bluuebunny/crossref_metadata_2025 huggingface dataset:
Fractural analysis, microstructural, mechanical and tribological behaviour of vanadium trioxide-reinforced copper metal matrix composite by ultrasonic-assisted stir casting technique
Authors: John Jabinth , Natarajan Selvakumar , Shi Jing , SC Vettivel
Published: September 2023

In this work, pure copper is reinforced with vanadium trioxide (V2O3) at various weight percentages, such as Cu–0.5V2O3, Cu–1V2O3, Cu–1.5V2O3, and Cu–2V2O3. This copper metal matrix composite (CMMC) with primary copper element and secondary V2O3 is fabricated through an ultrasonic-assisted stir casting technique. The uniform distribution of secondary particles is achieved using ultrasonic waves generated by the probe and mechanical stirrer. The characterization of developed CMMC is done by X-ray diffraction and energy-dispersive X-ray spectroscopy. The samples are subjected to grain measurement using an optical microscope, which showed the relationship between grain size and enhancement of mechanical properties. The fabricated samples are also subjected to mechanical testing to determine their tensile strength, ultimate strength, Vickers hardness and impact strength. Fractography is also done by using a scanning electron microscope to understand the mechanism for the failure of tensile specimens. Dry sliding wear behaviour is also carried out to determine the wear resistance of CMMC. The results of numerous experiments showed that the grain size of CMMC improved with V2O3 addition. The increased strength-to-weight ratio leads to obtaining better properties at low cost. The enhancement in wear behaviour and mechanical properties of CMMC also paves the way for a newly developed material with V2O3 as secondary reinforcement along with copper as the primary element to be used in various applications.
“Fake it or hide it till you make it”: A thematic analysis of hiding techniques in physical education among students in secondary school
Authors: Johansen Bjørn Tore , Kjær Ingirid Geirsdatter Heald , Hordvik Mats Melvold , Solstad Bård Erlend
Published: September 2023

Some students find engaging in physical education (PE) problematic or undesirable to the extent that it makes them adopt strategies to avoid taking part, also known as hiding techniques. There is a need to get a deeper understanding of hiding techniques as a behavioral strategy in PE, especially the underlying causes as to why students choose to engage in them. Hence, the purpose of the current study was two-fold: (a) to investigate the situations and activities in which students engage in hiding techniques in PE and (b) to elucidate students’ motives for engaging in these hiding techniques. 10 Norwegian ninth-grade students (six girls and four boys, all aged 14 years) participated in in-depth interviews using vignettes. Reflexive thematic analysis of the data revealed that hiding techniques can be characterized into active and passive hiding techniques. Active hiding techniques were divided into: “avoiding the ball,” “reducing effort,” and “social dizziness.” Passive hiding techniques were divided into: “forgetting gym clothing,” “faking soreness,” and “warming the bench.” Furthermore, the use of different hiding techniques was found to be situationally related and activity specific. The findings also revealed the following motives for using hiding techniques: low perceived competence, fear of failure, too high expectations, and exposure of perceived low athletic skills. The findings of the current study allow us to reflect on possible ways to organize PE to prevent the use of hiding techniques.
Splenic flexure mobilization and anastomotic leakage in anterior resection for rectal cancer: A multicentre cohort study
Authors: Rutegård Martin , Svensson Johan , Segelman Josefin , Matthiessen Peter , Lydrup Marie-Louise , Park Jennifer , Gerdin Anders , Sjöström Olle , Staffan Maria , Jangmalm Staffan , Royson Hanna , Tsimogiannis Konstantinos , Anderin Kajsa , Nygren Jonas , Hurtig Jennie , Golshani Parisa
Published: September 2023

Background and objective:

Some colorectal surgeons advocate routine splenic flexure mobilization (SFM) when performing anterior resection for rectal cancer to ensure a tension-free anastomosis. Meta-analyses of smaller studies suggest that this approach does not influence anastomotic leakage rates, but larger multicentre studies are needed to confirm the safety of a selective strategy. The aim of this study is to evaluate the impact of SFM on anastomotic leakage.

Methods:

This is a retrospective multicentre cohort study, comprising 1109 patients operated with anterior resection for rectal cancer in 2014–2018. Exposure was SFM, while anastomotic leakage within a year constituted the outcome. Stratified analyses were performed for type of mesorectal excision and surgical approach, as well as sensitivity analysis considering vascular tie placement. Multivariable Cox regression with hazard ratios (HRs) and 95% confidence intervals (CIs) was employed to adjust for confounding, while multiple imputation was used for missing data.

Results:

SFM was performed in 381 patients (34.4%). Anastomotic leakage occurred in 83 (21.8%) and 123 (20.3%) patients operated with and without SFM, respectively. SFM was neither clearly detrimental nor beneficial regarding anastomotic leakage (adjusted HR = 0.82; 95% CI: 0.59–1.15), with no apparent differences for total or partial mesorectal excision and minimally invasive or open surgery. Concurrent high vascular ligation did not impact these results, and there was no evidence of interaction from centers with a more common use of SFM.

