Medical Illustration Design Characteristic Evaluation

Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation

The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Medical Illustration design

Detailed Description

The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations.

The investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.

• Study Type: Interventional
• Enrollment (Estimated): 8200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Bickmore, PhD; Phone Number: 6173735477; Email: t.bickmore@northeastern.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Not yet recruiting
      • Tufts Medical Center
      • Contact: Cameron Neeson; Phone Number: 6176365747; Email: cameron.neeson@tuftsmedicalcenter.org
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Northeastern University
      • Contact: Madison Blain; Phone Number: (617) - 858 - 6727; Email: m.blain@northeastern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Over 18 years old
• Speaks English or Spanish fluently
• Is able to independently consent
• Has adequate corrected vision to read patient education documents

Exclusion Criteria:

* None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

20

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical Illustration Design Distinction 1, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 1, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 2, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 2, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 3, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 3, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 4, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 4, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 5, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 5, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 6, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 6, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 7, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 7, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 8, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 8, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 9, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 9, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 10, version A	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
Experimental: Medical Illustration Design Distinction 10, version B	Other: Medical Illustration design; We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge	A multiple-item knowledge test designed to test comprehension of the patient education document	Baseline and 30 minutes
State Anxiety scale from State-Trait Anxiety Inventory	Self-report state anxiety scale from the State-Trait Anxiety Inventory. 20 items, 4-point Likert scale. A higher score indicates more severe anxiety with a potential range from 20 to 80.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading Effort	Likert items to assess perceived effort in reading a document and illustration	30 minutes
Acceptability	Likert items to assess acceptability and appropriateness of the illustration	30 minutes
Satisfaction with the medical illustration	Likert items to assess satisfaction with the document and illustration	30 minutes

Collaborators and Investigators

• Sponsor: Northeastern University
• Collaborators: Boston University; Tufts Medical Center
• Investigators: Principal Investigator: Timothy Bickmore, PhD, Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 427440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Transcripts from 100 cognitive interviews, and quantitative measures of comprehension and anxiety from 7,600 participant reactions to patient education documents will be generated. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.
• IPD Sharing Time Frame: Prior to end of the study.
• IPD Sharing Access Criteria: Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No