bluuebunny/crossref_metadata_2025 huggingface dataset:
NoiseCapture smartphone application as pedagogical support for education and public awareness
Authors: Guillaume Gwenaël , Aumond Pierre , Bocher Erwan , Can Arnaud , Écotière David , Fortin Nicolas , Foy Cédric , Gauvreau Benoit , Petit Gwendall , Picaut Judicaël
Published: May 2022

Teaching science subjects such as acoustics to youth or the general public can be facilitated by illustrating physical phenomena or scientific issues using fun experiences. A few years ago, our team developed a smartphone application named NoiseCapture with the aim of offering to anyone the opportunity to measure their sound environment and to share their geolocated measurements with the community in order to build a collective noise map. Since then, NoiseCapture team members have experimented with numerous interventions in schools or scientific events for the general public based on the app to explain not only societal and environmental issues related to noise but also to teach acoustic notions and to address technical and scientific topics associated with sound measurement. This paper describes some of the interventions implemented, in particular, in a school context through training courses given to middle school and university students, as well as teachers of secondary school, that focused on basic knowledge of buildings and environmental acoustics, on the practice of acoustic measurement, and on noise mapping. Some examples of interventions with the general public are also presented that were mostly integrated into scientific events.
Marathon Performance and Pacing in the Doha 2019 Women’s IAAF World Championships: Extreme Heat, Suboptimal Pacing, and High Failure Rates
Authors: Beal Harry , Corbett Jo , Davis Danielle , Barwood Martin J.
Published: May 2022

Purpose: The Doha 2019 women’s World Championship marathon took place in extreme hot (32 °C), humid conditions (74% relative humidity) culminating in unprecedented (41%) failure rates. We explored whether extreme heat or suboptimal pacing was responsible for diminished performance against a temperate “control” (London 2017: 19 °C, 59% relative humidity) and whether physical characteristics (eg, body surface area, estimated maximal oxygen uptake, habitual heat exposure) explained performance. Method: Five-kilometer-pace (km·h−1) data underwent repeated-measures analyses of hot (Doha, n = 40) versus temperate pacing and performance (London, n = 78) within and between marathon pacing (finisher quartiles normalized against personal best; n = 10 per group) and within hot marathon finishers versus nonfinishers (up to 10 km; normalized data). Possible predictors (multiple regression) of hot marathon pacing were explored. Tests to .05 alpha level, partial eta squared () indicates effect size. Results: Mean (SD) of Doha (14.82 [0.96] km·h−1) pace was slower (London: 15.74 [0.96] km·h−1; P = .00; ). In hot conditions, athletes finishing in positions 1 to 10 (group 1) started more conservatively (93.7% [2.1%] of personal best) than slower runners (groups 3 and 4; 96.6% [2.8%] of personal best; P < .05, ). Groups were not different at 15 km and then slowed immediately (groups 3 and 4) or after 20 km (group 2). Finishers and nonfinishers adopted similar pace up to 10 km (P > .05, ). World ranking predicted (P = .00; r2 = .248) average pace in Doha. Conclusion: Extreme hot conditions reduced performance. Top 10 athletes adopted a conservative initial pace, whereas lower-placing athletes adopted a faster, aggressive start. Pacing alone does not explain high failure rates in nonfinishers. Athletes competing in the heat should initially pace conservatively to optimize performance.
The cell polarity protein Vangl2 in the muscle shapes the neuromuscular synapse by binding to and regulating the tyrosine kinase MuSK
Authors: Boëx Myriam , Cottin Steve , Halliez Marius , Bauché Stéphanie , Buon Céline , Sans Nathalie , Montcouquiol Mireille , Molgó Jordi , Amar Muriel , Ferry Arnaud , Lemaitre Mégane , Rouche Andrée , Langui Dominique , Baskaran Asha , Fontaine Bertrand , Messéant Julien , Strochlic Laure
Published: May 2022

The development of the neuromuscular junction (NMJ) requires dynamic trans-synaptic coordination orchestrated by secreted factors, including Wnt family morphogens. To investigate how these synaptic cues in NMJ development are transduced, particularly in the regulation of acetylcholine receptor (AChR) accumulation in the postsynaptic membrane, we explored the function of Van Gogh–like protein 2 (Vangl2), a core component of Wnt planar cell polarity signaling. We found that conditional, muscle-specific ablation of
Vangl2
in mice reproduced the NMJ differentiation defects seen in mice with global
Vangl2
deletion. These alterations persisted into adulthood and led to NMJ disassembly, impaired neurotransmission, and deficits in motor function. Vangl2 and the muscle-specific receptor tyrosine kinase MuSK were functionally associated in Wnt signaling in the muscle. Vangl2 bound to and promoted the signaling activity of MuSK in response to Wnt11. The loss of
Vangl2
impaired RhoA activation in cultured mouse myotubes and caused dispersed, rather than clustered, organization of AChRs at the postsynaptic or muscle cell side of NMJs in vivo. Our results identify Vangl2 as a key player of the core complex of molecules shaping neuromuscular synapses and thus shed light on the molecular mechanisms underlying NMJ assembly.
Osmotic stress activates RIPK3/MLKL-mediated necroptosis by increasing cytosolic pH through a plasma membrane Na
+
/H
+
exchanger
Authors: Zhang Wenbin , Fan Weiliang , Guo Jia , Wang Xiaodong
Published: May 2022

