bluuebunny/crossref_metadata_2025 huggingface dataset:
Pregnancy-related interventions in mothers at risk for gestational
diabetes in Asian India and low and middle-income countries (PRIMORDIAL
study): protocol for a randomised controlled trial
Authors: Vasan Senthil K , Jobe Modou , Mathews Jiji , Cole Fatoumata , Rathore Swathi , Jarjou Ousman , Thompson Dylan , Jarde Alexander , Bittaye Mustapha , Ulijaszek Stanley , Fall Caroline , Osmond Clive , Prentice Andrew , Karpe Fredrik
Published: November 2022

Introduction

Lifestyle modification is the mainstay of gestational diabetes
mellitus (GDM) prevention. However, clinical trials evaluating the
safety and efficacy of diet or physical activity (PA) in low-income and
middle-income settings such as Africa and India are lacking. This trial
aims to evaluate the efficacy of yoghurt consumption and increased PA
(daily walking) in reducing GDM incidence in high-risk pregnant
women.

Methods and analysis

The study is a 2×2 factorial, open-labelled, multicentre randomised
controlled trial to be conducted in Vellore, South India and The Gambia,
West Africa. ‘High-risk’ pregnant women (n=1856) aged ≥18 years and ≤16
weeks of gestational age, with at least one risk factor for developing
GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or
(4) standard antenatal care. Participants will be followed until 32
weeks of gestation with total active intervention lasting for a minimum
of 16 weeks. The primary endpoint is GDM incidence at 26–28 weeks
diagnosed using International Association of the Diabetes and Pregnancy
Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32
weeks. Secondary endpoints include absolute values of fasting plasma
glucose concentration at 32 weeks gestation, maternal blood pressure,
gestational weight gain, intrapartum and neonatal outcomes. Analysis
will be both by intention to treat and per-protocol. Continuous outcome
measurements will be analysed using multiple linear regression and
binary variables by logistic regression.

Ethics and dissemination

The study is approved by Oxford Tropical Research Ethics Committee
(44–18), ethics committees of the Christian Medical College, Vellore
(IRB 11367) and MRCG Scientific Coordinating Committee (SCC 1645) and
The Gambia Government/MRCG joint ethics committee (L2020.E15). Findings
of the study will be published in peer-reviewed scientific journals and
presented in conferences.

Trial registration number

NCT18467720.
Connected device and therapeutic patient education to promote physical
activity among women with localised breast cancer (DISCO trial): protocol
for a multicentre 2×2 factorial randomised controlled trial
Authors: Touillaud Marina , Fournier Baptiste , Pérol Olivia , Delrieu Lidia , Maire Aurélia , Belladame Elodie , Pérol David , Perrier Lionel , Preau Marie , Leroy Tanguy , Fassier Jean-Baptiste , Fillol Florie , Pascal Sébastien , Durand Thierry , Fervers Béatrice
Published: November 2022

Introduction

Despite safety and benefits of physical activity during treatment of
localised breast cancer, successful exercise strategies remain to be
determined. The primary objective of the ‘dispositif connecté’, that is,
connected device in English trial is to evaluate the efficacy of two
6-month exercise interventions, either single or combined, concomitant
to adjuvant treatments, on the physical activity level of patients with
breast cancer, compared with usual care: an exercise programme using a
connected device (activity tracker, smartphone application, website) and
a therapeutic patient education intervention. Secondary objectives are
to evaluate adherence to interventions, their impact at 6 and 12 months,
representations and acceptability of interventions, and to assess the
cost-effectiveness of the interventions using quality-adjusted
life-years.

Methods and analysis

This is a 2×2 factorial, multicentre, phase III randomised
controlled trial. The study population (with written informed consent)
will consist of 432 women diagnosed with primary localised invasive
breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy
and/or radiotherapy. They will be randomly allocated between one of four
arms: (1) web-based connected device (evolving target number of daily
steps and an individualised, semisupervised, adaptive programme of two
walking and one muscle strengthening sessions per week in autonomy), (2)
therapeutic patient education (one educational diagnosis, two collective
educational sessions, one evaluation), (3) combination of both
interventions and (4) control. All participants will receive the
international physical activity recommendations. Assessments (baseline,
6 and 12 months) will include physical fitness tests, anthropometrics
measures, body composition (CT scan, bioelectrical impedance),
self-administered questionnaires (physical activity profile (Recent
Physical Activity Questionnaire), quality of life (European Organization
for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30,
EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation
(Evaluation of Deprivation and Inequalities in Health Examination
Centres), lifestyle, physical activity barriers, occupational status)
and biological parameters (blood draw).

Ethics and dissemination

This study was reviewed and approved by the French Ethics Committee.
The findings will be disseminated to the scientific and medical
community via publications in peer-reviewed journals and conference
presentations.

Trial registration number

NCT03529383; Pre-results.
Protocol for targeting insomnia in school-aged children with autism
spectrum disorder without intellectual disability: a randomised control
trial
Authors: McCrae Christina S , Mazurek Micah O , Curtis Ashley F , Beversdorf David Q , Deroche Chelsea B , Golzy Mojgan , Sohl Kristin A , Ner Zarah H , Davis Beth Ellen , Stearns Melanie A , Nair Neetu
Published: November 2022

Introduction

Insomnia affects up to 80% of children with autism spectrum disorder
(ASD). Negative consequences of insomnia in ASD include decreased
quality of life (QOL), impaired learning and cognition, increased
stereotypic and challenging behaviours, and increased parental stress.
Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a
promising treatment for dealing with insomnia and its negative
consequences but has not yet been studied in school-aged children with
ASD and comorbid insomnia. Access to healthcare is another challenge for
children with ASD, particularly in rural and underserved regions.
Previous studies indicate that ASD and insomnia share common
arousal-based underpinnings, and we hypothesise that CBT-CI will reduce
the hyperarousal associated with insomnia and ASD. This trial will be
the first to examine CBT-CI adapted for children with ASD and will
provide new information about two different modes of delivery across a
variety of primary and secondary child and parent sleep and related
outcomes. Knowledge obtained from this trial might allow us to develop
new or modify current treatments to better target childhood insomnia and
ASD.

