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Identifying Early-Phase Clinical Trial Participants at Risk for Experiencing Worse Clinical Outcomes.
- Source :
- JCO Oncology Practice; Jun2023, Vol. 19 Issue 6, pe829-e837, 9p
- Publication Year :
- 2023
-
Abstract
- PURPOSE: To identify early-phase clinical trial (EP-CT) participants at risk for experiencing worse clinical outcomes and describe receipt of supportive care services. METHODS: A retrospective review of the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 examined baseline characteristics, clinical outcomes, and receipt of supportive care services. The validated Royal Marsden Hospital (RMH) prognosis score was calculated using data at the time of EP-CT enrollment (scores range from 0 to 3; scores = 2 indicate poor prognosis). Differences in patient characteristics, clinical outcomes, and receipt of supportive care services were compared on the basis of RMH scores. RESULTS: Among 350 patients (median age = 63.2 years [range, 23.0-84.3 years], 57.1% female, 98.0% metastatic cancer), 31.7% had an RMH score indicating a poor prognosis. Those with poor prognosis RMH scores had worse overall survival (hazard ratio [HR], 2.00; P < .001), shorter time on trial (HR, 1.53; P < .001), and lower likelihood of completing the dose-limiting toxicity period (odds ratio, 0.42; P = .006) versus those with good prognosis scores. Patients with poor prognosis scores had greater risk of emergency room visits (HR, 1.66; P = .037) and hospitalizations (HR, 1.69; P = .016) while on trial, and earlier hospice enrollment (HR, 2.22; P = .006). Patients with poor prognosis scores were significantly more likely to receive palliative care consultation (46.8% v 27.6%; P < .001), but not other supportive care services. CONCLUSION: This study found that RMH prognosis score could identify patients at risk for decreased survival, shorter time on trial, and greater use of health care services. The findings underscore the need to develop supportive care interventions targeting EP-CT participants' distinct needs. [ABSTRACT FROM AUTHOR]
- Subjects :
- HUMAN research subjects
SOCIAL support
ACADEMIC medical centers
PATIENT selection
MEDICAL care
RETROSPECTIVE studies
ACQUISITION of data
CANCER patients
MEDICAL records
DESCRIPTIVE statistics
KAPLAN-Meier estimator
RESEARCH funding
ADVERSE health care events
ELECTRONIC health records
ODDS ratio
TUMORS
LOGISTIC regression analysis
PALLIATIVE treatment
PROPORTIONAL hazards models
DISEASE risk factors
Subjects
Details
- Language :
- English
- ISSN :
- 26881527
- Volume :
- 19
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- JCO Oncology Practice
- Publication Type :
- Academic Journal
- Accession number :
- 164271700
- Full Text :
- https://doi.org/10.1200/OP.22.00742