 23-item questionnaire representing physical, psychological, and social QOL dimensions. CONCLUSIONS: We have comprehensively explored on HS's possible effect on the QOL of the affected individuals and identified a 23-item HS-specific QOL questionnaire. The questionnaire proved to be feasible, acceptable, and comprehensible in the second round of pilot testing. With HiSQOL, researchers can measure HS-specific QOL in future clinical trials, potentially enabling them to discover more effective treatment options. It is envisaged, that after thorough validation in a trial setting, a streamlined version of HISQOL may also become available for clinical use in daily practice.

Swiss (German) Version of the Actinic Keratosis Quality of Life questionnaire.

BACKGROUND: Actinic keratosis (AK) is a sun-induced skin lesion that may progress to invasive squamous cell carcinoma of the skin. Recently, the Actinic Keratosis Quality of Life questionnaire (AKQoL) was designed for patients with AK in Denmark as a specific quality of life instrument for AK patients. OBJECTIVE: The objective of this study was to adapt the AKQoL for the German language region of Switzerland and to evaluate its psychometric properties (validity, reliability). METHODS: Translation and cultural adaptation of the questionnaire were assessed by using the technique of cognitive interviewing. During the translation process, 34 patients with AK from the Department of Dermatology, University Hospital Zurich, were interviewed in 3 sessions of cognitive interviewing. The translated questionnaire was then distributed together with the Dermatology Life Quality Index (DLQI) to a second group of 113 patients for validation and reliability testing. Within this group, we measured the internal consistency by the Cronbach coefficient α and Spearman correlation coefficient between the AKQoL and the DLQI. RESULTS: The problems encountered during the translation process led to changes in 5 categories as described by Epstein: stylistic changes, change in breadth, change in actual meaning, change in frequency and time frame, change in intensity. We found a Cronbach α of 0.82, an acceptable internal consistency. The Spearman correlation coefficient between total scores of AKQoL and DLQI was 0.57. CONCLUSION: We culturally adapted and validated a Swiss (German) version of the AKQoL questionnaire applicable for the population of a university center in Switzerland to measure and monitor the quality of life in patients with AK.

Association of Resilience With Depression and Health-Related Quality of Life for Patients With Hidradenitis Suppurativa.

Importance: Hidradenitis suppurativa (HS) places a significant burden on the health-related quality of life (HRQOL) of patients, many of whom have depression. Resilience can play a role in mitigating the negative stressors, such as the symptoms of HS, on patients' mental health. Objective: To investigate the correlation among resilience, depression, and HRQOL for patients with HS. Design, Setting, and Participants: This cross-sectional survey study of 154 patients from 2 referral centers in the United States and in Denmark was conducted from June 1, 2016, to March 31, 2017. Patients were considered eligible if they were 18 years or older and had a visit for HS at 1 of the 2 referral centers in the past 2 years (from January 1, 2014, through December 31, 2016). Patients were excluded if they declined to participate, could not read or write in English or Danish, or had a cognitive disability that would preclude their understanding of the survey questions. Main Outcomes and Measures: The survey instrument included 4 questionnaires: (1) a sociodemographic and clinical characteristics questionnaire, (2) the Brief Resilient Coping Scale, (3) the Hospital Anxiety and Depression Scale, and (4) the Dermatology Life Quality Index. The main outcome of interest was the HRQOL as measured by the Dermatology Life Quality Index. Results: All 154 patients submitted a completed survey. The mean (SD) age of the participants was 40.93 (13.5) years; most participants were women (130 [84.4%]), and most participants self-identified as white (139 [90.2%]). The rate of depression among the patients in this study was comparable to those reported in previous studies; 55 patients (35.7%) were classified as having depression, and 32 patients (20.8%) had borderline depressive symptoms. Patient-rated HS severity and the depression score each independently estimated 27% and 10% of variation in HRQOL, respectively. The interaction term for resilience and depression was significant, indicating that resilience moderates depression. Analysis of the mediation effects of resilience was not significant, indicating that resilience did not mediate the association between depressive symptoms and HRQOL. The resilience score was significantly associated with depressive symptoms (regression coefficient a = -0.21; P < .001), and the depressive symptoms score (c = 0.637; P < .001) was significantly associated with lower HRQOL (c' = 0.644; P < .001). However, both the direct association (b = 0.033; P = .86) and the indirect association (a × b = 0.007; P = .87) of resilience with HRQOL were not significant. Conclusions and Relevance: Patients with higher resilience levels experienced a smaller decrease in HRQOL as depressive symptoms increased. Because the findings suggest that resilience can be taught, there is an opportunity to develop a resiliency training program and investigate its role in stress levels and depressive symptoms, as well as in HRQOL and disease activity.

