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The role of the gut microbiota in carcinogenesis is increasingly being acknowledged. Recent studies in multiple breast cancer mouse models have found that antibiotics, by altering the gut microbiota, can accelerate tumour growth. In humans, a recent cohort study restricted to triple negative breast cancer showed that breast cancer patients using a greater number of antibiotics had markedly worse survival. These studies have raised concerns about repeated antibiotic use in breast cancer patients. In this Registered Report, we investigated whether breast cancer patients using oral antibiotics had increased breast cancer-specific mortality. In population-based cohorts (n = 44,452), we did not observe a statistically significant association between antibiotic prescriptions after diagnosis and breast cancer-specific mortality (adjusted HR = 1.07 95% CI 0.87, 1.33) apart from prescriptions of 12 or more antibiotics (adjusted HR = 1.62 95% CI 1.31, 2.01). This association was weaker after adjustment for infections (adjusted HR = 1.44 95% 1.14, 1.81), when restricted to antibiotics within five years (adjusted HR = 1.33 95% 0.95, 1.84), and was similar for deaths from other causes (adjusted HR = 1.69 95% 1.19, 2.41). Frequent antibiotic users had higher cancer-specific mortality but the attenuation of associations in sensitivity analyses, and similar findings for other causes of death, suggest this increase may reflect residual confounding. Protocol registration: The Stage 1 protocol for this Registered Report was accepted in principle on 7 November 2023. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.24746721.v1 . Studies in mouse models have suggested a link between antibiotic use and breast cancer but epidemiological evidence in human populations is inconsistent. Here, the authors use linked electronic health records from England and Wales to investigate the association between oral antibiotic use and survival in women with breast cancer.

IntroductionDysmenorrhoea affects up to 70%–91% of adolescents who menstruate, with approximately one-third experiencing severe symptoms with impacts on education, work and leisure. Dysmenorrhoea can occur without identifiable pathology, but can indicate underlying conditions, including congenital genital tract anomalies or endometriosis. There is a need for evidence about the management and incidence of dysmenorrhoea in primary care, the impact of treatments in adolescence on long-term outcomes and when to consider the possibility of endometriosis in adolescence.Methods and analysisThis study aims to improve the evidence base for adolescents presenting to primary care with dysmenorrhoea. It comprises three interlinked studies. Using the QResearch Database, the study population includes all female at birth participants aged 10–19 years any time between 1 January 2000 and 30 June 2021. We will undertake (1) a descriptive study documenting the prevalence of coded dysmenorrhoea in primary care, stratified by demographic variables, reported using descriptive statistics; (2) a prospective open cohort study following an index cohort of all adolescents recorded as attending primary care with dysmenorrhoea and a comparator cohort of five times as many who have not, to determine the HR for a diagnosis of endometriosis, adenomyosis, ongoing menstrual pain or subfertility (considered singly and in combination) anytime during the study period; and (3) a nested case–control study for adolescents diagnosed with endometriosis, using conditional logistic regression, to determine the OR for symptom(s) preceding this diagnosis.Ethics and disseminationThe project has been independently peer reviewed and received ethics approval from the QResearch Scientific Board (reference OX46 under REC 18/EM/0400).In addition to publication in peer-reviewed academic journals, we will use the combined findings to generate a resource and infographic to support shared decision-making about dysmenorrhoea in community health settings. Additionally, the findings will be used to inform a subsequent qualitative study, exploring adolescents’ experiences of menstrual pain.

