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采用自动化招募流程生成多发性硬化症患者的无偏研究样本。

Using an automated recruitment process to generate an unbiased study sample of multiple sclerosis patients.

机构信息

Mellen Center for Treatment and Research in Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.

出版信息

Telemed J E Health. 2010 Jan-Feb;16(1):63-8. doi: 10.1089/tmj.2009.0078.

DOI:10.1089/tmj.2009.0078
PMID:20064056
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2998972/
Abstract

The objective of this study was to test the efficiency of an automated recruitment methodology developed as a component of a practical controlled trial to assess the benefits of a Web-based personal health site to guide self-management of multiple sclerosis symptoms called Mellen Center Care On-line. We describe the study's automated recruitment methodology using clinical and administrative databases and assess the comparability between subjects who completed informed consent (IC) forms, and individuals who were invited to participate but did not reply, designated as patient nonresponders (PNR). The IC and PNR groups were compared on demographics, number of physician or advanced practice nurse/physician assistant visits during the 12 months prior to the initial invitation, and level of disability as measured by the Charlson Comorbidity Index (CCI). Out of a total dynamic potential pool of 2,421 patients, 2,041 had been invited to participate, 309 had become ineligible to participate during the study, and 71 individuals remained in the pool at the end of recruitment. The IC group had a slightly greater proportion of females. Both groups were predominantly white with comparable marital status. The groups had comparable mean household income, education level, and commercial insurance. The computed mean CCI was similar between the groups. The only significant difference was that the PNR group had fewer clinic visits in the preceding 12 months. The subjects were highly representative of the target population, indicating that there was little bias in our selection process despite a constantly changing pool of eligible individuals.

摘要

本研究的目的是测试一种自动化招募方法的效率,该方法是一项实用对照试验的组成部分,旨在评估基于网络的个人健康网站对多发性硬化症症状自我管理的益处,该网站名为 Mellen 中心在线护理。我们使用临床和管理数据库描述了研究的自动化招募方法,并评估了完成知情同意书(IC)表格的受试者与被邀请参加但未回复的个体(称为患者无应答者 [PNR])之间的可比性。比较了 IC 组和 PNR 组的人口统计学特征、在最初邀请前 12 个月内与医生或高级实践护士/医师助理的就诊次数,以及 Charlson 合并症指数(CCI)衡量的残疾程度。在 2421 名有动态潜在参与人数中,有 2041 人被邀请参加,309 人在研究期间失去了参与资格,71 人在招募结束时仍留在池中。IC 组中女性比例略高。两组均以白种人为主,婚姻状况相似。两组的家庭收入中位数、教育水平和商业保险中位数相当。两组的 CCI 平均值相似。唯一的显著差异是 PNR 组在过去 12 个月的就诊次数较少。研究对象非常代表目标人群,表明我们的选择过程几乎没有偏见,尽管合格个体的数量不断变化。

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本文引用的文献

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J Healthc Inf Manag. 2007 Summer;21(3):44-8.
2
Usage patterns of a personal health record by elderly and disabled users.老年人和残疾用户对个人健康记录的使用模式。
AMIA Annu Symp Proc. 2007 Oct 11;2007:409-13.
3
Physicians' perceptions of an electronic health record-based clinical trial alert approach to subject recruitment: a survey.医生对基于电子健康记录的临床试验警报式受试者招募方法的看法:一项调查
BMC Med Inform Decis Mak. 2008 Apr 2;8:13. doi: 10.1186/1472-6947-8-13.
4
Raising the ivory tower: the production of knowledge and distrust of medicine among African Americans.打破象牙塔:非裔美国人的知识生产与对医学的不信任
J Med Ethics. 2007 Mar;33(3):177-80. doi: 10.1136/jme.2006.016329.
5
Using web-based screening to enhance efficiency of HMO clinical trial recruitment in women aged forty and older.利用基于网络的筛选来提高健康维护组织(HMO)对40岁及以上女性临床试验招募的效率。
Clin Trials. 2007;4(1):102-5. doi: 10.1177/1740774506075863.
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The EHR solution to clinical trial recruitment in physician groups.针对医师群体临床试验招募的电子健康记录解决方案。
Health Manag Technol. 2006 Dec;27(12):22-5.
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