ReviewJournal of clinical epidemiology2021
A structured methodology review showed analyses of functional outcomes are frequently limited to "survivors only" in trials enrolling patients at high risk of death.
Review in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 18 citations in OpenAlex.
- Long-term mortality and health-related quality of life with lower versus higher oxygenation targets in intensive care unit patients with COVID-19 and severe hypoxaemia.Intensive care medicine · 2024Trial
- Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial.The Lancet. Respiratory medicine · 2024Trial
- Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium.Intensive care medicine · 2024Trial
- Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia.Intensive care medicine · 2022Trial
- Electronic Patient-Reported Health-Related Quality of Life Trajectories in ICU Survivors: A Multicentre Pilot Study-Within-a-Trial Protocol.Acta anaesthesiologica Scandinavica · 2026Article
- Comparative effectiveness of single-stage versus two-stage revision for hip prosthetic joint infection: emulation of the INFORM target trial using electronic health record data.Archives of orthopaedic and trauma surgery · 2026Observational
- Long-Term Morbidity Associated With Non-COVID-19 Pneumonia in Patients Receiving Mechanical Ventilation.CHEST critical care · 2025Article
- Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveThis 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
settingUsing 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").
resultsOf 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%]).
conclusionIn 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.