Quality control measures over 30 years in a multicenter clinical study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study

Gayle M. Lorenzi, Barbara H. Braffett, Valerie L. Arends, Ronald P. Danis, Lisa Diminick, Kandace A. Klumpp, Anthony D. Morrison, Elsayed Z. Soliman, Michael W. Steffes, Patricia A. Cleary, J. Crandall, M. Reid, J. Brown-Friday, S. Engel, J. Sheindlin, M. Phillips, H. Martinez, H. Shamoon, H. Engel, R. Gubitosi-KlugL. Mayer, S. Pendegast, H. Zegarra, D. Miller, L. Singerman, S. Smith-Brewer, M. Novak, J. Quin, Saul Genuth, M. Palmert, E. Brown, J. McConnell, P. Pugsley, P. Crawford, W. Dahms, D. Brillon, M. E. Lackaye, S. Kiss, R. Chan, A. Orlin, M. Rubin, V. Reppucci, T. Lee, M. Heinemann, S. Chang, B. Levy, L. Jovanovic, M. Richardson, B. Bosco, A. Dwoskin, R. Hanna, S. Barron, R. Campbell, F. Whitehouse, D. Kruger, J. K. Jones, P. A. Edwards, A. Bhan, J. D. Carey, E. Angus, A. Thomas, M. McLellan, A. Galprin, R. Bergenstal, M. Johnson, K. Gunyou, L. Thomas, J. Laechelt, P. Hollander, M. Spencer, D. Kendall, R. Cuddihy, P. Callahan, S. List, J. Gott, N. Rude, B. Olson, M. Franz, G. Castle, R. Birk, J. Nelson, D. Freking, L. Gill, W. Mestrezat, D. Etzwiler, K. Morgan, L. P. Aiello, E. Golden, P. Arrigg, V. Asuquo, R. Beaser, L. Bestourous, J. Cavallerano, R. Cavicchi, O. Ganda, O. Hamdy, R. Kirby, T. Murtha, D. Schlossman, S. Shah, G. Sharuk, P. Silva, P. Silver, M. Stockman, J. Sun, E. Weimann, H. Wolpert, L. M. Aiello, A. Jacobson, L. Rand, J. Rosenzwieg, D. M. Nathan, M. E. Larkin, M. Christofi, K. Folino, J. Godine, P. Lou, C. Stevens, E. Anderson, H. Bode, S. Brink, C. Cornish, D. Cros, L. Delahanty, A. DeManbey, C. Haggan, J. Lynch, C. McKitrick, D. Norman, D. Moore, M. Ong, C. Taylor, D. Zimbler, S. Crowell, S. Fritz, K. Hansen, C. Gauthier-Kelly, F. J. Service, G. Ziegler, R. Colligan, L. Schmidt, B. French, R. Woodwick, R. Rizza, W. F. Schwenk, M. Haymond, J. Pach, J. Mortenson, B. Zimmerman, A. Lucas, L. Luttrell, M. Lopes-Virella, S. Caulder, C. Pittman, N. Patel, K. Lee, M. Nutaitis, J. Fernandes, K. Hermayer, S. Kwon, A. Blevins, J. Parker, J. Colwell, D. Lee, J. Soule, P. Lindsey, M. Bracey, A. Farr, S. Elsing, T. Thompson, J. Selby, T. Lyons, S. Yacoub-Wasef, M. Szpiech, D. Wood, R. Mayfield, M. Molitch, B. Schaefer, L. Jampol, A. Lyon, M. Gill, Z. Strugula, L. Kaminski, R. Mirza, E. Simjanoski, D. Ryan, C. Johnson, A. Wallia, S. Ajroud-Driss, P. Astelford, N. Leloudes, A. Degillio, O. Kolterman, G. Lorenzi, M. Goldbaum, K. Jones, M. Prince, M. Swenson, I. Grant, R. Reed, R. Lyon, M. Giotta, T. Clark, G. Friedenberg, W. I. Sivitz, B. Vittetoe, J. Kramer, M. Bayless, R. Zeitler, H. Schrott, N. Olson, L. Snetselaar, R. Hoffman, J. MacIndoe, T. Weingeist, C. Fountain, D. Counts, S. Johnsonbaugh, M. Patronas, M. Carney, P. Salemi, R. Liss, M. Hebdon, T. Donner, J. Gordon, R. Hemady, A. Kowarski, D. Ostrowski, S. Steidl, B. Jones, W. H. Herman, C. L. Martin, R. Pop-Busui, D. A. Greene, M. J. Stevens, N. Burkhart, T. Sandford, J. Floyd, J. Bantle, N. Wimmergren, J. Terry, D. Koozekanani, S. Montezuma, B. Rogness, M. Mech, T. Strand, J. Olson, L. McKenzie, C. Kwong, F. Goetz, R. Warhol, D. Hainsworth, D. Goldstein, S. Hitt, J. Giangiacomo, D. S. Schade, J. L. Canady, M. R. Burge, A. Das, R. B. Avery, L. H. Ketai, J. E. Chapin, M. L. Schluter, J. Rich, C. Johannes, D. Hornbeck, M. Schutta, P. A. Bourne, A. Brucker, S. Braunstein, S. Schwartz, B. J. Maschak-Carey, L. Baker, T. Orchard, L. Cimino, T. Songer, B. Doft, S. Olson, D. Becker, D. Rubinstein, R. L. Bergren, J. Fruit, R. Hyre, C. Palmer, N. Silvers, L. Lobes, P. Paczan Rath, P. W. Conrad, S. Yalamanchi, J. Wesche, M. Bratkowksi, S. Arslanian, J. Rinkoff, J. Warnicki, D. Curtin, D. Steinberg, G. Vagstad, R. Harris, L. Steranchak, J. Arch, K. Kelly, P. Ostrosaka, M. Guiliani, M. Good, T. Williams, K. Olsen, A. Campbell, C. Shipe, R. Conwit, D. Finegold, M. Zaucha, A. Drash, A. Morrison, J. I. Malone, M. L. Bernal, P. R. Pavan, N. Grove, E. A. Tanaka, D. McMillan, J. Vaccaro-Kish, L. Babbione, H. Solc, T. J. DeClue, S. Dagogo-Jack, C. Wigley, H. Ricks, A. Kitabchi, E. Chaum, M. B. Murphy, S. Moser, D. Meyer, A. Iannacone, S. Yoser, M. Bryer-Ash, S. Schussler, H. Lambeth, P. Raskin, S. Strowig, M. Basco, S. Cercone, B. Zinman, A. Barnie, R. Devenyi, M. Mandelcorn, M. Brent, S. Rogers, A. Gordon, N. Bakshi, B. Perkins, L. Tuason, F. Perdikaris, R. Ehrlich, D. Daneman, K. Perlman, S. Ferguson, J. Palmer, R. Fahlstrom, I. H. De Boer, J. Kinyoun, L. Van Ottingham, S. Catton, J. Ginsberg, J. Dupre, C. McDonald, J. Harth, M. Driscoll, T. Sheidow, J. Mahon, C. Canny, D. Nicolle, P. Colby, I. Hramiak, N. W. Rodger, M. Jenner, T. Smith, W. Brown, M. May, J. Lipps Hagan, A. Agarwal, T. Adkins, R. Lorenz, S. Feman, L. Survant, N. H. White, L. Levandoski, G. Grand, M. Thomas, D. Joseph, K. Blinder, G. Shah, D. Burgess, I. Boniuk, J. Santiago, W. Tamborlane, P. Gatcomb, K. Stoessel, P. Ramos, K. Fong, P. Ossorio, J. Ahern, J. Lachin, P. Cleary, J. Backlund, I. Bebu, B. Braffett, L. Diminick, X. Gao, W. Hsu, K. Klumpp, M. Larsen, P. McGee, W. Sun, S. Villavicencio, K. Anderson, L. Dews, Naji Younes, B. Rutledge, K. Chan, D. Rosenberg, B. Petty, A. Determan, D. Kenny, C. Williams

