Fogarty Justin, Siriruchatanon Mutita, Makarov Danil, Langford Aisha, Kang Stella
Department of Radiology, New York University Grossman School of Medicine, New York, NY, United States.
Department of Urology, New York University Grossman School of Medicine, New York, NY, United States.
JMIR Res Protoc. 2022 Sep 2;11(9):e41451. doi: 10.2196/41451.
Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences.
This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions.
Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material.
This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022.
A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs.
ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/41451.
手术是治疗直径达4厘米的局限性小肾肿块（SKM）最常见的方法，尽管缺乏证据表明其能提高总体生存率。随着证据支持大多数SKM生长缓慢，非手术治疗方案越来越受到认可。决策辅助工具（DA）已被证明可提高患者对治疗方案权衡的理解以及总体决策质量，并可能促使患者根据个人健康优先事项和偏好对所有主要方案进行考量。
这项初步随机对照试验（RCT）主要旨在评估一种新的基于网络的DA对SKM患者治疗决策的影响，即手术与非手术治疗方案的选择。次要目标包括评估决策结果：决策冲突、决策满意度，以及对纳入手术与非手术干预权衡因素的个体治疗偏好的理解。
三个阶段构成了一个关于SKM治疗的新的基于网络的DA的构建和评估过程。在第1阶段，通过一个纳入患者焦点小组的多学科设计委员会，以印刷形式开发了该DA。第2阶段是一项观察性研究，在随机分组接受印刷版DA或机构教育材料后，对患者知识和决策措施进行评估，该研究确定了应用于基于网络的DA的进一步教育需求。第3阶段将初步评估基于网络的DA：在一项初步RCT中，50名被诊断为SKM的成年人将在一家大型学术医疗中心的泌尿外科诊所接受基于网络的DA或现有的基于网络的机构网站。基于网络的DA应用风险沟通以及关于诊断和治疗方案的信息，引出对治疗方案的偏好，并根据考虑合并症、年龄组和肿瘤特征的获益/危害分析的决策分析模型，提供一组与医生共同考虑的选项。在查看教育材料前后将收集问卷和治疗决策数据。
此阶段将包括一项从2022年8月至2023年1月的初步RCT，以确定可行性并初步评估决策结果。2018年至2020年的先前研究阶段支持了在临床咨询前在泌尿外科诊所提供印刷版DA的可行性，并表明患者在咨询前对诊断和治疗方案的了解增加，且更倾向于非手术治疗。本研究由美国国立癌症研究所资助。招募将于2022年8月开始。
已设计出一种基于网络的DA，以满足为SKM做出治疗决策的患者的教育需求，并考虑合并症以及与治疗相关的获益和风险。初步试验的结果将评估基于网络的DA在个性化治疗决策以及帮助患者权衡其SKM的手术与非手术治疗方案属性方面的潜力。
ClinicalTrials.gov NCT05387863；https://clinicaltrials.gov/ct2/show/NCT05387863。
国际注册报告标识符（IRRID）：PRR1-10.2196/41451。
