Ranjani H, Weber M B, Anjana R M, Lakshmi N, Narayan K M Venkat, Mohan V
Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Chennai, India.
Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Diabetes Res Clin Pract. 2015 Oct;110(1):51-59. doi: 10.1016/j.diabres.2015.07.013. Epub 2015 Aug 13.
To describe recruitment challenges in a randomized controlled translational trial (RCTT) of diabetes prevention in India.
The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a RCTT, comparing standard of care to a step-wise model of diabetes prevention. Overweight adults with prediabetes were identified through a two-step screening process (1) field-based screening: minimal testing with a random capillary glucose measurement and (2) clinic-based screening including an Oral Glucose Tolerance Test (OGTT).
Individuals from the community (n=19377) were screened at residential locations, offices, educational institutions, places of worship, parks and beaches. Of these, 3535 (18.2%) 'high-risk' participants based on capillary glucose values were eligible for step 2 screening with OGTT. However, only 21.5% participated. An additional 521 participants directly entered step 2 via direct referrals from our clinical/research databases, study participant referrals and targeted advertisements. Of the 1285 individuals who underwent an OGTT, 710 (55.3%) were eligible for randomization, and 602 (84.8%) were randomized into the trial. The ratio of participants entering from step 1 to step 2 was 25:1 (3.9%) and from step 2 to randomization 2:1 (47%). Average staff time for recruitment was 350 h per week for an 11-person team.
Nearly 55 people needed to be screened with a questionnaire plus capillary glucose test to randomize one participant with prediabetes. Using a 2-step strategy requires additional staff time, but considerably reduces the need for OGTT's, thereby minimizing participant burden and study costs.
描述印度一项糖尿病预防随机对照转化试验（RCTT）中的招募挑战。
糖尿病社区生活方式改善项目（D-CLIP）是一项RCTT，将标准治疗与逐步糖尿病预防模式进行比较。通过两步筛查过程识别超重的糖尿病前期成年人：（1）基于现场的筛查：用随机毛细血管血糖测量进行最少检测；（2）基于诊所的筛查，包括口服葡萄糖耐量试验（OGTT）。
在社区场所（n = 19377）对个人进行筛查，包括居民区、办公室、教育机构、宗教场所、公园和海滩。其中，基于毛细血管血糖值的3535名（18.2%）“高危”参与者有资格进行OGTT第二步筛查。然而，只有21.5%的人参与。另外521名参与者通过我们的临床/研究数据库、研究参与者推荐和定向广告的直接推荐直接进入第二步。在1285名接受OGTT的个体中，710名（55.3%）有资格随机分组，602名（84.8%）被随机纳入试验。从第一步进入第二步的参与者比例为25:1（3.9%），从第二步到随机分组的比例为2:1（47%）。一个11人团队的平均每周招募工作人员时间为350小时。
需要用问卷加毛细血管血糖检测筛查近55人才能随机纳入一名糖尿病前期参与者。采用两步策略需要额外的工作人员时间，但大大减少了OGTT的需求，从而将参与者负担和研究成本降至最低。
