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评估临床试验中抑郁症数字干预措施的患者依从性和参与度:系统文献回顾。

Assessing Patient Adherence to and Engagement With Digital Interventions for Depression in Clinical Trials: Systematic Literature Review.

机构信息

Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, NJ, United States.

Oxford PharmaGenesis Inc, Newtown, PA, United States.

出版信息

J Med Internet Res. 2023 Aug 11;25:e43727. doi: 10.2196/43727.

Abstract

BACKGROUND

New approaches to the treatment of depression are necessary for patients who do not respond to current treatments or lack access to them because of barriers such as cost, stigma, and provider shortage. Digital interventions for depression are promising; however, low patient engagement could limit their effectiveness.

OBJECTIVE

This systematic literature review (SLR) assessed how participant adherence to and engagement with digital interventions for depression have been measured in the published literature, what levels of adherence and engagement have been reported, and whether higher adherence and increased engagement are linked to increased efficacy.

METHODS

We focused on a participant population of adults (aged ≥18 years) with depression or major depressive disorder as the primary diagnosis and included clinical trials, feasibility studies, and pilot studies of digital interventions for treating depression, such as digital therapeutics. We screened 756 unique records from Ovid MEDLINE, Embase, and Cochrane published between January 1, 2000, and April 15, 2022; extracted data from and appraised the 94 studies meeting the inclusion criteria; and performed a primarily descriptive analysis. Otsuka Pharmaceutical Development & Commercialization, Inc (Princeton, New Jersey, United States) funded this study.

RESULTS

This SLR encompassed results from 20,111 participants in studies using 47 unique web-based interventions (an additional 10 web-based interventions were not described by name), 15 mobile app interventions, 5 app-based interventions that are also accessible via the web, and 1 CD-ROM. Adherence was most often measured as the percentage of participants who completed all available modules. Less than half (44.2%) of the participants completed all the modules; however, the average dose received was 60.7% of the available modules. Although engagement with digital interventions was measured differently in different studies, it was most commonly measured as the number of modules completed, the mean of which was 6.4 (means ranged from 1.0 to 19.7) modules. The mean amount of time participants engaged with the interventions was 3.9 (means ranged from 0.7 to 8.4) hours. Most studies of web-based (34/45, 76%) and app-based (8/9, 89%) interventions found that the intervention group had substantially greater improvement for at least 1 outcome than the control group (eg, care as usual, waitlist, or active control). Of the 14 studies that investigated the relationship between engagement and efficacy, 9 (64%) found that increased engagement with digital interventions was significantly associated with improved participant outcomes. The limitations of this SLR include publication bias, which may overstate engagement and efficacy, and low participant diversity, which reduces the generalizability.

CONCLUSIONS

Patient adherence to and engagement with digital interventions for depression have been reported in the literature using various metrics. Arriving at more standardized ways of reporting adherence and engagement would enable more effective comparisons across different digital interventions, studies, and populations.

摘要

背景

对于那些对现有治疗方法无反应或由于成本、污名化和提供者短缺等障碍而无法获得这些治疗方法的患者,需要新的抑郁症治疗方法。针对抑郁症的数字干预措施很有前途,但患者参与度低可能会限制其效果。

目的

本系统文献综述(SLR)评估了已发表文献中如何衡量数字干预措施对抑郁症的患者依从性和参与度,报告了哪些水平的依从性和参与度,以及更高的依从性和增加的参与度是否与疗效的提高有关。

方法

我们专注于一个成年患者(年龄≥18 岁)人群,他们患有抑郁症或主要抑郁症,作为主要诊断,并包括治疗抑郁症的数字干预措施的临床试验、可行性研究和试点研究,如数字疗法。我们从 Ovid MEDLINE、Embase 和 Cochrane 中筛选了 756 条 2000 年 1 月 1 日至 2022 年 4 月 15 日之间发表的独特记录;从符合纳入标准的 94 项研究中提取数据并进行评估;并进行了主要描述性分析。大冢制药开发与商业化公司(美国新泽西州普林斯顿)资助了这项研究。

结果

这项 SLR 涵盖了来自 20111 名参与者的结果,这些参与者参与了 47 项不同的基于网络的干预措施(另外 10 项基于网络的干预措施没有名称描述)、15 项移动应用程序干预措施、5 项可通过网络访问的基于应用程序的干预措施和 1 项 CD-ROM。依从性最常被测量为完成所有可用模块的参与者百分比。不到一半(44.2%)的参与者完成了所有模块;然而,平均接受的剂量是可用模块的 60.7%。尽管不同研究中对数字干预措施的参与度的测量方式不同,但最常见的是测量完成的模块数量,平均值为 6.4(平均值范围为 1.0 至 19.7)个模块。参与者与干预措施互动的平均时间为 3.9(平均值范围为 0.7 至 8.4)小时。大多数基于网络(34/45,76%)和基于应用程序(8/9,89%)的干预措施研究发现,干预组的至少 1 项结果明显优于对照组(例如,常规护理、候补名单或活性对照)。在 14 项研究中,有 9 项(64%)研究调查了参与度与疗效之间的关系,发现数字干预措施的参与度增加与参与者的结果改善显著相关。本 SLR 的局限性包括发表偏倚,这可能会夸大参与度和疗效,以及参与者多样性低,这降低了普遍性。

结论

文献中使用各种指标报告了抑郁症数字干预措施的患者依从性和参与度。采用更标准化的报告依从性和参与度的方法将能够更有效地比较不同的数字干预措施、研究和人群。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0aa6/10457707/fea60101875c/jmir_v25i1e43727_fig1.jpg

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