Social Science Research Group, Department of Health Sciences, University of Leicester, Leicester, UK.
Clin Trials. 2010 Dec;7(6):696-704. doi: 10.1177/1740774510381286. Epub 2010 Aug 20.
The randomized controlled trial (RCT) has a well-established role in assessing drug therapies, but its adoption in developing surgical interventions has been slow. Patients' perspectives on surgical RCTs, especially those including a patient preference option, have received little attention.
To characterize participants' experiences and views of recruitment to a pilot trial (CARPET1) of two surgical treatments for urinary incontinence and vaginal prolapse that included a patient preference option.
Semi-structured qualitative interviews with 16 women who participated in the CARPET1 trial. Data analysis was based on the constant comparative method.
Women's experiences of taking part in a patient preference trial.
Women's motives for participating in CARPET1 focused on the possibility of additional care and, as a secondary motive, the wish to help with research. Most participants expressed a treatment preference rather than accepting randomization. Most were pleased with the information they received, and acknowledged the principle of equipoise, but there was substantial variability in their understanding of aspects of the trial, including randomization. Randomization was considered by women to be appropriate only when both treatments were equally suitable and they had no strong preference. Women suggested that the main influence on their willingness to be randomized was the recruiting clinician's opinion. Importantly, despite the recruiting clinicians being heavily involved in conception of CARPET1, they did not seem to be in equipoise at the level of the individual patient.
This being a small study it was not possible to interview women who declined trial participation or to observe consultations between surgeons and patients.
CARPET1 appears to have been more a surgeon preference trial than a patient preference trial. Substantial challenges may remain in conducting RCTs in surgery, particularly where surgeons have preferences about what they perceive as the best option for an individual patient.
随机对照试验（RCT）在评估药物疗法方面具有成熟的作用，但在开发外科干预措施方面的采用速度较慢。患者对外科 RCT 的看法，尤其是那些包含患者偏好选择的 RCT，很少受到关注。
描述参与一项针对尿失禁和阴道脱垂两种外科治疗方法的先导试验（CARPET1）的患者的经验和观点，该试验包含患者偏好选择。
对 16 名参与 CARPET1 试验的女性进行半结构化定性访谈。数据分析基于恒定比较法。
女性参与患者偏好试验的经验。
女性参与 CARPET1 的动机主要集中在获得额外治疗的可能性上，其次是帮助研究的愿望。大多数参与者表达了对治疗的偏好，而不是接受随机分组。大多数人对他们所获得的信息感到满意，并承认了均衡原则，但对试验的各个方面，包括随机分组，理解存在很大差异。女性认为，只有当两种治疗方法都同样适用且她们没有强烈偏好时，随机分组才是合适的。女性表示，她们是否愿意接受随机分组的主要影响因素是招募医生的意见。重要的是，尽管招募医生在 CARPET1 的构思中扮演了重要角色，但他们在个体患者层面上似乎并不处于均衡状态。
这是一项小型研究，因此无法采访拒绝参与试验的女性，也无法观察外科医生和患者之间的咨询情况。
CARPET1 似乎更像是外科医生偏好试验，而不是患者偏好试验。在外科领域进行 RCT 可能仍然存在重大挑战，特别是当外科医生对他们认为是针对个别患者最佳选择的方案存在偏好时。
