bluuebunny/crossref_metadata_2025 huggingface dataset:
Family-based habit intervention to promote parent support for child physical activity in Canada: protocol for a randomised trial
Authors: Medd Emily R , Beauchamp Mark R , Blanchard Chris M , Carson Valerie , Gardner Benjamin , Warburton Darren ER , Rhodes Ryan E
Published: April 2023

Introduction

Regular physical activity (PA) participation has many important physical and psychological health benefits, managing and preventing over 25 chronic conditions. Being more physically active as a child is associated with being more active as an adult, but less than 10% of Canadian children are achieving the recommended PA guidelines of 60 minutes per day of moderate to vigorous PA. Parental support is a predictor of child PA, but parent intention to support child PA does not always predict enacted support. Targeting factors that assist in the sustainability of parent support behaviour of child PA may have an impact on child PA. The purpose of this study is to evaluate an intervention designed to promote habit formation of parental support (HABIT, independent variable) on child PA (dependant variable) compared with a planning and education group (PLANNING) and an education only group (EDUCATION).

Methods and analysis

The three conditions will be compared using a 6-month longitudinal randomised trial. Eligible families have at least one child aged 6–12 years who is not meeting the 2011 Canadian PA Guidelines. Intervention materials are delivered at baseline, with check-in sessions at 6 weeks and 3 months. Child’s moderate-to-vigorous PA, measured by accelerometry, is assessed at baseline, 6 weeks, 3 months and 6 months as the primary outcome. At baseline and 6 months, children perform fitness testing. Parents and children complete questionnaires at all timepoints. So far, 123 families have been recruited from the Greater Victoria and surrounding area. Recruitment will be continuing through 2020 with a target of 240 families.

Ethics and dissemination

This protocol has been approved by the University of Victoria Human Research Ethics Board (Victoria, Canada). Results will be shared at conferences as presentations and as published manuscripts. Study findings will be made available to interested participants.

Trial registration number

NCT03145688
Early Psychosis Intervention-Spreading Evidence-based Treatment (EPI-SET): protocol for an effectiveness-implementation study of a structured model of care for psychosis in youth and emerging adults
Authors: Kozloff Nicole , Foussias George , Durbin Janet , Sockalingam Sanjeev , Addington Jean , Addington Donald , Ampofo Augustina , Anderson Kelly K , Barwick Melanie , Bromley Sarah , Cunningham Jasmyn E A , Dahrouge Simone , Duda Lillian , Ford Catherine , Gallagher Sheila , Haltigan John D , Henderson Joanna , Jaouich Alexia , Miranda Dielle , Mitchell Patrick , Morin Josette , de Oliveira Claire , Primeau Valerie , Serhal Eva , Soklaridis Sophie , Urajnik Diana , Whittard Krista , Zaheer Juveria , Kurdyak Paul , Voineskos Aristotle N
Published: April 2023

Introduction

While early psychosis intervention (EPI) has proliferated in recent years amid evidence of its effectiveness, programmes often struggle to deliver consistent, recovery-based care. NAVIGATE is a manualised model of EPI with demonstrated effectiveness consisting of four components: individualised medication management, individual resiliency training, supported employment and education and family education. We aim to implement NAVIGATE in geographically diverse EPI programmes in Ontario, Canada, evaluating implementation and its effect on fidelity to the EPI model, as well as individual-level outcomes (patient/family member-reported and interviewer-rated), system-level outcomes (captured in provincial administrative databases) and engagement of participants with lived experience.

Methods and analysis

This is a multisite, non-randomised pragmatic hybrid effectiveness-implementation type III mixed methods study coordinated at the Centre for Addiction and Mental Health (CAMH) in Toronto. Implementation is supported by the Provincial System Support Program, a CAMH-based programme with provincial offices across Ontario, and Extension of Community Healthcare Outcomes Ontario Mental Health at CAMH and the University of Toronto. The primary outcome is fidelity to the EPI model as measured using the First Episode Psychosis Services—Fidelity Scale. Four hundred participants in the EPI programmes will be recruited and followed using both individual-level assessments and health administrative data for 2 years following NAVIGATE initiation. People with lived experience will be engaged in all aspects of the project, including through youth and family advisory committees.

Ethics and dissemination

Research ethics board approval has been obtained from CAMH and institutions overseeing the local EPI programmes. Study findings will be reported in scientific journal articles and shared with key stakeholders including youth, family members, programme staff and policymakers.

