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Countermeasures against COVID-19: how to navigate medical practice through a nascent, evolving evidence base -- a European multicentre mixed methods study

Por: Eibensteiner · F. · Ritschl · V. · Stamm · T. · Cetin · A. · Schmitt · C. P. · Ariceta · G. · Bakkaloglu · S. · Jankauskiene · A. · Klaus · G. · Paglialonga · F. · Edefonti · A. · Ranchin · B. · Shroff · R. · Stefanidis · C. J. · Vandewalle · J. · Verrina · E. · Vondrak · K. · Zurowska
Objectives

In a previously published Delphi exercise the European Pediatric Dialysis Working Group (EPDWG) reported widely variable counteractive responses to COVID-19 during the first week of statutory public curfews in 12 European countries with case loads of 4–680 infected patients per million. To better understand these wide variations, we assessed different factors affecting countermeasure implementation rates and applied the capability, opportunity, motivation model of behaviour to describe their determinants.

Design

We undertook this international mixed methods study of increased depth and breadth to obtain more complete data and to better understand the resulting complex evidence.

Setting

This study was conducted in 14 paediatric nephrology centres across 12 European countries during the COVID-19 pandemic.

Participants

The 14 participants were paediatric nephrologists and EPDWG members from 12 European centres.

Main outcome measures

52 countermeasures clustered into eight response domains (access control, patient testing, personnel testing, personal protective equipment policy, patient cohorting, personnel cohorting, suspension of routine care, remote work) were categorised by implementation status, drivers (expert opinion, hospital regulations) and resource dependency. Governmental strictness and media attitude were independently assessed for each country and correlated with relevant countermeasure implementation factors.

Results

Implementation rates varied widely among response domains (median 49.5%, range 20%–71%) and centres (median 46%, range 31%–62%). Case loads were insufficient to explain response rate variability. Increasing case loads resulted in shifts from expert opinion-based to hospital regulation-based decisions to implement additional countermeasures despite increased resource dependency. Higher governmental strictness and positive media attitude towards countermeasure implementation were associated with higher implementation rates.

Conclusions

COVID-19 countermeasure implementation by paediatric tertiary care centres did not reflect case loads but rather reflected heterogeneity of local rules and of perceived resources. These data highlight the need of ongoing reassessment of current practices, facilitating rapid change in ‘institutional behavior’ in response to emerging evidence of countermeasure efficacy.

Mediating effect of coping style on the relationship between clinical leadership and quality of work life among nurses in tertiary-level hospitals in China: a cross-sectional study

Por: Li · H. · Chang · H. · Tao · Z. · Zhang · D. · Shi · Y. · Li · X.
Objective

To explore the association between clinical leadership and quality of work life, as well as the mediating role of coping style in this relationship.

Setting

Three tertiary-level hospitals in Liaoning Province, China.

Participants

A total of 1209 nurses were recruited for this study. Registered nurses who work full time with at least 1 year of work experience were eligible as subjects. Exclusion criteria were nurses who work indirectly with patients, such as in education, administration or research.

Primary and secondary outcome measures

Questionnaires consisting of the work-related Quality of Life Scale, the Nurse Leadership Scale and the Simplified Coping Style Questionnaire, as well as a demographic data sheet, were used to collect participant information. Pearson’s correlation analysis, hierarchical multiple regression analysis, and asymptotic and resampling strategies were used to analyse the data.

Results

The mean overall quality of work life score among Chinese nurses was 3.50±0.60. After adjusting for demographic characteristics, clinical leadership was positively associated with the score of quality of work life (β=0.55, p

Conclusions

Clinical leadership was positively associated with quality of work life and coping style partially mediated the relationship between clinical leadership and quality of work life among nurses in China. Implementing measures focusing on both clinical leadership and coping style may provide success in improving the quality of work life of nurses.

