scholarly journals Preventing dementia

2005 ◽  
Vol 11 (3) ◽  
pp. 176-183 ◽  
Author(s):  
Nitin Purandare ◽  
Clive Ballard ◽  
Alistair Burns
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Multiple Risk Factors ◽  
Incident Dementia ◽  
Treatment Of Hypertension ◽  
Intervention Trials ◽  
Randomised Controlled

Epidemiological evidence has identified key strategies that may be used in the prevention of both Alzheimer's disease and vascular dementia. These strategies may be loosely divided into three areas: treatment of vascular risk factors, neuroprotection and increasing neuronal reserves. Evidence from randomised controlled trials already exists for treatment of hypertension but results for statins have been disappointing. Most of the intervention trials currently in progress focus on one or two risk factors and include cognition or dementia only as a secondary outcome. The potential of intervention strategies awaits confirmation by randomised controlled trials that target multiple risk factors in at-risk people with mild cognitive impairment, with incident dementia as the primary outcome.

scholarly journals Registration and publication of emergency and elective randomised controlled trials in surgery: a cohort study from trial registries

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021700 ◽  
Author(s):  
Rachael L Morley ◽  
Matthew J Edmondson ◽  
Ceri Rowlands ◽  
Jane M Blazeby ◽  
Robert J Hinchliffe
Keyword(s):  
Outcome Measures ◽  
Emergency Surgery ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Surgical Trials ◽  
Surgical Interventions ◽  
Randomised Controlled

ObjectivesEmergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials.DesignThe clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword ‘surgery’. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE.ParticipantsResults with no surgical interventions were excluded. The remaining results were manually categorised into ‘emergency’ or ‘elective’ and ‘surgical’ or ‘adjunct’ by two reviewers.Primary outcome measuresNumber of RCTs registered in emergency versus elective surgery.Secondary outcome measuresNumber of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery.Results2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) −0.06, 95% CI −0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD −0.18, 95% CI −0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD −0.04, 95% CI −0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD −0.18, 95% CI −0.43 to 0.07).ConclusionFewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.

scholarly journals Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020623 ◽  
Author(s):  
Kirthi Menon ◽  
Aya Mousa ◽  
Barbora de Courten
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Chronic Disease ◽  
Chronic Diseases ◽  
Randomised Controlled Trials ◽  
Disease Risk ◽  
Primary Data ◽  
Controlled Trials ◽  
Chronic Disease Risk ◽  
Randomised Controlled

IntroductionAgeing of populations globally, coupled with the obesity epidemic, has resulted in the rising prevalence of chronic diseases including diabetes, cardiovascular diseases, cancers and neurodegenerative disorders. Prevention of risk factors that contribute to these diseases is key in managing the global burden of chronic diseases. Recent studies suggest that carnosine, a dipeptide with anti-inflammatory, antioxidative and antiglycating properties may have a role in the prevention of chronic diseases; however, no previous reviews have examined the effects of carnosine and other histidine-containing peptides (HCDs) on chronic disease risk factors and outcomes. We aim to conduct a comprehensive systematic review to examine the effects of supplementation with carnosine and other HCDs on chronic disease risk factors and outcomes and to identify relevant knowledge gaps.Methods and analysisElectronic databases including Medline, Cumulative Index of Nursing and Allied Health, Embase and all Evidence-Based Medicine will be systematically searched to identify randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing supplementation with carnosine and/or other HCDs versus placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will screen titles and abstracts for eligibility according to prespecified inclusion criteria, after which two independent reviewers will perform data extraction and quality appraisal. Meta-analyses, metaregression and subgroup analyses will be conducted where appropriate.Ethics and disseminationEthics approval is not required as this review does not involve primary data collection. This review will generate level-one evidence regarding the effects of carnosine supplementation on chronic disease risk factors and outcomes and will be disseminated through peer-reviewed publications and at conference meetings to inform future research on the efficacy of carnosine supplementation for the prevention of chronic diseases.PROSPERO registration numberCRD42017075354.

scholarly journals Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e038887
Author(s):  
Maximilian Siebert ◽  
Jeanne Fabiola Gaba ◽  
Laura Caquelin ◽  
Henri Gouraud ◽  
Alain Dupuy ◽  
...  
Keyword(s):  
Medical Journal ◽  
Data Sharing ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Cross Sectional Survey ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Data Set ◽  
Randomised Controlled

ObjectiveTo explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.DesignA cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).SettingICMJE website; PubMed/Medline.Eligibility criteriaICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.Main outcome measuresThe primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors. For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.ResultsEight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%). One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements. In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).ConclusionThe implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals. The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.RegistrationThe protocol was registered before the start of the research on the Open Science Framework (https://osf.io/n6whd/).

scholarly journals Multifactorial e- and mHealth interventions for cardiovascular disease primary prevention: Protocol for a systematic review and meta-analysis of randomised controlled trials

