Refusal to participate in heart failure studies: do age and gender matter?

Refusal to participate in heart failure studies: do age and gender matter?
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DOI:
10.1111/jocn.13135
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发表时间:
2016-04-01
影响因子:
4.2
通讯作者:
Pressler, Susan J.
Pressler, Susan J.
中科院分区:
医学2区
文献类型:
--
作者:
Harrison, Jordan M.;Jung, Miyeon;Pressler, Susan J.

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目的和目的本回顾性研究的目的是评估心力衰竭患者拒绝参与研究的原因,为干预措施提供信息以提高入组率。研究背景未能将老年心力衰竭患者(年龄在65岁至65岁之间)和女性纳入研究可能导致抽样偏倚,威胁研究的有效性。本研究回顾性分析了来自4个州的788名患者的4项心力衰竭研究的拒绝数据。方法采用schi - square和合并t检验来分析被邀请参加四项研究之一但拒绝参加的心力衰竭患者的拒绝数据(n=300)。结果300例患者(男性66%,平均年龄6533岁)的拒绝原因包括:不感兴趣(n=163)、太忙(n=64)、旅行负担(n=50)、病重(n=38)、家庭问题(n=14)、承诺太多(n=13)和隐私问题(n=4)。卡方分析显示,男性和女性之间的原因频率没有差异(p < 0.05)。拒绝接受治疗的患者平均年龄比研究参与者大。结论部分原因与患者相关;其他人则是学习依赖型。“不感兴趣”是最常见的原因,超过50%的患者拒绝了,招聘措施应以激发患者的兴趣为目标。可能需要额外的努力来招募年长的参与者。然而,拒绝的理由不分性别都是一致的。与临床实践的相关性心力衰竭研究人员应该积极主动地接触更多的女性和65岁以上的患者。由于拒绝理由的类型没有性别差异,男性和女性可以采用类似的招聘策略。然而,在心力衰竭研究中纳入具有代表性比例的女性已被证明是难以捉摸的,可能需要研究人员付出巨大的努力。采用策略来激发对研究的兴趣对于招募心力衰竭患者至关重要,他们绝大多数将缺乏兴趣作为拒绝的首要原因。
Aims and objectivesThe objective of this retrospective study was to evaluate reasons heart failure patients decline study participation, to inform interventions to improve enrollment.BackgroundFailure to enrol older heart failure patients (age>65) and women in studies may lead to sampling bias, threatening study validity.DesignThis study was a retrospective analysis of refusal data from four heart failure studies that enrolled 788 patients in four states.MethodsChi-Square and a pooled t-test were computed to analyse refusal data (n=300) obtained from heart failure patients who were invited to participate in one of the four studies but declined.ResultsRefusal reasons from 300 patients (66% men, mean age 6533) included: not interested (n=163), too busy (n=64), travel burden (n=50), too sick (n=38), family problems (n=14), too much commitment (n=13) and privacy concerns (n=4). Chi-Square analyses showed no differences in frequency of reasons (p>005) between men and women. Patients who refused were older, on average, than study participants.ConclusionsSome reasons were patient-dependent; others were study-dependent. With not interested' as the most common reason, cited by over 50% of patients who declined, recruitment measures should be targeted at stimulating patients' interest. Additional efforts may be needed to recruit older participants. However, reasons for refusal were consistent regardless of gender.Relevance to clinical practiceHeart failure researchers should proactively approach a greater proportion of women and patients over age 65. With no gender differences in type of reasons for refusal, similar recruitment strategies can be used for men and women. However, enrolment of a representative proportion of women in heart failure studies has proven elusive and may require significant effort from researchers. Employing strategies to stimulate interest in studies is essential for recruiting heart failure patients, who overwhelmingly cited lack of interest as the top reason for refusal.