FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
Hoy — Abril 13th 2021Tus fuentes RSS

Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)

Por: Thapar · A. · Lawton · R. · Burgess · L. · Shalhoub · J. · Bradbury · A. · Cullum · N. · Epstein · D. · Gohel · M. · Horne · R. · Hunt · B. J. · Norrie · J. · Davies · A. H.
Introduction

Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.

Methods and analysis

Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.

Ethics and dissemination

UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.

Trial registration number

ISRCTN registration number 73041168.

Multivariate analysis of the impact of weather and air pollution on emergency department visits for night-time headaches among children: retrospective, clinical observational study

Por: Yamaguchi · H. · Nozu · K. · Ishiko · S. · Nagase · H. · Ninchoji · T. · Nagano · C. · Takeda · H. · Unzaki · A. · Ishibashi · K. · Morioka · I. · Iijima · K. · Ishida · A.
Objectives

To examine the association between the number of visits to the emergency department (ED) by children for night-time headaches and exposure to multifaceted factors, such as meteorological conditions and air pollution.

Design

We conducted a clinical observational time-series analysis study.

Setting

We reviewed consecutive patients younger than 16 years of age at the primary ED centre in Kobe city, Japan, during the night shift (19:30–7:00 hours) between 1 January 2011 and 31 December 2019.

Participants

In total, 265 191 children visited the ED; 822 presented with headache during the study period.

Primary outcome measures

We investigated the effects of meteorological factors and air pollutants by multivariate analysis of Poisson regression estimates. A subanalysis included the relationship between the number of patients with night-time headaches and the above factors by sex. Furthermore, the effect of typhoon landing on patient visits for headache was also analysed. Headache was not classified because examinations were performed by general paediatricians (non-specialists).

Results

The number of patients with night-time headaches displayed distinct seasonal changes, with peaks during the summer. Multivariate analysis of Poisson regression estimates revealed a significant positive relationship between the number of patients for headache and mean temperature. Subanalysis by sex indicated a positive relationship between the number of patients with headache and mean temperature in both sexes; however, it was significant only for females. No relationship was found between the number of patients with headache and air pollution. There was no change in the number of patients for night-time headaches 3 days before and after typhoon landing.

Conclusions

High temperature is the main factor for visiting ED for night-time headaches among children in Kobe city. Our results suggest that preventive measures against night-time headaches may be possible by reducing time spent outside during summer.

Knowledge, attitude and experience of episiotomy practice among obstetricians and midwives: a cross-sectional study from China

Por: Yang · J. · Bai · H.
Objective

Episiotomy is still performed widely by obstetricians and midwives in some Chinese maternity units, but the reasons are unknown. This study aims to determine the knowledge, attitude and experience towards the practice of episiotomy among obstetricians and midwives in China’s public hospitals and consider strategies to reduce its practice.

Methods

A cross-sectional web survey using a self-administered questionnaire was conducted among obstetricians and midwives in 90 public hospitals in Henan Province, China.

Results

900 (82.21%) participants completed the questionnaire. Average knowledge level (4.15, SD=1.10) on complications and overuse was identified among participants. Episiotomy was performed more frequently in secondary hospitals than in tertiary hospitals (p

Conclusion

In sum, episiotomy was driven by previous training, practitioners’ experience and local norms rather than the latest medical evidence. Clinicians in secondary hospitals and senior clinicians are key training targets. It is urgent to improve current clinical policies and surgical procedure guidelines for obstetricians and midwives regarding episiotomy.

Development of the Prevent for Work questionnaire (P4Wq) for assessment of musculoskeletal risk in the workplace: part 1--literature review and domains selection

Por: Langella · F. · Christensen · S. W. M. · Palsson · T. S. · Hogh · M. · Gagni · N. · Bellosta-Lopez · P. · Christiansen · D. H. · Delle Chiaie · M. · Domenech-Garcia · V. · Johnston · V. · Szeto · G. P. Y. · Villafane · J. H. · Herrero · P. · Berjano · P.
Objective

This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.

Design

Literature review and survey study.

Setting and participants

A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.

Interventions and outcome

To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.

Results

Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.

Conclusions

No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.

Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey

Por: Hermelijn · S. · Kersten · C. · Mullassery · D. · Muthialu · N. · Cobanoglu · N. · Gartner · S. · Bagolan · P. · Mesas Burgos · C. · Sgro · A. · Heyman · S. · Till · H. · Suominen · J. · Schurink · M. · Desender · L. · Losty · P. · Ertresvag · K. · Tiddens · H. A. W. M. · Wijnen · R. M. H
Introduction

A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM.

Methods and analysis

This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus.

Ethics and dissemination

Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.

Expert consensus on moving towards a value-based healthcare system in the Netherlands: a Delphi study

Por: Steinmann · G. · Delnoij · D. · van de Bovenkamp · H. · Groote · R. · Ahaus · K.
Objectives

While the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC.

Design

The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.

Setting and participants

A Dutch expert panel consisting of nine members participated in a two-round survey.

Primary and secondary outcome measures

We developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel.

Results

After two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking.

Conclusion

This paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC’s widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea.

Stressors for emergency department nurses: Insights from a cross‐sectional survey

Abstract

Aims and Objectives

This study aimed to profile stress, exploring whether demographics and/or other factors uniquely contribute to stress for emergency departments nurses.

Background

Nursing has been identified as a stressful profession with the potential to have negative impacts on nurses’ physical and mental health. Nurses working in emergency departments face unique daily stressors.

Design

Cross‐sectional survey using a correlational design.

Methods

The survey was distributed in May 2019 to ED nurses working in New South Wales (NSW), Australia. A total of 242 nurses completed the survey, of which 190 cases were analysed. A standardised scale was used in the survey, the Expanded Nursing Stress Scale (ENSS). The sampling method for this research was non‐probability purposive sampling. STROBE checklist was used for this manuscript.

Results

The results of this study indicated that emergency department nurses experience stress in their work settings. Stress is experienced predominantly because of problems in dealing with patients and their families, high workloads, and uncertainty concerning treatment.

Conclusions

The results of this study provide valuable insights into the work‐related stress experienced by emergency department nurses. This information can be used to inform the development of strategies to minimise stress for emergency nurses.

Relevance to clinical practice

This study builds on existing, and contributes to new, knowledge about the current stressors for emergency department nurses. The results provide insights into how policies and procedures may need to be adjusted and interventions developed, that can help in reducing stress.

Chinesisation, adaptation and validation of the Chelsea Critical Care Physical Assessment Tool in critically ill patients: a cross-sectional observational study

Por: Zhang · Z. · Wang · G. · Wu · Y. · Guo · J. · Ding · N. · Jiang · B. · Wei · H. · Li · B. · Yue · W. · Tian · J.
Purpose

To translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).

Study design

Cross-sectional observational study.

Methods

Forward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.

Results

The content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p

Conclusions

CPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.

Predicting the risk of drug-drug interactions in psychiatric hospitals: a retrospective longitudinal pharmacovigilance study

Por: Wolff · J. · Hefner · G. · Normann · C. · Kaier · K. · Binder · H. · Domschke · K. · Hiemke · C. · Marschollek · M. · Klimke · A.
Objectives

The aim was to use routine data available at a patient’s admission to the hospital to predict polypharmacy and drug–drug interactions (DDI) and to evaluate the prediction performance with regard to its usefulness to support the efficient management of benefits and risks of drug prescriptions.

Design

Retrospective, longitudinal study.

Setting

We used data from a large multicentred pharmacovigilance project carried out in eight psychiatric hospitals in Hesse, Germany.

Participants

Inpatient episodes consecutively discharged between 1 October 2017 and 30 September 2018 (year 1) or 1 January 2019 and 31 December 2019 (year 2).

Outcome measures

The proportion of rightly classified hospital episodes.

Methods

We used gradient boosting to predict respective outcomes. We tested the performance of our final models in unseen patients from another calendar year and separated the study sites used for training from the study sites used for performance testing.

Results

A total of 53 909 episodes were included in the study. The models’ performance, as measured by the area under the receiver operating characteristic, was ‘excellent’ (0.83) and ‘acceptable’ (0.72) compared with common benchmarks for the prediction of polypharmacy and DDI, respectively. Both models were substantially better than a naive prediction based solely on basic diagnostic grouping.

