bluuebunny/crossref_metadata_2025 huggingface dataset:
Study protocol for a randomised controlled trial of ultrasound-guided pulsed radiofrequency of the genicular nerves in the treatment of patients with osteoarthritis knee pain
Authors: Mata Javier , Valentí Pedro , Hernández Beatriz , Mir Bartolome , Aguilar Jose Luis
Published: May 2024

Introduction

The goals for the management of patients with osteoarthritis (OA) of the knee are to control pain and to minimise disability. Because the number of patients will increase as the population ages, alternative approaches to alleviate their joint pain other than conventional treatments are necessary. The purpose of this article is to present a refined protocol to determine if there is long-term improvement in pain and function after ultrasound-guided pulsed radiofrequency treatment of the genicular nerves (GNs) in patients with chronic painful knee OA.

Methods and analysis

This study is a randomised, double-blind, placebo-controlled, parallel design trial. One hundred and forty-two outpatients with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: ultrasound-guided sham GN pulsed radiofrequency without active treatment and ultrasound-guided real GN pulsed radiofrequency. The primary outcome measures will be the observed changes from baseline pain intensity based on visual analogue scale (VAS). The possible changes in the secondary efficacy variables from the baseline as assessed by the Goldberg Anxiety and Depression Scale, pain medication use, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC subscales) and VAS pain intensity are also to be included in the study. These variables will be assessed at baseline, 1 month, 3 months, 6 months and 1 year after treatment.

Ethics and dissemination

The protocol was approved by the Research Ethic Committee of the Balearic Islands (IB 3223/16 PI). The results will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration

Trial registration numberNCT02915120; Pre-results
Study protocol for statin web-based investigation of side effects (StatinWISE): a series of randomised controlled N-of-1 trials comparing atorvastatin and placebo in UK primary care
Authors: Herrett Emily , Williamson Elizabeth , Beaumont Danielle , Prowse Danielle , Youssouf Nabila , Brack Kieran , Armitage Jane , Goldacre Ben , MacDonald Thomas , Staa Tjeerd van , Roberts Ian , Shakur-Still Haleema , Smeeth Liam
Published: May 2024

Introduction

Statins are effective at preventing cardiovascular disease, widely prescribed and their use is growing. Uncertainty persists about whether they cause symptomatic muscle adverse effects, such as pain and weakness, in the absence of statin myopathy. Discrepancies between data from observational studies, which suggest statins are associated with excess muscle symptoms, and from randomised trials, which suggest no such excess, have caused confusion. N-of-1 trials offer the opportunity to establish whether muscle symptoms during statin use are caused by statins in particular individuals.

Methods and analysis

This series of 200 randomised, double-blinded N-of-1 trials in primary care will determine (1) the effect of statins on all muscle symptoms and (2) the effect of statins on muscle pain that is perceived to be statin related. Patients who are considering discontinuing statin use due to muscle symptoms and those who have discontinued in the last 3 years due to such symptoms will be recruited. Participants will be randomised to a sequence of six 2-month treatment periods during which they will receive atorvastatin 20 mg per day or matched placebo. On each of the last 7 days of each treatment period, participants will rate their muscle symptoms on a Visual Analogue Scale (VAS).

At the end of their trial, participants will be shown numerical and graphical summaries of their own symptom data during statin and placebo periods. The primary analysis on the aggregate data from all participants will be a linear mixed model for VAS muscle symptom score, comparing scores during treatment with statin and placebo.

Ethics and dissemination

This trial received a favourable opinion from South Central-Hampshire A Research Ethics Committee. Results will be published in a peer-reviewed medical journal. Dissemination of results to patients will take place via the media, website (statinwise.lshtm.ac.uk) and patient organisations.

Trial registration number

ISRCTN30952488.
How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the ’Active Herts' physical activity programme
Authors: Howlett Neil , Jones Andy , Bain Lucy , Chater Angel
Published: May 2024

Introduction

There is a high prevalence of inactive adults in the UK, and many suffer from conditions such as cardiovascular disease (CVD) or poor mental health. These coexist more frequently in areas of higher socioeconomic deprivation. There is a need to test the effectiveness, acceptability and sustainability of physical activity programmes. Active Herts uses novel evidence-based behaviour change techniques to target physical inactivity.

Methods and analysis

Active Herts is a community physical activity programme for inactive adults aged 16+ with one or more risk factors for CVD and/or a mild to moderate mental health condition. This evaluation will follow a mixed-methods longitudinal (baseline, and 3-month, 6-month and 12-month follow-ups) design. Pragmatic considerations mean delivery of the programme differs by locality. In two areas programme users will receive a behaviour change technique booklet, regular consultations, a booster phone call, motivational text messages and signposting to 12 weeks of exercise classes. In another two areas programme users will also receive 12 weeks of free tailored exercise classes, with optional exercise ‘buddies’ available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, well-being, psychological capability and reflective motivation as secondary outcomes. A process evaluation will explore the views of stakeholders, delivery staff and programme leads. Economic evaluation will examine the programme costs against the benefits gained in terms of reduced risk of morbidity.

