Evidence map›Paper›PMID 26611435›Full record

ArticleContemporary clinical trials2016

Embedding clinical interventions into observational studies.

Anne B Newman, M Larissa Avilés-Santa, Garnet Anderson, Gerardo Heiss, Wm James Howard, Mitchell Krucoff, Lewis H Kuller, Cora E Lewis, Jennifer G Robinson, Herman Taylor and 2 more

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Ayurvedic research for direct public benefit.Journal of Ayurveda and integrative medicine
    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

12 authors.

Anne B NewmanDepartment of Epidemiology, Graduate School of Public Health, University of Pittsburgh, A527 Crabtree Hall, 130 DeSoto Street, Pittsburgh, PA 15261, USA. Electronic address: newmana@edc.pitt.edu.
M Larissa Avilés-SantaDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Suite 10018, Bethesda, MD 20892-7936, USA. Electronic address: avilessantal@nhlbi.nih.gov.
Garnet AndersonFred Hutchinson Cancer Research Center, Public Health Sciences Division, 1100 Fairview Ave N, M3-A410, PO Box 19024, Seattle, WA 98109, USA. Electronic address: garnet@whi.org.
Gerardo HeissDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 137 E Franklin St, Ste 306, Chapel Hill, NC 27514-3628, USA. Electronic address: gerardo_heiss@unc.edu.
Wm James HowardMedstar Health Research Institute, Medstar Washington Hospital Center, Department of Internal Medicine, Rm. 6A 126, 110 Irving St. NW, Washington, DC 20010, USA. Electronic address: wm.james.howard@medstar.net.
Mitchell KrucoffDepartments of Medicine and Cardiology, Duke University Medical Center, 508 Fulton Street, Room A3006, Durham, NC 27705, USA. Electronic address: mitchell.krucoff@duke.edu.
Lewis H KullerDepartment of Epidemiology, Graduate School of Public Health, University of Pittsburgh, 130 N. Bellefield Avenue, Room 550, Pittsburgh, PA 15213, USA. Electronic address: kullerl@edc.pitt.edu.
Cora E LewisUniversity of Alabama School of Medicine, Division of Preventive Medicine, Medical Towers 614, 1717 11th Avenue South, Birmingham, AL 35205, USA. Electronic address: bethlew@uab.edu.
Jennifer G RobinsonDepartment of Epidemiology, University of Iowa, 145 North Riverside Drive, S455 CPBH, Iowa City, IA 52242, USA. Electronic address: jennifer-g-robinson@uiowa.edu.
Herman TaylorJackson Heart Study, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA. Electronic address: htaylor@umc.edu.
Roberto P TreviñoSocial and Health Research Center, 1302 South Saint Mary's Street, San Antonio, TX 78210, USA. Electronic address: rtrevino@sahrc.org.
William WeintraubCenter for Heart & Vascular Health, Christiana Care Health System, 4755 Ogletown-Stanton Road, Suite 1070, Newark, DE 19713, USA. Electronic address: wweintraub@christianacare.org.

Funding

Subproject Title: Clinical Research Education, Mentoring and Career Development CoreU54GM104941 · NIGMS · UNIVERSITY OF DELAWARE · PI Gregory E Hicks · 2013 to 2026
$60.5M
VARIABILITY, STABILITY & SMOOTHNESS OF WALKINGP30AG024827 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JENNIFER S BRACH · 2004 to 2026
$28.6M
NIA NIH HHS P30 AG024827NIGMS NIH HHS U54 GM104941
6 · The paper itself

Abstract

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed.

Indexed as

Epidemiologic StudiesClinical Trials as TopicCohort StudiesCost-Benefit AnalysisHumansObservational Studies as TopicResearch DesignClinical trialCohortEpidemiologyHybrid designObservational study

Identifiers

PMID26611435
PMCPMC5626440

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.