Evidence map›Paper›PMID 39989038›Full record

ArticleJournal of the National Cancer Institute. Monographs2025

Best practices and pragmatic approaches for patient-reported outcomes and quality of life measures in cancer clinical trials.

Hanna Bandos, Pedro A Torres-Saavedra, Eva Culakova, Heather J Gunn, Minji K Lee, Fenghai Duan, Reena S Cecchini, Joseph M Unger, Amylou C Dueck, Jon A Steingrimsson

Abstract read
In one paragraph

Article in Journal of the National Cancer Institute. Monographs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 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

10 authors.

Hanna BandosNRG Oncology Statistics and Data Management Center, Pittsburgh, PA 15213, United States.ORCID 0000-0003-1798-8054
Pedro A Torres-SaavedraBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20850, United States.
Eva CulakovaDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, NY 14642, United States.
Heather J GunnDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ 85259, United States.
Minji K LeeDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN 55902, United States.
Fenghai DuanDepartment of Biostatistics and Center for Statistical Sciences, School of Public Health, Brown University, Providence, RI 02912, United States.
Reena S CecchiniNRG Oncology Statistics and Data Management Center, Pittsburgh, PA 15213, United States.
Joseph M UngerSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA 98109, United States.
Amylou C DueckDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ 85259, United States.
Jon A SteingrimssonDepartment of Biostatistics and Center for Statistical Sciences, School of Public Health, Brown University, Providence, RI 02912, United States.

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Towards a preventive cancer vaccine for children with constitutional mismatch repair deficiencyUG1CA189955 · NCI · PUBLIC HEALTH INSTITUTE · PI BRAD H POLLOCK, Michael E. Roth · 2014 to 2026
$62.5M
Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9M
ACRIN UG1CA189828Children's Oncology Group 5UG1CA189955-11Community Oncology Research ProgramECOGNCI NIH HHS P30 CA015083NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180822NCI NIH HHS U10CA180822NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189824NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA189955NCI NIH HHS UG1 CA189961NCI NIH HHS UG1 CA189974NIH HHSNRG Oncology UG1CA189867SWOG UG1CA189974University of Rochester UG1CA189961Wake Forest University UG1CA189824
6 · The paper itself

Abstract

Patient-reported outcomes (PROs) are often collected in cancer clinical trials. Data obtained from trials with PROs are essential in evaluating participant experiences relating to symptoms, financial toxicity, or health-related quality of life. Although most features of clinical trial design, implementation, and analyses apply to trials with PROs, several considerations are unique. In this paper, we focus on specific issues such as selection of the tool, timing and frequency of assessments, and data collection methods. We discuss how the estimand framework can be used in connection with PROs, properties of common estimation methods, and handling of missing outcomes. With a plethora of literature available, we aim to summarize best practices and pragmatic approaches to the design and analysis of the studies incorporating PROs.

Indexed as

Clinical Trials as TopicNeoplasmsPatient Reported Outcome MeasuresQuality of LifeHumansPractice Guidelines as TopicResearch Design

Identifiers

PMID39989038
PMCPMC11848031

What OpenQuestion holds

Textmetadata
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.