Semi-structured interview schedule and stakeholder session brainstorming prompts for research into diagnostic technologies for suspected serious infection

Antibiotic resistance occurs when bacteria that cause infections become resistant to antibiotics. It represents a threat to the lives of millions of people around the world if urgent action is not taken. When patients present to emergency care with a suspected infection, it is often difficult for healthcare professionals to know if the infection is caused by bacteria (which could require antibiotics) or a virus (which may be treatable with anti-viral medications but cannot be treated with antibiotics). There is no reliable test which can rapidly confirm bacterial infection, and typically, laboratory tests take 24-48 hours to give results. This means that, often, antibiotics are prescribed to the patient before confirmation of the presence or type of infection. Healthcare professionals worry about missing a diagnosis of sepsis, a common, potentially life-threatening complication of infection.

PROTECT was established to bring together a team of researchers to plan and prepare a platform trial, where multiple diagnostic technologies for suspected serious infection can be evaluated rapidly and, if shown to be safe and clinically and cost-effective, adopted quickly into care to benefit the patient. The team have constructed a flexible, adaptive platform trial design to comprehensively evaluate commercially available interventions across the patient pathway, in order to robustly establish clinical utility. The proposed platform, embedded in routine NHS care, is designed to address the complex problem of antimicrobial optimisation in a clinical area where diagnostics which support immediate clinical decision-making can enhance quality of care and patient safety, and reduce the risk of complications.

The PROTECT Acceleration Award encompassed mapping decision-making pathways for patients with suspected infections and determining intervention entry points in the clinical pathway. Information on care pathways for patients potentially at risk of deterioration from severe bacterial infection was elicited by the NIHR Newcastle In Vitro Diagnostics Co-operative (NMIC). The aims were to identify:

• Entry points along care pathways for those with suspected infection.

• Current practice in testing for serious infections across settings, including timepoints along the pathway where decisions are made regarding antibiotic treatment and criteria-based progression from pre-hospital to admission to ward.

• Points in the care pathway where interventions could be introduced for maximum clinical and cost-effectiveness and efficiency.

• Barriers and facilitators to test implementation.

A stakeholder event was held where small-group discussions, lasting one hour, took place. The discussion guide was followed.

The results from the stakeholder discussions were further expanded upon in semi-structured interviews with clinical experts. The interview guide was developed to ensure the interviews addressed the main themes and aims of interest.

The material in this record is referenced in the paper "Mapping decision-making pathways: Determination of intervention entry points for diagnostic tests in suspected serious infection", which is also linked in the 'References' field below.