Evaluating the influence of taxation and social security policies on psychological distress: A microsimulation study of the UK during the COVID-19 economic crisis.

Economic determinants are important for population health, but actionable evidence of how policies can utilise these pathways remains scarce. This study employs a microsimulation framework to evaluate the effects of taxation and social security policies on population mental health. The UK economic crisis caused by the COVID-19 pandemic provides an informative context involving an economic shock accompanied by one of the strongest discretionary fiscal responses amongst OECD countries. The analytical setup involves a dynamic, stochastic, discrete-time microsimulation model (SimPaths) projecting changes in psychological distress given predicted economic outcomes from a static tax-benefit microsimulation model (UKMOD) based on different policy scenarios. We contrast projections of psychological distress for the working-age population from 2017 to 2025 given the observed policy environment against a counterfactual scenario where pre-crisis policies remained in place. Levels of psychological distress and potential cases of common mental disorders (CMDs) were assessed with the 12-item General Health Questionnaire (GHQ-12). The UK policy response to the economic crisis is estimated to have prevented a substantial fall (over 12 percentage points, %pt) in the employment rate in 2020 and 2021. In 2020, projected psychological distress increased substantially (CMD prevalence increase >10%pt) under both the observed and the counterfactual policy scenarios. Through economic pathways, the policy response is estimated to have prevented a further 3.4%pt [95%UI 2.8%pt, 4.0%pt] increase in the prevalence of CMDs, approximately 1.2 million cases. Beyond 2021, as employment levels rapidly recovered, psychological distress returned to the pre-pandemic trend. Sustained preventative effects on poverty are estimated, with projected levels 2.1%pt [95%UI 1.8%pt, 2.5%pt] lower in 2025 than in the absence of the observed policy response. The study shows that policies protecting employment during an economic crisis are effective in preventing short-term mental health losses and have lasting effects on poverty levels. This preventative effect has substantial public health benefits.

Introducing the revised framework for developing and evaluating complex interventions: A challenge and a resource for nursing research.

This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research.

Reprint of: 'A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance'.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Complement-mediated thrombotic microangiopathy on a background of Alport syndrome: A case report.

Here we present a case of complement-mediated thrombotic microangiopathy (TMA) in a patient who has a background of Stage 5 chronic kidney disease secondary to Alport syndrome. We explain our approach to the diagnosis of TMA, especially the reliance on non-renal manifestations of TMA and the role of kidney biopsy given there was a background of advanced kidney impairment at baseline.

Climate warming shifts riverine macroinvertebrate communities to be more sensitive to chemical pollutants.

Freshwaters are highly threatened ecosystems that are vulnerable to chemical pollution and climate change. Freshwater taxa vary in their sensitivity to chemicals and changes in species composition can potentially affect the sensitivity of assemblages to chemical exposure. Here we explore the potential consequences of future climate change on the composition and sensitivity of freshwater macroinvertebrate assemblages to chemical stressors using the UK as a case study. Macroinvertebrate assemblages under end of century (2080-2100) and baseline (1980-2000) climate conditions were predicted for 608 UK sites for four climate scenarios corresponding to mean temperature changes of 1.28 to 3.78°C. Freshwater macroinvertebrate toxicity data were collated for 19 chemicals and the hierarchical species sensitivity distribution model was used to predict the sensitivity of untested taxa using relatedness within a Bayesian approach. All four future climate scenarios shifted assemblage compositions, increasing the prevalence of Mollusca, Crustacea and Oligochaeta species, and the insect taxa of Odonata, Chironomidae, and Baetidae species. Contrastingly, decreases were projected for Plecoptera, Ephemeroptera (except for Baetidae) and Coleoptera species. Shifts in taxonomic composition were associated with changes in the percentage of species at risk from chemical exposure. For the 3.78°C climate scenario, 76% of all assemblages became more sensitive to chemicals and for 18 of the 19 chemicals, the percentage of species at risk increased. Climate warming-induced increases in sensitivity were greatest for assemblages exposed to metals and were dependent on baseline assemblage composition, which varied spatially. Climate warming is predicted to result in changes in the use, environmental exposure and toxicity of chemicals. Here we show that, even in the absence of these climate-chemical interactions, shifts in species composition due to climate warming will increase chemical risk and that the impact of chemical pollution on freshwater macroinvertebrate biodiversity may double or quadruple by the end of the 21st century.

