Research The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial
Research The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial
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DOI：
10.1186/1745-6215-11-39
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发表时间：
2010-04-15
期刊：
影响因子：
2.5
通讯作者：
Lloyd, Keith
中科院分区：
文献类型：
--
作者：
McGregor, Joanna;Brooks, Caroline;Lloyd, Keith
背景：临床试验的招募可能具有挑战性。我们确定了匿名的潜在参与者，以评估使用常规收集的数据来确定潜在的试验参与者的可行性。我们讨论这种方法的优势和局限性，评估其潜在的价值，报告遇到的挑战和伦理问题。方法：斯旺西大学的健康信息研究单位的安全匿名信息链接（SAIL）数据库的常规收集的健康记录进行了询问，使用结构化查询语言（SQL）。读取代码用于创建入选/排除标准的算法，以识别合适的匿名参与者。两名独立的临床医生对潜在参与者的资格进行了评估。使用kappa统计量和类间相关性评估评估者间可靠性。结果：研究人群（N = 37263）包括在英国斯旺西五家全科诊所注册的所有成年人。使用该算法确定了867名匿名潜在参与者。灵敏度和特异性结果> 0.9表明该算法具有较高的准确度。评分员间信度结果表明，确认评分员之间的高度一致。类内相关系数（Cronbach的阿尔法）> 0.9，建议优秀的协议和Kappa系数> 0.8，几乎完美agreement.Conclusions：这个概念研究的证明表明，常规收集的初级保健数据可用于确定潜在的参与者为一个务实的随机对照试验叶酸增强抗抑郁治疗抑郁症。将需要进一步的工作，以评估其他条件和设置的普遍性，并纳入这种方法，以支持电子增强招聘（EER）。
Background: Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered.Methods: Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL) database of routinely collected health records was interrogated, using Structured Query Language (SQL). Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation.Results: The study population (N = 37263) comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha) > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement.Conclusions: This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER).