Population Health Sciences, University of Bristol, Bristol, UK.
Population Health Sciences, University of Bristol, Bristol, UK.
Clin Oncol (R Coll Radiol). 2020 Jun;32(6):382-389. doi: 10.1016/j.clon.2020.01.029. Epub 2020 Feb 20.
De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them.
A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a 'plan of action' to optimise recruitment.
Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. 'Tips' documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet.
This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.
降阶梯试验具有挑战性，有时由于招募效果不佳而失败。OPTIMAPrelim 随机对照试验（ISRCTN42400492）将早期乳腺癌患者随机分配至化疗组与“试验导向”化疗组，可能出现无需化疗的结果，这可能比常规治疗带来更少的获益。尽管面临挑战，OPTIMAPrelim 仍提前达到了招募目标。本研究报告了招募挑战的根本原因和成功克服这些挑战的策略。
采用混合方法的招募干预措施（QuinteT Recruitment Intervention）来调查招募困难，并将反馈结果用于干预措施并优化正在进行的招募。使用描述性、主题性和对话分析方法对定量的站点水平招募数据、音频记录的招募预约（n=46）、与试验人员/招募人员（肿瘤学家/护士）的定性访谈（n=22）以及面向患者的文件进行分析。将研究结果进行三角剖分，以制定“行动计划”来优化招募。
尽管初衷良好，但肿瘤学家的常规做法使招募复杂化。由于根据肿瘤临床病理特征推荐化疗的常规做法，他们对偏离常规做法感到不适，导致并非所有符合条件的患者都被接触到。音频记录的招募预约揭示了常规做法如何破坏了招募。在呈现随机对照试验之前，倾向于为化疗提供理由，并暗示化疗会带来更多/更少的获益，这破坏了均衡并使患者难以参与 OPTIMAPrelim。为了解决这些挑战，对个体和小组招募人员的反馈进行了重点关注，并讨论了有关接触患者的不适的沟通问题和符合条件的患者案例。有关如何组织讨论和传达均衡的“技巧”文件以及对患者信息表的修订，已在各站点传播。
这是第一项阐明肿瘤学家常规做法与降阶梯试验招募之间紧张关系的研究。尽管需要时间和资源，但这些挑战可以通过在试验进行时提供具体的反馈和培训来解决。
