Clinical trials in dermatology.
Ontology highlight
ABSTRACT:
SUBMITTER: Torre K
PROVIDER: S-EPMC5555277 | biostudies-other | 2017 Sep
REPOSITORIES: biostudies-other
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Project description:BACKGROUND:Assessment of treatment effects in clinical trials requires valid information on treatment adherence, adverse events and symptoms. Paper-based diaries are often inconvenient and have limited reliability, particularly for outpatient trials. OBJECTIVES:To investigate the utility of an electronic diary (e-diary) application for patients with skin diseases in outpatient clinical trials. METHODS:An e-diary application was developed and technically validated. Treatment adherence was defined as topical administration by the patient, and patient-reported outcomes, i.e. pain and itch, were evaluated by the e-diary in six clinical trials on newly tested topical drugs. Additionally, the proportion of patients capturing the applied topical drug by camera and filling in the pain and itch scores was defined as e-diary adherence, and patients' perception of usefulness and acceptability of the e-diary were evaluated. RESULTS:Treatment adherence rates of the included 256 patients were high (median 98%, range 97-99%). E-diary adherence was also high with a median of 93% (range 87-97%) for capturing the applied drug by camera, and 89% (range 87-96%) and 94% (range 87-96%) for entering respectively the itch and pain score. Daily symptom scores provided good insights into the disease burden, and patients rated the e-diary as good to excellent with respect to user acceptability. CONCLUSIONS:The results suggest that the e-diary is an excellent way to ensure proper treatment administration, indicated by both the high user acceptability scores and high treatment adherence. Moreover, the e-diary may also be valuable for frequent and reliable monitoring of patient-reported outcomes in daily clinical practice.
| S-EPMC7064941 | biostudies-literature
Project description:Importance:It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. Objective:To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Design, Setting, and Participants:Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Main Outcomes and Measures:Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Results:Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10?000, and 18 accepted more than $50?000. Financial payments amounted to a mean of $157?177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7?701?681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Conclusions and Relevance:Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.
| S-EPMC5817443 | biostudies-other
Project description:Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence.The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4?mg/kg/day) to prednisolone (0.75?mg/kg/day). A total of 140 participants are to be recruited over a period of 4?years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6?weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18?years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis).Patients who require topical therapy are asked to enter a parallel observational study (case series). If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial.Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14.
| S-EPMC3423010 | biostudies-literature
Project description:Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.
| S-EPMC7553305 | biostudies-literature
Project description:Skin and subcutaneous diseases affect millions of people worldwide, causing significant morbidity. Biologics are becoming increasingly useful for the treatment of many skin diseases, particularly as alternatives for patients who have failed to tolerate or respond to conventional systemic therapies. Biological therapies provide a targeted approach to treatment through interaction with specific components of the underlying immune and inflammatory disease processes. This review article examines the increasing evidence base for biologics in dermatology, including well-established treatments and novel agents.
| S-EPMC3816698 | biostudies-literature
Project description:Objectives: To identify similarities and differences in gene expression data in the MEK/ERK and PI3K pathways and to determine how histone modification affects these same pathways. Goal: To identify and functionally characterize novel targets of these signaling pathways in the context of chondrocyte differentiation. Keywords: Teatment, signaling, one-colour array, signaling pathway comparison
2008-01-31 | GSE8488 | GEO
Project description:Evolutionarily, man is a terrestrial mammal, adapted to land. Aviation and now space/microgravity environment, hence, pose new challenges to our physiology. Exposure to these changes affects the human body in acute and chronic settings. Since skin reflects our mental and physical well-being, any change/side effects of this environment shall be detected on the skin. Aerospace industry offers a unique environment with a blend of all possible occupational disorders, encompassing all systems of the body, particularly the skin. Aerospace dermatologists in the near future shall be called upon for their expertise as we continue to push human physiological boundaries with faster and more powerful military aircraft and look to colonize space stations and other planets. Microgravity living shall push dermatology into its next big leap-space, the final frontier. This article discusses the physiological effects of this environment on skin, effect of common dermatoses in aerospace environment, effect of microgravity on skin, and occupational hazards of this industry.
