Consensus And Norms for Medical Visualization Academic Standards Study - A Modified Delphi Study

NCT07684703 | Not Yet Recruiting

• 1 other identifier: 202606124RIND
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.to develop and validate core consensus statements on professional standards for medical visualization (consensus threshold ≥75%).
2. 2.to quantify the distribution of divergence in professional opinion.

Conditions

Medical Visualization; Medical Illustration; Consensus

Keywords

Medical Visualization; Medical illustration; Modified Delphi method; Expert consensus

Outcome Measures

Primary Outcomes (2)

• Proportion of Statements Reaching Expert Consensus

  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."

  Through study completion, approximately 12 months

• Agreement Rate for Each Consensus Statement

  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.

  Through study completion, approximately 12 months

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Panel Retention Rate Across Delphi Rounds

  Through study completion, approximately 12 months

Study Arms (1)

Delphi Panel

Experts were invited from medical illustration training programs or professional associations worldwide.

Other: Delphi procedure

Interventions

Delphi procedure OTHER

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.

Delphi Panel

Eligibility Criteria

• Age: 27 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target expert panel size for this study was set at 35 to 50 members. The Delphi method is a structured consensus-building process rather than a hypothesis-testing framework, and no formal statistical power calculation method applicable to Delphi studies currently exists in the literature. The recruitment channel involved the principal investigator compiling a roster of domain experts based on program directors or departmental contacts accredited training institutions, with the principal investigator issuing personalized invitations directly. The invitation process followed a standardized email procedure in three stages: (1) Initial invitation: the principal investigator sent a personalized email explaining the study objectives, expected time commitment (approximately 15 minutes per round), the anonymity mechanism, and data protection measures; (2) Follow-up reminder: if the invitee did not respond within 14 days, a first reminder was sent; if there was still no respon.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Johns Hopkins University: collaborator
• University of Maryland, Baltimore County: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Related Publications (8)

• Alon L, Shoval DH, Levkovich I. Bias, representation, and clinical fidelity in AI-generated images for medical education: a systematic literature review. NPJ Digit Med. 2026 Apr 18;9(1):469. doi: 10.1038/s41746-026-02608-3.

  PMID: 42000932 BACKGROUND

• Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006 Oct;29(5):489-97. doi: 10.1002/nur.20147.

  PMID: 16977646 BACKGROUND

• Manyara AM, Purvis A, Ciani O, Collins GS, Taylor RS. Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilize? J Clin Epidemiol. 2024 Oct;174:111485. doi: 10.1016/j.jclinepi.2024.111485. Epub 2024 Jul 26.

  PMID: 39069013 BACKGROUND

• Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.

  PMID: 38261576 BACKGROUND

• Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.

  PMID: 28190381 BACKGROUND

• Young JQ, Van Merrienboer J, Durning S, Ten Cate O. Cognitive Load Theory: implications for medical education: AMEE Guide No. 86. Med Teach. 2014 May;36(5):371-84. doi: 10.3109/0142159X.2014.889290. Epub 2014 Mar 4.

  PMID: 24593808 BACKGROUND

• Calkins CM, Franciosi JP, Kolesari GL. Human anatomical science and illustration: the origin of two inseparable disciplines. Clin Anat. 1999;12(2):120-9. doi: 10.1002/(SICI)1098-2353(1999)12:23.0.CO;2-V.

  PMID: 10089038 BACKGROUND

• Hajar R. Medical illustration: art in medical education. Heart Views. 2011 Apr;12(2):83-91. doi: 10.4103/1995-705X.86023. No abstract available.

  PMID: 22121469 BACKGROUND

Related Links

• 23\. Accreditation Review Committee for the Medical Illustrator (ARC-MI). Standards and Guidelines for the Accreditation of Educational Programs in Medical Illustration. Chicago, IL: CAAHEP; 2014.

Study Officials

• Monal, Yu-Hsuan Chang, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monal, Yu-Hsuan Chang, M.D.

CONTACT

886-935891029; monal@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)