Methods and analysis

Children (N=180) 6–12 years of age with ASD and insomnia will be
recruited from an established autism database, a paediatric clinic and
community outreach in the Columbia, MO and surrounding areas.
Participants will be randomised to CBT-CI adapted for children with ASD
(in-person or remote using computers with cameras) or Sleep Hygiene and
Related Education. Participants will be assessed at baseline,
post-treatment, 6-month and 12-month follow-ups. The following
assessments will be completed regarding the children: objective and
subjective sleep, daytime functioning (adaptive functioning, attention,
challenging behaviours, anxiety), QOL and physiological arousal (heart
rate variability) and parents: objective and subjective sleep, daytime
functioning (anxiety, depression, fatigue), QOL, physiological arousal
and parental burden/stress.

Ethics and dissemination

Ethics approval was obtained in January 2020 from the University of
Missouri. Ethics approval was obtained in July 2020 from the US Army
Medical Research and Development Command, Office of Research Protections
and Human Research Protection Office. All data are expected to be
collected by 2024. Full trial results are planned to be published by
2025. Secondary analyses of baseline data will be subsequently
published.

Trial registration number

NCT04545606; Pre-results.
Integrating HIV, diabetes and hypertension services in Africa: study
protocol for a cluster randomised trial in Tanzania and Uganda
Authors: Mfinanga Sayoki Godfrey , Nyirenda Moffat J , Mutungi Gerald , Mghamba Janneth , Maongezi Sarah , Musinguzi Joshua , Okebe Joseph , Kivuyo Sokoine , Birungi Josephine , van Widenfelt Erik , Van Hout Marie-Claire , Bachmann Max , Garrib Anupam , Bukenya Dominic , Cullen Walter , Lazarus Jeffrey V , Niessen Louis Wihelmus , Katahoire Anne , Shayo Elizabeth Henry , Namakoola Ivan , Ramaiya Kaushik , Wang Duolao , Cuevas LE , Etukoit Bernard M , Lutale Janet , Meshack Shimwela , Mugisha Kenneth , Gill Geoff , Sewankambo Nelson , Smith Peter G , Jaffar Shabbar
Published: November 2022

Introduction

HIV programmes in sub-Saharan Africa are well funded but programmes
for diabetes and hypertension are weak with only a small proportion of
patients in regular care. Healthcare provision is organised from
stand-alone clinics. In this cluster randomised trial, we are evaluating
a concept of integrated care for people with HIV infection, diabetes or
hypertension from a single point of care.

Methods and analysis

32 primary care health facilities in Dar es Salaam and Kampala
regions were randomised to either integrated or standard vertical care.
In the integrated care arm, services are organised from a single clinic
where patients with either HIV infection, diabetes or hypertension are
managed by the same clinical and counselling teams. They use the same
pharmacy and laboratory and have the same style of patient records.
Standard care involves separate pathways, that is, separate clinics,
waiting and counselling areas, a separate pharmacy and separate medical
records. The trial has two primary endpoints: retention in care of
people with hypertension or diabetes and plasma viral load suppression.
Recruitment is expected to take 6 months and follow-up is for 12 months.
With 100 participants enrolled in each facility with diabetes or
hypertension, the trial will provide 90% power to detect an absolute
difference in retention of 15% between the study arms (at the 5%
two-sided significance level). If 100 participants with HIV infection
are also enrolled in each facility, we will have 90% power to show
non-inferiority in virological suppression to a delta=10% margin (ie,
that the upper limit of the one-sided 95% CI of the difference between
the two arms will not exceed 10%). To allow for lost to follow-up, the
trial will enrol over 220 persons per facility. This is the only trial
of its kind evaluating the concept of a single integrated clinic for
chronic conditions in Africa.

Ethics and dissemination

The protocol has been approved by ethics committee of The AIDS
Support Organisation, National Institute of Medical Research and the
Liverpool School of Tropical Medicine. Dissemination of findings will be
done through journal publications and meetings involving study
participants, healthcare providers and other stakeholders.

Trial registration number

NCT43896688.
Combined use of a broad-panel respiratory multiplex PCR and procalcitonin
to reduce duration of antibiotics exposure in patients with severe
community-acquired pneumonia (MULTI-CAP): a multicentre, parallel-group,
open-label, individual randomised trial conducted in French intensive care
units
Authors: Voiriot Guillaume , Fartoukh Muriel , Durand-Zaleski Isabelle , Berard Laurence , Rousseau Alexandra , Armand-Lefevre Laurence , Verdet Charlotte , Argaud Laurent , Klouche Kada , Megarbane Bruno , Patrier Juliette , Richard Jean-Christophe , Reignier Jean , Schwebel Carole , Souweine Bertrand , Tandjaoui-Lambiotte Yacine , Simon Tabassome , Timsit Jean-François
Published: November 2022

Introduction

At the time of the worrying emergence and spread of bacterial
resistance, reducing the selection pressure by reducing the exposure to
antibiotics in patients with community-acquired pneumonia (CAP) is a
public health issue. In this context, the combined use of molecular
tests and biomarkers for guiding antibiotics discontinuation is
attractive. Therefore, we have designed a trial comparing an integrated
approach of diagnosis and treatment of severe CAP to usual
care.