Conclusions:

SFM did not seem to influence the risk of anastomotic leakage after anterior resection for rectal cancer, regardless of type of mesorectal excision, use of minimally invasive surgery, or high vascular ligation.
Infants’ emotional and social experiences during and after the transition to early childhood education and care
Authors: Gath Megan E , Herold Laura , Hunkin Elise , McNair Lynn J , Redder Bridgette , Rutanen Niina , White E Jayne
Published: September 2023

The socio-emotional experiences of infants during transitions to early childhood education and care (ECEC) and across their first year in these out-of-home contexts are not well known. In an international project across five countries (New Zealand, Finland, Australia, Scotland and the United States), observational data, video of key moments, plus re-probing interviews with parents and teachers concerning 10 infants (six females) aged 5–13 months were collected across the first year of ECEC. An embedded case study design was used to analyse infant experiences from both quantitative and qualitative perspectives. Findings indicated low positive affect on infants’ first day of ECEC that increased after the first week and throughout the first year of ECEC. Drop-off periods remained a time of negative emotionality for the first month of ECEC. Over time more positive emotional experiences were evident, with peer interactions fostering positive affect, activeness and involvement, while one-on-one interactions with teachers were an important context for interpersonal engagement and well-being. These findings shed light on the highly charged emotional experience for infants when they transition to institutional care, and how these might be ameliorated in practice.
A case of Lemierre’s syndrome causing panhypopituitarism, cavernous sinus thrombosis, ischaemic stroke and pulmonary embolism
Authors: Dewdney Charlotte J , Anderson Joseph J , Dewar Simon , Doubal Fergus , Burgess Frederick R , Subedi Deepak , Lyall Marcus J
Published: September 2023

Infection is a rare cause of panhypopituitarism and has not been reported in the context of Lemierre’s syndrome. We present the case of a previously well 19-year-old man, who presented acutely unwell with meningitis and sepsis. Fusobacterium necrophorum was isolated from peripheral blood cultures and identified on cerebrospinal fluid with 16S rDNA Polymerase Chain Reaction (PCR). Imaging demonstrated internal jugular vein thrombosis with subsequent cavernous venous sinus thrombosis. Pituitary function tests were suggestive of panhypopituitarism. The patient was diagnosed with Lemierre’s syndrome complicated by meningitis, cavernous sinus thrombosis, base of skull osteomyelitis, ischaemic stroke and panhypopituitarism. He was treated with 13 weeks of intravenous antibiotics followed by 3 weeks of oral amoxicillin, and anticoagulated with dalteparin then apixaban. His panhypopituitarism was managed with hydrocortisone, levothyroxine and desmopressin.
Inflammation in the proximal colon is a risk factor for the development of colorectal neoplasia in inflammatory bowel disease patients with primary sclerosing cholangitis
Authors: Jamil Omar K. , Shaw Dustin , Deng Zifeng , Dinardi Nicholas , Fillman Natalie , Khanna Shivani , Krugliak Cleveland Noa , Sakuraba Atsushi , Weber Christopher R. , Cohen Russell D. , Dalal Sushila , Jabri Bana , Rubin David T. , Pekow Joel
Published: September 2023

Background:

Patients with primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD) have an increased risk of developing colorectal neoplasia (CRN) in the proximal colon.

Objectives:

To evaluate whether duration and severity of inflammation are linked to the development of CRN in this population.

Design:

Retrospective, case–control chart review of patients with PSC and IBD at a tertiary care center.

Methods:

Disease activity was scored per colonic segment at each colonoscopy prior to the first instance of observed CRN using a modified Mayo endoscopic sub-score and histologic assessment. Patients in the CRN-positive group were compared to controls that did not.

Results:

In all, 72 PSC-IBD patients with no history of CRN were identified, 13 of whom developed CRN after at least one colonoscopy at our institution. Patients in the CRN-positive group had significantly more endoscopic ( p < 0.01) and histologic ( p < 0.01) inflammation in the right compared to the control group prior to the development of dysplasia. There was significantly greater endoscopic inflammation in the segment of the colon with a dysplastic lesion than other segments of the colon ( p = 0.018). Patients with moderate/severe lifetime endoscopic ( p = 0.02) or histologic inflammation ( p = 0.04) score had a lower probability of remaining free of dysplasia during follow-up. Nearly half of the patients with dysplasia had invisible lesions found on random biopsy.

