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This is a mixed-methods, multi-centre feasibility study. Formal advice and peer-review with regards to study design was sought from the Southampton Research Design Service (RDS), the NIHR CRN Wessex, and patient contributors during the development of the grant application. We will recruit up to ten GP practices, each given 20-40 FebriDx tests (300 in total). Up to four clinicians per practice will be trained to use the test. A sequential explanatory approach to data collection will be taken (21), with quantitative data analysis in stage one, followed by qualitative interviews with the study's practice participants in stage two.
It can be difficult to tell the difference between viral and bacterial infections. Many patients are therefore prescribed antibiotics unnecessarily. Overuse of antibiotics is leading to a crisis of 'antibiotic resistance', where antibiotics no longer work for some infections.
FebriDx ® is a new hand-held test that uses a 'finger-prick' of blood, and within 10 minutes, provides a result that can help clinicians decide whether an infection is likely to be caused by a virus or bacteria. This could help clinicians decide when antibiotics are needed, but the test has not been adequately tested in primary care.
We would like to do a future study to test whether FebriDx can safely reduce antibiotic prescriptions in primary care.
However, before we do this, we need to do a smaller 'feasibility' study to explore how easy to use the FebriDx test is and, what GPs and patients think of the test, and to help us design a larger future study.
Aims
Methods
We will recruit up to ten GP practices, each given 20-40 FebriDx tests (300 total).
Stage one Patients with a chest infection will be invited to participate if their clinician has decided that they are likely to prescribe antibiotics. Following consent, the clinician will record some basic information about the patient, and the patient will undergo the FebriDx test. The clinician will then record whether or not they prescribed antibiotics and if they think the test had an effect on their decision. Patients will also undergo an optional nasopharyngeal swab.
Stage two Clinicians and patients will be interviewed on how useful they think FebriDx testing is, and how they think we should design a larger future study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febridx | Other | Undergo FebriDx testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FebriDx | Diagnostic Test | Testing of finger-prick blood sample using FebriDx |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The proportion of patients recruited as compared to the number invited to participate | Six months |
| Antibiotic prescription rate at study visit | The proportion of patients prescribed antibiotics at the study visit | At study visit (baseline) |
| Antibiotic prescription rate over entire study period | The proportion of patients prescribed antibiotics within 30 days of recruitment | Within 30 days of recruitment |
| Test failure rate | The proportion of Febridx tests which fail to provide a valid result | After FebriDx use (baseline) |
| Ease-of-use scores | The average ease-of-use score for the device as determined by users. Each user will be asked to grade the device according to a modified US Clinical Laboratory Improvement Amendments (CLIA) categorisation criteria Within each of the 11 categories, a score of '1' indicates the lowest level of complexity, and the score of '3' indicates the highest level, to derive a measure of complexity (total score range 1 - 33) | Six months |
| Subsequent healthcare contacts | The proportion of patients undergoing subsequent healthcare contact | Within 30 days of recruitment |
| Subsequent serious complication rate | The proportion of patients undergoing significant complications (sepsis, ITU admission, or death) |
| Measure | Description | Time Frame |
|---|---|---|
| FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection | FebriDx sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for diagnosis of viral infection, as determined by comparison of FebriDx result with nasopharyngeal swab analysis by gold-standard viral PCR | Within one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Wilcox | Contact | 02380591759 | christopher.wilcox@soton.ac.uk | |
| Nick Francis | Contact | Nick.francis@soton.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Wilcox | University of Southampton | Principal Investigator |
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| Within 30 days of recruitment |