Hansson Emma, Löfstrand Jonas, Larsson Camilla, Uusimaki Alexandra, Svensson Karolina, Ekman Anna, Svensson Mikael, Paganini Anna
Department of Plastic Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Region Västra Götaland, Sahlgrenska University Hospital, Department of Plastic and Reconstructive Surgery, Gothenburg, Sweden.
BMJ Open. 2024 Jul 17;14(7):e084025. doi: 10.1136/bmjopen-2024-084025.
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. Randomised controlled trials (RCTs) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The objective of this study is to compare implant-based and autologous breast reconstruction in non-irradiated patients. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction.
The study design partially randomised patient preference trial might be a way to overcome the aforementioned challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose the method. The study is designed as a superiority trial based on the patient-reported questionnaire BREAST-Q and 124 participants will be randomised. In the preference cohort, patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60 months. Embedded qualitative studies and within-trial economic evaluation will be performed. The primary outcome is patient-reported breast-specific quality of life/satisfaction, and the secondary outcomes are complications, factors affecting satisfaction and cost-effectiveness.
The study has been approved by the Swedish Ethical Review Authority (2023-04754-01). Results will be published in peer-reviewed scientific journals and presented at peer-reviewed scientific meetings.
NCT06195865.
尽管乳房重建是乳腺癌治疗的一个重要组成部分，但几乎没有高质量的证据表明哪种方法最有效。随机对照试验（RCT）通常被认为能提供最可靠的科学证据，但在乳房重建中进行RCT存在重大障碍，使得招募患者以及获得无偏倚且具有普遍性的结果都成为挑战。本研究的目的是比较非放疗患者中基于植入物的乳房重建和自体乳房重建。此外，该研究旨在为乳房重建的试验决策提供更多证据。
部分随机化患者偏好试验的研究设计可能是克服上述挑战的一种方法。在本研究中，同意随机分组的患者将被随机分配到基于植入物的乳房重建和自体乳房重建组，而有强烈偏好的患者将能够选择重建方法。该研究设计为基于患者报告问卷BREAST-Q的优效性试验，将随机分配124名参与者。在偏好队列中，将纳入患者，直到62名参与者选择了最不受欢迎的方案。随访时间为60个月。将进行嵌入式定性研究和试验中的经济学评估。主要结局是患者报告的乳房特异性生活质量/满意度，次要结局是并发症、影响满意度的因素和成本效益。
本研究已获得瑞典伦理审查局批准（2023-04754-01）。研究结果将发表在同行评审的科学期刊上，并在同行评审的科学会议上展示。
NCT06195865。
