WHI Investigators Meeting

May 3-4, 2012

Status of follow-up: Extension II

Response to mailings Overall Response

F33 Overall MRC SRC Overall MRC SRC

Year 1 91.7% 87.9% 92.9% 97.2% 96.5% 97.4%

Year 2 89.1% 86.0% 90.2%

WHI Productivity-Ancillary Studies

Funding success 2009 – 38 submitted, 17 funded, 45% 2010 – 40 submitted, 16 funded, 40% 2011 – 41 submitted, 7 funded 17% with 11

still pending

Robert Brunner, Chair, Ancillary Studies Committee

ASC members Co-chair, Marian Neuhouser Garnet Anderson Tim Assimes Bette Caan Charles Eaton Gerardo Heiss Li Jiao Karen Johnson Lew Kuller Jennifer Lin Simin Liu Gloria Sarto Eric Whitsel

Publications and Presentations

Cynthia Thomson Barbara Howard

P&P Members Peggye Dilworth-Anderson Hoda Anton-Culver Rowan Chlebowski Laura Coker Jennifer Hays-Grudo Keri Monda Kari North Mary Jo O’Sullivan Ross Prentice Stephen Rapp Sylvia Smoller Lesley Tinker Robert Wallace Jean Wactawski-Wende

Linda Van Horn Shirley Beresford Giselle Corbie-Smith Mark Espeland Nora Franceschini Margery Gass Jane Kotchen Andrea LaCroix Simin Liu Yvonne Michael Jacques Rossouw Michael Simon Sally Shumaker Marcia Stefanick

Top 10 lead authors:Rowan Chlebowski, Ross Prentice, Geoffrey Kabat, Judith Hsia, JoAnn

Manson, Jacques Rossouw, Zhao Chen, Mark Espeland, Barbara Howard, Karen Margolis

Outcomes Advisory Committee Marian Limacher,

Chair Karen Margolis, Co-chair Matt Allison Charles Eaton Susan Heckbert Charles Kooperberg Joyce Noonan (OC Rep.) Marcia Ko Andrea LaCroix Kamakshi Lakshminarayan Shari Ludlam Bernedine Lund Jennifer Robinson

Outcomes status Extension I cases adjudication complete except

Retrospective DVT cases (N=300, target completion, 8/2012)

HF All 11,000 cancer Extension I cases have been

coded Since 10/01/10

7990 outcomes identified 5992 cases were sent forward adjudication

Electronic adjudication has been implemented for CVD/fracture/death outcomes

Abstraction of HF cases is moving forward at UNC

Cancers identified in WHI

Cancer Site NBreast 7787Lung 2246Colorectal 2211Endometrial 1321Lymphoma 1133GU 804Melanoma (skin) 769Ovary 685Other GI 606Leukemia 575Pancreas 559Thyroid 345Multiple Myeloma 342Other Gyn 274Brain 201Head and Neck 114Other/unknown/Ill-defined 791

Total2076

3

Adjudicators Carl Chelius Eric Whitsel George Hess Judith Hsia Karen Margolis Kathryn Rexrode Kim Miller Linda Loes Marcia Ko Marian Limacher Maurizio Trevisan Stephanie Connelly Steve Sidney Susan Heckbert

Beth Lewis Charles Eaton Matt Allison Stroke Amie Hsia Brian Silver Enrique Leira Jana Wold Jose Merino Kamakshi

Lakshminarayan Lenore Ocava John Lynch

New Initiatives Long-Life Study (CCC)/OPACH (Andrea LaCroix, PI)

Consent mailings started in February—1602 consented Visits started in March—381 completed, 532 scheduled Projected completion of visits by second quarter 2013

Clinical Trial working group (Mark Espeland, chair) Reviewed 19 concept proposals Selected 2 to support for studywide effort

Manson and Sesso Factorial design of 2 dietary supplements, alpha linoleic acid and

cacao 10,000 women at elevated CVD risk

Stefanick A pragmatic trial of physical activity

Resources Sharepoint

Access at www.whiscience.org

Data enclave Physical enclave in place Seeking CMS/IRB approval for virtual enclave

Medicare data CCC has files covering 1991-2010 Application for Part D has been developed Annual updates expected

Regional Center Analysts

Scientific Interest Groups & Chairs Aging: Stephen Rapp Bone, Fracture and Body Composition: Carolyn

Crandall, Jean Wactawski-Wende Cancer: Bette Caan, Ross Prentice, Rowan

Chlebowski Cardiovascular Disease: Marcia Stefanick Genetics, Proteomics & Biomarkers: Rebecca

Jackson Health Services: Karen Margolis Minorities and Health Disparities: Laura Coker

Scientific Interest Groups & Chairs Nutrition/Energy Balance: Marian Neuhouser Diabetes and Obesity: Lesley Tinker, Jean

Wactawski-Wende Physical and Built Environment: Eric Whitsel Physical Activity: Marcia Stefanick Psychosocial & Behavioral Health: Sally

Shumaker

Rebecca Jackson, SRWG chair