Evidence map›Paper›PMID 29551717›Full record

ReviewPreventive medicine2018

Design and analysis of group-randomized trials in cancer: A review of current practices.

David M Murray, Sherri L Pals, Stephanie M George, Andrey Kuzmichev, Gabriel Y Lai, Jocelyn A Lee, Ranell L Myles, Shakira M Nelson

Abstract readReview
In one paragraph

Review in Preventive medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

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

  1. Pooled it
  2. Trial
  3. Using the NIH Research Methods Resources Website.Prevention science : the official journal of the Society for Prevention Research · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Common Methodological Problems in Randomized Controlled Trials of Preventive Interventions.Prevention science : the official journal of the Society for Prevention Research · 2021
    Review
  16. The Importance of Evaluating Health Disparities Research.American journal of public health · 2019
    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

8 authors.

David M MurrayOffice of Disease Prevention, Division of Program Coordination Planning and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, MD, United States. Electronic address: david.murray2@nih.gov.
Sherri L PalsHealth Informatics, Data Management, and Statistics Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, United States.
Stephanie M GeorgeOffice of Disease Prevention, Division of Program Coordination Planning and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, MD, United States.
Andrey KuzmichevOffice of the Surgeon General, Office of the Assistant Secretary for Health, Department of Health and Human Services, United States.
Gabriel Y LaiEnvironmental Epidemiology Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Rockville, MD, United States.
Jocelyn A LeeProject Genomics Evidence Neoplasia Information Exchange (GENIE), Executive Office, American Association for Cancer Research, Philadelphia, PA, United States.
Ranell L MylesOffice of Disease Prevention, Division of Program Coordination Planning and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, MD, United States.
Shakira M NelsonScientific Programs, American Association for Cancer Research, Philadelphia, PA, United States.

Funding

Intramural NIH HHS Z99 OD999999
6 · The paper itself

Abstract

The purpose of this paper is to summarize current practices for the design and analysis of group-randomized trials involving cancer-related risk factors or outcomes and to offer recommendations to improve future trials. We searched for group-randomized trials involving cancer-related risk factors or outcomes that were published or online in peer-reviewed journals in 2011-15. During 2016-17, in Bethesda MD, we reviewed 123 articles from 76 journals to characterize their design and their methods for sample size estimation and data analysis. Only 66 (53.7%) of the articles reported appropriate methods for sample size estimation. Only 63 (51.2%) reported exclusively appropriate methods for analysis. These findings suggest that many investigators do not adequately attend to the methodological challenges inherent in group-randomized trials. These practices can lead to underpowered studies, to an inflated type 1 error rate, and to inferences that mislead readers. Investigators should work with biostatisticians or other methodologists familiar with these issues. Funders and editors should ensure careful methodological review of applications and manuscripts. Reviewers should ensure that studies are properly planned and analyzed. These steps are needed to improve the rigor and reproducibility of group-randomized trials. The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) has taken several steps to address these issues. ODP offers an online course on the design and analysis of group-randomized trials. ODP is working to increase the number of methodologists who serve on grant review panels. ODP has developed standard language for the Application Guide and the Review Criteria to draw investigators' attention to these issues. Finally, ODP has created a new Research Methods Resources website to help investigators, reviewers, and NIH staff better understand these issues.

Indexed as

HumansNational Institutes of Health (U.S.)NeoplasmsRandomized Controlled Trials as TopicResearch DesignRisk FactorsUnited States

Identifiers

PMID29551717
PMCPMC5930119

What OpenQuestion holds

Textmetadata
LicenceTDM
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.