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招募老年人参与随机对照饮食干预试验——有那么难吗?

Recruiting older people to a randomised controlled dietary intervention trial--how hard can it be?

机构信息

Department of oncology, Faculty of Medicine and Dentistry and Health, The University of Sheffield, Royal Hallamshire Hospital, Glossop Rd, Sheffield, S10 2JF, UK.

出版信息

BMC Med Res Methodol. 2010 Feb 22;10:17. doi: 10.1186/1471-2288-10-17.

Abstract

BACKGROUND

The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited.

METHODS

This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study). The number of people approached and recruited, and the reasons for exclusion, will be discussed.

RESULTS

Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General) Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods). The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study.

CONCLUSION

The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets.

摘要

背景

一项人体干预试验的成功取决于招募合格志愿者的能力。许多试验因不切实际的招募目标和有缺陷的招募策略而失败。为了准确预测招募率,研究人员需要了解各种招募策略的相对成功率。很少有发表的试验包括此类信息,而且筛选或接触的参与者人数并不总是被引用。

方法

本文将详细描述为招募参加为期 6 个月的随机对照饮食干预试验而采用的招募策略,该试验旨在探索饮食与免疫功能之间的关系(FIT 研究)。将讨论所接触和招募的人数以及排除的原因。

结果

共有 217 名参与者参加了试验。总共向潜在的招募者发送了 7482 封信件,使用的是当地家庭(全科)医生提供的姓名和地址。843 名潜在的招募者回复了所有的招募方式(528 名来自 GP 信件,315 名来自其他方式)。通过筛选电话访谈确定了那些回复者的资格,其中 217 名被认为符合条件并同意参加研究。

结论

该研究展示了多种招募方法在成功招募老年人参加随机对照试验中的应用。最成功的招募方法是通过 NHS 信头纸用全科医生提供的联系方式向潜在的招募者发信。该方法实现了 90%的招募。充足的招募是研究项目成功的基础,因此必须采取适当的策略来确定合格的个人并实现招募目标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b824/2843618/2765c453a59e/1471-2288-10-17-1.jpg

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