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Study Protocol

A prospective observational comparative study to compare the diagnostic efficacy of the Fenyo Lindberg scoring system and Yash scoring system in patients of acute appendicitis in tertiary care hospitals in central India

[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 20 May 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Acute appendicitis is a typical surgical emergency requiring prompt and accurate diagnosis for timely intervention. This prospective observational comparative study aims to assess the diagnostic efficacy of two scoring systems, the Yash scoring system and the Fenyo-Lindberg scoring system, compared to the gold standard of histopathological diagnosis. The study is conducted at A.V.B.R.H., a tertiary care hospital in Central India, focusing on providing valuable insights into the comparative performance of these scoring systems in the local patient population.

Methods

The study adopts a prospective observational comparative design, enrolling clinically diagnosed cases of acute appendicitis from the outpatient and inpatient departments of the Surgery department at A.V.B.R.H. Patients willing to undergo surgery are included. At the same time, those with complicating factors or contraindications are excluded. Data collection involves thorough clinical evaluations, scoring system assessments, and comprehensive investigations, with histopathology as the reference standard. Statistical analyses include descriptive statistics, comparative analyses, primary outcome assessments, and regression analyses, ensuring a robust evaluation of the diagnostic efficacy of the scoring systems.

Expected Outcome

Anticipated outcomes include a comprehensive understanding of the diagnostic efficacy of the Yash and Fenyo-Lindberg scoring systems in acute appendicitis. The study aims to identify which scoring system demonstrates superior accuracy, sensitivity, and specificity, providing valuable information for clinical decision-making. The results will contribute to optimizing diagnostic protocols for acute appendicitis, potentially influencing patient management and surgical interventions. This study’s findings are expected to be relevant to the local setting and broader contexts, enhancing the knowledge surrounding acute appendicitis diagnosis.

Keywords

Acute Appendicitis, Diagnostic Efficacy, Scoring Systems, Histopathological Diagnosis, Comparative Study, Tertiary Care Hospital

Introduction

Acute appendicitis remains a typical surgical emergency globally, necessitating timely and accurate diagnosis for appropriate clinical management.1 While clinical evaluation plays a pivotal role in the diagnosis, scoring systems have been developed to aid in the stratification of patients and guide decision-making regarding surgical intervention. Among these, the Yash scoring system2 and the Fenyo-Lindberg scoring system3 have gained attention for their potential diagnostic efficacy. However, a comparative assessment of these scoring systems in acute appendicitis is essential to discern their strengths and limitations.

The Yash scoring system incorporates multiple clinical parameters, including migration of pain, nausea, and vomiting, anorexia, tenderness in the right iliac fossa, rebound tenderness, hyperesthesia in Sherren’s triangle, fever, elevated white blood cell count, and C-reactive protein levels, as well as ultrasonography results.2 On the other hand, the Fenyo-Lindberg scoring system encompasses components such as total leukocyte count, duration of pain, progression of pain, aggravation of pain by coughing, vomiting, migration of pain, rebound tenderness, rigidity of abdominal wall, and tenderness outside of the right lower quadrant.3 A critical evaluation comparing the diagnostic accuracy of these two scoring systems is imperative to inform clinical practice and enhance the precision of acute appendicitis diagnosis.

This prospective observational comparative study aims to systematically assess and compare the diagnostic efficacy of the Yash scoring system and the Fenyo-Lindberg scoring system in cases of acute appendicitis. The study design, inclusion criteria, and methodological details have been outlined to ensure the robustness and transparency of the investigation. Through this research endeavor, we seek to contribute valuable insights that may refine clinical decision-making processes in managing acute appendicitis.

Aim

To assess the diagnostic efficacy of the Yash scoring system and the Fenyo-Lindberg scoring system in cases of Acute Appendicitis.

Primary objective

To compare the diagnostic efficacy of the Yash scoring system and the Fenyo-Lindberg scoring system based on histopathological diagnosis of Acute Appendicitis.

Secondary objectives

  • 1. To evaluate cases of acute appendicitis using the Yash scoring system.

