Evidence map›Paper›PMID 24926413›Full record

ArticleJournal of personalized medicine2014

Design and implementation of a randomized controlled trial of genomic counseling for patients with chronic disease.

Kevin Sweet, Erynn S Gordon, Amy C Sturm, Tara J Schmidlen, Kandamurugu Manickam, Amanda Ewart Toland, Margaret A Keller, Catharine B Stack, J Felipe García-España, Mark Bellafante and 7 more

Open access · goldAbstract read
In one paragraph

Article in Journal of personalized medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 11% of its field
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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Decision coaching for people making healthcare decisions.The Cochrane database of systematic reviews · 2021
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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

17 authors at 6 institutions in 1 country.

Kevin SweetDivision of Human Genetics, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA ; Center for Personalized Health Care, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA.
Erynn S GordonCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA ; Invitae, 458 Brannan Street, San Francisco, CA 94107, USA.
Amy C SturmDivision of Human Genetics, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA ; Center for Personalized Health Care, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA.
Tara J SchmidlenCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA.
Kandamurugu ManickamDivision of Human Genetics, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA ; Center for Personalized Health Care, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA.
Amanda Ewart TolandDivision of Human Genetics, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA.
Margaret A KellerCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA ; American Red Cross, 700 Spring Garden Street, Philadelphia, PA 19123, USA.
Catharine B StackCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA ; American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106, USA.
J Felipe García-EspañaCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA.
Mark BellafanteCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA.
Neeraj TayalDepartment of Internal Medicine, Ohio State University College of Medicine, Columbus, OH 43420, USA; Neeraj.Tayal@osumc.edu.
Peter EmbiDepartment of Bioinformatics, Ohio State University College of Medicine, Columbus, OH 43420, USA; Peter.Embi@osumc.edu.
Philip BinkleyDivision of Cardiovascular Medicine, Ohio State University College of Medicine, Columbus, OH 43420, USA.
Ray E HershbergerDivision of Human Genetics, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA ; Division of Cardiovascular Medicine, Ohio State University College of Medicine, Columbus, OH 43420, USA.
Wolfgang SadeeProgram in Pharmacogenomics, Department of Pharmacology, The Ohio State University College of Medicine, Columbus, OH 43420, USA; Wolfgang.Sadee@osumc.edu.
Michael ChristmanCoriell Institute for Medical Research, 403 Haddon Avenue, Camden, NJ 08103, USA.
Clay MarshCenter for Personalized Health Care, Ohio State University Wexner Medical Center, Columbus, OH 43420, USA.
The Ohio State University · USThe Ohio State University Wexner Medical Center · USCoriell Institute For Medical Research · USAmerican College of Physicians · USAmerican Red Cross · USInvitae (United States) · US

Funding

Pharmacogenomics of Anti-platlet Intervention-2 (PAPI-2) StudyU01HL105198 · NHLBI · UNIVERSITY OF MARYLAND BALTIMORE · PI SHULDINER, ALAN R. · 2010 to 2014
$13.6M
Expression Genetics in Drug TherapyU01GM092655 · NIGMS · OHIO STATE UNIVERSITY · PI SADEE, WOLFGANG · 2010 to 2014
$8.6M
Assessing the utility of genomic counseling for common complex diseasesR21HG006575 · NHGRI · OHIO STATE UNIVERSITY · PI CHRISTMAN, MICHAEL F, SWEET, KEVIN M. · 2013 to 2014
$477k
NHGRI NIH HHS R21 HG006575NHLBI NIH HHS U01 HL105198NIGMS NIH HHS U01 GM092655
6 · The paper itself

Abstract

We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling-active arm, versus web-based only return of results-control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

Indexed as

actionablecounselinggenomicsimplementationmedicinepatientspharmacogenomicsrandomizedrisk perception

Identifiers

PMID24926413
PMCPMC4051230
OpenAlexW2120298350

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.