Which outcomes are reported in cellulitis trials?: results of a review of outcomes included in cellulitis trials and a patient priority setting survey

Smith, Emma; Patel, Mitesh; Thomas, Kim

Abstract

Background

There is an emerging need to develop consistent outcomes in clinical trials to allow effective comparison of treatment effects. No systematic review has previously looked at the reporting of outcome measures used in randomised controlled trials (RCTs) on treatment and prevention of cellulitis (erysipelas).
Objectives

The primary aim of this review was to describe the breadth of outcomes reported from RCTs on cellulitis treatment and prevention. The secondary aim was to identify outcome themes from patient and health care professionals’ feedback from a cellulitis priority setting partnership (PSP).
Methods

We conducted a review of all outcome measures used in RCTs from two recent Cochrane reviews. Free text responses from a cellulitis priority setting survey were used to understand the perspectives of patients and healthcare professionals.
Results

Outcomes from 42 RCTs on treatment of cellulitis and six RCTs on prevention of cellulitis were reviewed. Only 28 trials stated their primary outcome. For trials assessing treatment of cellulitis, clinical response to treatment was categorised in 25 different ways. Five of these trials used an outcome that was in accordance with FDA guidance and only four trials incorporated either quality of life or patient satisfaction. For trials assessing prevention of cellulitis, recurrence was the key outcome measure. From the cellulitis PSP, prevention of recurrence, clinical features and long-term disease impact were the most important outcome themes for patients.
Conclusions

We have shown that in cellulitis treatment and prevention research, there is significant heterogeneity in clinical outcomes, inadequate focus on patient-reported outcomes, and a disparity between what is currently measured and what patients and healthcare professionals feel is important. We recommend that future cellulitis treatment trials consider the use of longer-term outcomes to capture recurrence and long-term morbidity, as well as short-term resolution of acute infection.

Citation

Smith, E., Patel, M., & Thomas, K. (2018). Which outcomes are reported in cellulitis trials?: results of a review of outcomes included in cellulitis trials and a patient priority setting survey. British Journal of Dermatology, 178(5), 1028-1034. https://doi.org/10.1111/bjd.16235

• Journal Article Type: Article
• Acceptance Date: Dec 4, 2017
• Online Publication Date: Dec 9, 2017
• Publication Date: 2018-05
• Deposit Date: Jan 16, 2018
• Publicly Available Date: Dec 10, 2018
• Journal: British Journal of Dermatology
• Print ISSN: 0007-0963
• Electronic ISSN: 1365-2133
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 178
• Issue: 5
• Pages: 1028-1034
• DOI: https://doi.org/10.1111/bjd.16235
• Keywords: Cellulitis; Erysipelas; Outcomes; core outcome set; priority setting partnership
• Public URL: https://nottingham-repository.worktribe.com/output/899405
• Publisher URL: http://onlinelibrary.wiley.com/doi/10.1111/bjd.16235/full
• Additional Information: This is the peer reviewed version of the following article: Smith, E., Patel, M. and Thomas, K. (), Which outcomes are reported in cellulitis trials? Results of a review of outcomes included in cellulitis trials and a patient priority setting survey. Br J Dermatol. Accepted Author Manuscript, which has been published in final form at http://dx.doi.org/10.1111/bjd.16235. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.