Journal of comparative effectiveness research
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Clinical trial designs often fail to deliver data that jointly satisfy evolving demands of both regulatory and reimbursement authorities. We propose a new multi-tiered trial design to integrate efficacy and effectiveness, and address the evolving needs of authorities. ⋯ Trial arms may be staggered over time to reflect the current state of randomized and non-randomized data of the experimental drug, and thereby still prioritize safety. At the same time, the mixed randomized trial allows for the collection of real-world data in a randomized setting, and thereby reduces selection bias.
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The availability of routinely collected health data, such as health administrative data, electronic health records, prescription records and disease registries, has increased in the information age. This has led to an explosion of reports of comparativeness effectiveness research using such data. ⋯ The Journal of Comparative Effectiveness Research has endorsed these guidelines. In this commentary, the RECORD checklist is reprinted and members of the RECORD working committee reflect on the importance of these reporting guidelines for the field of comparative effectiveness research.
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To compare the effectiveness of primary percutaneous coronary intervention (pPCI) and fibrinolytic therapy (FL) for the acute management of ST elevation myocardial infarction (STEMI). ⋯ pPCI is the preferred treatment strategy for STEMI. However, FL with subsequent percutaneous coronary intervention remains a viable option for those in rural areas.
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This systematic review identifies possible decision aids that promote perioperative advance care planning (ACP) and synthesizes the available evidence regarding their use. Using PubMed, EMBASE, Cochrane, SCOPUS, Web of Science, CINAHL, PsycINFO and Sociological Abstracts, researchers identified and screened articles for eligibility. Data were abstracted and risk of bias assessed for included articles. ⋯ Fifty unique outcomes were reported with no head-to-head comparisons conducted. Findings are likely generalizable to a perioperative population and can inform development of a perioperative ACP decision aid. Future studies should compare the effectiveness of ACP decision aids.