Jamie L Estock1, Ivan-Thibault Pham2, Holly K Curinga3, Benjamin J Sprague4, Monique Y Boudreaux-Kelly5, Jeanette Acevedo6, Katrina Jacobs7. 1. Center for Medical Product End-user Testing, VA [US Department of Veterans Affairs] Pittsburgh Healthcare System (VAPHS), Pittsburgh. Electronic address: jamie.estock@va.gov. 2. Center for Medical Product End-user Testing, VAPHS, is User Researcher, Bose Corporation, Framingham, Massachusetts. 3. Resuscitation Education Initiative Program, VAPHS. 4. Quality and Patient Safety, Medicine Service Line, VAPHS, is Clinical Instructor of Medicine, Division of General Internal Medicine, University of Pittsburgh Medical Center. 5. VAPHS. 6. VA Hudson Valley Health Care System, Montrose, New York. 7. VA National Center for Patient Safety, Ann Arbor, Michigan. Please address correspondence to Jamie Estock.
Abstract
BACKGROUND:Blood glucose (BG) testing is the most widely performed point-of-care (POC) test in a hospital setting. Multiple adverse events reported to the Food and Drug Administration (FDA) revealed that treatment decisions may be affected by information displayed on the POC glucometer's results screen. A randomized, crossover simulation study was conducted to compare two results screen configurations for ACCU-CHEK Inform II, a POC glucometer. METHODS: Prior to the study, a heuristic evaluation of the results screen configurations and a pilot study were conducted to select the two results screen configurations for comparison. At two multicampus medical centers, 66 nurse participants experienced two computer-based simulation scenarios that asked them to interpret glucometer readings and make treatment decisions for simulated patients with 32 mg/dL BG levels and subtle symptoms of hypoglycemia. One scenario displayed a numeric value ("32 mg/dL"), and the other displayed a range abbreviation, such as "RR LO" (out of reportable range; low). Treatment errors were recorded when the participant did not treat the hypoglycemic patient with glucose or when they administered insulin. RESULTS: When ACCU-CHEK Inform II displayed an "RR LO" reading, 10.6% of participants made a treatment error, including 6.7% of participants with prior training on the meaning of an "RR LO" reading. None of the participants made a treatment error when ACCU-CHEK Inform II displayed a "32 mg/dL" reading. CONCLUSION: Displaying a numeric BG reading eliminated potentially life-threating treatment errors caused by confusing range abbreviations. Manufacturers should consider these findings during future research and development of POC glucometers. Published by Elsevier Inc.
RCT Entities:
BACKGROUND:Blood glucose (BG) testing is the most widely performed point-of-care (POC) test in a hospital setting. Multiple adverse events reported to the Food and Drug Administration (FDA) revealed that treatment decisions may be affected by information displayed on the POC glucometer's results screen. A randomized, crossover simulation study was conducted to compare two results screen configurations for ACCU-CHEK Inform II, a POC glucometer. METHODS: Prior to the study, a heuristic evaluation of the results screen configurations and a pilot study were conducted to select the two results screen configurations for comparison. At two multicampus medical centers, 66 nurse participants experienced two computer-based simulation scenarios that asked them to interpret glucometer readings and make treatment decisions for simulated patients with 32 mg/dL BG levels and subtle symptoms of hypoglycemia. One scenario displayed a numeric value ("32 mg/dL"), and the other displayed a range abbreviation, such as "RR LO" (out of reportable range; low). Treatment errors were recorded when the participant did not treat the hypoglycemic patient with glucose or when they administered insulin. RESULTS: When ACCU-CHEK Inform II displayed an "RR LO" reading, 10.6% of participants made a treatment error, including 6.7% of participants with prior training on the meaning of an "RR LO" reading. None of the participants made a treatment error when ACCU-CHEK Inform II displayed a "32 mg/dL" reading. CONCLUSION: Displaying a numeric BG reading eliminated potentially life-threating treatment errors caused by confusing range abbreviations. Manufacturers should consider these findings during future research and development of POC glucometers. Published by Elsevier Inc.