Consensus, Medical Illustration, Medical Visualization
Conditions
Keywords
Medical Visualization, Medical illustration, Modified Delphi method, Expert consensus
Brief summary
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: 1. to develop and validate core consensus statements on professional standards for medical visualization (consensus threshold ≥75%). 2. 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.
Detailed description
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. In Round 1, all panel members rate the 10 statements on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). For any item rated 1 or 2, respondents provide an open-ended comment explaining their reasoning. Between rounds, the research team compiles descriptive statistics for each item. Each panel member receives (a) their own prior ratings, (b) anonymized group statistics (mean, median, interquartile range, and rating distribution), and (c) a summary of anonymized qualitative comments. Two research team members independently review qualitative comments using content analysis and draft revision recommendations. Items reaching consensus are finalized and removed from subsequent rounds. In Rounds 2 and 3, panel members re-rate only those items that have not yet reached consensus, in light of group feedback. No real-time interaction or group discussion takes place at any stage. Consensus Definition An item reaches inclusion consensus when all three of the following criteria are met simultaneously: (1) 75% or more of panel members rate the item 4 or 5; (2) the group median is 4 or higher; and (3) the interquartile range (IQR) is 1 or less. An item reaches exclusion consensus if 75% or more of panel members rate it 1 or 2. Items that do not meet either threshold after three rounds are classified as non-consensus and reported descriptively. Stopping Criteria The consultation process ends after a maximum of three rounds, regardless of item-level consensus status. If all items reach consensus before the third round, the process ends early. If the number of continuously participating members falls below 15 in any round, that round is considered unable to guarantee representativeness, and the Delphi process is terminated early. Statistical Analysis Plan Descriptive statistics summarize expert ratings for each item, reported as mean ± standard deviation (SD), supplemented by median and IQR. All tests are two-tailed, with p \< 0.05 considered statistically significant. Inter-rater agreement is assessed using Kendall's coefficient of concordance (W), interpreted as weak (W \< 0.3), moderate (0.3 ≤ W ≤ 0.7), or strong (W \> 0.7). All analyses are performed in IBM SPSS Statistics; graphical visualizations are produced in GraphPad Prism.
Interventions
The study involves generating consensus statements by experts on medical visualization from around the world on professional standards for medical illustration and visualization - covering accuracy and scientific rigor, accessibility and diversity, and disclosure and ethics - using a modified Delphi process.
Sponsors
Study design
Eligibility
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Statements Reaching Expert Consensus | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Rater Reliability | Through study completion, approximately 12 months | Kendall's coefficient of concordance (W) measuring the degree of agreement among expert panel members across all rated items. Interpretive thresholds: weak (W \< 0.3), moderate (0.3 ≤ W ≤ 0.7), strong (W \> 0.7). |
| Demographic and Professional Composition of the Expert Panel | Through study completion, approximately 12 months | Descriptive summary of the expert panel composition, including distribution of primary professional discipline (e.g., surgical illustration, anatomical/educational illustration, molecular/cellular visualization, 3D modeling, animation/interactive media, patient education, science communication), geographic region (North America, Europe, East Asia), highest educational degree, years of professional experience, and experience with generative AI imaging tools. |
| Number of Delphi Rounds Required to Reach Consensus per Statement | Through study completion, approximately 12 months | The number of Delphi rounds (out of a maximum of 3) required for each individual statement to meet the predefined consensus threshold. Statements not reaching consensus after 3 rounds are classified as "non-consensus" and reported descriptively. |
| Qualitative Themes of Expert Disagreement | Through study completion, approximately 12 months | Thematic categories identified through content analysis of open-ended written comments provided by panel members. |
Countries
Taiwan
Contacts
National Taiwan University Hospital