Reporting of equity in observational epidemiology: A methodological review.

Background: Observational studies can inform how we understand and address persisting health inequities through the collection, reporting and analysis of health equity factors. However, the extent to which the analysis and reporting of equity-relevant aspects in observational research are generally unknown. Thus, we aimed to systematically evaluate how equity-relevant observational studies reported equity considerations in the study design and analyses. Methods: We searched MEDLINE for health equity-relevant observational studies from January 2020 to March 2022, resulting in 16 828 articles. We randomly selected 320 studies, ensuring a balance in focus on populations experiencing inequities, country income settings, and coronavirus disease 2019 (COVID-19) topic. We extracted information on study design and analysis methods. Results: The bulk of the studies were conducted in North America (n = 95, 30%), followed by Europe and Central Asia (n = 55, 17%). Half of the studies (n = 171, 53%) addressed general health and well-being, while 49 (15%) focused on mental health conditions. Two-thirds of the studies (n = 220, 69%) were cross-sectional. Eight (3%) engaged with populations experiencing inequities, while 22 (29%) adapted recruitment methods to reach these populations. Further, 67 studies (21%) examined interaction effects primarily related to race or ethnicity (48%). Two-thirds of the studies (72%) adjusted for characteristics associated with inequities, and 18 studies (6%) used flow diagrams to depict how populations experiencing inequities progressed throughout the studies. Conclusions: Despite over 80% of the equity-focused observational studies providing a rationale for a focus on health equity, reporting of study design features relevant to health equity ranged from 0-95%, with over half of the items reported by less than one-quarter of studies. This methodological study is a baseline assessment to inform the development of an equity-focussed reporting guideline for observational studies as an extension of the well-known Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guideline.

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

BACKGROUND: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. METHODS: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. FINDINGS: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. INTERPRETATION: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. FUNDING: Versus Arthritis.

Evaluation of the Healthy Start voucher scheme on maternal vitamin use and child breastfeeding: a natural experiment using data linkage.

Background: Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Despite the introduction of many policies for the early-years age group, including voucher schemes, with the aim of improving nutrition, there is limited evidence of their impact on health. Objectives: To assess the effectiveness of the Healthy Start voucher scheme on infant, child and maternal outcomes, and to capture the lived experiences of the Healthy Start voucher scheme for low-income women. Design: This was a natural experiment study using existing data sets, linked to routinely collected health data sets, with a nested qualitative study of low-income women and an assessment of the health economics. Setting: Representative sample of Scottish children and UK children. Participants: Growing Up in Scotland cohort 2 (n = 2240), respondents to the 2015 Infant Feeding Study (n = 8067) and a sample of 40 participants in the qualitative study. Interventions: The Health Start voucher, a means-tested scheme that provides vouchers worth £3.10 per week to spend on liquid milk, formula milk, fruit and vegetables. Main outcome measures: Infant and child outcomes - breastfeeding initiation and duration; maternal outcomes - vitamin use pre and during pregnancy. Results: The exposed group were women receiving the Healthy Start voucher (R), with two control groups: eligible and not claiming the Healthy Start voucher (E) and nearly eligible. There was no difference in vitamin use during pregnancy for either comparison (receiving the Healthy Start voucher, 82%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.10 vs. receiving the Healthy Start voucher, 87%; nearly eligible, 88%; p = 0.43) in the Growing Up in Scotland cohort. Proportions were similar for the Infant Feeding Study cohort (receiving the Healthy Start voucher, 89%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.01 vs. receiving the Healthy Start voucher, 89%; nearly eligible, 87%; p = 0.01); although results were statistically significantly different, these were small effect sizes. There was no difference for either comparison in breastfeeding initiation or breastfeeding duration in months in Growing Up in Scotland, but there was a negative effect of the Healthy Start voucher in the Infant Feeding Survey. This contrast between data sets indicates that results are inconclusive for breastfeeding. The qualitative study found that despite the low monetary value the women valued the Healthy Start voucher scheme. However, the broader lives of low-income women are crucial to understand the constraints to offer a healthy diet. Limitations: Owing to the policy being in place, it was difficult to identify appropriate control groups using existing data sources, especially in the Infant Feeding Study. Conclusions: As the Healthy Start voucher scheme attempts to influence health behaviour, this evaluation can inform other policies aiming to change behaviour and use voucher incentives. The null effect of Healthy Start vouchers on the primary outcomes may be due to the value of the vouchers being insufficient to change the broader lives of low-income women to offer a healthy diet. Future work: The methods developed to undertake an economic evaluation alongside a natural experiment using existing data can be used to explore the cost-effectiveness of the Healthy Start voucher scheme. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Journals Library website for further project information.

