title: 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.
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.
authors.affiliation: Division 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.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Sparks
authors.affiliation: Division 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.
authors.forename: Maura D
authors.initials: MD
authors.lastname: Iversen
authors.affiliation: Division 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.
authors.forename: Rachel
authors.initials: R
authors.lastname: Miller Kroouze
authors.affiliation: Division 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.
authors.forename: Taysir G
authors.initials: TG
authors.lastname: Mahmoud
authors.affiliation: Division 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.
authors.forename: Nellie A
authors.initials: NA
authors.lastname: Triedman
authors.affiliation: Division 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.
authors.forename: Sarah S
authors.initials: SS
authors.lastname: Kalia
authors.affiliation: Department 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.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Atkinson
authors.affiliation: Division 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.
authors.forename: Bing
authors.initials: B
authors.lastname: Lu
authors.affiliation: Division of Rheumatology, University of Colorado School of Medicine, 1775 Aurora Court, Aurora, CO 80045, USA. Electronic address: Kevin.Deane@ucdenver.edu.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Deane
authors.affiliation: Division 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.
authors.forename: Karen H
authors.initials: KH
authors.lastname: Costenbader
authors.affiliation: Division 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.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Green
authors.affiliation: Division 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.
authors.forename: Elizabeth W
authors.initials: EW
authors.lastname: Karlson
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000453:epidemiology* / Q000235:genetics; D015415:Biomarkers; D004032:Diet; D005190:Family; D005260:Female; D020022:Genetic Predisposition to Disease; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009909:Oral Health; D050177:Overweight / Q000453:epidemiology; D010353:Patient Education as Topic / Q000458:organization & administration*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D012737:Sex Factors; D012907:Smoking / Q000453:epidemiology; D012959:Socioeconomic Factors; D055815:Young Adult
chemical_list: D015415:Biomarkers
keywords: Behavior; Fish; Genetics; Obesity; Periodontitis; Personalized medicine; Rheumatoid arthritis; Smoking