bluuebunny/crossref_metadata_2025 huggingface dataset:
Majlis Taklim and The Path Of Women's Islamization In Indonesia
Authors: Latief Hilman , Madjid Abd.
Published: February 2023

Women's religious gatherings or Islamic study circles in Indonesian public spaces have become remarkably diverse. These informal learning groups, referred to as majlis taklim, have flourished across Indonesia, from large towns to small villages, and have become places for Muslim communities to increase their awareness of Islam and improve their spirituality. Although majlis taklim are non‐gendered organizations, they are formed in many places by women's groups with different social and economic backgrounds. This paper analyzes the adaptability of women‐run majlis taklim in terms of offering and religious discourse to transform society's spiritual and social lives. Apart from nurturing members' self‐spiritual feelings, the models of majlis taklim in formulating discourse and addressing women participants represent Islamization's trajectory in Indonesia, characterized by two types of religious orientations: domesticating discourse and empowerment efforts.
Re‐Visiting the Meaning of ‘ẓann’ in the Qurʾān
Authors: Galadari Abdulla
Published: February 2023

The Qurʾānic term, ‘ẓann,’ is usually understood and translated as conjecture. However, I argue that the Qurʾān uses ‘ẓann’ to mean dogmatic zeal or, in other words, being zealous to a certain belief. For conjecture, the Qurʾān uses the root ‘ḥ‐s‐b,’ such as, ‘ayaḥsabu.’ Although the Qurʾān may criticize some people's conjectures, it does not criticize the act of formulating opinions with the root ‘ḥ‐s‐b.’ However, the Qurʾān does criticize the act of ‘ẓann.’ This further emphasizes the distinction between conjecture and ‘ẓann,’ according to the Qurʾān. The main emphasis is that when the Qurʾān requires people to shun most ‘ẓann,’ it is argued that it is asking to shun zealous beliefs and dogmas, and it is not asking to shun the formulation of conjectures. The method used is philological, in which the cognates are analyzed in their contexts and compared with their uses in the Qurʾān. Defining ‘ẓann’ as dogmatic zeal rather than conjecture has far‐reaching implications in understanding Qurʾānic epistemology and the epistemic process it expects its audience to have.
Kaempferol‐3‐rhamnoside overaccumulation in flavonoid 3′‐hydroxylase tt7 mutants compromises seed coat outer integument differentiation and seed longevity
Authors: Niñoles Regina , Arjona Paloma , Azad Sepideh M. , Hashim Aseel , Casañ Jose , Bueso Eduardo , Serrano Ramón , Espinosa Ana , Molina Isabel , Gadea Jose
Published: February 2023

Seeds slowly accumulate damage during storage, which ultimately results in germination failure. The seed coat protects the embryo from the external environment, and its composition is critical for seed longevity. Flavonols accumulate in the outer integument. The link between flavonol composition and outer integument development has not been explored.

Genetic, molecular and ultrastructural assays on loss‐of‐function mutants of the flavonoid biosynthesis pathway were used to study the effect of altered flavonoid composition on seed coat development and seed longevity.

Controlled deterioration assays indicate that loss of function of the flavonoid 3′ hydroxylase gene TT7 dramatically affects seed longevity and seed coat development. Outer integument differentiation is compromised from 9 d after pollination in tt7 developing seeds, resulting in a defective suberin layer and incomplete degradation of seed coat starch. These distinctive phenotypes are not shared by other mutants showing abnormal flavonoid composition. Genetic analysis indicates that overaccumulation of kaempferol‐3‐rhamnoside is mainly responsible for the observed phenotypes. Expression profiling suggests that multiple cellular processes are altered in the tt7 mutant.

Overaccumulation of kaempferol‐3‐rhamnoside in the seed coat compromises normal seed coat development. This observation positions TRANSPARENT TESTA 7 and the UGT78D1 glycosyltransferase, catalysing flavonol 3‐O‐rhamnosylation, as essential players in the modulation of seed longevity.
Persulfidation protects from oxidative stress under nonphotorespiratory conditions in Arabidopsis
Authors: García‐Calderón Margarita , Vignane Thibaut , Filipovic Milos R. , Ruiz M. Teresa , Romero Luis C. , Márquez Antonio J. , Gotor Cecilia , Aroca Angeles
Published: February 2023

Hydrogen sulfide is a signaling molecule in plants that regulates essential biological processes through protein persulfidation. However, little is known about sulfide‐mediated regulation in relation to photorespiration.

Here, we performed label‐free quantitative proteomic analysis and observed a high impact on protein persulfidation levels when plants grown under nonphotorespiratory conditions were transferred to air, with 98.7% of the identified proteins being more persulfidated under suppressed photorespiration. Interestingly, a higher level of reactive oxygen species (ROS) was detected under nonphotorespiratory conditions.

Analysis of the effect of sulfide on aspects associated with non‐ or photorespiratory growth conditions has demonstrated that it protects plants grown under suppressed photorespiration. Thus, sulfide amends the imbalance of carbon/nitrogen and restores ATP levels to concentrations like those of air‐grown plants; balances the high level of ROS in plants under nonphotorespiratory conditions to reach a cellular redox state similar to that in air‐grown plants; and regulates stomatal closure, to decrease the high guard cell ROS levels and induce stomatal aperture. In this way, sulfide signals the CO2‐dependent stomata movement, in the opposite direction of the established abscisic acid‐dependent movement.

