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1.
Clin Exp Dermatol ; 2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38733332

ABSTRACT

BACKGROUND: Early identification, diagnosis and symptom control of psoriatic arthritis (PsA) in patients with psoriasis remain unmet medical needs. OBJECTIVES: To compare the impact of disease and other characteristics between patients with psoriasis who screened positive for PsA using the Psoriasis Epidemiology Screening Tool (PEST) (screen-positive group) and patients who (i) have PsA (PsA group) or (ii) screened negative for PsA (screen-negative group). Also, to determine the proportion of patients at a patient-acceptable symptom state (PASS) in the screen-positive and PsA groups. METHODS: This was a cross-sectional analysis of the CorEvitas Psoriasis Registry. We included a convenience sample of patients with psoriasis from the screen-positive and PsA groups who completed the Psoriatic Arthritis Impact of Disease-12 (PsAID12), and a comparator screen-negative group who did not complete the PsAID12. We report descriptive summaries of demographics, comorbidities, psoriasis characteristics, patient-reported outcome measures and the proportion of patients at PASS (i.e. PsAID12 ≤ 4). RESULTS: The screen-positive, PsA and screen-negative groups included 369, 70 and 4724 patients, respectively. The screen-positive and PsA groups had a similar impact of disease, demographics, comorbidities and psoriasis characteristics (d < 0.337). Mean PsAID12 scores were 3.1 (SD 2.3) and 3.7 (SD 2.6) in the screen-positive and PsA groups, respectively. Compared with patients who screened negative for PsA, patients who screened positive exhibited higher rates of selected known predictors of PsA such as older age, longer psoriasis duration, nail disease and inverse psoriasis. The proportion of patients at PASS was 56% and 67% for the PsA and screen-positive groups, respectively. CONCLUSIONS: The similar profiles between screen-positive and PsA groups, in comparison with the screen-negative group, support observations of possible underdiagnosis of PsA and the increased impact of disease, especially musculoskeletal disease, among patients who screen positive for PsA. The high percentage of patients not at an acceptable symptom state in the PsA and screen-positive groups highlights the need to optimize care in PsA.

2.
J Drugs Dermatol ; 23(4): e118-e119, 2024 04 01.
Article in English | MEDLINE | ID: mdl-38564398

ABSTRACT

Interleukin (IL)-4-targeted therapies have revolutionized management of inflammatory dermatoses.


Subject(s)
Biological Products , Neoplasms , Psoriasis , Humans , Interleukin-4 , Neoplasms/drug therapy , Psoriasis/therapy , Biological Therapy
3.
Arch Dermatol Res ; 316(5): 125, 2024 Apr 18.
Article in English | MEDLINE | ID: mdl-38637431

ABSTRACT

Patients with autoimmune bullous diseases are at an increased risk of infection, both from the underlying skin disease and from immunosuppressive treatments. Limited information is available on vaccine beliefs and behaviors in dermatology patients and adults with autoimmune bullous diseases in particular. To understand vaccine decision making, identify perceived risks and benefits of vaccinations, and discuss individual experiences in patients with autoimmune bullous diseases in the United States. A qualitative study was performed utilizing semi-structured interviews, and analysis was conducted on NVivo. Patterns were identified in the coded data, and representative quotations were recorded for each major theme. Interviews were conducted between February 15, 2022 and September 15, 2022. Twenty patients with a diagnosis of bullous pemphigoid, mucous membrane pemphigoid, pemphigus vulgaris, or pemphigus foliaceous were interviewed. Of the 20 participants, 14 (70%) were female, with a mean (SD, range) age of 64.8 (13.2, 34-83) years. Key themes that emerged from qualitative analysis of the interviews included patient concerns regarding their increased susceptibility to infection, potential exacerbation of skin disease following vaccination, and the effect of immunosuppressive medications on humoral response to vaccines. Lack of appointment availability, difficulty accessing vaccines, and cost were commonly identified barriers to vaccination. These findings provide valuable knowledge for dermatologists in regard to providing counseling specific to patient concerns and to improve communication surrounding vaccination in the dermatology setting.


