Online Care Versus In-Person Care for Improving Quality of Life in Psoriasis: A Randomized Controlled Equivalency Trial.
ABSTRACT: This 12-month, pragmatic, randomized controlled equivalency trial evaluated whether an online, collaborative connected-health model results in equivalent improvements in quality of life compared with in-person care for psoriasis. Overall, 296 adults with physician-diagnosed psoriasis from ambulatory clinics were randomly assigned to either online or in-person care; all were analyzed for outcomes. In the online group, patients and primary care providers sought dermatologists' care directly and asynchronously online. The in-person group sought care face to face. Interventions did not allow blinding of participants; investigators were blinded during analysis. Across 12 months, for the online group, the mean ± standard deviation decline in Skindex-16 from baseline across follow-up visits was 9.02 ± 20.67 compared with 10.55 ± 23.50 for the in-person group. The difference in Skindex-16 between the two groups was -0.83 (95% confidence interval = -5.18 to 3.51), and this was within the equivalence margin (±7.0). For the online group, the mean ± standard deviation decline in Dermatology Life Quality Index was 1.64 ± 4.34 compared with 1.18 ± 4.77 for the in-person group. The difference in Dermatology Life Quality Index between the two groups was -0.45 (95% confidence interval = -1.29 to 0.38) and was within the equivalence margin (±2.5). In conclusion, the online model was as effective as in-person care in improving quality of life among psoriasis patients. This study was funded by the Patient-Centered Outcomes Research Institute and is registered on clinicaltrials.gov (NCT02358135).
Project description:BACKGROUND:Previous research suggests that technology-enabled health care delivery may improve access to dermatologic specialty care. Outcomes research using validated outcomes measures is necessary for evaluation of novel health care delivery models. OBJECTIVE:We sought to compare the clinical equivalence of a novel patient-centered online health care delivery model with standard in-office care for follow-up treatment of patients with psoriasis. METHODS:A total of 64 participants with psoriasis were randomized to receive follow-up care either in-office or online over a 24-week period. Patients randomized to the online group underwent standardized training on capturing high-quality digital images of their psoriatic skin and transmitting these images and clinical history to a dermatologist securely. The dermatologist then performed asynchronous, online evaluation and provided recommendations directly to patients. We used clinically validated disease severity and quality-of-life measures to assess effectiveness between the models. RESULTS:Both online and in-office groups showed improvement in psoriasis disease severity as measured by mean improvement in Psoriasis Area and Severity Index (online group: mean = -3.4, in-office: mean = -3.4). Patient-centered online care resulted in similar improvement in psoriasis severity compared with in-person follow-up care (mean difference in Psoriasis Area and Severity Index change 0.1, 95% confidence interval -2.2 to 2.3, a priori equivalence margin of 2.5). Investigator Global Assessment and Dermatology Life Quality Index scores also improved during the study period; no significant differences existed between the two groups. LIMITATIONS:The follow-up period was limited to 24 weeks. CONCLUSION:A patient-centered online model may be an effective alternative to in-office care for follow-up management of psoriasis.
Project description:Importance:Innovative, online models of specialty-care delivery are critical to improving patient access and outcomes. Objective:To determine whether an online, collaborative connected-health model results in equivalent clinical improvements in psoriasis compared with in-person care. Design, Setting, and Participants:The Patient-Centered Outcomes Research Institute Psoriasis Teledermatology Trial is a 12-month, pragmatic, randomized clinical equivalency trial to evaluate the effect of an online model for psoriasis compared with in-person care. Participant recruitment and study visits took place at multicenter ambulatory clinics from February 2, 2015, to August 18, 2017. Participants were adults with psoriasis in Northern California, Southern California, and Colorado. The eligibility criteria were an age of 18 years or older, having physician-diagnosed psoriasis, access to the internet and a digital camera or mobile phone with a camera, and having a primary care physician. Analyses were on an intention-to-treat basis. Interventions:Participants were randomized 1:1 to receive online or in-person care (148 randomized to online care and 148 randomized to in-person care). The online model enabled patients and primary care physicians to access dermatologists online asynchronously. The dermatologists provided assessments, recommendations, education, and prescriptions online. The in-person group sought care in person. The frequency of online or in-person visits was determined by medical necessity. All participants were exposed to their respective interventions for 12 months. Main Outcomes and Measures:The prespecified primary outcome was the difference in improvement in the self-administered Psoriasis Area and Severity Index (PASI) score between the online and in-person groups. Prespecified secondary outcomes included body surface area (BSA) affected by psoriasis and the patient global assessment score. Results:Of the 296 randomized participants, 147 were women, 149 were men, 187 were white, and the mean (SD) age was 49 (14) years. The adjusted difference between the online and in-person groups in the mean change in the self-administered PASI score during the 12-month study period was -0.27 (95% CI, -0.85 to 0.31). The difference in the mean change in BSA affected by psoriasis between the 2 groups was -0.05% (95% CI, -1.58% to 1.48%). Between-group differences in the PASI score and BSA were within prespecified equivalence margins, which demonstrated equivalence between the 2 interventions. The difference in the mean change in the patient global assessment score between the 2 groups was -0.11 (95% CI, -0.32 to 0.10), which exceeded the equivalence margin, with the online group displaying greater improvement. Conclusions and Relevance:The online, collaborative connected-health model was as effective as in-person management in improving clinical outcomes among patients with psoriasis. Innovative telehealth delivery models that emphasize collaboration, quality, and efficiency can be transformative to improving patient-centered outcomes in chronic diseases. Trial Registration:ClinicalTrials.gov Identifier: NCT02358135.
