What question did this study set out to answer?

Characterize how contemporary randomized clinical trials in adult intensive care unit (ICU) patients select, define, and statistically analyze patient-important outcomes other than mortality.

July 27, 2022Critical Care Medicine

Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review

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Why the study?

Contemporary adult ICU trials increasingly report patient-important outcomes other than mortality, introducing challenges with outcome definitions, handling of deceased patients, missing data, and statistical methods.

Key Points

Characterize how contemporary randomized clinical trials in adult intensive care unit (ICU) patients select, define, and statistically analyze patient-important outcomes other than mortality.
Systematic search of 10 selected journals for randomized clinical trials conducted primarily in adult ICU patients published between January 1, 2018, and May 5, 2022.
Dual, independent screening and data extraction of trials reporting at least one non-mortality patient-important outcome, including 'days alive without' measures, functional/cognitive/neurologic outcomes, and health-related quality of life.
Evaluated 687 outcomes across 167 trials, finding that 32% of trials used a non-mortality patient-important outcome as a primary or co-primary endpoint, led by 'days alive without' metrics.
Deceased patients were excluded and analyses restricted to survivors only in 62% of functional/cognitive/neurologic outcomes (103 distinct outcomes) and 89% of health-related quality of life outcomes (29 distinct outcomes), both of which suffered from higher missing data rates.
Analyses relied primarily on nonparametric tests (31%), linear regression/t tests (27%), chi-square-like tests (12%), and proportional odds logistic regression (9%), with 38% failing to report actual treatment effect size estimates.

Structured PICO

Population

167 RCTs (reporting 687 outcomes) conducted primarily in adult ICU patients published between 1 January 2018 and 5 May 2022

Outcome

Handling of patient-important outcomes other than mortality (outcome choices/definitions, handling of deceased patients and missing data, choices of effect measures and statistical methods)

There is substantial variation and suboptimal methodological choices in how contemporary ICU trials handle and report patient-important outcomes other than mortality.

Discussion

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Implication

Inconsistent handling of outcomes, death, and missing data in ICU RCTs warrants interpretive caution; leaves open need for standardized methods.

Cite This Study

Granholm et al. (2022) studied this question.

synapsesocial.com/papers/6a72b7063ce530166bc35df1 https://doi.org/10.1097/ccm.0000000000005637

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Implication

Inconsistent handling of outcomes, death, and missing data in ICU RCTs warrants interpretive caution; leaves open need for standardized methods.

Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Patient-Important Outcomes Other Than Mortality in Contemporary ICU Trials: A Scoping Review

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Also Consider