bluuebunny/crossref_metadata_2025 huggingface dataset:
Risks and benefits of urinary catheterisation during inpatient diuretic therapy for acute heart failure: a retrospective, non-inferiority, cohort study
Authors: John Gregor , Arcens Marc , Berra Gregory , Garin Nicolas , Carballo David , Carballo Sebastian , Stirnemann Jerome
Published: August 2022

Objectives

Patients with acute congestive heart failure (HF) regularly undergo urinary catheterisation (UC) at hospital admission. We hypothesised that UC has no clinical benefits with regard to weight loss during inpatient diuretic therapy for acute congestive HF and increases the risk of urinary tract infection (UTI).

Design

Retrospective, non-inferiority study.

Setting

Geneva University Hospitals’ Department of Medicine, a tertiary centre.

Participants

In a cohort of HF patients, those catheterised within 24 hours of diuretic therapy (n=113) were compared with non-catheterised patients (n=346).

Primary and secondary outcome measures

The primary endpoint was weight loss 48 hours after starting diuretic therapy. Secondary endpoints were time needed to reach target weight, discontinuation of intravenous diuretics and resolution of respiratory failure. Complications included the time to a first UTI, first hospital readmission and death.

Results

A total of 48-hour weight loss was not statistically different between groups and the adjusted difference was below the non-inferiority boundary of 1 kg (0.43 kg (95% CI: −0.03 to 0.88) in favour of UC, p<0.01 for non-inferiority). UC was not associated with time to reaching target weight (adjusted HR 1.0; 95% CI: 0.7 to 1.5), discontinuation of intravenous diuretics (aHR 0.9; 95% CI: 0.7 to 1.2) or resolution of respiratory failure (aHR 1.1; 95% CI: 0.5 to 2.4). UC increased the risk of UTI (aHR 2.5; 95% CI: 1.5 to 4.2) but was not associated with hospital readmission (aHR 1.1; 95% CI: 0.8 to 1.4) or 1-year mortality (aHR 1.4; 95% CI: 1.0 to 2.1).

Conclusion

In this retrospective study, with no obvious hourly diuresis-based diuretic adjustment strategy, weight loss without UC was not inferior to weight loss after UC within 24 hours of initiating diuretic treatment. UC had no impact on clinical improvement and increased the risk of UTI. This evidence, therefore, argues against the systematic use of UC during a diuretic therapy for HF.
Diabetes among adults in Bangladesh: changes in prevalence and risk factors between two cross-sectional surveys
Authors: Chowdhury Muhammad Abdul Baker , Islam Mirajul , Rahman Jakia , Uddin Md Jamal , Haque Md. Rabiul
Published: August 2022

Objective/research question

To investigate the change in the prevalence and risk factors of diabetes among adults in Bangladesh between 2011 and 2018.

Design

The study used two waves of nationally representative cross-sectional data extracted from the Bangladesh Demographic and Health Surveys in 2011 and 2017–2018.

Setting

Bangladesh.

Participants

14 376 adults aged ≥35 years.

Primary outcome

Diabetes mellitus (type 2 diabetes).

Results

From 2011 to 2018, the diabetes prevalence among adults aged ≥35 years increased from 10.95% (880) to 13.75% (922) (p<0.001), with the largest-relative increase (90%) among obese individuals. Multivariable logistic regression analysis identified age and body mass index (BMI) were the key risk factors for diabetes. Adults who were overweight or obese were 1.54 times (adjusted OR (AOR): 1.54, 95% CI: 1.20 to 1.97) more likely to develop diabetes than normal-weight individuals in 2011, and 1.22 times (AOR: 1.22, 95% CI: 1.00 to 1.50) and 1.44 times (AOR: 1.44, 95% CI: 1.13 to 1.84) more prone to develop diabetes in 2018. Other significant risk factors for diabetes were marital status, education, geographical region, wealth index and hypertension status in both survey years.

Conclusion

A high prevalence of diabetes was observed and it has been steadily increasing over time. To enhance diabetes detection and prevention among adults in Bangladesh, population-level interventions focusing on health education, including a healthy diet and lifestyle, are required.
Risk for neonatal hypoglycaemia and bradycardia after beta-blocker use during pregnancy or lactation: a systematic review and meta-analysis protocol
Authors: de Bruin Rosalie , van Dalen Sarah L , Franx Shamaya J , Simons Sinno HP , Flint Robert B , van den Bosch Gerbrich E
Published: August 2022

Introduction

Beta-blockers are often used during pregnancy to treat diseases such as pre-existing hypertension, arrhythmias or pregnancy-related hypertension. Since beta-blockers are able to cross the placenta and can pass into breast milk, they could potentially harm the neonate. Known potential neonatal side effects of maternal beta-blocker use are hypoglycaemia and bradycardia. This systematic review and meta-analysis aims to investigate the risk for neonatal hypoglycaemia and bradycardia after exposure to beta-blockers in utero or through lactation.

