Real-world severe COVID-19 outcomes associated with use of antivirals and neutralising monoclonal antibodies in Scotland.

We sought to investigate the incidence of severe COVID-19 outcomes after treatment with antivirals and neutralising monoclonal antibodies, and estimate the comparative effectiveness of treatments in community-based individuals. We conducted a retrospective cohort study investigating clinical outcomes of hospitalisation, intensive care unit admission and death, in those treated with antivirals and monoclonal antibodies for COVID-19 in Scotland between December 2021 and September 2022. We compared the effect of various treatments on the risk of severe COVID-19 outcomes, stratified by most prevalent sub-lineage at that time, and controlling for comorbidities and other patient characteristics. We identified 14,365 individuals treated for COVID-19 during our study period, some of whom were treated for multiple infections. The incidence of severe COVID-19 outcomes (inpatient admission or death) in community-treated patients (81% of all treatment episodes) was 1.2% (n = 137/11894, 95% CI 1.0-1.4), compared to 32.8% in those treated in hospital for acute COVID-19 (re-admissions or death; n = 40/122, 95% CI 25.1-41.5). For community-treated patients, there was a lower risk of severe outcomes (inpatient admission or death) in younger patients, and in those who had received three or more COVID-19 vaccinations. During the period in which BA.2 was the most prevalent sub-lineage in the UK, sotrovimab was associated with a reduced treatment effect compared to nirmaltrelvir + ritonavir. However, since BA.5 has been the most prevalent sub-lineage in the UK, both sotrovimab and nirmaltrelvir + ritonavir were associated with similarly lower incidence of severe outcomes than molnupiravir. Around 1% of those treated for COVID-19 with antivirals or neutralising monoclonal antibodies required hospital admission. During the period in which BA.5 was the prevalent sub-lineages in the UK, molnupiravir was associated with the highest incidence of severe outcomes in community-treated patients.

Risk of cardiovascular events following COVID-19 in people with and without pre-existing chronic respiratory disease.

BACKGROUND: COVID-19 is associated with cardiovascular outcomes in the general population, but it is unknown whether people with chronic respiratory disease (CRD) have a higher risk of cardiovascular events post-COVID-19 compared with the general population and, if so, what respiratory-related factors may modify this risk in these people. METHODS: Primary and secondary care data from the National Health Service England were used to define a population of adults in England with COVID-19 (index date) between 1 January 2020 and 30 November 2021. Adjusted Cox proportional hazard regression was used to quantify the association between CRD, asthma-related factors, chronic obstructive pulmonary disease (COPD)-related factors, and risk of cardiovascular events. Asthma-specific factors included baseline asthma control, exacerbations, and inhaled corticosteroid (ICS) dose. COPD-specific risk factors included baseline ICS and exacerbations. Secondary objectives quantified the impact of COVID-19 hospitalisation and vaccine dose on cardiovascular outcomes. RESULTS: Of 3 670 455 people, those with CRD had a higher risk of cardiovascular events [adjusted hazard ratio (HRadj), 1.08; 95% confidence interval (CI) 1.06-1.11], heart failure (HRadj, 1.17; 95% CI, 1.12-1.22), angina (HRadj, 1.13; 95% CI, 1.06-1.20) and pulmonary emboli (HRadj, 1.24; 95% CI, 1.15-1.33) compared with people without CRD. In people with asthma or COPD, baseline exacerbations were associated with a higher risk of cardiovascular outcomes (HRadj, 1.36; 95% CI, 1.27-1.00 and HRadj, 1.35; 95% CI, 1.24-1.46, respectively). Regardless of CRD, the risk of cardiovascular events was lower with increasing COVID-19 vaccine dose. CONCLUSIONS: Higher risk of cardiovascular events post-COVID-19 might be explained by the underlying severity of the CRD, and COVID-19 vaccines were beneficial to both people with and those without CRD with regards to cardiovascualr events.

Characterising meaningful patient and public involvement in the pharmaceutical industry research setting: a retrospective quality assessment.

