Laryionava Katsiaryna, Mehlis Katja, Bierwirth Elena, Mumm Friederike, Hiddemann Wolfgang, Heußner Pia, Winkler Eva C
National Center for Tumor Diseases, Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Interdisciplinary Center of Psycho-Oncology, University Hospital Grosshadern, Ludwig-Maximilians University, Munich, Germany.
JMIR Res Protoc. 2018 Jun 15;7(6):e157. doi: 10.2196/resprot.9698.
Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment.
The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of-life decisions and to evaluate the impact of this guideline on clinical practice regarding the following target goals: reduction of decisional conflicts, improvement of documentation transparency and traceability, reduction of distress of the caregiver team, and better knowledge and consideration of patients' preferences.
This is a protocol for a pre-post interventional study that analyzes the clinical practice on treatment limitation before and after the guideline implementation. An embedded researcher design with a mixed-method approach encompassing both qualitative and quantitative methods is used. The study consists of three stages: (1) the preinterventional phase, (2) the intervention (development and implementation of the guideline), and 3) the postinterventional phase (evaluation of the guideline's impact on clinical practice). We evaluate the process of decision-making related to limiting treatment from different perspectives of oncologists, nurses, and patients; comparing them to each other will allow us to develop the guideline based on the interests of all parties.
The first preintervention data of the project have already been published, which detailed a qualitative study with oncologists and oncology nurses (n=29), where different approaches to initiation of end-of-life discussions were ethically weighted. A framework for oncologists was elaborated, and the study favored an anticipatory approach of preparing patients for forgoing therapy throughout the course of disease. Another preimplementational study of current decision-making practice (n=567 patients documented) demonstrated that decisions to limit treatment preceded the death of many cancer patients (62/76, 82% of deceased patients). However, such decisions were usually made in the last week of life, which was relatively late.
The intervention will be evaluated with respect to the following endpoints: better knowledge and consideration of patients' treatment wishes; reduction of decisional conflicts; improvement of documentation transparency and traceability; and reduction of the psychological and moral distress of a caregiver team.
RR1-10.2196/9698.
许多晚期癌症患者在临近死亡时接受化疗，转诊至姑息治疗或临终关怀机构的时间过晚，因此在治疗过程中或重症监护病房死亡。肿瘤学家在让患者适当参与关于限制肿瘤特异性治疗或延长生命治疗的决策方面仍存在困难。
《晚期护理计划与限制治疗研究的伦理政策》的目的是制定临终决策的伦理指南，并评估该指南对临床实践的影响，具体涉及以下目标：减少决策冲突、提高文件记录的透明度和可追溯性、减轻护理团队的痛苦，以及更好地了解和考虑患者的偏好。
这是一项前后对照干预研究的方案，分析指南实施前后治疗限制方面的临床实践。采用嵌入式研究设计，结合定性和定量的混合方法。该研究包括三个阶段：（1）干预前阶段，（2）干预阶段（指南的制定和实施），以及（3）干预后阶段（评估指南对临床实践的影响）。我们从肿瘤学家、护士和患者的不同角度评估与限制治疗相关的决策过程；相互比较将使我们能够根据各方利益制定指南。
该项目的首批干预前数据已经发表，其中详细介绍了一项针对肿瘤学家和肿瘤护士（n = 29）的定性研究，对启动临终讨论的不同方法进行了伦理权衡。为肿瘤学家制定了一个框架，该研究支持在疾病全过程中让患者为放弃治疗做好准备的前瞻性方法。另一项关于当前决策实践的实施前研究（记录了n = 567例患者）表明，许多癌症患者在死亡前就做出了限制治疗的决定（62/76，82%的已故患者）。然而，此类决定通常在生命的最后一周做出，相对较晚。
将根据以下终点评估干预措施：更好地了解和考虑患者的治疗意愿；减少决策冲突；提高文件记录的透明度和可追溯性；以及减轻护理团队的心理和道德痛苦。
RR1-10.2196/9698
