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The lived experience of women with a high-risk pregnancy: a phenomenology investigation

: Pregnancy is a time of transformation, hope, expectation, and worry for women and their families – none more so than when the pregnancy is at-risk. The objective of this study was to describe the lived experience of women during high-risk pregnancy.

A machine learning approach for the prediction of pulmonary hypertension

by Andreas Leha, Kristian Hellenkamp, Bernhard Unsöld, Sitali Mushemi-Blake, Ajay M. Shah, Gerd Hasenfuß, Tim Seidler

Background

Machine learning (ML) is a powerful tool for identifying and structuring several informative variables for predictive tasks. Here, we investigated how ML algorithms may assist in echocardiographic pulmonary hypertension (PH) prediction, where current guidelines recommend integrating several echocardiographic parameters.

Methods

In our database of 90 patients with invasively determined pulmonary artery pressure (PAP) with corresponding echocardiographic estimations of PAP obtained within 24 hours, we trained and applied five ML algorithms (random forest of classification trees, random forest of regression trees, lasso penalized logistic regression, boosted classification trees, support vector machines) using a 10 times 3-fold cross-validation (CV) scheme.

Results

ML algorithms achieved high prediction accuracies: support vector machines (AUC 0.83; 95% CI 0.73–0.93), boosted classification trees (AUC 0.80; 95% CI 0.68–0.92), lasso penalized logistic regression (AUC 0.78; 95% CI 0.67–0.89), random forest of classification trees (AUC 0.85; 95% CI 0.75–0.95), random forest of regression trees (AUC 0.87; 95% CI 0.78–0.96). In contrast to the best of several conventional formulae (by Aduen et al.), this ML algorithm is based on several echocardiographic signs and feature selection, with estimated right atrial pressure (RAP) being of minor importance.

Conclusions

Using ML, we were able to predict pulmonary hypertension based on a broader set of echocardiographic data with little reliance on estimated RAP compared to an existing formula with non-inferior performance. With the conceptual advantages of a broader and unbiased selection and weighting of data our ML approach is suited for high level assistance in PH prediction.

Prevalence and correlates of smoking and nicotine dependence: results of a nationwide cross-sectional survey among Singapore residents

Por: Shahwan · S. · Abdin · E. · Shafie · S. · Chang · S. · Sambasivam · R. · Zhang · Y. · Vaingankar · J. A. · Teo · Y. Y. · Heng · D. · Chong · S. A. · Subramaniam · M.
Background

Since the Singapore Mental Health Study in 2010 which reported a 16.0% prevalence rate for current smokers and 4.5% for nicotine dependence, new anti-smoking strategies have been implemented. The aim of this study was to compare smoking trends from the 2010 study with the second Singapore Mental Health Study in 2016 (SMHS 2016).

Methods

A survey of 6126 individuals aged 18 years and above randomly selected among Singapore residents was conducted using the same methodology as the 2010 study. The measures used in this analysis were sociodemographic questions, the Composite International Diagnostic Interview which assessed for psychiatric disorders, the Fagerstrom Test for Nicotine Dependence and a list of chronic physical conditions that were prevalent in Singapore. Logistic regression analyses were used to test for associations between smoking/nicotine-dependence and other measures.

Results

In the SMHS 2016, 16.1% were current smokers and 3.3% were nicotine-dependent. As compared with non-smokers, current smokers were more likely to be younger, male gender, of ethnic minority and had lower/vocational education level. Younger age, male gender, lower/vocational education and psychiatric disorders (major depression, bipolar disorder and alcohol use disorders) predicted nicotine dependence. No associations were found between nicotine dependence and any of the chronic conditions.

Conclusion

The prevalence of current smokers in the population has plateaued while that of nicotine dependence has decreased from 2010. However, the study did not investigate the use of e-cigarettes. Inequalities in smoking and nicotine dependence continue to pervade the population particularly among those of ethnic minority, lower/vocational education and the mentally ill.