Conclusion

This study has shown that polypharmacy and DDI can be predicted from routine data at patient admission. These predictions could support an efficient management of benefits and risks of hospital prescriptions, for instance by including pharmaceutical supervision early after admission for patients at risk before pharmacological treatment is established.

Relationship between workers return to work, job retention and income in industrial accidents in Korea: a longitudinal study

Por: Bae · S. W. · Jeong · I. · Yoon · J.-H. · Lee · S. W. · Kim · T. H. · Won · J.-U.
Objective

This study aims to compare workers’ income before and after an occupational injury, with regard to return to work and job retention, over a period of 5 years.

Design

This study was designed as a longitudinal study.

Setting

The Panel Study of Workers’ Compensation Insurance (PSWCI) survey targeted workers involved in industrial accidents for which medical care was terminated in the year 2012.

Participants

The panel study was conducted on a final sample of 2000 workers who were selected proportionally by region (nine regions) after priority assignment by disability rating (six levels). A total of 1458 workers were finally included in this study.

Methods

This study used data from the first to fifth PSWCI. To identify the effect on income after occupational injury considering return to work and job retention, we used the generalised estimating equation.

Results

In regard to workers’ return to work, the OR that income after an occupational injury would be higher than that before an occupational injury was 3.17 (2.41–4.17) for those who returned to original work and 2.32 (1.81–2.97) for those re-employed as compared with who did not return to work and 1.27 (1.07–1.15) for those who retained their job as compared with those who did not. The ORs were 2.91 (2.26–3.75) for those who were re-employed and retained jobs and 2.96 (2.15–4.08) for those who returned to original work and did not retain jobs as compared with those who did not return to work and did not retain jobs.

Conclusions

It is important for accident victims to retain their jobs to maintain their economic status.

Comprehensive mutagenesis identifies the peptide repertoire of a p53 T-cell receptor mimic antibody that displays no toxicity in mice transgenic for human HLA-A*0201

by Iva Trenevska, Amanda P. Anderson, Carol Bentley, Tasneem Hassanali, Sarah Wiblin, Shaun Maguire, Francesco Pezzella, Alison H. Banham, Demin Li

T-cell receptor mimic (TCRm) antibodies have expanded the repertoire of antigens targetable by monoclonal antibodies, to include peptides derived from intracellular proteins that are presented by major histocompatibility complex class I (MHC-I) molecules on the cell surface. We have previously used this approach to target p53, which represents a valuable target for cancer immunotherapy because of the high frequency of its deregulation by mutation or other mechanisms. The T1-116C TCRm antibody targets the wild type p5365-73 peptide (RMPEAAPPV) presented by HLA-A*0201 (HLA-A2) and exhibited in vivo efficacy against triple receptor negative breast cancer xenografts. Here we report a comprehensive mutational analysis of the p53 RMPEAAPPV peptide to assess the T1-116C epitope and its peptide specificity. Antibody binding absolutely required the N-terminal arginine residue, while amino acids in the center of the peptide contributed little to specificity. Data mining the immune epitope database with the T1-116C binding consensus and validation of peptide recognition using the T2 stabilization assay identified additional tumor antigens targeted by T1-116C, including WT1, gp100, Tyrosinase and NY-ESO-1. Most peptides recognized by T1-116C were conserved in mice and human HLA-A2 transgenic mice showed no toxicity when treated with T1-116C in vivo. We conclude that comprehensive validation of TCRm antibody target specificity is critical for assessing their safety profile.

Investigation of hypertensive arteriopathy-related and cerebral amyloid angiopathy-related small vessel disease scores in patients from a memory clinic: a prospective single-centre study

Por: Matsuda · K. · Shindo · A. · Ii · Y. · Tabei · K.-i. · Ueda · Y. · Ishikawa · H. · Matsuura · K. · Yoshimaru · K. · Taniguchi · A. · Kato · N. · Satoh · M. · Maeda · M. · Tomimoto · H.
Objective

The severity of cerebral small vessel disease (SVD) is assessed through neuroimaging findings, including hypertensive arteriopathy (HA)-SVD and cerebral amyloid angiopathy (CAA)-SVD. HA-SVD and CAA-SVD have been collectively estimated as total scores: the HA-SVD and CAA-SVD scores, respectively. Previous reports suggest that HA-SVD scores are associated with cognitive function; however, the relationship between CAA-SVD scores and cognitive function remains unclear. Therefore, we examined the association between CAA-SVD scores and cognitive function. Furthermore, we developed a modified CAA-SVD score considering cortical microinfarcts and posterior dominant white matter hyperintensities, which are imaging findings of CAA, and examined the association between these scores and cognitive function in the same patient group.

