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Decision MakingNCT05272189

Project 3 Example: Human-AI Collaboration Tester (HAICT) Exp. 7

A study testing Simulated Second Reader AI and Target Prevalence in people with Decision Making and Computer Aided Diagnosis, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is one part of a "bundle" of experiments that constitute Project Three of a National Eye Institute grant. Project Three includes a series of experiments that investigate how changing the input from a simulated AI can affect the decisions made by human observers in a two-alternative forced choice task (like… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Decision Making, Computer Aided Diagnosis
What is being tested?
Simulated Second Reader AI and Target Prevalence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 4 Nov 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - All welcome to enroll on line

Who cannot join

  • Must pass the Ishihara color vision screening test
  • 20/25 vision (with correction)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Visual Attention Lab / Brigham and Women's Hospital

    Boston, Massachusetts, 02215

Other trials in United States

About this study

The study is one part of a "bundle" of experiments that constitute Project Three of a National Eye Institute grant. Project Three includes a series of experiments that investigate how changing the input from a simulated AI can affect the decisions made by human observers in a two-alternative forced choice task (like the decision to recall a woman for further examination in mammography). HAICT 7, the experiment described here, investigates how changing prevalence affects human performance when AI is used as a Second Reader.

Read the detailed description

This text is the text of the pre-registration for the HAICT 7 experiment as described on the Open Science Framework. https://osf.io/hngu4/

NOTE: This study is representative of studies conducted in Project 3 of this grant. There are multiple experiments in the bundle of experiments represented by Project 3 but it is not possible to register a bundle of studies on CT.gov.

NOTE: Since the pronoun comment is advisory, we will leave it for now.

Human-AI Collaboration Tester (HAICT) Exp. 7 (lightly edited from OSF)

  1. Data collection. Have any data been collected for this study already? (Yes/No) yes
  2. Hypothesis. What's the main question being asked or hypothesis being tested in this study?

Background: In a variety of search experiments, both basic and clinical, the data have been consistent with a situation where the variability of the signal (or target) is greater than the variability of the noise (distractors). The classic sign of this is a zROC function with a slope < 1 - typically around 0.6. A slope of 1.0 is indicative of an equal variance 2AFC task. For the HAICT task that we have been testing, we would expect equal variance, but we think it would be worth checking so we will systematically vary prevalence which will shift criterion. That will sweep out an ROC curve that we can examine.

We will also test the Second Reader faux-AI in order to determine if low prevalence makes Second Reader worse.

  • (H1): We expect to replicate the finding that human criteria become more conservative as prevalence declines.
  • (H2): We predict that the slope of the resulting zROC will be 1.0.
  • (H3): We hypothesize that low prevalence will make Second Reader AI less effective because the positive predictive value of its comments will be low.
  1. Dependent variable. Describe the key dependent variable(s) specifying how they will be measured. The main dependent variables of interest are accuracy (and the signal detection derivatives of accuracy, d' and c), reaction time, and subjective ratings on the survey following each block.
  2. Conditions. How many and which conditions will participants be assigned to?

This series of experiments investigates how changing the input from a simulated AI can affect the decisions made by human observers in a two-alternative forced choice task (like the decision to recall a woman for further examination in mammography). We have developed a paradigm called the Human-AI Collaboration Tester (HAICT) that allows for efficient testing of interactions between a human and a simulated AI.

The observers' task in all conditions is to give a 2AFC decision about whether a stimulus is "bad" or "not bad." To use language roughly mimicking a medical diagnosis, each stimulus is referred to as a "case." Observers are asked to make a 2AFC decision about arrays of colored shapes. The decision is made based on the predominant color of the case. The number of elements of each color are drawn from one of two normal distributions, one for positive (bad) stimuli and the other for negative (not bad) stimuli.

The results from previous HAICT experiments (3 and 4) showed that human performance in the Second Reader condition drops off significantly at low prevalence. Performance in the Second Reader condition was better than Baseline when the prevalence of bad cases was 50% but was significantly worse than Baseline when prevalence was only 10%. In this experiment, we manipulate the prevalence of "bad" cases in the Second Reader and Baseline conditions. Four different prevalence rates will be tested - 10%, 33%, 67%, and 90%. Observers will complete 8 blocks (2 AI rules x 4 prevalence rates), and block order is random.