Effectiveness of interventions to reduce COVID-19 transmission in a large urban jail: a model-based analysis

Por: Malloy · G. S. P. · Puglisi · L. · Brandeau · M. L. · Harvey · T. D. · Wang · E. A.
Objectives

We aim to estimate the impact of various mitigation strategies on COVID-19 transmission in a US jail beyond those offered in national guidelines.

Design

We developed a stochastic dynamic transmission model of COVID-19.

Setting

One anonymous large urban US jail.

Participants

Several thousand staff and incarcerated individuals.

Interventions

There were four intervention phases during the outbreak: the start of the outbreak, depopulation of the jail, increased proportion of people in single cells and asymptomatic testing. These interventions were implemented incrementally and in concert with one another.

Primary and secondary outcome measures

The basic reproduction ratio, R0, in each phase, as estimated using the next generation method. The fraction of new cases, hospitalisations and deaths averted by these interventions (along with the standard measures of sanitisation, masking and social distancing interventions).

Results

For the first outbreak phase, the estimated R0 was 8.44 (95% credible interval (CrI): 5.00 to 13.10), and for the subsequent phases, R0,phase 2=3.64 (95% CrI: 2.43 to 5.11), R0,phase 3=1.72 (95% CrI: 1.40 to 2.12) and R0,phase 4=0.58 (95% CrI: 0.43 to 0.75). In total, the jail’s interventions prevented approximately 83% of projected cases, hospitalisations and deaths over 83 days.

Conclusions

Depopulation, single celling and asymptomatic testing within jails can be effective strategies to mitigate COVID-19 transmission in addition to standard public health measures. Decision makers should prioritise reductions in the jail population, single celling and testing asymptomatic populations as additional measures to manage COVID-19 within correctional settings.

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial

Por: Kastner · M. · Makarski · J. · Hayden · L. · Hamid · J. S. · Holroyd-Leduc · J. · Twohig · M. · Macfarlane · C. · Hynes · M. T. · Prasaud · L. · Sklar · B. · Honsberger · J. · Wang · M. · Kramer · G. · Hobden · G. · Armson · H. · Ivers · N. · Leung · F.-H. · Liu · B. · Marr · S. · Greiver · M
Introduction

In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.

Methods and analysis

We will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.

Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.

Ethics and dissemination

Ethics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.

Trial registration number

NCT04437238.

Population-based otoscopic and audiometric assessment of a birth cohort recruited for a pneumococcal vaccine trial 15-18 years earlier: a protocol

Por: Chan · K. · Carosone-Link · P. · Bautista · M. T. G. · Sanvictores · D. · Uhler · K. · Tallo · V. · Lucero · M. G. · De Jesus · J. · Simoes · E. A. F.
Introduction

A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.

Methods and analysis

Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.

Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.

Ethics and dissemination

The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.

Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.

Trial registration number

ISRCTN 62323832; Post-results.

Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study): protocol for a randomised controlled trial

Por: Vasan · S. K. · Jobe · M. · Mathews · J. · Cole · F. · Rathore · S. · Jarjou · O. · Thompson · D. · Jarde · A. · Bittaye · M. · Ulijaszek · S. · Fall · C. · Osmond · C. · Prentice · A. · Karpe · F.
Introduction

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

Methods and analysis

The study is a 2x2 factorial, open-labelled, multicentre randomised controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. ‘High-risk’ pregnant women (n=1856) aged ≥18 years and ≤16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or (4) standard antenatal care. Participants will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 16 weeks. The primary endpoint is GDM incidence at 26–28 weeks diagnosed using International Association of the Diabetes and Pregnancy Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32 weeks. Secondary endpoints include absolute values of fasting plasma glucose concentration at 32 weeks gestation, maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression.

Ethics and dissemination

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

Trial registration number

ISRCTN18467720.

Impact of temperature and relative humidity on the transmission of COVID-19: a modelling study in China and the United States

Por: Wang · J. · Tang · K. · Feng · K. · Lin · X. · Lv · W. · Chen · K. · Wang · F.
Objectives

We aim to assess the impact of temperature and relative humidity on the transmission of COVID-19 across communities after accounting for community-level factors such as demographics, socioeconomic status and human mobility status.

