NCT05244122

Brief Summary

Imagine that a dermatologist spends the morning seeing patients who have been referred for suspicion of skin cancer. Many of them do, in fact, have skin lesions that require treatment. For this set of patients, disease 'prevalence' would be high. Suppose that the next task is to spend the afternoon giving annual screening exams to members of the general population. Here disease prevalence will be low. Would the morning's work influence decisions about patients in the afternoon? It is known from other contexts that recent history can influence current decisions and that target prevalence has an impact on decisions. In this study, decisions were decisions about skin lesions from individuals with varying degrees of expertise, using an online, medical imaging labelling app (DiagnosUs). This allowed examination of the effects of feedback history and prevalence in a single study. Blocks of trials could be of low or high prevalence, with or without feedback. Over 300,000 individual judgements were collected. (taken from Wolfe, J. M. (2022). How one block of trials influences the next: Persistent effects of disease prevalence and feedback on decisions about images of skin lesions in a large online study. . Cognitive Research: Principles and Implications (CRPI), 7, 10. doi: https://doi.org/10.1186/s41235-022-00362-0

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,121

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 22, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5 days

First QC Date

February 8, 2022

Results QC Date

October 17, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

dermatologysignal detection theoryprevalence effectsbase rate effectsonline studyBESH

Outcome Measures

Primary Outcomes (2)

  • Change in D' Between Pairs of Blocks.

    D' (d-prime) is defined as z-transform of the true positive rate - z-transform of false positive rate. True positive is when you say that a real melanoma is a melanoma. False positive is when you say that a nevis is a melanoma. A correction of 0.5 error is added to avoid calculation problems when z=0 or z=1. D' of zero indicates no ability to discriminate. D' \> zero indicates some ability to discriminate. The change of interest is the D' for Block 2 when it follows Block 1 compared to the D' for Block 2 averaged across all conditions.

    Participants could be in the study for as little as two blocks in one day up to 24 blocks collected over 6 days.

  • Change in Criterion Between Pairs of Blocks.

    Criterion, c, corresponds to the position of the midpoint between the z-transformed probabilities of hits (correct yes responses) and false alarms (incorrect yes responses). It is calculated as -\[z(p(h))+z(p(FA))\]/2. The criterion, c, z-score quantifies the distance away from being unbiased in units of standard deviations. A Z-score of 0 is said to be unbiased. Negative values for c indicate a more relaxed criterion for saying yes. Positive numbers indicate a more strict criterion for saying yes.

    Participants could be in the study for as little as two blocks in one day up to 24 blocks collected over 6 days.

Study Arms (1)

Feedback X Prevalence Using Dermatology Stimuli

EXPERIMENTAL

In this experiment, observers (Os) completed blocks of 80 trials. On each trial, they saw an image of a spot on the skin. They classified this as a melanoma (cancer) or a nevis (benign). Blocks could be of low prevalence (20% cancer cases, 16 images) or high prevalence (50%, 40 images). Os either did received trial by trial "Feedback" about their performance accuracy, or they did not. Thus, there were four types of block. Low prevalence, No Feedback Low prevalence, Feedback High prevalence, No Feedback High prevalence, Feedback Each of these four types of block was made available to Os on each of 6 days. Os could elect to view each of the four blocks each day. Our particular interest was in the effect of performing one block on performance on an immediately subsequent block.

Behavioral: FeedbackBehavioral: Prevalence

Interventions

FeedbackBEHAVIORAL

presence or absence of trial by trial feedback

Feedback X Prevalence Using Dermatology Stimuli
PrevalenceBEHAVIORAL

In some blocks, skin cancer "target" images were present on 50% of trials (high prevalence). In other blocks, disease prevalence was 20%.

Feedback X Prevalence Using Dermatology Stimuli

Eligibility Criteria

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

You may qualify if:

  • All welcome to enroll on line

You may not qualify if:

  • Under 18 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Visual Attention Lab, Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Wolfe JM. How one block of trials influences the next: persistent effects of disease prevalence and feedback on decisions about images of skin lesions in a large online study. Cogn Res Princ Implic. 2022 Feb 2;7(1):10. doi: 10.1186/s41235-022-00362-0.

MeSH Terms

Interventions

Prevalence

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Limitations and Caveats

Convenience sample of 803 participants is unbalanced. Online study lacks control over the display and ambient lighting. Other statistical analyses could be performed

Results Point of Contact

Title
Jeremy Wolfe, Principle Investigator
Organization
BrighamHospital

Study Officials

  • Jeremy M Wolfe, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Observers were naive about the hypothesis but could have figured out if a specific condition did or did not have feedback, for example. Once the data were collected, investigators could determine what conditions were tested on which observers
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: We tested \~800 observers on line in a study where they could participate in multiple conditions. We were looking for the effect of condition 1 on condition N+1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

June 22, 2021

Primary Completion

June 27, 2021

Study Completion

June 27, 2021

Last Updated

October 26, 2022

Results First Posted

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

IPD available on OSF. Other details available on request.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Available currently and indefinitely.
Access Criteria
OSF is publicly available. Other requests to jwolfe@bwh.harvard.edu

Available IPD Datasets

Individual Participant Data Set Access

Locations