Conclusions:

Endoscopic and histologic inflammation in the proximal colon are risk factors for CRN in patients with PSC-IBD. PSC-IBD patients frequently have subclinical inflammation, and these findings support the practice of regular assessment of disease activity and random biopsy of inflamed and uninflamed areas in patients with PSC with the goal of reducing inflammation to prevent the development of CRN.
Predictive biomarkers for immune checkpoint inhibitor response in urothelial cancer
Authors: Parent Pauline , Marcq Gautier , Adeleke Sola , Turpin Anthony , Boussios Stergios , Rassy Elie , Penel Nicolas
Published: September 2023

Immune checkpoint inhibitors (ICIs) are commonly used to treat patients with advanced urothelial cancer. However, a significant number of patients do not respond to ICI, and the lack of validated predictive biomarkers impedes the success of the ICI strategy alone or in combination with chemotherapy or targeted therapies. In addition, some patients experience potentially severe adverse events with limited clinical benefit. Therefore, identifying biomarkers of response to ICI is crucial to guide treatment decisions. The most evaluated biomarkers to date are programmed death ligand 1 expression, microsatellite instability/defective mismatch repair phenotype, and tumor mutational burden. Other emerging biomarkers, such as circulating tumor DNA and microbiota, require evaluation in clinical trials. This review aims to examine these biomarkers for ICI response in urothelial cancer and assess their analytical and clinical validation.
Behind the scenes: A critical discourse analysis of Botswana government power plays on Facebook during two post-millennial state-owned organizational crises
Authors: Simon Chedza , Rees Sian , Thomas Richard
Published: September 2023

This article examines Facebook posts in Botswana to determine how government public relations (PR) practitioners used language to help protect the reputation of two state-owned agencies during times of crisis. For insufficiently prepared PR practitioners, crises can quickly become complex owing to the proliferation of social media which has dramatically reshaped crisis communication in non-Western, multicultural contexts. While crisis communication has drawn more scholarly interest, the way the Botswana Government use language to maintain power and legitimacy during emergencies represents a fresh case study. We use Critical Discourse Analysis (CDA) in our scrutiny of the Botswana Development Corporation (BDC) crisis of 2011, and the Botswana Railways (BR) crisis of 2019. The analysis reveals a corporate ideology of economic development used as an underlying manipulative and propagandistic form of organized persuasive communication (OPC) strategy aimed at establishing and maintaining power. The article also demonstrates how, via this strategy, the government uses state power to galvanize support and mobilize audiences to rally behind state-owned organizations.
Perceived COVID-19 Threat, Psychological Distress, and Increases in Alcohol and Cannabis Use at the Onset of the Pandemic in Racially Diverse Emerging Adults
Authors: Marks Laura Reid , Yang Yanyun , Miller Heather H. , Morgan Michael , Yoon Eunhui , Naar Sylvie
Published: September 2023

We examined the associations among perceived Coronavirus disease 2019 (COVID-19) threat, psychological distress, and perceived increases in alcohol and cannabis use since the onset of the pandemic in a sample of 1,339 Asian, Black, and White emerging adults (18–25 years). We investigated how these relationships changed based on sex assigned at birth, political affiliation, race, and college student status. Correlation analyses demonstrated a significant positive relationship between perceived COVID-19 threat and psychological distress, as well as a significant positive relationship between perceived COVID-19 threat and perceived increases in alcohol use for emerging adults. Multi-group analyses revealed that Black emerging adults displayed the strongest association between perceived COVID-19 threat and perceived increases in alcohol use whereas college students displayed a stronger association between perceived COVID-19 threat and psychological distress than emerging adults not attending college.
Oxygen saturation targets for children with respiratory distress: a systematic review
Authors: Louman Sam , van Stralen Karlijn J. , Pijnenburg Mariëlle W.H. , Koppelman Gerard H. , Boehmer Annemie L.M.
Published: September 2023

Background

In children with respiratory distress, supplemental oxygen is indicated at peripheral oxygen saturation (SpO2) thresholds of 90–94%. However, these thresholds are poorly studied. We conducted a systematic review to summarise the existing evidence forSpO2thresholds in children with respiratory distress.

Methods

Electronic databases and registries were searched for original articles published from 1 January 2010 to 7 January 2022 comparing two or moreSpO2thresholds in children with respiratory distress. Primary outcomes were safety, including mortality, neurocognitive outcomes and readmissions, and effectiveness, including admission rate and length of hospital stay. Methodological appraisal was performed using the Cochrane Risk of Bias 2 (RoB-2) or Risk of Bias in Non-Randomized Studies – of Interventions (ROBINS-I) tools. Results were narratively synthesised.

Results

We retrieved 3384 results; seven studies were included. Lower thresholds ranged from 80% to 92% and were compared with higher thresholds ranging from 92% to 94%. Studies were highly heterogeneous in setting, design, population and outcomes. Risk of bias varied from low to high. LowerSpO2thresholds had equivalent mortality, neurocognitive outcomes and readmissions or re-attendance to healthcare to higher thresholds. LowerSpO2thresholds showed a significant decrease in admission rates by up to 40% and shortened hospitalisation duration by 10–18 h.

