Zheng Miao, Yin Changlin, Cao Ying, Zhang Yonghui, Zhang Kuoliang, Zhang Xiaoqin, Bian Wei, Wang Lihua
Graduate School, Guizhou University of Traditional Chinese Medicine, Guiyang City, Guizhou Province, China.
Department of Critical Care Medicine, Southwest Hospital of Third Military Medical University (Amy Medical University), Chongqing, China.
BMJ Open. 2021 Feb 12;11(2):e043385. doi: 10.1136/bmjopen-2020-043385.
Shared decision making is endorsed by guidelines for both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially those focusing on decisions about renal replacement therapy for intensive care unit (ICU) patients with acute kidney injury. The decision aids provide evidence-based support for shared decision making, to achieve better decisions through enhanced knowledge of treatment options and treatment aligns with patients' preferences and values. Therefore, our objectives are to develop and evaluate a decision aid systematically and rigorously for family surrogate decision makers of ICU patients with acute kidney injury who need renal replacement therapy.
We will use a systematic development process that focuses on user-centred design to develop and evaluate the decision aid in three phases: (1) development of a draft prototype for the decision aid based on extensive literature reviews, interviews with key stakeholders and evidence synthesis; (2) alpha testing ('near live' usability) the decision aid during simulated clinical encounters to test its comprehensibility, acceptability and usability and (3) beta testing ('live' usability) to examine the aid's clinical feasibility. User testing will be conducted using mixed-methods approach to support iterative revision of the decision aid. The IPDASi (V.4.0) will be used for following qualitative assessment. All interviews will be analysed by Colaizzi's seven-step approach to qualitative analysis. The coding scheme will use to analyse user interactions. Questionnaire surveys will be analysed using paired sample t-tests when related to the before-and-after survey, otherwise using one-sample t-test.
Ethical approval for this research was obtained from the Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA (Ref: KY2020104). All participants will sign a formal informed consent form. The findings will be published in peer-reviewed journals and reported in appropriate meetings.
ChiCTR2000031613.
共同决策得到了急性肾损伤和重症医学指南的认可。然而，对于有效的干预措施仍有巨大需求，尤其是针对重症监护病房（ICU）急性肾损伤患者的肾脏替代治疗决策的干预措施。决策辅助工具为共同决策提供基于证据的支持，通过增强对治疗选择的了解来做出更好的决策，并且使治疗符合患者的偏好和价值观。因此，我们的目标是为需要肾脏替代治疗的ICU急性肾损伤患者的家庭替代决策者系统且严格地开发和评估一种决策辅助工具。
我们将采用以用户为中心设计的系统开发过程，分三个阶段开发和评估决策辅助工具：（1）基于广泛的文献综述、与关键利益相关者的访谈以及证据综合，开发决策辅助工具的草案原型；（2）在模拟临床会诊期间对决策辅助工具进行α测试（“接近真实”的可用性测试），以测试其可理解性、可接受性和可用性；（3）进行β测试（“真实”可用性测试）以检验该辅助工具的临床可行性。将使用混合方法进行用户测试，以支持对决策辅助工具的迭代修订。将使用IPDASi（V.4.0）进行以下定性评估。所有访谈将采用科莱齐的七步定性分析方法进行分析。编码方案将用于分析用户交互。问卷调查在与前后调查相关时将使用配对样本t检验进行分析，否则使用单样本t检验。
本研究已获得中国人民解放军陆军军医大学第一附属医院伦理委员会的伦理批准（编号：KY2020104）。所有参与者将签署正式的知情同意书。研究结果将发表在同行评审期刊上，并在适当的会议上报告。
ChiCTR2000031613。
