Eimear Ryan, Harmeet Gill, Róisín Doogue, David McCann, Andrew W Murphy, Peter Hayes
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引用次数: 0
Abstract
Background: Stroke has devastating consequences for survivors. Hypertension is the most important modifiable risk factor, and its management largely takes place in primary care. However, most stroke-based research does not occur in this setting. Ongoing hypertension and a risk of further stroke are a major concern for both patients and their general practitioners. We aim to assess whether it is feasible to assess prognosis in persons, with a previous stroke or transient ischemic attack (TIA), in general practice, and whether a well-powered observational study is possible.
Methods: We performed a search of the electronic health record of individuals previously identified as having had a stroke or TIA, to assess prognosis over 3 years. Feasibility was assessed by meeting five criteria: (1) all general practices approached participated, (2) greater than 90% of patient records were accessible, (3) all study outcomes were available to review, (4) that collection data was less than 15 min per patient, and (5) a power calculation for a planned observational study could take place.
Results: All six general practices approached participated freely, and 193/196 patients' files were reidentified (98.5%). Twenty-eight cardiovascular events were recorded-most commonly a repeat TIA or ischemic stroke. Data collection took on average 5.5 min per file, and a power calculation for a planned observational study was completed.
Conclusion: This study demonstrates that the proposed methodology for a full cohort study within general practice of patients post-stroke/TIA is both acceptable to practices and feasible. An adequately powered, "time-to-event" study is possible.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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