bluuebunny/crossref_metadata_2025 huggingface dataset:
Retrospective cross-sectional analysis of concurrent VTE diagnosis in hospitalised socially excluded individuals in Ireland
Authors: Carpenter Chloe , O’ Farrell Anne , Ní Áinle Fionnuala , Ní Cheallaigh Clíona , Kevane Barry
Published: January 2024

Objective

Social exclusion (such as that experienced by people who are homeless, incarcerated or use drugs) increases morbidity across a range of diseases but is poorly captured in routine data sets. The aim of this study was to use a novel composite variable in a national-level hospital usage dataset to identify social exclusion and to determine whether social exclusion is associated with concurrent venous thromboembolism (VTE) in hospitalised patients in Ireland. Identifying and characterising this association in people who are socially excluded will inform VTE prevention and treatment strategies.

Design

Retrospective cross-sectional study.

Setting

Irish Hospital Inpatient Enquiry (HIPE) system, which collects diagnostic information by International Classification of Diseases Tenth Revision code on all hospital admission episodes in the Ireland.

Participants

All hospital admission episodes involving a VTE diagnosis (in a primary ‘Dx 1’ or secondary ‘Dx 2–30’ coding position) during a 12-month period in the Ireland were identified from consolidated, national-level datasets derived from the Irish HIPE system. Social exclusion was defined as the presence of one or more indicators of homelessness, drug use, incarceration, health hazards due to socioeconomic status or episodes of healthcare terminated prematurely.

Results

Of 5701 admission episodes involving a VTE diagnosis (in a primary or secondary position) during the study period, 271 (4.8%) related to an individual affected by social exclusion. Among hospitalised individuals identified as being socially excluded based on the novel composite variable, the likelihood of having a concurrent VTE diagnosis was over twofold greater than that observed in the general population (OR 2.14, 95% CI 1.79 to 2.26; p<0.001).

Conclusion

These data suggest that VTE (primary and secondary) is over-represented in hospitalised socially excluded persons in Ireland and that the development of strategies to address this potentially life-threatening accompanying condition in this vulnerable patient group must be prioritised.
Epidemiological characteristics of suspected adenomyosis in the Chinese physical examination population: a nested case-control study
Authors: Huang Yanyan , Su Xueyao , Chen Ke , Zhang Lijun , Xu Wei , Pu Yang , Xu Fan , Gong Ruoyan , Zhang Jiayuan , Nie Yuxian , Shi Qiuling
Published: January 2024

Objectives

We aimed to explore the epidemiological characteristics of suspected adenomyosis within a physical examination population in China.

Design

A retrospective, nested case-control study; we matched healthy people and those with potential adenomyosis on a 1:2 ratio by age.

Setting

A tertiary hospital health management centre.

Participants

We included 15–60 years old women who underwent at least one uterine examination from October 2017 to December 2020, excluding those who had undergone hysterectomy and menopause.

Primary and secondary outcome measures

We estimated the incidence and prevalence rate of suspected adenomyosis. Conditional logistic regression was used to estimate associations between serum biomarkers and potential adenomyosis. Areas under the receiver-operating characteristic curves (AUC) were used to determine the cut-off point of the cancer antigen 125 (CA125) level for suspected adenomyosis.

Results

A total of 30 629 women had uterus-related imaging examinations; 877 had suspected adenomyosis. The standardised incidence and prevalence of suspected adenomyosis was 1.32% and 2.35%, respectively, for all age groups. The conditional logistic regression analysis results showed that total bilirubin≥18.81 µmol/L (HR: 2.129; 95% CI 1.067 to 4.249; p<0.0321) and CA125 levels (HR: 1.014; 95% CI 1.002 to 4.731; p<0.0273) were positively correlated with onset of suspected adenomyosis; body mass index>24 kg/m2(HR: 1.262; 95% CI 1.055 to 1.511; p<0.0109), CA125 levels (HR: 1.007; 95% CI 1.006 to 1.009; p<0.0001), and blood platelet levels (HR: 1.002; 95% CI 1 to 1.003; p<0.0141) were positively correlated with potential adenomyosis. The optimal cut-off of CA125 for new suspected adenomyosis was 10.714 U/mL, with a sensitivity of 77.42%, specificity of 53.76%, and AUC of 0.7841 (95% CI 0.7276 to 0.8407).

Conclusions

The disease burden of suspected adenomyosis remains huge and can be informed by biomarkers. The disease-specific threshold of CA125 will support further preventive strategy development in population.