Trial registration number

NCT03919760.
Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial
Authors: Ramos-Petersen Laura , Nester Christoper J , Gijon-Nogueron Gabriel , Ortega-Avila Ana Belen
Published: April 2023

Introduction

Rheumatoid arthritis (RA) involves changes to foot structure and function, and there is an association between RA and foot pain. This pain affects those patient’s physical activity and experience of daily living. While there is clinical evidence for the value of foot orthoses (FO) on foot pain, there is a wide range of FO available and there is little evidence on the relative benefits of one orthoses type over another, especially in terms of their impact on physical activity and associated well-being. The aim of this study is to compare physical activity, general and foot health and foot health experiences in people with RA when wearing three different types of FO.

Methods and analysis

A randomised controlled trial with three arms will compare the effects of (1) custom FO made using a direct adaptation technique, (2) custom FO made through a digital design and production process and (3) prefabricated orthoses. The primary outcome is physical activity measured using a GENEActiv bracelet. Secondary outcomes will be pain, function and disability and associated foot and general health evaluated using existing questionnaires. Semistructured interviews will identify patients’ experiences of the orthoses and living with RA.

Ethics and dissemination

The study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee (SPAR-001). The results will be disseminated regardless of the magnitude or direction of effect.

Trial registration number

NCT03170947.
Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol
Authors: Jaber Samir , Rolle Amélie , Jung Boris , Chanques Gerald , Bertet Helena , Galeazzi David , Chauveton Claire , Molinari Nicolas , De Jong Audrey
Published: April 2023

Introduction

Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.

Methods and analysis

The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57’”. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.

Trial registration details

ClinicalTrials.gov Identifier:NCT04079387.
Randomised multicentre clinical trial to evaluate voriconazole pre-emptive genotyping strategy in patients with risk of aspergillosis: vorigenipharm study protocol
Authors: Monserrat Villatoro Jaime , García García Irene , Bueno David , de la Cámara Rafael , Estébanez Miriam , López de la Guía Ana , Abad-Santos Francisco , Antón Cristina , Mejía Gina , Otero María José , Ramírez García Elena , Frías Iniesta Jesús , Carcas Antonio , Borobia Alberto M
Published: April 2023

Introduction

Invasive aspergillosis is the most important cause of morbidity and mortality in patients with haematological diseases. At present, voriconazole is the first-line treatment for invasive fungal disease. The pharmacokinetic interindividual variability of voriconazole depends on genetic factors. CYP450 is involved in 70%–75% of total metabolism of voriconazole, mainly CYP3A4 and CYP2C19, with the remaining 25%–30% of metabolism conducted by monooxygenase flavins. CYP2C19 single nucleotide polymorphisms could explain 50%–55% of variability in voriconazole metabolism.

Materials and methods

The main objective is to compare efficiency of pre-emptive voriconazole genotyping with routine practice. The primary outcome is serum voriconazole on the fifth day within the therapeutic range. The secondary outcome is the combined variables of therapeutic failure and adverse events within 90 days of first administration, associated with voriconazole. A total of 146 patients at risk of invasive aspergillosis who will potentially receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient ultimately receives voriconazole, they will be randomised (1:1 experimental/control). In the experimental arm, patients will receive a dose according to a pharmacogenetic algorithm, including CYP2C19 genotype and clinical and demographic information. In the control arm, patients will receive a dose according to clinical practice guidelines. In addition, a Spanish National Healthcare System (NHS) point-of-view cost-effectiveness evaluation will be performed. Direct cost calculations for each arm will be performed.

Conclusion

This trial will provide information about the viability and cost-effectiveness of the implementation of a pre-emptive voriconazole genotyping strategy in the Spanish NHS.

Ethics and dissemination

A Spanish version of this protocol has been evaluated and approved by the La Paz University Hospital Ethics Committee and the Spanish Agency of Medicines and Medical Devices. Trial results will be submitted for publication in an open peer-reviewed medical speciality-specific publication.