Conclusions

The currentSpO2thresholds of 90–94% in children with respiratory distress may be too high, which could lead to unnecessary hospitalisations and prolonged hospitalisation duration.SpO2thresholds as low as 88% are potentially safe in children with respiratory distress and may reduce hospitalisation rates and length of stay. However, high-quality evidence is needed to support this.
Burden of refractory and unexplained chronic cough on patients’ lives: a cohort study
Authors: Puente-Maestu Luis , Dávila Ignacio , Quirce Santiago , Crespo-Lessmann Astrid , Martínez-Moragón Eva , Sola Javier , Nieto María Luisa , González-Barcala Francisco Javier , Cea-Calvo Luis , Sánchez-Jareño Marta , Rivas-Pardinas Cristina , Domingo Christian
Published: September 2023

Background

Chronic cough (cough lasting for ≥8 weeks) can lead to significant impairment in quality of life (QoL). Using patient-reported outcomes, this cohort study assessed the perceived impact of chronic cough on QoL and everyday life in patients from outpatient hospital clinics with refractory chronic cough (RCC) or unexplained chronic cough (UCC).

Methods

This was a multicentre, non-interventional survey study. Cough severity was assessed on a 0−100 mm Visual Analogue Scale (VAS). Frequency, intensity and disruptiveness of cough were assessed using an adaptation of the Cough Severity Diary. The impact of cough on QoL was assessed using the Leicester Cough Questionnaire (LCQ). The physical impact of cough and associated impact on everyday life activities were explored using purpose-designed questions.

Results

191 patients responded to the survey; 121 (63.4%) had RCC and 149 were women (78.0%). Mean score on the cough severity VAS was 62.9 mm. Mean LCQ total score of 11.9 indicated reduced QoL. Cough impaired patients’ everyday life, including the inability to speak fluently (58.0% of patients) and feeling tired/drained (46.6%). Women perceived poorer chronic cough-related QoL than men, as reflected by lower LCQ scores, and greater impairment of physical health, including cough-related stress urinary incontinence, and psychological health.

Conclusions

Patients with RCC/UCC experience a significant burden in their everyday life, including impaired QoL, and perceive a negative impact on physical and psychological health and everyday activities, affecting work, relationships and leisure activities. The impact appears to be greater in women than men for several of the aspects studied.
Italian Orthopaedic and Traumatology Society (SIOT) position statement on the non-surgical management of knee osteoarthritis
Authors: Pesare Elisa , Vicenti Giovanni , Kon Elisaveta , Berruto Massimo , Caporali Roberto , Moretti Biagio , Randelli Pietro S.
Published: September 2023

Background

Knee osteoarthritis (OA) is a chronic disease associated with a severe impact on quality of life. However, unfortunately, there are no evidence-based guidelines for the non-surgical management of this disease. While recognising the gap between scientific evidence and clinical practice, this position statement aims to present recommendations for the non-surgical management of knee OA, considering the available evidence and the clinical knowledge of experienced surgeons. The overall goal is to offer an evidenced-based expert opinion, aiding clinicians in the management of knee OA while considering the condition, values, needs and preferences of individual patients.

Methods

The study design for this position statement involved a preliminary search of PubMed, Google Scholar, Medline and Cochrane databases for literature spanning the period between January 2021 and April 2023, followed by screening of relevant articles (systematic reviews and meta-analyses). A Società Italiana Ortopedia e Traumatologia (SIOT) multidisciplinary task force (composed of four orthopaedic surgeons and a rheumatologist) subsequently formulated the recommendations.

Results

Evidence-based recommendations for the non-surgical management of knee OA were developed, covering assessment, general approach, patient information and education, lifestyle changes and physical therapy, walking aids, balneotherapy, transcutaneous electrical nerve stimulation, pulsed electromagnetic field therapy, pharmacological interventions and injections.

Conclusions

For non-surgical management of knee OA, the recommended first step is to bring about lifestyle changes, particularly management of body weight combined with physical exercise and/or hydrotherapy. For acute symptoms, non-steroidal anti-inflammatory drugs (NSAIDs), topic or oral, can be used. Opioids can only be used as third-line pharmacological treatment. Glucosamine and chondroitin are also suggested as chronic pharmacological treatment. Regarding intra-articular infiltrative therapy, the use of hyaluronic acid is recommended in cases of chronic knee OA [platelet-rich plasma (PRP) as second line), in the absence of active acute disease, while the use of intra-articular injections of cortisone is effective and preferred for severe acute symptoms.
The electronic properties of boron-doped germanium nanocrystals films
Authors: Shan Dan , Wang Menglong , Sun Daoyuan , Cao Yunqing
Published: September 2023

Various doping concentrations of boron (B)-doped germanium nanocrystal (Ge NC) films were prepared using the plasma-enhanced chemical vapor deposition (PECVD) technique followed by thermal annealing treatment. The electronic properties of B-doped Ge NCs films combined with the microstructural characterization were investigated. It is worthwhile mentioning that the Hall mobilities $${\mu }_{\mathrm{Hall}}$$

μ
Hall

of Ge NCs films were enhanced after B doping and reached to the maximum of 200 cm2 V−1, which could be ascribed to the reduction in surface defects states in the B-doped films. It is also important to highlight that the temperature-dependent mobilities $${\mu }_{\mathrm{H}}(T)$$

