Swansea University Medical School, Singleton Park, Swansea, UK.
Department of Nursing, The College of Human and Health Sciences, Swansea University, Singleton Park, Swansea, UK.
Sci Rep. 2018 May 16;8(1):7668. doi: 10.1038/s41598-018-25954-z.
Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.
大多数随机对照试验（RCT）都是短期的，由于成本和可用资源的限制，它们很少有机会被重新访问或延长。不能保证治疗效果在研究结束后不会发生变化。在这里，我们展示了通过电子随访来丰富标准试验设计的可行性、益处和成本效益。我们对一项研究益生菌对 2005-2007 年出生的儿童哮喘和湿疹影响的 RCT 进行了为期 5 年的电子随访，传统的现场随访时间为两年。在五年后，我们使用安全、常规、匿名、基于个人的电子健康服务数据库来识别和分析参与者和试验结果。在两年时，我们识别出了 93%的参与者，并将现场工作与电子健康记录进行了比较，突出了一致性和分歧性的领域。保留了来自社会经济水平较低的群体的儿童，减少了志愿者偏差。在 5 年时，我们只识别出了 82%的参与者。这些数据允许对哮喘终点进行首次稳健的分析。我们没有发现孕妇和婴儿补充益生菌可以预防 5 岁时的哮喘或湿疹的迹象。继续进行更长时间的随访在技术上是简单直接的。
