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Trajectories of asthma symptom presenting as wheezing and their associations with family environmental factors among children in Australia: evidence from a national birth cohort study

Por: Shahunja · K. M. · Sly · P. D. · Chisti · M. J. · Mamun · A.
Objectives

Asthma is one of the greatest health burdens, yet contributors to asthma symptom trajectories are understudied in Australian children. We aimed to assess the trajectories of asthma symptom and their associations with several family environmental factors during the childhood period in Australia.

Design

Secondary analysis from a cross-sequential cohort study.

Setting

Nationwide representative data from the ‘Longitudinal Study of Australian Children (LSAC)’.

Participants

Participants from the LSAC birth cohort.

Outcome measures

Asthma symptom trajectory groups.

Methods

Asthma symptom presenting as wheezing, family environmental factors and sociodemographic data (2004–2018) were obtained from the LSAC. Group-based trajectory modelling was applied to identify asthma symptom trajectories and multivariable logistic regression models were used to assess the associations between these and environmental factors.

Results

Of 5107 children in the LSAC cohort, 3846 were included in our final analysis. We identified three distinct asthma symptom trajectories from age 0/1 year to 14/15 years: ‘low/no’ (69%), ‘transient high’ (17%) and ‘persistent high’ (14%). Compared with the ‘low/no’ group, children exposed to ‘moderate and declining’ (relative risk ratio (RRR): 2.22, 95% CI 1.94 to 2.54; RRR: 1.26, 95% CI 1.08 to 1.46) and ‘high and persistent’ prevalence of maternal smoking (RRR: 1.41, 95% CI 1.23 to 1.60; RRR: 1.26, 95% CI 1.10 to 1.44) were at increased risk of being classified into the ‘transient high’ and ‘persistent high’ trajectories of asthma symptom. Persistently bad external dwelling conditions (RRR: 1.27, 95% CI 1.07 to 1.51) were associated with ‘transient high’ trajectory while ‘moderate and increasing’ conditions of cluttered homes (RRR: 1.37, 95% CI 1.20 to 1.56) were associated with ‘persistent high’ trajectory of asthma symptom. Exposure to tobacco smoke inside the house also increased the risk of being in the ‘persistent high’ trajectory group (RRR: 1.30, 95% CI 1.12 to 1.50).

Conclusion

Poor home environment increased the risk of asthma symptom during childhood. Improving home environment and reducing exposure to tobacco smoke may facilitate a favourable asthma symptom trajectory during childhood.

I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations

Por: Files · D. C. · Matthay · M. A. · Calfee · C. S. · Aggarwal · N. R. · Asare · A. L. · Beitler · J. R. · Berger · P. A. · Burnham · E. L. · Cimino · G. · Coleman · M. H. · Crippa · A. · Discacciati · A. · Gandotra · S. · Gibbs · K. W. · Henderson · P. T. · Ittner · C. A. G. · Jauregui
Introduction

The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.

Methods and analysis

The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.

Ethics and dissemination

ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.

Trial registration number

NCT04488081.

Value-based healthcare in Latin America: a survey of 70 healthcare provider organisations from Argentina, Brazil, Chile, Colombia and Mexico

Por: Makdisse · M. · Ramos · P. · Malheiro · D. · Katz · M. · Novoa · L. · Cendoroglo Neto · M. · Ferreira · J. H. G. · Klajner · S.
Objectives

Value-based healthcare (VBHC) is a health system reform gradually being implemented in health systems worldwide. A previous national-level survey has shown that Latin American countries were in the early stages of alignment with VBHC. Data at the healthcare provider organisations (HPOs) level are lacking. This study aim was to investigate how HPOs in five Latin American countries are implementing VBHC.

Design

Mixed-methods research was conducted using online questionnaire, semistructured interviews based on selected elements of the value agenda (from December 2018 to June 2020), analyses of aggregated data and documents. Qualitative analysis was performed using NVivo QSR International, 1.6.1 (4830). Quantitative analysis used Fisher’s exact test. Univariate analysis was used to compare organisations in relation to the implementation of VBHC initiatives. A p≤0.05 was considered significant.

Participants

Top and middle-level executives from 70 HPOs from Argentina, Brazil, Chile, Colombia and Mexico.

Results

The definition of VBHC varied across participating organisations. Although the value equation had been cited by 24% of participants, its composition differed in most case from the original Equation. Most VBHC initiatives were related to care delivery organisation (56.9%) and outcomes measurement (22.4%) but in most cases, integrated practice unit features had not been fully developed and outcome data was not used to guide improvement. Information, stakeholders buy-in, compensation and fragmented care delivery were the most cited challenges to VBHC implementation. Fee-for-service predominated, although one-third of organisations were experimenting with alternative payment models.