μ
H

(
T
)

exhibited different temperature dependence trends in the Ge NCs films before and after B doping. A comprehensive investigation was conducted to examine the distinct carrier transport properties in B-doped Ge NC films, and a detailed discussion was presented, focusing on the scattering mechanisms involved in the transport process.
Transcriptome sequencing and metabolome analysis reveal the metabolic reprogramming of partial hepatectomy and extended hepatectomy
Authors: Li Zeyuan , Peng Bo , Chen Shilian , Li Jiaping , Hu Kai , Liao Lijuan , Xie Qiuli , Yao Mei , Liang Lixing , Tomlinson Stephen , Yuan Guandou , He Songqing
Published: September 2023

Surgical resection remains a critical treatment option for many patients with primary and secondary hepatic neoplasms. Extended hepatectomy (eHx) may be required for some patients with large tumors, which may cause liver failure and death. Partial hepatectomy (pHx) and eHx mouse models were constructed, liver tissues were sampled at 18, 36, and 72 h posthepatectomy. Transcriptome and metabolome analyses were employed to explore the different potential mechanisms in regeneration and injury between pHx and eHx. The results showed that eHx was associated with more severe liver injury and lower survival rates than pHx. Transcriptomics data showed there were 1842, 2129, and 1277 differentially expressed genes (DEGs) in eHx and 962, 1305, and 732 DEGs in pHx at 18, 36, and 72 h posthepatectomy, respectively, compared with the those in the sham groups. Compared with pHx, the number of DEGs in the eHx group reached a maximum of 230 at 18 h after surgery and decreased sequentially to 87 and 43 at 36 and 72 h. Metabolomics analysis identified a total of 1399 metabolites, and 48 significant differentially produced metabolites (DPMs) were screened between eHx and pHx. Combined analysis of DEGs and DPMs indicated that cholesterol metabolism and insulin resistance may be two important pathways for liver regeneration and mouse survival postextended hepatectomy. Our results showed the global influence of pHx and eHx on the transcriptome and metabolome in mouse liver, and revealed cholesterol metabolism and insulin resistance pathways might be involved in regeneration post-pHx and -eHx.
Nasal splinting and mouth breathing training reduce emergence delirium after endoscopic sinus surgery: a randomized controlled trial
Authors: Xu Hongjiao , Shen Zhenyuan , Gu Yuyu , Hu Yaodan , Jiang Jihong , Li Xiang , Zhao Yanfang , Zhu Minmin , Li Jinbao
Published: September 2023

Background

Emergence delirium (ED) is generally occurred after anesthesia associated with increased risks of long-term adverse outcomes. Therefore, this study aimed to evaluate the efficacy of preconditioning with nasal splint and mouth-breathing training on prevention of ED after general anesthesia.

Methods

This randomized controlled trial enrolled 200 adult patients undergoing ESS. Patients were randomized to receive either nasal splinting and mouth breathing training (n = 100) or standard care (n = 100) before surgery. The primary outcome was the occurrence of ED within 30 min of extubation, assessed using the Riker Sedation-Agitation Scale. Logistic regression identified risk factors for ED.

Results

Totally 200 patients were randomized and 182 aged from 18 to 82 years with 59.9% of males were included in the final analysis (90 in C-group and 92 in P-group). ED occurred in 16.3% of the intervention group vs. 35.6% of controls (P = 0.004). Male sex, smoking and function endoscopic sinus surgery (FESS) were independent risk factors for ED.

Conclusions

Preoperative nasal splinting and mouth breathing training significantly reduced the incidence of emergence delirium in patients undergoing endoscopic sinus surgery.

Trial Registration

ChiCTR1900024925 (https://www.chictr.org.cn/index.aspx) registered on 3/8/2019.
Qualitative analysis of a remote monitoring intervention for managing heart failure
Authors: Klaiman Tamar , Iannotte L. G. , Josephs Michael , Russell Louise B. , Norton Laurie , Mehta Shivan , Troxel Andrea , Zhu Jingsan , Volpp Kevin , Asch David A.
Published: September 2023

Background

Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients’ weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology.

Objective

The goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention.

Approach

This was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial’s processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions.

Key results

Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms.

Conclusion

Our qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes.

Trial registration

ClinicalTrials.gov Identifier: NCT02708654.
A systematic review of randomised controlled trials with adaptive and traditional group sequential designs – applications in cardiovascular clinical trials
Authors: Zhang Jufen , Saju Christy
Published: September 2023

Background

Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it can reduce pre-planned sample size and trial resources. In contrast, trials with adoptive designs provide greater flexibility and are more efficient due to the ability to modify trial design according to the interim analysis results. In this systematic review, we aim to explore characteristics of adaptive and traditional group sequential trials in practice and to gain an understanding how these trial designs are currently being reported in cardiology.

Methods

PubMed, Embase and Cochrane Central Register of Controlled Trials database were searched from January 1980 to June 2022. Randomised controlled phase 2/3 trials with either adaptive or traditional group sequential design in patients with cardiovascular disease were included. Descriptive statistics were used to present the collected data.