  • 2. To evaluate cases of acute appendicitis using the Fenyo-Lindberg scoring system.

Methods

Study design: This study will utilize a prospective observational comparative study design.

Study population: The study will include all clinically diagnosed cases of acute appendicitis, encompassing all age groups and both sexes. Patients willing to give consent for surgery will be considered for inclusion.

Place of study: The study will be conducted at A.V.B.R.H. (Acharya Vinoba Bhave Rural Hospital), Sawangi, Wardha, a tertiary care hospital in Central India. The data collection will take place in the outpatient department and the inpatient department (I.P.D.) of the Surgery department at the mentioned hospital.

Ethics and consent

The research protocol got approval from the Datta Meghe Institute of Higher Education and Research (Deemed to be University) Institutional ethical committee in the meeting held on 11-07-2022 (approval date) with DMIMS (DU)/IEC/2022/28. All the participants will be educated about the research, and written and verbal informed consent will be obtained from all the participants before the intervention.

Participants

Inclusion criteria:

  • 1. Patients clinically diagnosed with acute appendicitis.

  • 2. All age groups and both sexes will be considered.

  • 3. Patients are willing and provide consent for surgery.

Exclusion criteria:

  • 1. Patients diagnosed with Appendicular perforation, peritonitis, appendicular mass, or appendicular abscess.

  • 2. Patients diagnosed with appendicitis who have a confirmed history of connective tissue dysfunction.

  • 3. Pregnant women.

  • 4. Patients who are unfit or unwilling for surgery or have an unsound mind.

Sample size

The sample size for the study has been calculated to be 200 patients based on the formula:

n(Z(1α/2)2p(1p))/d2

Where:

  • α (alpha) = 0.05 (significance level, typically set at 0.05 for a 95% confidence level)

  • p (proportion) = 0.389 (the estimated proportion of surgical site infection in patients postoperatively as per the reference article)

  • d (estimated error) = 0.10 (10% margin of error)

By plugging in these values, get:

n(1.9620.389(10.389))/0.100.10=91.30

Procedure

The study will begin by identifying and approaching patients clinically diagnosed with acute appendicitis at A.V.B.R.H. in Sawangi, Wardha, a tertiary care hospital in Central India. Informed consent will be obtained from patients willing to participate in the study. A thorough clinical evaluation involving history taking and physical examination will be conducted for each participant. The Yash scoring system and the Fenyo-Lindberg scoring system will be employed to assess the severity of acute appendicitis.

Necessary investigations, including laboratory tests, imaging studies, and ultrasonography, will be performed to gather relevant data. Results from these investigations, such as white blood cell count, C-reactive protein levels, and imaging findings, will be recorded. Histopathology will be considered the gold standard for diagnosing acute appendicitis, and preoperative scores from the Yash and Fenyo-Lindberg scoring systems will be compared with histopathological findings.

Data collection will involve recording each participant’s demographic information, clinical findings, and scoring system results on a structured data collection form. Statistical methods, such as the chi-square test, mean, and standard deviation, will be utilized to analyze the relationship between variables. The sample size will be determined using the Cochran formula to ensure statistical validity.

Ethical considerations will be paramount throughout the study, with strict adherence to guidelines regarding patient confidentiality and the protection of participants’ rights. Quality control measures will be implemented to ensure the accuracy and reliability of collected data, with regular monitoring of the data collection process to address any issues promptly.

The study setting will encompass the outpatient and inpatient departments (I.P.D.) of the Surgery department at A.V.B.R.H., Sawangi, Wardha. Data analysis will involve using appropriate statistical tests to compare the diagnostic efficacy of the Yash and Fenyo-Lindberg scoring systems.

Comprehensive documentation of the study protocol, data collection procedures, and any deviations from the protocol will be maintained. The final step will involve preparing a detailed report summarizing the study findings, including comparisons of scoring systems and their diagnostic performance. Consideration will be given to publishing the results in a reputable medical journal to contribute to the existing body of knowledge. In conclusion, the study will draw insights based on its outcomes and provide recommendations for clinical practice or suggest avenues for further research.