Project description:BACKGROUND: Interest in health-related quality of life (HRQoL) outcome research in dermatology is increasing, especially in the systemic treatment of psoriasis with biologic agents. In other specialties, such as oncology, the application of a HRQoL intervention is considered to be an aid for monitoring disease and treatment over time, for the communication with the patient, and for improving treatment outcome. However, in dermatology practice, the application of this intervention is relatively new. Moreover, evidence on the effectiveness of a HRQoL intervention in dermatology is missing. It is hypothesized that the application of a HRQoL intervention in dermatology practice will have a positive impact on patients' HRQoL as well as on doctor-patient communication. METHODS/DESIGN: In a prospective multicenter cluster randomized controlled trial, patients diagnosed with moderate to severe psoriasis who receive biologic treatment, will be followed for 48 weeks. The study sites, and not the patients, will be randomly allocated via a computer-based randomization system to either the intervention (treatment with etanercept and standardized HRQoL assessment and communication) or the control group (treatment with etanercept alone). The HRQoL intervention will include 1) the electronic assessment of the Skindex-29, a well-studied dermatology-specific HRQoL questionnaire, and 2) the communication of the resulting Skindex-29 data with the patient. Prior to study start, dermatologists in the intervention group will be educated and trained in standardized HRQoL assessment and communication using the Skindex-29. At six consecutive visits, patients at study sites in the intervention group will be asked to complete the Skindex-29 on a desk-top pc at the clinic, just before their consultation with the dermatologist. A print-out of the completed questionnaire will be made and, guided by this print-out, feedback on the HRQoL scores will be given during the consultation. Primary outcome parameters are the impact of the HRQoL intervention on patients' HRQoL, and the effect of the HRQoL intervention on doctor-patient communication. Secondary outcomes include health status and disease severity. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR): NTR1364.
Project description:Although research on quality of life and dermatologic conditions is well represented in the literature, information on teledermatology's effect on quality of life is virtually absent.To determine the effect of store and forward teledermatology on quality of life.Two-site, parallel-group, superiority randomized controlled trial.Dermatology clinics and affiliated sites of primary care at 2 US Department of Veterans Affairs medical facilities.Patients being referred to a dermatology clinic were randomly assigned, stratified by site, to teledermatology or the conventional consultation process. Among the 392 patients who met the inclusion criteria and were randomized, 326 completed the allocated intervention and were included in the analysis.Store and forward teledermatology (digital images and a standardized history) or conventional text-based consultation processes were used to manage the dermatology consultations. Patients were followed up for 9 months.The primary end point was change in Skindex-16 scores, a skin-specific quality-of-life instrument, between baseline and 9 months. A secondary end point was change in Skindex-16 scores between baseline and 3 months.Patients in both randomization groups demonstrated a clinically significant improvement in Skindex-16 scores between baseline and 9 months with no significant difference by randomization group (P = .66, composite score). No significant difference in Skindex-16 scores by randomization group between baseline and 3 months was found (P = .39, composite score).Compared with the conventional consultation process, store and forward teledermatology did not result in a statistically significant difference in skin-related quality of life at 3 or 9 months after referral.clinicaltrials.gov Identifier: NCT00488293.
