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1. Factors influencing enrollment of African Americans in the Look AHEAD trial

Author

David L, Mount, Cralen, Davis, Betty, Kennedy, Susan, Raatz, Kathy, Dotson, Tiffany L, Gary-Webb, Sheikilya, Thomas, Karen C, Johnson, Mark A, Espeland, and Cecilia, Farach

Subjects
Male, Gerontology, Ethnic group, Type 2 diabetes, Article, law.invention, Randomized controlled trial, law, Weight loss, Lifestyle intervention, medicine, Humans, Aged, Randomized Controlled Trials as Topic, Differential impact, Pharmacology, business.industry, Patient Selection, General Medicine, Middle Aged, medicine.disease, Black or African American, Clinical trial, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Female, medicine.symptom, Look-ahead, business
Abstract

Background Many factors have been identified that influence the recruitment of African Americans into clinical trials; however, the influence of eligibility criteria may not be widely appreciated. We used the experience from the Look AHEAD (Action for Health in Diabetes) trial screening process to examine the differential impact eligibility criteria had on the enrollment of African Americans compared to other volunteers. Methods Look AHEAD is a large randomized clinical trial to examine whether assignment to an intensive lifestyle intervention designed to produce and maintain weight loss reduces the long-term risk of major cardiovascular events in adults with type 2 diabetes. Differences in the screening, eligibility, and enrollment rates between African Americans and members of other racial/ethnic groups were examined to identify possible reasons. Results Look AHEAD screened 28,735 individuals for enrollment, including 6226 (21.7%) who were self-identified African Americans. Of these volunteers, 12.9% of the African Americans compared to 19.3% of all other screenees ultimately enrolled ( p < 0.001). African Americans no more often than others were lost to follow-up or refused to attend clinic visits to establish eligibility. Furthermore, the enrollment rates of individuals with histories of cardiovascular disease and diabetes therapy did not markedly differ between the ethnic groups. Higher prevalence of adverse levels of blood pressure, heart rate, HbA1c, and serum creatinine among African American screenees accounted for the greater proportions excluded (all p < 0.001). Conclusions Compared to non-African Americans, African American were more often ineligible for the Look AHEAD trial due to comorbid conditions. Monitoring trial eligibility criteria for differential impact, and modifying them when appropriate, may ensure greater enrollment yields.

Published
2011
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2. Measurement characteristics of the ankle–brachial index: results from the Action for Health in Diabetes study

