Stakeholders' views and experiences on implementing new diagnostics in primary care to support management of community-acquired acute respiratory tract infections: a qualitative study.

Background: The majority of antibiotics are prescribed in primary care for respiratory tract infections. Point-of-care tests (POCTs) for the management of community-acquired acute respiratory tract infections (CA-ARTI) have been developed to help optimize antibiotic prescribing. While some countries in Europe have adopted these tests in primary care settings, most have not. Stakeholders, such as policy-makers, regulators, the diagnostic industry, and scientific associations, have roles in the implementation of new diagnostics in primary care. The aim of this study is to explore these stakeholders' views and experiences, and identify areas of unmet need relating to POCT implementation. Methods: Stakeholders were recruited using purposive sampling and snowballing. Between March 2021 and May 2022, semi-structured interviews were conducted online with stakeholders in Belgium, the UK and from European Union (EU) -level organizations. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed inductively and deductively using thematic analysis. Results: Twenty-six stakeholders participated: eleven from EU-level organizations, seven from Belgium, and eight from the UK. Five themes were identified. Stakeholders felt a balance of top-down and bottom-up approaches were an optimal strategy to the implementation of POCTs. Stakeholders stressed the need to engage with clinicians to act as champions for tests to help raise awareness and generate new evidence on how tests are used. While acknowledging the potential of POCTs for improving patient outcomes and impacting antibiotic prescribing behavior, some raised concerns on how tests would be used in practice and wished to see national data on effectiveness. COVID-19 catalyzed the use of tests, but stakeholders were pessimistic that processes for approving diagnostics during the pandemic would be replicated in the future. Conclusion: Stakeholders provided recommendations for research and practice. Robust reimbursement policies could alleviate financial burden from clinicians and patients, encouraging practices to adopt POCTs. Industry is likely to benefit from engaging as early on as possible with other stakeholders. Due to uncertainty among stakeholders on the impact of POCTs on antibiotic prescribing, further evidence is needed to understand how practices adopt POCTs and the implications for stewardship. Monitoring how POCTs are used can inform future guidelines on successful diagnostic implementation.

Measuring clinical outcomes of highly multiplex molecular diagnostics for respiratory infections: A systematic review and conceptual framework.

Objectives: To review methodologies and outcomes reporting among these studies and to develop a conceptual framework of outcomes to assist in guiding studies and production of clinical metrics. Data sources: PubMed and Embase from January 1, 2012, thru December 1, 2021. Study eligibility criteria: Studies evaluating highly multiplex molecular respiratory diagnostics and their impact on either clinical or economic outcomes. Methods: A systematic literature review (SLR) of methodologies and outcomes reporting was performed. A qualitative synthesis of identified SLRs and associated primary studies was conducted to develop conceptual framework for outcomes. Results: Ultimately, 4 systemic literature reviews and their 12 associated primary studies were selected for review. Most primary studies included patient outcomes focusing on antimicrobial exposure changes such as antibiotic (80%) and antiviral use (50%) or occupancy changes such as hospital length of stay (60%). Economic outcomes were infrequently reported, and societal outcomes, such as antibiotic resistance impact, were absent from the reviewed literature. Qualitative evidence synthesis of reported outcomes yielded a conceptual framework of outcomes to include operational, patient, economic, and societal domains. Conclusions: Our review highlights the significant heterogeneity in outcomes reporting among clinical impact studies for highly multiplex molecular respiratory diagnostics. Furthermore, we developed a conceptual framework of outcomes domains that may act as a guide to improve considerations in outcomes selection and reporting when evaluating clinical impact of these tests. These improvements may be important in synthesizing the evidence for informing clinical decision making, guidelines, and financial reimbursement.