- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244122
PROJECT 2 EXAMPLE: Feedback X Prevalence Using Dermatology Stimuli
Prevalence Effects in Visual Search: Theoretical and Practical Implications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This description is based on a preregistration on the Open Science Framework site. Note that this is a "BESH" study. This type of research is not designed as a traditional clinical trial, but it is being reported here because of changes in NIH clinical trial reporting rules. This is one study from Project 2 of NE017001.
Levari et al (2018) found that people responded to a decrease in the prevalence of a stimulus by expanding their concept of it. Specifically, they asked observers to judge on each trial whether a dot, drawn from a blue-purple continuum, was blue or not. The results showed that observers were more likely to call ambiguous stimuli "blue" when blue items were less prevalent. In signal detection theory (SDT) terms, this is a liberal shift of response criterion. This is "prevalence induced concept change" (PICC). However, previous results obtained the opposite results in a long series of experiments on prevalence effects. The standard finding is that Os miss more targets at low prevalence. When blue is rare, they are less likely to call something blue. In SDT terms, this is a conservative criterion shift. This is the classic Low Prevalence Effect (LPE). In a round of earlier experiments, Lyu et al (2021) found that feedback is a critical variable. With trial-by-trial feedback, we get an LPE. With no feedback, the data usually show PICC results.
Do LPE and PICC effects show up when experts view stimuli in their expert domain? There is evidence for the LPE from search tasks (e.g. Evans, K. K., Birdwell, R. L., & Wolfe, J. M. (2013). If You Don't Find It Often, You Often Don't Find It: Why Some Cancers Are Missed in Breast Cancer Screening. . PLoS ONE 8(5): e64366. , 8(5), e64366. doi: doi:10.1371/journal.pone.0064366). However, PICC evidence has not been collected and there is no data from single item decision tasks like the "Is this dot blue?" task. This is important because criterion shifts of the sort described above can have obvious health care implications.
This study will repeat the basic "Is this dot blue" experiment using dermatology stimuli (Is this melanoma or just a nevus (a mole)?)
Hypotheses:
(H1) without feedback, Os are more likely to label a spot as cancer when cancer prevalence is low (prevalence-induced-concept-change).
(H2) that with feedback, Os are less likely to label a spot as cancer when cancer prevalence is low (classic low prevalence effect)
Dependent variable
The main dependent variable is the proportion of cancer responses as a function of the cancer prevalence in the image set, but we will also record reaction times.
Conditions
How many and which conditions will participants be assigned to?
Four conditions will be run, between observers.
- 50% cancer images with feedback
- 50% cancer images without feedback
- 20% cancer images with feedback
- 20% cancer images without feedback
Observers will make a simple 2-alternative forced-choice (2AFC) cancer/no cancer decision.
Observers will be awarded points based on the correctness of the answer (more correct, more points)
There will be 200 trials in each block. That will produce 40 target present trials in the low prevalence conditions which should produce a hit rate that is not too coarse.
Stimuli will be images of moles from the ISIC archive. Each image comes with a known answer of either melanoma (cancer) or nevus (negative).
Analyses
The data will produce a continuum from not-cancer to cancer based on the observers responses in the 50% with feedback condition. This will give yield a psychometric function rising (it may be assumed) from near 0% cancer responses to near 100%.
Using that ordering, psychometric functions will be generated for the other three conditions.
To examine the effect of prevalence and the presence and absence of feedback on observers' response behavior, \run a logistic regression with prevalence and feedback as factors in a generalized mixed model will be run using jamovi software.
The data will also be used to compute the signal detection measures of sensitivity (d') and criterion (c) based on the actual truth about the images. That is, "cancer" responses will be coded as True positives if the images show cancer and as "false positives" if they do not. T-tests will be performed to examine whether d' and/or c (criterion) change significantly as a function of prevalence and feedback.
Outliers and Exclusions
N/A
Sample Size
Separate blocks of trials will be run and conditions will be compared with unpaired t-tests.
G* Power says suggests 36 observers PER GROUP or a total of 144 observers for alpha = 0.05, power = 0.80. The plan will be to attempt to run 45 Os per group, anticipating about 20% loss of Os due to the vagaries of online testing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Visual Attention Lab, Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All welcome to enroll on line
Exclusion Criteria:
- Under 18 yrs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Feedback X Prevalence Using Dermatology Stimuli
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. |
presence or absence of trial by trial feedback
In some blocks, skin cancer "target" images were present on 50% of trials (high prevalence).
In other blocks, disease prevalence was 20%.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in D' Between Pairs of Blocks.
Time Frame: Participants could be in the study for as little as two blocks in one day up to 24 blocks collected over 6 days.
|
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.
Time Frame: Participants could be in the study for as little as two blocks in one day up to 24 blocks collected over 6 days.
|
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2007P000646-A
- R01EY017001 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Study Data/Documents
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Individual Participant Data Set
Information comments: This is the Open Science Framework page for these data. The title is Levari Exp. 17: Feedback X Prevalence using dermatology stimuli
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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