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Obesity is one of the major contributors to the excess mortality seen in people with severe mental illness (SMI) and in low- and middle-income countries people with SMI may be at an even greater risk. In this study, we aimed to determine the prevalence of obesity and overweight in people with SMI and investigate the association of obesity and overweight with sociodemographic variables, other physical comorbidities, and health-risk behaviours. This was a multi-country cross-sectional survey study where data were collected from 3989 adults with SMI from three specialist mental health institutions in Bangladesh, India, and Pakistan. The prevalence of overweight and obesity was estimated using Asian BMI thresholds. Multinomial regression models were then used to explore associations between overweight and obesity with various potential determinants. There was a high prevalence of overweight (17·3 %) and obesity (46·2 %). The relative risk of having obesity (compared to normal weight) was double in women (RRR = 2·04) compared with men. Participants who met the WHO recommendations for fruit and vegetable intake had 2·53 (95 % CI: 1·65–3·88) times greater risk of having obesity compared to those not meeting them. Also, the relative risk of having obesity in people with hypertension is 69 % higher than in people without hypertension (RRR = 1·69). In conclusion, obesity is highly prevalent in SMI and associated with chronic disease. The complex relationship between diet and risk of obesity was also highlighted. People with SMI and obesity could benefit from screening for non-communicable diseases, better nutritional education, and context-appropriate lifestyle interventions.
In both population-based and clinical cohorts, cross-sectional and longitudinal studies have reported associations between a range of non-specific markers of immune activation (e.g., pro-inflammatory cytokines) or chronic inflammation (e.g., C-reactive protein [CRP]) and depressive and other mood disorders (Dowlati et al. 2010; Hickie et al. 2018; Khandaker et al. 2017; Orsolini et al. 2022; Valkanova et al. 2013). The clinico-pathological significance, and directional relationships, of these associations tended to be downplayed as the systemic levels of these inflammatory markers were not in the ranges typical of active infective, inflammatory or significant autoimmune diseases.
Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users.
A single-blind RCT comparing 16 sessions of EMDRp + TAU v. TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomization assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the ‘promise of efficacy’ of EMDRp on relevant clinical outcomes.
Sixty participants (100% of the recruitment target) received TAU or EMDR + TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp + TAU participants received at least eight therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp + TAU v. TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety, and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status.
The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-center trial of EMDRp is feasible and warranted.
Background:Clostridioides difficile infection (CDI) often recurs in patients aged ≥65 years and those with comorbidities. Clinical trials often exclude patients with history of immunosuppression, malignancy, renal insufficiency, or other comorbidities. In a phase 3 trial (ECOSPOR III), SER-109 was superior to placebo in reducing recurrent CDI (rCDI) risk at week 8 and was well tolerated. We report integrated safety data for SER-109 in a broad patient population through week 24 from phase 3 studies: ECOSPOR III and ECOSPOR IV. Methods: ECOSPOR III was a double-blind, placebo-controlled trial conducted in participants with ≥2 CDI recurrences randomized 1:1 to placebo or SER-109. ECOSPOR IV was an open-label, single-arm study conducted in 263 patients with rCDI enrolled in 2 cohorts: (1) rollover participants from ECOSPOR III with on-study recurrence and (2) participants with ≥1 CDI recurrence, inclusive of the current episode. In both studies, the investigational product was administered as 4 oral capsules over 3 days. Treatment-emergent adverse events (TEAEs) were collected through week 8; serious TEAEs and TEAEs of special interest (ie, bacteremia, abscess, meningitis) were collected through week 24. Results: In total, 349 participants received SER-109 in ECOSPOR III and/or ECOSPOR IV (mean age 64.2; 68.8% female). Chronic diseases included cardiac disease (31.2%), immunocompromised or immunosuppressed (21.2%), diabetes (18.9% ), and renal impairment or failure (13.2%). Overall, 221 (63.3%) of 349 participants who received SER-109 experienced TEAEs through week 24. Most were mild to moderate and gastrointestinal. The most common (>5% of participants) treatment related TEAEs were flatulence, abdominal pain and distension, decreased appetite, constipation, nausea, fatigue, and diarrhea. No participants experienced a treatment-related TEAE leading to study withdrawal. Invasive infections were observed in 28 participants (8%); those with identified pathogens were unrelated to SER-109 species, and all were deemed unrelated to treatment by the investigators. There were 11 deaths (3.2%) and 48 participants (13.8%) with serious TEAEs, none of which were deemed treatment related. There were no clinically important differences in the safety profile across subgroups of sex, race, prior antibiotic regimen, or number of CDI recurrences. No safety signals were observed in participants with renal impairment or failure, diabetes, cardiac disease, or immunocompromised or immunosuppressed individuals. Conclusions: In this integrated analysis of phase 3 trials, SER-109, an investigational microbiome therapeutic, was well tolerated in this vulnerable patient population with prevalent comorbidities. No infections, nor those with identified pathogens, were attributed to SER-109 or product species. This safety profile might be expected because this purified product is composed of spore-forming Firmicutes normally abundant in the healthy microbiome.
