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Consensus Building for Development of Outpatient Adverse Drug Event Triggers

Mull, Hillary J. MPP*†; Nebeker, Jonathan R. MD, MS‡§; Shimada, Stephanie L. PhD†∥; Kaafarani, Haytham M. A. MD, MPH; Rivard, Peter E. PhD***; Rosen, Amy K. PhD*†

Journal of Patient Safety: June 2011 - Volume 7 - Issue 2 - p 66-71
doi: 10.1097/PTS.0b013e31820c98ba
Original Articles

Objectives: Adverse drug event (ADE) detection is an important priority of patient safety research. Trigger tools have been developed to help identify ADEs. As part of a larger study, we developed complex and specific trigger algorithms intended for concurrent use with clinical care to detect outpatient ADEs. This article assesses the use of a modified Delphi process to obtain expert consensus on the value of these triggers.

Methods: We selected a panel of distinguished clinical and research experts to participate in the modified Delphi process. We created a set of outpatient ADE triggers based on literature review, clinical input, and methodological expertise. The importance of the targeted ADEs, associated drug classes, and trigger logic was used to rate each trigger. Specific criteria were developed to establish consensus.

Results: The modified Delphi process established consensus on 6 outpatient ADE triggers to test with patient-level data based on high ratings of utility for patient-level interventions. These triggers focused on detecting ADEs caused by the following drugs or drug classes: bone marrow toxins, potassium raisers, potassium reducers, creatinine, warfarin, and sedative hypnotics. Participants reported including all aspects of the trigger in their ratings, despite our efforts to separate evaluation of clinical need and trigger logic. Participants' expertise affected the evaluation of trigger rules, leading to contradictory feedback on how to improve trigger design.

Conclusions: The efficiency of the modified Delphi method could be improved by allowing participants to produce an overall summary score that incorporates both the clinical value and the general logic of the trigger. Revising and improving trigger design should be conducted in a separate process limited only to trigger experts.

From the *Center for Organization, Leadership, and Management Research, VA Boston Healthcare System; †Boston University School of Public Health, Boston, Massachusetts; ‡Salt Lake City VA Medical Center; §University of Utah, Salt Lake City, Utah; ∥Center for Health Quality, Outcomes and Economic Research, a VA Center of Excellence, Bedford, Massachusetts; ¶Department of Surgery, Tufts Medical Center; and **Suffolk University, Boston, Massachusetts.

Correspondence: Hillary J. Mull, MPP, Center for Organization, Leadership, and Management Research, VA Boston Healthcare System, 150 S Huntington Ave (152M), Boston, MA 02130 (e-mail:

This research was funded through contract no. HHSA29020060012 Task Order no. 3 awarded to Amy Rosen, PhD, by the Agency for Healthcare Research and Quality.

© 2011 Lippincott Williams & Wilkins, Inc.