| S-EPMC5286758 | biostudies-other
Project description:IntroductionArt education interventions improve observation skills among dermatology residents, but there is limited data regarding their benefits to wellness and clinical communication.MethodsResidents in the Stanford dermatology residency program participated in an arts-based education session, repeated in the fall of 2018 and 2019, that included a rotation of observational exercises adapted from the Artful Thinking program through Harvard Project Zero. The 2018 session featured exercises on identification and understanding of visual observation, while the 2019 session featured exercises on perspectives and objectivity of visual observation. Participants completed preintervention, postintervention, and 3-month follow-up surveys in fall 2018 and a postintervention survey in fall 2019.ResultsTwenty-one residents participated in the 2018 education session and produced an adequate response rate (62%-90%) across surveys. At 3 months, five of 13 residents (39%) reported new use of art for mindfulness and stress reduction, 12 of 13 (92%) could recall an example of use of observation to improve patient communication, and four of 13 (31%) confirmed and described adjustments to their handoff technique. In 2019, 13 out of 18 participants (72%) completed the postintervention survey. Responses reinforced themes from the prior iteration but focused on perspective, objectivity, context, and uncertainty in observations. Respondents also identified additional arenas of communication to benefit from these observational techniques.DiscussionDermatology residents increased use of art for personal wellness and adjusted clinical communication strategies after a single arts-based education session. Annual repetition with novel exercises maintained engagement and yielded additional participant insights.
| S-EPMC8015639 | biostudies-literature
Project description:IntroductionPatients with psoriasis (PsO) experience impaired health-related quality of life due to physical and psychosocial burdens. The objective of this study was to assess the correlation between change in Psoriasis Area and Severity Index (PASI) score and selected Dermatology Life Quality Index (DLQI) domain scores in patients with moderate-to-severe PsO and those with PsO and comorbid psoriatic arthritis (PsA).MethodsThis post hoc analysis of four phase 3 clinical trials included patients with moderate-to-severe PsO randomized to secukinumab 150/300 mg, etanercept, or placebo. Pairwise latent growth models were applied to assess the longitudinal correlation between change in PASI scores and changes in three DLQI domain scores (daily activities, leisure activities, and symptoms/feelings). The initial (baseline to week 12) and sustained (week > 12 to week 52) treatment exposures were analysed by population type (total, PsO only, and PsO with comorbid PsA) and treatment arm (secukinumab, etanercept, or placebo).ResultsAmong the total population (N = 2401), PASI change was positively correlated with change in each assessed DLQI domain; correlations were weak to moderate over the initial treatment exposure period (β range, 0.20-0.29; all P < 0.001) and moderate to strong over the sustained exposure period (β range, 0.63-0.69; all P < 0.001). Similar trends were observed regardless of the presence of comorbid PsA. These relationships were confirmed among patients treated with secukinumab, etanercept, or placebo.ConclusionsImprovements in PASI scores were directly moderately related to improvements in DLQI domain scores from initiation of treatment and extended over time, regardless of presence of comorbid PsA or treatment received.Clinical trial registrationERASURE (NCT01365455), FIXTURE (NCT01358578), FEATURE (NCT01555125), and JUNCTURE (NCT01636687).
| S-EPMC8322374 | biostudies-literature
Project description:The systemic vasculitides include a heterogenous group of diseases characterised by inflammation of blood vessels. Evidence for treatment in this group of patients is limited due to rarity of the diseases, incomplete understanding of the pathogenesis and lack of appropriate biomarkers. In the last 20 years, international collaboration and networking led to clinical trials in a select subgroup of patients with systemic vasculitis. Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is the most studied subgroup. This article discusses the treatment options of AAV in light of evidence from clinical trials. Treatment of AAV, which includes an induction and a maintenance phase, is dependent on the severity of the disease. Oral or intravenous cyclophosphamide and high-dose glucocorticoids are considered to be standard of care for induction of remission in AAV patients with generalised disease. Latest evidence supports rituximab as an alternative to cyclophosphamide especially in relapsing patients and is increasingly being used in patients who cannot have cyclophosphamide. Plasma exchange and intravenous immunoglobulins (IVIGs) are used as adjunctive therapies for induction. Azathioprine or methotrexate (in non-renal patients) is considered to be the choice for remission maintenance, whilst mycophenolate mofetil is reserved for patients who cannot tolerate either of them. Rituximab is also being increasingly used for remission maintenance in relapsing patients. Even though an enormous progress has been made in the outlook of patients with AAV, a number of questions remain unanswered with regard to the optimal treatment strategy.
| S-EPMC5566121 | biostudies-other