Evidence map›Paper›PMID 27365013›Full record

ArticleClinical trials (London, England)2016

Use of administrative data to increase the practicality of clinical trials: Insights from the Women's Health Initiative.

Garnet L Anderson, Carolyn J Burns, Joseph Larsen, Pamela A Shaw

Abstract readComparative Study
In one paragraph

Article in Clinical trials (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. The Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) Study: Description and Baseline Characteristics of Participants.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2018
    Article
  12. 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

4 authors.

Garnet L AndersonWHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA garnet@whi.org.
Carolyn J BurnsWHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Joseph LarsenWHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Pamela A ShawDepartment of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.

Funding

Women's Health Initiative Strong & Healthy (WHISH) NIA Exercise MaterialsU01HL122280 · NHLBI · STANFORD UNIVERSITY · PI STEFANICK, MARCIA L. · 2015 to 2019
$6.9M
Physical Activity to Improve CV Health in Older Women: A Pragmatic Trial -- DCCU01HL122273 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI KOOPERBERG, CHARLES L, LACROIX, ANDREA Z. · 2015 to 2019
$4.2M
NHLBI NIH HHS HHSN268201100046CNHLBI NIH HHS U01 HL122273NHLBI NIH HHS U01 HL122280
6 · The paper itself

Abstract

backgroundTo reduce research costs in the context of pragmatic trials, consideration is given to using administrative data (Medicare claims) to ascertain clinical outcomes.

methodsIn the historical context of the Women's Health Initiative, the correspondence between selected cardiovascular events derived from Medicare claims was compared to those documented and adjudicated in this large-scale prevention trial.

resultsClassification performance varies somewhat by type of outcome, but hazard ratios and confidence intervals derived from the two data sources were quite comparable.

conclusionThese encouraging results provided the needed support to launch a new embedded pragmatic trial of physical activity that will rely heavily on Medicare claims to ascertain cardiovascular disease incidence in the majority of those randomized.

Indexed as

AgedCardiovascular DiseasesClinical Trials as TopicFemaleHumansIncidenceInsurance Claim ReviewMedicareMiddle AgedUnited StatesWomen's Healthclaims dataMedicare linkagemisclassificationmismeasured outcomesPragmatic trials

Identifiers

PMID27365013
PMCPMC5059108

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.