The results of the PRUDENCE trial, published in The Lancet Primary Care took place in 13 European countries. Part of the randomised controlled trial with 2,639 patients in all 13 countries was an in-depth qualitative evaluation involving clinicians and patients in six countries.
Together, the studies provide the most comprehensive evaluation to date of whether rapid diagnostic testing can meaningfully decrease antibiotic use in real-world primary care settings without having a negative impact on patient recovery.
Around 90% of antibiotics are prescribed by GPs in primary care, and most of these prescriptions are for respiratory infections such as sore throats and coughs, which are usually caused by viruses and do not need antibiotics.
Point-of-care tests have been widely promoted as a diagnostic tools to help clinicians in treatment decision making, thereby reducing unnecessary prescriptions.
Clinical trial across 13 countries shows no overall reduction in antibiotic prescribing
The clinical trial ran from December 2021 to January 2024. The trial enrolled 2,639 patients aged one year and older who presented with a cough or sore throat. All participants were included because their clinician was considering to prescribe antibiotics.
Participants were randomly assigned to usual care alone or to usual care plus a point-of-care testing strategy. Depending on symptoms and season, testing could include a CRP test (a blood test measuring inflammation), a group A streptococcus test (a rapid throat swab), an influenza A and B test, or a combination of these tests depending on clinical presentation and influenza season.
Antibiotics were prescribed to 45.7% of patients in the point-of-care testing group and 47.1% in the usual care group, a difference that is not statistically significant. Both groups recovered at the same rate, taking an average of four days to return to their usual daily activities. The study also found no increase in complications or serious adverse events linked to the testing strategy.
The trial concludes that point-of-care testing, when introduced as a standalone strategy in situations where clinicians are already inclined to prescribe antibiotics, does not substantially reduce antibiotic prescribing.
Qualitative study reveals why testing alone is insufficient
The qualitative study embedded within the trial explored how clinicians and patients experienced and used point-of-care testing. Researchers conducted in-depth interviews with 56 patients and 33 clinicians across six countries.
The findings from this study help explain why the trial did not lead to a reduction in prescribing rates.
Clinicians often used test results to confirm decisions they had already made, rather than to change them. When the initial clinical assessment strongly suggested a bacterial infection, clinicians frequently prioritised clinical judgement over test results. They also highlighted importance of relying on clinical intuition, and questioned the accuracy of the test rather than revising their prescribing decision.
Point of care tests were more effective in cases of genuine diagnostic uncertainty, when symptoms were non-specific or when it was difficult to distinguish a bacterial from a viral infection. In these cases, a test result could change the prescribing decision in either direction. However, perceived patient expectations, perceived severity of illness, timing of presentation, and cultural norms around antibiotics often outweighed test results.
The question is no longer whether point of care tests work in primary care, but under what conditions they can function optimally and how policy and medical practice can actively create those conditions.
Professor Sarah Tonkin-Crine at the Nuffield Department of Primary Care Health Sciences and senior co-author of the qualitative study, said: ‘The results of our study suggest that diagnostic tests alone are not sufficient. Clinicians across six very different countries and health systems described the same patterns; the primacy of clinical intuition, the pressure of perceived patient expectations and the difficulty of acting on a test result those conflicts with your own assessment. are fundamental to how clinical decisions. This tells us that point-of-care testing needs to be part of a broader strategy, one that includes clinician training, communication support, and clear guidance on how to act safely on test results.’
Professor Chris Butler, Associate Head for Research at the Nuffield Department of Primary Health Care Sciences and lead author of the trial, said: ‘Point-of-care tests have real potential, but our study shows that diagnostics on their own do not inevitably change prescribing decisions. When clinicians are already leaning towards antibiotics, test results often reinforce that choice. To make a meaningful difference, rapid testing must be combined with clear guidance, clinician training, and support to manage patient expectations. In addition, we need better evidence about the safety of following the prescribing implications of tests.’
Diagnostic testing has been widely promoted in national and international action plans as a key mechanism to reduce inappropriate antibiotic use. The results of these studies suggest that diagnostics tests alone are not sufficient to reduce antibiotic prescribing. They must be combined with structured clinician training, clear guidance on the safety of following test results, and strategies to address the cognitive dissonance- the discomfort of holding conflicting information that arises when test results challenge a clinician’s initial assessment.
The paper, ‘Point-of-care testing strategy versus usual care to safely reduce antibiotic prescribing for acute respiratory tract infections in primary care (PRUDENCE): a pragmatic, randomised controlled trial in 13 countries‘, is published in The Lancet Primary Care.
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