Trial registration number

ChiCTR2100049520, 2021/8/2.
Nursing core competencies for postresuscitation care in Iran: a qualitative study
Authors: Zali Mahnaz , Rahmani Azad , Powers Kelly , Hassankhani Hadi , Namdar-Areshtanab Hossein , Gilani Neda
Published: January 2024

Objective

This study explored nurses’ perceptions of the core competencies required for providing postresuscitation care in both in-hospital and out-of-hospital cardiac arrest.

Design

Qualitative conventional content analysis.

Participants

17 nurses selected with purposeful sampling method.

Setting

Three educational hospitals in northwest of Iran.

Data collection and analysis

Semi-structured interviews were used for data collection and they were analysed using conventional content analysis.

Results

Seven main categories have emerged from the data. The core competencies for nurses providing postresuscitation were identified as: quality assurance, providing evidence-based care, monitoring and presence, situation management, professionalism, positive attitude and providing family centred care.

Conclusions

The postresuscitation period is a unique and critical time requiring highly competent nursing care. Several core competencies for providing high-quality nursing care during postresuscitation period were identified through nurses’ experience in caring for patients postresuscitation.
Understanding symptoms suggestive of long COVID syndrome and healthcare use among community-based populations in Manitoba, Canada: an observational cross-sectional survey
Authors: Kosowan Leanne , Sanchez-Ramirez Diana C , Katz Alan
Published: January 2024

Objective

This study aims to characterise respondents who have COVID-19 and long COVID syndrome (LCS), and describe their symptoms and healthcare utilisation.

Design

Observational cross-sectional survey.

Setting

The one-time online survey was available from June 2022 to November 2022 to capture the experience of residents in Manitoba, Canada.

Participant

Individuals shared their experience with COVID-19 including their COVID-19 symptoms, symptoms suggestive of LCS and healthcare utilisation. We used descriptive statistics to characterise patients with COVID-19, describe symptoms suggestive of LCS and explore respondent health system use based on presenting symptoms.

Results

There were 654 Manitobans who responded to our survey, 616 (94.2%) of whom had or provided care to someone who had COVID-19, and 334 (54.2%) reported symptoms lasting 3 or more months. On average, respondents reported having 10 symptoms suggestive of LCS, with the most common being extreme fatigue (79.6%), issues with concentration, thinking and memory (76.6%), shortness of breath with activity (65.3%) and headaches (64.1%). Half of the respondents (49.2%) did not seek healthcare for COVID-19 or LCS. Primary care was sought by 66.2% respondents with symptoms suggestive of LCS, 15.2% visited an emergency department and 32.0% obtained care from a specialist or therapist. 62.6% of respondents with symptoms suggestive of LCS reported reducing work, school or other activities which demonstrate its impact on physical function and health-related quality of life.

Conclusion

Consistent with the literature, there are a variety of symptoms experienced among individuals with COVID-19 and LCS. Healthcare providers face challenge in providing care for patients with a wide range of symptoms unlikely to respond to a single intervention. These findings support the value of interdisciplinary COVID-19 clinics due to the complexity of the syndrome. This study confirms that data collected from the healthcare system do not provide a comprehensive reflection of LCS.
Qualitative interview study of strategies to support healthcare personnel mental health through an occupational health lens
Authors: Brown-Johnson Cati , DeShields Cheyenne , McCaa Matthew , Connell Natalie , Giannitrapani Susan N , Thanassi Wendy , Yano Elizabeth M , Singer Sara J , Lorenz Karl A , Giannitrapani Karleen
Published: January 2024

Background

Employee Occupational Health (‘occupational health’) clinicians have expansive perspectives of the experience of healthcare personnel. Integrating mental health into the purview of occupational health is a newer approach that could combat historical limitations of healthcare personnel mental health programmes, which have been isolated and underused.

Objective

We aimed to document innovation and opportunities for supporting healthcare personnel mental health through occupational health clinicians. This work was part of a national qualitative needs assessment of employee occupational health clinicians during COVID-19 who were very much at the centre of organisational responses.

Design

This qualitative needs assessment included key informant interviews obtained using snowball sampling methods.

Participants

We interviewed 43 US Veterans Health Administration occupational health clinicians from 29 facilities.

Approach

This analysis focused on personnel mental health needs and opportunities, using consensus coding of interview transcripts and modified member checking.

Key results

Three major opportunities to support mental health through occupational health involved: (1) expanded mental health needs of healthcare personnel, including opportunities to support work-related concerns (eg, traumatic deployments), home-based concerns and bereavement (eg, working with chaplains); (2) leveraging expanded roles and protocols to address healthcare personnel mental health concerns, including opportunities in expanding occupational health roles, cross-disciplinary partnerships (eg, with employee assistance programmes (EAP)) and process/protocol (eg, acute suicidal ideation pathways) and (3) need for supporting occupational health clinicians’ own mental health, including opportunities to address overwork/burn-out with adequate staffing/resources.

