Department of Haematology and Medical Oncology, University Medical Centre, Robert-Koch-Str. 40, Goettingen, Germany.
Department of Medical Statistics, University Medical Centre, Von-Siebold-Str. 3, Goettingen, Germany.
BMC Palliat Care. 2022 Sep 28;21(1):167. doi: 10.1186/s12904-022-01057-5.
The advance directive represents patients' health care choices and fosters patients' autonomy. Nevertheless, understanding patients' wishes based on the information provided in advance directives remains a challenge for health care providers. Based on the ethical premises of positive obligation to autonomy, an advanced directive that is disease-centred and details potential problems and complications of the disease should help health care providers correctly understand patients' wishes. To test this hypothesis, a pilot-study was conducted to investigate whether physicians could make the correct end-of-life decision for their patients when patients used a disease-centred advance directive compared to a common advance directive. MATERIAL AND METHODS: A randomised, controlled, prospective pilot study was designed that included patients with non-small cell lung cancer (NSCLC) stage VI from the Department of Haematology and Medical Oncology, University Medical Centre, Goettingen. Patients were randomised into intervention and control groups. The control group received a common advance directive, and the intervention group received a disease-centred advance directive. Both groups filled out their advance directives and returned them. Subsequently, patients were asked to complete nine medical scenarios with different treatment decisions. For each scenario the patients had to decide whether they wanted to receive treatment on a 5-point Likert scale. Four physicians were given the same scenarios and asked to decide on the treatment according to the patients' wishes as stated in their advance directives. The answers by patients and physicians were then compared to establish whether physicians had made the correct assumptions.
Recruitment was stopped prior to reaching anticipated sample target. 15 patients with stage IV NSCLC completed the study, 9 patients were randomised into the control group and 6 patients in the intervention group. A total of 135 decisions were evaluated. The concordance between physicians' and patients' answers, was 0.83 (95%-CI 0.71-0.91) in the intervention group, compared to 0.60 (95%-CI 0.48-0.70) in the control group, and the difference between the two groups was statistically significant (p = 0.005).
This pilot study shows that disease-centred advance directives help physicians understand their NSCLC patients' wishes more precisely and make treatment choices according to these wishes.
The study is registered at the German Clinical Trial Register (no. DRKS00017580, registration date 27/08/2019).
预立医疗指示代表了患者的医疗保健选择，促进了患者的自主权。然而，基于预立医疗指示提供的信息理解患者的意愿仍然是医疗保健提供者面临的挑战。基于积极自主义务的伦理前提，以疾病为中心并详细说明疾病潜在问题和并发症的预立医疗指示应该有助于医疗保健提供者正确理解患者的意愿。为了验证这一假设，进行了一项试点研究，以调查与使用常见预立医疗指示相比，当患者使用以疾病为中心的预立医疗指示时，医生是否能够为其患者做出正确的临终决策。
设计了一项随机、对照、前瞻性试点研究，纳入了来自哥廷根大学医学中心血液学和肿瘤医学系的非小细胞肺癌（NSCLC）IV 期患者。患者被随机分为干预组和对照组。对照组接受常见的预立医疗指示，干预组接受以疾病为中心的预立医疗指示。两组都填写了他们的预立医疗指示并交回。随后，患者被要求完成九个具有不同治疗决策的医疗场景。对于每个场景，患者都必须在 5 点李克特量表上决定是否接受治疗。四名医生获得了相同的场景，并根据患者在预立医疗指示中表达的意愿决定治疗。然后将患者和医生的答案进行比较，以确定医生是否做出了正确的假设。
在达到预期的样本目标之前，招募被停止。15 名 IV 期 NSCLC 患者完成了研究，9 名患者被随机分配到对照组，6 名患者被分配到干预组。共评估了 135 个决策。干预组中医生和患者答案的一致性为 0.83（95%CI 0.71-0.91），对照组为 0.60（95%CI 0.48-0.70），两组之间的差异具有统计学意义（p=0.005）。
这项试点研究表明，以疾病为中心的预立医疗指示有助于医生更准确地理解非小细胞肺癌患者的意愿，并根据这些意愿做出治疗选择。
该研究在德国临床试验注册处注册（注册号：DRKS00017580，注册日期：2019 年 8 月 27 日）。
