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ФАС: сговор фармкомпаний – причина высоких цен при закупках ЛС в школы и больницы

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При госзакупках лекарственных средств в детские учреждения было выявлено более тысячи сговоров, рассказал глава ФАС Игорь Артемьев. По его словам, на российском рынке почти все тендеры проходят с нарушениями.

Identification of Susceptible Loci and Enriched Pathways for Bipolar II Disorder Using Genome-Wide Association Studies

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Background:

This study aimed to identify susceptible loci and enriched pathways for bipolar disorder subtype II.

Methods:

We conducted a genome-wide association scan in discovery samples with 189 bipolar disorder subtype II patients and 1773 controls, and replication samples with 283 bipolar disorder subtype II patients and 500 controls in a Taiwanese Han population using Affymetrix Axiom Genome-Wide CHB1 Array. We performed single-marker and gene-based association analyses, as well as calculated polygeneic risk scores for bipolar disorder subtype II. Pathway enrichment analyses were employed to reveal significant biological pathways.

Results:

Seven markers were found to be associated with bipolar disorder subtype II in meta-analysis combining both discovery and replication samples (P<5.0×10–6), including markers in or close to MYO16, HSP90AB3P, noncoding gene LOC100507632, and markers in chromosomes 4 and 10. A novel locus, ETF1, was associated with bipolar disorder subtype II (P<6.0×10–3) in gene-based association tests. Results of risk evaluation demonstrated that higher genetic risk scores were able to distinguish bipolar disorder subtype II patients from healthy controls in both discovery (P=3.9×10–4~1.0×10–3) and replication samples (2.8×10–4~1.7×10–3). Genetic variance explained by chip markers for bipolar disorder subtype II was substantial in the discovery (55.1%) and replication (60.5%) samples. Moreover, pathways related to neurodevelopmental function, signal transduction, neuronal system, and cell adhesion molecules were significantly associated with bipolar disorder subtype II.

Conclusion:

We reported novel susceptible loci for pure bipolar subtype II disorder that is less addressed in the literature. Future studies are needed to confirm the roles of these loci for bipolar disorder subtype II.

How does age-related macular degeneration affect real-world visual ability and quality of life? A systematic review

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Objectives

To review systematically the evidence of age-related macular degeneration (AMD) affecting real-world visual ability and quality of life (QoL). To explore trends in specific topics within this body of the literature.

Design

Systematic review.

Methods

A systematic literature search was carried out using MEDLINE, EMBASE, CINAHL, PsycINFO, PsychARTICLES and Health and Psychosocial Instruments for articles published up to January 2015 for studies including people diagnosed with AMD, assessing real-world visual ability or QoL as an outcome. Two researchers screened studies for eligibility. Details of eligible studies including study design, characteristics of study population and outcomes measured were recorded in a data extraction table. All included studies underwent quality appraisal using the Mixed Methods Appraisal Tool 2011 Version (MMAT).

Results

From 5284 studies, 123 were eligible for inclusion. A range of approaches were identified, including performance-based methods, quantitative and qualitative patient-reported outcome measures (PROMs). AMD negatively affects tasks including mobility, face recognition, perception of scenes, computer use, meal preparation, shopping, cleaning, watching TV, reading, driving and, in some cases, self-care. There is evidence for higher rates of depression among people with AMD than among community dwelling elderly. A number of adaptation strategies have been associated with AMD of varying duration. Much of the research fails to report the type of AMD studied (59% of included studies) or the duration of disease in participants (74%). Of those that do report type studied, the breakdown is as follows: wet AMD 20%, dry AMD 4% and both types 17%.

Conclusions

There are many publications highlighting the negative effects of AMD in various domains of life. Future research should focus on delivering some of this research knowledge into patient management and clinical trials and differentiating between the types of AMD.