Methods and analysis

The multiplex PCR and procalcitonin to reduce duration of
antibiotics exposure in patients with severe-CAP (MULTI-CAP) trial is a
multicentre (n=20), parallel-group, superiority, open-label, randomised
trial. Patients are included if adult admitted to intensive care unit
for a CAP. Diagnosis of pneumonia is based on clinical criteria and a
newly appeared parenchymal infiltrate. Immunocompromised patients are
excluded. Subjects are randomised (1:1 ratio) to either the intervention
arm (experimental strategy) or the control arm (usual strategy). In the
intervention arm, the microbiological diagnosis combines a respiratory
multiplex PCR (mPCR) and conventional microbiological investigations. An
algorithm of early antibiotic de-escalation or discontinuation is
recommended, based on mPCR results and the procalcitonin value. In the
control arm, only conventional microbiological investigations are
performed and antibiotics de-escalation remains at the clinician’s
discretion. The primary endpoint is the number of days alive without any
antibiotic from the randomisation to day 28. Based on our hypothesis of
2 days gain in the intervention arm, we aim to enrol a total of 450
patients over a 30-month period.

Ethics and dissemination

The MULTI-CAP trial is conducted according to the principles of the
Declaration of Helsinki, is registered in Clinical Trials and has been
approved by the Committee for Protection of Persons and the National
French Drug Safety Agency. Written informed consents are obtained from
all the patients (or representatives). The results will be disseminated
through educational institutions, submitted to peer-reviewed journals
for publication and presented at medical congresses.

Trial registration number

NCT03452826; Pre-results.
Protocol for a case–control study investigating the clinical phenotypes
and genetic regulation of endometriosis in Indian women: the ECGRI
study
Authors: Gajbhiye Rahul K. , Montgomery Grant , Pai Murlidhar V , Phukan Pranay , Shekhar Shashank , Padte Kedar , DasMahapatra Pramathes , John Bimal M. , Shembekar Chaitanya , Bhurke Aishwarya V. , Bagde Nilajkumar , Kulkarni Ketki , Sardeshpande Nagendra , Humane Anil , Mahobia Swati , Shah Millind , Singh Uma , Srivastava Aarti , Mishra Gita , Warty Neeta , Chandra Sunita , Mahale Smita D.
Published: November 2022

Introduction

Endometriosis is one of the common, gynaecological disorders
associated with chronic pelvic pain and subfertility affecting ~10% of
reproductive age women. The clinical presentation, etiopathogenesis of
endometriosis subtypes and associated risk factors are largely unknown.
Genome-Wide Association (GWA) Studies (GWAS) provide strong evidence for
the role of genetic risk factors contributing to endometriosis. However,
no studies have investigated the association of the GWAS-identified
single-nucleotide polymorphism (SNPs) with endometriosis risk in the
Indian population; therefore, one-sixth of the world’s population is not
represented in the global genome consortiums on endometriosis. The
Endometriosis Clinical and Genetic Research in India (ECGRI) study aims
to broaden our understanding of the clinical phenotypes and genetic
risks associated with endometriosis.

Methods and analysis

ECGRI is a large-scale, multisite, case–control study of 2000
endometriosis cases and 2000 hospital controls to be recruited over 4
years at 15 collaborating study sites across India covering
representative Indian population from east,north-east, north, central,
west and southern geographical zones of India. We will use the World
Endometriosis Research Foundation Endometriosis Phenome and Biobanking
Harmonisation Project (WERF-EPHect) data collection instruments for
capturing information on clinical, epidemiological, lifestyle,
environmental and surgical factors. WERF-EPHect standard operating
procedures will be followed for the collection, processing and storage
of biological samples. The principal analyses will be for main outcome
measures of the incidence of endometriosis, disease subtypes and disease
severity determined from the clinical data. This will be followed by
GWAS within and across ethnic groups.

Ethics and dissemination

The study is approved by the Institutional Ethics Committee of
Indian Council of Medical Research-National Institute for Research in
Reproductive Health and all participating study sites. The study is also
approved by the Health Ministry Screening Committee of the Government of
India. The results from this study will be actively disseminated through
discussions with endometriosis patient groups, conference presentations
and published manuscripts.
Single session compared with multiple sessions of education and exercise
for older adults with spinal pain in an advanced practice physiotherapy
model of care: protocol for a randomised controlled trial
Authors: Lafrance Simon , Santaguida Carlo , Perreault Kadija , Bath Brenna , Thavorn Kednapa , Feldman Debbie , Hébert Luc J , Fernandes Julio , Desmeules François
Published: November 2022

Objectives

To assess the effectiveness and cost-effectiveness of a single
session compared with multiple sessions of education and exercise for
older adults with spinal pain treated conservatively in an advanced
practice physiotherapy model of care.

