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COVID-19 in Ethiopia: a geospatial analysis of vulnerability to infection, case severity and death

Por: Alene · K. A. · Gelaw · Y. A. · Fetene · D. M. · Koye · D. N. · Melaku · Y. A. · Gesesew · H. · Birhanu · M. M. · Adane · A. A. · Muluneh · M. D. · Dachew · B. A. · Abrha · S. · Aregay · A. · Ayele · A. A. · Bezabhe · W. M. · Gebremariam · K. T. · Gebremedhin · T. · Gebremedhin · A. T.
Background

COVID-19 has caused a global public health crisis affecting most countries, including Ethiopia, in various ways. This study maps the vulnerability to infection, case severity and likelihood of death from COVID-19 in Ethiopia.

Methods

Thirty-eight potential indicators of vulnerability to COVID-19 infection, case severity and likelihood of death, identified based on a literature review and the availability of nationally representative data at a low geographic scale, were assembled from multiple sources for geospatial analysis. Geospatial analysis techniques were applied to produce maps showing the vulnerability to infection, case severity and likelihood of death in Ethiopia at a spatial resolution of 1 kmx1 km.

Results

This study showed that vulnerability to COVID-19 infection is likely to be high across most parts of Ethiopia, particularly in the Somali, Afar, Amhara, Oromia and Tigray regions. The number of severe cases of COVID-19 infection requiring hospitalisation and intensive care unit admission is likely to be high across Amhara, most parts of Oromia and some parts of the Southern Nations, Nationalities and Peoples’ Region. The risk of COVID-19-related death is high in the country’s border regions, where public health preparedness for responding to COVID-19 is limited.

Conclusion

This study revealed geographical differences in vulnerability to infection, case severity and likelihood of death from COVID-19 in Ethiopia. The study offers maps that can guide the targeted interventions necessary to contain the spread of COVID-19 in Ethiopia.

Risk factors for COVID-19 infection, disease severity and related deaths in Africa: a systematic review

Por: Gesesew · H. A. · Koye · D. N. · Fetene · D. M. · Woldegiorgis · M. · Kinfu · Y. · Geleto · A. B. · Melaku · Y. A. · Mohammed · H. · Alene · K. A. · Awoke · M. A. · Birhanu · M. M. · Gebremedhin · A. T. · Gelaw · Y. A. · Shifti · D. M. · Muluneh · M. D. · Tegegne · T. K. · Abrha · S. · A
Objective

The aim of this study was to provide a comprehensive evidence on risk factors for transmission, disease severity and COVID-19 related deaths in Africa.

Design

A systematic review has been conducted to synthesise existing evidence on risk factors affecting COVID-19 outcomes across Africa.

Data sources

Data were systematically searched from MEDLINE, Scopus, MedRxiv and BioRxiv.

Eligibility criteria

Studies for review were included if they were published in English and reported at least one risk factor and/or one health outcome. We included all relevant literature published up until 11 August 2020.

Data extraction and synthesis

We performed a systematic narrative synthesis to describe the available studies for each outcome. Data were extracted using a standardised Joanna Briggs Institute data extraction form.

Results

Fifteen articles met the inclusion criteria of which four were exclusively on Africa and the remaining 11 papers had a global focus with some data from Africa. Higher rates of infection in Africa are associated with high population density, urbanisation, transport connectivity, high volume of tourism and international trade, and high level of economic and political openness. Limited or poor access to healthcare are also associated with higher COVID-19 infection rates. Older people and individuals with chronic conditions such as HIV, tuberculosis and anaemia experience severe forms COVID-19 leading to hospitalisation and death. Similarly, high burden of chronic obstructive pulmonary disease, high prevalence of tobacco consumption and low levels of expenditure on health and low levels of global health security score contribute to COVID-19 related deaths.

Conclusions

Demographic, institutional, ecological, health system and politico-economic factors influenced the spectrum of COVID-19 infection, severity and death. We recommend multidisciplinary and integrated approaches to mitigate the identified factors and strengthen effective prevention strategies.

Municipal contraceptive services, socioeconomic status and teenage pregnancy in Finland: a longitudinal study

Por: Jalanko · E. · Gyllenberg · F. · Krstic · N. · Gissler · M. · Heikinheimo · O.
Objectives

Declining teenage pregnancy rates have been linked to improved access to youth-friendly contraceptive services, but information on the combined association of these services and socioeconomic factors with teenage pregnancy is lacking.