Conclusions

Occupational health can enact strategies to support personnel mental health: to structurally sustain attention, use social cognition tools (eg, suicidality protocols or expanded job descriptions); to leverage distributed attention, enhance interdisciplinary collaboration (eg, chaplains for bereavement support or EAP) and to equip systems with resources and allow for flexibility during crises, including increased staffing.
Causes of maternal deaths in Sierra Leone from 2016 to 2019: analysis of districts’ maternal death surveillance and response data
Authors: Shafiq Yasir , Caviglia Marta , Juheh Bah Zainab , Tognon Francesca , Orsi Michele , K. Kamara Abibatu , Claudia Caracciolo , Moses Francis , Manenti Fabio , Barone-Adesi Francesco , Sessay Tom
Published: January 2024

Introduction

Sierra Leone is among the top countries with the highest maternal mortality rates. Although progress has been made in reducing maternal mortality, challenges remain, including limited access to skilled care and regional disparities in accessing quality care. This paper presents the first comprehensive analysis of the burden of different causes of maternal deaths reported in the Maternal Death Surveillance and Response (MDSR) system at the district level from 2016 to 2019.

Methods

The MDSR data are accessed from the Ministry of Health and Sanitation, and the secondary data analysis was done to determine the causes of maternal death in Sierra Leone. The proportions of each leading cause of maternal deaths were estimated by districts. A subgroup analysis of the selected causes of death was also performed.

Results

Overall, obstetric haemorrhage was the leading cause of maternal death (39.4%), followed by hypertensive disorders (15.8%) and pregnancy-related infections (10.1%). Within obstetric haemorrhage, postpartum haemorrhage was the leading cause in each district. The burden of death due to obstetric haemorrhage slightly increased over the study period, while hypertensive disorders showed a slightly decreasing trend. Disparities were found among districts for all causes of maternal death, but no clear geographical pattern emerged. Non-obstetric complications were reported in 11.5% of cases.

Conclusion

The MDSR database provides an opportunity for shared learning and can be used to improve the quality of maternal health services. To improve the accuracy and availability of data, under-reporting must be addressed, and frontline community staff must be trained to accurately capture and report death events.
Interventions to promote the health and well-being of children under 5s experiencing homelessness in high-income countries: a scoping review
Authors: Tu Yanxin , Sarkar Kaushik , Svirydzenka Nadia , Palfreyman Zoe , Parry Yvonne Karen , Ankers Matthew , Parikh Priti , Raghavan Raghu , Lakhanpaul Monica
Published: January 2024

Objectives

Homelessness among families with children under 5 residing in temporary accommodation is a growing global concern, especially in high-income countries (HICs). Despite significant impacts on health and development, these ‘invisible’ children often fall through the gaps in policy and services. The study’s primary objective is to map the content and delivery methods of culturally sensitive interventions for children under 5 experiencing homelessness in HICs.

Design

A scoping review guided by the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist.

Data sources

Databases include PubMed, Medline, SCOPUS, The Cochrane Library and Google Scholar were searched up to 24 March 2022.

Eligibility criteria

This scoping review includes studies that describe, measure or evaluate intervention strategies aimed at improving child health programmes, specifically those yielding positive outcomes in key areas like feeding, nutrition, care practices and parenting.

Data extraction and synthesis

Articles were selected and evaluated by two independent reviewers, with a dispute resolution system involving a third reviewer for contested selections. The methodological quality of the studies was assessed using various tools including the Risk of Bias (RoB) tool, Cochrane RoB V.2.0, the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), each selected according to the type of article.

Results

The database search yielded 951 results. After deduplication, abstract screening and full review, 13 articles met the inclusion criteria. Two predominant categories of intervention delivery methods were identified in this research: group-based interventions (educational sessions) and individual-based interventions (home visits).

Conclusion

This review highlights effective interventions for promoting the health and well-being of children under 5 experiencing homelessness, including educational sessions and home visits. Research has supported the importance of home visiting to be instrumental in breaking down language, cultural and health literacy barriers.
Evaluating the long-term impact of large-scale trainings: an exposure based cross-sectional study on female genital mutilation-related knowledge, attitudes and practices among Sudanese midwives in Khartoum State
Authors: Ahmed Wisal , Abdelrahim Mohammed , Gloyd Stephen , Farquhar Carey , Puttkammer Nancy
Published: January 2024

Objectives

To examine the long-term impact of large-scale training targeting midwives in a setting where they are the main female genital mutilation (FGM) practitioners. We hypothesised that trained midwives would have significantly higher knowledge, greater opposition to midwives’ involvement in this practice, and improved clinical practice in FGM prevention and care compared with non-trained midwives.

