Evidence map›Paper›PMID 24355197›Full record

ArticleContemporary clinical trials2014

Characteristics associated with informed consent for genetic studies in the ACCORD trial.

Denise G Simons-Morton, Jeffrey C Chan, Angela R Kimel, Peter E Linz, Cynthia L Stowe, John Summerson, Walter T Ambrosius

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Genetic counseling and testing for Asian Americans: a systematic review.Genetics in medicine : official journal of the American College of Medical Genetics · 2021
    Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

7 authors.

Denise G Simons-MortonDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, 2701 Rockledge Drive, Bethesda, MD 20892, USA. Electronic address: simonsd@nih.gov.
Jeffrey C ChanDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, 2701 Rockledge Drive, Bethesda, MD 20892, USA. Electronic address: jeffreycchan@gmail.com.
Angela R KimelDivision of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd., Winston-Salem, NC 27157, USA. Electronic address: angiekimel@gmail.com.
Peter E LinzNaval Hospital San Diego, Cardiology Department, 34800 Bob Wilson Dr., San Diego, CA 92134, USA. Electronic address: peter.linz@mercyships.org.
Cynthia L StoweDivision of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd., Winston-Salem, NC 27157, USA. Electronic address: cstowe@wakehealth.edu.
John SummersonDivision of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd., Winston-Salem, NC 27157, USA. Electronic address: jsummers@wakehealth.edu.
Walter T AmbrosiusDivision of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd., Winston-Salem, NC 27157, USA. Electronic address: wambrosi@wakehealth.edu.

Funding

PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095183 · HC · MINNEAPOLIS MEDICAL RESEARCH FDN, INC. · PI GRIMM, RICHARD H · 1999 to 2000
$1.9M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095181 · HC · CASE WESTERN RESERVE UNIVERSITY · PI THIBONNIER, MARC · 1999 to 2000
$1.8M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095184 · HC · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BIGGER, J T · 1999 to 2000
$1.7M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095182 · HC · WAKE FOREST UNIVERSITY · PI GOFF, DAVID C · 1999 to 2000
$1.6M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUS-N01HC95178N01HC095178 · HC · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BYINGTON, ROBERT · 1999 to 2006
$1.5M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETER MELLLITN01HC095180 · HC · UNIVERSITY OF WASHINGTON · PI PROBSTFIELD, JEFFREY · 1999 to 2000
$1.5M
S-nitrosothiol analyzer for the clinical diagnosis of cardiovascular disease markR44HL095181 · NHLBI · ACCORD BIOMATERIALS, INC. · PI PISANO, MICHAEL R · 2010 to 2011
$1.4M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095179 · HC · MCMASTER UNIVERSITY · PI GERSTEIN, HERTZEL C · 1999 to 2000
$1.3M
S-nitrosothiol analyzer for the clinical diagnosis of cardiovascular disease markR43HL095181 · NHLBI · ACCORD BIOMATERIALS, INC. · PI HANDA, HILTESH · 2009 to 2009
$93k
Intramural NIH HHS Z99 OD999999NHLBI NIH HHS N01 HC095178NHLBI NIH HHS N01 HC095179NHLBI NIH HHS N01 HC095180NHLBI NIH HHS N01 HC095181NHLBI NIH HHS N01 HC095182NHLBI NIH HHS N01 HC095183NHLBI NIH HHS N01 HC095184NHLBI NIH HHS N01-HC-95178NHLBI NIH HHS N01-HC-95179NHLBI NIH HHS N01-HC-95180NHLBI NIH HHS N01-HC-95181NHLBI NIH HHS N01-HC-95182NHLBI NIH HHS N01-HC-95183NHLBI NIH HHS N01-HC-95184NHLBI NIH HHS Y01 HC001010NHLBI NIH HHS Y01 HC009035NHLBI NIH HHS Y1-HC-1010NHLBI NIH HHS Y1-HC-9035
6 · The paper itself

Abstract

backgroundPrior studies found that some groups have lower genetic consent rates than others. Participant consent for genetic studies enables randomized trials to examine effects of interventions compared to control in participants with different genotypes.

methodsUnadjusted and multivariate associations between genetic consent rates and participant, study, and consent characteristics in 9573 participants approached for genetics consent in the multicenter Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which used a layered genetics consent.

resultsEighty-nine percent of eligible participants consented to genetic studies ("Any Consent") and 64.7% consented to studies of any genes by any investigator ("Full Consent"), with similar rates in randomized groups. Controlling for multiple characteristics, African-Americans had lower consent rates than others (Any Consent Odds Ratio, OR = 0.62, p = 0.0004; Full Consent OR = 0.67, p < 0.0001). Those with high school or higher education level had higher rates than less than high school graduates (Full Consent ORs 1.41-1.69, p-values < 0.0001). Consent rates were lower when genetics consent was separate from the main trial consent on the same day (Any Consent OR 0.30; Full Consent OR 0.52, p values < 0.0001) or on a subsequent day (Any Consent OR 0.70, p = 0.0022; Full Consent OR 0.76, p = 0.0002).

conclusionHigh rates of consent for genetic studies can be obtained in complex randomized trials, with lower consent rates in African-Americans, in participants with less than high-school education, and for sharing samples with other investigators. A genetics consent separated from the main trial consent was associated with lower consent rates.

Indexed as

Patient SelectionAdultAgedAsianBlack or African AmericanBody Mass IndexCardiovascular DiseasesDiabetes Mellitus, Type 2DyslipidemiasEducational StatusEthnicityFemaleGenetic TestingHispanic or LatinoHumansHypertensionGeneticsInformed consentRecruitment

Identifiers

PMID24355197
PMCPMC3918951

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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.