Necroptosis is a form of cell death triggered by stimuli such as the tumor necrosis factor family of cytokines, which induce necrotic cell death through the RIPK1-RIPK3-MLKL pathway. We report here that necroptosis is also activated by extracellular osmotic stresses. Unlike the previously identified inducers of necroptosis, osmotic stress stimulated necroptosis through the direct activation of the kinase activity of RIPK3 by an increase in cytosolic pH mediated by the Na
+
/H
+
exchanger SLC9A1. Knockout, knockdown, or chemical inhibition of SLC9A1 blocked necroptosis induced by osmotic stresses. Moreover, setting intracellular pH at above-physiological values directly activated RIPK3 and necroptosis. The activation of RIPK3 by osmotic stresses did not require its RHIM domain, the protein-interacting domain required for the activation of RIPK3 when cells respond to other previously identified necroptotic stimuli. These results thus delineate a pathway that activates necroptosis in response to osmotic stresses.
Lymph node colonization and metastasis
Authors: Baek Amy E.
Published: May 2022

Lymph nodes open an immune-tolerant pathway for metastasis.
The Novel Amidase PcnH Initiates the Degradation of Phenazine-1-Carboxamide in Sphingomonas histidinilytica DS-9
Authors: Ren Yijun , Zhang Mingliang , Gao Siyuan , Zhu Qian , Ke Zhijian , Jiang Wankui , Qiu Jiguo , Hong Qing
Published: May 2022

Phenazines have been widely acknowledged as a natural antibiotic for more than 150 years, but their degradation mechanisms are still not completely elucidated. Compared with the studies on the degradation mechanism of PCA and PYO, little is known regarding PCN degradation by far.
Human Cytomegalovirus IE2 Both Activates and Represses Initiation and Modulates Elongation in a Context-Dependent Manner
Authors: Ball Christopher B. , Li Ming , Parida Mrutyunjaya , Hu Qiaolin , Ince Deniz , Collins Geoffrey S. , Meier Jeffery L. , Price David H.
Published: May 2022

HCMV infects more than half of the world population and persists lifelong in its hosts. Although generally asymptomatic, HCMV infection can lead to life-threating disease in immunosuppressed individuals.
Many Keys Unlock the Doors for Virus Entry
Authors: Gallagher Tom
Published: May 2022

To successfully infect, viruses must respond to cues that promote their genome delivery into host cells. These keys to virus entry frequently reside inside endocytic vesicles.
Whole-Genome Sequences of Two Klebsiella pneumoniae Strains (Sequence Types 23 and 35) from Wildlife
Authors: Cornacchia A. , Chiaverini A. , Centorotola G. , Di Domenico M. , Cocco A. , Ancora M. , Cammà C. , D’Alterio N. , Di Francesco C. E. , Pomilio F.
Published: May 2022

This report describes the draft genomes of two
Klebsiella pneumoniae
strains that were isolated from two wild boars collected during epidemiological surveillance and monitoring of wild fauna in the Abruzzo and Molise regions. The strains belonged to sequence type 23 (ST23) and ST35, which are frequently reported in clinical cases.
Comparative Genomics Identifies Features Associated with Methicillin-Resistant Staphylococcus aureus (MRSA) Transmission in Hospital Settings
Authors: Adediran Timileyin , Hitchcock Stephanie , O’Hara Lyndsay M. , Michalski Jane M. , Johnson J. Kristie , Calfee David P. , Miller Loren G. , Hazen Tracy H. , Harris Anthony D. , Rasko David A.
Published: May 2022

Methicillin-resistant
Staphylococcus aureus
(MRSA) is considered a serious threat to public health and contributes to the dissemination of
S. aureus
in both the healthcare and community setting. Transmission of MRSA between patients via healthcare worker (HCW) has been described.
Supplemental Material: Zircon-modeled melts shed light on the formation of Earth’s crust from the Hadean to the Archean
Authors: Carley Tamara L. , al. et
Published: May 2022

Data Set S1 (compilation of all zircon age dates and TE, supporting references, KdZrc[Ti], and model melts), and Data Set S2 (compilation of whole-rock data [MOR, Mount St. Helens] and supporting references). 
Exercise dose–response relationship with heart rate variability in individuals with overweight and obesity: protocol for a systematic review and meta-analysis of randomised controlled trials
Authors: Sinha Mukesh Kumar , Maiya G Arun , Moga Ana Maria , K N Shivashankar , Shankar N Ravi , K Vaishali
Published: May 2022

Introduction

Obesity is a chronic relapsing disease process and serious public health concern that can lead to chronic diseases, medical complications and a higher risk of disability. Another significant feature of obesity is dysfunction in cardiac autonomic function, which leads to changes in parasympathetic and sympathetic regulation, which can be measured using heart rate variability (HRV). The objective of this review is to estimate the extent to which exercise doses impacts on HRV among individuals living with overweight and obesity class I and II.