Ethics and dissemination

This study was been approved by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of East Anglia. Informed written consent will be obtained from programme users in the evaluation. Results will be published in peer-reviewed journals, presented at conferences, and shared through the study website and local community outlets.

Trial registration number

ClinicalTrials.gov ID number:NCT03153098.
How biomarkers reflect the prognosis and treatment of necrotising soft tissue infections and the effects of hyperbaric oxygen therapy: the protocol of the prospective cohort PROTREAT study conducted at a tertiary hospital in Copenhagen, Denmark
Authors: Polzik Peter , Johansson Pär I , Hyldegaard Ole
Published: May 2024

Introduction

Not enough is known regarding the prognosis and treatment of necrotising soft tissue infections (NSTIs). Mortality has been shown to be 25%–35%, with survivors coping with amputations and prolonged rehabilitation. This study will evaluate soluble urokinase-type plasminogen activator receptor (suPAR) as a possible prognostic marker of NSTI severity and mortality, as well as whether hyperbaric oxygen therapy (HBOT) can modulate markers of endothelial damage during NSTI. We hypothesise that in patients with NSTI, suPAR can provide prognostic risk assessment on hospital admission and that HBOT can reduce the endothelial damage that these patients are exposed to.

Methods and analysis

This is a prospective observational study. Biomarkers will be measured in 150 patients who have been diagnosed with NSTI. On admission, baseline blood samples will be obtained. Following surgery and HBOT, daily blood samples will be obtained in order to measure endothelial and prognostic biomarkers (soluble thrombomodulin, syndecan-1, sE-selectin, vascular endothelial (VE)-cadherin, protein C and suPAR levels). Clinical data will be acquired during the first 7 days of stay in the intensive care unit. The primary outcomes in studies I and II will be endothelial biomarker levels after HBOT, and in study III suPAR levels as a marker of disease prognosis and severity.

Ethics and dissemination

The study has been approved by the Regional Scientific Ethical Committee of Copenhagen (H-16021845) and the Danish Data Protection Agency (RH-2016-199). Results will be presented at national and international conferences and published in peer-reviewed scientific journals.

Trial registration number

ClinicalTrials.gov IdentifierNCT03147352. (Pre-results)
Multicentre prospective randomised single-blind controlled study protocol of the effect of an additional parent-administered sensorimotor stimulation on neurological development of preterm infants: Primebrain
Authors: Pelc Karine , Daniel Irit , Wenderickx Bernard , Dan Bernard
Published: May 2024

Introduction

Preterm and very low birthweight infants are at increased risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. Several early intervention approaches have been designed in the hope of optimising neurological development in this context. It seems important that the intervention takes into account parental mental health, focuses on parent–child interactions and lasts sufficiently long. This study aims to evaluate the effects of a stimulation programme administered by parents until 6 months post-term on motor and neurophysiological development of infants born preterm.

Methods and analysis

Participants will be infants born <32 weeks’ gestation and/or with a birth weight <1500 g recruited prospectively from two tertiary neonatal intensive care units. They will be randomly assigned to receive nationally recommended follow-up only (control group) or also a stimulation programme between 37 weeks’ gestation and 6 months’ corrected age. Perinatal, clinical neurodevelopmental, socio-demographic and neuroimaging (ultrasonography or MRI) data will be collected. Bayley Scales of Infant Development will be used up to 24 months’ corrected age and Parental Stress Index at 6, 12, 18 and 24 months’ corrected age. High-density (64 or 128 electrodes) EEG, visual, somatosensory and long latency auditory evoked potentials will be recorded at term age, 3, 6, 12, 18 and 24 months’ corrected age. They will be analysed for spatiotemporal frequency bands contents and source localisation.

Ethics and dissemination

The study was approved by the Ethics Committees of the Hôpital Universitaire des Enfants Reine Fabiola and CHU Saint-Pierre. Results dissemination will be made for stakeholders and families, reports will be written for parents, healthcare providers and policymakers, and scientific papers will be published.

Trial registration number

NCT02159534; Pre-results.
Sensing interstitial glucose to nudge active lifestyles (SIGNAL): feasibility of combining novel self-monitoring technologies for persuasive behaviour change
Authors: Whelan Maxine E , Kingsnorth Andrew P , Orme Mark W , Sherar Lauren B , Esliger Dale W
Published: May 2024

Introduction

Increasing physical activity (PA) reduces the risk of developing diabetes, highlighting the role of preventive medicine approaches. Changing lifestyle behaviours is difficult and is often predicated on the assumption that individuals are willing to change their lifestyles today to reduce the risk of developing disease years or even decades later. The self-monitoring technologies tested in this study will present PA feedback in real time, parallel with acute physiological data. Presenting the immediate health benefits of being more physically active may help enact change by observing the immediate consequences of that behaviour. The present study aims to assess user engagement with the self-monitoring technologies in individuals at moderate-to-high risk of developing type 2 diabetes.

