Navigating the landscape of core outcome set development in dermatology

Cecilia A C Prinsen; Phyllis I Spuls; Jan Kottner; Kim S Thomas; Christian Apfelbacher; Joanne R Chalmers; Stefanie Deckert; Masutaka Furue; Louise Gerbens; Jamie Kirkham; Eric L Simpson; Murad Alam; Katrin Balzer; Dimitri Beeckman; Viktoria Eleftheriadou; Khaled Ezzedine; Sophie E R Horbach; John R Ingram; Alison M Layton; Karsten Weller; Thomas Wild; Albert Wolkerstorfer; Hywel C Williams; Jochen Schmitt

doi:10.1016/j.jaad.2019.03.009

Navigating the landscape of core outcome set development in dermatology

J Am Acad Dermatol. 2019 Jul;81(1):297-305. doi: 10.1016/j.jaad.2019.03.009. Epub 2019 Mar 13.

Authors

Cecilia A C Prinsen¹, Phyllis I Spuls², Jan Kottner³, Kim S Thomas⁴, Christian Apfelbacher⁵, Joanne R Chalmers⁴, Stefanie Deckert⁶, Masutaka Furue⁷, Louise Gerbens², Jamie Kirkham⁸, Eric L Simpson⁹, Murad Alam¹⁰, Katrin Balzer¹¹, Dimitri Beeckman¹², Viktoria Eleftheriadou⁴, Khaled Ezzedine¹³, Sophie E R Horbach¹⁴, John R Ingram¹⁵, Alison M Layton¹⁶, Karsten Weller¹⁷, Thomas Wild¹⁸, Albert Wolkerstorfer², Hywel C Williams⁴, Jochen Schmitt⁶

Affiliations

¹ Amsterdam UMC, Department of Epidemiology and Biostatistics, Vrije Universiteit University Medical Center, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
² Amsterdam UMC, Department of Dermatology, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, the Netherlands.
³ Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany; University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium. Electronic address: jan.kottner@charite.de.
⁴ Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, United Kingdom.
⁵ Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
⁶ Center for Evidence-Based Healthcare, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
⁷ Department of Dermatology, Kyushu University, Fukuoka, Japan.
⁸ Medical Research Council North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
⁹ Department of Dermatology, Oregon Health & Science University, Portland, Oregon.
¹⁰ Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
¹¹ Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.
¹² University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.
¹³ Department of Dermatology and Evaluation of Therapeutics, EA7379, Paris-Est University, University Paris Est Créteil, University Hospital Departments Viruses, Immunity, and Cancer, Créteil, France.
¹⁴ Amsterdam UMC, Department of Plastic, Reconstructive, and Hand Surgery, University of Amsterdam, Amsterdam, the Netherlands.
¹⁵ Division of Infection and Immunity, University Hospital of Wales, Cardiff University, Cardiff, United Kingdom.
¹⁶ Hull York Medical School, University of York, York, United Kingdom; Harrogate and District National Health Service Foundation Trust, Harrogate, United Kingdom.
¹⁷ Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
¹⁸ Department of Plastic, Aesthetic, and Hand Surgery, Interdisciplinary Center for Treatment of Chronic Wounds, Dessau Medical Center, Dessau, Germany; Department of Dermatology, Venereology, Allergology, and Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany; Institut of Applied Bio-Sciences and Process Management, University of Applied Science Anhalt, Koethen, Germany.

PMID: 30878565
DOI: 10.1016/j.jaad.2019.03.009

Abstract

The development of core outcome sets (COSs; ie, a minimum set of core outcomes that should be measured and reported in all trials or in clinical practice for a specific condition) in dermatology is increasing in pace. A total of 44 dermatology-related COS projects have been registered in the online Core Outcome Measures in Effectiveness Trials database (http://www.comet-initiative.org/studies/search) and include studies on 26 different skin diseases. With the increasing number of COSs in dermatology, care is needed to ensure the delivery of high-quality COSs that meet quality standards when using state-of-the-art methods. In 2015, the Cochrane Skin-Core Outcome Set Initiative (CS-COUSIN) was established. CS-COUSIN is an international, multidisciplinary working group aiming to improve the development and implementation of COSs in dermatology. CS-COUSIN has developed guidance on how to develop high-quality COSs for skin diseases and supports dermatology-specific COS initiatives. Currently, 17 COS development groups are affiliated with CS-COUSIN and following standardized COS development processes. To ensure successful uptake of COSs in dermatology, researchers, clinicians, systematic reviewers, guideline developers, and other stakeholders should use existing COSs in their work.

Keywords: CS-COUSIN; Cochrane Skin; clinical trials; core outcome set; dermatology; development; implementation.

Publication types

Review

MeSH terms

Clinical Trials as Topic*
Dermatology / organization & administration*
Female
Global Health
Humans
Male
Outcome Assessment, Health Care*
Program Development
Program Evaluation
Registries*
Research Design
Skin Diseases / diagnosis*
Skin Diseases / therapy*