This method takes into account the quality of evidence, the balance between benefits versus harms, endpoint relevance, and costs.
However, it will consider stopping for harm if the primary endpoint occurs significantly more often in the access arm with P < 0.01 or if mortality is significantly higher in the access arm with P < 0.05.
Abandon Treatment Platform: Harm (in efficacy or safety endpoints).
This review concentrated on dichotomous outcomes reflecting clinically relevant endpoints of efficacy and harm, and included four atypical antipsychotics over the short, medium, and long term, with trials included if they were published up to December 2006.
This allows for the same robust estimate of the treatment effect and harmful effects as in aggregated data meta-analysis, only now more flexibility is possible regarding the choice of endpoints, subgroups and potential harms.
The experimental procedures were designed to minimize the extent and duration of any harm and included predefined clinical and parasitological endpoints to avoid unnecessary suffering.
Under these circumstances, even if the two lines in Figure 1 were superimposed, acceptance of the potential surrogate endpoint could still lead to harm.
Again, different diets also can have an impact ranging from moderate to severe lasting harm, and a generally accepted objective humane endpoint that were previously widely used in various experimental animal models is loss in body weight [ 202- 206].
Main endpoint: 1) Proportion of articles reporting harm in the abstract; and 2) Proportion of articles that reported harm in the abstract when harm was reported in the main body of the article.
As the purpose of this review was to inform clinical practice, endpoints unequivocally associated with patient benefit or harm were emphasized, as were RCTs of sufficient power to assess these.