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

Original languageEnglish (US)
Article numbere0141286
JournalPloS one
Volume10
Issue number11
DOIs
StatePublished - Nov 3 2015

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Epidemiology
Diabetes Complications
Medical problems
Quality assurance
Quality Control
Multicenter Studies
quality control
Quality control
diabetes
epidemiology
clinical trials
control methods
Reading
longitudinal studies
Electrocardiography
committees
photographs
Longitudinal Studies
Outcome Assessment (Health Care)
Clinical Studies

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Quality control measures over 30 years in a multicenter clinical study : Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. / Lorenzi, Gayle M.; Braffett, Barbara H.; Arends, Valerie L.; Danis, Ronald P.; Diminick, Lisa; Klumpp, Kandace A.; Morrison, Anthony D.; Soliman, Elsayed Z.; Steffes, Michael W.; Cleary, Patricia A.; Crandall, J.; Reid, M.; Brown-Friday, J.; Engel, S.; Sheindlin, J.; Phillips, M.; Martinez, H.; Shamoon, H.; Engel, H.; Gubitosi-Klug, R.; Mayer, L.; Pendegast, S.; Zegarra, H.; Miller, D.; Singerman, L.; Smith-Brewer, S.; Novak, M.; Quin, J.; Genuth, Saul; Palmert, M.; Brown, E.; McConnell, J.; Pugsley, P.; Crawford, P.; Dahms, W.; Brillon, D.; Lackaye, M. E.; Kiss, S.; Chan, R.; Orlin, A.; Rubin, M.; Reppucci, V.; Lee, T.; Heinemann, M.; Chang, S.; Levy, B.; Jovanovic, L.; Richardson, M.; Bosco, B.; Dwoskin, A.; Hanna, R.; Barron, S.; Campbell, R.; Whitehouse, F.; Kruger, D.; Jones, J. K.; Edwards, P. A.; Bhan, A.; Carey, J. D.; Angus, E.; Thomas, A.; McLellan, M.; Galprin, A.; Bergenstal, R.; Johnson, M.; Gunyou, K.; Thomas, L.; Laechelt, J.; Hollander, P.; Spencer, M.; Kendall, D.; Cuddihy, R.; Callahan, P.; List, S.; Gott, J.; Rude, N.; Olson, B.; Franz, M.; Castle, G.; Birk, R.; Nelson, J.; Freking, D.; Gill, L.; Mestrezat, W.; Etzwiler, D.; Morgan, K.; Aiello, L. P.; Golden, E.; Arrigg, P.; Asuquo, V.; Beaser, R.; Bestourous, L.; Cavallerano, J.; Cavicchi, R.; Ganda, O.; Hamdy, O.; Kirby, R.; Murtha, T.; Schlossman, D.; Shah, S.; Sharuk, G.; Silva, P.; Silver, P.; Stockman, M.; Sun, J.; Weimann, E.; Wolpert, H.; Aiello, L. M.; Jacobson, A.; Rand, L.; Rosenzwieg, J.; Nathan, D. M.; Larkin, M. E.; Christofi, M.; Folino, K.; Godine, J.; Lou, P.; Stevens, C.; Anderson, E.; Bode, H.; Brink, S.; Cornish, C.; Cros, D.; Delahanty, L.; DeManbey, A.; Haggan, C.; Lynch, J.; McKitrick, C.; Norman, D.; Moore, D.; Ong, M.; Taylor, C.; Zimbler, D.; Crowell, S.; Fritz, S.; Hansen, K.; Gauthier-Kelly, C.; Service, F. J.; Ziegler, G.; Colligan, R.; Schmidt, L.; French, B.; Woodwick, R.; Rizza, R.; Schwenk, W. F.; Haymond, M.; Pach, J.; Mortenson, J.; Zimmerman, B.; Lucas, A.; Luttrell, L.; Lopes-Virella, M.; Caulder, S.; Pittman, C.; Patel, N.; Lee, K.; Nutaitis, M.; Fernandes, J.; Hermayer, K.; Kwon, S.; Blevins, A.; Parker, J.; Colwell, J.; Lee, D.; Soule, J.; Lindsey, P.; Bracey, M.; Farr, A.; Elsing, S.; Thompson, T.; Selby, J.; Lyons, T.; Yacoub-Wasef, S.; Szpiech, M.; Wood, D.; Mayfield, R.; Molitch, M.; Schaefer, B.; Jampol, L.; Lyon, A.; Gill, M.; Strugula, Z.; Kaminski, L.; Mirza, R.; Simjanoski, E.; Ryan, D.; Johnson, C.; Wallia, A.; Ajroud-Driss, S.; Astelford, P.; Leloudes, N.; Degillio, A.; Kolterman, O.; Lorenzi, G.; Goldbaum, M.; Jones, K.; Prince, M.; Swenson, M.; Grant, I.; Reed, R.; Lyon, R.; Giotta, M.; Clark, T.; Friedenberg, G.; Sivitz, W. I.; Vittetoe, B.; Kramer, J.; Bayless, M.; Zeitler, R.; Schrott, H.; Olson, N.; Snetselaar, L.; Hoffman, R.; MacIndoe, J.; Weingeist, T.; Fountain, C.; Counts, D.; Johnsonbaugh, S.; Patronas, M.; Carney, M.; Salemi, P.; Liss, R.; Hebdon, M.; Donner, T.; Gordon, J.; Hemady, R.; Kowarski, A.; Ostrowski, D.; Steidl, S.; Jones, B.; Herman, W. H.; Martin, C. L.; Pop-Busui, R.; Greene, D. A.; Stevens, M. J.; Burkhart, N.; Sandford, T.; Floyd, J.; Bantle, J.; Wimmergren, N.; Terry, J.; Koozekanani, D.; Montezuma, S.; Rogness, B.; Mech, M.; Strand, T.; Olson, J.; McKenzie, L.; Kwong, C.; Goetz, F.; Warhol, R.; Hainsworth, D.; Goldstein, D.; Hitt, S.; Giangiacomo, J.; Schade, D. S.; Canady, J. L.; Burge, M. R.; Das, A.; Avery, R. B.; Ketai, L. H.; Chapin, J. E.; Schluter, M. L.; Rich, J.; Johannes, C.; Hornbeck, D.; Schutta, M.; Bourne, P. A.; Brucker, A.; Braunstein, S.; Schwartz, S.; Maschak-Carey, B. J.; Baker, L.; Orchard, T.; Cimino, L.; Songer, T.; Doft, B.; Olson, S.; Becker, D.; Rubinstein, D.; Bergren, R. L.; Fruit, J.; Hyre, R.; Palmer, C.; Silvers, N.; Lobes, L.; Paczan Rath, P.; Conrad, P. W.; Yalamanchi, S.; Wesche, J.; Bratkowksi, M.; Arslanian, S.; Rinkoff, J.; Warnicki, J.; Curtin, D.; Steinberg, D.; Vagstad, G.; Harris, R.; Steranchak, L.; Arch, J.; Kelly, K.; Ostrosaka, P.; Guiliani, M.; Good, M.; Williams, T.; Olsen, K.; Campbell, A.; Shipe, C.; Conwit, R.; Finegold, D.; Zaucha, M.; Drash, A.; Morrison, A.; Malone, J. I.; Bernal, M. L.; Pavan, P. R.; Grove, N.; Tanaka, E. A.; McMillan, D.; Vaccaro-Kish, J.; Babbione, L.; Solc, H.; DeClue, T. J.; Dagogo-Jack, S.; Wigley, C.; Ricks, H.; Kitabchi, A.; Chaum, E.; Murphy, M. B.; Moser, S.; Meyer, D.; Iannacone, A.; Yoser, S.; Bryer-Ash, M.; Schussler, S.; Lambeth, H.; Raskin, P.; Strowig, S.; Basco, M.; Cercone, S.; Zinman, B.; Barnie, A.; Devenyi, R.; Mandelcorn, M.; Brent, M.; Rogers, S.; Gordon, A.; Bakshi, N.; Perkins, B.; Tuason, L.; Perdikaris, F.; Ehrlich, R.; Daneman, D.; Perlman, K.; Ferguson, S.; Palmer, J.; Fahlstrom, R.; De Boer, I. H.; Kinyoun, J.; Van Ottingham, L.; Catton, S.; Ginsberg, J.; Dupre, J.; McDonald, C.; Harth, J.; Driscoll, M.; Sheidow, T.; Mahon, J.; Canny, C.; Nicolle, D.; Colby, P.; Hramiak, I.; Rodger, N. W.; Jenner, M.; Smith, T.; Brown, W.; May, M.; Lipps Hagan, J.; Agarwal, A.; Adkins, T.; Lorenz, R.; Feman, S.; Survant, L.; White, N. H.; Levandoski, L.; Grand, G.; Thomas, M.; Joseph, D.; Blinder, K.; Shah, G.; Burgess, D.; Boniuk, I.; Santiago, J.; Tamborlane, W.; Gatcomb, P.; Stoessel, K.; Ramos, P.; Fong, K.; Ossorio, P.; Ahern, J.; Lachin, J.; Cleary, P.; Backlund, J.; Bebu, I.; Braffett, B.; Diminick, L.; Gao, X.; Hsu, W.; Klumpp, K.; Larsen, M.; McGee, P.; Sun, W.; Villavicencio, S.; Anderson, K.; Dews, L.; Younes, Naji; Rutledge, B.; Chan, K.; Rosenberg, D.; Petty, B.; Determan, A.; Kenny, D.; Williams, C.

