Community paramedic point of care testing: validity and usability of two commercially available devices.

BACKGROUND: Community Paramedics (CPs) require access to timely blood analysis in the field to guide treatment and transport decisions. Point of care testing (POCT), as opposed to laboratory analysis, may offer a solution, but limited research exists on CP POCT. The purpose of this study was to compare the validity of two devices (Abbott i-STAT® and Alere epoc®) by CPs in the community. METHODS: In a CP programme responding to 6000 annual patient care events, a split sample validation of POCT against traditional laboratory analysis for seven analytes (sodium, potassium, chloride, creatinine, hemoglobin, hematocrit, and glucose) was conducted on a consecutive sample of patients. The difference of proportion of discrepant results between POCT and laboratory was compared using a two sample proportion test. Usability was analysed by survey of CP experience, a linear mixed effects model of Systems Usability Scale (SUS) adjusted for CP clinical and POCT experience, an expert heuristic evaluation of devices, a review of device-logged errors, and coded observations of POCT use during quality control testing. RESULTS: Of 1649 episodes of care screened for enrollment, 174 required a blood draw, with 108 episodes (62.1%) enrolled from 73 participants. Participants had a mean age of 58.7 years (SD16.3); 49% were female. In 4 of 646 (0.6%) comparisons, POCT reported a critical value but the laboratory did not; with no statistically significant (p = 0.323) difference between i-STAT® (0.9%;95%CI:0.0,1.9%) compared with epoc® (0.3%;95%CI:0.0,0.9%). There were no instances of the laboratory reporting a critical value when POCT did not. In 88 of 1046 (8.4%) comparisons the a priori defined acceptable difference between POCT and the laboratory was exceeded; occurring more often in epoc® (10.7%;95%CI:8.1,13.3%) compared with i-STAT® (6.1%;95%CI:4.1,8.2%)(p = 0.007). Eighteen of 19 CP surveys were returned, with 11/18 (61.1%) preferring i-STAT® over epoc®. The i-STAT® had a higher mean SUS score (higher usability) compared with epoc® (84.0/100 vs. 59.6/100; p = 0.011). There were no statistically significant differences in device logged errors between i-STAT® and epoc® (p = 0.063). CONCLUSIONS: CP programmes can expect clinically valid results from POCT. Device usability assessments should be considered with any local implementation as the two POCT systems have different strengths.

WITHDRAWN: Performance of Community Blood Glucose Meters in Calgary, Alberta: An Analysis of Quality Assurance Data.

OBJECTIVE: The self-monitoring of blood glucose plays a critical role in management of diabetes mellitus. Although laboratory comparisons of glucose meter accuracy are often acceptable, clinical comparisons show frequent inaccuracies. In this paper, we evaluate the accuracy of self-monitoring blood glucose meters using glucose meter and serum comparisons from a large Canadian laboratory. METHODS: This study was performed using secondary data obtained from the Laboratory Information System of Calgary Services, the sole provider of laboratory testing to Calgary and surrounding areas. We examined anonymous quality assurance data for glucose meter comparisons performed on home glucose meters between January 1, 2010, and April 30, 2013. RESULTS: A total of 39 542 comparisons were recorded on 18 540 different subjects. Overall, 6.7% of differences were greater than the current International Standards Organization standard of 15%, and 3.7% exceeded the Canadian guideline of 20%. CONCLUSIONS: Glucose meter checks were infrequently performed (on average, once per 1.6 years). A significant subset of meter results was inaccurate.

Performance of community blood glucose meters in calgary, alberta: an analysis of quality assurance data.

OBJECTIVE: The self-monitoring of blood glucose plays a critical role in management of diabetes mellitus. Although laboratory comparisons of glucose meter accuracy are often acceptable, clinical comparisons show frequent inaccuracies. In this paper, we evaluate the accuracy of self-monitoring blood glucose meters using glucose meter and serum comparisons from a large Canadian laboratory. METHODS: This study was performed using secondary data obtained from the Laboratory Information System of Calgary Services, the sole provider of laboratory testing to Calgary and surrounding areas. We examined anonymous quality assurance data for glucose meter comparisons performed on home glucose meters between January 1, 2010, and April 30, 2013. RESULTS: A total of 39 542 comparisons were recorded on 18 540 different subjects. Overall, 6.7% of differences were greater than the current International Standards Organization standard of 15%, and 3.7% exceeded the Canadian guideline of 20%. CONCLUSIONS: Glucose meter checks were infrequently performed (on average, once per 1.6 years). A significant subset of meter results was inaccurate.