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We believe that the situation of equipoise prevailing now is different from that prevailing before the publication of the two RCTS on ICU patients and the combined analysis made here.
In an equivalence study there is a-priory a situation of equipoise with respect to the efficacy of two drugs.
Additionally a situation of equipoise currently exists, whereby clinicians can see the potential benefits of ECMO, but do not have enough evidence to make an informed choice as to the best treatment for their patient.
In very early times of clinical trials some people argued that in the situation of equipoise the informed consent of the patient may weaken the scientific rigor of the trial because of potentially biased samples, early dropouts, patients' knowledge about possible side effects, and so on.
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A situation of clinical equipoise is especially difficult to achieve in placebo-controlled clinical trials, and also when a new drug under development is compared with a commercialized drug.
In situations of clinical equipoise, also known as preference-sensitive decisions, it is widely argued that individual patient preferences [ 7] should become the guiding principle for patients making informed decisions together with their healthcare providers [ 8].
The authors suggest a revision of informed consent doctrine, and propose shared decision-making as a prerequisite and adjunct to the informed consent process between provider and patient for preference-sensitive care or situations of clinical equipoise.
RCTs require a setting of equipoise, a situation where both patients and clinicians feel a genuine conscious uncertainty as to the optimal management strategy.
Eligibility criteria will differ from site to site, according to local perceptions of equipoise.
It should be noted that the ethics of equipoise predominantly focus on the situations when the patient is already considered for enrollment in a RCT: discussion about alternative courses of actions depicted in the rest of Figure 1 rarely occurs [ 39, 44- 46].
It is a wonder that he can sustain that sort of equipoise.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com