bluuebunny/crossref_metadata_2025 huggingface dataset:
Languaging as refusal
Authors: Aparna Kolar , Hamzah Saba
Published: September 2023

How are we refusing to be the bridge in ‘diversity’ responses in academia? What processes open up when we refuse the word and the singular language of ‘borders’ circulating in border studies and gender studies in the Netherlands? Where are we refusing from? Who is the subject-object of refusal? What is the language of refusal? How to speak from our burning guts that refuse to refuse in a language that doesn’t speak to our daily lives and struggles? How are we refusing the violence of research processes promoting the individual ‘trophy’ academic/artist in academic and cultural institutions while holding one’s own and each other’s bodies and power asymmetries shaping our writing processes for healing? How does one listen to the silences in histories of slavery, war, patriarchy, colonial trauma, and gender violence passing through our bodies while writing? In this essay we reflect on these questions by interspersing pieces of texts, experiences, excerpts (from thesis/thesis-related events), visuals, and poetry, by entangling biographies, traumas and memories situated in our everyday contexts and processes of teaching, writing for healing and for a living.  Languaging becomes a location where we speak from, inspired and yet in tension with Anzaldúa (Hamzah 2020). Languaging (Kramsch et al. 2015) is our practice of refusal to refuse in one dominant language. We language a call for a poetics of refusal. We intentionally make the fleeting process known to each other and open it up to the reader, in holding each other’s bodies as they are collapsing and healing. In doing so we invite the reader to struggle with us in the process of naming our struggles that emerge from refusing to refuse singularly in English, refusing to write by partitioning our guts and everyday battles with patriarchy, refusing the writing subject as fully knowing what one is refusing.
Experimental Research on Effects of Combustion Air Humidification on Energy and Environment Performance of a Gas Boiler
Authors: Zhang Qunli , Li Yanxin , Zhang Qiuyue , Jiao Yuqing , Shi Qiu , Lü Xiaoshu
Published: September 2023

To increase the waste heat recovery (WHR) efficiency of gas boiler and decrease NOx emissions, a flue gas total heat recovery (FGTHR) system integrating direct contact heat exchanger (DCHE) and combustion air humidification (CAH) is put forward. The experimental bench and technical and economic analysis models are set up to simulate and evaluate the WHR performance and NOx emissions in various operation situations. The results show that when the air humidity ratio elevates from 3 g/kgdry air to 60 g/kgdry air, the dew point temperature increases by 7.9 °C. When the flue gas temperature approaches the dew point temperature, the rate of improvement of the FGTHR system's total heat efficiency notably rises. With spray water (SW) flowrate and temperature of 0.075 kg/s and 45 °C, the WHR efficiency relatively increases by up to 8.4%. The maximum sensible and latent heat can be recovered by 4468 w and 3774 w, respectively. The flue gas temperature can be reduced to 46.55 °C, and the average NOx concentration is 39.6 mg/m3. Compared with the non-humidified condition, the NOx and CO2 emissions relative reduction of the FGTHR system are 61.2% and 8.7%. The payback period of FGTHR system is 2 years. Through simulation, it can be concluded that the decrease in exhaust flue gas temperature and velocity, as well as the increase in exhaust flue gas humidity, has a negative impact on the diffusion of NOx in the atmosphere.
Defining microglial-synapse interactions
Authors: Eyo Ukpong , Molofsky Anna Victoria
Published: September 2023

The brain’s resident macrophages have many roles beyond synaptic pruning
Future generations are watching
Authors: Parikh Sudip
Published: September 2023

In many ways, the current US scientific enterprise is the intellectual descendant of 87 scientists who gathered in Philadelphia 175 years ago to establish the American Association for the Advancement of Science (AAAS, the publisher of
Science
). They joined disparate, scattered scientific disciplines to identify and address key challenges of the day. Today’s research community and AAAS itself are reflections of their backgrounds and actions—for better or worse. Fairly or not, society judges the AAAS founders by the consequences of their choices for today. When future generations reflect upon the state of the world and science’s role in shaping it, will they celebrate what AAAS and the research community have done?
Klebsiella
phage KP34gp57 capsular depolymerase structure and function: from a serendipitous finding to the design of active mini-enzymes against
K. pneumoniae
Authors: Maciejewska Barbara , Squeglia Flavia , Latka Agnieszka , Privitera Mario , Olejniczak Sebastian , Switala Paulina , Ruggiero Alessia , Marasco Daniela , Kramarska Eliza , Drulis-Kawa Zuzanna , Berisio Rita
Published: September 2023

Virion-associated depolymerases are large trimeric and multi-domain proteins that constitute the phage arsenal to degrade the polysaccharide layers in their bacterial host. Thus, as recombinant proteins, they are endowed with huge potential in biotechnology and medicine. In this study, we elucidated the structural and functional features of the capsular depolymerase KP34gp57 from the
Klebsiella
phage KP34. Based on the crystal structure and site-directed mutagenesis, we localized the key catalytic residues in an intra-subunit deep groove. Moreover, we engineered several N- and C-terminally truncated versions of KP34gp57 to dissect the role of each domain in the enzyme’s stability and catalytic activity. Serendipitously, our studies revealed C-terminally trimmed KP34gp57 variants that did not trimerize and were sufficiently stable to preserve full catalytic activity as monomers. The elaboration of trimmed monomeric and fully active phage depolymerases is innovative in the field, as no previous example exists apart from bacterial enzymes. Mini phage depolymerases can be optionally combined within chimeric enzymes to extend their activity range, facilitating their use in stand-alone treatments. Moreover, the intra-subunit and inter-subunit locations of the catalytic pocket in phage depolymerases might suggest differences in their evolutionary origin.