Methods and analysis

A systematic literature search will be performed using PubMed/Medline, Scopus, EMBASE, ProQuest, CINAHL, Web of Science and the Cochrane Library for articles dating from 1965 to December 2021. Inclusion criteria include studies designed as parallel-arm randomised trials, enrolling adolescent and adult individuals with overweight (body mass index, BMI≥25 to ≤29.9) and obesity (class I BMI: 30–34.9 and class II BMI: 35–39.9) undergoing aerobic or resistance training or concurrent exercise training. For data synthesis, sensitivity analysis, subgroup analysis and risk of bias assessment, Stata V.13.0 software will be used.

Ethics and dissemination

Formal ethical approval is not required. This systematic review will be submitted to a peer-reviewed journal.

PROSPERO registration number

CRD42019104154.
Exploring the experiences and challenges for patients undergoing cranioplasty: a mixed-methods study protocol
Authors: Mee Harry , Clement Clare , Anwar Fahim , Whiting Gemma , Timofeev Ivan , Helmy Adel , Hutchinson Peter John , Kolias Angelos G
Published: May 2022

Introduction

Cranioplasty is a widely practised neurosurgical procedure aimed at reconstructing a skull defect, but its impact on a patient’s rehabilitation following a traumatic brain injury (TBI) or stroke could be better understood. In addition, there are many issues that a TBI patient or the patient who had a stroke and their families may have to adapt to. Insight into some of the potential social barriers, including issues related to social engagement and cosmetic considerations, would be beneficial. Currently, little is known about how this procedure impacts a patient’s recovery, the patient’s perceptions of rehabilitation precranioplasty and postcranioplasty and the broader issues of cosmesis and social reintegration. This study hopes to understand some of these issues and therefore help inform clinicians of some of the difficulties and perceptions that patients and their relatives may have.

Methods and analysis

A mixed-methods study. Data will be collected through focus groups with healthcare professionals (HCPs) and semi-structured interviews with patients and their relatives, field notes, a researcher diary and a patient questionnaire. Different perspectives will be brought together through method triangulation. Patient and relative data will be analysed using interpretive phenomenological analysis, and HCPs data will be analysed thematically using deductive and inductive coding.

Ethics and dissemination

Ethical approval has been obtained from the Wales REC 7 ethics committee (Rec ref: 19/WA/0315). There is limited literature regarding a patient’s perception of the cranioplasty process, the potential impact on rehabilitation and how this may impact their reintegration into the community. The results of this study will be presented at national brain injury conferences and published in peer-reviewed, national and international journals.
Optimising colorectal cancer screening in Shanghai, China: a modelling study
Authors: Cenin Dayna , Li Pei , Wang Jie , de Jonge Lucie , Yan Bei , Tao Sha , Lansdorp-Vogelaar Iris
Published: May 2022

Introduction

To reduce the burden of colorectal cancer (CRC) in Shanghai, China, a CRC screening programme was commenced in 2013 inviting those aged 50–74 years to triennial screening with a faecal immunochemical test (FIT) and risk assessment. However, it is unknown whether this is the optimal screening strategy for this population. We aimed to determine the optimal CRC screening programme for Shanghai in terms of benefits, burden, harms and cost-effectiveness.

Methods

Using Microsimulation Screening Analysis-Colon (MISCAN-Colon), we estimated the costs and effects of the current screening programme compared with a situation without screening. Subsequently, we estimated the benefits (life years gained (LYG)), burden (number of screening events, colonoscopies and false-positive tests), harms (number of colonoscopy complications) and costs (Renminb (¥)) of screening for 324 alternative screening strategies. We compared several different age ranges, screening modalities, intervals and FIT cut-off levels. An incremental cost-effectiveness analysis determined the optimal strategy assuming a willingness-to-pay of ¥193 931 per LYG.

Results

Compared with no screening, the current screening programme reduced CRC incidence by 40% (19 cases per 1000 screened individuals) and CRC mortality by 67% (7 deaths). This strategy gained 32 additional life years, increased colonoscopy demand to 1434 per 1000 individuals and cost an additional ¥199 652. The optimal screening strategy was annual testing using a validated one-sample FIT, with a cut-off of 10 µg haemoglobin per gram from ages 45 to 80 years (incremental cost-effectiveness ratio, ¥62 107). This strategy increased LY by 0.18% and costs by 27%. Several alternative cost-effective strategies using a validated FIT offered comparable benefits to the current programme but lower burden and costs.

Conclusions

Although the current screening programme in Shanghai is effective at reducing CRC incidence and mortality, the programme could be optimised using a validated FIT. When implementing CRC screening, jurisdictions with limited health resources should use a validated test.
Drivers of paediatric inpatient experience: retrospective analysis of casemix factors for the Alberta Paediatric Inpatient Experience Survey in Alberta, Canada
Authors: Steele Brian Jacob , Fairie Paul , Kemp Kyle , Santana Maria-Jose
Published: May 2022

Objective

In Alberta, the Alberta Paediatric Inpatient Experience Survey (APIES) is used as a proxy-reported measure of paediatric experience. To our knowledge, the influence of casemix factors on patient experience as measured by paediatric patient experience surveys have not been reported within Canadian paediatric samples. In this paper, we sought to determine the patient and respondent factors associated with paediatric inpatient experiences in Alberta, Canada.