Results

Of 456 articles found in the initial search, 56 were identified including 43 (76.8%) trials with traditional group sequential design and 13 (23.2%) with adaptive. Most trials were large, multicentre, led by the USA (50%) and Europe (28.6%), and were funded by companies (78.6%). For trials with group sequential design, frequency of interim analyses was determined mainly by the number of events (47%). 67% of the trials stopped early, in which 14 (32.6%) were due to efficacy, and 5 (11.6%) for futility. The commonly used stopping rule to terminate trials was O’Brien- Fleming-type alpha spending function (10 (23.3%)). For trials with adaptive designs, 54% of the trials stopped early, in which 4 (30.8%) were due to futility, and 2 (15.4%) for efficacy. Sample size re-estimation was commonly used (8 (61.5%)). In 69% of the trials, simulation including Bayesian approach was used to define the statistical stopping rules. The adaptive designs have been increasingly used (from 0 to 1999 to 38.6% after 2015 amongst adaptive trials). 25% of the trials reported “adaptive” in abstract or title of the studies.

Conclusions

The application of adaptive trials is increasingly popular in cardiovascular clinical trials. The reporting of adaptive design needs improving.
Factors associated with balance impairments in the community-dwelling elderly in urban China
Authors: Xia Qinghua , Zhou Peng , Li Xia , Li Xiaofen , Zhang Lei , Fan Xuefei , Zhao Zhoulan , Jiang Yu , Zhu Jianhong , Wu Hongmei , Zhang Mengdi
Published: September 2023

Background

Identification of factors relevant to balance performance impairments in the elderly population was critical for developing effective interventions and preventions. However, there have been very limited data available based on large scale studies. The present study identified factors that independently contributed to performance impairments in overall balance, domains of static balance, postural stability, and dynamic balance, and individual items.

Methods

A total of 1984 community-dwelling Chinese elderly from urban areas of Shanghai were recruited. Information on demographic characteristic, exercise, and health status were collected with a face-to-face interview. Balance performances were assessed on site by trained investigators based on the X16 balance testing scale. To identify the effectors, ordinal logistic regression analysis was applied for overall balance, static balance, postural stability, and dynamic balance. Binary logistic regression analysis was used for 16 items.

Results

The community-dwelling elderly residents were aged from 60 to 97 years old. With increases of age, risks of impairments in overall balance increased gradually (ORs from 1.26 to 3.20, all P < 0.01). In the elderly with overweight and obesity, there was higher proportion of balance impairments compared to the elderly with normal BMI (OR = 1.26, P < 0.001). Regular exercise every week was associated with reduced risks of balance impairments (ORs from 0.63 to 0.73, all P < 0.001). Presences with vision lesion (ORs from 1.28 to 1.59, all P < 0.001), moderate hearing impairment (OR = 1.54, P < 0.001), somesthesis dysfunction (ORs from 1.59 to 13.26, all P < 0.001), and cerebrovascular disease (OR = 1.45, P = 0.001) were related to increased risks of balance impairments. Likewise, age, exercise, vision, hearing, somesthesis, and cerebrovascular disease were significantly associated with static balance, postural stability, and dynamic balance. Both overweight and obesity and underweight were associated with higher proportions of dynamic balance impairments. Regular exercise was significantly related to reduced risks of impairments in 15 out of the 16 items.

Conclusions

In the elderly, age, overweight and obesity, exercise, vision, hearing, somesthesia, and cerebrovascular disease were dominant factors associated with impairments in overall balance, domains of static balance, postural stability, and dynamic balance, and most individual items.

Trial registration

Not applicable.
Experiences of stigma, psychological distress, and facilitative coping among pregnant people with gestational diabetes mellitus
Authors: Sun Shufang , Pellowski Jennifer , Pisani Claire , Pandey Diksha , Go Mallory , Chu MyDzung , Ruan Jenny , Werner Erika F.
Published: September 2023

Background

Gestational diabetes mellitus (GDM) has been rising in the United States, and it poses significant health risks to pregnant individuals and their infants. Prior research has shown that individuals with GDM also experience prevalent stress and mental health issues, which can further contribute to glucose regulation difficulties. Stigma associated with GDM may contribute to these mental health challenges, yet there is a lack of focused research on GDM-related stigma, its impact on psychological health, and effective coping mechanisms. Thus, this qualitative study aims to understand individuals’ experiences related to GDM stigma, mental health, and facilitative coping.

Methods

In-depth, semi-structured interviews were conducted with 14 individuals with a current or recent (within the last year) diagnosis of GDM. Thematic analysis was employed to guide data analysis.

Results

Four themes emerged from data analysis: (1) experience of distal GDM stigma including stigmatizing provider interactions, stigma from non-medical spaces, and intersecting stigma with weight, (2) internalized GDM stigma, such as shame, guilt, and self-blame, (3) psychological distress, which included experiences of stress and overwhelm, excessive worry and fear, and loneliness and isolation, and (4) facilitative coping mechanisms, which included diagnosis acceptance, internet-based GDM community, active participation in GDM management, social and familial support, and time for oneself.

