Standards and guidelines for observational studies: quality is in the eye of the beholder.

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.

Model for a patient-centered comparative effectiveness research center.

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.

PCOR, CER, and CBPR: alphabet soup or complementary fields of health research?

Comparative effectiveness research (CER) and community- based participatory research (CBPR) are two fields of research that do not have a history of strong collaboration. However, CER and CBPR researchers could benefit from interdisciplinary collaboration to design and implement relevant, timely, action-oriented research. This commentary explores field-specific definitions of stakeholders and then outlines various roles stakeholders might play within grant-funded research. Questions such as "What stakeholders should be involved?" and "How are stakeholders involved?" are addressed. The goal of this commentary is to highlight how the expertise and experiences of CBPR investigators can enhance the field of CER and to describe strategies for encouraging stakeholder involvement in CER research through the lens of CBPR. It is recommended that a team-based approach to conducting stakeholder-engaged CER encourages multiple stakeholders and "end users" to contribute their diverse expertise to the research process and contributes to the development of research with an increased likelihood of improving patient health and healthcare.

Pennsylvania SBIRT Medical and Residency Training: developing, implementing, and evaluating an evidenced-based program.

Medical residents do not receive adequate training in screening, brief intervention, and referral to treatment (SBIRT) for alcohol and other drug use disorders. The federally funded Pennsylvania SBIRT Medical and Residency Training program (SMaRT) is an evidence-based curriculum with goals of training residents in SBIRT knowledge and skills and disseminating the curriculum throughout the medical residency programs. The SMaRT program collaborates with 4 hospital systems and 7 residency sites, with a target of 1147 residents to be trained. This brief report describes the design of the SMaRT program curriculum, implementation across settings and programs, and its evaluation methods.