Blog Archive

Αλέξανδρος Γ. Σφακιανάκης

Tuesday, December 8, 2020

Association of food industry ties with findings of studies examining the effect of dairy food intake on cardiovascular disease and mortality: systematic review and meta-analysis

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Objective

To determine if the association of dairy foods with cardiovascular disease (CVD) outcomes differs between studies with food industry ties versus those without industry ties. To determine whether studies with or without industry ties differ in their risk of bias.

Eligibility criteria

We included cohort and case–control studies that estimated the association of dairy foods with CVD outcomes in healthy adults.

Information sources

We searched eight databases on 1 February 2019 from 2000 to 2019 and hand searched reference lists.

Risk of bias

We used the Risk of Bias in Non-Randomised Studies-of Exposure tool.

Included studies

43 studies (3 case–controls, 40 cohorts).

Synthesis of results

There was no clear evidence of an association between studies with industry ties (1/14) versus no industry ties (8/29) and the reporting of favourable results, risk ratio (RR)=0.26 (95% CI 0.04 to 1.87; n=43 studies) and studies with industry ties (4/14) versus no industry ties (11/29) and favourable conclusions, RR=0.75 (95% CI 0.29 to 1.95; n=43). Studies with industry sponsorship, (HR=0.78; n=3 studies) showed a decreased magnitude of risk of CVD outcomes compared with studies with no industry sponsorship (HR=0.97; n=18) (ratio of HRs 0.80 (95% CI 0.66 to 0.97); p=0.03).

Strengths and limitations of evidence

Every study had an overall high risk of bias rating; this was primarily due to confounding.

Interpretation

There was no clear evidence of an association between studies with food industry ties and the reporting of favourable results and conclusions compared with studies without industry ties. The statistically significant difference in the magnitude of effects identified in industry-sponsored studies compared with non-industry-sponsored studies, however, is important in quantifying industry influence on studies included in dietary guidelines.

PROSPERO registration number

CRD42019129659.

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Home cardiac rehabilitation programme for people with heart failure and their caregivers

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Introduction

Despite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based programmes might improve accessibility. The aim of SCOT: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is to assess the implementation of the REACH-HF home-based CR intervention in the context of the National Health Service (NHS) in Scotland.

This paper presents the design and protocol for this observational implementation study. Specific objectives of SCOT:REACH-HF are to: (1) assess service-level facilitators and barriers to the implementation of REACH-HF; (2) compare real-world patient and caregiver outcomes to those seen in a prior clinical trial; and (3) estimate the economic (health and social) impact of implementing REACH-HF in Scotland.

Methods and analysis

The REACH-HF intervention will be delivered in partnership with four 'Beacon sites' across six NHS Scotland Health Boards, covering rural and urban areas. Health professionals from each site will be trained to facilitate delivery of the 12-week programme to 140 people with heart failure and their caregivers. Patient and caregiver outcomes will be assessed at baseline and 4-month follow-up. Assessments include the Minnesota Living with Heart Failure Questionnaire (MLHFQ), five-dimension EuroQol 5L, Hospital Anxiety and Depression Scale, and the Caregiver Burden Questionnaire. Qualitative interviews will be conducted with up to 20 health professionals involved in programme delivery (eg, cardiac nurses, physiotherapists). 65 facilitator-patient consultations will be audio recorded and assessed for fidelity. Integrative analysis will address key research questions on fidelity, context and CR participant-related outcomes. The SCOT:REACH-HF findings will inform the future potential roll-out of REACH-HF in Scotland.

Ethics and dissemination

The study has been given ethical approval by the West of Scotland Research Ethics Service (reference 20/WS/0038, approved 25 March 2020). Written informed consent will be obtained from all participants. The study is listed on the ISRCTN registry with study ID ISRCTN53784122. The research team will ensure that the study is conducted in accordance with both General Data Protection Regulations and the University of Glasgow's Research Governance Framework. Findings will be reported to the funder and shared with Beacon Sites, to facilitate service evaluation, planning and good practice. To broaden interest in, and understanding of REACH-HF, we will seek to publish in peer-reviewed scientific journals and present at stakeholder events, national and international conferences.

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Effect of Housing First on violence-related traumatic brain injury in adults with experiences of homelessness and mental illness: findings from the At Home/Chez Soi randomised trial, Toronto site

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Objectives

People experiencing homelessness have a high prevalence and incidence of traumatic brain injury (TBI) due to violence. Little is known about the effectiveness of interventions to reduce TBI in this population. This study assessed the effect of Housing First (HF) on violence-related TBI in adults with experiences of homelessness and mental illness.

Design

Pragmatic randomised trial.

Participants

381 participants in the Toronto site of the At Home/Chez randomised trial.

Intervention

HF participants were provided with scattered-site housing using rent supplements and supports from assertive community treatment or intensive case management teams (n=218, 57.2%). Control participants had access to treatment as usual (TAU) in the community (n=163, 42.8%).

Main outcome measures

Primary outcomes were an incident physical violence-related TBI event and the number of physical violence-related TBI events during the follow-up period (January 2014 to March 2017). Interval-censored survival time regression and zero-inflated negative binomial regression were used to assess the effect of HF on primary outcomes.

