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HuGENet™ Workshops

Strengthening the Reporting of Genetic RIsk Prediction Studies (GRIPS) HuGENet Workshop

The rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but the quality and completeness of reporting varies. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network (HuGENet™) developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines such as the STrengthening the REporting of Genetic Association Studies (STREGA) initiative.

These recommendations aim to enhance the transparency of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct, or analysis. The GRIPS Statement and Explanation and Elaboration papers were published simultaneously in multiple journals in March 2011, including the Annals of Internal Medicine, PLos Medicine, BMJ, Circulation: Cardiovascular Genetics, European Journal of Clinical Investigation, European Journal of Epidemiology, European Journal of Human Genetics, Genetics in Medicine, Genome Medicine, and Journal of Clinical Epidemiology.

HuGENet™ is a global initiative committed to the development and integration of the knowledge base on human genetic variants & health.

Wednesday, December 16th through Thursday, December 17th, 2009 Atlanta, GA



December 16, 2009
8:00 am Introduction to workshop – objectives procedures and anticipated outputs Cecile Janssens, Erasmus University; Muin Khoury, CDC
8:10 am Roadmap for efficient and reliable translational research for genetic risk prediction – Muin Khoury, CDC
8:20 am Overview of existing guidance on reporting of risk prediction studies – Mark Hlatky, Stanford University
8:40 am Empirical evidence on reporting of risk prediction studies: methodological comparison of recent studies that aimed at predicting health outcomes – Cecile Janssens, Erasmus University
9:00 am The STREGA statement and discussion – Julian Little, University of Ottawa
9:40 am Short Break
Moderated session: Issues in Reporting of Study Design of Genetic Risk Prediction (Moderator: Debbie Winn, NIH/NCI)
10:00 am Reporting of rationale for choice of disease and population: what is the clinical scenario? – Christopher O’Donnell, NIH/NHLBI
10:20 am Reporting of general study design issues and statistical analyses – Cecile Janssens, Erasmus University
10:40-11:00 am Reporting of rationale for choice of genes and variants investigated in risk prediction – Cornelia van Duijn, Erasmus University
11:00 am Discussion
Moderated session: Analytic Issues in Evaluation of Genetic Risk Prediction (Moderator: David Ransohoff, University of North Carolina)
11:15 am Overview of evaluation of measures of clinical validity and utility – Holly Janes, Fred Hutchinson Cancer Research Center
11:35 am Assessing the incremental value beyond clinical risk models – Peter Kraft, Harvard University
11:55 am Complexities and reclassification in clinical risk models – Michael Pencina, Boston University
12:15 pm Discussion
12:30 pm Lunch break
Breakout groups: Developing reporting guidelines for reporting individual GRIPS
1:30 pm Breakout Groups-orientation – Cecile Janssens, Erasmus University
1:45 pm 3 Breakout groups to propose guidelines for reporting genetic risk prediction studies with a focus on individual studies: 1. Methods (Moderator: Nicole Dowling, CDC) 2. Results (Moderator: Marta Gwinn, CDC) 3. Intro/discussion/abstract (Moderators: Debbie Winn and Sheri Schully, NIH/NCI)
3:00 pm Short break
3:15-5:00 pm Presentations and discussion of findings from the breakout groups (Moderator: Jeremy Grimshaw, OHRI)

December 17, 2009
7:30 am Breakfast
8:15 am Plenary session; procedures for the day; brief issues for breakout sessions – Cecile Janssens, Erasmus University; Muin Khoury, CDC
Moderated session: Evaluation of Genetic Risk Prediction beyond individual studies (Moderator: Paolo Boffetta, IARC)
8:30 am Methods of combining information across studies – Muin Khoury, CDC; John Ioannidis, University of Ioannina* [*not present]
9:00 am Lessons from EGAPP™- Measuring clinical validity and utility of genetic risk predictions – Muin Khoury, CDC; Stephanie Melillo, CDC
9:30 am How can networks and consortia be used for genetic risk predictions- Daniela Seminara, NIH/NCI
10:00 am Break
10:30 am Discussion
12:00 pm Lunch
Moderated session Developing Reporting Guidelines for GRIPS (Moderator: Jeremy Grimshaw, OHRI)
1:00 pm Presentation of conclusions from the break-out groups, and discussion Breakout moderators from Day 1: 1. Methods (Moderator: Nicole Dowling, CDC) 2. Results (Moderator: Marta Gwinn, CDC) 3. Intro/discussion/abstract (Moderators: Debbie Winn and Sheri Schully, NIH/NCI)
2:30 pm Process for developing, disseminating, evaluating GRIPS – Muin Khoury, CDC; Cecile Janssens, Erasmus University
3:00 pm Adjourn

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