Conclusions

A wide variation in the definition and level of VBHC implementation existed across organisations. Our finding suggests investments in information systems and on education of key stakeholders will be key to foster VBHC implementation in the region. Further research is needed to identify successful implementation cases that may serve as regional benchmark for other Latin American organisations advancing with VBHC.

Effect of a perinatal care quality improvement package on patient satisfaction: a secondary outcome analysis of a cluster-randomised controlled trial

Por: Brunell · O. · Chaulagain · D. · KC · A. · Bergström · A. · Malqvist · M.
Objective

To investigate the effect of a quality improvement (QI) package on patient satisfaction of perinatal care.

Design

Secondary analysis of a stepped-wedge cluster-randomised controlled trial. Participating hospitals were randomised by size into four different wedges.

Setting

12 secondary-level public hospitals in Nepal.

Participants

Women who gave birth in the hospitals at a gestational age of ≥22 weeks, with fetal heart sound at admission. Adverse outcomes were excluded. One hospital was excluded due to data incompleteness and four low-volume hospitals due to large heterogeneity. The final analysis included 54 919 women.

Intervention

Hospital management was engaged and facilitators were recruited from within hospitals. Available perinatal care was assessed in each hospital, followed by a bottle-neck analysis workshop. A 3-day training in essential newborn care was carried out for health workers involved in perinatal care, and a set of QI tools were introduced to be used in everyday practice (skill-checks, self-assessment checklists, scoreboards and weekly Plan–Do–Study–Act meetings). Refresher training after 6 months.

Outcome measure

Women’s satisfaction with care during childbirth (a prespecified secondary outcome).

Results

The likelihood of women being overall satisfied with care during childbirth increased after the intervention (adjusted OR (aOR): 1.66, 95% CI: 1.59 to 1.73). However, the proportions of overall satisfaction were low (control 58%, intervention 62%). Women were more likely to be satisfied with education and information from health workers after intervention (aOR: 1.34, 95% CI: 1.29 to 1.40) and to have been treated with dignity and respect (aOR: 1.81, 95% CI: 1.52 to 2.16). The likelihood of having experienced abuse during the hospital stay decreased (aOR: 0.42, 95% CI: 0.34 to 0.51) and of being satisfied with the level of privacy increased (aOR: 1.14, 95% CI: 1.09 to 1.18).

Conclusions

Improvements in patient satisfaction were indicated after the introduction of a QI-package on perinatal care. We recommend further studies on which aspects of care are most important to improve women’s satisfaction of perinatal care in hospitals in Nepal.

Trial registration number

ISRCTN30829654.

Is grip strength linked to body composition and cardiovascular risk markers in primary schoolchildren? Cross-sectional data from three African countries

Por: Gerber · M. · Ayekoe · S. · Bonfoh · B. · Coulibaly · J. T. · Daouda · D. · Gba · B. C. · Kouassi · B. · Traore · S. G. · du Randt · R. · Nqweniso · S. · Walter · C. · Finda · M. F. · Minja · E. G. · Mollel · G. J. · Masanja · H. · Okumu · F. O. · Beckmann · J. · Gall · S. · Lang · C. · Z Lo
Objectives

Muscular strength represents a specific component of health-related fitness. Hand grip strength (HGS) is used as an indicator for musculoskeletal fitness in children. HGS can also be used as a marker of cardiometabolic risk, but most available HGS data are derived from Western high-income countries. Therefore, this study examines whether HGS is associated with body composition and markers of cardiovascular risk in children from three sub-Saharan African countries.

Design

Cross-sectional study.

Setting

Public primary schools (grade 1–4) in Taabo (Côte d’Ivoire), Gqeberha (South Africa) and Ifakara (Tanzania).

Participants

Data from 467 children from Côte d’Ivoire (210 boys, 257 girls), 864 children from South Africa (429 boys, 435 girls) and 695 children from Tanzania (334 boys, 361 girls) were analysed.

Primary and secondary outcome measures

Body composition (assessed via bioelectrical impedance analysis) was the primary outcome. Cardiovascular risk markers were considered as secondary outcome. Blood pressure was measured with an oscillometric monitor, and blood markers (cholesterol, triglycerides, glycated haemoglobin) via Afinion point-of-care testing. HGS (independent variable) was assessed with a hydraulic hand dynamometer. Inferential statistics are based on mixed linear regressions and analyses of covariance.