Design

We conducted an exposure based cross-sectional study, using closed-ended and open-ended questions during phone interviews.

Setting

Khartoum State in Sudan has a high prevalence of FGM (88%) mainly performed by midwives.

Participants

Midwives who received (n=127) and did not receive FGM training (n=55).

Primary and secondary outcome measures

We developed primary outcomes aligned to the three levels (reaction, learning and behaviour) of Kirkpatrick’s training evaluation model for descriptive and multivariable analyses in Stata.

Results

All the midwives interviewed were female, mostly village midwives (92%) and worked in health centres (89%). The mean age and midwifery experience was 51 years (SD=10) and 23 years (SD=12), respectively. Overall, most midwives (>90%) reported being supportive of FGM discontinuation. Midwives who had FGM training were more aware that performing FGM violates code of conduct (p=0.001) and reported to always counsel patients to abandon FGM (p<0.001) compared with midwives who did not report training. However, these associations were not statistically significant in multivariable logistic regression model adjusting for age. Exploratory analysis of training curricula showed higher knowledge, correct attitude and practices among those who reported in-service training before 2016.

Conclusion

Though past trainings were associated with higher knowledge and greater opposition to midwives’ involvement in FGM, this was not translated into appropriate corrective clinical procedures among affected women during labour. The Sudan Ministry of Health invested heavily in training midwives and it would be important to investigate why trained midwives do not implement recommended FGM-related clinical management.
Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact
Authors: LaRoche Jason Keith , Alvarenga Rodrigo , Collins Michael , Costelloe Thomas , De Soete Wouter , Faludi Jeremy , Rens Kristel
Published: January 2024

Objective

This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.

Design

Retrospective analysis.

Data source

Internal data held by Janssen Pharmaceuticals.

Studies included

Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021.

Main outcome

Measure CO2equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.

Results

The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions.

Conclusions

Decentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society’s transition towards electric vehicles may result in further reductions.

Trial registration number

NCT04208061.
Cohort profile: the National Congenital Anomaly Registration Dataset in England
Authors: Broughan Jennifer M. , Wreyford Ben , Martin Danielle , Melis Gabriella , Randall Kay , Obaro Ewoma , Broggio John , Aldridge Nicholas , Stoianova Sylvia , Johnson Chloe , Gibbard Donna , Stevens Sarah , Fleming Kate M
Published: January 2024

Purpose

The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), part of National Disease Registration Service in National Health Service England, quality assures, curates and analyses individual data on the pregnancies, fetuses, babies, children and adults with congenital anomalies and rare diseases across England. The congenital anomaly (CA) register provides a resource for patients and their families, clinicians, researchers and public health professionals in furthering the understanding of CAs.

Participants

NCARDRS registers CAs occurring in babies born alive and stillborn, fetal losses and terminations in England. NCARDRS collects data from secondary and tertiary healthcare providers, private providers and laboratories covering fetal medicine, maternity or paediatric services. Data describe the pregnancy, mother, baby and anomaly. Established in 2015, NCARDRS expanded CA registration coverage from 22% of total births in England in 2015 to national coverage, which was achieved in 2018. Prior to 2015, data collection was performed independently by regional registers in England; these data are also held by NCARDRS.

Findings to date

NCARDRS registers approximately 21 000 babies with CAs per year with surveillance covering around 600 000 total births, the largest birth coverage for a CA register globally. Data on prevalence, risk factors and survival for children with CAs are available. Data have been used in several peer-reviewed publications. Birth prevalence statistics, including public health indicators such as the association with maternal age, infant and perinatal mortality, are published annually. NCARDRS supports clinical audit for screening programmes and service evaluation.

Future plans

NCARDRS provides a valuable resource for the understanding of the epidemiology, surveillance, prevention and treatment of CAs. Currently, approximately 21 000 new registrations of babies or fetuses with suspected or confirmed CAs are added each year. Identifiers are collected, enabling linkage to routinely collected healthcare and population statistics, further enhancing the value of the data.
Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids
Authors: Al-Hendy Ayman , Segars James H , Taylor Hugh S , González Frank , Siblini Hiba , Zamah Musa , Alkelani Hiba , Singh Bhuchitra , Flores Valerie A , Christman Gregory M , Johnson Jeremy J , Huang Hao , Zhang Heping
Published: January 2024

Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.
Economic burden of adverse perinatal outcomes from births to age 5 years in high-income settings: a protocol for a systematic review
Authors: Haile Tsegaye Gebremedhin , Pereira Gavin , Norman Richard , Tessema Gizachew A
Published: January 2024

Background

Adverse perinatal outcomes such as preterm, small for gestational age, low birth weight, congenital anomalies, stillbirth and neonatal death have devastating impacts on individuals, families and societies, with significant lifelong health implications. Despite extensive knowledge of the significant and lifelong health implications of adverse perinatal outcomes, information on the economic burden is limited. Estimating this burden will be crucial for designing cost-effective interventions to reduce perinatal morbidity and mortality. Thus, we will quantify the economic burden of adverse perinatal outcomes from births to age 5 years in high-income countries.

Methods and analysis

A systematic review of all primary studies published in English in peer-reviewed journals on the economic burden for at least one of the adverse perinatal outcomes in high-income countries from 2010 will be searched in databases—MEDLINE (Ovid), EconLit, CINAHL (EBSCO), Embase (Ovid) and Global Health (Ovid). We will also search using Google Scholar and snowballing of the references list of included articles. The search terms will include three main concepts—costs, adverse perinatal outcome(s) and settings. We will use the Consolidated Health Economics Evaluation Reporting Standards 2022 and 17 criteria from the critical appraisal of cost-of-illness studies to assess the quality of each study. We will report the findings based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 statement. Costs will be converted into a common currency (US dollar), and we will estimate the pooled cost and subgroup analysis will be done. The reference lists of included papers will be reviewed.

Ethics and dissemination

This systematic review will not involve human participants and requires no ethical approval. The results of this review will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42023400215.
Effect of methylene blue on outcomes in patients with distributive shock: a meta-analysis of randomised controlled trials
Authors: Huang Xinhui , Yan Wenqing , Chen Zhi , Qian Yihong
Published: January 2024

Objective

This meta-analysis aimed to demonstrate the effect of methylene blue (MB) in patients with distributive shock.

Design

Meta-analysis.

Methods

According to the Prospective International Register of Systematic Reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the relevant randomised controlled trials (RCTs) via PubMed, Embase and Cochrane Library from the date of database inception to 19 April 2023. The primary outcome was mortality during follow-up, and secondary outcomes included mean arterial pressure (mm Hg), mechanical ventilation time (hours), intensive care unit (ICU) length of stay (LOS) (days), hospital LOS (days) and heart rate (times/min).

Results

This study included six RCTs with 265 participants. The study showed no significant difference in mortality between the MB and placebo groups (ORs: 0.59; 95% CI 0.32 to −1.06). However, MB reduced the duration of mechanical ventilation (mean difference (MD): −0.68; 95% CI −1.23 to −0.14), ICU LOS (MD: −1.54; 95% CI −2.61 to −0.48) and hospital LOS (MD: −1.97; 95% CI −3.92 to −0.11).

Conclusions

The use of MB may not reduce mortality in patients with distributive shock, but may shorten the duration of mechanical ventilation, ICU LOS and hospital LOS. More clinical studies are needed to confirm these findings in the future.

Trial registration number

CRD42023415938.
Factors influencing implementation and sustainability of interventions to improve oral health and related health behaviours in adults experiencing severe and multiple disadvantage: a mixed-methods systematic review
Authors: John Deepti A , Adams Emma A , McGowan Laura J , Joyes Emma C , Richmond Catherine , Beyer Fiona R , Landes David , Watt Richard G , Sniehotta Falko F , Paisi Martha , Bambra Clare , Craig Dawn , Kaner Eileen , Ramsay Sheena E
Published: January 2024

Objectives

Among people experiencing severe and multiple disadvantage (SMD), poor oral health is common and linked to smoking, substance use and high sugar intake. Studies have explored interventions addressing oral health and related behaviours; however, factors related to the implementation of these interventions remain unclear. This mixed-methods systematic review aimed to synthesise evidence on the implementation and sustainability of interventions to improve oral health and related health behaviours among adults experiencing SMD.

Methods

Bibliographic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, EBSCO, Scopus) and grey literature were searched from inception to February 2023. Studies meeting the inclusion criteria were screened and extracted independently by two researchers. Quality appraisal was undertaken, and results were synthesised using narrative and thematic analyses.

Results

Seventeen papers were included (published between 1995 and 2022). Studies were mostly of moderate quality and included views from SMD groups and service providers. From the qualitative synthesis, most findings were related to aspects such as trust, resources and motivation levels of SMD groups and service providers. None of the studies reported on diet and none included repeated offending (one of the aspects of SMD). From the quantitative synthesis, no difference was observed in programme attendance between the interventions and usual care, although there was some indication of sustained improvements in participation in the intervention group.