Design

Prospective study.

Setting

Single centre study from a memory clinic.

Participants

Subjects were diagnosed with mild cognitive impairment (MCI) or mild dementia in our memory clinic between February 2017 and July 2019 and underwent clinical dementia rating scale and brain MRI assessment. A total of 42 patients (aged 75.3±9.12 years) were registered prospectively.

Primary and secondary outcome measures

We evaluated intellectual function, memory, frontal lobe function and constructional ability. Furthermore, the relationship between each score and cognitive function was examined.

Results

The CAA-SVD score showed significant associations with cognitive function (R2=0.63, p=0.016), but the HA-SVD score did not (R2=0.41, p=0.35). The modified CAA-SVD score was also significantly associated with cognitive function (R2=0.65, p=0.008).

Conclusion

Cognitive function is associated with the CAA-SVD score, and more efficiently with the modified CAA-SVD score, in memory clinic patients. Although we have not validated the weighting of the modified CAA-SVD score, these scores can be a predictor of cognitive deterioration in patients with MCI and mild dementia.

Impact of hierarchical hospital reform on patients with diabetes in China: a retrospective observational analysis

Por: Xu · J. · Wang · X. · Hao · H. · Wang · J. · Nicholas · S.
Objectives

We assess whether China’s diabetes pilot hierarchical diagnosis and treatment reforms shifted patient healthcare-seeking behaviour towards primary health institutions (PHIs) and away from secondary and tertiary hospitals. From the patients’ perspective, we evaluate whether the hierarchical system saw the decline of average hospital cost, out-of-pocket (OOP) expenses and the increase of reimbursement rate in PHIs. From the health system’s perspective, we also assessed whether the share of PHIs in total costs, total visits and reimbursement rate increased and the share of secondary and tertiary hospitals decreased.

Methods

Data were collected from the health insurance bureau of 11 cities in Shandong Province, China between 2015 and 2017, which included 9 118 518 outpatient visits and 622 739 inpatient visits. For both inpatients and outpatients and the health system, we analysed health services-seeking characteristics including hospital costs, hospital visits, OOP expense and reimbursements of hospital costs. Binary logistic regression was conducted to analyse the influencing factors of seeking PHI health services.

Results

PHIs remained the lowest hospital cost provider, but average hospital costs declined across all three healthcare levels of PHIs, secondary hospitals and tertiary hospitals from 2015 to 2017. The hierarchical system aimed to shift patients to PHIs, increasing PHIs’ share of total hospital costs. However, the PHI share of total outpatient costs declined 12.0%, while rising 15.0% in secondary hospitals, the opposite of the goal of the hierarchical medical system. Average outpatient visits rose roughly at the same rate in PHIs (5.1%) as secondary hospitals (6.8%), with no evidence of a shift in patient visits between hospital levels over 2015–2017. Average inpatient visits fell across all levels of hospitals, with no significant difference in the rate of decline between PHIs (9.4%) and secondary (7.5%) and tertiary (7.8%) hospitals. For outpatient and inpatient services, the binary logistic regression showed that over the 2015–2017 period patients with diabetes increasingly used higher level hospitals rather than PHIs (p

Conclusions

The implementation of the hierarchical medical system for patients with diabetes did not achieve its goal of increasing PHI utilisation and decreasing secondary and tertiary hospital utilisation. Enhancing the utilisation of PHIs for diabetes and other patients requires further health reform, including educating patients on PHI use, further reforming the health insurance schemes, improving PHI facilities and encouraging referrals to PHIs from higher level hospitals.

