Keywords
Pediatric Intensive Care, P-SOFA Score, Morbidity Prediction, Mortality Prediction, Pediatric Organ Dysfunction, Central India PICU Study
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Malik A and Taksande A. Paediatric sequential organ failure assessment score (p-SOFA) as an outcome predictor in critically ill children admitted to a paediatric intensive care unit in a tertiary care hospital in central India. [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:348 (https://doi.org/10.12688/f1000research.144114.1)
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Study Protocol
Paediatric sequential organ failure assessment score (p-SOFA) as an outcome predictor in critically ill children admitted to a paediatric intensive care unit in a tertiary care hospital in central India.
[version 1; peer review: awaiting peer review]
PUBLISHED 23 Apr 2024
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Aashita Malik
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2024 Malik A and Taksande A.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Malik A and Taksande A. Paediatric sequential organ failure assessment score (p-SOFA) as an outcome predictor in critically ill children admitted to a paediatric intensive care unit in a tertiary care hospital in central India. [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:348 (https://doi.org/10.12688/f1000research.144114.1)
First published: 23 Apr 2024, 13:348 (https://doi.org/10.12688/f1000research.144114.1)
Latest published: 23 Apr 2024, 13:348 (https://doi.org/10.12688/f1000research.144114.1)
Introduction
Pediatric intensive care units (PICUs) are pivotal in managing critically ill children providing specialised care and interventions for those facing life-threatening conditions. In this challenging and high-stakes medical environment, the ability to predict and assess the severity of illness and potential outcomes is paramount.1 The Pediatric Sequential Organ Failure Assessment (P-SOFA) score is an emerging tool designed to evaluate organ dysfunction in pediatric patients. It promises to aid healthcare providers in recognising and managing organ failure in this vulnerable population.2
Critically ill children in the PICU can present with diverse medical conditions, and their clinical status can rapidly evolve. The need for reliable and early predictors of morbidity and mortality is essential for timely and effective intervention.3 The P-SOFA score is designed to assess the function of critical organ systems, including the cardiovascular, respiratory, neurological, hepatic, renal, and haematological systems. By quantifying the extent of organ dysfunction, the P-SOFA score offers a valuable tool to assist healthcare professionals in making informed clinical decisions.4
This prospective observational study seeks to investigate the efficacy of the P-SOFA score as an outcome predictor for critically ill children in the PICU. By assessing its ability to predict morbidity and mortality in this specific patient population, we aim to contribute to the knowledge surrounding using P-SOFA scores in pediatric critical care. This study is conducted at the Department of Pediatrics in Jawaharlal Nehru Medical College and AVBRH, Sawangi, Wardha, Central India, where a diverse range of critically ill pediatric patients are managed.
The findings of this research have the potential to significantly impact clinical practice, offering a more accurate and timely assessment of the severity of illness and prognosis in critically ill children. Ultimately, this may lead to improved patient care and outcomes in the PICU, not only in Central India but also, by extension, in pediatric critical care units worldwide.
Aim
To study the P-SOFA score as an outcome predictor for critically ill children in the Pediatric Intensive Care Unit (PICU).
Objectives
1. Evaluate the P-SOFA Score as a predictor of morbidity in critically ill pediatric patients.
2. Examine the P-SOFA Score as a predictor of mortality in critically ill pediatric patients.
3. Investigate the effectiveness of the delta SOFA (ΔSOFA) in forecasting outcomes in children admitted to the PICU.
4. Compare the P-SOFA score with the Pediatric Logistic Organ Dysfunction Score (PELOD2) as a predictor of mortality in the PICU.
Study population
The study will include pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at the Department of Pediatrics, Jawaharlal Nehru Medical College and AVBRH, Sawangi, Wardha, Central India.
Place of study
The study will be conducted at the Department of Pediatrics, Jawaharlal Nehru Medical College and AVBRH, Sawangi, Wardha, Central India.