Results

Across all study sites, higher HGS was associated with lower body fat, higher muscle mass and higher fat-free mass (p

Conclusions

HGS assessment is popular due to its simplicity, feasibility, practical utility and high reliability of measurements. This is one of the first HGS studies with children from sub-Saharan Africa. There is a great need for further studies to examine whether our findings can be replicated, to develop reference values for African children, to establish links to other health outcomes, and to explore whether HGS is associated with later development of cardiovascular risk markers.

Trial registration number

ISRCTN29534081.

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial)

Por: Galvao · D. A. · Taaffe · D. R. · Hayne · D. · Lopez · P. · Lyons-Wall · P. · Tang · C. I. · Chambers · S. K. · Devine · A. · Spry · N. · Jeffery · E. · Kudiarasu · C. · Joseph · D. · Newton · R. U.
Introduction

Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer.

Methods and analysis

A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7–12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches.

Ethics and dissemination

Ethics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021–02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings.

Trial registration number

ACTRN12621001312831.

Risk of SARS-CoV-2 infection among front-line healthcare workers in Northeast Brazil: a respondent-driven sampling approach

Objectives

We assessed the prevalence of SARS-CoV-2 infection, personal protective equipment (PPE) shortages and occurrence of biological accidents among front-line healthcare workers (HCW).

Design, setting and participants

Using respondent-driven sampling, the study recruited distinct categories of HCW attending suspected or confirmed patients with COVID-19 from May 2020 to February 2021, in the Recife metropolitan area, Northeast Brazil.

Outcome measures

The criterion to assess SARS-CoV-2 infection among HCW was a positive self-reported PCR test.

Results

We analysed 1525 HCW: 527 physicians, 471 registered nurses, 263 nursing assistants and 264 physical therapists. Women predominated in all categories (81.1%; 95% CI: 77.8% to 84.1%). Nurses were older with more comorbidities (hypertension and overweight/obesity) than the other staff. The overall prevalence of SARS-CoV-2 infection was 61.8% (95% CI: 55.7% to 67.5%) after adjustment for the cluster random effect, weighted by network, and the reference population size. Risk factors for a positive RT-PCR test were being a nursing assistant (OR adjusted: 2.56; 95% CI: 1.42 to 4.61), not always using all recommended PPE while assisting patients with COVID-19 (OR adj: 2.15; 95% CI: 1.02 to 4.53) and reporting a splash of biological fluid/respiratory secretion in the eyes (OR adj: 3.37; 95% CI: 1.10 to 10.34).

Conclusions

This study shows the high frequency of SARS-CoV2 infection among HCW presumably due to workplace exposures. In our setting, nursing assistant comprised the most vulnerable category. Our findings highlight the need for improving healthcare facility environments, specific training and supervision to cope with public health emergencies.

Early empiric anti-Mycobacterium tuberculosis therapy for sepsis in sub-Saharan Africa: a protocol of a randomised clinical trial

Por: Said · B. · Nuwagira · E. · Liyoyo · A. · Arinaitwe · R. · Gitige · C. · Mushagara · R. · Buzaare · P. · Chongolo · A. · Jjunju · S. · Twesigye · P. · Boulware · D. R. · Conaway · M. · Null · M. · Thomas · T. A. · Heysell · S. K. · Moore · C. C. · Muzoora · C. · Mpagama · S. G.
Introduction

Sub-Saharan Africa shoulders the highest burden of global sepsis and associated mortality. In high HIV and tuberculosis (TB) prevalent settings such as sub-Saharan Africa, TB is the leading cause of sepsis. However, anti-TB therapy is often delayed and may not achieve adequate blood concentrations in patients with sepsis. Accordingly, this multisite randomised clinical trial aims to determine whether immediate and/or increased dose anti-TB therapy improves 28-day mortality for participants with HIV and sepsis in Tanzania or Uganda.

Methods and analysis

This is a phase 3, multisite, open-label, randomised controlled clinical 2x2 factorial superiority trial of (1) immediate initiation of anti-TB therapy and (2) sepsis-specific dose anti-TB therapy in addition to standard of care antibacterials for adults with HIV and sepsis admitted to hospital in Tanzania or Uganda. The primary endpoint is 28-day mortality. A sample size of 436 participants will provide 80% power for testing each of the main effects of timing and dose on 28-day mortality with a two-sided significance level of 5%. The expected main effect for absolute risk reduction is 13% and the expected OR for risk reduction is 1.58.

