Generic outcome set for the international registry on Laser trEAtments in Dermatology (LEAD): a protocol for a Delphi study to achieve consensus on what to measure
Thierry Passeron,
Murad Alam,
Frederike Fransen,
Phyllis Spuls,
Ashraf Badawi,
Pablo Boixeda,
Merete Haedersdal,
Iltefat Hamzavi,
Lene Hedelund,
Kristen M Kelly,
Tara Kono,
Hans Joachim Laubach,
Woraphong Manuskiatti,
Leonardo Marini,
Keyvan Nouri,
Uwe Paasch,
Cecilia A.C. (Sanna) Prinsen,
Ines Verner,
Albert Wolkerstorfer
Affiliations
Thierry Passeron
INSERM U1065, Team 12, Centre Méditerranéen de Médecine Moléculaire, Université Côte d'Azur, Nice, France
Murad Alam
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois (IL), United States
Frederike Fransen
Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands
Phyllis Spuls
Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands
Ashraf Badawi
Dermatology Unit, Department of Medical Applications of Lasers, National Institute of Laser Enhanced Sciences, Cairo University, Giza, Egypt
Pablo Boixeda
Dermatology Department, Ramón y Cajal Hospital, Madrid, Spain
Merete Haedersdal
Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark
Iltefat Hamzavi
Department of Dermatology, Henry Ford Hospital, Detroit, Michigan, USA
Beckman Laser Institute, University of California, Irvine, California, USA
Tara Kono
Department of Plastic and Reconstructive Surgery, Tokai University School of Medicine, Isehera, Japan
Hans Joachim Laubach
Dermatology and Venereology, Hopitaux Universitaires de Geneve, Geneva, Switzerland
Woraphong Manuskiatti
Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand
Leonardo Marini
Dermatology, SDC—The Skin Doctors’ Center, Trieste, Italy
Keyvan Nouri
Dermatology and Cutaneous Surgery, University of Miami School of Medicine, Miami, Florida, USA
Uwe Paasch
University of Leipzig, Leipzig, UK
Cecilia A.C. (Sanna) Prinsen
Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands
Ines Verner
Dermatology, Verner clinic, Tel Aviv, Israel
Albert Wolkerstorfer
Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands
Introduction While laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes (what to measure) for implementation in the international registry on Laser trEAtments in Dermatology (LEAD). The registry is focused on collecting research data on various laser treatments for skin disorders.Methods and analysis By reviewing the literature and involvement of key stakeholder groups and adult patients in need or after laser surgery and health professionals, a preliminary list of outcomes will be generated and categorised into domains. Using these outcomes, an international three-round Delphi study will be performed to rate the importance of outcomes in the selection of a generic outcome set. Participants are allowed to provide new outcomes to the preliminary list for revisions during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcomes to be used in the LEAD registry.Ethics and dissemination An ethics approval was not applicable (W19_290 # 18.336). The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations.
