Funding of Studies Supporting IA Guideline Recommendations in Cardiovascular Medicine—A Systematic Review

Abstract Each guideline recommendation from the American Heart Association and the American College of Cardiology includes an indication of the level of supporting evidence and the associated strength of recommendation with “IA” recommendations representing those with the highest quality supporting evidence and the least amount of uncertainty for benefit. In this analysis, study type and funding sources were systematically tabulated across these IA guideline recommendations over the past 5 years. Nearly half of studies supporting IA guideline recommendations were randomized controlled trials (45%). Overall, about one third of studies supporting IA recommendations were publicly funded (34.9%) with slightly more funded through industry sources (43.5%). Funding sources varied based on the type of intervention being studied with randomized controlled trials of device, diagnostic, and pharmacological interventions reflecting predominantly industry‐funded studies. Over time, studies supporting IA cardiology guideline are funded by industry about twice as often as public sources. Thus, data of adequate quality to support cardiovascular guideline recommendations come from a variety of sources.

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The reporting of coenrolment in protocols of publicly funded randomized controlled trials was infrequent and variable

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2021.01.002 ◽

2021 ◽

Vol 133 ◽

pp. 94-100

Author(s):

Tanaya Maslekar ◽

Samuel Peat ◽

Jamshaid Karim ◽

Catherine Moriarty ◽

David G. Jayne ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Controlled Trials ◽

Publicly Funded ◽

Randomized Controlled

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Does pregabalin effectively and safely relieve postoperative pain in patients undergoing pulmonary resections?

Interactive CardioVascular and Thoracic Surgery ◽

10.1093/icvts/ivz132 ◽

2019 ◽

Vol 29 (4) ◽

pp. 555-560 ◽

Cited By ~ 1

Author(s):

Shuangjiang Li ◽

Wenbiao Zhang ◽

Shan Cheng ◽

Yongjiang Li

Keyword(s):

Randomized Controlled Trial ◽

Postoperative Pain ◽

Randomized Controlled Trials ◽

Controlled Trial ◽

Perioperative Period ◽

Control Group ◽

Controlled Trials ◽

Clinical Question ◽

Randomized Controlled ◽

Study Type

Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether pregabalin could effectively and safely reduce postoperative pain in patients undergoing pulmonary resections. Altogether 23 papers were found using the reported search, of which 6 randomized controlled trials represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Five of 6 randomized controlled trials demonstrated that the application of oral pregabalin during the perioperative period could effectively reduce postoperative pain after pulmonary resections without compromising patients’ safety. One randomized controlled trial reported no difference in the postoperative pain levels between the pregabalin group and the control group. The rates of adverse effects were generally found to be decreased in patients who received pregabalin compared to the patients who received routine analgesia, although 2 studies reported significantly higher incidences of mild drowsiness and dizziness among the pregabalin-treated patients. Currently available evidence supports that the perioperative administration of pregabalin can effectively and safely relieve postoperative pain for patients undergoing pulmonary resections.

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Dietary saturated fat and heart disease: a narrative review

Nutrition Reviews ◽

10.1093/nutrit/nuz091 ◽

2019 ◽

Vol 78 (6) ◽

pp. 474-485 ◽

Cited By ~ 5

Author(s):

Jeffery L Heileson

Keyword(s):

Heart Disease ◽

Randomized Controlled Trials ◽

Observational Studies ◽

Meta Analysis ◽

Saturated Fat ◽

Heart Association ◽

Controlled Trials ◽

Randomized Controlled ◽

Disease Outcomes ◽

Meta Analyses

Abstract The American Heart Association (AHA) recently published a meta-analysis that confirmed their 60-year-old recommendation to limit saturated fat (SFA, saturated fatty acid) and replace it with polyunsaturated fat to reduce the risk of heart disease based on the strength of 4 Core Trials. To assess the evidence for this recommendation, meta-analyses on the effect of SFA consumption on heart disease outcomes were reviewed. Nineteen meta-analyses addressing this topic were identified: 9 observational studies and 10 randomized controlled trials. Meta-analyses of observational studies found no association between SFA intake and heart disease, while meta-analyses of randomized controlled trials were inconsistent but tended to show a lack of an association. The inconsistency seems to have been mediated by the differing clinical trials included. For example, the AHA meta-analysis only included 4 trials (the Core Trials), and those trials contained design and methodological flaws and did not meet all the predefined inclusion criteria. The AHA stance regarding the strength of the evidence for the recommendation to limit SFAs for heart disease prevention may be overstated and in need of reevaluation.