Conclusion

This review provides some evidence that trust, adequate resources and motivation levels are potentially important in implementing interventions to improve oral health and substance use among SMD groups. Further research is needed from high quality studies and focusing on diet in this population.

PROSPERO registration number

CRD42020202416.
Cross-sectional survey of sexual health professionals’ experiences and perceptions of the 2022 mpox outbreak in the UK
Authors: Hayes Rosalie , Dakin Francesca , Smuk Melanie , Paparini Sara , Apea Vanessa , Dewsnap Claire , Waters L , Anderson Jane , Orkin Chloe M
Published: January 2024

Objective

To understand the experiences and perceptions of sexual health professionals responding to the May 2022 mpox outbreak in the UK.

Design

Cross-sectional, anonymous, online survey collecting quantitative and qualitative data. Convenience sample recruited via an international network of sexual health and HIV clinicians responding to mpox and promoted through clinical associations and social media. Survey domains included: clinical workload; preparedness, support, and training; safety at work; vaccination; and well-being. Qualitative descriptive analysis of open-text responses was conducted to support interpretation of the quantitative data.

Participants

Participants who were employed as sexual health professionals in the UK and had direct clinical experience of mpox were included in the analysis. The survey was completed between 11 August and 31 October 2022 by 139 respondents, the majority of whom were doctors (72.7%), cis-female (70.5%) and White (78.4%).

Results

70.3% reported that they were required to respond to mpox in addition to their existing clinical responsibilities, with 46.8% working longer hours as a result. In the open-text data, respondents highlighted that workload pressures were exacerbated by a lack of additional funding for mpox, pre-existing pressures on sexual health services, and unrealistic expectations around capacity. 67.6% of respondents reported experiencing negative emotional impact due to their mpox work, with stress (59.0%), fatigue (43.2%) and anxiety (36.0%) being the most common symptoms. 35.8% stated that they were less likely to remain in their profession because of their experiences during the mpox outbreak. In the open-text data, these feelings were ascribed to post-COVID exhaustion, understaffing and frustration among some participants at the handling of the mpox response.

Conclusions

These findings indicate that sexual health services require increased funding and resources, along with evidence-based well-being interventions, to support sexual health professionals’ outbreak preparedness and recovery.
Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide
Authors: Chen Yang , Shah Anoop , Jani Yogini , Higgins Daniel , Saleem Nausheen , Chafer Kris , Sydes Matthew Robert , Asselbergs Folkert W , Lumbers R Thomas
Published: January 2024

Introduction

Acute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct to pharmacological therapy with loop diuretics, but there is a lack of evidence from traditional randomised controlled trials (RCTs) to support the safety and effectiveness of this intervention in the acute setting.

This study aims to explore the feasibility of using computer alerts within the electronic health record (EHR) system to invite clinical care teams to enrol patients into a pragmatic RCT at the time of clinical decision-making. It will additionally assess the effectiveness of using an alert to help address the clinical research question of whether oral fluid restriction is a safe and effective adjunct to pharmacological therapy for patients admitted with fluid overload.

Methods and analysis

THIRST (Randomised ControlledTrial within the electronicHealth record of anInterruptive alert displaying a fluidRestrictionSuggestion in patients with the treatableTrait of congestion) Alert is a single-centre, parallel-group, open-label pragmatic RCT embedded in the EHR system that will be conducted as a feasibility study at an National Health Service (NHS) hospital in London. The clinical care team will be invited to enrol suitable patients in the study using a point-of-care alert with a target sample size of 50 patients. Enrolled patients will then be randomised to either restricted or unrestricted oral fluid intake. Two primary outcomes will be explored (1) the proportion of eligible patients enrolled in the study and (2) the mean difference in oral fluid intake between randomised groups. A series of secondary outcomes are specified to evaluate the effectiveness of the alert, adherence to the randomised treatment allocation and the quality of data generated from routine care, relevant to the outcomes of interest.

Ethics and dissemination

This study was approved by Riverside Research Ethics Committee (Ref: 22/LO/0889) and will be published on completion.

Trial registration number

NCT05869656.
Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years: CONSIDERING-AF study design
Authors: Etminani Farzaneh , Sandgren Emma , Holm Johan , Magnusson Peter , Modica Angelo , Moberg Karin , Davidsson Thomas , Stalpe Linda , Kiflemariam Sara , Younan Ninia , Parikh Purvee , Wadhwa Manish , Sundin Anna , Engdahl Johan
Published: January 2024

Introduction

Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.