Predictors of poor health and functional recovery following road trauma: protocol of a British Columbian inception cohort study

Por: Shum · L. K. · Chan · H. · Erdelyi · S. · Pei · L. X. · Brubacher · J. R.
Introduction

Road trauma (RT) is a major public health problem affecting physical and mental health, and may result in prolonged absenteeism from work or study. It is important for healthcare providers to know which RT survivors are at risk of a poor outcome, and policy-makers should know the associated costs. Unfortunately, outcome after RT is poorly understood, especially for RT survivors who are treated and released from an emergency department (ED) without the need for hospital admission. Currently, there is almost no research on risk factors for a poor outcome among RT survivors. This study will use current Canadian data to address these knowledge gaps.

Methods and analysis

We will follow an inception cohort of 1500 RT survivors (16 years and older) who visited a participating ED within 24 hours of the accident. Baseline interviews determine pre-existing health and functional status, and other potential risk factors for a poor outcome. Follow-up interviews at 2, 4, 6, and 12 months (key stages of recovery) use standardised health-related quality of life tools to determine physical and mental health outcome, functional recovery, and healthcare resource use and lost productivity costs.

Ethics and dissemination

The Road Trauma Outcome Study is approved by our institutional Research Ethics Board. This study aims to provide healthcare providers with knowledge on how quickly RT survivors recover from their injuries and who may be more likely to have a poor outcome. We anticipate that this information will be used to improve management of all road users following RT. Healthcare resource use and lost productivity costs will be collected to provide a better cost estimate of the effects of RT. This information can be used by policy-makers to make informed decisions on RT prevention programmes.

Help-seeking behaviour and attitudes towards internet-administered psychological support among adolescent and young adults previously treated for cancer during childhood: protocol for a survey and embedded qualitative interview study in Sweden

Por: Woodford · J. · Manberg · J. · Cajander · A. · Enebrink · P. · Harila-Saari · A. · Hagström · J. · Karlsson · M. · Placid Solimena · H. · von Essen · L.
Introduction

A subgroup of adolescent and young adult childhood cancer survivors (AYACCS) are at increased risk of psychological distress. Despite this, AYACCS experience difficulties accessing psychological support. E-mental health (e-MH) may offer a solution to reduce this treatment gap. However, research examining e-MH for AYACCS has experienced difficulties with recruitment, retention and adherence. Such difficulties may relate to: (1) help-seeking behaviour and/or (2) e-MH acceptability. The overall study aims are to: (1) examine potential associations between health service use factors, informed by Andersen’s behavioural model of health services use, and help-seeking behaviour; (2) examine attitudes towards e-MH interventions; and (3) explore perceived need for mental health support; past experience of receiving mental health support; preferences for support; and barriers and facilitators to help-seeking.

Methods and analysis

An online and paper-based cross-sectional self-report survey (98 items) and embedded qualitative interview study across Sweden, with a target sample size of n=365. Participants are aged 16–39 years, diagnosed with cancer when 0–18 years and have completed successful cancer treatment. The survey examines sociodemographic and clinical characteristics, actual help-seeking behaviour, attitudes towards e-MH, stigma of mental illness, mental health literacy, social support and current symptoms of depression, anxiety, and stress. Survey respondents with past and/or current experience of mental health difficulties are invited into the qualitative interview study to explore: (1) perceived need for mental health support; (2) past experience of receiving mental health support; (3) preferences for support; and (4) barriers and facilitators to help-seeking. Potential associations between health service use factors and help-seeking behaviour are examined using univariable and multivariable logistic regressions. Qualitative interviews are analysed using content analysis.

Ethics and dissemination

Ethical approval has been obtained from the Swedish Ethical Review Authority (Dnr: 2020-06271). Results will be disseminated in scientific publications and academic conference presentations.

Trial registration number

ISRCTN70570236.

Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Por: Kaforau · L. S. K. · Tessema · G. A. · Jancey · J. · Dhamrait · G. K. · Bugoro · H. · Pereira · G. F.
Introduction

Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth outcomes that are prevalent in low-income and middle-income settings such as the Pacific Island region. It is widely accepted that the excess burden of adverse birth outcomes is attributable to socioeconomic and environmental factors that predispose families to excess risk. Our review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island region and to identify the risk factors of adverse birth outcomes in the Pacific Island region.

