Cohort profile: characterisation, determinants, mechanisms and consequences of the long-term effects of COVID-19 – providing the evidence base for health care services (CONVALESCENCE) in the UK

Purpose
The pathogenesis of the long-lasting symptoms which can follow an infection with the SARS-CoV-2 virus (‘long covid’) is not fully understood. The ‘COroNaVirus post-Acute Long-term EffectS: Constructing an evidENCE base’ (CONVALESCENCE) study was established as part of the Longitudinal Health and Wellbeing COVID-19 UK National Core Study. We performed a deep phenotyping case-control study nested within two cohorts (the Avon Longitudinal Study of Parents and Children and TwinsUK) as part of CONVALESCENCE.

Participants
From September 2021 to May 2023, 349 participants attended the CONVALESCENCE deep phenotyping clinic at University College London. Four categories of participants were recruited: cases of long covid (long covid(+)/SARS-CoV-2(+)), alongside three control groups: those with neither long covid symptoms nor evidence of prior COVID-19 (long covid(-)/SARS-CoV-2(-); control group 1), those who self-reported COVID-19 and had evidence of SARS-CoV-2 infection, but did not report long covid (long covid(-)/SARS-CoV-2(+); control group 2) and those who self-reported persistent symptoms attributable to COVID-19 but no evidence of SARS-CoV-2 infection (long covid(+)/SARS-CoV-2(-); control group 3). Remote wearable measurements were performed up until February 2024.

Findings to date
This cohort profile describes the baseline characteristics of the CONVALESCENCE cohort. Of the 349 participants, 141 (53±15 years old; 21 (15%) men) were cases, 89 (55±16 years old; 11 (12%) men) were in control group 1, 75 (49±15 years old; 25 (33%) men) were in control group 2 and 44 (55±16 years old; 9 (21%) men) were in control group 3.

Future plans
The study aims to use a multiorgan score calculated as the cumulative total for each of nine domains (ie, lung, vascular, heart, kidney, brain, autonomic function, muscle strength, exercise capacity and physical performance). The availability of data preceding acute COVID-19 infection in cohorts may help identify the consequences of infection independent of pre-existing subclinical disease and also provide evidence of determinants that influence the development of long covid.

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Effectiveness of postpartum care to improve womens health and quality of life in Southeast Asia: a scoping review protocol

Introduction
The first 3 months post partum is a critical transition period for women and families, which is characterised by physical, psychological and social adaptation. The first year post partum is also a critical phase for women’s health, given their physical recovery and adjustment to motherhood. The WHO 2023 recommendations highlight the importance of a postnatal care focus, including maternal health assessment, mental health support, nutritional interventions, postpartum contraceptive use and home care visits. This scoping review aims to map the evidence of the effectiveness of postpartum care on women’s health and quality of life in the Southeast Asia region.

Methods and analysis
This scoping review will be guided by the methodological principles developed by Arksey and O’Malley. This review will also consider observational studies, including cohort studies, case-control studies and cross-sectional studies. For inclusion, studies should be selected for eligibility based on the following criteria: articles investigating the uptake of postpartum women (women who have had childbirth up to 42 days after delivery) in Southeast Asian countries. The search will comprise peer-reviewed articles from 2013 to 2023 from the following electronic databases: PubMed/MEDLINE, ProQuest, EBSCO, Scopus, Web of Science and Google Scholar. We use both keywords in the title and/or abstract and subject headings as appropriate. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Protocols to develop the protocol and use the PRISMA flow diagram to present the results for scoping reviews.

Ethics and dissemination
A scoping review is a novel approach for examining the breadth of literature regarding the connection between the effectiveness of postpartum care and women’s health and quality of life and, as a secondary analysis, does not require ethics approval. The results of this review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

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[Articles] Incident cytopenia and risk of subsequent myeloid neoplasm in age-related clonal hematopoiesis: a multi-biobank case-control study

Longitudinal analysis across three large cohorts found that it is rare for patients with CHIP to develop MN without first developing cytopenia. The risk for MN among patients with CHIP resides almost entirely among those with cytopenia. These findings suggest that cytopenia is a critical step in progression from CHIP to MN, underscoring its utility as an endpoint in cancer prevention trials for CHIP patients.

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Model-based estimation of thyroid cancer incidence from ultrasound examinations in the Fukushima Health Management Survey: estimated results considering the non-examinees in the first, second and third rounds of the cohort study

Background
In October 2011, the Fukushima prefectural government started a thyroid ultrasound examination (TUE) as part of the Fukushima Health Management Survey following the Fukushima Daiichi Nuclear Power Plant accident. The proportion of examinees is an important factor when interpreting the results.

Objectives
To construct models that assess the relationship between the proportion of non-examinees and the characteristics of eligible participants in the first-round to third-round TUEs. Using these models, estimate the number of thyroid cancer cases in the entire population for each survey, considering non-examinees.

Design
Model-based estimation using cohort survey data.

Settings
Fukushima Health Management Survey from 2011 to 2017.

Participants
Children and adolescents aged 18 years or younger (363 342 individuals) who were identified through resident registration records, resided in Fukushima Prefecture at the time of the accident, and were eligible for each TUE.