In: PloS one, Vol. 10, No. 11, e0141286, 03.11.2015.

Research output: Contribution to journalArticle

Lorenzi, GM, Braffett, BH, Arends, VL, Danis, RP, Diminick, L, Klumpp, KA, Morrison, AD, Soliman, EZ, Steffes, MW, Cleary, PA, Crandall, J, Reid, M, Brown-Friday, J, Engel, S, Sheindlin, J, Phillips, M, Martinez, H, Shamoon, H, Engel, H, Gubitosi-Klug, R, Mayer, L, Pendegast, S, Zegarra, H, Miller, D, Singerman, L, Smith-Brewer, S, Novak, M, Quin, J, Genuth, S, Palmert, M, Brown, E, McConnell, J, Pugsley, P, Crawford, P, Dahms, W, Brillon, D, Lackaye, ME, Kiss, S, Chan, R, Orlin, A, Rubin, M, Reppucci, V, Lee, T, Heinemann, M, Chang, S, Levy, B, Jovanovic, L, Richardson, M, Bosco, B, Dwoskin, A, Hanna, R, Barron, S, Campbell, R, Whitehouse, F, Kruger, D, Jones, JK, Edwards, PA, Bhan, A, Carey, JD, Angus, E, Thomas, A, McLellan, M, Galprin, A, Bergenstal, R, Johnson, M, Gunyou, K, Thomas, L, Laechelt, J, Hollander, P, Spencer, M, Kendall, D, Cuddihy, R, Callahan, P, List, S, Gott, J, Rude, N, Olson, B, Franz, M, Castle, G, Birk, R, Nelson, J, Freking, D, Gill, L, Mestrezat, W, Etzwiler, D, Morgan, K, Aiello, LP, Golden, E, Arrigg, P, Asuquo, V, Beaser, R, Bestourous, L, Cavallerano, J, Cavicchi, R, Ganda, O, Hamdy, O, Kirby, R, Murtha, T, Schlossman, D, Shah, S, Sharuk, G, Silva, P, Silver, P, Stockman, M, Sun, J, Weimann, E, Wolpert, H, Aiello, LM, Jacobson, A, Rand, L, Rosenzwieg, J, Nathan, DM, Larkin, ME, Christofi, M, Folino, K, Godine, J, Lou, P, Stevens, C, Anderson, E, Bode, H, Brink, S, Cornish, C, Cros, D, Delahanty, L, DeManbey, A, Haggan, C, Lynch, J, McKitrick, C, Norman, D, Moore, D, Ong, M, Taylor, C, Zimbler, D, Crowell, S, Fritz, S, Hansen, K, Gauthier-Kelly, C, Service, FJ, Ziegler, G, Colligan, R, Schmidt, L, French, B, Woodwick, R, Rizza, R, Schwenk, WF, Haymond, M, Pach, J, Mortenson, J, Zimmerman, B, Lucas, A, Luttrell, L, Lopes-Virella, M, Caulder, S, Pittman, C, Patel, N, Lee, K, Nutaitis, M, Fernandes, J, Hermayer, K, Kwon, S, Blevins, A, Parker, J, Colwell, J, Lee, D, Soule, J, Lindsey, P, Bracey, M, Farr, A, Elsing, S, Thompson, T, Selby, J, Lyons, T, Yacoub-Wasef, S, Szpiech, M, Wood, D, Mayfield, R, Molitch, M, Schaefer, B, Jampol, L, Lyon, A, Gill, M, Strugula, Z, Kaminski, L, Mirza, R, Simjanoski, E, Ryan, D, Johnson, C, Wallia, A, Ajroud-Driss, S, Astelford, P, Leloudes, N, Degillio, A, Kolterman, O, Lorenzi, G, Goldbaum, M, Jones, K, Prince, M, Swenson, M, Grant, I, Reed, R, Lyon, R, Giotta, M, Clark, T, Friedenberg, G, Sivitz, WI, Vittetoe, B, Kramer, J, Bayless, M, Zeitler, R, Schrott, H, Olson, N, Snetselaar, L, Hoffman, R, MacIndoe, J, Weingeist, T, Fountain, C, Counts, D, Johnsonbaugh, S, Patronas, M, Carney, M, Salemi, P, Liss, R, Hebdon, M, Donner, T, Gordon, J, Hemady, R, Kowarski, A, Ostrowski, D, Steidl, S, Jones, B, Herman, WH, Martin, CL, Pop-Busui, R, Greene, DA, Stevens, MJ, Burkhart, N, Sandford, T, Floyd, J, Bantle, J, Wimmergren, N, Terry, J, Koozekanani, D, Montezuma, S, Rogness, B, Mech, M, Strand, T, Olson, J, McKenzie, L, Kwong, C, Goetz, F, Warhol, R, Hainsworth, D, Goldstein, D, Hitt, S, Giangiacomo, J, Schade, DS, Canady, JL, Burge, MR, Das, A, Avery, RB, Ketai, LH, Chapin, JE, Schluter, ML, Rich, J, Johannes, C, Hornbeck, D, Schutta, M, Bourne, PA, Brucker, A, Braunstein, S, Schwartz, S, Maschak-Carey, BJ, Baker, L, Orchard, T, Cimino, L, Songer, T, Doft, B, Olson, S, Becker, D, Rubinstein, D, Bergren, RL, Fruit, J, Hyre, R, Palmer, C, Silvers, N, Lobes, L, Paczan Rath, P, Conrad, PW, Yalamanchi, S, Wesche, J, Bratkowksi, M, Arslanian, S, Rinkoff, J, Warnicki, J, Curtin, D, Steinberg, D, Vagstad, G, Harris, R, Steranchak, L, Arch, J, Kelly, K, Ostrosaka, P, Guiliani, M, Good, M, Williams, T, Olsen, K, Campbell, A, Shipe, C, Conwit, R, Finegold, D, Zaucha, M, Drash, A, Morrison, A, Malone, JI, Bernal, ML, Pavan, PR, Grove, N, Tanaka, EA, McMillan, D, Vaccaro-Kish, J, Babbione, L, Solc, H, DeClue, TJ, Dagogo-Jack, S, Wigley, C, Ricks, H, Kitabchi, A, Chaum, E, Murphy, MB, Moser, S, Meyer, D, Iannacone, A, Yoser, S, Bryer-Ash, M, Schussler, S, Lambeth, H, Raskin, P, Strowig, S, Basco, M, Cercone, S, Zinman, B, Barnie, A, Devenyi, R, Mandelcorn, M, Brent, M, Rogers, S, Gordon, A, Bakshi, N, Perkins, B, Tuason, L, Perdikaris, F, Ehrlich, R, Daneman, D, Perlman, K, Ferguson, S, Palmer, J, Fahlstrom, R, De Boer, IH, Kinyoun, J, Van Ottingham, L, Catton, S, Ginsberg, J, Dupre, J, McDonald, C, Harth, J, Driscoll, M, Sheidow, T, Mahon, J, Canny, C, Nicolle, D, Colby, P, Hramiak, I, Rodger, NW, Jenner, M, Smith, T, Brown, W, May, M, Lipps