Skip to main content
construction release_alert
The Scholars Team is working with OIT to resolve some issues with the Scholars search index
cancel
Journal cover image

The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.

Publication ,  Journal Article
Vassy, JL; Lautenbach, DM; McLaughlin, HM; Kong, SW; Christensen, KD; Krier, J; Kohane, IS; Feuerman, LZ; Blumenthal-Barby, J; Roberts, JS ...
Published in: Trials
March 2014

Whole genome sequencing (WGS) is already being used in certain clinical and research settings, but its impact on patient well-being, health-care utilization, and clinical decision-making remains largely unstudied. It is also unknown how best to communicate sequencing results to physicians and patients to improve health. We describe the design of the MedSeq Project: the first randomized trials of WGS in clinical care.This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts: (a) disease-specific genomic medicine in a cardiomyopathy clinic and (b) general genomic medicine in primary care. We are recruiting 8 to 12 cardiologists, 8 to 12 primary care physicians, and approximately 200 of their patients. Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS. Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity. We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients' genome reports. Using varied data sources, including surveys, semi-structured interviews, and review of clinical data, we measure the attitudes, behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results.The impact of emerging sequencing technologies on patient care is unclear. We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future. That is, our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and, through physicians, to their patients. This project will not only illuminate the impact of integrating genomic medicine into the clinical care of patients but also inform the design of future studies.ClinicalTrials.gov identifier NCT01736566.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Trials

DOI

EISSN

1745-6215

ISSN

1745-6215

Publication Date

March 2014

Volume

15

Start / End Page

85

Related Subject Headings

  • Young Adult
  • Sequence Analysis, DNA
  • Research Design
  • Prognosis
  • Primary Health Care
  • Predictive Value of Tests
  • Phenotype
  • Middle Aged
  • Male
  • Inservice Training
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Vassy, J. L., Lautenbach, D. M., McLaughlin, H. M., Kong, S. W., Christensen, K. D., Krier, J., … MedSeq Project. (2014). The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine. Trials, 15, 85. https://doi.org/10.1186/1745-6215-15-85
Vassy, Jason L., Denise M. Lautenbach, Heather M. McLaughlin, Sek Won Kong, Kurt D. Christensen, Joel Krier, Isaac S. Kohane, et al. “The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.Trials 15 (March 2014): 85. https://doi.org/10.1186/1745-6215-15-85.
Vassy JL, Lautenbach DM, McLaughlin HM, Kong SW, Christensen KD, Krier J, et al. The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine. Trials. 2014 Mar;15:85.
Vassy, Jason L., et al. “The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.Trials, vol. 15, Mar. 2014, p. 85. Epmc, doi:10.1186/1745-6215-15-85.
Vassy JL, Lautenbach DM, McLaughlin HM, Kong SW, Christensen KD, Krier J, Kohane IS, Feuerman LZ, Blumenthal-Barby J, Roberts JS, Lehmann LS, Ho CY, Ubel PA, MacRae CA, Seidman CE, Murray MF, McGuire AL, Rehm HL, Green RC, MedSeq Project. The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine. Trials. 2014 Mar;15:85.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

ISSN

1745-6215

Publication Date

March 2014

Volume

15

Start / End Page

85

Related Subject Headings

  • Young Adult
  • Sequence Analysis, DNA
  • Research Design
  • Prognosis
  • Primary Health Care
  • Predictive Value of Tests
  • Phenotype
  • Middle Aged
  • Male
  • Inservice Training