Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology
| Autor: | Kathryn Gordon, Beverly Clayton, Fiona Kennedy, Zoe Rogers, Galina Velikova, Elaine O'Connell Francischetto, Julia Brown, Kate Absolom, Jane M Blazeby |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty 2019-20 coronavirus outbreak Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) MEDLINE Patient reporting 03 medical and health sciences 0302 clinical medicine Quality of life (healthcare) Neoplasms Medicine Adverse Drug Reaction Reporting Systems Humans 030212 general & internal medicine Prospective Studies Intensive care medicine Adverse effect Aged Oncology (nursing) business.industry Health Policy Middle Aged Clinical trial Oncology 030220 oncology & carcinogenesis Quality of Life Feasibility Studies Female Electronics business |
| Zdroj: | Kennedy, F, Absolom, K, Clayton, B, Rogers, Z, Gordon, K, O'Connell Francischetto, E, Blazeby, J M, Brown, J & Velikova, G 2020, ' Electronic Patient Reporting of Adverse Events and Quality of Life : A Prospective Feasibility Study in General Oncology ', JCO Oncology Practice . https://doi.org/10.1200/OP.20.00118 |
| ISSN: | 2688-1527 |
| Popis: | PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL). METHODS: Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored. RESULTS: Of 520 patients, 249 consented (47.9%)—mean age was 62 years, 51% were male, and 70% were married—and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff. CONCLUSION: Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting. |
| Databáze: | OpenAIRE |
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