Hagan, J, Agarwal, A, Adkins, T, Lorenz, R, Feman, S, Survant, L, White, NH, Levandoski, L, Grand, G, Thomas, M, Joseph, D, Blinder, K, Shah, G, Burgess, D, Boniuk, I, Santiago, J, Tamborlane, W, Gatcomb, P, Stoessel, K, Ramos, P, Fong, K, Ossorio, P, Ahern, J, Lachin, J, Cleary, P, Backlund, J, Bebu, I, Braffett, B, Diminick, L, Gao, X, Hsu, W, Klumpp, K, Larsen, M, McGee, P, Sun, W, Villavicencio, S, Anderson, K, Dews, L, Younes, N, Rutledge, B, Chan, K, Rosenberg, D, Petty, B, Determan, A, Kenny, D & Williams, C 2015, 'Quality control measures over 30 years in a multicenter clinical study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study', PloS one, vol. 10, no. 11, e0141286. https://doi.org/10.1371/journal.pone.0141286
Lorenzi, Gayle M. ; Braffett, Barbara H. ; Arends, Valerie L. ; Danis, Ronald P. ; Diminick, Lisa ; Klumpp, Kandace A. ; Morrison, Anthony D. ; Soliman, Elsayed Z. ; Steffes, Michael W. ; Cleary, Patricia A. ; Crandall, J. ; Reid, M. ; Brown-Friday, J. ; Engel, S. ; Sheindlin, J. ; Phillips, M. ; Martinez, H. ; Shamoon, H. ; Engel, H. ; Gubitosi-Klug, R. ; Mayer, L. ; Pendegast, S. ; Zegarra, H. ; Miller, D. ; Singerman, L. ; Smith-Brewer, S. ; Novak, M. ; Quin, J. ; Genuth, Saul ; Palmert, M. ; Brown, E. ; McConnell, J. ; Pugsley, P. ; Crawford, P. ; Dahms, W. ; Brillon, D. ; Lackaye, M. E. ; Kiss, S. ; Chan, R. ; Orlin, A. ; Rubin, M. ; Reppucci, V. ; Lee, T. ; Heinemann, M. ; Chang, S. ; Levy, B. ; Jovanovic, L. ; Richardson, M. ; Bosco, B. ; Dwoskin, A. ; Hanna, R. ; Barron, S. ; Campbell, R. ; Whitehouse, F. ; Kruger, D. ; Jones, J. K. ; Edwards, P. A. ; Bhan, A. ; Carey, J. D. ; Angus, E. ; Thomas, A. ; McLellan, M. ; Galprin, A. ; Bergenstal, R. ; Johnson, M. ; Gunyou, K. ; Thomas, L. ; Laechelt, J. ; Hollander, P. ; Spencer, M. ; Kendall, D. ; Cuddihy, R. ; Callahan, P. ; List, S. ; Gott, J. ; Rude, N. ; Olson, B. ; Franz, M. ; Castle, G. ; Birk, R. ; Nelson, J. ; Freking, D. ; Gill, L. ; Mestrezat, W. ; Etzwiler, D. ; Morgan, K. ; Aiello, L. P. ; Golden, E. ; Arrigg, P. ; Asuquo, V. ; Beaser, R. ; Bestourous, L. ; Cavallerano, J. ; Cavicchi, R. ; Ganda, O. ; Hamdy, O. ; Kirby, R. ; Murtha, T. ; Schlossman, D. ; Shah, S. ; Sharuk, G. ; Silva, P. ; Silver, P. ; Stockman, M. ; Sun, J. ; Weimann, E. ; Wolpert, H. ; Aiello, L. M. ; Jacobson, A. ; Rand, L. ; Rosenzwieg, J. ; Nathan, D. M. ; Larkin, M. E. ; Christofi, M. ; Folino, K. ; Godine, J. ; Lou, P. ; Stevens, C. ; Anderson, E. ; Bode, H. ; Brink, S. ; Cornish, C. ; Cros, D. ; Delahanty, L. ; DeManbey, A. ; Haggan, C. ; Lynch, J. ; McKitrick, C. ; Norman, D. ; Moore, D. ; Ong, M. ; Taylor, C. ; Zimbler, D. ; Crowell, S. ; Fritz, S. ; Hansen, K. ; Gauthier-Kelly, C. ; Service, F. J. ; Ziegler, G. ; Colligan, R. ; Schmidt, L. ; French, B. ; Woodwick, R. ; Rizza, R. ; Schwenk, W. F. ; Haymond, M. ; Pach, J. ; Mortenson, J. ; Zimmerman, B. ; Lucas, A. ; Luttrell, L. ; Lopes-Virella, M. ; Caulder, S. ; Pittman, C. ; Patel, N. ; Lee, K. ; Nutaitis, M. ; Fernandes, J. ; Hermayer, K. ; Kwon, S. ; Blevins, A. ; Parker, J. ; Colwell, J. ; Lee, D. ; Soule, J. ; Lindsey, P. ; Bracey, M. ; Farr, A. ; Elsing, S. ; Thompson, T. ; Selby, J. ; Lyons, T. ; Yacoub-Wasef, S. ; Szpiech, M. ; Wood, D. ; Mayfield, R. ; Molitch, M. ; Schaefer, B. ; Jampol, L. ; Lyon, A. ; Gill, M. ; Strugula, Z. ; Kaminski, L. ; Mirza, R. ; Simjanoski, E. ; Ryan, D. ; Johnson, C. ; Wallia, A. ; Ajroud-Driss, S. ; Astelford, P. ; Leloudes, N. ; Degillio, A. ; Kolterman, O. ; Lorenzi, G. ; Goldbaum, M. ; Jones, K. ; Prince, M. ; Swenson, M. ; Grant, I. ; Reed, R. ; Lyon, R. ; Giotta, M. ; Clark, T. ; Friedenberg, G. ; Sivitz, W. I. ; Vittetoe, B. ; Kramer, J. ; Bayless, M. ; Zeitler, R. ; Schrott, H. ; Olson, N. ; Snetselaar, L. ; Hoffman, R. ; MacIndoe, J. ; Weingeist, T. ; Fountain, C. ; Counts, D. ; Johnsonbaugh, S. ; Patronas, M. ; Carney, M. ; Salemi, P. ; Liss, R. ; Hebdon, M. ; Donner, T. ; Gordon, J. ; Hemady, R. ; Kowarski, A. ; Ostrowski, D. ; Steidl, S. ; Jones, B. ; Herman, W. H. ; Martin, C. L. ; Pop-Busui, R. ; Greene, D. A. ; Stevens, M. J. ; Burkhart, N. ; Sandford, T. ; Floyd, J. ; Bantle, J. ; Wimmergren, N. ; Terry, J. ; Koozekanani, D. ; Montezuma, S. ; Rogness, B. ; Mech, M. ; Strand, T. ; Olson, J. ; McKenzie, L. ; Kwong, C. ; Goetz, F. ; Warhol, R. ; Hainsworth, D. ; Goldstein, D. ; Hitt, S. ; Giangiacomo, J. ; Schade, D. S. ; Canady, J. L. ; Burge, M. R. ; Das, A. ; Avery, R. B. ; Ketai, L. H. ; Chapin, J. E. ; Schluter, M. L. ; Rich, J. ; Johannes, C. ; Hornbeck, D. ; Schutta, M. ; Bourne, P. A. ; Brucker, A. ; Braunstein, S. ; Schwartz, S. ; Maschak-Carey, B. J. ; Baker, L. ; Orchard, T. ; Cimino, L. ; Songer, T. ; Doft, B. ; Olson, S. ; Becker, D. ; Rubinstein, D. ; Bergren, R. L. ; Fruit, J. ; Hyre, R. ; Palmer, C. ; Silvers, N. ; Lobes, L. ; Paczan