Project description:<b>Background: </b>Psoriasis is a multifactorial inflammatory disease prevalent in dermatology. We aimed to understand the perceptions of patients living with psoriasis in relation to their quality of life and to identify aspects to improve it.<br><br><b>Methods: </b>This is qualitative research carried out in a dermatology outpatient clinic of the São Paulo State University (UNESP) medical school, Botucatu, Brazil, with 81 psoriasis patients. The interviews were transcribed and analysed using the Discourse of the Collective Subject method (DCS).<br><br><b>Results: </b>Quality of life was linked to well-being, happiness, leisure, good food and financial stability. However, disease symptoms, social and clothing restrictions, impairment of professional activities and the absence of a cure, negatively influenced their perceptions. Suggestions for improvements included an increase of public awareness, stress reduction, disease acceptance and multidisciplinary care.<br><br><b>Conclusion: </b>The meanings of quality of life revealed by the participants are subjective, multidimensional, linked to moments experienced by them and to the health-disease process. Public health policies promoting reduction in social stigma and stress as well as multidisciplinary approaches towards care can contribute to improvements of QoL in psoriasis.
Project description:The aim of this study was to assess the psychometric properties of the Brazilian version of Skindex-16 in patients with various skin diseases.Dermatologic assessments were performed for the diagnosis and classification of the severity of skin conditions. The clinical feasibility of Skindex-16 was assessed based on the time required to complete the questionnaire and the number of unanswered items. The participants (n = 110) answered the Hospital Anxiety and Depression Scale (HADS), the Dermatology Life Quality Index (DLQI) and the Skindex-16 (Portuguese/Brazil version) questionnaires. Convergent validity was assessed based on the correlation of the Skindex-16 with the DLQI and HADS subscales. Known-groups validity was assessed based on the comparison of the mild, moderate and severe disease groups using the Kruskal-Wallis test. Internal consistency was assessed using Cronbach's alpha and test-retest reproducibility using the intraclass correlation coefficient (ICC) obtained with 29 participants who answered the Skindex-16 a second time 3 to 10 days after the first assessment.The mean time to answer the questionnaire was 2 min 41 sec. Cronbach's alpha scores were 0.867, 0.930 and 0.888 for the Skindex-16 domains symptoms, emotions and functioning, respectively. The ICCs were 0.947, 0.860 and 0.843 for the Skindex-16 domains symptoms, emotions and functioning, respectively. All three Skindex-16 scales exhibited strong correlations with DLQI. Moderate correlations were found between HADS subscales and the Skindex-16 emotions domain. Known-groups validity showed differences in all three Skindex-16 domains between the mild and moderate skin disease groups (emotions: p < 0.001; symptoms: p = 0.049; functioning: p < 0.001) and between the mild and severe skin disease groups (emotions: p = 0.002; symptoms: p = 0.001; functioning: p = 0.002).The Portuguese/Brazil version of Skindex-16 is a valid and reliable instrument to assess the quality of life of patients with skin diseases.
Project description:BACKGROUND:Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin disease characterized by painful inflamed nodules, recurrent abscesses and fistulas located in apocrine gland-bearing body sites. The negative impact of HS on patient's quality of life (QoL) has been reported to be greater than other dermatologic conditions as psoriasis and atopic eczema, and its improvement is an important goal in disease management. Nowadays, there are no specific validated QoL instruments available for HS and generic dermatologic questionnaires are used. OBJECTIVE:The objective of this study was to demonstrate the validity, reliability and responsiveness of HIDRAdisk, a new innovative tool designed for rapid assessment of HS burden and, at the same time, an intuitive graphic visualization of the measurement outcome. METHODS:A multicentre, longitudinal, observational study was conducted to validate the HIDRAdisk compared with other validated questionnaires [Skindex-16, Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-General Health (WPAI:GH)] and to evaluate its correlation with disease severity in Italian patients with any degree of HS severity, as measured by Hurley stage and HS Physician Global Assessment (HS-PGA). RESULTS:A total of 140 patients (59% women; mean age 34.9 ± 11.0 years) were enrolled in 27 dermatologic centres. HIDRAdisk showed a strong correlation with Skindex-16 and DLQI, and a good one with WPAI:GH (correlation coefficient: 0.7568, 0.6651 and 0.5947, respectively) and a statistically significant correlation with both Hurley stage and HS-PGA. Very good internal consistency (Cronbach coefficient >0.80; intraclass correlation coefficient >0.6), with correlation between the 10 items, good test-retest reliability (Spearman correlation coefficient, 0.8331; P < 0.0001) and responsiveness to changes were demonstrated. CONCLUSION:Our study shows that HIDRAdisk, a short and innovative visual HS QoL instrument, has been psychometrically validated in Italian language and it may help improve the management of HS once implemented in routine clinical practice.
