Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Trials

Stefanie Deckert¹  Jochen Schmitt¹  Karina C. Furlan²  Emily Poon²  Brian R. Chen²  Victoria Godinez-Puig²  Murad Alam²  Arianna F. Yanes²  Daniel I. Schlessinger²  Sanjana Iyengar²  Sarah G. Chiren²  Todd V. Cartee³  Joseph F. Sobanko⁴  Ian A. Maher⁵  Anastasia O. Kurta⁵ 

[1] Centre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden;Department of Dermatology, Feinberg School of Medicine, Northwestern University;Department of Dermatology, Penn State Health, Milton S. Hershey Medical Center;Department of Dermatology, Perelman Center for Advanced Medicine, Hospital of the University of Pennsylvania;Department of Dermatology, St. Louis University School of Medicine;

关键词: Core outcome set;    Delphi;    Consensus;    Stakeholders;    Squamous cell carcinoma;    Systematic review;   

DOI  :  10.1186/s13063-017-2069-2

来源: DOAJ

【 摘 要 】

Abstract Background Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Methods/design Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Discussion Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

【 授权许可】

Unknown