■提供给潜在试验参与者的信息在他们的决策中起着至关重要的作用。印刷的试验参与者信息表一再受到批评,因为它们太长和技术性,没有吸引力,难以导航。另一种选择是通过多媒体(文本,动画,视频,音频,图表和照片)。然而,关于多媒体参与者信息对研究招募率的影响的证据有限,尤其是儿童和年轻人。
■研究目标如下:1.通过参与式设计开发模板多媒体信息资源,用于招募儿童和年轻人参加试验2。为了评估一系列试验中的多媒体信息资源,为了测试它们对招聘和保留率的影响,和参与者决策,通过比较多媒体信息资源而不是印刷参与者信息表的提供,并比较除印刷的参与者信息表外的多媒体信息资源的提供。
■两阶段研究:1.多媒体信息资源开发,包括定性研究;用户测试研究;可读性指标;增强患者和公众参与2。多媒体信息资源\'评估包括在招募儿童和年轻人的主持试验中进行的试验研究。
■涉及18岁以下患者的英国试验。
■发展阶段:n=120(儿童和年轻人,父母,临床医生,审判人员)。评估阶段:n=1906(要求儿童和年轻人参加试验)。
■多媒体信息资源(包括文本,音频,\'说话的头\'视频,特定于试验的和通用的试验动画)。已打印参与者信息表。
■主要结果:比较仅多媒体信息资源和仅打印参与者信息表提供的试验招募率。次要结果:将多媒体信息资源和打印的参与者信息表与仅打印的参与者信息表提供进行比较的试验招募率;试验保留率;参与者决策质量。在两阶段随机效应荟萃分析中计算并合并每个试验的结果。
■第一阶段生成了两个多媒体信息资源模板:(1)6-11岁儿童;(2)12-18岁儿童和父母。在试验中的第二阶段研究中,多媒体信息资源改善了试验招募,与单独打印的信息相比[比值比(OR)=1.54;95%置信区间(CI)1.05~2.28;p=0.03;I2=0%].将仅提供打印的参与者信息表与提供的多媒体信息资源和打印的参与者信息表进行比较,对试验招募没有影响(OR=0.89;95%CI0.53~1.50;I2=0%).多媒体信息资源和印刷的参与者信息表在试验保留或参与者决策质量方面没有差异。在一项假设试验环境下的研究中,仅提供多媒体信息资源比仅提供印刷参与者信息表提供更高的“信息易于理解”(Z=3.03;p=0.003)和“我对决策有信心”(Z=2.00;p=0.044)。
■由于样本量有限,无法在荟萃分析中包含来自一项试验中的三项研究的数据,问卷回报率很低,这降低了研究结果的强度。
■与标准患者信息表相比,多媒体信息的使用增加了涉及儿童和年轻人的试验的招募率。
■应该进一步评估多媒体信息对招募涉及儿童和年轻人的试验的影响。评估多媒体信息资源对试用招聘人员之间沟通的任何影响都是有价值的,儿童和年轻人,和父母。
■该试验注册为TRECAISRCTN73136092和北爱尔兰试验方法学研究中心SWATRepository(SWAT97)。
■该奖项由国家健康与护理研究所(NIHR)健康与社会护理提供研究计划(NIHR奖参考:14/21/21)资助,并在《健康与社会护理提供研究》中全文发表。11号24.有关更多奖项信息,请参阅NIHR资助和奖励网站。
临床试验对国家卫生服务很重要,但是很难招募到足够的人。我们对如何改进招聘不够了解,尤其是在招募儿童和年轻人的时候。人们通常通过印刷信息被告知审判,这通常是漫长而复杂的。多媒体信息(文本,音频,漫画和视频)可能是一种更好的告诉人们的方式。重要的是要测试多媒体干预是否可以提供帮助。这样做的一种方法是运行“试验中的研究”,人们以不同的方式接收信息。我们创建了两个多媒体干预,一个是父母和年轻人被要求同意,对年幼的孩子来说更简单。一些内容适用于所有试验,一些关于具体试验的人被要求考虑。我们通过与儿童和年轻人密切合作来设计这些产品,父母和医护人员。我们在六个试验中测试了多媒体信息(尽管只有三个试验给了我们足够的数据)。孩子们,年轻人和他们的父母看到了标准的印刷信息或我们的多媒体信息。然后我们收集了他们决策的数据,审判招募以及人们是否留在审判中。看到多媒体信息的儿童和年轻人比收到标准印刷信息的儿童和年轻人更有可能被招募。一旦被招募到审判中,接受多媒体或印刷信息的人同样可能留在试验中.人们对多媒体和印刷信息的看法也相似,但这一发现可能受到少数人返回问卷的影响。我们的研究提供了证据,表明多媒体信息可以用于儿童和年轻人的试验,并且它增加了同意参加的人数,但还需要进一步的工作。
UNASSIGNED: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people.
UNASSIGNED: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets.
UNASSIGNED: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources\' evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people.
UNASSIGNED: United Kingdom trials involving patients aged under 18.
UNASSIGNED: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials).
UNASSIGNED: Multimedia information resources (comprising text, audio, \'talking heads\' video, trial-specific and trial-generic animations). Printed participant information sheets.
UNASSIGNED: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis.
UNASSIGNED: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of \'information was easy to understand\' (Z = 3.03; p = 0.003) and \'I had confidence in decision-making\' (Z = 2.00; p = 0.044) than printed participant information sheet-only provision.
UNASSIGNED: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.
UNASSIGNED: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.
UNASSIGNED: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.
UNASSIGNED: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.
Clinical trials are important to National Health Service care, but it can be difficult to recruit enough people. We do not know enough about how to improve recruitment, especially when trying to recruit children and young people. People are normally told about a trial through printed information, which is often long and complex. Multimedia information (text, audio, cartoons and video) might be a better way of telling people. It is important to test whether multimedia interventions can help. One way of doing this is to run a ‘Study Within A Trial’ where people receive information in different ways. We created two multimedia interventions, one for parents and young people being asked for consent, and a simpler one for younger children. Some content applied to all trials, and some about the specific trial people were being asked to consider. We designed these by working closely with children and young people, parents and healthcare staff. We tested the multimedia information in six trials (although only three gave us enough data). Children, young people and their parents saw either standard printed information or our multimedia information. We then collected data on their decision-making, trial recruitment and whether people stayed in the trial. Children and young people who saw multimedia information were more likely to be recruited than those who received standard printed information. Once recruited to a trial, people given multimedia or printed information were similarly likely to remain in the trial. People’s views on multimedia and printed information were also similar, but this finding could have been affected by small numbers of people returning questionnaires. Our study provides evidence that multimedia information can be used in trials with children and young people and that it increases the number of people who agree to take part, but further work is needed.