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用于识别符合入选临床试验条件患者的桌面软件:使用SARMA招募到ROAD可行性试验中

Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial.

作者信息

Treweek Shaun, Pearson Ewan, Smith Natalie, Neville Ron, Sargeant Paul, Boswell Brian, Sullivan Frank

机构信息

Clinical and Population Sciences and Education, University of Dundee, Dundee, UK.

出版信息

Inform Prim Care. 2010;18(1):51-8. doi: 10.14236/jhi.v18i1.753.

Abstract

BACKGROUND

Recruitment to trials in primary care is often difficult, particularly when practice staff need to identify study participants with acute conditions during consultations. The Scottish Acute Recruitment Management Application (SARMA) system is linked to general practice electronic medical record (EMR) systems and is designed to provide recruitment support to multi-centre trials by screening patients against trial inclusion criteria and alerting practice staff if the patient appears eligible. For patients willing to learn more about the trial, the software allows practice staff to send the patient's contact details to the research team by text message.

AIM

To evaluate the ability of the software to support trial recruitment.

DESIGN OF STUDY

Software evaluation embedded in a randomised controlled trial.

SETTING

Five general practices in Tayside and Fife, Scotland.

METHODS

SARMA was used to support recruitment to a feasibility trial (the Response to Oral Agents in Diabetes, or ROAD trial) looking at users of oral therapy in diabetes. The technical performance of the software and its utility as a recruitment tool were evaluated.

RESULTS

The software was successfully installed at four of the five general practices and recruited 11 of the 29 participants for ROAD (other methods were letter and direct invitation by a practice nurse) and had a recruitment return of 35% (11 of 31 texts sent led to a recruitment). Screen failures were relatively low (7 of 31 referred). Practice staff members were positive about the system.

CONCLUSION

An automated recruitment tool can support primary care trials in Scotland and has the potential to support recruitment in other jurisdictions. It offers a low-cost supplement to other trial recruitment methods and is likely to have a much lower screen failure rate than blanket approaches such as mailshots and newspaper campaigns.

摘要

背景

在基层医疗中开展试验的招募工作往往困难重重,尤其是当执业人员需要在诊疗过程中识别患有急性疾病的研究参与者时。苏格兰急性招募管理应用程序(SARMA)系统与全科医疗电子病历(EMR)系统相连,旨在通过根据试验纳入标准筛查患者,并在患者似乎符合条件时提醒执业人员,为多中心试验提供招募支持。对于愿意进一步了解试验的患者,该软件允许执业人员通过短信将患者的联系方式发送给研究团队。

目的

评估该软件支持试验招募的能力。

研究设计

嵌入随机对照试验的软件评估。

研究地点

苏格兰泰赛德和法夫的五家全科医疗机构。

方法

使用SARMA来支持一项可行性试验(糖尿病口服药物反应试验,即ROAD试验)的招募工作,该试验针对糖尿病口服治疗的使用者。对该软件的技术性能及其作为招募工具的效用进行了评估。

结果

该软件在五家全科医疗机构中的四家成功安装,为ROAD试验招募了29名参与者中的11名(其他招募方法包括信件和执业护士直接邀请),招募回报率为35%(发送的31条短信中有11条促成了招募)。筛查失败率相对较低(31条转诊中有7条)。执业人员对该系统持积极态度。

结论

自动化招募工具可为苏格兰的基层医疗试验提供支持,并有可能在其他司法管辖区支持招募工作。它为其他试验招募方法提供了低成本的补充,并且可能比邮寄宣传和报纸宣传等全面覆盖的方法具有低得多的筛查失败率。

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