Methods and analysis

We will conduct a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic electronic search will be conducted using EMBASE, Medline, Cochrane Central Register of Trials and Web of Science from initiation to April 2021. Our primary outcome will be the risk for hypoglycaemia or bradycardia in neonates exposed to beta-blockers in utero or through lactation in comparison with unexposed neonates. All articles will be screened by title and abstract twice by different independent review authors. Next, standardised methodological quality assessment will be conducted for each included article and finally a meta-analysis will be performed.

Ethics and dissemination

Ethical approval is not required. The results of this study will help to assess the need for postnatal glucose and heart rate monitoring of the neonate after maternal beta-blocker exposure. Our findings will be communicated to the target audience through peer-reviewed publication.

PROSPERO registration number

CRD42021264269.
Models of comprehensive care for older persons with chronic diseases: a systematic review with a focus on effectiveness
Authors: Barajas-Nava Leticia A , Garduño-Espinosa Juan , Mireles Dorantes Juan M , Medina-Campos Raúl , García-Peña M Carmen
Published: August 2022

Introduction

Ageing entails a variety of physiological changes that increase the risk of chronic non-communicable diseases. The prevalence of these diseases leads to an increase in the use of health services. The care models implemented by health systems should provide comprehensive long-term healthcare. We conducted this systematic review to determine whether any model of care for older persons have proven to be effective.

Methods

A systematic review of literature was carried out to identify randomised clinical trials that have assessed how effective a care model for older patients with chronic diseases. A searches electronic databases such as MEDLINE, Turning Research Into Practice Database, Cochrane Library and Cochrane Central Register of controlled Trials was conducted from January 1966 to January 2021. Two independent reviewers assessed the eligibility of the studies. Interventions were identified and classified according to the taxonomies developed by the Cochrane Effective Practice and Organisation of Care and Cochrane Consumers and Communication groups.

Results

Of the 4952 bibliographic references that were screened, 577 were potentially eligible and the final sample included 25 studies that evaluated healthcare models in older people with chronic diseases. In the 25 care models, the most frequently implemented interventions were educational, and those based on the provision of healthcare. Only 22% of the outcomes of interventions were identified as being effective, whereas 21% were identified as being partially effective; thus, more than 50% of the outcomes were identified as being ineffective.

Conclusions

It was not possible to determine a care model as effective. The interventions implemented in the models are variable. The most effective outcomes were focused on improving the patient–healthcare professional relationship in the early stages of the intervention. The interventions addressed in the studies were similar to public health interventions as their main objectives focused on promoting health. Most studies were of low methodological quality.
Association between transoesophageal echocardiography monitoring indicators and the incidence of postoperative acute kidney injury in coronary artery bypass grafting: a study protocol for a prospective multicenter cohort study
Authors: Liu Binghua , Lv Meng , Wang Haiyan , Sun Yongtao , Song Xiumei , Dong Ling , Feng Hai , Wang Yuelan
Published: August 2022

Introduction

Previous studies on transoesophageal echocardiography in coronary artery bypass grafting mainly focused on whether to change the surgical plan rather than improve the clinical prognosis. Currently, there are sparse studies on the relationship between transoesophageal echocardiography indicators and the prognosis of patients undergoing coronary artery bypass grafting. The primary aim of this study is to explore the association between transoesophageal echocardiography monitoring indicators the respiratory variability of inferior vena cava diameter, tricuspid annular plane systolic excursion and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Methods and analysis

We designed this prospective multicenter cohort study, which included approximately 150 adult patients (≥18 years) undergoing elective coronary artery bypass surgery. Different hospitals will be assessed to obtain information on the prevalence, risk factors, management strategies and outcomes in coronary artery bypass surgery. The cohort will be followed after the coronary artery bypass surgery period, up to 30 days after enrolment. The incidence of postoperative acute kidney injury and baseline data will be presented by descriptive statistics. We will use Freidman inspection and multivariable logistic regression to assess the association between transoesophageal echocardiography monitoring indicators and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Ethics and dissemination

The study has been approved by the ethics committee of Shandong Provincial Qianfoshan Hospital, China (approval number: YXLL-KY-2021(067)). This is an observational study that poses no risk to the patients. All participants will obtain informed consent according to the ethics committee before patient enrolment. Funding sources will have no influence on data handling, analyses or writing of the manuscript. The article is planned for submission in an international peer-reviewed journal.

Trial registration number

NCT05139108.
Global impact of COVID-19 on surgeons and team members (GlobalCOST): a cross-sectional study
Authors: Jaffry Zahra , Raj Siddarth , Sallam Asser , Lyman Stephen , Negida Ahmed , Yiu Chi Fung Antony , Sobti Anshul , Bua Nelson , Field Richard E , Abdalla Hassan , Hammad Rawad , Qazi Nadeem , Singh Bijayendra , Brennan Peter A , Hussein Amr , Narvani Ali , Jones Adrian , Imam Mohamed A
Published: August 2022

Objectives

To investigate the impact of COVID-19 on the well-being of surgeons and allied health professionals as well as the support provided by their institutions.

Design

This cross-sectional study involved distributing an online survey through medical organisations, social media platforms and collaborators.

Setting

It included all staff based in an operating theatre environment around the world.

