A Pilot Study on the Collection of Adverse Event Data from the Patient Using an Electronic Platform in a Cancer Clinical Trial Unit
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View abstract on PubMed
Summary
This summary is machine-generated.Patient-reported adverse event data in cancer trials show low agreement with clinician data but reduce staff workload. Electronic platforms improve data completeness and efficiency for adverse event collection.
Area Of Science
- Clinical Trials
- Patient Safety
- Data Management
Background
- Accurate adverse event (AE) data collection is vital for patient safety in cancer clinical trials.
- Traditional AE data collection workflows are evolving to incorporate patient-reported outcomes (PROs) for improved completeness.
- This study investigated the implementation of a patient-reported data workflow in a clinical trial setting.
Purpose Of The Study
- To evaluate the agreement between patient-reported and clinician-reported adverse event data.
- To assess the efficiency of using an electronic platform for AE data collection compared to traditional methods.
- To determine the impact of patient-reported data on data completeness in cancer clinical trials.
Main Methods
- A single-site study at a tertiary hospital in Australia.
- Participants used the 'My Health My Way' (MHMW) electronic platform to report symptoms weekly for 24 weeks.
- Comparison of AE data from MHMW with patient medical charts, assessing agreement (Kappa, Gwet's AC1) and time/missing data.
Main Results
- Low agreement observed between patient- and clinician-reported AEs (Kappa: -0.482, Gwet's AC1: -0.159).
- Only 30% of total AEs were reported by both sources.
- MHMW significantly reduced data compilation time (2.19 min vs. 5.73 min) and missing data points (1.4 vs. 7.8) compared to medical notes.
Conclusions
- Confirms low agreement between patient- and clinician-reported AE data.
- Electronic patient-reported platforms can significantly reduce research staff workload for AE data collection.
- Implementation of electronic platforms enhances efficiency and completeness of AE data in cancer trials.
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