RESULTS: Challenges, many of them critical, were a regular occurrence: dealing with unforeseen obstacles, establishing and maintaining physician buy-in, establishing and maintaining staff buy-in, implementing the protocol as directed and with minimal intrusiveness, maintaining enthusiasm for the project over time, and knowing where (and where not) to allocate the Study's time, energy, and money. Strategies were developed to overcome or minimize the impact of problems on a case-by-case basis.
CONCLUSIONS: Successful practice-based research requires an awareness of study design issues and an appreciation of clinical practice logistics and priorities. Every effort must be made to include doctors and office staff in the implementation of the study in a manner that minimizes the study's intrusiveness and its economic impact on office organization, routine, and personnel. Investigators must understand and accept that there will be areas of the research environment over which they have no direct control. The challenges will be many, but they will be diminished by the rewards.
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