Financial support: This study was funded by Seres Therapeutics.
Background: Carbapenem-resistant Acinetobacter baumannii (CRAB) has emerged as a major cause of bloodstream infection among hospitalized patients in low- and middle-income countries (LMICs). CRAB infections can be difficult to treat and are devastating in neonates (~30% mortality). CRAB outbreaks are hypothesized to arise from reservoirs in the hospital environment, but outbreak investigations in LMICs seldom incorporate whole-genome sequencing (WGS). Methods: WGS (Illumina NextSeq) was performed at the National Institute for Communicable Diseases (South Africa) on 43 preserved A. baumannii isolates from a 530-bed referral hospital in Gaborone, Botswana, from March 2021–August 2022. This included 23 blood-culture isolates from 21 unique patients (aged 2 days–69 years) and 20 environmental isolates collected at the 36-bed neonatal unit in April–June 2021. Infections were considered healthcare-associated if the culture was obtained >72 hours after hospital arrival (or sooner in inborn infants). Blood cultures were incubated using an automated system (BACT/ALERT, BioMérieux) and were identified using manual methods. Environmental isolates were identified using selective or differential chromogenic media (CHROMagarTM). Taxonomic assignment, multilocus sequence typing (MLST), antimicrobial resistance gene identification, and phylogenetic analyses were performed using publicly accessible analysis pipelines. Single-nucleotide polymorphism (SNP) matrices were used to assess clonal lineage. Results: All 23 blood isolates and 5 (25%) of 20 environmental isolates were confirmed as A. baumannii; thus, 28 A. baumannii isolates were included in the phylogenetic analysis. MLST revealed that 22 (79%) of 28 isolates were sequence type 1 (ST1), including all 19 healthcare-associated blood isolates and 3 (60%) of 5 environmental isolates. Genes encoding for carbapenemases (blaNDM-1, blaOXA-23) and biocide resistance (qacE) were present in all 22 ST1 isolates; colistin resistance genes were not identified. Phylogenetic analysis of the ST1 clade demonstrated spatial clustering by hospital unit. Related isolates spanned wide ranges in time (>1 year), suggesting ongoing transmission from environmental sources (Fig. 1). An exclusively neonatal clade (0–2 SNPs) containing all 8 neonatal blood isolates was closely associated with 3 environmental isolates from the neonatal unit: a sink drain, bed rail, and a healthcare worker’s hand. Conclusions: WGS analysis of clinical and environmental A. baumannii revealed the presence of unit-specific CRAB clones, with evidence of ongoing transmission likely driven by persistent environmental reservoirs. This research highlights the potential of WGS to detect hospital outbreaks and reaffirms the importance of environmental sampling to identify and remediate reservoirs (eg, sinks) and vehicles (eg, hands and equipment) within the healthcare environment.
Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The Causal Roadmap is an explicit, itemized, iterative process that guides investigators to prespecify study design and analysis plans; it addresses a wide range of guidance within a single framework. By supporting the transparent evaluation of causal assumptions and facilitating objective comparisons of design and analysis choices based on prespecified criteria, the Roadmap can help investigators to evaluate the quality of evidence that a given study is likely to produce, specify a study to generate high-quality RWE, and communicate effectively with regulatory agencies and other stakeholders. This paper aims to disseminate and extend the Causal Roadmap framework for use by clinical and translational researchers; three companion papers demonstrate applications of the Causal Roadmap for specific use cases.