Our findings suggest that the high persulfidation level under suppressed photorespiration reveals an essential role of sulfide signaling under these conditions.
Seed priming can enhance and retain stress tolerance in ensuing generations by inducing epigenetic changes and trans‐generational memory
Authors: Louis Noble , Dhankher Om Parkash , Puthur Jos T.
Published: February 2023

The significance of priming in enhancing abiotic stress tolerance is well‐established in several important crops. Priming positively impacts plant growth and improves stress tolerance at multiple developmental stages, and seed priming is one of the most used methods. Seed priming influences the pre‐germinative metabolism that ensures proper germination, early seedling establishment, enhanced stress tolerance and yield, even under unfavourable environmental conditions. Seed priming involves pre‐exposure of seeds to mild stress, and this pre‐treatment induces specific changes at the physiological and molecular levels. Interestingly, priming can improve the efficiency of the DNA repair mechanism, along with activation of specific signalling proteins and transcription factors for rapid and efficient stress tolerance. Notably, such acquired stress tolerance may be retained for longer duration, namely, later developmental stages or even subsequent generations. Epigenetic and chromatin‐based mechanisms such as DNA methylation, histone modifications, and nucleosome positioning are some of the key molecular changes involved in priming/stress memory. Further, the retention of induced epigenetic changes may influence the priming‐induced trans‐generational stress memory. This review discusses known and plausible seed priming‐induced molecular mechanisms that govern germination and stress memory within and across generations, highlighting their role in regulating the plant response to abiotic stresses. Understanding the molecular mechanism for activation of stress‐responsive genes and the epigenetic changes resulting from seed priming will help to improve the resiliency of the crops for enhanced productivity under extreme environments.
Water permeability of different aerial tissues of carnations is related to cuticular wax composition
Authors: Cheng Guiping , Ye Changchun , Zhang Jiajun , Li Hongmei , Jiang Yueming , Duan Xuewu
Published: February 2023

Cuticular wax protects aerial plant tissues against uncontrolled water loss. To compare the differences among tissues, cultivars, and postharvest stages, we characterized the surface morphology, water permeability, and chemical composition of cuticular wax on the leaf, calyx, and petals of two carnation cultivars (‘Master’ and ‘Lady green’) at two postharvest stages. Obvious differences in these characteristics were found among tissues but not among cultivars or postharvest stages. The leaf surface was relatively smooth, whereas convex cells were observed on the petals. The mean minimum conductance of leaves was significantly higher than that of the calyx, followed by that of petals. It ranged between 8.8 × 10−4 m s−1 for ‘Lady green’ leaves at Stage II and 3.6 × 10−5 m s−1 for ‘Master’ petals at Stage I. Petal wax contained high concentrations of n‐alkanes, whereas primary alcohols dominated in leaf wax. The weighted average chain length (ACL) was higher in petal wax than in leaf wax; it ranged from 19.6 in ‘Lady green’ leaves to 24.14 in ‘Lady green’ petals at Stage I. In conclusion, carnation petals are characterized by numerous convex cells on both the adaxial and abaxial surfaces, and their main cuticular wax components, alkanes, have a higher ACL than leaf cuticular wax, which contributes to their higher water barrier property. The results provide further evidence for the association between cuticular chemical composition and the physiological function of the cuticle in blocking water transpiration.
The moderating role of attachment in the association between physiological synchrony in married couples and supportive behavior in the transition to parenthood
Authors: Fogel‐Yaakobi Shlomit , Golland Yulia , Levit‐Binnun Nava , Borelli Jessica L. , Mikulincer Mario , Shai Dana
Published: February 2023

Despite supportive behaviors playing a central role in intimate relationships, the extent to which physiological and psychological factors are involved in the quality of the observed spousal support, remains largely unknown. From a physiological stance, cardiac synchrony has been identified as an important component involved in dyadic interpersonal interactions. This study aims to examine whether individual differences in attachment determine, at least to some extent, whether cardiac synchrony enhances or impedes the quality of the observed spousal support. Specifically, this study examines whether attachment style moderates the biobehavioral link between positive cardiac synchrony and observed spousal support. A total of 58 couples expecting their first child participated in a supportive interaction while their cardiovascular responses were recorded, and the quality of their caregiving behaviors was coded. Results indicated that couples' cardiovascular dynamics were synchronized during the supportive interaction. Furthermore, attachment moderated the association between positive cardiac synchrony and the behavioral manifestation of support, such that cardiac synchrony was negatively associated with the quality of support when offered by caregivers with higher scores of attachment anxiety. Our findings show that for those caregivers who have higher levels of anxious attachment—being synchronized with their care seeking spouses is associated with difficulties in providing effective support. We discuss these findings in the context of the emotion regulation difficulties characteristic of anxious attachment patterns. These findings suggest that future work could benefit from performing comprehensive studies that consider physiological, behavioral, and psychological constructs simultaneously.
Does frequency or duration of standing breaks drive changes in glycemic response? A randomized crossover trial
Authors: Toledo Meynard John L. , Ainsworth Barbara E. , Gaesser Glenn A. , Hooker Steven P. , Pereira Mark A. , Buman Matthew P.
Published: February 2023