Preventive strategies and factors associated with surgically treated necrotising enterocolitis in extremely preterm infants: an international unit survey linked with retrospective cohort data analysis

Por: Adams · M. · Bassler · D. · Darlow · B. A. · Lui · K. · Reichman · B. · Hakansson · S. · Norman · M. · Lee · S. K. · Helenius · K. K. · Lehtonen · L. · San Feliciano · L. · Vento · M. · Moroni · M. · Beltempo · M. · Yang · J. · Shah · P. S. · on behalf of the International Network for
Objectives

To compare necrotising enterocolitis (NEC) prevention practices and NEC associated factors between units from eight countries of the International Network for Evaluation of Outcomes of Neonates, and to assess their association with surgical NEC rates.

Design

Prospective unit-level survey combined with retrospective cohort study.

Setting

Neonatal intensive care units in Australia/New Zealand, Canada, Finland, Israel, Spain, Sweden, Switzerland and Tuscany (Italy).

Patients

Extremely preterm infants born between 240 to 286 weeks’ gestation, with birth weights

Exposures

NEC prevention practices (probiotics, feeding, donor milk) using responses of an on-line pre-piloted questionnaire containing 10 questions and factors associated with NEC in literature (antenatal steroids, c-section, indomethacin treated patent ductus arteriosus and sepsis) using cohort data.

Outcome measures

Surgical NEC rates and death following NEC using cohort data.

Results

The survey response rate was 91% (153 units). Both probiotic provision and donor milk availability varied between 0%–100% among networks whereas feeding initiation and advancement rates were similar in most networks. The 9792 infants included in the cohort study to link survey results and cohort outcomes, revealed similar baseline characteristics but considerable differences in factors associated with NEC between networks. 397 (4.1%) neonates underwent NEC surgery, ranging from 2.4%–8.4% between networks. Standardised ratios for surgical NEC were lower for Australia/New Zealand, higher for Spain, and comparable for the remaining six networks.

Conclusions

The variation in implementation of NEC prevention practices and in factors associated with NEC in literature could not be associated with the variation in surgical NEC incidence. This corroborates the current lack of consensus surrounding the use of preventive strategies for NEC and emphasises the need for research.

Prevalence and correlates of long-term e-cigarette and nicotine replacement therapy use: a prospective study in England

Por: Jackson · S. E. · Hill · E. · Shahab · L. · Beard · E. · Michie · S. · Brown · J.
Objectives

To examine the prevalence of, and sociodemographic and smoking-related characteristics associated with, long-term e-cigarette use compared with long-term nicotine replacement therapy (NRT) use.

Design

Cross-sectional and prospective survey, the Smoking Toolkit Study, with baseline data collected between September 2014 and September 2016 and follow-ups at 6 and 12 months.

Setting

England.

Participants

Population representative sample of 40 933 adults aged 16+ years.

Main outcome measures

Prevalence of long-term (≥12 months) use of e-cigarettes and NRT by retrospective self-report among baseline respondents (all adults, n=40 933; smokers, n=8406) and current use at baseline, 6 months and 12 months in a subsample of smokers who responded to follow-up (n=733).

Results

Of baseline respondents, 1.5% (95% CI 1.4% to 1.6%, n=604) of adults and 3.9% (95% CI 3.5% to 4.3%, n=327) of smokers were long-term e-cigarette users and 0.5% (95% CI 0.4% to 0.6%, n=205) of adults and 1.3% (95% CI 1.1% to 1.5%, n=112) of smokers were long-term NRT users. Assessed prospectively, 13.4% (95% CI 10.9% to 15.9%, n=100) of smokers were long-term e-cigarette users and 1.9% (95% CI 0.9% to 2.9%, n=14) were long-term NRT users. Among all adults, long-term use by never smokers of either e-cigarettes (0.1%, n=27) or NRT (0.0%, n=7) was rare. Among past-year smokers, long-term e-cigarette and NRT use was higher among older smokers compared with those who were 16–34 years old (OR range=1.55–5.21). Long-term e-cigarette use only was lower in smokers who were less educated (OR=0.63, 95% CI 0.49 to 0.81), from social grades C2DE (OR=0.66, 95% CI 0.52 to 0.84) and with children in the household (OR=0.66, 95% CI 0.51 to 0.85). Long-term e-cigarette use and long-term NRT use were higher among smokers more motivated to quit (OR=2.05, 95% CI 1.63 to 2.60 and OR=2.33, 95% CI 1.57 to 3.46).

