scholarly journals Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047271
Author(s):  
Jeffrey M Pernica ◽  
Fiona Smaill ◽  
April J Kam ◽  
Amy Bartholomew ◽  
Quynh Doan ◽  
...  
Keyword(s):  
Point Of Care ◽  
Randomised Trial ◽  
Antibiotic Use ◽  
Streptococcal Pharyngitis ◽  
Primary Study ◽  
Standard Laboratory ◽  
Open Label ◽  
Caregiver Satisfaction ◽  
Clinician Satisfaction ◽  
Antigen Tests

IntroductionStreptococcal pharyngitis, which commonly occurs in children, should be treated with antibiotics. Clinical prediction rules to differentiate streptococcal pharyngitis from viral infection are not recommended in children. Rapid point-of-care (POC) antigen tests have limited sensitivity and so are not often used in Canadian paediatric emergency departments (EDs). Standard paediatric practice is to rely on laboratory-based testing, which often results in a delay before the results can be communicated to the patient; this may impede appropriate prescribing, decrease caregiver satisfaction and delay recovery. The objective of this study is to determine whether a novel rapid molecular POC assay for streptococcal pharyngitis leads to more appropriate antibiotic use in children seeking care in a paediatric ED than standard laboratory-based testing.Methods and analysisA randomised, superiority, open-label, trial with two parallel groups. Children presenting to a tertiary paediatric ED at least 3 years of age who have a throat swab ordered for diagnosis of streptococcal pharyngitis will be eligible; those who have taken antibiotics within 72 hours prior to presentation and those with additional active infections will be excluded. The primary study outcome will be appropriate antibiotic treatment at 3–5 days postenrolment. Secondary outcomes include time to symptom resolution, caregiver satisfaction, caregiver/child absenteeism, number of subsequent healthcare visits, clinician satisfaction and incremental cost-effectiveness of POC testing. A total of 352 participants will be needed.Ethics and disseminationAll study documentation has been approved by the Hamilton Integrated Research Ethics board and informed consent will be obtained from all participants. Data from this trial will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines.Trial registration numberNCT04247243.

scholarly journals Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036147
Author(s):  
Lindsey K Reif ◽  
Marie Elmase Belizaire ◽  
Grace Seo ◽  
Vanessa Rouzier ◽  
Patrice Severe ◽  
...  
Keyword(s):  
Viral Load ◽  
Viral Suppression ◽  
Point Of Care ◽  
Randomised Trial ◽  
Art Adherence ◽  
Test Results ◽  
Standard Laboratory ◽  
Adherence Counselling ◽  
Youth Living With Hiv ◽  
Living With Hiv

IntroductionAdolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.Methods and analysisThis non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10–24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.Ethics and disseminationThis study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.Trial registration numberNCT03288246.

Testing for resistance: Point-of-care testing as a communicational tool in antibiotic prescribing

2018 ◽  
Vol 14 (3) ◽  
pp. 229-240
Author(s):  
Johanna Lindell
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
Antibiotic Use ◽  
Treatment Recommendation ◽  
Antibiotic Prescribing ◽  
Communicative Practices ◽  
Effective Strategies ◽  
Reactive Protein ◽  
Point Of Care Test ◽  
Test Result

As antibiotic resistance becomes a growing health emergency, effective strategies are needed to reduce inappropriate antibiotic use. In this article, one such strategy – communicative practices associated with the C-reactive protein point-of care test – is investigated. Building on a collection of 31 videorecorded consultations from Danish primary care, and using conversation analysis, this study finds that the rapid test can be used throughout the consultation to incrementally build the case for a nonantibiotic treatment recommendation, both when the test result is forecast and reported. The study also finds that the format of reports of elevated results differs from that of ‘normal’ results, resulting in a subtle shift of authority from doctor to test.

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