Title: Trends in Biochemical Sciences

Title: Trials

ISO Abbreviated Title: Trials

JCR Abbreviated Title: Trials

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: Impact Factor

? Haykowsky, M., Scott, J., Esch, B., Schopflocher, D., Myers, J., Paterson, I., Warburton, D., Jones, L. and Clark, A.M. (2011), A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: Start early and go longer for greatest exercise benefits on remodeling. Trials, 12, Article Number: 92.

Full Text: 2011\Trials12, 92.pdf

Abstract: Background: the effects of variations in exercise training on Left ventricular (LV) remodeling in patients shortly after Myocardial Infarction (MI) are important but poorly understood. Methods: Systematic review incorporating meta-analysis using meta-regression. Studies were identified via systematic searches of: OVID MEDLINE (1950 to 2009), Cochrane Central Register of Controlled Trials (1991 to 2009), AMED (1985 to 2009), EMBASE (1988 to 2009), PUBMED (1966 to 2009), SPORT DISCUS (1975 to 2009), SCOPUS (1950 to 2009) and Web of Science (1950 to 2009) using the medical subject headings: myocardial infarction, post myocardial infarction, post infarction, heart attack, ventricular remodeling, ventricular volumes, ejection fraction, left ventricular function, exercise, exercise therapy, kinesiotherapy, exercise training. Reference lists of all identified studies were also manually searched for further relevant studies. Studies selected were randomized controlled trials of exercise training interventions reporting ejection fraction (EF) and/or ventricular volumes in patients following recent MI (<= 3 months) post-MI patients involving control groups. Studies were excluded if they were not randomized, did not have a ‘usual-care’ control (involving no exercise), evaluated a non-exercise intervention, or did not involve human subjects. Non-English studies were also excluded. Results: After screening of 1029 trials, trials were identified that reported EF (12 trials, n = 647), End Systolic Volumes (ESV) (9 trials, n = 475) and End Diastolic Volumes (EDV) (10 trials, n = 512). Meta-regression identified that changes in EF effect size difference decreased as the time between MI and initiation of the exercise program lengthened, and increased as the duration of the program increased (Q = 25.48, df = 2, p < 0.01, R(2) = 0.76). Greater reductions in ESV and EDV (as indicated by effect size decreases) occurred with earlier initiation of exercise training and with longer training durations (ESV: Q = 23.89, df = 2, p < 0.05, R(2) = 0.79; EDV: Q = 27.42, df = 2, p < 0.01, R(2) = 0.83). Differences remained following sensitivity analysis. Each week that exercise was delayed required an additional month of training to achieve the same level of benefit on LV remodeling. Conclusions: Exercise training has beneficial effects on LV remodeling in clinically stable post-MI patients with greatest benefits occurring when training starts earlier following MI (from one week) and lasts longer than 3 months.

Keywords: Analysis, Cardiac Rehabilitation, Cochrane, Control, Control Groups, Coronary-Artery-Disease, Dysfunction, Embase, Exercise, Exercise Therapy, Human, Improvement, Intervention, Interventions, Medical, MEDLINE, Meta Analysis, Meta-Analysis, Methods, Myocardial Infarction, Of-Science, Patients, Prevention, Randomized Clinical-Trials, Randomized Controlled Trials, Review, Science, Scopus, Screening, Sensitivity, Sport, Survival, Systematic, Systematic Review, Therapy, Training, Web, Web-of-Science

? Savard, L.A., Thompson, D.R. and Clark, A.M. (2011), A meta-review of evidence on heart failure disease management programs: the challenges of describing and synthesizing evidence on complex interventions. Trials, 12, Article Number: 194.

Full Text: 2011\Trials12, 194.pdf

Abstract: Background: Despite favourable results from past meta-analyses, some recent large trials have not found Heart Failure (HF) disease management programs to be beneficial. To explore reasons for this, we evaluated evidence from existing meta-analyses. Methods: Systematic review incorporating meta-review was used. We selected meta-analyses of randomized controlled trials published after 1995 in English that examined the effects of HF disease management programs on key outcomes. Databases searched: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), DARE, NHS EED, NHS HTA, Ageline, AMED, Scopus, Web of Science and CINAHL; cited references, experts and existing reviews were also searched. Results: 15 meta-analyses were identified containing a mean of 18.5 randomized trials of HF interventions +/- 10.1 (range: 6 to 36). Overall quality of the meta-analyses was very mixed (Mean AMSTAR Score = 6.4 +/- 1.9; range 2-9). Reporting inadequacies were widespread around populations, intervention components, settings and characteristics, comparison, and comparator groups. Heterogeneity (statistical, clinical, and methodological) was not taken into account sufficiently when drawing conclusions from pooled analyses. Conclusions: Meta-analyses of heart failure disease management programs have promising findings but often fail to report key characteristics of populations, interventions, and comparisons. Existing reviews are of mixed quality and do not adequately take account of program complexity and heterogeneity.