Conclusions

In the adult population in England, long-term use of e-cigarettes and long-term use of NRT are almost exclusively by current or ex-smokers. Only a minority of past-year smokers retrospectively report long-term e-cigarette or NRT use, but this figure may be an underestimate, especially for e-cigarette use, which is more than threefold higher when assessed prospectively.

Neurodevelopmental disorders among term infants exposed to antenatal corticosteroids during pregnancy: a population-based study

Por: Melamed · N. · Asztalos · E. · Murphy · K. · Zaltz · A. · Redelmeier · D. · Shah · B. R. · Barrett · J.
Objective

An increasing proportion of fetuses are exposed to antenatal corticosteroids (ACS). Despite their immediate beneficial effects, the long-term safety of ACS has been an ongoing source of concern. In the current study, we assessed the likelihood of neurodevelopmental problems among term infants exposed to ACS earlier in pregnancy compared with non-exposed term infants.

Design

Retrospective cohort study (2006–2011). Median duration of follow-up was 7.8 (IQR 6.4–9.2) years.

Setting

Population-based study, Ontario, Canada.

Participants

All live singleton infants born at term (≥370/7 weeks gestation) (n=529 205).

Exposure

ACS during pregnancy.

Primary and secondary outcome measures

A composite of diagnostic or billing codes reflecting proven or suspected neurodevelopmental problems during childhood including audiometry testing, visual testing or physician service claim with a diagnosis code related to a suspected neurocognitive disorder.

Results

At 5 years of age, the cumulative rate for the primary outcome was higher among infants exposed to ACS compared with non-exposed infants: 61.7% (3346/5423) vs 57.8% (302 520/523 782), respectively (p

Conclusions

We found an association among term infants between exposure to ACS during pregnancy and healthcare utilisation during childhood related to suspected neurocognitive and neurosensory disorders.

Effectiveness of digital technology interventions to reduce loneliness in adults: a protocol for a systematic review and meta-analysis

Por: Shah · S. G. S. · Nogueras · D. · van Woerden · H. · Kiparoglou · V.
Introduction

Loneliness is an emerging public health problem that is associated with social, emotional, mental and physical health issues. The application of digital technology (DT) interventions to reduce loneliness has significantly increased in the recent years. The effectiveness of DT interventions needs to be assessed systematically.

Methods and analysis

Aim: To undertake a systematic review and meta-analysis on the effectiveness of DT interventions to reduce loneliness among adults.

Design: Systematic review and meta-analysis.

Data sources: PubMed, Medline, CINAHL, EMBASE and Web of Science.

Publication period: 1 January 2010 to 31 July 2019.

Inclusion criteria: Primary studies involving the application of DT interventions to reduce loneliness, involving adult participants (aged ≥18 years), follow-up period ≥3 months and published in the English language.

Synthesis and meta-analysis: A narrative summary of the characteristics of included studies, findings by the type of DT intervention, and the age, gender and ethnicity of participants. A meta-analysis by the study design and duration of follow-up and determination of random effects size using the RevMan V.5 software.

Quality of evidence and bias: Quality of evidence assessed the RoB V.2.0 (revised tool for Risk of Bias in randomized trials) and ROBINS-I (Risk Of Bias in Non-randomized Studies—of Interventions) tools for randomised control trials and non-randomised studies, respectively. Heterogeneity between studies will be determined by the I2 and Cochran’s Q statistics and publication bias checked with funnel plots and the Egger’s test.

Ethics and dissemination

Ethics approval was not required for this protocol. The findings will be disseminated through journal articles and conference presentations.

PROSPERO registration number

CRD42019131524

Diagnosis and treatment for hyperuricemia and gout: a systematic review of clinical practice guidelines and consensus statements

Por: Li · Q. · Li · X. · Wang · J. · Liu · H. · Kwong · J. S.-W. · Chen · H. · Li · L. · Chung · S.-C. · Shah · A. · Chen · Y. · An · Z. · Sun · X. · Hemingway · H. · Tian · H. · Li · S.
Objectives

Despite the publication of hundreds of trials on gout and hyperuricemia, management of these conditions remains suboptimal. We aimed to assess the quality and consistency of guidance documents for gout and hyperuricemia.

Design

Systematic review and quality assessment using the appraisal of guidelines for research and evaluation (AGREE) II methodology.

