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
Open Access
- 28 June 2020
- Vol. 10 (6), e038145
- https://doi.org/10.1136/bmjopen-2020-038145
Abstract
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.Funding Information
- European Academy of Dermatology and Venereology (reference number 2017-035)
This publication has 23 references indexed in Scilit:
- Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’Trials, 2014
- The comet initiativeTrials, 2013
- A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapseTrials, 2013
- Developing core outcome sets for clinical trials: issues to considerTrials, 2012
- Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerationsQuality of Life Research, 2011
- GRADE guidelines: 3. Rating the quality of evidenceJournal of Clinical Epidemiology, 2011
- Standardising outcomes for clinical trials and systematic reviewsTrials, 2007
- Masers to magic bullets: an updated history of lasers in dermatologyClinics in Dermatology, 2007
- Lasers in dermatology: Four decades of progressJournal of the American Academy of Dermatology, 2003
- Qualitative Research: Consensus methods for medical and health services researchBMJ, 1995