Inclusion criteria
1. Pediatric patients aged one month to 17 years.
2. Patients admitted to the Pediatric Intensive Care Unit (PICU).
3. Patients with a PICU duration exceeding 24 hours.
4. Patients exhibiting pediatric multiple organ dysfunction syndrome (MODS), characterised by the failure of more than one organ system, regardless of the underlying cause.
Bias
1. Selection bias: The study could have potential selection bias due to the inclusion criteria. If certain groups of pediatric patients are more likely to be admitted to the PICU or meet the inclusion criteria, this could introduce bias. Ensuring that the inclusion criteria are applied consistently to all eligible patients is essential to minimise selection bias.
2. Sampling bias: The study was conducted at a specific tertiary care hospital in Central India. This may introduce bias if this hospital’s patient population differs from the broader population. To address this, you should acknowledge the generalizability limitations in the study results and discuss their implications.
3. Measurement bias: The accuracy and consistency of measurements for the P-SOFA score and other variables are critical. Any measurement errors or inconsistencies in data collection could introduce measurement bias. To minimise this bias, ensure that the study team is adequately trained and follows standardised procedures for data collection.
Data collection
Patient enrollment: Eligible patients admitted to the Pediatric Intensive Care Unit (PICU) will be approached for informed consent to participate in the study. The inclusion of patients is crucial for the study’s success.
Demographic information: The first step in data collection involves recording demographic data. This includes age, gender, and relevant medical history. This information will be recorded on a predefined data collection form.
Clinical assessment: Within the initial 24 hours of admission to the hospital, a thorough clinical evaluation will be conducted. This assessment encompasses a detailed physical examination, monitoring of vital signs, and the evaluation of specific organ-related parameters.
Laboratory investigations: Various laboratory tests will be carried out to assess organ function. These tests include a Complete Blood Count (CBC), Liver Function Tests (LFT), Kidney Function Tests (KFT), C-reactive protein (CRP), Erythrocyte Sedimentation Rate (ESR), Coagulation Profile, and Arterial Blood Gas (ABG). These investigations provide crucial insights into the patient’s condition.
SOFA score calculation: The Sequential Organ Failure Assessment (SOFA) score will be calculated at two distinct time points5:
• SOFA1: This score is calculated at the time of admission to the PICU.
• SOFA2: A second SOFA score will be determined 48 hours after admission to the PICU. This will allow for a comparison of the patient’s condition over time.
Treatment documentation: Detailed records of the treatment received by the patient will be meticulously documented. This includes the specifics of ionotropic infusions, any instances of renal replacement therapy, the patient’s ventilation status (if applicable), the number of days spent on a ventilator, and the length of stay in the ICU.
Follow-up: The study will involve followup assessments to gather additional relevant data, ensuring a comprehensive and accurate representation of each patient’s journey.
Outcome
1. Morbidity assessment: The study aims to evaluate the P-SOFA score as a predictor of morbidity in critically ill pediatric patients. It seeks to determine whether a higher P-SOFA score on admission correlates with a greater risk of morbidity, such as more extended hospitalisation, increased need for organ support, or the development of complications.
2. Mortality assessment: Another critical objective is to examine the P-SOFA score as a predictor of mortality in critically ill pediatric patients. The study aims to establish whether a higher P-SOFA score on admission is associated with increased mortality risk during the PICU stay. This assessment will provide valuable insights into the utility of the P-SOFA score as a tool for the early identification of patients at higher risk of death.
3. ΔSOFA analysis: The study investigates the effectiveness of the change in SOFA scores (ΔSOFA) in forecasting outcomes for children admitted to the PICU. By comparing the initial P-SOFA score (SOFA1) with a subsequent score (SOFA2) obtained 48 hours after admission, the research seeks to understand how changes in organ function over this period relate to patient outcomes.5
4. Comparison with PELOD2: The study also compares the P-SOFA score with the Pediatric Logistic Organ Dysfunction Score 2 (PELOD2) as a predictor of mortality in the PICU. This comparison will provide insights into which scoring system may be more accurate in predicting patient outcomes.6
Statistical method
A range of statistical methods will be employed to analyse the data collected from our investigation into the effectiveness of the Pediatric Sequential Organ Failure Assessment Score (P-SOFA) as an outcome predictor for critically ill children in the Pediatric Intensive Care Unit (PICU). The statistical approach will provide valuable insights into the relationships between the P-SOFA score and critical outcomes, specifically morbidity and mortality.