Methods and analysis

In this pragmatic randomised controlled trial, 152 older adults (≥65
years old) with neck or back pain initially referred for a consultation
in neurosurgery, but treated conservatively, will be recruited through
the advanced practice physiotherapy neurosurgery CareAxis programme in
the Montreal region (Quebec, Canada). In the CareAxis programme, older
patients with spinal pain are triaged by an advance practice
physiotherapist and are offered conservative care and only potential
surgical candidates are referred to a neurosurgeon. Participants will be
randomised into one of two arms: 1—a single session or 2—multiple
sessions (6 sessions over 12 weeks) of education and exercise with the
advance practice physiotherapist (1:1 ratio). The primary outcome
measure will be the Brief Pain Inventory (pain severity and interference
subscales). Secondary measures will include self-reported disability
(the Neck Disability Index or Oswestry Disability Index), the Pain
Catastrophizing Scale, satisfaction with care questionnaires (9-item
Visit-specific Satisfaction Questionnaire and MedRisk), and the
EQ-5D-5L. Participants’ healthcare resources use and related costs will
be measured. Outcomes will be collected at baseline and at 6, 12 and 26
weeks after enrolment. Intention-to-treat analyses will be performed,
and repeated mixed-model analysis of variance will assess differences
between treatment arms. Cost-utility analyses will be conducted from the
perspective of the healthcare system.

Ethics and dissemination

Ethics approval has been obtained from theComité
d’éthique de la recherche du CIUSS de
l’Est-de-l’Île-de-Montréal(FWA00001935 and
IRB00002087). Results of this study will be presented to different
stakeholders, published in peer-reviewed journals and presented at
international conferences.

Protocol version

V.4 August 2021.

Trial registration number

NCT04868591; Pre-results.
Functional recovery following hospitalisation of patients diagnosed with
COVID-19: a protocol for a longitudinal cohort study
Authors: Reid Julie C , Costa Andrew P , Duong MyLinh , Ho Terence , Kruisselbrink Rebecca , Raina Parminder , Kirkwood Renata , Jones Aaron , Corriveau Sophie , Griffith Lauren E , Haider Shariq , Marcucci Maura , Markle-Reid Maureen , Morrison Hope , Raghavan Natya , Schumacher Connie , Vrkljan Brenda , Junek Mats , Martin Leslie , Patel Ameen , Girolametto Carla , Pitre Tyler , Beauchamp Marla K
Published: November 2022

Introduction

COVID-19 is an international public health crisis with more than 132
million infections worldwide. Beyond acute infection, emerging data
indicate patients diagnosed with COVID-19 may experience persistent
sequelae similar to survivors of sepsis or acute respiratory syndromes,
including mobility limitations and fatigue. However, there is limited
evidence on the trajectory of functional recovery in those hospitalised
with COVID-19. The primary aim of the Coronavirus Registry Functional
Recovery (COREG-FR) study is to understand the trajectory of functional
recovery among individuals hospitalised for COVID-19 over the medium (up
to 6 months) and longer term (6–12 months) that will guide clinical care
and optimal management of serious COVID-19 illness and
recovery.

Methods and analysis

COREG-FR is a multicentre longitudinal cohort study. We will enrol a
minimum of 211 adults age 18 years and older with COVID-19 from five
hospitals. Participants will be followed from admission to hospital as
an inpatient, to hospital discharge, and at 3-month, 6-month, 9-month
and up to 12-month post-hospital discharge. We will conduct telephone
interviews at ward admission and discharge, and telephone interviews
plus in-person assessments of physical function and lung function at all
remaining follow-ups. Our primary outcome is the Activity Measure for
Post-Acute Care mobility scale measured at all time points. We will
conduct linear mixed effects regression analyses to explore determinants
of functional outcomes after COVID-19 illness. Subgroup analyses based
on age (≤65 vs >65 years), frailty status (Clinical Frailty Scale
score ≤4 vs >5) and variants of concern will be conducted.

Ethics and dissemination

COREG-FR has been approved by Research Ethics Boards at
participating sites. We will disseminate this work through peer-reviewed
manuscripts, presentations at national and international meetings and
through the established COREG website (www.coregontario.ca). COREG-FR is designed as a data
platform for future studies evaluating COVID-19 recovery.

Trial registration number

NCT04602260; Pre-results.
Immediate versus postponed single blastocyst transfer in modified natural
cycle frozen embryo transfer (mNC-FET): a study protocol for a multicentre
randomised controlled trial
Authors: Bergenheim Sara Johanna , Saupstad Marte , Pistoljevic Nina , Lyng Forman Julie , Larsen Elisabeth Clare , Bogstad Jeanette Wulff , Fynbo Malene , Hashem Nadia , Freiesleben Nina La Cour , Nøhr Bugge , Andersen Lars Franch , Humaidan Peter , Ziebe Soren , Pinborg Anja Bisgaard , Løssl Kristine
Published: November 2022

Introduction

Today, it is widespread practice to postpone frozen embryo transfer
(FET) in a modified natural cycle (mNC) for at least one menstrual cycle
after oocyte retrieval and failed fresh embryo transfer or freeze-all.
The rationale behind this practice is the concern that suboptimal
ovarian, endometrial or endocrinological conditions following ovarian
stimulation may have a negative impact on endometrial receptivity and
implantation. However, two recent systematic reviews and meta-analyses
based on retrospective data did not support this practice. As
unnecessary delay in time to transfer and pregnancy should be avoided,
the aim of this study is to investigate if immediate single blastocyst
transfer in mNC-FET is non-inferior to standard postponed single
blastocyst transfer in mNC-FET in terms of live birth rate.

Methods and analysis

Multicentre randomised controlled non-blinded trial including 464
normo-ovulatory women aged 18–40 years undergoing single blastocyst
mNC-FET after a failed fresh or freeze-all cycle. Participants are
randomised 1:1 to either FET in the first menstrual cycle following the
stimulated cycle (immediate FET) or FET in the second or subsequent
cycle following the stimulated cycle (postponed FET). The study is
designed as a non-inferiority trial and primary analyses will be
performed as intention to treat and per protocol.