Ethics and dissemination

This clinical trial will determine the optimal content, dosing and timing of antimicrobial therapy for sepsis in high HIV and TB prevalent settings. The study is funded by the National Institutes of Health in the US. Institutional review board approval was conferred by the University of Virginia, the Tanzania National Institute for Medical Research, and the Uganda National Council for Science and Technology. Study results will be published in peer-reviewed journals and in the popular press of Tanzania and Uganda. We will also present our findings to the Community Advisory Boards that we convened during study preparation.

Trial registration number

ClinicalTrials.gov (NCT04618198).

Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial

Por: Cepeda · M. · Hubbard · D. · Oparil · S. · Schwartz · J. E. · Jaeger · B. C. · Hardy · S. T. · Medina · J. · Chen · L. · Muntner · P. · Shimbo · D.
Introduction

For many people, blood pressure (BP) levels differ when measured in a medical office versus outside of the office setting. Out-of-office BP has a stronger association with cardiovascular disease (CVD) events compared with BP measured in the office. Many BP guidelines recommend measuring BP outside of the office to confirm the levels obtained in the office. Ambulatory BP monitoring (ABPM) can assess out-of-office BP but is not available in many US practices and some individuals find it uncomfortable. The aims of the Better BP Study are to (1) test if unattended office BP is closer to awake BP on ABPM compared with attended office BP, (2) assess if sleep BP assessed by home BP monitoring (HBPM) agrees with sleep BP from a full night of ABPM and (3) compare the strengths of associations of unattended versus attended office BP, unattended office BP versus awake BP on ABPM and sleep BP on HBPM versus ABPM with markers of end-organ damage.

Methods and analysis

We are recruiting 630 adults not taking antihypertensive medication in Birmingham, Alabama, and New York, New York. Participants are having their office BP measured with (attended) and without (unattended) a technician present, in random order, using an automated oscillometric office BP device during each of two visits within one week. Following these visits, participants complete 24 hours of ABPM and one night of HBPM, in random order. Psychosocial factors, anthropometrics, left ventricular mass index and albumin-to-creatinine ratio are also being assessed.

Ethics and dissemination

This study was approved by the University of Alabama at Birmingham and the Columbia University Medical Center Institutional Review Boards. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

Trial registration number

NCT04307004.

Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders

Por: Hampsey · E. · Meszaros · M. · Skirrow · C. · Strawbridge · R. · Taylor · R. H. · Chok · L. · Aarsland · D. · Al-Chalabi · A. · Chaudhuri · R. · Weston · J. · Fristed · E. · Podlewska · A. · Awogbemila · O. · Young · A. H.
Introduction

Neurodegenerative and psychiatric disorders (NPDs) confer a huge health burden, which is set to increase as populations age. New, remotely delivered diagnostic assessments that can detect early stage NPDs by profiling speech could enable earlier intervention and fewer missed diagnoses. The feasibility of collecting speech data remotely in those with NPDs should be established.

Methods and analysis

The present study will assess the feasibility of obtaining speech data, collected remotely using a smartphone app, from individuals across three NPD cohorts: neurodegenerative cognitive diseases (n=50), other neurodegenerative diseases (n=50) and affective disorders (n=50), in addition to matched controls (n=75). Participants will complete audio-recorded speech tasks and both general and cohort-specific symptom scales. The battery of speech tasks will serve several purposes, such as measuring various elements of executive control (eg, attention and short-term memory), as well as measures of voice quality. Participants will then remotely self-administer speech tasks and follow-up symptom scales over a 4-week period. The primary objective is to assess the feasibility of remote collection of continuous narrative speech across a wide range of NPDs using self-administered speech tasks. Additionally, the study evaluates if acoustic and linguistic patterns can predict diagnostic group, as measured by the sensitivity, specificity, Cohen’s kappa and area under the receiver operating characteristic curve of the binary classifiers distinguishing each diagnostic group from each other. Acoustic features analysed include mel-frequency cepstrum coefficients, formant frequencies, intensity and loudness, whereas text-based features such as number of words, noun and pronoun rate and idea density will also be used.

Ethics and dissemination

The study received ethical approval from the Health Research Authority and Health and Care Research Wales (REC reference: 21/PR/0070). Results will be disseminated through open access publication in academic journals, relevant conferences and other publicly accessible channels. Results will be made available to participants on request.

Trial registration number

NCT04939818.