To examine differences in noticing and use of nutrition information comparing jurisdictions with and without mandatory menu labelling policies and examine differences among sociodemographic groups.
Cross-sectional data from the International Food Policy Study (IFPS) online survey.
IFPS participants from Australia, Canada, Mexico, United Kingdom and USA in 2019.
Adults aged 18–99; n 19 393.
Participants in jurisdictions with mandatory policies were significantly more likely to notice and use nutrition information, order something different, eat less of their order and change restaurants compared to jurisdictions without policies. For noticed nutrition information, the differences between policy groups were greatest comparing older to younger age groups and comparing high education (difference of 10·7 %, 95 % CI 8·9, 12·6) to low education (difference of 4·1 %, 95 % CI 1·8, 6·3). For used nutrition information, differences were greatest comparing high education (difference of 4·9 %, 95 % CI 3·5, 6·4) to low education (difference of 1·8 %, 95 % CI 0·2, 3·5). Mandatory labelling was associated with an increase in ordering something different among the majority ethnicity group and a decrease among the minority ethnicity group. For changed restaurant visited, differences were greater for medium and high education compared to low education, and differences were greater for higher compared to lower income adequacy.
Participants living in jurisdictions with mandatory nutrition information in restaurants were more likely to report noticing and using nutrition information, as well as greater efforts to modify their consumption. However, the magnitudes of these differences were relatively small.
This is to be a series of three volumes covering Bedfordshire churches in the nineteenth century. The volumes will contain descriptions of churches “on the eve of restoration” together with contemporary illustrations –most of which will be published for the first time.
For each church, there will be extracts from original records amplified by a commentary and explanatory footnotes. The main source material consists of:
1. Extracts from church inventories – mainly 1822
2. Antiquarian notes on churches by Archdeacon Bonney, c.1840
4. Articles on churches by W.A. – John Martin, the librarian at Woburn Abbey - 1845-1854
5. Church descriptions by Sir Stephen Glynne 1830-1870
There is considerable value in having these key sources, with illustrations and commentary, in one place. The descriptions by Bonney and Glynne are purely factual, but John Martin’s articles, highlighting abuses and neglect, make colourful and at times controversial reading. Bonney’s visitation notes - and the supporting evidence from contemporary records such as churchwardens’ accounts – give a clear indication that church buildings were far from neglected in the opening decades of the nineteenth century. Together these sources document features that can still be seen today, and provide information on others that have been lost.
The aim has been to present the text of contemporary sources in their original state, to convey a feeling for the times as well as to provide information. It is recognised that most of the sources could have been condensed by editing - for instance the lists of registers in the glebe terriers and the quotations in the articles by W.A. – but the Editorial Group felt that they should nevertheless be published in extenso.
The introductory commentary for each church includes a summary of the history of the building, focusing especially on eighteenth and nineteenth century restoration and alterations. These introductory notes are generally brief, but may be longer where differences between present and past external appearance merit detailed discussion. Detailed footnotes explain and amplify features mentioned in the text of the original sources and so lead the reader to additional research material.
Bedfordshire churches on the eve of restoration are well documented in a number of sources. First, there are a great many pictures of churches by artists such as Thomas Fisher and George Shepherd dating from the early Cl9th. Secondly, there are the manuscript sources which describe the condition of church buildings and ornaments in the years leading up to “the age of restoration”.
These sources are described and discussed in detail below. In outline, however, they include the glebe terriers for 1822 which describe the plan of each church and list the ornaments and furnishings. As Archdeacon of Bedford from 1821 to 1844, Dr. Henry Kaye Bonney compiled two notebooks on the churches in his care. In the one, he made detailed architectural notes on each church and its fittings, and in the other he kept a record of the orders made at his archidiaconal visitations between 1823 and 1839. Another commentator was John Martin, the Librarian at Woburn Abbey, who using the signature W.A. wrote a series of pithy articles on Bedfordshire churches for the Northampton Mercury and Bedfordshire Times between 1845 and 1854. Lastly, there are the notebooks of Sir Stephen Glynne who visited over a third of the churches in the County between 1830 and 1870.