Design

Retrospective analysis of patient experience survey data.

Setting

Inpatiet acute care hospitals in Alberta, Canada.

Intervention and main outcome measures

Retrospective analyses were conducted using APIES surveys linked with eligible inpatient records (n=6262). Descriptive statistics were reported. χ2 tests were performed to assess distribution of casemix between general and paediatric hospitals. Logistic regression was performed with overall hospital experience as the dependent variable with casemix and hospital variables as independent variables.

Results

Casemix characteristics were unevenly distributed between general and paediatric hospitals. Compared with reference categories, older respondents, healthier patients and treatment at paediatric facilities had increased odds of providing most-positive ratings. Increased respondent education was associated with decreased odds of providing most-positive ratings. Likelihood-ratio tests showed that most casemix variables improved model fit, except for respondent relationship to the patient.

Conclusions

To improve reports of paediatric inpatient experience, administrators and providers require reliable and comparable measurement. Both the Child Hospital Consumer Assessment of Healthcare Providers and Systems and other measures of patient and family experience need to consider patient and respondent characteristics when interpreting results. Considered with other research from patient experience in Alberta, we discuss future directions and quality improvement implications.
Oral pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations
Authors: O Murchu Eamon , Marshall Liam , Teljeur Conor , Harrington Patricia , Hayes Catherine , Moran Patrick , Ryan Mairin
Published: May 2022

Objective

To conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) of the effectiveness and safety of oral pre-exposure prophylaxis (PrEP) to prevent HIV.

Methods

Databases (PubMed, Embase and the Cochrane Register of Controlled Trials) were searched up to 5 July 2020. Search terms for ‘HIV’ were combined with terms for ‘PrEP’ or ‘tenofovir/emtricitabine’. RCTs were included that compared oral tenofovir-containing PrEP to placebo, no treatment or alternative medication/dosing schedule. The primary outcome was the rate ratio (RR) of HIV infection using a modified intention-to-treat analysis. Secondary outcomes included safety, adherence and risk compensation. All analyses were stratified a priori by population: men who have sex with men (MSM), serodiscordant couples, heterosexuals and people who inject drugs (PWIDs). The quality of individual studies was assessed using the Cochrane risk-of-bias tool, and the certainty of evidence was assessed using GRADE.

Results

Of 2803 unique records, 15 RCTs met our inclusion criteria. Over 25 000 participants were included, encompassing 38 289 person-years of follow-up data. PrEP was found to be effective in MSM (RR 0.25, 95% CI 0.1 to 0.61; absolute rate difference (RD) −0.03, 95% CI −0.01 to −0.05), serodiscordant couples (RR 0.25, 95% CI 0.14 to 0.46; RD −0.01, 95% CI −0.01 to −0.02) and PWID (RR 0.51, 95% CI 0.29 to 0.92; RD −0.00, 95% CI −0.00 to −0.01), but not in heterosexuals (RR 0.77, 95% CI 0.46 to 1.29). Efficacy was strongly associated with adherence (p<0.01). PrEP was found to be safe, but unrecognised HIV at enrolment increased the risk of viral drug resistance mutations. Evidence for behaviour change or an increase in sexually transmitted infections was not found.

Conclusions

PrEP is safe and effective in MSM, serodiscordant couples and PWIDs. Additional research is needed prior to recommending PrEP in heterosexuals. No RCTs reported effectiveness or safety data for other high-risk groups, such as transgender women and sex workers.

PROSPERO registration number

CRD42017065937.
What are the environmental factors that affect implementation of the Manchester Healthy Schools programme? A qualitative exploration of staff perspectives
Authors: Goldthorpe Joanna , Vaughan Matthew , Keyworth Chris , Epton Tracy , Calam Rachel , Armitage Chris
Published: May 2022

Objectives

Primary/elementary schools are crucial settings for early weight management interventions but effects on children’s weight are small. This may be because the environments in which these schools are situated support unhealthy behaviours that lead to weight gain (obesogenic environments). Staff working in schools have a unique insight into the environmental factors that might affect their efforts to support child health and weight management interventions. The aim of this study is to explore the views of staff in relation to the perceived effects of the environmental context in which they deliver a child health promotion intervention.

Methods

Staff from five schools involved in delivering the Manchester Healthy Schools programme were interviewed (N=19). These interviews were transcribed verbatim and analysed thematically.

Results

Three themes were produced: opportunities to be healthy; importance of funding, resources and governance; and resources available to households and neighbourhoods.

Conclusion

The views of school staff were consistent with themes identified in other relevant literature. Although there were serendipitous opportunities to capitalise on local resources, such as using nearby land and leisure facilities for outdoor physical activities, many barriers relating to local environmental and resource features were reported. Joined up, multi-agency solutions such as place-based approaches might be able to offer schools some resource-based support; however, more research is needed to establish the best way to achieve the best outcomes for children.
Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app)
Authors: Kim In-Cheol , Lee Ji Hyun , Choi Dong-Ju , Park Sung-Ji , Lee Ju-Hee , Park Sang Min , Kim Mina , Kim Hack-Lyoung , Lee Sunki , Kim In Jai , Choi Seonghoon , Bang Jaehun , Ali Bilal , Hussain Musarrat , Ali Taqdir , Lee Sungyoung
Published: May 2022

Introduction

High adherence to oral anticoagulants is essential for stroke prevention in patients with atrial fibrillation (AF). We developed a smartphone application (app) that pushes alarms for taking medication and measuring blood pressure (BP) and heart rate (HR) at certain times of the day. In addition to drug alarms, the habit of measuring one’s BP and HR may reinforce drug adherence by improving self-awareness of the disease. This pilot study aims to test the feasibility and efficacy of the smartphone app-based intervention for improving drug adherence in patients with AF.