Methods and analysis

45 individuals with a moderate-to-high risk, aged ≥40 years old and using a compatible smartphone, will be invited to take part in a 7-week protocol. Following 1 week of baseline measurements, participants will be randomised into one of three groups: group 1— glucose feedback followed by biobehavioural feedback (glucose plus PA); group 2—PA feedback followed by biobehavioural feedback; group 3—biobehavioural feedback. A PA monitor and a flash glucose monitor will be deployed during the intervention. Participants will wear both devices throughout the intervention but blinded to feedback depending on group allocation. The primary outcome is the level of participant engagement and will be assessed by device use and smartphone usage. Feasibility will be assessed by the practicality of the technology and screening for diabetes risk. Semistructured interviews will be conducted to explore participant experiences using the technologies.

Trial registration number

ISRCTN17545949. Registered on 15/05/2017.
Association between secondhand smoke exposure and serum sex hormone concentrations among US female adults: a cross-sectional analysis using data from the National Health and Nutrition Examination Survey, 2013–2016
Authors: Li Shuna , Feng Aozi , Peng Yongjia , Li Li , Huang Liying , He Ningxia , Zeng Mengnan , Lyu Jun
Published: May 2024

Objective

To estimate the association between secondhand smoke (SHS) exposure and serum sex hormone concentrations in female adults (never smokers and former smokers).

Design

Cross-sectional analysis.

Setting

US National Health and Nutrition Examination Survey, 2013–2016.

Outcome measures

Serum sex hormone measures included total testosterone (TT) and oestradiol (E2), sex hormone-binding globulin (SHBG), the ratio of TT and E2 and free androgen index (FAI). Isotope dilution–liquid chromatography tandem mass spectrometry was used to measure serum TT and E2. SHBG was measured using immunoassay. The ratio of TT and E2 and FAI were calculated. SHS exposure was defined as serum cotinine concentration of 0.05–10 ng/mL.

Participants

A total of 622 female participants aged ≥20 years were included in the analysis.

Results

For never smokers, a doubling of serum cotinine concentration was associated with a 2.85% (95% CI 0.29% to 5.47%) increase in TT concentration and a 6.29% (95% CI 0.68% to 12.23%) increase in E2 in fully adjusted models. The never smokers in the highest quartile (Q4) of serum cotinine level exhibited a 10.30% (95% CI 0.78% to 20.72%) increase in TT concentration and a 27.75% (95% CI 5.17% to 55.17%) increase in E2 compared with those in the lowest quartile (Q1). For former smokers, SHBG was reduced by 4.36% (95% CI −8.47% to −0.07%, p for trend=0.049) when the serum cotinine level was doubled, and the SHBG of those in Q4 was reduced by 17.58% (95% CI −31.33% to −1.07%, p for trend=0.018) compared with those in Q1.

Conclusion

SHS was associated with serum sex hormone concentrations among female adults. In never smokers, SHS was associated with increased levels of TT and E2. In former smokers, SHS was associated with decreased SHBG levels.
The use and application of Lean Management methods to research processes—a scoping review protocol
Authors: Wraae Caroline Ariane Dahl , Opstrup Niels , Kyvik Kirsten Ohm , Brixen Kim , Wien Charlotte
Published: May 2024

Introduction

Waste in medical research is a relatively well-known issue. However, only a few initiatives exist to address this issue. Lean Management methods (Lean) were developed in industrial manufacturing and later applied within healthcare improvement. Overall, the results from studies of the application of Lean to healthcare appear to be positive in terms of greater efficiency regarding treatment outcomes and patient care. Nevertheless, the application of Lean to improve research processes is not well studied and, given that research alongside clinical practice and experiential knowledge provides the foundation for the treatment and care of patients, it is paramount to identify approaches and review the degree to which they increase efficiency within research procedures. Therefore, this review will scope the landscape of studies that investigated Lean and how to implement Lean in research processes, particularly regarding healthcare research.

Methods and analysis

Our approach follows the methodological framework of Arksey and O’Malley for conducting scoping reviews (PRISMA-ScR). The search strategy for this scoping review was developed using the PCC model. We will identify the relevant literature by searching four search databases: Scopus, Web of Science, Academic Search Premier and Business Source Complete. Next, we will use citation pearl growing to identify all relevant published literature. The data charting process will follow the PRISMA-ScR checklist and will be organised using NVivo. We will generate qualitative and quantitative assessments of the extracted data by using NVivo, RStudio and Excel. We will follow the PRISMA-ScR guideline when reporting the results.

Ethics and dissemination

The review will comprise existing published studies and no primary data will be collected. Our findings will be shared through open access peer-reviewed journals, national and international conferences and emails to all relevant collaborative relationships. We plan to disseminate our findings via academic social media platforms, newspaper articles and blogposts.
Exploring the influence of health system factors on adaptive capacity in diverse hospital teams in Norway: a multiple case study approach
Authors: Fagerdal Birte , Lyng Hilda Bø , Guise Veslemøy , Anderson Janet E , Braithwaite Jeffrey , Wiig Siri
Published: May 2024

Objectives

Understanding flexibility and adaptive capacities in complex healthcare systems is a cornerstone of resilient healthcare. Health systems provide structures in the form of standards, rules and regulation to healthcare providers in defined settings such as hospitals. There is little knowledge of how hospital teams are affected by the rules and regulations imposed by multiple governmental bodies, and how health system factors influence adaptive capacity in hospital teams. The aim of this study is to explore the extent to which health system factors enable or constrain adaptive capacity in hospital teams.