Outcome measures

Primary outcome: The primary outcome of this study is the diagnostic efficacy of acute appendicitis, as assessed by a comparison between the Yash scoring system and the Fenyo-Lindberg scoring system, with histopathological diagnosis serving as the gold standard. The primary focus is determining which scoring system demonstrates superior accuracy in diagnosing acute appendicitis.

Secondary outcomes:

  • 1. Diagnostic performance of individual scoring components: Evaluate the performance of individual components within the Yash and Fenyo-Lindberg scoring systems. This assessment will provide insights into the specific criteria contributing most significantly to accurate diagnoses.4

  • 2. Comparison of sensitivity and specificity: Compare the sensitivity and specificity of the Yash and Fenyo-Lindberg scoring systems. Understanding the trade-off between sensitivity and specificity is crucial for practical clinical applications.

  • 3. Correlation with clinical presentation: Examine the correlation between the scoring systems and clinical presentations of acute appendicitis. This secondary outcome aims to assess the systems' ability to align with the diverse clinical manifestations of the condition.

  • 4. Impact on decision-making for surgery: Investigate how the utilization of each scoring system affects the decision-making process regarding surgical intervention. This secondary outcome explores the practical implications of the scoring systems on patient management.

  • 5. Exploratory analysis of patient subgroups: Perform exploratory analyses to assess the performance of the scoring systems within specific patient subgroups, such as different age categories or gender. This analysis aims to identify any variations in diagnostic efficacy across diverse patient populations.

Data management

In this prospective observational comparative study on acute appendicitis, a meticulous data management approach will be employed to ensure the accuracy and reliability of collected information. Structured data collection forms will be designed, encompassing various parameters such as demographic details, clinical findings, scoring system results, laboratory test outcomes, imaging findings, and histopathological results. Trained personnel will be responsible for accurate data entry, utilizing electronic tools to minimize errors, and implementing double-entry verification for critical data points. The collected data will be securely stored in password-protected databases, with regular backups to prevent loss and maintain data integrity. Continuous data cleaning procedures will be implemented to identify and rectify errors or inconsistencies, supported by validation checks during data entry. The study will prioritize participant confidentiality by using anonymized identifiers in datasets and limiting access to authorized personnel. An audit trail will be maintained to track any modifications to the dataset, ensuring transparency and accountability in data management. A comprehensive data analysis plan will be developed and aligned with the study objectives, and thorough documentation of the entire data management process will be maintained, including data dictionaries and any deviations from the initial plan. Clear communication channels and collaboration among team members will be established to address challenges and questions related to data collection and entry, ultimately contributing to the validity and reliability of the study findings.

Statistical analysis of the study

The statistical analysis of this prospective observational comparative study on acute appendicitis will follow a comprehensive approach to derive meaningful insights from the collected data. Initially, descriptive statistics will be computed, including means and standard deviations for continuous variables and frequencies and percentages for categorical variables, to provide a clear overview of the study population. Comparative analyses, employing statistical tests like the chi-square test for categorical variables and t-tests or Mann-Whitney U tests for continuous variables, will be conducted to assess any differences in baseline characteristics between groups evaluated by the Yash and Fenyo-Lindberg scoring systems.

Moving to the primary outcome, the diagnostic efficacy of each scoring system will be rigorously examined. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy will be compared with histopathological diagnosis. Receiver operating characteristic (ROC) curves will be constructed to visually compare the two scoring systems’ discriminatory ability.

Secondary outcomes will undergo meticulous analysis, including the diagnostic performance of individual scoring components, a comparison of sensitivity and specificity, correlation with clinical presentation, impact on decision-making for surgery, and exploratory analyses of patient subgroups. Logistic regression will be considered to assess the independent contribution of individual components to overall diagnostic accuracy.

To ensure statistical power and precision, the sample size will be reassessed. Subgroup analyses based on relevant demographic factors will be explored to identify potential variations in diagnostic efficacy among different patient populations. Multivariable analyses will address confounding variables, and interactions between variables that may impact diagnostic performance will be carefully examined.

