Characterisation of digital therapeutic clinical trials: a systematic review with natural language processing.

Digital therapeutics (DTx) are a somewhat novel class of US Food and Drug Administration-regulated software that help patients prevent, manage, or treat disease. Here, we use natural language processing to characterise registered DTx clinical trials and provide insights into the clinical development landscape for these novel therapeutics. We identified 449 DTx clinical trials, initiated or expected to be initiated between 2010 and 2030, from ClinicalTrials.gov using 27 search terms, and available data were analysed, including trial durations, locations, MeSH categories, enrolment, and sponsor types. Topic modelling of eligibility criteria, done with BERTopic, showed that DTx trials frequently exclude patients on the basis of age, comorbidities, pregnancy, language barriers, and digital determinants of health, including smartphone or data plan access. Our comprehensive overview of the DTx development landscape highlights challenges in designing inclusive DTx clinical trials and presents opportunities for clinicians and researchers to address these challenges. Finally, we provide an interactive dashboard for readers to conduct their own analyses.

Effectiveness of an Opioid Stewardship Guideline in Renal Transplant Recipients Post-Discharge.

Previous literature suggests that kidney transplant recipients (KTRs) do not use the majority of opioid tablets prescribed after transplant surgery. This study analyzed the effectiveness of a new pain management guidance in KTRs after discharge from transplant surgery at a renal transplant center. The single center pre-, post- study compared the number of opioid refill requests, patient-reported pain control, multimodal analgesic agents, and opioid tablets prescribed at discharge in both pre- and post- cohorts. A total of 127 patients were included. Data was collected through standardized patient interviews and chart review from electronic medical records. The pre-guidance and post-guidance cohorts had no detectable difference in refill requests (p = 0.365) nor pain control (p = 0.324) post-discharge. The post-group had a significant reduction in opioid tablets prescribed at discharge (22 tablets ± 10 vs 10 tablets ± 2, p = <0.0001) with a significant increase in acetaminophen (p = 0.005) and lidocaine patches (p = <0.0001) prescribed at discharge. Both groups used a mean of three opioid tablets within the first week after discharge. The guidance resulted in 700 fewer opioid tablets in the community during the study time frame, with no difference in pain control nor refill requests after discharge.

Inpatient administration of opioids and risk for post-operative ileus in older adults.

OBJECTIVE: Post-operative ileus (POI) is a common and potentially serious complication after surgery. We assessed the incidence and identified predictors of POI in older surgical patients. DESIGN: A retrospective observational study. SETTING: University of California-San Francisco electronic medical record data. PARTICIPANTS: Opioid-naïve, noncancer patients, aged 65 and older, who underwent elective surgery in the period 2017-2019. EXPOSURE: Administration of opioid analgesics per day of hospitalization in opioid naïve patients. MAIN OUTCOMES MEASURE: Incidence of POI and likelihood of developing POI. RESULTS: In the study period, 3 percent of opioid naïve patients developed POI. Patients with POI used on average 197.1 oral morphine equivalents (OMEs) per day of hospitalization compared to 82.5 OME in patients without POI (p = 0.013). Yet, there were not statistically significant differences in post-operative pain scores between patients with and without POI. General surgery (p = 0.0031), length of surgery (p = 0.0031), and hospital length of stay (p < 0.0001) were significant predictors of the risk for developing POI. Adjusted inpatient administration of more than 90 OME per day of hospitalization was associated with a four times greater risk for developing POI (p = 0.016). Developing POI was associated with 6.5 (95 percent confidence interval: 5.2-7.8) additional days of hospitalization among patients who developed POI compared to patients who did not develop POI (p < 0.0001). CONCLUSIONS: Adjusted inpatient administration of more than 90 OME significantly increased the risk for developing POI in opioid-naïve older patients. Developing POI after surgery significantly increased the hospital length of stay. Optimizing inpatient administration of opioids may prevent opioid use-related POI and longer hospitalizations.