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

Volumn 10, Issue 11, 2015, Pages

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

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b GEORGE WASHINGTON UNIVERSITY   (United States)

^c UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^d UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^e UNIVERSITY OF SOUTH FLORIDA   (United States)

^f WAKE FOREST SCHOOL OF MEDICINE   (United States)

^g ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^h CASE WESTERN RESERVE UNIVERSITY   (United States)

ⁱ WEILL CORNELL MEDICAL COLLEGE   (United States)

^j HENRY FORD HEALTH SYSTEM   (United States)

^k INTERNATIONAL DIABETES CENTER   (United States)

^l JOSLIN DIABETES CENTER   (United States)

^m MASSACHUSETTS GENERAL HOSPITAL   (United States)

ⁿ MAYO CLINIC   (United States)

^o MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^p NORTHWESTERN UNIVERSITY   (United States)

^q UNIVERSITY OF CALIFORNIA   (United States)

^r UNIVERSITY OF IOWA   (United States)

^s UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^t UNIVERSITY OF MICHIGAN   (United States)

^u UNIVERSITY OF MINNESOTA   (United States)

^v UNIVERSITY OF MISSOURI   (United States)

^w UNIVERSITY OF NEW MEXICO   (United States)

^x UNIVERSITY OF PENNSYLVANIA   (United States)

^y UNIVERSITY OF PITTSBURGH   (United States)

^z UNIVERSITY OF TENNESSEE   (United States)

^aa UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^ab UNIVERSITY OF TORONTO   (Canada)

^ac UNIVERSITY OF WASHINGTON   (United States)

^ad UNIVERSITY OF WESTERN ONTARIO   (Canada)

^ae VANDERBILT UNIVERSITY   (United States)

^af WASHINGTON UNIVERSITY   (United States)

^ag YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLOOD PRESSURE MEASUREMENT; CERTIFICATION; CLINICAL STUDY; DIABETES CONTROL; DIABETES MELLITUS; DIGITAL IMAGING; HUMAN; INFORMATION PROCESSING; MEDICAL HISTORY; MULTICENTER STUDY (TOPIC); ONLINE SYSTEM; OUTCOME ASSESSMENT; PROFESSIONAL STANDARD; QUALITY CONTROL; REPRODUCIBILITY; ADOLESCENT; ADULT; CLINICAL TRIAL; CONTROLLED STUDY; DIABETES COMPLICATIONS; FEMALE; FOLLOW UP; HEALTH CARE QUALITY; MALE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; DIABETES COMPLICATIONS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; QUALITY ASSURANCE, HEALTH CARE;

EID: 84951763118     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0141286     Document Type: Article

References (22)

1. Whitney CW, Lind BK, Wahl PW. Quality assurance and quality control in longitudinal studies. Epidemiol Rev 1998; 20(1):71-80. PMID: 9762510
2. Gassman JJ, Owen WW, Kuntz TE, Martin JP, Amoroso WP. Data quality assurance, monitoring, and reporting. Control Clin Trials 1995 Apr; 16(2 Suppl):104S-136S. PMID: 7789140
3. Neta G, Samet J, Rajaraman P. Quality Control and Good Epidemiological Practice. 2014.
4. Cushman M, Cornell ES, Howard PR, Bovill EG, Tracy RP. Laboratory methods and quality assurance in the Cardiovascular Health Study. Clin Chem 1995 Feb; 41(2):264-270. PMID: 7874780
5. Bergmann MM, Bussas U, Boeing H. Follow-up procedures in EPIC-Germany - data quality aspects. European Prospective Investigation into Cancer and Nutrition. Ann Nutr Metab 1999; 43(4):225-234. PMID: 10592371
6. Hilner JE, McDonald A, Van Horn L, Bragg C, Caan B, Slattery ML, et al. Quality control of dietary data collection in the CARDIA study. Control Clin Trials 1992 Apr; 13(2):156-169. PMID: 1316830
7. Prud'homme GJ, Canner PL, Cutler JA. Quality assurance and monitoring in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Control Clin Trials 1989 Sep; 10(3 Suppl):84S-94S. PMID: 2680275
8. The DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993 Sep 30; 329(14):977-986. PMID: 8366922
9. The DCCT/EDIC Research Group. Epidemiology of Diabetes Interventions and Complications (EDIC). Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort. Diabetes Care 1999 Jan; 22(1):99-111. PMID: 10333910
10. The DCCT Research Group. The Diabetes Control and Complications Trial (DCCT). Design and methodologic considerations for the feasibility phase. Diabetes 1986 May; 35(5):530-545. PMID: 2869996
11. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology 1978 Jan; 85(1):82-106. PMID: 345173
12. Prineas RJ, Crow RS, Zhang ZM. The Minnesota Code Manual of Electrocardiographic Findings. 2nd ed. London: Springer; 2010.
13. Klein BE, Davis MD, Segal P, Long JA, Harris WA, Haug GA, et al. Diabetic retinopathy. Assessment of severity and progression. Ophthalmology 1984 Jan; 91(1):10-17. PMID: 6709313
14. Carletta J. Assessing agreement on classification tasks: the kappa statistic. Computational Linguistics 1996; 22(2):249-254.
15. White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, et al. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control and Complications Trial. Arch Ophthalmol 2008 Dec; 126(12):1707-1715. doi: 10.1001/archopht.126.12.1707 PMID: 19064853
16. Kemperman FA, Weber JA, Gorgels J, van Zanten AP, Krediet RT, Arisz L. The influence of ketoacids on plasma creatinine assays in diabetic ketoacidosis. J Intern Med 2000 Dec; 248(6):511-517. PMID: 11155144
17. Greenberg N, Roberts WL, Bachmann LM, Wright EC, Dalton RN, Zakowski JJ, et al. Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles. Clin Chem 2012 Feb; 58(2):391-401. doi: 10.1373/clinchem.2011.172288 PMID: 22166253
18. de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Zinman B, et al. Longitudinal changes in estimated and measured GFR in type 1 diabetes. J Am Soc Nephrol 2014 Apr; 25(4):810-818. doi: 10.1681/ASN.2013050557 PMID: 24309189
19. Younes N, Cleary PA, Steffes MW, de Boer IH, Molitch ME, Rutledge BN, et al. Comparison of urinary albumin-creatinine ratio and albumin excretion rate in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study. Clin J Am Soc Nephrol 2010 Jul; 5(7):1235-1242. doi: 10.2215/CJN.07901109 PMID: 20448066
20. Hubbard LD, Sun W, Cleary PA, Danis RP, Hainsworth DP, Peng Q, et al. Comparison of digital and film grading of diabetic retinopathy severity in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Arch Ophthalmol 2011 Jun; 129(6):718-726. doi: 10.1001/archophthalmol.2011.136 PMID: 21670338
21. Hubbard LD, Danis RP, Neider MW, Thayer DW, Wabers HD, White JK, et al. Brightness, contrast, and color balance of digital versus film retinal images in the age-related eye disease study 2. Invest Ophthalmol Vis Sci 2008 Aug; 49(8):3269-3282. doi: 10.1167/iovs.07-1267 PMID: 18421079
22. Kramer JR, Bayless ML, Lorenzi GM, Ziegler GK, Larkin ME, Lackaye ME, et al. Participant characteristics and study features associated with high retention rates in a longitudinal investigation of type 1 diabetes mellitus. Clin Trials 2012 Dec; 9(6):798-805. doi: 10.1177/1740774512458986 PMID: 23027646