I’m wearing a mask, but are they?: Perceptions of self-other differences in COVID-19 health behaviors

by James Adaryukov, Sergej Grunevski, Derek D. Reed, Timothy J. Pleskac

As information about COVID-19 safety behavior changed, people had to judge how likely others were to protect themselves through mask-wearing and vaccination seeking. In a large, campus-wide survey, we assessed whether University of Kansas students viewed others’ protective behaviors as different from their own, how much students assumed others shared their beliefs and behaviors, and which individual differences were associated with those estimations. Participants in our survey (N = 1, 704; 81.04% white, 64.08% female) estimated how likely they and others were to have worn masks on the University of Kansas campus, have worn masks off-campus, and to seek a vaccine. They also completed measures of political preference, numeracy, and preferences for risk in various contexts. We found that participants estimated that others were less likely to engage in health safety behaviors than themselves, but that their estimations of others were widely shared. While, in general, participants saw themselves as more unique in terms of practicing COVID-19 preventative behaviors, more liberal participants saw themselves as more unique, while those that were more conservative saw their own behavior as more similar to others. At least for masking, this uniqueness was false—estimates of others’ health behavior were lower than their actual rates. Understanding this relationship could allow for more accurate norm-setting and normalization of mask-wearing and vaccination.

Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial

Por: Groves-Williams · D. · McHugh · G. A. · Bennell · K. L. · Comer · C. · Hensor · E. M. A. · Conner · M. · Nelligan · R. K. · Hinman · R. S. · Kingsbury · S. R. · Conaghan · P. G.
Introduction

Persistent, knee pain is a common cause of disability. Education and exercise treatment are advocated in all clinical guidelines; however, the increasing prevalence of persistent knee pain presents challenges for health services regarding appropriate and scalable delivery of these treatments. Digital technologies may help address this, and this trial will evaluate the feasibility and acceptability of two electronic-rehabilitation interventions: ‘My Knee UK’ and ‘Group E-Rehab’.

Methods and analysis

This protocol describes a non-blinded, randomised feasibility trial with three parallel groups. The trial aims to recruit 90 participants (45 years or older) with a history of persistent knee pain consistent with a clinical diagnosis of knee osteoarthritis. Participants will be randomly assigned in a 1:1:1 allocation ratio. The ‘My Knee UK’ intervention arm will receive a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12 weeks; the ‘Group E-Rehab’ intervention arm will receive group-based physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions for 12 weeks; the control arm will receive usual physiotherapy care or continue with their usual self-management (depending on their recruitment path). Feasibility variables, patient-reported outcomes and clinical findings measured at baseline, 3 and 9 months will be assessed and integrated with qualitative interview data from a subset of Group E-Rehab and My Knee UK participants. If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.

Ethics and dissemination

The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). The results of the study will be disseminated to study participants, the study grant funder and will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN15564385.

Impact of leadership behaviour on physician well-being, burnout, professional fulfilment and intent to leave: a multicentre cross-sectional survey study

Por: Mete · M. · Goldman · C. · Shanafelt · T. · Marchalik · D.
Objective

To examine how perceived leadership behaviours affect burnout, professional fulfilment and intent to leave the organisation among physicians.

Design

Anonymous cross-sectional survey study from November 2016 to October 2018.

Setting

12 036 attending and resident physicians at 11 healthcare organisations participating in the Physician Wellness Academic Consortium (PWAC) were surveyed to assess burnout and professional fulfilment and their drivers.

Participants

A sample of 5416 attending physicians with complete data on gender, specialty, leadership, burnout and professional fulfilment.

Main outcomes and measures

The leadership behaviour of each physician’s supervisor was assessed using the Mayo Clinic Participatory Management Leadership Index and categorised in tertiles. Multivariable logistic regression analyses examined the effect of leadership behaviour rating of each physician’s supervisor on burnout, professional fulfilment and intent to leave controlling for gender and specialty.

Results

The response rate was 45% across 11 institutions. Half of the respondents were female. Professional fulfilment increased with increasing tertiles of leadership behaviour rating (19%, 34%, 47%, p

Conclusion

Perceived leadership behaviours have a strong relationship with burnout, professional fulfilment and intent to leave among physicians. Organisations should consider leadership development as a potential vehicle to improve physician wellness and prevent costly physician departures.

Behavioral factors associated with SARS-CoV-2 infection

Por: Cajar · M. D. · Tan · F. C. C. · Boisen · M. K. · Krog · S. M. · Nolsoee · R. · Collatz Christensen · H. · Andersen · M. P. · Moeller · A. L. · Gerds · T. A. · Pedersen-Bjergaard · U. · Lindegaard · B. · Kristensen · P. L. · Christensen · T. B. · Torp-Pedersen · C. · Lendorf · M. E.
Objective

To study the association between behavioural factors and incidence rates of SARS-CoV-2 infection.