Design

A qualitative multiple case study using observation and semistructured interviews was conducted between November 2020 and June 2021. Data were analysed through qualitative content analysis with a combined inductive and deductive approach.

Setting

Two hospitals situated in the same health region in Norway.

Participants

Members from 8 different hospital teams were observed during their workday (115 hours) and were subsequently interviewed about their work (n=30). The teams were categorised as structural, hybrid, coordinating and responsive teams.

Results

Two main health system factors were found to enable adaptive capacity in the teams: (1) organisation according to regulatory requirements to ensure adaptive capacity, and (2) negotiation of various resources provided by the governing authorities to ensure adaptive capacity. Our results show that aligning to local context of these health system factors affected the team’s adaptive capacity.

Conclusions

Health system factors should create conditions for careful and safe care to emerge and provide conditions that allow for teams to develop both their professional expertise and systems and guidelines that are robust yet sufficiently flexible to fit their everyday work context.
Residents’ willingness towards first-contact with primary health care under uncertainty in healthcare: a cross-sectional study in rural China
Authors: Song Fei , Wei Ran , Wang Chenzhou , Zhang Yan
Published: May 2024

Objective

To estimate Chinese rural residents’ willingness degree of initially contacting primary healthcare (PHC) under uncertainty in healthcare and to explore its influencing factors.

Setting

This study collected primary data from rural residents in Dangyang, Hubei Province in China.

Participants

The study investigated 782 residents and 701 finished the survey. The response rate was 89.64%. A further 27 residents failed the internal consistency test, so the effective sample size was 674.

Design

In this cross-sectional study, residents’ willingness was reflected by the threshold of disease severity for PHC (TDSP), the individual maximal disease scope for considering PHC based on residents’ decision-making framework. TDSP was measured through scenario tests. Univariate analysis and unordered multiple logistic regression were used to explore the influencing factors of three-level TDSP: low, general, and high.

Results

Only 28.2% of respondents had high TDSP and high willingness towards PHC. Compared with general TDSP, respondents who were younger than 40 (OR 7.344, 95% CI 2.463 to 21.894), rich (OR 1.913, 95% CI 1.083 to 3.379), highly risk-averse (OR 1.958, 95% CI 1.016 to 3.774), had substitute medical decision-maker (OR value of parent/child was 2.738, 95% CI 1.386 to 5.411) and had no visits to PHC in the last 6 months (OR 2.098, 95% CI 1.316 to 3.346) tended to have low TDSP and low willingness towards PHC. Compared with general TDSP, no factors were found to significantly influence respondents’ high TDSP.

Conclusions

TDSP can be a good indicator of residents’ willingness. TDSP results demonstrate rural residents’ generally low willingness towards first-contact with PHC that some residents refuse to consider PHC even for mild diseases. This study provides practical significance for elaborating the underutilisation of PHC from resident decision-making and offers advice to policymakers and researchers for future modifications.
Knowledge, attitude and practice of poststroke depression among patients with poststroke depression and their family members in Heilongjiang Province, China: a cross-sectional study
Authors: Zhao Bin , Wang Yujue , Xu Ning , Xu Jiaben , Yang Keqin
Published: May 2024

Objective

This study aimed to investigate the knowledge, attitude and practice (KAP) of poststroke depression (PSD) among patients with PSD and their family members.

Design

Web-based cross-sectional study.

Setting

This study was conducted in Heilongjiang Province between October 2022 and April 2023.

Participants

Patients with PSD and their family members.

Primary and secondary outcome measures

KAP scores.

Method

The self-administered questionnaire comprised demographic characteristics, knowledge dimension, attitude dimension and practice dimensions.

Results

A total of 489 valid questionnaires were collected, with the average age of the subjects was 54.68±13.80 years, and including 258 (53.09%) patients who had a stroke. The mean scores for KAP were 6.36±2.66 (possible range: 0–10), 29.07±5.18 (possible range: 8–40) and 37.50±8.49 (possible range: 10–50), respectively. Concerning KAP scores, no differences were found between patients with PSD and their family members. Multivariate logistic regression analysis showed that retirement (OR=0.29, 95% CI 0.11 to 0.77, p=0.012) and monthly income less than ¥2000 (OR=0.46, 95% CI 0.27, 0.79, p=0.005) were independently associated with adequate knowledge. Knowledge (OR=2.12, 95% CI 1.44 to 3.14, p<0.001) was independently associated with positive attitude. Knowledge (OR=3.85, 95% CI 2.53 to 5.86, p<0.001) and attitude (OR=1.62, 95% CI 1.06 to 2.47, p=0.024) were independently associated with proactive practice.

Conclusion

Patients and their family members had insufficient knowledge, positive attitude and moderate practice towards PSD. Retirement and low monthly income were associated with insufficient knowledge, while knowledge was associated with positive attitude and proactive practice.
Protocol for the Chinese Real-World Evidence for Acute Spinal Cord Injury (ChiRES) study: a prospective, observational, multicentre cohort study of acute spinal cord injury
Authors: Yuan Wenjian , Sun Jiuxiao , Li Qingyang , Zheng Ruiyuan , Guan Bin , Chen Zhuo , Ding Jiaming , Sun Qingyu , Fu Runhan , Wang Wei , Fan Yuxuan , Kang Yi , Sun Chao , Li Ang , Wu Dongjin , Wang Dachuan , Qi Lei , Chen Lingxiao , Feng Shiqing , Zhou Hengxing
Published: May 2024

Introduction

Spinal cord injury (SCI) is a catastrophic event with devastating physical, social and occupational consequences for patients and their families. The number of patients with acute SCI in China continues to grow rapidly, but there have been no large prospective cohort studies of patients with acute SCI. This proposed study aims to establish a multicentre, extensive sample cohort of clinical data and biological samples of patients in China, which would aid the systematisation and standardisation of clinical research and treatment of acute SCI, thus reducing the heavy burden of acute SCI on patients and society.

Methods and analysis

The Chinese Real-World Evidence for Acute Spinal Cord Injury (ChiRES) study is an observational, multicentre cohort study of patients with acute SCI admitted to the Qilu Hospital of Shandong University and other participating centres with prospective collection of their clinical data and biological samples. We aim to recruit 2097 patients in this study. Demographics, disease history, emergency intervention information, motor and sensory examinations, surgical information, medication information and rehabilitation evaluation will be recorded. This will facilitate the development of a prediction model for complications and prognosis of patients with acute SCI and an evaluation of the current management of acute SCI. Among these variables, detailed information on surgical treatment will also be used to assess procedures for acute SCI treatment. Outcome measurements, including the International Standard for Neurological Classification of Spinal Cord Injury examinations, the occurrence of complications and death, will be performed repeatedly during follow-up. We will analyse imaging data and blood samples to develop SCI imaging markers and biomarkers.

Ethics and dissemination

This study protocol has been approved by the Medical Ethics Committee of the Qilu Hospital of Shandong University and all other participating centres. The findings will be disseminated in peer-reviewed journals and academic conferences.
Theories, models and frameworks to understand barriers to the provision of mobility-assistive technologies: a scoping review
Authors: Aldawood Asma , Hind Daniel , Rushton Simon , Field Becky
Published: May 2024

Objectives

There is strong evidence that mobility-assistive technologies improve occupational performance, social participation, educational and employment access and overall quality of life in people with disabilities. However, people with disabilities still face barriers in accessing mobility products and related services. This review aims to summarise and synthesise: (1) theories, models and frameworks that have been used to understand mobility-assistive technology access, (2) determinants of access and (3) gaps in knowledge.

Design

A scoping review using the five-step framework by Arksey and O’Malley.

Data sources

We searched the MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and SCOPUS databases for publications published between 2000 and 2024. We searched for articles published up to 20 March 2024.

Eligibility criteria

We included English-published literature in peer-reviewed journals that reported (a) barriers to the provision of mobility-assistive technologies, (b) including at least one theory, model or framework and (c) between 2000 and 2024.

Data extraction and synthesis

We extracted the study characteristics, theories, models, framework usage, research recommendations, key findings on mobility-assistive technology barriers and theoretical propositions. We conduct a theoretical synthesis guided by Turner’s approach.

Results

We included 18 articles that used 8 theories, models and frameworks, synthesised into 9 propositions. The synthesised theory emphasises that mobility is essential for human flourishing, and that certain health conditions may impose restrictions on mobility. This impact can be alleviated by two direct determinants: (1) the provision of suitable services and (2) their comprehensive provision. Policies and costs influence these services indirectly. Environmental and personal factors also affect the use of these services. Ineffectively addressing these determinants can limit access to mobility-assistive technologies and subsequent disabilities.

Conclusion

Our synthetic model describes the logic of providing evidence-based mobility-assistive technologies, and we identify the determinants of access that can act as targets for future work to improve the provision of mobility-assistive technologies.
The outcome and related risk factors of unvaccinated patients with end-stage kidney disease during the Omicron pandemic: a multicentre retrospective study
Authors: Zhang Quanchao , Lu Caibao , Wu Shaofa , He Jin , Wang Han , Li Jie , Wu Zhifen , Tang Bingshuang , Yang Bingfeng , Liao Shengli , Wang Liao , Chen Hongwei , Li Moqi , He Wenchang , Wang Yiqin , Jiang Lili , Zhao Jing-Hong , Nie Ling
Published: May 2024

Objectives

The study aims to identify the outcome and the related factors of unvaccinated patients with end-stage kidney disease during the Omicron pandemic.

Design

A multicentre retrospective study of patients with end-stage kidney disease undergone maintenance haemodialysis (HD) in China.

Setting

6 HD centres in China.

Participants

A total of 654 HD patients who tested positive for SARS-CoV-2 were ultimately included in the study.

Outcome measures

The primary outcomes of interest were adverse outcomes, including hospitalisation due to COVID-19 and all-cause mortality.