Rath, P. ; Conrad, P. W. ; Yalamanchi, S. ; Wesche, J. ; Bratkowksi, M. ; Arslanian, S. ; Rinkoff, J. ; Warnicki, J. ; Curtin, D. ; Steinberg, D. ; Vagstad, G. ; Harris, R. ; Steranchak, L. ; Arch, J. ; Kelly, K. ; Ostrosaka, P. ; Guiliani, M. ; Good, M. ; Williams, T. ; Olsen, K. ; Campbell, A. ; Shipe, C. ; Conwit, R. ; Finegold, D. ; Zaucha, M. ; Drash, A. ; Morrison, A. ; Malone, J. I. ; Bernal, M. L. ; Pavan, P. R. ; Grove, N. ; Tanaka, E. A. ; McMillan, D. ; Vaccaro-Kish, J. ; Babbione, L. ; Solc, H. ; DeClue, T. J. ; Dagogo-Jack, S. ; Wigley, C. ; Ricks, H. ; Kitabchi, A. ; Chaum, E. ; Murphy, M. B. ; Moser, S. ; Meyer, D. ; Iannacone, A. ; Yoser, S. ; Bryer-Ash, M. ; Schussler, S. ; Lambeth, H. ; Raskin, P. ; Strowig, S. ; Basco, M. ; Cercone, S. ; Zinman, B. ; Barnie, A. ; Devenyi, R. ; Mandelcorn, M. ; Brent, M. ; Rogers, S. ; Gordon, A. ; Bakshi, N. ; Perkins, B. ; Tuason, L. ; Perdikaris, F. ; Ehrlich, R. ; Daneman, D. ; Perlman, K. ; Ferguson, S. ; Palmer, J. ; Fahlstrom, R. ; De Boer, I. H. ; Kinyoun, J. ; Van Ottingham, L. ; Catton, S. ; Ginsberg, J. ; Dupre, J. ; McDonald, C. ; Harth, J. ; Driscoll, M. ; Sheidow, T. ; Mahon, J. ; Canny, C. ; Nicolle, D. ; Colby, P. ; Hramiak, I. ; Rodger, N. W. ; Jenner, M. ; Smith, T. ; Brown, W. ; May, M. ; Lipps Hagan, J. ; Agarwal, A. ; Adkins, T. ; Lorenz, R. ; Feman, S. ; Survant, L. ; White, N. H. ; Levandoski, L. ; Grand, G. ; Thomas, M. ; Joseph, D. ; Blinder, K. ; Shah, G. ; Burgess, D. ; Boniuk, I. ; Santiago, J. ; Tamborlane, W. ; Gatcomb, P. ; Stoessel, K. ; Ramos, P. ; Fong, K. ; Ossorio, P. ; Ahern, J. ; Lachin, J. ; Cleary, P. ; Backlund, J. ; Bebu, I. ; Braffett, B. ; Diminick, L. ; Gao, X. ; Hsu, W. ; Klumpp, K. ; Larsen, M. ; McGee, P. ; Sun, W. ; Villavicencio, S. ; Anderson, K. ; Dews, L. ; Younes, Naji ; Rutledge, B. ; Chan, K. ; Rosenberg, D. ; Petty, B. ; Determan, A. ; Kenny, D. ; Williams, C. / Quality control measures over 30 years in a multicenter clinical study : Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. In: PloS one. 2015 ; Vol. 10, No. 11.
@article{9706e4e59cbb4d62a2d62748cd0ed76d,
title = "Quality control measures over 30 years in a multicenter clinical study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study",
abstract = "Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.",
author = "Lorenzi, {Gayle M.} and Braffett, {Barbara H.} and Arends, {Valerie L.} and Danis, {Ronald P.} and Lisa Diminick and Klumpp, {Kandace A.} and Morrison, {Anthony D.} and Soliman, {Elsayed Z.} and Steffes, {Michael W.} and Cleary, {Patricia A.} and J. Crandall and M. Reid and J. Brown-Friday and S. Engel and J. Sheindlin and M. Phillips and H. Martinez and H. Shamoon and H. Engel and R. Gubitosi-Klug and L. Mayer and S. Pendegast and H. Zegarra and D. Miller and L. Singerman and S. Smith-Brewer and M. Novak and J. Quin and Saul Genuth and M. Palmert and E. Brown and J. McConnell and P. Pugsley and P. Crawford and W. Dahms and D. Brillon and Lackaye, {M. E.} and S. Kiss and R. Chan and A. Orlin and M. Rubin and V. Reppucci and T. Lee and M. Heinemann and S. Chang and B. Levy and L. Jovanovic and M. Richardson and B. Bosco and A. Dwoskin and R. Hanna and S. Barron and R. Campbell and F. Whitehouse and D. Kruger and Jones, {J. K.} and Edwards, {P. A.} and A. Bhan and Carey, {J. D.} and E. Angus and A. Thomas and M. McLellan and A. Galprin and R. Bergenstal and M. Johnson and K. Gunyou and L. Thomas and J. Laechelt and P. Hollander and M. Spencer and D. Kendall and R. Cuddihy and P. Callahan and S. List and J. Gott and N. Rude and B. Olson and M. Franz and G. Castle and R. Birk and J. Nelson and D. Freking and L. Gill and W. Mestrezat and D. Etzwiler and K. Morgan and Aiello, {L. P.} and E. Golden and P. Arrigg and V. Asuquo and R. Beaser and L. Bestourous and J. Cavallerano and R. Cavicchi and O. Ganda and O. Hamdy and R. Kirby and T. Murtha and D. Schlossman and S. Shah and G. Sharuk and P. Silva and P. Silver and M. Stockman and J. Sun and E. Weimann and H. Wolpert and Aiello, {L. M.} and A. Jacobson and L. Rand and J. Rosenzwieg and Nathan, {D. M.} and Larkin, {M. E.} and M. Christofi and K. Folino and J. Godine and P. Lou and C. Stevens and E. Anderson and H. Bode and S. Brink and C. Cornish and D. Cros and L. Delahanty and A. DeManbey and C. Haggan and J. Lynch and C. McKitrick and D. Norman and D. Moore and M. Ong and C. Taylor and D. Zimbler and S. Crowell and S. Fritz and K. Hansen and C. Gauthier-Kelly and Service, {F. J.