评估共决策干预对肾细胞癌患者的影响：SDM-RCC研究方案
Evaluating the Impact of a Shared Decision-making Intervention for Patients with Renal Cell Carcinoma: The SDM-RCC Study Protocol
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影响因子:9.3
分区:医学1区 Top / 泌尿学与肾脏学1区 肿瘤学2区
发表日期:2025 Apr
作者:
Cato C Bresser, Mirjam M Garvelink, Birgitta M M van den Berg, Franklin C K Dolk, Paul B van der Nat, Harm H E van Melick
DOI:
10.1016/j.euo.2024.09.003
摘要
本研究旨在评估针对肾细胞癌（RCC）患者的综合性共决策（SDM）干预措施对决策过程和结果的影响。该干预包括在线患者决策辅助（PtDAs）和对医护人员（HCPs）使用PtDAs及SDM的培训。研究在荷兰六家医院进行，是一项多中心、前瞻性、前后对照队列研究，针对局部或转移性RCC患者。主要结局指标为通过OPTION-5评分衡量的决策过程的质量。次要指标包括感知的决策质量、决策的实现情况及干预的应用情况（用户统计和访谈）。采用问卷数据进行定量分析，访谈则基于既定框架进行编码以进行定性分析。研究结果有望加深对RCC患者决策过程的理解，从患者、医护人员和观察者角度评估。预期所采用的SDM工具能支持患者的决策过程。患者摘要：我们正在进行一项关于支持肾癌患者共同决策的工具效果的试验。本文介绍了该试验的方案。
Abstract
The aim of the SDM-RCC study is to evaluate the impact of a comprehensive shared decision-making (SDM) intervention for patients with renal cell carcinoma (RCC) on the decision-making process and outcomes. The intervention includes online patient decision aids (PtDAs) and training of health care professionals (HCPs) in the use of PtDAs and SDM. The study is a multicenter, prospective pretest-posttest cohort in six Dutch hospitals, focusing on patients with localized or metastatic RCC. The primary outcome is the observed quality of the decision-making process, measured using OPTION-5 scores. Secondary outcomes include perceived quality of the decision-making process, decision quality, and implementation of the intervention (user statistics and interviews). Quantitative analysis will be performed on questionnaire data, while qualitative analysis will be performed on interviews using coding based on established frameworks. The study results could improve understanding of the decision-making process for RCC patients from patient, HCP, and observer perspectives. The SDM tool implemented is expected to support the decision-making process. PATIENT SUMMARY: We are conducting a trial on the effects of a tool to support shared decision-making by patients with kidney cancer who are facing treatment decisions. This paper outlines the protocol that will be used for the trial.