Design

Case–control web-based questionnaire study.

Setting

Questionnaire data were collected in the Capital Region of Denmark in December 2020 when limited restrictions were in place, while the number of daily SARS-CoV-2 cases increased rapidly.

Participants

8913 cases of laboratory-confirmed SARS-CoV-2 infection were compared with two groups of controls: (1) 34 063 individuals with a negative SARS-CoV-2 test from the same date (negative controls, NCs) and 2) 25 989 individuals who had never been tested for a SARS-CoV-2 infection (untested controls, UC). Controls were matched on sex, age, test date and municipality.

Exposure

Activities during the 14 days prior to being tested positive for SARS-CoV-2 or during the same period for matched controls and precautions taken during the entire pandemic.

Main outcomes and measures

SARS-CoV-2 infection incidence rate ratios (IRR).

Results

Response rate was 41.4% (n=93 121). Using public transportation, grocery shopping (IRR: NC: 0.52; UC: 0.63) and outdoor sports activities (NC: 0.75; UC: 0.96) were not associated with increased rate of SARS-CoV-2 infection. Most precautions, for example, using hand sanitizer (NC: 0.79; UC: 0.98), physical distancing (NC: 0.79; UC: 0.82) and avoiding handshakes (NC: 0.74; UC: 0.77), were associated with a lower rate of infection. Activities associated with many close contacts, especially indoors, increased rate of infection. Except for working from home, all types of occupation were linked to increased rate of infection.

Conclusions

In a community setting with moderate restrictions, activities such as using public transportation and grocery shopping with the relevant precautions were not associated with an increased rate of SARS-CoV-2 infection. Exposures and activities where safety measures are difficult to maintain might be important risk factors for infection. These findings may help public health authorities tailor their strategies for limiting the spread of SARS-CoV-2.

Impact of the COVID-19 pandemic on utilisation of facility-based essential maternal and child health services from March to August 2020 compared with pre-pandemic March-August 2019: a mixed-methods study in North Shewa Zone, Ethiopia

Por: Bekele · C. · Bekele · D. · Hunegnaw · B. M. · Van Wickle · K. · Gebremeskel · F. A. · Korte · M. · Tedijanto · C. · Taddesse · L. · Chan · G. J.
Introduction

Health systems are often weakened by public health emergencies that make it harder to access health services. We aimed to assess maternal, newborn and child health (MNCH) service utilisation during the first 6 months of the COVID-19 pandemic compared with prior to the pandemic.

Methods

We conducted a mixed study design in eight health facilities that are part of the Birhan field site in Amhara, Ethiopia and compared the trend of service utilisation in the first 6 months of COVID-19 with the corresponding time and data points of the preceding year.

Result

New family planning visits (43.2 to 28.5/month, p=0.014) and sick under 5 child visits (225.0 to 139.8/month, p=0.007) declined over the first 6 months of the pandemic compared with the same period in the preceding year. Antenatal (208.9 to 181.7/month, p=0.433) and postnatal care (26.6 to 19.8/month, p=0.155) visits, facility delivery rates (90.7 to 84.2/month, p=0.776), and family planning visits (313.3 to 273.4/month, p=0.415) declined, although this did not reach statistical significance. Routine immunisation visits (37.0 to 36.8/month, p=0.982) for children were maintained. Interviews with healthcare providers and clients highlighted several barriers to service utilisation during COVID-19, including fear of disease transmission, economic hardship, and transport service disruptions and restrictions. Enablers of service utilisation included communities’ decreased fear of COVID-19 and awareness-raising activities.

Conclusion

We observed a decline in essential MNCH services particularly in sick children and new family planning visits. To improve the resiliency of fragile health systems, resources are needed to continuously monitor service utilisation and clients’ evolving concerns during public health emergencies.

Dosage of joint mobilisation for the management of rotator cuff-related shoulder pain: protocol for a scoping review

Por: Wang · S. · Chapple · C. M. · Quinn · D. · Tumilty · S. · Ribeiro · D. C.
Introduction

Rotator cuff-related shoulder pain is the most common diagnosis of shoulder pain, which ranks as the third most common musculoskeletal disorder. The first-line treatment for patients with rotator cuff-related shoulder pain is physiotherapy, and joint mobilisation is widely used in conjunction with other modalities. The type and dosage of joint mobilisations could influence treatment outcomes for patients with rotator cuff-related shoulder pain, although research evidence is inconclusive.

Objectives

To (1) systematically search, identify and map the reported type and dosage of joint mobilisations used in previous studies for the management of patients with rotator cuff-related shoulder pain; and (2) summarise the rationale for adopting a specific joint mobilisation dosage.

