Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study
Bibliographic record
Abstract
BACKGROUND: Ostomy surgeries involving the placement of an ostomy bag (eg, colostomy, ileostomy, urostomy, etc) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on the health-related quality of life of ostomy patients. OBJECTIVE: In the present study, we plan to assess the quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth-linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy-specific, health-related quality of life as compared to baseline measurement before the use of the sensor. METHODS: A total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, cross-over pilot study using an Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy-specific, health-related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy-specific, health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for Patients with an Ostomy. Secondary outcomes of general health-related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey and the Olbrisch Ostomy Adjustment Scale Short Form 2. RESULTS: The project was funded by the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine. Enrollment is currently underway and data analysis is expected to be completed in 2018. CONCLUSIONS: Proposed benefits of mobile, internet-linked personal health monitors, such as the Ostom-i, include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an inpatient as well as improved quality of life. Prior studies have demonstrated decreased health-related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i alert sensor affects the health-related quality of life of its users. The Ostom-i alert sensor has the potential to improve quality of life of users by giving them the freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner. TRIAL REGISTRATION: ClinicalTrials.gov NCT02319434; https://clinicaltrials.gov/ct2/show/NCT02319434 (Archived at WebCite at http://www.webcitation.org/6xhFDThmq).
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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 | 0.013 | 0.008 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.024 | 0.005 |
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".