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.

中文翻译：

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社区护理人员护理点测试：两种市售设备的有效性和可用性。

背景技术社区护理人员（CP）需要在现场进行及时的血液分析，以指导治疗和运输决策。相对于实验室分析，即时检验（POCT）可能提供了解决方案，但对CP POCT的研究有限。这项研究的目的是比较社区中CP两种设备（Abbotti-STAT®和Alereepoc®）的有效性。方法在应对6000例年度患者护理事件的CP计划中，对连续患者样本进行POCT相对于传统实验室分析的七种分析物（钠，钾，氯，肌酐，血红蛋白，血细胞比容和葡萄糖）的分离样本验证。使用两次样本比例测试比较了POCT和实验室之间差异结果比例的差异。通过对CP经验的调查，针对CP临床和POCT经验调整的系统可用性量表（SUS）的线性混合效应模型，对设备的专家启发式评估，对设备记录的错误的审查以及对POCT使用的编码观察，来分析可用性在质量控制测试中。结果在筛查入组的1649例护理中，有174例需要抽血，其中73例入选了108例（62.1％）。参与者的平均年龄为58.7岁（SD16.3）；49％是女性。在646个比较中有4个（0.6％），POCT报告有临界值，但实验室没有。i-STAT®（0.9％; 95％CI：0.0,1.9％）与epoc®（0.3％; 95％CI：0.0,0.9％）之间无统计学差异（p = 0.323）。POCT并未提供实验室报告临界值的实例。在1046的88中（8。4％）的比较超出了POCT与实验室之间的先验定义的可接受差异；与i-STAT®（6.1％; 95％CI：4.1,8.2％）相比，epoc®（10.7％; 95％CI：8.1,13.3％）发生率更高（p = 0.007）。返回了19个CP调查中的18个，其中11/18（61.1％）首选i-STAT®而不是epoc®。与epoc®相比，i-STAT®的平均SUS评分更高（可用性更高）（84.0 / 100与59.6 / 100； p = 0.011）。i-STAT®和epoc®之间的设备记录错误没有统计学上的显着差异（p = 0.063）。结论CP程序可望从POCT获得临床有效的结果。设备的可用性评估应在任何本地实施中考虑，因为两个POCT系统具有不同的优势。与i-STAT®（6.1％; 95％CI：4.1,8.2％）相比，epoc®（10.7％; 95％CI：8.1,13.3％）发生率更高（p = 0.007）。返回了19个CP调查中的18个，其中11/18（61.1％）首选i-STAT®而不是epoc®。与epoc®相比，i-STAT®的平均SUS评分更高（可用性更高）（84.0 / 100与59.6 / 100； p = 0.011）。i-STAT®和epoc®之间的设备记录错误没有统计学上的显着差异（p = 0.063）。结论CP程序可望从POCT获得临床有效的结果。设备的可用性评估应在任何本地实施中考虑，因为两个POCT系统具有不同的优势。与i-STAT®（6.1％; 95％CI：4.1,8.2％）相比，epoc®（10.7％; 95％CI：8.1,13.3％）发生率更高（p = 0.007）。返回了19个CP调查中的18个，其中11/18（61.1％）较之于epoc®更喜欢i-STAT®。与epoc®相比，i-STAT®的平均SUS评分更高（可用性更高）（84.0 / 100与59.6 / 100； p = 0.011）。i-STAT®和epoc®之间的设备记录错误没有统计学上的显着差异（p = 0.063）。结论CP程序可望从POCT获得临床有效的结果。设备的可用性评估应在任何本地实施中考虑，因为两个POCT系统具有不同的优势。与epoc®相比，i-STAT®的平均SUS评分更高（可用性更高）（84.0 / 100与59.6 / 100； p = 0.011）。i-STAT®和epoc®之间的设备记录错误没有统计学上的显着差异（p = 0.063）。结论CP程序可望从POCT获得临床有效的结果。设备的可用性评估应在任何本地实施中考虑，因为两个POCT系统具有不同的优势。与epoc®相比，i-STAT®的平均SUS评分更高（可用性更高）（84.0 / 100与59.6 / 100； p = 0.011）。i-STAT®和epoc®之间的设备记录错误没有统计学上的显着差异（p = 0.063）。结论CP程序可望从POCT获得临床有效的结果。设备的可用性评估应在任何本地实施中考虑，因为两个POCT系统具有不同的优势。