Maintaining study validity in a changing clinical environment.

BACKGROUND: Nurse scientists who conduct intervention research in a variety of clinical settings find themselves facing numerous challenges posed by today's changing and sometimes complex health care environment. Maintaining study validity thus becomes a major focus of interventional research, but existing literature does not fully address challenges to study validity nor offer potential solutions. OBJECTIVES: The purposes of this paper are to 1) discuss methodologic challenges to maintaining study validity of intervention research that is conducted in a changing clinical environment, and 2) share strategies for maximizing study validity. METHODS: A recently completed intervention study is used as an example to discuss two specific areas that affected study validity, provide examples of selected threats to validity, and outline strategies used to minimize these threats. RESULTS: Careful definition of goals, thoughtful decision making, and implementation of specific strategies to maintain study validity helped increased the rigor of the research. CONCLUSIONS: Investigators conducting intervention research in changing clinical settings can reduce threats to study validity and increase design rigor by considering clinical realities (e.g., clinician-researcher role conflict) when making methodologic decisions, becoming familiar with the setting, and involving clinicians in the research.