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

Wound 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.

Prevalence of pressure injury and associated factors in hospitalized adult patients with cancer.

INTRODUCTION: Hospitalized cancer patients experience limitations in their daily activities resulting from the severity of their condition. Such changes alter patients' sensory perception and hinder their mobility, thus predisposing them to the development of PI. OBJECTIVE: The goal of this study was to analyze the prevalence of PI and associated factors in hospitalized cancer patients. MATERIALS AND METHODS: This observational, epidemiological, cross-sectional, descriptive study was carried out in the inpatient and ICU settings of an oncological hospital in São Paulo, Brazil. RESULTS: A total of 341 patients who met the inclusion criteria and agreed to participate in the study were interviewed and assessed. Data obtained in the interviews were analyzed for logistic regression analysis. Pressure injury prevalence was 10% (34 patients). The use of disposable diapers was significantly associated with the development of PI, with a 6.077 increased chance of PI in such patients in the ICU setting. In this epidemiologic study of 341 hospitalized cancer patients, the prevalence of PI was 10%. The use of disposable diapers was the only factor associated with the presence of PI after logistic regression analysis. CONCLUSION: Knowing the risk factors of this specific population was essential to implement actions and optimize indications of disposable diaper use. There is an absence of epidemiologic records due to limited publications available on the subject; creating a program to prevent PI development within the inpatient, assisted population.