Participants

1590 complete responses were received from 54 countries between 15 July and 15 December 2020. The average age of participants was 30–40 years old, 64.9% were men and 32.5% of a white ethnic background. 79.5% were surgeons with the remainder being nurses, assistants, anaesthetists, operating department practitioners or classified other.

Main outcome measures

Participants that had experienced any physical illness, changes in mental health, salary or time with family since the start of the pandemic as well as support available based on published recommendations.

Results

32.0% reported becoming physically ill. This was more likely in those with reduced access to personal protective equipment (OR 4.62; CI 2.82 to 7.56; p<0.001) and regular breaks (OR 1.56; CI 1.18 to 2.06; p=0.002). Those with a decrease in salary (29.0%) were more likely to have an increase in anxiety (OR 1.50; CI 1.19 to 1.89; p=0.001) and depression (OR 1.84; CI 1.40 to 2.43; p<0.001) and those who spent less time with family (35.2%) were more likely to have an increase in depression (OR 1.74; CI 1.34 to 2.26; p<0.001). Only 36.0% had easy access to occupational health, 44.0% to mental health services, 16.5% to 24/7 rest facilities and 14.2% to 24/7 food and drink facilities. Fewer measures were available in countries with a low Human Development Index.

Conclusions

This work has highlighted a need and strategies to improve conditions for the healthcare workforce, ultimately benefiting patient care.
Testing the efficacy of a motor analogy designed to promote safe landing by older adults who fall accidentally: a study protocol for a randomised control study
Authors: Oladi Sana , Uiga Liis , Hebert-Losier Kim , Masters Rich S W
Published: August 2022

Introduction

Falling is associated with adverse effects on the health of older people. The majority of research into falls among older people has focused on prevention, with less attention to ‘how to fall safely’. Previous research suggests that motor analogies can be used to promote safe landing by young adults; however, the efficacy of this technique for older people remains unknown. This study aims to determine whether a motor analogy is useful for promoting safe falling in the older adult population.

Methods and analysis

The study adopts a randomised, controlled, single-blinded study design. People 65 years and older will be randomly allocated to a control condition or a motor analogy condition. They will receive a nudge in a forward, backward or sideways direction (randomised order), which will initiate a fall. The nudge will occur at variable (randomised) time points, so participants will not be aware of when they will fall. Participants in the motor analogy condition will be instructed to ‘land like a feather’, whereas participants in the control condition will be instructed to ‘land safely’. The primary outcome parameters are maximum impact force (normalised by mass) applied to different body segments during impact and fracture risk ratio of wrists and hips. A two-way multivariate analysis of variance will be conducted to examine differences between the motor analogy and control conditions as a function of the different variables.

Ethics and dissemination

The University of Waikato Human Research Ethics Committee (Health 2021#45) has granted ethical approval. Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12621001189819. Registered on 6 September 2021.
Moral distress among clinicians working in US safety net practices during the COVID-19 pandemic: a mixed methods study
Authors: Pathman Donald E , Sonis Jeffrey , Rauner Thomas E , Alton Kristina , Headlee Anna S , Harrison Jerry N
Published: August 2022

Objective

To explore the causes and levels of moral distress experienced by clinicians caring for the low-income patients of safety net practices in the USA during the COVID-19 pandemic.

Design

Cross-sectional survey in late 2020, employing quantitative and qualitative analyses.

Setting

Safety net practices in 20 US states.

Participants

2073 survey respondents (45.8% response rate) in primary care, dental and behavioural health disciplines working in safety net practices and participating in state and national education loan repayment programmes.

Measures

Ordinally scaled degree of moral distress experienced during the pandemic, and open-ended response descriptions of issues that caused most moral distress.

Results

Weighted to reflect all surveyed clinicians, 28.4% reported no moral distress related to work during the pandemic, 44.8% reported ‘mild’ or ‘uncomfortable’ levels and 26.8% characterised their moral distress as ‘distressing’, ‘intense’ or ‘worst possible’. The most frequently described types of morally distressing issues encountered were patients not being able to receive the best or needed care, and patients and staff risking infection in the office. Abuse of clinic staff, suffering of patients, suffering of staff and inequities for patients were also morally distressing, as were politics, inequities and injustices within the community. Clinicians who reported instances of inequities for patients and communities and the abuse of staff were more likely to report higher levels of moral distress.

Conclusions

During the pandemic’s first 9 months, moral distress was common among these clinicians working in US safety net practices. But for only one-quarter was this significantly distressing. As reported for hospital-based clinicians during the pandemic, this study’s clinicians in safety net practices were often morally distressed by being unable to provide optimal care to patients. New to the literature is clinicians’ moral distress from witnessing inequities and other injustices for their patients and communities.
Camrelizumab in patients with advanced non-squamous non-small cell lung cancer: a cost-effective analysis in China
Authors: Xie Qian , Zheng Hanrui , Su Na , Li Qiu
Published: August 2022

Objective

Camrelizumab is a selective, humanised, high-affinity IgG4 kappa monoclonal antibody against programmed cell death 1 that shows effective antitumour activity with acceptable toxicity in multiple tumour types. The CameL trial demonstrated that camrelizumab plus chemotherapy (CC) significantly prolonged the median progression-free survival and median overall survival versus chemotherapy alone (CA) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Our study was conducted to investigate the cost-effectiveness of the two strategies in chemotherapy-naive patients with advanced non-squamous NSCLC.