Trial registration number

Eudra-CT: 2019-000376-41 andNCT04238884.
Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation
Authors: Tamisier Renaud , Damy Thibaud , Davy Jean-Marc , Verbraecken Johan A , Bailly Sébastien , Lavergne Florent , Palot Alain , Goutorbe Frédéric , Pépin Jean-Louis , d'Ortho Marie-Pia
Published: April 2023

Purpose

FACE is a prospective cohort study designed to assess the effect of adding adaptive servoventilation (ASV) to standard care on morbidity and mortality in patients with chronic heart failure (HF) with preserved (HFpEF), mid-range (HFmrEF) or reduced ejection fraction (HFrEF) who have sleep-disordered breathing (SDB) with an indication for ASV. We describe the study design, ongoing data collection and baseline participant characteristics.

Participants

Consecutive patients with HFpEF, HFmrEF or HFrEF plus SDB with central sleep apnoea (CSA) and indication for ASV were enrolled in the study cohort between November 2009 and December 2018; the ASV group includes those treated with ASV and the control group consists of patients who refused ASV or stopped treatment early. Follow-up is based on standard clinical practice, with visits at inclusion, after 3, 12 and 24 months of follow-up. Primary endpoint is the time to first event: all-cause death or unplanned hospitalisation (or unplanned prolongation of a planned hospitalisation) for worsening of HF, cardiovascular death or unplanned hospitalisation for worsening of HF, and all-cause death or all-cause unplanned hospitalisation.

Findings to date

503 patients have been enrolled, mean age of 72 years, 88% male, 31% with HFrEF. HF was commonly of ischaemic origin, and the number of comorbidities was high. SDB was severe (median Apnoea–Hypopnoea Index 42/hour), and CSA was the main indication for ASV (69%). HF was highly symptomatic; most patients were in NYHA class II (38%) or III (29%).

Future plans

Patient follow-up is ongoing. Given the heterogeneous nature of the enrolled population, a decision was made to use latent class analysis to define homogeneous patient subgroups, and then evaluate outcomes by cluster, and in the ASV and control groups (overall and within patient clusters). First analysis will be performed after 3 months, a second analysis at the 2-year follow-up.

Trial registration number

NCT01831128.
Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study
Authors: Siddiqui Tahreem Ghazal , Cheng Socheat , Gossop Michael , Kristoffersen Espen Saxhaug , Grambaite Ramune , Lundqvist Christofer
Published: April 2023

Objectives

Central nervous system depressants (CNSDs) such as opioids, benzodiazepine and Z-hypnotics are commonly used. However, CNSDs may influence cognitive function, especially in older hospitalised patients with comorbidities. The aim was to examine the association between CNSD use and cognitive function in older patients. We assessed global and domain specific cognitive function, among hospitalised older patients, including covariates for comorbidity, anxiety and depression.

Design

Cross-sectional hospital-based study.

Settings

Data was collected consecutively from inpatients at somatic wards of a general university hospital.

Participants

Older patients between 65 and 90 years with/without CNSD use for ≥4 weeks.

Outcome measures

The main outcome was cognitive function assessed by Cognistat. Secondary outcomes were routine clinical tests in the wards (mini-mental state examination (MMSE), trail making test (TMT) A and B, and clock drawing tests). Analyses were bivariate and multiple linear regression, adjusted for age, gender, and education. Covariates were comorbidity, depression and anxiety scores.

Results

The main result indicated that CNSD users (n=100) had (β=–3.4, 95% CI 6.27 to –0.58, p=0.017) lower Cognistat score than non-users (n=146), adjusted for age, gender, education, anxiety and depression, but not significant when including covariate for comorbidity (β= –2.50 - 5.45; –0.46, p=0.097). Comorbidity was associated with cognitive function (β=−0.77, 95% CI −1.22 to −0.14, p=0.014). Cognistat subdimensions associated with CNSD use were language (p=0.017) and calculation (p=0.003). In clock drawing test, users had lower scores than non-users (β=−0.80, 95% CI 1.24 to −0.36, p=0.004), but no significant difference was found with MMSE and TMT A or B. Z-hypnotics were associated with reduced cognitive function.

Conclusion

Among older hospitalised patients, global cognition and specific cognitive functions were associated with long-term use of CNSD medication as well as with somatic comorbidity.

Trial registration number

NCT0316208122 May 2017.
Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial
Authors: Njuguna Irene N , Beima-Sofie Kristin , Mburu Caren W , Mugo Cyrus , Neary Jillian , Itindi Janet , Onyango Alvin , Richardson Barbra A , Rubin Means Arianna , Sharma Monisha , Weiner Bryan J , Wagner Anjuli D , Oyiengo Laura , Wamalwa Dalton , John-Stewart Grace
Published: April 2023

Introduction

Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes.

