Reporting trends of randomised controlled trials in heart failure with preserved ejection fraction: a systematic review
نویسندگان
چکیده
BACKGROUND Heart failure with preserved ejection fraction (HFpEF) causes significant cardiovascular morbidity and mortality. Current consensus guidelines reflect the neutral results from randomised controlled trials (RCTs). Adequate trial reporting is a fundamental requirement before concluding on RCT intervention efficacy and is necessary for accurate meta-analysis and to provide insight into future trial design. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement provides a framework for complete trial reporting. Reporting quality of HFpEF RCTs has not been previously assessed, and this represents an important validation of reporting qualities to date. OBJECTIVES The aim was to systematically identify RCTs investigating the efficacy of pharmacological therapies in HFpEF and to assess the quality of reporting using the CONSORT 2010 statement. METHODS MEDLINE, EMBASE and CENTRAL databases were searched from January 1996 to November 2015, with RCTs assessing pharmacological therapies on clinical outcomes in HFpEF patients included. The quality of reporting was assessed against the CONSORT 2010 checklist. RESULTS A total of 33 RCTs were included. The mean CONSORT score was 55.4% (SD 17.2%). The CONSORT score was strongly correlated with journal impact factor (r=0.53, p=0.003) and publication year (r=0.50, p=0.003). Articles published after the introduction of CONSORT 2010 statement had a significantly higher mean score compared with those published before (64% vs 50%, p=0.02). CONCLUSIONS Although the CONSORT score has increased with time, a significant proportion of HFpEF RCTs showed inadequate reporting standards. The level of adherence to CONSORT criteria could have an impact on the validity of trials and hence the interpretation of intervention efficacy. We recommend improving compliance with the CONSORT statement for future RCTs.
منابع مشابه
Pentoxifylline for heart failure: a systematic review.
BACKGROUND Recent trials have indicated a beneficial effect of pentoxifylline on measures of inflammation and markers of cardiac dysfunction in people with heart failure. However, it is uncertain whether pentoxifylline should be used routinely in the management of heart failure. OBJECTIVE To determine the effectiveness of pentoxifylline in heart failure. DESIGN Systematic review of randomis...
متن کاملDrug treatment effects on outcomes in heart failure with preserved ejection fraction: a systematic review and meta-analysis
BACKGROUND Clinical drug trials in patients with heart failure and preserved ejection fraction have failed to demonstrate improvements in mortality. METHODS We systematically searched Medline, Embase and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCT) assessing pharmacological treatments in patients with heart failure with left ventricular (LV) ejecti...
متن کاملAdverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis.
OBJECTIVES To quantify the incidence of major adverse events (AEs) occurring in hospital or within 30 days after surgery in patients undergoing coronary artery bypass graft (CABG) surgery and to identify risk factors for these AEs. METHODS Systematic review and analysis of studies published in English since 1990. Studies of isolated standard CABG reporting postoperative incidence of myocardia...
متن کاملTrends in prevalence and outcome of heart failure with preserved ejection fraction.
BACKGROUND The prevalence of heart failure with preserved ejection fraction may be changing as a result of changes in population demographics and in the prevalence and treatment of risk factors for heart failure. Changes in the prevalence of heart failure with preserved ejection fraction may contribute to changes in the natural history of heart failure. We performed a study to define secular tr...
متن کاملCurrent Treatment of Heart Failure with Preserved Ejection Fraction: Should We Add Life to the Remaining Years or Add Years to the Remaining Life?
ACCORDING TO THE EJECTION FRACTION, PATIENTS WITH HEART FAILURE MAY BE DIVIDED INTO TWO DIFFERENT GROUPS: heart failure with preserved or reduced ejection fraction. In recent years, accumulating studies showed that increased mortality and morbidity rates of these two groups are nearly equal. More importantly, despite decline in mortality after treatment in regard to current guideline in patient...
متن کامل