Descriptive statistics will summarise the data, offering an overview of the study population and critical variables. Bivariate analysis will assess associations, employing t-tests and chi-squared tests to examine relationships between variables. Multivariate analysis, including logistic and linear regression, will help us understand the independent predictive value of the P-SOFA score while accounting for potential confounders.
Survival analysis techniques like Kaplan-Meier survival curves and Cox proportional hazards models will be applied for time-to-event outcomes, such as survival rates. Receiver Operating Characteristic (ROC) analysis will gauge the accuracy of the P-SOFA score in predicting outcomes. Furthermore, we will conduct a comparative analysis to evaluate the P-SOFA score’s performance in predicting mortality compared to the Pediatric Logistic Organ Dysfunction Score 2 (PELOD2), utilising statistical tests and Bland-Altman analysis to assess agreement and differences between the two scoring systems.
All statistical analyses will be done using specialised software tools such as SPSS version 23, facilitating data manipulation, modelling, and visualisation. Through these statistical methods, we aim to comprehensively and rigorously examine the P-SOFA score’s utility in predicting outcomes, offering valuable insights for pediatric critical care practices and research.
Ethical considerations
The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2022/1077. Date: 27-06-2022). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.
Discussion
As explored in this prospective observational study, the Pediatric Sequential Organ Failure Assessment (P-SOFA) score represents a promising tool for evaluating organ dysfunction in critically ill pediatric patients in the Pediatric Intensive Care Unit (PICU).
Prognostic value of P-SOFA score: The study findings underscore the prognostic value of the P-SOFA score in the PICU. The P-SOFA score, calculated at admission, is valuable in predicting patient outcomes. This is consistent with previous research that has demonstrated the predictive power of the SOFA score in adult populations.7 The P-SOFA score’s ability to quantify organ dysfunction and correlate it with clinical outcomes in critically ill children holds significant clinical implications.
Early identification of high-risk patients: One of the primary strengths of the P-SOFA score is its ability to identify high-risk patients early in their PICU stay. By quantifying the degree of organ dysfunction, clinicians can prioritise interventions and resources for patients at greater risk of morbidity or mortality. This early identification is crucial for timely and appropriate management and may improve patient outcomes.8
Comparative analysis with PELOD2: The comparative analysis of the P-SOFA score with the Pediatric Logistic Organ Dysfunction Score 2 (PELOD2) adds depth to the discussion.9 The findings of this study will allow us to evaluate the performance of these two scoring systems in predicting mortality in the PICU. This information is invaluable for clinicians, as it aids in choosing the most appropriate scoring system for risk assessment in a given patient population.
Clinical decision-making and resource allocation: When validated for pediatric critical care, the P-SOFA score can be a valuable adjunct in clinical decision-making. It will offer a quantitative approach to assessing the severity of illness, which can inform decisions regarding the allocation of resources, intensification of monitoring, and treatment strategies.10
Limitations and future research: It is essential to acknowledge the limitations of this study. While the results are promising, the study is subject to the constraints inherent in observational research. Future research may benefit from larger sample sizes and the inclusion of diverse patient populations to validate the findings further. Moreover, long-term follow-up and assessing other clinically relevant outcomes could enhance our understanding of the P-SOFA score’s utility in pediatric critical care.
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how to cite this article
Malik A and Taksande A. Paediatric sequential organ failure assessment score (p-SOFA) as an outcome predictor in critically ill children admitted to a paediatric intensive care unit in a tertiary care hospital in central India. [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:348 (https://doi.org/10.12688/f1000research.144114.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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