PMID- 32595165 OWN - NLM STAT- MEDLINE DCOM- 20210215 LR - 20210215 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 10 IP - 6 DP - 2020 Jun 28 TI - 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. PG - e038145 LID - 10.1136/bmjopen-2020-038145 [doi] LID - e038145 AB - 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. CI - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. FAU - Fransen, Frederike AU - Fransen F AUID- ORCID: 0000-0003-0550-7970 AD - Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands frederikefransen@gmail.com m-alam@northwestern.edu. FAU - Spuls, Phyllis AU - Spuls P AD - Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands. AD - Department of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam University Medical Center, Amsterdam, The Netherlands. FAU - Alam, Murad AU - Alam M AD - Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois (IL), United States frederikefransen@gmail.com m-alam@northwestern.edu. AD - Department of Dermatology, Northwestern Memorial Hospital, Arkes Family Pavilion, Chicago, Illinois (IL), United States. FAU - Badawi, Ashraf AU - Badawi A AD - Dermatology Unit, Department of Medical Applications of Lasers, National Institute of Laser Enhanced Sciences, Cairo University, Giza, Egypt. FAU - Boixeda, Pablo AU - Boixeda P AD - Dermatology Department, Ramon y Cajal Hospital, Madrid, Spain. FAU - Haedersdal, Merete AU - Haedersdal M AD - Dermatology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark. AD - Massachusetts General Hospital, Harvard Medical School Boston, Boston, United States. FAU - Hamzavi, Iltefat AU - Hamzavi I AD - Department of Dermatology, Henry Ford Hospital, Detroit, Michigan, USA. FAU - Hedelund, Lene AU - Hedelund L AD - Dermatology, Aarhus Universitetshospital, Aarhus, Denmark. FAU - Kelly, Kristen M AU - Kelly KM AD - Beckman Laser Institute, University of California, Irvine, California, USA. FAU - Kono, Tara AU - Kono T AD - Department of Plastic and Reconstructive Surgery, Tokai University School of Medicine, Isehera, Japan. FAU - Laubach, Hans Joachim AU - Laubach HJ AD - Dermatology and Venereology, Hopitaux Universitaires de Geneve, Geneva, Switzerland. FAU - Manuskiatti, Woraphong AU - Manuskiatti W AD - Faculty of Medicine Siriraj Hospital, Department of Dermatology, Mahidol University, Bangkok, Thailand. FAU - Marini, Leonardo AU - Marini L AD - Dermatology, SDC-The Skin Doctors' Center, Trieste, Italy. FAU - Nouri, Keyvan AU - Nouri K AD - Dermatology and Cutaneous Surgery, University of Miami School of Medicine, Miami, Florida, USA. FAU - Paasch, Uwe AU - Paasch U AD - University of Leipzig, Leipzig, UK. FAU - Passeron, Thierry AU - Passeron T AD - Dermatology, Centre Hospitalier Universitaire de Nice, Nice, Provence-Alpes-Cote d'Azu, France. FAU - Prinsen, Cecilia A C Sanna AU - Prinsen CACS AD - Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands. FAU - Verner, Ines AU - Verner I AD - Dermatology, Verner clinic, Tel Aviv, Israel. FAU - Wolkerstorfer, Albert AU - Wolkerstorfer A AD - Dermatology, Amsterdam UMC, Amsterdam, Noord-Holland, The Netherlands. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200628 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Consensus MH - Delphi Technique MH - Dermatology/*methods MH - Humans MH - Laser Therapy/*methods MH - Outcome Assessment, Health Care MH - Registries MH - Research Design MH - Stakeholder Participation PMC - PMC7322331 OTO - NOTNLM OT - dermatology OT - laser therapy OT - surgical dermatology COIS- Competing interests: None declared. EDAT- 2020/07/01 06:00 MHDA- 2021/02/16 06:00 PMCR- 2020/06/28 CRDT- 2020/06/30 06:00 PHST- 2020/06/30 06:00 [entrez] PHST- 2020/07/01 06:00 [pubmed] PHST- 2021/02/16 06:00 [medline] PHST- 2020/06/28 00:00 [pmc-release] AID - bmjopen-2020-038145 [pii] AID - 10.1136/bmjopen-2020-038145 [doi] PST - epublish SO - BMJ Open. 2020 Jun 28;10(6):e038145. doi: 10.1136/bmjopen-2020-038145.