Recruitment and retention of participants for an international type 1 diabetes prevention trial: A coordinators' perspective
Recruitment and retention of participants for an international type 1 diabetes prevention trial: A coordinators' perspective
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DOI：
10.1177/1740774513510070
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发表时间：
2014-04-01
期刊：
影响因子：
2.7
通讯作者：
Catteau, Jacki
中科院分区：
文献类型：
--
作者：
Franciscus, Margaret;Nucci, Anita;Catteau, Jacki
研究背景降低遗传风险人群中胰岛素依赖型糖尿病的研究（Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk，TRIGR）是第一个多中心的国际1型糖尿病（T1D）预防研究。TRIGR的一个独特之处是招募符合条件的孕妇和新生儿进行长期随访评估。PurposeOur目的是从研究协调员的角度总结用于进行TRIGR的招募和保留策略。MethodsTRIGR旨在测试断奶到含有水解牛奶蛋白的配方奶粉与完整牛奶蛋白的配方奶粉是否有效降低T1D的发展风险。根据人类白细胞抗原（HLA）谱和家族史，确定T1D风险增加的婴儿中的相关自身抗体和T1D。多个策略，适合当地的问题，需要招募和遵循的目标数量infants.ResultsThis研究在美国，加拿大，澳大利亚和12个国家在欧洲进行。在全球登记的5606名母亲中，有5000名婴儿被随机分组。其中，2159例符合HLA条件，并入组本研究的8个月干预和10年随访期。TRIGR研究在招募4.7年后达到了应计目标，比最初预测的时间长2.7年。挑战包括难以找到患有T1D的父亲，T1D母亲的早产率高于预期，以及在试验期间实施新的隐私法规。大多数参与者是从研究中心附近的初级保健产前诊所和TRIGR研究中心附属的综合医院或儿科中心招募的。因特网和杂志广告被认为有助于招募家庭。替代后续战略提供给家庭谁希望减少或停止participation.LimitationsOur经验是有限的，以一个单一的国际多中心trial.ConclusionsTRIGR协调员在招聘和干预期间发挥了关键作用，并继续在保留家庭和儿童在10年的随访期间为每个孩子。
BackgroundThe Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments.PurposeOur purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators.MethodsTRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants.ResultsThis study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation.LimitationsOur experience is limited to a single international multicenter trial.ConclusionsTRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child.