Author

Edward W. Lipkin, Jane Tavares, Laurie Bissett, Sarah Ledbury, Kathy Dotson, JoAnn A. Phillipp, Lynne Lichtermann, Carmen Pal, Susan Green, Ann V. Schwartz, Michael T. McDermott, Dace L. Trence, Vicki A. Maddy, Suzanne Phelan, Cara Walcheck, Jack Rejeski, Michael C. Nevitt, Paulette Cohrs, Thomas A. Wadden, Ronald J. Prineas, Kristi Rau, Magpuri Perpetua, Siran Ghazarian, Terry Barrett, Lynne E. Wagenknecht, Robert I. Berkowitz, Virginia Harlan, Jennifer Mayer, George L. Blackburn, Gary D. Miller, Jeff Honas, Sarah Michaels, Rita Donaldson, Jeanne Carls, Barbara Harrison, Barbara J. Maschak-Carey, Amy Dobelstein, Charlotte Bragg, Jackie Day, Canice E. Crerand, Debra Clark, Karen T. Vujevich, Kathy Lane, Rina R. Wing, Renee Davenport, Shandiin Begay, Alain G. Bertoni, Sharon D. Jackson, Steven E. Kahn, Richard S. Crow, Valerie Goldman, Sarah A. Jaramillo, Kristina P. Schumann, David M. Nathan, William H. Herman, James O. Hill, Kati Szamos, Steven M. Haffner, Osama Hamdy, Karen C. Johnson, Judy Bahnson, Mary Lou Klem, Denise G. Simons-Morton, David E. Kelley, Emily A. Finch, Maureen Malloy, Donna Wolf, Leeann Carmichael, Deborah Robles, Diane Hirsch, Elizabeth Bovaird, Justin Glass, Robert Kuehnel, Brenda Montgomery, Didas Fallis, Jennifer Gauvin, Kim Landry, Michaela Rahorst, Renate H. Rosenthal, William C. Knowler, Robert W. Jeffery, Monika M. Safford, John P. Foreyt, Ellen J. Anderson, Michelle Chan, Cathy Manus, Julie Currin, Elizabeth J. Mayer-Davis, Erin Patterson, Jeanne M. Clark, Mara Z. Vitolins, Nancy Scurlock, Stanley Heshka, Ken C. Chiu, Vicki DiLillo, Donna H. Ryan, Mary Evans, La Donna James, Edward W. Gregg, Gary D. Foster, Connie Mobley, Christian Speas, Eva Obarzanek, Caitlin Egan, Renee Bright, Frank L. Greenway, Robert S. Schwartz, Robert C. Kores, Ann Goebel-Fabbri, Anna Bertorelli, Ann McNamara, Patricia Lipschutz, Heather Chenot, Maria Sun, Helen Chomentowski, Carlos Lorenzo, Pamela Coward, Matthew L. Maciejewski, Donald A. Williamson, Heather Turgeon, Alan McNamara, Barbara Bancroft, Jonathan Krakoff, Debi Celnik, Erica Ferguson, Molly Gee, Lewis H. Kuller, Tatum Charron, Deborah Maier, Amelia Hodges, Linda M. Delahanty, Mary Anne Holowaty, Janet Krulia, Rebecca Danchenko, Van S. Hubbard, Rebecca S. Reeves, Lindsey Munkwitz, Linda Foss, Don Kieffer, Kara I. Gallagher, Paul M. Ribisl, Heather McCormick, David F. Williamson, Carrie Combs, Birgitta I. Rice, Edward S. Horton, Zhu Ming Zhang, Stanley Schwartz, Sharon Hall, Clara Smith, Janet Bonk, Richard Ginsburg, Cathy Roche, Mark A. Espeland, Jennifer Rush, Elizabeth Tucker, Tricia Skarpol, Maureen Daly, Susan Z. Yanovski, Nita Webb, John P. Bantle, George A. Bray, Amy A. Gorin, Theresa Michel, Lori Lambert, Lauren Lessard, Jennifer Patricio, Greg Strylewicz, Charles Campbell, Wei Lang, Cecilia Farach, Richard Carey, Vincent Pera, Carolyne Campbell, Medhat Botrous, Robert H. Knopp, William R. Hiatt, David M. Reboussin, Carolyn Thorson, Daniel Edmundowicz, Marsha Miller, Mandy Shipp, Jacqueline Wesche-Thobaben, Monica Mullen, Louise Hesson, Ruby Johnson, Henry J. Pownall, Xavier Pi-Sunyer, Natalie Robinson, Barbara Steiner, Enrico Cagliero, Sheikilya Thomas, Carol Percy, Paula Bolin, Debra Force, Lawton S. Cooper, Kathy Horak, Juliet Mancino, M. Patricia Snyder, Salma Benchekroun, Stephen P. Glasser, Douglas A. Raynor, Jeanne Charleston, Richard R. Rubin, Gracie Cunningham, Lawrence J. Cheskin, Anthony N. Fabricatore, Brandi Armand, Kimberley Chula-Maquire, Helen Lambeth, April Hamilton, Cynthia Hayashi, Straci Gilbert, Kerry J. Stewart, Cora E. Lewis, Mohammed F. Saad, Janelia Smiley, Andrea M. Kriska, Richard F. Hamman, J. P. Massaro, Barb Elnyczky, Lisa Palermo, Tammy Monk, Donna Green, Patrick Reddin, Peter H. Bennett, Kerry Ovalle, Pat Harper, Therese Ockenden, Kerin Brelje, Christos S. Mantzoros, Santica M. Marcovina, Amy Keranen, Deborah F. Tate, John M. Jakicic, Trena Johnsey, Judith G. Regensteiner, Bernadette Todacheenie, Ray Carvajal, Sarah Bain, Minnie Roanhorse, Sandra Sangster, Tina Killean, Jennifer Perault, Bruce Redmon, Jeffrey M. Curtis, Abbas E. Kitabchi, Anne E. Mathews, Shiriki K. Kumanyika, Rob Nicholson, Allison Strate, Hollie A. Raynor, L. Christie Oden, Ashok Balasubramanyam, Leigh A. Shovestull, Tina Morgan, Judith Regenseiner, Roque M. Murillo, Delia S. West, Jason Maeda, Kathryn Hayward, Patricia E. Hogan, Kristin Wallace, Maria G. Montez, John A. Shepherd, Loretta Rome, Judith E. Soberman, Peter B. Jones, Andrea Crisler, Enrique Caballero, Frederick L. Brancati, and Brent VanDorsten

