Practical clinical trials for translating research to practice: design and measurement recommendations.
BACKGROUND
There is a pressing need for practical clinical trials (PCTs) that are more relevant to clinicians and decision-makers, but many are unaware of these trials. Furthermore, such trials can be challenging to conduct and to report.


OBJECTIVE
The objective of this study was to build on the seminal paper by Tunis et al (Practical clinical trials. Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-1632.) and to provide recommendations and examples of how practical clinical trials can be conducted and the results reported to enhance external validity without sacrificing internal validity.


RESULTS
We discuss evaluating practical intervention options, alternative research designs, representativeness of samples participating at both the patient and the setting/clinician level, and the need for multiple outcomes to address clinical and policy implications.


CONCLUSIONS
We provide a set of specific recommendations for issues to be reported in PCTs to increase their relevance to clinicians and policymakers, and to help reduce the gap between research and practice.
Glasgow
Russell E
RE
Kaiser Permanente Colorado, Clinical Research Unit, Denver, Colorado, USA. russg@ris.net
Magid
David J
DJ
Beck
Arne
A
Ritzwoller
Debra
D
Estabrooks
Paul A
PA
D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003657:Decision Making; D019317:Evidence-Based Medicine; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome