NCT04332783

Brief Summary

Remote-store-and-forward teledermatology has recently grown exponentially in popularity and use as an efficient, accurate, and cost-effective way to improve the health and well-being of countless patients. Despite advances in machine learning and computer vision, the screening and reading of dermatological images still depends on the visual system of human observers (e.g., clinicians), who receive extensive training to best recognize lesions and anomalies. In remote store-and-forward teledermatology settings, clinicians may examine hundreds of images on a daily basis, seeing several images one after the other. A main underlying assumption of their work is that clinician percepts and decisions about a current image are completely independent from prior viewings. However, we and other groups demonstrated that the visual system has visual serial dependencies (VSDs) at many levels, from perception to decision making, including in clinical tasks. These sequential dependencies, replicated hundreds of times in the literature, mean that what was seen in the past influences (and captures) what is seen and reported at this moment. Theoretically, VSDs are helpful in an autocorrelated natural world, but they are suboptimal in visual tasks conducted in artificial situations where images are not always related. Importantly, serial dependencies in perceptual processing could thus produce significant errors during diagnostic judgments of dermatological images. Our central hypothesis is that VSD can have a disruptive effect in asynchronous remote-store-and-forward teledermatology judgments that impairs accurate detection and recognition of lesions. This hypothesis is supported by our robust pilot data, which show that VSD strongly biases lesion classification in both untrained observers and expert clinicians. The rationale for the proposed research projects is that once it is known how serial dependence arises and how it impacts judgments, we can understand how to control for it. Hence, accuracy of lesion detection and diagnosis can significantly improve. The specific objectives of this proposal are to establish (Aim 1), identify (Aim 2) and mitigate (Aim 3) the impact of VSD on remote-store-and-forward dermatological judgments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,120

participants targeted

Target at P75+ for not_applicable

Timeline
79mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2019Oct 2032

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2032

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

12.3 years

First QC Date

March 31, 2020

Last Update Submit

January 30, 2026

Conditions

Keywords

Visual PerceptionPsychophysicsVisual Search

Outcome Measures

Primary Outcomes (1)

  • Serial Dependence Assessment using psychophysical procedures

    This is a medical image perception experiment using psychophysical methods, including continuous report match-to-sample and method-of-constant stimuli designs. Human observers, including clinicians and untrained observers, are recruited to classify or discriminate medical images. Each observer participates in approximately 300 trials in a session. On each trial, observers view a medical image on a computer monitor and are asked to make either a match-to-sample or a two-alternative forced choice decisions about the image. Observer responses on each trial are classified in terms of their accuracy. Outcome measures include hit rate, false alarm rate, sensitivity, selectivity, d', and criterion. Changes in these metrics from trial-to-trial throughout the course of the experiment are quantified as metrics of sequential biases that might be present in observer judgments.

    Each participant is tested for 30-60 minutes in a psychophysical experiment.

Study Arms (2)

Healthy Typical Adults

EXPERIMENTAL

Observers including clinicians and non-clinicians will be asked to participate in computer based tasks in which they visually search for, detect, localize, and categorize medical images.

Behavioral: psychophysics of sequential biases (no drug or patient work)

Healthy typical adults

EXPERIMENTAL

Observers including clinicians and non-clinicians will be asked to participate in computer based tasks in which they visually search for, detect, localize, and categorize medical images.

Behavioral: psychophysics of sequential biases (no drug or patient work)

Interventions

Psychophysical experiment on sequential effects in medical image perception. Observers, including clinicians, perform psychophysical continuous report match-to-sample and forced-choice discrimination judgments of medical images. Observer discrimination accuracy is measured on a trial-wise basis and sequential effects in those judgments are measured. Images can be presented with different interstimulus intervals and in different spatial locations and in different orders. Accuracy, and other signal detection metrics are computed as a function of these factors.

Healthy Typical AdultsHealthy typical adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have normal or corrected to normal vision with contacts or glasses.

You may not qualify if:

  • Subjects may not be under the age of 18 to participate.
  • Subjects may not participate if they are blind.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

RECRUITING

Study Officials

  • David Whitney, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Wolters, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

April 1, 2019

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

October 30, 2032

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified participant data may be shared with other researchers who are interested or when peer-reviewed journals require this. The data will be anonymized and will not be linked to any individual participant identity.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Upon request or as required by peer-reviewed journals.
Access Criteria
None; access granted on request or by journals, as required for publication; in either case, a URL will be posted to access anonymized, de-identified data via an OSF link.

Locations