Design, setting and participants

A Markov simulation model was generated based on the CameL trial. The two simulated treatments included CC and CA.

Primary and secondary outcome measures

Utility was derived from published literature, and costs were calculated based on those at our hospital in Chengdu, China. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the cost-effectiveness of the two treatment arms.

Results

In the overall population, the total costs were $27 223.40 and $13 740.10 for CC and CA treatment, respectively. The CC treatment produced 1.37 quality-adjusted life years (QALYs), and the CA treatment produced 1.17 QALYs. Hence, patients who were in the CC group spent an additional $13 483.30 and generated an increase of 0.20 QALYs, resulting in an ICER of $67 416.50 per QALY.

Conclusions

For chemotherapy-naive patients with advanced non-squamous NSCLC, CC is not considered a cost-effective treatment versus CA in China when considering a willingness-to-pay threshold of $31 500 per QALY.

Trial registration number

NCT03134872
How can equitable video visit access be delivered in primary care? A qualitative study among rural primary care teams and patients
Authors: Goldstein Karen M , Perry Kathleen R , Lewinski Allison , Walsh Conor , Shepherd-Banigan Megan E , Bosworth Hayden B , Weidenbacher Hollis , Blalock Dan V , Zullig Leah L
Published: August 2022

Objective

The COVID-19 pandemic sparked exponential growth in video visit use in primary care. The rapid shift to virtual from in-person care exacerbated digital access disparities across racial groups and rural populations. Moving forward, it is critical to understand when and how to incorporate video visits equitably into primary care. We sought to develop a novel clinical algorithm to guide primary care clinics on how and when to employ video visits as part of care delivery.

Design

Qualitative data collection: one team member conducted all patient semistructured interviews and led all focus groups with four other team members taking notes during groups.

Setting

3 rural primary care clinics in the USA.

Participants

24 black veterans living in rural areas and three primary care teams caring for black veterans living in rural areas.

Primary and secondary outcome measures

Findings from semistructured interviews with patients and focus groups with primary care teams.

Results

Key issues around appropriate use of video visits for clinical teams included having adequate technical support, encouraging engagement during video visits and using video visits for appropriate clinical situations. Patients reported challenges with broadband access, inadequate equipment, concerns about the quality of video care, the importance of visit modality choice, and preferences for in-person care experience over virtual care. We developed an algorithm that requires input from both patients and their care team to assess fit for each clinical encounter.

Conclusions

Informed matching of patients and clinical situations to the right visit modality, along with individual patient technology support could reduce virtual access disparities.
Severe COVID-19 outcomes among patients with autoimmune rheumatic diseases or transplantation: a population-based matched cohort study
Authors: Marozoff Shelby , Lu Na , Loree Jonathan M , Xie Hui , Lacaille Diane , Kopec Jacek A , Esdaile John , Aviña-Zubieta J Antonio
Published: August 2022

Objectives

To assess the risk of severe COVID-19 outcomes in patients with autoimmune rheumatic diseases (ARDs) and transplant recipients compared with matched general population comparators.

Design

Population-based matched cohort study using administrative health data sets.

Setting

British Columbia, Canada.

Participants

All adults with test-positive SARS-CoV-2 infections. SARS-CoV-2-positive patients with ARDs and those with transplantation were matched to SARS-CoV-2-positive general population comparators on age (±5 years), sex, month/year of initial positive SARS-CoV-2 test and health authority.

Outcome measures

COVID-19-related hospitalisations, intensive care unit (ICU) admissions, invasive ventilation and COVID-19-specific mortality. We performed multivariable conditional logistic regression models adjusting for socioeconomic status, Charlson Comorbidity Index, hypertension, rural address and number of previous COVID-19 PCR tests.

Results

Among 6279 patients with ARDs and 222 transplant recipients, all SARS-CoV-2 test positive, risk of hospitalisation was significantly increased among patients with ARDs (overall ARDs (adjusted OR (aOR) 1.30; 95% CI 1.19 to 1.43)); highest within ARDs: adult systemic vasculitides (aOR 2.18; 95% CI 1.17 to 4.05) and transplantation (aOR 10.56; 95% CI 6.88 to 16.22). Odds of ICU admission were significantly increased among patients with ARDs (overall ARDs (aOR 1.30; 95% CI 1.11 to 1.51)); highest within ARDs: ankylosing spondylitis (aOR 2.03; 95% CI 1.18 to 3.50) and transplantation (aOR 8.13; 95% CI 4.76 to 13.91). Odds of invasive ventilation were significantly increased among patients with ARDs (overall ARDs (aOR 1.60; 95% CI 1.27 to 2.01)); highest within ARDs: ankylosing spondylitis (aOR 2.63; 95% CI 1.14 to 6.06) and transplantation (aOR 8.64; 95% CI 3.81 to 19.61). Risk of COVID-19-specific mortality was increased among patients with ARDs (overall ARDs (aOR 1.24; 95% CI 1.05 to 1.47)); highest within ARDs: ankylosing spondylitis (aOR 2.15; 95% CI 1.02 to 4.55) and transplantation (aOR 5.48; 95% CI 2.82 to 10.63).

