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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.

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 acute deterioration and care complexity individual factors associated with health outcomes in hospitalised patients with COVID-19: a multicentre cohort study

Background

Evidence about the impact of systematic nursing surveillance on risk of acute deterioration of patients with COVID-19 and the effects of care complexity factors on inpatient outcomes is scarce. The aim of this study was to determine the association between acute deterioration risk, care complexity factors and unfavourable outcomes in hospitalised patients with COVID-19.

Methods

A multicentre cohort study was conducted from 1 to 31 March 2020 at seven hospitals in Catalonia. All adult patients with COVID-19 admitted to hospitals and with a complete minimum data set were recruited retrospectively. Patients were classified based on the presence or absence of a composite unfavourable outcome (in-hospital mortality and adverse events). The main measures included risk of acute deterioration (as measured using the VIDA early warning system) and care complexity factors. All data were obtained blinded from electronic health records. Multivariate logistic analysis was performed to identify the VIDA score and complexity factors associated with unfavourable outcomes.

Results

Out of a total of 1176 patients with COVID-19, 506 (43%) experienced an unfavourable outcome during hospitalisation. The frequency of unfavourable outcomes rose with increasing risk of acute deterioration as measured by the VIDA score. Risk factors independently associated with unfavourable outcomes were chronic underlying disease (OR: 1.90, 95% CI 1.32 to 2.72; p

Conclusion

The systematic nursing surveillance of the status and evolution of COVID-19 inpatients, including the careful monitoring of acute deterioration risk and care complexity factors, may help reduce deleterious health outcomes in COVID-19 inpatients.

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.

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.

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.

Association between cardiometabolic disease and severe COVID-19: a nationwide case-control study of patients requiring invasive mechanical ventilation

Por: Svensson · P. · Hofmann · R. · Häbel · H. · Jernberg · T. · Nordberg · P.
Aims

The risks associated with diabetes, obesity and hypertension for severe COVID-19 may be confounded and differ by sociodemographic background. We assessed the risks associated with cardiometabolic factors for severe COVID-19 when accounting for socioeconomic factors and in subgroups by age, sex and region of birth.

Methods and results

In this nationwide case–control study, 1.086 patients admitted to intensive care with COVID-19 requiring mechanical ventilation (cases), and 10.860 population-based controls matched for age, sex and district of residency were included from mandatory national registries. ORs with 95% CIs for associations between severe COVID-19 and exposures with adjustment for confounders were estimated using logistic regression. The median age was 62 years (IQR 52–70), and 3003 (24.9%) were women. Type 2 diabetes (OR, 2.3 (95% CI 1.9 to 2.7)), hypertension (OR, 1.7 (95% CI 1.5 to 2.0)), obesity (OR, 3.1 (95% CI 2.4 to 4.0)) and chronic kidney disease (OR, 2.5 (95% CI 1.7 to 3.7)) were all associated with severe COVID-19. In the younger subgroup (below 57 years), ORs were significantly higher for all cardiometabolic risk factors. The risk associated with type 2 diabetes was higher in women (p=0.001) and in patients with a region of birth outside European Union(EU) (p=0.004).

Conclusion

Diabetes, obesity and hypertension were all independently associated with severe COVID-19 with stronger associations in the younger population. Type 2 diabetes implied a greater risk among women and in non-EU immigrants. These findings, originating from high-quality Swedish registries, may be important to direct preventive measures such as vaccination to susceptible patient groups.

Trial registration number

Clinicaltrial.gov (NCT04426084).

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.

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.

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.

Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)

Por: Krause · N. · Riemann-Lorenz · K. · Steffen · T. · Rahn · A. C. · Pöttgen · J. · Stellmann · J.-P. · Köpke · S. · Friede · T. · Icks · A. · Vomhof · M. · Temmes · H. · van de Loo · M. · Gold · S. M. · Heesen · C.
Introduction

Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS.

Methods and analysis

A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses.

Ethics and dissemination

The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars.

Trial registration number

ClinicalTrials.gov Registry (NCT03968172); Pre-results.

Illness perception in patients with chronic kidney disease and kidney failure: a scoping review protocol

Por: Ng · J. H. · Vialet · J. · Diefenbach · M. A.
Introduction

Patient education is a crucial component in the management of chronic kidney disease (CKD); however, many education programmes do not tailor to patients’ disease-related belief and emotional reactions. According to Leventhal’s self-regulation model, such beliefs and reactions, known as illness perceptions, are a part of patients’ understanding of their disease and treatment-related actions. The existing research of illness perception in the field of nephrology has been heterogenous in terms of study outcomes and in study population; and the evidence of how illness perceptions affect behavioural and decisional outcomes is limited. This scoping review aims to map and summarise the evidence of published literature on illness perception among patients with CKD not yet treated by dialysis and kidney failure.

Methods and analysis

This study bases its approach on Joanna Brigg’s Institute Guidelines on scoping review methods. The search strategy was developed together with a medical information specialist. Searches will be performed on acceptance of publication in the following databases: PubMed, EMBASE, PsycINFO via Ovid, Scopus and the Cumulative Index to Nursing and Allied Health Literature. Searches will be run without incorporating a date restriction in order to capture content from the databases’ inception to present day. Search terms including ‘illness perception’, ‘kidney disease’ and ‘kidney failure’ will be screened in titles and abstracts. Two independent researchers will screen the abstracts and full text for full eligibility. We will include studies focusing on illness perception of patients with CKD with estimated glomerular filtration rate 2, kidney failure or recipients of kidney transplant. We will exclude patients

Ethics and dissemination

This study does not require internal review board approval. We will present the findings of this scoping review in a peer-reviewed journal.

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.

Help-seeking behaviours among older adults: a scoping review protocol

Por: Teo · K. · Churchill · R. · Riadi · I. · Kervin · L. · Cosco · T.
Introduction

Despite evidence that illustrates the unmet healthcare needs of older adults, there is limited research examining their help-seeking behaviour, of which direct intervention can improve patient outcomes. Research in this area conducted with a focus on ethnic minority older adults is also needed, as their help-seeking behaviours may be influenced by various cultural factors. This scoping review aims to explore the global literature on the factors associated with help-seeking behaviours of older adults and how cultural values and backgrounds may impact ethnic minority older adults’ help-seeking behaviours in different ways.

Methods and analysis

The scoping review process will be guided by the methodology framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews guidelines. The following electronic databases will be systematically searched from January 2005 onwards: MEDLINE/PubMed, Web of Science, PsycINFO, CINAHL and Scopus. Studies of various designs and methodologies consisting of older adults aged 65 years or older, who are exhibiting help-seeking behaviours for the purpose of remedying a physical or mental health challenge, will be considered for inclusion. Two reviewers will screen full texts and chart data. The results of this scoping review will be summarised quantitatively through numerical counts and qualitatively through a narrative synthesis.

Ethics and dissemination

As this is a scoping review of published literature, ethics approval is not required. Results will be disseminated through publication in a peer-reviewed journal.

Discussion

This scoping review will synthesise the current literature related to the help-seeking behaviours of older adults and ethnic minority older adults. It will identify current gaps in research and potential ways to move forward in developing or implementing strategies that support the various health needs of the diverse older adult population.

Registration

This scoping review protocol has been registered with the Open Science Framework (https://osf.io/69kmx).

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