Methods and analysis

A total of 10 university hospitals in Korea will participate in this randomised control trial. Patients with AF, being treated with edoxaban for stroke prevention will be included in this study. Total of 500 patients will be included and the patients will be randomised to the conventional treatment group (250 patients) and the app conditional feedback group (250 patients). Patients in the app conditional feedback group will use the medication reminder app for medication and BP check alarms. The automatic BP machine will be linked to the smartphone via Bluetooth. The measured BP and HR will be updated automatically on the smartphone app. The primary endpoint is edoxaban adherence by pill count measurement at 3 and 6 months of follow-up. Secondary endpoints are clinical composite endpoints including stroke, systemic embolic event, major bleeding requiring hospitalisation or transfusion, or death during the 6 months. As of 24t November 2021, 80 patients were enrolled.

Ethics and dissemination

This study was approved by the Seoul National University Bundang Hospital Institutional Review Board and will be conducted according to the principles of the Declaration of Helsinki. The study results will be published in a reputable journal.

Trial registration number

KCT0004754.
Study protocol of the HGCSG1803: a phase II multicentre, non-randomised, single-arm, prospective trial of combination chemotherapy with oxaliplatin, irinotecan and S-1 (OX-IRIS) as first-line treatment for metastatic or relapsed pancreatic cancer
Authors: Nakano Shintaro , Kawamoto Yasuyuki , Yuki Satoshi , Harada Kazuaki , Miyagishima Takuto , Sogabe Susumu , Dazai Masayoshi , Sato Atsushi , Ishiguro Atsushi , Nakamura Michio , Kajiura Shinya , Takahashi Yasuo , Tateyama Miki , Hatanaka Kazuteru , Tsuji Yasushi , Sasaki Takahide , Shindo Yoshiaki , Kobayashi Tomoe , Yokota Isao , Sakamoto Naoya , Sakata Yuh , Komatsu Yoshito
Published: May 2022

Introduction

Combination chemotherapy with oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) has become one of the standard treatments for metastatic pancreatic cancer. However, the use of FOLFIRINOX requires prolonged infusion. Therefore, we planned to develop a new combination chemotherapy regimen with oxaliplatin, irinotecan and S-1 (OX-IRIS) for advanced pancreatic cancer. In the phase Ⅰ study that was conducted previously, the safety and recommended dose of OX-IRIS were assessed. In this study, we will evaluate the efficacy and safety of OX-IRIS.

Methods and analysis

The HGCSG1803 study started as a multicentre, non-randomised, single-arm, prospective, phase II study in December 2019. Eligible subjects were patients with untreated metastatic or relapsed pancreatic cancer. OX-IRIS is administered as follows: 30 min infusion of antiemetic; 2-hour infusion of oxaliplatin (65 mg/m2); 1.5-hour infusion of irinotecan (100 mg/m2) on day 1 and 15 of each 4-week cycle; and oral S-1 (40 mg/m2) twice daily from after dinner on day one to after breakfast on day 15, followed by a 14-day rest, to be repeated every 2 weeks until disease progression, unacceptable toxicity or patient refusal. The primary endpoint is response rate. The secondary endpoints are overall and progression-free survival, safety and dose for each drug. Using a binomial test, a sample size of 40 patients was set with a threshold value of 10% and expected value of 30%. Registration of 40 cases is planned from 18 institutions in Japan.

Ethics and dissemination

All the procedures will be conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki of 1964 and its later versions. All the patients will receive written information about the trial and will provide informed consent before enrolment. This trial was approved by the Hokkaido University Certified Review Board (approval No: 018-037).

Trial registration number

jRCTs011190008.
Association between work situation and life satisfaction during the COVID-19 pandemic: prospective cohort study in Norway
Authors: Carlsen Ellen Øen , Caspersen Ida H , Ask Helga , Brandlistuen Ragnhild Eek , Trogstad Lill , Magnus Per
Published: May 2022

Objectives

To estimate the impact of being laid off from work, having to work from home or having been diagnosed with COVID-19 on self-reported satisfaction with life.

Design

Nationwide population-based cohort study.

Setting

Norway.

Participants

We followed more than 80 000 participants in an ongoing cohort study, the Norwegian Mother, Father and Child Cohort Study (MoBa), during the COVID-19 pandemic. We analysed current life satisfaction in April and again in September/October 2020 for subjects whose work situation and infection status had changed.

Main outcome measures

Self-reported satisfaction with life, using a scale from 0 (worst) to 10 (best). We analysed the scale both continuously and as a binary variable (<or ≥6).

