Comparative effectiveness of sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in patients on kidney replacement therapy: observational study using the OpenSAFELY-UKRR and SRR databases.

Background: Due to limited inclusion of patients on kidney replacement therapy (KRT) in clinical trials, the effectiveness of coronavirus disease 2019 (COVID-19) therapies in this population remains unclear. We sought to address this by comparing the effectiveness of sotrovimab against molnupiravir, two commonly used treatments for non-hospitalised KRT patients with COVID-19 in the UK. Methods: With the approval of National Health Service England, we used routine clinical data from 24 million patients in England within the OpenSAFELY-TPP platform linked to the UK Renal Registry (UKRR) to identify patients on KRT. A Cox proportional hazards model was used to estimate hazard ratios (HRs) of sotrovimab versus molnupiravir with regards to COVID-19-related hospitalisations or deaths in the subsequent 28 days. We also conducted a complementary analysis using data from the Scottish Renal Registry (SRR). Results: Among the 2367 kidney patients treated with sotrovimab (n = 1852) or molnupiravir (n = 515) between 16 December 2021 and 1 August 2022 in England, 38 cases (1.6%) of COVID-19-related hospitalisations/deaths were observed. Sotrovimab was associated with substantially lower outcome risk than molnupiravir {adjusted HR 0.35 [95% confidence interval (CI) 0.17-0.71]; P = .004}, with results remaining robust in multiple sensitivity analyses. In the SRR cohort, sotrovimab showed a trend toward lower outcome risk than molnupiravir [HR 0.39 (95% CI 0.13-1.21); P = .106]. In both datasets, sotrovimab had no evidence of an association with other hospitalisation/death compared with molnupiravir (HRs ranged from 0.73 to 1.29; P > .05). Conclusions: In routine care of non-hospitalised patients with COVID-19 on KRT, sotrovimab was associated with a lower risk of severe COVID-19 outcomes compared with molnupiravir during Omicron waves.

Shared decision making: a personal view from two kidney doctors and a patient.

Shared decision making (SDM) combines the clinician's expertise in the treatment of disease with the patient's expertise in their lived experience and what is important to them. All decisions made in the care of patients with kidney disease can potentially be explored through SDM. Adoption of SDM in routine kidney care faces numerous institutional and practical barriers. Patients with chronic disease who have become accustomed to paternalistic care may need support to engage in SDM-even though most patients actively want more involvement in decisions about their care. Nephrologists often underestimate the risks and overestimate the benefits of investigations and treatments and often default to recommending burdensome treatments rather than discussing prognosis openly. Guideline bodies continue to issue recommendations written for healthcare professionals without providing patient decision aids. To mitigate health inequalities, care needs to be taken to provide SDM to all patients, not just the highly health-literate patients least likely to need additional support in decision making. Kidney doctors spend much of their time in the consulting room, and it is unjustifiable that so little attention is paid to the teaching, audit and maintenance of consultation skills. Writing letters to the patient to summarise the consultation rather than sending them a copy of a letter between health professionals sets the tone for a consultation in which the patient is an active partner. Adoption of SDM will require nephrologists to relinquish long-established paternalistic models of care and restructure care around the values and preferences of patients.

Comparative effectiveness of two- and three-dose COVID-19 vaccination schedules involving AZD1222 and BNT162b2 in people with kidney disease: a linked OpenSAFELY and UK Renal Registry cohort study.