Methods and analysis

In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ≥100 adolescents and young adults age 10–24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1 year. The primary outcome is transition readiness among ALWHIV ages 15–24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided α=0.05.

Ethics and dissemination

The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers.

Trials registration number

NCT03574129.
Rotator cuff-related shoulder pain: does the type of exercise influence the outcomes? Protocol of a randomised controlled trial
Authors: Dubé Marc-Olivier , Desmeules François , Lewis Jeremy , Roy Jean-Sébastien
Published: April 2023

Introduction

Lifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP.

Methods and analysis

In this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not.

Ethics and dissemination

Ethics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.

Trial registration number

NCT03892603.
A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial)
Authors: Fuller Brian M , Roberts Brian W , Mohr Nicholas M , Pappal Ryan D , Stephens Robert J , Yan Yan , Carpenter Chris , Kollef Marin H , Avidan Michael Simon
Published: April 2023

Introduction

Sedation is a cornerstone therapy in the management of patients receiving mechanical ventilation and is highly influential on outcome. Early sedation depth appears especially influential, as early deep sedation is associated with worse outcome when compared with light sedation. Our research group has shown that patients receiving mechanical ventilation in the emergency department (ED) are exposed to deep sedation commonly, and ED sedation depth is impactful on intensive care unit (ICU) care and clinical outcomes. While extensive investigation has occurred for patients in the ICU, comparatively little data exist from the ED. Given the influence that ED sedation seems to carry, as well as a lack of ED-based sedation trials, there is significant rationale to investigate ED-based sedation as a means to improve outcome.

Methods and analysis

This is a multicentre (n=3) prospective, before-and-after pilot trial examining the feasibility of implementing targeted sedation in the immediate postintubation period in the ED. A cohort of 344 patients receiving mechanical ventilation in ED will be included. Feasibility outcomes include: (1) participant recruitment; (2) proportion of Richmond Agitation-Sedation Scale (RASS) scores in the deep sedation range; (3) reliability (agreement) of RASS measurements performed by bedside ED nurses; and (4) adverse events. The proportion of deep sedation measurements before and after the intervention will be compared using the χ2test. Logistic regression will be used to compare before-and-after differences, adjusting for potential confounders. The inter-rater correlation coefficient will be used to assess paired observations between a study team member and bedside ED nurses, and to describe reliability of RASS measurements.

Ethics and dissemination

The Human Research Protection Office at Washington University in St. Louis School of Medicine has approved the study. The publication of peer-reviewed manuscripts and the presentation of abstracts at scientific meetings will be used to disseminate the work.

Registration

ClinicalTrials.gov identifierNCT04410783.
Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery
Authors: Drury Nigel E , Bi Rehana , Woolley Rebecca L , Stickley John , Morris Kevin P , Montgomerie James , van Doorn Carin , Dunn Warwick B , Madhani Melanie , Ives Natalie J , Kirchhof Paulus , Jones Timothy J
Published: April 2023

Introduction

Myocardial protection against ischaemic-reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, with current strategies, myocardial injury occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. Remote ischaemic preconditioning, the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial will assess whether remote ischaemic preconditioning, applied to both lower limbs immediately prior to surgery, reduces myocardial injury in cyanotic and acyanotic young children.

Methods and analysis

The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect. Participants will be randomised in a 1:1 ratio to either bilateral remote ischaemic preconditioning (3×5 min cycles) or sham immediately prior to surgery, with follow-up until discharge from hospital or 30 days, whichever is sooner. The primary outcome is reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12 hours, and lengths of stay in the paediatric intensive care unit and the hospital.

Ethics and dissemination

The trial was approved by the West Midlands-Solihull National Health Service Research Ethics Committee (16/WM/0309) on 5 August 2016. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a local charity.

Trial registration number

NCT12923441.
COVID-19 pandemic: a qualitative study with an opportunity-centric approach from an ICU perspective in a teaching hospital. Upsides worth to secure?
Authors: Klein Dorthe O , Moelans Bodine , Savelberg Wilma , van der Horst Iwan C C , Van Mook Walther N K A , Rennenberg Roger J M W
Published: April 2023

Objectives

During the COVID-19 pandemic, the staff in the intensive care unit (ICU) was materially, physically and emotionally challenged. This qualitative study investigated the effects that ICU staff experienced and were considered of value to be permanently implemented.

