NCT04130607

Brief Summary

A recent Institute of Medicine monograph brought attention to high rates of diagnostic error and called for better educational efforts to improve diagnostic accuracy.1 Educational methods, however, are rarely tested and some educational efforts may be ineffective and wasteful.2 In this study, we plan to examine whether explicit instruction on diagnostic methods will have an effect on diagnostic accuracy of 2nd-year medical students and internal medicine residents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

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

May 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

October 15, 2019

Last Update Submit

October 15, 2019

Conditions

Keywords

Teaching Strategies, Diagnostic reasoning

Outcome Measures

Primary Outcomes (1)

  • Accuracy of participants probability revisions were compared to posttest probability revisions that were calculated using Bayes Rule. An effect size was calculated to measure how close students matched the calculated revision.

    To perform the effect size analysis, two transformations were performed. First, the difference between the subjective estimate and the Bayesian calculation of post-test probability was squared to remove negative differences and permit combining of the effects of positive and negative test results. Second, a correction based on the intrinsic error of a probability estimate was applied by dividing each squared difference by p(1-p). In this manner, we transformed each raw difference to a squared effect size (difference / error of difference). Finally, the square root was computed, to transform the data back to an effect size. The resulting effect size was then used for statistical analysis. For this primary analysis, a mixed model ANOVA was used.

    Post-test was taken within 72 hours of instructional phase completion.

Study Arms (3)

Analytical

EXPERIMENTAL

Students will receive brief instruction in probability, sensitivity, specificity, and likelihood ratios, with distributions and calculations. Pretest and posttest probabilities will be computed for two cases for each of the three conditions listed above.

Other: Conceptual teaching

Experiential

ACTIVE COMPARATOR

Students will receive a brief instruction conceptually discussing sensitivity and specificity (e.g. "a sensitive test will be positive at even low levels of disease. However, this can lead to a number of false positive errors, when the test is positive even when there is no disease. As a result, it is most useful for ruling out a diagnosis"). They will then work through a total of 30 cases, 10 for each condition, in blocked sequence. For each brief written case they will be asked for a probability of diagnosis after the clinical information is presented. The test result will then be given and they will be asked for a post-test probability. Their estimate will be compared to the computed value based on published estimates of sensitivity and specificity and feedback provided.

Other: Conceptual teaching

No Explicit Instruction or Examples

PLACEBO COMPARATOR

Students will receive 3 passages from a clinical text related to each of the 3 conditions in the study and asked to study them for 15 min each.

Other: Conceptual teaching

Interventions

The present study is designed to contrast two instructional methods - explicit instruction in likelihood ratios and pretest/posttest probabilities versus implicit instruction based on presentation of multiple cases. These will be compared to a "no intervention" control group.

Also known as: Teaching through examples, No active teaching
AnalyticalExperientialNo Explicit Instruction or Examples

Eligibility Criteria

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

You may qualify if:

  • Medical Student at McMaster University or Eastern Virginia Medical School
  • Completed 18 months of coursework

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • Brush JE Jr, Lee M, Sherbino J, Taylor-Fishwick JC, Norman G. Effect of Teaching Bayesian Methods Using Learning by Concept vs Learning by Example on Medical Students' Ability to Estimate Probability of a Diagnosis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918023. doi: 10.1001/jamanetworkopen.2019.18023.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware of the other arms in the trial
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized trial of teaching methods with 3 arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

May 15, 2018

Primary Completion

January 1, 2019

Study Completion

October 15, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations