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复发性和难治性多发性骨髓瘤患者症状监测数字健康干预措施的适应性与评估:混合方法试点实施研究

Adaptation and Evaluation of a Symptom-Monitoring Digital Health Intervention for Patients With Relapsed and Refractory Multiple Myeloma: Pilot Mixed-Methods Implementation Study.

作者信息

Biran Noa, Anthony Kouyaté Robin, Yucel Emre, McGovern Gillian E, Schoenthaler Antoinette M, Durling Olivia G, Unawane Rashmi, Schutt Andrew, Panjabi Sumeet

机构信息

Division of Multiple Myeloma, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, United States.

Amgen Inc, Thousand Oaks, CA, United States.

出版信息

JMIR Form Res. 2020 Nov 17;4(11):e18982. doi: 10.2196/18982.

Abstract

BACKGROUND

Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM.

OBJECTIVE

Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow.

METHODS

A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods.

RESULTS

A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system.

CONCLUSIONS

Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.

摘要

背景

复发难治性多发性骨髓瘤(RRMM)是一种需要全身治疗的骨髓癌,这通常会导致严重的症状负担。最近的研究发现,在临床环境中实施的电子患者报告结局(ePRO)干预措施对其他肿瘤患者群体产生了积极效果。RRMM患者缺乏类似方法有效性的证据。

目的

最近对数字健康干预措施的建议要求公布迭代开发过程的描述,以提高可重复性和可比性。本研究是一项实施试点,旨在评估RRMM患者对ePRO干预措施的可接受性和适用性,并探讨其对临床工作流程的影响。

方法

从新泽西州哈肯萨克的约翰·图勒癌症中心招募了11名RRMM患者。患者使用移动应用程序在4个疗程中报告17种症状,每个疗程间隔一周。患者也可以临时报告症状。当报告达到预定义阈值时,会向诊所发出警报,患者会收到自动指导。使用定性和定量方法评估研究终点。

结果

共有9名患者(平均年龄69.7岁)完成了研究。总体而言,83%(30/36)的每周疗程完成。患者认为完成报告所需的频率和时间是可以接受的。所有患者都认为该应用程序易于使用和理解。医护人员认为他们收到的警报需要改进。患者和医护人员一致认为,患者报告超过4周会有益处。患者认为他们接受的培训足够,但单次培训包含的信息过多。所有患者都认为跟踪的症状是合适的;医护人员建议缩短列表。所有患者都知道如何使用该应用程序进行每周报告,但对临时使用感到困惑。医护人员认为临时报告功能可以删除。患者和医护人员都没有查看应用程序中的数据报告,但都认可其潜在价值。患者报告称,通过提高对自身症状的认识,从症状报告中受益。诊所工作人员报告称,应用程序警报过多且重复。他们在现有工作流程中难以应对警报,部分原因是数据未集成到电子病历系统中。

结论

总体而言,该干预措施被认为对RRMM患者是可接受的且适用的。确定了将该干预措施整合到临床工作流程中的摩擦点。诊所工作人员提供了解决这些问题的建议。一旦实施此类修改,RRMM患者的ePRO数据可用于为临床研究和护理提供信息并加以改进。本研究强调了采用迭代方法实施的重要性,该方法应包括所有利益相关者,以确保成功采用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b0a8/7709004/285d7fd94d49/formative_v4i11e18982_fig1.jpg

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