Intervention strategies to break up sitting have mostly focused on the modality (i.e., comparing different intensities and/or type of activities) and less on how frequency and duration of breaks affect health outcomes. This study compared the efficacy of different strategies to break up sitting time [i.e., high frequency, low duration standing breaks (HFLD) and low frequency, high duration standing breaks (LFHD)] in reducing postprandial glucose. Eleven sedentary and prediabetic adults (mean ± SD age = 46.8 ± 10.6 years; 73% female) participated in a cross‐over trial. There were six blocks that represented all potential combinations (ordering) of the study conditions and participants were randomly assigned to a block. Each participant underwent three 7.5‐h laboratory visits (1 week apart) where they engaged in either continuous sitting, HFLD, or LFHD condition while performing their usual office‐related tasks. Standardized breakfast and lunch meals were provided. Postprandial mean glucose, area under the curve (AUC), and incremental area under the curve (iAUC) were evaluated using mixed models. Compared with LFHD condition, the HFLD standing breaks condition significantly lowered mean glucose by −9.94 (−14.13, −5.74) mg/dL·h after lunch, and by −6.23 (−9.93, −2.52) mg/dL·h, for the total lab visit time. Overall, the results favor frequently interrupting sitting with standing breaks to improve glycemic control in individuals with prediabetes. Further studies are needed with larger sample sizes to confirm the results.
Sustainable development and sacrifice in the rural North
Authors: Stiernström Arvid
Published: February 2023

In this article, I examine how the grand narratives of sustainability, development and mining impact local governance in a Swedish municipality. I do this by studying three mining projects under implementation and relate them to notions of development and sacrifice to lend insights into what the new trends of mining in Europe outlined above mean for the rural North. I regard sustainable development as a political concept ascribed to activities (such as political programmes or investments). Based on ethnographic fieldwork in the Storuman municipality, I show how politicians, political parties and government administrators position themselves in relation to the three mining projects. I provide a detailed account of perceptions, responses and practices in a local government that engage with three mining companies seeking to open mines within the municipal borders. I show how a tug of war between ideas of sustainable development or survival through sacrifice depoliticises and stabilises a dominant political line in favour of mining within local politics. While the respondents differed in what they thought that sacrifice might lead to, ranging from environmental disaster and social suffering to economic prosperity, I reveal a process wherein sustainable development becomes translated into ‘that which must be sacrificed’.
How do I save cell therapy product's storage space?
Authors: Kim Grace H. , Patel Nita , Reich‐Slotky Ronit
Published: February 2023

Background

Availability of liquid nitrogen (LN2) freezer storage space is a major challenge for many transplant programs as they continue to grow and accumulate products. The recent trend of allogeneic grafts cryopreservation that started during the COVID‐19 pandemic, made the situation even worse requiring an increase in storage capacity. Multi‐compartment cryopreservation bags can help save storage space but can be tricky to use. Here, we describe the validation of muti‐compartment cryopreservation bags for the purpose of donor lymphocyte infusion (DLI) aliquots.

Methods

We validated the use of five compartment cryobags for cryopreservation of cell therapy products. Four products were cryopreserved using these bags and each compartment was tested post‐thaw for product volume distribution, total cell count recovery, and viability. Additionally, the integrity of both bag compartments and labels was assessed as well.

Results

All tested specimens met post‐thaw viability and TNC recovery acceptability criteria. Fill volume was optimized at 24–25 mL for acceptable volume distribution between aliquots. With proper heat sealing between compartments, all aliquots retain their integrity and cryopreservation labels were adherent and legible.

Conclusions

Muti‐compartment bags can be used successfully for cryopreservation of cell therapy products and increase storage capacity.
Mining of Stress-related Genes in Pigmented and Non-pigmented Rice using Gene Co-expression Network and Clustering Approaches
Authors: Zainal Abidin Rabiatul Adawiah , Aleng Nor Afiqah , Sew Yun Shin , Abu Bakar Norliza , Simoh Sanimah
Published: February 2023

Pigmented rice has been associated with stress-resistant traits, such as resistance to abiotic and biotic stresses, but the genes network that is responsible for such traits remains limited. Hence, this study aims to identify stress-related genes in the pigmented rice using computational approaches. The gene co-expression network was constructed using Pearson Correlation Coefficient (PCC) ≥ 0.9 among differentially expressed genes (DEGs) of trancriptomes between pigmented and non-pigmented rice. The gene co-expression network was clustered using Markov Cluster algorithm (MCL) to identify the functional modules and the hub genes for each module were determined. The functional analyses were performed to each module to determine the related gene ontology (GO) and pathway. Protein-protein interaction (PPI) from STRING database was used to validate the functional analyses. A total of 721 DEGs were used to construct the gene co-expression network of pigmented and non-pigmented rice varieties. Of these, 614 DEGs with 15,259 edges were identified by PCC. Using MCL, 10 clusters were identified in the gene co-expression network of pigmented and non-pigmented rice varieties. Three clusters were enriched with seven GO terms (i.e., response to stress, response to stimulus, transcription factor activity) that are related to stress-resistant traits, indicating the highly correlated genes were the stress-related genes. Interestingly, nine hub genes were found to be related to drought tolerance, disease resistance and hormone biosynthesis. Validation of hub genes using STRING database revealed that 48 hub genes were also connected in the PPI network, suggesting their potential as candidate proteins in stress-related traits. This study demonstrated that the molecular interaction network and the network clustering approach are efficient in identifying the stress-related genes, which could provide new insights in understanding plant responses to abiotic and biotic stresses.
Effect of Bee Pollen Kelulut Bees on HBA1C in Type 2 Diabetes Mellitus Patients
Authors: Setyawan Annaas Budi , Satria Andri Praja , Arung Enos Tangke , Paramita Swandari
Published: February 2023

Bee pollen has been used for generations to treat various diseases, including diabetes mellitus, because it inhibits alpha glucosidase enzyme. Two major problems suffered by patients with type 2 Diabetes Mellitus (DM) are linked to insulin resistance and impaired insulin secretion. They often occur in patients aged above 30 years and obese patients. High blood glucose and other complications, including increased HBA1C, are some of the risks faced by people with type 2 diabetes mellitus. This study aimed to reveal the efficacy of bee pollen in lowering the HBA1C levels of patients with type 2 DM. Subjects were gave bee pollen kelulut bees to the intervention group, twice a day in the morning during 4 weeks.  This study was quasy experimental research. It involved 30 patients who were divided into the intervention group and the control group. Data were analysis determined the differences in the control and intervention groups using the Mann Whitney test. The result of pre- and post-group was p value=0.001(<0.05), meaning that there was a significant difference in median cholesterol levels, while the result difference of the two groups was p value=0.033 (<0.05), implying there was a significant difference in HBA1C levels of the two groups. Bee pollen has been shown to lower HBA1C and have a potential as a non-pharmacological treatment in patients with type 2 DM.
Severity of coeliac disease and clinical management study when using a non-metabolised medication: a phase I pharmacokinetic study
Authors: Chretien Marc L , Bailey David G , Asher Linda , Parfitt Jeremy , Driman David , Gregor Jamie , Dresser George K
Published: February 2023

Objective

The non-metabolised antihistamine fexofenadine has oral absorption resulting from transporter activity. Uptake by enterocyte organic anion transporting polypeptides and efflux by an ATP-binding cassette transporter (P-glycoprotein) are primary determinants. Coeliac disease-mediated lesions to the small intestinal mucosa may alter oral absorption of the drug probe, fexofenadine.

Design

A phase I, open-label, single-dose, pharmacokinetic study

Setting

London, Ontario, Canada

Participants

Patients with coeliac disease (n=41) with positive serology and healthy individuals (n=48).

Main outcome measures

Patients with coeliac disease—duodenal histology and oral fexofenadine pharmacokinetics within a 3-week period. Healthy individuals—oral fexofenadine pharmacokinetics with water and grapefruit juice.

Results

Patients with coeliac disease were stratified by disease severity: Group A (n=15, normal), B+C (n=14, intraepithelial lymphocytosis with/without mild villous blunting) and D (n=12, moderate to severe villous blunting). Patients with coeliac disease in groups A, B+C and D and healthy individuals receiving water had similar fexofenadine AUC0–8(2038±304, 2259±367, 2128±410, 1954±138 ng.h/mL; p>0.05; mean±SEM) and Cmax (440±73, 513±96, 523±104, 453±32 ng/mL; p>0.05), respectively. These four groups all had higher fexofenadine AUC0–8(1063±59; p<0.01) and Cmax (253±18; p<0.05) compared with those for healthy individuals receiving grapefruit juice. Coeliac groups had a positive linear trend between disease severity and fexofenadine Tmax (2.0±0.3, 2.7±0.4, 3.1±0.5 hours; p<0.05).

Conclusions

Coeliac disease severity based on duodenal histopathology did not affect oral fexofenadine bioavailability. Increased Tmax suggested absorption distal to the duodenum (jejunum + ileum), where histology seems more normal which may be the key determinant. Patients with coeliac disease may not require consideration for alternative clinical drug management for a number of non-metabolised and transport-mediated medications.
Does problem-based learning improve patient empowerment and cardiac risk factors in patients with coronary heart disease in a Swedish primary care setting? A long-term prospective, randomised, parallel single randomised trial (COR-PRIM)
Authors: Andreae Christina , Tingström Pia , Nilsson Staffan , Jaarsma Tiny , Karlsson Nadine , Kärner Köhler Anita
Published: February 2023

Objectives

To investigate long-term effects of a 1-year problem-based learning (PBL) on self-management and cardiac risk factors in patients with coronary heart disease (CHD).

Design

A prospective, randomised, parallel single centre trial.

Settings

Primary care settings in Sweden.

