Sham Surgery and Reasonable Risk

نویسنده

  • Alex John London
چکیده

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Ethical Aspects of Placebo (“sham”) Surgery

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Sham Surgery and Reasonable Risks

O of the most fundamental tensions within clinical research arises from the need to balance the goal of advancing the frontiers of science in order to improve the standard of care available to future persons with the goal of responding with diligence and compassion to the important interests and health needs of the research participants who make such progress possible (Jonas 1969; see also Lond...

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What is the risk of sham surgery in Parkinson disease clinical trials? A review of published reports.

Placebo, or sham surgery, as a control condition in surgical clinical trials in Parkinson disease (PD) remains controversial. The authors reviewed the adverse effects reported in double blind, placebo surgery controlled trials for PD. Placebo surgeries were generally safe and well tolerated but the number of subjects receiving the procedure was small. Harm occurred more frequently in subjects r...

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Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial.

BACKGROUND Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery. METHODS Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a...

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Sham surgery controls are

Debate continues about the ethics of sham surgery controls. The most powerful argument for sham surgery controls is that rigorous experiments are needed to demonstrate safety and efficacy of surgical procedures. Without such experiments, there is danger of adopting worthless procedures in clinical practice. Opponents of sham surgery controls argue that sham surgery constitutes unacceptable viol...

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تاریخ انتشار 2015