Evidence map›Paper›PMID 35900186›Full record

ArticleJournal of the National Cancer Institute2022

Listening to the Patient Voice Adds Value to Cancer Clinical Trials.

Michael D Brundage, Norah L Crossnohere, Jennifer O'Donnell, Samantha Cruz Rivera, Roger Wilson, Albert W Wu, David Moher, Derek Kyte, Bryce B Reeve, Alexandra Gilbert and 3 more

Abstract readEditorialComment
In one paragraph

Article in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. Emerging Ethical Challenges in Manufacturing of Cell-Based Medicines.Advances in experimental medicine and biology · 2025
    Review
  14. Review
  15. Article
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  17. Assessment tools for patient-reported outcomes in multiple myeloma.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
  18. Article
  19. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Michael D BrundageQueen's University Cancer Research Institute, Cancer Care and Epidemiology, Kingston, ON, Canada.ORCID 0000-0002-5104-0497
Norah L CrossnohereDepartment of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH, USA.ORCID 0000-0002-2811-1330
Jennifer O'DonnellQueen's University Cancer Research Institute, Cancer Care and Epidemiology, Kingston, ON, Canada.
Samantha Cruz RiveraCentre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Roger WilsonNCRI Consumer Forum National Cancer Research Institute, London, UK.
Albert W WuJohns Hopkins Bloomberg School of Public Health and School of Medicine, Baltimore, MD, USA.
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Derek KyteCentre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Bryce B ReeveCenter for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
Alexandra GilbertLeeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.
Ronald C ChenDepartment of Radiation Oncology, University of Kansas Medical Center, Kansas City, KS, USA.
Melanie J CalvertCentre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Claire SnyderJohns Hopkins Bloomberg School of Public Health and School of Medicine, Baltimore, MD, USA.

Funding

Cancer Research UK 28301Cancer Research UK 28832
6 · The paper itself

Abstract

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials.

Indexed as

NeoplasmsPatient Reported Outcome MeasuresDrug DevelopmentHealth PolicyHumans

Identifiers

PMID35900186
PMCPMC9552306

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.