Design

A retrospective cross-sectional regression analysis via the Fama-MacBeth procedure is adopted.

Setting

We use the data for COVID-19 daily symptom-onset cases for 100 Chinese cities and COVID-19 daily confirmed cases for 1005 US counties.

Participants

A total of 69 498 cases in China and 740 843 cases in the USA are used for calculating the effective reproductive numbers.

Primary outcome measures

Regression analysis of the impact of temperature and relative humidity on the effective reproductive number (R value).

Results

Statistically significant negative correlations are found between temperature/relative humidity and the effective reproductive number (R value) in both China and the USA.

Conclusions

Higher temperature and higher relative humidity potentially suppress the transmission of COVID-19. Specifically, an increase in temperature by 1°C is associated with a reduction in the R value of COVID-19 by 0.026 (95% CI (–0.0395 to –0.0125)) in China and by 0.020 (95% CI (–0.0311 to –0.0096)) in the USA; an increase in relative humidity by 1% is associated with a reduction in the R value by 0.0076 (95% CI (–0.0108 to –0.0045)) in China and by 0.0080 (95% CI (–0.0150 to –0.0010)) in the USA. Therefore, the potential impact of temperature/relative humidity on the effective reproductive number alone is not strong enough to stop the pandemic.

Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review

Por: Bose · G. · Graveline · J. · Yogendrakumar · V. · Shorr · R. · Fergusson · D. A. · Le Gal · G. · Coutinho · J. · Mendonca · M. · Viana-Baptista · M. · Nagel · S. · Dowlatshahi · D.
Objectives

Current guidelines do not recommend direct oral anticoagulants (DOACs) to treat cerebral venous thrombosis (CVT) despite their benefits over standard therapy. We performed a systematic review to summarise the published experience of DOAC therapy in CVT.

Data sources

MEDLINE, Embase and COCHRANE databases up to 18 November 2020.

Eligibility criteria

All published articles of patients with CVT treated with DOAC were included. Studies without follow-up information were excluded.

Data extraction and synthesis

Two independent reviewers screened articles and extracted data. A risk of bias analysis was performed.

Primary and secondary outcome measures

Safety data included mortality, intracranial haemorrhage (ICH) or other adverse events. Efficacy data included recurrent CVT, recanalisation rates and disability by modified Rankin Scales (mRS).

Results

33 studies met inclusion criteria. One randomised controlled trial, 5 observational cohorts and 27 case series or studies reported 279 patients treated with DOAC for CVT: 41% dabigatran, 47% rivaroxaban, 10% apixaban and 2% edoxaban, in addition to 315 patients treated with standard therapy. The observational cohorts showed a similar risk of death in DOAC and standard therapy arms (RR 2.12, 95% CI 0.29 to 15.59). New ICH was reported in 2 (0.7%) DOAC-treated patients and recurrent CVT occurred in 4 (1.5%). A favourable mRS between 0 and 2 was reported in 94% of DOAC-treated patients, more likely than standard therapy in observational cohorts (RR 1.13, 95% CI 1.02 to 1.25).

Conclusion

The evidence for DOAC use in CVT is limited although suggests sufficient safety and efficacy despite variability in timing and dose of treatment. This systematic review highlights that further rigorous trials are needed to validate these findings and to determine optimal treatment regimens.

Impact of parental socioeconomic status on offsprings mental health: protocol for a longitudinal community-based study

Por: Li · M. · O'Donnell · K. J. · Caron · J. · D'Arcy · C. · Meng · X.
Introduction

Socioeconomic status (SES) affects physical and mental health and cognitive functioning. The association between SES changes (SES mobility) and health has ethical and political implications in that the pernicious effects of inequality and the differential impact on social classes of economic and social policies. There is a lack of research conducted to explore the intergenerational transmission of parental SES changes on the offspring’s mental health and cognitive functioning. We aim to fill this gap and identify roles of parental SES changes in offspring’s mental health and cognitive outcomes.