Results

The average age of the patients was 57 years, with 33.6% of them being over 65 years. Among the patients, 57.5% were male. During the follow-up period, 158 patients (24.2%) experienced adverse outcomes, and 93 patients (14.2%) died. The majority of patients (88/158) developed adverse outcomes within 30 days, and most deaths (77/93) occurred within 1 month. An advanced multivariable Cox regression analysis identified that adverse outcomes were associated with various factors while all-cause mortality was related to advanced age, male gender, high levels of C reactive protein (CRP) and low levels of prealbumin. The Kaplan-Meier curves demonstrated significantly higher all-cause mortality rates in the older, male, high CRP and low prealbumin subgroups.

Conclusions

Among unvaccinated HD patients with confirmed Omicron infections, various factors were found to be linked to adverse outcomes. Notably, age, sex, CRP and prealbumin had a substantial impact on the risk of all-cause mortality.
A Qualitative evaluation in community settings in England exploring the experiences of coaches delivering the NHS Low Calorie Diet programme pilot to ethnically diverse participants
Authors: Dhir Pooja , Maynard Maria , Drew Kevin J , Homer Catherine Verity , Bakhai Chirag , Ells Louisa Jane
Published: May 2024

Background

The management of type 2 diabetes (T2D) within diverse ethnic populations requires a culturally tailored approach. However, little is known about the experiences of coaches delivering interventions for T2D, such as the National Health Service (NHS) Low Calorie Diet (LCD) programme, to people from diverse ethnic backgrounds.

Objective

To explore the experiences of coaches delivering an NHS programme using total diet replacement approaches to individuals from diverse ethnic backgrounds, to inform the effective tailoring and equitable delivery of future interventions.

Design

Qualitative study.

Setting

Individuals delivering the NHS LCD programme.

Participants

One-to-one semistructured interviews were conducted with seven health coaches delivering the NHS LCD programme. Inclusion criteria included participants delivering the NHS LCD programme either from a minoritised ethnic background or delivering the programme to those from ethnic minority and white British backgrounds.

Main outcome measures

Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts.

Results

Key themes highlighted the following experiences of delivering the LCD programme: (1) training and support needs; (2) needing to understand culture and ethnicity; (3) the impact of language; (4) the use of resources in providing dietary advice and (5) experiences of cultural tailoring. The themes highlight the need to prioritise person-centred care, to integrate culturally tailored approaches and for provision of education and training to those delivering health programmes.

Conclusion

These findings describe the experiences of health coaches in tailoring delivery and emphasise the role of cultural competence in ensuring equitable and effective healthcare interventions for diverse populations. This learning can inform future programmes and policies aimed at promoting inclusive healthcare practices.
At the threshold of viability: to resuscitate or not to resuscitate – the perspectives of Israeli neonatologists
Authors: Sperling Daniel , Riskin Arieh , Borenstein-Levin Liron , Hochwald Ori
Published: May 2024

Objective

This study aims to examine the perspectives of neonatologists in Israel regarding resuscitation of preterm infants born at 22–24 weeks gestation and their consideration of parental preferences. The factors that influence physicians’ decisions on the verge of viability were investigated, and the extent to which their decisions align with the national clinical guidelines were determined.

Study design

Descriptive and correlative study using a 47-questions online questionnaire.

Results

90 (71%) of 127 active neonatologists in Israel responded. 74%, 50% and 16% of the respondents believed that resuscitation and full treatment at birth are against the best interests of infants born at 22, 23 and 24 weeks gestation, respectively. Respondents’ decisions regarding resuscitation of extremely preterm infants showed significant variation and were consistently in disagreement with either the national clinical guidelines or the perception of what is in the best interest of these newborns. Gender, experience, country of birth and the level of religiosity were all associated with respondents’ preferences regarding treatment decisions. Personal values and concerns about legal issues were also believed to affect decision-making.

Conclusion

Significant variation was observed among Israeli neonatologists regarding delivery room management of extremely premature infants born at 22–24 weeks gestation, usually with a notable emphasis on respecting parents’ wishes. The current national guidelines do not fully encompass the wide range of approaches. The country’s guidelines should reflect the existing range of opinions, possibly through a broad survey of caregivers before setting the guidelines and recommendations.
Early goal enteral nutrition associated with decreased in-hospital death in mechanically ventilated critically ill adults: a retrospective cohort study
Authors: Powierza Camilla S , Doyle Margaret M , Wasden Katherine , Intihar Taylor A , Korwin Amy S , Honiden Shyoko , Knauert Melissa P
Published: May 2024

Introduction

Early enteral nutrition (EN) in critically ill adult patients is thought to improve mortality and morbidity; expert guidelines recommend early initiation of EN in critically ill adults. However, the ideal schedule and dose of EN remain understudied.

Study objective

Our objective was to evaluate the relationship between achieving 70% of recommended EN within 2 days of intubation (‘early goal EN’) and clinical outcomes in mechanically ventilated medically critically ill adults. We hypothesised that early goal EN would be associated with reduced in-hospital death.