[Diagnosis and treatment of hidradenitis suppurativa].

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease defined by recurrent nodules, tunnels and scarring involving the intertriginous regions. Although patients with HS present a distinct symptomatology with a subsequent impairment of quality of life, an overall diagnostic time of seven years has been reported. A better and broader understanding of this disease may potentially reduce the diagnostic delay. This review provides an updated overview of diagnosis, monitoring tools as well as early treatment interventions.

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes.

INTRODUCTION: Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS. METHOD AND ANALYSIS: An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation. ETHICS AND DISSEMINATION: The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted.

Differences in Disease-specific Quality of Life in Patients with Actinic Keratosis in Australia and Denmark.

Actinic keratosis (AK) negatively influences patient quality of life as measured by the disease-specific Actinic Keratosis Quality of Life (AKQoL) questionnaire. The quality of life in Australian patients was significantly less affected than in Danish patients. We hypothesize that general factors such as public awareness and cultural connotations of AK, may influence the impact of AK on quality of life (QoL).

Patients' perspectives on actinic keratosis.

Many factors influence patients' perspectives on actinic keratosis (AK). The wish to keep a sense of control prompts many to seek information, which they then interpret according to their personal perspective. Speculations regarding the risk of getting skin cancer and emotional reactions may be expected due to worries about the worsening of the condition, losing control, and participating in UV-related activities. In their contact with physicians, treatment can be an additional issue. Treatment of AK may cause pain and may in itself result in a perceived diminished quality of life. The Actinic Keratosis Quality of Life questionnaire can be used as a valuable tool to represent the effects of treatment on quality of life and to classify patient subpopulations. Studies have suggested that AK patients are more compliant compared to those with other skin diseases. Still fear of stigmatisation may be present during treatment, which may disturb social life. Social and personal factors are crucial to patients' coping strategies, and financial aspects may have an impact on advisable UV-related behaviours. Some AK patients may benefit from interventions to improve their stress response capacity. The clear causality of AK requires a change in behaviour, which is met by multi-conditioned resistance. The physician should be aware that patients might feign acceptance but justify continued UV exposure to themselves with a variety of arguments. Tanning is of great importance for the self-esteem of many AK patients, and tanning addiction should be considered.

Interpretation of the skin cancer quality of life score: a validated quality of life questionnaire for non-melanoma skin cancer.

BACKGROUND: Health-related quality of life (HRQoL) instruments are used increasingly. In order to assign clinical meaning to HRQoL scores, the interpretation of instruments is essential but lagging in dermatology. OBJECTIVE: To establish a clinical interpretation of the Skin Cancer Quality of Life questionnaire (SCQoL), a newly validated HRQoL instrument for patients with non-melanoma skin cancer (NMSC), using an anchor-based method, and to test the responsiveness. METHODS: Receiver-operating characteristic analysis was used to propose clinically meaningful cut-off scores for SCQoL including 101 patients with NMSC. RESULTS: The following bands were established: score 0-3 corresponds to no impairment, 4-6 corresponds to mild impairment, 7-10 to moderate impairment and 11-27 to severe impairment of HRQoL. Testing the responsiveness shows a moderate effect size and significantly lower scores only for the domain emotion and the global item. CONCLUSION: Using proposed clinical cut-off scores for SCQoL may help clinicians in their decision-making, help monitoring clinical improvement and classify patients just as e.g. the Dermatology Life Quality Index can.

Patients' perceptions of topical treatments of actinic keratosis.

OBJECTIVES: In recent years, a number of topical treatments suitable for field-directed therapy of actinic keratosis (AK) have been developed. Non-surgical treatment of AK however requires strict adherence by patients. Patients' views on the different possible topical treatments are therefore relevant to the choice of treatment. The aim of the study was to disclose the "silent perspectives" by focusing on user experiences and individual perspectives on topical treatment. MATERIALS AND METHODS: Telephone interviews and face-to-face interviews were conducted with patients having had treatment with one or more of the following: imiquimod 5%, diclofenac sodium gel 3%, 5-fluorouracil (5-FU) cream 5% or photodynamic therapy. RESULTS: 24 patients with AK were interviewed. Experiences of pain, discharging ulcers and efficiency of the treatment were of major importance. There was a general focus on appearance, social contacts and leisure time, although this appeared to be of lesser importance. Patients' perception of treatment instructions identified a risk of misunderstandings. CONCLUSION: Patients are primarily concerned with therapeutic efficiency. Pain and ulcers are central indicators, but appearance, social contacts and leisure time can also be considered as additional indicators of satisfaction. A firm focus on patient instruction is suggested.