IMPORTANCE

In this work, we determined the structure of
Klebsiella
phage KP34p57 capsular depolymerase and dissected the role of individual domains in trimerization and functional activity. The crystal structure serendipitously revealed that the enzyme can exist in a monomeric state once deprived of its C-terminal domain. Based on the crystal structure and site-directed mutagenesis, we localized the key catalytic residues in an intra-subunit deep groove. Consistently, we show that C-terminally trimmed KP34p57 variants are monomeric, stable, and fully active. The elaboration of monomeric, fully active phage depolymerases is innovative in the field, as no previous example exists. Indeed, mini phage depolymerases can be combined in chimeric enzymes to extend their activity ranges, allowing their use against multiple serotypes.
From divergent to convergent plate boundary: A ca. 200 Ma Wilson cycle recorded by ultrahigh-pressure eclogites in the Dora-Maira Massif, Western Alps
Authors: Chen Xin , Schertl Hans-Peter , Chopin Christian , Lin Chenggui , Lin Hao , Li Haiquan , Lv Junleng , Nowlan Elke Ursula
Published: September 2023

Sparse eclogite exposure in accretionary-to-collisional orogens cannot only reveal the sites of ancient subduction zones and plate boundaries, but also elucidate the multi-stage tectonic evolution in the Wilson cycle. The southern part of the Dora-Maira Massif in the Western Alps is well known for its ultrahigh-pressure (UHP) rocks and contains small occurrences of petrographically distinct types of eclogite. Due to the lack of detailed geochronological and geochemical data on these rocks, the nature of their protolith and related geodynamic setting has remained unknown. In the current study, 33 samples from 13 localities were studied by whole-rock major- and trace-element analysis, and a selection of the samples were studied using Sr-Nd-Hf isotopes, as well as high-resolution elemental mapping and U-Pb geochronology of zircon. According to macroscopic appearance, petrography, chemical composition, and principal-component analysis of multi-elements, two major types are distinguished. Light-colored eclogite is phengite-rich, commonly foliated, bears kyanite and quartz/coesite, shows relatively high MgO, K2O, SiO2, εNd(t) (−2.2 to +1.4), and εHf(t) (+3.5 to +7), with a protolith geochemically similar to an enriched-type mid-oceanic-ridge basalt (E-MORB). Dark eclogite generally is massive, rutile-rich, shows higher values of Ti, Fe, P, Nb, and Zr, εNd(t) values between −2.8 and −0.8, εHf(t) values between −6.1 and −3.2, with an oceanic island basalt (OIB)-type protolith composition. Magmatic zircon cores, which are characterized by steep heavy rare earth element (HREE) patterns and negative Eu anomalies, yield consistent protolith ages of ca. 253−252 Ma in both eclogite types. Metamorphic zircon domains with flat HREE patterns and insignificant Eu anomalies yield a younger mean age of ca. 34 Ma, which is the age commonly assigned to eclogite-facies UHP metamorphism. Considering the various geochemical signatures of E-MORB- to OIB-like eclogites and the regional tectonic evolution, their protolith is best explained as rocks, which crystallized from rift-related basaltic magma, associated with the break-up of the Pangea Supercontinent that eventually resulted in the birth of the Piemonte-Liguria Ocean (Alpine Tethys Ocean) between the future Eurasia and Adria plates. Therefore, the UHP eclogites in the Dora-Maira Massif likely fingerprint a multi-stage tectonic evolution from divergent (continental extension, rifting) to convergent (subduction zone) plate boundary, corresponding to the beginning and end of a Wilson cycle. Incidentally, they reveal that mafic rocks in the Alpine basement units may not be polymetamorphic, but may actually consist of post-Variscan products that underwent only Alpine metamorphism.
Provision of evaluation and management visits by nurse practitioners and physician assistants in the USA from 2013 to 2019: cross-sectional time series study
Authors: Patel Sadiq Y , Auerbach David , Huskamp Haiden A , Frakt Austin , Neprash Hannah , Barnett Michael L , James Hannah O , Smith Laura Barrie , Mehrotra Ateev
Published: September 2023

Objective

To examine the proportion of healthcare visits are delivered by nurse practitioners and physician assistants versus physicians and how this has changed over time and by clinical setting, diagnosis, and patient demographics.

