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Discussion

Different approaches are available for defining a treatment effect on a functional outcome that is “truncated due to death.” We have focused attention on the perspective of the regulator—that is, on advantages and disadvantages of the approaches within the context of principled design and analysis of randomized controlled trials. However, the ability of clinicians to interpret and communicate the potential benefits of interventions to patients may require different considerations. In the setting of severely ill patients, what potential benefits of the interventions are most relevant to the patient? Knowing the average benefit of an intervention among survivors is important; however, the clinician must also advise on characteristics of those who survive. Communicating the SACE to patients offers unique challenges to the clinician. Even if the treatment shows benefit among the always survivors, the clinician does not have the ability to identify whether a specific patient is in this group but could provide information on the distribution of always survivors and mortality benefiters under certain assumptions.

The composite endpoint approach offers the unique ability to provide useful thresholds to patients—for example, in scenario 2, 50% of patients receiving control survive past 72 days, whereas 50% of patients receiving intervention survive to 12 months with cognition scores greater than 54 (above the population norm of 50). However, the composite endpoint approach relies on the ability to order mortality and the functional outcome, which requires extensive input from clinicians and patients before conducting a randomized controlled trial. Studies examining the values and preferences of severely ill patients suggest that some patients consider severe cognitive impairment as a state worse than death 20 ; however, more research is needed to rigorously rank mortality and functional outcomes according to patient values and preferences. We have described in detail the composite endpoint approach proposed by Lachin, yet other composite endpoint approaches exist (eg, the Glasgow outcome scale has been used in randomized controlled trials of patients with serious neurological illness, 21 and quality adjusted life years (QALYs) 22 have been used in critical care trials) with similar challenges to those described above.

We have highlighted that there is no perfect choice among the three statistical approaches for defining a treatment effect when functional outcomes are “truncated due to death.” The choice should be driven by expected effects of the intervention and by the target patient population. Keeping this in mind, we make two recommendations for planning a randomized trial among patients with a high risk of death. First, when it is biologically unlikely for treatment assignment to impact mortality, the survivors analysis provides an unbiased estimate of the effect of treatment on the functional outcome and can be used. Second, when patient mortality is the primary outcome and is hypothesized to differ across treatment groups, the survivors analysis may produce misleading results. This would be the case if the intervention promoted survival among patients with greater morbidity than the always survivors. In such studies, alternatives to the survivors analysis should be considered. If mortality and functional outcomes can be ordered, we recommend the composite endpoint approach over the SACE approach in such settings. While SACE defines a causal effect, the assumptions required to estimate the SACE are restrictive and untestable from the observed data.

Footnotes

Contributors: EC, DOS, DMN, and TDG conceived the study, designed the study, drafted the manuscript, or critically revised the manuscript for important intellectual content. EC, AL, CW, and MDH acquired, analyzed, or interpreted the data. All authors gave final approval of the version to be published and are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. EC and TDG are the guarantors.

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