Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis

Objective To investigate whether discrepancies in trials of use of bone marrow stem cells in patients with heart disease account for the variation in reported effect size in improvement of left ventricular function. Design Identification and counting of factual discrepancies in trial reports, and sample size weighted regression against therapeutic effect size. Meta-analysis of trials that provided sufficient information. Data sources PubMed and Embase from inception to April 2013. Eligibility for selecting studies Randomised controlled trials evaluating the effect of autologous bone marrow stem cells for heart disease on mean left ventricular ejection fraction. Results There were over 600 discrepancies in 133 reports from 49 trials. There was a significant association between the number of discrepancies and the reported increment in EF with bone marrow stem cell therapy (Spearman’s r=0.4, P=0.005). Trials with no discrepancies were a small minority (five trials) and showed a mean EF effect size of −0.4%. The 24 trials with 1-10 discrepancies showed a mean effect size of 2.1%. The 12 with 11-20 discrepancies showed a mean effect of size 3.0%. The three with 21-30 discrepancies showed a mean effect size of 5.7%. The high discrepancy group, comprising five trials with over 30 discrepancies each, showed a mean effect size of 7.7%. Conclusions Avoiding discrepancies is difficult but is important because discrepancy count is related to effect size. The mechanism is unknown but should be explored in the design of future trials because in the five trials without discrepancies the effect of bone marrow stem cell therapy on ejection fraction is zero

Electromagnetic Wave Theory and Remote Sensing

Contains reports on six research projects.Joint Services Electronics Program (Contract DAAG29-80-C-0104)National Science Foundation (Grant ENG78-23145)National Science Foundation (Grant ECS82-03390)Schlumberger-Doll Research CenterNational Aeronautics and Space Administration (Contract NAG 5-141)National Aeronautics and Space Administration (Contract NAS5-26861)National Aeronautics and Space Administration (Contract NAG5-270

Automated Assessment of Image Quality in 2D Echocardiography Using Deep Learning

Echocardiography is the most used modality for assessing cardiac functions. The reliability of the echocardiographic measurements, however, depends on the quality of the images. Currently, the method of image quality assessment is a subjective process, where an echocardiography specialist visually inspects the images. An automated image quality assessment system is thus required. Here, we have reported on the feasibility of using deep learning for developing such automated quality scoring systems. A scoring system was proposed to include specific quality attributes for on-axis, contrast/gain and left ventricular (LV) foreshortening of the apical view. We prepared and used 1,039 echocardiographic patient datasets for model development and testing. Average accuracy of at least 86% was obtained with computation speed at 0.013ms per frame which indicated the feasibility for real-time deployment

Doppler assessment of aortic stenosis: a 25-operator study demonstrating why reading the peak velocity is superior to velocity time integral

Aims Measurements with superior reproducibility are useful clinically and research purposes. Previous reproducibility studies of Doppler assessment of aortic stenosis (AS) have compared only a pair of observers and have not explored the mechanism by which disagreement between operators occurs. Using custom-designed software which stored operators’ traces, we investigated the reproducibility of peak and velocity time integral (VTI) measurements across a much larger group of operators and explored the mechanisms by which disagreement arose. Methods and results Twenty-five observers reviewed continuous wave (CW) aortic valve (AV) and pulsed wave (PW) left ventricular outflow tract (LVOT) Doppler traces from 20 sequential cases of AS in random order. Each operator unknowingly measured each peak velocity and VTI twice. VTI tracings were stored for comparison. Measuring the peak is much more reproducible than VTI for both PW (coefficient of variation 10.1 vs. 18.0%; P < 0.001) and CW traces (coefficient of variation 4.0 vs. 10.2%; P < 0.001). VTI is inferior because the steep early and late parts of the envelope are difficult to trace reproducibly. Dimensionless index improves reproducibility because operators tended to consistently over-read or under-read on LVOT and AV traces from the same patient (coefficient of variation 9.3 vs. 17.1%; P < 0.001). Conclusion It is far more reproducible to measure the peak of a Doppler trace than the VTI, a strategy that reduces measurement variance by approximately six-fold. Peak measurements are superior to VTI because tracing the steep slopes in the early and late part of the VTI envelope is difficult to achieve reproducibly

Difficulty in detecting discrepancies in a clinical trial report: 260-reader evaluation

Background: Scientific literature can contain errors. Discrepancies, defined as two or more statements or results that cannot both be true, may be a signal of problems with a trial report. In this study, we report how many discrepancies are detected by a large panel of readers examining a trial report containing a large number of discrepancies. Methods: We approached a convenience sample of 343 journal readers in seven countries, and invited them in person to participate in a study. They were asked to examine the tables and figures of one published article for discrepancies. 260 participants agreed, ranging from medical students to professors. The discrepancies they identified were tabulated and counted. There were 39 different discrepancies identified. We evaluated the probability of discrepancy identification, and whether more time spent or greater participant experience as academic authors improved the ability to detect discrepancies. Results: Overall, 95.3% of discrepancies were missed. Most participants (62%) were unable to find any discrepancies. Only 11.5% noticed more than 10% of the discrepancies. More discrepancies were noted by participants who spent more time on the task (Spearman’s ρ = 0.22, P < 0.01), and those with more experience of publishing papers (Spearman’s ρ = 0.13 with number of publications, P = 0.04). Conclusions: Noticing discrepancies is difficult. Most readers miss most discrepancies even when asked specifically to look for them. The probability of a discrepancy evading an individual sensitized reader is 95%, making it important that, when problems are identified after publication, readers are able to communicate with each other. When made aware of discrepancies, the majority of readers support editorial action to correct the scientific record

Electromagnetic Wave Theory and Remote Sensing

Contains reports on seven research projects.Joint Services Electronics Program (Contract DAAG29-80-C-0104)National Science Foundation (Grant ENG 78-23145)Schlumberger-Doll Research CenterU.S. Air Force - Hanscom (Contract F19628-80-C-0052)National Aeronautics and Space Administration (Grant NAG5-16)Draper Laboratory (Contract DL-H-182642)National Aeornautics and Space Administration (Contract NAG5-141

Electromagnetic Wave Theory and Remote Sensing

Contains reports on seven research projects.Joint Services Electronics Program (Contract DAAG29-83-K-0003)National Science Foundation (Grant ECS82-03390)Schlumberger-Doll Research CenterNational Aeronautics and Space Administration (Contract NAG5-141)National Aeronautics and Space Administration (Contract NAS5-26861)National Aeronautics and Space Administration (Contract NAG5-270)U.S. Navy - Office of Naval Research (Contract N00014-83-K-0258