Participants

157 patients with stable CHD completed the study. Subjects with reading and writing impairments, mental illness or expected survival less than 1 year were excluded.

Intervention

Participants were randomised and assigned to receive either PBL (intervention) or home-sent patient information (control group). In this study, participants were followed up at baseline, 1, 3 and 5 years.

Primary and secondary outcomes

Primary outcome was patient empowerment (Swedish Coronary Empowerment Scale, SWE-CES) and secondary outcomes General Self-Efficacy Scale (GSES), self-rated health status (EQ-VAS), high-density lipoprotein cholesterol (HDL-C), body mass index (BMI), weight and smoking. Outcomes were adjusted for sociodemographic factors.

Results

The PBL intervention group resulted in a significant improved change in SWE-CES over the 5-year period (mean (M), 39.39; 95% CI 37.88 to 40.89) compared with the baseline (M 36.54; 95% CI 35.40 to 37.66). PBL intervention group increased HDL-C level (M 1.39; 95% CI 1.28 to 1.50) compared with baseline (M 1.24; 95% CI 1.15 to 1.33) and for EQ-VAS (M 77.33; 95% CI 73.21 to 81.45) compared with baseline (M 68.13; 95% CI 63.66 to 72.59) while these outcomes remained unchanged in the control group. There were no significant differences in BMI, weight or scores on GSES, neither between nor within groups over time. The overall proportion of smokers was significantly higher in the control group than in the experimental group.

Conclusion

One-year PBL intervention had positive effect on patient empowerment, health status and HDL-C at a 5-year follow-up compared with the control group. PBL education aiming to improve patient empowerment in cardiac rehabilitation should account for sociodemographic factors.

Trial registration number

NCT01462799.
Development and validation of a prediction model for intrapartum cesarean delivery based on the artificial neural networks approach: a protocol for a prospective nested case–control study
Authors: Huang Chuanya , Luo Biru , Wang Guoyu , Chen Peng , Ren Jianhua
Published: February 2023

Introduction

Although intrapartum caesarean delivery can resolve dystocia, it would still lead to several adverse outcomes for mothers and children. The obstetric care professionals need effective tools that can help them to identify the possibility and risk factors of intrapartum caesarean delivery, and further implement interventions to avoid unnecessary caesarean birth. This study aims to develop a prediction model for intrapartum caesarean delivery with real-life data based on the artificial neural networks approach.

Methods and analysis

This study is a prospective nested case–control design. Pregnant women who plan to deliver vaginally will be recruited in a tertiary hospital in Southwest China from March 2022 to March 2024. The clinical data of prelabour, intrapartum period and psychosocial information will be collected. The case group will be the women who finally have a baby with intrapartum caesarean deliveries, and the control group will be those who deliver a baby vaginally. An artificial neural networks approach with the backpropagation algorithm multilayer perceptron topology will be performed to construct the prediction model.

Ethics and dissemination

Ethical approval for data collection was granted by the Ethics Committee of West China Second University Hospital, Sichuan University, and the ethical number is 2021 (204). Written informed consent will be obtained from all participants and they can withdraw from the study at any time. The results of this study will be published in peer-review journal.
What should the standard be for passing and mastery on the Critical Thinking about Health Test? A consensus study
Authors: Nsangi Allen , Aranza Diana , Asimwe Roger , Munaabi-Babigumira Susan Kyomuhendo , Nantongo Judith , Nordheim Lena Victoria , Ochieng Robert , Oyuga Cyril , Uwimana Innocent , Dahlgren Astrid , Oxman Andrew
Published: February 2023

Objective

Most health literacy measures rely on subjective self-assessment. The Critical Thinking about Health Test is an objective measure that includes two multiple-choice questions (MCQs) for each of the nine Informed Health Choices Key Concepts included in the educational resources for secondary schools. The objective of this study was to determine cut-off scores for passing (the border between having and not having a basic understanding and the ability to apply the nine concepts) and mastery (the border between having mastered and not having mastered them).

Design

Using a combination of two widely used methods: Angoff’s and Nedelsky’s, a panel judged the likelihood that an individual on the border of passing and another on the border of having mastered the concepts would answer each MCQ correctly. The cut-off scores were determined by summing up the probability of answering each MCQ correctly. Their independent assessments were summarised and discussed. A nominal group technique was used to reach a consensus.

Setting

The study was conducted in secondary schools in East Africa.

Participants

The panel included eight individuals with 5 or more years’ experience in the following areas: evaluation of critical thinking interventions, curriculum development, teaching of lower secondary school and evidence-informed decision-making.

Results

The panel agreed that for a passing score, students had to answer 9 of the 18 questions and for a mastery score, 14 out of 18 questions correctly.