Methods and analysis

We will follow the methodological framework outlined by Arksey and O’Malley and report the results as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guideline. Two authors will independently screen and extract data from the six databases: PubMed, Scopus, Web of Science, CINAHL, Cochrane Library and SPORTDiscus, with publication date from their inceptions to 25 August 2021. A third author will be consulted if the two authors disagree about the inclusion of any study in the review. We will summarise the results using descriptive statistics and qualitative thematic analysis.

Ethics and dissemination

Ethical approval is not required for this protocol. Mapping and summarising the reported type and dosage of joint mobilisations for patients with rotator cuff-related shoulder pain from previous studies will provide a foundation for further optimal selection of type and dosage of joint mobilisations for treating patients with rotator cuff-related shoulder pain. The review is part of an ongoing research that focuses on joint mobilisation for patients with rotator cuff-related shoulder pain. The results will be disseminated through presentations at academic conferences and a peer-reviewed publication.

Protocol on establishing a prospective enhanced surveillance of vaccine preventable diseases in residential aged care facilities in Central Queensland, Australia: an observational study

Por: Hashan · M. R. · Chapman · G. · Walker · J. · Jayne Davidson · S. · Auriac · J. · Smoll · N. · Kirk · M. · Akbar · D. · Booy · R. · Khandaker · G.
Introduction

Infectious diseases are a major cause of mortality and morbidity among the highly vulnerable occupants of residential aged care facilities (RACFs). The burden of vaccine preventable diseases (VPDs) among RACFs residents is mostly unknown and there is a lack of quality data from population-based prospective VPD surveillance in RACFs. The increasing burden of emerging and existing VPDs (eg, COVID-19, influenza, pneumococcal, pertussis and varicella-zoster) necessitates the establishment of an active enhanced surveillance system to provide real-time evidence to devise strategies to reduce the burden of VPDs in RACFs.

Method and analysis

This study proposes a prospective active enhanced surveillance that will be implemented in RACFs across the Central Queensland (CQ) region. The study aims to measure the burden, identify aetiologies, risk factors, predictors of severe outcomes (eg, hospitalisations, mortality) and impact of the existing National Immunization Program (NIP) funded vaccines in preventing VPDs in this vulnerable population. CQ Public Health Unit (CQPHU) will implement the active surveillance by collecting demographic, clinical, pathological, diagnostic, therapeutic and clinical outcome data from the RACFs based on predefined selection criteria and case report forms as per routine public health practices. Descriptive statistics, univariate and multivariate regression analysis will be conducted to identify the predictors of morbidity and clinical outcomes following infection.

Ethics and dissemination

The study has been approved by the CQHHS Human Research Ethics Committee (HREC) (reference number HREC/2021/QCQ/74305). This study involves data that is routinely collected as part of the surveillance of notifiable conditions under the Public Health Act 2005. The CQHHS HREC approved a request to waive consent requirements of study participants as researchers will be provided non-identifiable data. The findings from the study will be actively disseminated through publication in peer-reviewed journals, conference presentations, social and print media, federal, state, and local authorities to reflect on the results that may facilitate revision of policy and highlight the stakeholders, funding bodies both locally and internationally.

Refreshing medical students intravenous-cannulation skills: a blinded observer three-arm randomised comparison of mental imagery, part-task trainer simulation and written instructions

Por: Berger-Estilita · J. · Blülle · R. · Stricker · D. · Balmer · M. · Greif · R. · Berendonk · C.
Introduction

Intravenous cannulation is a core competence in medicine, but is considered challenging to learn. This study investigates the effectiveness of three educational strategies used to refresh the intravenous cannulation skills of first-year medical students: mental imagery, part-task trainer simulation and written instructions.

Materials and methods

In this single-centre randomised controlled trial, first-year medical students were assigned to one of three different refresher tutorials on intravenous cannulation. Six months after their compulsory 4 hour instructor-led intravenous-cannulation course, each student was randomised to a 6 min self-learning tutorial: a mental imagery audioguide session, hands-on intravenous cannulation on a part-task trainer or reading written instructions.

Immediately after the refresher tutorials, trained evaluators who were blinded to the randomised group assessed the students’ performance. Each evaluator completed a 15-item standardised checklist in an Objective Structured Clinical Examination (OSCE) station for intravenous cannulation. We performed a descriptive analysis of the data and a one-way analysis of variance. Additionally, we investigated the influence of previous intravenous cannulation experience on the total OSCE score.