Subject(s)
Autoimmune Diseases , Pemphigoid, Bullous , Pemphigus , Vaccines , Adult , Humans , Female , Male , Decision Making
5.
JAMA Dermatol ; 160(5): 550-563, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38265774

ABSTRACT

Importance: Multiple patient-reported outcome measures (PROMs) for health-related quality of life (HRQL) exist for patients with psoriasis. Evidence for the content validity and other measurement properties of these PROMs is critical to determine which HRQL PROMs could be recommended for use. Objective: To systematically review the validity of HRQL-focused PROMs used in patients with psoriasis. Evidence Review: Using PubMed and Embase, full-text articles published in English or Spanish on development or validation studies for psoriasis-specific, dermatology-specific, or generic HRQL PROMs were included. Development studies included original development studies, even if not studied in psoriasis patients per Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations. If a study included multiple diagnoses, more than 50% of patients had to have psoriasis or psoriasis-specific subgroup analyses available. Data extraction and analysis followed the COSMIN guidelines. Two independent reviewers extracted and analyzed the data, including PROM characteristics, quality of measurement properties (structural validity, internal consistency, cross-cultural validity, reliability, measurement error, criterion validity, construct validity, and responsiveness), and level of evidence. PROMs were classified into 3 levels of recommendations: (1) PROM recommended for use; (2) PROM requires further validation; and (3) PROM not recommended for use. Findings: Overall, 97 articles were identified for extraction. This included 19 psoriasis-specific, 8 skin-specific, and 6 generic PROMs. According to COSMIN standards, most measures identified received a B recommendation for use, indicating their potential but requiring further validation. Only the Rasch reduced version of the Impact of Psoriasis Questionnaire (IPSO-11 Rasch) received an A recommendation for use given that it had sufficient content validity, structural validity, and internal consistency. Conclusions and Relevance: This study identified a significant lack of information concerning the quality of HRQL measures in psoriasis. This gap in knowledge can be attributed to the fact that traditional measures were developed using validation criteria that differ from the current standards in use. Consequently, additional validation studies in accordance with contemporary standards will be useful in aiding researchers and clinicians in determining the most suitable measure for assessing HRQL in patients with psoriasis.


Subject(s)
Patient Reported Outcome Measures , Psoriasis , Quality of Life , Psoriasis/psychology , Psoriasis/therapy , Humans , Reproducibility of Results
6.
Arch Dermatol Res ; 316(1): 36, 2023 Dec 12.
Article in English | MEDLINE | ID: mdl-38085346

ABSTRACT

Vaccination rates among adults in the United States, including dermatology patients, remain suboptimal. Previous research has concluded that outpatient specialty offices often have administrative and patient-related barriers to administering vaccines in their clinics, however, this has never been examined specifically in dermatology. This study aims to examine dermatologists' perspectives on vaccine education in dermatology clinics, identify facilitators and barriers to vaccine administration in dermatology clinics, and explore strategies to improve vaccination rates in dermatology patients. Virtual, semi-structured interviews were conducted with board-certified dermatologists to explore their perspectives on vaccines in dermatology clinic. The Consolidated Framework for Implementation Research was used to analyze the data. Participating dermatologists were 60% female (n = 9) and 40% male (n = 6) and had a median of 7 years of clinic experience (min-max: 3-39 years). Vaccine education emerged as one of the prominent themes during the interview with dermatologists, who emphasized the importance of comprehensive vaccine education for both healthcare providers and patients. Barriers identified encompassed patient hesitancy, lack of provider knowledge, resource limitations, and logistical challenges. Dermatologists proposed solutions such as standardized protocols, improved patient communication, enhanced coordination with other healthcare providers, and increased clinic resources. These results emphasize that dermatologists can play a crucial role in advocating for and addressing preventative care through vaccine implementation and provide a high-level framework to think about implementation. Additionally, this study highlights the need for comprehensive vaccine education, systematic implementation strategies, and organizational support within dermatology clinics to improve vaccine administration for patients.


Subject(s)
Dermatology , Vaccines , Adult , Humans , Male , United States , Female , Dermatologists , Vaccination , Health Personnel
7.
J Rheumatol ; 50(Suppl 2): 71-77, 2023 11.
Article in English | MEDLINE | ID: mdl-37527861

ABSTRACT

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) leadership congregated for a strategic planning meeting before the 2022 GRAPPA annual meeting in New York, USA. Meeting aims were to review GRAPPA's performance in relation to its 2016 goals and identify successes and areas for further improvement, identify key GRAPPA priorities and activities for the next 5 years, and explore committee structures to best support these aims.


