Recruitment to a clinical trial from the databases of specialists in Parkinson's disease
Recruitment to a clinical trial from the databases of specialists in Parkinson's disease
复制标题
DOI：
10.1016/j.parkreldis.2006.06.004
复制
发表时间：
2007-01-01
影响因子：
4.1
通讯作者：
Carolyn, Fitton
中科院分区：
文献类型：
--
作者：
Ashburn, Ann;Ruth, M. Pickering;Carolyn, Fitton
背景许多涉及居家老年人的临床试验招募率低。我们报告我们的经验，从专业的临床数据库中招募帕金森氏病（PD）的人，一个随机对照试验的个性化exercise.Methods：我们的目的是招募200个重复蹒跚与PD。受试者通过两个NHS信托基金的PD专家临床登记册招募。他们必须有一个确诊的PD，是独立的移动的，住在社区，是一个重复跌倒，并进行了筛选认知impairment.Results：出1107例患者的登记册上，457不符合试验的合格标准。另有151人因其他原因被排除在外。499人接受了家庭筛查访视：405人回复，305人同意接受试验筛查。在筛选的患者中，126人为非重复性跛行，22人未达到其他资格标准。在剩余的157名患者中，18名（11%）决定不参加试验，剩下139名患者入选试验。另外7人是从以前的非重复蹒跚的第二次筛选中招募的。在总共146例患者被招募：142到主试验和4到初始的试点phase.Conclusion：参与主试验的患者的百分比只有13%（95%置信区间11%至15%）的那些专家的注册表，大大低于估计，虽然动摇和重复动摇的比例是类似于以前的报道。(c)2006爱思唯尔有限公司保留所有权利。
Background. Many clinical trials involving elderly people living at home suffer from low recruitment. We report our experience of recruiting people with Parkinson's disease (PD) from specialist clinical databases, to a randomised controlled trial of personalised exercise.Methods: We aimed to recruit 200 repeat falters with PD. Subjects were recruited through the clinical registers of specialists in PD in two NHS trusts. They had to have a confirmed diagnosis of PD, be independently mobile, live in the community, be a repeat faller, and were screened for cognitive impairment.Results: Out of 1107 patients on the registers, 457 did not meet the eligibility criteria for the trial. A further 151 were excluded for other reasons. Four hundred and ninety-nine were approached to have a home screening visit: 405 replied and 305 agreed to be screened for the trial. Of those screened, 126 were non-repeat falters and 22 failed other eligibility criteria. Out of the remaining 157 patients, 18 (11%) decided not to participate in the trial which left 139 recruited to the trial. Seven more were recruited from a second screen of previous non-repeat falters. In total 146 patients were recruited: 142 to the main trial and four to the initial pilot phase.Conclusion: The percentage of patients who participated in the main trial was only 13% (95% confidence interval 11 % to 15%) of those on specialists' registers, considerably less than estimated, although the proportion of falters and repeat falters was similar to that previously reported. (c) 2006 Elsevier Ltd. All rights reserved.