Sebastien Barbarot1, Natasha K Rogers2, Katrina Abuabara3, Helene Aubert4, Joanne Chalmers2, Carsten Flohr5, Jon Hanifin6, Luigi Naldi7, David J Margolis8, Carle Paul9, Matthew J Ridd10, Marie-Louise Anna Schuttelaar11, Eric Simpson6, Marie Tauber9, Annika Volke12, Stephan Weidinger13, Sally R Wilkes2, Andreas Wollenberg14, Kim S Thomas15. 1. Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom; Department of Dermatology, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France. 2. Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom. 3. Department of Dermatology, University of California, San Francisco, California. 4. Department of Dermatology, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France. 5. Population-based Dermatology Research Unit, St John's Institute of Dermatology, Guy's and St Thomas' National Health Service Foundation Trust and King's College London, London, United Kingdom. 6. Department of Dermatology, Oregon Health and Science University, Portland, Oregon. 7. Study Center Italian Group for Epidemiologic Research in Dermatology and Department of Dermatology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy. 8. Departments of Dermatology and Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania. 9. Dermatology, Paul Sabatier University and Hôpital Larrey, Toulouse, France. 10. School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom. 11. Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 12. Department of Dermatology, University of Tartu, Tartu, Estonia. 13. Department of Dermatology, Venereology, and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. 14. Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Munich, Germany. 15. Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom. Electronic address: kim.thomas@nottingham.ac.uk.
Abstract
BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD. OBJECTIVE: We sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD. METHODS: We conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English. RESULTS: In all, 101 of 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%), and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to first flare was most commonly used for trials including flare data (21/52). Medication use was recorded based on quantity, potency, and frequency of application. LIMITATIONS: We included RCT data only. CONCLUSION: This review illustrates the difficulties in measuring long-term control, and points to the need for improved harmonization of outcomes.
BACKGROUND:Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD. OBJECTIVE: We sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD. METHODS: We conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English. RESULTS: In all, 101 of 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%), and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to first flare was most commonly used for trials including flare data (21/52). Medication use was recorded based on quantity, potency, and frequency of application. LIMITATIONS: We included RCT data only. CONCLUSION: This review illustrates the difficulties in measuring long-term control, and points to the need for improved harmonization of outcomes.
Authors: Susannah Mc George; Sanja Karanovic; David A Harrison; Anjna Rani; Andrew J Birnie; Fiona J Bath-Hextall; Jane C Ravenscroft; Hywel C Williams Journal: Cochrane Database Syst Rev Date: 2019-10-29
Authors: Annelie H Musters; Soudeh Mashayekhi; Jane Harvey; Emma Axon; Stephanie J Lax; Carsten Flohr; Aaron M Drucker; Louise Gerbens; John Ferguson; Sally Ibbotson; Robert S Dawe; Floor Garritsen; Marijke Brouwer; Jacqueline Limpens; Laura E Prescott; Robert J Boyle; Phyllis I Spuls Journal: Cochrane Database Syst Rev Date: 2021-10-28
Authors: Joanne R Chalmers; Rachel H Haines; Eleanor J Mitchell; Kim S Thomas; Sara J Brown; Matthew Ridd; Sandra Lawton; Eric L Simpson; Michael J Cork; Tracey H Sach; Lucy E Bradshaw; Alan A Montgomery; Robert J Boyle; Hywel C Williams Journal: Trials Date: 2017-07-21 Impact factor: 2.279
Authors: Marissa T Ayasse; Adnan Ahmed; Maria L Espinosa; Christina J Walker; Muhammad Yousaf; Jacob P Thyssen; Jonathan I Silverberg Journal: Arch Dermatol Res Date: 2020-11-22 Impact factor: 3.017
Authors: Laura M Howells; Joanne R Chalmers; Fiona Cowdell; Sonia Ratib; Miriam Santer; Kim S Thomas Journal: BMJ Open Date: 2017-11-15 Impact factor: 2.692
Authors: L Howells; K S Thomas; A V Sears; I Nasr; A Wollenberg; M L A Schuttelaar; G L E Romeijn; A S Paller; K Mueller; K Doytcheva; Y Kataoka; J Daguze; S Barbarot; L B von Kobyletzki; L Beckman; S Ratib; F Cowdell; M Santer; J R Chalmers Journal: J Eur Acad Dermatol Venereol Date: 2019-04-08 Impact factor: 6.166
Authors: L M Howells; J R Chalmers; S Gran; A Ahmed; C Apfelbacher; T Burton; L Howie; S Lawton; M J Ridd; N K Rogers; A V Sears; P Spuls; L von Kobyletzki; K S Thomas Journal: Br J Dermatol Date: 2020-02-20 Impact factor: 9.302