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Study Protocol

A cross-sectional observational study on quality assurance and radiation safety in interventional radiology

[version 1; peer review: 1 approved with reservations]
PUBLISHED 23 Apr 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Interventional Radiology (IR) is anticipated to play an increasingly pivotal role in modern healthcare, providing vital minimally invasive procedures for diagnosis and treatment. As the frequency and complexity of IR procedures continue to evolve, maintaining impeccable standards in quality assurance (QA) and radiation safety becomes paramount. This study is designed to assess prevailing QA practices comprehensively, gauge adherence to forthcoming radiation safety guidelines, and proactively identify areas primed for advancement within diverse interventional radiology units.

Methods

Employing a prospective cross-sectional observational design on 48 health professionals, an array of healthcare facilities, each equipped with a state-of-the-art IR unit, will be purposefully selected. The study cohort will encompass diverse participants, including interventional radiologists, radiologic technologists, nurses, and medical physicists. The study will be conducted in the Acharya Vinoba Bhave Rural Hospital’s facilities equipped with interventional radiology units. Analysis will be done by using R studio version 4.3.1 by using t-test and chi-square.

Expected results

The anticipated quantitative data analysis will undoubtedly yield nuanced insights into the participants’ multifaceted roles, experiences, and prospective perceptions concerning QA and radiation safety practices. In equal measure, the quantitative analysis is poised to uncover recurring thematic strands about the efficacy of current QA frameworks, radiation safety protocols, and the multifarious challenges envisaged in maintaining elevated standards.

Study implication

As this study unfolds, it will illuminate the evolving landscape of QA and radiation safety intrinsic to interventional radiology. This study is poised to guide future practice improvement, refine training paradigms, and shape forthcoming policies within this dynamic field by casting a discerning eye on potential gaps and imminent challenges. The conclusive insights are anticipated to underscore the enduring commitment required to ensure the safety of patients and healthcare professionals, concurrently fostering the pioneering trajectory of interventional radiology procedures.

Keywords

interventional radiology, quality assurance, radiation safety, cross-sectional study, healthcare professionals

Introduction

Interventional Radiology (IR) has witnessed remarkable advancements, becoming a cornerstone of modern medical practice. IR has revolutionized patient care across diverse medical disciplines by enabling minimally invasive procedures guided by imaging techniques. Ensuring meticulous quality assurance (QA) and stringent radiation safety measures has become a pivotal concern with interventional procedures’ expansion and increasing complexity.1,2

Quality assurance involves a systematic approach to maintaining and enhancing the quality of medical procedures, encompassing accuracy, safety, and efficiency. On the other hand, radiation safety revolves around the imperative to minimize ionizing radiation exposure to patients and healthcare practitioners. These dual imperatives – QA and radiation safety – underpin the foundations of responsible and effective interventional radiology practice.3

In light of the escalating significance of QA and radiation safety, it becomes imperative to thoroughly investigate their current status and efficacy within the context of interventional radiology. As IR evolves, guidelines shift, technologies improve, and patient demographics change, a robust understanding of how QA and radiation safety measures are employed becomes essential.4

This study embarks on a comprehensive exploration of the landscape of QA and radiation safety in interventional radiology. By assessing current practices, identifying potential gaps, and proposing recommendations, this research contributes to enhancing patient care, optimizing procedural accuracy, and safeguarding healthcare professionals’ well-being in the dynamic realm of interventional radiology.

Aim

The primary aim of this study is to conduct a thorough assessment of quality assurance (QA) practices and radiation safety measures within interventional radiology settings.

Objectives

  • 1. To evaluate the implementation of quality assurance measures in interventional radiology units.

  • 2. To assess healthcare professionals’ adherence to radiation safety guidelines.

  • 3. To identify potential gaps and challenges in maintaining radiation safety in interventional radiology.

  • 4. To propose recommendations for enhancing radiation safety and quality assurance practices in interventional radiology.

Methods

Study design

This study will employ a prospective cross-sectional observational design to investigate quality assurance (QA) practices and radiation safety in interventional radiology.5 This design allows for a comprehensive snapshot of the current QA and radiation safety state by capturing data at a specific time.

Study population

The study will target healthcare professionals directly involved in interventional radiology procedures, including radiologists, radiologic technologists, nurses, and medical physicists. These professionals collectively constitute the study population, reflecting the diverse roles within interventional radiology units.

Place of study

The study will be conducted in the Acharya Vinoba Bhave Rural Hospital’s facilities equipped with interventional radiology units.

Inclusion criteria

  • 1. Healthcare professionals actively engaged in interventional radiology procedures.

  • 2. Individuals who provide informed consent to participate.

Exclusion criteria

  • 1. Healthcare professionals are not directly involved in interventional radiology procedures.

  • 2. Individuals unwilling or unable to provide informed consent.

Sample size calculation

The sample size that will be used in this study has been determined based on the following formula using Mean Difference:

n1=n2=2(Zα+Zβ)2σ2(δ)2
Zα=1.96
α=Type I error at 5% at both sides two tailed
Zβ=1.28=Power at 90%

Primary Variable = Serum homocysteine level

(Mean±SD) pretest group = 13.46±5.05 (As per reference article6).

