Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Health Services Management Centre, School of Social Policy, University of Birmingham, Birmingham, B15 2RT, UK.
Trials. 2019 Jul 24;20(1):453. doi: 10.1186/s13063-019-3496-z.
Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates by conducting a pragmatic 'study within a trial' (SWAT) embedding a trial of a multimedia resource within an existing trial.
The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by patient and public involvement (PPI) contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised.
Nine point six percent of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (odds ratio (OR) = 0.844, 95% confidence interval (CI) 0.58 to 1.22). We also found no effects on the proportion of people responding to the invitation (OR = 1.02, 95% CI 0.79 to 1.33) or retention in the trial at 6 (ORs 0.84, 95% CI 0.57 to 1.22) and 12 months after randomisation (ORs 0.80, 95% CI 0.54 to 1.18), respectively.
The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population.
Current controlled trials ISRCTN 06710391 . Registered on 21 November 2013.
SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START). Registered on 11 January 2012.
高质量的信息对于试验的有效知情同意至关重要，但当前基于纸质的知情同意程序可能难以操作且难以理解，这可能会阻碍人们参与试验。多媒体资源可能能够提供更易获取和用户友好的信息。我们旨在通过在一项现有的试验中嵌入对多媒体资源的试验来测试提供对多媒体资源的访问是否会影响招募率，这是一项“试验中的试验”（SWAT）。
PSM COPD 研究纳入了来自初级保健的轻度慢性阻塞性肺疾病（COPD）症状患者，他们被随机分配接受护士提供的电话健康指导干预或常规初级保健。对于招募程序的 SWAT，参与招募的实践被聚类随机分配使用标准的纸质患者信息材料或标准的纸质患者信息材料加访问多媒体信息资源。多媒体资源由患者和公众参与（PPI）贡献者和研究人员开发，包括研究特定信息（例如研究目的、风险）和关于试验的通用信息（例如保密性、随机化）。我们列出了组件并使用动画和视频剪辑，由患者讨论他们的参与经验，与这些组件相匹配。主要结果是随机分配的参与者比例。
接受标准纸质患者信息材料和访问多媒体信息资源的患者中，有 9.6%被招募，而仅接受标准纸质材料的患者中，有 10.8%被招募（比值比（OR）=0.844，95%置信区间（CI）0.58 至 1.22）。我们还发现，对邀请的回应比例（OR=1.02，95%CI 0.79 至 1.33）或在随机分组后 6（ORs 0.84，95%CI 0.57 至 1.22）和 12 个月时的保留率（ORs 0.80，95%CI 0.54 至 1.18）没有影响。
该研究表明，在提供患者信息材料的同时提供多媒体信息资源对招募没有好处。这可能反映了患者对多媒体资源的参与有限。进一步使用多媒体资源将需要探索如何将内容明确匹配用户需求和偏好，以及鼓励参与的方法，以观察是否可以增强效果。更多将多媒体资源纳入正在进行的试验的 SWAT 将提供更精确的效果估计，并进一步探索效果如何因试验背景和招募过程、干预措施和患者人群而异。
当前对照试验 ISRCTN 06710391。于 2013 年 11 月 21 日注册。
SWAT 注册：SWAT 23：用于辅助试验招募的系统技术（MRC START）。于 2012 年 1 月 11 日注册。
