METHODS: Keyword searches in bibliographic databases and review of abstracts identified 120 relevant publications; in-depth targeted literature review of the qualitative studies identified key symptoms/functioning concepts. SML was conducted using publicly accessible social media sources with focus on ophthalmologic diseases using a pre-defined search string. Relevant posts from individuals with presbyopia (n = 270) were analysed and key concepts identified. Semi-structured CE interviews were conducted with individuals with presbyopia (US n = 30, Germany n = 10, France n = 10), and HCPs (US = 3, France n = 2, Germany n = 1, Japan n = 1) who were experienced in treating presbyopia. Verbatim transcripts were coded using thematic analysis. A conceptual model summarised concepts identified across sources RESULTS: Out of the total of 158 concepts identified across the three sources, qualitative CE interviews yielded the highest number of concepts (n = 151/158, 96%), with SML yielding a third of the concepts (n = 51/158, 32%) and the literature review yielding the fewest concepts (n = 33/158, 21%). Qualitative CE interviews provided greater depth of data than SML and literature reviews. SML and literature reviews were less costly and quicker to run than qualitative CE interviews and also were less burdensome for participants.
CONCLUSIONS: Qualitative CE interviews are considered the gold standard in providing greater depth of understanding of the patient experience, and more robust data. However, research requirements, budget, and available time should be considered when choosing the most appropriate research method. More time and cost-effective SML and literature review methods can be used to supplement qualitative CE interview data and provide early identification of measurement concepts. More research and regulatory guidance into less traditional qualitative methods, however, are needed to increase the value of SML and literature review data.
方法:在书目数据库中进行的关键词搜索和对摘要的回顾确定了120种相关出版物;对定性研究的深入有针对性的文献回顾确定了关键症状/功能概念。SML是使用可公开访问的社交媒体来源进行的,重点是眼科疾病,使用预定义的搜索字符串。分析了老花眼患者(n=270)的相关帖子,并确定了关键概念。对老花眼患者进行了半结构化CE访谈(美国n=30,德国n=10,法国n=10),和有治疗老花眼经验的HCP(美国=3,法国n=2,德国n=1,日本n=1)。使用主题分析对逐字记录进行编码。在三个来源中确定的158个概念中,定性CE访谈产生的概念数量最多(n=151/158,96%),SML产生了三分之一的概念(n=51/158,32%),文献综述产生的概念最少(n=33/158,21%)。定性CE访谈提供了比SML和文献综述更深入的数据。与定性CE访谈相比,SML和文献综述的成本更低,运行速度更快,并且对参与者的负担也更小。
结论:定性CE访谈被认为是提供更深入了解患者体验的黄金标准。和更强大的数据。然而,研究要求,预算,选择最合适的研究方法时,应考虑可用时间。更多的时间和成本效益的SML和文献综述方法可用于补充定性CE访谈数据,并提供测量概念的早期识别。更多的研究和监管指导进入不太传统的定性方法,然而,需要增加SML和文献综述数据的价值。