Background Sotrovimab is a neutralising monoclonal antibody (nMAB) currently available to treat extremely clinically vulnerable COVID-19 patients in England. Trials have shown it to have mild to moderate side effects, however, evidence regarding its safety in real-world settings remains insufficient. Methods Descriptive and multivariable logistic regression analyses were conducted to evaluate uptake, and a self-controlled case series analysis performed to measure the risk of hospital admission (hospitalisation) associated with 49 pre-specified suspected adverse outcomes in the period 2–28 days post-Sotrovimab treatment among eligible patients treated between December 11, 2021 and May 24, 2022. Results Here we show that among treated and untreated eligible individuals, the mean ages (54.6 years, SD: 16.1 vs 54.1, SD: 18.3) and sex distribution (women: 60.9% vs 58.1%; men: 38.9% vs 41.1%) are similar. There are marked variations in uptake between ethnic groups, which is higher amongst individuals categorised ethnically as Indian (15.0%; 95%CI 13.8, 16.3), Other Asian (13.7%; 95%CI 11.9, 15.8), white (13.4%; 95%CI 13.3, 13.6), and Bangladeshi (11.4%; 95%CI 8.8, 14.6); and lower amongst Black Caribbean individuals (6.4%; 95%CI 5.4, 7.5) and Black Africans (4.7%; 95%CI 4.1, 5.4). We find no increased risk of any of the suspected adverse outcomes in the period 2–28 days post-treatment. Conclusions We find no safety signals of concern for possible adverse outcomes in the period 2-28 days post treatment with Sotrovimab. However, there is evidence of unequal uptake of Sotrovimab treatment across ethnic groups. Patone et al. assess the safety of the neutralizing antibody Sotrovimab in the treatment of COVID-19. Uptake of Sotrovimab was found to be unequal in different ethnic groups, however, there was no indication of an increased risk of hospitalization from adverse outcomes in those studied. Plain language summary Sotrovimab is a medical treatment which may improve the chance of recovery and survival of patients with weak immune systems who have COVID-19. However, the safety of Sotrovimab treatment and the characteristics of the people who receive it are not well understood. We analysed the risk of serious side-effects which resulted in those who were treated with Sotrovimab needing to be hospitalised, along with the characteristics of the treated patients. No evidence of serious side-effects from Sotrovimab treatment requiring hospitalisation was found, but some ethnic groups were more likely to be treated than others. Therefore, there is evidence that Sotrovimab may be a safe treatment for people with weak immune systems who have COVID-19, but some work may be needed to make sure the treatment is used more equitably among different ethnic groups.

Background Electronic health records are increasingly used to conduct pregnancy-related research as pregnant women are under-represented in research. Creating a register of pregnancies by combining data from primary and secondary care will further facilitate research in pregnancy. This work describes the construction of an algorithm to create a unified pregnancy cohort in the QResearch database during the emergency phase of the COVID-19 pandemic. Methods National primary care records in the QResearch® database were linked to patient-level data from Hospital Episode Statistics (HES) datasets. Females aged 15-50 years with a pregnancy outcome recorded between 30 December 2020 and 30 September 2022 were included. Pregnancy (delivery/loss) episodes were identified and cohort demographics reported using a three-stage algorithm. Pregnancy start dates were derived using a combination of HES and primary care data, or individually estimated where no corresponding date could be identified. Results 266,758 women with 279,027 pregnancies are captured in the register. 232,673 pregnancies (83.4%) are deliveries (99.5% livebirths and 0.5% stillbirths) and 46,354 (16.6%) pregnancies are pregnancy losses. Pregnancy losses are highest amongst those of Caribbean (23.1%; n = 781) ethnicity and lowest in those of Pakistani ethnicity (13.9%, n = 1,579). 82.4% of pregnancies are derived from HES maternity records, 10.6% from primary care records, 3.4% from HES Admissions, and 3.6% from HES Procedures. Conclusion The construction of a pregnancy register in QResearch® offers a valuable resource for future research. Its methodology can be adapted to construct new cohorts over any period, providing a comprehensive resource on pregnancy outcomes and events. Plain language summary Digital patient records are being used to study pregnant women more and more frequently. However, a method to create a single, unified list of pregnancies using both hospital and GP data has not yet been designed for the university-based research database, QResearch, which contains health records for over 40 million people in the UK. The aim of this study was to develop a method of combining and sorting pregnancy records from multiple data sources to create a list, or register, of pregnancies. The method successfully identified women who gave birth, terminated, or lost a pregnancy during the COVID-19 pandemic in England. Furthermore, this method can be adapted to identify pregnancies over any period, making it a valuable resource for researchers who are interested in studying pregnant women in the future. Snelling et al. describe the methods used to establish a pregnancy register in the QResearch database. The resulting algorithm successfully sorts and consolidates delivery and pregnancy loss (incl. terminations) records from primary and secondary care datasets, creating a valuable resource for future research into pregnant populations in England.