Ingram Jenny, Beasant Lucy, Benson John, Brunt Adrian Murray, Maxwell Anthony, Harvey James Richard, Greenwood Rosemary, Roberts Nicholas, Williams Norman, Johnson Debbie, Winters Zoe
Bristol Medical School, University of Bristol, Bristol, BS8 1NU, UK.
Addenbrookes Hospital, Cambridge and School of Medicine Anglia Ruskin University, Cambridge, UK.
Pilot Feasibility Stud. 2022 Feb 28;8(1):46. doi: 10.1186/s40814-022-01007-1.
A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.
Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.
Overarching themes of (1) influences on equipoise and recruitment and (2) effects of a lack of equipoise were generated. Within these themes, health professional themes described the barriers to recruitment as 'the treatment landscape has changed', 'staff preferences and beliefs' which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of 'altruism and timing of trial approach', 'influences from consultants and others' and 'diagnostic journey doubts' all played a part in whether patients agreed to take part in the trial.
Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.
ISRCTN ( ISRCTN17987569 ) registered on April 20, 2018, and ClinicalTrials.gov ( NCT03514654 ).
2018年9月至2020年3月开展了一项多中心可行性试验（迈阿密试验），比较随机分配接受治疗性乳房成形术或乳房切除术的多原发性同侧乳腺癌女性的结局和生活质量。迈阿密外科试验旨在研究招募足够数量女性的情况。英国10家乳腺护理中心的多学科团队确定了190例多原发性同侧乳腺癌诊断患者；20例符合试验参与条件，但在联系后仅招募到4例患者。一项嵌套的定性研究旨在了解招募失败的原因。
2019年11月至2020年9月，对来自8家参与或试图参与迈阿密试验招募工作的医院乳腺护理中心的17名工作人员，以及来自4个中心的7名患者进行了访谈，这7名患者包括所有参与试验的患者以及一些拒绝参与的患者。访谈进行了录音，匿名处理，并采用主题方法进行分析，通过不断比较的过程将编码构建为主题和子主题。
产生了两个总体主题，即（1）对 equipoise 和招募的影响，以及（2）缺乏 equipoise 的影响。在这些主题中，卫生专业人员主题将招募障碍描述为“治疗格局已改变”、影响 equipoise 和患者建议的“工作人员偏好和信念”，以及两种治疗方法对患者而言差异有多大。患者主题中的“利他主义和试验接触时机”、“来自顾问和其他人的影响”以及“诊断过程疑虑”，都对患者是否同意参与试验起到了作用。
乳腺癌外科试验的招募障碍可能很大，特别是在所提供的治疗方法存在重大差异且医疗保健专业人员未向患者传达 equipoise 的情况下。患者可能会被众多参与研究试验的请求以及试验讨论的不恰当时间压得喘不过气来。对于外科干预措施，可能需要采用替代金标准随机对照试验的研究设计，以提供高质量的实践依据证据。
ISRCTN（ISRCTN17987569）于2018年4月20日注册，ClinicalTrials.gov（NCT03514654）。
