Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.
Christie Patient Centred Research (CPCR), The Christie NHS Foundation Trust, Manchester, UK.
BMC Cancer. 2024 Apr 19;24(1):500. doi: 10.1186/s12885-024-11963-x.
Our aim was to develop a validated Patient Reported Experience Measure (PREM) to capture patient and carer experience during participation in experimental cancer medicine trials (ECM): called PREM-ECM.
Mixed method design, consisting of four stages. Questionnaire items were produced for both patients and carers using interviews, focus groups, and cognitive interviews with patients and carers separately. For both patient and carer PREMs, a cross-sectional questionnaire study was conducted to identify final items for inclusion using hierarchical item reduction and Rasch analysis. Questionnaire validity and reliability were assessed, including administration feasibility.
Initial interview participants suggested the need for three PREMs, two specific to patients: (i) a 'prior' questionnaire that captured experiences of trial introduction, screening, consenting, and early trial experience (< 6 weeks post consent); and (ii) 'on-trial' that captured experiences of ongoing consent and trial participation; and (iii) a PREM specific for carers. The draft 25-item 'prior' questionnaire was completed by 162 patients and 162 patients completed the draft 35-item 'on-trial' questionnaire. Hierarchical and Rasch analysis produced a 14-item 'prior' list and a 15-item list for 'on-trial'. Both patient PREM's demonstrated a good fit to the Rasch model following Bonferroni correction (Xp = 0.008). The carer 34-draft item questionnaire was completed by 102 participants. Hierarchical and Rasch analysis produced a 13-item list for PREM-ECM-Carer, with good fit to the Rasch model ( Xp = 0.62). The pilot testing demonstrated the feasibility of all the PREMs in capturing patient and caregiver experiences in routine clinical settings.
The three PREM-ECM questionnaires will be the first validated experience measures for ECM trial patients and their carers. These questionnaires may be used to assess patients' and their carers' experiences of ECM and enable robust comparisons across cancer trial units highlighting areas for service improvement.
我们的目的是开发一种经过验证的患者报告体验测量（PREM），以捕捉参与实验性癌症药物试验（ECM）的患者和护理人员的体验：称为 PREM-ECM。
混合方法设计，包括四个阶段。使用访谈、焦点小组和患者和护理人员的认知访谈，分别为患者和护理人员制作问卷项目。对于患者和护理人员的 PREM，进行了横断面问卷调查研究，使用层次项目减少和 Rasch 分析来确定纳入的最终项目。评估了问卷的有效性和可靠性，包括管理可行性。
初步访谈参与者提出需要三种 PREM，两种专门针对患者：（i）“前期”问卷，用于捕捉试验介绍、筛选、同意和早期试验体验的经历（同意后<6 周）；和（ii）“在试验中”，用于捕捉持续同意和试验参与的经历；和（iii）专门针对护理人员的 PREM。25 项草案“前期”问卷由 162 名患者完成，35 项草案“在试验中”问卷由 162 名患者完成。层次和 Rasch 分析产生了 14 项“前期”清单和 15 项“在试验中”清单。经过 Bonferroni 校正后，患者 PREM 的两个都与 Rasch 模型拟合良好（Xp=0.008）。102 名参与者完成了护理人员 34 项草案问卷。层次和 Rasch 分析产生了 PREM-ECM-护理人员的 13 项清单，与 Rasch 模型拟合良好（Xp=0.62）。试点测试表明，所有 PREM 都能够在常规临床环境中捕捉患者和护理人员的体验，具有可行性。
这三个 PREM-ECM 问卷将是第一个经过验证的 ECM 试验患者及其护理人员的体验测量。这些问卷可用于评估患者及其护理人员对 ECM 的体验，并能够在癌症试验单位之间进行稳健比较，突出需要改进的领域。