Methods and analysis

This study will be based on a longitudinal cohort from the most populous municipality in the Canadian province of Quebec. Participants and their biological offspring will be invited to this study. For those with informed consent, we will collect their information on mental health, psychiatric disorders, cognitive functioning and early life experiences for offspring. Latent class growth analysis will be used to identify parental SES mobility groups. Multivariate regression analyses will be used to explore the roles of early life stress, parental SES mobility and their interactions in psychiatric disorders and cognitive functioning. Subgroup analyses (males and females) are also planned.

Ethics and dissemination

This study has been given ethical approval by the Research Ethics Board of the Douglas Mental Health University Institute (IUSMD-18/17). Each participant will provide informed consent on participation. We will disseminate research findings through publication in peer-reviewed academic journals and presentations at conferences. Lay summaries of major research findings will also be shared annually with our partners in the health system and community agencies located in the catchment area.

Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study

Por: Williams · A.-J. · Paramsothy · R. · Wu · N. · Ghaly · S. · Leach · S. · Paramsothy · S. · Corte · C. · O'Brien · C. · Burke · C. · Wark · G. · Samocha-Bonet · D. · Lambert · K. · Ahlenstiel · G. · Wasinger · V. · Dutt · S. · Pavli · P. · Grimm · M. · Lemberg · D. · Connor · S. · Leong · R.
Introduction

Crohn’s disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia’s first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.

Methods

The AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.

Ethics and dissemination

Ethical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.

Trial registration number

ACTRN12619000911190.

Population differences in vaccine responses (POPVAC): scientific rationale and cross-cutting analyses for three linked, randomised controlled trials assessing the role, reversibility and mediators of immunomodulation by chronic infections in the tropics

Por: Nkurunungi · G. · Zirimenya · L. · Natukunda · A. · Nassuuna · J. · Oduru · G. · Ninsiima · C. · Zziwa · C. · Akello · F. · Kizindo · R. · Akello · M. · Kaleebu · P. · Wajja · A. · Luzze · H. · Cose · S. · Webb · E. · Elliott · A. M. · POPVAC trial team · Elliott · Zirimenya · Nkurunungi
Introduction

Vaccine-specific immune responses vary between populations and are often impaired in low income, rural settings. Drivers of these differences are not fully elucidated, hampering identification of strategies for optimising vaccine effectiveness. We hypothesise that urban–rural (and regional and international) differences in vaccine responses are mediated to an important extent by differential exposure to chronic infections, particularly parasitic infections.

Methods and analysis

Three related trials sharing core elements of study design and procedures (allowing comparison of outcomes across the trials) will test the effects of (1) individually randomised intervention against schistosomiasis (trial A) and malaria (trial B), and (2) Bacillus Calmette-Guérin (BCG) revaccination (trial C), on a common set of vaccine responses. We will enrol adolescents from Ugandan schools in rural high-schistosomiasis (trial A) and rural high-malaria (trial B) settings and from an established urban birth cohort (trial C). All participants will receive BCG on day ‘0’; yellow fever, oral typhoid and human papilloma virus (HPV) vaccines at week 4; and HPV and tetanus/diphtheria booster vaccine at week 28. Primary outcomes are BCG-specific IFN- responses (8 weeks after BCG) and for other vaccines, antibody responses to key vaccine antigens at 4 weeks after immunisation. Secondary analyses will determine effects of interventions on correlates of protective immunity, vaccine response waning, priming versus boosting immunisations, and parasite infection status and intensity. Overarching analyses will compare outcomes between the three trial settings. Sample archives will offer opportunities for exploratory evaluation of the role of immunological and ‘trans-kingdom’ mediators in parasite modulation of vaccine-specific responses.

