Computational protocol: ACS network-based implementation of therapeutic hypothermia for the treatment of comatose out-of-hospital cardiac arrest survivors improves clinical outcomes: the first European experience

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Protocol publication

[…] Based on the data obtained by Knafelj et al. [] in a similar population of OHCA survivors, we assumed the occurrence of the primary study end point (i.e. hospital survival with a favourable neurological outcome with CPC-1 and CPC-2), in 55% and 16% of patients treated with and without MTH, respectively. With these assumptions it was calculated before the enrolment of both control and MTH group patients that it takes at least 30 patients per group to demonstrate the significance of the difference in the occurrence of the primary study end point between patients treated with and without MTH, allowing for 90.5% power with a 2-sided alpha value of 0.05. To compensate for potential loss of study participants due to various reasons, we enrolled 5 additional patients.The Shapiro-Wilk test was applied to verify normal distribution of the investigated continuous variables. Continuous variables were presented as mean values ± standard deviations or medians and their interquartile ranges depending on the presence or absence of normal distribution. Therefore inter-group comparisons were performed with Student’s t test for independent samples or the Mann–Whitney unpaired rank sum test when appropriate. Categorical variables were expressed as the number of patients presenting the given feature and the percentage of patients in the analysed group. Categorical variables were compared using the χ2 test with the Yates’ correction if required.Univariate and multivariate logistic regression models were used to identify predictors of efficacy end points. Variables with a p-value of ≤0.1 in the univariate analysis were introduced into the multivariate logistic regression model. Subsequently, variables with no significant impact on the prevalence of efficacy end points (p ≥ 0.05) were one by one removed from the multivariate model according to their decreasing p-values. Relations between investigated variables and the likelihood of efficacy end points were estimated with the use of odds ratios (OR) with 95% confidence intervals (95% CI). Optimal cut-off points were determined using the receiver operator characteristic (ROC) analysis. Additionally, for end points for which the difference in their occurrence between patients treated with and without MTH reached statistical significance, we calculated the NNT and its 95% CI.Two-sided differences were considered significant at p < 0.05. The statistical analysis and sample size calculation were carried out using the Statistica 10.0 package (StatSoft, Tulsa, OK, USA), while MedCalc 12.0 (MedCalc Software, Mariakerke, Belgium) statistical software was used for the ROC analysis. […]

Pipeline specifications

Software tools Statistica, MedCalc
Application Miscellaneous
Organisms Homo sapiens
Diseases Diabetic Angiopathies, Heart Arrest, Pneumonia, Thrombosis, Acute Coronary Syndrome