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SHELBY L. CORMAN, PHARM.D., BCPS, is Clinical Specialist, Drug Information Center, and Assistant Professor, Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh (UP), Pittsburgh, PA. SUSAN J. SKLEDAR, M.P.H., is Director, Drug Use and Disease State Management Program (DUDSMP), UP Medical Center, and Associate Professor, Department of Pharmacy and Therapeutics, School of Pharmacy, UP. COLLEEN M. CULLEY, PHARM.D., BCPS, is Clinical Specialist, DUDSMP, UP Medical Center, and Assistant Professor, Department of Pharmacy and Therapeutics, School of Pharmacy, UP.

Address correspondence to Dr. Corman at the Drug Information Center, University of Pittsburgh Medical Center, 302 Scaife Hall, 200 Lothrop Street, Pittsburgh, PA 15213 (cormansl{at}upmc.edu).

Purpose. Guidelines were developed for grading the quality, quantity, and consistency of drug literature in support of formulary recommendations. Methods. Four developmental steps were taken to create a comprehensive literature evaluation system. The first step identified the attributes of a body of literature that were most reflective of its applicability to patient care. The next step defined each domain (quality, quantity, consistency), as determined by the Agency of Healthcare Research and Quality (AHRQ), in terms of the specific qualities to be assessed; a value was assigned to those qualities. Also, a literature search was conducted to identify strategies for evaluating bodies of literature employed in published assessment tools. Following the analysis of previously published systems, which were evaluated with respect to their inclusion of the AHRQ-identified domains, the next step was the development of specific domains and definitions to get a composite grade (with "better" evidence earning more points) for formulary recommendations. The final step was the creation of a system that aggregated the final score for the recommendation. The recommendation was categorized according to quality, quantity, and consistency of supporting evidence, and the total number of points was calculated and the recommendation given letter and numerical grades. Results. The guidelines that were developed allow the user to accurately, consistently, and easily determine the strength of recommendations for a body of literature that may be conflicting. The addition of criteria for quantity and consistency to previously-published grading systems has made the guidelines more objective. Conclusion. A system that accounts for the quality, quantity, and consistency of drug literature was developed to assist in making formulary decisions. Index terms: Decision-making; Formularies; Guidelines; Literature; Methodology; Quality assurance