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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.

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.

Feasibility of continuous monitoring of vital signs in surgical patients on a general ward: an observational cohort study

Por: Leenen · J. P. L. · Dijkman · E. M. · van Dijk · J. D. · van Westreenen · H. L. · Kalkman · C. · Schoonhoven · L. · Patijn · G. A.
Objective

To determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward.

Design

Observational cohort study.

Setting

Tertiary teaching hospital.

Participants

Postoperative abdominal surgical patients (n=30) and nurses (n=23).

Interventions

Patients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2 min. Values and trends were visualised and alerts sent to the nurses.

Outcomes

System fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires.

Results

Thirty patients were monitored for a median duration of 81 hours (IQR 47–143) per patient, resulting in 115 217 measurements per parameter. In total, 19% (n=21 311) of heart rate, 51% (n=59 184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10 269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1–4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2–4.8) and satisfaction 3.7 (IQR 3.2–4.8), but agreed on ease of learning at 5.0 (IQR 4.0–5.8). Neutral scores were mostly related to the perceived limited fidelity of the system.

Conclusions

Continuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses’ ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.

Risk of COVID-19 hospital admission and COVID-19 mortality during the first COVID-19 wave with a special emphasis on ethnic minorities: an observational study of a single, deprived, multiethnic UK health economy

Por: Singh · B. M. · Bateman · J. · Viswanath · A. · Klaire · V. · Mahmud · S. · Nevill · A. · Dunmore · S. J.
Objectives

The objective of this study was to describe variations in COVID-19 outcomes in relation to local risks within a well-defined but diverse single-city area.

Design

Observational study of COVID-19 outcomes using quality-assured integrated data from a single UK hospital contextualised to its feeder population and associated factors (comorbidities, ethnicity, age, deprivation).

Setting/participants

Single-city hospital with a feeder population of 228 632 adults in Wolverhampton.

Main outcome measures

Hospital admissions (defined as COVID-19 admissions (CA) or non-COVID-19 admissions (NCA)) and mortality (defined as COVID-19 deaths or non-COVID-19 deaths).

Results

Of the 5558 patients admitted, 686 died (556 in hospital); 930 were CA, of which 270 were hospital COVID-19 deaths, 47 non-COVID-19 deaths and 36 deaths after discharge; of the 4628 NCA, there were 239 in-hospital deaths (2 COVID-19) and 94 deaths after discharge. Of the 223 074 adults not admitted, 407 died. Age, gender, multimorbidity and black ethnicity (OR 2.1 (95% CI 1.5 to 3.2), p

Conclusions

Wolverhampton’s results, reflecting high ethnic diversity and deprivation, are similar to other studies of black ethnicity, age and comorbidity risk in COVID-19 but strikingly different in South Asians and for deprivation. Sequentially considering population and then hospital-based NCA and CA outcomes, we present a complete single health economy picture. Risk factors may differ within ethnic groups; our data may be more representative of communities with high Black, Asian and minority ethnic populations, highlighting the need for locally focused public health strategies. We emphasise the need for a more comprehensible and nuanced conveyance of risk.

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.

Changes in prescribing rates of sodium-containing medications in the UK from 2009 to 2018: a cross-sectional study with interrupted time series analysis

Por: Ju · C. · Wei · L. · Mackenzie · I. S. · MacDonald · T. M. · George · J.
Objective

Effervescent, soluble, dispersible formulations contain considerable amounts of sodium. In 2013, we previously confirmed the association between sodium-containing medications and cardiovascular risks. This study aimed to determine the changes in the prescribing pattern in clinical practice following this publication.

Design

A longitudinal cross-sectional study.

Setting

Primary care in the UK from 2009 to 2018.

Participants

Prescribing information in The Health Improvement Network (THIN) and Prescription Cost Analysis (PCA) databases in the UK.

Outcome measurements

Prescription rates per 10 000 inhabitants were calculated using the number of prescriptions or the number of drug-using patients over the total number of inhabitants, and the prescription rates were measured at annual intervals. Prescribing trends from 2009 to 2018 were indexed with yearly data from THIN and PCA. Interrupted time series analysis (ITSA) was conducted with monthly data in THIN.

Results

From the THIN database, a total of 3 651 419 prescription records from 446 233 patients were included. The prescribing rate of sodium-containing medications changed from 848.3/10 000 inhabitants in 2009 to 571.6/10 000 inhabitants in 2018. The corresponding figures from PCA data were of 631.0/10 000 inhabitants in 2009 and 423.8/10 000 inhabitants in 2018. ITSA showed the prescribing trend reduced significantly during the postpublication period (prescribing rate: slope change=–0.26; 95% CI –0.45 to –0.07; p=0.009; proportion of patients: slope change=–0.22; 95% CI –0.35 to –0.09; p

Conclusions

The prescribing of sodium-containing medications in the UK primary care has declined significantly during the postpublication period. Changes in the prescribing trends for sodium-containing medications varied across regions of the UK and patient age groups.

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.

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.

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.

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation

Por: Ribeiro · D. C. · Spiers · K. · Thomas · L. · Leilua · K. · Wilkes · M. · Norton · S. · Lamb · S. E.
Objectives

To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain.

Design

A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain.

Methods

We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC).

Results

TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%.

Conclusions

Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.

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.

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.

Impact of team-based community healthcare on preventable hospitalisation: a population-based cohort study in Taiwan

Por: Jan · C.-F. J. · Chang · C.-J. J. · Hwang · S.-J. · Chen · T.-J. · Yang · H.-Y. · Chen · Y.-C. · Huang · C.-K. · Chiu · T.-Y.
Objectives

The objective of this study was to explore the impact of Taiwan’s Family Practice Integrated Care Project (FPICP) on hospitalisation.

Design

A population-based cohort study compared the hospitalisation rates for ambulatory care sensitive conditions (ACSCs) among FPICP participating and non-participating patients during 2011–2015.

Setting

The study accessed the FPICP reimbursement database of Taiwan’s National Health Insurance (NHI) administration containing all NHI administration-selected patients for FPICP enrolment.

Participants

The NHI administration-selected candidates from 2011 to 2015 became FPICP participants if their primary care physicians joined the project, otherwise they became non-participants.

Interventions

The intervention of interest was enrolment in the FPICP or not. The follow-up time interval for calculating the rate of hospitalisation was the year in which the patient was selected for FPICP enrolment or not.

Primary outcome measures

The study’s primary outcome measures were hospitalisation rates for ACSC, including asthma/chronic obstructive pulmonary disease (COPD), diabetes or its complications and heart failure. Logistic regression was used to calculate the ORs concerning the influence of FPICP participation on the rate of hospitalisation for ACSC.

Results

The enrolled population for data analysis was between 3.94 and 5.34 million from 2011 to 2015. Compared to non-participants, FPICP participants had lower hospitalisation for COPD/asthma (28.6–35.9 vs 37.9–42.3) and for diabetes or its complications (10.8–14.9 vs 12.7–18.1) but not for congestive heart failure. After adjusting for age, sex and level of comorbidities by logistic regression, participation in the FPICP was associated with lower hospitalisation for COPD/asthma (OR 0.91, 95% CI 0.87 to 0.94 in 2015) and for diabetes or its complications (OR 0.87, 95% CI 0.83 to 0.92 in 2015).

Conclusion

Participation in the FPICP is an independent protective factor for preventable ACSC hospitalisation. Team-based community healthcare programs such as the FPICP can strengthen primary healthcare capacity.

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