Real-World Evidence of Point-of-Care Glucometers: Enhanced Passive Surveillance and Adverse Event Reporting Status in Korea and the United States

Choi, Sooin; Choi, Soo Jeong; Kim, Jin Kuk; Lee, Yong-Wha; Lee, You Kyoung

doi:10.3343/alm.2023.43.5.515

Cited by 4 publications

(1 citation statement)

References 9 publications

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“…Currently, regulatory agencies rely primarily on passive surveillance systems to detect the presence of AEs and ARs, a common example being surveillance systems to monitor potential adverse effects of vaccines [ 12 , 13 ]. This model has also been used for other healthcare-related purposes, such as monitoring the safety of point-of-care products, new healthcare products and dengue prevention [ 14 – 16 ]. However, the success of these systems is largely dependent on spontaneous reporting by both patients and healthcare professionals, the individual's discretion in recognizing when an AE should be recorded, and their ability to submit a thorough report for assessment [ 17 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics

Ng,

Zhao,

Wang

et al. 2024

Chin Med

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Background This study aimed to investigate the rates and causality of patient-reported adverse events (AEs) associated with concomitant Chinese Herbal Medicine (CHM) and Western Medicine prescription drug (WMPD) consumption through active surveillance in Singapore’s Traditional Chinese Medicine (TCM) clinics. Methods A cross-sectional study was conducted at five TCM clinics across Singapore from 8th May till 8th July 2023. Patients were screened to determine rates of CHM and WMPD consumption, and then interviewed if an AE was reported. An expert committee assessed the AE reports to determine causality. Along with descriptive statistics, odds ratios were calculated to determine AE occurrence likelihoods for patients who consumed both CHM and WMPD compared to CHM consumption alone. Results 1028 patients were screened and 62.65% of them reported concurrent CHM-WMPD consumption. Patients who consumed CHM and WMPD were 3.65 times more likely to experience an AE as compared to CHM consumption alone. 18 AE reports were adjudicated, with most AEs deemed unlikely due to CHM consumption. Conclusions A large proportion of patients consumed CHM and WMPD concurrently, thus increasing their risk of experiencing AEs compared to those consuming CHM only. Active surveillance is applicable for detecting AEs, collecting data for causality assessment, and analysis.

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Section: Introductionmentioning

confidence: 99%

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics

Ng,

Zhao,

Wang

et al. 2024

Chin Med

View full text Add to dashboard Cite

show abstract

Development of a Systematic Quality Control Program for Point-of-Care Glucose Testing

Jo,

Choi,

Lee

et al. 2023

J Lab Med Qual Assur

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Background: While glucose point-of-care testing (POCT) is widely utilized, it is often carried out by clinical staff who may lack specific test-related training, potentially leading to inadequate quality control (QC) procedures. This study aimed to establish a comprehensive quality management system for glucose POCT. Methods: We implemented a systematic approach encompassing quality assurance, equipment maintenance, operator training, and competency assessment in alignment with the Clinical and Laboratory Standards Institute guidelines POCT12-A3. To facilitate structured internal QC, the results of glucose POCT were automatically analyzed within the laboratory information system (LIS). An adjusted acceptable range was defined as mean±2 standard deviations (SD) based on 1 month of QC result analysis operator performance was enhanced through a tailored training program, and proficiency tests were conducted on all glucometers to assess competency. Results: Leveraging the LIS allowed the application of quality control rules to glucose POCT, enabling swift error identification and response. Analysis of one month's QC results revealed that for high-concentration samples, the warning rate using the adjusted range was significantly higher than that using the provided range (1.1% vs. 2.7%, P<0.01). A maintenance schedule was established, encompassing monthly upkeep for glucometers and collective replacement of all QC materials every 3 months. Operator training was facilitated through both face-to-face education and instructional videos. During proficiency testing, four devices initially exhibited deviations beyond 3SD, which were subsequently rectified upon re-examination. Conclusions:The implementation of a systematic and efficient quality control system, as demonstrated in this study, holds the potential to yield accurate and dependable glucose POCT results.

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A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics.

Ng,

Zhao,

Wang

et al. 2023

Preprint

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Background This study aimed to investigate the rates and causality of patient-reported adverse events (AEs) associated with concomitant Chinese Herbal Medicine (CHM) and Western Medicine prescription drug (WMPD) consumption through active surveillance in Singapore’s Traditional Chinese Medicine (TCM) clinics. Methods A cross-sectional study was conducted at five TCM clinics across Singapore from 8th May till 8th July 2023. Patients were screened to determine rates of CHM and WMPD consumption, and then interviewed if an AE was reported. An expert committee assessed the AE reports to determine causality. Along with descriptive statistics, odds ratios were calculated to determine AE occurrence likelihoods for patients who consumed both CHM and WMPD compared to CHM consumption alone. Results 1028 patients were screened and 62.65% of them reported concurrent CHM-WMPD consumption. Patients who consumed CHM and WMPD were 3.65 times more likely to experience an AE as compared to CHM consumption alone. 18 AE reports were adjudicated, with most AEs deemed unlikely due to CHM consumption. Conclusions A large proportion of patients consumed CHM and WMPD concurrently, thus increasing their risk of experiencing AEs compared to those consuming CHM only. Active surveillance is feasible for detecting AEs, collecting data for causality assessment, and analysis.

show abstract

Real-World Evidence of Point-of-Care Glucometers: Enhanced Passive Surveillance and Adverse Event Reporting Status in Korea and the United States

Cited by 4 publications

References 9 publications

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics

Development of a Systematic Quality Control Program for Point-of-Care Glucose Testing

A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics.

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