Ethics and dissemination

Ethical approval has been granted by the Scientific Ethical
Committee of the Capital Region of Denmark (J-nr.: H-19086300). Data
will be handled according to Danish law on personal data protection in
accordance with the general data protection regulation. Participants
will complete written consent forms regarding participation in the study
and storage of blood samples in a biobank for future research. The study
will be monitored by a Good Clinical Practice (GCP)-trained study nurse
not otherwise involved in the study. The results of this study will be
disseminated by publication in international peer-reviewed scientific
journals.

Trial registration number

NCT04748874; Pre-results.
Perioperative intravenous S(+)-ketamine for acute postoperative pain in
adults: study protocol for a multicentre, randomised, open-label,
positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)
Authors: Wang Hong , Duan Chong-Yang , Huang Wen-Qi , Zhao Ping , Zhou Li-Zhi , Liu Yan-Hong , Liu Cun-Ming , Chu Hai-Chen , Wang Qiang , Diao Yu-Gang , Hua Zhen , Meng Qing-Tao , Li Hao , Zhang Xiao-Ying , Mi Wei-Dong , Chen Ping-Yan
Published: November 2022

Introduction

Postoperative pain remains incompletely controlled for decades.
Recently, multimodal analgesia is emerging as a potential approach in
the management of postoperative pain. Therein, S(+)-ketamine is
appealing as an adjuvant drug in multimodal analgesia due to its unique
pharmacological advantages. This pragmatic clinical trial (SAFE-SK-A
trial) is designed to investigate the analgesic effect and safety of
S(+)-ketamine for acute postoperative pain in adults and explore the
optimal strategy of perioperative intravenous S(+)-ketamine in a
real-world setting.

Methods and analysis

This multicentre, randomised, open-label, positive-controlled,
pragmatic clinical trial (SAFE-SK-A study) is planned to conduct in 80
centres from China and recruit a total of 12 000 adult participants
undergoing a surgical procedure under general anaesthesia. Patient
recruitment started in June 2021 and will end in June 2022. Participants
will be randomised in a ratio of 2:1 to either receive perioperative
intravenous S(+)-ketamine plus conventional anaesthesia or conventional
anaesthesia only. Given the pragmatic nature of the study, no specific
restriction as to the administration dosage, route, time, synergistic
regimen or basic analgesics. Primary endpoints are the area under the
broken line of Numerical Rating Scale (NRS) scores for pain intensity
and the total opioid consumption within 48 hours postoperative.
Secondary endpoints are postoperative NRS scores, the anaesthesia
recovery time, time of first rescue analgesia, the incidence of rescue
analgesia, the incidence of postoperative delirium, patient
questionnaire for effect, changes from baseline in cognitive function
and anxiety and depression, as well as the adverse events and
pharmacoeconomic outcomes. The general linear model will be used for the
primary endpoint, and appropriate methods will be used for the secondary
endpoints.

Ethics and dissemination

This trial has been approved by the local Institutional Review Board
(S2021-026-02) and conducted following the Declaration of Helsinki.
Results of this trial will be publicly disclosed and published in
scientific journals.

Trial registration number

NCT04837170; Pre-results.
Comparative efficacy and complications of long-acting and intermediate-acting insulin regimens for adults with type 1 diabetes: an individual patient data network meta-analysis
Authors: Veroniki Areti Angeliki , Seitidis Georgios , Stewart Lesley , Clarke Mike , Tudur-Smith Catrin , Mavridis Dimitris , Yu Catherine H , Moja Lorenzo , Straus Sharon E , Tricco Andrea C
Published: November 2022

Objective

To examine the comparative efficacy and complications of long-acting and intermediate-acting insulin for different patient characteristics for type 1 diabetes mellitus (T1DM).

Design

Systematic review and individual patient data (IPD) network meta-analysis (NMA).

Data sources

MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched through June 2015.

Eligibility criteria

Randomised controlled trials (RCTs) on adults with T1DM assessing glycosylated haemoglobin (A1c) and severe hypoglycaemia in long-acting and intermediate-acting insulin regimens.

Data extraction and synthesis

We requested IPD from authors and funders. When IPD were not available, we used aggregate data. We conducted a random-effects model, and specifically a one-stage IPD-NMA for those studies providing IPD and a two-stage IPD-NMA to incorporate those studies not providing IPD.

Results

We included 28 RCTs plus one companion report, after screening 6680 titles/abstracts and 205 full-text articles. Of the 28 RCTs, 27 studies provided data for the NMA with 7394 participants, of which 12 RCTs had IPD on 4943 participants. The IPD-NMA for A1c suggested that glargine once daily (mean difference [MD]=−0.31, 95% confidence interval [CI]: −0.48 to −0.14) and detemir once daily (MD=−0.25, 95% CI: –0.41 to −0.09) were superior to neutral protamine Hagedorn (NPH) once daily. NPH once/two times per day improved A1c compared with NPH once daily (MD=−0.30, 95% CI: –0.50 to −0.11). Results regarding complications in severe hypoglycaemia should be considered with great caution due to inconsistency in the evidence network. Accounting for missing data, there was no evidence of inconsistency and long-acting insulin regimens ranked higher regarding reducing severe hypoglycaemia compared with intermediate-acting insulin regimens (two-stage NMA: glargine two times per day SUCRA (Surface Under the Cumulative Ranking curve)=89%, detemir once daily SUCRA=77%; one-stage NMA: detemir once daily/two times per day SUCRA=85%). Using multiple imputations and IPD only, complications in severe hypoglycaemia increased with diabetes-related comorbidities (regression coefficient: 1.03, 95% CI: 1.02 to 1.03).

