Analysis of the efficacy/effectiveness outcomes of therapeutic interventions of randomized clinical trials for pressure ulcers in adults: systematic survey

• Grant number: 18/04413-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2018
• End date: June 30, 2019
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Luciana Patrícia Fernandes Abbade
• Grantee: Arthur Pollo Deonizio
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Introduction: Pressure ulcers (PU) have a high incidence level, mainly in hospitalization units . Randomized controlled trials (RCTs) of therapeutics interventions in PU require complete reporting of along with clear description of outcomes in the publication to minimize inconsistencies and promote good clinical attention practice based on the best scientific evidences .Objectives: The primary objective of this study is to assess the completeness of the descriptons of the outcomes of therapeutic interventions in RCTs in adult patients with PU. The secondary objectives include: types of reported primary outcomes, measurement methods or tools used to evaluate the outcomes and the quality of results of reported outcomes. Methods: We will conduct a systematic survey of RCTs published from January 2006 to April 2017. The selection process of the studies will be done in two stages of screening: title and abstract, and full text revision, always by two researchers independently. The completeness of the outcome will be according to the five elements: domain, specific technique, metrics of outcome data, aggregation method and time points that were used for analysis. The quality of the result of reported outcome will be classified as complete, incomplete and unreported outcome. It will be carried out a descriptive analysis of number, type and degrees of outcome specification in the included RCTs. The frequency of categories in each domain of the outcomes will also be report. Dissemination: This will be the first systematic research with analysis of the outcomes and quality of results of therapeutic interventions in pressure ulcers. After completion, this review will be submitted to a peer-reviewed biomedical journal for publication.