Outcome measures
Modelling the relationship between non-examinee status and individual characteristics, and estimating the number of cases in the entire population for each survey round.

Results
The area under the receiver operating characteristic curve of the constructed models ranged from 0.815 to 0.905. In the first-round, second-round and third-round TUEs, 115, 70 and 30 cases were observed among 294 921, 258 771 and 208 955 examinees, respectively, whereas the estimated number of cases in the entire population including the non-examinees was 177.3 (95% CI 167.0 to 188.0), 126.3 (95% CI 106.3 to 150.2) and 49.7 (95% CI 35.8 to 71.9), respectively.

Conclusions
These estimates were higher than the actual number of observed cases because they considered non-examinees. Our model for non-examination showed a high discriminant accuracy and was considered to capture well the factors that resulted in non-examinees. This study’s findings provide valuable information for studies considering the number of potential thyroid cancer cases among non-examinees and may facilitate appropriate interpretation of reports and prospective survey outcome management.

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Clinical study of adebrelimab in combination with apatinib and irinotecan for PD-1 inhibitor-ineffective advanced-stage gastric cancer: study protocol for a single-arm, single-centre, exploratory trial

Introduction
Immunotherapy has revolutionised cancer treatment. Immune checkpoint inhibitors have demonstrated significant efficacy across multiple tumour types, including gastric cancer, where several approved programmed cell death 1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitors show promising antitumour activity. While PD-L1 expression serves as a predictive biomarker for PD-1 inhibitor response, and PD-L1-positive patients generally show better outcomes, therapeutic resistance remains a challenge. Many initial responders eventually develop resistance, and surprisingly, some PD-L1-positive patients fail to achieve expected response rates, indicating emerging resistance mechanisms in potentially responsive populations. Adebrelimab, a PD-L1 inhibitor, demonstrates mechanistic advantages over PD-1 inhibitors, with clinical studies suggesting promising therapeutic potential. When combined with irinotecan, apatinib has shown efficacy in second-line gastric cancer treatment. This study aims to evaluate the efficacy and safety of combining adebrelimab with apatinib and irinotecan for advanced gastric cancer refractory to PD-1 inhibitors.

Method and analysis
This single-arm, single-centre exploratory trial will be conducted at Renji Hospital, enrolling 32 patients aged 18–75 years. Eligible patients must have initially achieved partial response, complete response or stable disease with progression-free survival (PFS)≥3 months during prior immunotherapy but subsequently progressive disease on imaging. Treatment will continue until meeting discontinuation criteria. The primary endpoint is objective response rate with Clopper-Pearson 95% CI. Secondary endpoints include disease control rate (95% CI), PFS and overall survival (estimated by Kaplan-Meier method), along with safety assessments.

Ethics and dissemination
All participants will provide informed consent. The protocol has been approved by the Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (LY2023-201-C). The results will be disseminated through peer-reviewed manuscripts, reports and presentations.

Trial registration number
ChiCTR2300077329.

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Womens perspectives of decision-making for labour and birth: a qualitative antenatal-postnatal paired interview study

Objectives
To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.

Design
Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).

Setting
Large maternity hospital in the Southwest of England.

Participants
Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.

Data collection
Telephone interviews with a single researcher using a semistructured interview topic guide.

Data analysis
Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.

Results
Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.

Conclusions
Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.

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Joint Exposure to Ozone and Temperature and Acute Myocardial Infarction Among Adults Aged 18 to 64 Years in the United States

Circulation, Ahead of Print. BACKGROUND:Previous research suggests that exposures to air pollution and nonoptimal temperatures are associated with a higher risk of acute myocardial infarction (AMI), but few studies examined the exposures jointly. Furthermore, moderate exposures were often overlooked. We evaluated short-term exposure to ambient ozone pollution and ambient temperature jointly and over the entire range of exposures, with the occurrence of AMI among adults aged 18 to 64 years (an understudied population) in the contiguous United States.METHODS:We identified eligible individuals with incident AMI insured by a nationwide private insurance company from 2016 to 2020. We designed a time-stratified case-crossover study in which each patient’s ambient exposure to ozone and temperature on the day of their AMI was compared with their exposures on a nearby day. We used a 2-stage model to investigate the associations with joint exposures: (1) fitting climate- and region-specific models with statistical interaction terms between ozone and temperature, and (2) using a multivariate random-effects meta-analysis to pool the region-specific estimates.RESULTS:We included 270 123 adults with incident AMI and observed a significant association between joint ozone-temperature exposures and increased AMI. Compared with the reference of ozone at 35 ppb and temperature at the first percentile, joint exposure to ozone at 60 ppb and temperature at the 95th percentile at lag 0 day was associated with a 33% (95% CI, 16%–51%) increase in incident AMI, and joint exposure to ozone at 50 ppb and temperature at the median was associated with a 15% (95% CI, 4%–28%) increase. There was heterogeneity by sex, with women showing increased odds when both ozone and temperature were high and men showing increased odds when either ozone or temperature was high.CONCLUSIONS:Joint exposure to ozone pollution and high temperature increased the probability of AMI among younger adults, even when 1 of the exposures was moderate. This study highlights the importance of addressing exposures to ozone and nonoptimal temperature simultaneously in AMI prevention strategies.

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