Remote Mobile Outpatient Monitoring in Transplant (Reboot) 2.0: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: The number of solid organ transplants in Canada has increased 33% over the past decade. Hospital readmissions are common within the first year after transplant and are linked to increased morbidity and mortality. Nearly half of these admissions to the hospital appear to be preventable. Mobile health (mHealth) technologies hold promise to reduce admission to the hospital and improve patient outcomes, as they allow real-time monitoring and timely clinical intervention. OBJECTIVE: This study aims to determine whether an innovative mHealth intervention can reduce hospital readmission and unscheduled visits to the emergency department or transplant clinic. Our second objective is to assess the use of clinical and continuous ambulatory physiologic data to develop machine learning algorithms to predict the risk of infection, organ rejection, and early mortality in adult heart, kidney, and liver transplant recipients. METHODS: Remote Mobile Outpatient Monitoring in Transplant (Reboot) 2.0 is a two-phased single-center study to be conducted at the University Health Network in Toronto, Canada. Phase one will consist of a 1-year concealed randomized controlled trial of 400 adult heart, kidney, and liver transplant recipients. Participants will be randomized to receive either personalized communication using an mHealth app in addition to standard of care phone communication (intervention group) or standard of care communication only (control group). In phase two, the prior collected data set will be used to develop machine learning algorithms to identify early markers of rejection, infection, and graft dysfunction posttransplantation. The primary outcome will be a composite of any unscheduled hospital admission, visits to the emergency department or transplant clinic, following discharge from the index admission. Secondary outcomes will include patient-reported outcomes using validated self-administered questionnaires, 1-year graft survival rate, 1-year patient survival rate, and the number of standard of care phone voice messages. RESULTS: At the time of this paper's completion, no results are available. CONCLUSIONS: Building from previous work, this project will aim to leverage an innovative mHealth app to improve outcomes and reduce hospital readmission in adult solid organ transplant recipients. Additionally, the development of machine learning algorithms to better predict adverse health outcomes will allow for personalized medicine to tailor clinician-patient interactions and mitigate the health care burden of a growing patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT04721288; https://www.clinicaltrials.gov/ct2/show/NCT04721288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/26816.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.031 | 0.031 |
| Meta-epidemiology (narrow) | 0.008 | 0.004 |
| Meta-epidemiology (broad) | 0.014 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.006 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.009 | 0.010 |
| Insufficient payload (model declined to judge) | 0.088 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".