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Всю донорскую кровь в США предложили проверить на вирус Зика

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Минздрав США призывает провести анализы всего банка донорской крови на вирус Зика, пишут в пятницу американские СМИ.
В Управлении по надзору за качеством пищевых продуктов и медикаментов заявили, что “существует неясность в том, что касается природы и распространения вируса Зика”.

Всю донорскую кровь в США предложили проверить на вирус Зика

Published by:

Минздрав США призывает провести анализы всего банка донорской крови на вирус Зика, пишут в пятницу американские СМИ.
В Управлении по надзору за качеством пищевых продуктов и медикаментов заявили, что “существует неясность в том, что касается природы и распространения вируса Зика”.

Incidence and duration of type-specific human papillomavirus infection in high-risk HPV-naïve women: results from the control arm of a phase II HPV-16/18 vaccine trial

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Objectives

Persistence of human papillomaviruses (HPVs) is necessary for cervical carcinogenesis. We evaluated incidence and duration of type-specific HPV infections and the influence of age and number of sexual partners.

Methods

Data were obtained from 553 women (15–25 years), who were seronegative and DNA-negative for high-risk HPV (HR-HPV) types and were enrolled in the placebo arm of a randomised trial of the HPV-16/18 vaccine (NCT00689741/NCT00120848). They were followed for 6.3 years. Cervicovaginal samples were self-collected at 3-month intervals for up to 27 months, and cervical samples were collected by clinicians at 6-month intervals until study end. Samples were tested for HPV types using a broad-spectrum PCR assay. Incidence rate ratios (RRs) and 95% CIs were used to estimate the association among age, sexual habits and HPV acquisition.

Results

Incidence rates (95% CI) using cervical samples were 11.8 (10.4 to 13.4) and 5.6 (4.7 to 6.6) per 1000 women-months for HR-HPVs and low-risk HPVs (LR-HPVs), respectively. Equivalent rates in combined cervicovaginal and cervical samples were 17.2 (15.4 to 19.2) and 6.9 (5.9 to 8.0), respectively. 54 per cent of HR-HPV types from combined cervicovaginal and cervical samples persisted for 1 year compared with 32.3% for LR-HPV types. The risk of acquiring any HPV infection was higher among women aged <21 years (RR=1.33, 95% CI 1.1 to 1.7) and women having >1 sexual partner (RR=1.83, 95% CI 1.4 to 2.4) at baseline.

Conclusions

HR-HPV infections were more common and lasted longer on average than LR-HPV infections. HPV acquisition was more common in younger women with multiple sexual partners.

Trial registration number

NCT00689741, NCT00120848; Post-results.

Consumption of fruits and vegetables and associations with risk factors for non-communicable diseases in the Yangon region of Myanmar: a cross-sectional study

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Objectives

To explore the intake of fruits and vegetables in the Yangon region, Myanmar, and to describe associations between intake of fruits and vegetables (FV) and established risk factors for non-communicable diseases.

Design

2 cross-sectional studies, using the STEPs methodology.

Setting

Urban and rural areas of the Yangon region of Myanmar.

Participants

1486, men and women, 25–74 years, were recruited through a multistage cluster sampling method. Institutionalised people, military personnel, Buddhist monks and nuns were not invited. Physically and mentally ill people were excluded.

Results

Mean intake of fruit was 0.8 (SE 0.1) and 0.6 (0.0) servings/day and of vegetables 2.2 (0.1) and 1.2 (0.1) servings/day, in urban and rural areas, respectively. Adjusted for included confounders (age, sex, location, income, education, smoking and low physical activity), men and women eating ≥2 servings of fruits and vegetables/day had lower odds than others of hypertriglyceridaemia (OR 0.72 (95% CI 0.56 to 0.94)). On average, women eating at least 2 servings of fruits and vegetables per day had cholesterol levels 0.28 mmol/L lower than the levels of other women. When only adjusted for sex and age, men eating at least 2 servings of fruits and vegetables per day had cholesterol levels 0.27 mmol/L higher than other men.

Conclusions

A high intake of FV was associated with lower odds of hypertriglyceridaemia among men and women. It was also associated with cholesterol levels, negatively among women and positively among men.

Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy (FALCON trial): study protocol for a multicentre randomised controlled trial

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Introduction

Misidentification of the extrahepatic bile duct anatomy during laparoscopic cholecystectomy (LC) is the main cause of bile duct injury. Easier intraoperative recognition of the biliary anatomy may be accomplished by using near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG). Promising results were reported for successful intraoperative identification of the extrahepatic bile ducts compared to conventional laparoscopic imaging. However, routine use of ICG fluorescence laparoscopy has not gained wide clinical acceptance yet due to a lack of high-quality clinical data. Therefore, this multicentre randomised clinical study was designed to assess the potential added value of the NIRF imaging technique during LC.

Methods and analysis

A multicentre, randomised controlled clinical trial will be carried out to assess the use of NIRF imaging in LC. In total, 308 patients scheduled for an elective LC will be included. These patients will be randomised into a NIRF imaging laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. The primary end point is time to ‘critical view of safety’ (CVS). Secondary end points are ‘time to identification of the cystic duct (CD), of the common bile duct, the transition of CD in the gallbladder and the transition of the cystic artery in the gallbladder, these all during dissection of CVS’; ‘total surgical time’; ‘intraoperative bile leakage from the gallbladder or cystic duct’; ‘bile duct injury’; ‘postoperative length of stay’, ‘complications due to the injected ICG’; ‘conversion to open cholecystectomy’; ‘postoperative complications (until 90 days postoperatively)’ and ‘cost-minimisation’.

Ethics and dissemination

The protocol has been approved by the Medical Ethical Committee of Maastricht University Medical Center/Maastricht University; the trial has been registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

NCT02558556.

Systematic review and meta-analysis of randomised controlled trials on the effects of potassium supplements on serum potassium and creatinine

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Objectives

High potassium intake could prevent stroke, but supplementation is considered hazardous. We assessed the effect of oral potassium supplementation on serum or plasma potassium levels and renal function.

Setting

We updated a systematic review of the effects of potassium supplementation in randomised clinical trials carried out worldwide, published in 2013, extending it to July 2015. We followed the PRISMA guidelines.

Participants

Any individual taking part in a potassium supplementation randomised clinical trial. Studies included met the following criteria: randomised clinical trials, potassium supplement given and circulating potassium levels reported.

Intervention

Oral potassium supplementation.

Primary outcome measures

Serum or plasma potassium and serum or plasma creatinine.

Results

A total of 20 trials (21 independent groups) were included (1216 participants from 12 different countries). All but 2 were controlled (placebo n=16, control n=2). Of these trials, 15 were crossover, 4 had a parallel group and 1 was sequential. The duration of supplementation varied from 2 to 24 weeks and the amount of potassium given from 22 to 140 mmol/day. In the pooled analysis, potassium supplementation caused a small but significant increase in circulating potassium levels (weighted mean difference (WMD) 0.14 mmol/L, 95% CI 0.09 to 0.19, p<1×10–5), not associated with dose or duration of treatment. The average increase in urinary potassium excretion was 45.75 mmol/24 hours, 95% CI 38.81 to 53.69, p<1×10–5. Potassium supplementation did not cause any change in circulating creatinine levels (WMD 0.30 µmol/L, 95% CI –1.19 to 1.78, p=0.70).

Conclusions

In short-term studies of relatively healthy persons, a moderate oral potassium supplement resulted in a small increase in circulating potassium levels and no change in renal function.

Validation of an algorithm to determine the primary care treatability of emergency department visits

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Objectives

We propose a new claims-computable measure of the primary care treatability of emergency department (ED) visits and validate it using a nationally representative sample of Medicare data.

Study design and setting

This is a validation study using 2011–2012 Medicare claims data for a nationally representative 5% sample of fee-for-service beneficiaries to compare the new measure’s performance to the Ballard variant of the Billings algorithm in predicting hospitalisation and death following an ED visit.

Outcomes

Hospitalisation within 1 day or 1 week of an ED visit; death within 1 week or 1 month of an ED visit.