Methods and analysis

CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.

Ethics and dissemination

This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.

Trial registration number

NCT05838781.
Eyecare practitioner perspectives and attitudes towards myopia and myopia management in the UK
Authors: Coverdale Sophie , Rountree Lindsay , Webber Kathryn , Cufflin Matthew , Mallen Edward , Alderson Alison , Ghorbani-Mojarrad Neema
Published: January 2024

Objective

Many children with progressive myopia are still prescribed single-vision correction. An investigation into UK eyecare practitioners’ (ECPs) perceptions of myopia management was carried out to ascertain factors which may be limiting its implementation and uptake within clinical practice.

Methods and analysis

Online focus groups were held with UK ECPs. Participants were encouraged to discuss their knowledge of the available myopia management options, their perception of how myopia management is being delivered in the UK and any barriers limiting ECPs' prescribing of these management options in practice. The discussions were transcribed and analysed thematically.

Results

Focus groups were held with 41 ECPs from primary and secondary eyecare. ECPs felt that provision of myopia management in the UK is variable. Most ECPs believe they have sufficient knowledge, but felt a lack of confidence in decision-making and practical experience. Less experienced ECPs sought more definitive guidance to support their decision-making. ECPs desired clarity on their duty of care obligations and were concerned over possible future litigation if they had not offered, or referred for, myopia management when indicated. The greatest barrier appears to be financial—treatment is expensive and ECPs are uncomfortable communicating this to parents. Many barriers were indicative of systemic problems within UK eyecare, such as commercial pressures, inadequate National Health Service funding and poor public awareness of paediatric eyecare.

Conclusion

Myopia management is not implemented consistently across the UK. To improve accessibility, changes are required at multiple levels, from individual ECPs through to wider stakeholders in UK eyecare provision.
RCAd-LTH-shPD-L1, a double-gene recombinant oncolytic adenovirus with enhanced antitumor immunity, increases lymphocyte infiltration and reshapes the tumor microenvironment
Authors: Meng Yuan , Liu Haotian , Zhu Haoran , Zhang Wanrong , Sun Dong , Han Xuefei , Liu Ying , Luo Guangzuo
Published: January 2024

Background

With the successful development of modern immunotherapy, immune checkpoint inhibitors (ICIs) are currently considered potential therapeutic options for patients with cancer. However, the therapeutic potential of ICIs in human cancer is mainly limited by their systemic toxicity and low response rate, which suggests the necessity of local drug delivery with an effective vector and reshaping the immunosuppressive tumor microenvironment (TME) to enhance ICI therapy. Here, we constructed a novel double-gene recombinant oncolytic adenovirus named RCAd-LTH-shPD-L1 based on the RCAd virus platform armed with a DNA fragment encoding an anti-VEGF antibody and shRNA to inhibit PD-L1 expression.

Methods

The correct assembly of RCAd-LTH-shPD-L1 was characterized by analyzing its secretion, antigen specificity, and replication using western blotting, ELISA and quantitative PCR, respectively. The in vitro effects of RCAd-LTH-shPD-L1 on cell proliferation, vasculogenic, and cell migration were assessed. Antitumor effects and therapeutic mechanisms were evaluated in vivo using immunodeficient and humanized immune system mouse models. The TME was studied by ELISA, immunohistochemistry and flow cytometry.

Results

RCAd-LTH-shPD-L1 cells secreted anti-VEGF antibodies and inhibited the expression of PD-L1 in cancer cells. Moreover, RCAd-LTH-shPD-L1 exerted a specific cytotoxic effect on human cancer cells, but not on murine cancer cells or normal human cells. RCAd-LTH-shPD-L1 elicited a more potent antitumor effect in an immunodeficient mouse model and a humanized immune system mouse model than RCAd-shPD-L1, as demonstrated by the significant decrease in tumor growth. Furthermore, RCAd-LTH-shPD-L1 modulated the TME, which led to lymphocyte infiltration and alteration of their immune phenotype, as characterized by downregulation of anoxic factor HIF-1α and angiogenesis marker CD31, upregulation of cytokine such as IFN-γ, IL-6 and IL-12.