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Pharmacotherapy for acute myocardial infarction

Journal of Korean Medical Association ◽

10.5124/jkma.2021.64.2.139 ◽

2021 ◽

Vol 64 (2) ◽

pp. 139-151

Author(s):

Sung Soo Kim ◽

Hyun Kuk Kim

Keyword(s):

Myocardial Infarction ◽

Acute Myocardial Infarction ◽

Randomized Controlled Trials ◽

Clinical Decision Making ◽

Heart Association ◽

Coronary Intervention ◽

Clinical Decision ◽

Controlled Trials ◽

Randomized Controlled ◽

Consensus Document

Clinical practice guidelines published by the European Society of Cardiology and the American College of Cardiology/ American Heart Association provide recommendations based on evidence, including randomized controlled trials and registry data, for clinicians to enable efficient clinical decision-making and improve prognosis for patients with acute myocardial infarction (AMI). However, there are several differences in practice, health systems, and races between Korea and Western countries; further, many studies on pharmacotherapy were conducted in the prepercutaneous coronary intervention era. An expert consensus document on pharmacotherapy for AMI was recently published following demands for the establishment of Korean guideline reflecting data in the modern percutaneous coronary intervention era. In this review, we summarized AMI guidelines from Europe, America, Japan, and Korea, and analyzed studies on pharmacotherapy for AMI including well-organized randomized controlled trials by Korean researchers and large-sized registry datasets, such as the Korea Acute Myocardial Infarction Registry and the Korean National Health Insurance Service.

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Quality of reporting of cranial irradiation techniques in randomized controlled trials of primary brain tumors: A systematic review

PLoS ONE ◽

10.1371/journal.pone.0241566 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241566

Author(s):

Teng Hwee Tan ◽

Desiree Chen ◽

Yu Yang Soon ◽

Jeremy Chee Seong Tey

Keyword(s):

Brain Tumors ◽

Randomized Controlled Trials ◽

Cranial Irradiation ◽

Controlled Trials ◽

Quality Of Reporting ◽

Primary Brain Tumors ◽

Randomized Controlled ◽

Fractionation Schedule ◽

Adequate Quality

Background To assess the quality of reporting of cranial irradiation (CR) techniques in randomized controlled trials (RCTs) of primary brain tumors. Methods We searched PubMed and EMBASE for RCTs of primary brain tumors, published from January 1999 to November 2019 which included CR as one of the intervention arms. We assessed the initial RCTs report on whether they reported the prespecified ten criteria for CR technique adequately. Multivariable logistic regression was performed to determine the factors that were predictive of adequate quality of reporting. Results We found 85 eligible trial reports. There was significant variability in the quality of reporting among the included studies. Total radiotherapy (RT) dose and fractionation schedule were reported adequately in more than 90% of the included trials. The organs at risk dose constraints, treatment verification procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in less than 30% of included trials. Twenty-three trials (27%) reported seven criteria or more adequately. Multivariable analysis showed that trials conducted by cooperative groups, published RT quality assurance results and having a low risk of bias in the methodological quality have higher odds of having adequate quality in reporting of CR technique (judged as adequate reporting in seven criteria or more). Conclusions The quality of reporting on CR techniques in the RCTs of primary brain tumors is variable and suboptimal. Guidelines should be introduced to improve clarity and ensure consistency in the quality of reporting.