Design

Cross-sectional time series study.

Setting

National data from the traditional Medicare insurance program in the USA.

Participants

Of people using Medicare (ie, those older than 65 years, permanently disabled, and people with end stage renal disease), a 20% random sample was taken.

Main outcome measures

The proportion of physician, nurse practitioner, and physician assistant visits in the outpatient and skilled nursing facility settings delivered by physicians, nurse practitioners, and physician assistants, and how this proportion varies by type of visit and diagnosis.

Results

From 1 January 2013 to 31 December 2019, 276 million visits were included in the sample. The proportion of all visits delivered by nurse practitioners and physician assistants in a year increased from 14.0% (95% confidence interval 14.0% to 14.0%) to 25.6% (25.6% to 25.6%). In 2019, the proportion of visits delivered by a nurse practitioner or physician assistant varied across conditions, ranging from 13.2% for eye disorders and 20.4% for hypertension to 36.7% for anxiety disorders and 41.5% for respiratory infections. Among all patients with at least one visit in 2019, 41.9% had one or more nurse practitioner or physician assistant visits. Compared with patients who had no visits from a nurse practitioner or physician assistant, the likelihood of receiving any care was greatest among patients who were lower income (2.9% greater), rural residents (19.7%), and disabled (5.6%).

Conclusion

The proportion of visits delivered by nurse practitioners and physician assistants in the USA is increasing rapidly and now accounts for a quarter of all healthcare visits.
Measurable and immeasurable spread of knowledge for research impact: a reflection on the validated NutComp tool
Authors: Ball Lauren , Lepre Breanna , Van Dorssen Clare
Published: September 2023

Background

Contemporary research now includes effort to generate impact beyond the creation of new knowledge.

Methods

This report provides an illustrative case study of tactful research planning and dissemination for impact and provides an emerging pathway for others to holistically track reach, spread and uptake, to create a nuanced impact narrative.

Results

Nutrition Competence Tool (NutComp) is a validated tool that assesses the self-perceived competence of health professionals in providing nutrition care. Since open-access publication in 2015, it has been used by researchers and health professionals in 28 countries across 6 continents. The reach, spread, uptake and impact of NutComp are summarised, including indicators to support impact tracking for knowledge.

Conclusion

Given the complex phenomenon of research impact, careful planning is required to capture and attribute research impact.
Effectiveness of music-based interventions to address well-being in people with a vision impairment: a scoping review
Authors: Somani Nurbanu , Beukes Eldre , Street Alexander , Lindsay Rosie , Smith Lee , Allen Peter M
Published: September 2023

Objectives

The objectives of this review were to identify the types of music-based interventions and associated accessibility challenges for people who have visual impairment (VI) and their reported effects on psychological, physiological and social well-being.

Design

A scoping review was developed according to the Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist and guidelines. A narrative synthesis was conducted to map out the types of music-based interventions undertaken and to compare the therapeutic outcomes. The studies were evaluated according to the music reporting checklist.

Results

In total 5082 records were identified, 69 full-text articles were screened and 13 studies were included. Eleven studies included younger children and teenagers, two focused on adults with acquired VI. Ten studies involved active music therapy strategies and three used passive music listening. Eleven of the studies focused on social outcomes and two reported mental health. Although the studies reported that music-based intervention strategies improved psychosocial well-being in people with a VI, conclusions could not be drawn as robust outcome measures were not generally used and only four of the studies included any statistical analysis.

Conclusions

Although potential was evident, details of intervention protocols and training requirements were not sufficiently reported and further, high-quality evidence-based studies are required.
Incidence, characteristics and outcome of post-stroke recrudescence in the Chinese population: a single-centre observational study
Authors: Pu Ming-Jun , Yu Jia-Lun , Hu Xiao , Deng Lan , Chen Chu , Lv Xin-Ni , Li Zuo-Qiao , Wang Zi-Jie , Xie Peng , Li Qi
Published: September 2023

Objectives

The aim of our observational study was to investigate the incidence, clinical characteristics and outcome of post-stroke recrudescence (PSR) in the Chinese population.

Design and setting

Single-centre prospective observational study in China.

Participants

A total of 1114 patients who had a suspected stroke were prospectively screened from October 2020 to February 2022.

Outcome measures

The primary outcome was the proportion of patients with functional independence defined as a score of 0–2 on the modified Rankin Scale (mRS) at 3 months. Secondary outcomes were: early neurological improvement (ENI), defined as a National Institutes of Health Stroke Scale (NIHSS) score of 0 or an improvement of ≥2 points from admission at 24 hours; mortality within 3 months; stroke recurrence within 3 months and length of stay in hospital.