} and G. Ziegler and R. Colligan and L. Schmidt and B. French and R. Woodwick and R. Rizza and Schwenk, {W. F.} and M. Haymond and J. Pach and J. Mortenson and B. Zimmerman and A. Lucas and L. Luttrell and M. Lopes-Virella and S. Caulder and C. Pittman and N. Patel and K. Lee and M. Nutaitis and J. Fernandes and K. Hermayer and S. Kwon and A. Blevins and J. Parker and J. Colwell and D. Lee and J. Soule and P. Lindsey and M. Bracey and A. Farr and S. Elsing and T. Thompson and J. Selby and T. Lyons and S. Yacoub-Wasef and M. Szpiech and D. Wood and R. Mayfield and M. Molitch and B. Schaefer and L. Jampol and A. Lyon and M. Gill and Z. Strugula and L. Kaminski and R. Mirza and E. Simjanoski and D. Ryan and C. Johnson and A. Wallia and S. Ajroud-Driss and P. Astelford and N. Leloudes and A. Degillio and O. Kolterman and G. Lorenzi and M. Goldbaum and K. Jones and M. Prince and M. Swenson and I. Grant and R. Reed and R. Lyon and M. Giotta and T. Clark and G. Friedenberg and Sivitz, {W. I.} and B. Vittetoe and J. Kramer and M. Bayless and R. Zeitler and H. Schrott and N. Olson and L. Snetselaar and R. Hoffman and J. MacIndoe and T. Weingeist and C. Fountain and D. Counts and S. Johnsonbaugh and M. Patronas and M. Carney and P. Salemi and R. Liss and M. Hebdon and T. Donner and J. Gordon and R. Hemady and A. Kowarski and D. Ostrowski and S. Steidl and B. Jones and Herman, {W. H.} and Martin, {C. L.} and R. Pop-Busui and Greene, {D. A.} and Stevens, {M. J.} and N. Burkhart and T. Sandford and J. Floyd and J. Bantle and N. Wimmergren and J. Terry and D. Koozekanani and S. Montezuma and B. Rogness and M. Mech and T. Strand and J. Olson and L. McKenzie and C. Kwong and F. Goetz and R. Warhol and D. Hainsworth and D. Goldstein and S. Hitt and J. Giangiacomo and Schade, {D. S.} and Canady, {J. L.} and Burge, {M. R.} and A. Das and Avery, {R. B.} and Ketai, {L. H.} and Chapin, {J. E.} and Schluter, {M. L.} and J. Rich and C. Johannes and D. Hornbeck and M. Schutta and Bourne, {P. A.} and A. Brucker and S. Braunstein and S. Schwartz and Maschak-Carey, {B. J.} and L. Baker and T. Orchard and L. Cimino and T. Songer and B. Doft and S. Olson and D. Becker and D. Rubinstein and Bergren, {R. L.} and J. Fruit and R. Hyre and C. Palmer and N. Silvers and L. Lobes and {Paczan Rath}, P. and Conrad, {P. W.} and S. Yalamanchi and J. Wesche and M. Bratkowksi and S. Arslanian and J. Rinkoff and J. Warnicki and D. Curtin and D. Steinberg and G. Vagstad and R. Harris and L. Steranchak and J. Arch and K. Kelly and P. Ostrosaka and M. Guiliani and M. Good and T. Williams and K. Olsen and A. Campbell and C. Shipe and R. Conwit and D. Finegold and M. Zaucha and A. Drash and A. Morrison and Malone, {J. I.} and Bernal, {M. L.} and Pavan, {P. R.} and N. Grove and Tanaka, {E. A.} and D. McMillan and J. Vaccaro-Kish and L. Babbione and H. Solc and DeClue, {T. J.} and S. Dagogo-Jack and C. Wigley and H. Ricks and A. Kitabchi and E. Chaum and Murphy, {M. B.} and S. Moser and D. Meyer and A. Iannacone and S. Yoser and M. Bryer-Ash and S. Schussler and H. Lambeth and P. Raskin and S. Strowig and M. Basco and S. Cercone and B. Zinman and A. Barnie and R. Devenyi and M. Mandelcorn and M. Brent and S. Rogers and A. Gordon and N. Bakshi and B. Perkins and L. Tuason and F. Perdikaris and R. Ehrlich and D. Daneman and K. Perlman and S. Ferguson and J. Palmer and R. Fahlstrom and {De Boer}, {I. H.} and J. Kinyoun and {Van Ottingham}, L. and S. Catton and J. Ginsberg and J. Dupre and C. McDonald and J. Harth and M. Driscoll and T. Sheidow and J. Mahon and C. Canny and D. Nicolle and P. Colby and I. Hramiak and Rodger, {N. W.} and M. Jenner and T. Smith and W. Brown and M. May and {Lipps Hagan}, J. and A. Agarwal and T. Adkins and R. Lorenz and S. Feman and L. Survant and White, {N. H.} and L. Levandoski and G. Grand and M. Thomas and D. Joseph and K. Blinder and G. Shah and D. Burgess and I. Boniuk and J. Santiago and W. Tamborlane and P. Gatcomb and K. Stoessel and P. Ramos and K. Fong and P. Ossorio and J. Ahern and J. Lachin and P. Cleary and J. Backlund and I. Bebu and B. Braffett and L. Diminick and X. Gao and W. Hsu and K. Klumpp and M. Larsen and P. McGee and W. Sun and S. Villavicencio and K. Anderson and L. Dews and Naji Younes and B. Rutledge and K. Chan and D. Rosenberg and B. Petty and A. Determan and D. Kenny and C. Williams",
year = "2015",
month = "11",
day = "3",
doi = "10.1371/journal.pone.0141286",
language = "English (US)",
volume = "10",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "11",

