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Summary: Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG‐COUSIN) supports the development of core outcomes in dermatology. In the second CSG‐COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. [ABSTRACT FROM AUTHOR]

The article focuses on a study which examines the quality of life (QoL) of patients with hidradenitis suppurativa (HS), a chronic, inflammatory disease and relapsing skin disease, in Denmark. Topics discussed include the worldwide prevalence of HS, the psychological effects of HS, and level of depression experienced by HS patients. Also mentioned is the high rate of unemployment among people with HS.

Summary: Hidradenitis suppurativa (HS) is a long‐lasting skin disease with flares of painful boils in areas where skin meets skin, such as the armpits and groins. It affects somewhere between 1 and 40 people out of 1000 worldwide. When trying to measure the effect of a treatment in a clinical trial, so‐called 'outcome measurement instruments' are used. These are ways of estimating 'how much' disease is present. It is obviously important that outcome measurement instruments measure the right thing and do not vary at random. It has previously been shown that outcome measurement instruments used in HS trials lack proof of their reliability. This study therefore aimed to find out how consistently 12 HS‐experienced dermatologists would score 24 patients with HS, using nine different instruments. The study showed that one called Hurley staging was an acceptable instrument in terms of consistency of scores. However, Hurley staging is suited only for severity staging e.g. to guide the most appropriate treatment in each stage. For instruments designed to measure changes in disease severity, low agreement between the rating dermatologists was found. Therefore, the results question whether HS physical signs are best measured by traditional instruments based on a physician counting individual HS lesions (affected patches). As a result, other assessment methods of physical signs in HS, using technology such as ultrasound, should also be considered. Linked Article: Thorlacius et al. Br J Dermatol 2019; 181:483–491 [ABSTRACT FROM AUTHOR]

Summary: Hidradenitis suppurativa (HS) is an uncommon skin condition that causes painful swollen red bumps in the folds of the body (underarms, under breasts, groin, and buttocks). It can be mistaken for bacterial abscess or boils, but HS is not caused by bacteria. HS occurs in about 0.1–1% people in the US and Europe. The authors include people with HS, dermatologists, surgeons, members of the pharmaceutical industry and medical regulators from 13 countries and four continents. This study aimed to find out what clinical trials for HS should measure, such as symptoms (e.g. pain, itch), physical changes (e.g. skin redness or swelling), or impact on people's lives (e.g. quality of life). To do this, the study included two groups: people with HS and healthcare providers (physicians, pharmaceutical industry representatives, and regulatory representatives) and conducted in‐person meetings with presentations and discussions as well as surveys to gather opinions on which measures to include. The result of the meetings, discussions, and surveys showed that at least 70% of the people with HS and healthcare providers recommended that clinical trials include measures of: (1) physical changes due to HS (e.g. redness); (2) changes in the course of HS (e.g. flare‐ups); (3) quality of life changes due to HS specifically; (4) satisfaction (e.g. satisfaction with treatment) ; (5) pain; (6) other symptoms (e.g. itching); and a global rating (i.e. overall rating, considering everything, of the severity of the condition). This work is important because it included many different types of people who contribute to HS treatment, including the people who have HS, develop or regulate treatments, and treat people with HS. More work is coming, and it will focus on final suggestions on what to measure and how to measure it in trials treating HS. [ABSTRACT FROM AUTHOR]