Series: Pragmatic trials and real world evidence: Paper 4. Informed consent
نویسندگان
چکیده
منابع مشابه
Informed consent for pragmatic trials--the integrated consent model.
Learning health care systems hold great promise for improving medical care by systematically integrating the delivery of medical services with clinical research. In such systems, the generation of knowledge would be “embedded into the core of the practice of medicine,” leading to “continual improvement in care.”1 But is the goal of systematically integrating knowledge generation with health car...
متن کاملPatients’ beliefs regarding informed consent for low-risk pragmatic trials
BACKGROUND The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-ris...
متن کاملAcupuncture trials and informed consent.
Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informe...
متن کاملReal-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?
INTRODUCTION Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. Explanatory and pragmatic are the extremes of a continuum. This d...
متن کاملPublic preferences on written informed consent for low‐risk pragmatic clinical trials in Spain
AIMS Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study wa...
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ژورنال
عنوان ژورنال: Journal of Clinical Epidemiology
سال: 2017
ISSN: 0895-4356
DOI: 10.1016/j.jclinepi.2017.03.019