Methods

This scoping review will follow the five-staged Arksey and O’Malley’s framework and consultation with Solomon Islands’ health stakeholders. A preliminary literature review was undertaken to understand the scope of the review. We will use Medical Subject Heading and keyword terms for adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest and Springer Link databases for articles published from 1 January 2000. The subsequent searches will be undertaken via Google Scholar and the internet browser to world health organisation and regional health organisations for published and unpublished reports on non-indexed studies. All articles retrieved will be managed with EndNote software. Eligible studies will be screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for final selection. In the charting phase, we will extract the data into Excel spreadsheets. The results will be presented as numerical and thematic summaries that map risk factors and prevalence to the population and cultures of the Pacific Island region.

Ethics and dissemination

Formal ethical approval is not required as primary or administrative data will not be collected. However, we will seek ethics approval for the stakeholder consultation from the Research Office of Curtin University and the Solomon Islands. The findings of this study will be published in peer-reviewed journals and presented in national and regional conferences and disseminated to stakeholders.

Ethics approval

There will be no direct contact with human or patients in the case of the scoping review; therefore, no ethics will be required. However, we will seek ethical approval from the Research Ethics Office of Curtin University and the Health Research and Ethics Committee in the Solomon Islands for stakeholder consultation. Dissemination will be made through regional conferences and publication in peer-reviewed journals.

New screening tool for neonatal nutritional risk in China: a validation study

Por: Zhou · M. · Li · Y. · Yin · H. · Zhang · X. · Hu · Y.
Objective

A neonatal nutritional risk screening tool (NNRST) was developed by using Delphi and analytic hierarchy processes in China. We verified the accuracy of this tool and analysed whether it effectively screened neonates with nutritional risk.

Design

Prospective validation study.

Setting and participants

In total, 338 neonates who were admitted to the neonatal unit of Children’s Hospital of Chongqing Medical University from May–July 2016 completed the study. Nutritional risk screening and length and head circumference measurements were performed weekly. Weight was measured every morning, and other relevant clinical data were recorded during hospitalisation.

Main outcome measures

We evaluated the sensitivity, specificity, validity, reliability, and positive and negative predictive value of the screening tool. Various characteristics of neonates in different risk groups were analysed to determine the rationality of the nutritional risk classification.

Results

The sensitivity, specificity, and positive and negative predictive values were 85.11%, 91.07%, 60.61% and 97.43%, respectively. The criterion validity was texted by the Spearman correlation analysis (r=0.530) and independent samples non-parametric tests (p=0.000). The content validity (Spearman correlation coefficient) was 0.321–0.735. The inter-rater reliability (kappa value) was 0.890. Among the neonatal clinical indicators, gestational age, birth weight, length, admission head circumference, admission albumin, admission total proteins, discharge weight, discharge length and head circumference decreased with increasing nutrition risk level; the length of stay and the rate of parenteral nutrition support increased with increasing nutrition risk level. In the comparison of complications during hospitalisation, the incidence of necrotising enterocolitis and congenital gastrointestinal malformation increased with increasing nutrition risk level.

Conclusion

The validation results for the NNRST are reliable. The tool can be used to preliminarily determine the degree of neonatal nutritional risk, but its predictive value needs to be determined in future large-sample studies.

Trial registration number

ChiCTR2000033743.

Protocol for a pilot single-centre, parallel-arm, randomised controlled trial of dietary inulin to improve gut health in solid organ transplantation: the DIGEST study

Por: Singer · J. · Li · Y. J. · Ying · T. · Aouad · L. J. · Gracey · D. M. · Wyburn · K. · Macia · L. · Wu · H. · Chadban · S. J.
Introduction

Kidney transplantation remains the best treatment for end-stage kidney disease, however the requirement for indefinite immunosuppression increases the risk of cardiovascular disease, cancer and infection, leading to a reduction in long-term patient and graft survival. The gut microbiome is a critical determinant of health and modulates host immunity and metabolism through a number of recognised pathways, including through the production of immunomodulatory short-chain fatty acids (SCFA). Dietary supplementation with non-digestible fibre can augment the microbial production of SCFA and lead to favourable immune and metabolic outcomes, although this has yet to be shown in human kidney transplant recipients.