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Evaluation of Risks of Bias in Addiction Medicine Randomized Controlled Trials

Alcohol and Alcoholism ◽

10.1093/alcalc/agaa074 ◽

2020 ◽

Author(s):

Cole Wayant ◽

Daniel Tritz ◽

Jarryd Horn ◽

Matt Crow ◽

Matt Vassar

Keyword(s):

Sensitivity Analysis ◽

High Risk ◽

Randomized Controlled Trials ◽

Risk Of Bias ◽

Controlled Trials ◽

Publicly Funded ◽

Addiction Medicine ◽

Randomized Controlled ◽

Trial Outcomes ◽

Risk Judgments

Abstract Aims Perhaps the most important step when designing and conducting randomized controlled trials (RCTs) in addiction is to put methodological safeguards in place to minimize the likelihood for bias to affect trial outcomes. In this study, we applied the revised Cochrane risk of bias tool (ROB 2) to RCTs of drug, alcohol or tobacco interventions. Methods We searched for trials published in 15 addiction medicine journals over a 7-year period. Our primary endpoint is the risk of bias of included studies. We conducted a sensitivity analysis of publicly funded trials. Results Overall, included RCTs were most often at high risk of bias per our judgments (244/487, 50.1%). However, significant proportions of included RCTs were at low risk of bias (123/487, 25.3%) or some concerns for bias (120/497, 24.6%). RCTs with behavioral modification interventions (19/44, 43.2%) and alcohol interventions (80/150, 53.3%) had the highest proportion of high-risk judgments. In a sensitivity analysis of publicly funded RCTs), 195/386 (50.5%) were at high risk of bias. Conclusions Approximately half of included drug, alcohol or tobacco RCTs in our sample were judged to be at high risk of bias with the most common reason being a lack of proper blinding or proper description of blinding. Key action items to reduce bias in future addiction RCTs include adequate randomization, blinding and inclusion of a trial registry number and protocol.

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Study sponsorship and the nutrition research agenda: analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity

Public Health Nutrition ◽

10.1017/s1368980016003128 ◽

2016 ◽

Vol 20 (7) ◽

pp. 1306-1313 ◽

Cited By ~ 12

Author(s):

Alice Fabbri ◽

Nicholas Chartres ◽

Gyorgy Scrinis ◽

Lisa A Bero

Keyword(s):

Randomized Controlled Trials ◽

Systematic Reviews ◽

Conflicts Of Interest ◽

Controlled Trials ◽

Nutrition Interventions ◽

Research Topics ◽

Randomized Controlled ◽

Funding Sources ◽

Nutrition Research ◽

Cochrane Reviews

AbstractObjectiveTo categorize the research topics covered by a sample of randomized controlled trials (RCT) included in systematic reviews of nutrition interventions to address obesity; to describe their funding sources; and to explore the association between funding sources and nutrition research topics.DesignCross-sectional study.SubjectsRCT included in Cochrane Reviews of nutrition interventions to address obesity and/or overweight.ResultsTwo hundred and thirteen RCT from seventeen Cochrane Reviews were included. Funding source and authors’ conflicts of interest were disclosed in 82·6 and 29·6 % of the studies, respectively. RCT were more likely to test an intervention to manipulate nutrients in the context of reduced energy intake (44·2 % of studies) than food-level (11·3 %) and dietary pattern-level (0·9 %) interventions. Most of the food industry-sponsored studies focused on interventions involving manipulations of specific nutrients (66·7 %). Only 33·1 % of the industry-funded studies addressed dietary behaviours compared with 66·9 % of the non-industry-funded ones (P=0·002). The level of food processing was poorly considered across all funding sources.ConclusionsThe predominance of RCT examining nutrient-specific questions could limit the public health relevance of rigorous evidence available for systematic reviews and dietary guidelines.

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283Endovascular thrombectomy as a means to improve survival in acute ischemic stroke - A meta-analysis

European Heart Journal ◽

10.1093/eurheartj/ehz747.0087 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

Y Lin ◽

V Schulze ◽

M Brockmeyer ◽

C Parco ◽

A Karathanos ◽

...