Together these sources provide a colourful image of the appearance, condition and atmosphere of Bedfordshire churches at a time when on the one hand they were nearer their mediaeval state than they are today but when on the other they were arguably in their greatest need of attention.
Glebe Terriers (extracts) 1822
After the Reformation, the ecclesiastical authorities became increasingly aware of the need to keep proper records of church possessions. The documents known as glebe terriers fulfil this purpose, and include terriers (recording property and endowments) and inventories (listing goods and chattels). The existence of such records helped to prevent the loss and misappropriation of church property.
Terriers had been compiled for purely parochial purposes in mediaeval times, but in compliance with an archiepiscopal order or canon of 1571 it became a requirement for copies of these documents to be lodged in diocesan registries for safe-keeping.
Although the present church dates chiefly from the Cl4th and Cl5th, the foundations of the Cl2th church were discovered during excavations in 1975. The later church has a chancel, nave with north and south aisles, south porch and west tower. It retains its Cl5th roof with angels and shields (though the painted decoration is modem) and there is a ceilure above the former rood.
In 1696 a private pew was constructed for Lord Ashbumham of Ampthill Park in the south aisle of the church. Sir Christopher Wren and his pupil Nicholas Hawksmoor were involved in the design, and the pew was built by Alexander Fort, the King’s joiner. There was a heated legal dispute between Lord Ashburnham and Lord Ailesbury of Houghton House about this pew, which was eventually removed in 1847. The entrance through the east wall of the south aisle is shown in Buckler’s drawing dated 1835 (Plate 2). Lord Ailesbury had his own pew in the church, and there are faculties and papers regarding other Cl8th pews. In 1827 Boissier described the church as “crowded with pews & galleries”. Between 1823 and 1839 Bonney ordered several improvements to the pews, and in 1845 W.A. was highly critical of the arrangement of the church interior.
A faculty was obtained in 1728 to replace the pulpit, take down the chancel screen, and alter various windows. It was probably at this date that the pulpit was placed centrally in the chancel arch where it remained until 1847. Other repairs and alterations in the Cl8th and early Cl9th are recorded in the churchwardens’ accounts from 1718, vestry minutes from 1767, and churchwardens bills from 1823 (listed individually by Andrew Underwood) in the parish records.
Restoration came in 1847-8 under James Tacy Wing of Bedford, who provided new seats and galleries in the nave (Plate 3) and renewed the east window, repaired the roof and stonework, and added a small vestry on the north side of the chancel. In 1851-2 the church was lit by gas.
The tracery of the windows in the south aisle was renewed in 1872-3. Further work followed in 1877 when the vestry on the north side of the chancel was enlarged under James Piers St. Aubyn, although not all the work authorised by the faculty was carried out.
The parish churches of England are among the most noble and conspicuous of the nation’s architectural monuments. Their survival, however, owes more to chance than to good stewardship. Neglect, decay, and deliberate destruction are as much a part of their history as the work of dedicated benefactors and parishioners who strove to make our churches worthy for Christian worship.
As the sources selected for inclusion in this series demonstrate all too clearly, many Bedfordshire churches were in a dilapidated state in the opening decades of the nineteenth century. Others, whilst structurally sound and decently furnished for the worship of the day, needed “restoration” – a term meaning much more than just repair. This was the situation facing the Victorians who – far from vandalising our heritage – sought to restore these precious buildings from years of neglect and adapt them to suit the new liturgical arrangements of the time.
The coming of the ecclesiological movement in the 1840s brought a new concern for the ceremonial aspects of worship – the ministry of the sacraments instead of the ministry of the word. This entailed a change in the arrangement of church buildings, the old “preaching boxes” of the Cl8th giving way to churches in which all attention focused on the chancel and the holy table in the sanctuary. The reformers often exaggerated the poor state of church buildings as a means of drawing attention to the need for change, and the Victorians were invariably critical of alterations and repairs carried out in previous centuries when utility had been regarded as more important than sanctity.