Setting

ICU in an university medical centre during the first wave of the COVID-19 pandemic.

Design

An opportunity-centric approach was applied in individual semi-structured interviews to optimise the achieved results and was guided by the theoretical model of appreciative inquiry (AI).

Participants

Fifteen ICU staff members (8 nurses and 7 intensivists) participated.

Results

Working during the COVID-19 pandemic catalysed interprofessional collaboration and team learning in the ICU on an individual and team level, centred around a common goal: taking care of critically ill patients with COVID-19. The effect of interprofessional collaboration was that provisions were taken care of quicker than usual, without bureaucratic delays. However, this effect was experienced to be transient. Also, ICU staff perceived limited possibilities to help patients and families around the palliative phase, and they perceived a lack of appreciation from higher management. This is a point of future attention: how to make this perceived lack of appreciation more visible to all (ICU) staff.

Conclusion

Regarding our primary question, the ICU staff voiced that the direct communication and collaboration are the most important elements of the COVID-19 peak they would like to preserve. Furthermore, it was learnt that consolation and support for family members should not be forgotten. Considering the results, we believe that further research concerning team reflexivity might contribute to (or enhance) our knowledge about working together during and after a crisis.
Multicentre study protocol comparing standard NRP to deveLoped Educational Modules for Resuscitation of Neonates in the Delivery Room with Congenital Heart Disease (LEARN-CHD)
Authors: Levy Philip , Thomas Alyssa R , Law Brenda Hiu Yan , Joynt Chloe , Gupta Ruby , Elshenawy Summer , Reed Danielle , Pavlek Leeann R , Shepherd Jennifer , Gowda Sharada , Johnson Beth Ann , Ball Molly , Ali Noorjahan
Published: April 2023

Introduction

Infants born with critical congenital heart defects (CCHDs) have unique transitional pathophysiology that often requires special resuscitation and management considerations in the delivery room (DR). While much is known about neonatal resuscitation of infants with CCHDs, current neonatal resuscitation guidelines such as the neonatal resuscitation programme (NRP) do not include algorithm modifications or education specific to CCHDs. The implementation of CCHD specific neonatal resuscitation education is further hampered by the large number of healthcare providers (HCPs) that need to be reached. Online learning modules (eLearning) may provide a solution but have not been designed or tested for this specific learning need. Our objective in this study is to design targeted eLearning modules for DR resuscitation of infants with specific CCHDs and compare HCP knowledge and team performance in simulated resuscitations among HCPs exposed to these modules compared with directed CCHD readings.

Methods and analysis

In a prospective multicentre trial, HCP proficient in standard NRP education curriculum are randomised to either (a) directed CCHD readings or (b) CCHD eLearning modules developed by the study team. The efficacy of these modules will be evaluated using (a) individual preknowledge/postknowledge testing and (b) team-based resuscitation simulations.

Ethics and dissemination

This study protocol is approved by nine participating sites: the Boston Children’s Hospital Institutional Review Board (IRB-P00042003), University of Alberta Research Ethics Board (Pro00114424), the Children’s Wisconsin IRB (1760009-1), Nationwide Children’s Hospital IRB (STUDY00001518), Milwaukee Children’s IRB (1760009-1) and University of Texas Southwestern IRB (STU-2021-0457) and is under review at following sites: University of Cincinnati, Children’s Healthcare of Atlanta, Children’s Hospital of Los Angeles and Children’s Mercy-Kansas City. Study results will be disseminated to participating individuals in a lay format and presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.
Trends in the availability of community-based home visiting services for oldest-old in China, 2005–2018
Authors: Li Zhong , Xuan Mingsong , Gao Yukuan , He Ruibo , Qian Dongfu , Hung Peiyin
Published: April 2023

Objectives

This study aims to examine trends in neighbourhood availability of community-based home visiting services (CHVS) (ie, coverage by local primary healthcare providers) over time and disparities in service availability according to individual characteristics using nationwide data of oldest-old individuals (age >80) in China.

Design

Repeated, cross-sectional study.

Setting

This study derived nationally representative data from the 2005–2018 Chinese Longitudinal Health Longevity Survey.

