Evidence map›Paper›PMID 29572075›Full record

ReviewUrologic oncology2019

Key design and analysis principles for quality of life and patient-reported outcomes in clinical trials.

Joseph M Unger, Riha Vaidya, John L Gore

Abstract readReview
In one paragraph

Review in Urologic oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Health-related quality of life in patients newly diagnosed with prostate cancer: CAPLIFE study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Article
  3. Article
  4. Article
  5. Observational
  6. Prostate cancer: a tale of two sides.Nature reviews. Urology · 2019
    Article
  7. 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

3 authors.

Joseph M UngerSWOG Statistical Center, Seattle, WA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: junger@fredhutch.org.
Riha VaidyaSWOG Statistical Center, Seattle, WA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
John L GoreDepartment of Urology, University of Washington, Seattle Cancer Care Alliance, Seattle, WA.

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
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
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189974
6 · The paper itself

Abstract

Advances in early detection and therapy have increased the number of prostate cancer survivors, leading to a greater emphasis on examining patient-reported outcomes (PROs). PROs augment clinical outcomes, providing a more comprehensive assessment of the patient experience, including symptoms and quality of life, that may impact the overall evaluation of new therapies. The successful incorporation of PROs into clinical trials requires adherence to key design and analysis principles. We present these principles and argue that adherence to these principles is vital to ensure valid interpretation of clinical trial findings, identify meaningful differences among investigational strategies, and better translate clinical trial results to diverse stakeholders.

Indexed as

Clinical Trials as TopicPatient Reported Outcome MeasuresProstatic NeoplasmsQuality of LifeHumansMalePatient-reported outcomesProstate cancerQuality of life

Identifiers

PMID29572075
PMCPMC6148417

What OpenQuestion holds

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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.