The analyses will be conducted using appropriate statistical software, such as R Studio Version 4.3.1, and the code and parameters used will be provided for reproducibility. To determine statistical significance, a predetermined significance level (e.g., 0.05) will be set for hypothesis testing. The statistical analysis results will be interpreted in alignment with the study objectives, offering valuable insights into the comparative diagnostic efficacy of the Yash and Fenyo-Lindberg scoring systems in the context of acute appendicitis.

Study status

The study still needs to be started.

Discussion

Acute appendicitis is a typical surgical emergency, and accurate diagnosis is pivotal for timely and appropriate clinical management.5 This study protocol aims to prospectively compare the diagnostic efficacy of the Yash scoring system and the Fenyo-Lindberg scoring system in cases of acute appendicitis, shedding light on their respective roles in clinical practice.

With its comprehensive inclusion of clinical parameters and imaging results, the Yash scoring system has been advocated for its potential to enhance diagnostic accuracy.2 In contrast, the Fenyo-Lindberg scoring system focuses on clinical features, prioritizing simplicity in its approach.6 This study’s intention to compare these two scoring systems aligns with the need for evidence-based approaches to acute appendicitis diagnosis.

Our findings will contribute to the ongoing discourse on refining diagnostic strategies for acute appendicitis. A study by Yash et al. demonstrated the utility of their scoring system in a specific population.2 The comparative aspect of our research will offer a broader perspective, potentially identifying nuances in diagnostic performance across diverse patient groups.

However, this study has its limitations. The reliance on a single tertiary care hospital may limit the generalizability of our findings to other settings. Additionally, the study’s observational nature may introduce biases despite rigorous methodology. The potential impact of confounding variables, such as variations in disease presentation among different age groups, needs careful consideration during data analysis.

Considering these limitations, future research could explore the external validation of the identified scoring systems in different healthcare settings and patient populations. Furthermore, a long-term followup could assess the clinical outcomes of the diagnostic decisions guided by these scoring systems.

Ethics and consent

The research protocol got approval from the Datta Meghe Institute of Higher Education and Research (Deemed to be University) Institutional ethical committee in the meeting held on 11-07-2022 (approval date) with DMIMS (DU)/IEC/2022/28. All the participants will be educated about the research and written and verbal informed consent will be obtained from all the participants before the intervention.

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how to cite this article
Srinivasa Reddy DE and Tote DD. A prospective observational comparative study to compare the diagnostic efficacy of the Fenyo Lindberg scoring system and Yash scoring system in patients of acute appendicitis in tertiary care hospitals in central India [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:513 (https://doi.org/10.12688/f1000research.145731.1)
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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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 20 May 2024
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Reviewer Report 06 Aug 2024
Emad M Abdelrahman, Benha University, Banha, Al Qalyubia Governorate, Egypt 
Approved with Reservations
VIEWS 5
Thank you for the manuscript
overall the topic is very important
However, some points need to be clear in the abstract  
please stick to the general rules for the sections
background, aim, methods, results, conclusion
... Continue reading
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CITE
HOW TO CITE THIS REPORT
Abdelrahman EM. Reviewer Report For: A prospective observational comparative study to compare the diagnostic efficacy of the Fenyo Lindberg scoring system and Yash scoring system in patients of acute appendicitis in tertiary care hospitals in central India [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:513 (https://doi.org/10.5256/f1000research.159716.r302948)
NOTE: 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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Reviewer Report 16 Jul 2024
kumar Hari Rajah, Taylors University School of Medicine and Health Science, Selangor, Malaysia 
Approved
VIEWS 4
This is a study protocol for a prospective observational comparative study on the diagnostic efficacy of the Fenyo lindberg scoring system and the yash scoring system in patients with acute appendicitis. The inclusion and exclusion criteria are well defined, the ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Hari Rajah k. Reviewer Report For: A prospective observational comparative study to compare the diagnostic efficacy of the Fenyo Lindberg scoring system and Yash scoring system in patients of acute appendicitis in tertiary care hospitals in central India [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:513 (https://doi.org/10.5256/f1000research.159716.r302944)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 20 May 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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