Results

Temporary and permanent layoffs, working from a home-based office, and getting a COVID-19 diagnosis were all associated with modestly, but significantly lower concurrent life satisfaction, both in the total on a population level and for subjects experiencing a change in job status between spring and autumn. The associations with change in work situation were stronger for men. For men with permanent job loss, the adjusted odds ratio (OR) for low life satisfaction (<6) was 3.2 (95% CI 2.4 to 4.2) in April and 4.9 (95% CI 3.5 to 6.9) in autumn. Among all, a suspected or confirmed COVID-19 diagnosis was associated with an adjusted OR for low life satisfaction of 1.9 (95% CI 1.6 to 2.3) in spring. The strength of associations between work situation and life satisfaction did not vary much across socio-economic strata, but layoffs were more common among those with low education.

Conclusion

Layoffs, home office and infection status had clear impact on the quality of life as measured with a global life satisfaction scale. These findings suggest that social differentials in quality of life, are increasing during the pandemic.
Support programmes for parents of children with intellectual disabilities: a scoping review protocol
Authors: Marais Janene Elizabeth , Wegner Lisa , Mthembu Thuli
Published: May 2022

Introduction

Evidence shows that parents of children with intellectual disabilities experience high levels of stress, emotional challenges and higher levels of depression. Despite these challenges, support for parents has tended to be peripheral in healthcare services of children. There is a lack of research attention given to support programmes for parents of children with intellectual disabilities despite the importance of parenting for the optimal development of children with intellectual disabilities.

Methods and analysis

This review will follow the Joanna Briggs Institute scoping review methods manual. The search for relevant studies will be in Medline (EbscoHost), PsychARTICLES, PubMed, CINHAL, Academic Search Complete and SAePublications. Reference mining of full review studies will be conducted. A three-step search strategy will be used, including the use of information management software to manage the search results and to remove duplications. An independent reviewer will extract data using a data extraction tool. Furthermore, another reviewer will screen the included articles in conjunction with the results of the scoping review. The data extracted will be presented in a tabular format with a narrative summary related to the key findings.

Ethics and dissemination

This scoping review has received ethical approval (BM20/4/26). A summary of the findings of the study will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding of the support programmes available to parents of children with intellectual disabilities. This could be the first step in highlighting the gaps and future directions for the development and implementation of support programmes for parents of children with intellectual disabilities.

Registration details

Marais JE, Wegner L, Mthembu T. Support programs for parents of children with intellectual disabilities: a scoping review [Internet].OSF; 2021. Available from:https://osf.io/en6cs/.
Rescuing Cancer Immunity by Plasma Exchange in Metastatic Melanoma (ReCIPE-M1): protocol for a single-institution, open-label safety trial of plasma exchange to clear sPD-L1 for immunotherapy
Authors: Davidson Tara M , Foster Nathan , Lucien Fabrice , Markovic Svetomir , Dong Haidong , Winters Jeffrey L , Park Sean S , Orme Jacob J
Published: May 2022

Background

Patients with metastatic melanoma rely on PD-(L)1 immunotherapy, but only one-third of patients experience treatment response and all initial responders eventually develop resistance. Tumour-derived extracellular vesicles expressing Programmed death ligand 1 (evPD-L1) and soluble Programmed death ligand 1 (sPD-L1) in peripheral blood of patients with melanoma limit PD-(L)1 immunotherapy and correlate with poor survival. Therapeutic plasma exchange (TPE) removes immunosuppressive evPD-L1 and sPD-L1. We hypothesise that TPE may rescue and restore antimelanoma immunity.

Methods

In this two-arm study, 60 patients with metastatic melanoma progressing on checkpoint inhibition will be accrued. All patients will undergo radiotherapy on days 1–5 (at least one measurable lesion will not be irradiated) and ongoing checkpoint inhibition on day 8 and every 2–3 weeks per standard of care. Patients with baseline sPD-L1 level of ≥1.7 ng/mL and adequate clinical capacity will be enrolled in the TPE intervention arm and will undergo TPE on days 5–7, in addition to standard of care radiotherapy and immunotherapy. Other patients will remain in the standard of care arm.

The primary endpoint of the study is to evaluate safety. Secondary endpoints include kinetics of sPD-L1 and evPD-L1 and clinical response by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Study registered at ClinicalTrials.gov (NCT04581382).

Ethics and dissemination

This trial has been approved by the Mayo Clinic Institutional Review Board. It will assess the safety and feasibility of TPE in improving outcomes for PD-(L)1 inhibitor immunotherapy in melanoma. Data will be maintained on a secure database with deidentified patient information. Data will be shared on publication in a peer-reviewed journal without the aid of professional writers. If successful, this trial will lay the ground for phase II studies that will include cancer treated with PD-(L)1 inhibitors which may benefit from TPE such as renal, bladder and lung cancers.