Results

The Minnesota algorithm is a strong predictor of hospitalisations and deaths, with performance similar to or better than the most commonly used existing algorithm to assess the severity of ED visits. The Billings/Ballard algorithm is a better predictor of death within 1 week of an ED visit; this finding is entirely driven by a small number of ED visits where patients appear to have been dead on arrival.

Conclusions

The procedure-based approach of the Minnesota algorithm allows researchers to use the clinical judgement of the ED physician, who saw the patient to determine the likely severity of each visit. The Minnesota algorithm may thus provide a useful tool for investigating ED use in Medicare beneficiaries.

Do choosing wisely tools meet criteria for patient decision aids? A descriptive analysis of patient materials

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Objectives

Choosing Wisely is a remarkable physician-led campaign to reduce unnecessary or harmful health services. Some of the literature identifies Choosing Wisely as a shared decision-making approach. We evaluated the patient materials developed by Choosing Wisely Canada to determine whether they meet the criteria for shared decision-making tools known as patient decision aids.

Design

Descriptive analysis of all Choosing Wisely Canada patient materials.

Data source

In May 2015, we selected all Choosing Wisely Canada patient materials from its official website.

Main outcomes and measures

Four team members independently extracted characteristics of the English materials using the International Patient Decision Aid Standards (IPDAS) modified 16-item minimum criteria for qualifying and certifying patient decision aids. The research team discussed discrepancies between data extractors and reached a consensus. Descriptive analysis was conducted.

Results

Of the 24 patient materials assessed, 12 were about treatments, 11 were about screening and 1 was about prevention. The median score for patient materials using IPDAS criteria was 10/16 (range: 8–11) for screening topics and 6/12 (range: 6–9) for prevention and treatment topics. Commonly missed criteria were stating the decision (21/24 did not), providing balanced information on option benefits/harms (24/24 did not), citing evidence (24/24 did not) and updating policy (24/24 did not). Out of 24 patient materials, only 2 met the 6 IPDAS criteria to qualify as patient decision aids, and neither of these 2 met the 6 certifying criteria.

Conclusions

Patient materials developed by Choosing Wisely Canada do not meet the IPDAS minimal qualifying or certifying criteria for patient decision aids. Modifications to the Choosing Wisely Canada patient materials would help to ensure that they qualify as patient decision aids and thus as more effective shared decision-making tools.

Evaluating outpatient transition clinics: a mixed-methods study protocol

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Introduction

To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC).

Methods and analysis

We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care.

Ethics

The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246).

Dissemination

Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016–2018).

Improving skills and care standards in the support workforce for older people: a realist synthesis of workforce development interventions

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Objectives

This evidence review was conducted to understand how and why workforce development interventions can improve the skills and care standards of support workers in older people’s services.

Design

Following recognised realist synthesis principles, the review was completed by (1) development of an initial programme theory; (2) retrieval, review and synthesis of evidence relating to interventions designed to develop the support workforce; (3) ‘testing out’ the synthesis findings to refine the programme theories, and establish their practical relevance/potential for implementation through stakeholder interviews; and (4) forming actionable recommendations.

Participants

Stakeholders who represented services, commissioners and older people were involved in workshops in an advisory capacity, and 10 participants were interviewed during the theory refinement process.

Results

Eight context–mechanism–outcome (CMO) configurations were identified which cumulatively comprise a new programme theory about ‘what works’ to support workforce development in older people’s services. The CMOs indicate that the design and delivery of workforce development includes how to make it real to the work of those delivering support to older people; the individual support worker’s personal starting points and expectations of the role; how to tap into support workers’ motivations; the use of incentivisation; joining things up around workforce development; getting the right mix of people engaged in the design and delivery of workforce development programmes/interventions; taking a planned approach to workforce development, and the ways in which components of interventions reinforce one another, increasing the potential for impacts to embed and spread across organisations.

Conclusions

It is important to take a tailored approach to the design and delivery of workforce development that is mindful of the needs of older people, support workers, health and social care services and the employing organisations within which workforce development operates. Workforce development interventions need to balance the technical, professional and emotional aspects of care.

Trial registration number

CRD42013006283.

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