Levine M N, Gafni A, Markham B, MacFarlane D
Hamilton Regional Cancer Centre, Ontario, Canada.
Ann Intern Med. 1992 Jul 1;117(1):53-8. doi: 10.7326/0003-4819-117-1-53.
The objective of this study was to develop an instrument to help clinicians inform patients with breast cancer of risks and benefits of adjuvant chemotherapy as derived from clinical trials and to help the informed patient decide whether she prefers treatment or no treatment. The instrument consists of a visual aid (called the decision board) and written material. It provides detailed information on a patient's choices (chemotherapy or no chemotherapy), outcomes (recurrence or not), probabilities of outcomes and their meaning, and quality of life associated with treatment choice and outcome. The validity and reliability of the instrument were evaluated in 30 healthy female volunteers. It was first administered using standard estimates of recurrence for node-negative breast cancer (15% risk of recurrence without treatment, which is reduced to 10% with chemotherapy). A preference for treatment (or no treatment) was then elicited. The validity was evaluated by changing the information provided on risks and benefits and determining whether the preference changed in a predictable manner. To test for reliability, the instrument was administered 2 weeks later. Seventeen women chose chemotherapy and 13 chose no chemotherapy. In the former group, 14 women (82%) switched preference when the magnitude of benefit was reduced, and 16 (94%) switched when the toxicity of treatment was increased. For those women who chose not to receive chemotherapy, 12 (92%) switched when the benefit was increased and 100% switched when toxicity was eliminated. The reliability was excellent (kappa = 0.86). The instrument has been used to elicit treatment preferences in 37 newly presenting patients with high-risk, node-negative breast cancer and has been found to be acceptable and helpful to the patient.
本研究的目的是开发一种工具，以帮助临床医生告知乳腺癌患者辅助化疗的风险和益处（这些风险和益处源自临床试验），并帮助已充分了解信息的患者决定她是倾向于接受治疗还是不接受治疗。该工具由一种视觉辅助工具（称为决策板）和书面材料组成。它提供了有关患者选择（化疗或不化疗）、结果（复发或不复发）、结果的概率及其含义，以及与治疗选择和结果相关的生活质量的详细信息。该工具的有效性和可靠性在30名健康女性志愿者中进行了评估。首先使用淋巴结阴性乳腺癌复发的标准估计值进行管理（不治疗时复发风险为15%，化疗后降至10%）。然后引出对治疗（或不治疗）的偏好。通过改变提供的风险和益处信息并确定偏好是否以可预测的方式改变来评估有效性。为了测试可靠性，两周后再次使用该工具。17名女性选择化疗，13名选择不化疗。在前一组中，当益处程度降低时，14名女性（82%）改变了偏好，当治疗毒性增加时，16名（94%）改变了偏好。对于那些选择不接受化疗的女性，当益处增加时，12名（92%）改变了偏好，当毒性消除时，100%改变了偏好。可靠性极佳（kappa = 0.86）。该工具已用于引出37名新诊断的高危、淋巴结阴性乳腺癌患者的治疗偏好，并且已发现该工具对患者是可接受且有帮助的。