United Kingdom governments have introduced many policies to support infants and their families. Most of these policies have not been evaluated in terms of health outcomes. Therefore, there is limited evidence for policy-makers about whether or not the right policies are in place to make a difference to the health of young children and their families. We investigated the impact of the Healthy Start voucher scheme (worth £3.10 per week to spend on milk, fruit and vegetables) on the health of low-income mothers, and their infants and young children, in particular vitamin use of mothers and breastfeeding of infants. Using survey data, there were high rates of vitamin use during pregnancy, but fewer women taking vitamins before pregnancy. There was no effect of Healthy Start vouchers on taking vitamins before or during pregnancy. There was inconclusive evidence of the effect of Healthy Start vouchers on breastfeeding, indicating that use of the vouchers does not discourage breastfeeding in women with low incomes. From interviews with mothers, we found that they valued the Healthy Start vouchers and understood the aims of the policy. Healthy Start vouchers were not mentioned in decision-making around breastfeeding. Women's choice to breast or formula feed was based on a range of other factors, such as support to breastfeed. They wanted to provide a healthy diet for their families, but owing to living on low incomes did not always manage it. Policy-makers still need more evidence about the effects of voucher schemes to improve the health of low-income mothers, and their infants and young children. The decision-makers require evidence to determine where to allocate limited resources. There is a need to improve support for low-income families to provide their families with a healthy diet.

Mixed cryoglobulinaemia vasculitis secondary to marginal zone lymphoma in a patient with end-stage renal failure on haemodialysis.

Cryoglobulinaemia vasculitis can present with a variety of symptoms and there is limited data on the incidence and presentation of cryoglobulinaemia vasculitis in haemodialysis patients. We report a case of a 63-year-old male who had a series of presentations with rash, visual changes, abdominal pain, weight loss, fevers and digital ischaemia. This is on a background of a congenital single kidney with end-stage renal failure secondary to diabetes and hypertension, receiving haemodialysis for nearly 5 years. He initially experienced a leukocytoclastic vasculitis rash confirmed on skin biopsy, followed by multiple hospital presentations for undifferentiated abdominal pain and fever of unknown source. Jejunal biopsy revealed intestinal vasculitis. His peripheral blood flow cytometry and bone marrow biopsy were consistent with marginal zone lymphoma (indolent subtype, IgM kappa clone). Further testing revealed a type II cryoglobulinaemia consisting of an IgM kappa monoclonal band with polyclonal IgG (cryocrit 5%). A diagnosis of cryoglobulinaemia vasculitis was established and he was treated with pulsed methylprednisolone and rituximab therapy. However, after receiving three doses of rituximab the patient developed a presumed vasculitis-associated pulmonary haemorrhage for which he received treatment with five sessions of plasma exchange. His symptoms resolved and cryocrit reduced to < 1% after his final dose of rituximab. The clinical features of cryoglobulinaemia may be difficult to detect in chronic haemodialysis patients and vigilance is required.

The health impact of Scotland's Baby Box Scheme: a natural experiment evaluation using national linked health data.