}

TY - JOUR

T1 - Quality control measures over 30 years in a multicenter clinical study

T2 - Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study

AU - Lorenzi, Gayle M.

AU - Braffett, Barbara H.

AU - Arends, Valerie L.

AU - Danis, Ronald P.

AU - Diminick, Lisa

AU - Klumpp, Kandace A.

AU - Morrison, Anthony D.

AU - Soliman, Elsayed Z.

AU - Steffes, Michael W.

AU - Cleary, Patricia A.

AU - Crandall, J.

AU - Reid, M.

AU - Brown-Friday, J.

AU - Engel, S.

AU - Sheindlin, J.

AU - Phillips, M.

AU - Martinez, H.

AU - Shamoon, H.

AU - Engel, H.

AU - Gubitosi-Klug, R.

AU - Mayer, L.

AU - Pendegast, S.

AU - Zegarra, H.

AU - Miller, D.

AU - Singerman, L.

AU - Smith-Brewer, S.

AU - Novak, M.

AU - Quin, J.

AU - Genuth, Saul

AU - Palmert, M.

AU - Brown, E.

AU - McConnell, J.

AU - Pugsley, P.

AU - Crawford, P.

AU - Dahms, W.

AU - Brillon, D.

AU - Lackaye, M. E.

AU - Kiss, S.

AU - Chan, R.

AU - Orlin, A.

AU - Rubin, M.

AU - Reppucci, V.

AU - Lee, T.

AU - Heinemann, M.

AU - Chang, S.

AU - Levy, B.

AU - Jovanovic, L.

AU - Richardson, M.

AU - Bosco, B.

AU - Dwoskin, A.

AU - Hanna, R.

AU - Barron, S.

AU - Campbell, R.