Translation and validation of the Cancer-Related Fatigue Scale in Greek in a sample of patients with advanced prostate cancer

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Objective

To translate and validate the Cancer-Related Fatigue (CRF) Scale in the Greek language.

Design

A cross-sectional descriptive design was used in order to translate and validate the CRF Scale in Greek. Factor analyses were performed to understand the psychometric properties of the scale and to establish construct, criterion and convergent validity.

Setting

Outpatients’ oncology clinics of two public hospitals in Cyprus.

Participants

148 patients with advanced prostate cancer undergoing chemotherapy.

Results

The Cancer Fatigue Scale (CFS) had good stability (test–retest reliability r=0.79, p<0.001) and good internal consistency (Cronbach’s α coefficient for all 15 items α=0.916). Furthermore, the Kaiser-Meyer-Olkin Measure of Sampling Adequacy (KMO value) was found to be 0.743 and considered to be satisfactory (>0.5). The correlations between the CFS physical scale (CFS-FS scale) and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 physical subscales were found to be significant (r=–0.715). The same occurred between CFS cognitive and EORTC cognitive subscale (r=–0.579). Overall, the criterion validity was verified. The same occurs for the convergent validity of the CFS since all correlations with the Global Health Status (q29–q30) were found to be significant.

Conclusions

This is the first validation study of the CRF Scale in Greek and warrant of its use in the assessment of prostate cancer patient’s related fatigue. However, further testing and validation is needed in the early stages of the disease and in patients in later chemotherapy cycles.

Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs

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Objective

To explore the impact of providing additional information about the potential benefits of simvastatin in a patient leaflet on attitudes and beliefs.

Design

Interview-based study using a generic qualitative approach and framework analysis.

Participants

21 participants receiving a prescription for simvastatin were recruited from a general practitioner practice (from a total of 120). 8 participants were women; the age range was 55–92.

Intervention

Participants were provided with leaflets showing one of 3 types of additional benefit information: (1) textual statement, (2) number needed to treat (NNT) or (3) natural frequency. Semistructured interviews explored patient’s attitudes and beliefs.

Results

A descriptive narrative of preferences for format suggested patients prefer textual as opposed to numerical benefit information. Significant barriers to the acceptance of numerical benefit information included difficulty in understanding the numbers. Patients overestimated the benefits of statins and expressed surprise at the numerical information.

Conclusions

Textual information was preferred but numerical information, in particular in the form of a natural frequency, may help patients make judgements about their medicines. NNTs were found to be very difficult to understand. This raises the prospect that some patients might reject medicines because of disappointment with the perceived low benefits of their medicines. The self-reported impact on behaviour appeared minimal with reports of intentions to ‘do what the doctor tells me’. Further research is needed to explore the impact of such statements on people who are yet to be prescribed a statin.

Physical activity as intervention for age-related loss of muscle mass and function: protocol for a randomised controlled trial (the LISA study)

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Introduction

Physical and cognitive function decline with age, accelerating during the 6th decade. Loss of muscle power (forcexvelocity product) is a dominant physical determinant for loss of functional ability, especially if the lower extremities are affected. Muscle strength training is known to maintain or even improve muscle power as well as physical function in older adults, but the optimal type of training for beneficial long-term training effects over several years is unknown. Moreover, the impact of muscle strength training on cognitive function and brain structure remains speculative. The primary aim of this randomised controlled trial is to compare the efficacy of two different 1 year strength training regimens on immediate and long-lasting improvements in muscle power in retirement-age individuals. Secondary aims are to evaluate the effect on muscle strength, muscle mass, physical and cognitive function, mental well-being, health-related quality of life and brain morphology.

Methods and analysis

The study includes 450 home-dwelling men and women (62–70 years). Participants are randomly allocated to (1) 1 year of supervised, centre-based heavy resistance training, (2) home-based moderate intensity resistance training or (3) habitual physical activity (control). Changes in primary (leg extensor power) and secondary outcomes are analysed according to the intention to treat principle and per protocol at 1, 2, 4, 7 and 10 years.