Conclusions

Long-acting insulin regimens reduced A1c compared with intermediate-acting insulin regimens and were associated with lower severe hypoglycaemia. Of the observed differences, only glargine once daily achieved a clinically significant reduction of 0.30%. Results should be interpreted with caution due to very low quality of evidence.

PROSPERO registration number

CRD42015023511.
Risk of cardiovascular events leading to hospitalisation afterStreptococcus pneumoniaeinfection: a retrospective cohort LIFE Study
Authors: Nishimura Naoaki , Fukuda Haruhisa
Published: November 2022

Objectives

To elucidate the risk of cardiovascular event occurrence followingStreptococcus pneumoniaeinfection.

Design

Retrospective cohort study using a LIFE Study database.

Setting

Three municipalities in Japan.

Participants

Municipality residents who were enrolled in either National Health Insurance or the Latter-Stage Elderly Healthcare System from April 2014 to March 2020.

Exposure

Occurrence ofS. pneumoniaeinfection.

Primary outcome measures

Occurrence of one of the following cardiovascular events that led to hospitalisation afterS. pneumoniaeinfection: (1) coronary heart disease (CHD), (2) heart failure (HF), (3) stroke or (4) atrial fibrillation (AF).

Results

S. pneumoniae-infected patients were matched with non-infected patients for each cardiovascular event. We matched 209 infected patients and 43 499 non-infected patients for CHD, 179 infected patients and 44 148 non-infected patients for HF, 221 infected patients and 44 768 non-infected patients for stroke, and 241 infected patients and 39 568 non-infected patients for AF. During follow-up, the incidence rates for the matched infected and non-infected patients were, respectively, 38.6 (95% CI 19.9 to 67.3) and 30.4 (29.1 to 31.8) per 1000 person-years for CHD; 69.6 (41.9 to 108.8) and 50.5 (48.9 to 52.2) per 1000 person-years for HF; 75.4 (48.3 to 112.2) and 35.5 (34.1 to 36.9) per 1000 person-years for stroke; and 34.7 (17.9 to 60.6) and 11.2 (10.4 to 12.0) per 1000 person-years for AF. Infected patients were significantly more likely to develop stroke (adjusted HR: 2.05, 95% CI 1.22 to 3.47; adjusted subdistribution HR: 1.94, 95% CI 1.15 to 3.26) and AF (3.29, 1.49 to 7.26; 2.74, 1.24 to 6.05) than their non-infected counterparts.

Conclusions

S. pneumoniaeinfections elevate the risk of subsequent stroke and AF occurrence. These findings indicate that pneumococcal infections have short-term effects on patients’ health and increase their midterm to long-term susceptibility to serious cardiovascular events.
Factors influencing receipt of an antibiotic prescription among insured patients in Tanzania: a cross-sectional study
Authors: Khalfan Mohamed Ally , Sasi Philip , Mugusi Sabina
Published: November 2022

Objectives

There are limited data on factors influencing antibiotic prescription among insured patients. We assessed for correlates of an antibiotic prescription among insured patients.

Design

A cross-sectional study.

Setting

The study was conducted at the National Health Insurance Fund offices, Dar es Salaam, Tanzania.

Data source

We captured data from the claim forms, containing inpatient and outpatient treatment information for insured patients, for the month of September 2019.

Outcome variable

Receipt of an antibiotic prescription.

Exposure variables

Age, sex, diagnosis, prescriber qualification, health facility level, ownership and department were exposure variables. Predictors of receipt of an antibiotic prescription were determined by Poisson regression analysis.

Results

Of 993 analysed patients, the mean (±SD) age was 36.3 (±23.2) years, 581 (58.5%) were females and 535 (53.9%) were adults. The prevalence of antibiotic prescription was 46.4% (95% CI 42.8% to 50.0%). Strong predictors of an antibiotic prescription were being a child (1.7, 95% CI 1.3 to 2.2); acute upper respiratory tract infection (URTI) of multiple and unspecified sites (1.6, 95% CI 1.3 to 1.4); chronic rhinitis, nasopharyngitis and pharyngitis (4.0, 95% CI 2.4 to 6.4); being attended by a clinical officer (1.9, 95% CI 1.2 to 3.0); attending a health centre (1.5, 95% CI 1.1 to 2.0); attending a public facility (1.2, 95% CI 1.0 to 1.4) and visiting an inpatient department (2.0, 95% CI 1.2 to 3.4).

Conclusions

Among insured patients, being a child, acute URTI, being attended by a clinical officer or dental therapist, being attended by an assistant medical/dental officer, attending a health centre or a district hospital, attending a public health facility and visiting an inpatient department predicted an antibiotic prescription. Incorporation of these findings in revisions or establishment of targeted antimicrobial stewardship programmes may lead to better antibiotic prescribing practices that are critical for combating antibiotic resistance.
Traumatic stress symptoms in family caregivers of patients with acute leukaemia: protocol for a multisite mixed methods, longitudinal, observational study
Authors: Jibb Lindsay A , Nanos Stephanie M , Alexander Sarah , Malfitano Carmine , Rydall Anne , Gupta Sumit , Schimmer Aaron D , Zimmermann Camilla , Hales Sarah , Nissim Rinat , Marmar Charles , Schultebraucks Katharina , Mah Kenneth , Rodin Gary
Published: November 2022

Introduction

The diagnosis, progression or recurrence of cancer is often highly traumatic for family caregivers (FCs), but systematic assessments of distress and approaches for its prevention and treatment are lacking. Acute leukaemia (AL) is a life-threatening cancer of the blood, which most often presents acutely, requires intensive treatment and is associated with severe physical symptoms. Consequently, traumatic stress may be common in the FCs of patients with AL. We aim to determine the prevalence, severity, longitudinal course and predictors of traumatic stress symptoms in FCs of patients with AL in the first year after diagnosis, and to understand their lived experience of traumatic stress and perceived support needs.