Keyword(s):

Ischemic Stroke ◽

Randomized Controlled Trials ◽

Acute Ischemic Stroke ◽

Meta Analysis ◽

Intravenous Thrombolysis ◽

Heart Association ◽

Study Data ◽

Controlled Trials ◽

Number Needed To Treat ◽

Randomized Controlled

Abstract Background and purpose Although endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) is guideline-recommended to improve functional recovery, thus far there are only inconclusive data from underpowered singular trials of EVT vs. medical therapy (MT) on mortality. We here aimed to perform a meta-analysis on short-term mortality in guideline-relevant EVT vs. MT randomized controlled trials (RCTs). Methods All randomized controlled trials (RCT) reporting EVT vs. MT in the latest 2018 American Stroke Association/American Heart Association (ASA/AHA) Guidelines were eligible for inclusion. Data were abstracted by two independent investigators and double-checked by four others. Study data were integrated using the Cochran-Mantel-Haenszel method and a random-effects model to compute summary statistics of risk ratios (RR) with 95% confidence intervals (CI). Ninety-day mortality and intracranial hemorrhage (ICH) were analyzed. Results Ten of the twelve guideline-relevant EVT vs. MT RCTs (DAWN, DEFUSE 3, ESCAPE, EXTEND-IA, MR CLEAN, MR RESCUE, REVASCAT, SWIFT PRIME, THERAPY, THRACE) with 2,313 patients were selected for inclusion. Studies IMS III and SYNTHESIS were excluded due to their very infrequent use of EVT. Stent retrievers (Trevo, Solitaire, Merci) were most frequently applied, followed by thrombus aspiration (Penumbra). Intravenous thrombolysis was administered in addition to EVT in the majority of patients. In the pooled meta-analysis of all eligible RCTs, EVT significantly reduced the risk for 90-day mortality by 3.7% compared to MT (15.0% vs. 18.7%; RR 0.81 with CI 0.68 to 0.98; p=0.03), accounting for a number-needed-to-treat of 27 to prevent one all-cause death. Trends were similar in early-window (RR 0.83) and late-window trials only (RR 0.76). There was no difference in the risk for ICH in EVT vs. MT (4.2% vs. 4.0%; RR 1.11 with CI 0.71 to 1.72; p=0.65). All included trials were published in high-quality journals and risk of bias was judged low. Conclusions This meta-analysis lends evidence to EVT benefits for survival already during the first 90 days after acute ischemic stroke. These results further highlight the evolution of interventional techniques in this setting.

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Acupuncture and Related Therapies for Treatment of Postoperative Ileus in Colorectal Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/3178472 ◽

2018 ◽

Vol 2018 ◽

pp. 1-18 ◽

Cited By ~ 3

Author(s):

Yihong Liu ◽

Brian H. May ◽

Anthony Lin Zhang ◽

Xinfeng Guo ◽

Chuanjian Lu ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Randomized Controlled Trials ◽

Postoperative Ileus ◽

Meta Analysis ◽

Abdominal Distension ◽

Controlled Trials ◽

Gastrointestinal Function ◽

Supporting Evidence ◽

Randomized Controlled

Delays in recovery of intestinal function following abdominal surgery are associated with longer hospital stays, increased postoperative complications, and higher costs to the health care system. Studies of acupuncture for postoperative ileus and other postoperative issues have reported improvements. This systematic review and meta-analysis aimed to assess whether acupuncture assisted recovery following surgery for colorectal cancer (CRC). Randomized controlled trials (RCTs) were identified from major English and Chinese language biomedical databases. Participants (aged 18 years plus) had received surgical resection for CRC. 22 studies (1,628 participants) were included. Five were sham-controlled. Outcomes included gastrointestinal function recovery (21 studies), recovery of urinary function (1 study), postoperative abdominal distension (3 studies), and quality of life (1 study). Meta-analyses found significant reductions in time to first bowel sounds, first flatus, and first defecation in both the sham-controlled and nonblinded studies. These results suggested that the addition of acupuncture following CRC surgery improved recovery of gastrointestinal function based on four blinded good quality RCTs (281 participants) and 17 nonblinded lower quality RCTs (1,265 participants). The best available evidence was for interventions that included electroacupuncture at the point ST36 Zusanli and there is supporting evidence for other types of acupuncture therapies that involve stimulation of this point. This review is registered with the following: systematic review registration in PROSPERO: CRD42017079590.

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