Ethics and dissemination

The study is expected to generate new insights into training-induced promotion of functional ability and independency after retirement and will help to formulate national recommendations regarding physical activity schemes for the growing population of older individuals in western societies. Results will be published in scientific peer-reviewed journals, in PhD theses and at public meetings. The study is approved by the Regional Ethical Committee (Capital Region, Copenhagen, Denmark, number H-3-2014-017).

Trial registration number

NCT02123641.

Cohort profile: the diabetes-tuberculosis treatment outcome (DITTO) study in Pakistan

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Purpose

Pakistan is faced with an increasing prevalence of diabetes in addition to its existing high burden of tuberculosis (TB). Diabetes has a detrimental effect on treatment outcomes of patients with TB, which may hinder achieving the goals of the End-TB strategy by 2030. We conducted a prospective cohort study to determine difference between treatment outcomes among patients with diabetes and new pulmonary tuberculosis (PTB) and patients without diabetes and new PTB. This would help generate contextual and valid scientific evidence from a developing country like Pakistan with its unique interplay of sociocultural, economic and health system factors to inform policy and practice.

Participants

This paper outlines the baseline characteristics of 614 new cases of PTB, aged 15 years and older, which were followed up prospectively at 2nd, 5th and 6th months while on antituberculosis treatment and at 6 months after treatment completion.

Findings to date

We ascertained patients’ diabetic status by conducting random and fasting blood glucose tests and their glycaemic control by determining glycosylated haemoglobin. Treatment outcomes were established using standardised definitions provided by WHO. The assessment of 614 respondents’ diabetic status revealed that 113 (18%) were diabetic and 501 (82%) were non-diabetic. A greater proportion of patients with diabetes and PTB were illiterate (n=74/113, 65.5%) as compared to patients without diabetes and PTB (n=249/501, 50%) (p=0.035). More patients with diabetes and PTB gave a history of heart disease (n=14/113, 12%) and hypertension (n=26/113, 23%) as compared to patients without diabetes and PTB (n=2/501, 0.4% (heart disease) and n=13 501, 3% (hypertension)) (p<0.001). Unfavourable treatment outcome was more likely among patients with diabetes and PTB (n=23/93, 25%) as opposed to patients without diabetes and PTB (n=46/410, 11%) (p=0.001).

Future plans

We are negotiating with the government regarding funding for a further 2-year follow-up of the cohort to ascertain death and relapse in the post-treatment period and also differentiate between re-infection and recurrence among these patients with respect to their diabetic status.

HOspitals and patients WoRking in Unity (HOW R U?): protocol for a prospective feasibility study of telephone peer support to improve older patients’ quality of life after emergency department discharge

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Introduction

Older people presenting to an emergency department (ED) have a higher likelihood of social isolation, loneliness and depression; which are all associated with negative health outcomes and increased health service use, including higher rates of ED attendance. The HOW R U? study aims to ascertain the feasibility and acceptability of a postdischarge telephone support programme for older ED patients following discharge. The intervention, which aims to improve quality of life, will be delivered by hospital-based volunteers.

Methods and analysis

A multicentre prospective uncontrolled feasibility study will enrol 50 community-dwelling patients aged ≥70 years with symptoms of loneliness or depression who are discharged home within 72 hours from the ED or acute medical ward. Participants will receive weekly supportive telephone calls over a 3-month period from a volunteer-peer. Feasibility will be assessed in terms of recruitment, acceptability of the intervention to participants and level of retention in the programme. Changes in level of loneliness (UCLA-3 item Loneliness Scale), mood (Geriatric Depression Scale-5 item) and health-related quality of life (EQ-5D-5L and EQ-VAS) will also be measured postintervention (3 months).