Conclusions

The risk of severe COVID-19 outcomes is increased in certain patient groups with ARDs or transplantation, although the magnitude differs across individual diseases. Strategies to mitigate risk, such as booster vaccination, prompt diagnosis and early intervention with available therapies, should be prioritised in these groups according to risk.
Feasibility and safety of combining repetitive transcranial magnetic stimulation and quadriceps strengthening exercise for chronic pain in knee osteoarthritis: a study protocol for a pilot randomised controlled trial
Authors: Chang Wei-Ju , Adie Sam , Naylor Justine M , Chowdhury Nahian , Finn Harrison , Rizzo Rodrigo R N , O’Hagan Edel , Schabrun Siobhan M
Published: August 2022

Introduction

Knee osteoarthritis is a leading cause of disability, resulting in pain and reduced quality of life. Exercise is the cornerstone of conservative management but effects are, at best, moderate. Early evidence suggests that repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) may improve the effect of exercise in knee osteoarthritis. This pilot study aims to (1) determine the feasibility, safety and participant-rated response to an intervention adding M1 rTMS to exercise in knee osteoarthritis; (2) elucidate physiological mechanisms in response to the intervention; (3) provide data to conduct a sample size calculation for a fully powered trial.

Methods and analysis

This is a pilot randomised, assessor-blind, therapist-blind and participant-blind, sham-controlled trial. Thirty individuals with painful knee osteoarthritis will be recruited and randomly allocated to receive either: (1) active rTMS+exercise or (2) sham rTMS+exercise intervention. Participants will receive 15 min of either active or sham rTMS immediately prior to 30 min of supervised muscle strengthening exercise (2×/week, 6 weeks) and complete unsupervised home exercises. Outcome measures of feasibility, safety, pain, function and physiological mechanisms will be assessed before and/or after the intervention. Feasibility and safety will be analysed using descriptive analysis. Within-group and between-group comparisons of pain and function will be conducted to examine trends of efficacy.

Ethics and dissemination

This study has been approved by the University of New South Wales Human Research Ethics Committee (HC210954). All participants will provide written informed consent. The study results will be submitted for peer-reviewed publication.

Trial registration number

ACTRN12621001712897p.
Estimating the health workforce requirements and costing to reach 70% COVID-19 vaccination coverage by mid-2022: a modelling study and global estimates
Authors: Boniol Mathieu , Siyam Amani , Desai Shalini , Gurung Santosh , Mirelman Andrew , Nair Tapas Sadasivan , Diallo Khassoum , Campbell James
Published: August 2022

Objectives

The implementation of COVID-19 vaccination globally poses unprecedented stress to health systems particularly for countries with persisting health workforce shortages prior the pandemic. The present paper estimates the workforce requirement to reach 70% COVID-19 vaccination coverage in all countries by mid-2022 using service target–based estimation.

Methods

Health workforce data from National Health Workforce Accounts and vaccination coverage reported to WHO as of January 2022 were used. Workload parameters were used to estimate the number of health workers needed with a service target–based approach, the gap and the scale-up required partially accounting for countries’ challenges, as well as the associated costs in human resources.

Results

As of 1 January 2022, only 34 countries achieved 70% COVID-19 vaccination coverage and 61 countries covered less than a quarter of their population. This analysis showed that 1 831 000 health workers working full time would be needed to reach a global coverage of 70% COVID-19 vaccination by mid-2022. To avoid severe disruptions to health system, 744 000 additional health workers should be added to domestic resources mostly (77%) in low-income countries. In a sensitivity analysis, allowing for vaccination over 12 months instead of 6 months would decrease the scale-up to 476 000 health workers. The costing for the employment of these 744 000 additional health workers is estimated to be US$2.5 billion. In addition to such a massive scale-up, it is estimated that 29 countries would have needed to redeploy more than 20% of their domestic workforce, placing them at serious risk of not achieving the mid-year target.

Conclusion

Reaching 70% global coverage with COVID-19 vaccination by mid-2022 requires extraordinary efforts not before witnessed in the history of immunisation programmes. COVID-19 vaccination programmes should receive rapid and sustainable investment in health workforce.
Ku-gaa-gii pimitizi-win, the COVID-19 cohort study of people experiencing homelessness in Toronto, Canada: a study protocol
Authors: Richard Lucie , Nisenbaum Rosane , Liu Michael , McGeer Allison , Mishra Sharmistha , Gingras Anne-Claude , Gommerman Jennifer L , Sniderman Ruby , Pedersen Cheryl , Spandier Olivia , Jenkinson Jesse I R , Baral Stefan , Mejia-Lancheros Cilia , Agarwal Arnav , Jamal Alainna J , Ostrowski Mario , Dhalla Irfan , Stewart Suzanne , Gabriel Mikaela , Brown Michael , Hester Joe , Hwang Stephen W
Published: August 2022

