Postrandomization Confounding Challenges the Applicability of Randomized Clinical Trials in Comparative Effectiveness Research
نویسندگان
چکیده
whAt Is the PRoBleM? Different from trials for regulatory approvals of new interventions aimed to test the efficacy, comparative effectiveness research (CER) is the direct comparison of existing health‐care interventions (compared with active controls) to examine which treatment works best, for whom, and under what settings.[1] Therefore, CER is indispensable to assist consumers, clinicians, purchasers, and policy makers to make evidence‐based decisions. Actually, an obvious uprising tendency of CER after 2004 was displayed and a majority of CER was performed by randomized clinical trials (RCTs) with active controlled interventions.
منابع مشابه
Challenges in the Design, Conduct, Analysis, and Reporting of Randomized Clinical Trial Studies in Iran: A Qualitative Study
Background and Objectives: Randomized clinical trials are the gold standard for evaluating the effectiveness and safety of medical interventions. Some unpredictable challenges may affect the results of these studies. Therefore, the aim of this study was to identify the challenges of clinical trial studies in different stages including design, conduct, analysis, and reporting. Methods: This ...
متن کاملManagement of Asthma and Chronic Obstructive Pulmonary Disease with Combination Inhaled Corticosteroids and Long-Acting β-Agonists: A Review of Comparative Effectiveness Research
The value of combination therapy with inhaled corticosteroids and long-acting β-agonists (ICS/LABA) is well recognized in the management of asthma and chronic obstructive pulmonary disease (COPD). Despite differences in the pharmacological properties between two well-established ICS/LABA products (budesonide/formoterol and fluticasone/salmeterol), data from randomized clinical trials (RCTs) and...
متن کاملNetwork meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities
Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-...
متن کاملComparative Effectiveness Research in Pediatric Infectious Diseases.
Comparative-effectiveness research (CER) is a hot topic. There are several definitions for CER, but the Institute ofMedicine defines CER as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat andmonitor a clinical condition or to improve the delivery of care” [1]. Comparative-effectiveness research focuses more on eff...
متن کاملEthical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems
Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical chal...
متن کامل