BACKGROUND: Scotland's Baby Box Scheme (SBBS) is a national programme offering a box of essential items to all pregnant women in Scotland intended to improve infant and maternal health. We aimed to evaluate the effect of SBBS on selected infant and maternal health outcomes at population and subgroup levels (maternal age and area deprivation). METHODS: Our complete-case, intention-to-treat evaluation used national health data (from the Scottish Morbidity Record [SMR] 01, SMR02, and the Child Health Surveillance Programme-Pre School), linking birth records to postnatal hospitalisation and universal health visitor records in Scotland. We considered maternal-infant pairs of all live-singleton births 2 years either side of SBBS introduction (Aug 17, 2015, to Aug 11, 2019). We estimated step-changes and trend-changes in outcomes (hospital admission and self-reported exclusive breastfeeding, tobacco smoke exposure, and infant sleeping position) by week of birth using segmented Poisson regression, adjusting for over-dispersion and seasonality where necessary. FINDINGS: The analysis comprised 182 122 maternal-infant pairs. The prevalence of tobacco smoke exposure reduced after SBBS introduction: step decrease of 10% (prevalence ratio 0·904 [95% CI 0·865-0·946]; absolute decrease of 1·6% 1 month post-introduction) for infants and 9% (0·905 [0·862-0·950]; absolute decrease of 1·9% 1 month post-introduction) for the primary carer. There was no evidence of changes in infant and maternal all-cause hospital admissions or infant sleeping position. Among mothers younger than 25 years, there was a 10% step-increase in breastfeeding prevalence (1·095 [1·004-1·195]; absolute increase of 2·2% 1 month post-introduction) at 10 days and 17% (1·174 [1·037-1·328]) at 6-8 weeks postnatal. Although associations were robust to most sensitivity analyses, for smoke exposure associations were only observed early in the postnatal period. INTERPRETATION: SBBS reduced infant and primary carer tobacco smoke exposure, and increased breastfeeding among young mothers in Scotland. However, absolute effects were small. FUNDING: Medical Research Council, Scottish Government Chief Scientist Office, and National Records of Scotland.

Natural experiments for the evaluation of place-based public health interventions: a methodology scoping review.

Introduction: Place-based public health evaluations are increasingly making use of natural experiments. This scoping review aimed to provide an overview of the design and use of natural experiment evaluations (NEEs), and an assessment of the plausibility of the as-if randomization assumption. Methods: A systematic search of three bibliographic databases (Pubmed, Web of Science and Ovid-Medline) was conducted in January 2020 to capture publications that reported a natural experiment of a place-based public health intervention or outcome. For each, study design elements were extracted. An additional evaluation of as-if randomization was conducted by 12 of this paper's authors who evaluated the same set of 20 randomly selected studies and assessed 'as-if ' randomization for each. Results: 366 NEE studies of place-based public health interventions were identified. The most commonly used NEE approach was a Difference-in-Differences study design (25%), followed by before-after studies (23%) and regression analysis studies. 42% of NEEs had likely or probable as-if randomization of exposure (the intervention), while for 25% this was implausible. An inter-rater agreement exercise indicated poor reliability of as-if randomization assignment. Only about half of NEEs reported some form of sensitivity or falsification analysis to support inferences. Conclusion: NEEs are conducted using many different designs and statistical methods and encompass various definitions of a natural experiment, while it is questionable whether all evaluations reported as natural experiments should be considered as such. The likelihood of as-if randomization should be specifically reported, and primary analyses should be supported by sensitivity analyses and/or falsification tests. Transparent reporting of NEE designs and evaluation methods will contribute to the optimum use of place-based NEEs.

Understanding inequalities in mental health by family structure during COVID-19 lockdowns: evidence from the UK Household Longitudinal Study.

PURPOSE: The COVID-19 pandemic increased psychiatric distress and impacts differed by family structure. We aimed to identify mechanisms contributing to these inequalities. METHODS: Survey data were from the UK Household Longitudinal Study. Psychiatric distress (GHQ-12) was measured in April 2020 (first UK lockdown; n = 10,516), and January 2021 (lockdown re-introduced following eased restrictions; n = 6,893). Pre-lockdown family structure comprised partner status and presence of children (< 16 years). Mediating mechanisms included: active employment, financial strain, childcare/home-schooling, caring, and loneliness. Monte Carlo g-computation simulations were used to adjust for confounding and estimate total effects and decompositions into: controlled direct effects (effects if the mediator was absent), and portions eliminated (PE; representing differential exposure and vulnerability to the mediator). RESULTS: In January 2021, after adjustment, we estimated increased risk of distress among couples with children compared to couples with no children (RR: 1.48; 95% CI 1.15-1.82), largely because of childcare/home-schooling (PE RR: 1.32; 95% CI 1.00-1.64). Single respondents without children also had increased risk of distress compared to couples with no children (RR: 1.55; 95% CI 1.27-1.83), and the largest PE was for loneliness (RR: 1.16; 95% CI 1.05-1.27), though financial strain contributed (RR: 1.05; 95% CI 0.99-1.12). Single parents demonstrated the highest levels of distress, but confounder adjustment suggested uncertain effects with wide confidence intervals. Findings were similar in April 2020 and when stratified by sex. CONCLUSION: Access to childcare/schooling, financial security and social connection are important mechanisms that need addressing to avoid widening mental health inequalities during public health crises.