Subjects
Male, medicine.medical_specialty, Brachial Artery, Blood Pressure, Type 2 diabetes, Overweight, Sensitivity and Specificity, Article, Cohort Studies, Risk Factors, Internal medicine, Diabetes mellitus, medicine, Humans, Obesity, cardiovascular diseases, Aged, Peripheral Vascular Diseases, Framingham Risk Score, business.industry, Middle Aged, medicine.disease, Surgery, body regions, medicine.anatomical_structure, Standard error, Blood pressure, Diabetes Mellitus, Type 2, Cardiology, Female, Ankle, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Algorithms, Ankle Joint, Cohort study
Abstract

Abstract Many protocols have been used in clinical and research settings for collecting systolic blood pressure (SBP) measurements to calculate the ankle–brachial index (ABI); however, it is not known how useful it is to replicate measurements and which measures best reflect cardiovascular risk. Standardized measurements of ankle and arm SBP from 5140 overweight or obese individuals with type 2 diabetes were used to estimate sources of variation. Measurement characteristics of leg-specific ABI, as calculated using a standard algorithm based on the highest SBP of the dorsalis pedis or posterior tibial arteries, were projected using simulations. Coefficients of variability ranged from 2% to 3% when single SBP measurements were used and ABI was overestimated by 2–3%. Taking two SBP measurements at each site reduced standard errors and bias each by 30–40%. The sensitivity of detecting low ABI ranges exceeded 90% for ABI within 0.05 of the 0.90 clinical cut-point. The average and the minimum of the two (i.e. right and left) leg-specific ABI values had similar U-shaped relationships with Framingham risk scores; however, the average leg ABI had slightly greater precision. Replicating SBP measurements reduces the error and bias of ABI. Averaging leg-specific values may increase power for characterizing cardiovascular disease risk.

Published
2008
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3. Consent for Genetics Studies Among Clinical Trial Participants: Findings from Action for Health in Diabetes (Look AHEAD)