Ethics and dissemination

Ethics approval has been obtained from relevant Ugandan and UK ethics committees. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications.

Trial registration numbers

ISRCTN60517191, ISRCTN62041885, ISRCTN10482904.

Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study

Por: Ren · T. · Li · Y. · Zhang · X. · Geng · Y. · Shao · Z. · Li · M. · Wu · X. · Wang · X.-A. · Liu · F. · Wu · W. · Shu · Y. · Bao · R. · Gong · W. · Dong · P. · Dang · X. · Liu · C. · Liu · C. · Sun · B. · Liu · J. · Wang · L. · Hong · D. · Qin · R. · Jiang · X. · Zhang · X. · Xu · J. · Jia · J. · Yang · B.
Introduction

Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population.

Methods and analysis

The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers.

Ethics and dissemination

The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019–085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences.

Trial registration number

NCT04140552, Pre-results.

Sepsis in patients with haematological versus solid cancer: a retrospective cohort study

Por: Bou Chebl · R. · Safa · R. · Sabra · M. · Chami · A. · Berbari · I. · Jamali · S. · Makki · M. · Tamim · H. · Abou Dagher · G.
Objectives

This study aims to examine the outcome of haematological and patients with solid cancer presenting with sepsis to the emergency department (ED).

Design

Single-centred, retrospective cohort study. Setting conducted at an academic emergency department of a tertiary hospital.

Participants

All patients >18 years of age admitted with sepsis were included.

Interventions

Patients were stratified into two groups: haematological and solid malignancy.

Primary and secondary outcome

The primary outcome of the study was in-hospital mortality. Secondary outcomes included intensive care unit (ICU) mortality, ICU and hospital lengths of stay and mechanical ventilation duration.

Results

442 sepsis cancer patients were included in the study, of which 305 patients (69%) had solid tumours and 137 patients (31%) had a haematological malignancy. The mean age at presentation was 67.92 (±13.32) and 55.37 (±20.85) (p

Conclusion

Solid tumour patients with sepsis or septic shock are at the same risk of mortality as patients with haematological tumours. However, haematological malignancy patients admitted with sepsis or septic shock have higher rates of bacteraemia.

Psychometric evaluation of the Arthritis Self-Efficacy Scale in Chinese adults with rheumatic diseases: a cross-sectional study

Por: Tsai · T.-Y. · Lu · M.-C. · Livneh · H. · Lin · M.-C. · Lai · N.-S. · Guo · H.-R.
Objective

The Arthritis Self-Efficacy Scale (ASES) was designed to assess the degree of self-efficacy among patients with arthritis. Though the original English version of this instrument has shown a high degree of reliability and validity, a Chinese version of this scale has yet to be validated. Therefore, the aim of this cross-sectional study was to evaluate the psychometric characteristics of the Chinese version of ASES (C-ASES) in a population of Chinese adults with rheumatic diseases (RDs).

Methods

After completing backward translation and expert validity, a convenient sample of 258 qualified participants with RDs from a hospital in Taiwan were recruited to explore the content validity, concurrent validity, construct validity, internal consistency reliability and test–retest reliability of C-ASES.

Results

The C-ASES has demonstrated acceptable internal consistency and test–retest reliability, with a Cronbach α of 0.91 and intraclass correlation coefficient of 0.89, respectively. Concurrent validity was acceptable, with significant correlation between the subscales of the C-ASES and perceived depressive symptoms, as measured by the Taiwanese Depression Questionnaire (p

Conclusion

Empirical data support the assertion that C-ASES is a reliable and valid screening instrument to assess self-efficacy in Chinese-speaking patients with RDs. C-ASES may be useful as a reference guide in providing appropriate interventions for bolstering self-efficacy among Chinese-speaking patients with RDs.