Conclusions

In summary, our data demonstrated that the localized delivery of anti-VEGF antibodies and shPD-L1 by engineered RCAd-LTH-shPD-L1 is a highly effective and safe strategy for cancer immunotherapy. Moreover, the data underscore the potential of combining local virotherapy and anti-angiogenic therapy with ICIs as an effective TME therapy for poorly infiltrating tumors.
Experience of patients considering or using checkpoint inhibitors in cancer treatment: a systematic review of qualitative research
Authors: Yip Raphael , Arnolda Gaston , Lamprell Klay , Nic Giolla Easpaig Bróna , Chittajallu Renuka , Delaney Geoff , Olver Ian , Liauw Winston , Braithwaite Jeffrey
Published: January 2024

Increasing numbers of patients with cancer are considering or undergoing immunotherapy, however, little is known about patients’ perspectives on this treatment. We undertook a systematic review for use by clinicians and researchers, consolidating published qualitative research studies on patient experience of checkpoint inhibitor therapy. A search of Medline, Embase, and PsycINFO was carried out for publications in English to 30 June 2022. Publications were selected if they reported a qualitative study of patient experience with checkpoint inhibitor therapy for cancer, either by patients or their families or carers. Quality was appraised using the Johanna Briggs Institute quality assessment tool for qualitative studies. A thematic synthesis was conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses standard was followed. We identified 17 eligible studies published between 2017 and 2022, 9 using mixed methods, and 8 solely using qualitative methods. Most studies reported on the experiences of patients with advanced stage melanoma and were using the earliest approved checkpoint inhibitors for cancer therapy. Studies met most formal quality criteria but varied in the extent of their qualitative explorations of data; some mixed methods studies had limited reporting of qualitative results. Through thematic synthesis, we categorized study findings into four domains: (1) treatment decision-making; (2) success with immunotherapy; (3) treatment-related adverse events (AEs); and (4) quality of life on immunotherapy. Our review identified several areas with potential for improving the care system. These include, for example: routinely linking patients to peers who have experienced this therapy; improving the capacity of patients and carers to identify and report AEs faster; and supporting patients and carers to live with changed circumstances after successful treatment. Most studies focused on patients who had successful treatment, effectively excluding those who do not respond or who discontinue due to serious side effects; future research targets are suggested.
Intratumoral administration of the immunologic adjuvant AS01Bin combination with autologous CD1c (BDCA-1)+/CD141 (BDCA-3)+myeloid dendritic cells plus ipilimumab and intravenous nivolumab in patients with refractory advanced melanoma
Authors: Tijtgat Jens , Geeraerts Xenia , Boisson Anais , Stevens Latoya , Vounckx Manon , Dirven Iris , Schwarze Julia Katharina , Raeymaeckers Steven , Forsyth Ramses , Van Riet Ivan , Tuyaerts Sandra , Willard-Gallo Karen , Neyns Bart
Published: January 2024

Background

Patients with advanced melanoma who progress after treatment with immune checkpoint-inhibitors (ICI) and BRAF-/MEK-inhibitors (ifBRAFV600mutated) have no remaining effective treatment options. The presence of CD1c (BDCA-1)+and CD141 (BDCA-3)+myeloid dendritic cells (myDC) in the tumor microenvironment correlates with pre-existing immune recognition and responsiveness to immune checkpoint blockade. The synthetic saponin-based immune adjuvant AS01Benhances adaptive immunity through the involvement of myDC.

Methods

In this first-in-human phase I clinical trial, patients with metastatic melanoma refractory to ICI and BRAF-/MEK inhibitors (when indicated) were recruited. Patients received an intravenous administration of low-dose nivolumab (10 mg, every 2 weeks) plus an intratumoral (IT) administration of 10 mg ipilimumab and 50 µg (0.5 mL) AS01B(every 2 weeks). All myDC, isolated from blood, were injected on day 2 into the same metastatic lesion. Tumor biopsies and blood samples were collected at baseline and repeatedly on treatment. Multiplex immunohistochemistry (mIHC) was performed on biopsy sections to characterize and quantify the IT and peritumoral immune cell composition.

Results

Study treatment was feasible and well tolerated without the occurrence of unexpected adverse events in all eight patients. Four patients (50%) obtained a complete response (CR) in the injected lesions. Of these, two patients obtained an overall CR, and one patient a partial response. All responses are ongoing after more than 1 year of follow-up. One additional patient had a stable disease as best response. The disease control rate was 50%. Median progression-free survival and overall survival were 24.1 and 41.9 weeks, respectively. Baseline tumor biopsies from patients who responded to treatment had features of T-cell exclusion. During treatment, there was an increased T-cell infiltration, with a reduced mean distance between T cells and tumor cells. Peripheral blood immune cell composition did not significantly change during study treatment.

Conclusions

Combining an intratumoral injection of CD1c (BDCA-1)+and CD141 (BDCA-3)+myDC with repeated IT administration of ipilimumab and AS01Band systemic low-dose nivolumab is safe, feasible with promising early results, worthy of further clinical investigation.

Trial registration number

ClinicalTrials.gov identifierNCT03707808.