Trial registration number

NCT04581382.
Treatment of unresectable locally advanced pancreatic cancer with percutaneous irreversible electroporation (IRE) following initial systemic chemotherapy (LAP-PIE) trial: study protocol for a feasibility randomised controlled trial
Authors: Rai Zainab L , Ranieri Veronica , Palmer Daniel H , Littler Peter , Ghaneh Pauleh , Gurusamy Kurinchi , Manas Derek , Pizzo Elena , Psarelli Eftychia Eirini , Gilmore Roopinder , Peddu Praveen , Bartlett David C , de Liguori Carino Nicola , Davidson Brian R
Published: May 2022

Background

Approximately 30% of patients with pancreas cancer have unresectable locally advanced disease, which is currently treated with systemic chemotherapy. A new treatment option of irreversible electroporation (IRE) has been investigated for these patients since 2005. Cohort studies suggest that IRE confers a survival advantage, but with associated, procedure-related complications. Selection bias may account for improved survival and there have been no prospective randomised trials evaluating the harms and benefits of therapy. The aim of this trial is to evaluate the feasibility of a randomised comparison of IRE therapy with chemotherapy versus chemotherapy alone in patients with locally advanced pancreatic cancer (LAPC).

Methods and analysis

Eligible patients with LAPC who have undergone first-line 5-FluoroUracil, Leucovorin, Irinotecan and Oxaliplatin chemotherapy will be randomised to receive either a single session of IRE followed by (if indicated) further chemotherapy or to chemotherapy alone (standard of care). Fifty patients from up to seven specialist pancreas centres in the UK will be recruited over a period of 15 months. Trial follow-up will be 12 months. The primary outcome measure is ability to recruit. Secondary objectives include practicality and technical success of treatment, acceptability of treatment to patients and clinicians and safety of treatment. A qualitative study has been incorporated to evaluate the patient and clinician perspective of the locally advanced pancreatic cancer with percutaneous irreversible electroporation trial. It is likely that the data obtained will guide the structure, the primary outcome measure, the power and the duration of a subsequent multicentre randomised controlled trial aimed at establishing the clinical efficiency of pancreas IRE therapy. Indicative procedure-related costings will be collected in this feasibility trial, which will inform the cost evaluation in the subsequent study on efficiency.

Ethics and dissemination

The protocol has received approval by London-Brent Research Ethics Committee reference number 21/LO/0077.

Results will be analysed following completion of trial recruitment and follow-up. Results will be presented to international conferences with an interest in oncology, hepatopancreaticobiliary surgery and interventional radiology and be published in a peer-reviewed journal.

Trial registration number

ISRCTN14986389.
Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy: study protocol
Authors: Siltari Aino , Riikonen Jarno , Koskimäki Juha , Pakarainen Tomi , Ettala Otto , Boström Peter , Seikkula Heikki , Kotsar Andres , Tammela Teuvo , Helminen Mika , Raittinen Paavo V , Lehtimäki Terho , Fode Mikkel , Østergren Peter , Borre Michael , Rannikko Antti , Marttila Timo , Salonen Arto , Ronkainen Hanna , Löffeler Sven , Murtola Teemu J
Published: May 2022

Introduction

Blood cholesterol is likely a risk factor for prostate cancer prognosis and use of statins is associated with lowered risk of prostate cancer recurrence and progression. Furthermore, use of statins has been associated with prolonged time before development of castration resistance (CR) during androgen deprivation therapy (ADT) for prostate cancer. However, the efficacy of statins on delaying castration-resistance has not been tested in a randomised placebo-controlled setting.

This study aims to test statins’ efficacy compared to placebo in delaying development of CR during ADT treatment for primary metastatic or recurrent prostate cancer. Secondary aim is to explore effect of statin intervention on prostate cancer mortality and lipid metabolism during ADT.

Methods and analysis

In this randomised placebo-controlled trial, a total of 400 men with de novo metastatic prostate cancer or recurrent disease after primary treatment and starting ADT will be recruited and randomised 1:1 to use daily 80 mg of atorvastatin or placebo. All researchers, study nurses and patients will be blinded throughout the trial. Patients are followed until disease recurrence or death. Primary outcome is time to formation of CR after initiation of ADT. Serum lipid levels (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and trigyserides) are analysed to test whether changes in serum cholesterol parameters during ADT predict length of treatment response. Furthermore, the trial will compare quality of life, cardiovascular morbidity, changes in blood glucose and circulating cell-free DNA, and urine lipidome during trial.

Ethics and dissemination

This study is approved by the Regional ethics committees of the Pirkanmaa Hospital District, Science centre, Tampere, Finland (R18065M) and Tarto University Hospital, Tarto, Estonia (319/T-6). All participants read and sign informed consent form before study entry. After publication of results for the primary endpoints, anonymised summary metadata and statistical code will be made openly available. The data will not include any information that could make it possible to identify a given participant.

Trial registration number

Clinicaltrial.gov:NCT04026230, Eudra-CT: 2016-004774-17, protocol code: ESTO2, protocol date 10 September 2020 and version 6.
Physical morbidity and psychological and social comorbidities at five stages during pregnancy and after childbirth: a multicountry cross-sectional survey
Authors: McCauley Mary , White Sarah , Bar-Zeev Sarah , Godia Pamela , Mittal Pratima , Zafar Shamsa , van den Broek Nynke
Published: May 2022

Objective

Maternal morbidity affects millions of women, the burden of which is highest in low resource settings. We sought to explore when this ill-health occurs and is most significant.

Settings

A descriptive observational cross-sectional study at primary and secondary-level healthcare facilities in India, Pakistan, Kenya and Malawi.