Methods

We conducted a retrospective cohort study of mechanically ventilated adult patients admitted to our medical intensive care unit during 2013–2019. We assessed the proportion of recommended total EN provided to the patient each day following intubation until extubation, death or 7 days whichever was shortest. Patients who received 70% or more of their recommended total daily EN within 2 days of intubation (ie, ‘baseline period’) were considered to have achieved ‘early goal EN’; these patients were compared with patients who did not (‘low EN’). The primary outcome was in-hospital death; secondary outcomes were successful extubation and discharge alive.

Results

938 patients met eligibility criteria and survived the baseline period. During the 7-day postintubation period, 64% of all patients reached 70% of recommended daily calories; 33% of patients achieved early goal EN. In unadjusted and adjusted models, early goal EN versus low EN was associated with a lower incidence of in-hospital death (subdistribution HR (SHR) unadjusted=0.63, p=0.0003, SHR adjusted=0.73, p=0.02). Early goal EN was also associated with a higher incidence of successful extubation (SHR unadjusted=1.41, p<0.00001, SHR adjusted=1.27, p=0.002) and discharge alive (SHR unadjusted=1.54, p<0.00001, SHR adjusted=1.24, p=0.02).

Conclusions

Early goal EN was associated with significant improvement in clinical metrics of decreased in-hospital death, increased extubation and increased hospital discharge alive.
Fabry disease: development and progression of left ventricular hypertrophy despite long-term enzyme replacement therapy
Authors: Maurizi Niccolo , Nowak Albina , Gruner Christiane , Namdar Mehdi , Schmied Christian , Porretta Alessandra Pia , Barbey Guillaume , Monzambani Veronique , Monney Pierre , Barbey Frédéric
Published: May 2024

Background

Enzyme replacement therapy (ERT) may halt or attenuate disease progression in patients with Anderson-Fabry disease (AFD). However, whether left ventricular hypertrophy (LVH) can be prevented by early therapy or may still progress despite ERT over a long-term follow-up is still unclear.

Methods

Consecutive patients with AFD from the Independent Swiss-Fabry Cohort receiving ERT who were at least followed up for 5 years were included. Cardiac progression was defined as an increase of >10 g/m
2
in left ventricular mass index (LVMI) between the first and the last available follow-up transthoracic echocardiography.

Results

60 patients (35 (23–48) years, 39 (65%) men) were followed up for 10.5 (7.2–12.2) years. 22 had LVH at ERT start (LVMI of 150±38 g/m
2
). During follow-up, 22 (36%, 34±15 years) had LVMI progression of 12.1 (7–17.6) g/m
2
per 100 patient-years, of these 7 (11%, 29±13 years) with no LVH at baseline. Three of them progressed to LVH. LVMI progression occurred mostly in men (17 of 39 (43%) vs 5 of 21 (24%), p<0.01) and after the age of 30 years (17 of 22 (77%)). LVH at ERT start was associated with LVMI progression (OR 1.3, 95% CI 1.1 to 2.6; p=0.02). A total of 19 (31%) patients experienced a major AFD-related event. They were predominantly men (17 of 19, 89%), older (45±11 vs 32±9 years) with baseline LVH (12 of 19, 63%), and 10 of 19 (52%) presented with LVMI progression.

Conclusions

Over a median follow-up of >10 years under ERT, 36% of the patients still had LVMI cardiac progression, and 32%, predominantly older men, experienced major AFD-related events. LVH at treatment initiation was a strong predictor of LVMI progression and adverse events on ERT.
Characterising the challenges of managing difficult red blood cell alloantibodies in liver transplant recipients
Authors: Chornenkyy Yevgen , Fink Margaret Catherine , Felicelli Christopher , Stowell Sean R , Ramsey Glenn Eugene , Yang Guang-Yu
Published: May 2024

Aims

Formation of red blood cell alloantibodies (RBCAs) complicates transfusion support in liver transplantation (LT). Difficult RBCAs (DAs, >3 antibodies or antibodies for which <25% donors are antigen negative) further challenge care. This study characterises DA outcomes relative to non-difficult RBCAs (NDAs).

Methods

Single-centre, retrospective analysis of LT patients (2002–2021). RBCAs were defined as clinically significant antibodies. DAs were compared with NDAs.

Results

89 patients had clinically significant RBCAs (DA=50, NDA=39). More DAs were anti-Jka, anti-M; fewer were anti-E, anti-K (all p<0.05). DA patients often had multiple antibodies (44% vs 12.8% NDA, p=0.0022). Probability of finding antigen-negative blood was lower for DAs (17.4% vs 68.1% NDA, p<0.0001) as was RBCs received (9.4 vs 14.7 units in NDA, p=0.0036). Although survival was similar, patients with DAs had more adverse reactions (8% vs 0%, p=0.128). Some antibodies appeared to occur with specific liver diseases (such as primary sclerosing cholangitis, alcoholic steatohepatitis and recurrent disease); however, due to low sample size, definitive conclusions cannot be made.