Methods and analysis

This two-site longitudinal, observational, mixed methods study will recruit 223 adult FCs of paediatric or adult patients newly diagnosed with AL from two tertiary care centres. Quantitative data will be collected from self-report questionnaires at enrolment, and 1, 3, 6, 9 and 12 months after admission to hospital for initial treatment. Quantitative data will be analysed using descriptive and machine learning approaches and a multilevel modelling (MLM) approach will be used to confirm machine learning findings. Semi-structured qualitative interviews will be conducted at 3, 6 and 12 months and analysed using a grounded theory approach.

Ethics and dissemination

This study is funded by the Canadian Institutes of Health Research (CIHR number PJT 173255) and has received ethical approval from the Ontario Cancer Research Ethics Board (CTO Project ID: 2104). The data generated have the potential to inform the development of targeted psychosocial interventions for traumatic stress, which is a public health priority for high-risk populations such as FCs of patients with haematological malignancies. An integrated and end-of-study knowledge translation strategy that involves FCs and other stakeholders will be used to interpret and disseminate study results.
Patient clusters and cost trajectories in the Swiss Atrial Fibrillation cohort
Authors: Aebersold Helena , Serra-Burriel Miquel , Foster-Wittassek Fabienne , Moschovitis Giorgio , Aeschbacher Stefanie , Auricchio Angelo , Beer Jürg Hans , Blozik Eva , Bonati Leo H , Conen David , Felder Stefan , Huber Carola A , Kuehne Michael , Mueller Andreas , Oberle Jolanda , Paladini Rebecca E , Reichlin Tobias , Rodondi Nicolas , Springer Anne , Stauber Annina , Sticherling Christian , Szucs Thomas D , Osswald Stefan , Schwenkglenks Matthias
Published: November 2022

Objective

Evidence on long-term costs of atrial fibrillation (AF) and associated factors is scarce. As part of the Swiss-AF prospective cohort study, we aimed to characterise AF costs and their development over time, and to assess specific patient clusters and their cost trajectories.

Methods

Swiss-AF enrolled 2415 patients with variable duration of AF between 2014 and 2017. Patient clusters were identified using hierarchical cluster analysis of baseline characteristics. Ongoing yearly follow-ups include health insurance clinical and claims data. An algorithm was developed to adjudicate costs to AF and related complications.

Results

A subpopulation of 1024 Swiss-AF patients with available claims data was followed up for a median (IQR) of 3.24 (1.09) years. Average yearly AF-adjudicated costs amounted to SFr5679 (€5163), remaining stable across the observation period. AF-adjudicated costs consisted mainly of inpatient and outpatient AF treatment costs (SFr4078; €3707), followed by costs of bleeding (SFr696; €633) and heart failure (SFr494; €449). Hierarchical analysis identified three patient clusters: cardiovascular (CV; N=253 with claims), isolated-symptomatic (IS; N=586) and severely morbid without cardiovascular disease (SM; N=185). The CV cluster and SM cluster depicted similarly high costs across all cost outcomes; IS patients accrued the lowest costs.

Conclusion

Our results highlight three well-defined patient clusters with specific costs that could be used for stratification in both clinical and economic studies. Patient characteristics associated with adjudicated costs as well as cost trajectories may enable an early understanding of the magnitude of upcoming AF-related healthcare costs.
Peripheral spondyloarthritis and psoriatic arthritissine psoriase: are we dealing with semantics or clinically meaningful differences?
Authors: Ziade Nelly , Bou Absi Michel , Baraliakos Xenofon
Published: November 2022

Diagnosing peripheral spondyloarthritis (pSpA) remains a significant challenge due to the lack of specific disease biomarkers and the overlap with other SpA subtypes, mainly psoriatic arthritis (PsA), which represents a diagnostic challenge particularly in the absence of skin psoriasis (PsAsine psoriase). This narrative review aimed to compare the epidemiology, genetic susceptibility, pathophysiology, classification criteria, disease phenotype and burden, and therapeutic guidelines between patients diagnosed with pSpA and those with PsAsine psoriase,to determine if the two entities should be considered jointly or distinctly. Globally, pSpA appears to be more inclusive compared with PsAsine psoriase. Areas of similarities include age of onset, number of joints involved and prevalence of axial involvement. However, patients with pSpA have a male gender predominance, a higher prevalence of HLA-B27, enthesitis and involvement of large joints of the lower limbs, whereas patients with PsAsine psoriasehave a higher prevalence HLA-Cw6, dactylitis and involvement of hand distal interphalangeal joints. Therefore, the difference between pSpA and PsAsine psoriasegoes beyond semantics. The few dissimilarities should drive scientific efforts to reach a better characterisation of pSpA as an individual disease. Accordingly, randomised clinical trials should target patients with well-defined pSpA to identify effective therapies in this population.
Free educational material on the EULAR school of rheumatology website
Authors: Edwards Christopher J
Published: November 2022