Defining precision health: a scoping review protocol

Por: Ryan · J. C. · Viana · J. N. · Sellak · H. · Gondalia · S. · O'Callaghan · N.
Introduction

Precision health is a nascent field of research that would benefit from clearer operationalisation and distinction from adjacent fields like precision medicine. This clarification is necessary to enable precision health science to tackle some of the most complex and significant health problems that are faced globally. There is a pressing need to examine the progress in human precision health research in the past 10 years and analyse this data to first, find similarities and determine discordances in how precision health is operationalised in the literature and second, identify gaps and future directions for precision health research.

Methods and analysis

To define precision health and map research in this field, a scoping review will be undertaken and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches of scientific databases (Medline, Embase, Scopus, Web of Science and PsycINFO) and grey literature sources (Google Scholar, Google Patents) identified 8053 potentially eligible articles published from 1 January 2010 to 30 June 2020. Following removal of duplicates, a total of 3190 articles were imported for screening. Article data will be extracted using a customised extraction template on Covidence and analysed descriptively using narrative synthesis.

Ethics and dissemination

Ethics approval is not required. Findings will be disseminated through professional networks, conference presentations and publication in a scientific journal.

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally--Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study

Por: Kumaran · K. · Krishnaveni · G. V. · Suryanarayana · K. G. · Prasad · M. P. · Belavendra · A. · Atkinson · S. · Balasubramaniam · R. · Bandsma · R. H. J. · Bhutta · Z. A. · Chandak · G. R. · Comelli · E. M. · Davidge · S. T. · Dennis · C.-L. · Hammond · G. L. · Jha · P. · Joseph · K.
Introduction

The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.

Methods and analysis

The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.

The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.

An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.

Ethics and dissemination

The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.

Trial registration number

ISRCTN20161479, CTRI/2020/12/030134; Pre-results.

Prospective meta-analysis protocol on randomised trials of renin-angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension

Por: Gnanenthiran · S. R. · Borghi · C. · Burger · D. · Charchar · F. · Poulter · N. R. · Schlaich · M. P. · Steckelings · U. M. · Stergiou · G. · Tomaszewski · M. · Unger · T. · Wainford · R. D. · Williams · B. · Rodgers · A. · Schutte · A. E.
Introduction

Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2.

Methods and analysis

RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data.

Ethics and dissemination

Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.

Different doses of prucalopride in treating chronic idiopathic constipation: a meta-analysis and Bayesian analysis

Por: Yang · T. · Wang · K. · Cao · Y. · Wen · J. · Wei · S. · Li · H. · Yang · X. · Xiao · T.
Objective

This study aims to explore the incremental benefit of different doses of prucalopride in treating chronic idiopathic constipation (CIC).

Methods

PubMed, EMBASE, MEDLINE, Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, VIP medicine information and Wanfang databases were comprehensively searched up to March 2020. Prospective trials with different doses of prucalopride versus placebo were selected. The frequency of spontaneous bowel movements (SBMs) per week and the treatment-emergent adverse events (TEAEs), such as headache, arrhythmia, diarrhoea, dizziness, nausea and vomiting, were first synthesised in a meta-analysis. The probability of optimal dose of prucalopride was then ranked by random-effects within Bayesian analysis.

Results

14 high-quality randomised controlled trials with 4328 patients were ultimately included. SBMs per week increased significantly after using 1 mg (OR: 2.40, 95% CI 1.32 to 4.37), 2 mg (OR: 2.55, 95% CI 1.93 to 3.36) and 4 mg (OR: 2.51, 95% CI 1.92 to 3.28) prucalopride. Bayesian analysis demonstrated 1 mg dose obtained the maximum SBMs per week (OR: 3.31, 95% credible interval 1.72 to 6.16, probability rank=0.70) indirectly compared with 2 mg and 4 mg doses. TEAEs were higher significantly in 2 mg (risk ratio (RR): 1.20, 95% CI 1.09 to 1.33) and 4 mg (RR: 1.14, 95% CI 1.07 to 1.22) prucalopride. The 1 mg dose did not reach statistical significance (RR: 1.17, 95% CI 0.94 to 1.44).

