Replicating cardiovascular outcome trials of medications used to treat type 2 diabetes using real-world data: A systematic review of observational studies
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Background: Cardiovascular outcome trials (CVOTs) are mandated by the U.S. Food and Drug Administration to assess the cardiovascular safety of new antidiabetic medications before entering the market. However, CVOTs often involve highly selective populations and results may not generalize to real-world settings. Methods: Our study aimed to synthesize observational studies to assess the generalizability of CVOTs to real-world settings. We systematically reviewed observational studies that emulated previous CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and sodium glucose cotransporter-2 (SGLT-2) inhibitors among patients with type 2 diabetes. We searched the MEDLINE, EMBASE and Cochrane databases for observational studies that focused on trial emulation or cross-sectional studies that reported the proportion of real-world patients eligible for completed CVOTs. Two independent reviewers screened articles, extracted data, and assessed study concordance with randomized controlled trial (RCT) results. Results: Nineteen studies were included in our systematic review, including four cohort studies that emulated previous RCTs and 15 cross-sectional studies that evaluated trial eligibility. Results between RCTs and real-world data (RWD) were concordant for all drug classes in finding non-inferiority. The median eligibility percentage ranged from 13% to 31% for SGLT-2 inhibitor trials and 12% to 43% for GLP-1 receptor agonist trials. Conclusions: These results suggest that, while RCTs and RWD are concordant in their estimates, the trials lack representativeness. More research is needed on the replication of CVOTs using RWD to understand how different replication methods may impact findings.Many questions in human health research can only be answered with observational studies. In contrast to controlled experiments or well-planned, experimental randomized clinical trials, observational studies are subject to a number of potential problems that may bias their results.Some of the more important problems affecting observational studies are described and illustrated by examples. Additional information is provided with reference to a selection of the literature.Factors that may bias the results of observational studies can be broadly categorized as: selection bias resulting from the way study subjects are recruited or from differing rates of study participation depending on the subjects' cultural background, age, or socioeconomic status, information bias, measurement error, confounders, and further factors.Observational studies make an important contribution to medical knowledge. The main methodological problems can be avoided by careful study planning. An understanding of the potential pitfalls is important in order to critically assess relevant publications.
Information bias
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72 preschoolers and 72 school children observed the original discrimination of nonreversal shift (NRS) followed by 14 NRS trials by themselves. The observational trials were 10 or 30 in each age group. The correct (_??_) or incorrect (×) responses on the 1st (unchanged pair) and the 2nd (changed pair) trials of NRS were mainly measured. In preschoolers, both dependent observational-learning mode (_??_-× responses: DOL) and independent observational-learning mode (_??_-_??_ and ×-×: IOL) were found, but no observational-trial effects on the modes were found. In school children, DOL occurred significantly more than IOL in both groups, and the observational-trial effect was also found. Subproblem analyses suggested that the _??_-× responses were indeed the “dependent” mode rather than the “independent” one.
Observational learning
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Observational methods such as OW AS. RULA. and REBA have been widely used to identify posture-related risks of musculoskeletal disorders in industry, since they are useful and efficient in evaluating postural stresses. However. there are few studies comparing the methods and providing guidelines for selecting and using the methods. They have been developed based on different backgrounds and with different application areas. Each method has its own characteristics. which must be considered in selecting and using them. In this study. 17 male subjects evaluated 42 different working postures that frequently assumed in the automobile assembly line using a psychophysical method. The postures were then evaluated by different observational methods. The results of the observational methods were compared with psychophysically evaluated stresses. The observational methods resulted in different values of stresses for certain postures. For some postures showing high values of perceived discomfort. the observational methods showed different values of stresses. These results showed that the observational methods should be used differently according to application area and they have some weak points to be improved.
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The purposes of this study were to develop and implement an observational training program and to assess the effects of a video observational training program on video and live observational proficiency. Physical education majors took a pretest in both a video and a live environment to assess observational proficiency. The task was observing children batting and answering questions regarding the critical features of the movement. The students were then placed into either a treatment ( n = 12) or a control ( n = 11) group. There were no differences between groups on either assessment ( p > .05). The treatment group then participated in a video observational training program. After the training, all subjects took a posttest in each environment to assess observational proficiency. The training was found to be effective in improving video observational proficiency ( p < .05) but not live observational proficiency ( p > .05). These results provide support for the effectiveness of video observational training in developing video observational proficiency but not live observational proficiency.
Observational learning
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The Quasi-purchase system of research outcome is a research funds' system based upon research outcome. The thesis analyses the characteristics of research outcomes' honour under the quasi-purchase system of research outcome. It researches the evaluation of the follow-up impact of the honoured outcome. And make a greater impact on the honoured outcome for incentives and penalties for false results of the proposal.
Honour
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Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.
Causality
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The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.
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