Between about 1840 and 1914 virtually every parish church in England was in some measure restored, and vast sums of money were spent on what was seen to be one of the most worthy causes of the Victorian era. Many churches were rescued from the brink of collapse and given a new lease of life. Some were restored to their former glory. Others were mutilated beyond recognition or wholly rebuilt. Churches viewed by the Victorians as “tainted by classical alterations” were gothicised. Sound buildings were “improved” to suit the needs of a new religious age.
Churches remaining “unrestored” in appearance are to be seen at Chaigrave, Dean, Knotting, Odell, Shelton and Wymington (to name a few of the more rewarding examples in the County), but sadly the phrase “over restored” is all too common in the Bedfordshire volume of Dr. Nikolaus Pevsner’s Buildings of England series.
A brief general survey of post-Reformation church work in the County will be useful as an introduction to the subject. It seems sensible to frame the review round the work of architects - the designers of buildings and of furnishing schemes - who worked at different periods and in different styles. In this way, it is possible to view the changes in ecclesiastical taste in the County in their broader national context.
Post-Reformation church building to 1800
In general terms, church building activity came to an abrupt end at the time of the Reformation. There are, however, exceptions and recent studies in the neighbouring county of Huntingdonshire have demonstrated the extent of building work and improvements to churches into the seventeenth century. This may be untypical of the general picture, and Bedfordshire lacks any particularly distinguished examples of churches dating from the period between 1550 and 1800. Those mentioned below are all relatively minor when compared with the treasures in neighbouring counties, such as:
In Bedfordshire, Hulcote church was rebuilt by the Chemocke family in the late sixteenth century. It is gothic in form, but with a distinctly Renaissance feel. The tower at Blunham was rebuilt in 1583. At Odell there is a fine screen and ringing gallery of 1637 in the tower arch. At Campton, the north aisle dates from 1649. Whipsnade church was rebuilt in 1719. Melchboume has a seventeenthcentury porch brought, it is said, from Woodford in Northamptonshire. The body of the church was rebuilt in the classical style in about 1770. Shillington tower, destroyed in a storm in 1701, was rebuilt in brick in 1750. The 1783 black basalt Wedgwood font at Cardington - another formerly existed at Melchboume - is a particularly memorable example of eighteenth-century church furnishing. In every one of these cases the identity of the architect is unknown.
Having lived and worked in Bedfordshire for the past sixteen years, I have visited every church in the County in the course of my work. While on the staff of the Bedfordshire County Record Office I have been responsible for surveying and listing all the church records, and I am fortunate that this has enabled me to develop an intimate knowledge of the churches and their history.
It is my hope that in preparing these volumes I may be able to pass on some of this knowledge for the benefit of people interested either in specific churches or in the subject generally. I should like to thank the Society for publishing this book. I also wish to thank Gordon Vowles, the General Editor, and my colleagues on the Editorial Group for their constructive comments and suggestions throughout its gestation period.
Formal acknowledgment is due to the authorities and owners who have allowed the publication of their material. The 1822 glebe terriers are published here by kind permission of Lincoln Diocesan Record Office. Archdeacon Bonney’s church notes were among the manuscripts transferred to the County Record Office from the old Bedford Library, while Bonney’s visitation notes appear by kind permission of the present Archdeacon of Bedford, the Ven. Malcolm Lesiter. Sir Stephen Glynne’s Bedfordshire church notes are published by kind permission of Sir William Gladstone. Thanks are also due to Geoffrey Veysey, the Clwyd County Archivist, for providing information on the notes and for allowing me to quote from his article about Sir Stephen Glynne. The sources of illustrations are acknowledged separately.
Material for this volume has been gathered from several record repositories and institutions. My first debt of gratitude is to my colleagues in the Bedfordshire County Record Office, but I must also thank the staff at the British Library, the British Newspaper Library, the library of the Society of Antiquaries of London, the Bedfordshire County Library Service, Lambeth Palace Library, Cambridge University Library, Lincolnshire Archives, and the Hertfordshire County Record Office for their help and advice.
Thanks are also due to all those who have typed parts of the text including Deborah Blake and Ellen Collier, but especially to Pauline Newbery on whom the main body of the work has fallen.