Subject(s)
Arthritis, Psoriatic , Dermatology , Psoriasis , Rheumatology , Humans
8.
J Rheumatol ; 50(Suppl 2): 47-50, 2023 11.
Article in English | MEDLINE | ID: mdl-37453734

ABSTRACT

The International Dermatology Outcome Measures (IDEOM) organization presented an update on its progress related to patient-centered outcome measures for psoriasis (PsO) and psoriatic arthritis (PsA) at the 2022 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Musculoskeletal (MSK) Symptoms working group presented an update on the development of the IDEOM Musculoskeletal Questionnaire (IDEOM MSK-Q). The IDEOM MSK-Q is a patient-reported outcome measure intended to capture MSK symptoms and describe their intensity and impact on health-related quality of life in patients with psoriatic disease. IDEOM also presented the progress of the integration of the Psoriasis Epidemiology Screening Tool (PEST) and Psoriatic Arthritis Impact of Disease (PsAID) questionnaires into the Epic electronic health record system. This will allow for automated PsA screening and symptom measurement in the hopes of improving disease detection and treat-to-target strategies. The Treatment Satisfaction working group discussed the development of the DermSat-7, a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The DermSat-7 is currently being validated in a multicenter study of patients with PsO.


Subject(s)
Arthritis, Psoriatic , Dermatology , Psoriasis , Rheumatology , Humans , Arthritis, Psoriatic/diagnosis , Quality of Life , Psoriasis/diagnosis , Outcome Assessment, Health Care
9.
J Rheumatol ; 2023 May 01.
Article in English | MEDLINE | ID: mdl-37127321

ABSTRACT

OBJECTIVE: The aim of this systematic review and metaanalysis is to summarize evidence regarding the relationship between psoriatic arthritis (PsA) and sleep problems. METHODS: We identified 36 eligible studies-26 cross-sectional, 7 cohort, and 3 interventional studies-in PubMed and Embase. RESULTS: The prevalence of self-reported sleep problems in patients with PsA ranged from 30% to 85%. A metaanalysis of 6 studies that used the Pittsburgh Sleep Quality Index revealed a prevalence of poor sleep quality for patients with PsA of 72.9% (95% CI 63-81.8; I2 = 78%), which was statistically higher than in healthy controls (26.9%, 95% CI 11.7-45.4; I2 = 81%) but not significantly different than in patients with psoriasis (59.8%, 95% CI 46.9-72.1; I2 = 51%). Sleep disturbance was ranked in the top 4 health-related quality of life domains affected by PsA. One study suggested a bidirectional relationship between PsA and obstructive sleep apnea. Predictors of sleep problems included anxiety, pain, erythrocyte sedimentation rate, depression, fatigue, physical function, and tender or swollen joint count. Tumor necrosis factor inhibitors, guselkumab, and filgotinib (a Janus kinase inhibitor) were associated with improved sleep outcomes. CONCLUSION: Poor sleep quality is prevalent in patients with PsA. Objective sleep measures (ie, actigraphy and polysomnography) have not been used in PsA studies, and evidence on the validity of patient-reported sleep measures in PsA is lacking. Future studies should validate self-reported sleep measures in PsA, explore how sleep quality relates to PsA disease activity and symptoms using both objective and subjective sleep measures, assess the efficacy of strategies to manage sleep problems, and assess the effects of such management on symptoms and disease signs in patients with PsA.

10.
Arch Dermatol Res ; 315(6): 1583-1592, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36749390

ABSTRACT

Having a chronic disease is one of the most consistent factors associated with vaccine uptake for adults in the general population, but vaccination beliefs and behaviors specific to those with chronic skin diseases have not been explored. The objective of this study was to explore factors associated with vaccine uptake and barriers to vaccination in adults with psoriasis and eczema. Virtual, video-based semi-structured interviews were performed with adults who self-reported a diagnosis of psoriasis or eczema. Interviews explored themes around healthcare decision making, perceived risks/benefits to vaccination, barriers, and vaccine knowledge. Thematic analysis was used to analyze the data. Of 34 study participants, 25 participants (74%) were females and 9 (26%) were males, with a mean age of 50.8 years (SD: 16.4, range: 24-71 yrs). Half of participants (n = 17) had psoriasis, and half (n = 17) had eczema. Participants recognized both personal and societal benefits to vaccines. Common vaccination barriers identified were access to appointments, concerns about side effects, and misinformation. Physicians, friends/family, and media, including internet resources, were health information resources identified by patients. These results summarize the unique patient perspective around vaccine uptake in adults with eczema and psoriasis and represent an important first step in a multi-pronged approach to improve vaccination rates in adults with chronic skin diseases.


Subject(s)
Eczema , Psoriasis , Skin Diseases , Vaccines , Adult , Female , Humans , Male , Middle Aged , Health Knowledge, Attitudes, Practice , Vaccination , Vaccines/adverse effects , Young Adult , Aged
11.
JAAD Int ; 10: 77-83, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36688102

ABSTRACT

Background: Alopecia areata (AA) is a disease of hair loss in which patients may benefit from comprehensive understanding of AA's disease process and therapeutic options during treatment decision-making. Objective: Determine factors influencing patients' AA treatment decision-making. Methods: Qualitative interviews were conducted using semi-structured interview guides. Interviews were coded using inductive thematic analysis. Results: Twenty-one participants with AA were interviewed. Coding interrater reliability was κ = 0.87-0.91, indicating strong-almost perfect agreement. Participants faced multiple barriers, including lack of access to health care (n = 10, 47.6%) and lack of transparency about their condition and treatment options (n = 9, 42.9%). Information about AA was sought from primarily the internet (n = 15, 71.4%) and physician recommendation (n = 15, 71.4%). When choosing AA treatments, patients often considered treatment efficacy (n = 21, 100%), safety (n = 21, 100%), and convenience of use (n = 20, 95.2%). Limitations: Referral and regional biases may be present and limit generalizability. Conclusions: Patients with AA face various challenges including medical uncertainty and lack of information. Patients need trustworthy and accessible sources of information regarding their treatment that also take into consideration their preferences and values.

12.
J Rheumatol ; 49(6 Suppl 1): 40-43, 2022 06.
Article in English | MEDLINE | ID: mdl-35365577

ABSTRACT

The International Dermatology Outcome Measures (IDEOM) initiative presented an update on their progress related to instruments for psoriasis (PsO) and psoriatic arthritis (PsA) patient-centered outcome measures at the 2021 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). The Treatment Satisfaction working group presented the development of a 7-item treatment satisfaction questionnaire specific for dermatological conditions. The group is beginning by assessing the validity and reliability of the instrument in PsO patient populations, with the ultimate goal of validating it for use in multiple dermatological diseases. The Musculoskeletal Symptoms working group discussed how implementation of a screening measurement tool in patients with PsO can help identify unknown diagnoses of PsA or prevent worsening of symptoms.


Subject(s)
Arthritis, Psoriatic , Dermatology , Psoriasis , Rheumatology , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/therapy , Humans , Psoriasis/diagnosis , Psoriasis/therapy , Reproducibility of Results , Skin
14.
J Nucl Cardiol ; 29(1): 37-42, 2022 Feb.
Article in English | MEDLINE | ID: mdl-32419071

ABSTRACT

BACKGROUND: Psoriasis is a common chronic inflammatory skin disorder that is associated with excess cardiovascular risk. Inflammation is a key mediator in the onset and progression of these cardiometabolic abnormalities; however, the excess cardiovascular risk conferred by psoriatic disease remains understudied. We investigated the prevalence and severity of CMD in patients with psoriasis and determined whether CMD is a result of CV risk factors and atherosclerotic burden. METHODS: This was a consecutive retrospective cohort study of patients with psoriasis, normal myocardial perfusion, and LV ejection fraction (EF) > 50% (N = 62) and matched controls without psoriasis (N = 112). Myocardial perfusion and myocardial flow reserve (MFR) were quantified using PET imaging. Atherosclerotic burden was determined by semi-quantitative computed tomography (CT) coronary calcium assessment. RESULTS: The prevalence of CMD (defined as MFR < 2) was 61.3% in patients with psoriatic disease, compared to 38.4% in a matched control population (P = .004). Furthermore, patients with psoriasis had a more severe reduction in adjusted MFR (2.3 ± .81 vs 1.92 ± .65, respectively, P = .001). The degree of atherosclerotic burden, as assessed by qualitative calcium score, was similar between psoriasis and controls. CONCLUSIONS: Patients with psoriasis without overt CAD demonstrated a high prevalence of coronary vasomotor abnormalities that are not entirely accounted for by the commonly associated coronary risk factors or the burden of atherosclerosis.