2019 ◽  
Vol 5 ◽  
pp. 205520761989048
Author(s):  
Artur Direito ◽  
Jonathan Rawstorn ◽  
Jacqueline Mair ◽  
Reza Daryabeygi-Khotbehsara ◽  
Ralph Maddison ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Community Dwelling ◽  
Controlled Trials ◽  
Cvd Risk ◽  
Health Lifestyle ◽  
Randomised Controlled ◽  
Preventative Interventions

Objective Cardiovascular diseases (CVD) are a leading cause of mortality and disease burden. Preventative interventions to augment the population-level adoption of health lifestyle behaviours that reduce CVD risk are a priority. Face-to-face interventions afford individualisation and are effective for improving health-related behaviours and outcomes, but they are costly and resource intensive. Electronic and mobile health (e- and mHealth) approaches aimed at modifying lifestyle risk factors may be an effective and scalable approach to reach many individuals while preserving individualisation. This systematic review aims to (a) determine the effectiveness of multifactorial e- and mHealth interventions on CVD risk and on lifestyle-related cardiometabolic risk factors and self-management behaviours among adults without CVD; and (b) describe the evidence on adverse events and on the cost-effectiveness of these interventions. Methods Methods were detailed prior to the start of the review in order to improve conduct and prevent inconsistent decision making throughout the review. This protocol was prepared following the PRISMA-P 2015 statement. MEDLINE, CINAHL, Embase, PsycINFO, Web of Science, Cochrane Public Health Group Specialised Register and CENTRAL electronic databases will be searched between 1991 and September 2019. Eligibility criteria are: (a) population: community-dwelling adults; (b) intervention/comparison: randomised controlled trials comparing e- or mHealth CVD risk preventative interventions with usual care; and (c) outcomes: modifiable CVD risk factors. Selection of study reports will involve two authors independently screening titles and abstracts, followed by a full-text review of potentially eligible reports. Two authors will independently undertake data extraction and assess risk of bias. Where appropriate, meta-analysis of outcome data will be performed. Discussion This protocol describes the pre-specified methods for a systematic review that will provide quantitative and narrative syntheses of current multifactorial e- and mHealth CVD preventative interventions. A systematic review and meta-analysis will be conducted following the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions and reported according to PRISMA guidelines.

scholarly journals Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031151 ◽  
Author(s):  
Karin A Wasmann ◽  
Pieta Wijsman ◽  
Susan van Dieren ◽  
Willem Bemelman ◽  
Christianne Buskens
Keyword(s):  
Systematic Review ◽  
External Validity ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Internal Validity ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Lost To Follow Up

ObjectiveRandomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.DesignSystematic review and meta-analyses.Data sourcesMEDLINE, Embase, PsycINFO and the Cochrane Library.Eligibility criteria for selecting studiesRPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.Data extraction and synthesisTwo independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.ResultsIn total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI −0.178 to 0.364, p=0.502).ConclusionsPatients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.PROSPERO registration numberCRD42019094438.

Effects of strawberry intervention on cardiovascular risk factors: a meta-analysis of randomised controlled trials

2020 ◽  
Vol 124 (3) ◽  
pp. 241-246
Author(s):  
Qi Gao ◽  
Li-Qiang Qin ◽  
Ahmed Arafa ◽  
Ehab S. Eshak ◽  
Jia-Yi Dong
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Blood Glucose ◽  
Randomised Controlled Trials ◽  
Ldl Cholesterol ◽  
Meta Analysis ◽  
Fasting Blood Glucose ◽  
Controlled Trials ◽  
Baseline Levels ◽  
Randomised Controlled

AbstractWe conducted a meta-analysis of randomised controlled trials (RCT) to examine the effects of strawberry interventions on cardiovascular risk factors. We searched multiple databases including PubMed, Web of Science and Scopus to identify eligible studies published before 19 May 2019. The endpoints were blood pressure, total cholesterol (TC), HDL-cholesterol, LDL-cholesterol, TAG, fasting blood glucose, endothelial function and inflammatory factors. Pooled analyses were performed using random- or fixed-effects models according to a heterogeneity test. We also conducted sub-group analyses by baseline endpoint levels. We included eleven RCT in this meta-analysis (six for blood pressure, seven for lipid profile, seven for fasting blood glucose and six for C-reactive protein (CRP)). Overall, the strawberry interventions significantly reduced CRP levels by 0·63 (95 % CI −1·04, −0·22) mg/l but did not affect blood pressure, lipid profile or fasting blood glucose in the main analyses. Our analysis stratified by baseline endpoint levels showed the strawberry interventions significantly reduced TC among people with baseline levels >5 mmol/l (−0·52 (95 % CI −0·88, −0·15) mmol/l) and reduced LDL-cholesterol among people with baseline levels >3 mmol/l (−0·31 (95 % CI −0·60, −0·02) mmol/l). There was little evidence of heterogeneity in the analysis and no evidence of publication bias. In summary, strawberry interventions significantly reduced CRP levels and may improve TC and LDL-cholesterol in individuals with high baseline levels.

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