Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants?
Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants?
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DOI：
10.1186/s13063-015-0582-8
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发表时间：
2015-03-07
期刊：
影响因子：
2.5
通讯作者：
Mackenzie, Isla S.
中科院分区：
文献类型：
--
作者：
Jennings, Claudine G.;MacDonald, Thomas M.;Mackenzie, Isla S.
背景：临床试验的患者招募是一项重大挑战，老年人、社会剥夺者和患有多种合并症的患者往往代表性不足。向患者支付参与研究的奖励的想法是有争议的，需要证据来评估这作为一种招募策略。方法：在本研究中，我们试图评估100英镑的奖励对临床试验招募的影响，以及这项奖励是否吸引了更多的老年人和社会贫困患者。共有1015名潜在患者参加5项临床试验（SCOT、FAST和PATHWAY 1、2和3），随机分组，接受标准试验邀请函或包含100英镑激励报价的试验邀请函。为了获得付款，患者必须参加筛查访问并同意接受筛查（即签署同意书）。为了保持平等，最终所有签署了同意书的病人都能得到100英镑的报酬。结果：100英镑激励方案使第一封邀请函的积极响应率由24.7%提高到31.6%，提高了6.9% （P < 0.05）。激励方案使签署同意书的患者人数增加了5.1% （P < 0.05）。对邀请函作出积极反应的患者平均年龄为66.5 +/- 8.7岁，而对邀请信作出消极反应的患者平均年龄为68.9 +/- 9.0岁。激励措施对患者的年龄没有影响。在大多数社会贫困地区，激励措施并没有改善患者的反应，这些地区患者的反应总体上明显较低。结论：100英镑的奖励性支付在患者对临床试验邀请信的反应和同意接受筛查的患者数量方面都有微小但显著的改善。这种奖励没有吸引到老年人或社会地位较低的患者。
Background: Patient recruitment into clinical trials is a major challenge, and the elderly, socially deprived and those with multiple comorbidities are often underrepresented. The idea of paying patients an incentive to participate in research is controversial, and evidence is needed to evaluate this as a recruitment strategy.Method: In this study, we sought to assess the impact on clinical trial recruitment of a 100 pound incentive payment and whether the offer of this payment attracted more elderly and socially deprived patients. A total of 1,015 potential patients for five clinical trials (SCOT, FAST and PATHWAY 1, 2 and 3) were randomised to receive either a standard trial invitation letter or a trial invitation letter containing an incentive offer of 100 pound. To receive payment, patients had to attend a screening visit and consent to be screened (that is, sign a consent form). To maintain equality, eventually all patients who signed a consent form were paid 100 pound.Results: The 100 pound incentive offer increased positive response to the first invitation letter from 24.7% to 31.6%, an increase of 6.9% (P < 0.05). The incentive offer increased the number of patients signing a consent form by 5.1% (P < 0.05). The mean age of patients who responded positively to the invitation letter was 66.5 +/- 8.7 years, whereas those who responded negatively were significantly older, with a mean age of 68.9 +/- 9.0 years. The incentive offer did not influence the age of patients responding. The incentive offer did not improve response in the most socially deprived areas, and the response from patients in these areas was significantly lower overall.Conclusion: A 100 pound incentive payment offer led to small but significant improvements in both patient response to a clinical trial invitation letter and in the number of patients who consented to be screened. The incentive payment did not attract elderly or more socially deprived patients.