• Marc L Berger, Bradley C Martin, Don Husereau, Karen Worley, J Daniel Allen, Winnie Yang, Nicole C Quon, C Daniel Mullins, Kristijan H Kahler, and William Crown.
• Real World Data and Analytics, Pfizer, New York, NY, USA.
• Value Health. 2014 Mar 1; 17 (2): 143-56.

AbstractEvidence-based health care decisions are best informed by comparisons of all relevant interventions used to treat conditions in specific patient populations. Observational studies are being performed to help fill evidence gaps. Widespread adoption of evidence from observational studies, however, has been limited because of various factors, including the lack of consensus regarding accepted principles for their evaluation and interpretation. Two task forces were formed to develop questionnaires to assist decision makers in evaluating observational studies, with one Task Force addressing retrospective research and the other Task Force addressing prospective research. The intent was to promote a structured approach to reduce the potential for subjective interpretation of evidence and drive consistency in decision making. Separately developed questionnaires were combined into a single questionnaire consisting of 33 items. These were divided into two domains: relevance and credibility. Relevance addresses the extent to which findings, if accurate, apply to the setting of interest to the decision maker. Credibility addresses the extent to which the study findings accurately answer the study question. The questionnaire provides a guide for assessing the degree of confidence that should be placed from observational studies and promotes awareness of the subtleties involved in evaluating those. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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