Green Sophie M C, Smith Samuel G
Leeds Institute of Health Sciences, University of Leeds, Leeds, England, LS2 9LU, UK.
NIHR Open Res. 2024 May 30;4:32. doi: 10.3310/nihropenres.13547.1. eCollection 2024.
Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer, which increases the risk of recurrence and mortality. A consistently reported barrier to adherence is low perceived necessity of AET and high concerns. Existing interventions to support medication beliefs have mixed effectiveness and rarely target medication beliefs specifically. We developed an information leaflet with five candidate components aiming to increase necessity beliefs about AET and reduce concerns; (1) diagrams explaining how AET works; (2) icon arrays displaying the benefits of AET; (3) information about the prevalence of side-effects; (4) answers to common concerns and (5) quotes and pictures from breast cancer survivors. Guided by the multiphase optimisation strategy (MOST), we aimed to optimise the content of the information leaflet. We planned for the dataset to be open access to provide an exemplar for other investigators to use.
The content of the leaflet was optimised in a fully powered online 2 factorial experiment. Each candidate component of the leaflet was operationalised as a factor with two levels; on vs off or enhanced vs basic. Healthy women (n=1604) completed the beliefs about medicines questionnaire and were randomised to view one of 32 versions of the information leaflet. The 32 versions comprised unique combinations of the factor levels corresponding to the five candidate intervention components. Time spent on the information leaflet page of the survey was recorded. After viewing the information leaflet, participants completed the beliefs about medicines questionnaire again, a true/false questionnaire assessing their objective knowledge of AET, a subjective rating of their knowledge of AET, and a questionnaire evaluating their satisfaction with the information they received.
The factorial dataset provides the opportunity for other investigators interested in using the MOST framework to learn about complex factorial designs, using a real dataset.
乳腺癌女性辅助内分泌治疗（AET）的依从性较低，这会增加复发和死亡风险。一直以来，依从性的一个障碍是对AET的必要性认识不足和担忧程度较高。现有的支持用药信念的干预措施效果参差不齐，而且很少专门针对用药信念。我们编写了一份包含五个候选组成部分的信息手册，旨在增强对AET的必要性信念并减少担忧；（1）解释AET作用机制的图表；（2）展示AET益处的图标阵列；（3）关于副作用发生率的信息；（4）对常见问题的解答；（5）乳腺癌幸存者的引述和图片。在多阶段优化策略（MOST）的指导下，我们旨在优化信息手册的内容。我们计划使数据集开放获取，为其他研究人员提供一个范例以供使用。
在一项充分有力的在线二因素实验中对手册内容进行优化。手册的每个候选组成部分都作为一个有两个水平的因素进行操作化；开启与关闭或增强与基本。健康女性（n = 1604）完成了用药信念问卷，并被随机分配查看32个版本信息手册中的一个。这32个版本由与五个候选干预组成部分相对应的因素水平的独特组合构成。记录调查中在信息手册页面上花费的时间。查看信息手册后，参与者再次完成用药信念问卷、一份评估其对AET客观知识的是非问卷、对其AET知识的主观评分以及一份评估其对所接收信息满意度的问卷。
该析因数据集为其他有兴趣使用MOST框架的研究人员提供了一个机会，可通过一个真实数据集了解复杂的析因设计。