Conclusions

DA LT recipients contain >1 RBCA, have a lower probability of finding antigen negative blood and may experience more adverse transfusion event (ATE). Despite this, the incidence of ATEs was still quite low.
Implications for driving based on the risk of seizures after ischaemic stroke
Authors: Schubert Kai Michael , Bicciato Giulio , Sinka Lucia , Abraira Laura , Santamarina Estevo , Álvarez-Sabín José , Ferreira-Atuesta Carolina , Katan Mira , Scherrer Natalie , Terziev Robert , Döhler Nico , Erdélyi-Canavese Barbara , Felbecker Ansgar , Siebel Philip , Winklehner Michael , von Oertzen Tim J , Wagner Judith N , Gigli Gian Luigi , Nilo Annacarmen , Janes Francesco , Merlino Giovanni , Valente Mariarosaria , Zafra-Sierra María Paula , Mayor-Romero Luis Carlos , Conrad Julian , Evers S , Lochner Piergiorgio , Roell Frauke , Brigo Francesco , Bentes Carla , Peralta Rita , Pinho e Melo Teresa , Keezer Mark R , Duncan John Sidney , Sander Josemir W , Tettenborn Barbara , Koepp Matthias , Galovic Marian
Published: May 2024

Background

In addition to other stroke-related deficits, the risk of seizures may impact driving ability after stroke.

Methods

We analysed data from a multicentre international cohort, including 4452 adults with acute ischaemic stroke and no prior seizures. We calculated the Chance of Occurrence of Seizure in the next Year (COSY) according to the SeLECT2.0prognostic model. We considered COSY<20% safe for private and <2% for professional driving, aligning with commonly used cut-offs.

Results

Seizure risks in the next year were mainly influenced by the baseline risk-stratified according to the SeLECT2.0score and, to a lesser extent, by the poststroke seizure-free interval (SFI). Those without acute symptomatic seizures (SeLECT2.00–6 points) had low COSY (0.7%–11%) immediately after stroke, not requiring an SFI. In stroke survivors with acute symptomatic seizures (SeLECT2.03–13 points), COSY after a 3-month SFI ranged from 2% to 92%, showing substantial interindividual variability. Stroke survivors with acute symptomatic status epilepticus (SeLECT2.07–13 points) had the highest risk (14%–92%).

Conclusions

Personalised prognostic models, such as SeLECT2.0, may offer better guidance for poststroke driving decisions than generic SFIs. Our findings provide practical tools, including a smartphone-based or web-based application, to assess seizure risks and determine appropriate SFIs for safe driving.
Curriculum mapping to audit and grow longitudinal graduate medical education leadership training
Authors: Goodwin Andrew , Hughes Kathryn , Hartzell Joshua , Johnson William Rainey
Published: May 2024

Background

Residents need and want practical leadership training, yet leadership curricula are lacking in graduate medical education (GME). We describe our process of curriculum mapping, a method for auditing a curriculum, and its role in iterative leadership curriculum development.

Aims

To show how to create a curriculum map for auditing a curriculum using examples from our leadership curriculum and to demonstrate its value through case examples of leadership education integration into existing resident experiences.

Methods

We selected our recent systematic review on current leadership curricula to prioritise leadership content given it was the basis for our initial curriculum. We identified existing resident experiences where training can occur. We use the selected content and training environments, layered with a modified Miller’s pyramid, to construct a curriculum map.

Results

Our curriculum map provides an example of curriculum auditing that reveals opportunities for leadership training that could be integrated into current residency experiences. We provide case examples of application.

Discussion

Effective leadership training should address critical topics and capitalise on experiential learning opportunities that exist within residency training programmes. The training must be seamlessly integrated into the demanding obligations of GME trainees, a process that can be achieved using curriculum mapping. Curriculum mapping can provide insight into a residency programme’s leadership curriculum and create a direction for future leadership curriculum development.
Perspectives of a single-anode cylindrical chamber operating in ionization mode and high gas pressure
Authors: Bouet R. , Busto J. , Cecchini V. , Charpentier P. , Chapellier M. , Dastgheibi-Fard A. , Druillole F. , Jollet C. , Hellmuth P. , Gros M. , Lautridou P. , Meregaglia A. , Navick X. F. , Piquemal F. , Roche M. , Thomas B.
Published: May 2024

As part of the R2D2 (Rare Decays with Radial Detector) R &D, the use of a gas detector with a spherical or cylindrical cathode, equipped with a single anode and operating at high pressure, was studied for the search of rare phenomena such as neutrinoless double-beta decay. The presented measurements were obtained with a cylindrical detector, covering gas pressures ranging from 1 to 10 bar in argon and 1 to 6 bar in xenon, using both a point-like source of $$^{210} $$

210

Po (5.3 MeV $$\alpha $$
α
) and a diffuse source of $$^{222}$$

222

Rn (5.5 MeV $$\alpha $$
α
). Analysis and interpretation of the data were developed using the anodic current waveform. Similar detection performances were achieved with both gases, and comparable energy resolutions were measured with both sources. As long as the purity of the gas was sufficient, no significant degradation of the measured energy was observed by increasing the pressure. At the highest operating pressure, an energy resolution better than 1.5% full-width at half-maximum (FWHM) was obtained for both gaseous media, although optimal noise conditions were not reached.