Conclusions

Findings demonstrate the relevance of GDM stigma in mental health among people with GDM and the need for addressing GDM stigma and psychological health in this population. Interventions that can reduce GDM stigma, improve psychological wellness, and enhance positive coping may facilitate successful GDM management and healthy birth outcomes. Future quantitative, theory-driven research is needed to understand the prevalence of GDM stigma experiences and mechanisms identified in the current study, as well as among marginalized populations (e.g., individuals of color, sexual and gender minorities).
Towards patient-led follow-up after curative surgical resection of stage I, II and III colorectal cancer (DISTANCE-trial): a study protocol for a stepped-wedge cluster-randomised trial
Authors: Swartjes Hidde , Qaderi Seyed M. , Teerenstra Steven , Custers Jose A. E. , Elferink Marloes A. G. , van Wely Bob J. , Burger Jacobus W. A. , van Grevenstein Wilhelmina M. U. , van Duijvendijk Peter , Verdaasdonk Emiel G. G. , de Roos Marnix A. J. , Coupé Veerle M. H. , Vink Geraldine R. , Verhoef Cornelis , de Wilt Johannes H. W.
Published: September 2023

Background

Colorectal cancer (CRC) is among the most frequently diagnosed cancers. Approximately 20–30% of stage I-III CRC patients develop a recurrent tumour or metastases after curative surgical resection. Post-operative follow-up is indicated for the first five years after curative surgical resection. As intensified follow-up after curative surgical resection has shown no effect on survival, patient organisations and policy makers have advocated for a more patient-centred approach to follow-up. The objective of this study is to successfully implement patient-led, home-based follow-up (PHFU) in six hospitals in The Netherlands, with as ultimate aim to come to a recommendation for a patient-centred follow-up schedule for stage I-III CRC patients treated with surgical resection with curative intent.

Methods

This study is designed as a stepped-wedge cluster-randomised trial (SW-CRT) in six participating centres. During the trial, three centres will implement PHFU after six months; the other three centres will implement PHFU after 12 months of inclusion in the control group. Eligible patients are those with pT2-4N0M0 or pT1-4N1-2M0 CRC, who are 18 years or older and have been free of disease for 12 months after curative surgical resection. The studied intervention is PHFU, starting 12 months after curative resection. The in-hospital, standard-of-care follow-up currently implemented in the participating centres functions as the comparator. The proportion of patients who had contact with the hospital regarding CRC follow-up between 12–24 months after curative surgical resection is the primary endpoint of this study. Quality of life, fear of cancer recurrence, patient satisfaction, cost-effectiveness and survival are the secondary endpoints.

Discussion

The results of this study will provide evidence on whether nationwide implementation of PHFU for CRC in The Netherlands will be successful in reducing contact between patient and health care provider. Comparison of PROMs between in-hospital follow-up and PHFU will be provided. Moreover, the cost-effectiveness of PHFU will be assessed.

Trial registration

Dutch Trail Register (NTR): NL9266 (Registered on January 1st, 2021).
Analysis of myosin genes in HNSCC and identify MYL1 as a specific poor prognostic biomarker, promotes tumor metastasis and correlates with tumor immune infiltration in HNSCC
Authors: Li Ce , Guan Rui , Li Wenming , Wei Dongmin , Cao Shengda , Chang Fen , Wei Qun , Wei Ran , Chen Long , Xu Chenyang , Wu Kainan , Lei Dapeng
Published: September 2023

Head neck squamous cell carcinoma (HNSCC) is one of the most common malignant tumors which ranks the sixth incidence in the world. Although treatments for HNSCC have improved significantly in recent years, its recurrence rate and mortality rate remain high. Myosin genes have been studied in a variety of tumors, however its role in HNSCC has not been elucidated. GSE58911 and GSE30784 gene expression profile analysis were performed to detect significantly dys-regulated myosin genes in HNSCC. The Cancer Genome Atlas (TCGA) HNSCC database was used to verify the dys-regulated myosin genes and study the relationship between these genes and prognosis in HNSCC. The results showed that MYL1, MYL2, MYL3, MYH2, and MYH7 were down-regulated, while MYH10 was up-regulated in patients with HNSCC. Interestingly, MYL1, MYL2, MYH1, MYH2, and MYH7 were shown to be unfavorable prognostic markers in HNSCC. It is also worth noting that MYL1 was a specific unfavorable prognostic biomarker in HNSCC. MYL1, MYL2, MYL3, MYH2, MYH7, and MYH10 promoted CD4 + T cells activation in HNSCC. MYL1 was proved to be down-regulated in HNSCC tissues compared to normal tissues at protein levels. MYL1 overexpression had no effect on proliferation, but significantly promoted migration of Fadu cells. MYL1 increased EGF and EGFR protein expression levels. Moreover, there is a positive correlation between MYL1 expression and Tcm CD8 cells, Tcm CD4 + cells, NK cells, Mast cells, NKT cells, Tfh cells and Treg cells in HNSCC. Overall, MYL1 facilitates tumor metastasis and correlates with tumor immune infiltration in HNSCC and these effects may be associated with the EGF/EGFR pathway.
Perceptions of everyday life during lenient COVID-19 restrictions in Sweden- an interview study
Authors: Lindgren Ingrid , Trulsson Schouenborg Anna , Larsson Caroline , Stigmar Kjerstin
Published: September 2023