There is lots of educational content including free educational material for all those interested in rheumatic and musculoskeletal diseases (RMDs) on the EULAR School of Rheumatology (ESOR) website. It’s easy to access and just three clicks can take you straight to the content you need. Search for ESOR in your web browser (1), click on ‘catalog’, click on ‘free learning material’. Choose what you need, one more click, and you’re there. In particular, the EULAR imaging library and EULAR learning material for RA will give you lots of images and slides to help with your presentations. EULAR has a long history of providing education for rheumatologists, health professionals in rheumatology and people with RMDs. This commitment to education is enshrined in the EULAR strategy and will always be a large part of what EULAR does.
ON MICROSTRUCTURE AND CAVITATION EROSION BEHAVIOR OF MICROWAVE-SYNTHESIZED Ni-Al2O3-BASED COMPOSITE CLADDINGS
Authors: BANSAL SANDEEP , KAUSHAL SARBJEET , GUPTA DHEERAJ , JAIN VIVEK
Published: November 2022

In this study, Ni-Al2O3-based composite clads on SS-316 substrates using a microwave irradiation method have been developed. Microwave-processed clads were characterized using various nondestructive techniques to investigate microstructure, phase analysis, porosity assessment and measurement of microhardness. The findings of the microstructural analysis demonstrated the formation of solid, metallurgically bonded and defect-free clads with a thickness of approximately 970[Formula: see text][Formula: see text]m. X-ray diffraction (XRD) phase analysis study confirmed the existence of hard and intermetallic phases in the clad region. Composite clad region exhibited a low porosity value of [Formula: see text]1.3%. The average microhardness of the clad region was 3.63 times that of the substrate region. Further, cavitation erosion (CE) behavior of the developed clads was investigated using vibration CE test rig under various stand-off distances and immersion depths. CE results showed that the composite clads exhibited 6.9 times better erosion resistance than SS-316 substrate. CE resistance increased with an increase in stand-off distance and the depth of immersion.
A HIGH-PERFORMANCE ELECTRODE FOR SUPERCAPACITORS: CH3NH3PbI3 PEROVSKITE/ MULTIWALLED CARBON NANOTUBE (MAPbI3/MWCNT) COMPOSITES
Authors: KORKMAZ SATIYE
Published: November 2022

This study investigated the supercapacitor performance of the MAPbI3/MWCNT composite electrode produced by spin coating. The produced electrode’s structural properties and surface morphology were analyzed by FESEM, EDX, XRD, and FTIR. Filling the voids in the MWCNT structure by MAPbI3 perovskite crystals increases the charge density but provides ease of charge transport. The supercapacitor electrode performance was determined using specific capacitances calculated from current–voltage measurements in the potential range of [Formula: see text]0.5–2 V at 25, 50, 75, and 100 mV/s scan rates. The maximum specific capacitance was 845.03 F/g at 25 mV/s. The electrode’s capacitance ratios to the capacitance at 100 mV/s were calculated as 25.8%, 37.3%, and 54.6% for 25, 50, and 75 mV/s scan rates, respectively. Current–voltage cycles are important because they show that the electrode has a stable structure.
Self-focusing of a Bessel–Gaussian laser beam in plasma under density transition
Authors: Thakur Vishal , Kumar Sandeep , Kant Niti
Published: November 2022

The model given by Patil et al., for the self-focusing of lowest-order Bessel–Gaussian laser beam, is revisited by introducing the exponential plasma density ramp in this paper. Plasma density changes due to combined effect of the relativistic and ponderomotive nonlinearities, which arise due to the nonuniform spatial profile of the laser beam leading to stronger self-focusing. Under paraxial ray approximation, the expression for the evolution of laser-beam width parameter is obtained and solved numerically in order to achieve self-focusing. We have observed that as Bessel beam propagates through the plasma, it does not diffract and spread out, which is in contrast to the usual behavior of light that spreads out after being focused down to the small spot. Laser spot size decreases considerably under the presence of exponential density ramp. This study will be useful for better understanding the self-focusing mechanism of lasers as it becomes effective for the optimized parameters under the proposed situation. Bessel laser beams play an important role in enhancing the energy gain in laser-driven accelerators. In addition, for all laser-driven plasma-based accelerators, it appears possible to guide a laser beam over large distances using a plasma density channel, thus enhancing the acceleration length and the energy gain.
Flower pollination student psychology optimization-integrated context deep learning and probabilistic-based fusion for image inpainting
Authors: Kingsley S. , Sethukarasi T.
Published: November 2022

Image inpainting is the process to fill missing pixels in the damaged image and this process has drawn more attraction and gained active and expensive research topic in recent decades, because the high quality in the image inpainting benefits a greater range of applications, like object removal, photo restoration, and so on. Inpainting of larger quality of the image needs to fill the empty regions with plausible content in the damaged image. The existing inpainting methods either fill image regions by stealing the image patches or semantically create coherent patches from the regional context. Most of the traditional models perform well on small holes images, but restoring the image with large holes still results a challenging task. To overcome such issues and to generate effective inpainting results, a proposed method named the hybrid context deep learning approach is designed in order to fill empty regions of crack images. Moreover, the proposed method is more effective by employing a hybrid optimization algorithm for training of classifier to generate a more robust and accurate inpainted result. The developed model includes two different deep learning classifiers to accomplish the process of image inpainting in such a way that the results are fused through the probabilistic model. Moreover, the proposed approach attains higher performance by the metrics such as Peak signal-to-noise ratio (PSNR), Structural Similarity Index (SSIM), Second Derivative like Measure of Enhancement (SDME), and Universal Quality Index (UQI) with the values of 38.02[Formula: see text]db, 0.867, 54.32[Formula: see text]db, and 0.864, respectively.