AI Article Synopsis
- The review analyzed statistical methods used in randomized controlled trials (RCTs) involving high-risk patients and offered recommendations for future reporting.
- A search through PubMed found 434 eligible RCTs, revealing that a significant percentage of these focused on analyzing treatment effects among "survivors only."
- The analysis highlighted the potential for misleading conclusions when focusing only on survivors and called for improved standards in reporting RCTs, especially in light of recent trials related to COVID-19 and critical illness.
Article Abstract
Objective: This structured methodology review evaluated statistical approaches used in randomized controlled trials (RCTs) enrolling patients at high risk of death and makes recommendations for reporting future RCTs.
Study Design And Setting: Using PubMed, we searched for RCTs published in five general medicine journals from January 2014 to August 2019 wherein mortality was ≥10% in at least one randomized group. We abstracted primary and secondary outcomes, statistical analysis methods, and patient samples evaluated (all randomized patients vs. "survivors only").
Results: Of 1947 RCTs identified, 434 met eligibility criteria. Of the eligible RCTs, 91 (21%) and 351 (81%) had a primary or secondary functional outcome, respectively, of which 36 (40%) and 263 (75%) evaluated treatment effects among "survivors only". In RCTs that analyzed all randomized patients, the most common methods included use of ordinal outcomes (e.g., modified Rankin Scale) or creating composite outcomes (primary: 41 of 91 [45%]; secondary: 57 of 351 [16%]).
Conclusion: In RCTs enrolling patients at high risk of death, statistical analyses of functional outcomes are frequently conducted among "survivors only," for which conclusions might be misleading. Given the growing number of RCTs conducted among patients hospitalized with COVID-19 and other critical illnesses, standards for reporting should be created.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8464482 | PMC |
| http://dx.doi.org/10.1016/j.jclinepi.2021.03.027 | DOI Listing |
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