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 t oday's changing and sometimes complex health care environment. Maintaining study validity thus becomes a major focus of interventional research, but e xisting literature does not fully address challenges to study validity nor offer potential solutions. Objectives: The purposes of this paper are to 1) discuss methodologic chall enges to maintaining study validity of intervention research that is conduc ted in a changing clinical environment, and 2) share strategies for maximiz ing study validity. Methods: A recently completed intervention study is used as an example to d iscuss two specific areas that affected study validity, provide examples of selected threats to validity, and outline strategies used to minimize thes e threats. Results: Careful definition of goals, thoughtful decision making, and imple mentation of specific strategies to maintain study validly helped increased the rigor of the research. Conclusions: Investigators conducting intervention research in changing cli nical settings can reduce threats to study validity and increase design rig or by considering clinical realities (e.g., clinician-researcher role confl ict) when making methodologic decisions, becoming familiar with the setting , and involving clinicians in the research.