Results and discussion

On analysing the 309 students’ results, we did not find differences in the total rating of the performance (in percentage) between the three groups at the OSCE station (mental imagery group: 72.0%±17.9%; part-task trainer group: 74.4%±15.6%; written instructions group: 69.9%±16.6%, p=0.158). Multiple linear regression showed a small but statistically significant effect of students’ previous intravenous cannulation experience on OSCE performance. With the same outcome, written instructions and mental imagery had a better return on effort, compared with resource-intensive hands-on training with part-task trainers.

Conclusion

A single, short refresher seems to have a limited effect on intravenous-cannulation skills in first-year medical students. Less resource-intensive interventions, such as written instructions or mental imagery, are effective compared with hands-on part-task trainer simulation for refreshing this simple but important skill.

Trial registration number

AEARCTR-0008043.

Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III trial

Por: Coulson · A. B. · Royle · K.-L. · Pawlyn · C. · Cairns · D. A. · Hockaday · A. · Bird · J. · Bowcock · S. · Kaiser · M. · de Tute · R. · Rabin · N. · Boyd · K. · Jones · J. · Parrish · C. · Gardner · H. · Meads · D. · Dawkins · B. · Olivier · C. · Henderson · R. · Best · P. · Owen · R. · Jenne
Introduction

Multiple myeloma is a bone marrow cancer, which predominantly affects older people. The incidence is increasing in an ageing population.

Over the last 10 years, patient outcomes have improved. However, this is less apparent in older, less fit patients, who are ineligible for stem cell transplant. Research is required in this patient group, taking into account frailty and aiming to improve: treatment tolerability, clinical outcomes and quality of life.

Methods and analysis

Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma is a national, phase III, multicentre, randomised controlled trial comparing standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide to lenalidomide+ixazomib, in patients with newly diagnosed multiple myeloma not suitable for stem cell transplant. Overall, 740 participants will be registered into the trial to allow 720 and 478 to be randomised at induction and maintenance, respectively.

All participants will receive IRD induction with the dosing strategy randomised (1:1) at trial entry. Patients randomised to the standard, reactive arm will commence at the full dose followed by toxicity dependent reactive modifications. Patients randomised to the adaptive arm will commence at a dose level determined by their International Myeloma Working Group frailty score. Following 12 cycles of induction treatment, participants alive and progression free will undergo a second (double-blind) randomisation on a 1:1 basis to maintenance treatment with lenalidomide+placebo versus lenalidomide+ixazomib until disease progression or intolerance.

Ethics and dissemination

Ethical approval has been obtained from the North East—Tyne & Wear South Research Ethics Committee (19/NE/0125) and capacity and capability confirmed by local research and development departments for each participating centre prior to opening to recruitment. Participants are required to provide written informed consent prior to trial registration. Trial results will be disseminated by conference presentations and peer-reviewed publications.

Trial registration number

ISRCTN17973108, NCT03720041.

Intraoperative haemodynamic optimisation using the Hypotension Prediction Index and its impact on tissular perfusion: a protocol for a randomised controlled trial

Por: Lorente · J. V. · Jimenez · I. · Ripolles-Melchor · J. · Becerra · A. · Wesselink · W. · Reguant · F. · Mojarro · I. · Fuentes · M. d. l. A. · Abad-Motos · A. · Agudelo · E. · Herrero-Machancoses · F. · Callejo · P. · Bosch · J. · Monge · M. I.
Introduction

Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index (HPI) developed using machine learning techniques, allows the prediction of arterial hypotension analysing the arterial pressure waveform. The use of this index may reduce the duration and severity of intraoperative hypotension in adults undergoing non-cardiac surgery. This study aims to determine whether a treatment protocol based on the prevention of arterial hypotension using the HPI algorithm reduces the duration and severity of intraoperative hypotension compared with the recommended goal-directed fluid therapy strategy and may improve tissue oxygenation and organ perfusion.

Methods and analysis

We will conduct a multicentre, randomised, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Haemodynamic management in the control group will be based on standard haemodynamic parameters. Haemodynamic management of patients in the intervention group will be based on functional haemodynamic parameters provided by the HemoSphere platform (Edwards Lifesciences), including dynamic arterial elastance, dP/dtmax and the HPI. Tissue oxygen saturation will be recorded non-invasively and continuously by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be the intraoperative time-weighted average of a mean arterial pressure

Ethics and dissemination

Ethics committee approval was obtained from the Ethics Committee of Hospital Gregorio Marañón (Meeting of 27 July 2020, minutes 18/2020, Madrid, Spain). Findings will be widely disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT04301102.

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