[version 1; peer review: 1 not approved]
No competing interests were disclosed.
Pleural infections pose a significant clinical challenge, with diverse outcomes that are often difficult to predict. The renal (urea), age, fluid purulence, infection source, dietary (albumin) (RAPID) score, a clinical tool designed to assess the risk of adverse outcomes in pleural infections, holds the potential as a prognostic indicator. This study aims to evaluate the prognostic value of the RAPID score in patients with pleural infections attending a tertiary care hospital in Central India. This hospital-based prospective cross-sectional observational study will span from July 2022 to June 2024, enrolling 50 adult patients aged 18 years and older admitted to the Department of Respiratory Medicine, a tertiary care hospital in central India. Data will be collected using a structured proforma, encompassing demographic data, clinical history, and comorbidities. Diagnostic investigations, including pleural fluid analysis, laboratory tests, sputum analysis, and radiological assessments, will be performed upon enrolment. RAPID scores will be calculated at admission, stratifying patients into low, medium, and high-risk categories. Treatment will follow established pleural infection protocols, with patients receiving empirical antibiotics and tailored treatment based on culture sensitivity results. Patients will be monitored for three months post-admission, and outcomes such as hospital stay duration, tube thoracostomy need, intercostal drainage tube duration, medical management success, surgical referral rates, surgical interventions, and 30-day and 90-day mortality rates will be assessed. This study aims to contribute valuable insights into the prognostic value of the RAPID score in pleural infections and factors influencing patient outcomes. The findings may facilitate more informed clinical decision-making and improve the management of pleural infections, ultimately enhancing patient care and outcomes.
Pleural infections, commonly called pleuritis or pleurisy, are inflammatory conditions affecting the pleura, the thin double-layered membrane surrounding the lungs and lining the chest cavity. These infections present a challenging clinical scenario characterised by a spectrum of etiologies, varied clinical presentations, and outcomes that range from mild and self-limiting to severe and life-threatening. Managing pleural infections demands a nuanced understanding of the disease process, prompt diagnosis, and appropriate therapeutic interventions.
Central to the effective management of pleural infections is the accurate assessment of disease severity and the prediction of clinical outcomes. Prognostic tools that can reliably stratify patients based on their risk of complications, such as prolonged hospitalisation, the need for invasive procedures like tube thoracostomy, or adverse events like mortality, are invaluable in guiding clinical decision-making and optimising patient care.
The renal (urea), age, fluid purulence, infection source, dietary (albumin) (RAPID) score (a risk score for adverse outcomes in pleural infection) has emerged as one tool designed to assist clinicians in assessing the risk of adverse outcomes in patients with pleural infections. It encompasses a set of clinical parameters that, when combined, generate a numerical score reflecting the patient's risk profile. While the RAPID score has shown promise in predicting outcomes in pleural infections, its utility in the specific context of Central India remains an open question. The region's unique patient demographics, disease patterns, and healthcare infrastructure may introduce variables that impact the score's accuracy and applicability.
This study endeavours to fill this critical knowledge gap by conducting a comprehensive investigation into the prognostic value of the RAPID score in patients with pleural infections attending a tertiary care hospital in Central India. By assessing the performance of the RAPID score in this specific population, we aim to provide valuable insights into its reliability as a prognostic tool and its potential role in optimising patient management strategies. The study also seeks to identify other factors that may influence patient outcomes in pleural infections, contributing to a more holistic understanding of this complex clinical entity.
Through rigorous data collection, analysis, and correlation with clinical outcomes, this research aspires to provide clinicians with a refined prognostic tool to enhance their ability to predict and manage pleural infections effectively. Ultimately, this pursuit of knowledge can improve patient care, reduce complications, and enhance healthcare delivery in the realm of pleural infections in Central India.
To assess the prognostic value of the RAPID score in patients with pleural infections attending a tertiary care hospital in Central India.
To determine the prognostic accuracy of the RAPID score in predicting outcomes of patients with pleural infections. To identify and analyse factors associated with poor outcomes, such as prolonged hospitalisation, the need for tube thoracostomy, surgical intervention, and mortality in patients with pleural infections.
This study will adopt a hospital-based prospective design, specifically a cross-sectional observational study.
The study will be conducted from July 2022 to June 2024. All eligible patients presenting with pleural infection at the Department of Respiratory Medicine, tertiary care hospital of central India, Wardha, will be considered for inclusion during this period.
The study population will comprise patients who present with pleural infection and meet the inclusion and exclusion criteria while seeking admission to the Department of Respiratory Medicine, Tertiary Care Hospital of Central India, Wardha.
A total of 50 patients will be included in the study. This sample size has been determined based on feasibility and available resources.
Adult patients aged 18 years or older. Patients diagnosed with pleural infection.
Patients who declined to participate in the study.
A structured proforma
Upon enrolment in the study, all patients will undergo an extensive battery of diagnostic investigations, including:
Pleural fluid will be aspirated using ultrasound guidance. The collected pleural fluid will undergo analysis, which includes assessment of total cell count, differential cell count, protein levels, glucose levels, lactate dehydrogenase (LDH) levels, adenosine deaminase (ADA) levels, acid-fast bacillus (AFB) staining, cartridge-based nucleic acid amplification test (CBNAAT) or true nucleic acid amplification test (truNAAT), gram staining, culture sensitivity testing, and cytological examination.
A complete blood picture (CBC) will be conducted. Renal function tests (RFT), liver function tests (LFT), random blood sugar (RBS), serum albumin levels, and HIV screening will also be performed.
Sputum samples will be obtained for CBNAAT/truNAAT testing, gram staining, and culture sensitivity analysis.
