Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review

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Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorMcMaster University-
Autor(es): dc.creatorMiranda, Jéssica Steffany-
Autor(es): dc.creatorAbbade, Luciana P. F.-
Autor(es): dc.creatorAbbade, Joelcio Francisco-
Autor(es): dc.creatorThabane, Lehana-
Autor(es): dc.creatorMbuagbaw, Lawrence-
Autor(es): dc.creatorPascon, Gisele Chicone-
Autor(es): dc.creatorCampanili, Ticiane Carolina Gonçalves Faustino-
Autor(es): dc.creatorSantos, Larissa Paula-
Autor(es): dc.creatorde Gouveia Santos, Vera Lúcia Conceição-
Data de aceite: dc.date.accessioned2025-08-21T22:53:40Z-
Data de disponibilização: dc.date.available2025-08-21T22:53:40Z-
Data de envio: dc.date.issued2025-04-29-
Data de envio: dc.date.issued2024-01-31-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1111/iwj.14351-
Fonte completa do material: dc.identifierhttps://hdl.handle.net/11449/303419-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/303419-
Descrição: dc.descriptionWound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.-
Descrição: dc.descriptionResearch Group in Enterostomal Therapy: stomas acute and chronic wounds and urinary and anal incontinences. School of Nursing University of São Paulo-
Descrição: dc.descriptionDepartment of Dermatology and Radiotherapy São Paulo State University Julio de Mesquita Filho - Faculty of Medicine, Botucatu Campus-
Descrição: dc.descriptionDepartment of f Gynecology and Obstetrics São Paulo State University Julio de Mesquita Filho - Faculty of Medicine, Botucatu Campus-
Descrição: dc.descriptionDepartment of Health Research Methods Evidence and Impact (HEI) McMaster University-
Descrição: dc.descriptionDepartment of Dermatology and Radiotherapy São Paulo State University Julio de Mesquita Filho - Faculty of Medicine, Botucatu Campus-
Descrição: dc.descriptionDepartment of f Gynecology and Obstetrics São Paulo State University Julio de Mesquita Filho - Faculty of Medicine, Botucatu Campus-
Idioma: dc.languageen-
Relação: dc.relationInternational Wound Journal-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectpressure injury-
Palavras-chave: dc.subjectrandomized clinical trial-
Palavras-chave: dc.subjectreview-
Palavras-chave: dc.subjecttreatment outcome-
Palavras-chave: dc.subjectvalidity of results-
Título: dc.titleDeficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review-
Tipo de arquivo: dc.typevídeo-
Aparece nas coleções:Repositório Institucional - Unesp

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