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| Name | Class |
|---|---|
| Duke University | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duke Health System Electronic Health Record | Patients who received Duloxetine or Vortioxetine |
| |
| Johns Hopkins Health System Electronic Health Record | Patients who received Duloxetine or Vortioxetine |
| |
| Randomized Controlled Trial 1 (NCT01153009) | Patients who received Duloxetine or Vortioxetine |
| |
| Randomized Controlled Trial 2 (NCT01140906) | Patients who received Duloxetine or Vortioxetine |
| |
| Randomized Controlled Trial 3 (NCT00672620) | Patients who received Duloxetine or Vortioxetine |
| |
| Randomized Controlled Trial 4 (NCT00635219) | Patients who received Duloxetine or Vortioxetine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine, Vortioxetine | Drug | Medications for major depressive disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores | Higher score indicates greater severity of major depressive disorder. | 6 months |
| 9-question Patient Health Questionnaire (PHQ-9) or PHQ-2 scores | Higher score indicates greater severity of major depressive disorder. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency room visits or inpatient admissions with diagnosis of depression or suicidality | A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No". | 6 months |
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Duke University Health System Electronic Health Record (EHR) System and Johns Hopkins Health System EHR System
Inclusion criteria:
Exclusion criteria:
- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.
4 randomized controlled trials (RCTs)
Inclusion criteria:
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Patients who received Duloxetine or Vortioxetine
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Stuart, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Hwanhee Hong, PhD | Department of Biostatistics & Bioinformatics, Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39964207 | Result | Hua K, Wojdyla D, Carnicelli A, Granger C, Wang X, Hong H. Network Meta-Analysis With Individual Participant-Level Data of Time-to-Event Outcomes Using Cox Regression. Stat Med. 2025 Feb 28;44(5):e70027. doi: 10.1002/sim.70027. | |
| 39967285 | Result | Hua K, Wang X, Hong H. Network Meta-Analysis of Time-to-Event Endpoints With Individual Participant Data Using Restricted Mean Survival Time Regression. Biom J. 2025 Feb;67(1):e70037. doi: 10.1002/bimj.70037. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Emergency room visits or inpatient admissions with diagnosis of depression or suicidality |
A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter with depression or suicidality International Classification of Diseases (ICD) codes, otherwise equals to "No". |
| 1 year |
| Emergency room visits or inpatient admissions for any reason | A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No". | 6 months |
| Emergency room visits or inpatient admissions for any reason | A binary outcome equals to 'Yes' if the patient ever had any emergency department or inpatient hospital admission encounter after the prescription, otherwise equals to "No". | 1 year |
| 41496761 | Result | Brantner CL, Nguyen TQ, Parikh H, Zhao C, Hong H, Stuart EA. Precision Mental Health: Predicting Heterogeneous Treatment Effects for Depression through Data Integration. J R Stat Soc Ser C Appl Stat. 2025 Dec 12:10.1093/jrsssc/qlaf068. doi: 10.1093/jrsssc/qlaf068. Online ahead of print. |
| 38273647 | Result | Brantner CL, Nguyen TQ, Tang T, Zhao C, Hong H, Stuart EA. Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects. Stat Med. 2024 Mar 30;43(7):1291-1314. doi: 10.1002/sim.9955. Epub 2024 Jan 25. |
| 41669555 | Result | Brantner CL, Yu W, Zhao C, Jeon K, Ringlein GV, Wang Q, Lemoto E, Nguyen TQ, Gagliardi JP, Zandi PP, Goldstein BA, Stuart EA, Hong H. The challenges of integrating diverse data sources: A case study in major depression. Health Serv Outcomes Res Methodol. 2024 Oct 23:10.1007/s10742-025-00363-8. doi: 10.1007/s10742-025-00363-8. Online ahead of print. |
| 38638306 | Result | Brantner CL, Chang TH, Nguyen TQ, Hong H, Stefano LD, Stuart EA. Methods for Integrating Trials and Non-experimental Data to Examine Treatment Effect Heterogeneity. Stat Sci. 2023 Nov;38(4):640-654. doi: 10.1214/23-sts890. Epub 2023 Nov 6. |
| D006571 |
| Heterocyclic Compounds |
| D010879 | Piperazines |