The CANVAS (Consensus And Norms for Medical Visualization Academic Standards) Study: Developing Professional Standards for Effective Medical Visualization - A Modified Delphi Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Statements Reaching Expert Consensus
研究概览
简要总结
The goal of this observational study (modified Delphi consensus study) is to establish an international expert consensus on professional standards for medical visualization in medical visualization experts from from around the world, each with a minimum of five years of relevant professional experience. The specific objectives are:
- to develop and validate core consensus statements on professional standards for medical visualization (consensus threshold ≥75%).
- to quantify the distribution of divergence in professional opinion.
Participants will:
Fill out a short background survey about their job title, training, work setting, location, and experience with AI image tools.
Rate 10 statements about medical visualization standards on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree). These statements cover three topics: accuracy, accessibility, and ethics. Participants will complete up to 3 rounds of anonymous online surveys.
Write comments to explain why they disagree with any statement they rate 1 or 2.
Between rounds, review a summary showing their own earlier ratings and the group's overall results (with no names attached). Then, re-rate any statements the group has not yet agreed on.
详细描述
This study uses a modified Delphi design to develop consensus-based professional standards for medical visualization. The standard Delphi method typically begins with open-ended questions to generate initial statements. In this modified version, a systematic literature review and a focus group replace that first open-ended round, reducing participant burden and producing a more structured starting questionnaire. The study follows the Conducting and Reporting of Delphi Studies (CREDES) framework and reports results according to the Accurate Consensus Reporting Document (ACCORD) checklist. All activities are conducted online. There is no physical study site.
Questionnaire Development The initial questionnaire was developed in two stages. In the first stage, a systematic literature review identified existing frameworks, guidelines, and evidence related to professional standards in medical visualization. Three databases were searched: PubMed (title and abstract fields), Embase (title field), and the Cochrane Library (title field). The search terms were "medical illustration" OR "medical visualization," limited to clinical studies and review articles published between May 2016 and May 2026. The research team also hand-searched professional guidelines from the Association of Medical Illustrators (AMI) and the Institute of Medical Illustrators (IMI), as well as all issues of The Journal of Biocommunication (JBC). A total of 20 articles were included for synthesis.
In the second stage, the principal investigator convened a focus group of domain experts, including clinicians and three practicing medical illustrators. The group held three online meetings to discuss the literature review findings and draft the initial statements. To protect the independence of the Delphi process, no focus group member serves on the Delphi expert panel. This process produced a 10-item questionnaire organized into three domains: (i) Accuracy and Scientific Rigor (4 items), (ii) Accessibility and Diversity (3 items), and (iii) Disclosure and Ethics (3 items).
Content Validity Assessment Before distribution to the Delphi panel, 10 cross-disciplinary experts rated the relevance of each item on a 4-point scale (1 = not relevant; 4 = highly relevant). Items with an item-level Content Validity Index (I-CVI) of 0.83 or higher were retained. Items scoring between 0.70 and 0.83 were revised. Items below 0.70 were deleted. None of these 10 validators serve on the Delphi expert panel.
Delphi Round Procedures The study includes up to three sequential rounds of anonymous rating, all conducted via the REDCap platform deployed by the Information Technology Office of National Taiwan University Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 27 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experts were invited from medical illustration training programs or professional associations worldwide. Inclusion criteria required that invitees meet at least one of the following conditions:
- •Inclusion Criteria:
- •Current faculty or staff at one of the accredited degree-granting institutions in medical and scientific illustration
- •Current member of a nationally/regionally recognized medical illustration association
- •Holder of the Certified Medical Illustrator (CMI) credential issued by the Board of Certification of Medical Illustrators
- •Current visualization editor or supervisor at a high-impact medical journal.
- •Required to possess at least five years of professional experience in medical visualization or a related discipline
- •Willing to complete the Delphi questionnaire, having provided informed consent prior to questionnaire commencement.
排除标准
- •Prior participation in the focus group or validity assessment stages of this study's initial questionnaire development
- •Direct financial interest in commercial AI medical imaging products or related services
- •Inability to complete the questionnaire in the designated language (English) in the absence of a corresponding language version.
- •Individuals meeting any of the above criteria were excluded to preserve the independence of the consensus process.
研究组 & 干预措施
Delphi Panel
Experts were invited from medical illustration training programs or professional associations worldwide.
干预措施: Delphi procedure (Other)
结局指标
主要结局
Proportion of Statements Reaching Expert Consensus
时间窗: Through study completion, approximately 12 months
The proportion of the 10 initial professional standard statements (across three domains: Accuracy \& Scientific Rigor; Accessibility \& Diversity; Disclosure \& Ethics) that reach the predefined consensus threshold, defined as the simultaneous fulfillment of three criteria: (1) ≥75% of panel members assigning a rating of 4 or 5 on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree); (2) group median ≥4; and (3) interquartile range (IQR) ≤1. Items meeting all three criteria are classified as "inclusion consensus." Items rated 1 or 2 by ≥75% of panel members are classified as "exclusion consensus." Items meeting neither threshold after three rounds are classified as "non-consensus."
Agreement Rate for Each Consensus Statement
时间窗: Through study completion, approximately 12 months
The percentage of expert panel members rating each of the 10 professional standard statements as 4 (Agree) or 5 (Strongly Agree) on a 5-point Likert scale, reported per round. This is the principal component of the tripartite consensus definition.
次要结局
- Inter-Rater Reliability(Through study completion, approximately 12 months)
- Demographic and Professional Composition of the Expert Panel(Through study completion, approximately 12 months)
- Number of Delphi Rounds Required to Reach Consensus per Statement(Through study completion, approximately 12 months)
- Qualitative Themes of Expert Disagreement(Through study completion, approximately 12 months)