Participants

A final analytical sample of 38 032 oldest-old individuals.

Primary outcome measures

Availability of CHVS was defined as having home visiting services in one’s neighbourhood. Cochran-Armitage tests were used to test linear trends in the proportions of oldest-old with service availability. Weighted logistic regression models were used to examine variations in service availability across individual characteristics.

Results

Of 38 032 oldest-old individuals, availability of CHVS decreased from 9.7% in 2005 to 7.8% in 2008/2009, followed by continual increases to 33.7% in 2017/2018. These changes were similar between rural and urban oldest-old. After accounting for individual characteristics, in 2017/2018, compared with their counterparts, urban residents who had white-collar jobs before retirement and those residing in Western and Northeast China were less likely to have service availability. Oldest-old with disabilities, those living alone and those with low incomes did not report having greater availability of CHVS in either 2005 or 2017/2018.

Conclusions

Despite the increasing service availability over the past 13 years, persistent geographical disparities in the availability of CHVS remain. As of 2017/2018, only one in three oldest-old in China reported having service availability, which raises concerns regarding continuity of care across different settings of services for those most in need, especially those living alone or with disabilities. National policies and targeting efforts are necessary to improve the availability of CHVS and reduce inequity in service availability for optimal long-term care to the oldest-old population in China.
Validation of the Pediatric Resuscitation and Trauma Outcome (PRESTO) model in injury patients in Tanzania
Authors: Keating Elizabeth M , Mitao Modesta , Kozhumam Arthi , Souza Joao Vitor , Anthony Cecilia S , Costa Dalton Breno , Staton Catherine A , Mmbaga Blandina T , Vissoci Joao Ricardo Nickenig
Published: April 2023

Introduction

Sub-Saharan Africa has the highest rate of unintentional paediatric injury deaths. The Pediatric Resuscitation and Trauma Outcome (PRESTO) model predicts mortality using patient variables available in low-resource settings: age, systolic blood pressure (SBP), heart rate (HR), oxygen saturation, need for supplemental oxygen (SO) and neurologic status (Alert Verbal Painful Unresponsive (AVPU)). We sought to validate and assess the prognostic performance of PRESTO for paediatric injury patients at a tertiary referral hospital in Northern Tanzania.

Methods

This is a cross-sectional study from a prospective trauma registry from November 2020 to April 2022. We performed exploratory analysis of sociodemographic variables and developed a logistic regression model to predict mortality using R (V.4.1). The logistic regression model was evaluated using area under the receiver operating curve (AUC).

Results

499 patients were enrolled with a median age of 7 years (IQR 3.41–11.18). 65% were boys, and in-hospital mortality was 7.1%. Most were classified as alert on AVPU Scale (n=326, 86%) and had normal SBP (n=351, 98%). Median HR was 107 (IQR 88.5–124). The logistic regression model based on the original PRESTO model revealed that AVPU, HR and SO were statistically significant to predict in-hospital mortality. The model fit to our population revealed AUC=0.81, sensitivity=0.71 and specificity=0.79.

Conclusion

This is the first validation of a model to predict mortality for paediatric injury patients in Tanzania. Despite the low number of participants, our results show good predictive potential. Further research with a larger injury population should be done to improve the model for our population, such as through calibration.
Retrospective analysis of cataract surgery outcomes in China from 2009 to 2018: from a national registry system data
Authors: Feng Jingjing , Jan Catherine , Peng Yaguang , He Mingguang , An Lei , Zhan Leilei , Shi Wei , Peng Xiaoxia , Shang Wenhan , Li Wei , Xu Xiao , Yao Li
Published: April 2023

Objective

To evaluate patients’ benefits after cataract surgery and to form recommendations for Chinese national health policy decision makers and administration departments based on the quality of cataract treatments.

Method

An observational study based on real-world data source from the National Cataract Recovery Surgery Information Registration and Reporting System.

