Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension-HAEL Study: a study within a trial.
Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension-HAEL Study: a study within a trial.
复制标题
老年高血压患者体育锻炼临床试验的招募方法和收益率-HAEL研究：试验中的研究。
DOI：
10.1186/s12874-022-01535-7
复制
发表时间：
2022-02-10
影响因子：
4
通讯作者：
Umpierre D
中科院分区：
文献类型：
--
作者：
Botton CE;Santos LP;Moraes BG;Monteiro RB;Gomes MLB;Wilhelm EN;Pinto SS;Umpierre D
虽然高血压在老年人中的患病率很高，但临床试验的招募是一个挑战。我们的主要目的是描述HAEL研究的招募方法和收率。次要目的是探讨排除的原因和描述入组参与者的特征。这是一项试验中的描述性研究。HAEL研究是一项巴西随机双中心平行试验，估计有184名参与者。招聘策略基于四种方法：电子健康记录、口头宣传、印刷和电子传单以及新闻媒体。获选率是按研究中心、年龄和性别、按招募方法计算的，随机分配的参与者人数与筛选的志愿者总数之比。此外，我们描述了筛选阶段排除的原因，以及入组者的人口统计学特征。数据以绝对/相对频率和平均值±标准差表示。共有717人接受了筛查，其中168人在32个月内被随机分配。在整个样本中，口口相传的回收率更高（30.1%）。然而，在试验中随机分配的参与者的绝对数量中，新闻媒体的贡献最大（39.9%）。协调中心和参与中心在产量比和随机参与者的绝对数量上存在差异。在筛选阶段被排除在外的主要原因是打算参加研究的人的身体活动状况（61.5%）。在纳入的220名参与者中，52名被排除，主要是因为他们不符合资格标准（26.9%）。大多数筛选的志愿者是60-69岁的女性（60.2%）（59.5%），大多数随机参与者是高加索/白人（78.0%）。多种招聘方式构成了有效的招聘策略。我们观察到，大约每四个被筛选的个体中就有一个被分配到干预组。即便如此，在获得具有代表性的巴西老年高血压患者样本方面仍存在局限性。数据显示，种族和年龄群体的代表性不足。这个特警没有注册。
Although the prevalence of hypertension is high in older adults, clinical trial recruitment is a challenge. Our main aim was to describe the HAEL Study recruitment methods and yield rates. The secondary objectives were to explore the reasons for exclusion and to describe the characteristics of the enrolled participants. This is a descriptive study within a trial. The HAEL Study was a Brazilian randomized two-center, parallel trial with an estimated sample of 184 participants. The recruitment strategy was based on four methods: electronic health records, word of mouth, print and electronic flyer, and press media. The yield rate was the ratio of the number of participants who underwent randomization to the total number of volunteers screened, calculated for overall, per recruitment method, by study center and by age group and sex. Additionally, we described the reasons for exclusion in the screening phase, as well as the demographic characteristics of those enrolled. The data are presented in absolute/relative frequencies and mean ± standard deviation. A total of 717 individuals were screened, and 168 were randomized over 32 months. The yield rate was higher for word of mouth (30.1%) in the overall sample. However, press media contributed the most (39.9%) to the absolute number of participants randomized in the trial. The coordinating center and participating center differed in methods with the highest yield ratios and absolute numbers of randomized participants. The main reason for exclusion in the screening phase was due to the physically active status in those intending to participate in the study (61.5%). Out of 220 participants included, 52 were excluded mainly because they did not meet the eligibility criteria (26.9%). Most of the screened volunteers were women (60.2%) age 60–69 years (59.5%), and most of the randomized participants were Caucasian/white (78.0%). Multiple recruitment methods constituted effective strategies. We observed that approximately one of every four individuals screened was allocated to an intervention group. Even so, there were limitations in obtaining a representative sample of older Brazilian adults with hypertension. Data show an underrepresentation of race and age groups. This SWAT was not registered.
登录
查看更多内容
影响因子：
5.4
作者：
Cornelissen VA;Smart NA
通讯作者：
Smart NA
影响因子：
5.4
作者：
MacDonald HV;Johnson BT;Huedo-Medina TB;Livingston J;Forsyth KC;Kraemer WJ;Farinatti PT;Pescatello LS
通讯作者：
Pescatello LS
DOI：
10.1038/s41581-019-0244-2
发表时间：
2020-04
期刊：
Nature reviews. Nephrology
影响因子：
--
作者：
Mills KT;Stefanescu A;He J
通讯作者：
He J
影响因子：
8.3
作者：
Nolan, Robert P.;Floras, John S.;Chen, Maggie H.
通讯作者：
Chen, Maggie H.
DOI：
10.1093/gerona/glt064
发表时间：
2013-12-01
影响因子：
5.1
作者：
Marsh, Anthony P.;Lovato, Laura C.;Guralnik, Jack M.
通讯作者：
Guralnik, Jack M.