Design and setting

This retrospective longitudinal register-based study covers the annual teenage childbirth and induced abortion rates in the 100 largest municipalities in Finland in 2000–2018. We investigated the combined association of regional, socioeconomic (ie, education level and need for social assistance) and adolescent contraceptive service variables (ie, free-of-charge contraception, an adolescent-only clinic and availability of over-the-counter emergency contraception (OTC EC)) with teenage childbirth and induced abortion rates at the municipality level by using Poisson mixed-effects model.

Primary outcome measures

Annual teenage childbirth and induced abortion rates as numbers per 1000 teenage girls aged 15–19 years old in the 100 largest municipalities in Finland from 2000 to 2018.

Results

The following variables were significantly associated with both lower teenage childbirth and induced abortion rates when adjusted for all the other variables used in the model: providing free-of-charge contraception (rate ratio (RR) 0.82 (95% CI 0.73 to 0.92) and RR 0.87 (95% CI 0.79 to 0.96), respectively), availability of OTC EC without age limit (RR 0.70 (95% CI 0.67 to 0.75) and RR 0.74 (95% CI 0.71 to 0.78), respectively), and high education level of the municipality (RR 0.94 (95% CI 0.94 to 0.95) and RR 0.94 (95% CI 0.93 to 0.94), respectively).

Conclusion

Providing free-of-charge contraception and availability of OTC EC without age limit are associated with lower teenage pregnancy rates. These services combined with proper counselling are thus important contents of youth-friendly contraceptive services that should be provided equally for all teenagers in order to further reduce teenage pregnancy rates.

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.

Impact of non-communicable disease multimorbidity on health service use, catastrophic health expenditure and productivity loss in Indonesia: a population-based panel data analysis study

Por: Marthias · T. · Anindya · K. · Ng · N. · McPake · B. · Atun · R. · Arfyanto · H. · Hulse · E. S. · Zhao · Y. · Jusril · H. · Pan · T. · Ishida · M. · Lee · J. T.
Objectives

To examine non-communicable diseases (NCDs) multimorbidity level and its relation to households’ socioeconomic characteristics, health service use, catastrophic health expenditures and productivity loss.

Design

This study used panel data of the Indonesian Family Life Survey conducted in 2007 (Wave 4) and 2014 (Wave 5).

Setting

The original sampling frame was based on 13 out of 27 provinces in 1993, representing 83% of the Indonesian population.

Participants

We included respondents aged 50 years and above in 2007, excluding those who did not participate in both Waves 4 and 5. The total number of participants in this study are 3678 respondents.

Primary outcome measures

We examined three main outcomes; health service use (outpatient and inpatient care), financial burden (catastrophic health expenditure) and productivity loss (labour participation, days primary activity missed, days confined in bed). We applied multilevel mixed-effects regression models to assess the associations between NCD multimorbidity and outcome variables,

Results

Women were more likely to have NCD multimorbidity than men and the prevalence of NCD multimorbidity increased with higher socioeconomic status. NCD multimorbidity was associated with a higher number of outpatient visits (compared with those without NCD, incidence rate ratio (IRR) 4.25, 95% CI 3.33 to 5.42 for individuals with >3 NCDs) and inpatient visits (IRR 3.68, 95% CI 2.21 to 6.12 for individuals with >3 NCDs). NCD multimorbidity was also associated with a greater likelihood of experiencing catastrophic health expenditure (for >3 NCDs, adjusted OR (aOR) 1.69, 95% CI 1.02 to 2.81) and lower participation in the labour force (aOR 0.23, 95% CI 0.16 to 0.33) compared with no NCD.

Conclusions

NCD multimorbidity is associated with substantial direct and indirect costs to individuals, households and the wider society. Our study highlights the importance of preparing health systems for addressing the burden of multimorbidity in low-income and middle-income countries.

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 impact of different hypertension management guidelines based on the prospective population-based Heinz Nixdorf Recall study

Por: Gronewold · J. · Kropp · R. · Lehmann · N. · Stang · A. · Mahabadi · A. · Weimar · C. · Dichgans · M. · Moebus · S. · Kröger · K. · Hoffmann · B. · Jöckel · K.-H. · Erbel · R. · Hermann · D. · on behalf of the Heinz Nixdorf Recall Study Investigative Group
Objective

Hypertension guidelines strongly differ between societies. The current American College of Cardiology/American Heart Association (ACC/AHA) guideline recommends higher proportions of the general population for antihypertensive medication than the previous American and European guidelines. How cardiovascular risk differs between persons with and without antihypertensive medication recommendation has not been examined. Additionally, the population impact of American, European and international guidelines has not been compared systematically within the same study population.