AI rules to be tested:

  1. Baseline - No AI input. Observer classifies each case as "bad" or "not" bad on their own.
  2. Second Reader - The observer makes an initial decision about every case. The AI silently classifies stimuli using a conservative criterion (c = 0.5). The logic for the conservative criterion is that the second reader is being used to cut down on false positive responses and so it is intended to question positive human responses that might be marginal. If the observer and AI disagree, then the AI informs the human observer. The observer is then given a chance to either change their response or go with their first opinion. As in Experiments 1-5, the AI d-prime is fixed at 2.2. Feedback is known to increase the prevalence effect, so feedback will be given in both the practice and the test trials. Observers will complete 20 practice trials and 200 test trials in each block. Immediately after each block is completed, observers will be shown a summary of their performance. After the Second Reader blocks, they will also be asked to answer three subjective questions about the usefulness of the AI (see "Files" for more details).
  3. Analyses. Specify exactly which analyses you will conduct to examine the main question/hypothesis. First, we summarize the number of hits, true negatives, misses, and false alarms in each block. From this, we can calculate the accuracy, the positive predictive value, sensitivity (d-prime), and the criterion for each observer under each of the different conditions. Given measures of performance at 4 levels of prevalence, we can estimate the ROC curve (pHit x pFA) and the zROC function (zHit x zFA). We will test the hypothesis that the slope of the zROC is equal to 1 (the consequence of an equal variance 2AFC task).
  4. More analyses. Any secondary analyses? We will look to see if the observers' subjective opinions about the AI are correlated with variables such as the empirical d-prime, or the positive predictive value.
  5. Sample size. How many observations will be collected or what will determine sample size? No need to justify decision, but be precise about exactly how the number will be determined. We will test 12 observers. This is consistent with the sample sizes of previous experiments.
  6. Other. Is there anything else that you would like to pre-register? (e.g., data exclusions, variables collected for exploratory purposes, unusual analyses planned?)

N/A

Being tested
Simulated Second Reader AI, Target Prevalence
Keywords
Signal detection, VIsual Perception, BESH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulated Second Reader AIBehavioural

    In this experiment, in some conditions, the participant makes their decision in the presence of information about a simulated artificial intelligence decision.

  • Target PrevalenceBehavioural

    Also called Base Rate

    The frequency with which targets are presented varies from 10% to 90%

Study groups in NCT05272189
Study groupRoleWhat they receive
ExperimentExperimentalAll participants are tested in all conditions of this experiment.
Receives: Behavioral: Simulated Second Reader AI; Behavioral: Target Prevalence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. D'

    D' (d-prime) is the signal detection theory measure of the level of performance on a task. It is computed by calculating the proportion of true positive responses =(true positive trials)/(true positive + false negative trials) = p(TP) and by calculating the proportion of false positive responses =(false positive trials)/(false positive + true negative trials) = p(FP). These values are transformed into 'z-scores' (for example, using NORMSINV in Excel to calculate the inverse of the standard normal distribution). D' is defined as Z(TP)-Z(FP). Its range is from 0 for cases where no signal can be discriminated from the noise, to ~4.0. The upper limit is not defined, but 4 would mean that and observer is essentially perfect at discriminating signal from noise.

    Measured: Data are collected within a session of about an hour.

  2. Criterion

    Criterion, like D' (see above) is calculated from z(TP) and z(FP). Criterion ( c ) = (z(TP)+z(FP))/-2. A value of zero means that the observer is equally likely to make a positive (e.g. 'target present') response as a negative (absent) response. Positive values mean that the observer is more likely to say "absent" (a "conservative" criterion). Negative values mean the observer is more likely to say "present" (a "liberal" criterion). Liberal and conservative have no political connotations in this case. Criterion values almost always fall between -2 and 2.

    Measured: Data are collected within a session of about an hour.

Secondary outcomes (1)
  1. Reaction Time

    This is the measure of how long it takes to make a response.

    Measured: Data are collected within a session of about an hour.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start1 Jan 2020
  3. Primary completion1 Aug 2024
  4. Study completion4 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272189
Sponsor's protocol ID
2007P000646-B
Other IDs
R01CA207490
Status last verified
Dec 2025
First submitted
18 Feb 2022
Last updated
20 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified raw data will be posted on the experiment's OSF page and will also be available on request to the PI.

Questions about this trial

What is this clinical trial studying?

A study testing Simulated Second Reader AI and Target Prevalence in people with Decision Making and Computer Aided Diagnosis, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

D' (time frame: Data are collected within a session of about an hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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Clinical Trial NCT05272189 | AzTrials