OBJECTIVES: Patient and public involvement (PPI) in clinical research has a well-established infrastructure in the UK, and while there has been good progress within pharmaceutical-industry-sponsored research, further improvements are still needed. This review aims to share learnings from quality assessments of historical PPI projects within Pfizer UK to inform future projects and drive PPI progress in the pharmaceutical industry. DESIGN AND SETTING: Internal assessments of Pfizer UK PPI projects were conducted to identify all relevant projects across the medicines development continuum between 2017 and 2021. Five sample projects were developed into case studies. OUTCOME MEASURE: Retrospective quality assessments were performed using the Patient Focused Medicines Development (PFMD) Patient Engagement Quality Guidance (PEQG) tool. Recommendations for improvement were developed. RESULTS: Retrospective case study analysis and quality framework assessment revealed benefits of PPI to both Pfizer UK and to external partners, as well as challenges and learnings to improve future practice. Recommendations for improvement based on these findings focused on processes and procedures for PPI, group dynamics and diversity for PPI activities, sharing of expertise, the importance of bidirectional and timely feedback, and the use of understandable language in materials. CONCLUSIONS: PPI in medicines development is impactful and beneficial but is still being optimised in the pharmaceutical industry. Using the PFMD PEQG tool to define gaps, share learnings and devise recommendations for improvement helps to ensure that PPI is genuine and empowering, rather than tokenistic. Ultimately, these recommendations should be acted on to further embed PPI as an integral part of medicines development and health research within the pharmaceutical industry. This article includes a plain language summary in the supplement.

Patient Experiences of Communication with Healthcare Professionals on Their Healthcare Management around Chronic Respiratory Diseases.

BACKGROUND: Communication is an important clinical tool for the prevention and control of diseases, to advise and inform patients and the public, providing them with essential knowledge regarding healthcare and disease management. This study explored the experience of communication between healthcare professionals (HCPs) and people with long-term lung conditions, from the patient perspective. METHODS: This qualitative study analyzed the experience of people with chronic lung disease, recruited via Asthma & Lung UK (A&LUK) and COPD research databases. A&LUK invited people who had expressed a desire to be involved in research associated with their condition via their Expert Patient Panel and associated patients' groups. Two focus group interviews (12 participants) and one individual interview (1 participant) were conducted. Thematic analysis was used for data analysis. RESULTS: Two main themes were identified and we named them 'involving communication' and 'communication needs to be improved. 'They included seven subthemes: community-led support increased the patients' social interaction with peers; allied-HCP-led support increased patients' satisfaction; disliking being repeatedly asked the same basic information; feeling communication was unengaging, lacking personal specifics and the use of medical terminology and jargon. CONCLUSIONS: The study has identified what most matters in the process of communication with HCPs in people with long-term respiratory diseases of their healthcare management. The findings of the study can be used to improve the patient-healthcare professional relationship and facilitate a better communication flow in long-term healthcare management.

Sharing real-world data for public benefit: a qualitative exploration of stakeholder views and perceptions.

BACKGROUND: There has been an increasing interest in the use of "real-world" data to inform care decision making that could lead to public health benefit. Routinely collected service and activity data associated with the administration of care services and service-users (such as electronic health records or electronic social care records), hold potential to better inform effective and responsive decision-making about health and care services provided to national and local populations. This study sought to gain an in-depth understanding regarding the potential to unlock real world data that was held in individual organisations, to better inform public health decision-making. This included sharing data between and within health service providers and local governing authorities, but also with university researchers to inform the evidence base. METHODS: We used qualitative methods and carried out a series of online workshops and interviews with stakeholders (senior-level decision-makers and service leads, researchers, data analysts, those with a legal and governance role, and members of the public). We identified recurring themes in initial workshops, and explored these with participants in subsequent workshops. By this iterative process we further refined the themes identified, compared views and perceptions amongst different stakeholder groups, and developed recommendations for action. RESULTS: Our study identified key elements of context and timing, the need for a different approach, and obstacles including governmental and legal, organisational features, and process factors which adversely affect the sharing of real world data. The findings also highlighted a need for improved communication about data for secondary uses to members of the public. CONCLUSION: The Covid-19 pandemic context and changes to organisational structures in the health service in England have provided opportunities to address data sharing challenges. Change at national and local level is required, within current job roles and generating new jobs roles focused on the use and sharing of real-world data. The study suggests that actions can be taken to unlock the potential of real-world data for public health benefit, and provides a series of recommendations at a national level, for organisational leaders, those in data roles and those in public engagement roles.