Results

A total of 959 patients with cerebral infarction and 30 patients without an available magnetic resonance imaging (MRI) scan were excluded. Among the 125 included patients, 27 cases of PSR (2.4%), 50 cases of transient ischaemic attack (TIA) (4.5%) and 48 cases of stroke mimics (SMs) (4.3%) were identified. A higher frequency of infection at admission (22.2% vs 2%, p=0.007) was observed in patients with PSR compared with patients with TIA, and a lower proportion of functional independence at 3 months (80% vs 98%, p=0.015) was seen. Patients with TIA had a higher frequency of ENI compared with patients with PSR and SMs (98% vs 59.3%, p<0.001; 98% vs 52.1%, p<0.001). Patients with PSR exhibited a higher frequency of grade 2 Fazekas deep white matter hyperintensity compared with those with SMs (33.3% vs 8.3%, p=0.010).

Conclusions

PSR is not uncommon in patients presenting with stroke symptoms and can be distinguished from TIA and SMs based on a combination of clinical features and trigger in the Chinese population. The neurological deficits of patients with PSR often resolve within several days following the resolution of the trigger.
Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer: protocol summary of the Emerald-Pancreas phase 1/expansion study located at Oxford University Hospital, UK
Authors: Teoh Suliana , Ooms Alexander , George Ben , Owens Rob , Chu Kwun-Ye , Drabble Joe , Robinson Maxwell , Parkes Matthew J , Swan Lynda , Griffiths Lucinda , Nugent Killian , Good James , Maughan Tim , Mukherjee Somnath
Published: September 2023

Introduction

Online adaptive MR-guided radiotherapy allows for dose escalation to pancreatic cancer while sparing surrounding critical organs. We seek to evaluate the safety of delivering hypofractionated five-fraction, three-fraction and single-fraction MR-guided stereotactic ablative radiotherapy (SABR) to the pancreas.

Methods and analysis

This is a single-centre three-arm phase 1 non-randomised safety study. Patients with localised pancreatic cancer will receive either 50 Gy in five (biological equivalent dose (BED10)=100 Gy), 39 Gy in three (BED10=90 Gy) or 25 Gy in a single fraction (BED10=87.5 Gy) MR-guided daily online adaptive radiotherapy. Each fractionation regimen will be assessed as independent cohorts to determine tolerability, assessed continuously using Bayesian conjugate posterior beta distributions. The primary endpoint of the study is to establish the safety of five-fraction, three-fraction and single-fraction MR-guided hypofractionation SABR in localised pancreatic cancer by assessing dose-limiting toxicities. Secondary endpoints include overall survival, progression-free survival, local control rates, overall control rate, resection rates, long-term toxicities and freedom from second-line chemotherapy. This study plans to also explore imaging and immune biomarkers that may be useful to predict outcome and personalise treatment. The trial will recruit up to 60 patients with a safety run-in.

Ethics and dissemination

The trial is approved by the West Midlands—Black Country Research Ethics Committee 22/WM/0122. The results will be disseminated via conference presentations, peer-reviewed scientific journals and submission to regulatory authorities. The data collected for the study, including individual participant data, will be made available to researchers on request to the study team and with appropriate reason, via octo-enquiries@oncology.ox.ac.uk. The shared data will be deidentified participant data and will be available for 3 years following publication of the study. Data will be shared with investigator support, after approval of a proposal and with a signed data access agreement.

Trial registration number

ISRCTN10557832
Identifying regional disparities of infant mortality rates in Bangladesh: insights from nationwide cross-sectional studies and a statistical modelling approach using linear mixed effects model with temporal variability
Authors: Islam Tarikul , Akter Noor Jahan
Published: September 2023

Objective

The major objective of this project is to find the best suitable model for district-wise infant mortality rate (IMR) data of Bangladesh over the period 2014–2020 that captures the regional variability and overtime variability of the data.

Design, setting and participants

Data from seven consecutive cross-sectional surveys that were conducted in Bangladesh between 2014 and 2020 as a part of the Sample Vital Registration System (SVRS) were used in this study. The study included a total of 13 173 (with 390 infant deaths), 17 675 (with 512 infant deaths), 17 965 (with 501 infant deaths), 23 205 (with 556 infant deaths), 23 094 (with 498 infant deaths), 23 090 (with 497 infant deaths) and 23 297 (with 495 infant deaths) complete cases from SVRS datasets for each respective year.

Method

A linear mixed effects model (LMM) with a quadratic trend over time in the fixed effects part and a nested random intercept, as well as a nested random slope for a linear trend over time in the part of the random effect, was implemented to describe the situation. This model was selected based on two popular selection criteria: Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC).

Results

The LMMs analysis results demonstrated statistically significant variations in IMR across different districts and over time. Examining the district-specific area under the logarithm of the IMR curves yielded valuable insights into the disparities in IMR among different districts and regions. Furthermore, a significant inverse relationship was observed between IMR and life expectancy at birth, underscoring the significance of mitigating IMR as a means to enhance population health outcomes.

