RESUMEN
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.