Evidence map›Paper›PMID 25151341›Full record

Trial reportContemporary clinical trials2014

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

Jeffrey A Sparks, Maura D Iversen, Rachel Miller Kroouze, Taysir G Mahmoud, Nellie A Triedman, Sarah S Kalia, Michael L Atkinson, Bing Lu, Kevin D Deane, Karen H Costenbader and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02046005 (Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

NCT02046005 nacompletednot on this map

Communication of Biomarker, Genetic, and Lifestyle Risk Factor Profiles for Rheumatoid Arthritis to First Degree Relatives

TypeinterventionalSponsorBrigham and Women's HospitalRan2014 to 2018Enrolled238ConditionsFirst Degree Relatives of Rheumatoid Arthritis PatientsArmsPRE-RA, PRE-RA Plus, General Rheumatoid Arthritis Education
3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

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  11. Commentary: 20 years online with "Your Disease Risk".Cancer causes & control : CCC · 2021
    Article
  12. Review
  13. Review
  14. Article
  15. Mini-Review: Human Microbiome and Rheumatic Diseases.Frontiers in cellular and infection microbiology · 2020
    Review
  16. Review
  17. Article
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  20. Review
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.

Jeffrey A SparksDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: jasparks@partners.org.
Maura D IversenDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA; Department of Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, 360 Huntington Ave., Boston, MA 02115, USA; Department of Women's and Children's Health, Karolinska Institutet, Solnavägen 1, Stockholm 171 77, Sweden. Electronic address: m.iversen@neu.edu.
Rachel Miller KroouzeDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: rkroouze@partners.org.
Taysir G MahmoudDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: tmahmoud@partners.org.
Nellie A TriedmanDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: ntriedman@partners.org.
Sarah S KaliaDivision of Genetics, Brigham and Women's Hospital and Harvard Medical School, 41 Avenue Louis Pasteur, Suite 301, Boston, MA 02115, USA. Electronic address: skalia@genetics.med.harvard.edu.
Michael L AtkinsonDepartment of Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, 181 Longwood Avenue, Boston, MA 02115, USA. Electronic address: nhmla@channing.harvard.edu.
Bing LuDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: blu1@partners.org.
Kevin D DeaneDivision of Rheumatology, University of Colorado School of Medicine, 1775 Aurora Court, Aurora, CO 80045, USA. Electronic address: Kevin.Deane@ucdenver.edu.
Karen H CostenbaderDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: kcostenbader@partners.org.
Robert C GreenDivision of Genetics, Brigham and Women's Hospital and Harvard Medical School, 41 Avenue Louis Pasteur, Suite 301, Boston, MA 02115, USA. Electronic address: rcgreen@genetics.med.harvard.edu.
Elizabeth W KarlsonDivision of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, 45 Francis St., Boston, MA 02115, USA. Electronic address: ekarlson@partners.org.

Funding

Trial of risk mangement for prevention of accelerated atherosclerosis in SLEP60AR047782 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI KATZ, JEFFREY NEIL · 2001 to 2016
$18.8M
Integration of Whole Genome Sequencing into Clinical MedicineU01HG006500 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 2012 to 2016
$11.5M
Novel Biomarkers and Prediction Models for Rheumatoid ArthritisR01AR049880 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H, KARLSON, ELIZABETH W · 2003 to 2018
$8.7M
Risk Evaluation and Education for Alzheimer's Disease (REVEAL IV)R01HG002213 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 1999 to 2012
$7.6M
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint PainR01AR059086 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2010 to 2021
$5.4M
Cardiovascular Disease Epidemiology in Patients with LupusK24AR066109 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2014 to 2023
$1.7M
Novel Biomarkers and Causal Pathways in RA SusceptbilityR01AR059073 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2010 to 2013
$1.5M
Genetic Predictors of Early Atherosclerosis in SLEK24AR052403 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI KARLSON, ELIZABETH W · 2005 to 2014
$1.5M
Impact of Direct to Consumer Genetic TestingR01HG005092 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C., ROBERTS, SCOTT · 2010 to 2012
$1.1M
Characterizing Communicating Genetic Risk Alzheimer'sK24AG027841 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 2006 to 2010
$914k
NHGRI NIH HHS HG002213NHGRI NIH HHS HG005092NHGRI NIH HHS HG006500NHGRI NIH HHS R01 HG002213NHGRI NIH HHS R01 HG005092NHGRI NIH HHS U01 HG006500NIAMS NIH HHS AR047782NIAMS NIH HHS AR049880NIAMS NIH HHS AR052403NIAMS NIH HHS K24 AR052403NIAMS NIH HHS K24 AR066109NIAMS NIH HHS P60 AR047782NIAMS NIH HHS R01 AR049880NIAMS NIH HHS R01 AR059073NIAMS NIH HHS R01 AR059086NIA NIH HHS AG027841NIA NIH HHS K24 AG027841
6 · The paper itself

Abstract

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention.

Indexed as

FamilyHealth BehaviorResearch DesignAdolescentAdultAgedAge FactorsArthritis, RheumatoidBiomarkersDietFemaleGenetic Predisposition to DiseaseHumansLife StyleMaleMiddle AgedBiomarkersBehaviorFishGeneticsObesityPeriodontitisPersonalized medicineRheumatoid arthritisSmoking

Identifiers

PMID25151341
PMCPMC4175164

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Registered trials

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.