Person:

Merola, Joseph

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.

To inform our ongoing efforts to develop defining features to be incorporated into a novel set of classification criteria for discoid lupus erythematosus (DLE), we conducted a literature review using the Ovid MEDLINE database. A search was performed to identify studies reporting criteria used to distinguish DLE from other cutaneous lupus erythematosus subtypes. We examined which clinical, histopathologic, and serologic features have data to support their use as effective features in distinguishing DLE from other potential disease mimickers and cutaneous lupus subsets. Through our search, we were also able to identify gaps that exist in the literature which can inform future directions for research endeavors. We found that localization of lesions, characteristic features of damage, and the absence of high titer Ro/SSA antibody seem most effective in differentiating DLE from other cutaneous lupus erythematosus subtypes. Histopathologic features and class of immunoreactant deposition appear to be less helpful.

To inform our ongoing efforts to develop defining features to be incorporated into a novel set of classification criteria for discoid lupus erythematosus (DLE), we conducted a literature review using the Ovid MEDLINE database. A search was performed to identify studies reporting criteria used to distinguish DLE from other cutaneous lupus erythematosus subtypes. We examined which clinical, histopathologic, and serologic features have data to support their use as effective features in distinguishing DLE from other potential disease mimickers and cutaneous lupus subsets. Through our search, we were also able to identify gaps that exist in the literature which can inform future directions for research endeavors. We found that localization of lesions, characteristic features of damage, and the absence of high titer Ro/SSA antibody seem most effective in differentiating DLE from other cutaneous lupus erythematosus subtypes. Histopathologic features and class of immunoreactant deposition appear to be less helpful.

Currently, no standardized classification criteria exist for cutaneous lupus erythematosus. With increased interest in studying cutaneous lupus erythematosus, specifically discoid lupus erythematosus, it is our aim to apply previously adopted methods from rheumatology to dermatologic diseases to develop feasible, validated, and standardized classification criteria useful in both academic and community practice. Here we report the progress to date to define discoid lupus erythematosus using clinical, histopathologic, and serologic features by means of a Delphi method—using a series of iterative questionnaires sent to expert stakeholders. We present specific updates from the World Congress of Dermatology 2015 meeting, at which a nominal group of expert stakeholders met to discuss the results of round 1 of the Delphi process to further clarify and harmonize specific classification items for inclusion into round 2.

Background: Psoriasis (PsO) and psoriatic arthritis (PsA) are related conditions with poorly defined transition among them, risk factors for progression, complex treatment algorithms, and biomarkers for treatment response and long-term outcomes. We describe the development of a PsO/PsA registry at an academic medical center. Methods: We developed a single-center PsO/PsA longitudinal disease registry including biorepository that captures relevant disease markers and treatment choices in a circumscribed population with a defined catchment area. We searched the electronic medical record for patients with visits in the last year for PsO or PsA. They formed the potentially eligible registry population. Baseline patient and provider questionnaires were developed using standardized measures, including demographics, comorbidities, medications, specific disease characteristics, functional status, quality of life, mental health, and resource use. An abbreviated set of items was collected every six month and at visits with treatment changes or disease flares. Biospecimens included blood (serum, plasma, DNA, RNA) and skin biopsy samples, with repeat collections of serum and plasma. Data from the EMR to augment the registry questionnaires are available on all patients. Discussion Searching the Brigham EMR system from 2013 through 2014, we found 1694 patients with PsO and 1028 with PsA. Their mean age was 55 years and 53% were female. Of these 17% had diabetes, 38% hyperlipidemia, and 45% hypertension. The median BMI was 29.6. PsA patients used more systemic prednisone, MTX, and TNF alpha inhibitors (47%, 60%, and 66%) compared to PsO patients (28%, 20% and 21%). We have collected plasma in 410 patients, DNA/RNA in 453 patients. In conclusion, we have developed a PsO/PsA registry to better define longitudinal disease characteristics, perform biomarker studies, and examine treatment trends.