Conclusions

The study concludes that 1 mg dose at commencement could be safer in treating CIC and that 2 mg prucalopride could be more efficacious in terms of SBMs per week outcome receiving.

PROSPERO registration number

CRD42019136679.

Key elements of effective postgraduate GP educational environments: a mixed methods study

Por: Malau-Aduli · B. S. · Alele · F. O. · Heggarty · P. · Reeve · C. · Teague · P.-A.
Objectives

Evidence in the literature suggests that satisfaction with postgraduate general practice (GP) training is associated with the quality of the educational environment. This study aimed to examine GP registrars’ level of satisfaction with a distributed model of training in a regional educational environment and investigate the relationship between satisfaction and academic performance.

Study design

A longitudinal 3-year study was conducted among GP registrars at James Cook University using a sequential explanatory mixed methods research design. GP registrars’ satisfaction was obtained using the scan of postgraduate educational environment domains tool. A focus group discussion was conducted to explore GP registrars’ perceptions of satisfaction with the educational environment.

Setting

James Cook University General Practice Training (JCU GPT) programme.

Participants

Six hundred and fifty one (651) GP registrars enrolled between 2016 and 2018 at JCU GPT programme.

Results

651 registrars completed the satisfaction survey between 2016 and 2018. Overall, 92% of the registrars were satisfied with the educational training environment. Registrars who had become fellows reported higher satisfaction levels compared with those who were still in training (mean=4.39 vs 4.20, p=0.001). However, academic performance had no impact on level of satisfaction with the educational environment. Similarly, practice location did not influence registrars’ satisfaction rates. Four themes (rich rural/remote educational environment, supportive learning environment, readiness to continue with rural practice and practice culture) emerged from the thematic data analysis.

Conclusion

A clinical learning environment that focuses on and supports individual learning needs is vital for effective postgraduate medical training. This study suggests that JCU GPT programme’s distributed model fostered a satisfying and supportive training environment with rich educational experiences that enhance retention of GP registrars in rural/remote North Queensland, Australia. The findings of this study may be applicable to other settings with similar training models.

Suicide capacity within the ideation-to-action framework: a scoping review protocol

Por: Bayliss · L. T. · Lamont-Mills · A. · du Plessis · C. · Morgan · T.
Introduction

A core facilitator of the transition from suicidal thoughts to suicide attempt is the individual’s capacity for suicide. Suicide capacity is a theoretically universal concept adaptable for specific groups that is hypothesised to comprise three contributing factors: acquired capability, for example, previous self-harm; dispositional, such as genetic influences and practical, knowledge of and access to lethal means. Given that suicide capacity as a concept is continuing to develop, a review and synthesis of the current literature is timely to ensure future research and development of suicide prevention strategies are based on evidential knowledge. The aim of this review is to map the available evidence to provide an overview of factors that contribute to an adult’s capacity for suicide.

Methods and analysis

This review will encompass five stages. Studies will be identified through broad search strings applied to 11 academic databases: Academic Search Ultimate, APA PsycArticles, APA PsycINFO, CINAHL, Psychology & Behavioural Sciences, & Sociology Source Ultimate via EBSCOHost Megafile Ultimate; PubMed; Science Direct; Wiley Online; Taylor & Francis and ProQuest dissertations and theses. Grey literature databases and key suicide organisations will also be searched for relevant literature. Two reviewers will independently screen titles and abstracts then review full texts to identify articles meeting inclusion criteria. Articles will be assessed for eligibility based on suicide attempt history, primary research study design, language and publication date. Data from eligible full texts will be extracted using a predesigned template for analysis. The synthesisation method will be textual narrative synthesis with an incorporated quality appraisal checklist tool.

Ethics and dissemination

Ethics approval is not required for this scoping review as no human participants are involved. Study findings will be shared with key suicide organisations, through peer-reviewed publications, and conference presentations.

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