Data sources

PubMed and EMBASE (27 October 2016), two Chinese academic databases, eight guideline databases, and Google and Google scholar (July 2017).

Eligibility criteria

We included the latest version of international and national/regional clinical practice guidelines and consensus statements for diagnosis and/or treatment of hyperuricemia and gout, published in English or Chinese.

Data extraction and synthesis

Two reviewers independently screened searched items and extracted data. Four reviewers independently scored documents using AGREE II. Recommendations from all documents were tabulated and visualised in a coloured grid.

Results

Twenty-four guidance documents (16 clinical practice guidelines and 8 consensus statements) published between 2003 and 2017 were included. Included documents performed well in the domains of scope and purpose (median 85.4%, range 66.7%–100.0%) and clarity of presentation (median 79.2%, range 48.6%–98.6%), but unsatisfactory in applicability (median 10.9%, range 0.0%–66.7%) and editorial independence (median 28.1%, range 0.0%–83.3%). The 2017 British Society of Rheumatology guideline received the highest scores. Recommendations were concordant on the target serum uric acid level for long-term control, on some indications for urate-lowering therapy (ULT), and on the first-line drugs for ULT and for acute attack. Substantially inconsistent recommendations were provided for many items, especially for the timing of initiation of ULT and for treatment for asymptomatic hyperuricemia.

Conclusions

Methodological quality needs improvement in guidance documents on gout and hyperuricemia. Evidence for certain clinical questions is lacking, despite numerous trials in this field. Promoting standard guidance development methods and synthesising high-quality clinical evidence are potential approaches to reduce recommendation inconsistencies.

PROSPERO registration number

CRD42016046104.

Studying the effect of structured ostomy care training on quality of life and anxiety of patients with permanent ostomy

Abstract

Patients with ostomy are faced with several physical, psychological, and social challenges and need to be prepared to overcome these challenges. Studies have shown that training plays an important role in helping patients to adapt with ostomy, live with it, and improve their psychological well‐being and quality of life (QOL). Therefore, the present study aimed to determine the effect of structured ostomy care training on QOL and anxiety of the patients with permanent ostomy. In this randomised clinical trial study, 60 eligible participants were recruited from the only ostomy clinic in Kerman, Iran. They were selected using a purposive sampling method and randomly assigned to either a control group that received routine ostomy care or an intervention group that attended oral and practical training and a question and answer session by a trained ostomy nurse and received an ostomy information booklet besides their routine care. Outcome variables were anxiety and QOL in general and its physical, mental, social, and spiritual dimensions in detail. By using the anxiety subscale of Hospital Anxiety and Depression Scale (HADS) and City of Hope‐quality of life [COH‐QOL], data were collected before and 2 months after intervention in both groups. Data were analysed by SPSS version 19 using χ², analysis of variance (ANOVA), independent t, and paired t test and multiple regression analysis. The results showed that the intervention group had significantly lower mean scores in anxiety (P = .001) and a higher mean score in overall QOL (P = .009) compared with the control group. The most significant increase was observed for psychological, social, and physical aspects, and the least was in the spiritual aspect, all of which improved after intervention. After controlling the effects of confounding variables such as age, ostomy period, and number of children, the structured training programme still had a positive effect on QOL. Structured ostomy care training, including face‐to‐face education and personal practice of using ostomy equipment, along with written material provided by the ostomy nurse specialist, may lead to an increase in the overall QOL and a decrease in the perceived anxiety level in patients. This type of training is not routinely delivered to ostomy patients in our health care setting, so it is feasible to prepare surgical wards and to educate nurses to work with their patients before and after ostomy creation. Furthermore, to ease patients' religious concerns, we recommend counselling, and the support of religious leaders in the Muslim community may play a key role to adaptation regarding religious matters after ostomy surgeries and alleviate patients' concerns.

Evaluating the effects of social networking sites addiction, task distraction, and self‐management on nurses' performance 评估沉迷社交网站、注意力分散以及自我管理对护士表现的影响

Abstract

Aims

The purpose of this study was to explore the relationship of social networking sites (SNSs) addiction on nurses’ performance and how this relationship was mediated by task distraction and moderated by self‐management.

Design

This cross‐sectional study is designed to empirically test the relationship of SNSs addiction, task distraction, and self‐management with the nurses’ performance.

