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PPAS in set-up.

VALUE-Dx involves two clinical studies:

1. A two-week Pont-Prevalence Audit Study (PPAS) in Winter season I (January 2020)

AIM

This study aims to record information about patients who receive treatment for community acquired acute respiratory tract infection (CA-ARTI) e.g. cough, sore throat. This will help researchers benchmark patterns of antibiotic prescribing in contrasting European settings simply by observing what happens in routine care.

WHY THIS IS IMPORTANT

The invention of antibiotics was a major breakthrough in medical science. Antibiotics are used to treat illness caused by bacteria. Development of these medicines meant that illnesses, like pneumonia, which were often fatal, could be treated. That saved millions of lives. The effectiveness of antibiotics is decreasing because they are being overused. Microorganisms that are being exposed to antibiotics change genetically over time and develop resistance. As a result “superbugs” are developing. We have no effective treatment for these “superbugs”. The development of resistance to antibiotics is a major public health concern worldwide. Unhelpful, clinically unwarranted variation in care is a major contributor. Point of care testing that is proven to be cost effective in clinical trials could help improve the quality of care and thus patient outcomes especially for CA-ARTI, the commonest acute reasons for consulting health services in community care setting and for antibiotic use. However, an initial description of the presentation (case mix) and management of CA-ARTI in different community care settings is urgently needed.

METHODS

The study will run over a 2 week period in approximately 20 European countries. Researchers will collect information from health settings where antibiotics are often prescribed for patients who have respiratory infections, including general practice, urgent care centres, accident and emergency and other acute services in hospitals, paediatric care centres, and long term care facilities, both in and out of office-hours care.

 

2. A platform, response-adaptive randomised controlled trial in winter seasons II and III (PRUDENCE).

AIM

The trial will evaluate the use of clinical algorithms that include a diagnostic test for community acquired acute respiratory tract infection compared to usual care without the addition of a diagnostic test and/or using different diagnostic tests. The trial may therefore have several arms. We will assess effectiveness in terms of both reductions in antibiotic prescribing and in terms of patient recovery, as reduction in antibiotic prescribing should not be at the expense of poorer outcomes for patients.

METHODS

This will be a multi-country, prospective, platform, response-adaptive, randomised clinical trial in community care. We will be able to drop arms as soon as they are proven to meet (or proven not to meet) pre-specified thresholds for effectiveness or non-effectiveness, and add in new arms during the course of the trial itself (platform trial). The proportion of participants allocated to trial arms may be altered at pre-specified assessment points in response to emerging trial outcomes against predetermined criteria about performance to enhance study efficiency (response adaptive randomization).

BENEFITS TO THE PATIENT AND NHS

Support community care prescribers in their decision to prescribe antibiotics to patients with CA-ARTI to those that need them. This should result in changes in antimicrobial prescribing/reduced antimicrobial resistance.