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Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes.

ABSTRACT: Although clozapine has demonstrated superior efficacy in patients with schizophrenia and other serious mental health illness, drug utilization rates are significantly low due to safety concerns and administration challenges. Previous research indicates that current barriers to clozapine use include lack of confidence and knowledge by prescriber, therapeutic monitoring requirements, lack of support and infrastructure to for adequate monitoring and patient adherence, and inadequate understanding of clozapine's benefit-risk profile by policy makers and payers. One potential solution to optimizing clozapine therapy and improving clinical outcomes is the use of point-of-care testing (POCT) devices. Although the drug development process for currently used therapeutics is widely acknowledged, little is known regarding the development of POCT devices by the clinical community. The aim of this review is to provide a summary of the regulatory approval process and current availability of POCT devices for monitoring clozapine therapeutics. The potential role of POCT devices in clinical trials to inform personalized dosing strategies and improve patient outcomes will also be discussed.

SUBMITTER: Kalaria SN

PROVIDER: S-EPMC6708436 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes.

Kalaria Shamir N SN Kelly Deanna L DL

Neuropsychiatric disease and treatment 20190820

Although clozapine has demonstrated superior efficacy in patients with schizophrenia and other serious mental health illness, drug utilization rates are significantly low due to safety concerns and administration challenges. Previous research indicates that current barriers to clozapine use include lack of confidence and knowledge by prescriber, therapeutic monitoring requirements, lack of support and infrastructure to for adequate monitoring and patient adherence, and inadequate understanding o ...[more]

PMID: 31692521

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Project description:BackgroundCommunity 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.MethodsIn 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.ResultsOf 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).ConclusionsCP 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.

Dataset Information

Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes.

Publications

Development of point-of-care testing devices to improve clozapine prescribing habits and patient outcomes.

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