Conclusion

This study accentuates district-wise and temporal variability when modelling IMR data and highlights regional heterogeneity in infant mortality rates in Bangladesh. Area-based programmes should be created for mothers residing in locations with a higher risk of IMR. Further research can examine socioeconomic elements generating these discrepancies.
Neoadjuvant chemoradiation therapy combined with immunotherapy for microsatellite stable ultra-low rectal cancer (CHOICE II): study protocol of a multicentre prospective randomised clinical trial
Authors: Zhou Leqi , Yu Guanyu , Wen Rongbo , Jia Hang , Zhang Tianshuai , Peng Zhiying , Fan Hao , Pan Anfu , Yu Yue , Zhu Xiaoming , Gong Haifeng , Gao Xianhua , Lou Zheng , Zhang Wei
Published: September 2023

Introduction

Neoadjuvant chemoradiotherapy (nCRT) could bring tumour shrinking and downstaging and increase the probability of organ preservation for patients with low rectal cancer. But for ultra-low rectal cancer, there is little possibility for organ preservation. Immunotherapy has been shown to have significant survival benefits in microsatellite instability-high patients but poor response in microsatellite stable (MSS) patients. Studies have demonstrated that radiotherapy and immunotherapy have synergistic effects in cancer treatment. There is no existing evidence about the clinical efficacy of immunotherapy combined with nCRT for patients with MSS ultra-low rectal cancer.

Method and analysis

This trial is an open-labelled multicentre prospective randomised controlled trial (NCT05215379) with two parallel groups and allocation ratio 1:1 (nCRT+immunotherapy vs nCRT group). Eligible participants will be aged 18–75 years, with a desire for anus preservation, confirmed cT1–3aN0–1M0rectal adenocarcinoma, confirmed MSS type, inferior margin of ≤5 cm from the anal verge. The primary endpoint of this trial is complete clinical response (cCR) rate. Immunotherapy is added after 1 week of chemoradiotherapy for two cycles, and then the patients will be administered two cycles of immunotherapy and CAPOX. The evaluations will be carried out after the completion of the whole neoadjuvant therapy. We expect the programme to improve the cCR rate and the quality of life for patients with ultra-low rectal cancer.

Ethics and dissemination

This trial was approved by the Ethics committee of Changhai Hospital and other medical centres (Grant number:CHEC2022-118). The results of this study will provide further insight into the clinical efficacy of immunotherapy in combination with nCRT in patients with MSS ultra-low rectal cancer.

Trial registration number

NCT05215379.
The role of stress and health behaviour in linking weight discrimination and health: a secondary data analysis in England
Authors: Hackett Ruth A , Jackson Sarah E , Corker Elizabeth , Steptoe Andrew
Published: September 2023

Objective

To examine the role of stress and health-risk behaviours in relationships between weight discrimination and health and well-being.

Design

Secondary data analysis of an observational cohort study.

Setting

The English Longitudinal Study of Ageing.

Participants

Data were from 4341 adults (≥50 years) with overweight/obesity.

Primary outcome measures

We tested associations between perceived weight discrimination at baseline (2010/2011) and self-rated health, limiting long-standing illness, depressive symptoms, quality of life and life satisfaction over 4-year follow-up (2010/2011; 2014/2015). Potential mediation by stress exposure (hair cortisol) and health-risk behaviours (smoking, physical inactivity, alcohol consumption) was assessed.

Results

Cross-sectionally, perceived weight discrimination was associated with higher odds of fair/poor self-rated health (OR=2.05 (95% CI 1.49 to 2.82)), limiting long-standing illness (OR=1.76 (95% CI 1.29 to 2.41)) and depressive symptoms (OR=2.01 (95% CI 1.41 to 2.85)) and lower quality of life (B=−5.82 (95% CI −7.01 to −4.62)) and life satisfaction (B=−2.36 (95% CI −3.25 to −1.47)). Prospectively, weight discrimination was associated with higher odds of fair/poor self-rated health (OR=1.63 (95% CI 1.10 to 2.40)) and depressive symptoms (OR=2.37 (95% CI 1.57 to 3.60)) adjusting for baseline status. Those who reported discrimination had higher hair cortisol concentrations (B=0.14 (95% CI 0.03 to 0.25)) and higher odds of physical inactivity (OR=1.90 (95% CI 1.18 to 3.05)). These variables did not significantly mediate associations between discrimination and health outcomes.

Conclusions

Weight discrimination is associated with poor health and well-being. While this discrimination is associated with stress exposure and physical inactivity, these variables explain little of the association between discrimination and poorer outcomes.
Evaluation of the effectiveness and safety of oral vancomycin versus placebo in the prevention of recurrence ofClostridioides difficileinfection in patients under systemic antibiotic therapy: a phase III, randomised, double-blind clinical trial
Authors: San-Juan Rafael , Origuen Julia , Campion Karen , Fernández-Ruiz Mario , Diaz-Pollan Beatriz , Callejas-Diaz Alejandro , Candela Giancarlo , Orellana Maria Angeles , Lora David , Llorente Muñoz Irene , Garcia Maria Teresa , Martinez-Uña Maite , Ferrari Jose Miguel , Aguado Jose M
Published: September 2023

Introduction

Clostridioides difficileinfection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT.

