Emily K Sims1, Susan Geyer2, Suzanne Bennett Johnson3, Ingrid Libman4, Laura M Jacobsen5, David Boulware2, Lisa E Rafkin6, Della Matheson6, Mark A Atkinson5, Henry Rodriguez6, Maria Spall7, Helena Elding Larsson8, Diane K Wherrett9, Carla J Greenbaum10, Jeffrey Krischer2, Linda A DiMeglio7. 1. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN eksims@iu.edu. 2. Health Informatics Institute, University of South Florida, Tampa, FL. 3. Florida State University College of Medicine, Tallahassee, FL. 4. Division of Endocrinology, Diabetes and Metabolism, University of Pittsburgh and UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA. 5. Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL. 6. University of Miami Miller School of Medicine Diabetes Research Institute, Miami, FL. 7. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN. 8. Department of Clinical Sciences, Lund University Clinical Research Center, Skåne University Hospital, Malmö, Sweden. 9. Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada. 10. Diabetes Research Program, Benaroya Research Institute, Seattle, WA.
Abstract
OBJECTIVE: To better understand potential facilitators of individual engagement in type 1 diabetes natural history and prevention studies through analysis of enrollment data in the TrialNet Pathway to Prevention (PTP) study. RESEARCH DESIGN AND METHODS: We used multivariable logistic regression models to examine continued engagement of eligible participants at two time points: 1) the return visit after screening to confirm an initial autoantibody-positive (Ab+) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. RESULTS: Of 5,387 subjects who screened positive for a single autoantibody (Ab), 4,204 (78%) returned for confirmatory Ab testing. Younger age was associated with increased odds of returning for Ab confirmation (age <12 years vs. >18 years: odds ratio [OR] 2.12, P < 0.0001). Racial and ethnic minorities were less likely to return for confirmation, particularly nonwhite non-Hispanic (OR 0.50, P < 0.0001) and Hispanic (OR 0.69, P = 0.0001) relative to non-Hispanic white subjects. Of 8,234 subjects, 5,442 (66%) were identified as eligible to be enrolled in PTP OGTT monitoring. Here, younger age and identification as multiple Ab+ were associated with increased odds of returning for OGTT monitoring (age <12 years vs. >18 years: OR 1.43, P < 0.0001; multiple Ab+: OR 1.36, P < 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, P = 0.004). Site-specific factors, including site volume and U.S. site versus international site, were also associated with differences in rates of return for Ab+ confirmation and enrollment into monitoring. CONCLUSIONS: These data confirm clear differences between successfully enrolled populations and those lost to follow-up, which can serve to identify strategies to increase ongoing participation.
OBJECTIVE: To better understand potential facilitators of individual engagement in type 1 diabetes natural history and prevention studies through analysis of enrollment data in the TrialNet Pathway to Prevention (PTP) study. RESEARCH DESIGN AND METHODS: We used multivariable logistic regression models to examine continued engagement of eligible participants at two time points: 1) the return visit after screening to confirm an initial autoantibody-positive (Ab+) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. RESULTS: Of 5,387 subjects who screened positive for a single autoantibody (Ab), 4,204 (78%) returned for confirmatory Ab testing. Younger age was associated with increased odds of returning for Ab confirmation (age <12 years vs. >18 years: odds ratio [OR] 2.12, P < 0.0001). Racial and ethnic minorities were less likely to return for confirmation, particularly nonwhite non-Hispanic (OR 0.50, P < 0.0001) and Hispanic (OR 0.69, P = 0.0001) relative to non-Hispanic white subjects. Of 8,234 subjects, 5,442 (66%) were identified as eligible to be enrolled in PTP OGTT monitoring. Here, younger age and identification as multiple Ab+ were associated with increased odds of returning for OGTT monitoring (age <12 years vs. >18 years: OR 1.43, P < 0.0001; multiple Ab+: OR 1.36, P < 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, P = 0.004). Site-specific factors, including site volume and U.S. site versus international site, were also associated with differences in rates of return for Ab+ confirmation and enrollment into monitoring. CONCLUSIONS: These data confirm clear differences between successfully enrolled populations and those lost to follow-up, which can serve to identify strategies to increase ongoing participation.
Authors: Antoinette Moran; Brian Bundy; Dorothy J Becker; Linda A DiMeglio; Stephen E Gitelman; Robin Goland; Carla J Greenbaum; Kevan C Herold; Jennifer B Marks; Philip Raskin; Srinath Sanda; Desmond Schatz; Diane K Wherrett; Darrell M Wilson; Jeffrey P Krischer; Jay S Skyler; Linda Pickersgill; Eelco de Koning; Anette-G Ziegler; Bernhard Böehm; Klaus Badenhoop; Nanette Schloot; Jens Friis Bak; Paolo Pozzilli; Didac Mauricio; Marc Y Donath; Luis Castaño; Ana Wägner; Hans Henrik Lervang; Hans Perrild; Thomas Mandrup-Poulsen Journal: Lancet Date: 2013-04-05 Impact factor: 79.321
Authors: Jay S Skyler; Jeffrey P Krischer; Joseph Wolfsdorf; Catherine Cowie; Jerry P Palmer; Carla Greenbaum; David Cuthbertson; Lisa E Rafkin-Mervis; H Peter Chase; Ellen Leschek Journal: Diabetes Care Date: 2005-05 Impact factor: 19.112
Authors: Dana Dabelea; Ronny A Bell; Ralph B D'Agostino; Giuseppina Imperatore; Judith M Johansen; Barbara Linder; Lenna L Liu; Beth Loots; Santica Marcovina; Elizabeth J Mayer-Davis; David J Pettitt; Beth Waitzfelder Journal: JAMA Date: 2007-06-27 Impact factor: 56.272
Authors: Emily K Sims; Rachel E J Besser; Colin Dayan; Cristy Geno Rasmussen; Carla Greenbaum; Kurt J Griffin; William Hagopian; Mikael Knip; Anna E Long; Frank Martin; Chantal Mathieu; Marian Rewers; Andrea K Steck; John M Wentworth; Stephen S Rich; Olga Kordonouri; Anette-Gabriele Ziegler; Kevan C Herold Journal: Diabetes Date: 2022-04-01 Impact factor: 9.337
Authors: Sarah K Popp; Federica Vecchio; Debra J Brown; Riho Fukuda; Yuri Suzuki; Yuma Takeda; Rikako Wakamatsu; Mahalakshmi A Sarma; Jessica Garrett; Anna Giovenzana; Emanuele Bosi; Antony Ra Lafferty; Karen J Brown; Elizabeth E Gardiner; Lucy A Coupland; Helen E Thomas; Beng H Chong; Christopher R Parish; Manuela Battaglia; Alessandra Petrelli; Charmaine J Simeonovic Journal: JCI Insight Date: 2022-01-25
Authors: Kimber M Simmons; Angela M Mitchell; Aimon A Alkanani; Kristen A McDaniel; Erin E Baschal; Taylor Armstrong; Laura Pyle; Liping Yu; Aaron W Michels Journal: Diabetes Date: 2020-05-21 Impact factor: 9.461