Participants

Women attending for routine antenatal care, childbirth or postnatal care at the study healthcare facilities.

Primary and secondary outcomes

Physical morbidity (infectious, medical, obstetrical), psychological and social comorbidity were assessed at five stages: first half of pregnancy (≤20 weeks), second half of pregnancy (>20 weeks), at birth (within 24 hours of childbirth), early postnatal (day 1–7) and late postnatal (week 2–12).

Results

11 454 women were assessed: India (2099), Malawi (2923), Kenya (3145) and Pakistan (3287) with similar numbers assessed at each of the five assessment stages in each country. Infectious morbidity and anaemia are highest in the early postnatal stage (26.1% and 53.6%, respectively). For HIV, malaria and syphilis combined, prevalence was highest in the first half of pregnancy (10.0%). Hypertension, pre-eclampsia and urinary incontinence are most common in the second half of pregnancy (4.6%, 2.1% and 6.6%). Psychological (depression, thoughts of self-harm) and social morbidity (domestic violence, substance misuse) are significant at each stage but most commonly reported in the second half of pregnancy (26.4%, 17.6%, 40.3% and 5.9% respectively). Of all women assessed, maternal morbidity was highest in the second half of pregnancy (81.7%), then the early postnatal stage (80.5%). Across the four countries, maternal morbidity was highest in the second half of pregnancy in Kenya (73.8%) and Malawi (73.8%), and in the early postnatal stage in Pakistan (92.2%) and India (87.5%).

Conclusions

Women have significant maternal morbidity across all stages of the continuum of pregnancy and childbirth, and especially in the second half of pregnancy and after childbirth.
Barriers and facilitators to resuming meaningful daily activities among critical illness survivors in the UK: a qualitative content analysis
Authors: Scheunemann Leslie , White Jennifer S , Prinjha Suman , Eaton Tammy L , Hamm Megan , Girard Timothy D , Reynolds Charles , Leland Natalie , Skidmore Elizabeth R
Published: May 2022

Objective

To identify critical illness survivors’ perceived barriers and facilitators to resuming performance of meaningful activities when transitioning from hospital to home.

Design

Secondary content analysis of semistructured interviews about patients’ experiences of intensive care (primary analysis disseminated on the patient-facing websitewww.healthtalk.org). Two coders characterised patient-perceived barriers and facilitators to resuming meaningful activities. To facilitate clinical application, we mapped the codes onto the Person-Task-Environment model of performance, a patient-centred rehabilitation model that characterises complex interactions among the person, task and environment when performing activities.

Setting

United Kingdom, 2005–2006.

Participants

39 adult critical illness survivors, sampled for variation among demographics and illness experiences.

Results

Person-related barriersincluded negative mood or affect, perceived setbacks; weakness or limited endurance; pain or discomfort; inadequate nutrition or hydration; poor concentration/confusion; disordered sleep/hallucinations/nightmares; mistrust of people or information; and altered appearance.Task-related barriersincluded miscommunication and managing conflicting priorities.Environment-related barriersincluded non-supportive health services and policies; challenging social attitudes; incompatible patient–family coping (emotional trauma and physical disability); equipment problems; overstimulation; understimulation; and environmental inaccessibility.Person-related facilitatorsincluded motivation or attitude; experiencing progress; and religion or spirituality.Task-related facilitatorsincluded communication.Environment-related facilitatorsincluded support from family, friends or healthcare providers; supportive health services and policies; equipment; community resources; medications; and accessible housing. Barriers decreased and facilitators increased over time. Six barrier–facilitator domains dominated based on frequency and emphasis across all performance goals: mood/motivation, setbacks/progress, fatiguability/strength; mis/communication; lack/community support; lack/health services and policies.

Conclusions

Critical illness survivors described a comprehensive inventory of 18 barriers and 11 facilitators that align with the Person-Task-Environment model of performance. Six dominant barrier–facilitator domains seem strong targets for impactful interventions. These results verify previous knowledge and offer novel opportunities for optimising patient-centred care and reducing disability after critical illness.
Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients’ Attitudes Towards Deprescribing (rPATD) questionnaire
Authors: de Juan-Roldán Jose Ignacio , Castillo-Jimena Marcos , González-Hevilla Alba , Sánchez-Sánchez Clara , García-Ruiz Antonio J , Gavilán-Moral Enrique
Published: May 2022

Objectives

Successful deprescribing depends largely on factors related to the patient. The revised Patients’ Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties.

Design

Cross-sectional validation study.

Setting

Primary care settings in Málaga (Spain).

Participants

A sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study.

Main outcome measures

In the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach’s alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test–retest reliability were analysed.

Results

Confirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors:involvement,burden,appropriatenessandconcerns about stopping. The Cronbach’s alpha coefficient of the factors ranged from 0.683 to 0.879. Theburden,appropriatenessandconcerns about stoppingfactors were significantly correlated with the BMQ Specific-Concerns Score, except for theconcerns about stoppingfactor in the older adults’ version. The consistency of the items between administration times (test–retest reliability) showed weighted Cohen’s kappa values ranging from moderate (>0.4) to very good (>0.8).

Conclusions

The Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.