Keywords: Admission, Care, Clinical-Outcomes, Cochrane, Database, Databases, Disease, Disease Management, Embase, Heterogeneity, Intervention, Interventions, Management, MEDLINE, Metaanalysis, Methods, Older Patients, Outcomes, Randomized Controlled Trials, Randomized Controlled-Trials, Readmission, Review, Science, Scopus, Statement, Statistical, Systematic, Systematic Review, Systematic Reviews, Web of Science

? Erpeldinger, S., Fayolle, L., Boussageon, R., Flori, M., Laine, X., Moreau, A. and Gueyffier, F. (2013), Is there excess mortality in women screened with mammography: A meta-analysis of non-breast cancer mortality. Trials, 14, Article Number: 368.

Full Text: 2013\Trials14, 368.pdf

Abstract: Background: the objective of our meta-analysis and systematic review was to analyze non-breast cancer mortality in women screened with mammography versus non-screened women to determine whether there is excess mortality caused by screening. Methods: We searched PubMed and the Web of Science up to 30 November 2010. We included randomized controlled trials with non-breast cancer mortality as the main endpoint. Two authors independently assessed trial quality and extracted data. Results: There was no significant difference between groups at 13-year follow-up (odds ratio = 1.00 (95% CI 0.98 to 1.03) with average heterogeneity I-2 = 61%) regardless of the age and the methodological quality of the included studies. The meta-analysis did not reveal excess non-breast cancer mortality caused by screening. If screening does have an effect on excess mortality, it is possible to provide an estimate of its maximum value through the upper confidence interval in good-quality methodological studies: up to 3% in the screened women group (12 deaths per 100,000 women). Conclusions: the all-cause death rate was not significantly reduced by screening when compared to the rate observed in unscreened women. However, mammography screening does not seem to induce excess mortality. These findings improve information given to patients. Finding more comprehensive data is now going to be difficult given the complexity of the studies. Individual modeling should be used because the studies fail to include all the aspects of a complex situation. The risk/benefit analysis of screening needs to be regularly and independently reassessed.

Keywords: Age, Age 40, Analysis, Article, Authors, Breast Cancer, Breast-Cancer, Cancer, Complexity, Confidence, Data, Death, Death Rates, Efficacy, England, Floor, Follow-Up, France, Groups, Heterogeneity, Information, Inn, Interval, London, Mammography, Medicine, Meta Analysis, Meta-Analysis, Metaanalysis, Methods, Model, Modeling, Mortality, Needs, Nov, Odds Ratio, Patients, Project, Pubmed, Quality, Quality Of, Randomized, Randomized Controlled Trials, Randomized Controlled-Trial, Research, Results, Review, Science, Screening, Systematic Review, Trial, Trials, Value, Web of Science, Women

? Brueton, V.C., Vale, C.L., Choodari-Oskooei, B., Jinks, R. and Tierney, J.F. (2014), Measuring the impact of methodological research: A framework and methods to identify evidence of impact. Trials, 15, Article Number: 464.

Full Text: 2014\Trials15, 464.pdf

Abstract: Background: Providing evidence of impact highlights the benefits of medical research to society. Such evidence is increasingly requested by research funders and commonly relies on citation analysis. However, other indicators may be more informative. Although frameworks to demonstrate the impact of clinical research have been reported, no complementary framework exists for methodological research. Therefore, we assessed the impact of methodological research projects conducted or completed between 2009 and 2012 at the UK Medical Research Council Clinical Trials Unit Hub for Trials Methodology Research Hub, with a view to developing an appropriate framework. Methods: Various approaches to the collection of data on research impact were employed. Citation rates were obtained using Web of Science (http://www.webofknowledge.com/) and analyzed descriptively. Semistructured interviews were conducted to obtain information on the rates of different types of research output that indicated impact for each project. Results were then pooled across all projects. Finally, email queries pertaining to methodology projects were collected retrospectively and their content analyzed. Results: Simple citation analysis established the citation rates per year since publication for 74 methodological publications; however, further detailed analysis revealed more about the potential influence of these citations. Interviews that spanned 20 individual research projects demonstrated a variety of types of impact not otherwise collated, for example, applications and further developments of the research; release of software and provision of guidance materials to facilitate uptake; formation of new collaborations and broad dissemination. Finally, 194 email queries relating to 6 methodological projects were received from 170 individuals across 23 countries. They provided further evidence that the methodologies were impacting on research and research practice, both nationally and internationally. We have used the information gathered in this study to adapt an existing framework for impact of clinical research for use in methodological research. Conclusions: Gathering evidence on research impact of methodological research from a variety of sources has enabled us to obtain multiple indicators and thus to demonstrate broad impacts of methodological research. The adapted framework developed can be applied to future methodological research and thus provides a tool for methodologists to better assess and report research impacts.

Keywords: Analysis, Benefits, Cancer, Citation, Citation Analysis, Citation Rates, Citations, Clinical, Clinical Research, Clinical Trials, Clinical-Trial, Collaborations, Collection, Complementary, Content, Data, Developing, Evidence, Framework, From, Guidance, Impact, Impact Measurement, Impacts, Indicators, Influence, Information, Interviews, Medical, Medical Research, Methodological Research, Methodologies, Methodology, Methods, Model, Nov, Potential, Practice, Prognostic Research, Publication, Publications, Rates, Release, Research, Research Impact, Research Output, Results, Science, Society, Software, Sources, Types Of Research, UK, Uptake, Web, Web Of Science