Evidence map›Paper›PMID 37445406›Full record

ReviewJournal of clinical medicine2023

Making Sense of Composite Endpoints in Clinical Research.

Daniela Baracaldo-Santamaría, John Edwin Feliciano-Alfonso, Raul Ramirez-Grueso, Luis Carlos Rojas-Rodríguez, Camilo Alberto Dominguez-Dominguez, Carlos Alberto Calderon-Ospina

Abstract readReview
In one paragraph

Review in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing 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

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

  1. Cough, dyspnea, or chest pain? an examination of the composite endpoint in metastatic non-small cell lung cancer clinical trials.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Letter to the Editor concerning "Development of machine learning models for predicting patient-perceived benefit following lumbar disc herniation or spinal stenosis surgery" by Z.A. Toh, et al. (Eur Spine J [2025]; doi:10.1007/s00586-025-09304-y).European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025
    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

6 authors.

Daniela Baracaldo-SantamaríaPharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá 111221, Colombia.ORCID 0000-0002-1285-456X
John Edwin Feliciano-AlfonsoSchool of Medicine, Universidad El Bosque, Bogotá 110121, Colombia.
Raul Ramirez-GruesoPharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá 111221, Colombia.
Luis Carlos Rojas-RodríguezPharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá 111221, Colombia.ORCID 0000-0002-9989-6980
Camilo Alberto Dominguez-DominguezSchool of Medicine and Health Sciences, Universidad del Rosario, Bogotá 111221, Colombia.
Carlos Alberto Calderon-OspinaPharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá 111221, Colombia.ORCID 0000-0002-7305-8727

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Multiple drugs currently used in clinical practice have been approved by regulatory agencies based on studies that utilize composite endpoints. Composite endpoints are appealing because they reduce sample size requirements, follow-up periods, and costs. However, interpreting composite endpoints can be challenging, and their misuse is not uncommon. Incorrect interpretation of composite outcomes can lead to misleading conclusions that impact patient care. To correctly interpret composite outcomes, several important questions should be considered. Are the individual components of the composite outcome equally important to patients? Did the more and less important endpoints occur with similar frequency? Do the component endpoints exhibit similar relative risk reductions? If these questions receive affirmative answers, the use and interpretation of the composite endpoint would be appropriate. However, if any component of the composite endpoint fails to satisfy the aforementioned criteria, interpretation can become difficult, necessitating additional steps. Regulatory agencies acknowledge these challenges and have specific considerations when approving drugs based on studies employing composite endpoints. In conclusion, composite endpoints are valuable tools for evaluating the efficacy and net clinical benefit of interventions; however, cautious interpretation is advised.

Indexed as

data interpretationendpoint determinationoutcome assessmentrandomized controlled trialstreatment outcome

Identifiers

PMID37445406
PMCPMC10342974

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.