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participants who are 3 years of age or older at the time of the visit
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participants who are 3 years of age or older at the time of the visit • Medication inventory: List of currently prescribed medications. SEARCH participants with an IPS will be invited to complete the IPV if they meet the following eligibility criteria. If <10 years of age and have type 1 diabetes, we will invite 50% of non-Hispanic White and 100% of all minority youth to participate in the IPV. All youth with type 2 diabetes will be invited to the visit. To encourage IPV participation, a remuneration of $80.00 in cash or gift cards will be offered. Some centers may offer assistance with transportation in order to facilitate these visits. We will seek to complete a 70% rate among those participants invited to the IPV (Table 5-2). Table 5-2. Estimated Number of Cases Registered, and Participating in the IPS and IPV Per Year Center Estimated N Incident cases/year NHW<10 Other Total Estimated N IPS/year Estimated N IPV/year* SC 70 206 276 248 179 OH 51 113 164 147 104 CO 132 244 376 338 236 CA 15 213 228 205 156 WA 75 154 229 206 145 Total 343 930 1,273 1,144 820 5.1.3. Mortality Surveillance To address Aim 3 of this study, we will conduct surveillance of mortality including all- cause and cause-specific mortality in the incident cohorts. All centers will systematically identify deaths that occur between the date of diagnosis and December 31, 2010 among youth in the 2002-2008 incident cohorts (registered during SEARCH 1 and 2) using the National Death Index (NDI) as the primary source, plus individual case reports of deaths made to the study team during the course of the study. The NDI is a central computerized index of death record information from State vital statistics offices nationwide. By the spring 2012, the NDI will include death record information through 2010. Due to HIPAA and IRB considerations that preclude this activity from being done centrally, each center will submit their cases to the NDI. The NDI Plus service will be used so that any potential matches are returned with the cause of death codes. Subjects Section 5A - Case Ascertainment & Data Collection (Phase 3 - 1/2011) Section 5A - Page 6 Registry Study (rev. 8/2011) who are known to be deceased will be submitted separately to obtain cause of death. Records will be searched for all years for which vital status cannot be confirmed. Death certificates and reports of deaths by immediate family members or the participant’s health care provider will also be considered definitive evidence of mortality. Next of kin will not be contacted when a death is identified. Based on the 9,448 incident 2002-2008 cases registered to date, we anticipate that we will have ≈ 46,863 person-years (p-y) of follow-up with a mean follow-up time of 5 years for the cohort (35,836 p-y for T1D; 9.144 p-y for T2D). P-Y of follow-up will be calculated from the date of diagnosis until the date of death or December 31, 2010. We will examine all-cause mortality as well as cause-specific mortality. Cause of death will be obtained from the codes on the death using a standardized international protocol. In the analyses of risk and cause of death using this population-based cohort, we will evaluate the association between mortality and cause-specific mortality by gender, age, race/ethnicity, and DM type. In addition, targeted exploratory subgroup analysis will be conducted to examine the associations between variables measured at SEARCH visits including history of acute complications. |