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

Pawan Chaple; Anurag Luhariya

doi:10.12688/f1000research.141724.1

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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]

Pawan Chaple ¹, Anurag Luhariya²

PUBLISHED 23 Apr 2024

Author details Author details

¹ Hospital Administration, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India
² Consultant and Medical Physicist and RSO, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Pawan Chaple
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Anurag Luhariya
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

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

Corresponding author: Pawan Chaple

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Chaple P and Luhariya 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: 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) First published: 23 Apr 2024, 13:363 (https://doi.org/10.12688/f1000research.141724.1) Latest published: 23 Apr 2024, 13:363 (https://doi.org/10.12688/f1000research.141724.1)

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:

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Z_{α} = 1.96

α = Type I error at 5% at both sides two tailed

Z_{β} = 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 size N = n 1 = n 2 = 2 \frac{{(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.

Data availability

No data are associated with this study.

References

1. Soares GM, Murphy TP: Clinical Interventional Radiology: Parallels with the Evolution of General Surgery. Semin. Intervent. Radiol. 2005; 22: 10–14. PubMed Abstract | Publisher Full Text | Free Full Text
2. Midulla M, Pescatori L, Chevallier O, et al.: Future of IR: Emerging Techniques, Looking to the Future … and Learning from the Past. J. Belg. Soc. Radiol. 2019; 103: 12. PubMed Abstract | Publisher Full Text | Free Full Text
3. Hamady M, McCafferty I: The rocky road to recognizing interventional radiology as a full clinical speciality. CVIR Endovascular. 2021; 4: 7. PubMed Abstract | Publisher Full Text | Free Full Text
4. Garg T, Shrigiriwar A: Radiation Protection in Interventional Radiology. Indian J. Radiol. Imaging. 2022; 31: 939–945. PubMed Abstract | Publisher Full Text | Free Full Text
5. Foley SJ, Evanoff MG, Rainford LA: A questionnaire survey reviewing radiologists’ and clinical specialist radiographers’ knowledge of CT exposure parameters. Insights Imaging. 2013; 4: 637–646. PubMed Abstract | Publisher Full Text | Free Full Text
6. Inaba Y, Chida K, Kobayashi R, et al.: A cross-sectional study of the radiation dose and image quality of X-ray equipment used in IVR. J. Appl. Clin. Med. Phys. 2016; 17: 391–401. PubMed Abstract | Publisher Full Text | Free Full Text
7. Abildgaard JS, Saksvik PØ, Nielsen K: How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions. Front. Psychol. 2016; 7. PubMed Abstract | Publisher Full Text | Free Full Text
8. Frane N, Bitterman A: Radiation Safety and Protection. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023.
9. Guetterman TC, Fetters MD, Creswell JW: Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays. Ann. Fam. Med. 2015; 13: 554–561. PubMed Abstract | Publisher Full Text | Free Full Text
10. Hughes RG: Tools and Strategies for Quality Improvement and Patient Safety.Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008.

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 23 Apr 2024

Author details Author details

¹ Hospital Administration, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India
² Consultant and Medical Physicist and RSO, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Pawan Chaple
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Anurag Luhariya
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 23 Apr 2024, 13:363

https://doi.org/10.12688/f1000research.141724.1

Copyright

© 2024 Chaple P and Luhariya 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.

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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)

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Open Peer Review

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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

https://doi.org/10.5256/f1000research.155193.r350601

· 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

· 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 aims of the study? Please rephrase for clarity.
· Improve the language to avoid using mixed styles or overly generic terms, such as "state-of-the-art," which can be vague.
· Although the research design specifies an observational study, the data collection tools have not been included or described.
· The authors should incorporate a quantitative data collection tool, such as a survey, to measure:

Quality control (QC) metrics
Adherence to radiation protection standards

· The inclusion criteria must be specific. It is insufficient to state "health professionals simply." Since the study focuses on radiation practices, only radiation workers directly involved in IR operations should be included—namely, radiographers and radiologists.

Many paper investigating similar topics could be used as a reference to your study. These may help improve the study protocol. While it is not necessary for the author to cite these works, they are offered as a resource to refine the study's approach. [Ref 1], [Ref 2] and [Ref 3].