Methods and analysis

Dietary inulin for gut health in solid-organ transplantation (DIGEST) is a single-centre, unblinded, pilot parallel-arm randomised controlled trial designed to assess the feasibility and adherence of dietary inulin, a naturally occurring dietary fibre, in the early post-transplant period in kidney transplant recipients. Participants will be randomised at day 28 post-transplant to a 4-week period of dietary inulin (10–20 g/day) in addition to standard care, or standard care alone, and followed-up until week 12 post-transplant.

The primary outcomes of the study are: (i) the feasibility of participant recruitment, randomisation and retention; (ii) adherence to the intervention (inulin) and (iii) the tolerability of inulin determined by changes in gastrointestinal symptoms as scored on the Gastrointestinal Symptom Rating Scale.

Secondary outcomes include: (1) glycaemic variability determined by continuous glucose monitoring; (2) abundance of SCFA-producing microbiota, as determined by 16s rRNA sequencing of the faecal metagenome; (3) serum SCFA concentrations; (4) peripheral blood immune cell populations; (5) recipient inflammatory and metabolic profiles and (6) the incidence of biopsy-proven acute rejection and kidney function determined by estimated glomerular filtration rate.

Ethics and dissemination

All study visits, clinical and laboratory assessments will be integrated into usual post-transplant care, creating no additional healthcare encounters or procedures. The risks associated with this study are minor. Inulin has been shown to be well tolerated across a variety of cohorts, with the occurrence of short-term adverse gastrointestinal symptoms self-limiting. However, with gastrointestinal adverse events common following kidney transplantation, the tolerability of inulin in this cohort remains unknown. The results of DIGEST will be published in peer-reviewed journals and presented at academic conferences. This study has been approved by the Sydney Local Health District’s Ethics Committee (Royal Prince Alfred Hospital Zone).

Trial registration number

ACTRN12620000623998.

Use of psychotropic drugs and drugs with anticholinergic properties among residents with dementia in intermediate care facilities for older adults in Japan: a cohort study

Por: Hamada · S. · Kojima · T. · Hattori · Y. · Maruoka · H. · Ishii · S. · Okochi · J. · Akishita · M.
Objectives

To evaluate the prescription and discontinuation of psychotropic drugs (PD) and drugs with anticholinergic properties (DAP) in residents with dementia admitted to Roken, a major type of long-term care facility in Japan.

Design

Cohort study.

Setting

A nationwide questionnaire survey across 3598 Roken in Japan in 2015 (up to five randomly selected residents per facility).

Participants

This study included 1201 residents from 343 Roken (response rate: 10%). We determined the presence and severity of dementia using a nationally standardised measure.

Primary and secondary outcome measures

Prescriptions of PD and DAP at admission and 2 months after admission were evaluated. Multivariable logistic regression was used to evaluate the associations of residents’ baseline characteristics with prescriptions or discontinuation.

Results

Prescription rates decreased for antidementia drugs (19.4% to 13.0%), hypnotics (25.1% to 22.6%) and anxiolytics (12.3% to 10.7%), whereas those for other PD, such as antipsychotics (13.2% to 13.6%), antidepressants (7.4% to 6.7%), antiepileptic drugs (7.1% to 7.8%) and DAP (35.2% to 36.6%) did not statistically significantly decrease. Some factors were associated with the prescriptions, for example, for antipsychotics, older age (≥85 years) (adjusted OR (aOR), 0.60; 95% CI 0.43 to 0.85) and being bedridden (aOR 0.67; 95% CI 0.47 to 0.97) were associated with a lower use of antipsychotics, whereas severe dementia was associated with a higher use of antipsychotics (aOR 3.26; 95% CI 2.26 to 4.70). At an individual level, a quarter of residents prescribed PD or DAP at admission had discontinued at least one PD or DAP, respectively, 2 months after admission. Antidementia drug use in severe dementia (aOR 1.86; 95% CI 1.04 to 3.31) and PD use in older age (aOR 1.61; 95% CI 1.00 to 2.60; in residents with disabling dementia) were associated with discontinuation.

Conclusions

There is possible scope for deprescribing PD and DAP in Roken residents with dementia to mitigate the risks of adverse events.

❌