Methods and analysis

We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group).

Ethics and dissemination

Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital ‘12 de Octubre’ (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders.

Trial registration number

NCT05320068.
Role of cultural brokering in advancing holistic primary care for diabetes and obesity: a participatory qualitative study
Authors: Luig Thea , Ofosu Nicole N , Chiu Yvonne , Wang Nancy , Omar Nasreen , Yip Lydia , Aleba Sarah , Maragang Kiki , Ali Mulki , Dormitorio Irene , Lee Karen K , Yeung Roseanne O , Campbell-Scherer Denise
Published: September 2023

Objectives

Diabetes and obesity care for ethnocultural migrant communities is hampered by a lack of understanding of premigration and postmigration stressors and their impact on social and clinical determinants of health within unique cultural contexts. We sought to understand the role of cultural brokering in primary healthcare to enhance chronic disease care for ethnocultural migrant communities.

Design and setting

Participatory qualitative descriptive–interpretive study with the Multicultural Health Brokers Cooperative in a Canadian urban centre. Cultural brokers are linguistic and culturally diverse community health workers who bridge cultural distance, support relationships and understanding between providers and patients to improve care outcomes. From 2019 to 2021, we met 16 times to collaborate on research design, analysis and writing.

Participants

Purposive sampling of 10 cultural brokers representing eight different major local ethnocultural communities. Data include 10 in-depth interviews and two observation sessions analysed deductively and inductively to collaboratively construct themes.

Results

Findings highlight six thematic domains illustrating how cultural brokering enhances holistic primary healthcare. Through family-based relational supports and a trauma-informed care, brokering supports provider–patient interactions. This is achieved through brokers’ (1) embeddedness in community relationships with deep knowledge of culture and life realities of ethnocultural immigrant populations; (2) holistic, contextual knowledge; (3) navigation and support of access to care; (4) cultural interpretation to support health assessment and communication; (5) addressing psychosocial needs and social determinants of health and (6) dedication to follow-up and at-home management practices.

Conclusions

Cultural brokers can be key partners in the primary care team to support people living with diabetes and/or obesity from ethnocultural immigrant and refugee communities. They enhance and support provider–patient relationships and communication and respond to the complex psychosocial and economic barriers to improve health. Consideration of how to better enable and expand cultural brokering to support chronic disease management in primary care is warranted.
Looking at the fringes of MedTech innovation: a mapping review of horizon scanning and foresight methods
Authors: Garcia Gonzalez-Moral Sonia , Beyer Fiona R , Oyewole Anne O , Richmond Catherine , Wainwright Luke , Craig Dawn
Published: September 2023

Objectives

Horizon scanning (HS) is a method used to examine signs of change and may be used in foresight practice. HS methods used for the identification of innovative medicinal products cannot be applied in medical technologies (MedTech) due to differences in development and regulatory processes. The aim of this study is to identify HS and other methodologies used for MedTech foresight in support to healthcare decision-making.

Method

A mapping review was performed. We searched bibliographical databases including MEDLINE, Embase, Scopus, Web of Science, IEEE Xplore and Compendex Engineering Village and grey literature sources such as Google, CORE database and the International HTA database. Our searches identified 8888 records. After de-duplication, and manual and automated title, abstracts and full-text screening, 49 papers met the inclusion criteria and were data extracted.

Results

Twenty-five single different methods were identified, often used in combination; of these, only three were novel (appearing only once in the literature). Text mining or artificial intelligence solutions appear as early as 2012, often practised in patent and social media sources. The time horizon used in scanning was not often justified. Some studies regarded experts both as a source and as a method. Literature searching remains one of the most used methods for innovation identification. HS methods were vaguely reported, but often involved consulting with experts and stakeholders.

Conclusion

Heterogeneous methodologies, sources and time horizons are used for HS and foresight of MedTech innovation with little or no justification provided for their use. This review revealed an array of known methods being used in combination to overcome the limitations posed by single methods. The review also revealed inconsistency in methods reporting, with a lack of any consensus regarding best practice. Greater transparency in methods reporting and consistency in methods use would contribute to increased output quality to support informed timely decision-making.
Protocol for a double-blinded randomised controlled trial to assess the effect of faecal microbiota transplantations on thyroid reserve in patients with subclinical autoimmune hypothyroidism in the Netherlands: the IMITHOT trial
Authors: Fenneman Aline C , Rampanelli Elena , van der Spek Anne H , Fliers Eric , Nieuwdorp Max
Published: September 2023

Background

Hashimoto’s thyroiditis (HT) is a common endocrine autoimmune disease affecting roughly 5% of the general population and involves life-long treatment with levothyroxine, as no curative treatment yet exists. Over the past decade, the crosstalk between gut microbiota and the host immune system has been well-recognised, identifying the gut microbiome as an important factor in host health and disease, including susceptibility to autoimmune diseases. Previous observational studies yielded a link between disruption of the gut microbiome composition and HT. This is the first study that investigates the potential of restoring a disrupted gut microbiome with faecal microbiota transplantations (FMTs) to halt disease progression and dampen autoimmunity.

