As in therapeutic associations, randomized trials are better suited to establish the preventable harm association when the risk of harm is moderate to high and the association small (when multiple contributing factors exist and noise and bias are of similar size as the signal or effect being detected).
The panel held that the plaintiff established the likelihood that irreparable harm would result if an injunction did not issue because she was subject to death threats and took action as soon as she began receiving the threats.
Although further studies need to establish the benefit-harm balance of ASA compared with VKA and the new oral anticoagulants, ASA use for secondary prevention of recurrent VTE may be valuable in patients with arterial disease who are at low to moderate risk of recurrent VTE.
Some suggest that this issue of disclosure is the Pentagon Papers redux -- that unless some real and imminent threat can be established, the First Amendment trumps hypothetical harm -- no matter how likely it is to occur, thus requiring full disclosure.
But evidence of harm may be insufficiently established, the judge said, "based on questionable and scientifically incomplete studies that may not have included minors".
In addition to the need for more research, a preventive public health response requires mitigation of exposures to potential neurodevelopmental toxicants when available evidence establishes the plausibility of harm, despite residual toxicologic uncertainties.
For causes weakly associated with harm (e.g., low quality handoffs among trainees), studies with rigorous protection against bias (e.g., randomized trials) would be needed to establish that harm is indeed preventable by affecting a specific causal pathway (e.g., improved communication tools to enhance resident handoff).
However, as establishing the nature and degree of harm is a notoriously subjective process, it is difficult to develop precise thresholds for what constitutes harm or otherwise, not least as the type and severity of harm depends on the nature of the target.
Even when clear definitions of harms are established before the study, harm rates may be underestimated [14].
Even when clear definitions of harms are established before the study, harm rates may be underestimated [ 14].
