The Dermatology Life Quality Index as the primary outcome in randomized clinical trials: a systematic review.

Abstract

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. 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. 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. 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 interventions (17 of 24 studies, 68%) were systemic drugs, with biologics (liraglutide, alefacept, secukinumab, ustekinumab, adalimumab) accounting for 5 of 25 pharmacological interventions (20%). Topical treatments comprised 32% (8 studies), whereas nonpharmacological interventions (n = 8) were 24% of the total interventions (N = 33). Three studies used nontraditional medicines. Eight studies were multicentred (33.3%), with trials conducted in at least 14 different countries, and four studies (16.7%) were conducted in multiple countries. The Jadad risk of bias scale showed that bias was uncertain or low, as 87.5% of studies had Jadad scores of ≥ 3. This study provides evidence for use of the DLQI as a primary outcome in clinical trials. Researchers and clinicians can use this data to inform decisions about further use of the DLQI as a primary outcome.