(Mean±SD) posttest group = 9.87±4.84

Mean difference = 3.59

Pooled standard deviation = (5.05 + 4.84)/2 = 4.945

Sample sizeN=n1=n2=2(1.96+1.28)2(3.59)2(4.945)2=40

Considering 20% drop out = 8

Total sample size required = 40 + 8 = 48

Enrollment

Enrollment of participants will be carried out through voluntary participation. Informed consent will be obtained from each participant, clearly outlining the study’s objectives, procedures, and the use of collected data.

Data collection

Structured questionnaire: As a central data collection component, a structured questionnaire will be distributed to the identified participants. We will use a standard questionnaire developed by Foley et al.5 The questionnaire has been meticulously designed to comprehensively capture essential insights about the participants’ roles, experiences, training, and perceptions of quality assurance (QA) and radiation safety practices within interventional radiology.5

Statistical methods

The collected quantitative data from structured questionnaires will undergo rigorous analysis using the RStudio software, a versatile statistical computing and graphics platform. This analysis will involve steps designed to extract valuable insights from the data. Upon receiving the raw data from the questionnaires, a data cleaning process will be initiated within RStudio to identify and rectify any inconsistencies or errors. Subsequently, the data will be prepared for analysis, organized, and appropriately formatted.

Descriptive statistics will be computed using RStudio to summarize the data and provide a clear overview of participants’ responses. Frequencies, percentages, means, and standard deviations will be calculated to quantify and describe various aspects of participants’ perspectives on quality assurance (QA) and radiation safety practices. Comparative analyses will be performed to explore potential patterns or differences among different participant groups. RStudio will be used to conduct chi-square tests for categorical data or t-tests for continuous data, shedding light on any significant response differences.

Correlation analysis, if relevant, will be carried out using RStudio to examine potential relationships between variables. For example, we might explore whether there is a correlation between years of experience and perceptions of radiation safety. Regression analysis, another statistical technique available in RStudio, will be employed to understand predictive relationships between variables. This involves examining whether certain factors, such as the level of training, predict a higher adherence to QA protocols. Graphical representations generated within RStudio will visually depict the quantitative findings. Bar charts, histograms, and scatter plots will effectively communicate insights derived from the data.

Discussion

The comprehensive assessment of quality assurance (QA) practices and radiation safety within interventional radiology settings holds significant implications for patient care, healthcare professionals, and the broader medical community. The findings of this study will contribute to a deeper understanding of the current state of QA and radiation safety practices, fostering informed decision-making and potential improvements in interventional radiology procedures.

Insights into QA implementation

The study’s approach of collecting quantitative data will yield valuable insights into implementing QA practices within interventional radiology units. By analyzing participants’ perspectives on QA protocols, the study will shed light on the extent to which standardized procedures are being followed. This insight is crucial in ensuring interventional procedures’ accuracy, consistency, and safety. Identifying areas of successful QA implementation will provide benchmarks for other facilities to emulate and learn from.7

Radiation safety adherence

Adherence to radiation safety guidelines is a paramount concern in interventional radiology due to the inherent exposure to ionizing radiation. The study’s evaluation of participants’ perceptions and practices related to radiation safety will offer insights into how effectively healthcare professionals minimize radiation exposure for patients and themselves. Understanding the level of adherence to safety protocols will guide interventions to enhance safety measures and potentially reduce radiation-related risks.8

Recommendations for improvement

The combined analysis of quantitative data will provide a nuanced view of the challenges, strengths, and potential opportunities for improvement in interventional radiology practices. These insights will form the basis for evidence-based recommendations to enhance patient care and safety. The study’s outcomes may influence the development of updated QA protocols, the implementation of targeted training programs, and the establishment of more robust radiation safety measures.9

Implications for patient care and safety

Ultimately, the study’s findings will resonate beyond the confines of the research setting, impacting patient care and safety directly. Healthcare facilities can tailor their strategies to ensure optimal patient outcomes by identifying successful QA practices and areas requiring improvement. Ensuring consistent adherence to radiation safety guidelines will safeguard patients and healthcare professionals, upholding the principle of “no harm”.10

Limitations and future directions

It is important to acknowledge the potential limitations of the study. The cross-sectional nature of the design provides a snapshot of practices at a specific time, limiting our ability to capture longitudinal trends. The available resources and time frame may also constrain the study’s scope. In the future, a longitudinal study could explore how QA practices evolve and their impact on patient outcomes.

Ethical considerations

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. We will prioritize the interviewee’s privacy and comfort during the interview process. Reference Number: DMIHER (DU)/IEC/2022/119.

Dissemination

This study protocol will be published in an indexed journal.

Study status

The study has yet to start.

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Chaple P and Luhariya A. A cross-sectional observational study on quality assurance and radiation safety in interventional radiology [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:363 (https://doi.org/10.12688/f1000research.141724.1)
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
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PUBLISHED 23 Apr 2024
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Reviewer Report 31 Dec 2024
Mohamed M Abuzaid, University of Sharjah, Sharjah, United Arab Emirates 
Approved with Reservations
VIEWS 3
·  Interventional radiology (IR) is not anticipated but actively performed and is not considered minimally invasive. (Please clarify further if needed.)
·  What do you mean by "expected results"? Are you referring to the anticipated outcomes or the purposeful ... Continue reading
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Abuzaid MM. Reviewer Report For: A cross-sectional observational study on quality assurance and radiation safety in interventional radiology [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:363 (https://doi.org/10.5256/f1000research.155193.r350601)
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 23 Apr 2024
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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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