Background: Kidney disease is a key risk factor for COVID-19-related mortality and suboptimal vaccine response. Optimising vaccination strategies is essential to reduce the disease burden in this vulnerable population. We therefore compared the effectiveness of two- and three-dose schedules involving AZD1222 (AZ; ChAdOx1-S) and BNT162b2 (BNT) among people with kidney disease in England. Methods: With the approval of NHS England, we performed a retrospective cohort study among people with moderate-to-severe kidney disease. Using linked primary care and UK Renal Registry records in the OpenSAFELY-TPP platform, we identified adults with stage 3-5 chronic kidney disease, dialysis recipients, and kidney transplant recipients. We used Cox proportional hazards models to compare COVID-19-related outcomes and non-COVID-19 death after two-dose (AZ-AZ vs BNT-BNT) and three-dose (AZ-AZ-BNT vs BNT-BNT-BNT) schedules. Findings: After two doses, incidence during the Delta wave was higher in AZ-AZ (n = 257,580) than BNT-BNT recipients (n = 169,205; adjusted hazard ratios [95% CIs] 1.43 [1.37-1.50], 1.59 [1.43-1.77], 1.44 [1.12-1.85], and 1.09 [1.02-1.17] for SARS-CoV-2 infection, COVID-19-related hospitalisation, COVID-19-related death, and non-COVID-19 death, respectively). Findings were consistent across disease subgroups, including dialysis and transplant recipients. After three doses, there was little evidence of differences between AZ-AZ-BNT (n = 220,330) and BNT-BNT-BNT recipients (n = 157,065) for any outcome during a period of Omicron dominance. Interpretation: Among individuals with moderate-to-severe kidney disease, two doses of BNT conferred stronger protection than AZ against SARS-CoV-2 infection and severe disease. A subsequent BNT dose levelled the playing field, emphasising the value of heterologous RNA doses in vulnerable populations. Funding: National Core Studies, Wellcome Trust, MRC, and Health Data Research UK.

Factors influencing the utilisation of free-standing and alongside midwifery units in England: a qualitative research study.

OBJECTIVE: To identify factors influencing the provision, utilisation and sustainability of midwifery units (MUs) in England. DESIGN: Case studies, using individual interviews and focus groups, in six National Health Service (NHS) Trust maternity services in England. SETTING AND PARTICIPANTS: NHS maternity services in different geographical areas of England Maternity care staff and service users from six NHS Trusts: two Trusts where more than 20% of all women gave birth in MUs, two Trusts where less than 10% of all women gave birth in MUs and two Trusts without MUs. Obstetric, midwifery and neonatal clinical leaders, managers, service user representatives and commissioners were individually interviewed (n=57). Twenty-six focus groups were undertaken with midwives (n=60) and service users (n=52). MAIN OUTCOME MEASURES: Factors influencing MU use. FINDINGS: The study findings identify several barriers to the uptake of MUs. Within a context of a history of obstetric-led provision and lack of decision-maker awareness of the clinical and economic evidence, most Trust managers and clinicians do not regard their MU provision as being as important as their obstetric unit (OU) provision. Therefore, it does not get embedded as an equal and parallel component in the Trust's overall maternity package of care. The analysis illuminates how implementation of complex interventions in health services is influenced by a range of factors including the medicalisation of childbirth, perceived financial constraints, adequate leadership and institutional norms protecting the status quo. CONCLUSIONS: There are significant obstacles to MUs reaching their full potential, especially free-standing midwifery units. These include the lack of commitment by providers to embed MUs as an essential service provision alongside their OUs, an absence of leadership to drive through these changes and the capacity and willingness of providers to address women's information needs. If these remain unaddressed, childbearing women's access to MUs will continue to be restricted.

Involving service users in the Birth Timing project, a data linkage study analysing the timing of births and their outcomes.

