Eric J Lenze1, Alex Ramsey2, Patrick J Brown3, Charles F Reynolds4, Benoit H Mulsant5, Helen Lavretsky6, Steven P Roose3. 1. Department of Psychiatry, Washington University, St. Louis, MO, USA. Electronic address: lenzee@wustl.edu. 2. Department of Psychiatry, Washington University, St. Louis, MO, USA. 3. College of Physicians and Surgeons, Columbia University and New York State Psychiatric Institute, New York, NY, USA. 4. Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. 5. Centre for Addiction and Mental Health and Department of Psychiatry, University of Toronto, Canada. 6. Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, USA.
Abstract
OBJECTIVES: Clinical trials can benefit from patient perspectives to inform trial design, such as choice of outcome measures. We engaged older adults in focus groups and surveys to get their perspective regarding needs in clinical research. The goal was to inform the development of a new clinical trial of medication strategies for treatment-resistant depression in older adults. METHODS: Older adults with depression participated in focus groups and a subsequent survey in St. Louis and New York. They were queried regarding research design features including outcomes, clinical management, mobile technology and iPad-administered assessments, the collection of DNA, and the receipt of their personal results. RESULTS: Patients told us: (1) psychological well-being and symptomatic remission are outcomes that matter to them; (2) it is important to measure not only benefits but risks (such as risk of falling) of medications; (3) for pragmatic trials in clinical settings, the research team should provide support to clinicians to ensure that medications are properly prescribed; (4) technology-based assessments are acceptable but there were concerns about data security and burden; (5) DNA testing is very important if it could improve precision care; (6) participants want to receive aggregate findings and their own personal results at the end of the study. CONCLUSIONS: Patients gave useful and wide-ranging guidance regarding clinical and comparative effectiveness research in older adults. We discuss these findings with the goal of making the next generation of geriatric studies more impactful and patient-centered.
OBJECTIVES: Clinical trials can benefit from patient perspectives to inform trial design, such as choice of outcome measures. We engaged older adults in focus groups and surveys to get their perspective regarding needs in clinical research. The goal was to inform the development of a new clinical trial of medication strategies for treatment-resistant depression in older adults. METHODS: Older adults with depression participated in focus groups and a subsequent survey in St. Louis and New York. They were queried regarding research design features including outcomes, clinical management, mobile technology and iPad-administered assessments, the collection of DNA, and the receipt of their personal results. RESULTS:Patients told us: (1) psychological well-being and symptomatic remission are outcomes that matter to them; (2) it is important to measure not only benefits but risks (such as risk of falling) of medications; (3) for pragmatic trials in clinical settings, the research team should provide support to clinicians to ensure that medications are properly prescribed; (4) technology-based assessments are acceptable but there were concerns about data security and burden; (5) DNA testing is very important if it could improve precision care; (6) participants want to receive aggregate findings and their own personal results at the end of the study. CONCLUSIONS:Patients gave useful and wide-ranging guidance regarding clinical and comparative effectiveness research in older adults. We discuss these findings with the goal of making the next generation of geriatric studies more impactful and patient-centered.
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