Derivation and Validation of the Extended Care (Ex-Care) Model II

Study Overview
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Brief Summary
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The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is: •Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery? Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death). The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.

Detailed Description
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From four predictors collected preoperatively ( American Society of Anesthesiology Physical Status (ASA-PS) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the Ex-Care II model. Discrimination and calibration measures will be used to determine the accuracy of the model. In addition, each predictor will have their odds ratio calculated for the study outcome. Once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.

Official Title
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Derivation and Validation of a National Multicenter In-hospital Mortality Risk Stratification Model - the Ex-Care Model II

Conditions
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Postoperative Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study Exclusion Criteria: Diagnostic procedures, with sedation only or with local anesthesia Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Derivation Cohort<br>The derivation cohort will correspond to approximately 70% of the total sample to be analyzed in the study. The Ex-Care II risk model will build upon it. It is composed of patients operated in the participating institutions. | |
| Validation Cohort<br>Composed of the remaining 30% of the sample. It will be used for the external validation of the Ex-Care II model | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop and validate a model for predicting the risk of in-hospital death within 30 days postoperatively, from a sample composed of patients operated in Brazil | From four predictors collected preoperatively, the developed model will be able to estimate the probability of in-hospital death of patients undergoing surgery in Brazilian hospitals. For the creation of this tool, multilevel logistic regression will be made with hospital as a random effect | Surgery day up to 30 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop smartphone application contemplating the new model developed | In order to facilitate the use of the Ex-Care II model by health professionals involved in perioperative care, it will be created and made available on the main platforms for smartphones application that will allow the measurement of surgical risk by this new tool. | Preoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk assessement, validation study, postoperative, mortality