Methods

Data were collected by conducting an online survey on nurses across the world using a web‐based questionnaire developed through ‘Google Docs’ and distributed through Facebook from 13 August 2018 – 17 November 2018. The Facebook groups were searched using the selected key terms. In total, 45 groups were found to have relevance to this research; therefore, request was made to the admins of these groups to participate in this research and to post a link in their groups. Only 19 group admins responded positively by uploading a link of the research instrument on their respective group pages and 461 members of these groups participated in the research.

Results

Results of the data collected from 53 different countries indicated that SNSs addiction results in lowering the nurses’ performance. This relationship is further strengthened by task distraction introduced as a mediating variable. The results show that self‐management mediates the relationship between SNSs addiction and employees’ performance. Moreover, the results of the study confirm that self‐management reduces the negative impact of SNSs addiction on nurses’ performance.

Conclusion

Social networking sites (SNSs) addiction and task distraction reduce the nurses’ performance, whereas self‐management enhances nurses’ performance.

Impact

This study addresses the problem of using SNSs at the workplace and its potential effect on nurses’ performance. Results demonstrate that SNSs addiction reduces the performance which is further decreased by task distraction; however, self‐management of nurses can enhance the nurses’ performance. The research has numerous theoretical and practical implications for hospital administration, doctors, and nurses.

目的

此项研究旨在探讨沉迷社交网站(SNSs)与护士表现之间的关系,并探讨注意力分散和自我管理如何调解这种关系。

设计

此项横断面研究的目的是为了实证检测沉迷社交网站(SNSs)、注意力分散和自我管理与护士表现之间的关系。

方法通过使用一份基于网络的问卷针对全球护士进行在线调查,收集到了数据,其中调查问卷是通过“谷歌Docs”开发的,并且于2018年8月13日至2018年11月17日在Facebook上发布。Facebook组是通过搜索选定关键词完成。共有45组数据与本研究相关;因此要求这些组的管理员参与这项研究,并在他们的组中发布链接。只有19名小组管理员积极响应,在他们的小组页面上发布了研究工具的链接,共461名小组成员参与了研究。

结果

收集自53个不同国家的数据表明,沉迷社交网站(SNSs)导致护士表现下降。作为一个中介变量,注意力分散进一步加强了这种关系。研究结果表明,自我管理调节了沉迷社交网站(SNSs)与雇员表现之间的关系。此外,此项研究的结果表明自我管理能够降低沉迷社交网站(SNSs)对护士表现的负面影响。

结论

沉迷社交网站(SNSs)和注意力分散降低了护士的表现,而自我管理则会提高护士的工作表现。

影响

此项研究探讨了工作场所使用社交网站(SNSs)的问题及其对护士表现的潜在影响。结果表明,沉迷社交网站(SNSs)会降低工作表现,而注意力分散会进一步降低表现;然而,护士的自我管理可以提高护士的表现。该研究对医院管理、医生和护士都具有重要的理论和实践意义。

A Protocol to Assess Feasibility, Acceptability, and Usability of Mobile Technology for Symptom Management in Pediatric Transplant Patients

imageBackground Pediatric blood and marrow transplant (PBMT) patients experience significant symptom distress, and the use of mobile health (mHealth) technologies may enhance symptom management by providing patient-generated health data to foster personalized health strategies. Objectives The aim of this study was to present a study protocol to explore feasibility, acceptability, and usability of integrating mHealth technologies to collect and monitor symptom data for PBMT patients. Methods An exploratory mixed-methods design is employed for 20 PBMT patients to monitor symptoms using real-time data from two mHealth devices: (a) a self-developed mHealth application and (b) a wearable tracking device. Patient-Reported Outcomes Measurement Information System surveys for fatigue, pain, and sleep disturbance are obtained monthly. Interviews are conducted to obtain further feasibility and usability data. Results The study began in October 2017; data collection should be completed in 2018. Feasibility and usability results to monitor and record symptom-related data daily via mobile devices will be reported. Patient-Reported Outcomes Measurement Information System surveys and interviews will further explore patients’ symptoms and experiences with the mobile devices. Discussion This study will be among the first to explore the feasibility, acceptability, and usability of integrating multiple mHealth technologies to obtain patient-generated symptom data for the PBMT population. Results will enhance our understanding of how these data present, interact, and cluster together throughout the posttransplant period for these children and lead to symptom management strategies. Results will focus on a high-risk population that potentially stands to benefit from the use of mobile technologies.