Conclusion

There was wide variation in the judgements made by individual panel members for many of the questions, but they quickly reached a consensus on the cut-off scores after discussions.
Study protocol for PREPARE: a phase II feasibility/safety randomised controlled trial on PeRiopErative Penicillin AlleRgy TEsting
Authors: De Luca Joseph F , James Fiona , Vogrin Sara , Chua Kyra , Fletcher Luke , Nazareth Justin , Guha Ranjan , Hardidge Andrew , Douglas Ned , Carruthers John , Stewardson Andrew , Cheng Allen C , Johnson Douglas , Douglass Jo , Peel Trisha , Trubiano Jason
Published: February 2023

Introduction

Patient-reported antibiotic allergy labels (AALs) are common. These labels have been demonstrated to have a negative impact on use of appropriate antibiotics and patient-related health outcomes. These patients are more likely to receive suboptimal antibiotics, have increased rates of surgical site infections and are more likely to be colonised with multidrug-resistant organisms. Increasing recognition that antibiotic allergy forms a key part of good antimicrobial stewardship has led to calls for greater access to antibiotic allergy assessment.

PREPARE is a pilot randomised controlled trial of beta-lactam allergy assessment and point of care delabelling in perioperative patients utilising a validated antibiotic allergy assessment tool that has been repurposed into a smartphone application. The aim of the study is to assess the feasibility and safety of this approach in the perioperative outpatient setting.

Methods and analysis

Adult participants requiring elective surgery and are likely to require prophylactic intravenous antibiotics will be recruited. During the intervention phase, participants will be randomised to the intervention or control arm, with control patients receiving usual standard of care. Those randomised to intervention undertake a risk assessment via the smartphone application, with those deemed low risk proceeding to direct oral provocation with either a penicillin or cephalosporin. Study outcomes will be evaluated in the postintervention phase, 30 and 90 days after surgery.

Feasibility of intervention delivery and recruitment will be reported as proportions with respective 95% CIs. Participants who experience an antibiotic adverse event will be reported by group with respective 95% CIs and compared using modified Poisson regression model with robust SE estimation.

Ethics and dissemination

This protocol has received approval from the Austin Health human research and ethics committee, Heidelberg, Victoria, Australia (HREC/17/Austin/575). Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences.

Trial registration number

ACTRN12620001295932.
Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community–RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol
Authors: Furukawa Toshi A , Tajika Aran , Sakata Masatsugu , Luo Yan , Toyomoto Rie , Horikoshi Masaru , Akechi Tatsuo , Kawakami Norito , Nakayama Takeo , Kondo Naoki , Fukuma Shingo , Noma Hisashi , Christensen Helen , Kessler Ronald C , Cuijpers Pim , Wason James M S
Published: February 2023

Introduction

The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive–behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.

Methods and analysis

Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants’ characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50.

Ethics and dissemination

The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).

Trial registration number

UMIN000047124.
Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
Authors: Shah Tayyab , McCarthy Marianne , Nasir Irem , Archer Herb , Ragheb Elio , Kluger Jonathan , Kashyap Nitu , Paredes Carlos , Patel Prashant , Lu Jing , Kandel Prakash , Song Christopher , Khan Mustafa , Huang Haocheng , Ul Haq Faheem , Ahmad Rami , Howes Christopher , Cambi Brian , Lancaster Gilead , Cleman Michael , Dela Cruz Charles , Parise Helen , Lansky Alexandra
Published: February 2023

Objective

To evaluate the effect of colchicine and high-intensity rosuvastatin in addition to standard of care on the progression of COVID-19 disease in hospitalised patients.

Design

A pragmatic, open-label, multicentre, randomised controlled trial conducted from October 2020 to September 2021. Follow-up was conducted at 30 and 60 days. The electronic medical record was used at all stages of the trial including screening, enrolment, randomisation, event ascertainment and follow-up.

Setting

Four centres in the Yale New Haven Health System.

Participants

Non-critically ill hospitalised patients with COVID-19.

Interventions

Patients were randomised 1:1 to either colchicine plus high-intensity rosuvastatin in addition to standard of care versus standard of care alone. Assigned treatment was continued for the duration of index hospitalisation or 30 days, whichever was shorter.

Primary and secondary outcome measures

The prespecified primary endpoint was progression to severe COVID-19 disease (new high-flow or non-invasive ventilation, mechanical ventilation, need for vasopressors, renal replacement therapy or extracorporeal membrane oxygenation, or death) or arterial/venous thromboembolic events (ischaemic stroke, myocardial infarction, deep venous thrombosis or pulmonary embolism) evaluated at 30 days.

Results

Among the 250 patients randomised in this trial (125 to each arm), the median age was 61 years, 44% were women, 15% were Black and 26% were Hispanic/Latino. As part of the standard of care, patients received remdesivir (87%), dexamethasone (92%), tocilizumab (18%), baricitinib (2%), prophylactic/therapeutic anticoagulation (98%) and aspirin (91%). The trial was terminated early by the data and safety monitoring board for futility. No patients were lost to follow-up due to electronic medical record follow-up. There was no significant difference in the primary endpoint at 30 days between the active arm and standard of care arm (15.2% vs 8.8%, respectively, p=0.17).

Conclusions

In this small, open-label, randomised trial of non-critically ill hospitalised patients with COVID-19, the combination of colchicine and rosuvastatin in addition to standard of care did not appear to reduce the risk of progression of COVID-19 disease or thromboembolic events, although the trial was underpowered due to a lower-than-expected event rate. The trial leveraged the power of electronic medical records for efficiency and improved follow-up and demonstrates the utility of incorporating electronic medical records into future trials.