Background

Both COVID-19 and its associated societal restrictions have affected individuals’ health and everyday life. In Sweden, more lenient public health restrictions were implemented, with individuals asked to act responsibly in terms of reducing spread of disease. The majority of studies reporting on experiences of Covid-19 restrictions have been in the context of more substantial mandatory rules aimed at reducing social contact, therefore it is important to describe how more lenient restrictions have impacted individuals’ well-being. This study aims to describe perceptions of everyday life during the first wave of the COVID-19 pandemic, perceived by individuals with no underlying medical condition, and living with more lenient public health restrictions in Sweden.

Method

The participants were recruited from individuals who originally had participated in an online survey about life satisfaction, health, and physical activity. Fifteen individuals (median age 49, range 26–76 years, seven women) in various social situations, such as living alone/cohabiting, having children at home, geographical area and size of city were interviewed. Qualitative content analysis was applied to the data.

Results

An overall theme “Both hindrances and opportunities in important life domains were experienced within the same person during lenient Covid-19 restrictions” was derived and covered three categories: “New possibilities of flexibility in work and better health”, “Life went on as usual with minor adjustments” and “Everyday life changed and became more difficult” together with eight subcategories. For most participants, both facilitating and hindering important domains in life were described. Unexpected findings were positive experiences regarding working from home, physical activities, leisure time activities and the balance between work and leisure time. In areas where only minor adjustments were made, life was perceived as going on as before. On the other hand, restrictions increased worries and were perceived to have negative effects on social participation.

Conclusion

The impact of the pandemic and lenient restrictions in Sweden on the participants´ everyday life was multifaceted. Both hindrances and opportunities in important life domains were experienced within the same person. An increased flexibility in work- and leisure activities were perceived having positive effects for health and wellbeing and led to a better balance in life.
A cross-sectional study: family communication, anxiety, and depression in adolescents: the mediating role of family violence and problematic internet use
Authors: Huang Xin-cheng , Zhang Yue-ning , Wu Xiao-yu , Jiang Yang , Cai Hao , Deng Yu-qian , Luo Yuan , Zhao Li-ping , Liu Qin-ling , Luo Sheng-yue , Wang Yan-yan , Zhao Li , Jiang Mao-min , Wu Yi-bo
Published: September 2023

Objective

The objective of this study is to explore the relationship between family communication, family violence, problematic internet use, anxiety, and depression and validate their potential mediating role.

Methods

The study population consisted of Chinese adolescents aged 12 to 18 years, and a cross-sectional survey was conducted in 2022. Structural equation models were constructed using AMOS 25.0 software to examine the factors that influence adolescent anxiety and depression and the mediating effects of problematic internet use and family violence.

Results

The results indicate that family communication was significantly and negatively related to family violence (β = -.494, p < 0.001), problematic internet use (β = -.056, p < .05), depression (β = -.076, p < .01), and anxiety (β = -.071, p < .05). And the finds also indicate that family violence mediated the relationships between family communication and depression (β = -.143, CI: -.198 -.080), and between family communication and anxiety (β = -.141; CI: -.198 -.074). Chain indirect effects between family communication and depression (β = -.051; CI: -.081 -.030) or anxiety (β = -.046; CI: -.080 -.043) via family violence and then through problematic internet use were also found in the present study.

Conclusions

In conclusion, positive family communication is crucial in reducing anxiety and depression in adolescents. Moreover, problematic internet use and family violence mediate the effects of positive family communication on anxiety and depression. Therefore, improving family communication and promoting interventions aimed at reducing family violence and problematic internet use can help reduce anxiety and depression in adolescents, thus promoting their healthy development.
Cultural interventions addressing disparities in the HIV prevention and treatment cascade among Black/African Americans: a scoping review
Authors: Vitsupakorn Shawin , Pierce Nia , Ritchwood Tiarney D.
Published: September 2023

Culture is an important determinant of HIV risk and protective behaviors; yet, we know little about how it is integrated in HIV interventions. This scoping review characterizes the integration of culture in HIV prevention and treatment interventions focused on Black/African Americans. We searched MEDLINE, PsycINFO, CINAHL, and Google Scholar for peer-reviewed manuscripts published between July 1, 2011, and June 28, 2021. Twenty-five interventions were identified, with 96% focused on prevention. Most (40%) targeted men who have sex with men or transgender women. Only three were grounded in cultural theory. Although all interventions were labeled “culturally based,” only two explicitly defined culture. Moreover, there was much diversity regarding the ways in which interventions integrated cultural elements, with some conflating race/ethnicity with culture. To improve uptake and HIV-related outcomes, interventions integrating culture are greatly needed. Additionally, HIV interventions purporting to be “culturally based” must include basic information to support rigor and reproducibility.