Introduction

Initial reports suggest people experiencing homelessness (PEH) are at high risk for SARS-CoV-2 infection and associated morbidity and mortality. However, there have been few longitudinal evaluations of the spread and impact of COVID-19 among PEH. This study will estimate the prevalence and incidence of COVID-19 infections in a cohort of PEH followed prospectively in Toronto, Canada. It will also examine associations between individual-level and shelter-level characteristics with COVID-19 infection, adverse health outcomes related to infection and vaccination. Finally, the data will be used to develop and parameterise a mathematical model to characterise SARS-CoV-2 transmission dynamics, and the transmission impact of interventions serving PEH.

Design, methods and analysis

Ku-gaa-gii pimitizi-win will follow a random sample of PEH from across Toronto (Canada) for 12 months. 736 participants were enrolled between June and September 2021, and will be followed up at 3-month intervals. At each interval, specimens (saliva, capillary blood) will be collected to determine active SARS-CoV-2 infection and serologic evidence of past infection and/or vaccination, and a detailed survey will gather self-reported information, including a detailed housing history. To examine the association between individual-level and shelter-level characteristics on COVID-19-related infection, adverse outcomes, and vaccination, shelter and healthcare administrative data will be linked to participant study data. Healthcare administrative data will also be used to examine long-term (up to 5 years) COVID-19-related outcomes among participants.

Ethics and dissemination

Ethical approval was obtained from the Unity Health Toronto and University of Toronto Health Sciences Research Ethics Boards (# 20-272). Ku-gaa-gii pimitizi-win was designed in collaboration with community and service provider partners and people having lived experience of homelessness. Findings will be reported to groups supporting Ku-gaa-gii pimitizi-win, Indigenous and other community partners and service providers, funding bodies, public health agencies and all levels of government to inform policy and public health programs.
Evaluating the Management of chronic Pelvic girdle Pain following pregnancy (EMaPP): study protocol for a randomised controlled feasibility trial to compare a customised pelvic orthosis with standard care
Authors: Halliday Bradley John , Chatfield Sarah , Cameron Lee , Hosking Joanne , Shawe Jill , Hawton Annie , Hayward Christopher , Carter Kirsty , Freeman Jennifer A
Published: August 2022

Introduction

An estimated 10% of women experience severe, chronic pelvic girdle pain post partum. This has significant physical, psychological and socioeconomic consequences. Typically, such pain is recalcitrant to conservative management; hence the need to identify effective management strategies. Customised Dynamic Elastomeric Fabric Orthoses may be an option to address this gap; designed to improve pain by providing support while optimising movement and function. Currently, no studies have evaluated the clinical and cost-effectiveness, or acceptability of these customised orthoses in postpartum women.

Methods and analysis

EMaPP is a pragmatic, multicentre randomised controlled feasibility trial with an embedded qualitative study and economic evaluation. Sixty participants with pregnancy-related severe pelvic girdle pain >3 months post partum will be recruited. Participants will be randomly allocated in a 1:1 ratio (stratified by centre and presence/absence of lumbo-pelvic pain pre pregnancy) to receive either standard care (standardised information and exercise) or intervention (orthosis plus standard care). All participants will be asked to complete a battery of self-report questionnaires (including pain, function, health-related quality of life and health and social care resource use), via a web-based application at baseline, 12 weeks and 24 weeks. Pain levels and medication usage will be reported fortnightly. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates and intervention adherence. Five clinicians and 10 participants will be interviewed to explore their experiences of the trial procedures and receiving the intervention.

Ethics and dissemination

This study was approved by: National Research Ethics Scheme (NRES Committee Health and Care Research Wales Research Ethics Committee (21/WM/0155) and University of Plymouth Faculty of Health Research Ethics and Integrity Committee (ref:2966). Results will be made available to participants, the funders, staff, general public and other researchers through a range of mechanisms.

Trial status

Currently recruiting.

Trial registration number

ISRCTN67232113.
Cohort profile: population-based cohorts of patients with colorectal cancer and of their relatives in Geneva, Switzerland
Authors: Benhamou Simone , Fournier Evelyne , Puppa Giacomo , McKee Thomas , Ris Frédéric , Rubbia-Brandt Laura , Viassolo Valeria , Zilli Thomas , Zlobec Inti , Chappuis Pierre Olivier , Rapiti Elisabetta
Published: August 2022

Purpose

Colorectal cancer (CRC) is the third leading cause of cancer death worldwide. Variability between patients in prognosis and treatment response is partially explained by traditional clinicopathological factors. We established a large population-based cohort of patients with CRC and their first-degree and second-degree relatives registered in the Canton of Geneva, to evaluate the role of family history and tumour biomarkers on patient outcomes.

