Evidence development and publication planning: strategic process.
A number of decisions in the health care field rely heavily on published clinical evidence. A systematic approach to evidence development and publication planning is required to develop a portfolio of evidence that includes at minimum information on efficacy, safety, durability of effect, quality of life, and economic outcomes. The approach requires a critical assessment of available literature, identification of gaps in the literature, and a strategic plan to fill the gaps to ensure the availability of evidence demanded for clinical decisions, coverage/payment decisions and health technology assessments. The purpose of this manuscript is to offer a six-step strategic process leading to a portfolio of evidence that meets the informational needs of providers, payers, and governmental agencies concerning patient access to a therapy.
Health Policy and Planning, Medtronic Inc., 7000 Central Ave NE, RCE395, Minneapolis, MN 55432, USA. michael.wittek@medtronic.com
Michael R
MR
Wittek
Mary
M
Jo Williams
Angeline M
AM
Carlson
D003661:Decision Support Techniques; D019317:Evidence-Based Medicine / Q000458:organization & administration*; D006287:Health Planning Guidelines; D006801:Humans; D051188:Knowledge Bases; D008954:Models, Biological; D010934:Planning Techniques; D011642:Publications; D011643:Publishing / Q000458:organization & administration*; D015203:Reproducibility of Results; D012107:Research Design