Evidence map›Paper›PMID 38807143›Full record

SynthesisCritical care (London, England)2024

Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review.

Humphrey G M Walker, Alastair J Brown, Ines P Vaz, Rebecca Reed, Max A Schofield, Jeffrey Shao, Vinodh B Nanjayya, Andrew A Udy, Toby Jeffcote

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Critical care (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Humphrey G M Walker *Department of Critical Care, St Vincent's Hospital, Melbourne, VIC, Australia. hgmwalker@me.com.
Alastair J Brown *Department of Critical Care, St Vincent's Hospital, Melbourne, VIC, Australia.
Ines P VazDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.
Rebecca ReedDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.
Max A SchofieldDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.
Jeffrey ShaoMonash University, Melbourne, VIC, Australia.
Vinodh B NanjayyaDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.
Andrew A UdyDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.
Toby JeffcoteDepartment of Intensive Care and Hyperbaric Medicine, The Alfred Hospital, Melbourne, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of composite outcome measures (COM) in clinical trials is increasing. Whilst their use is associated with benefits, several limitations have been highlighted and there is limited literature exploring their use within critical care. The primary aim of this study was to evaluate the use of COM in high-impact critical care trials, and compare study parameters (including sample size, statistical significance, and consistency of effect estimates) in trials using composite versus non-composite outcomes.

methodsA systematic review of 16 high-impact journals was conducted. Randomised controlled trials published between 2012 and 2022 reporting a patient important outcome and involving critical care patients, were included.

results8271 trials were screened, and 194 included. 39.1% of all trials used a COM and this increased over time. Of those using a COM, only 52.6% explicitly described the outcome as composite. The median number of components was 2 (IQR 2-3). Trials using a COM recruited fewer participants (409 (198.8-851.5) vs 584 (300-1566, p = 0.004), and their use was not associated with increased rates of statistical significance (19.7% vs 17.8%, p = 0.380). Predicted effect sizes were overestimated in all but 6 trials. For studies using a COM the effect estimates were consistent across all components in 43.4% of trials. 93% of COM included components that were not patient important.

conclusionsCOM are increasingly used in critical care trials; however effect estimates are frequently inconsistent across COM components confounding outcome interpretations. The use of COM was associated with smaller sample sizes, and no increased likelihood of statistically significant results. Many of the limitations inherent to the use of COM are relevant to critical care research.

Indexed as

Critical CareOutcome Assessment, Health CareRandomized Controlled Trials as TopicHumansJournal Impact FactorCritical careCritical care outcomesOutcome assessmentRandomized controlled trials as topic

Identifiers

PMID38807143
PMCPMC11134769

What OpenQuestion holds

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Registered trials

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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.