Methods

We compared the prevalence of antihypertensive medication recommendation according to the American (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure 7 (JNC7), ACC/AHA 2017), European (European Society of Hypertension (ESH)/European Society of Cardiology (ESC) 2013/2018), and international (WHO/International Society of Hypertension (ISH) 2003, ISH 2020) guidelines in 3092 participants of the population-based Heinz Nixdorf Recall study not taking antihypertensive medication at the baseline examination (58.1±7.5 years, 48.7% males). We furthermore compared incident cardiovascular events during the 5-year follow-up between participants with and without antihypertensive medication recommendation.

Results

The ACC/AHA 2017 guideline recommended the highest percentage of participants for antihypertensive medication (45.8%) compared with the JNC7 (37.2%), ESH/ESC 2013 (17.8%), ESC/ESH 2018 (26.7%), WHO/ISH 2003 (20.3%) or ISH 2020 (25.0%) guidelines. Participants with antihypertensive medication recommendation according to the ACC/AHA 2017 guideline had a significantly higher incidence of cardiovascular events during the 5-year follow-up compared with participants without this recommendation (2.5% vs 1.1%, p=0.003).

Conclusions

Our results call for randomised controlled trials to investigate whether applying the stricter ACC/AHA 2017 recommendation leads to a reduction in cardiovascular disease.

Identifying the competencies of Chinas paediatric residents: a modified Delphi method study

Por: Wang · Y. · Wang · T. · Wang · A. · Chen · S. · Jiao · L. · Shi · J. · Feng · X. · Meng · K.
Purpose

Standardised Training of Paediatric Resident (STPR) plays an essential role in training qualified paediatricians. Until now, China had no paediatric resident competency index system to effectively guide and evaluate the competence of paediatric residents. This study aimed to establish a competency index system for paediatric residents in China to provide a reference for improving the training system and quality of STPR.

Study design and setting

This study conducted two rounds of Delphi expert consultation survey among paediatric medical experts (n=16), followed by screening, revising and supplementing indicators using the boundary value method. Next, the analytic hierarchy process was used to determine the weight of indicators and finally establish a competency index system for paediatric residents.

Results

The results of the statistical analysis revealed a positive coefficient of 100% for both rounds of expert consultation. The expert authority coefficient values were 0.82 and 0.83, and the expert coordination coefficient test was p

Conclusions

In this study, a competency index system for paediatric residents was constructed following the characteristics and quality requirements for paediatric residents in China and is expected to significantly improve the overall level of paediatricians’ medical service quality and supply.

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.

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.

Epidemiology of chronic pain in children and adolescents: a protocol for a systematic review update

Por: Tutelman · P. R. · Langley · C. L. · Chambers · C. T. · Parker · J. A. · Finley · G. A. · Chapman · D. · Jones · G. T. · Macfarlane · G. J. · Marianayagam · J.
Introduction

Chronic pain, defined as persistent or recurring pain or pain lasting longer than 3 months, is a common childhood problem and can profoundly impact children’s physical, psychological and social functioning. The last comprehensive systematic review estimating the prevalence of chronic pain in children and adolescents was published in 2011. Since then, the literature on paediatric chronic pain has grown substantially. This manuscript outlines a protocol for an updated systematic review to provide updated estimates of the prevalence of various forms of chronic pain in children and adolescence. The review will also examine the relationship between sociodemographic and psychosocial factors related to chronic pain prevalence.

Methods and analysis

This review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will search EMBASE, PubMed, CINAHL and PsycINFO for observational studies published in English between 2009 and 2020 reporting population-based estimates of chronic non-disease-related pain prevalence in children or adolescents (age ≤19 years). Two independent reviewers will screen the titles and abstracts retrieved from the search based on predefined eligibility criteria. The full texts of relevant studies will then be assessed by two reviewers. Studies meeting inclusion criteria will be categorised according to the type of pain investigated: headache only, abdominal pain only, back pain only, musculoskeletal pain, combined pain, general pain and other pain. Data will be extracted using customised forms and studies will be assessed for risk of bias using a 10-item tool developed by Hoy et al (2012). A narrative synthesis will summarise the prevalence estimates of paediatric chronic pain and associated sociodemographic and psychosocial correlates. Meta-analyses and meta-regressions will be performed if the data permit.

