- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414853
Free Text Prediction Algorithm for Appendicitis
Prospective Study of a Free-text Diagnosis Prediction Algorithm for Appendicitis in the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Developing machine learning models that have a strong prediction power for diagnosis of appendicitis from physician entered free text input can improve diagnostic accuracy of doctors. It also offers the possibility of using prediction algorithms to improve routine clinical care. In the future, multiple machine learning models can be combined to increase prediction accuracy and prediction algorithms can be extended to other diagnoses.
18,000 cases of emergency department presentations over 10 years were used as a training and validation dataset. To develop the appendicitis prediction model, deep learning neural networks with a customized medical ontology were used. The diagnostic accuracy of the model is expressed as sensitivity (recall), specificity and F1 score (harmonic mean). The developed diagnosis predictive model shows high sensitivity (86.3%), specificity (91.9%) and F1 score (88.8) in diagnosing appendicitis from patients presenting with abdominal pain.
The predictive model algorithm will also highlight words in the free text (entered by the attending physician) that it assigns higher probability for predicting an outcome. The doctors will be instructed to provide a percentage likelihood of appendicitis based on the clinical presentation and any available laboratory investigations. The doctor is then shown the prediction of the algorithm as well as the highlighted words for the patient entered. He/she must then provide another prediction of the likelihood of appendicitis after seeing the algorithm generated prediction.
The aim is to evaluate the performance of the algorithm and to assess if usage of the algorithm is able to help emergency doctors improve their diagnosis of appendicitis. The prediction results will be tabulated to assess accuracy of the algorithm, doctors before algorithm input and doctors after receiving algorithm input. The accuracy will be expressed as sensitivity, specificity, accuracy, positive prediction value, F1 score and F0.5 score.
Approximately 100 emergency doctors will be recruited over the course of 1 year as participants in the study. The doctors will be split randomly assigned to two groups - the algorithm arm and the no algorithm arm. The randomization will be by time (weekly) using variable block randomization of 4 and 6. The patients will be followed up for the final discharge diagnoses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 119074
- National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Attending physicians will be recruited as study participants and randomised weekly into "algorithm use" versus "no algorithm use".
Patients who fulfilled the above eligibility criteria will have their data collected and entered into the predictive algorithm.
Description
Eligibility criteria of doctors- Inclusion criteria: Junior doctors working in the Emergency Department Exclusion criteria: Refusal of consent
Eligibility criteria of patients-
Inclusion Criteria:
- Presence of abdominal pain, OR
- Presence of gastrointestinal symptoms such as nausea, vomiting or diarrhea, OR
- Fever with anorexia
Exclusion Criteria:
- Previous history of appendicectomy
- Refusal of consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
With algorithm use
|
A free-text prediction software that predicts the probability of acute appendicitis
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|
No algorithm use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of predictive algorithm for acute appendicitis
Time Frame: 30 days
|
Accuracy of predictive algorithm and accuracy of doctors with input from the algorithm in diagnosing acute appendicitis
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kee Yuan Ngiam, Dr, National University Hospital, Singapore
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-171-000-456-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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