Subject(s)
Coronary Artery Disease , Myocardial Ischemia , Myocardial Perfusion Imaging , Psoriasis , Calcium , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/epidemiology , Coronary Circulation , Humans , Myocardial Perfusion Imaging/methods , Positron-Emission Tomography/methods , Psoriasis/complications , Psoriasis/diagnostic imaging , Psoriasis/epidemiology , Retrospective Studies
15.
Int J Dermatol ; 61(1): 84-88, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33998670

ABSTRACT

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory condition related to multiple systemic diseases and infections. METHODS: This retrospective cross-sectional study from 1999 to 2015 used the database of Clalit Health Services, the largest managed care organization in Israel, to explore the association between HS and hepatitis B and C. Sociodemographic and clinical information was compared using χ2 tests for sex and socioeconomic status and t-tests for age. Logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) to compare the odds of hepatitis B and C in those with and without HS. RESULTS: In multivariate analysis controlling for sex, age as a continuous variable, Arab ancestry, and history of drug abuse, HS was associated with a 1.87-fold increased odds (95% CI 1.11-3.17, P = 0.019) of hepatitis B (HBV). HS was also associated with HCV in multivariate analysis controlling for sex, age per year, Arab ancestry, alcohol use, and drug use, with a 1.74-fold increased odds (95% CI 1.05-2.89, P = 0.032) of hepatitis C (HCV) among those with HS as compared to controls. CONCLUSIONS: This study demonstrated an association between HS and both hepatitis B and hepatitis C.


Subject(s)
Hepatitis B , Hepatitis C , Hidradenitis Suppurativa , Cross-Sectional Studies , Hepatitis B/complications , Hepatitis B/epidemiology , Hepatitis C/complications , Hepatitis C/epidemiology , Hidradenitis Suppurativa/complications , Hidradenitis Suppurativa/epidemiology , Humans , Retrospective Studies
16.
J Am Acad Dermatol ; 87(5): 1075-1080, 2022 11.
Article in English | MEDLINE | ID: mdl-34098000

ABSTRACT

The problem of suboptimal treatment adherence among patients with dermatologic or other diseases has not been adequately addressed in health care. Despite a wide range of efficacious therapies, nonadherence remains a primary driver of suboptimal clinical outcomes. Novel solutions to address this unmet need can be found in behavioral economics. By leveraging our understanding of human decision-making, we may better promote treatment adherence, thereby improving quality of life and decreasing economic burdens. Behavioral economics has been studied extensively in relation to topics such as health policy and health behaviors; however, there is a dearth of research applying this approach to chronic diseases and only a handful within dermatology. We conducted a scoping review in PubMed to identify articles that discuss behavioral economics and its application to treatment adherence in dermatologic patients, with a particular focus on psoriasis, followed by a summary of key ethical considerations. We found that such principles can be employed in cost-effective, scalable interventions that improve patient adherence to a range of medical therapies and lifestyle modifications.


Subject(s)
Economics, Behavioral , Quality of Life , Dermatologists , Health Behavior , Humans , Medication Adherence , Patient Compliance
17.
Dermatology ; 238(3): 430-437, 2022.
Article in English | MEDLINE | ID: mdl-34537770

ABSTRACT

BACKGROUND: The International Dermatology Outcome Measures (IDEOM) initiative is a non-profit organization that aims to develop evidence-based outcome measurements to evaluate the impact of treatments for patients with dermatological disease. IDEOM includes all key stakeholders in dermatology (patient, physician, industry, insurer, and government) during the process of developing such outcome measurements. SUMMARY: Here, we provide an update of IDEOM activities that were presented at the 2020 IDEOM Virtual Annual Meeting (October 23-24, 2020). During the meeting, multiple IDEOM workgroups (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) shared their progress to date, as well as future directions in developing and validating Patient-Reported Outcome Measures. Updates on demonstrating efficacy in clinicals trials by the US Food and Drug Administration are also summarized. KEY MESSAGES: In this report, we summarize the work presented by each IDEOM workgroup (psoriasis, psoriatic arthritis, hidradenitis suppurativa, acne, pyoderma gangrenosum, and actinic keratosis) at the 2020 IDEOM Virtual Annual Meeting.


Subject(s)
Acne Vulgaris , Arthritis, Psoriatic , Dermatology , Hidradenitis Suppurativa , Keratosis, Actinic , Psoriasis , Pyoderma Gangrenosum , Arthritis, Psoriatic/diagnosis , Arthritis, Psoriatic/drug therapy , Humans , Outcome Assessment, Health Care , Psoriasis/therapy
19.
JAMA Dermatol ; 158(1): 79-83, 2022 Jan 01.
Article in English | MEDLINE | ID: mdl-34668921

ABSTRACT

IMPORTANCE: Rising costs of topical steroids have increased overall health care and patient out-of-pocket costs while increasing administrative burden on dermatologists and office staff. OBJECTIVE: To explore factors affecting the decision-making process for dermatologists around topical steroid prescriptions, determine the association of insurance coverage and cost, and assess willingness to implement solutions to decrease out-of-pocket topical steroid costs for patients. DESIGN, SETTING, AND PARTICIPANTS: This qualitative study was conducted from June to November 2020 and used semistructured interviews of 16 dermatologists who reflected a mix of physicians in academic, nonacademic, and private practice until thematic saturation was reached. Each interview was independently coded by 2 researchers. Code frequency and interrater reliability were determined using NVIVO software. Data analysis was conducted from November 2020 to March 2021. MAIN OUTCOMES AND MEASURES: Factors influencing dermatologist decision-making around topical steroid selection, outcomes of unaffordable medications on patients, solution recommendations, and perspectives on a system to automatically substitute topical steroid for cheaper alternatives of the same class and vehicle. RESULTS: Of the 16 dermatologists, 8 (50.0%) were women, 8 (50.0%) were men, 1 (6.3%) was Asian, 2 (12.5%) were Latinx, and 12 (75.0%) were White. The interrater reliability ranged from κ = 0.86 to κ = 0.98, indicating excellent agreement. Most physicians (13 [81%]) thought about costs regularly when making choices about topical steroids. All physicians identified a scenario in which patients could not obtain medication based on cost. In these cases, 15 (94%) reported that they try to find an alternative medication by calling the pharmacist or insurance company. Despite a desire to consider cost at the time of prescribing, physicians reported not knowing medication costs before prescribing because of the variability of insurance coverage (15 [94%]), lack of transparency (12 [75%]), and fluctuating drug prices (12 [75%]). In addition to affecting patients, 14 physicians (88%) reported that a patient's inability to afford medications increases administrative burden. Physicians suggested that they were open to solutions that focused on increased cost transparency (10 [63%]) and improved electronic health record technologies. Furthermore, 14 (88%) were willing to use a system to allow the substitution of one topical steroid for another of the same class and vehicle. CONCLUSIONS AND RELEVANCE: The results of this qualitative study suggest that opacity around drug costs reduces access for patients and is followed by administrative stress for physicians and staff. Dermatologists are receptive to systems that provide greater transparency for drug costs or automate substitution of equivalent cheaper drugs for patients.


Subject(s)
Drug Costs , Physicians , Female , Health Expenditures , Humans , Male , Reproducibility of Results , Steroids
20.
Lupus Sci Med ; 8(1)2021 12.
Article in English | MEDLINE | ID: mdl-34969875

ABSTRACT

OBJECTIVE: The lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies. METHODS: We conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined. RESULTS: Proposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument. CONCLUSION: This work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.


Subject(s)
Lupus Erythematosus, Cutaneous , Lupus Erythematosus, Systemic , Humans , Lupus Erythematosus, Cutaneous/diagnosis , Lupus Erythematosus, Cutaneous/therapy , Outcome Assessment, Health Care , Quality of Life , Severity of Illness Index
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