Author

W. Jack Rejeski, Deborah F. Tate, Ray Carvajal, Renee Davenport, Shandiin Begay, Peter B. Jones, Roque M. Murillo, Laurie Bissett, Valerie Goldman, Maria G. Montez, Karen C. Johnson, Lynne E. Wagenknecht, Ann V. Schwartz, Alain G. Bertoni, Sharon D. Jackson, Virginia Harlan, Jeffrey M. Curtis, E. S. Kahn, Paula Bolin, K. Dotson, Erica Ferguson, Abbas E. Kitabchi, Donald A. Williamson, Elizabeth Bovaird, Renee Bright, Patricia E. Hogan, Barbara Bancroft, Richard S. Crow, Elizabeth Tucker, Maureen Malloy, Kathy Lane, Tricia Skarphol, Julie Currin, Anne E. Mathews, Linda M. Delahanty, Jennifer Gauvin, Mara Z. Vitolins, Theresa Michel, Shiriki K. Kumanyika, Mark A. Espeland, Jennifer Rush, Kristina P. Schumann, Anna Bertorelli, Allison Strate, Denise G. Simons-Morton, David E. Kelley, Carrie Combs, Nita Webb, Eva Obarzanek, Wei Lang, Rebecca S. Reeves, M. Patricia Snyder, Douglas A. Raynor, Susan Green, Robert Kuehnel, Richard Ginsburg, John P. Bantle, Gary D. Miller, L. Christie Oden, Richard Carey, Sarah Michaels, Rebecca Danchenko, Linda Foss, Gary D. Foster, Caitlin Egan, Jeanne Carls, Brenda Montgomery, Carlos Lorenzo, Lori Lambert, Medhat Botrous, Sarah Bain, Minnie Roanhorse, Heather McCormick, Michael T. McDermott, Edward W. Lipkin, Jane Tavares, Jason Maeda, Kathryn Hayward, Ann Goebel-Fabbri, Ann McNamara, Sandra Sangster, Cathy Roche, Cecilia Farach, David M. Nathan, Cathy Manus, Donna Wolf, William H. Herman, Paulette Cohrs, Patricia Lipschutz, P. J. Foreyt, Kara I. Gallagher, Thomas A. Wadden, Ronald J. Prineas, Kristi Rau, Tina Killean, Kerrin Brelje, Jennifer Perault, Justin Glass, George L. Blackburn, Edward W. Gregg, Anthony N. Fabricatore, Charles Campbell, Vicki A. Maddy, Steven E. Kahn, Emily A. Finch, Janet Bonk, Lauren Lessard, C. W. Knowler, M. Montez, Barbara Harrison, Barbara J. Maschak-Carey, Stephen P. Glasser, Molly Gee, Brandi Armand, Tatum Charron, Kristin Wallace, Jennifer Patricio, John A. Shepherd, Monica Mullen, Robert H. Knopp, Heather Chenot, Connie Mobley, Richard R. Rubin, Elizabeth J. Mayer-Davis, David M. Reboussin, Judith G. Regensteiner, Bernadette Todacheenie, Alan McNamara, Amelia Hodges, Mary Anne Holowaty, S. M. Haffner, Robert S. Schwartz, Paul M. Ribisl, B. Montgomery, Carol Percy, B. D. W. Harrison, Mohammed F. Saad, Frank L. Greenway, Osama Hamdy, Van S. Hubbard, Dace L. Trence, Magpuri Perpetua, Mandy Shipp, Sharon Hall, Kim Landry, William C. Knowler, Christian Speas, Louise Hesson, Ruby Johnson, Deborah Maier, David F. Williamson, Deborah Robles, Zhu Ming Zhang, Janelia Smiley, Jennifer Mayer, Henry J. Pownall, Andrea M. Kriska, A. S. Jaramillo, Nancy Scurlock, Vicki DiLillo, Karen T. Vujevich, S. Terry Barrett, James O. Hill, Amy Dobelstein, Clara Smith, Heather Turgeon, Sarah Ledbury, Kathy Dotson, JoAnn A. Phillipp, Carmen Pal, A. Enrique Caballero, Natalie Robinson, Jonathan Krakoff, Debi Celnik, Sheikilya Thomas, J. P. Massaro, Mary Lou Klem, Ellen J. Anderson, Amy A. Gorin, Stanley Schwartz, Jeanne M. Clark, Enrico Cagliero, Leigh A. Shovestull, Didas Fallis, Siran Ghazarian, Lawton S. Cooper, Kathy Horak, Pamela Coward, Carolyn Thorson, Diane Hirsch, Robert I. Berkowitz, Stanley Heshka, Matthew L. Maciejewski, Salma Benchekroun, Erin Patterson, Rita Donaldson, La Donna James, Tina Morgan, Robert W. Jeffery, Monika M. Safford, John P. Foreyt, Xavier Pi-Sunyer, Barbara Steiner, Michelle Chan, Leeann Carmichael, Barb Elnyczky, Charlotte Bragg, Delia S. West, Jacqueline Wesche-Thobaben, Canice E. Crerand, Lisa Palermo, Tammy Monk, Amy Keranen, April Hamilton, Patrick Reddin, Helen Chomentowski, Peter H. Bennett, Kati Szamos, Cynthia Hayashi, Kerry J. Stewart, Kerry Ovalle, Judy Bahnson, Pat Harper, John M. Jakicic, Janet Krulia, J. Bruce Redmon, Vincent Pera, Michaela Rahorst, Trena Johnsey, Maureen Daly, Susan Z. Yanovski, George A. Bray, Lindsey Munkwitz, Birgitta I. Rice, Edward S. Horton, Lawrence J. Cheskin, Daniel Edmundowicz, Marsha Miller, Therese Ockenden, Rena R. Wing, Christos S. Mantzoros, Santica M. Marcovina, Greg Strylewicz, Carolyne Campbell, Ken C. Chiu, Cora E. Lewis, Richard F. Hamman, Staci Gilbert, Don Kieffer, Frederick L. Brancati, Brent VanDorsten, Lynne Lichtermann, Juliet Mancino, Jeanne Charleston, Helen Lambeth, Suzanne Phelan, Cara Walcheck, Kimberley Chula-Maguire, Michael C. Nevitt, Donna H. Ryan, Hollie A. Raynor, Lewis H. Kuller, Ashok Balasubramanyam, Rob Nicholson, and Loretta Rome

Subjects
Research design, Male, medicine.medical_specialty, Genetic Research, Alternative medicine, Type 2 diabetes, 01 natural sciences, Article, Ethics, Research, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Patient Education as Topic, Weight loss, Informed consent, Medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, 0101 mathematics, Aged, Pharmacology, Genetics, Research ethics, Clinical Trials as Topic, Informed Consent, business.industry, General Medicine, Middle Aged, medicine.disease, humanities, Clinical trial, Diabetes Mellitus, Type 2, Research Design, Female, medicine.symptom, business, Risk Reduction Behavior, Cohort study, Ethics Committees, Research
Abstract

Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.

Published
2006

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