Malhotra Shweta, Musgrave Stanley D, Pinnock Hilary, Price David, Ryan Dermot P
Clinical Department of General Practice and Primary Care, University of Aberdeen, UK; Department of Emergency Medicine, SUNY Downstate and Kings County Hospital, Brooklyn, NY, USA.
Clinical Department of General Practice and Primary Care, University of Aberdeen, UK.
Pragmat Obs Res. 2012 Aug 23;3:51-55. doi: 10.2147/POR.S34380. eCollection 2012.
Achieving target recruitment in randomized controlled trials (RCTs) is challenging. This paper compares our experience of recruiting for an RCT with the predictions made in our proposal.
Participating UK primary care practices searched their computer databases to identify patients (12 years and over) with asthma who may be poorly controlled. Postal invitations were sent to all patients identified. Respondees were prescreened by phone, to assess their asthma control and establish their mobile phone suitability. Potentially eligible patients were booked for a trial recruitment visit.
We recruited 288 patients (2.4% of those invited) across 32 practices, with a total list size of 311,926 patients. This compares to our predicted recruitment of 312 patients from a population of 72,000 patients in six to eight practices. In addition to the recognized problem of poor response rates, the major challenges were insufficiently discriminating computer searches and incompatibilities between mobile phone handsets, networks and the asthma application.
Our data have implications for clinicians, managers, and researchers in primary care. Researchers in this area may wish to consider our data when designing their recruitment strategies. Improved coding of asthma morbidity data in clinical practice would ease identification of poorly controlled patients, both for clinical interventions and recruitment to trials. If telehealth is to become mainstream, there needs to be standardization of applications, operating platforms, and network capabilities.
在随机对照试验(RCT)中实现目标招募具有挑战性。本文将我们在一项RCT招募中的经验与我们提案中的预测进行了比较。
参与研究的英国基层医疗诊所搜索其计算机数据库,以识别可能控制不佳的哮喘患者(12岁及以上)。向所有识别出的患者发送邮寄邀请。通过电话对回复者进行预筛选,以评估他们的哮喘控制情况并确定他们是否适合使用手机。潜在符合条件的患者被安排进行试验招募访问。
我们在32家诊所招募了288名患者(占受邀者的2.4%),总名单规模为311,926名患者。相比之下,我们预计在六到八家诊所从72,000名患者中招募312名患者。除了公认的低回复率问题外,主要挑战还包括计算机搜索区分度不足以及手机、网络与哮喘应用程序之间的不兼容性。
我们的数据对基层医疗中的临床医生、管理人员和研究人员具有启示意义。该领域的研究人员在设计招募策略时可能希望考虑我们的数据。在临床实践中改进哮喘发病率数据的编码,将有助于识别控制不佳的患者,既有利于临床干预,也有利于试验招募。如果远程医疗要成为主流,应用程序、操作平台和网络功能需要标准化。