Ethics and dissemination

Research ethics and governance committee approval has been granted for this study by each participating centre (reference: 432/15 and 12-09-11-15). Study findings will inform the design and conduct of a future multicentre randomised controlled trial of a postdischarge volunteer-peer telephone support programme to improve social isolation, loneliness or depressive symptoms in older patients. Results will be disseminated through peer-reviewed journal publication, and conference and seminar presentation.

Trial registration number

ACTRN12615000715572, Pre-results.

Relationship between maternal hypoglycaemia and small-for-gestational-age infants according to maternal weight status: a retrospective cohort study in two hospitals

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Objective

The relationship between pre-pregnancy body mass index (BMI) and low glucose challenge test (GCT) results by maternal weight status has not been examined. This study aimed to clarify the relationship between a low GCT result and small for gestational age (SGA) by maternal weight status.

Design

A retrospective cohort study in 2 hospitals.

Setting

This study evaluated the obstetric records of women who delivered in a general community hospital and a tertiary perinatal care centre.

Participants

The number of women who delivered in both hospitals between January 2012 and December 2013 and underwent GCT between 24 and 28 weeks of gestation was 2140. Participants with gestational diabetes mellitus or diabetes during pregnancy, and GCT results of ≥140 mg/dL were excluded. Finally, 1860 women were included in the study.

Primary and secondary outcome measures

The participants were divided into low-GCT (≤90 mg/dL) and non-low-GCT groups (91–139 mg/dL). The 2 tests and multivariate logistic regression analyses were conducted to investigate the association between low GCT results and SGA by maternal weight status.

Results

The incidence of SGA was 11.4% (212/1860), and 17.7% (330/1860) of the women showed low GCT results. The patients were divided into 3 groups according to their BMI (underweight, normal weight and obese). When the patients were analysed separately by their weight status after controlling for maternal age, pre-pregnancy maternal weight, maternal weight gain during pregnancy, pregnancy-induced hypertension, thyroid disease and difference in hospital, low GCT results were significantly associated with SGA (OR 2.10; 95% CI 1.14 to 3.89; p=0.02) in the underweight group.

Conclusions

Low GCT result was associated with SGA at birth among underweight women. Examination of maternal glucose tolerance and fetal growth is necessary in future investigations.

‘You can’t be a person and a doctor: the work-life balance of doctors in training–a qualitative study

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Objectives

Investigate the work–life balance of doctors in training in the UK from the perspectives of trainers and trainees.

Design

Qualitative semistructured focus groups and interviews with trainees and trainers.

Setting

Postgraduate medical training in London, Yorkshire and Humber, Kent, Surrey and Sussex, and Wales during the junior doctor contract dispute at the end of 2015. Part of a larger General Medical Council study about the fairness of postgraduate medical training.

Participants

96 trainees and 41 trainers. Trainees comprised UK graduates and International Medical Graduates, across all stages of training in 6 specialties (General Practice, Medicine, Obstetrics and Gynaecology, Psychiatry, Radiology, Surgery) and Foundation.

Results

Postgraduate training was characterised by work–life imbalance. Long hours at work were typically supplemented with revision and completion of the e-portfolio. Trainees regularly moved workplaces which could disrupt their personal lives and sometimes led to separation from friends and family. This made it challenging to cope with personal pressures, the stresses of which could then impinge on learning and training, while also leaving trainees with a lack of social support outside work to buffer against the considerable stresses of training. Low morale and harm to well-being resulted in some trainees feeling dehumanised. Work–life imbalance was particularly severe for those with children and especially women who faced a lack of less-than-full-time positions and discriminatory attitudes. Female trainees frequently talked about having to choose a specialty they felt was more conducive to a work–life balance such as General Practice. The proposed junior doctor contract was felt to exacerbate existing problems.

Conclusions

A lack of work–life balance in postgraduate medical training negatively impacted on trainees’ learning and well-being. Women with children were particularly affected, suggesting this group would benefit the greatest from changes to improve the work–life balance of trainees.

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