Delphi Study on Quality Indicators for CEUS Imaging of the Liver Using SonoVue® Contrast Agent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Which proposed contrast-enhanced ultrasound (CEUS) quality criteria achieve expert consensus, defined as ≥70% of panellists assigning a score of 6 ("agree") or 7 ("strongly agree") on a 7-point Delphi Likert scale, by the end of Round 3?
研究概览
简要总结
This study aims to establish international consensus-based quality criteria for contrast-enhanced ultrasound (CEUS) examinations of the liver and to develop a standardized tool for assessing CEUS image and examination quality. CEUS is an established imaging technique used in clinical practice for the characterization and assessment of focal liver lesions and other liver abnormalities. Despite its increasing use, there are currently no universally accepted or validated standards for evaluating the quality and reproducibility of CEUS examinations.
The primary objective of this project is therefore to identify robust and clinically relevant quality indicators for liver CEUS examinations through an international Delphi consensus process. The study focuses specifically on CEUS examinations performed in adult patients using the ultrasound contrast agent SonoVue®.
The project is divided into two work packages (WP). In Work Package 1 (WP1), the study team will first conduct a structured review of the available literature and discuss potential CEUS quality criteria within the research group. Based on this process, an initial catalogue of quality indicators relating to technical, procedural, and imaging characteristics relevant to liver CEUS examinations will be developed.
These proposed criteria will subsequently be evaluated through a multi-round Delphi process involving an international and interdisciplinary panel of experienced CEUS users and experts. A minimum of 35 panellists will participate across all Delphi rounds. Participants will rate their level of agreement with each proposed quality criterion using a 7-point Likert scale and may suggest additional criteria in the first round where appropriate. Newly proposed criteria supported by more than 10% of participants will be included in subsequent Delphi rounds.
During each round, panellists will receive anonymised feedback summarising the responses of the group and will be invited to re-evaluate the relevance of the proposed criteria. This iterative process will continue for at least three rounds or until predefined consensus criteria are achieved. Consensus will be defined as at least 70% agreement with a rating of 6 or higher on the Likert scale.
In Work Package 2 (WP2), the consensus-based quality criteria identified in WP1 will be operationalised into a comprehensive and standardised rating scale for CEUS image and examination quality assessment. Individual criteria will be grouped into broader data derived quality domains and transformed into practical assessment items and prompts. The proposed rating scale will use a three point scoring system (0="unacceptable quality", 1="acceptable quality", 3="High quality". The resulting rating tool will then be circulated among all Delphi panel members who completed all three Delphi rounds for final review and feedback to ensure clarity, applicability, and international usability.
The overall goal of this study is to improve standardization, quality assurance, and reproducibility in liver CEUS images and examinations. The developed consensus criteria and rating scale may support clinical practice, future research studies, multicentre collaborations, and educational initiatives by enabling more consistent evaluation of CEUS image quality across institutions and countries.
详细描述
Contrast-enhanced ultrasound (CEUS) is an established and widely used imaging modality for the evaluation of focal liver lesions and other hepatic abnormalities. It plays an increasingly important role in clinical diagnostics due to its real-time imaging capability, safety profile, and broad availability. Despite its clinical relevance, there is currently no internationally standardised definition of adequate CEUS image quality, and no validated criteria exist for its objective assessment. As a result, interpretation and perceived diagnostic quality of CEUS examinations may vary considerably between operators, institutions, and healthcare systems.
The aim of this study is to develop internationally agreed, consensus-based quality criteria for adequate CEUS image and examination quality in liver examinations and to translate these criteria into a comprehensive, universally applicable and standardised rating tool. The overall objective is to improve the reproducibility, comparability, and standardisation of CEUS examinations in both clinical practice and research settings.
To achieve this, the study is structured into two work packages (WP). Work Package 1 (WP1) focuses on identifying and refining relevant quality criteria for CEUS of the adult liver through an international and interdisciplinary Delphi consensus process.
Work Package 2 (WP2) focuses on clustering and operationalising the agreed criteria into overarching domains and developing a structured rating scale for practical application.
In WP1, a preliminary set of potential quality indicators will be generated based on a structured literature review and expert discussion within the study team. These indicators will reflect technical, procedural, and image-related aspects of liver CEUS examinations. The most commonly applied CEUS context, adult liver imaging, will serve as the clinical focus of the study. The criteria will address adequate quality of liver CEUS examinations and imaging, including image related and examination related aspects on liver CEUS using SonoVue.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 6 years of active experience in ultrasound diagnostics in internal medicine, radiology, or a related clinical field
- •Independent performance of at least 5,000 ultrasound examinations Participation in structured CEUS training
- •Performance of at least 800 ultrasound examinations per year in routine clinical practice
- •Either: at least 100 independently performed CEUS examinations per year or more than 700 CEUS examinations in total
- •Regular participation in ultrasound-related meetings, case reviews, or quality assurance activities within their institution
- •Scientific involvement in CEUS, demonstrated by at least one peer-reviewed publication and/or active engagement in CEUS education or training
- •Signing the consent form of the participants
排除标准
- •Failure to meet the inclusion criteria
结局指标
主要结局
Which proposed contrast-enhanced ultrasound (CEUS) quality criteria achieve expert consensus, defined as ≥70% of panellists assigning a score of 6 ("agree") or 7 ("strongly agree") on a 7-point Delphi Likert scale, by the end of Round 3?
时间窗: Completion of Delphi Round 3 (within six months)
The number and individual content of proposed CEUS quality criteria that achieve predefined consensus after completion of the Delphi process. Consensus is defined as ≥70% of participating experts assigning a score of 6 ("agree") or 7 ("completely agree") on a 7-point Likert scale evaluating the statement: "This criterion indicates adequate quality of a CEUS examination." The rating is based on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate stronger agreement that the criterion reflects adequate CEUS image quality.
How many proposed contrast-enhanced ultrasound (CEUS) quality criteria achieve expert consensus, defined as ≥70% of panellists assigning a score of 6 ("agree") or 7 ("completely agree") on a 7-point Delphi Likert scale, by the end of Round 3?
时间窗: Completion of Delphi Round 3 (within six months)
The number of proposed CEUS quality criteria that achieve predefined consensus after completion of the Delphi process. Consensus is defined as ≥70% of participating experts assigning a score of 6 ("agree") or 7 ("completely agree") on a 7-point Likert scale evaluating the statement: "This criterion indicates adequate quality of a CEUS examination." The rating is based on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate stronger agreement that the criterion reflects adequate CEUS image quality.
次要结局
- What are the median ratings for each proposed CEUS quality criterion on the 7-point Delphi Likert scale by the end of Delphi Round 3?(After each Delphi round (within six months))
- How many quality domains are incorporated into the final CEUS image and examination quality rating scale derived from the consensus-based criteria?(Following completion of Work Package 2 (within six months))
- What percentage of experts approve the final contrast-enhanced ultrasound image quality rating scale using binary agreement responses?(Final rating scale evaluation survey (within six months))
- What percentage of experts assigns a score of 6 or 7 on the 7-point Delphi Likert scale to each proposed CEUS quality criterion across the Delphi rounds?(After each Delphi round (within six months))
- What are the median ratings for each proposed CEUS quality criterion on the 7-point Delphi Likert scale across the Delphi rounds?(After each Delphi round (within six months))
- What are the interquartile ranges (IQRs) of expert ratings for each proposed CEUS quality criterion on the 7-point Delphi Likert scale across the Delphi rounds?(After each Delphi round (within six months))
- How many quality domains are incorporated into the final CEUS image quality rating scale derived from the consensus-based criteria?(Following completion of Work Package 2 (within six months))
- What percentage of Experts Approving the Final Contrast-Enhanced Ultrasound Image Quality Rating Scale Using Binary Agreement Responses?(Final rating scale evaluation survey (within six months))