Implementation strategies for interventions to improve the management of chronic kidney disease (CKD) by primary care clinicians: protocol for a systematic review

Por: Kamath · C. C. · Dobler · C. C. · Lampman · M. A. · Erwin · P. J. · Matulis · J. · Elrashidi · M. · McCoy · R. G. · Alsawaz · M. · Pajouhi · A. · Vasdev · A. · Shah · N. D. · Murad · M. H. · Thorsteinsdottir · B.
Introduction

There is a considerable implementation gap in managing early stage chronic kidney disease (CKD) in primary care despite the high prevalence and risk for increased morbidity and mortality associated with CKD. This systematic review aims to synthesise the evidence of efficacy of implementation interventions aimed at primary care practitioners (PCPs) to improve CKD identification and management. We further aim to describe the interventions’ behavioural change components.

Methods and analysis

We will conduct a systematic review of studies from 2000 to October 2017 that evaluate implementation interventions targeting PCPs and which include at least one clinically meaningful CKD outcome. We will search several electronic data bases and conduct reference mining of related systematic reviews and publications. An interdisciplinary team will independently and in duplicate, screen publications, extract data and assess the risk of bias. Clinical outcomes will include all clinically meaningful medical management outcomes relevant to CKD management in primary care such as blood pressure, chronic heart disease and diabetes target achievements. Quantitative evidence synthesis will be performed, where possible. Planned subgroup analyses include by (1) study design, (2) length of follow-up, (3) type of intervention, (4) type of implementation strategy, (5) whether a behavioural or implementation theory was used to guide study, (6) baseline CKD severity, (7) patient minority status, (8) study location and (9) academic setting or not.

Ethics and dissemination

Approval by research ethics board is not required since the review will only include published and publicly accessible data. Review findings will inform a future trial of an intervention to promote uptake of CKD diagnosis and treatment guidelines in our primary care setting and the development of complementary tools to support its successful adoption and implementation. We will publish our findings in a peer-reviewed journal and develop accessible summaries of the results.

PROSPERO registration number

CRD42018102441.

Integrating tobacco cessation into routine dental practice: protocol for a qualitative study

Por: Shah · R. · Shah · R. · Shah · S. · Bhojani · U.
Introduction

Combined efforts to encompass different aspects of tobacco control have been in place for some time. Despite the recognition of the need to offer support to tobacco users to quit tobacco use, such support remains highly inadequate in India. However, little is known about the practice of oral health professionals (OHP) and the experiences and expectations of dental patients in the context of tobacco cessation (TC) services. In this article, we describe the protocol of a doctoral research project that explores OHPs and their patients in an Indian city. The aims are (A) to understand the functioning of the oral healthcare system towards TC and what changes to it will be needed to benefit TC and (B) to capture the views of dental patients on TC services provided by OHPs.

Methods and analysis

A cross-sectional qualitative study based on individual interviews with OHPs and dental patients will be carried out in the city of Ahmedabad, Gujarat, India. The OHP will be purposively selected from two major organisation types: (1) single-doctor dental clinics and (2) dental hospital attached to teaching institutions. The sample population will be divided into two subgroups: general OHP (dentists practising general dentistry irrespective of their qualification) and prosthodontists (dentists with a specialisation in prosthodontics). We will sample dental patients through convenient sampling from a public teaching hospital and select private dental care facilities. The sampling of OHPs and dental patients will continue until we reach data saturation. Interviews will be audio recorded, transcribed verbatim and coded by hand. The interview transcript will subsequently be analysed using thematic content analysis.

Ethics and dissemination

The study received ethical approval from the Institutional Ethical Committee of the Government Dental College and Hospital, Ahmedabad. The findings will be disseminated through conference presentations, peer-reviewed publications and to the study participants.

