Masaki Futamura1, Yael A Leshem2, Kim S Thomas3, Helen Nankervis3, Hywel C Williams3, Eric L Simpson4. 1. Division of Pediatrics, Nagoya Medical Center, Nagoya, Japan. 2. Department of Dermatology, Oregon Health and Science University, Portland, Oregon. 3. Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom. 4. Department of Dermatology, Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.
Abstract
BACKGROUND: Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear. OBJECTIVES: We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD. METHODS: We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features. RESULTS: Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries. LIMITATIONS: The search was restricted to the Global Resource of Eczema Trials database. CONCLUSION: Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required.
BACKGROUND: Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear. OBJECTIVES: We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD. METHODS: We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features. RESULTS: Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries. LIMITATIONS: The search was restricted to the Global Resource of Eczema Trials database. CONCLUSION: Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required.
Authors: Eric L Simpson; Emma Guttman-Yassky; David J Margolis; Steven R Feldman; Abrar Qureshi; Tissa Hata; Vera Mastey; Wenhui Wei; Laurent Eckert; Jingdong Chao; Renée J G Arnold; Tiffany Yu; Francis Vekeman; Mayte Suárez-Fariñas; Abhijit Gadkari Journal: JAMA Dermatol Date: 2018-08-01 Impact factor: 10.282
Authors: Timothy P Suh; Divya Ramachandran; Vidhi Patel; Kathryn L Jackson; Stephanie M Rangel; Anna B Fishbein; Amy S Paller Journal: J Am Acad Dermatol Date: 2020-01-21 Impact factor: 11.527
Authors: Stephanie J Lax; Jane Harvey; Emma Axon; Laura Howells; Miriam Santer; Matthew J Ridd; Sandra Lawton; Sinéad Langan; Amanda Roberts; Amina Ahmed; Ingrid Muller; Long Chiau Ming; Saumya Panda; Pavel Chernyshov; Ben Carter; Hywel C Williams; Kim S Thomas; Joanne R Chalmers Journal: Cochrane Database Syst Rev Date: 2022-03-11
Authors: Kim S Thomas; Lucy E Bradshaw; Tracey H Sach; Jonathan M Batchelor; Sandra Lawton; Eleanor F Harrison; Rachel H Haines; Amina Ahmed; Hywel C Williams; Taraneh Dean; Nigel P Burrows; Ian Pollock; Joanne Llewellyn; Clare Crang; Jane D Grundy; Juliet Guiness; Andrew Gribbin; Eleanor J Mitchell; Fiona Cowdell; Sara J Brown; Alan A Montgomery Journal: PLoS Med Date: 2017-04-11 Impact factor: 11.069
Authors: J I Silverberg; D Lei; M Yousaf; S R Janmohamed; P P Vakharia; R Chopra; R Chavda; S Gabriel; K R Patel; V Singam; R Kantor; D Y Hsu Journal: J Eur Acad Dermatol Venereol Date: 2020-09-01 Impact factor: 6.166
Authors: Mohamed A Kamal; Pavel Kovalenko; Matthew P Kosloski; Kamal Srinivasan; Yi Zhang; Manoj Rajadhyaksha; Ching-Ha Lai; Vanaja Kanamaluru; Christine Xu; Xian Sun; Eric L Simpson; Amy S Paller; Elaine C Siegfried; Brad Shumel; Ashish Bansal; Nidal Al-Huniti; John D Davis Journal: Clin Pharmacol Ther Date: 2021-08-24 Impact factor: 6.903