Methods and analysis

The IMITHOT trial is a randomised, double-blinded, placebo-controlled study evaluating either autologous or allogenic FMTs in medication-naïve patients with subclinical autoimmune hypothyroidism. In total, 34 patients will be enrolled to receive either three allogenic or autologous FMTs. FMT will be made of fresh stool and directly administered into the duodenum. Patients will be evaluated at baseline before the first FMT is administered and at 6, 12 and 24 months post-intervention to assess efficacy and adverse events. The primary outcome measure will be the net incremental increase (incremental area under the curve) on thyrotropin-stimulated free thyroxine and free triiodothyronine release at 6 and 12 months compared with baseline. Results will be disseminated via peer-reviewed journals and international conferences. The recruitment of the first patient and donor occurred on 18 December 2019.

Ethics and dissemination

Ethics approval was obtained from the hospital Ethics Committee (Medical Ethics Committee) at Amsterdam University Medical Center. The trial’s outcomes offer high-quality evidence that aids in unveiling distinct patterns within the gut microbiota potentially associated with improved thyroid function. Consequently, this may open avenues for the future clinical applications of microbial-targeted therapy in individuals at risk of developing overt HT.

Trial registration number

NL7931.
Using co-creation focus groups to customise a remote multidomain programme designed to increase dementia literacy
Authors: Wittich Walter , Kröger Edeltraut , Aubin Gabrielle , Fadhlaoui Asma , Anderson Nicole D , Ben Gaied Nouha , Itzhak Inbal , Belleville Sylvie
Published: September 2023

Objectives

To adapt the content and functionalities ofBrain Health PRO,a web-based multidomain program designed to increase dementia literacy, to the context and needs of users, providers and community organisations across Québec, Canada.

Design

Five consecutive qualitative co-creation focus group sessions 30–90 min in duration each, exploring potential barriers and facilitators to usability, accessibility, comprehensibility, participant recruitment and retention.

Setting

Virtual meetings.

Participants

A 15-member team based in Québec and Ontario, Canada, consisting of 9 researchers (including a graduate student and the project coordinator), representing occupational therapy, sensory rehabilitation, neuropsychology, psychology, health science and research methods, 3 informal caregivers of older adults living with cognitive decline and 3 members of the Federation of Quebec Alzheimer Societies.

Data analysis

Session recordings were summarised through both qualitative description and thematic analysis.

Results

The synthesised recommendations included adjustments around diversity, the complexity and presentation styles of the materials, suggestions on refining the web interface and the measurement approaches; it influenced aspects of participant recruitment, retention efforts and engagement with the content ofBrain Health PRO.

Conclusions

Co-creation in dementia prevention research is important because it involves collaboration between researchers, community support and service providers, and persons with lived experience as care providers, in the design and implementation of clinical studies. This approach helps to ensure that the content and presentation of educational material is relevant and meaningful to the target population and those involved in its delivery, and it leads to a greater understanding of their needs and perspectives.
Evaluation of hearing levels and vestibular function and the impact on cognitive performance in (pre)-symptomatic patients with DFNA9: protocol for a prospective longitudinal study (Rosetta study)
Authors: Gommeren Hanne , Moyaert Julie , Bosmans Joyce , Mertens Griet , Cras Patrick , Engelborghs Sebastiaan , Van Ombergen Angelique , Gilles Annick , Van Dam Debby , Van Rompaey Vincent
Published: September 2023

Introduction

Untreated hearing loss is the largest potentially modifiable risk factor for dementia. Additionally, vestibular dysfunction has been put forward as a potential risk factor for accelerated cognitive decline. Patients with Deafness Autosomal Dominant 9 (DFNA9) present with progressive sensorineural hearing loss and bilateral vestibulopathy and show significantly worse results in cognitive performance compared with a cognitively healthy control group. This highlights the need for adequate treatment to prevent further cognitive decline. This study aims to determine how hearing and vestibular function evolve in (pre-)symptomatic carriers of the p.Pro51Ser mutation in theCOCHgene and how this impacts their cognitive performance and health-related quality of life.

Methods and analysis

A prospective, longitudinal evaluation of hearing, vestibular function and cognitive performance will be acquired at baseline, 1-year and 2-year follow-up. A total of 40 patients with DFNA9 will be included in the study. The study will be a single-centre study performed at the ORL department at the Antwerp University Hospital (UZA), Belgium. The control group will encompass cognitively healthy subjects, already recruited through the GECkO study. The primary outcome measure will be the Repeatable Battery for the Assessment of Neuropsychological Status adjusted for the Hearing-Impaired total score. Secondary outcome measures include Cortical Auditory-Evoked Potentials, vestibular assessments and health-related quality of life questionnaires. The expected outcomes will aid in the development of gene therapy by providing insight in the optimal time window for the application of gene therapy for the inner ear.

