An observational study in Pressure Injury, sponsored by European Society of Intensive Care Medicine. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by European Society of Intensive Care Medicine · Observational
The objective of this study is to provide an up-to-date, global picture of the extent and patterns of pressure injuries in ICUs. Point prevalence studies are only of value when performed on a vast scale. To sample a representative cohort, it is the intention to recruit about 1200 ICUs with all continents covered and as many countries as possible within each continent.
The objective is to provide an up-to-date, international "global" picture of the extent and patterns of pressure injuries in ICUs. Thereto , the plan is to perform a 1-day, prospective, multicenter point-prevalence study. The large scale of the project should allow thorough epidemiological analyses. More precisely the study will enable to identify:
Pressures ulcer stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel.
Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure ulcers.
Statistical Plan
Power Calculation. For a risk factor with a prevalence in the study cohort of only 10% (for example patients with a BMI\<20) and an outcome difference of only 5% to be statistically significant(15% vs. 20% in decubitus occurrence rate), a sample size of 5255 patients is required (478 patients with the index risk factor and 4777 without) (alpha=0.05; Beta>0.80).
Data cleaning \&missing data. Exceptional values will be traced through distribution plotting. In case of uncertainties, the individual investigators will be contacted. Missing data will be handled by imputation (1, 2). Data quality checks will be performed, such as checks on completeness, consistency, correctness, and uniqueness.
Descriptives. A single final analysis is planned at the end of the study; no interim analyses are planned. Socio-demographic study cohort characteristics will be described as proportions for categorical variables and for continuous variables as mean and standard deviation if normally distributed or median and inter-quartile range if not normally distributed (according to the Kolmogorov-Smirnov test for normality).
The proportion of patients with decubitus (percentage, %, and their 95% confidence intervals) will be reported overall and according to geographic region (continent), country classification by income as defined by The World Bank (high-, upper-middle-, lower-middle-, and low-income countries), percentage of the gross domestic product spent on healthcare (obtained from the World Health Organization), and according to theEducation and Health Human Development Report of the United Nations Development Program. Subsequently, potentialdifferences in prevalence might offer the opportunity to evaluate variances in prevention measures on a large scale.
Modelling. Covariates that will be evaluated on their relationship with the presence of decubitus encompass various organizational aspects of the ICU (e.g. nurse-to-patient ratio), decubitus prevention measures (e.g. type of matrasses used), and patient-specific characteristics (e.g. age, underlying conditions, severity of acute illness, body morphology, BMI,length of ICU stay etc.). Covariates will be considered for adjusted analysis when they have an association with pressure injuries at a statistical level \<0.25 in unadjusted (univariate) analysis or because of their clinical relevance. A stepwise approach willbe used to eliminate terms from the regression model; p\<0.15 or p\<0.10 will beset as the limit to keep covariates in the model.
Relationships with binary outcome variables (e.g. decubitus, mortality) will be assessed by means of unadjusted statistical tests and multivariate logistic regression. The value of additional propensity score correction in the regression model will be assessed. Multinomial logistic regression will be performed to assess independent relationships with decubitus stages. Likewise, linear mixed-effect modelling will be used to assess unadjusted and adjusted relationships with continuous outcome variables (e.g. length of ICU stay and length of hospitalization). Results of logistic regression will be reported as adjusted odds ratios with 95% confidence intervals.
To develop a decubitus prediction model for distinct ICU populations (e.g., trauma, surgical or medical patients) models will be build using machine learning techniques (e.g. Random Forest, Gradient Boosting Machine). In the process different techniques will be applied in order to receive the optimal accuracy. In order to gain insight in the correlation between predictors and variables, regression techniques will be applied, as state above.
For validation of our models the study cohort will be split into a training, test and validation set. As such this gives a fair interpretation of the results. Alternatively ten-fold cross-validation can be applied to prevent overfitting.
Benchmarking for individual centers based on decubitus will be performed by providing directly or indirectly standardized risks based on fixed center effects in a logistic regression model (3, 4). Besides the presence of the binary quality outcome (i.e. decubitus) and the center code, this model also includes patient-specific baseline co-variates to adjust for differential case-mix. The Firth correction will be applied to the logistic regression model to maintain convergence in the presence of very small centers (5).
Statistical analysis will be performed using SPSS and R. The head investigator (SB) is responsible for all statistical analysis. Advanced statistical methods will be executed byMiekeDeschepper (Strategic Policy Cell at Ghent University Hospital).
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 13,340 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →European Society of Intensive Care Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.
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All , adult ICU patients present in the ICU.
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Exclusion Criteria:
major risk factors for pressure injury development.
Pressures injury stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance. Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure injuries.
Time frame: on the data collection day of 18 May 2018 (84 days follow-up)
Ran from May 2018 to primary completion in Dec 2018, 7 months.
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European Society of Intensive Care Medicine