Ethics and dissemination

Ethical approval is not required. Findings will be disseminated through publication in an academic journal, presentations at conferences and in various media.

PROSPERO registration number

CRD42020198690.

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.

Association between early working life patterns, in publicly and privately owned companies, and the course of future sickness absence due to mental disorders: a cohort study in Catalonia (Spain)

Por: Ayala-Garcia · A. · Serra · L. · Ubalde-Lopez · M.
Objectives

To assess the relationship between early working life patterns, at privately and publicly held companies, and the course of sickness absence (SA) due to mental disorders.

Methods

Cohort study of workers aged 18–28 years, affiliated with the Spanish social security system, living in Catalonia, who had at least one episode of SA due to mental disorders between 2012 and 2014. Individual prior working life trajectories were reconstructed through sequence analysis. Optimal matching analysis was performed to identify early working life patterns by clustering similar individual trajectories. SA trajectories were identified using latent class growth modelling analysis. Finally, the relationship between early working life patterns and subsequent SA trajectories was assessed via multinomial logistic regression models.

Results

Among both men and women, four labour market participation (LMP) patterns were identified: stable permanent employment (reference group), increasing permanent employment, fluctuating employment and delayed employment. Among women, an increasing permanent employment pattern in early working life was related to a decrease of accumulated SA days over time (adjusted OR (aOR) 2.08; 95% CI 1.18 to 3.66). In men, we observed a trend towards a middle stable accumulation of SA days in those with fluctuating employment (aOR 1.25, 95% CI 0.57 to 2.74) or delayed employment (aOR 1.79; 95% CI 0.59 to 5.41). In both men and women, an early working life in big companies was related to a more favourable SA trajectory.

Conclusions

Early LMP patterns characterised by an increasing stability—decreased number of transitions between temporary contracts and lack of social security coverage towards permanent contracts—were related to a better future SA course due to mental diagnosis.

Impact of BCG revaccination on the response to unrelated vaccines in a Ugandan adolescent birth cohort: randomised controlled trial protocol C for the 'POPulation differences in VACcine responses (POPVAC) programme

Por: Zirimenya · L. · Nkurunungi · G. · Nassuuna · J. · Natukunda · A. · Mutebe · A. · Oduru · G. · Kabami · G. · Akurut · H. · Onen · C. · Namutebi · M. · Serubanja · J. · Nakazibwe · E. · Akello · F. · Tumusiime · J. · Sewankambo · M. · Kiwanuka · S. · Kiwudhu · F. · Kizindo · R. · Kizza · M.
Introduction

There is evidence that BCG immunisation may protect against unrelated infectious illnesses. This has led to the postulation that administering BCG before unrelated vaccines may enhance responses to these vaccines. This might also model effects of BCG on unrelated infections.

Methods and analysis

To test this hypothesis, we have designed a randomised controlled trial of BCG versus no BCG immunisation to determine the effect of BCG on subsequent unrelated vaccines, among 300 adolescents (aged 13–17 years) from a Ugandan birth cohort. Our schedule will comprise three main immunisation days (week 0, week 4 and week 28): BCG (or no BCG) revaccination at week 0; yellow fever (YF-17D), oral typhoid (Ty21a) and human papillomavirus (HPV) prime at week 4; and HPV boost and tetanus/diphtheria (Td) boost at week 28. Primary outcomes are anti-YF-17D neutralising antibody titres, Salmonella typhi lipopolysaccharide-specific IgG concentration, IgG specific for L1-proteins of HPV-16/HPV-18 and tetanus and diphtheria toxoid-specific IgG concentration, all assessed at 4 weeks after immunisation with YF, Ty21a, HPV and Td, respectively. Secondary analyses will determine effects on correlates of protective immunity (where recognised correlates exist), on vaccine response waning and on whether there are differential effects on priming versus boosting immunisations. We will also conduct exploratory immunology assays among subsets of participants to further characterise effects of BCG revaccination on vaccine responses. Further analyses will assess which life course exposures influence vaccine responses in adolescence.

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 number

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.

Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

Por: Matthewson · A. · Bereznyakova · O. · Dewar · B. · Davis · A. · Fedyk · M. · Yogendrakumar · V. · Fergusson · D. A. · Gocan · S. · Dowlatshahi · D. · Fahed · R. · Shamy · M.
Introduction

Women have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.

Objective

In an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.

Methodology

This scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.

Significance

The scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.

Ethics and dissemination

Research ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

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.

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