A scoping review establishes need for consensus guidance on reporting health equity in observational studies.

OBJECTIVES: To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension. STUDY DESIGN AND SETTING: We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed "resources") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity. RESULTS: We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as "report the background of investigators". CONCLUSION: Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies.

Subsidised housing and diabetes mortality: a retrospective cohort study of 10 million low-income adults in Brazil.

INTRODUCTION: Housing-related factors can be predictors of health, including of diabetes outcomes. We analysed the association between subsidised housing residency and diabetes mortality among a large cohort of low-income adults in Brazil. RESEARCH DESIGN AND METHODS: A cohort of 9 961 271 low-income adults, observed from January 2010 to December 2015, was created from Brazilian administrative records of social programmes and death certificates. We analysed the association between subsidised housing residency and time to diabetes mortality using a Cox model with inverse probability of treatment weighting and regression adjustment. We assessed inequalities in this association by groups of municipality Human Development Index. Diabetes mortality included diabetes both as the underlying or a contributory cause of death. RESULTS: At baseline, the mean age of the cohort was 40.3 years (SD 15.6 years), with a majority of women (58.4%). During 29 238 920 person-years of follow-up, there were 18 775 deaths with diabetes as the underlying or a contributory cause. 340 683 participants (3.4% of the cohort) received subsidised housing. Subsidised housing residents had a higher hazard of diabetes mortality compared with non-residents (HR 1.17; 95% CI 1.05 to 1.31). The magnitude of this association was more pronounced among participants living in municipalities with lower Human Development Index (HR 1.30; 95% CI 1.04 to 1.62). CONCLUSIONS: Subsidised housing residents had a greater risk of diabetes mortality, particularly those living in low socioeconomic status municipalities. This finding suggests the need to intensify diabetes prevention and control actions and prompt treatment of the diabetes complications among subsidised housing residents, particularly among those living in low socioeconomic status municipalities.

Social, Geographical and Income Inequality as Demonstrated by the Coronary Calcium Score: An Ecological Study in Sydney, Australia.

BACKGROUND: The coronary calcium score is a non-invasive biomarker of coronary artery disease. The concept of "arterial age" transforms the coronary calcium score to an expected age based on the degree of coronary atherosclerosis. This study aimed to investigate the relationship of socioeconomic status with the burden of coronary artery disease within Sydney, Australia. METHODS: This was an ecological study at the postcode level of patients aged 45 and above who had completed a CT coronary calcium scan within New South Wales (NSW), Australia from January 2012 to December 2020. Arterial age difference was calculated as arterial age minus chronological age. Socioeconomic data was obtained for median income, Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) score and median property price. Linear regression was used for analysis. RESULTS: There were 17,102 patients across 325 postcodes within NSW, comprising 9129 males with a median arterial age difference of 7 years and 7972 females with -9 years. Income, IRSAD score and property price each had an inverse relationship with arterial age difference (p-values < 0.05). CONCLUSIONS: Income, socioeconomic status and local property prices are significantly correlated with premature coronary aging. Healthcare resource allocation and prevention should target the inequalities identified to reduce the burden of coronary artery disease.

Co-Benefits of Largescale Organic farming On huMan health (BLOOM): Protocol for a cluster-randomised controlled evaluation of the Andhra Pradesh Community-managed Natural Farming programme in India.