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

References

1. Abuzaid MM, Elshami W, Tekin HO: Infection control and radiation safety practices in the radiology department during the COVID-19 outbreak.PLoS One. 2022; 17 (12): e0279607 PubMed Abstract | Publisher Full Text
2. Abuzaid M, Elshami W, Hasan H: Knowledge and Adherence to Radiation Protection among Healthcare Workers at Operation Theater. Asian Journal of Scientific Research. 2018; 12 (1): 54-59 Publisher Full Text
3. Khandaker MU, Abuzaid MM, Mohamed IA, Yousef M, et al.: Investigation of the Radiographer's adherence and compliance with radiation protection and infection control practices during COVID-19 mobile radiography.Radiat Phys Chem Oxf Engl 1993. 2023; 210: 111023 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Medical Diagnostic Imaging and radiation protection

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Mohamed M Abuzaid, University of Sharjah, Sharjah, United Arab Emirates

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Reviewer Report

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31 Dec 2024 | for Version 1

Mohamed M Abuzaid, University of Sharjah, Sharjah, United Arab Emirates

4 Views Cite this report Responses(0)

Approved With Reservations

· 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 aims of the study? Please rephrase for clarity.
· Improve the language to avoid using mixed styles or overly generic terms, such as "state-of-the-art," which can be vague.
· Although the research design specifies an observational study, the data collection tools have not been included or described.
· The authors should incorporate a quantitative data collection tool, such as a survey, to measure:

Quality control (QC) metrics
Adherence to radiation protection standards

· The inclusion criteria must be specific. It is insufficient to state "health professionals simply." Since the study focuses on radiation practices, only radiation workers directly involved in IR operations should be included—namely, radiographers and radiologists.

Many paper investigating similar topics could be used as a reference to your study. These may help improve the study protocol. While it is not necessary for the author to cite these works, they are offered as a resource to refine the study's approach. [Ref 1], [Ref 2] and [Ref 3].

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

References

1. Abuzaid MM, Elshami W, Tekin HO: Infection control and radiation safety practices in the radiology department during the COVID-19 outbreak.PLoS One. 2022; 17 (12): e0279607 PubMed Abstract | Publisher Full Text
2. Abuzaid M, Elshami W, Hasan H: Knowledge and Adherence to Radiation Protection among Healthcare Workers at Operation Theater. Asian Journal of Scientific Research. 2018; 12 (1): 54-59 Publisher Full Text
3. Khandaker MU, Abuzaid MM, Mohamed IA, Yousef M, et al.: Investigation of the Radiographer's adherence and compliance with radiation protection and infection control practices during COVID-19 mobile radiography.Radiat Phys Chem Oxf Engl 1993. 2023; 210: 111023 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Medical Diagnostic Imaging and radiation protection

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

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[1] 1. Soares GM, Murphy TP: Clinical Interventional Radiology: Parallels with the Evolution of General Surgery. Semin. Intervent. Radiol. 2005; 22: 10–14. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Midulla M, Pescatori L, Chevallier O, et al.: Future of IR: Emerging Techniques, Looking to the Future … and Learning from the Past. J. Belg. Soc. Radiol. 2019; 103: 12. PubMed Abstract | Publisher Full Text | Free Full Text

[3] 3. Hamady M, McCafferty I: The rocky road to recognizing interventional radiology as a full clinical speciality. CVIR Endovascular. 2021; 4: 7. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Garg T, Shrigiriwar A: Radiation Protection in Interventional Radiology. Indian J. Radiol. Imaging. 2022; 31: 939–945. PubMed Abstract | Publisher Full Text | Free Full Text

[5] 5. Foley SJ, Evanoff MG, Rainford LA: A questionnaire survey reviewing radiologists’ and clinical specialist radiographers’ knowledge of CT exposure parameters. Insights Imaging. 2013; 4: 637–646. PubMed Abstract | Publisher Full Text | Free Full Text

[6] 6. Inaba Y, Chida K, Kobayashi R, et al.: A cross-sectional study of the radiation dose and image quality of X-ray equipment used in IVR. J. Appl. Clin. Med. Phys. 2016; 17: 391–401. PubMed Abstract | Publisher Full Text | Free Full Text

[7] 7. Abildgaard JS, Saksvik PØ, Nielsen K: How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions. Front. Psychol. 2016; 7. PubMed Abstract | Publisher Full Text | Free Full Text

[8] 8. Frane N, Bitterman A: Radiation Safety and Protection. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023.

[9] 9. Guetterman TC, Fetters MD, Creswell JW: Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays. Ann. Fam. Med. 2015; 13: 554–561. PubMed Abstract | Publisher Full Text | Free Full Text

[10] 10. Hughes RG: Tools and Strategies for Quality Improvement and Patient Safety.Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008.

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

Abstract

Background

Methods

Expected results

Study implication

Keywords

Introduction

Aim

Objectives

Methods

Study design

Study population

Place of study

Inclusion criteria

Exclusion criteria

Sample size calculation

Enrollment

Data collection

Statistical methods

Discussion

Insights into QA implementation

Radiation safety adherence

Recommendations for improvement

Implications for patient care and safety

Limitations and future directions

Ethical considerations

Dissemination

Study status

Data availability

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

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