Savelberg Wilma, Moser Albine, Smidt Marjolein, Boersma Liesbeth, Haekens Christel, van der Weijden Trudy
Oncology Center, Maastricht University Medical Center, Maastricht, The Netherlands.
Zuyd University of Applied Sciences, Heerlen, The Netherlands.
BMJ Open. 2015 Mar 31;5(3):e007698. doi: 10.1136/bmjopen-2015-007698.
The majority of patients diagnosed with early-stage breast cancer are in a position to choose between having a mastectomy or lumpectomy with radiation therapy (breast-conserving therapy). Since the long-term survival rates for mastectomy and for lumpectomy with radiation therapy are comparable, patients' informed preferences are important for decision-making. Although most clinicians believe that they do include patients in the decision-making process, the information that women with breast cancer receive regarding the surgical options is often rather subjective, and does not invite patients to express their preferences. Shared decision-making (SDM) is meant to help patients clarify their preferences, resulting in greater satisfaction with their final choice. Patient decision aids can be very supportive in SDM. We present the protocol of a study to β test a patient decision aid and optimise strategies for the implementation of SDM regarding the treatment of early-stage breast cancer in the actual clinical setting.
METHODS/DESIGN: This paper concerns a pre-implementation and post-implementation study, lasting from October 2014 to June 2015. The intervention consists of implementing SDM using a patient decision aid. The intervention will be evaluated using qualitative and quantitative measures, acquired prior to, during and after the implementation of SDM. Outcome measures are knowledge about treatment, perceived SDM and decisional conflict. We will also conduct face-to-face interviews with a sample of these patients and their care providers, to assess their experiences with the implementation of SDM and the patient decision aid.
This protocol was approved by the Maastricht University Medical Centre (MUMC) ethics committee. The findings will be disseminated through peer-reviewed journal articles and presentations at national conferences. Findings will be used to finalise a multi-faceted implementation strategy to test the implementation of SDM and a patient decision aid in terms of cost-effectiveness, in a multicentre cluster randomised controlled trial (RCT).
NTR4879.
大多数被诊断为早期乳腺癌的患者能够在乳房切除术和保乳手术（放疗）之间做出选择。由于乳房切除术和保乳手术加放疗的长期生存率相当，患者的知情偏好对于决策至关重要。尽管大多数临床医生认为他们确实让患者参与了决策过程，但乳腺癌女性所获得的有关手术选择的信息往往相当主观，且未促使患者表达自己的偏好。共同决策（SDM）旨在帮助患者明确自己的偏好，从而对最终选择更满意。患者决策辅助工具在共同决策中非常有帮助。我们展示一项研究方案，以对患者决策辅助工具进行β测试，并优化在实际临床环境中针对早期乳腺癌治疗实施共同决策的策略。
方法/设计：本文涉及一项实施前和实施后的研究，从2014年10月持续至2015年6月。干预措施包括使用患者决策辅助工具实施共同决策。将通过在共同决策实施之前、期间和之后获取的定性和定量措施对干预进行评估。结果指标包括对治疗的了解、感知到的共同决策和决策冲突。我们还将对这些患者及其护理人员的样本进行面对面访谈，以评估他们在实施共同决策和患者决策辅助工具方面的体验。
本方案已获得马斯特里赫特大学医学中心（MUMC）伦理委员会的批准。研究结果将通过同行评审的期刊文章和在全国会议上的报告进行传播。研究结果将用于确定多方面的实施策略，以便在多中心整群随机对照试验（RCT）中就成本效益测试共同决策和患者决策辅助工具的实施情况。
NTR4879。