Chest X-rays will be performed as a standard procedure. If clinically indicated, computed tomography (CT) scans of the chest will also be conducted.
RAPID scores will be calculated for each patient upon admission. Based on their calculated scores, these scores will be used to classify patients into risk groups, including low, medium, and high risk.
Patients will receive treatment per the standard protocol for managing pleural infections. This includes:
Empirical antibiotics: Patients will receive an initial course of empirical antibiotics, with subsequent adjustments based on the results of culture sensitivity testing. Initial antibiotic regimens may include penicillins with β-lactamase inhibitors or cephalosporins in conjunction with metronidazole or clindamycin. Tuberculosis patients will be treated with anti-tubercular therapy (ATT). Tube thoracostomy: Patients who require tube thoracostomy will undergo this procedure as needed, as determined by clinical evaluation.
Patients will be closely monitored over three months following admission. The study's primary outcomes will be assessed, including:
Length of hospital stay. Incidence of tube thoracostomy. Duration of intercostal drainage tube placement. Success or failure of medical management. Rates of surgical referrals and interventions. Mortality rates at 30 days (1 month) and 90 days (3 months).
Bias: Patients who consent to participate in the study may differ systematically from those who do not, leading to a biased sample. Overcoming bias: To minimise selection bias, ensure a representative sample by striving for consecutive enrolment of eligible patients. Additionally, conduct sensitivity analyses to assess the impact of potential selection bias on the results.
Bias: Errors or inaccuracies in measuring variables, such as laboratory tests, can introduce bias. Overcoming bias: Implement rigorous quality control procedures for data collection and measurement. Standardise procedures and use well-validated instruments and methods. Regularly calibrate equipment and train personnel involved in data collection.
Bias: Patients or healthcare providers may have difficulty recalling past events or may selectively remember information, leading to recall bias. Overcoming bias: Minimize recall bias by collecting data prospectively whenever possible. Use structured questionnaires and electronic medical records to reduce reliance on memory. Ensure that patients are interviewed or examined by personnel blinded to the study objectives.
Bias: Incomplete or missing data can introduce bias if certain patients are more likely to have missing data. Overcoming bias: Implement comprehensive data collection procedures and strive for complete data capture. Use appropriate statistical methods to handle missing data, such as multiple imputation or sensitivity analyses.
In this study protocol investigating the prognostic value of the RAPID score in pleural infections, various statistical methods will be employed to analyse the collected data and extract meaningful insights. Descriptive statistics will be used to summarise patient demographics and clinical variables, including mean, median, standard deviation, and frequency distributions. Bivariate analyses will explore associations between the RAPID score and different clinical outcomes and factors, employing statistical tests appropriate for the data type. Multivariate analyses, encompassing regression models, will assess the independent prognostic significance of the RAPID score while accounting for potential confounding variables. Survival analysis techniques like Kaplan-Meier curves and Cox proportional hazards regression will be applied for time-to-event outcomes. Receiver Operating Characteristic (ROC) analysis will gauge the RAPID score's discriminative ability. Subgroup and sensitivity analyses will be conducted to investigate variations in prognostic value and the robustness of the results.
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/2022/18). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study's objectives.
After the completion of the study, we will publish it in an indexed journal or conference.
The study has not yet started. After the publication of the protocol, we will start recruitment for the study.
Pleural infections, although relatively common, remain a diagnostic and therapeutic challenge due to their diverse etiologies, varied clinical presentations, and unpredictable outcomes.
The RAPID score, designed as a risk assessment tool for pleural infections, comprises easily accessible clinical parameters that aim to predict adverse outcomes such as prolonged hospitalisation, the need for invasive procedures, and mortality. The assessment of this score at admission allowed us to classify patients into low-, medium, and high-risk groups.
The findings of this study will offer insights into the utility of the RAPID score in this specific demographic and clinical context. The ability of the score to reliably identify patients at higher risk of adverse outcomes can significantly impact clinical decision-making. For instance, it can aid in prioritising resources for high-risk patients, intensifying monitoring, and guiding the choice and timing of therapeutic interventions.
Beyond the RAPID score, this study aims to identify additional factors influencing patient outcomes in pleural infections. These factors may include comorbidities, microbial aetiology, response to empirical antibiotics, and specific radiological or laboratory findings. By analysing these variables with the RAPID score, we aim to provide a more comprehensive understanding of the complex interplay of factors in pleural infection management.
The results of this study can have important clinical implications. If the RAPID score is a reliable prognostic tool in Central India, it can be integrated into routine clinical practice, aiding in risk stratification and resource allocation. This, in turn, can contribute to improved patient outcomes and resource utilisation in managing pleural infections.
Several limitations should be acknowledged in this study. The relatively modest sample size of 50 patients may affect the generalizability of the findings. Additionally, the study's single-center design may limit the external validity of the results. Moreover, the complex nature of pleural infections, which can involve various pathogens and clinical presentations, may introduce heterogeneity that necessitates careful consideration during data analysis.
No underlying data are associated with this article.
Zenodo: A cross-sectional study on the prognostic value of rapid score in pleural infection in patients attending tertiary care hospital of central India.
This project contains the following extended data:
Tool.docx (Patient Information and Data Collection Proforma)
Data are available under the terms of the
The scoring system may be detailed, including cut-offs for different categories.
Since it is yet to be validated for India, there is a need for comparison with the existing standard/ gold standard.
The part on bias is theoretical and may be omitted.
“The study will be conducted from July 2022 to June 2024. All eligible patients presenting with pleural infection at the Department of Respiratory Medicine, tertiary care hospital of central India, Wardha, will be considered for inclusion during this period.” and “A total of 50 patients will be included in the study” – these two sentences are not similar.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Reviewer Expertise:
Public Health
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.