Trial registration

NCT04472611.
Maternal and child outcomes for pregnant women with pre-existing multiple long-term conditions: protocol for an observational study in the UK
Authors: Lee Siang Ing , Hope Holly , O’Reilly Dermot , Kent Lisa , Santorelli Gillian , Subramanian Anuradhaa , Moss Ngawai , Azcoaga-Lorenzo Amaya , Fagbamigbe Adeniyi Francis , Nelson-Piercy Catherine , Yau Christopher , McCowan Colin , Kennedy Jonathan Ian , Phillips Katherine , Singh Megha , Mhereeg Mohamed , Cockburn Neil , Brocklehurst Peter , Plachcinski Rachel , Riley Richard D , Thangaratinam Shakila , Brophy Sinead , Hemali Sudasinghe Sudasing Pathirannehelage Buddhika , Agrawal Utkarsh , Vowles Zoe , Abel Kathryn Mary , Nirantharakumar Krishnarajah , Black Mairead , Eastwood Kelly-Ann
Published: February 2023

Introduction

One in five pregnant women has multiple pre-existing long-term conditions in the UK. Studies have shown that maternal multiple long-term conditions are associated with adverse outcomes. This observational study aims to compare maternal and child outcomes for pregnant women with multiple long-term conditions to those without multiple long-term conditions (0 or 1 long-term conditions).

Methods and analysis

Pregnant women aged 15–49 years old with a conception date between 2000 and 2019 in the UK will be included with follow-up till 2019. The data source will be routine health records from all four UK nations (Clinical Practice Research Datalink (England), Secure Anonymised Information Linkage (Wales), Scotland routine health records and Northern Ireland Maternity System) and the Born in Bradford birth cohort. The exposure of two or more pre-existing, long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (a) antenatal, (b) peripartum, (c) postnatal and long-term and (d) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a core outcome set. Comparisons will be made between pregnant women with and without multiple long-term conditions using modified Poisson and Cox regression. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data. Federated analysis will be conducted for each dataset and results will be pooled using random-effects meta-analyses.

Ethics and dissemination

Approval has been obtained from the respective data sources in each UK nation. Study findings will be submitted for publications in peer-reviewed journals and presented at key conferences.
Availability of refractive error correction services in selected Zambian hospitals: a cross-sectional quantitative study
Authors: Kapatamoyo Esnart , Sialubanje Cephas , Muma Kangwa I M , Syakantu Gardner , Minnies Deon
Published: February 2023

Objective

To assess the availability of refractive error correction services (RECS) in selected Zambian hospitals.

Methods

Between October 2021 and March 2022, we conducted a cross-sectional study design among 20 eye health service providers selected from 20 public health facilities offering RECS in 20 districts from 8 provinces of Zambia. A stratified random sampling technique was used to select study participants. A questionnaire was developed based on the access to healthcare services framework and distributed via email to respondents to collect their perspectives on the availability of RECS.

Results

All 20 respondents returned the completed questionnaires. Most facilities met the Ministry of Health recommended equipment requirement, though tonometers were lacking in some facilities. Out of the 20 facilities, 75% reported having optometry technologists as the main staff offering eye health services; 10% had an ophthalmologist; no facility had an optometrist; none conducted school-based programmes and only 1 facility (5%) was able to dispense spectacles soon after refraction because it had a spectacle manufacturing workshop.

Conclusion

These findings show limited availability of RECS in the 20 health facilities. They also confirm that challenges in staffing levels, insufficient equipment and low rate of spectacle dispensing negatively affect availability of these services. Furthermore, insufficient infrastructure undermines service delivery. Addressing these challenges is cardinal to improving RECS delivery and enhancing universal eye healthcare coverage in Zambia.
Clinical characteristics, diagnosis, outcomes and lung microbiome analysis of invasive pulmonary aspergillosis in the community-acquired pneumonia patients
Authors: Ao Zhi , Xu Huan , Li Mengqi , Liu Huifang , Deng Min , Liu Yuliang
Published: February 2023

Background

Invasive pulmonary aspergillosis (IPA) remains underestimated in patients with community-acquired pneumonia (CAP). This study aims to describe clinical features and outcomes of IPA in CAP patients, assess diagnostic performance of metagenomic next-generation sequencing (mNGS) for IPA and analyse lung microbiome via mNGS data.

Methods

This retrospective cohort study included CAP patients from 22 April 2019 to 30 September 2021. Clinical and microbiological data were analysed. Diagnostic performance of mNGS was compared with traditional detection methods. The lung microbiome detected by mNGS was characterised and its association with clinical features was evaluated.