INTRODUCTION: We report on service user participation in a population-based data linkage study designed to analyse the daily, weekly and yearly cycles of births in England and Wales, the outcomes for women and babies, and their implications for the NHS. Public Involvement and Engagement (PI&E) has a long history in maternity services, though PI&E in maternity data linkage studies is new in the United Kingdom. We have used the GRIPP2 short form, a tool designed for reporting public involvement in research. OBJECTIVES: We aimed to involve and engage a wide range of maternity service users and their representatives to ensure that our use of patient-identifiable routinely collected maternity and birth records was acceptable and that our research analyses using linked data were relevant to their expressed safety and quality of care needs. METHODS: A three-tiered approach to PI&E was used. Having both PI&E co-investigators and PI&E members of the Study Advisory Group ensured service user involvement was part of the strategic development of the project. A larger constituency of maternity service users from England and Wales was engaged through four regional workshops. RESULTS: Two co-investigators with experience of PI&E in maternity research were involved as service user researchers from design stage to dissemination. Four PI&E study advisors contributed service user perspectives. Engagement workshops attracted around 100 attendees, recruited largely from Maternity Services Liaison Committees in England and Wales, and a community engagement group. They supported the use of patient-identifiable data, believing the study had potential to improve safety and quality of maternity services. They contributed their experiences and concerns which will assist with interpretation of the analyses. CONCLUSION: Use of PI&E 'knowledge intermediaries' successfully bridged the gap between data intensive research and lived experience, but more inclusivity in involvement and engagement is required. Respecting the concerns and questions of service users provides social legitimacy and a relevance framework for researchers carrying out analyses.

An analysis of media reporting on the closure of freestanding midwifery units in England.

PROBLEM: Despite clinical guidelines and policy promoting choice of place of birth, 14 Freestanding Midwifery Units were closed between 2008 and 2015, closures reported in the media as justified by low use and financial constraints. BACKGROUND: The Birthplace in England Programme found that freestanding midwifery units provided the most cost-effective birthplace for women at low risk of complications. Women planning birth in a freestanding unit were less likely to experience interventions and serious morbidity than those planning obstetric unit birth, with no difference in outcomes for babies. METHODS: This paper uses an interpretative technique developed for policy analysis to explore the representation of these closures in 191 news articles, to explore the public climate in which they occurred. FINDINGS AND DISCUSSION: The articles focussed on underuse by women and financial constraints on services. Despite the inclusion of service user voices, the power of framing was held by service managers and commissioners. The analysis exposed how neoliberalist and austerity policies have privileged representation of individual consumer choice and market-driven provision as drivers of changes in health services. This normative framing presents the reasons given for closure as hard to refute and cultural norms persist that birth is safest in an obstetric setting, despite evidence to the contrary. CONCLUSION: The rise of neoliberalism and austerity in contemporary Britain has influenced the reform of maternity services, in particular the closure of midwifery units. Justifications given for closure silence other narratives, predominantly from service users, that attempt to present women's choice in terms of rights and a social model of care.

Exploring women's preferences for birth settings in England: A discrete choice experiment.

OBJECTIVE: To explore pregnant women's preferences for birth setting in England. DESIGN: Labelled discrete choice experiment (DCE). SETTING: Online survey. SAMPLE: Pregnant women recruited through social media and an online panel. METHODS: We developed a DCE to assess women's preferences for four hypothetical birth settings based on seven attributes: reputation, continuity of care, distance from home, time to see a doctor, partner able to stay overnight, chance of straightforward birth and safety for baby. We used a mixed logit model, with setting modelled as an alternative-specific constant, and conducted a scenario analysis to evaluate the impact of changes in attribute levels on uptake of birth settings. MAIN OUTCOME MEASURES: Women's preferences for birth setting. RESULTS: 257 pregnant women completed the DCE. All birth setting attributes, except 'time to see doctor', were significant in women's choice (p<0.05). There was significant heterogeneity in preferences for some attributes. Changes to levels for 'safety for the baby' and 'partner able to stay overnight' were associated with larger changes from baseline uptake of birth setting. If the preferences identified were translated into the real-world context up to a third of those who reported planning birth in an obstetric unit might choose a midwifery unit assuming universal access to all settings, and knowledge of the differences between settings. CONCLUSIONS: We found that 'safety for the baby', 'chance of a straightforward birth' and 'can the woman's partner stay overnight following birth' were particularly important in women's preferences for hypothetical birth setting. If all birth settings were available to women and they were aware of the differences between them, it is likely that more low risk women who currently plan birth in OUs might choose a midwifery unit.