Mother and Infant Research Unit, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJ, UK.
Clinical Research Fellow, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK.
BMC Med Res Methodol. 2023 Sep 28;23(1):214. doi: 10.1186/s12874-023-02016-1.
Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample. This paper, which reports a pilot study within a randomised controlled trial of induction of labour, reports the feasibility, and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index, a new mixed qualitative / quantitative PREM tool.
The single-sheet PaGES Index was completed by hypertensive pregnant women in two hospitals in Nagpur, India before and after taking part in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) randomised controlled trial. Participants recorded aspects of the impending birth they considered most important, and then ranked them. After the birth, participants completed the PaGES Index again, this time also scoring their satisfaction with each item. Forms were completed on paper in the local language or in English, supported by Research Assistants. Following translation (when needed), responses were uploaded to a REDCap database, coded in Excel and analysed thematically. A formal qualitative evaluation (qMOLI) was also conducted to obtain stakeholder perspectives of the PaGES Index and the wider trial. Semi-structured interviews were conducted with participants, and focus groups with researchers and clinicians. Data were managed using NVivo 12 software and analysed using the framework approach.
Participants and researchers found the PaGES Index easy to complete and administer; mothers valued the opportunity to speak about their experience. Qualitative analysis of the initial 68 PaGES Index responses identified areas of commonality and difference among participants and also when comparing antenatal and postnatal responses. Theme citations and associated comments scores were fairly stable before and after the birth. The qMOLI phase, comprising 53 one-to-one interviews with participants and eight focus groups involving 83 researchers and clinicians, provided support that the PaGES Index was an acceptable and even helpful means of capturing participant perspectives.
Subjective participant experiences are an important aspect of clinical trials. The PaGES Index was found to be a feasible and acceptable measure that unites qualitative research's explanatory power with the comparative power of quantitative designs. It also offers the opportunity to conduct a before-and-after evaluation, allowing researchers to examine the expectations and actual experiences of all clinical trial participants, not just a small sub-sample. This study also shows that, with appropriate research assistant input, the PaGES Index can be used in different languages by participants with varying literacy levels.
Clinical Trials.gov (21/11/2018) (NCT03749902).
患者报告的结局或经验测量（PROMS / PREMS）通常用于临床研究中，以评估参与者对试验干预措施的看法和经验以及相关的生活质量。根据参与者的自身优先级，纯定量方法缺乏理解研究干预措施对参与者实际影响所需的详细信息和灵活性。相反，纯定性评估耗时且通常仅限于小的、可能没有代表性的亚样本。本文报告了一项在诱导分娩的随机对照试验中的试点研究，报告了一种新的混合定性/定量 PREM 工具——参与者生成的体验和满意度（PaGES）指数的可行性和可接受性。
在印度那格浦尔的两家医院参加“米索前列醇或催产素引产”（MOLI）随机对照试验之前和之后，高血压孕妇填写了单页 PaGES 索引。参与者记录了他们认为即将到来的分娩中最重要的方面，然后对这些方面进行了排名。分娩后，参与者再次填写 PaGES 索引，同时对每个项目的满意度进行评分。参与者可以用当地语言或英语在纸上填写表格，研究助理会提供支持。在翻译（需要时）之后，将响应上传到 REDCap 数据库中，在 Excel 中进行编码并进行主题分析。还进行了正式的定性评估（qMOLI），以获得参与者对 PaGES 指数和更广泛试验的观点。对参与者进行了半结构化访谈，对研究人员和临床医生进行了焦点小组讨论。使用 NVivo 12 软件管理数据，并使用框架方法进行分析。
参与者和研究人员发现 PaGES 索引易于完成和管理；母亲们非常重视有机会谈论自己的经历。对最初的 68 个 PaGES 索引响应的定性分析确定了参与者之间以及产前和产后响应之间的共同点和差异。主题引用和相关评论得分在分娩前后相当稳定。qMOLI 阶段包括对 68 名参与者的 53 次一对一访谈和 83 名研究人员和临床医生的 8 次焦点小组讨论，为 PaGES 指数是一种可以接受甚至有助于捕获参与者观点的方法提供了支持。
主观的参与者体验是临床试验的一个重要方面。研究发现 PaGES 指数是一种可行且可接受的衡量标准，它将定性研究的解释力与定量设计的比较力结合在一起。它还提供了进行前后评估的机会，使研究人员能够检查所有临床试验参与者的期望和实际体验，而不仅仅是小的亚样本。这项研究还表明，在适当的研究助理的帮助下，参与者可以用不同的语言填写 PaGES 索引，并且参与者的读写水平也各不相同。
ClinicalTrials.gov（2018 年 11 月 21 日）（NCT03749902）。