Main results

IPA was diagnosed in 26 (23.4%) of 111 CAP patients. Patients with IPA displayed depressed immunity, higher hospital mortality (30.8% vs 11.8%) and intensive care unit mortality (42.1% vs 17.5%) compared with patients without IPA. The galactomannan (GM) antigen test had the highest sensitivity (57.7%) in detecting theAspergillusspp, followed by mNGS (42.3%), culture (30.8%) and smear (7.7%). The mNGS, culture and smear had 100% specificity, while GM test had 92.9% specificity. The microbial structure of IPA significantly differed from non-IPA patients (p<0.001; Wilcoxon test). Nineteen different species were significantly correlated with clinical outcomes and laboratory biomarkers, particularly forStreptococcus salivarius,Prevotella timonensisandHuman betaherpesvirus 5.

Conclusions

Our results reveal that patients withAspergillusinfection tend to have a higher early mortality rate. The mNGS may be suggested as a complement to routine microbiological test in diagnosis of patients at risk ofAspergillusinfection. The lung microbiota is associated with inflammatory, immune and metabolic conditions of IPA, and thus influences clinical outcomes.
Energy expenditure, dietary intake and energy availability in female professional football players
Authors: Dasa Marcus Smavik , Friborg Oddgeir , Kristoffersen Morten , Pettersen Gunn , Plasqui Guy , Sundgot-Borgen Jorunn Kaiander , Rosenvinge Jan H
Published: February 2023

Objectives

To quantify energy expenditure and intake in professional female footballers playing on a national and/or international level. Second, to determine the prevalence of low energy availability among these players, defined as <30 kcal/kg fat-free mass (FFM)/day.

Methods

Fifty-one players completed a 14-day prospective observational study during the 2021/2022 football season. Energy expenditure was determined using the doubly labelled water method. Energy intake was assessed using dietary recalls, while global positioning system determined the external physiological load. Descriptive statistics, stratification and the correlation between explainable variables and outcomes were conducted to quantify the energetic demands.

Results

The mean energy expenditure for all players (22±4 years) was 2918±322 kcal. Mean energy intake was 2274±450 kcal, resulting in a discrepancy of ~22%. Carbohydrate intake was below the recommended guidelines on match day at 4.5±1.9 g/kg. The mean energy availability was 36.7±17.7 kcal/kg FFM/day on matchday and 37.9±11.7 kcal/kg FFM/day on training days, resulting in a prevalence of 36% and 23% for low energy availability during the observational period, respectively.

Conclusion

These elite female football players displayed moderate energy expenditure levels and failed to meet the recommended levels of carbohydrate intake. In conjunction with inadequate nutritional periodisation, this will likely hamper performance through inadequate muscle glycogen resynthesis. In addition, we found a considerable prevalence of low energy availability on match and training days.
Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis
Authors: Gottlieb Alice B , McInnes Iain B , Rahman Proton , Kollmeier Alexa P , Xu Xie L , Jiang Yusang , Sheng Shihong , Shawi May , Chakravarty Soumya D , Lavie Frederic , Mease Philip J
Published: February 2023

Objective

Evaluate relationship between radiographic progression and clinical outcomes in post hoc analyses of patients with psoriatic arthritis (PsA) receiving up to 2 years of guselkumab therapy in the phase 3, placebo-controlled, randomised trial, DISCOVER-2.

Methods

Biologic-naïve adults with active PsA (≥5 swollen joints /≥5 tender joints ; C reactive protein ≥0.6 mg/dL) were randomised to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then every 8 weeks (Q8W); or placebo→guselkumab 100 mg Q4W (week 24). Radiographs (hands/feet) at week 0, week 24, week 52 and week 100 were scored via PsA-modified van der Heijde-Sharp (vdH-S) methodology. In these post hoc analyses, mean changes in vdH-S scores were summarised according to achievement of American College of Rheumatology 20/50/70 response; low disease activity (LDA) defined by Disease Activity in Psoriatic Arthritis (DAPSA) ≤14 or Psoriatic ArthritiS Disease Activity Score (PASDAS) ≤3.2, or minimal/very low disease activity (MDA/VLDA); and normalised physical function (Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤0.5). Response rates for achieving MDA/VLDA and each component were determined among patients with and without radiographic progression (change in total vdH-S score >0.5). No formal hypothesis testing was performed.

Results

664 of 739 treated patients in DISCOVER-2 continued study treatment at week 52 and were included in these analyses. Mean changes in vdH-S scores from weeks 0 to 100 among all patients in the Q4W and Q8W groups were 1.7 and 1.5, respectively. Among all guselkumab-randomised patients, those who achieved ACR20/50/70, DAPSA LDA, PASDAS LDA, MDA, VLDA and HAQ-DI ≤0.5 (normalised physical function) had smaller mean changes in vdH-S scores than did non-responders at week 52 (0.2–1.2 vs 1.7–4.1) and week 100 (0.3–1.2 vs 2.0–4.6). Relative to patients with radiographic progression, those without progression were more likely to achieve the MDA criteria related to swollen and tender joint counts, patient-reported pain and global assessment, and normalised physical function through week 100.

Conclusion

In these post hoc analyses, the achievement of low levels of disease activity, including MDA, was associated with diminished rates of radiographic progression observed in patients receiving up to 2 years of guselkumab. Radiographic non-progressors were more likely to achieve patient-reported MDA criteria of minimal pain and normalised physical function compared with radiographic non-responders.

Trial registration number

NCT03158285.