Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled trial with internal pilot and qualitative and quantitative investigation of microbial, behavioural and antibiotic mechanisms (the RAPID-TEST RCT)

Funding

National Institute for Health and Care Research (NIHR) Researcher Led Efficacy and Mechanism Evaluation Programme (EME) Ref. NIHR131758.

What is the problem?

Every year, millions of people seek help for coughs, colds, chest infections, sore throats and earaches. (‘respiratory infections’). On average, GPs and nurses (‘clinicians’) give antibiotics to half of these patients. This is more than is necessary and leads to antibiotic resistance, but they don’t always know who needs them, so often give them ‘just in case’.

We know most respiratory infections are caused by viruses, and that antibiotics only work on bacteria. If clinicians knew which were which, they could target antibiotics better. Clinicians could send swabs to hospitals, but laboratory testing takes 3 days, by which time most patients are improving, and it is clear antibiotics are not needed.

The UK government thinks getting swab results more quickly is critical to improving antibiotic use. Manufacturers are developing ‘point-of-care tests’ (POCTs) that can detect multiple viruses on swabs in 45 minutes – quick enough to make decisions the same day. It might seem obvious that POCTs should be used, but for four things. First, the technology is developing, and the price of the machines and tests is high, respectively £40,000 and £100 for one system, plus the NHS time to run and interpret them.

Second, current machines test mainly for viruses, like the ones causing common colds, ‘flu and COVID. But when a virus is detected, it does not mean it is causing the infection, because viruses can live harmlessly in our noses and throats. So, the clinician must still use their judgment about whether a bacterial infection is present.

Third, no test is 100% accurate. It might say ‘no virus’ when an important virus is present. This means patients could be given harmful advice or treatment. Finally, we know that the clinician’s decision to prescribe and the patient’s decision to take an antibiotic are influenced by the patient-clinician interaction and the patient’s expectations for antibiotics. So, knowing how a POCT works is not as simple as ‘presence of virus = antibiotic not necessary’.

What is the aim of the research?

POCT prices will fall, but we will still need to know if spending NHS resources on them is sensible. If POCTs improved how patients feel and reduced antibiotic prescribing at a reasonable price in routine care, we would say they were ‘cost-effective’. But there is no point in checking cost-effectiveness if POCTs don’t reduce antibiotic prescribing or help patients feel better. No study like that has been done. To date, two small studies have shown that clinicians like and would use POCTs.

We did one of these, and the results helped us design the present study, which aims to see if POCTs can reduce antibiotic prescribing and if so how. It will also see if POCTs help patients feel better quicker. If we get positive answers to these questions, a future study will check cost -effectiveness.

How will this be achieved?

We will invite people with respiratory infections seeking help from their GP. We will divide them into two groups at random (so they are similar) with the clinicians of one group receiving POCT results and the other continuing with usual care. Clinicians will prescribe antibiotics as they see fit, and participants followed up to see how long symptoms last.

Our PPI advisory group said getting antibiotics to the people who need them most is important and provided practical considerations for recruitment and follow up during COVID. One member has joined as a co-applicant and has been integral to the design and drafting of this application.

Who is leading the research?

Professor Alastair D Hay, Professor of Primary Care, Bristol Medical School.

Further information:

For more information or to get involved in this project, please contact bnssg.research@nhs.net.

The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.