The BLOOM study (co-Benefits of Largescale Organic farming On huMan health) aims to determine if a government-implemented agroecology programme reduces pesticide exposure and improves dietary diversity in agricultural households. To achieve this aim, a community-based, cluster-randomised controlled evaluation of the Andhra Pradesh Community-managed Natural Farming (APCNF) programme will be conducted in 80 clusters (40 intervention and 40 control) across four districts of Andhra Pradesh state in south India. Approximately 34 households per cluster will be randomly selected for screening and enrolment into the evaluation at baseline. The two primary outcomes, measured 12 months post-baseline assessment, are urinary pesticide metabolites in a 15% random subsample of participants and dietary diversity in all participants. Both primary outcomes will be measured in (1) adult men ≥18 years old, (2) adult women ≥18 years old, and (3) children <38 months old at enrolment. Secondary outcomes measured in the same households include crop yields, household income, adult anthropometry, anaemia, glycaemia, kidney function, musculoskeletal pain, clinical symptoms, depressive symptoms, women's empowerment, and child growth and development. Analysis will be on an intention-to-treat basis with an a priori secondary analysis to estimate the per-protocol effect of APCNF on the outcomes. The BLOOM study will provide robust evidence of the impact of a large-scale, transformational government-implemented agroecology programme on pesticide exposure and dietary diversity in agricultural households. It will also provide the first evidence of the nutritional, developmental, and health co-benefits of adopting agroecology, inclusive of malnourishment as well as common chronic diseases. Trial registration: Study registration: ISRCTN 11819073 (https://doi.org/10.1186/ISRCTN11819073). Clinical Trial Registry of India CTRI/2021/08/035434.

Improving social justice in observational studies: protocol for the development of a global and Indigenous STROBE-equity reporting guideline.

BACKGROUND: Addressing persistent and pervasive health inequities is a global moral imperative, which has been highlighted and magnified by the societal and health impacts of the COVID-19 pandemic. Observational studies can aid our understanding of the impact of health and structural oppression based on the intersection of gender, race, ethnicity, age and other factors, as they frequently collect this data. However, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline, does not provide guidance related to reporting of health equity. The goal of this project is to develop a STROBE-Equity reporting guideline extension. METHODS: We assembled a diverse team across multiple domains, including gender, age, ethnicity, Indigenous background, disciplines, geographies, lived experience of health inequity and decision-making organizations. Using an inclusive, integrated knowledge translation approach, we will implement a five-phase plan which will include: (1) assessing the reporting of health equity in published observational studies, (2) seeking wide international feedback on items to improve reporting of health equity, (3) establishing consensus amongst knowledge users and researchers, (4) evaluating in partnership with Indigenous contributors the relevance to Indigenous peoples who have globally experienced the oppressive legacy of colonization, and (5) widely disseminating and seeking endorsement from relevant knowledge users. We will seek input from external collaborators using social media, mailing lists and other communication channels. DISCUSSION: Achieving global imperatives such as the Sustainable Development Goals (e.g., SDG 10 Reduced inequalities, SDG 3 Good health and wellbeing) requires advancing health equity in research. The implementation of the STROBE-Equity guidelines will enable a better awareness and understanding of health inequities through better reporting. We will broadly disseminate the reporting guideline with tools to enable adoption and use by journal editors, authors, and funding agencies, using diverse strategies tailored to specific audiences.

Exploring the health and sociodemographic characteristics of people seeking advice with claiming universal credit: a cross-sectional analysis of UK citizens advice data, 2017-2021.

