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1.
J Clin Epidemiol ; 71: 3-10, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26548541

ABSTRACT

OBJECTIVES: Patient care decisions demand high-quality research. To assist those decisions, numerous observational studies are being performed. Are the standards and guidelines to assess observational studies consistent and actionable? What policy considerations should be considered to ensure decision makers can determine if an observational study is of high-quality and valid to inform treatment decisions? STUDY DESIGN AND SETTING: Based on a literature review and input from six experts, we compared and contrasted nine standards/guidelines using 23 methodological elements involved in observational studies (e.g., study protocol, data analysis, and so forth). RESULTS: Fourteen elements (61%) were addressed by at least seven standards/guidelines; 12 of these elements disagreed in the approach. Nine elements (39%) were addressed by six or fewer standards/guidelines. Ten elements (43%) were not actionable in at least one standard/guideline that addressed the element. CONCLUSION: The lack of observational study standard/guideline agreement may contribute to variation in study conduct; disparities in what is considered credible research; and ultimately, what evidence is adopted. A common set of agreed on standards/guidelines for conducting observational studies will benefit funders, researchers, journal editors, and decision makers.


Subject(s)
Evidence-Based Medicine/methods , Observational Studies as Topic/methods , Observational Studies as Topic/standards , Research Design , Humans
2.
Clin Transl Sci ; 8(2): 155-9, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25588873

ABSTRACT

This special report describes the systematic approach the University of Pittsburgh and the University of Pittsburgh Medical Center (UPMC) undertook in creating an infrastructure for comparative effectiveness and patient-centered outcomes research resources. We specifically highlight the administrative structure, communication and training opportunities, stakeholder engagement resources, and support services offered.


Subject(s)
Comparative Effectiveness Research/organization & administration , Patient-Centered Care/organization & administration , Communication , Data Collection , Humans , Leadership , Observational Studies as Topic , Pennsylvania , Program Development , Research Design , Translational Research, Biomedical/education , Translational Research, Biomedical/organization & administration , Universities
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