Participants

The cohort includes all patients with CRC diagnosed between 1985 and 2013. Detailed information on patient and tumour characteristics, treatment and outcomes were extracted from the Geneva Cancer Registry database, completed by medical records review and linkage with administrative and oncogenetics databases. Next-generation tissue microarrays were constructed from tissue samples of the primary tumour. A prospective follow-up of the cohort is realised annually to collect data on outcomes. First-degree and second-degree relatives of patients are identified through linkage with the Cantonal Population Office database and information about cancer among relatives is retrieved from the Geneva Cancer Registry database. The cohort of relatives is updated annually.

Findings to date

The cohort includes 5499 patients (4244 patients with colon cancer and 1255 patients with rectal cancer). The great majority of patients were diagnosed because of occurrence of symptoms and almost half of the cases were diagnosed with an advanced disease. At the end of 2019, 337 local recurrences, 1143 distant recurrences and 4035 deaths were reported. At the same date, the cohort of first-degree relatives included 344 fathers, 538 mothers, 3485 children and 375 siblings. Among them, we identified 28 fathers, 31 mothers, 18 siblings and 53 children who had a diagnosis of CRC.

Future plans

The cohort will be used for long-term studies of CRC epidemiology with focus on clinicopathological factors and molecular markers. These data will be correlated with the most up-to-date follow-up data.
Prudent healthcare in practice: integration of audiology services into primary care
Authors: Loescher Timothy , Allum Jack , Phillips Nicola
Published: August 2022

Background

Swansea Bay University Health Board (SB UHB) has been trialling a primary care audiology pathway since 2016. The pathway enables patients with hearing, tinnitus or wax problems to be triaged directly to the audiology department acting as the first point of contact, freeing up general practitioners, Ear, Nose and Throat consultants and nurses to see patients with more complex health conditions.

Purpose

To evaluate the efficiency of the SB UHB primary care audiology pathway.

Particular focus

Clinical outcomes of patients seen through the SB UHB primary care audiology pathway.

Overview

The vast majority of patients seen through the SB UHB primary care audiology pathway are managed without the need for onward referral (≥87%).
Use of parenteral nutrition in the first postnatal week in England and Wales: an observational study using real-world data
Authors: Webbe James , Battersby Cheryl , Longford Nicholas , Oughham Kayleigh , Uthaya Sabita , Modi Neena , Gale Chris
Published: August 2022

Background

Parenteral nutrition (PN) is used to provide supplemental support to neonates while enteral feeding is being established. PN is a high-cost intervention with beneficial and harmful effects. Internationally, there is substantial variation in how PN is used, and there are limited contemporary data describing use across Great Britain.

Objective

To describe PN use in the first postnatal week in infants born and admitted to neonatal care in England, Scotland and Wales.

Method

Data describing neonates admitted to National Health Service neonatal units between 1 January 2012 and 31 December 2017, extracted from routinely recorded data held the National Neonatal Research Database (NNRD); the denominator was live births, from Office for National Statistics.

Results

Over the study period 62 145 neonates were given PN in the first postnatal week (1.4% of all live births); use was higher in more preterm neonates (76% of livebirths at <28 weeks, 0.2% of term livebirths) and in neonates with lower birth weight. 15% (9181/62145) of neonates given PN in the first postnatal week were born at term. There was geographic variation in PN administration: the proportion of live births given PN within neonatal regional networks ranged from 1.0% (95% CIs 1.0 to 1.0) to 2.8% (95% CI 2.7 to 2.9).

Conclusions and relevance

Significant variation exists in neonatal PN use; it is unlikely this reflects optimal use of an expensive intervention. Research is needed to identify which babies will benefit most and which are at risk of harm from early PN.

Trial registration number

ClinicalTrials.gov: NCT03767634; registration date: 6 December 2018.
Prevalence of idiopathic scoliosis in athletes: a systematic review and meta-analysis
Authors: Mousavi Leila , Seidi Foad , Minoonejad Hooman , Nikouei Farshad
Published: August 2022

Objective

This study aimed to determine the prevalence of idiopathic scoliosis (IS) in child, adolescent and adult athletes of all sports activity levels.

Design

Systematic review with meta-analysis.

Data sources

Electronic databases (PubMed, Scopus, ProQuest, Sage journals, ScienceDirect, Google Scholar and Springer) were systematically searched up from inception to 28 September 2021.

Eligibility criteria for selecting studies

Observational investigations were included to evaluate the prevalence of IS in athletes (engaged in any type of individual and team sports). Congenital scoliosis, neuromuscular scoliosis, Scheuermann’s kyphosis and de novo scoliosis were not included. The risk of bias was assessed using the tool developed by Hoyet al.

Results

Twenty-two studies were included (N=57 470, range 15–46544, participants), thirteen studies were of high-quality. The estimated prevalence of IS in athletes was 27% (95% CI 20% to 35%, I2=98%), with a 95% prediction interval (1% to 69%). The prevalence of IS was significantly higher in female athletes (35%, 95% CI 27% to 34%, I2=98%). Ballet dancers showed a high IS prevalence (35%, 95% CI 24% to 47%, I2=98%). Recreational athletes showed a higher IS prevalence (33%, 95% CI 24% to 43%, I2=98%) than at competitive-level athletes (0.05%, 95% CI 0.03% to 0.08%, I2=98%), followed by elite (20%, 95% CI 13% to 27%, I2=98%).

Conclusions

The prevalence of IS in athletes was similar or higher to that as seen in other studies of the general population. IS prevalence may have a U-shaped relationship relative to level of competition. Further studies are required to determine which sports have the highest IS prevalence.
Women’s attitudes towards a human papillomavirus-based cervical cancer screening strategy: a systematic review
Authors: Nothacker Julia , Nury Edris , Roebl Mathieu Marianne , Raatz Heike , Meerpohl Joerg J , Schmucker Christine
Published: August 2022

Objective

To provide insights into women’s attitudes towards a human papillomavirus (HPV)-based cervical cancer screening strategy.

Data sources

Medline, Web of Science Core Collection, Cochrane Library, PsycINFO, CINAHL and ClinicalTrials.gov were systematically searched for published and ongoing studies (last search conducted in August 2021).

Methods of study selection

The search identified 3162 references. Qualitative and quantitative studies dealing with women’s attitudes towards, and acceptance of, an HPV-based cervical cancer screening strategy in Western healthcare systems were included. For data analysis, thematic analysis was used and synthesised findings were presented descriptively.

Tabulation, integration, and results

Twelve studies (including 9928 women) from USA, Canada, UK and Australia met the inclusion criteria. Women’s attitudes towards HPV-based screening strategies were mainly affected by the understanding of (i) the personal risk of an HPV infection, (ii) the implication of a positive finding and (iii) the overall screening purpose. Women who considered their personal risk of HPV to be low and women who feared negative implications of a positive finding were more likely to express negative attitudes, whereas positive attitudes were particularly expressed by women understanding the screening purpose. Overall acceptance of an HPV-based screening strategy ranged between 13% and 84%.

Conclusion

This systematic review provides insights into the attitudes towards HPV-based cervical cancer screening and its acceptability based on studies conducted with women from USA, Canada, UK and Australia. This knowledge is essential for the development of education and information strategies to support the implementation of HPV-based cervical cancer screening.

Systematic review registration

PROSPERO (CRD42020178957).
Targeting the extra domain A of fibronectin for cancer therapy with CAR-T cells
Authors: Martín-Otal Celia , Lasarte-Cia Aritz , Serrano Diego , Casares Noelia , Conde Enrique , Navarro Flor , Sánchez-Moreno Inés , Gorraiz Marta , Sarrión Patricia , Calvo Alfonso , De Andrea Carlos E , Echeveste José , Vilas Amaia , Rodriguez-Madoz Juan Roberto , San Miguel Jesús , Prosper Felipe , Hervas-Stubbs Sandra , Lasarte Juan Jose , Lozano Teresa
Published: August 2022

Background

One of the main difficulties of adoptive cell therapies with chimeric antigen receptor (CAR)-T cells in solid tumors is the identification of specific target antigens. The tumor microenvironment can present suitable antigens for CAR design, even though they are not expressed by the tumor cells. We have generated a CAR specific for the splice variant extra domain A (EDA) of fibronectin, which is highly expressed in the tumor stroma of many types of tumors but not in healthy tissues.

Methods

EDA expression was explored in RNA-seq data from different human tumor types and by immunohistochemistry in paraffin-embedded tumor biopsies. Murine and human anti-EDA CAR-T cells were prepared using recombinant retro/lentiviruses, respectively. The functionality of EDA CAR-T cells was measured in vitro in response to antigen stimulation. The antitumor activity of EDA CAR-T cells was measured in vivo in C57BL/6 mice challenged with PM299L-EDA hepatocarcinoma cell line, in 129Sv mice-bearing F9 teratocarcinoma and in NSG mice injected with the human hepatocarcinoma cell line PLC.

Results

EDA CAR-T cells recognized and killed EDA-expressing tumor cell lines in vitro and rejected EDA-expressing tumors in immunocompetent mice. Notably, EDA CAR-T cells showed an antitumor effect in mice injected with EDA-negative tumor cells lines when the tumor stroma or the basement membrane of tumor endothelial cells express EDA. Thus, EDA CAR-T administration delayed tumor growth in immunocompetent 129Sv mice challenged with teratocarcinoma cell line F9. EDA CAR-T treatment exerted an antiangiogenic effect and significantly reduced gene signatures associated with epithelial-mesenchymal transition, collagen synthesis, extracellular matrix organization as well as IL-6-STAT5 and KRAS pathways. Importantly, the human version of EDA CAR, that includes the human 41BB and CD3ζ endodomains, exerted strong antitumor activity in NSG mice challenged with the human hepatocarcinoma cell line PLC, which expresses EDA in the tumor stroma and the endothelial vasculature. EDA CAR-T cells exhibited a tropism for EDA-expressing tumor tissue and no toxicity was observed in tumor bearing or in healthy mice.

Conclusions

These results suggest that targeting the tumor-specific fibronectin splice variant EDA with CAR-T cells is feasible and offers a therapeutic option that is applicable to different types of cancer.