The Dermatology Life Quality Index as the primary outcome in randomized clinical trials: a systematic review
Abstract
BACKGROUND: Primary endpoint measures in clinical trials are typically measures of disease severity, with patient-reported outcome measures (PROMs) relegated as secondary endpoints. However, validation of some PROMs may be more rigorous than that of disease severity measures, which could provide support for a primary role for PROMs. OBJECTIVES: This study reports on 24 peer reviewed journal articles that used the Dermatology Life Quality Index (DLQI) as primary outcome, derived from a systematic review of randomized controlled trials (RCTs) utlizing DLQI, covering all diseases and interventions. METHODS: The study protocol was prospectively published on the PROSPERO database, and the study followed PRISMA guidelines. Searches were made using MEDLINE, The Cochrane Library, Embase, Web of Science, Scopus, CINAHL (EBSCO) and PsycINFO databases and records were combined into an Endnote database. Records were filtered for duplicates and selected based on study inclusion/exclusion criteria. Full-text articles were sourced and data were extracted by two reviewers into a bespoke REDCap database, with a third reviewer adjudicating disagreements. The Jadad scoring method was used to determine risk of bias. RESULTS: Of the 3220 publications retrieved from online searching, 457 articles met the eligibility criteria and included 198 587 patients. DLQI scores were used as primary outcomes in 24 (5.3%) of these studies comprising 15 different diseases and 3436 patients. Most study…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 3,436 participants or records.
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