Project description:Several studies have suggested that an HLA-Cw6+ allele can predict an improved outcome of treatment in psoriasis patients. The aim of the study was to assess whether the published association between HLA-Cw6 allele carriers and response to ustekinumab has the potential to impact treatment decisions.Differences in Psoriasis Activity and Severity Index 50, 75, and 90; Nail Psoriasis Severity Index; and Dermatology Life Quality Index at 16 weeks were evaluated between HLA-Cw6 allele carriers vs. non-carriers. Thirty patients with moderate-to-severe psoriasis under treatment with ustekinumab were included in our study.There was no difference between the two groups with respect to Psoriasis Activity and Severity Index 50, 75, and 90 or in terms of change in Nail Psoriasis Severity Index or Dermatology Life Quality Index.In our retrospectively analyzed cohort, we could not detect the previously reported better response in HLA-Cw6+ vs. HLA-Cw6- patients.
Project description:Psoriasis symptoms have a significant negative impact on health-related quality of life, impairing physical functioning and well-being.To evaluate the impact of brodalumab, a human anti-interleukin-17R monoclonal antibody, on psoriasis symptom severity as measured by a novel patient-reported outcome measure, the Psoriasis Symptom Inventory, and dermatology-specific health-related quality of life as measured by the Dermatology Life Quality Index (DLQI).This was a secondary analysis of a phase II, randomized, double-blind, placebo-controlled clinical study of patients with moderate-to-severe psoriasis (n = 198) treated with brodalumab or placebo. This analysis assessed Psoriasis Symptom Inventory scores and DLQI scores over time. Analyses were conducted on all patients who were randomized and received one or more injections of the study drug according to intention to treat using last observation carried forward to impute missing data.At week 12, subjects in the brodalumab groups had significant improvements in mean Psoriasis Symptom Inventory total scores [8.5 (70 mg), 15.8 (140 mg), 16.2 (210 mg) and 12.7 (280 mg)] compared with placebo (4.8). Mean improvements in DLQI were clinically meaningful (? 5.7) in the brodalumab groups (6.2, 9.1, 9.6 and 7.1, respectively) and significantly greater than placebo (3.1). Improvements in Psoriasis Symptom Inventory were observed as early as week 2 and in DLQI by week 4. All eight Psoriasis Symptom Inventory item scores improved significantly among the brodalumab groups by week 12.Results were from a single randomized clinical trial and may not generalize to broader patient populations. However, treatment with brodalumab provided significant improvement in psoriasis symptoms in patients with moderate-to-severe psoriasis.
Project description:Achieving a satisfying quality of life for a patient by applying individually matched therapy is, simultaneously, a great challenge and a priority for contemporary medicine. Patients with visible dermatological ailments are particularly susceptible to reduction in the general quality of life. Among the dermatological diseases, acne causes considerable reduction in the quality of life and changes in self-perception that lead to the worsening of a patient's mental condition, including depression and suicidal thoughts. As a result, difficulties in contact with loved ones, as well as social and professional problems are observed, which show that acne is not a somatic problem alone. To a large extent, it becomes a part of psychodermatology, becoming an important topic of public health in social medicine practice. Pharmacological treatment of acne is a challenge for a dermatologist and often requires the necessity of cooperating with a cosmetologist. Cosmetological treatments are aimed at improving the condition of the skin and reduction or subsiding of acne skin changes.The aim of this study was to assess the influence of selected cosmetological treatments on the general quality of life of patients with acne.The study group consisted of 101 women aged 19-29 years ([Formula: see text] years, SD =2.3 years). All subjects were diagnosed with acne vulgaris of the face. In the study group, the acne changes occurred over the course of 3-15 years ([Formula: see text] years, SD =2.7 years). Selected cosmetological treatments (intensive pulsing light, alpha-hydroxy acids, cavitation peeling, needle-free mesotherapy, diamond microdermabrasion and sonophoresis) were performed in series in the number depending on the particular patient's chosen treatment, after excluding contraindications. General quality of life of the patients was estimated using the Skindex-29 and Dermatology Life Quality Index (DLQI) questionnaires, before and after the cosmetological treatment.Statistical analysis of the data obtained from the Skindex-29 questionnaire in areas (emotions, symptoms and physical functioning) and DLQI questionnaire in areas (daily activities, leisure, work and school, personal relations and treatment) showed great improvement in the general quality of life after applying a series of cosmetological treatments. The results are statistically relevant at P<0.0001.The cosmetological treatment significantly improved the general quality of life of patients with acne vulgaris and their skin condition, which was evaluated by the Hellgren-Vincent scale. It was proven that therapy performed in cosmetological clinics may become an integral part of or complete dermatological treatment.