Results

A total of 14 157 463 original records were reported from 1 July 2009 to 31 December 2018. The factors that influenced the 3-day postsurgical best-corrected visual acuity (BCVA), the primary outcome, were analysed by logistic regression analysis. We found that a history of hypertension (OR=0.916) or diabetes (OR=0.912), presurgical pupil abnormality (OR=0.571) and high intraocular pressure (OR=0.578) were harmful to the postsurgical BCVA improvement (BCVA ≥6/20), while male sex (OR=1.113), better presurgical BCVA level (OR=5.996 for ≥6/12–<6/7.5 and OR=2.610 for >6/60–<6/12 taken ≤6/60 as reference), age-related cataract (OR=1.825) and intraocular lens implantation (OR=1.886) were statistically beneficial to the postsurgical BCVA improvement. Compared with extracapsular cataract extraction (ECCE) with large incision, the ECCE with small incision (OR value=1.810) and the phacoemulsification (OR=1.420) significantly improved the benefit probability.

Conclusion

ECCE with small incision has comparable effects on postsurgical BCVA improvement of phacoemulsification. Therefore, ECCE could be an alternative cataract surgical treatment in economically underdeveloped areas in China, provided the surgeons are adequately trained.
Moving beyond audit: driving system learning using a novel mortality classification system in a tertiary training hospital in Kenya
Authors: Steere Mardi , Mbugua Evelyn , Davis Richard E , Mailu Faith , Adam Mary B
Published: April 2023

Clinical classification systems have proliferated since the APGAR score was introduced in 1953. Numerical scores and classification systems enable qualitative clinical descriptors to be transformed into categorical data, with both clinical utility and ability to provide a common language for learning. The clarity of classification rubrics embedded in a mortality classification system provides the shared basis for discussion and comparison of results. Mortality audits have been long seen as learning tools, but have tended to be siloed within a department and driven by individual learner need. We suggest that the learning needs of the system are also important. Therefore, the ability to learn from small mistakes and problems, rather than just from serious adverse events, remains facilitated.

We describe a mortality classification system developed for use in the low-resource context and how it is ‘fit for purpose,’ able to drive both individual trainee, departmental and system learning. The utility of this classification system is that it addresses the low-resource context, including relevant factors such as limited prehospital emergency care, delayed presentation, and resource constraints. We describe five categories: (1) anticipated death or complication following terminal illness; (2) expected death or complication given clinical situation, despite taking preventive measures; (3) unexpected death or complication, not reasonably preventable; (4) potentially preventable death or complication: quality or systems issues identified and (5) unexpected death or complication resulting from medical intervention. We document how this classification system has driven learning at the individual trainee level, the departmental level, supported cross learning between departments and is being integrated into a comprehensive system-wide learning tool.
Bystander cardiopulmonary resuscitation and cardiac rhythm change over time in patients with out-of-hospital cardiac arrest
Authors: Shibahashi Keita , Kato Taichi , Hikone Mayu , Sugiyama Kazuhiro
Published: April 2023

Background

Whether and how bystander cardiopulmonary resuscitation (CPR) modifies the cardiac rhythm after out-of-hospital cardiac arrest (OHCA) over time remains unclear. We investigated the association between bystander CPR and the likelihood of ventricular fibrillation (VF) or ventricular tachycardia (VT) as the first documented cardiac rhythm.

Methods

We identified individuals with witnessed OHCA of cardiac origin from a nationwide population-based OHCA registry in Japan between 1 January 2005 and 31 December 2019. The first documented cardiac rhythm was compared between patients who received bystander CPR and those who did not, using a 1:2 propensity score-matched analysis.

Results

Of 309 900 patients with witnessed OHCA of cardiac origin, 71 887 (23.2%) received bystander CPR. Propensity score matching paired 71 882 patients who received bystander CPR with 143 764 who did not. The likelihood of detecting a VF/VT rhythm was significantly higher among patients who received bystander CPR than among those who did not (OR 1.66; 95% CI 1.63 to 1.69; p<0.001). Comparing the two groups at each time point, the difference in the proportions of patients with VF/VT rhythms peaked at 15–20 min but was insignificant at 30 min postcollapse (15 min after collapse; 20.9% vs 13.9%; p<0.001). The likelihood of a pulseless electrical activity rhythm was significantly lower in patients who received bystander CPR during the first 25 min postcollapse (15 min after collapse; 26.2% vs 31.5%; p<0.001). The two groups had no significant difference in the likelihood of asystole (15 min after collapse; 51.0% vs 53.3%; p=0.078).