Risk of infection associated with intravenous iron preparations: protocol for updating a systematic review

Por: Shah · A. · Sugavanam · A. · Reid · J. · Palmer · A. J. · Dickson · E. · Brunskill · S. · Doree · C. · Oliver · C. M. · Acheson · A. · Baikady · R. R. · Bampoe · S. · Litton · E. · Stanworth · S.
Introduction

The benefits and risk of intravenous iron have been documented in previous systematic reviews and continue to be the subject of randomised controlled trials (RCTs). An ongoing issue that continues to be raised is the relationship between administering iron and developing infection. This is supported by biological plausibility from animal models. We propose an update of a previously published systematic review and meta-analysis with the primary focus being infection.

Methods and analysis

We will include RCTs and non-randomised studies (NRS) in this review update. We will search the relevant electronic databases. Two reviewers will independently extract data. Risk of bias for RCTs and NRS will be assessed using the relevant tools recommended by The Cochrane Collaboration. Data extracted from RCTs and NRS will be analysed and reported separately. Pooled data from RCTs will be analysed using a random effects model. We will also conduct subgroup analyses to identify any patient populations that may be at increased risk of developing infection. We will provide a narrative synthesis on the definitions, sources and responsible pathogens for infection in the included studies. Overall quality of evidence on the safety outcomes of mortality and infection will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach.

Ethics and dissemination

This systematic review will only investigate published studies and therefore ethical approval is not required. The results will be broadly distributed through conference presentations and peer-reviewed publications.

Trial registration number

PROSPERO (CRD42018096023).

Development, integration and use of an ultra-high-strength gradient system on a human-size 3 T magnet for small animal MRI

by Kuan-Hung Cho, Sheng-Min Huang, Chang-Hoon Choi, Ming-Jye Chen, Hsuan-Han Chiang, Richard P. Buschbeck, Ezequiel Farrher, N. Jon Shah, Ruslan Garipov, Ching-Ping Chang, Hsu Chang, Li-Wei Kuo

This study aims to integrate an ultra-high-strength gradient coil system on a clinical 3 T magnet and demonstrate its preclinical imaging capabilities. Dedicated phantoms were used to qualitatively and quantitatively assess the performance of the gradient system. Advanced MR imaging sequences, including diffusion tensor imaging (DTI) and quantitative susceptibility mapping (QSM), were implemented and executed on an ex vivo specimen as well as in vivo rats. The DTI and QSM results on the phantom agreed well with those in the literature. Furthermore, studies on ex vivo specimens have demonstrated the applicability of DTI and QSM on our system to probe microstructural changes in a mild traumatic brain injury rat model. The feasibility of in vivo rat DTI was also demonstrated. We showed that the inserted ultra-high-strength gradient coil was successfully integrated on a clinically used magnet. After careful tuning and calibration, we verified the accuracy and quantitative preclinical imaging capability of the integrated system in phantom and in vivo rat brain experiments. This study can be essential to establish dedicated animal MRI platform on clinical MRI scanners and facilitate translational studies at clinical settings.

Protocol for the development of a core indicator set for reporting burn wound infection in trials: ICon-B study

Por: Davies · A. · Teare · L. · Falder · S. · Coy · K. · Dumville · J. C. · Collins · D. · Moore · L. · Dheansa · B. · Jenkins · A. T. A. · Booth · S. · Agha · R. · Shah · M. · Marlow · K. · Young · A.
Introduction

Systematic reviews of high-quality randomised controlled trials are necessary to identify effective interventions to impact burn wound infection (BWI) outcomes. Evidence synthesis requires that BWI is reported in a consistent manner. Cochrane reviews investigating interventions for burns report that the indicators used to diagnose BWI are variable or not described, indicating a need to standardise reporting. BWI is complex and diagnosed by clinician judgement, informed by patient-reported symptoms, clinical signs, serum markers of inflammation and bacteria in the wound. Indicators for reporting BWI should be important for diagnosis, frequently observed in patients with BWI and assessed as part of routine healthcare. A minimum (core) set of indicators of BWI, reported consistently, will facilitate evidence synthesis and support clinical decision-making.

Aims

The Infection Consensus in Burns study aims to identify a core indicator set for reporting the diagnosis of BWI in research studies.

Methods

(1) Evidence review: a systematic review of indicators used in trials and observational studies reporting BWI outcomes to identify a long list of candidate indicators; (2) refinement of the long list into a smaller set of survey questions with an expert steering group; (3) a two-round Delphi survey with 100 multidisciplinary expert stakeholders, to achieve consensus on a short list of indicators; (4) a consensus meeting with expert stakeholders to agree on the BWI core indicator set.