Ethics and dissemination

The ethical committee of UZA approved the study protocol on 19 December 2022 (protocol number B3002022000170). All participants have to give written initial informed consent in accordance with the Declaration of Helsinki. Results will be disseminated to the public through conference presentations, lectures and peer-reviewed scientific publications.
Patient-reported outcomes in clinical HIV care: protocol for a single-centre, multistage, mixed-methods study in Denmark
Authors: Borchmann Olivia , Weis Nina , Hansen Ann-Brit Eg , Storgaard Merete , Fetters Michael D , Chandanabhumma P Paul , Moseholm Ellen
Published: September 2023

Introduction

People with HIV-1 (PWH) have worse health-related quality of life (HRQoL) compared with the general population. Using patient-reported outcomes (PROs) may help reorient the focus of HIV care towards improving HRQoL. This study aims to develop, implement and evaluate the use of PROs in HIV care.

Methods and analysis

This is a Danish single-centre, multistage mixed-methods study consisting of four substudies (studies I–IV). Study I is a qualitative focus group interview study aiming to identify relevant PRO domains, and barriers and benefits to PRO use. Participants are 5–10 PWH and 5–10 HIV healthcare providers (HCPs). Data are thematically analysed. Results will guide the design of a PRO measure (PROM). Study II is a quantitative study aiming to assess PWH’s willingness and ability to engage with PRO. All PWH are consecutively invited to complete the PROMs before their next consultations. Demographic data are collected at enrolment. Differences between PWH who do/do not complete the PROMs are assessed. Study III is a quantitative before-and-after study aiming to assess the impact of PRO use on HCP awareness. Participants are all who complete the PROMs in Study II. In contrast to study II, HCPs are notified of the PROM results. The number of problems documented by the HCP in patients’ medical records during studies II and III are compared using χ2tests. Multiple regression models are used to identify factors associated with HCP awareness. Study IV is a qualitative study aiming to explore PWH and HCP experiences of using PROs. Participants are 15–20 PWH and 10–15 HCP. Data are collected from participant observation of PRO consultations and individual interviews. Data are analysed thematically.

Ethics and dissemination

This study is approved by the Danish Data Protection Agency. Participants will provide written consent prior to participation. Results will be published in peer-reviewed journals.
Significance and structure of clinical research in the UK: an introduction for gastroenterology and hepatology nurses
Authors: Olsen Billye J , Kemp Karen , Campbell Rachel , Kumar Shaila , Monje-Garcia Laura , Sebastian Shaji , Iqbal Tariq H , Radford Shellie Jean
Published: September 2023

This is the first of two articles from the joint British Society of Gastroenterology Nurses association and Research Committee working group. The group is dedicated to signposting and improving access to research for specialist nurses working in gastroenterology and hepatology. This article is an introduction to the significance and structure of the National Institute for Health Research clinical research landscape in the UK and the importance of encouraging nurse engagement in research. This paper describes and ‘demystifies’ the clinical trials infrastructure in the UK, which is one of the most organised in the world. Going forwards this working group will organise and conduct educational events encouraging specialist nurses to become more aware of and engage in clinical research in their area of practice.
Comparison of migration rates between traditional and tunneled adductor canal block catheters: a randomized controlled trial
Authors: Gleicher Yehoshua , dos Santos Fernandes Hermann , Peacock Sharon , Alekberli Tural , Di Grazia Vitaliano , Estrellas Regine , Wolfstadt Jesse , Matelski John , Siddiqui Naveed
Published: September 2023

Introduction

Total knee arthroplasty is associated with significant postoperative pain. Continuous adductor canal blocks via an inserted adductor canal catheter are effective analgesia interventions with the advantage of decreasing quadriceps weakness and the potential of extending the analgesic effect. The classical adductor canal catheter insertion technique may have a high likelihood of catheter dislodgement out of the canal. The interfascial plane between the sartorius muscle and femoral artery (ISAFE) approach has the potential of decreasing the adductor canal catheter migration. The purpose of this study was to evaluate the incidence of catheter dislodgment to outside the adductor canal, for ISAFE and classical approaches. We hypothesized that ISAFE approach would result in a lower dislodgment rate.

Methods

Ninety-seven patients for unilateral total knee arthroplasty were included and randomized to either ISAFE intervention group or conventional group. The primary outcome was the incidence of adductor canal catheter dislodged to outside the adductor canal, on ultrasound evaluation, 24 hours after the surgery. Secondary outcomes were pain scores, opioid consumption and continuous adductor canal block related complications for the first 48 hours after surgery.

Results

The catheters placed using ISAFE approach had a lower rate of dislodgement in comparison to the control group (18.6% vs 44.9%, respectively, p=0.01), at 24 hours after surgery; and lower pain scores for rest, on the first two postoperative days.

Conclusions

ISAFE group had a significantly lower rate of dislodgement at 24 hours. The continuous adductor canal block analgesic benefit for knee arthroplasty depends on the position of the tip of the catheter inside the adductor canal.