AU - Whitehouse, F.

AU - Kruger, D.

AU - Jones, J. K.

AU - Edwards, P. A.

AU - Bhan, A.

AU - Carey, J. D.

AU - Angus, E.

AU - Thomas, A.

AU - McLellan, M.

AU - Galprin, A.

AU - Bergenstal, R.

AU - Johnson, M.

AU - Gunyou, K.

AU - Thomas, L.

AU - Laechelt, J.

AU - Hollander, P.

AU - Spencer, M.

AU - Kendall, D.

AU - Cuddihy, R.

AU - Callahan, P.

AU - List, S.

AU - Gott, J.

AU - Rude, N.

AU - Olson, B.

AU - Franz, M.

AU - Castle, G.

AU - Birk, R.

AU - Nelson, J.

AU - Freking, D.

AU - Gill, L.

AU - Mestrezat, W.

AU - Etzwiler, D.

AU - Morgan, K.

AU - Aiello, L. P.

AU - Golden, E.

AU - Arrigg, P.

AU - Asuquo, V.

AU - Beaser, R.

AU - Bestourous, L.

AU - Cavallerano, J.

AU - Cavicchi, R.

AU - Ganda, O.

AU - Hamdy, O.

AU - Kirby, R.

AU - Murtha, T.

AU - Schlossman, D.

AU - Shah, S.

AU - Sharuk, G.

AU - Silva, P.

AU - Silver, P.

AU - Stockman, M.

AU - Sun, J.

AU - Weimann, E.

AU - Wolpert, H.

AU - Aiello, L. M.

AU - Jacobson, A.

AU - Rand, L.

AU - Rosenzwieg, J.

AU - Nathan, D. M.

AU - Larkin, M. E.

AU - Christofi, M.

AU - Folino, K.

AU - Godine, J.

AU - Lou, P.

AU - Stevens, C.

AU - Anderson, E.

AU - Bode, H.

AU - Brink, S.

AU - Cornish, C.

AU - Cros, D.

AU - Delahanty, L.

AU - DeManbey, A.

AU - Haggan, C.

AU - Lynch, J.

AU - McKitrick, C.

AU - Norman, D.

AU - Moore, D.

AU - Ong, M.

AU - Taylor, C.

AU - Zimbler, D.

AU - Crowell, S.

AU - Fritz, S.

AU - Hansen, K.

AU - Gauthier-Kelly, C.

AU - Service, F. J.

AU - Ziegler, G.

AU - Colligan, R.

AU - Schmidt, L.

AU - French, B.

AU - Woodwick, R.

AU - Rizza, R.

AU - Schwenk, W. F.

AU - Haymond, M.

AU - Pach, J.

AU - Mortenson, J.

AU - Zimmerman, B.

AU - Lucas, A.

AU - Luttrell, L.

AU - Lopes-Virella, M.

AU - Caulder, S.

AU - Pittman, C.

AU - Patel, N.

AU - Lee, K.

AU - Nutaitis, M.

AU - Fernandes, J.

AU - Hermayer, K.

AU - Kwon, S.

AU - Blevins, A.

AU - Parker, J.

AU - Colwell, J.

AU - Lee, D.

AU - Soule, J.

AU - Lindsey, P.

AU - Bracey, M.

AU - Farr, A.

AU - Elsing, S.

AU - Thompson, T.

AU - Selby, J.

AU - Lyons, T.

AU - Yacoub-Wasef, S.

AU - Szpiech, M.

AU - Wood, D.

AU - Mayfield, R.

AU - Molitch, M.

AU - Schaefer, B.

AU - Jampol, L.

AU - Lyon, A.

AU - Gill, M.

AU - Strugula, Z.

AU - Kaminski, L.

AU - Mirza, R.

AU - Simjanoski, E.

AU - Ryan, D.

AU - Johnson, C.

AU - Wallia, A.

AU - Ajroud-Driss, S.

AU - Astelford, P.

AU - Leloudes, N.

AU - Degillio, A.

AU - Kolterman, O.

AU - Lorenzi, G.

AU - Goldbaum, M.

AU - Jones, K.

AU - Prince, M.

AU - Swenson, M.

AU - Grant, I.

AU - Reed, R.

AU - Lyon, R.

AU - Giotta, M.

AU - Clark, T.

AU - Friedenberg, G.

AU - Sivitz, W. I.

AU - Vittetoe, B.

AU - Kramer, J.

AU - Bayless, M.

AU - Zeitler, R.

AU - Schrott, H.

AU - Olson, N.

AU - Snetselaar, L.

AU - Hoffman, R.

AU - MacIndoe, J.

AU - Weingeist, T.

AU - Fountain, C.

AU - Counts, D.

AU - Johnsonbaugh, S.

AU - Patronas, M.

AU - Carney, M.

AU - Salemi, P.

AU - Liss, R.

AU - Hebdon, M.

AU - Donner, T.

AU - Gordon, J.

AU - Hemady, R.

AU - Kowarski, A.

AU - Ostrowski, D.

AU - Steidl, S.

AU - Jones, B.

AU - Herman, W. H.

AU - Martin, C. L.

AU - Pop-Busui, R.

AU - Greene, D. A.

AU - Stevens, M. J.

AU - Burkhart, N.

AU - Sandford, T.

AU - Floyd, J.

AU - Bantle, J.

AU - Wimmergren, N.

AU - Terry, J.

AU - Koozekanani, D.

AU - Montezuma, S.

AU - Rogness, B.

AU - Mech, M.

AU - Strand, T.

AU - Olson, J.

AU - McKenzie, L.

AU - Kwong, C.

AU - Goetz, F.

AU - Warhol, R.

AU - Hainsworth, D.

AU - Goldstein, D.

AU - Hitt, S.

AU - Giangiacomo, J.

AU - Schade, D. S.

AU - Canady, J. L.

AU - Burge, M. R.

AU - Das, A.

AU - Avery, R. B.

AU - Ketai, L. H.

AU - Chapin, J. E.

AU - Schluter, M. L.

AU - Rich, J.

AU - Johannes, C.

AU - Hornbeck, D.

AU - Schutta, M.

AU - Bourne, P. A.

AU - Brucker, A.

AU - Braunstein, S.

AU - Schwartz, S.

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PY - 2015/11/3

Y1 - 2015/11/3

N2 - Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

AB - Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.

UR - http://www.scopus.com/inward/record.url?scp=84951763118&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84951763118&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0141286

DO - 10.1371/journal.pone.0141286

M3 - Article

C2 - 26529311

AN - SCOPUS:84951763118

VL - 10

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 11

M1 - e0141286

ER -