BACKGROUND: The UK Department for Work and Pensions (DWP) administers Universal Credit (UC) - the main UK benefit for people in- and out-of-work. UC is being rolled out nationally from 2013 to 2024. Citizens Advice (CA) is an independent charity that provides advice and support to people making a claim for UC. The aim of this study is to understand who is seeking advice from CA when making a UC claim and how the types of people seeking advice are changing as the rollout of UC continues. METHODS: Co-developed with Citizens Advice Newcastle and Citizens Advice Northumberland we performed longitudinal analysis of national data from Citizens Advice for England and Wales on the health (mental health and limiting long term conditions) and socio-demographic of 1,003,411 observations for people seeking advice with claiming UC over four financial years (2017/18 to 2020/21). We summarised population characteristics and estimated the differences between the four financial years using population-weighted t-tests. Findings were discussed with three people with lived experience of seeking advice to claim UC to help frame our interpretation and policy recommendations. RESULTS: When comparing 2017/18 to 2018/19, there was a significantly higher proportion of people with limiting long term conditions seeking advice with claiming UC than those without (+ 2.40%, 95%CI: 1.31-3.50%). However, as the rollout continued between 2018/29 and 2019/20 (-6.75%, 95%CI: -9.62%--3.88%) and between 2019/20 and 2020/21 (-2.09%, 95%CI: -2.54%--1.64%), there were significantly higher proportions of those without a limiting long term condition seeking advice than with. When comparing 2018/19 to 2019/20 and 2019/20 to 2020/21, there was a significant increase in the proportion of self-employed compared to unemployed people seeking advice with claiming UC (5.64%, 95%CI: 3.79-7.49%) and (2.26%, 95%CI: 1.29-3.23%) respectively. CONCLUSION: As the rollout for UC continues, it is important to understand how changes in eligibility for UC may impact on those who need help with applying for UC. Ensuring that the advice process and application process is responsive to a range of people with different needs can help to reduce the likelihood that the process of claiming UC will exacerbate health inequalities.

Implementation of a national smoke-free prison policy: an economic evaluation within the Tobacco in Prisons (TIPs) study.

OBJECTIVE: To determine the cost-effectiveness of a smoke-free prison policy in Scotland, through assessments of the trade-offs between costs (healthcare and non-healthcare-related expenditure) and outcomes (health and non-health-related non-monetary consequences) of implementing the policy. DESIGN: A health economic evaluation consisting of three analyses (cost-consequence, cost-effectiveness and cost-utility), from the perspectives of the healthcare payer, prison service, people in custody and operational staff, assessed the trade-offs between costs and outcomes. Costs associated with the implementation of the policy, healthcare resource use and personal spend on nicotine products were considered, alongside health and non-health outcomes. The cost-effectiveness of the policy was evaluated over 12-month and lifetime horizons (short term and long term). SETTING: Scotland's national prison estate. PARTICIPANTS: People in custody and operational prison staff. INTERVENTION: Implementation of a comprehensive (indoor and outdoor) smoke-free policy. MAIN OUTCOME MEASURES: Concentration of secondhand smoke, health-related quality of life (health utilities and quality-adjusted life-years (QALY)) and various non-health outcomes (eg, incidents of assaults and fires). RESULTS: The short-term analyses suggest cost savings for people in custody and staff, improvements in concentration of secondhand smoke, with no consistent direction of change across other outcomes. The long-term analysis demonstrated that implementing smoke-free policy was cost-effective over a lifetime for people in custody and staff, with approximate cost savings of £28 000 and £450, respectively, and improvement in health-related quality of life of 0.971 QALYs and 0.262, respectively. CONCLUSION: Implementing a smoke-free prison policy is cost-effective over the short term and long term for people in custody and staff.

Anti-GBM Disease after Oxford-AstraZeneca ChAdOx1 nCoV-19 Vaccination: A Report of Two Cases.

There have been reports of rare de novo glomerular diseases following vaccination for coronavirus disease 2019 (COVID-19). We report two cases of anti-glomerular basement membrane (GBM) disease in previously healthy females after Oxford-AstraZeneca COVID-19 vaccine (ChAdOx1 nCoV-19). The first case was a 69-year-old female who developed lethargy and anuria approximately 8 weeks after her first dose of Oxford-AstraZeneca COVID-19 vaccine. The second case was a 72-year-old female who developed malaise and diarrhoea approximately 3 weeks after her second dose of Oxford-AstraZeneca COVID-19 vaccine. Both cases had severe acute kidney injury, raised anti-GBM antibody titres, and renal biopsies consistent with anti-GBM disease. Both cases were commenced on haemodialysis and treated with high dose glucocorticoids, cyclophosphamide, and plasmapheresis. Neither patient had recovery of renal function, and both remain dialysis dependent. These cases add to the previously reported cases of anti-GBM disease after mRNA COVID-19 vaccination. As more COVID-19 vaccinations are administered worldwide, it would be important for clinicians to be aware of this possible association, and continued surveillance is warranted.