Ethics and dissemination

Participants will be recruited through professional bodies, such that ethical approval from the National Health Service (NHS) Health Research Authority (HRA) is not needed. The core indicator set will be disseminated through peer-reviewed publication, co-production with journal editors, research funders and professional bodies, and presentation at national conferences.

PROSPERO registration number

CRD42018096647.

Childhood Acute Illness and Nutrition (CHAIN) Network: a protocol for a multi-site prospective cohort study to identify modifiable risk factors for mortality among acutely ill children in Africa and Asia

Introduction

Children admitted to hospitals in resource-poor settings remain at risk of both inpatient and post-discharge mortality. While known risk factors such as young age and nutritional status can identify children at risk, they do not provide clear mechanistic targets for intervention. The Childhood Acute Illness and Nutrition (CHAIN) cohort study aims to characterise the biomedical and social risk factors for mortality in acutely ill children in hospitals and after discharge to identify targeted interventions to reduce mortality.

Methods and analysis

The CHAIN network is currently undertaking a multi-site, prospective, observational cohort study, enrolling children aged 1 week to 2 years at admission to hospitals at nine sites located in four African and two South Asian countries. The CHAIN Network supports the sites to provide care according to national and international guidelines. Enrolment is stratified by anthropometric status and children are followed throughout hospitalisation and for 6 months after discharge. Detailed clinical, demographic, anthropometric, laboratory and social exposures are assessed. Scheduled visits are conducted at 45, 90 and 180 days after discharge. Blood, stool and rectal swabs are collected at enrolment, hospital discharge and follow-up. The primary outcome is inpatient or post-discharge death. Secondary outcomes include readmission to hospital and nutritional status after discharge. Cohort analysis will identify modifiable risks, children with distinct phenotypes, relationships between factors and mechanisms underlying poor outcomes that may be targets for intervention. A nested case–control study examining infectious, immunological, metabolic, nutritional and other biological factors will be undertaken.

Ethics and dissemination

This study protocol was reviewed and approved primarily by the Oxford Tropical Research Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored. Results will be published in open access peer-reviewed scientific journals and presented to academic and policy stakeholders.

Trial registration number

NCT03208725.

Rotavirus vaccine impact assessment surveillance in India: protocol and methods

Por: Nair · N. P. · Reddy N · S. · Giri · S. · Mohan · V. R. · Parashar · U. · Tate · J. · Shah · M. P. · Arora · R. · Gupte · M. · Mehendale · S. M. · Investigators of the Rotavirus vaccine Impact Surveillance Network · Kang · G. · Vs · Gs · Babu · Pamu · Manohar · Pradhan · Dash · Mohak
Introduction

Rotavirus infection accounts for 39% of under-five diarrhoeal deaths globally and 22% of these deaths occur in India. Introduction of rotavirus vaccine in a national immunisation programme is considered to be the most effective intervention in preventing severe rotavirus disease. In 2016, India introduced an indigenous rotavirus vaccine (Rotavac) into the Universal Immunisation Programme in a phased manner. This paper describes the protocol for surveillance to monitor the performance of rotavirus vaccine following its introduction into the routine childhood immunisation programme.

Methods

An active surveillance system was established to identify acute gastroenteritis cases among children less than 5 years of age. For all children enrolled at sentinel sites, case reporting forms are completed and a copy of vaccination record and a stool specimen obtained. The forms and specimens are sent to the referral laboratory for data entry, analysis, testing and storage. Data from sentinel sites in states that have introduced rotavirus vaccine into their routine immunisation schedule will be used to determine rotavirus vaccine impact and effectiveness.

Ethics and dissemination

The Institutional Review Board of Christian Medical College, Vellore, and all the site institutional ethics committees approved the project. Results will be disseminated in peer-reviewed journals and with stakeholders of the universal immunisation programme in India.

Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dia

Por: Mak · W. Y. · Ong · L. M. · Goh · B. L. · Bavanandan · S. · Mushahar · L. · Leong · C. T. · Hooi · L. S.
Introduction

Peritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.

Methods and analysis

The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.

Ethics and dissemination

The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.

Trial registration number

NCT03177031; Pre-results.

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