The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial.
The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial.
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DOI：
10.1186/s13063-016-1631-7
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发表时间：
2016-10-13
期刊：
影响因子：
2.5
通讯作者：
LIFT Diabetes Research Team
中科院分区：
文献类型：
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作者：
Effoe VS;Katula JA;Kirk JK;Pedley CF;Bollhalter LY;Brown WM;Savoca MR;Jones ST;Baek J;Bertoni AG;LIFT Diabetes Research Team
在临床试验招募中使用电子病历（EMR）系统有可能提供一种非常可靠和具有成本效益的招募方法，可以改善临床试验中的受试者招募。我们在糖尿病治疗的生活方式干预（LIFT糖尿病）试验中检查了以EMR和其他传统方法的使用为中心的招募方法。LIFT糖尿病是一项随机对照试验，旨在研究两种对比干预措施对心血管疾病风险的影响：一种以社区为基础的强化生活方式计划，旨在实现减肥和一种以诊所为基础的增强型糖尿病自我管理计划。合格的参与者为21岁或以上的超重/肥胖（体重指数，BMI ≥25 kg/m2）2型糖尿病患者。招募策略包括使用EMR系统（主要），直接转介，媒体广告和社区筛选。共进行了1102次电话筛选，在21个月的时间内随机分配了260名参与者（61.5%来自EMR，平均年龄56.3岁，66.2%为女性，48.1%为非西班牙裔黑人），收益率为23.6%。招聘方法的招聘率不同，推荐的招聘率最高（27.5%）。心血管疾病史是从研究中排除的主要健康原因（16.5%）。另有8.9%的人因BMI <25 kg/m2（胰岛素使用者<27 kg/m2）而被排除，5.4%的人不能运动，5.2%的人HbA 1c> 11%，34.9%的人因其他非医学原因被排除。排除标准似乎对人种或种族的入组没有差异性影响。未来的临床研究应根据感兴趣的参与者人口统计学来调整其招募策略。有效的方法，如使用电子病历系统和转介应优先于劳动密集型，低收益的方法，如社区筛选和大规模邮寄。ClinicalTrials.gov：NCT01806727。2013年3月5日注册。本文的在线版本（doi：10.1186/s13063-016-1631-7）包含补充材料，可供授权用户使用。
The use of the electronic medical record (EMR) system in recruitment in clinical trials has the potential for providing a very reliable and cost-effective recruiting methodology which may improve participant recruitment in clinical trials. We examined a recruitment approach centered on the use of the EMR, as well as other traditional methods, in the Lifestyle Intervention for Treatment of Diabetes (LIFT Diabetes) trial. LIFT Diabetes is a randomized controlled trial designed to investigate the effects of two contrasting interventions on cardiovascular disease risk: a community-based intensive lifestyle program aimed at achieving weight loss and a clinic-based enhanced diabetes self-management program. Eligible participants were overweight/obese (body mass index, BMI ≥25 kg/m2) patients with type 2 diabetes who were aged 21 years or older. Recruitment strategies included the use of the EMR system (primary), direct referrals, media advertisements, and community screenings. A total of 1102 telephone screens were conducted, resulting in randomization of 260 participants (61.5 % from EMR, mean age 56.3 years, 66.2 % women, 48.1 % non-Hispanic blacks) over a 21-month period, with a yield of 23.6 %. Recruitment yields differed by recruitment method, with referrals having the highest yield (27.5 %). A history of cardiovascular disease was the main health reason for exclusion from the study (16.5 %). An additional 8.9 % were excluded for BMI <25 kg/m2 (<27 kg/m2 for insulin users), 5.4 % could not exercise, 5.2 % had an HbA1c >11 %, and 34.9 % were excluded for other non-medical reasons. Exclusion criteria did not appear to differentially affect enrollment in terms of race or ethnicity. Future clinical studies should tailor their recruitment strategies based on the participant demographics of interest. Efficient methods such as using the EMR system and referrals should be prioritized over labor-intensive, low-yielding methods such as community screenings and mass mailings. ClinicalTrials.gov: NCT01806727. Registered on 5 March 2013. The online version of this article (doi:10.1186/s13063-016-1631-7) contains supplementary material, which is available to authorized users.
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影响因子：
--
作者：
Parra-Medina, D;D'Antonio, A;Mayer-Davis, E
通讯作者：
Mayer-Davis, E
DOI：
10.1093/gerona/glt064
发表时间：
2013-12-01
影响因子：
5.1
作者：
Marsh, Anthony P.;Lovato, Laura C.;Guralnik, Jack M.
通讯作者：
Guralnik, Jack M.
影响因子：
6.2
作者：
JOSEPH, RR
通讯作者：
JOSEPH, RR
影响因子：
2.2
作者：
Blackwell, Caroline S.;Foster, Kara A.;Goff, David C., Jr.
通讯作者：
Goff, David C., Jr.
影响因子：
3.9
作者：
通讯作者：
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