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Which outcomes are reported in cellulitis trials? Results of a review of outcomes included in cellulitis trials and a patient priority setting survey
Author(s) -
Smith E.,
Patel M.,
Thomas K. S.
Publication year - 2018
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.16624
Subject(s) - cellulitis , medicine , clinical trial , randomized controlled trial , physical therapy , intensive care medicine , health care , surgery , economics , economic growth
Summary Cellulitis is a potentially serious bacterial infection of the skin tissue, usually occurring on the lower leg. In addition to short‐term signs and symptoms, the disease can have a significant long‐term impact on a patient's physical and mental health. Cellulitis also poses a significant burden to health services; for example, from 2014 to 2015 in England, 114,190 patients were treated in hospital for cellulitis with a median length hospital stay of 6 days. It has been recognised that many outcomes in clinical trials (meaning the results that the trial is looking for) vary from trial to trial, making it hard to compare results of different trials. For this reason, development of core outcome sets (COS) for trials would be useful. A COS is an agreed set of outcomes that should be measured and reported, as a minimum, in all clinical trials in a specific area of healthcare. The initial stage in developing a core outcome set is to identify what outcomes are available, and to establish which are most important and relevant for healthcare users. The purpose of this review, from the U.K., was to describe all the outcome measures reported in a type of trial called randomised control trials (RCTs) on the treatment and prevention of cellulitis. 48 trials were included in the final analysis, and each one had between one and eight outcome measures. The secondary aim of this study was to identify outcome themes from patient and healthcare professionals’ feedback from a cellulitis priority setting partnership (PSP). Priority Setting Partnerships help to bring patients, carers and clinicians together to identify and prioritise for research the treatment uncertainties which they agree are the most important. Prevention of recurrence was the most frequently stated outcome theme of importance from both patients and healthcare professionals. “Treatment‐focused” outcomes such as length of antibiotic therapy were also key priorities for healthcare professionals, while assessment of clinical features (redness, swelling and pain most commonly) were the next most important outcomes for patients. Surprisingly, only 2% of all outcome themes focused on quality of life and treatment satisfaction. The authors conclude that outcome measures for cellulitis should not only be consistent, to allow clinical trials to be adequately compared, but should be reflective of the real impact on patients’ day to day lives.