Results

Among study participants, 9.2% (n=35) had an incident physical violence-related TBI event, and the mean physical violence-related TBI events was 0.16 (SD ±0.6). Compared with TAU participants, HF participants did not have a significantly lower risk of an incident violence-related TBI event (adjusted HR : 0.58 (95% CI, 0.29 to 1.14)), but they had a significantly lower number of physical violence-related TBI events (unadjusted incidence rate ratio (IRR): 0.22 (95% CI, 0.06 to 0.78); adjusted IRR: 0.15 (95% CI, 0.05 to 0.48)).

Conclusion

HF may be a useful intervention to reduce the burden of TBI due to physical violence among homeless individuals with mental illness.

Trial registration number

ISRCTN42520374.

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Effect of bicyclol on blood biomarkers of NAFLD: a systematic review and meta-analysis

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Objective

Non-alcoholic fatty liver disease (NAFLD) is a global epidemic without effective therapeutic agents in the clinic. This meta-analysis aimed to assess the efficacy of the marketed hepatoprotectant bicyclol at improving blood biomarkers in patients with NAFLD.

Design

Electronic databases were searched for randomised controlled trials (RCTs) published up to August 2020 using bicyclol to treat NAFLD. The risk of bias, quality of evidence and publication bias were evaluated. Blood biomarkers, including alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), triglyceride (TG) and total cholesterol (TC), were analysed using Review Manager V.5.3 software. Outcomes with significant heterogeneity (I2 ≥75%) were divided into the bicyclol monotherapy subgroup and combination treatment subgroup.

Results

Twelve RCTs involving 1008 patients were finally included. No serious adverse events were reported in the bicyclol-treated groups. The total effective rate of bicyclol intervention for NAFLD was significantly higher than that of the control group. The decreases in the levels of AST (mean difference (MD) = –15.20; 95% CI –20.51 to –9.90; I2=74%), TBIL (MD = –1.72; 95% CI –2.72 to –0.72; I2=0%) and TC (MD = –0.52; 95% CI –0.70 to –0.34; I2=67%) treated by bicyclol were significantly higher than those in the control group. When a high heterogeneity existed (I2 ≥75%), subgroup analyses were conducted and revealed significantly decreased ALT levels (MD = –34.07; 95% CI –36.70 to –31.43; I2=0%) merely in the bicyclol monotherapy subgroup, while TG level (MD = –0.39; 95% CI –0.45 to –0.33; I2=0%) was decreased in the bicyclol combination therapy subgroup.

Conclusions

The study presents the evidence of bicyclol monotherapy and/or combination therapy for improving liver function and blood lipid biomarkers in patients with NAFLD. This preliminary study predicts that bicyclol might be an alternative drug for NAFLD therapy in the future.

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Cord blood transplantation for adult myeloid malignancies comparing high-dose cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF priming: G-CONCORD study protocol

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Introduction

A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues. To minimise graft failure and relapse after CBT, intensification of conditioning by the addition of high-dose cytosine arabinoside (CA) and concomitant continuous use of granulocyte-colony stimulating factor (G-CSF) are reported to convey a significantly better survival after CBT in some retrospective studies. To confirm the effect of G-CSF plus CA combination, in addition to the standard conditioning regimen, cyclophosphamide (CY)/total body irradiation (TBI), we design a randomised controlled study comparing CA/CY/TBI with versus without G-CSF priming (G-CSF combined conditioned cord blood transplantation [G-CONCORD] study).

Methods and analysis

This is a multicentre, open-label, randomised phase III study that aimed to compare G-CSF+CA/CY/TBI as a conditioning regimen for CBT with CA/CY/TBI. Patients with acute myeloid leukaemia or myelodysplastic syndrome, aged 16–55 years, are eligible. The target sample size is 160 and the registration period is 4 years. The primary endpoint is the 2-year disease-free survival rate after CBT. The secondary endpoints are overall survival, relapse, non-relapse mortality, acute and chronic graft-versus-host disease, engraftment rate, time to neutrophil recovery, short-term adverse events, incidence of infections and causes of death.

This study employs a single one-to-one web-based randomisation between the with-G-CSF versus without-G-CSF groups after patient registration. Combination of high-dose CA and CY/TBI in both groups is used for conditioning.

Ethics and dissemination

The study protocol was approved by the central review board, Nagoya University Certified Review Board, after the enforcement of the Clinical Trials Act in Japan. The manuscripts presenting data from this study will be submitted for publication in quality peer-reviewed medical journals. Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journals.

Trial registration numbers

UMIN000029947 and jRCTs041180059.

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Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial

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Introduction

Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.

The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.

Methodology

All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).< /p> Ethics and dissemination

The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.

Trial registration number

NCT03210311

Conclusion

The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.

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Peripheral blood correlates of virologic relapse after Sofosbuvir and Ribavirin treatment of Genotype-1 HCV infection

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Treatment of chronic hepatitis C virus infection with direct acting antiviral therapy results in viral elimination in over 90% of cases. The duration of treatment required to achieve cure differs between indiv...
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