Quality of life in non-melanoma skin cancer--the skin cancer quality of life (SCQoL) questionnaire.

BACKGROUND: Disease-specific quality of life (QoL) questionnaires are increasingly used to provide patient-reported out-come measures in both malignant and non-malignant disease. OBJECTIVE: To create, validate and test the psychometrics of the Skin Cancer Quality of Life (SCQoL), which was designed to measure health-related QoL in patients with non-melanoma skin cancer affecting any area and undergoing any therapy. METHODS AND MATERIALS: The SCQoL was developed in a stepwise approach. Three pilot studies (testing content and face validity) and psychometric testing (scale structure, reliability, domains and known-groups validity, concurrent and convergent validity) were conducted. Rasch analyses were performed on the final questionnaire. RESULTS: The initial 10-item questionnaire was reduced to 9 items following interviews and inter-item correlations. The nine item scale was confirmed by Item Response Theory (IRT) and internal consistency. Differential Item Functioning (DIF) was found for a single item, but the effect was small. CONCLUSION: The final 9-item SCQoL is unidimensional and consists of 3 domains covering function, emotions and control. Furthermore there is one single global item. The total score range from 0 to 27. Higher score denote a greater impairment of the QoL.

Psychosocial impact of hidradenitis suppurativa: a qualitative study.

Hidradenitis suppurativa influences patients' lives in many ways. It is therefore necessary to focus on the effects of the disease on daily life in order better to define patient-related outcomes in hidradenitis suppurativa studies. Interviews were conducted with 12 patients with hidradenitis suppurativa. Initial single interviews were followed by semi-structured and structured qualitative focus group interviews in order to improve the richness of the data and obtain in-depth understanding of the impact of the topics. Important topics were found to relate to aspects of interpersonal contact, especially in relation to smell and appearance, various emotional reactions, and feelings of lack of control. It was found that hidradenitis suppurativa has a great emotional impact on patients and promotes isolation due to fear of stigmatization. Shame and irritation are frequent and relate to smell, scars, itching and pain. Quality of life is adversely affected and professional support is needed.

Management of actinic keratosis patients: a qualitative study.

OBJECTIVES: In order to reinforce the appropriate UV-related behaviour of patients with actinic keratosis (AK), it is of importance to understand the underlying psychological aspects of having AK. MATERIALS AND METHODS: Open and systematic explorative interviews were conducted with 15 AK patients. Open, single interviews (n = 6) were made and summarized. Partly based on topics found by the single interviews, two qualitative group interviews (n = 7) with AK patients were performed. The topics of general importance were identified through analysis of the statements given at the group interviews. A third group interview (n = 2) was made to confirm the analytical results from the former interviews. RESULTS: Important topics for patients with AK were found to relate to the way to act in the sun (leisure time and outdoor work), a changed appearance, the seriousness of the AK diagnosis, control of the disease, and the sense of illness due to AK. Emotional reactions included worry, fear, irritation, doubt, guilt, and a relaxed attitude. CONCLUSION: It is suggested that the topics touched upon form psychological and pedagogical reference points for patient behaviour. Awareness of these topics is therefore recommended in the management of patient information related to AK.

Time spent on treatment (TSOT). An independent assessment of disease severity in atopic dermatitis.

INTRODUCTION: Time spent on treatment (TSOT) appears to reflect disease severity in pediatric patients with atopic dermatitis (AD). Our purpose was to examine the relationship between time spent on treatment and parental psychological parameters such as anxiety and depression. METHODS: TSOT was studied in a group of parents of patients with AD participating in an eczema school. TSOT included all types of topical treatment. In addition, dermatological life quality (the IDLQI questionnaire), depression (the MDI questionnaire), and anxiety (the STAI questionnaire) were assessed as well as the self-reported (by parent) disease severity, treatment effect, and confidence in treatment (VAS scales) using descriptive statistics, multiple linear regression, and rank correlations (Kendall's tau). RESULTS: TSOT was found to be significantly associated with parental age (older parents report lower TSOT) and IDLQI (low quality of life with high TSOT), whereas all the other parameters appeared redundant. Sex of the parent showed no effect on TSOT. CONCLUSION: Our data suggest that TSOT is not correlated with anxiety or depression. A positive independent correlation was found with general quality of life, offering mutual validation of the measures. The observations suggest that further investigation of TSOT as a surrogate measure of morbidity in AD may be of practical interest in order to develop an internationally comparable morbidity measure in AD.

Patient education and morbidity in atopic eczema.

Effective treatment of atopic eczema is dependent upon good management by the patients and parents. It is possible to encourage patients and improve their compliance through nurse consultation and Web-based information.