Systematic survey of pilot trials in Dermatology: a study protocol

• Grant number: 18/26427-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: June 01, 2019
• End date: May 31, 2020
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Luciana Patrícia Fernandes Abbade
• Grantee: Dirce Bortolosso da Silva
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Pilot or feasibility trial is defined as a small-scale study with the purpose of testing the viability of methods and procedures to be used in the design or conduct of a large-scale definitive trial. To be useful, a well-planned pilot trial must be completely and transparently reported. However, research shows that many pilot trials are poorly reported, leading to potential challenges in understanding the results of feasibility investigations and their implications for the future. Aims: to evaluate the quality of pilot trials published in dermatology and to explore the elements associated to the completeness of reporting. Methods:- Design: a systematic survey of published pilot studies.- Search strategy: we will search in the National Institutes of Health, PubMed for pilot trials published between January/2012 and July/2018, using a specific search strategy for the topic. The selection of the articles will be accomplished by a pair of independent reviewers via the reading of their title and abstract.- Inclusion criteria: randomized clinical trials published in English, within the domain of dermatology, containing the term pilot/feasibility study in their title, abstract or full text. - Data extraction: the data extraction of each selected article will be performed using a standardized spreadsheet. Two reviewers will extract the data and any discordance will be resolved by consensus. Then, the included articles will enter an assessment of their adequacy to the five major key points from the CONSORT Statement in pilot studies: I) title or abstract indicates it is a pilot study; II) objectives certify feasibility; III) outcomes assess feasibility; IV) success criteria to engage in a large-scale definitive trial and V) intention to move on to a major study.- Outcome: the primary outcome will be the percentage of studies that relate properly to all five key points.- Statistical analysis: we will use generalized estimating equations to determine if some factors as journal impact factor in the year of publication of the article, endorsement of the journal to the CONSORT Statement for clinical trials or pilot studies, date of publication, study funding (industry, government or unfunded) and pharmacological interventions will be associated to the completeness of reporting of the five points mentioned before. The program Statistical Package for Social Sciences (SPSS) version 22.0 (SPSS, Inc., 2009, Chicago, Illinois, EUA) will examine the data. Ethics and Dissemination: this will be the first systematic survey on the adequacy of pilot trials in dermatology. After its conclusion, this review will be submitted to peer reviewed journals.