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
Bibliographic record
Abstract
INTRODUCTION: Streptococcal 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 ANALYSIS: A 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 DISSEMINATION: All 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 NUMBER: NCT04247243.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.009 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.007 | 0.005 |
| Insufficient payload (model declined to judge) | 0.029 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".