Conclusion

Bystander CPR was associated with a higher VF/VT likelihood and a lower likelihood of pulseless electrical activity at first documented rhythm analysis. Our results support early CPR for OHCA and highlight the need for further research to understand whether and how CPR modifies the cardiac rhythm after arrest.
Retrograde endovascular recanalization of chronic common carotid total occlusion: a technical video
Authors: Radu Răzvan Alexandru , Cagnazzo Federico , Derraz Imad , Gascou Grégory , Costalat Vincent
Published: April 2023

Common carotid artery (CCA) occlusion with patency of the internal carotid artery (ICA) is a rare cause of stroke with no consensus on optimal management.1 Open surgery, most often CCA-subclavian or CCA-aortic arch bypass techniques, have been used to recanalize short proximal occlusions.1 2 Endovascular revascularization of chronic total ICA occlusion was proposed with promising results in previous reports.3–5 However, endovascular recanalization for chronic CCA occlusion has rarely been described in the literature, and the reports involved mainly right-sided occlusions or occlusions with residual CCA stumps.6 Anterograde endovascular management of chronic long left-sided CCA occlusions is problematic due to lack of support, notably when no proximal stump is present.4 In this video, we present a case of known long-chronic CCA occlusion managed by retrograde echo-guided ICA puncture and stent-assisted reconstruction.(video 1)

Video 1
Microstructure evolution of a compacted lateritic silt upon drying–wetting and loading
Authors: Gu Chuan , He Xuan , Ge Miaomiao , Liu Yuanyuan
Published: April 2023

Lateritic soil usually contains a large amount of iron and aluminium, which promotes the formation of large-size aggregations and further affects soil fabric. It has been demonstrated that the microstructure of soil influences the hydraulic and mechanical behaviour significantly. As a commonly used filling material with special mineral composition, the microstructure change of lateritic soil under common environment actions, such as wetting and loading, is thus of great importance. In this study, the microstructure properties of a lateritic silt under drying–wetting and one-dimensional compression were investigated using mercury intrusion porosimetry and scanning electron microscopy. Test results show that large-sized aggregates are formed in the compacted lateritic silt with 10% of hematite. These aggregates induce a bi-modal pore size distribution (PSD) which includes both micropore and macropore peaks. The different macropore distributions under various dry densities lead to scattered soil–water characteristic curves in a suction range less than 20 MPa. Changes in volume and pore structure mainly occur in the suction path within the “transition zone” where the dominant capillarity affects only the macropore. Drying causes an increase in macropores due to the decreased volume of aggregates, while has limited effect on micropores, whereas wetting weakens the bonding between aggregates, and induces a reduction in macropores. The compacted lateritic silt shows obvious collapse upon soaking, in which the collapse grows up to a peak and then turns to decrease with increasing stress level. Both loading and soaking lead to the collapse of macropores, whereas soaking tends to affect a broader range of pore sizes. It is inferred that, the strong particle cementation produced by hematite leads to a strong micropore structure, which is almost unaffected by the suction change under both confined and unconfined conditions. The PSD change due to the variation in suction is different from that observed on other compacted fine-grained soils, which verifies the effects of special mineral composition (iron and aluminium) on microstructure and further the hydro-mechanical behaviour of lateritic soil.
Gathering validity evidence in the development of a new version of the Attitude toward the Subject of Chemistry Inventory (ASCI-UE)
Authors: Rocabado Guizella A. , Montes Lilian H. , Ferreira Roberto , Rodríguez Cristina , Lewis Jennifer E.
Published: April 2023

Organic chemistry is one of the most feared and failed courses due to its complex and fast-paced nature. Investigating affective metrics that relate to achievement in these courses can be worthwhile, particularly when these metrics show predictive relationships to achievement. Attitude toward chemistry has been investigated utilizing a variety of instruments. We present herein an instrument related to the well-established Attitude toward the Subject of Chemistry Inventory (ASCIv2). This new instrument was developed utilizing The Standards of Psychological and Educational Measurement, which describe five aspects of validity evidence that should be gathered when using instruments in research. Content validity was gathered through consultation with experts. Response process validity was gathered through student interviews. Internal structural validity was collected through confirmatory factor analysis. Relations to other variables were investigated through correlation analysis and structural equation modeling. Consequential validity was studied through measurement invariance testing before comparing scores for subgroups (high- and low-achieving students). Additionally, reliability evidence was tested with Omega coefficients for each of the factors. We showed that all tests and analyses were done with high rigor, and that this new instrument, ASCI-UE, measuring utility and e motional satisfaction, can provide interesting results and implications for research and practice.