Microsoft Word search phase 3 Title Page Amendment

participants in SEARCH 2 understood the questions that dealt with transition.  
iii)
 
Topic 3: Satisfaction with Care: We will use existing questions from the 
SEARCH Quality of Care survey (based on CAHPS survey) to assess satisfaction 
with care provider for both pre and post transition subjects. 

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Section 5B - Data Collection (Phase 3 - 1/2011, rev. 8/2011) 
Section 5B - Page 10 
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iv)
 
Topic 4: Transition experience for those who have changed care providers.  We 
will add 3 questions about the transition process for those who reported a change 
in provider.  
5.1.17.
 
Validation sub-study: comparison of participant responses and medical records 
Participant/parent self-report of medical events and health care received is imperfect.  
Self-report may be limited by several factors, including the desire to give the correct or 
socially-desirable response, recall of events, and awareness of the services received.  
Further, recall accuracy may vary based on sociodemographic characteristics, such as 
education and income and the age of the respondent.  In a study that compared recall of 
ambulatory care services by adults with chronic health conditions with medical record 
review, the authors suggested that recall of “memorable” services, such as blood pressure 
measurement, may be substantially better than for more invisible services, such as 
specific tests being done using a blood sample 
(47)
.   
It is not feasible to conduct complete medical record reviews on all SEARCH Cohort 
Study participants.  Therefore, we will conduct a sub-study to validate self-report of key 
medical events and selected markers of health care quality against clinical medical 
information in the medical record.  Specifically, we will validate episodes of acute 
hypoglycemia requiring medical assistance (ED visit or hospitalization), DKA, ED visits, 
and hospitalizations.  To evaluate the validity of these data elements, we will use 
information in the medical record (including information stored in electronic health 
records and clinical databases) to assess the frequency of these services compared to the 
frequency reported on the survey.  A random sample of 25 charts for each center (total of 
1250 records) will be reviewed to assess the concordance.  With this number we can 
estimate 95% confidence intervals for the true concordance rate within +/- 20% for each 
site, and overall, if we find that the sites have consistent levels of concordance, we can 
estimate the 95% confidence interval for the true concordance within +/-8%.  In addition 
to examining the concordance rates, we will examine kappa statistics both within sites 
and overall t o see what level of agreement exists. 
5.2.
 
EXPANSION OF REPOSITORY OF BIOLOGICAL SPECIMENS 
The Northwest Lipid Metabolism and Diabetes Research Laboratories (NWRL) has been the 
Central Laboratory for the SEARCH for Diabetes in Youth Study since its inception.  In 
addition to performing analysis, the laboratory has stored, processed, and retrieved serum, 
plasma, urine and DNA samples collected from study participants for analysis at NWRL and 
other laboratories participating in SEARCH ancillary studies.  From the SEARCH Cohort Visit 
we will supplement this repository with additional stored plasma, serum, urine and DNA.  
Through the well-established SEARCH Ancillary Study policies, we encourage investigators 
outside of the SEARCH team to utilize this resource. 

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Section 5B - Data Collection (Phase 3 - 1/2011, rev. 8/2011) 
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Reference List 
 
1.
 
Wenzlau JM, Liu Y, Yu L, Moua O, Fowler KT, Rangasamy S, Walters J, Eisenbarth GS, 
Davidson HW, Hutton JC. A common nonsynonymous single nucleotide polymorphism in 
the SLC30A8 gene determines ZnT8 autoantibody specificity in type 1 diabetes. Diabetes 
2008 Oct;57(10):2693-7. 
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Sosenko JM, Palmer JP, Greenbaum CJ, Mahon J, Cowie C, Krischer JP, Chase HP, White 
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Albers JJ, Marcovina SM, Imperatore G, Snively BM, Stafford J, Fujimoto WY, Mayer-
Davis EJ, Petitti DB, Pihoker C, Dolan L, Dabelea DM. Prevalence and determinants of 
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1975 Dec;11(6):541-8. 
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JM, Liese AD, Liu L, Marcovina S, Rodriguez B. Diabetes in African American youth: 
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Mayer-Davis E, Nichols M, Liese AD, Bell R, Dabelea D, Johansen J, Pihoker C, Rodriguez 
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Cheng YJ, Gregg EW, Geiss LS, Imperatore G, Williams DE, Zhang X, Albright AL, 
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Klein R, Sharrett AR, Klein BE, Chambless LE, Cooper LS, Hubbard LD, Evans G. Are 
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Communities Study. Arterioscler Thromb Vasc Biol 2000 Jun;20(6):1644-50. 
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McGeechan K, Liew G, Macaskill P, Irwig L, Klein R, Klein BE, Wang JJ, Mitchell P, 
Vingerling JR, de Jong PT, Witteman JC, Breteler MM, Shaw J, Zimmet P, Wong TY. 
Prediction of incident stroke events based on retinal vessel caliber: a systematic review and 
individual-participant meta-analysis. Am J Epidemiol 2009 Dec 1;170(11):1323-32. 
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Klein R, Klein BE, Moss SE, Wong TY. Retinal vessel caliber and microvascular and 
macrovascular disease in type 2 diabetes: XXI: the Wisconsin Epidemiologic Study of 
Diabetic Retinopathy. Ophthalmology 2007 Oct;114(10):1884-92. 

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Section 5B - Data Collection (Phase 3 - 1/2011, rev. 8/2011) 
Section 5B - Page 12 
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11.
 
Bayu SM, Wang JJ, Donaghue KC, Cheung N, itez-Aguirre P, Jenkins A, Hsu W, Lee ML, 
Wong TY. Alterations in Retinal Microvascular Geometry in Young Type 1 Diabetes.